Abstract
The pharmacist’s role in medication reconciliation and patient counseling upon discharge from the orthopedic surgery department remains uncertain. The aim of this study was to assess the impact of a pharmacist-led medication reconciliation and patient counseling upon discharge from the orthopedic surgery department on the number of unintended medication discrepancies. This was a prospective, single-center, open-label, randomized controlled trial conducted over a 7-month period at a university medical center. The study included adult patients discharged from the orthopedic surgery department with at least one discharge medication. In the control arm, patients received the standard of care, while in the intervention arm, they received the standard of care in addition to incorporating a service provided by the pharmacy resident at discharge that consisted of performing medication reconciliation, providing patient counseling, then conducting telephone follow-up at day 3 post-discharge. The primary endpoint was the number of unintended discrepancies identified on day 30 post-discharge. Descriptive statistics were used to report all participants’ responses. Pearson χ2 test or Fisher’s exact test, where the expected cell count < 5, were used to report the association between categorical variables. Results were assumed to be significant when p < 0.05 for all statistical analyses. The study included a total of 178 patients. For the primary endpoint on day 30 post-discharge, a total of 40 unintended discrepancies were identified in 29 (16.3%) patients. Around 28% of patients in the control group had a least one unintended medication discrepancy, compared to 4.5% patients in the intervention group (p < 0.001). The most common discrepancies consisted of medication commission (35%). Some unintended discrepancies were classified as potentially serious (10%). Pharmacist-led medication reconciliation upon discharge from the orthopedic surgery department was associated with a significant reduction in the number of unintended medication discrepancies.
Subject terms: Diseases, Health care, Medical research
Introduction
Medication errors during transitions of care remain a significant patient safety concern, particularly in surgical settings where medication regimens are frequently modified. In orthopedic populations, 88.9% of inpatients were reported to experience at least one medication error upon admission, with a median of six errors per patient1; 8.1% experienced adverse events, including moderate-consequence events. Similarly, medication ordering errors were identified in 62% of orthopedic prescriptions, with 43% carrying moderate-to-high harm potential2. More broadly, discharge-related medication discrepancies have been observed in 41% of patients3, while other reports indicate that up to 53.4% of patients have potential medication errors prior to pharmacist intervention before discharge from the internal medicine units4. Importantly, discharge medication errors have been associated with hospital readmissions and increased healthcare costs5. Economically, preventable adverse drug events have been estimated to cost approximately 472 U.S. dollars per patient, further underscoring the cost-effectiveness of pharmacist-led medication reconciliation6. These data demonstrate medication errors are a substantial, preventable burden in orthopedic care transitions.
In fact, and according to ASHP, perioperative pharmacists play a key role in prescription services, patient counseling, and medication reconciliation at discharge, helping ensure the accuracy of discharge medications through early intervention and coordination7. Surgical patients often use chronic medications unrelated to their procedure, requiring careful perioperative management to avoid withdrawal, disease exacerbation, or increased surgical risk. Timely reintroduction of regular medications in the postoperative period may reduce morbidity and mortality8. In this context, medication reconciliation conducted for elderly patients admitted to an orthopedic surgery unit – following establishment of the best possible medication history – revealed that 75% of patients had at least one unintended discrepancy9. Furthermore, pharmacist recommendations were shown to play a substantial role in resolving most identified medication-related problems and significantly improving the efficacy and safety of medications in general surgery patients10.
According to the Lebanese Ministry of Public Health (MOPH), medication reconciliation should be performed during hospital admission and discharge to avoid potential errors11. However, only 40.7% of the Lebanese hospitals provide pharmacy services dedicated to performing medication reconciliation12. Currently, pharmacy services are not integrated into the orthopedic surgery departments of Lebanese hospitals. A study conducted in 2019 demonstrated that pharmacy-led medication reconciliation upon admission to orthopedic surgery department of a university medical center in Lebanon improves medication safety and decreases reconciliation errors13.
To date, no studies have examined the impact of pharmacist services on patient outcomes at discharge from orthopedic surgery departments in Lebanon, where pharmacists in hospital settings are not formally designated to perform medication reconciliation. The primary objective of this study is to assess the impact of a pharmacist-led medication reconciliation and patient counseling upon discharge from the orthopedic surgery department on the number of unintended medication discrepancies post-discharge.
Methods
Study design, setting, and participants
This was a prospective, single-center, open-label, randomized controlled trial conducted over a 7-month period between October 2022 and April 2023 in the orthopedic surgery department of a 140-bed tertiary care teaching hospital, the Lebanese American University Medical Center – Rizk Hospital (LAUMC-RH) in Beirut, Lebanon. The project was approved by the LAU Institutional Review Board (IRB) prior to the initiation of the data collection process (IRB approval number: LAU.SOP.ER1.14/Sep/2022). Accordingly, all study participants were requested to sign a written informed consent form before their inclusion in the study, to respect their autonomy and anonymity.
The study included adult patients (≥ 18 years) discharged from the orthopedic surgery department with at least one discharge medication. Participants were excluded if they were previously enrolled in another study, transferred to another hospital, or transferred to a unit other than surgery within the hospital.
Patient recruitment and intervention
A postgraduate year 1 (PGY1) pharmacy resident coordinated with the clinical coordinator of the orthopedic surgery department to identify patients planned for discharge from the service on a daily basis. Eligible patients were approached for consent by the pharmacy resident or a medical student. Patients who consented to participate in the study were randomly assigned in a 1:1 ratio to either the control arm or the intervention arm using block randomization with a block size of 4. Allocation concealment was not formally implemented.
In the control arm, patients received the standard of care as per hospital policy, in which nurses and/or physicians performed medication reconciliation at admission and discharge, followed by counseling to ensure proper post-discharge medication use. However, a structured pharmacist-led final medication review immediately prior to discharge was not a standardized component of usual care during the study period.
In the intervention arm, patients received the standard of care, in addition to a multicomponent pharmacist-led discharge intervention provided by the pharmacy resident. This included a detailed patient/caregiver interview, inspection of home medications brought by the patient when available, verification of appropriate resumption of chronic therapy after surgery, comparison of the physician-prescribed discharge medications with the medication reconciliation and discharge forms, discharge counseling by the pharmacy resident, and telephone follow-up on day 3 post-discharge.
All patients received a follow-up telephone call by the pharmacy resident at day 30 post-discharge to record the study endpoints. Data collected for all patients upon hospital discharge included patient demographics, past medical history, home medications full regimen, newly prescribed medications, level of education, and health literacy.
Study endpoints
The primary endpoint was the number of unintended medication discrepancies at day 30 post-discharge. An unintended medication discrepancy was defined as any omission of a medication or any change in the drug, dose, frequency, duration, or route of administration that was not explained by the current care plan, the patient’s clinical status, or substitution due to shortage. The potential severity of each discrepancy was classified using a validated scale, stratifying severity into four levels (1 = clinically insignificant, 2 = clinically significant, 3 = serious, and 4 = life-threatening)14. A clinically insignificant medication discrepancy refers to a discrepancy that would not likely cause harm; a clinically significant discrepancy has the potential to cause harm, and may require increased monitoring; a serious discrepancy has the potential to cause harm and likely to require additional intervention or could result in prolonged hospital length of stay; and a life-threatening discrepancy has the potential to cause death or likely lead to death15. Discrepancies were reviewed and classified by a panel of investigators, and final classification was based on consensus.
The secondary outcomes consisted of a composite endpoint of unplanned physician contact, emergency department (ED) visit, and hospital readmission; the individual components of the composite endpoint; occurrence of adverse drug events; and patient satisfaction. Patient satisfaction was assessed using selected questions from the Hospital Consumer Assessment of Healthcare Providers and Systems “HCAHPS” survey, adapted for the Lebanese population and health system16.
Statistical analysis
The collected data were coded, entered into SPSS version 29, verified for data entry errors, and analyzed. Descriptive statistics were used to report all participants’ responses. Continuous variables were presented as means and standard deviations and were compared between groups using the independent-samples t test. Categorical variables were presented as frequencies and percentages and were compared using the Pearson chi-square test or Fisher’s exact test, as appropriate when expected cell counts were < 5. Exact test statistics were reported where appropriate, in addition to p values. Results were assumed to be significant when p < 0.05 for all statistical analyses. The results were analyzed as per the intention-to-treat analysis. No formal a priori sample size or power calculation was performed. Given the baseline imbalance in selected health literacy-related variables, adjusted sensitivity analyses were performed using binary logistic regression, with the presence of at least one unintended medication discrepancy at day 30 as the dependent variable and study group assignment together with selected baseline health literacy-related variables as covariates.
Ethics
The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. Before initiation of the data collection, the investigators secured the approval of the Lebanese American University Institutional Review Board (IRB). (IRB approval number: LAU.SOP.ER1.14/Sep/2022). The authors also registered the study in the Lebanese Clinical Trials Registry (LBCTR) under registration number LBCTR2023125487 with a registration date in the national regulatory agency of 14/09/2022. The purpose of the study was elucidated and written consent was obtained before the participants were interviewed, respecting their autonomy and anonymity.
Results
Patient characteristics
The study included 178 patients with a mean age of 53 years. Most patients (70.2%) were admitted for elective orthopedic surgeries, and 40% had no chronic medical condition. The most commonly reported chronic diseases were hypertension (36%), dyslipidemia (27%), and diabetes (19%). Around 28% of the patients were on polypharmacy taking at least five medications at home. The baseline characteristics were balanced between the two groups except for health literacy-related questions and the admission diagnosis/surgery. More patients in the control group reported always having someone help them read hospital materials (39.3% versus 25.8%, p = 0.020), and always having problems learning about their medical condition because of difficulty understanding written information (29.2% vs. 25.8%, p < 0.001). However, more patients in the intervention group were extremely confident in understanding the indication, proper use, and side effects of the prescribed medication (67.4% versus 31.5%, p < 0.001). Figure 1 shows the patient enrollment flow diagram and Table 1 details the baseline characteristics of the study participants.
Fig. 1.
Patient enrollment flow diagram.
Table 1.
Baseline characteristics.
| Variable | Control group n = 89 |
Intervention group n = 89 |
P-value |
|---|---|---|---|
| Age – year (SD) | 53.73 (20.15) | 53.61 (20.65) | 0.968 |
| Male sex - n (%) | 45 (50.6) | 36 (40.4) | 0.228 |
| Allergies - n (%) | 17 (19.1) | 15 (16.9) | 0.846 |
| Type of surgery | 1.000 | ||
|
Elective Emergency |
62 (69.7) 27 (30.3) |
63 (70.8) 26 (29.2) |
|
| Admission diagnosis / surgery– n (%) | < 0.001 | ||
|
ACL reconstruction Fracture Hallux valgus Total knee replacement Tendon rupture Discectomy Tumor excision Missing |
21 (23.6) 13(14.6) 4 (4.5) 4 (4.5) 2 (2.2) 1 (1.1) 1 (1.1) 32 (36) |
22 (25.6) 24 (27.9) 9 (8.1) 9 (10.5) 2 (2.3) 2 (2.3) 2 (2.3) 0 |
|
| Level of education | 0.665 | ||
|
Did not complete high school High school degree Bachelor degree Postgraduate degree |
22 (29.3) 17 (22.7) 27 (36.0) 9 (12.0) |
18 (25.4) 12 (16.9) 32 (45.1) 9 (12.7) |
|
| Number of chronic medical conditions | 0.441 | ||
|
0 1 2 3 4 ≥5 |
35 (39.3) 17 (19.1) 12 (13.5) 15 (16.9) 7 (7.9) 3 (3.4) |
37 (42.0) 22 (25.0) 15 (17.0) 8 (9.1) 4 (4.5) 2 (2.3) |
|
| Chronic medical conditions | |||
|
Hypertension Dyslipidemia Diabetes Arrhythmias Hypothyroidism CVD GERD Apnea Cancer Asthma Anemia |
33 (37.1) 28 (33.3) 16 (18.0) 9 (10.1) 8 (9.0) 5 (5.6) 4 (4.5) 3 (3.4) 2 (2.3) 1 (1.1) 1 (1.1) |
31 (34.8) 18 (21.4) 17 (19.5) 5 (5.7) 5 (5.7) 4 (4.6) 2 (2.3) 1 (1.1) 2 (2.3) 2 (2.3) 2 (2.3) |
0.876 0.119 0.848 0.404 0.566 1.000 0.682 0.621 0.616 0.619 1.000 |
| Number of home medications | 0.068 | ||
|
0 1 2 3 4 ≥5 |
31 (34.8) 8 (9.0) 6 (6.7) 11 (12.4) 9 (10.1) 24 (27.0) |
19 (21.3) 20 (22.5) 10 (11.2) 7 (7.9) 7 (7.9) 26 (29.2) |
|
| Q1. How often do you have someone help you read hospital materials? | 0.020 | ||
|
Never Sometimes Frequently Always |
15 (16.9) 13 (14.6) 26 (29.2) 35 (39.3) |
11 (12.4) 30 (33.7) 25 (28.1) 23 (25.8) |
|
| Q2. How confident are you in understanding the indication, proper use, and side effects of the prescribed medication? | < 0.001 | ||
|
Not at all confident Slightly confident Very confident Extremely confident |
2 (2.2) 27 (30.3) 32 (36.0) 28 (31.5) |
1 (1.1) 8 (9.0) 20 (22.5) 60 (67.4) |
|
| Q3. How often do you have problems learning about your medical condition because of difficulty understanding written information? | < 0.0001 | ||
|
Never Sometimes Frequently Always |
9 (10.1) 20 (22.5) 34 (38.2) 6 (29.2) |
10 (11.2) 45 (50.6) 11 (12.4) 23 (25.8) |
|
*ACL: Anterior cruciate ligament.
*CVD: Cardiovascular disease.
*GERD: Gastroesophageal reflux disease.
On the day of discharge, medication reconciliation was performed for all patients in the intervention arm versus only 39.3% of the patients in the control arm (p < 0.001). All patients in both arms were counseled by either the pharmacy resident in the intervention arm or the physician in the control arm. All patients were handed the discharge instructions sheet in Arabic as per the hospital policy. Few patients (n = 2) in the intervention arm expressed barriers to learning (hearing difficulty and language barrier), while no such barriers were noted in the control arm. Most patients (36%) were discharged on four medications. The most commonly prescribed medications included narcotic (97%) and non-narcotic (65%) analgesics, non-steroidal anti-inflammatory drugs (60%), and anticoagulants (47%). The discharge data is presented in Table 2.
Table 2.
Discharge from the orthopedic surgery unit.
| Control group n= 89 |
Intervention group n= 89 |
P-value | |
|---|---|---|---|
| Medication reconciliation process performed as per hospital policy | 35 (39.3) | 89 (100) | < 0.001 |
| Discharge counseling performed | 89 (100) | 89 (100) | |
| Discharge counseling performed by | < 0.001 | ||
|
Physician Pharmacist Nurse |
89 (100) 0 0 |
0 89 (100) 0 |
|
| Discharge instruction sheet provided | 89 (100) | 89 (100) | |
| Barriers to learning | 0 | 2 (2.2) | 0.497 |
| Number of newly prescribed medications upon discharge | 0.916 | ||
|
1 2 3 4 ≥5 |
1 (1.1) 7 (7.9) 21 (23.6) 32 (36.0) 28 (31.5) |
3 (3.4) 6 (6.7) 19 (21.3) 32 (36.0) 29 (32.6) |
|
| Discharge medications classes | |||
|
Non-narcotic analgesics Narcotic analgesics NSAIDs Anticoagulant PPIs Vitamins Antibiotics Laxatives |
57 (64) 86 (96.6) 51 (57.3) 42 (47.2) 51 (57.3) 11 (12.4) 5 (5.6) 2 (2.2) |
58 (65.2) 85 (96.6) 55 (62.5) 41 (46.6) 57 (64.8) 8 (9.1) 6 (6.8) 1 (1.1) |
1.000 1.000 0.541 1.000 0.356 0.628 0.514 1.000 |
Primary endpoint
On day 30 post-discharge, a total of 40 unintended medication discrepancies were identified among 29 (16.3%) patients. The number of discrepancies was higher in the control arm, in which 36 discrepancies (90%) were identified among 25 patients in the control arm compared to four discrepancies (10%) among four patients in the intervention arm. The number of discrepancies per patient ranged from 0 to 5. The mean number of discrepancies per patient decreased from 0.43 in the control arm to 0.05 in the intervention arm (p < 0.001) (Table 3).
Table 3.
Study endpoints.
| Control group n = 89 |
Intervention group n = 89 |
P- value* | |
|---|---|---|---|
| Primary endpoint – unintended discrepancies at day 30 | |||
| Mean number of medication discrepancies (SD) | 0.43 (0.83) | 0.05 (0.22) | < 0.001† |
| Patients with ≥ 1 medication discrepancy, n (%) | 25 (28.1) | 4 (4.5) | < 0.001§ |
| Number of medication discrepancies, n (%) | < 0.001¥ | ||
|
0 1 2 3 5 Missing |
59 (70.2) 18 (21.4) 5 (6.0) 1 1 5 (5.6) |
77 (95.1) 4 (4.9) 0 0 0 8 (9.0) |
|
| Secondary endpoints at day 30 | |||
| Self-reported adverse drug events, n (%) | 9 (10.1) | 10 (11.2) | 1.000 |
| Composite endpoint of physician contact, readmissions or ED visits, n (%) | 8 (9.0) | 9 (10.1) | 0.636 |
| Contacted or seen clinician, n (%) | 4 (4.5) | 8 (9.0) | 0.308 |
| ED visit, n (%) | 4 (4.5) | 0 | 0.116 |
| Readmitted to same or another hospital, n (%) | 0 | 1 (1.1) | 0.405 |
| Follow-up at day 3 | |||
| Number of medication discrepancies | 3 (3.4) | ||
| Patient concern | 2 (2.2) | ||
| Reported side effect | 6 (6.7) | ||
| Contacted or seen clinician | 4 (4.9) | ||
*P-values were calculated using Pearson chi-square test, Fisher’s exact test, or independent-samples t-test, as appropriate.
† Independent-samples t-test, t (94.92) = 4.065; p < 0.001.
§ χ²(1) = 17.54, p < 0.001.
¥ Fisher’s exact test, p < 0.001.
In adjusted sensitivity analyses using the presence of at least one unintended medication discrepancy at day 30 as a binary outcome, the intervention remained significantly associated with a lower likelihood of discrepancy after adjustment for baseline imbalances in selected health literacy-related variables. In one model adjusting for medication-related confidence and difficulty understanding written health information, the adjusted odds ratio was 0.13 (95% CI 0.035–0.479; p = 0.002). In a second model adjusting for medication-related confidence and need for help reading hospital materials, the adjusted odds ratio was 0.145 (95% CI 0.047–0.445; p < 0.001).
Almost all unintended discrepancies involved oral medications, except for two cases related to the subcutaneous medication enoxaparin. The majority were associated with over-the-counter medications (52.5%). The most common identified discrepancy was commission (35%), followed by omission (30%), wrong duration (17.5%), wrong drug (10%), and wrong dose, frequency, route (2.5% each). Some unintended discrepancies involved high-alert medications (12.5%). The primary causes of discrepancies, as identified by the pharmacy resident, were mainly attributed to the patient’s knowledge (60%) or to the clinician’s knowledge (15%). Moreover, when the resident assessed the potential severity of the discrepancies, the majority of the unintended ones were clinically insignificant (65%), followed by clinically significant discrepancies (27.5%), with only 4% classified as potentially serious.
Secondary endpoints
For the secondary endpoints, there was no statistically significant difference among both groups for most of the studied endpoints, except for two: a higher percentage of patients in the intervention group reported receiving enough information about their discharge medications compared to the control group (88.8% vs. 79.8%, p = 0.008), and more patients in the intervention group confirmed understanding the indication of each medication (88.8% vs. 80.9%, p = 0.014) (Table 4).
Table 4.
Patient satisfaction.
| Control group n = 89 |
Intervention group n = 89 |
P-Value | |
|---|---|---|---|
| After you left the hospital, did you go directly to your own home, to someone else’s home, or to another health facility? | 1.000 | ||
|
Own home Another health facility Someone else’s home Missing |
80 (89.9) 1 (1.1) 0 8 (9.0) |
80 (89.9) 0 0 9 (10.1) |
|
| Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay? | 8.8 (1.79) | 9.1 (1.17) | 0.107 |
| Would you recommend this hospital to your friends and family? | 0.479 | ||
| Yes | 78 (87.6) | 78 (87.6) | |
| Did doctors, nurses or other hospital staff work with you and your family or caregiver in making plans for your care after you left the hospital? | 0.770 | ||
|
No Somewhat yes Definitely yes |
6 (6.7) 7 (7.9) 69 (77.5) |
4 (4.5) 3 (3.4) 73 (82.0) |
|
| When you left the hospital, did you understand what each of your medications was for? | 0.014 | ||
|
No Somewhat yes Definitely yes |
2 (2.2) 8 (9.0) 72 (80.9) |
1 (1.1) 0 79 (88.8) |
|
| Did you understand what you would need to do to care for yourself after you left the hospital? | 0.338 | ||
|
No Somewhat yes Definitely yes |
4 (4.5) 9 (10.1) 69 (77.5) |
5 (5.6) 3 (3.4) 72 (80.9) |
|
| During this hospital stay, did doctors, nurses or other hospital staff give your family/caregiver enough information about what symptoms or health problems to watch for after you left the hospital? | 0.287 | ||
|
No Somewhat yes Definitely yes |
6 (6.7) 6 (6.7) 70 (78.7) |
1 (1.1) 7 (7.9) 72 (80.9) |
|
| During this hospital stay, did doctors, nurses or other hospital staff give your family /caregiver enough information to care for you after you left the hospital? | 0.746 | ||
|
No Somewhat yes Definitely yes |
7 (7.9) 70 (78.7) 6 (6.7) |
5 (5.6) 71 (79.8) 4 (4.5) |
|
| During this hospital stay, did you get enough information about prescription or other medicines you would need to take after you left the hospital? | 0.008 | ||
|
No Somewhat yes Definitely yes |
7 (7.9) 5 (5.6) 71 (79.8) |
0 1 (1.1) 79 (88.8) |
|
| During this hospital stay, did doctors, nurses or other hospital staff talk with you about the follow-up care you would need after you left the hospital? | 0.286 | ||
|
No Somewhat yes Definitely yes |
7 (7.9) 8 (9.0) 67 (75.3) |
4 (4.5) 3 (3.4) 72 (81.8) |
|
| During this hospital stay, did doctors, nurses or other hospital staff give you enough information about symptoms or health problems to watch for? | 0.146 | ||
|
No Somewhat yes Definitely yes |
7 (8.3) 5 (6.0) 70 (83.3) |
1 (1.3) 7 (9.0) 70 (89.7) |
The number of reported adverse drug events was approximately the same between the control and intervention arms (10% vs. 10.7% respectively, p = 1). For the composite endpoint, approximately 10% of patients in both arms experienced physician contact, hospital readmission, or ED visits (p = 0.636). Regarding patient satisfaction, patients in the intervention group reported slightly higher satisfaction, with a mean hospital rating of 9.1/10 compared to 8.8/10 in the control group, though the difference was not statistically significant (p = 0.107).
Other endpoints were assessed on day 3 post-discharge. Only three medication discrepancies were identified and were found resolved on day 30. Moreover, two patients expressed concerns which were mainly related to allergy or bruising. As for adverse drug events, six patients experienced bruising, mood disorders, myalgia, hypertension, or tachycardia. The pharmacy resident advised the patients to report the adverse drug events and medication-related concerns to their treating physician. Two adverse drug events resulted in a change of medication, and one resulted in increased monitoring.
Discussion
In this randomized controlled open-label study, the authors aimed to assess the impact of a pharmacist-led medication reconciliation and patient counseling performed to adult patients discharged from the orthopedic surgery department with at least one discharge medication, on the number of unintended medication discrepancies.
The primary outcome showed a significant reduction in the number of unintended discrepancies among patients who received the intervention from a pharmacy resident compared to those who received the standard of care. The most common discrepancies were errors of commission (35%), followed by omissions (30%), which contrasts with previous studies where omissions were the most prevalent type of discrepancy13,17,18. This pattern may reflect characteristics specific to the present study population and local practice context. While non-prescription use of analgesics and antibiotics has been reported in Lebanon19, the present study was not designed to directly assess whether such behaviors contributed to the discrepancies observed in this cohort. Importantly, these errors of commission can lead to negative outcomes such as adverse drug events, drug-drug interactions or antibiotic resistance.
The high-alert medications involved in discrepancies included enoxaparin, rivaroxaban, apixaban, and tramadol. Most of the identified unintended discrepancies were classified as clinically insignificant such as the omission of analgesics and prophylactic proton pump inhibitors. While these discrepancies may not lead to immediate harm, their potential cumulative effect should not be overlooked. The intake of non-prescribed antibiotics and extending pregabalin beyond the prescribed duration were considered as potentially clinically significant. Potentially serious errors included the omission of anticoagulants and antibiotics as these could lead to deep vein thrombosis, pulmonary embolism, and worsening infection respectively, resulting in potential systemic adverse events20,21. The presence of clinically significant and serious discrepancies, although less frequent, underlines the necessity of a meticulous medication reconciliation process at discharge, to avert potentially harmful outcomes. However, none of these patients reported experiencing actual harm related to these discrepancies on day 30 post-discharge.
The secondary endpoints showed no significant differences between the control and intervention groups in terms of adverse drug events, unplanned physician contacts, emergency room admissions, and hospital readmissions. This aligns with the findings of published studies and reviews assessing the impact of medication reconciliation on health outcomes22,23. Despite the clinical validity of medication reconciliation, these studies did not show clear evidence in favor of the intervention on patient-centered health care outcomes22,23. In the current study, the pharmacist-led intervention had a measurable effect on the discharge process itself, particularly medication accuracy, but its impact on broader clinical outcomes was not demonstrated. However, this interpretation should remain cautious, as the study may not have been adequately powered to detect differences in these secondary clinical outcomes.
The identified adverse drug events at day 30 were mood disorders due to narcotics, gastrointestinal tract discomfort attributed to non-steroidal anti-inflammatory drugs, allergies, bruising caused by enoxaparin, vaginal bleeding due to acenocoumarol, skin rash, and dizziness. Only one patient reported going to the emergency department due to constipation and severe gastrointestinal discomfort. The pharmacy resident advised patients who experienced adverse drug events to follow-up with their physician.
The intervention group reported higher patient satisfaction, particularly in areas related to understanding discharge medications. Previous studies showed that patients reported higher satisfaction with the counseling services provided by pharmacists, appreciating their role, professionalism, clarity in delivering treatment information, and effective verbal and non-verbal communication skills24,25.
Although this was not a primary focus of the study, our findings revealed low compliance with the medication reconciliation process at discharge from the orthopedic surgery unit, with reconciliation performed for only 39% of patients in the control group. This rate is comparable to a 14–35% compliance rate reported in a multicenter study in Saudi Arabia26.
Patients in the intervention arm reported greater baseline confidence in understanding the indications, proper use, and potential side effects of their prescribed medications, which may have slightly amplified the effect of the intervention. This is consistent with previous research, as Persell et al. which demonstrated that limited health literacy was associated with a greater number of unreconciled medications27. Similarly, Qin et al. concluded that health literacy is significantly associated with increased medication knowledge and decreased medication discrepancy28. Importantly, in adjusted sensitivity analyses accounting for selected baseline health literacy-related variables, the intervention remained significantly associated with a lower likelihood of unintended medication discrepancies, supporting the robustness of the main finding.
Although admission diagnosis/surgery differed significantly between groups, this comparison should be interpreted with caution because of the unequal proportion of missing data between groups, which limits its interpretability as a true baseline imbalance.
Implications for practice
The findings of this study suggest several practical implications. Firstly, the integration of pharmacists in the discharge processes of orthopedic surgery patients is essential to ensure comprehensive medication reconciliation and patient counseling. Secondly, leveraging the expertise of pharmacy residents, as demonstrated in this study, presents an effective and sustainable model for improving documentation and enhancing adherence to medication safety practices.
To our knowledge, this study is the first prospective randomized controlled trial conducted in Lebanon to evaluate medication reconciliation and pharmacy services at discharge from an orthopedic surgery department, with assessment of patient outcomes 30 days post-discharge.
Although the study was designed as a randomized controlled trial, its open-label nature and certain methodological limitations, particularly the absence of formal allocation concealment, may reduce the overall strength of inference. The single-center design may limit the generalizability of the results, and the relatively short follow-up period may not capture long-term outcomes or the sustained impact of pharmacist-led interventions. In addition, the absence of a formal power calculation is an important methodological limitation and raises the possibility that the study was underpowered, particularly for secondary clinical outcomes. There is also potential for contamination and performance bias, as the open-label design and clinician awareness of the study may have led patients in the control group to receive higher levels of medication reconciliation and counseling than would typically occur in standard care, potentially diluting the observed intervention effect. Because the intervention was designed as a multicomponent pharmacist-led discharge intervention, the independent effect of each component could not be determined. Furthermore, because the PGY1 pharmacy resident who delivered the intervention was also involved in study procedures, the possibility of observer or ascertainment bias cannot be fully excluded. Although discrepancy classification and severity assessment were reviewed by a panel of investigators and final judgments were reached by consensus, the adjudication process was not blinded, and inter-rater reliability was not formally assessed.
Conclusion
In this single-center, open-label randomized controlled trial, pharmacist-led medication reconciliation and patient counseling at discharge were associated with a significant reduction in unintended medication discrepancies among orthopedic surgery patients. These findings suggest that integrating pharmacists into discharge processes may enhance medication safety and warrant confirmation in larger and more diverse populations. Further research in diverse practice settings is needed to better evaluate the broader impact of pharmacist involvement in transitions of care.
Acknowledgements
The authors would like to thank the Pharmacy Department of Lebanese American University Medical Center – Rizk Hospital for providing all the logistical support for this study. This study would not have been possible without the dedication and flexibility of the clinical orthopedic coordinator, Mrs. Mirna Nader, all the orthopedic resident physicians and nurses who were of great help and strived to comply with all study requirements, while performing their daily duties.
Author contributions
SD: Conceptualization; Methodology; Data curation; Writing – original draft - co-first author- LRK: Supervision; Project administration; Visualization; Writing – reviewing & editing - co-first author- AHH: Methodology; Data curation; Writing – original draft- NC: Methodology; Project administration; Resources; Visualization; Writing – reviewing & editing- CA: Conceptualization; Methodology; Project administration; Resources; Supervision- KY: Conceptualization; Methodology; Project administration; Resources; Supervision- ER: Conceptualization; Methodology; Data curation; Formal analysis; Project administration; Resources; Supervision; Visualization; Writing – original draft; Writing – reviewing & editing - corresponding author- All authors provided a critical review of the article for content and final approval of the version to be published.
Data availability
The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Declarations
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
These authors contributed equally: Souad Diab and Lamis R. Karaoui.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.