Protocol for the impact of medication therapy management on efficacy and safety of postoperative anticoagulation therapy in patients with colorectal cancer: an open-label, prospective and randomized clinical trial

Introduction

Anticoagulants are classified as high-risk medications (1), and their main adverse drug events (ADEs) are recurrent venous thromboembolism (VTE) and bleeding events (2). During anticoagulant therapy for patients with colorectal cancer (CRC), the 12-month cumulative incidence of recurrent VTE was 7.6%, whereas the cumulative incidence of major bleeding events was as high as 11.4% (3). Among patients admitted to the emergency department because of ADEs, 14.3% were attributed to the use of anticoagulants (4), with this percentage increasing to 27.5% among patients aged >65 years (5). In China, the rate of unplanned rehospitalization due to anticoagulant-related complications is 12% (6). In clinical practice, medication errors involving oral anticoagulants (OACs) are prevalent, accounting for 8.4–28.9% of hospitalized patients who received inappropriate prescriptions of direct oral anticoagulants (DOACs) (7). These errors are frequently linked to severe adverse events such as VTE recurrence, hemorrhage or patient mortality (8).

The medication therapy management (MTM) pathway encompasses a comprehensive range of clinical pharmacy interventions, including medication education, counseling, medication reconciliation, and other associated aspects. These interventions are provided by clinical pharmacists who have undergone rigorous standardized training (9). The MTM pathway may be effective in preventing potential medication-related problems (MRPs), ADEs, drug interactions, and off-label drug use (10). Notably, single-component pharmacist intervention, such as medication education or medication review, has shown conflicting efficacy in addressing the medication safety needs of postoperative CRC patients. For example, Karaoui et al. reported that pharmacist-conducted anticoagulant education did not reduce bleeding or readmission rates within 30 days (11). Meanwhile, Ashjian et al. found that medication reviews increased the likelihood of patients receiving appropriate anticoagulant prescriptions (12). In contrast to single-component intervention, multifaceted intervention models show more promising outcomes. Li et al. indicated that multifaceted pharmaceutical interventions were associated with a significantly lower incidence of gastrointestinal bleeding than the routine care (6.1% vs. 12.4%), but they did not investigate all indicators of anticoagulant-related ADEs (13). Unfortunately, Gurwitz et al. did not observe a reduction in ADEs with multifaceted pharmacist interventions in recently discharged patients prescribed high-risk medications (involving anticoagulants, diabetes agents, and opioids) (14). It may be attributed to the overly broad range of medications selected in this study, resulting in a negative outcome (14). Given these considerations, our study design incorporated the comprehensive MTM pathway, which was initiated upon patient admission and extended up to 6 months post-operation, focusing on anticoagulants in the perioperative setting. The hypothesis of this study posits that the pharmacist-led MTM pathway will significantly reduce the incidence of anticoagulant-related ADEs in postoperative CRC patients with acute VTE, as compared to the current clinical standard of care. We present this article in accordance with the SPIRIT reporting checklist (available at https://cco.amegroups.com/article/view/10.21037/cco-25-111/rc).

Methods

Study design and setting

This study will be a prospective, multicenter, open-label, randomized controlled trial. From January 2025 to December 2027, patients who will undergo radical CRC surgery and experience acute VTE that requires long-term anticoagulant therapy (e.g., three months) will be consecutively enrolled from four sites in China. The patients will be randomly assigned to intervention and control groups (Figure 1). In the intervention group, the patients will receive anticoagulant medication management via the MTM pathway implemented by clinical pharmacists. The control group will be managed according to the clinical standard of care. CIME, which include preventable or ameliorable ADEs and potential ADEs (medication-related errors that have not yet caused injury to a patient but have the potential to cause future harm if not addressed), will be assessed as primary outcomes. The recurrence of VTE, major bleeding, minor bleeding, clinically related non-major bleeding, and mortality will also be recorded to evaluate the efficacy and safety of anticoagulants in the MTM pathway.

Figure 1 Study flowchart. CIME, clinically important medication errors; CRC, colorectal cancer; MTM, medication therapy management; VTE, venous thromboembolism.

Population

This study will enroll patients from four tertiary hospitals (The Sixth Affiliated Hospital of Sun Yat-sen University, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University Cancer Center, and Guangzhou Red Cross Hospital) in China, with eligibility criteria defined as follows. Inclusion criteria include: (I) age between 18 and 80 years; (II) histopathologically confirmed CRC scheduled for elective radical surgery; (III) confirmed symptomatic or incidental VTE, (IV) requirement for therapeutic-dose anticoagulants for at least 3 months; and (V) eligibility for primary or secondary pharmaceutical care. Exclusion criteria include: (I) a history of hypersensitivity to anticoagulants; (II) screening abnormalities such as a platelet count below 50×10⁹/L, hemoglobin below 8 g/dL, hemodynamically unstable pulmonary embolism (PE) with systolic blood pressure below 90 mmHg or shock; (III) presence of acute hepatitis, chronic active hepatitis, liver cirrhosis; (IV) pregnant or lactating women; and (V) any condition judged by investigators to increase the risk of harm to the subject if they participate in the study. The eligibility criteria are listed in Table 1. It should be acknowledged that the enrollment of patients exclusively from China may limit the generalizability of the study results, as previous data have shown significant differences in VTE prophylaxis practices and related outcomes between the Chinese population and international cohorts (15). This is also the rationale for our study to generate evidence on optimizing anticoagulant management for the Chinese population.

Randomization

This study will be a randomized controlled trial, in which a study assistant assign eligible participants into intervention and control groups in a 1:1 ratio using a computer-generated random sequence via the web-based platform Study Randomizer (https://app.studyrandomizer.com/). We will ensure that patients are evenly distributed across the intervention and control groups on the basis of: (I) the number of high-risk medications they are taking (including anticoagulants, hypoglycemic agents, and opioid analgesics); and (II) age ≥65 years at the time of enrollment. To ensure strict allocation concealment, enrolling investigators have no access to the random sequence or group assignment results. The allocation outcome is only shared with the study assistant and clinical pharmacists responsible for delivering the MTM intervention. The study designers, medication reconciliation implementers, and data entry personnel are strictly separated, and all staff (excluding the study assistant and intervention-delivering clinical pharmacists) are unaware of patient group allocation.

Study procedure and treatment

Patients in the intervention group will follow the standardized MTM pathway (Figure 2), which is operationalized by a specific intervention manual. Rigorous pharmacist training and treatment fidelity monitoring are implemented to ensure intervention transparency and reproducibility. For the first step, pharmacists will obtain patients’ basic information through the hospital’s electronic medical record (EMR) system and conduct bedside interviews to establish a best possible medication history (BPMH). This BPMH will include details such as medication names, dosages, frequencies, administration routes, and whether each medication is discontinued after admission. Meanwhile, pharmacists will assess patients’ medication adherence and document the admission medication orders (AMO). In the second step, pharmacists will evaluate medications listed in the BPMH and AMO based on professional knowledge, referring to pharmacy databases and relevant drug instructions. They will record MRPs, their causes, interventions implemented, and intervention outcomes in a medication reconciliation list, and promptly feedback any medication errors identified in the AMO to attending physicians. The third step involves pharmacists assessing patients’ understanding of their medications and diseases during bedside interviews and providing guidance on all medication safety issues and concerns. To ensure patients’ comprehension and retention, pharmacists will adopt the “teach-back” method and distribute anticoagulant safety education materials related to the study. These materials cover key information including medication administration times, dietary precautions, scenario-specific guidance (e.g., actions to take when a dose is missed), and guidelines on when to contact healthcare providers. In the fourth step, after completing the medication therapy review (MTR), pharmacists will create a personal medication record (PMR) for each patient to comprehensively document their medication status and develop a medication-related action plan (MAP). The MAP will include an MRP list, recommended actions to address MRPs, and specific persons responsible for each action. Pharmacists will encourage patients to maintain and update the PMR and MAP regularly, keep them readily accessible, and provide these documents to physicians during routine consultations, hospitalizations, or discharges. The fifth step entails pharmacists implementing follow-up interventions. Within 6 months after discharge, individualized follow-up will be conducted to monitor patients’ medication status, track the resolution of MRPs, and ensure the continuous effectiveness of the PMR and MAP. In accordance with the Declaration of Helsinki and ethical principles, to minimize preventable harm, patients in the control group will receive the clinical standard of care, supplemented with at least one MTR service and educational materials on anticoagulants.

Figure 2 Detailed flowchart for the intervention group.

All pharmacists responsible for this trial must complete a training program that encompasses four core components: (I) antithrombotic guidelines; (II) EMR pertaining to anticoagulation-related ADEs; (III) textbooks on antithrombotic therapy; and (IV) real-world anticoagulant consultations. The training also emphasizes proficiency in recognizing and managing four common anticoagulant-related high-risk scenarios: (I) perioperative anticoagulant management; (II) the combined use of antiplatelet drugs and anticoagulant; (III) anticoagulant therapy decisions for patients at high bleeding risk; and (IV) inappropriate dosing of anticoagulant. A pre-training proficiency assessment is mandatory to ensure competence, and monthly refresher sessions are conducted to address new issues.

Study outcomes

The primary outcome will be anticoagulation therapy-related CIME, which will constitute a composite endpoint comprising preventable or ameliorable ADEs and potential ADEs arising from medication discrepancies or non-adherence. This represents a significant and meaningful indicator for patient safety interventions, because >50% patients will experience one or more CIME within several weeks post-discharge (16). Preventable ADEs are drug-related injuries associated with medication errors (17). Although some ADEs may not be entirely preventable, their duration or severity can be reduced and are thus termed ameliorable ADEs (18). Additionally, other medication-related issues may arise after discharge, known as potential ADEs (19). Although these situations have not yet harmed the patients, if left untreated, they could lead to future harm. The primary anticoagulant-related ADEs that this trial plans to consider encompass two categories: (I) ADEs associated with the therapeutic effects of anticoagulants, including all-cause mortality, suspected recurrence of deep vein thrombosis (DVT) and PE, confirmed symptomatic or incidental DVT, and confirmed symptomatic or incidental PE; and (II) ADEs related to major adverse drug reactions, such as major bleeding, clinically related non-major bleeding, and minor bleeding.

Two pharmacist investigators will conduct a review of the EMR of the patients at the time of hospital discharge. They will review outpatient encounters, discharge summaries, emergency department visits, and laboratory results, in accordance with a predefined, operationalized checklist for collecting raw data related to potential CIME indicators (e.g., symptoms, medication discrepancies, healthcare utilization) to minimize subjective bias. In addition, the pharmacist investigators will conduct standardized, pre-validated semi-structured telephone follow-up interviews with patients, with a specific focus on ADEs potentially associated with anticoagulant medications. The interview script contains no leading questions and is uniformly applied to all patients, irrespective of their group assignment, to prevent any influence on patients’ responses. During the follow-up, they will inquire about the severity of symptoms, their correlation with hospitalization and treatment, and resolution status. The interviews will also evaluate the utilization of home care services, physician consultations, laboratory services, and readmission experiences of the patients. Each review will adhere to a standardized protocol. At each follow-up, every patient will complete an incident identification form, and the following data will be collected: age, sex, and active medical conditions of the patient; time and date of the incident; name, dosage, and category of the implicated medication; documented indications for its use; other concomitant or as-needed medications; type and category of injury sustained; and source of information documenting the incident.

Then, a final review for CIME determination will be exclusively conducted by two physician investigators, who are completely blinded to patient group allocations. These physician investigators will assess the outcomes of CIME at 90 and 180 days post-discharge. They will independently examine each incident identification form, which containing only de-identified raw date, and categorize the incident, severity, and preventability. In cases of disagreement, they will engage in discussions to reach a consensus. If a consensus remains elusive, a third physician investigator will be consulted for settlement.

Secondary outcomes are observation indicators relevant to clinical pharmacy research, encompassing preventable or ameliorable ADEs, potential ADEs, medication adherence, incidence rate of drug-related problems, incidence rate of drug discrepancies, incidence rate of unintentional discrepancies, incidence rate of medication errors with potential for harm, intervention acceptability, intervention success rate, average length of hospital stay, average hospitalization cost, and overall survival rate.

Sample size calculation

This study is a multi-center, superiority, 1:1 parallel-group randomized controlled trial, with sample size estimation centered on the primary outcome. Multiple studies investigating pharmacist-led interventions for high-risk medications have reported that such interventions reduced ADEs incidence by approximately 59% (from 27% to 11%) (20,21), which initially suggested a potential sample size of 387 patients when assuming a two-sided significance level (α) of 0.05, statistical power (1-β) of 90%, and a 180-day follow-up period. However, since this study specifically focuses on anticoagulants, literature reports indicate that the incidence of anticoagulant-related ADEs is 21.5% [95% confidence interval (CI): 16.5–26.4%] (1). Considering the clinical context of our institution, the baseline ADEs incidence (VTE recurrence and bleeding events) in the control group was set to 30%. We hypothesized that the MTM intervention would reduce this incidence by 50%, a clinically meaningful effect size consistent with anticoagulant-focused pharmacist intervention studies. After accounting for a 10% dropout rate, the final minimum sample size was calculated as 327 patients using SPSS 23.0 software.

Subgroup analysis

Based on the findings from the study on medication errors and risk factors at the time of admission, being aged ≥65 years was identified as a risk factor for ADEs, showing a significant association with errors potentially requiring monitoring or causing harm [odds ratio (OR) =2.17, 95% CI: 1.09–4.30] (22). Additionally, the number of high-risk medications, including anticoagulants, hypoglycemic agents, and opioid analgesics, is a potential risk factor for ADEs. Therefore, a subgroup analysis will be conducted according to age (≥65 vs. <65 years) and the number of high-risk medications taken (e.g., categorized as none, one, or multiple high-risk medications).

To further clarify the intervention effect across specific clinical scenarios and outcome subtypes, additional predefined subgroup analyses will be implemented, including: (I) subgroup analysis stratified by four ADEs categories: periprocedural anticoagulant management, combined use of antiplatelet agents and anticoagulant, anticoagulant therapy decision in high bleeding risk patients, and inappropriate dosing of anticoagulant; (II) subgroup analysis based on clinical characteristics: presence of concomitant medications, receipt of preoperative or postoperative chemotherapy, primary tumor location, and surgical approach.

Statistical analyses

Statistical analyses will be conducted using SPSS 23.0, with continuous variables presented as mean ± standard deviation or median and categorical variables reported as frequencies and percentages. Two analysis populations are pre-specified to ensure rigor. The ITT population, defined as all randomized patients regardless of intervention completion or follow-up status, used as the primary analysis population to minimize selection bias. The per-protocol (PP) population, including only patients who completed the full intervention and 180-day follow-up without major protocol violations for supplementary analysis. For the primary outcome, binary logistic regression will be used for univariate and multivariate analyses to calculate OR and 95% CI. Univariate comparisons will use the Chi-squared test for categorical variables and the t-test for continuous variables; variables with P≤0.05 in univariate analysis will be included in multivariate binary logistic regression to adjust for potential confounding factors. Two-sided P values will be applied, with statistical significance set at P≤0.05. The amount and pattern of missing data will be summarized by treatment group. Sensitivity analyses will be performed using complete-case analysis and alternative imputations (best- and worst-case scenarios for missing primary outcomes) to assess the robustness of the results.

Ethics and dissemination

This study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. All participants will provide written informed consent prior to randomization. The protocol has been approved by the Ethics Committee of the Sixth Affiliated Hospital, Sun Yat-sen University (No. 2024ZSLYEC-572), and other participating institutions were informed of and agreed to the study. The results of this study will be disseminated through publication in peer-reviewed journals.

Discussion

VTE is a common and serious complication following CRC surgery, and inappropriate anticoagulant prescriptions can contribute to ADEs such as bleeding or preventable thrombotic events. In the CRC-VTE study, the incidence of VTE was 11.2% within 1 month of CRC surgery, with 78% of these cases being asymptomatic DVT events, accounting for 8.6% (15). Another study in China reported an incidence of as high as 38% asymptomatic DVT in after laparoscopic resection of rectosigmoid cancer, which is potentially linked to suboptimal prophylactic regimens (23). The RISTOS project noted that 40% of VTE events occurred after 21 days post-surgery (24), whereas another study revealed that nearly 33% of 30-day post-operative VTE cases were diagnosed after discharge (25). These findings highlight that focusing solely on in-hospital outcomes is insufficient for managing asymptomatic VTE. Moreover, anticoagulant medication errors predominantly occur after discharge, because patients’ clinical conditions and concomitant medication regimens are constantly changing (1). This underscores the need for optimized anticoagulant prescriptions to minimize ADEs.

Anticoagulant-related medication errors are often seen in four clinical scenarios: periprocedural anticoagulant management, combined use of antiplatelet agents and anticoagulants, anticoagulant treatment decisions in patients at high risk of bleeding, and inappropriate anticoagulant dosing. In periprocedural anticoagulant management, clinical practice frequently deviates from specialty-specific recommendations. Errors in the interruption, resumption, or bridging of anticoagulant can significantly shift the risk-benefit balance. Low molecular weight heparin (LMWH) bridging increases the incidence of major bleeding (from 1.3% to 3.2%) but does not reduce arterial thromboembolism (0.4% vs. 0.3%) (26). While standardized DOAC interruption results in lower rates of bleeding (0.9–1.9%) and thrombosis (0.2–0.6%) within 30 days (27).

In terms of combining use of antiplatelet agents and anticoagulant, more than one-third of anticoagulant patients experience inappropriate combination therapy (28,29). In a DOAC cohort without a clear indication for aspirin, adding aspirin increased bleeding events from 26.0 to 31.6 per 100 patient-years, and hospitalization rates from 6.5 to 9.1 per 100 patient-years, while the incidence of thrombosis did not decrease (28). Additionally, anticoagulant management after major bleeding remains uncertainty. While guidelines from the United States, Europe, and Asia generally suggest that OACs should be resumed following hemostasis in patients with an indication for long-term OACs use, considerable heterogeneity exists with respect to specific recommendations regarding the timing of resumption, and risk stratification (30-33). More than a quarter of the patients prematurely discontinued anticoagulant therapy after hemostasis, which markedly elevated their short- and long-term risks of VTE recurrence (34). Compared with patients who maintain long-term anticoagulant, those who discontinue early exhibit a 16% higher risk of VTE recurrence at 3 months and a 19% higher risk at 12 months (34). Dosing inaccuracies present comparable challenges. The most frequent types of anticoagulant-associated medication errors are incorrect rate or frequency of administration (26.1%) and missed or late dosing (20%) (35). Sub-therapeutic dosing is associated with an increased risk of ischemic stroke/systemic embolism [hazard ratio (HR) =1.59, 95% CI: 1.25–2.02] (36). Overdosing exacerbates bleeding and mortality (37).

Preventable anticoagulant-related errors impose a heavy burden, which is further exacerbated by the complexity of anticoagulant management among diverse patient populations. Therefore, there is an urgent need for structured and patient-centered interventions. MTM addresses the root causes of anticoagulant mismanagement, improves adherence to guidelines, enhances patient compliance, and enables timely intervention for MRPs. Standardized through the pathway and with rigorous pharmacist training, MTM offers a practical approach to optimize the safety and effectiveness of anticoagulants. Ultimately, it may reduce avoidable bleeding, thrombosis, and mortality in high-risk populations.

Acknowledgments

The authors thank AiMi Academic Services (www.aimieditor.com) for the English language editing and review services.

Footnote

Reporting Checklist: The authors have completed the SPIRIT reporting checklist. Available at https://cco.amegroups.com/article/view/10.21037/cco-25-111/rc

Peer Review File: Available at https://cco.amegroups.com/article/view/10.21037/cco-25-111/prf

Funding: This study was supported by the Sixth Affiliated Hospital of Sun Yat-sen University Clinical Research-‘1010’ Program (grant No. 1010PY2024-01) and Guangdong Provincial Hospital Pharmacy Research Fund (grant No. 2025A02019).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cco.amegroups.com/article/view/10.21037/cco-25-111/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. All participants will provide written informed consent prior to randomization. The protocol has been approved by the Ethics Committee of the Sixth Affiliated Hospital, Sun Yat-sen University (No. 2024ZSLYEC-572), and other participating institutions were informed of and agreed to the study.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Budnitz DS, Shehab N, Lovegrove MC, et al. US Emergency Department Visits Attributed to Medication Harms, 2017-2019. JAMA 2021;326:1299-309. [Crossref] [PubMed]
2. Moik F, Posch F, Zielinski C, et al. Direct oral anticoagulants compared to low-molecular-weight heparin for the treatment of cancer-associated thrombosis: Updated systematic review and meta-analysis of randomized controlled trials. Res Pract Thromb Haemost 2020;4:550-61. [Crossref] [PubMed]
3. Weitz JI, Haas S, Ageno W, et al. Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE. J Thromb Thrombolysis 2020;50:267-77. [Crossref] [PubMed]
4. Al-Arifi M, Abu-Hashem H, Al-Meziny M, et al. Emergency department visits and admissions due to drug related problems at Riyadh military hospital (RMH), Saudi Arabia. Saudi Pharm J 2014;22:17-25. [Crossref] [PubMed]
5. Shehab N, Lovegrove MC, Geller AI, et al. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. JAMA 2016;316:2115-25. [Crossref] [PubMed]
6. Liang JB, Lao CK, Tian L, et al. Impact of a pharmacist-led education and follow-up service on anticoagulation control and safety outcomes at a tertiary hospital in China: a randomised controlled trial. Int J Pharm Pract 2020;28:97-106. [Crossref] [PubMed]
7. van der Horst SFB, van Rein N, van Mens TE, et al. Inappropriate prescriptions of direct oral anticoagulants (DOACs) in hospitalized patients: A narrative review. Thromb Res 2023;231:135-40. [Crossref] [PubMed]
8. Al Rowily A, Jalal Z, Price MJ, et al. Prevalence, contributory factors and severity of medication errors associated with direct-acting oral anticoagulants in adult patients: a systematic review and meta-analysis. Eur J Clin Pharmacol 2022;78:623-45. [Crossref] [PubMed]
9. American Pharmacists Association. Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc (2003) 2008;48:341-53. [Crossref] [PubMed]
10. Rose AJ, Fischer SH, Paasche-Orlow MK. Beyond Medication Reconciliation: The Correct Medication List. JAMA 2017;317:2057-8. [Crossref] [PubMed]
11. Karaoui LR, Ramia E, Mansour H, et al. Impact of pharmacist-conducted anticoagulation patient education and telephone follow-up on transitions of care: a randomized controlled trial. BMC Health Serv Res 2021;21:151. [Crossref] [PubMed]
12. Ashjian E, Kurtz B, Renner E, et al. Evaluation of a pharmacist-led outpatient direct oral anticoagulant service. Am J Health Syst Pharm 2017;74:483-9. [Crossref] [PubMed]
13. Li X, Zuo C, Lu W, et al. Evaluation of Remote Pharmacist-Led Outpatient Service for Geriatric Patients on Rivaroxaban for Nonvalvular Atrial Fibrillation During the COVID-19 Pandemic. Front Pharmacol 2020;11:1275. [Crossref] [PubMed]
14. Gurwitz JH, Kapoor A, Garber L, et al. Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial. JAMA Intern Med 2021;181:610-8. [Crossref] [PubMed]
15. Wei Q, Wei ZQ, Jing CQ, et al. Incidence, prevention, risk factors, and prediction of venous thromboembolism in Chinese patients after colorectal cancer surgery: a prospective, multicenter cohort study. Int J Surg 2023;109:3003-12. [Crossref] [PubMed]
16. Kripalani S, Roumie CL, Dalal AK, et al. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med 2012;157:1-10. [Crossref] [PubMed]
17. Field TS, Mazor KM, Briesacher B, et al. Adverse drug events resulting from patient errors in older adults. J Am Geriatr Soc 2007;55:271-6. [Crossref] [PubMed]
18. Field TS, Gurwitz JH, Harrold LR, et al. Risk factors for adverse drug events among older adults in the ambulatory setting. J Am Geriatr Soc 2004;52:1349-54. [Crossref] [PubMed]
19. Davis TC, Wolf MS, Bass PF 3rd, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med 2006;145:887-94. [Crossref] [PubMed]
20. Choi YJ, Kim H. Effect of pharmacy-led medication reconciliation in emergency departments: A systematic review and meta-analysis. J Clin Pharm Ther 2019;44:932-45. [Crossref] [PubMed]
21. Cheema E, Alhomoud FK, Kinsara ASA, et al. The impact of pharmacists-led medicines reconciliation on healthcare outcomes in secondary care: A systematic review and meta-analysis of randomized controlled trials. PLoS One 2018;13:e0193510. [Crossref] [PubMed]
22. Gleason KM, McDaniel MR, Feinglass J, et al. Results of the Medications at Transitions and Clinical Handoffs (MATCH) study: an analysis of medication reconciliation errors and risk factors at hospital admission. J Gen Intern Med 2010;25:441-7. [Crossref] [PubMed]
23. Cheung HY, Chung CC, Yau KK, et al. Risk of deep vein thrombosis following laparoscopic rectosigmoid cancer resection in chinese patients. Asian J Surg 2008;31:63-8. [Crossref] [PubMed]
24. Agnelli G, Bolis G, Capussotti L, et al. A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: the @RISTOS project. Ann Surg 2006;243:89-95. [Crossref] [PubMed]
25. Davenport DL, Vargas HD, Kasten MW, et al. Timing and perioperative risk factors for in-hospital and post-discharge venous thromboembolism after colorectal cancer resection. Clin Appl Thromb Hemost 2012;18:569-75. [Crossref] [PubMed]
26. Douketis JD, Spyropoulos AC, Kaatz S, et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med 2015;373:823-33. [Crossref] [PubMed]
27. Douketis JD, Spyropoulos AC, Duncan J, et al. Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant. JAMA Intern Med 2019;179:1469-78. [Crossref] [PubMed]
28. Schaefer JK, Errickson J, Li Y, et al. Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication. JAMA Intern Med 2021;181:817-24. [Crossref] [PubMed]
29. Schaefer JK, Li Y, Gu X, et al. Association of Adding Aspirin to Warfarin Therapy Without an Apparent Indication With Bleeding and Other Adverse Events. JAMA Intern Med 2019;179:533-41. [Crossref] [PubMed]
30. Chan FKL, Goh KL, Reddy N, et al. Management of patients on antithrombotic agents undergoing emergency and elective endoscopy: joint Asian Pacific Association of Gastroenterology (APAGE) and Asian Pacific Society for Digestive Endoscopy (APSDE) practice guidelines. Gut 2018;67:405-17. [Crossref] [PubMed]
31. Gralnek IM, Stanley AJ, Morris AJ, et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy 2021;53:300-32. [Crossref] [PubMed]
32. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol 2020;76:594-622. [Crossref] [PubMed]
33. ASGE Standards of Practice Committee. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc 2016;83:3-16. [Crossref] [PubMed]
34. Alberts M, Zhdanava M, Pilon D, et al. Venous thromboembolism recurrence among one-and-done direct oral anticoagulant users: a retrospective longitudinal study. Int J Clin Pharm 2023;45:952-61. [Crossref] [PubMed]
35. Fanikos J, Tawfik Y, Almheiri D, et al. Anticoagulation-Associated Adverse Drug Events in Hospitalized Patients Across Two Time Periods. Am J Med 2023;136:927-936.e3. [Crossref] [PubMed]
36. Chan YH, Chao TF, Chen SW, et al. Off-label dosing of non-vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation. Heart Rhythm 2020;17:2102-10. [Crossref] [PubMed]
37. Yao X, Shah ND, Sangaralingham LR, et al. Non-Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction. J Am Coll Cardiol 2017;69:2779-90. [Crossref] [PubMed]