Cost-effectiveness of ward-based pharmacy care in surgical patients: protocol of the SUREPILL (Surgery & Pharmacy In Liaison) study.

BACKGROUND: Preventable adverse drug events (pADEs) are widely known to be a health care issue for hospitalized patients. Surgical patients are especially at risk, but prevention of pADEs in this population is not demonstrated before. Ward-based pharmacy interventions seem effective in reducing pADEs in medical patients. The cost-effectiveness of these preventive efforts still needs to be assessed in a comparative study of high methodological standard and also in the surgical population. For these aims the SUREPILL (Surgery & Pharmacy in Liaison) study is initiated. METHODS/DESIGN: A multi-centre controlled trial, with randomisation at ward-level and preceding baseline assessments is designed. Patients admitted to the surgical study wards for elective surgery with an expected length of stay of more than 48 hours will be included. Patients admitted to the intervention ward, will receive ward-based pharmacy care from the clinical pharmacy team, i.e. pharmacy practitioners and hospital pharmacists. This ward-based pharmacy intervention includes medication reconciliation in consultation with the patient at admission, daily medication review with face-to-face contact with the ward doctor, and patient counselling at discharge. Patients admitted in the control ward, will receive standard pharmaceutical care.The primary clinical outcome measure is the number of pADEs per 100 elective admissions. These pADEs will be measured by systematic patient record evaluation using a trigger tool. Patient records positive for a trigger will be evaluated on causality, severity and preventability by an independent expert panel. In addition, an economic evaluation will be performed from a societal perspective with the costs per preventable ADE as the primary economic outcome. Other outcomes of this study are: severity of pADEs, number of patients with pADEs per total number of admissions, direct (non-)medical costs and indirect non-medical costs, extra costs per prevented ADE, number and type of pharmacy interventions, length of hospital stay, complications registered in a national complication registration system for surgery, number of readmissions within three months after initial admission (follow-up), quality of life and number of non-institutionalized days during follow-up. DISCUSSION: This study will assess the cost-effectiveness of ward-based pharmacy care on preventable adverse drug events in surgical patients from a societal perspective, using a comparative study design. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2258.

Quality of pharmaceutical care in surgical patients.

BACKGROUND: Surgical patients are at risk for preventable adverse drug events (ADEs) during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements. OBJECTIVE: To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements. METHODS: For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam) participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients. RESULTS: Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and 'sensitivity to change'. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate). The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%). Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%). CONCLUSIONS: This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced.

Evidence based development of bedside clinical drug rules for surgical patients.

BACKGROUND: Surgical adverse events constitute a considerable problem. More than half of in-hospital adverse events are related to a surgical procedure. Medication related events are frequent and partly preventable. Due to the complexity and multidisciplinary nature of the surgical process, patients are at risk for drug related problems. Consistent drug management throughout the process is needed. OBJECTIVE: The aim of this study was to develop an evidence-based bedside tool for drug management decisions during the pre- and postoperative phase of the surgical pathway. SETTING: Tool development study performed in an academic medical centre in the Netherlands involving an expert panel consisting of a surgeon, a clinical pharmacist and a pharmacologist, all experienced in quality improvement. METHOD: Relevant medication related problems and critical pharmacotherapeutic decision steps in the surgical process were identified and prioritised by a team of experts. The final selection comprised undesirable effects or unintended outcomes related to surgery (e.g. pain, infection) and comorbidity related hazards (e.g. diabetes, cardiovascular diseases). To guide patient management, a list of bedside surgical drug rules was developed using international evidence-based guidelines. MAIN OUTCOME MEASURE: 55 bedside drug rules on 6 drug categories, specifically important for surgical practice, were developed: pain, respiration, infection, diabetes, cardiovascular diseases and anticoagulation. RESULTS: A total of 29 evidence-based guidelines were used to develop the Bedside Surgical Drug Rules tool. This tool consist of practical tables covering management regarding (1) the most commonly used drug categories during surgery, (2) comorbidities that require dosing adjustments and, (3) contra-indicated drugs in the perioperative period. CONCLUSION: An evidence-based approach provides a practical basis for the development of a bedside tool to alert and assist the care providers in their drug management decisions along the surgical pathway.

Adverse drug events in surgical patients: an observational multicentre study.

BACKGROUND: Errors occurring during different steps of the medication process can lead to adverse drug events (ADEs). Surgical patients are expected to have an increased risk for ADEs during hospitalization. However, detailed information about ADEs in the surgical patient is lacking. OBJECTIVE: In this study, we aim to measure the incidence and nature of (preventable) ADEs, potential risk factors for and outcome parameters of (preventable) ADEs in surgical patients. SETTING: Observational multicentre cohort study in which eight surgical wards participated from three Dutch hospitals, all using computerized physician order entry (CPOE) systems with clinical decision support. METHODS: Electively admitted surgical patients of the participating wards were included from March until June 2009. ADEs were measured using a standardized method with expert judgment. Incidence, severity, preventability and accountable medication were assessed. Poisson regression analysis was applied to determine the associations between possible risk factors and the occurrence of ADEs, expressed as incidence rate ratio (IRR). Also outcomes of ADEs in surgical patients were measured. MAIN OUTCOME MEASURE: The incidence and nature of (preventable) ADEs in surgical patients. RESULTS: A total of 567 surgical patients were included. We found an incidence of 27.5 ADEs and 4.2 preventable ADEs (pADEs) per 100 admissions (15.4 %). A quarter of the pADEs were severe or life-threatening. Opioids and anti-coagulation medication play a major role in the occurrence of ADEs and pADEs respectively. Univariate analysis revealed an American Society of Anesthesiologists classification of III or more as a risk factor for ADEs. Patients older than 65 years [IRR 2.77 (1.14-6.72)], with cardiovascular comorbidity [IRR 2.87 (1.13-7.28)], or undergoing vascular surgery [IRR 2.32 (1.01-5.32)] were at risk for pADEs. Patients experiencing an ADE had a significant longer duration of admission than patients without an ADE. CONCLUSIONS: Surgical patients are at considerable risk of experiencing one or more ADEs during their admission, also in CPOE-hospitals. Risk factors for pADEs are age older than 65 years, cardiovascular comorbidity, and vascular surgery. Intensified monitoring may be needed in patients with a higher than average risk for pADEs.

A targeted method for standardized assessment of adverse drug events in surgical patients.

OBJECTIVES: This study demonstrates the development, reliability and outcome of a targeted method for standardized assessment of adverse drug events (ADEs) in surgical patients. METHODS: Initial practice evaluation of this ADE assessment method was carried out in a prospective single centre cohort study. In total, 262 electively admitted surgical patients were included. The surgical trigger tool was applied to patients' medical records by two independent reviewers, and subsequent assessment of causality, severity and preventability of ADEs was carried out by two independent expert panels consisting of a consultant surgeon and a clinical pharmacologist. The surgical trigger tool and causality assessment method were each tested on reliability in a separate group of 50 randomly selected patients using Fleiss and Cohen's kappa statistics and percentages of agreement. Comparison of this method with an existing trigger tool method for ADEs was performed. RESULTS: Our surgical trigger tool contains 51 triggers. The inter- and intra-rater calculations showed substantial to almost perfect levels of agreement (kappa range 0.71-0.83), with a 97.8-98.5% percentage of agreement. Fair to substantial levels of agreement were calculated for causality, severity and preventability (kappa range 0.38-0.79). The percentages of inter- and intra-rater agreement were 68.9 and 70.5% for causality, 67.0 and 82.0% for severity, and both 98.4% for preventability, respectively. Compared with the existing trigger tool method for ADEs, we found an additional 363 triggers, 18 ADEs (an extra 20%) and 3 preventable ADEs in our surgical cohort. CONCLUSIONS: This targeted trigger tool for standardized assessment of ADEs in surgical patients shows excellent agreement between reviewers. The assessment of medication-related harm had acceptable agreement. Compared with an existing ADE trigger tool method, the present method found almost 20% extra ADEs. This method can be a useful alternative to existing trigger tool methods, in particular to assess medication safety in surgical patients.