Achieving excellence in the pharmaceutical care of the surgical patient. / Hacia la excelencia en la atención farmacéutica al paciente quirúrgico.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

[Translated article] Achieving excellence in the pharmaceutical care of the surgical patient.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the perioperative setting has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care team so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors during the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety.

BACKGROUND: Clinical decision support systems (CDSSs) are a good strategy for preventing medication errors and reducing the incidence and severity of adverse drug events (ADEs). However, these systems are not very effective and are subject to multiple limitations that prevent their implementation in clinical practice. OBJECTIVES: The objective of this study was to evaluate the effectiveness of an advanced CDSS, HIGEA, which generates alerts based on predefined clinical rules to identify patients at risk of an ADE. METHODS: A multidisciplinary team defined the system and the clinical rules focusing on medication errors commonly encountered in clinical practice. Four intervention programs were defined: (1) dose adjustment in renal impairment; (2) adjustment of anticoagulation/antiplatelet therapy; (3) detection of biochemical/hematologic toxicities; and (4) therapeutic drug monitoring. We performed a 6-month observational prospective study to analyze the effectiveness of these clinical rules by calculating the positive predictive value (PPV). RESULTS: The team defined 211 clinical rules. During the study period, HIGEA generated 1,086 alerts (8.9 alerts per working day), which were reviewed by pharmacists. Fifty-one percent (554/1,086) of alerts generated an intervention to prevent a possible ADE; of these, 66% (368/554) required a documented modification to therapy owing to a real prescription error intercepted. The intervention program that induced the highest number of modifications to therapy was the dose adjustment in renal impairment program (PPV = 0.51), followed by the adjustment of anticoagulation/antiplatelet therapy program (PPV = 0.24). The percentage of accepted interventions was similar in surgical units (68%), medical units (67%), and critical care units (63%). CONCLUSION: Our study offers evidence that HIGEA is highly effective in preventing potential ADEs at the prescription stage.

Impact of fampridine on quality of life: clinical benefit in real-world practice.

OBJECTIVES: To assess the effectiveness and tolerability of fampridine in patients with multiple sclerosis (MS) in real clinical practice and to analyse adherence to treatment and general satisfaction of patients in terms of quality of life (QOL). METHODS: Patients who started treatment with fampridine from May 2014 to October 2014 were included. Primary and secondary outcomes were Timed 25-Foot Walk (T25FW) and MS Walking Scale-12 (MSWS-12) respectively, measured at baseline and 2 weeks, 3 and 6 months. Adherence was measured by the Morisky-Green questionnaire, patient satisfaction with a visual analogue scale (VAS) and QOL with improvement in mobility, self-care, daily activities, pain/discomfort or anxiety/depression. RESULTS: 30 patients (46.7% women) of mean age 39 years, mean MS duration 13.7 years, mean Expanded Disability Status Scale score 5.8, 57% with relapsing-remitting MS were included. 22 patients (73%) continued to take treatment throughout the study period. Two weeks after treatment initiation all measures improved significantly from baseline (T25FW: -7.5 s, p<0.05; MSWS-12: -36.7, p<0.05). At 6 months, walking speed and self-perceived walking ability were significantly improved (T25FW: -3.8 s, p<0.05; MSWS-12: -30.0, p<0.05). Adverse events were reported by 30% of patients. Seizures were registered in one patient. 70% of patients were adherent with treatment. Median (IQR) general satisfaction VAS score was 8 (7-9). Patients reported an improvement in mobility (70%), anxiety/depression (33.3%), self-care (23.3%), daily activities (23.3%) and pain/discomfort (3.3%). CONCLUSIONS: Fampridine is effective and safe in patients with MS in real clinical practice up to 6 months. Adherence to treatment was suboptimal but patients' general satisfaction was high and fampridine improved several items of QOL.

Adding value through pharmacy validation: a safety and cost perspective.

RATIONALE, AIMS AND OBJECTIVES: Prescribing errors (PE) are frequent, cause significant harm to patients and prove costly. Few studies demonstrate the impact of pharmacist interventions. The objectives of this study were to characterize the severity and cost of the potential outcome of PE that pharmacists can prevent and to develop an economic analysis. METHOD: We performed a non-randomized, prospective, observational study of all prescriptions made to adult patients admitted to a 1300-bed tertiary teaching hospital in Madrid (Spain) by means of a computerized physician order entry tool combined with a clinical decision support system. We analysed PE intercepted through the pharmacist validation process between January and June 2013. An independent team determined the severity of the potential adverse drug event (ADE) and the probability of causing an ADE (PAE). We estimated the cost avoidance and performed an economic analysis. A kappa statistic was used to verify inter-observer agreement. RESULTS: 484 PE were intercepted: 36.2% of PE were classified as being of minor severity, 59.1% as moderate and 4.7% as serious. The most common type of moderate-serious PE found was excessive dose (30%, 94/309), followed by insufficient dose (20%, 62/309), and omission (19%, 58/309). The most frequent families of drugs involved in moderate-serious PE were antineoplastic agents (22.3%, 69/309) and antimicrobials (17.2%, 53/309). The PAE was higher than 40% in 49% of PE. We estimated a cost avoidance of €291,422 and a return on investment of €1.7 for each €1 spent on a pharmacist's salary. The overall inter-rater agreement for the participants was moderate for severity (κ = 0.57; P <0.005) and strong for the PAE (κ = 0.77; P <0.005). CONCLUSIONS: Pharmacists add important value in preventing PE, and their interventions are financially beneficial for the institution.

Use of failure mode, effect and criticality analysis to improve safety in the medication administration process.

RATIONALE, AIMS AND OBJECTIVES: To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index. METHODS: This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized. RESULTS: Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility. CONCLUSION: FMECA is a useful approach that can improve the medication administration process.

Prevalence of medication administration errors in two medical units with automated prescription and dispensing.

OBJECTIVE: To identify the frequency of medication administration errors and their potential risk factors in units using a computerized prescription order entry program and profiled automated dispensing cabinets. DESIGN: Prospective observational study conducted within two clinical units of the Gastroenterology Department in a 1537-bed tertiary teaching hospital in Madrid (Spain). MEASUREMENTS: Medication errors were measured using the disguised observation technique. Types of medication errors and their potential severity were described. The correlation between potential risk factors and medication errors was studied to identify potential causes. RESULTS: In total, 2314 medication administrations to 73 patients were observed: 509 errors were recorded (22.0%)-68 (13.4%) in preparation and 441 (86.6%) in administration. The most frequent errors were use of wrong administration techniques (especially concerning food intake (13.9%)), wrong reconstitution/dilution (1.7%), omission (1.4%), and wrong infusion speed (1.2%). Errors were classified as no damage (95.7%), no damage but monitoring required (2.3%), and temporary damage (0.4%). Potential clinical severity could not be assessed in 1.6% of cases. The potential risk factors morning shift, evening shift, Anatomical Therapeutic Chemical medication class antacids, prokinetics, antibiotics and immunosuppressants, oral administration, and intravenous administration were associated with a higher risk of administration errors. No association was found with variables related to understaffing or nurse's experience. CONCLUSIONS: Medication administration errors persist in units with automated prescription and dispensing. We identified a need to improve nurses' working procedures and to implement a Clinical Decision Support tool that generates recommendations about scheduling according to dietary restrictions, preparation of medication before parenteral administration, and adequate infusion rates.