Evaluation of vaccination coverage in heart failure patients in a tertiary center.

Background: Despite current recommendation, vaccination coverage (VC) for patients with heart failure (HF) remains far too limited. Aims: To evaluate the VC of HF patients followed in our hospital center and investigate the barriers to vaccination and the ways to address them. Methods: This was a cross-sectional monocentric descriptive study conducted between December 2019 and January 2021 at the University Hospital of Montpellier, France. Patients with HF history hospitalized in cardiology unit (CU) and patients in a HF telemonitoring program (TP) were included. An interview was conducted by a pharmacist to find out the patient's vaccination status against influenza and pneumococcus. For non-vaccinated patients, opinion and willingness to be vaccinated were also obtained. Results: Data from 335 patients were collected (185 in CU, 150 in TP). The mean age was 69.3 years and the proportion of males was 72%. About 65% were vaccinated against influenza in the last year (60% in CU, 72% in TP, p = 0.022) and 22% were up to date with pneumococcal vaccination (11% in CU, 35% in TP, p < 0.001). Among patients not vaccinated, 17% refused vaccination. Among unvaccinated patients who consider vaccination, 69% wanted to be vaccinated by their general practitioner (GP). Conclusions: The VC of HF patients remains insufficient. Patients in TP are more vaccinated than patients in CU, which could involve better management. The low rate of vaccinated patients is mainly explained by a lack of awareness. The medical team, including the clinical pharmacist by his dedicated time during medication reconciliation may play a major role in the management of hospitalized patients as well as GP's as local actors.

Impact of medication characteristics and adverse drug events on hospital admission after an emergency department visit: Prospective cohort study.

OBJECTIVES: Emergency department (ED) overcrowding is a problem for the delivery of adequate and timely emergency care. To improve patient flow and the admission process, the quick prediction of a patient's need for admission is crucial. We aimed to investigate the variables associated with hospitalisation after an ED visit, with a particular focus on the variables related to medication. METHODS: This prospective study was conducted from 2011 to 2018 in subacute medical ED of a French University Hospital. Specialised EDs (paediatric, gynaecologic, head and neck and psychiatric) and the outpatient unit of the ED were not included. Participation in this study was proposed to all adult patients who underwent a medication history interview with a pharmacist. Pharmacists conducted structured interviews for the completion of the medication history and the detection of adverse drug events (ADE). Relations between patient characteristics and hospitalisation were analysed using logistic regression. RESULTS: Among the 14 511 included patients, 5972 (41.2%) were hospitalised including 69 deaths. In total, 7458 patients (51.4%) took more than 5 medications and 2846 patients (19.6%) had an ADE detected during the ED visit. In hospitalised patients, bleeding (32.2%) and metabolic disorders (16.8%) were the most observed ADE symptoms. Variables associated with increased hospital admission included 2 demographic variables (age, male gender), 4 clinical variables (renal and hepatic failures, alcohol addiction, ED visit for respiratory reason) and 6 medication-related variables (medications >5, use of blood, systemic anti-infective, metabolism and antineoplastic/immunomodulating medications and ADE). CONCLUSION: We identified variables associated with hospitalisation including drug-related variables. These results point out the importance and the relevance of collecting medication data in a subacute medical ED (study registered on ClinicalTrials.gov, NCT03442010).

Clinical, Economic, and Organizational Impact of the Clinical Pharmacist in an Orthopedic and Trauma Surgery Department.

AIM: The aim of this study was to evaluate the clinical, economic, and organizational impact of clinical pharmacist services added to an adult orthopedic and trauma surgery unit in a university hospital. METHODS: This was a prospective, observational study performed from January to February 2017. All pharmacists' interventions were documented, and their clinical, economic, and organizational impact and the probability of adverse drug events (ADEs) were assessed using the clinical, economic and organizational scale three-dimensional scale. An expert panel composed of three clinical pharmacists, one surgeon and one anesthetist classified the pharmacist intervention. The potential clinical impact was determined through a consensus by the expert panel. Cost avoidance was calculated for serious ADEs with a major impact by avoiding an additional cost of €4912 per event and taking into account the probability of ADE occurrence. RESULTS: The pharmacists performed 1014 interventions for 28 days with a 95.3% acceptance rate by prescribers. Thirty-nine interventions were rated to have a major clinical impact (3.8%). The organizational impact was estimated favorable for 856 (84.4%) pharmacist interventions. Cost avoidance was estimated at €24,364, and the indirect costs benefit was estimated at €11,864 during the study. The cost-benefit ratio of the clinical pharmacist intervention was €1.94 in savings for every €1 invested. CONCLUSIONS: Clinical pharmacist services in an orthopedic and trauma surgery department have the potential to improve patient outcomes and avoid healthcare costs. Furthermore, the presence of a pharmacist in surgical units allows for communication between the unit and the pharmacy, which produces better fluidity and improves the quality of care.

Medication Errors at Hospital Admission and Discharge: Risk Factors and Impact of Medication Reconciliation Process to Improve Healthcare.

OBJECTIVE: First, the aim of the study was to assess the prevalence, characteristics, and severity of unintended medication discrepancies (UMDs) and medication errors (MEs) at admission and discharge of hospitalization. Second, the aim of the study was to identify clinical and hospitalization factors associated with risk of UMDs as well as characteristics of the medication reconciliation process associated with UMDs detection. METHODS: This prospective observational study included all adult patients admitted from 2013 to 2015 in the Endocrinology-Diabetology-Nutrition Department of Montpellier Hospital, France. Clinical pharmacists conducted medication reconciliation by collecting the best possible medication history from different sources and comparing it with admission and discharge prescriptions to identify discrepancies. Unintended medication discrepancies corrected by the physician were considered as MEs. Risk factors of UMDs were identified with logistic regression. RESULTS: Of 904 patients included, 266 (29.4%) had at least one UMD, at admission or at discharge. In total, 378 (98.2%) of 385 UMDs were considered to be MEs. Most MEs were omissions (59.3%). Medication errors were serious or very serious in 36% of patients and had potentially moderate severity in almost 40% of patients. The risk of UMDs increased constantly with the number of treatments (P < 0.001). Thyroid (adjusted odds ratio [OR] = 1.79, 95% CI = 1.12-2.86) and infectious diseases (adjusted OR = 1.80, 95% CI = 1.17-2.78) were associated with UMDs risk at admission. The best type of source for the detection of UMDs was the general practitioner or nurse (OR = 2.64, 95% CI = 1.51-4.63). CONCLUSIONS: Unintended medication discrepancies are frequent at hospital and depend on intrinsic clinical parameters but also on practice of medication reconciliation process, such as number and type of sources used.

Adverse Drug Events Detected by Clinical Pharmacists in an Emergency Department: A Prospective Monocentric Observational Study.

OBJECTIVES: Adverse drug events (ADEs) are a major public health issue in hospitals. They are difficult to detect because of incomplete or unavailable medication history. In this study, we aimed to assess the rate and characteristics of ADEs identified by pharmacists in an emergency department (ED) to identify factors associated with ADEs. METHODS: In this prospective observational study, we included consecutive adult patients presenting to the ED of a French 2600-bed tertiary care university hospital from November 2011 to April 2015. Clinical pharmacists conducted structured interviews and collected the medication history to detect ADEs (i.e., injuries resulting directly or indirectly from adverse drug reactions and noncompliance to medication prescriptions). Unsure ADE cases were reviewed by an expert committee. Relations between patient characteristics, type of ED visit, and ADE risk were analyzed using logistic regression. RESULTS: Among the 8275 included patients, 1299 (15.7%) presented to the ED with an ADE. The major ADE symptoms were bleeding, endocrine problems, and neurologic disorders. Moreover, ADEs led to the ED visit, hospitalization, and death in 87%, 49.3%, and 2.2% of cases, respectively. Adverse drug event risk was independently associated with male sex, ED visit for neurological symptoms, visit to the ED critical care unit, or ED short stay hospitalization unit, use of blood, anti-infective, antineoplastic, and immunomodulating drugs. CONCLUSIONS: This study improves the knowledge about ADE characteristics and on the patients at risk of ADE. This could help ED teams to better identify and manage ADEs and to improve treatment quality and safety.

Development and validation of a score to assess risk of medication errors detected during medication reconciliation process at admission in internal medicine unit: SCOREM study.

BACKGROUND: Medication errors (ME) can be reduced through preventive strategies such as medication reconciliation. Such strategies are often limited by human resources and need targeting high risk patients. AIMS: To develop a score to identify patients at risk of ME detected during medication reconciliation in a specific population from internal medicine unit. METHODS: Prospective observational study conducted in an internal medicine unit of a French University Hospital from 2012 to 2016. Adult hospitalised patients were eligible for inclusion. Medication reconciliation was conducted by a pharmacist and consisted in comparing medication history with admission prescription to identify MEs. Risk factors of MEs were analysed using multivariate stepwise logistic regression model. A risk score was constructed using the split-sample approach. The split was done at random (using a fixed seed) to define a development data set (N = 1256) and a validation sample (N = 628). A regression coefficient-base scoring system was used adopting the beta-Sullivan approach (Sullivan's scoring). RESULTS: Pharmacists detected 740 MEs in 368/1884 (19.5%) patients related to medication reconciliation. Female gender, number of treatments >7, admission from emergency department and during night or weekend were significantly associated with a higher risk of MEs. Risk score was constructed by attributing 1 or 2 points to these variables. Patients with a score ≥3 (OR [95% CI] 3.10 [1.15-8.37]) out of 5 (OR [95% CI] 8.11 [2.89-22.78]) were considered at high risk of MEs. CONCLUSIONS: Risk factors identified in our study may help prioritising patients admitted in internal medicine units who may benefit the most from medication reconciliation (ClinicalTrials.gov number NCT03422484).

Collaboration between cardiologist and clinical pharmacist on prescription quality: What is the potential clinical impact for cardiology patients?

OBJECTIVES: The aim of this study was to determine the effect of pharmacists' interventions (PI) on the potential clinical impact of medication errors, including the lack of therapeutic optimisation of patients with cardiologic diseases, such as heart failure and acute coronary syndrome). METHODS: This was an observational, prospective study conducted in the cardiology department of a French university hospital centre for a duration of 9 months. All prescriptions were analysed and PI were registered for clinical rating by pharmacists and cardiologist. RESULTS: A total of 532 PI cases were recorded in 339 patients, with a mean of 1.57 (±1.04) PI. The PI acceptance rate was 98.1%. "Dose adjustment" and "introduction therapy" were the most common interventions and represented 38.0% and 32.9%, respectively, of all PI. Statins were the most frequently involved drugs (18.1%), followed by ACE (Angiotensin Converting Enzyme) inhibitors (10.9%) and antiplatelet agents (9.3%). Moreover, 13.8% of PI potentially avoided a severe or very severe clinical impact (n = 71) and 38.6% had a significant impact altering the quality of life (n = 198). There was no significant difference between the average score performed by the clinical pharmacist included in the cardiology team and the one obtained by the cardiologist (P = .797). In contrast, a significant difference was observed for the average score established by the pharmacist localised in central pharmacy versus the rating of the cardiologist (P < .001). CONCLUSIONS: The collaboration between clinical pharmacists and cardiologists in the medical units seems to be beneficial to the quality of prescriptions, including the implementation of recommendations. The good rate of PI acceptance and the similar rating with the cardiologist show that there is a change in perspective of the pharmacist, being closer to the clinical reality.

Non-achievement of LDL-cholesterol targets in patients with diabetes at very-high cardiovascular risk receiving statin treatment: Incidence and risk factors.

BACKGROUND: Cardiovascular diseases are the first cause of mortality in patients with diabetes, and LDL-cholesterol is a well-established cardiovascular risk factor. This study aimed to assess rate of LDL-cholesterol target attainment among patients with diabetes at very-high cardiovascular risk treated with statins, and to identify predictive factors of non-attainment of target in this population. METHODS: Patients were recruited in the Nutrition-Diabetes unit of Montpellier University Hospital, France, from 2014 to 2017. We included all consecutive patients with type 1 or type 2 diabetes receiving statin treatment and at very-high cardiovascular risk according to 2016 ESC guidelines, therefore having a LDL-cholesterol target of <1.8 mmol/L. LDL-cholesterol levels were measured upon admission. Variables independently associated with non-attainment of LDL-Cholesterol target were assessed using multivariable logistic regression. RESULTS: 654 patients were included. Mean age was 63.8 years (SD 11.0), 41.9% were women and 42.3% had a history of cardiovascular disease. 59% of patients did not achieve LDL-cholesterol target, with a median value (interquartile range) of 2.4 mmol/L (2.1-2.9) versus 1.4 mmol/L (1.1-1.6) in patients at target. Risk of non-attainment of LDL-cholesterol target value was increased in women (odds ratio [95% confidence interval]: 2.27 [1.62-3.17]) and decreased in patients with history of coronary artery disease (0.64 [0.45-0.89]) or history of stroke or transient ischemic attack (0.59 [0.33-1.07]). CONCLUSIONS: Management of dyslipidemia is suboptimal, even in very-high risk patients with diabetes under statins. Lipid-lowering treatment should be intensified, in particular in very high risk patients with diabetes who are women or in primary cardiovascular prevention. Clinical Trial number: NCT03449784.

Patients with diabetes are at high risk of serious medication errors at hospital: Interest of clinical pharmacist intervention to improve healthcare.

BACKGROUND: Medication errors (ME) are major public health issues in hospitals because of their consequences on patients' morbi-mortality. This study aims to evaluate the prevalence of ME at admission and discharge of hospitalization in diabetic and non-diabetic patients, and determine their potential clinical impact. METHOD: This prospective observational study was conducted at the Endocrinology-Diabetology-Nutrition Department. All adult patients admitted were eligible. A total of 904 patients were included, of which 671 (74.2%) with diabetes mellitus. Clinical pharmacists conducted medication reconciliation: they collected the Best Possible Medication History and then compared it with admission and discharge prescriptions to identify medication discrepancies. ME were defined as unintended medication discrepancies if corrected by the physician. RESULTS: Clinical pharmacists allowed correcting ME in 176/904 (19.5%) patients at admission and in 86/865 (9.9%) patients at discharge. More than half of ME were omissions. Diabetic patients were more affected by ME than non-diabetic patients, both at admission (22.1% vs 12.0%, p<0.001) and at discharge (11.4% vs 5.7%, p=0.01). The diabetic group also had more potentially severe and very severe ME. Diabetic patients had on average twice more medications than non-diabetic patients (8.7±4.5 vs 4.4±3.4, p<0.001). The polypharmacy associated with diabetes, but not diabetes mellitus itself, was identified as a risk factor of ME. CONCLUSIONS: The intervention of clinical pharmacists allowed correcting 378 ME in 25.8% of the cohort before they caused harm. Clinicians, pharmacists and other health care providers should therefore work together to improve patients' safety, in particular in high-risk patients such as diabetic patients.

Influence of vitamins, trace elements, and iron on lipid peroxidation reactions in all-in-one admixtures for neonatal parenteral nutrition.

BACKGROUND: The purpose of this study was to evaluate the effect of vitamins, trace elements, or iron on lipid peroxidation in all-in-one parenteral nutrition (PN) admixtures for preterm neonates. METHODS: Malondialdehyde (MDA) concentrations were analyzed over a 24-hour period (H1-H24) in lipid-containing PN solutions that have a composition identical to that used in the routine clinical care of preterm infants. Six different solutions were prepared and evaluated when exposed to ambient light and light-protected conditions as follows: control (without vitamins [Vit], trace elements [TE], or iron [Fe] [Vit-TE-Fe-]), solution 1 (Vit+TE+Fe-), solution 2 (Vit+TE-Fe-), solution 3 (Vit-TE+Fe-), solution 4 (Vit-TE-Fe+), and solution 5 (Vit+TE+Fe+). RESULTS: MDA concentrations in PN solutions were significantly higher at H24 than at H0 when they contained multivitamins (P < .001), trace elements (P = .002), or iron saccharate (P = .018). MDA concentration was particularly high when all 3 micronutrients were present (P < .001) or when the solutions were exposed to ambient light. In solutions containing iron, MDA concentrations were elevated at H0, and levels did not change whether protected from (P < .001) or exposed to (P < .001) from light. CONCLUSIONS: The addition of vitamins and trace elements to PN solutions induces a significant increase in peroxidation products, which are lowered when admixtures are protected from light. Iron should not be included in these solutions, even if solutions are light-protected. By following these conditions it is possible to use all-in-one admixtures in the nutrition management of preterm infants.

Lipid peroxidation in all-in-one admixtures for preterm neonates: impact of amount of lipid, type of lipid emulsion and delivery condition.

AIM: To evaluate the effect of lipid emulsion composition and delivery condition on lipid peroxidation in typical all-in-one parenteral admixtures for preterm neonates. METHODS: Malonedialdehyde (MDA) concentrations were assessed in different all-in-one admixtures. We evaluated the effects of fat blend (three lipid emulsions) and the amount of lipids, as well as the effects of protecting bags and/or tubing from ambient light and storage for 72 h. MDA was measured by liquid chromatography/mass spectrometry. RESULTS: Three hundred and sixty samples were collected from 114 admixtures. Neither the type of lipid (p = 0.43) nor the interaction between light and type of lipid (p = 0.49) had any influence on final MDA concentrations, but the increase in MDA concentration at 24 h (T(24)) was related to light exposure (p < 0.001). The increase in MDA concentration was related to the increase in lipid amount in the admixture at T(0) (r = 0.77) and T(24) (r = 0.86). MDA concentrations in solutions stored for 72 h showed no significant increase, with no difference between the three lipid emulsions (p = 0.69). CONCLUSION: All-in-one admixtures may be interesting for the parenteral nutrition of preterm neonates. Protection from light and restricting the amount of lipid to what is required for appropriate energy provision are essential to limit lipid peroxidation.

Neurotoxicity related to valganciclovir in a child with impaired renal function: usefulness of therapeutic drug monitoring.

OBJECTIVE: To report a case of neurotoxicity related to antiviral drugs, discuss the involvement of concomitant medications, and document the pharmacokinetics of ganciclovir (administered as valganciclovir) in a child with impaired renal function. CASE SUMMARY: A 13-year-old boy with acute lymphoblastic leukemia was treated for cytomegalovirus retinitis with valganciclovir 450 mg every 2 days in the course of hematopoietic stem cell transplantation. Concomitant medication included omeprazole, furosemide, and acetaminophen. During treatment, when creatinine clearance decreased to 20 mL/min, the child presented with acute neurotoxicity, consisting of mental confusion and hallucinations, which resolved when all medications were stopped. Valganciclovir therapeutic monitoring showed high ganciclovir concentrations in the plasma (3.85 microg/mL) and cerebrospinal fluid (2.6 microg/mL) 48 hours after the last valganciclovir dose. After recovery of neurologic function, valganciclovir was resumed at a lower dosage (225 mg twice a week) with therapeutic drug monitoring and was well tolerated. However, the cytomegalovirus infection was not resolved. The leukemia relapsed, and the patient had terminal renal failure and died. The Naranjo probability scale indicated a probable relationship between valganciclovir and neurotoxicity. DISCUSSION: Drugs taken by this child (acyclovir, valganciclovir, omeprazole) have been reported to induce neurotoxicity, with the pharmacokinetics of the first 2 being altered by renal failure. At the time when acyclovir was first administered, symptoms of neurotoxicity were already apparent. Moreover, plasma concentrations of ganciclovir were very high during the course of the neurotoxicity. Thus, the adverse effects seemed related to an overdosage of valganciclovir and were worsened by the addition of acyclovir. CONCLUSIONS: This case is informative because few clinical and pharmacokinetic data are available concerning the use of valganciclovir in children. A study should be performed to determine the proper pediatric dose of valganciclovir with and without renal impairment to prevent the occurrence of adverse effects.