Folia Med (Plovdiv). 2021 Dec 31;63(6):913-918. doi: 10.3897/folmed.63.e59216.

ABSTRACT

INTRODUCTION: Lipid emulsions are increasingly used as an antidote to lipophilic drug intoxications. The dose recommended by the American Society of Regional Anesthesia is used primarily for the treatment of local anesthetic systemic toxicity. There is insufficient information about what the dose of lipid emulsions (LE) should be in other intoxications depending on their severity.

AIM: To determine the LE dose in a shock or haemodynamic instability in patients with acute exogenous intoxications treated with LE.

MATERIALS AND METHODS: Forty-nine patients with acute lipophilic drug intoxications were treated with LE in the Clinic of Toxicology at the Naval Hospital in Varna.Statistical analysis was performed using the statistical functions of Excel 2016 and the Statistica 7.0 software package.

RESULTS: The percentage of patients receiving a low dose of LE of 0.3 ml/kg (93.87%) was significantly higher than the percentage of patients treated with a medium (2.04%) and a high dose (4.08%) of LF. The high dose of LE of 1.5 ml/kg recommended by the American Society of Regional Anesthesia was administered to two patients (4.08%). In severe intoxications with exotoxic shock, the rate of LE administration varies from 20 ml/h to 40 ml/h.

CONCLUSIONS: In severe intoxications with cardiotoxic syndrome and haemodynamic instability, LE should be used in the dose as suggested by the American Society of Regional Anesthesia. It is possible to use lower doses of LE in the range of 0.3-0.6 ml/kg in all moderate poisonings administered by continuous intravenous infusion for 12-24-48 hours. No side effects were observed at these doses.

PMID:35851238 | DOI:10.3897/folmed.63.e59216

Zhongguo Zhong Yao Za Zhi. 2022 Jul;47(14):3693-3700. doi: 10.19540/j.cnki.cjcmm.20220520.401.

ABSTRACT

The safety problem of traditional Chinese medicine containing aristolochic acid is of great concern in China and abraod, which poses a challenge in clinical application and supervision. There are many types of aristolochic acid analogues(AAAs) and 178 have been reported. According to the structure, they are classified into aristolochic acids(AAs) and aristololactams(ALs). The toxi-city is remarkably different among AAAs of different types. For example, AA-Ⅰ has strong nephrotoxicity and carcinogenicity, and the toxicity of AA-Ⅱ is lower than that of AA-Ⅰ. Besides, AA-Ⅳa and AA-Ⅰa are considered to have no obvious nephrotoxicity and carcinogenicity. The types and content of AAAs are significantly different among traditional Chinese medicines derived from different Aristolochiaceae species. For example, Asari Radix et Rhizoma and Aristolochiae Herba mainly consist of AAAs without obvious toxicity(such as AA-Ⅳa). The content of AAAs in compound preparations is related to the proportions of the medicinals and the processing method. The content of AA-Ⅰ in some compound preparations is very low or below the detection limit. Therefore, the author concludes that AAAs of different types have different toxicity, but not all AAAs has nephrotoxicity and carcinogenicity. Moreover, the toxicity of traditional Chinese medicines containing AAAs should not be generalized and AA-Ⅰ and AA-Ⅱ should be emphasized. In this paper, it is suggested that traditional Chinese medicine containing AAAs should be used rationally and research, analysis, and toxicological study of AAAs species and content should be strengthened. In addition, limit standards of AA-Ⅰ and AA-Ⅱ should be formulated and science-based supervision should be performed.

PMID:35850825 | DOI:10.19540/j.cnki.cjcmm.20220520.401

Eur J Hosp Pharm. 2022 Jul 19:ejhpharm-2022-003465. doi: 10.1136/ejhpharm-2022-003465. Online ahead of print.

NO ABSTRACT

PMID:35853693 | DOI:10.1136/ejhpharm-2022-003465

Gan To Kagaku Ryoho. 2022 Jul;49(7):779-782.

ABSTRACT

BACKGROUND: The highest prevalence of drug-induced interstitial pneumonitis(IP)occurs in patients receiving antineoplastic agents, such as cytotoxic chemotherapeutic drugs, molecular targeted drugs, and immune checkpoint inhibitors. A certain period of the treatment for IP requires discontinuation of the anticancer therapy, resulting in progression of the malignant status.

CASE: A 70-year-old man was incidentally diagnosed with locally advanced unresectable pancreatic cancer in the course of his treatment for ventricular dysrhythmia. After the insertion of a pacing instrument, he was ensured to be eligible to receive combination chemotherapy with gemcitabine and nab-paclitaxel(GnP)as the primary regimen. Shortly after the second course of GnP, the patient had high fever and developed pneumomediastinum 3 days prior to the onset of IP. The GnP treatment was suspended, and the IP was treated with pulse steroid therapy. The respiratory disorder took approximately 3 months to resolve; however, this concomitantly led to aggravation of the malignancy, which developed multiple metastases to the liver. The patient was no longer allowed to receive antineoplastic treatment.

CONCLUSION: Although GnP may be a key regimen for the treatment of unresectable pancreatic cancer, patients should be closely monitored to ensure early detection of adverse events, such as interstitial pneumonia. Furthermore, drug-induced pneumomediastinum may be a precursor to the onset of interstitial pneumonia.

PMID:35851350

Indian J Pharmacol. 2022 May-Jun;54(3):177-182. doi: 10.4103/ijp.ijp_946_21.

ABSTRACT

OBJECTIVE: The objective of the study was to assess the efficacy and safety profiles of combined treatment of prednisolone with thalidomide (Gr-A) and prednisolone with clofazimine (Gr. B) in patients with erythema nodosum leprosum (ENL) or type 2 lepra reactions.

MATERIALS AND METHODS: Efficacy of both regimens was assessed on the basis of clinical recovery of recurrent ENL measured by reaction severity score (RSS), Visual Analog Scale (VAS), and recurrence of type 2 lepra reaction. The causality assessment of adverse drug reactions was done using the WHO UMC causality assessment scale.

RESULTS: The average age of patients with recurrent ENL was 42.8 years (male) and 51.8yrs (female) and had mean duration of leprosy and recurrent ENL 2.4 years and 2.09 years, respectively. 80% of nonrecurrence was observed in Gr-A versus 66% in Gr-B. Significant (P < 0.05) lower RSS and VAS was found in both the treatment groups as compared to pretreatment value. The reduction in RSS and VAS was statistically significant (P < 0.05) in Gr-A compared to Gr-B treatment.

CONCLUSION: Thalidomide combination with steroid was found to be more efficacious than clofazimine combination with steroid in the treatment of ENL both the treatment regimens showed few tolerable side effects. Improved strategies for the treatment and management of these reactions need to be developed.

PMID:35848688 | DOI:10.4103/ijp.ijp_946_21

Int J Clin Pract. 2022 Jun 28;2022:9619699. doi: 10.1155/2022/9619699. eCollection 2022.

ABSTRACT

METHODS: The study was based on a retrospective analysis of pharmacist interventions for DRPs detected during the medication order review and documented into the French Act-IP© database over a 12-year period. DRPs and PIs were analyzed, and independent factors of physician acceptance were assessed via multiple logistic regression.

RESULTS: Out of the 620,620 PIs registered, 29,694 targeted a PPI (4.8%). PPI's DRPs were mostly related to the prescription of a "drug not available at the hospital" (26.1%) and a "drug use without indication" (18.3%); PIs were mostly "drug switch" (35.9%) and "drug discontinuation" (26.1%). In all, 18,919 PIs were accepted by physicians (63.7%). Acceptance was significantly associated with patient age: less accepted for the 18-75 years group (OR = 0.59, 95 CI [0.46-0.76]), and the >75 years group (OR = 0.57, 95 CI [0.44-0.73]) vs. <18 years group; for the type of DRP, "drug use without indication" was the less accepted (OR = 0.73, 95 CI [0.63-0.85]); for the type of PI, "dose adjustment" was the less accepted (OR = 0.32, 95 CI [0.23-0.45]).

CONCLUSION: Pharmacists contribute to preventing DRPs associated with PPI prescriptions during the medication order review process. Moreover, they often detect PPIs used without indication and they propose drug discontinuation, which contributes to the PPI deprescribing process. PIs should be further developed in the future to reduce PPI overprescription.

PMID:35846437 | PMC:PMC9256420 | DOI:10.1155/2022/9619699

Cochrane Database Syst Rev. 2022 Jul 13;7:CD013136. doi: 10.1002/14651858.CD013136.pub2.

ABSTRACT

BACKGROUND: Attention Deficit Hyperactivity Disorder (ADHD) can co-occur in up to 40% of people with epilepsy. There is debate about the efficacy and tolerability of stimulant and non-stimulant drugs used to treat people with ADHD and co-occurring epilepsy.

OBJECTIVES: To assess the effect of stimulant and non-stimulant drugs on children and adults with ADHD and co-occurring epilepsy in terms of seizure frequency and drug withdrawal rates (primary objectives), as well as seizure severity, ADHD symptoms, cognitive state, general behaviour, quality of life, and adverse effects profile (secondary objectives).

SEARCH METHODS: We searched the following databases on 12 October 2020: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 9 October 2020), CINAHL Plus (EBSCOhost, 1937 onwards). There were no language restrictions. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialised Registers of Cochrane Review Groups including Epilepsy. SELECTION CRITERIA: We included randomised controlled trials of stimulant and non-stimulant drugs for people of any age, gender or ethnicity with ADHD and co-occurring epilepsy.

DATA COLLECTION AND ANALYSIS: We selected articles and extracted data according to predefined criteria. We conducted primary analysis on an intention-to-treat basis. We presented outcomes as risk ratios (RRs) with 95% confidence intervals (CIs), except for individual adverse effects where we quoted 99% CIs. We conducted best- and worst-case sensitivity analyses to deal with missing data. We carried out a risk of bias assessment for each included study using the Cochrane risk of bias tool and assessed the overall certainty of evidence using the GRADE approach.

MAIN RESULTS: We identified two studies that matched our inclusion criteria: a USA study compared different doses of the stimulant drug osmotic-release oral system methylphenidate (OROS-MPH) with a placebo in 33 children (mean age 10.5 ± 3.0 years), and an Iranian study compared the non-stimulant drug omega-3 taken in conjunction with risperidone and usual anti-seizure medication (ASM) with risperidone and ASM only in 61 children (mean age 9.24 ± 0.15 years). All children were diagnosed with epilepsy and ADHD according to International League Against Epilepsy and Diagnostic and Statistical Manual of Mental Disorders, fourth edition, criteria, respectively. We assessed both studies to be at low risk of detection and reporting biases, but assessments varied from low to high risk of bias for all other domains. OROS-MPH No participant taking OROS-MPH experienced significant worsening of epilepsy, defined as: 1. a doubling of the highest 14-day or highest two-day seizure rate observed during the 12 months before the trial; 2. a generalised tonic-clonic seizure if none had been experienced in the previous two years; or 3. a clinically meaningful intensification in seizure duration or severity (33 participants, 1 study; low-certainty evidence). However, higher doses of OROS-MPH predicted an increased daily risk of a seizure (P < 0.001; 33 participants, 1 study; low-certainty evidence). OROS-MPH had a larger proportion of participants receiving 'much improved' or 'very much improved' scores for ADHD symptoms on the Clinical Global Impressions for ADHD-Improvement tool (33 participants, 1 study; low-certainty evidence). OROS-MPH also had a larger proportion of people withdrawing from treatment (RR 2.80; 95% CI 1.14 to 6.89; 33 participants, 1 study; moderate-certainty evidence). Omega-3 Omega-3 with risperidone and ASM were associated with a reduction in mean seizure frequency by 6.6 seizures per month (95% CI 4.24 to 8.96; 56 participants, 1 study; low-certainty evidence) and an increase in the proportion of people achieving 50% or greater reduction in monthly seizure frequency (RR 2.79, 95% CI 0.84 to 9.24; 56 participants, 1 study; low-certainty evidence) compared to people on risperidone and ASM alone. Omega-3 with risperidone and ASM also had a smaller proportion of people withdrawing from treatment (RR 0.65, 95% CI 0.12 to 3.59; 61 participants, 1 study; low-certainty evidence) but a larger proportion of people experiencing adverse drug events (RR 1.40, 95% CI 0.44 to 4.42; 56 participants, 1 study; low-certainty evidence) compared to people on risperidone and ASM alone.

AUTHORS' CONCLUSIONS: In children with a dual-diagnosis of epilepsy and ADHD, there is some evidence that use of the stimulant drug OROS-MPH is not associated with significant worsening of epilepsy, but higher doses of it may be associated with increased daily risk of seizures; the evidence is of low-certainty. OROS-MPH is also associated with improvement in ADHD symptoms. However, this treatment was also associated with a large proportion of treatment withdrawal compared to placebo. In relation to the non-stimulant drug omega-3, there is some evidence for reduction in seizure frequency in children who are also on risperidone and ASM, compared to children who are on risperidone and ASM alone. Evidence is inconclusive whether omega-3 increases or decreases the risk of adverse drug events. We identified only two studies - one each for OROS-MPH and omega-3 - with low to high risk of bias. We assessed the overall certainty of evidence for the outcomes of both OROS-MPH and omega-3 as low to moderate. More studies are needed. Future studies should include: 1. adult participants; 2. a wider variety of stimulant and non-stimulant drugs, such as amphetamines and atomoxetine, respectively; and 3. additional important outcomes, such as seizure-related hospitalisations and quality of life. Clusters of studies which assess the same drug - and those that build upon the evidence base presented in this review on OROS-MPH and omega-3 - are needed to allow for meta-analysis of outcomes.

PMID:35844168 | DOI:10.1002/14651858.CD013136.pub2

Front Pharmacol. 2022 Jun 29;13:896104. doi: 10.3389/fphar.2022.896104. eCollection 2022.

ABSTRACT

The objective of this study was to apply a machine learning method to evaluate the risk factors associated with serious adverse events (SAEs) and predict the occurrence of SAEs in cancer inpatients using antineoplastic drugs. A retrospective review of the medical records of 499 patients diagnosed with cancer admitted between January 1 and December 31, 2017, was performed. First, the Global Trigger Tool (GTT) was used to actively monitor adverse drug events (ADEs) and SAEs caused by antineoplastic drugs and take the number of positive triggers as an intermediate variable. Subsequently, risk factors with statistical significance were selected by univariate analysis and least absolute shrinkage and selection operator (LASSO) analysis. Finally, using the risk factors after the LASSO analysis as covariates, a nomogram based on a logistic model, extreme gradient boosting (XGBoost), categorical boosting (CatBoost), adaptive boosting (AdaBoost), light-gradient-boosting machine (LightGBM), random forest (RF), gradient-boosting decision tree (GBDT), decision tree (DT), and ensemble model based on seven algorithms were used to establish the prediction models. A series of indicators such as the area under the ROC curve (AUROC) and the area under the PR curve (AUPR) was used to evaluate the model performance. A total of 94 SAE patients were identified in our samples. Risk factors of SAEs were the number of triggers, length of stay, age, number of combined drugs, ADEs occurred in previous chemotherapy, and sex. In the test cohort, a nomogram based on the logistic model owns the AUROC of 0.799 and owns the AUPR of 0.527. The GBDT has the best predicting abilities (AUROC = 0.832 and AUPR = 0.557) among the eight machine learning models and was better than the nomogram and was chosen to establish the prediction webpage. This study provides a novel method to accurately predict SAE occurrence in cancer inpatients.

PMID:35847000 | PMC:PMC9277092 | DOI:10.3389/fphar.2022.896104

J Pediatr Pharmacol Ther. 2022;27(5):436-442. doi: 10.5863/1551-6776-27.5.436. Epub 2022 Jul 6.

ABSTRACT

OBJECTIVE: Combining intranasal fentanyl (IN FENT) with inhaled nitrous oxide (N2O) seems to have good properties for pediatric procedural sedation and analgesia (PSA). This study aims to assess the side effect rate of the combined use of IN FENT and N2O.

METHODS: We performed a retrospective, single-center study. Patients treated in either the pediatric emergency department (PED) or the pediatric surgery outpatient clinic (PSOC) were included, if they received PSA with IN FENT and nitrous oxide with 50% oxygen (N2O 50%).

RESULTS: Three hundred seventy-five patients were included over a period of 4 years. Median age was 9.4 years (range, 3.1 to 15.9) and 39% of patients were female. Overall side effect rate was 30% (114 patients). Most frequent was dizziness (n = 63, 17%; 95% CI, 13-21), followed by nausea (n = 23, 6%; 95% CI, 4-9) and emesis (n = 14, 4%; 95% CI, 2-6), with 35 patients having either nausea and/or emesis (9%; 95% CI, 7-13). No serious side effects were recorded (0%; 95% CI, 0-0.1). Of 298 patients with information regarding satisfaction, 280 patients would like the same sedation for a similar procedure in the future (94%; 95% CI, 90-96). We found no relation between previously described risk factors and emesis and/or nausea.

CONCLUSIONS: N2O 50% combined with IN FENT can be recommended as an effective and safe treatment in the PED and the PSOC. While the side effect rate, primarily dizziness, nausea and emesis was substantial, antiemetic prophylaxis is not indicated owing to the overall low incidence of nausea and emesis.

PMID:35845565 | PMC:PMC9268112 | DOI:10.5863/1551-6776-27.5.436

BMC Pharmacol Toxicol. 2022 Jul 16;23(1):51. doi: 10.1186/s40360-022-00585-3.

ABSTRACT

BACKGROUND: The safety assessment of ulinastatin can guide clinical practice. The present study aimed to investigate the real-world safety of ulinastatin in China.

METHODS: This multicenter study retrospectively analyzed the post-marketing surveillance data of consecutive patients treated with ulinastatin between August 2014 and June 2017 in the general wards and the intensive care units (ICU) of nine hospitals in China. Adverse drug reactions/adverse drug events (ADRs/ADEs) were collected and evaluated in a post-marketing database.

RESULTS: A total of 11,252 consecutive patients were included in the study: 7009 ICU patients and 4243 general ward patients. Eleven patients with ADRs/ADEs were observed, including nine ICU patients and two general ward patients. The clinical manifestations were liver dysfunction (n = 5 ICU cases, n = 1 general case), thrombocytopenia (n = 2 ICU cases, n = 1 general case), leukopenia (n = 1 ICU case), and rash (n = 1 ICU case). During the study period, the drug ADR/ADE rate of ulinastatin injection was 0.98‰ (11/11,252 × 1000‰). Among the 11,252 valid patients, only 327 received ulinastatin in accordance with the drug specifications. After excluding unreasonable drug use, the calculated ADR rate was 3.06‰ (1/327 × 1000‰) (95% confidence interval: 0.0‰-17.1‰). In ICU and general ward patients, the use of other drugs combined with ulinastatin was associated with the occurrence of ADRs/ADEs (100% with ADRs/ADEs vs. 0% in controls, P < 0.001).

CONCLUSIONS: The incidence of ADRs/ADEs of ulinastatin is < 5‰. The ADRs/ADEs involved limited organs, mainly the skin, gastrointestinal tract, and blood. In most cases, the ADRs/ADEs gradually alleviated or recovered after drug withdrawal. The inappropriate/off-label use of ulinastatin should be the focus of surveillance.

PMID:35842685 | PMC:PMC9288682 | DOI:10.1186/s40360-022-00585-3

Actas Dermosifiliogr. 2022 Jul-Aug;113(7):725-727. doi: 10.1016/j.ad.2021.03.003. Epub 2022 Feb 17.

NO ABSTRACT

PMID:35842251 | DOI:10.1016/j.ad.2021.03.003

Am J Transl Res. 2022 Jun 15;14(6):3995-4005. eCollection 2022.

ABSTRACT

OBJECTIVES: To determine the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) treatment in Chinese patients with GT1b chronic hepatitis virus C (HCV) infections.

METHODS: In this retrospective study, 49 treatment-naive patients with chronic GT1b HCV infection were treated with GZR (100 mg) plus EBR (50 mg) for 12 weeks. The viral response was the primary endpoint and fibrosis stage changes during and after treatment, as well as the incidence of treatment-emergent adverse events (TEAE) were secondary endpoints.

RESULTS: After 2-week EBR/GZR treatment, the virologic response rate was 85.1% (80/94) and reached 100% (94/94) after 8 and 12 weeks of therapy. Sustained virologic response (SVR) rates were 100% at the 12, 24 and 48-week follow-ups. Multivariate analysis revealed that the baseline viral load of HCV RNA may affect the rapid 2-week virologic response (OR: 0.36, 95% CI: 0.14-0.92, P=0.034), but did not influence efficacy during further treatment or follow-ups. Fifteen patients with ≥1 TEAE (16.0%) were observed and 7 (7.4%) and 8 (8.5%) patients had mild ALT or AST elevations (1.1-2.5× BL), but no serious drug-related AEs occurred. Liver stiffness measurement (LSM), the AST to platelet ratio index (APRI) and the fibrosis index based on 4 factor (FIB4) scores were consistently reduced, especially in patients with high baseline assessments after 12 weeks' treatment and during follow-ups.

CONCLUSIONS: A 12-week EBR/GZR regimen shows high efficacy and safety in Chinese patients with GT1b HCV infections.

PMID:35836873 | PMC:PMC9274559

J Clin Transl Hepatol. 2022 Jun 28;10(3):543-552. doi: 10.14218/JCTH.2021.00271. Epub 2022 Jan 10.

ABSTRACT

Since their introduction in 1987, hydroxymethyl glutaryl coenzyme A reductase (HMG-CoA) inhibitors, more commonly known as statins, have become some of the most widely prescribed medications in the world. Though generally considered to be safe and well tolerated, statins have been associated with several side effects including mild liver dysfunction manifested by increases in aminotransferases. Rarely, statins have been noted to induce more serious hepatic injury, including liver injury with autoimmune features. Current literature supports statin induced liver injury presenting in either hepatocellular or cholestatic patterns, though with the former being the prevailing pattern of injury. Fortunately, severe liver injury is uncommon with statin use and is generally reversible without any intervention other than offending statin cessation. When evaluating cases of suspected statin-induced liver injury, a complete medical history, laboratory tests including a complete metabolic panel, autoimmune markers, and viral panel, as well as hepatic imaging, are crucial for a complete causality analysis with validated tools such as Roussel Uclaf Causality Assessment Method. The aim of this review is to review the current evidence for statin-induced liver injury and cholestasis.

PMID:35836753 | PMC:PMC9240239 | DOI:10.14218/JCTH.2021.00271

BMC Pulm Med. 2022 Jul 14;22(1):269. doi: 10.1186/s12890-022-02063-2.

ABSTRACT

BACKGROUND: The number of patients with nontuberculous mycobacterial pulmonary disease (NTM-PD) is rapidly increasing globally, especially in the older population. However, there is a dearth of evidence regarding the impact of aging on the treatment outcomes of NTM-PD.

METHODS: We analyzed consecutive patients who satisfied the diagnostic criteria for Mycobacterium avium complex (MAC)-PD and received antibiotic treatment between January 2009 and December 2020 at a tertiary referral hospital in Korea. The main outcomes were (1) long-term treatment success, defined by negative culture conversion for more than 12 months; and (2) adverse drug reactions (ADRs). Multivariable logistic regression model was used to evaluate the association between age and main outcomes.

RESULTS: A total of 614 patients (median age, 65 years, interquartile range [IQR] 57-73 years; men, 35.3%) were included. Median treatment duration (530 days, IQR 290-678 days; P for trend < 0.001) and long-term treatment success (P for trend = 0.026) decreased, whereas ADRs (P for trend < 0.001) increased significantly with age. Multivariable analyses demonstrated that age ≥ 80 years was an independent factor associated with ADRs (adjusted odds ratio [aOR] 3.29; 95% confidence interval [CI] 1.05-10.28) and worse treatment outcome (aOR 0.42; 95% CI 0.19-0.91).

CONCLUSIONS: Aging is associated with worse treatment outcome and frequent ADRs of patients with MAC-PD. Individualized treatment with reduced-intensity may be a reasonable alternative for older adults.

PMID:35836160 | PMC:PMC9284708 | DOI:10.1186/s12890-022-02063-2

J Allergy Clin Immunol Pract. 2022 Jul 11:S2213-2198(22)00695-X. doi: 10.1016/j.jaip.2022.06.046. Online ahead of print.

NO ABSTRACT

PMID:35835388 | DOI:10.1016/j.jaip.2022.06.046

BMC Geriatr. 2022 Jul 13;22(1):576. doi: 10.1186/s12877-022-03192-3.

ABSTRACT

BACKGROUND: Older patients often experience adverse drug events (ADEs) after discharge that may lead to unplanned readmission. Medication Reconciliation (MR) reduces medication errors that lead to ADEs, but results on healthcare utilization are still controversial. This study aimed to assess the effect of MR at discharge (MRd) provided to patients aged over 65 on their unplanned rehospitalization within 30 days and on both patients' experience of discharge and their knowledge of their medication.

METHODS: An observational multicenter prospective study was conducted in 5 hospitals in Brittany, France.

RESULTS: Patients who received both MR on admission (MRa) and MRd did not have significantly fewer deaths, unplanned rehospitalizations and/or emergency visits related to ADEs (OR = 1.6 [0.7 to 3.6]) or whatever the cause (p = 0.960) 30 days after discharge than patients receiving MRa alone. However, patients receiving both MRa and MRd were more likely to feel that their discharge from the hospital was well organized (p = 0.003) and reported more frequently that their community pharmacist received information about their hospital stay (p = 0.036).

CONCLUSIONS: This study found no effect of MRd on healthcare utilization 30 days after discharge in patients over 65, but the process improved patients' experiences of care continuity. Further studies are needed to better understand this positive impact on their drug care pathway in order to improve patients' ownership of their drugs, which is still insufficient. Improving both the interview step between pharmacist and patient before discharge and the transmission of information from the hospital to primary care professionals is needed to enhance MR effectiveness.

TRIAL REGISTRATION: NCT04018781 July 15, 2019.

PMID:35831783 | DOI:10.1186/s12877-022-03192-3

Can Fam Physician. 2022 Jul;68(7):e215-e226. doi: 10.46747/cfp.6807e215.

ABSTRACT

OBJECTIVE: To summarize evidence from published systematic reviews evaluating the effect of polypharmacy interventions on clinical and intermediate outcomes. It also summarizes the adverse events that may occur as a result of these interventions.

DATA SOURCES: A literature search was conducted using the electronic databases MEDLINE, Embase, CINAHL, Cochrane Central, and Cochrane Database of Systematic Reviews (PROSPERO registration number: CRD42018085767).

STUDY SELECTION: The search yielded a total of 21,329 citations, of which 619 were reviewed as full text and 5 met the selection criteria.

SYNTHESIS: The polypharmacy interventions were found to produce statistically significant reductions in potentially inappropriate prescribing and improved medication adherence; however, the observed effects on clinical and intermediate outcomes were inconsistent. None of the included reviews reported any significant benefit of polypharmacy interventions for quality-of-life outcomes. Specific to health care utilization and cost, polypharmacy interventions reduced health care resource usage and expenditure. The reviews reported no differences in adverse drug events between polypharmacy interventions and usual care groups. The overall certainty of evidence was reported as low to very low across included reviews.

CONCLUSION: Polypharmacy interventions are associated with reductions in potentially inappropriate prescribing and improvements in medication adherence. However, there is limited evidence of their effectiveness for clinical and intermediate outcomes.

PMID:35831093 | DOI:10.46747/cfp.6807e215

Rev Paul Pediatr. 2022 Jul 6;41:e2021197. doi: 10.1590/1984-0462/2023/41/2021197. eCollection 2022.

ABSTRACT

OBJECTIVE: The aim of this current report was to present a critical review of the use of cannabidiol (CBD) in the treatment of refractory epilepsies in the pediatric population.

DATA SOURCE: Literature review was carried out in the Medline (PubMed), Cochrane, and Scientific Electronic Library Online (SciELO) databases with the descriptors "Cannabidiol" and "Epilepsy." The search was not limited by the date of publication, language, or study design. A total of 69 articles were included in the review.

DATA SYNTHESIS: The efficacy of CBD in treating epileptic seizures has been confirmed by randomized controlled trials for Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. The incidence of side effects reported in subjects of the studies is high. However, most studies indicate a good safety profile and tolerance to the drug, with most of the adverse effects being mild to moderate and transient.

CONCLUSIONS: There is no consensus on the release of CBD as a therapeutic tool by the drug regulatory agencies worldwide. However, the use of CBD is promising since it has presented satisfactory results in crisis control in well-designed studies. In addition, this drug has a good safety and tolerance profile. However, further studies with a long follow-up period are needed to confirm its usefulness and the long-term safety in pediatric patients.

PMID:35830160 | DOI:10.1590/1984-0462/2023/41/2021197

BMJ Open Qual. 2022 Jul;11(3):e001708. doi: 10.1136/bmjoq-2021-001708.

ABSTRACT

INTRODUCTION: The use of intravenous administration systems with dose error reduction software (DERS) is advocated to mitigate avoidable medication harm. No large-scale analysis of UK data has been attempted. This retrospective descriptive study aimed to estimate the prevalence of hard limit events and to estimate the potential severity of DERS events.

METHOD: Twelve months of DERS data was obtained from two NHS trusts in England. Definitions for drug categories and clinical areas were standardised and an algorithm developed to extract hard maximum (HMX) events. Subject matter experts (SMEs) were asked to rate severity of all HMX events on a scale of 0 (no harm) to 10 (death). These were analysed by clinical area and drug category, per 1000 administrations.

RESULTS: A total of 745 170 infusions were administered over 644 052 patient bed days (PBDs). 45% of these (338 263) were administered with DERS enabled. HMX event incidence across the whole dataset was 17.9/1000 administrations (95% CI 17.5 to 18.4); 9.4/1000 PBDs (95% CI 9.2 to 9.7). 6067 HMX events were identified. 4604 were <2-fold deviations and excluded. HMX were identified in all drug categories. The highest incidence was antibacterial drugs (2.21%; 95% CI 2.13 to 2.29). Of the 1415 HMX events reviewed by SMEs, 747 (52.6%) were low/no harm. Drugs with greatest potential harm were antiarrhythmics (21.8/1000 administrations; 95% CI 16.3 to 29.1), parenteral anticoagulants (24.16/1000 administrations; 95% CI 15.3 to 37.9) and antiepileptics (20.86/1000 administrations; 95% CI 16.4 to 26.5). DERS has prevented severe harm or death in 110 patients in these hospitals. Medical and paediatric areas had higher prevalence of potentially harmful HMX events, but these were probably related to profile design.

CONCLUSION: Compliance with DERS in this study was 45%. DERS events are common, but potential harm is rare. DERS events are not related to specific clinical areas. There are some issues with definition and design of drug profiles that may cause DERS events, thus future work should focus on implementation and data standardisation for future large-scale analysis.

PMID:35820711 | DOI:10.1136/bmjoq-2021-001708

JAMA. 2022 Jul 12;328(2):173-183. doi: 10.1001/jama.2022.9600.

ABSTRACT

IMPORTANCE: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade.

OBJECTIVE: To determine the change in the rate of adverse events in hospitalized patients.

DESIGN, SETTING, AND PARTICIPANTS: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%).

EXPOSURES: Adults aged 18 years or older hospitalized during each included calendar year.

MAIN OUTCOMES AND MEASURES: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations.

RESULTS: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly.

CONCLUSIONS AND RELEVANCE: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety.

PMID:35819424 | DOI:10.1001/jama.2022.9600