Anatomical Therapeutic Chemical Code Research Articles

Drug Utilization Evaluation of Agents Administered for Prevention and Treatment of Cancer-Related Infections

Background: Due to the critical role of antibiotics and increasing trend of resistance in developing countries, comprehensive methods of antibiotic use is necessary to limit the threat of resistant microorganisms. In this study we compare antibiotics consumption by Defined Daily Dose (DDD) per 100 bed-days in Shahid Ghazi hospitals during three months in Tabriz, Iran. Methods: This is a retrospective study, which enrolled patients with malignancy who admitted to Shahid Ghazi hospital from January till March 2016. From all, 58 patients diagnosed with malignancy and received antibiotics for prophylaxis and/or treatment. For the purpose of Drug Utilization Evaluation (DUE) all antibiotics, antifungals and antiviruses consumption for any reason (prophylaxis, empiric therapy, targeted therapy) were recorded. Data on administered medications such as indication, duration, and dose were compared according to the guidelines of the NCCN 2.2016. The accuracy of antibiotics consumption was assessing by NCCN (2.2016) guideline. Anatomical Therapeutic Chemical (ATC) code J01 was explained as defined daily doses per 100 bed- days (DDD/100) according to the ATC/DDD classification. The amount of consumption was assessed with DDD per 100 bed-days in three months. Results: from 56 patients, 46 of them had hematologic malignancy and 10 of them had solid tumors. The indication of antibiotics and antifungal prophylaxis were wrong in 19.6% of indications. The prophylaxis dosage of antibiotics, antifungal, antiviral and PCP were wrong in 8.8%, 41.7%, 80% and 50%, respectively. The prophylaxis duration of antibiotics, antifungal, antiviral and PCP were wrong in 69.4%, 61.2%, 80% and 100% respectively. The dose adjustment of antibiotics with GFR and renal status of patients, in 8 of 9 patients (88.88%) who received meropenem, and in 9 of 23 patients (39.13%) who received imipenem, were not applicable according standard guidelines. The total consumption of systemic antibiotics in Ghazi Hospital during 3 months was 5091 (Table 7). From all patients 75% of them received antibiotics according to the ATC/DDD classification System. Conclusion: Specific strategies should be employed in infection control development and engage rational antibiotic utilization in order to reduce future resistant strains and increase anti-microbial efficacy.

Prescribing Trends of Biologic Disease-Modifying Anti-rheumatic Drugs Using a Claims Database from 6 Million People in Japan.

We conducted a descriptive epidemiological study from 2012 to 2018 using the JMDC Claims Database, a nationwide claims database, and described the annual changes based on the number of patients prescribed bDMARDs. Anti-rheumatic drugs were identified based on the Anatomical Therapeutic Chemical codes, including methotrexate, glucocorticoids, non-steroidal anti-inflammatory drugs and bDMARDs. From the database including 6,862,244 people, the data of 6407 patients with rheumatoid arthritis were extracted. The present study demonstrated that the proportion of patients prescribed bDMARDs was 1.0 per 1000 people, with those aged ≥ 65 years being the most common age group. The proportion of patients with rheumatoid arthritis who were prescribed bDMARDs increased significantly over time (p < 0.0001). Additionally, the concomitant proportions of methotrexate (p < 0.0001), non-steroidal anti-inflammatory drugs (p < 0.0001) and glucocorticoids (p = 0.0001) prescribed with bDMARDs decreased significantly over time. The increase in bDMARD monotherapy may be attributed to the new bDMARDs that have been launched sequentially; furthermore, physicians have come to recognise monotherapy as the mainstay of treatment. Future studies must accumulate evidence on the long-term efficacy and safety of bDMARDs.

Trends in Psychotropic Medication Prescriptions in Urban China From 2013 to 2017: National Population-Based Study.

Purpose: Psychotropic medications are commonly used for treating mental disorders; however, there is currently no study on how commonly they are used in China. This study reported the trends in psychotropic medications prescriptions in urban China.Methods: A national population-based study was conducted using the China Health Insurance Research Association database to estimate the period prescription prevalence of 11 major classes of psychotropic medications annually during 2013–2017. The World Health Organization Anatomical Therapeutic Chemical (ATC) classification codes were used to identify psychotropic medications.Results: The prescription prevalence of any psychotropic medication increased from 8.110% (8.106–8.114%) in 2013 to 11.362% (11.357–11.366%) in 2017. The prescription prevalence of six classes increased significantly during 2013–2017, including sedatives-hypnotics (from 3.177 to 5.388%), anxiolytics (from 1.436 to 2.200%), antiepileptic drugs (from 1.416 to 2.140%), antipsychotics (from 0.809 to 1.156%), antidepressants (from 0.891 to 1.045%), and psycholeptic polypills (from 0.682 to 0.866%). The prescription prevalence of antidementia drugs increased from 0.069 to 0.122%, and mood stabilizers increased from 0.029 to 0.037%, although not statistically significant. The prescription prevalence of nootropic drugs, attention deficit hyperactivity disorder (ADHD) medications and drugs used in the treatment of addictive disorders was largely stable. Psychotropic medication prescription increased with age for all classes except for ADHD medications and mood stabilizers.Conclusion: Increasing trends in prescription prevalence were observed for most classes of psychotropic medications in urban China, although the prevalence was still lower than that in most developed countries. Further research is warranted to explore the potential treatment gap between China and most developed countries.

Treatment Patterns and Resource Utilization of Pregnant Women with Inflammatory Rheumatic Diseases or Psoriasis in Germany: A Claims Database Analysis

BackgroundUncontrolled inflammatory disease activity can impact pregnancy outcomes and the health of the mother and child. This retrospective claims database analysis assessed treatment patterns before, during, and after pregnancy among women with inflammatory rheumatic disease (IRD; axial spondyloarthritis [axSpA], psoriatic arthritis [PsA], and rheumatoid arthritis [RA]) or psoriasis (PSO) in Germany.MethodsData were extracted from the BARMER sickness fund (2013–2017). Pregnant women (18–45 years) with documented IRD or PSO diagnoses were compared with age-matched controls from the same database for the analysis of patient characteristics, healthcare resource utilization, and pharmacological treatment during pregnancy. Reported measures included the proportion of women with pharmacological prescriptions or hospitalization/new prescription of corticosteroids or biologics in the 180 days before pregnancy, during pregnancy, and 180 days after delivery. Pre-specified prescription categories (such as disease-specific drugs [not including biologics]) were identified by anatomical therapeutic chemical classification codes. Extrapolated values to the German statutory health insurance population are reported.ResultsOverall, 2702 pregnant women with IRD (axSpA: 1063; PsA: 660; RA: 979) and 6527 with PSO were identified. The proportion of women with IRD receiving prescriptions for disease-specific drugs reduced during pregnancy and remained stable after delivery (before: 15.0%; during: 9.0%; after: 9.7%). The proportion of women with PSO receiving prescriptions for disease-specific drugs was low (before: 0.6%; during: 0.3%; after: 0.1%). The proportion of women with hospitalization/new prescription of corticosteroids or biologics decreased during pregnancy, compared with pre-pregnancy, and increased after delivery in women with IRD (before: 9.0%; during: 5.1%; after: 11.1%) and PSO (before: 3.5%; during: 1.9%; after: 2.7%).ConclusionsA reduction in pharmacological treatment during pregnancy was observed for women with IRD in Germany. Many women with IRD did not return to pre-pregnancy treatments after delivery, despite signs of disease exacerbation, such as hospitalization and initiation of treatment with corticosteroids/biologics, in this period.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00347-3.

Association between type 2 diabetes and osteoporosis risk: A representative cohort study in Taiwan.

Although previous studies have investigated the relationship between fracture risk and type 2 diabetes (T2D), cohort studies that estimate composite osteoporosis risk are lacking. This retrospective cohort study sought to determine the risk of osteoporosis in Taiwanese patients with T2D. Patients diagnosed with T2D between 2002 and 2015 identified through the 2002 Taiwan Survey of Hypertension, Hyperglycemia, and Hyperlipidemia were included. A total of 1690 men and 1641 women aged ≥40 years linked to the National Health Insurance Research Database (NHIRD) were followed up to the end of 2015 to identify the incidences of osteoporosis through ICD9-CM codes for osteoporosis or osteoporotic fractures or usage of anti-osteoporotic agents according to Anatomical Therapeutic Chemical codes determined from NHIRD. The person year approach and Kaplan-Meier analysis were then used to estimate the incidences and cumulative event rates, whereas the Cox proportional hazard model was used to calculate adjusted hazard ratios (HR) for osteoporosis events. A total of 792 new osteoporosis events were documented over a median follow-up duration of 13.6 years. Participants with T2D had higher osteoporosis risk [adjusted HR: 1.37, 95% confidence interval (CI): 1.11-1.69] compared with those without T2D. Subgroup analyses revealed that age had a marginally significant effect, indicating that T2D had a more pronounced effect on osteoporosis risk in younger population (<65 years old). No difference was found between patients stratified according to sex. In conclusion, T2D was significantly associated with increased osteoporosis risk, especially in younger participants.

Patient Factors Associated with Pharmaceutical Interventions for Inpatients at a Brazilian Teaching Hospital.

Pharmaceutical interventions aim to correct or prevent a drug-related problem (DRP) that might lead to negative clinical consequences and increase health care costs. To identify variables associated with the provision of pharmaceutical interventions by clinical pharmacists during hospitalization. In this retrospective cohort study, adult inpatients of the medical ward of the University Hospital of the University of São Paulo in São Paulo, Brazil, were followed from admission to discharge. Logistic regression models were used to evaluate the association between occurrence of at least 1 pharmaceutical intervention and the following baseline characteristics: sex, age, Charlson comorbidity index, renal failure, electrolyte imbalance, hemoglobin, platelet count, and use of a nasoenteric tube, as well as the number, second-level Anatomical Therapeutic Chemical (ATC) code, and administration route of prescribed medications. A total of 148 patients were included in the study, of whom 75 (50.7%) were men. The mean age was 62.8 (95% confidence interval [CI] 59.9-65.8) years, and the mean length of the hospital stay was 10.7 (95% CI 8.4-13.1) days. Analgesics (ATC code N02), the most common type of medication, were prescribed to 144 (97.3%) of the patients. Pharmaceutical interventions were performed for only 49 (33.1%) of the patients. One out of every 4 of these interventions was intended to obtain information not provided in the prescription, to allow the prescription to be completed and dispensing to proceed. According to the multivariate analysis, the odds ratio (OR) of occurrence of at least 1 pharmaceutical intervention increased for patients with electrolyte imbalance (OR 2.68, 95% CI 1.09-6.63; p = 0.033), patients using 5 to 8 medications (OR 8.73, 95% CI 1.07-71.36; p = 0.043), patients using 9 or more medications (OR 10.39, 95% CI 1.28-84.05; p = 0.028), and patients using at least 1 systemic antibacterial (ATC code J01; OR 2.76, 95% CI 1.30-5.84; p = 0.008). The findings of this study could allow the identification, at the time of admission and possibly before the occurrence of a DRP, of patients at higher risk of requiring a pharmaceutical intervention later during their hospital stay. To optimize patient care, clinical pharmacists should closely follow inpatients with electrolyte imbalance, polypharmacy, and/or use of systemic antibacterials.

No difference in antidepressant prescription in rheumatoid arthritis and controls. Results from a population-based, matched inception cohort

Objective: Depression occurs at least two times more often in rheumatoid arthritis (RA) patients than in controls, but little is known about the treatment of depression in RA. The primary objective of this study was to compare the 1 year period prevalence of antidepressant prescription in patients with RA versus controls. Method: We included a retrospective inception cohort of 509 patients with incident RA and 2545 frequency-matched population controls ascertained from 1995 to 2002. The cohort was followed until 31 December 2017 and linked with nationwide Danish registers. From the Danish National Prescription Register, we obtained information on redeemed prescriptions of antidepressants (Anatomical Therapeutic Chemical code N06A). Results: We did not demonstrate significant differences in the 1 year period prevalence ratios and the incidence rate ratios for either antidepressant prescription or the frequency of hospital admissions with depressive episode. The most frequent indication for antidepressant prescription in patients with RA was depression. Cox regression analyses showed no association between RA and antidepressant prescription. Conclusion: We found no significant differences in the occurrence of antidepressant prescription in patients with RA versus matched controls. The main indication for antidepressant prescription in RA was depression.

PNS22 Real-World DATA of ADR Reports in Signal Detection - DME Perspective

The Designated Medical Event (DME) is a serious medical event that is often causally associated with medicines. This way, EMA has developed a list of DME, through Medical Dictionary for Regulatory Activities (MedDRA). The list is used by the EMA and Member States to focus on suspected adverse drug reaction(ADR) reports that deserve special attention, irrespective of statistical criteria used to prioritise safety reviews. DME search in ADR reports is one of the methods used to detect safety signals. The objective of our study is to identify and characterize the reports of ADR that contain the DME, in Portugal. A retrospective study was conducted to identify and characterize the spontaneous ADR reports with DME, occurred in Portugal, between 2014 to 2019. A descriptive analysis was performed for the following data: type of notifier (consumer or healthcare professional), medicines classified by the Anatomical Therapeutic Chemical Code, ADR coded with MedDRA and description of ADR in the summary of product characteristics (SmPC). During this 5-year period, the Portuguese Pharmacovigilance System received 15344 reports, of these 1335 correspond to reports with DME (1305 by healthcare professionals; 30 by consumers). The annual percentage of reports with DME has been increasing, with the exception of the last year. The most frequent ATC group with or without DME is “Antiinfectives For Systemic Use”. The most frequent System Organ Classes of the reports with the DME is “Skin and subcutaneous tissue disorders”. Of the 1335 reports with DME terms, 130 of these reports are not described in the SmPC. It is important to obtain real-word data, especially in the area of drug safety, because it is a way to prevent ADR. In this way, notifiers should be made aware of the importance of sharing data related to ADR, thus increasing knowledge about the safety profile of medicines.

Outcomes measures in current Danish pharmacoepidemiological research: a protocol for a systematic mapping review

There is a growing interest in complementing the evidence on efficacy and safety of medicinal products gained by randomised clinical trials with real-world data and real-world evidence. Registries provide important sources of real-world data but are typically initiated for administrative purposes. The Danish national registries capture a wide range of information such as health care contacts, social, and economic data; and thereby offer unique possibilities for pharmacoepidemiological research. To gain insight into how registry-based outcome measures from mostly administrative databases are used in real-world evidence studies, the present literature review will investigate the current practice in registry-based studies using Danish health data. A systematic mapping review will be conducted using the literature databases PubMed®/MEDLINE and Scopus®. The search will include Danish registry-based studies aiming at evaluating the effectiveness or safety of medicinal products published from January 1st, 2018 to December 31st, 2019. Data extraction will include the Anatomical Therapeutic Chemical code level 2 of the medicinal product of interest, the outcome measures used, the registry of which the outcome measure has been obtained as well as how the quality of the outcome measure has been considered. The outcome measures extracted will be presented as a categorical overview. These categories will be associated with therapeutic exposure, registry of origin and refereed validation of the outcomes. This systematic mapping review will, as far as we know, be the first of its kind to map outcome measures from Danish national registries used for safety and efficacy studies.

Cardiac medication use in patients with suspected ischaemia without obstructive coronary arteries: sex differences and psychological distress.

BackgroundIschaemia without obstructive coronary arteries (INOCA) is more prevalent in women and associated with psychological distress. Pharmacological treatment goals are angina relief and cardiovascular risk management. The present study aims to examine sex differences in cardiac and non-cardiac medication use, as well as medication and sex differences related to consistent psychological distress in patients with suspected INOCA.DesignA TweeSteden mild stenosis observational cohort study in patients with suspected INOCA as detected by ischaemic reason for referral and non-obstructive arteries based on coronary angiography or computed tomography.MethodsMedication documented in the hospital records of 488 patients (53% women) was coded as angina relief medication, blood-pressure-lowering medication, antithrombotics, statins, and non-cardiac medication, using the Anatomical Therapeutic Chemical code. Depressive symptoms and anxiety were recoded as ‘consistent distress’ (above the cut-off score for depression and anxiety on validated questionnaires), ‘inconsistent distress’ (above the cut-off for depression or anxiety) or ‘no distress’ (below the cut-off).ResultsNo sex differences were observed in cardiac medication use. Women used anxiolytic benzodiazepines more often (12% vs 4%, p = 0.002) compared to men. Consistent distress was more prevalent in women (22% vs 15%, p = 0.004) and was related to the use of more angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and diuretics in women and to calcium antagonist use as well as lower adherence levels in men. Women who reported chest pain more often received angina relief medication and blood-pressure-lowering medication than men.ConclusionNo sex differences were observed in cardiac medication use in patients with suspected INOCA. Psychological distress may reflect hypertension and subsequent medication use in women, and experiencing chest pain and subsequent medication use in men.

Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database.

This case-non-case study aims to detect signals not currently listed on cephalosporin drug labels. From 2009 to 2018, adverse event (AE) reports concerning antibacterial drugs (anatomical therapeutic chemical (ATC) code J01) in the Korea Adverse Events Reporting System (KAERS) database were examined. For signal detection, three indices of disproportionality, proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were calculated. The list of signals was compared with ADRs on the drug labels from the United States, United Kingdom, Japan, and South Korea. A total of 163,800 cephalosporin–AE combinations and 72,265 all other J01–AE combinations were analyzed. This study detected 472 signals and 114 new signals that are not included on the drug labels. Cefatrizine–corneal edema (PRR, 440.64; ROR, 481.67; IC, 3.84) and cefatrizine–corneal ulceration (PRR, 346.22; ROR, 399.70; IC, 4.40) had the highest PRR, ROR, and IC among all signals. Additionally, six serious AEs that were not listed on drug labels such as cefaclor-induced stupor (ten cases) and cefaclor-induced respiratory depression (four cases) were found. Detecting signals using a national pharmacovigilance database is useful for identifying unknown ADRs. This study identified signals of cephalosporins that warrant further investigation.

Epidemiology of hidradenitis suppurativa in Taiwan: A 14‐year nationwide population‐based study

Hidradenitis suppurativa (HS), also called acne inversa, is an inflammatory skin disease, which causes HS patients to suffer from recurrent symptoms and severe comorbidities. The aim of this article was to provide evidence on the epidemiology of HS in Taiwan through a retrospective population-based cohort study. The patients with International Classification of Diseases, Ninth Revision, Clinical Modification code 705.83 and Anatomical Therapeutic Chemical codes for HS treatments from 2000 to 2013 in the National Health Insurance Research Database, which covers 99.9% Taiwanese residents, were enrolled in this 14-year nationwide population-based cohort study. The age- and sex-standardized prevalence, incidence, and the prescription pattern for HS were analyzed. The annual percent change (APC) was used to estimate the trend of prevalence and incidence of HS from 2000 to 2013. During 2000-2013 in Taiwan, the 14-year period prevalence rate was 185.6/100000 (95% confidence interval [CI], 177.3-194.3) with an APC of -2.96% (95% CI, -1.73 to -4.17) and the mean annual adjusted incidence rate from 2001 to 2013 was 11.8/100000 (95% CI, 11.2-12.5) with an APC of -4.65% (95% CI, -3.32 to -5.95). Female:male ratio was 0.92 and the most common onset age was 15-24years. Major treatments were systemic corticosteroids, systemic antihistamines, systemic antibiotics, and topical antibiotics. An increasing tendency of using systemic antibiotics was noted. In Taiwan, decreasing incidence and prevalence of HS was shown during 2000-2013. Relatively lower incidence and prevalence were noted compared to Western countries. Male predominance was revealed, and the use of systemic antibiotics became the mainstream in treatment for HS.

An In Silico Method for Predicting Drug Synergy Based on Multitask Learning.

To make better use of all kinds of knowledge to predict drug synergy, it is crucial to successfully establish a drug synergy prediction model and leverage the reconstruction of sparse known drug targets. Therefore, we present an in silico method that predicts the synergy scores of drug pairs based on multitask learning (DSML) that could fuse drug targets, protein-protein interactions, anatomical therapeutic chemical codes, a priori knowledge of drug combinations. To simultaneously reconstruct drug-target protein interactions and synergistic drug combinations, DSML benefits indirectly from the associations with relation through proteins. In cross-validation experiments, DSML improved the ability to predict drug synergy. Moreover, the reconstruction of drug-target interactions and the incorporation of multisource knowledge significantly improved drug combination predictions by a large margin. The potential drug combinations predicted by DSML demonstrate its ability to predict drug synergy.

Analysis of patient access to orphan drugs in Turkey

BackgroundRare diseases are life-threatening, serious, and chronic conditions that require complex care and have a low prevalence. An estimated one in 15 people worldwide are affected by rare diseases. This study aims to analyze the accessibility, reimbursement status, licensed status, and Anatomical Therapeutic Chemical (ATC) codes of drugs that the European Medicines Agency (EMA) in Turkey considers to be “orphan” pharmaceuticals.MethodsThe drugs included in this analysis were obtained from the list of orphan drugs published by the EMA. Orphan drugs’ accessibility and licensing status in Turkey were obtained from the Health Implementation Communiqué published by the Social Security Institution (SGK) and the List of Abroad Active Substance and List of Licensed Products published by the Turkey Pharmaceuticals and Medical Devices Agency (TİTCK). Descriptive analysis was applied to determine the accessibility status of orphan drugs identified by the EMA in Turkey.ResultsBased on the EMA, 105 pharmaceuticals were approved with “orphan drug” status except for drugs that have lost orphan drug status, decommissioned in the European Union and withdrawn from the European Community Register by January 2020. Of the 105 rare drugs on the EMA list, 34 were inaccessible in Turkey. Of the 71 available drugs, 23 (32%) were licensed and 48 (68%) were unlicensed in Turkey. 17 (74%) of licensed products and 17 (35%) of unlicensed products were covered by reimbursement. When orphan drugs’ ATC codes were examined, the most common ATC group was found to be “L—Antineoplastic and Immunomodulatory” agents.ConclusionAn orphan drug incentive policy is very important to ensure early access to the drugs used to treat rare diseases. Considering the capacity and prices for orphan drugs in Turkey, it can be said that many patients with rare diseases have difficulty in their treatment. It is obvious that such a policy must prepare for the regulation of orphan drugs in Turkey.

Real-World Evidence of the Incidence of and Risk Factors for Type 1 Diabetes Mellitus and Hypothyroidism as Immune-Related Adverse Events Associated With Programmed Cell Death-1 Inhibitors

ObjectiveThe incidence of type 1 diabetes mellitus (T1DM) and hypothyroidism as immune-related adverse events (irAEs) after programmed cell death-1 inhibitor (PD-1i) administration has not yet been sufficiently evaluated in a real clinical setting. To assess the incidence of T1DM and hypothyroidism among PD-1is and to identify the risk factors associated with hypothyroidism using a large claims database. MethodsThis cohort study used the Shizuoka Kokuho database in Japan from 2012 to 2018, including approximately 2.2 million people. We enrolled 695 PD-1i-treated patients. T1DM and hypothyroidism as irAEs were identified using International Classification of Diseases 10th Revision and Anatomical Therapeutic Chemical classification codes. Risk factors for hypothyroidism were explored using the multivariable Fine and Gray regression model after adjusting for age group and sex, treating death as a competing risk. ResultsThe cumulative incidences of T1DM and hypothyroidism were 0.3% and 8.3%, respectively. We described the detailed onset timing of irAEs in patients with T1DM and hypothyroidism; hypothyroidism was observed evenly within 1 year of the PD-1i prescription. Sex and certain cancer types, such as lung and urothelial cancers, were significantly associated with subdistribution hazard ratio (sHR) (female: sHR, 2.04 [95% CI, 1.20-3.47]; lung cancer: sHR, 0.55 [95% CI, 0.32-0.95]; and urothelial carcinoma: sHR, 2.40 [95% CI, 1.05-5.49]). ConclusionThe incidence of T1DM and hypothyroidism as irAEs and associated risk factors identified in this analysis were comparable to those found in previous studies. The use of a large claims database to detect irAEs, such as T1DM and hypothyroidism, may lead to safer use of PD-1is.

PNS119 Qualitative and Quantitative Comparison between Essential Drug LIST of Russian Federation and Analogous Drug Lists of England and Italy

Vital and Essential Drug List (VEDL) of Russia contains drugs, which are reimbursed and whose prices are limited by government. Most of developed countries have analogous drug lists. The aim of our study was to compare Russian VEDL and analogous English and Italian lists qualitatively and quantitatively. English and Italian drug lists used in this study were identified through search in open sources. The qualitative and quantitative analysis was performed to explore: a) whether drugs from English and Italian lists are registered in Russia; b) complementarity of VEDL and English and Italian lists; c) ATC (Anatomical Therapeutic Chemical) code based consistency d) ICD-10 (International Classification of Diseases) based indication coverage within ATC group L «Antineoplastic and immunomodulating agents». Four English and one Italian lists were analyzed. From English and Italian lists 41% and 23% of drugs respectively are not registered in Russia, while 67% and 53% of drugs respectively are not included in the VEDL. Ratio of drugs by ATC groups generally is also leaning towards England and Italy in comparison with Russia (208 medications in English list vs 161 in VEDL in ATC group L), while ratio of drugs indications from ATC group L by all ICD-10 codes favorable towards VEDL in compare with English list (1143 vs 519 indications). Results of this study show that absolute amount of medications and ATC groups distribution in Russian VEDL are inferior to English and Italian lists. However, indication coverage of ATC group L in VEDL is superior to English lists. This situation could be related with Russian regulation processes specialty, particularly, reimbursement by all indications. Results of such type of studies could be helpful as a source of information on coverage of different therapeutic groups in vary of healthcare setting and may help to define areas that require optimization.

Psychotropic medication utilisation in adult cancer patients in China: A cross-sectional study based on national health insurance database

BackgroundPsychotropic medications are useful to treat psychiatric disorders which are frequently underdiagnosed and undertreated in cancer patients. Evidence on utilisation of psychotropic medications in cancer patients was absent in China. This study aimed to analyse the prevalence and the potential predictors of psychotropic medication use in adult cancer patients in China. MethodsWe analysed cross-sectional data from the China Health Insurance Association database in 2015–2017, which contained health care utilisation information for a national representative sample of basic medical insurance beneficiaries. Cancer patients aged above 18 were identified by International Classification of Disease 10th revision code C00–C97. Psychotropic medications were defined following the Anatomical Therapeutic Chemical codes: antipsychotics (N05A), anxiolytics (N05B), hypnotics and sedatives (N05C), and antidepressants (N06A, N06CA). We calculated the prevalence of psychotropic medication use in cancer patients, and applied multivariable logistic regression to identify its potential predictors. FindingsA total of 260,364 adults with cancer were identified in the database, of which 48,111 (18•5%) were prescribed at least one psychotropic medication comprising antipsychotics (3763, 1•4%), anxiolytics (15,902, 6•1%), hypnotics and sedatives (37,040, 14•2%), and antidepressants (2379, 0•9%). Patients with solid tumours had higher prevalence of psychotropic medication use than patients with lymphoid and hematopoietic malignancies (e.g. female genital organs, adjusted odds ratio (OR)=2•25, 95%CI=2•09–2•44). The prevalence of psychotropic medication use in cancer patients in the Eastern region was significantly higher than those of cancer patients in the Western regions (OR=2•33, 95%CI=2•27–2•40). Compared with the Urban Rural Resident Basic Medical Insurance beneficiaries, cancer patients covered by the Urban Employee Basic Medical Insurance were more likely to use psychotropic medications (OR=1•18, 95%CI=1•15–1•20). Midazolam was the most frequently used psychotropic (21,728, 45•2%), and flupentixol–melitracen was the most commonly used antidepressant (1176, 2•4%) among all psychotropic medication users in the sample. InterpretationThe prevalence of psychotropic medication use in Chinese adult cancer patients was inequitable. Further attention will be needed to be paid to the mental health of cancer patients in China. FundingNo funding.

A systematically collated library of prescribing safety indicators for people with chronic kidney disease

BackgroundPeople with chronic kidney disease (CKD) have high levels of co-morbidity and polypharmacy placing them at increased risk of prescribing-related harm. Tools for assessing prescribing safety in the general population using prescribing safety indicators (PSIs) have been established. However, people with CKD pose different prescribing challenges to people without kidney disease. Therefore, PSIs designed for use in the general population may not include all PSIs relevant to a CKD population.The aim of this study was to systematically collate a library of PSIs relevant to people with CKD.MethodsA systematic literature search identified papers reporting PSIs. CKD-specific PSIs were extracted and categorised by Anatomical Therapeutic Chemical (ATC) classification codes. Duplicate PSIs were removed to create a final list of CKD-specific PSIs.ResultsNine thousand, eight hundred fifty-two papers were identified by the systematic literature search, of which 511 proceeded to full text screening and 196 papers were identified as reporting PSIs. Following categorisation by ATC code and duplicate removal, 841 unique PSIs formed the final set of CKD-specific PSIs. The five ATC drug classes containing the largest proportion of CKD-specific PSIs were: Cardiovascular system (26%); Nervous system (13.4%); Blood and blood forming organs (12.4%); Alimentary and metabolism (12%); and Anti-infectives for systemic use (11.3%).ConclusionCKD-specific PSIs could be used alone or alongside general PSIs to assess the safety and quality of prescribing within a CKD population.

New prescription of antihyperglycemic agents among patients with diabetes in Germany: Moderate concordance between health insurance data and self-reports.

To analyze the concordance of new prescription of antihyperglycemic agents between two data sources: patients' self-reports and statutory health insurance (SHI) data among patients with diabetes. Within a cross-sectional study, 494 patients with diabetes were interviewed if and which new prescriptions of diabetes medication they received within the last 3 or 6 months. SHI data for 12 months were linked to cover these periods. For the agreement measurement, SHI data was set as reference, and kappa, positive predictive value (PPV), and sensitivity were calculated for single Anatomical Therapeutic Chemical (ATC) codes and cumulated code groups. The number of new prescriptions within 3 or 6 months was low, with 5.5% (n = 27) for Metformin/self-report being the highest. Contingency tables were unbalanced and showed large numbers in the no/no-cells. Regarding non-agreement, we found new prescriptions slightly more often in SHI data only than in self-reports only, with insulin and metformin representing an exception. Agreement results were moderate with large confidence intervals (CI). The values for cumulated "all drugs in diabetes" were: kappa = 0.58 (95% CI: 0.51-0.65), PPV = 62.0 (53.4-70.2), sensitivity = 55.6 (47.3-63.6). Patients reported a low number of new prescriptions within the last 3 or 6 months. In general we found moderate agreement and in case of non-agreement that self-report no/SHI yes was slightly more frequent than vice versa. These results were based on small case numbers, but could nevertheless be considered when collecting self-reported information on the prescription of antihyperglycemic agents.

Oral adverse effects: drug-induced tongue disorders.

ObjectivesDue to a worldwide increase in drug consumption, oral healthcare professionals are frequently confronted with patients using one or more drugs. A large number of drugs can be accompanied with adverse drug reactions in the orofacial region, amongst others of the tongue. This paper aims to give an overview of drugs that are known to be accompanied with tongue disorders.Materials and methodsThe national drug information database for Dutch pharmacists, composed of scientific drug information, guidelines and summaries of product characteristics, was analysed for drug‐induced tongue disorders. “MedDRA classification” and “Anatomical Therapeutic Chemical codes” were used to categorize the disorders.ResultsThe database comprises of 1645 drugs of which 121 (7.4%) are documented to be accompanied with tongue disorders as an adverse effect. Drug‐induced tongue disorders are predominantly observed in the following drug categories: “nervous systems,” “anti‐infectives for systemic use” and “alimentary tract and metabolism”. The most common drug‐induced tongue disorders are glossitis, tongue oedema, tongue discoloration and burning tongue.ConclusionHealthcare professionals are frequently confronted with drugs that can cause tongue disorders. The overview of drugs reported in this article supports clinicians in their awareness, diagnosis and treatment of drug‐induced tongue disorders.