Anatomical Therapeutic Chemical Group Research Articles

Polypharmacy in Older Patients with Multimorbidity: The Agreement Between Patient and General Practitioner-Reported Drugs Observed in a Pilot cRCT.

Polypharmacy (≥5 drugs) increases the risk of discrepancies between patient- and general practitioner (GP)-reported drugs, leading to adverse outcomes. This explorative analysis assesses the agreement between patient- and GP-reported drugs under the influence of a paper-based patient portfolio in a pilot cluster randomized controlled trial (cRCT). Complete data were available for 68 patients aged 65 or older (26 were female), with multimorbidity, polypharmacy, and at least one hospitalization in the past year. Agreement was assessed for drug name and strength level. Differences between the intervention and control group (IG/CG) and comparisons between two time points (six-month interval) stratified according to gender were analyzed using Wilcoxon and Mann-Whitney U tests (α = 5%). To evaluate the reasons for discrepancies, the agreement of active pharmaceutical ingredients (APIs) and anatomical therapeutic chemical (ATC) groups was analyzed. At baseline, the agreement was 72.1% for the IG and 73.9% for the CG. Inclusion of the reported drug strength reduced the agreement in both groups (IG 66.7%, CG 60.0%). Agreement for the IG decreased statistically significantly after six months (-5.4%). ATC groups B, C, and H had the highest agreement, while N, R, and Z had the lowest. Large discrepancies in the drugs reported, due to the APIs and the corresponding ATC group, were observed.

A pharmacovigilance study of drug-reduced male semen quality based on the Food and Drug Administration adverse event reporting system database.

Real-world big data studies on drug-reduced male semen quality are few and far between, with most studies based on animal trials, small scale retrospective studies, or a limited number of pre-market clinical trials. This study aimed to identify culprit drugs that reduced male semen quality based on the United States Food and Drug Administration adverse event reporting system. The Medical Dictionary for Regulatory Activities preferred terms and standardized Medical Dictionary for Regulatory Activities queries were used to define reduced male semen quality. Adverse events related to drug-reduced male semen quality were then analyzed by disproportionality analysis using the United States Food and Drug Administration adverse event reporting system data between 2004 and 2023. At the preferred term level, 59 drugs with risk signals were detected to be associated with drug-reduced male semen quality, with the three most frequently reported second-level Anatomical Therapeutic Chemical groups being antineoplastic agents (n=16, 27.12%), psychoanaleptics (n=9, 15.25%), and psycholeptics (n=6, 10.17%). At the standardized Medical Dictionary for Regulatory Activities queries level, the five drugs with the greatest number of cases were finasteride (845 cases, IC025=7.72), dutasteride (163 cases, IC025=7.22), tamsulosin (148 cases, IC025=5.99), testosterone (101 cases, IC025=4.08), and valproic acid (54 cases, IC025=2.44). Additionally, clinical information about drug-reduced male semen quality is absent from the Summary of Product Characteristics of 41 drugs in our study. Using the United States Food and Drug Administration adverse event reporting system database, we offer a list of drugs with risk signals for reducing male semen quality. In the future, there is still a need for more studies on drugs whose effects on male semen quality are not fully understood.

Comparison of pre-and postoperative medication costs in patients who underwent bariatric surgery - a nationwide data analysis.

Bariatric surgery has known health benefits and may lower the medication-related costs. This study aimed to assess the cost of medications prior to and after bariatric surgery in the Polish nationwide registry. The study included 2,390 adults. The analysis was conducted separately for a 12-month pre-operative period, and a 12-month postoperative period. The total costs of medication and cost per anatomical therapeutic chemical group were assessed and the mean cost per patient in the preoperative and postoperative periods was compared. The study showed a significant increase in the overall medication costs and mean costs of medications per patient in the year after bariatric surgery. This increase was related mainly to low-molecular-weight heparins used in the 1st month after surgery. Alternatively, costs of medication used in the cardiovascular system diseases and anti-infectives decreased significantly. The total costs of hypoglycemic agents were reduced by 46%, antihypertensive medications by 29%, and lipid-lowering drugs by 38. In general, medication costs are higher in the first year after surgery. The increase results from the perioperative use of low-molecular-weight heparins, whereas a significant cost reduction of glucose-, lipid-lowering, antihypertensive, and anti-infective medications was observed.

Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies.

This work aimed to analyse the pharmacogenetic information in the Spanish Drug Regulatory Agency (AEMPS) Summary of Products Characteristics (SmPC), evaluating the presence of pharmacogenetic biomarkers, as well as the associated recommendations. A total of 55.4% of the 1891 drug labels reviewed included information on pharmacogenetic biomarker(s). Pharmacogenomic information appears most frequently in the "antineoplastic and immunomodulating agents", "nervous system", and "cardiovascular system" Anatomical Therapeutic Chemical groups. A total of 509 different pharmacogenetic biomarkers were found, of which CYP450 enzymes accounted for almost 34% of the total drug-biomarker associations evaluated. A total of 3679 drug-biomarker pairs were identified, 102 of which were at the 1A level (PharmGKB® classification system), and 33.33% of these drug-pharmacogenetic biomarker pairs were assigned to "actionable PGx", 12.75% to "informative PGx", 4.9% to "testing recommended", and 4.9% to "testing required". The rate of coincidence in the assigned PGx level of recommendation between the AEMPS and regulatory agencies included in the PharmGKB® Drug Label Annotations database (i.e., the FDA, EMA, SWISS Medic, PMDA, and HCSC) ranged from 45% to 65%, being 'actionable level' the most frequent. On the other hand, discrepancies between agencies did not exceed 35%. This study highlights the presence of relevant pharmacogenetic information on Spanish drug labels, which would help avoid interactions, toxicity, or lack of treatment efficacy.

Spontaneous adverse drug reactions reported in a thirteen-year pharmacovigilance program in a tertiary university hospital.

We aimed to assess the characteristics of adverse drug reactions (ADRs) collected in a university hospital. A retrospective analysis of ADRs spontaneously reported in the Hospital Pharmacovigilance Program database (RutiRAM) over a 13-year period was conducted. The analysis included a description of ADRs [System Organ Class (SOC)] and their seriousness, the drugs involved [level 1 of the Anatomical Therapeutic Chemical (ATC) Classification System], drug-drug interactions, medication errors, drugs 'under additional monitoring', positive rechallenge, and the 'pharmacovigilance interest' of ADRs. An ADR was considered of 'pharmacovigilance interest' when it was serious, and/or produced sequelae, and/or affected the paediatric population, and/or when the suspected drug was 'under additional monitoring'. Additionally, an exploratory analysis for bivariate associations through an automated method was performed. A total of 2,148 spontaneous ADRs were registered in the RutiRAM database, with 92.5% recorded by medical doctors. The mean age of cases was 59.2years (SD 20.9), range 1 day-99years; 5.7% were paediatric, 46.2% adults, and 48.1% elderly. The drugs most often involved were anti-infectives (ATC group J), mainly amoxicillin-clavulanic acid. 'Blood system disorders' were the most frequent SOC ADRs, and skin rashes were the most frequent ADRs. The 63.2% of ADRs were considered of 'pharmacovigilance interest'. Almost half of ADRs were hospital-acquired, and these were related to medication error; serious ADRs were related to drug-drug interactions and elderly patients, and involved drugs 'under additional monitoring' were related to younger ones. This is the first study to overview of ADRs reported in an HPVP over more than a decade. Almost two-thirds of the ADRs collected in the RutiRAM database are of sufficient quality to be classified as 'pharmacovigilance interest', and thus can contribute to signal detection and the issuing of drug alerts by pharmacovigilance systems. Analysing ADRs in hospitals contributes to patient safety by implementing relevant actions to prevent medication errors or ADRs, some of which can be applied to other centres.

Medication errors related to high-alert medications in a paediatric university hospital – a cross-sectional study analysing error reporting system data

BackgroundPaediatric patients are prone to medication errors, and only a few studies have explored errors in high-alert medications in children. The present study aimed to investigate the prevalence and nature of medication errors involving high-alert medications and whether high-alert medications are more likely associated with severe patient harm and higher error risk classification compared to other drugs.MethodsThis study was a cross-sectional report of self-reported medication errors in a paediatric university hospital in 2018–2020. Medication error reports involving high-alert medications were investigated by descriptive quantitative analysis to identify the prevalence of different drugs, Anatomical Therapeutic Chemical groups, administration routes, and the most severe medication errors. Crosstabulation and Pearson Chi-Square (χ2) tests were used to compare the likelihood of more severe consequences to the patient and higher error risk classification between medication errors involving high-alert medications and other drugs.ResultsAmong the reported errors (n = 2,132), approximately one-third (34.8%, n = 743) involved high-alert medications (n = 872). The most common Anatomical Therapeutic Chemical subgroups were blood substitutes and perfusion solutions (B05; n = 345/872, 40%), antineoplastic agents (L01; n = 139/872, 16%), and analgesics (N02; n = 98/872, 11%). The majority of high-alert medications were administered intravenously (n = 636/872, 73%). Moreover, IV preparations were administered via off-label routes (n = 52/872, 6%), such as oral, inhalation and intranasal routes. Any degree of harm (minor, moderate or severe) to the patient and the highest risk classifications (IV-V) were more likely to be associated with medication errors involving high-alert medications (n = 743) when compared to reports involving other drugs (n = 1,389).ConclusionsPreventive risk management should be targeted on high-alert medications in paediatric hospital settings. In these actions, the use of intravenous drugs, such as parenteral nutrition, concentrated electrolytes, analgesics and antineoplastic agents, and off-label use of medications should be prioritised. Further research on the root causes of medication errors involving high-alert medications and the effectiveness of safeguards is warranted.

Use of pharmaceuticals amongst athletes tested by Anti-Doping Norway in a five-year period.

The aim of the study was to map the use of pharmaceuticals by Norwegian athletes registered on doping control forms (DCFs) in a five-year period to examine general and some class specific use of pharmaceuticals across sports and athlete levels. Anonymous data from DCFs collected in 2015-2019 were manually entered into a database using the Anatomical Therapeutic Chemical (ATC) system for classification of the pharmaceuticals. Variables entered were year of control, gender, age group, athlete level, sport, test type, nationality, and pharmaceuticals (and dietary supplements) used. Pain killers in the ATC groups M01 A (Nonsteroidal anti-inflammatory drugs - NSAIDs) and N02 B (other analgesics), and anti-asthmatics in ATC groups R03 A and R03 B were the most frequently used pharmaceuticals. National level athletes reported more use of pharmaceuticals (1.4 ± 1.7 pharmaceuticals per form) than recreational level athletes (0.9 ± 1.2). The highest proportion of DCFs containing information about at least one pharmaceutical were found in speed skating (79.1%), alpine skiing (74.0%), rowing (72.4%) and cross-country skiing (71.7%). Painkillers were most frequently used in muscular endurance sports (30.4% and 21.2 % for M01A and N02 B, respectively) and ball and team sports (17.9% and 17.0%). Use of hypnotics was reported from ice-hockey players and alpine skiers in around 8% of the cases. Use of anti-asthmatics was most often reported amongst athletes specially exposed to cold, chemicals and heavy endurance training. Athletes in specialized sports requiring high levels of strength and/or endurance reported a higher use of pharmaceuticals out-of-competition compared to in-competition, while there was no such difference in complex sports, such as team, gymnastic, aiming and combat sports.

Availability of essential medicines, progress and regional distribution in China: a systematic review and meta-analysis.

Essential medicines are the backbone of healthcare and meet the priority healthcare needs of the population. However, approximately one-third of the global population does not have access to essential medicines. Although China formulated essential medicine policies in 2009, the progress of availability of essential medicines and regional variations remains unknown. Therefore, this study was conducted to evaluate the availability of essential medicines, their progress, and regional distribution in China in the last decade. We searched eight databases from their inception to February 2022, relevant websites, and reference lists of included studies. Two reviewers selected studies, extracted data, and evaluated the risk of bias independently. Meta-analyses were performed to quantify the availability of essential medicines, their progress, and regional distribution. Overall 36 cross-sectional studies conducted from 2009 to 2019 were included, with regional data for 14 provinces. The availability of essential medicines in 2015-2019 [28.1%, 95% confidence interval (CI): 26.4-29.9%] was similar to that in 2009-2014 (29.4%, 95% CI: 27.5-31.3%); lower in the Western region (19.8%, 95% CI: 18.1-21.5%) than Eastern (33.8%, 95% CI: 31.6-36.1%) and Central region (34.5%, 95% CI: 30.6-38.5%); very low for 8 Anatomical Therapeutic Chemical (ATC) categories (57.1%), and low for 5 categories (35.7%) among all ATC groups. The availability of essential medicines in China is low compared with the World Health Organization goal, has not changed much in the last decade, is unequal across regions, and lacks data for half of provinces. For policy-making, the monitoring system of the availability of essential medicines is to be strengthened to enable long-term surveillance, especially in provinces where the data has been missing. Meanwhile, Joint efforts from all stakeholders are warranted to improve the availability of essential medicines in China toward the universal health coverage target. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=315267, identifier: PROSPERO CRD42022315267.

Associations of early childhood medication exposure and molar incisor hypomineralization (MIH): A routine data analysis

ObjectivesMolar incisor hypomineralization (MIH) has become a major oral health problem of widely unknown origin. Besides genetic predisposition, exposure to certain drugs in early childhood are suspected to be associated with MIH. Aim of this routine data analysis was to examine associations of MIH and exposure to medication as well as perinatal factors. MethodsIndividuals with MIH were identified in claims data using a validated predefined specific treatment pattern. The database was a comprehensive routine data set of a major national health insurance company (BARMER, Germany). Based on this treatment pattern a MIH group and an unaffected control group were formed for analysis. Various medical data including medical diagnoses and prescriptions were available. Associations were examined comparing results for a set of variables in both groups. Differences between the groups were tested for significance using T-tests (P<0.01). ResultsBetween 2010 to 2019, a total of 298,502 children between 6 and 9 years of age were included in this analysis. 22,947 were assigned to the MIH group. For individuals in this group, significantly larger prescription quantities in the main ATC (Anatomical, Therapeutic, Chemical) groups J (antiinfectives for systemic use), R (respiratory system) and S (sensory organs) were found in the first 4 years of life compared to MIH unaffected individuals. With antibiotics, there were both significantly larger prescription quantities and significantly higher numbers of respective prescriptions in the first 4 years of life. The differences amounted up to about 10.62% in frequently used antibiotics to be found in ATC J01D (other beta-lactam antibacterials) for the number of prescriptions in the 4th year of life. No association was found for premature birth, mode of delivery or the use of antipyretic or anti-inflammatory medication. ConclusionsWhile perinatal factors do not seem to be associated with MIH development, early life exposure to antibiotics might play a role. Clinical Significance StatementAlthough causal relations can still not be proven, a responsible use of the unquestionably beneficial antibiotics is encouraged from a clinical point of view.

Evaluation of prescribing pattern based on World Health Organization indicators in Maharashtra during COVID-19 pandemic

Introduction: Community pharmacy (CP) is one of the health care centers that have a key role to play in the current COVID-19 pandemic period. Prescriptions monitoring studies are essential as this helps in understanding the current prescribing pattern adopted by physicians. Furthermore, only few CP-based research studies were noted. This study was conducted with an aim to study prescribing pattern using World Health Organization (WHO) indicators from few community pharmacies in Maharashtra, India, during COVID-19 Pandemic period. Material and Methods: An observational study was conducted and sample comprised of prescriptions collected from different parts of Maharashtra (Mumbai, Pune. and Nashik). One thousand and fifty-six prescriptions were collected and data was collected for a period of 6 months (August 2020–January 2021). The variables of interest in this study were: Number of medications in each prescription, number of prescriptions with generic names, number of antibiotics and injectables in each prescription, number of prescribed drugs from essential drug list (EDL), and defined daily dose (DDD). Results: Out of 3058 drugs prescribed, it was found that average number of drugs per prescription was 2.89 (standard deviation ± 1.37). Only 23 (0.75%) were prescribed by generic name. Antibiotics and injectables were 399 (37.78%) and 29 (2.74%), respectively. Drugs that were prescribed from EDL were only 920 (30.08%). The total class of antimicrobial agents prescribed (Anatomical Therapeutic Chemical group J01) was 13. After calculating DDD, DDD of Azithromycin was found to the highest (81.6 g). Conclusion: Among five WHO indicators, only the percentage of encounters with an injection was in compliance with the WHO recommended value. Further studies are required for better understanding of this area.

Proposal for Handling of Medicine Shortages Based on a Comparison of Retrospective Risk Analysis.

Introduction: We reviewed and compared current drug shortages and shortage management practices in six selected countries (Hungary, Belgium, Spain, Switzerland, Australia, United States) based on the most comprehensive national shortage databases for each country, for four Anatomical Therapeutic Chemical (ATC) groups, to analyze the criticality of drug shortages across countries and identify best practices in shortage management strategies. Materials and Methods: Countries were selected to cover a wide geographical range of high-income nations where a lack of economic power as a potential source of drug shortages is not observable. ATC groups were selected based on a pre-examination of the databases to analyze groups most often in shortage, and groups where the absence of which could have a severe negative impact on treatment outcomes. The bias originating from the different reporting systems had to be reduced to gain comprehensive and comparable information. The first bias-reducing mechanism was transforming the raw number of shortages into proportion per million people. Secondly, critical cases were classified, and thirdly, critical cases were compared with the Word Health Organization (WHO) Essential Medicine Lists. Results: The results indicate that every European country studied reports significantly higher total and critical shortages per population compared to the US and Australia. Within Europe, Hungary reports the highest number of cases both for total and critical shortages, while Spain has the lowest results in both aspects. While in the US and Australia critical shortages were observable in similar proportions across all ATC groups, in European countries ATC groups of anti-infectives for systemic use (J) and the nervous system (N) were found to account for a notably higher proportion of critical shortages. Current shortage management practices were examined in each country and classified into five groups to identify common best practices. Conclusions: Due to the different characterization of reporting systems, several bias-reducing mechanisms should be applied to compare and evaluate shortages. In addition, European harmonization should be initiated to create mutually acknowledged definitions and reporting systems, which could be the basis of good drug shortage handling practices in Europe.

Drugs Associated With Ischemic Stroke: A Review for Clinicians.

Certain drugs may increase the risk of ischemic stroke (IS). Our goal was to review associations between frequently used drugs and IS. We created an initial list of frequently used drugs to search Pubmed/MEDLINE from 1966 to 2020 and reviewed phase III and IV data, case series, and drug authorities' safety warnings to assess a potential association with IS. Drugs were grouped according to the World Health Organization Anatomical Therapeutic Chemical Classification System. Predefined criteria were applied to establish a level of evidence for an association, from A (high level of evidence of association) to E (high level of evidence of absence of association). In addition, we assessed relative risks and reviewed potential mechanisms of IS facilitation. We assessed 81 drugs or drug classes from 11 World Health Organization Anatomical Therapeutic Chemical Groups. We identified a high level of association for erythropoietin, combined contraceptives, oral estrogen replacement therapy, bevacizumab, tamoxifen, and antipsychotics and a moderate level for ponatinib, nilotinib, darunavir, and gonadotropin-releasing hormone agonists. Drug dose and treatment duration may modify the risk. For a substantial number of drugs, we found no association, and for others, there were insufficient data to categorize risk. We identified a high level of association of IS with a limited number of drugs, a potential association with some, and a lack of data for others. The summarized information may help clinicians to estimate the contribution of a drug to an IS, to better assess drug benefit-risk ratios, and to support decisions about using specific drugs.

Analysis of the Consumption of Non-Oncological Medicines: A Methodological Study on Patients of the Ada Cohort.

Cancer patients are identified as fragile patients who are often immunodepressed and subject to secondary diseases. The Ada cohort comprises cancer survivors aged 15–39 years at diagnosis included in 34 Italian cancer registries. This study aimed to analyze the possible excess of non-cancer medicines use on the basis of the medicine database of the Ada cohort. Records of medicines present in the pharmaceutical flows collected by eight Lombardy cancer registries and used by patients with any type of cancer were extracted for the year 2012. Medicine consumption data were processed to assign a defined daily dose value and to evaluate the consumption of medicines belonging to different groups of the ATC (Anatomical Therapeutic Chemical) classification. The values were compared with values in the Lombardy population. Medicine consumption related to 8150 patients was analyzed, for a total of 632,675 records. ATC groups A and C for females and group N for both sexes showed significant increases. Group J for males and group M for females showed intermediate increases, and group H for both sexes showed smaller increases. This method allowed the identification of excess medicine use to reduce cancer therapy side effects and primary disease sequelae in this group of patients.

Variations in the Consumption of Antimicrobial Medicines in the European Region, 2014-2018: Findings and Implications from ESAC-Net and WHO Europe.

Background: Surveillance of antimicrobial consumption (AMC) is important to address inappropriate use. AMC data for countries in the European Union (EU) and European Economic Area (EEA) and Eastern European and Central Asian countries were compared to provide future guidance. Methods: Analyses of 2014–2018 data from 30 EU/EEA countries of the European Surveillance of Antibiotic Consumption network (ESAC-Net) and 15 countries of the WHO Regional Office for Europe (WHO Europe) AMC Network were conducted using the Anatomical Therapeutic Chemical (ATC) classification and Defined Daily Dose (DDD) methodology. Total consumption (DDD per 1000 inhabitants per day) of antibacterials for systemic use (ATC group J01), relative use (percentages), trends over time, alignment with the WHO Access, Watch, Reserve (AWaRe) classification, concordance with the WHO global indicator (60% of total consumption should be Access agents), and composition of the drug utilization 75% (DU75%) were calculated. Findings: In 2018, total consumption of antibacterials for systemic use (ATC J01) ranged from 8.9 to 34.1 DDD per 1000 inhabitants per day (population-weighted mean for ESAC-Net 20.0, WHO Europe AMC Network 19.6, ESAC-Net Study Group, and WHO Europe AMC Network Study Group). ESAC-Net countries consumed more penicillins (J01C; 8.7 versus 6.3 DDD per 1000 inhabitants per day), more tetracyclines (J01A; 2.2 versus 1.2), less cephalosporins (J01D; 2.3 versus 3.8) and less quinolones (J01M; 1.7 versus 3.4) than WHO Europe AMC Network countries. Between 2014 and 2018, there were statistically significant reductions in total consumption in eight ESAC-Net countries. In 2018, the relative population-weighted mean consumption of Access agents was 57.9% for ESAC-Net and 47.4% for the WHO Europe AMC Network. For each year during 2014–2018, 14 ESAC-Net and one WHO Europe AMC Network countries met the WHO global monitoring target of 60% of total consumption being Access agents. DU75% analyses showed differences in the choices of agents in the two networks. Interpretation: Although total consumption of antibacterials for systemic use was similar in the two networks, the composition of agents varied substantially. The greater consumption of Watch group agents in WHO Europe AMC Network countries suggests opportunities for improved prescribing. Significant decreases in consumption in several ESAC-Net countries illustrate the value of sustained actions to address antimicrobial resistance.

Psychotropic Use among Older Adults Living at Home: Use of the Anatomical Therapeutic Chemical (ATC) Drug Classification System and Beers Criteria®

The study examined medication use among older adults living at home and connection between background characteristics, urban/rural residency, and medication use according to Anatomical Therapeutic Chemical (ATC) drug classification system and Beers Criteria®. Population-based cross-sectional study, participants (N = 175) were randomly selected from the Icelandic national registry, randomized by age, gender, and residence. On average, participants took 2.9 medications: 20% used psychotropics and 15% used psychotropics in ATC groups N05/N06A, which are deemed inappropriate for this age group according to Beers Criteria. Beers Criteria are useful for recognizing possible inappropriate medications for older adults and can be utilized by mental health nurses to assess the appropriateness of geriatric pharmaceutical treatments.

Development of a method for the analysis of the lists of medicines and its application for the analysis of the lists of medicines in Russia, England, and Italy

Objective: the development and approbation of the method for comparative analysis of the lists of medicines in different countries and systems of healthcare.Material and methods. Based on the open-access data on the lists of medicines published on official websites of the authorized regulators, the authors selected the national lists of medicines of Russia, England, and Italy for the development and approbation of the method. It was proposed to use three parameters: the absolute number of medicines by international nonproprietary name (INN); the structure of the lists based on anatomical therapeutic chemical (ATC) classification; and the coverage of the indications based on the International Classification of Diseases, 10th edition (ICD-10). The results of the analysis provided grounds for the review of the approaches to the formation of the lists of medicines required for medical help in Russia, England, and Italy and reimbursed from the state budget.Results. The number of medicines by INN in the national lists of England and Italy exceeds the total number of drugs included in the list of vital essential and desirable (VED) in Russia. All the analyzed lists were characterized by an uneven distribution of medicines within the lists by the ATC groups. The lists of medicines in England and Italy significantly exceed the list of VED by the number of the included medicines by all ATC groups excluding groups J and H in comparison with Italy, and groups J and V in comparison with England. At the same time, the list of VED significantly exceeds the list in England by the number of covered indications from the ATC L group. During the approbation, the method showed to be effective and can be used for further comparative studies of the national lists of medicines.Conclusion. Non-uniform lists of medicines by ATC-codes show that each country has priority areas in their healthcare systems. The list of VED can be shorter by the absolute number of the included medicines in England and Italy but it can exceed them by the coverage of indications due to peculiarities of the procedure of the list formation (reimbursement of medicines by all the registered indications). The results of the study with the proposed method can serve for the optimization of the VED list and the analysis of therapeutic areas that are undercovered.

Price cap regulation in the Colombian pharmaceutical market: An impact evaluation

We evaluate the impact of a price cap regulation implemented in the Colombian pharmaceutical market between 2011 and 2014. To do so, we take advantage of a unique data set where we observe three sources of variation: i) differences across eighteen groups in the Anatomical Therapeutic Chemical (ATC) classification system of the WHO, ii) the existence of regulated (treated) and unregulated (control) groups within each of these eighteen ATC groups, and iii) differences in time (before and after regulation) for the eighteen ATC groups. A triple differences model with fixed time effects and cluster errors is used to identify the impact of this regulation. We find that the price-cap regulation contributed to reduce prices in three of the eighteen groups and increase average prices for ten of them. We confirm then that the focal point effect generated by a price-cap regulation can generate unintended distortions. More specifically, our results reveal that the implementation of this price cap regulation potentially increased -public and private- expenditure by 30%, only for the 2,422 drugs in the eighteen ATC groups we study.

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.

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.

Adverse drug reaction reporting in Canada: consumer versus physician reports

In Canada, adverse drug reaction (ADR) reporting was initiated in 1965. Since 2003, consumers have been able to report ADRs directly to Health Canada. This study compares consumer-reported ADRs with physician-reported ADRs based on seriousness, system organ class (SOC), and anatomical therapeutic chemical (ATC) classification. This retrospective observational study evaluated ADR reports received by the Canadian Vigilance ADR Reporting Database from January 2000 to December 2014. A total of 198,781 spontaneous ADR reports were analyzed in terms of who reported the ADR, the seriousness of the ADR, and category of ADR by SOC and ATC group. Chi-square tests for independence and odds ratios were used to detect statistically significant differences between reporters (consumers and physicians) based on seriousness, SOC, and ATC classification. Of 198,781 serious and non-serious ADR reports, 28.7% were from consumers, 26.6% from physicians, 22.9% from pharmacists, 21.4% from other healthcare professionals, and 0.5% from lawyers, with consumers reporting significantly more ADRs than physicians (p < 0.0001). Significant differences in ADR reporting were found between consumers and physicians, in terms of ADR seriousness, ATC classification, and SOC involved. ‘General disorders and administrative site conditions’ was the most common SOC in both consumer and physician reports of serious ADRs. This study, the first Canadian study to compare consumer and physician ADR reports, showed that consumers and physicians reported ADRs differently with regard to SOC and ATC classification. Consumer and physician reports should be included in post-marketing surveillance. Further research is required to investigate the extent to which additional information from consumer reports contribute to signal identification when assessing drug safety.