Counterfeit medicines in Peru: a retrospective review (1997-2014).
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ABSTRACT:
SUBMITTER: Medina E
PROVIDER: S-EPMC4823432 | biostudies-other | 2016 Apr
REPOSITORIES: biostudies-other
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Project description:BackgroundPeople living with human immunodeficiency virus (HIV) (PLWH) form a vulnerable population for the onset of infective endocarditis (IE). We aimed to analyze the epidemiological trend of IE, as well as its microbiological characteristics, in PLWH during the combined antiretroviral therapy era in Spain.MethodsWe performed a retrospective study (1997-2014) in PLWH with data obtained from the Spanish Minimum Basic Data Set. We selected 1800 hospital admissions with an IE diagnosis, which corresponded to 1439 patients.ResultsWe found significant downward trends in the periods 1997-1999 and 2008-2014 in the rate of hospital admissions with an IE diagnosis (from 21.8 to 3.8 events per 10,000 patients/year; p < 0.001), IE incidence (from 18.2 to 2.9 events per 10,000 patients/year; p < 0.001), and IE mortality (from 23.9 to 5.5 deaths per 100,000 patient-years; p < 0.001). The most frequent microorganisms involved were staphylococci (50%; 42.7% Staphylococcus aureus and 7.3% coagulase-negative staphylococci (CoNS)), followed by streptococci (9.3%), Gram-negative bacilli (8.3%), enterococci (3%), and fungus (1.4%). During the study period, we found a downward trend in the rates of CoNS (p < 0.001) and an upward trends in streptococci (p = 0.001), Gram-negative bacilli (p < 0.001), enterococci (p = 0.003), and fungus (p < 0.001) related to IE, mainly in 2008-2014. The rate of community-acquired IE showed a significant upward trend (p = 0.001), while the rate of health care-associated IE showed a significant downward trend (p < 0.001).ConclusionsThe rates of hospital admissions, incidence, and mortality related to IE diagnosis in PLWH in Spain decreased from 1997 to 2014, while other changes in clinical characteristics, mode of acquisition, and pathogens occurred over this time.
| S-EPMC6723534 | biostudies-literature
Project description:BackgroundNocardia is an opportunistic pathogen that can cause life-threatening disease. We aimed to characterize the epidemiological, microbiological, and clinical features of nocardiosis in the tropical north of Australia.MethodsWe conducted a retrospective cohort study of nocardiosis diagnosed between 1997 and 2014. Population-based incidences were calculated using district population data.ResultsClinically significant nocardiosis was identified in 61 patients. The unadjusted population-based annual incidence of nocardiosis was 2.02 (95% confidence interval [CI], 1.55-2.60) per 100000 people and was 1.7 (95% CI, .96-2.90) fold higher in Indigenous compared with non-Indigenous persons (P = .027). Of 61 patients, 47 (77%) had chronic lung disease, diabetes, and/or hazardous alcohol consumption; 22 (36%) were immunocompromised; and 8 (13%) had no identified comorbidities. Disease presentations included pulmonary (69%; 42 of 61), cutaneous (13%; 8 of 61), and disseminated nocardiosis (15%; 9 of 61). The most commonly identified species were Nocardia asteroides and Nocardia cyriacigeorgica (each 11%). Linezolid was the only antimicrobial to which isolates were universally susceptible; 89% (48 of 54), 60% (32 of 53), and 48% (26 of 54) of isolates were susceptible to trimethoprim-sulfamethoxazole, ceftriaxone, and imipenem, respectively. Eighteen patients (30%) required intensive care unit (ICU) admission, and 1-year mortality was 31%.ConclusionsThe incidence of nocardiosis in tropical Australia is amongst the highest reported globally. Nocardiosis occurs in both immunocompromised and immunocompetent hosts, and it is associated with high rates of ICU admission, 1-year mortality, and resistance to commonly recommended antimicrobials. Diagnosis should be considered in patients with consistent clinical features, particularly if they are Indigenous or have chronic lung disease.
| S-EPMC5144655 | biostudies-literature
Project description:BackgroundMany medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled.AimsTo investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period.MethodsA retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer.ResultsA total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved.ConclusionsThis study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP).
| S-EPMC10496228 | biostudies-literature
Project description:OBJECTIVE:To explore the quality and safety of medicines in Canada. DESIGN:A retrospective review of drug recalls and risk communication documents conveying issues relating to defective (ie, substandard and falsified) medicines. SETTING:The Health Canada website search for drug recalls and risk communication documents issued between 2005 and 2013. ELIGIBILITY CRITERIA:Drug recalls and risk communication documents related to quality defect in medicinal products. MAIN OUTCOME MEASURE:Relevant data about defective medicines reported in drug recalls and risk communication documents, including description of the defect, type of formulation, year of the recall and category of the recall or the document. RESULTS:There were 653 defective medicines of which 649 were substandard. The number of defective medicines reported by Health Canada increased from 42 in 2005 to 143 in 2013. The two most frequently reported types of defects were stability (205 incidents) and contamination issues (139 incidents). Some of these defects were found to be more prominent and repetitive over other types within some manufacturers. Tablet formulation (251 incidents) was the formulation most frequently compromised. No significant differences were observed between the manufacturers and distributors in the number of substandard medicines reported under each defect type. There were only four falsified medicines reported over the 9-year period. CONCLUSIONS:Substandard medicines are a problem in Canada and have resulted in an increasing number of recalled medicines. Most of the failures were related to stability issues, raising the need to investigate the root causes and for stringent preventative measures to be implemented by manufacturers.
| S-EPMC4216865 | biostudies-other
Project description:Phage therapy has regained interest in recent years due to the alarming spread of antibiotic resistance. Whilst phage cocktails are commonly sold in pharmacies in countries such as Georgia and Russia, this is not the case in western countries due to western regulatory agencies requiring a thorough characterization of the drug. Here, DNA sequencing of constituent biological entities constitutes a first step. The pyophage (PYO) cocktail is one of the main commercial products of the Georgian Eliava Institute of Bacteriophage, Microbiology and Virology and is used to cure skin infections. Since its first production in the 1930s, the composition of the cocktail has been periodically modified to add phages effective against emerging pathogenic strains. In this paper, we compared the composition of three PYO cocktails from 1997 (PYO97), 2000 (PYO2000) and 2014 (PYO2014). Based on next generation sequencing, de novo assembly and binning of contigs into draft genomes based on tetranucleotide distance, thirty and twenty-nine phage draft genomes were predicted in PYO97 and PYO2014, respectively. Of these, thirteen and fifteen shared high similarity to known phages. Eleven draft genomes were found to be common in the two cocktails. One of these showed no similarity to publicly available phage genomes. Representatives of phages targeting E. faecalis, E. faecium, E. coli, Proteus, P. aeruginosa and S. aureus were found in both cocktails. Finally, we estimated larger overlap of the PYO2000 cocktail to PYO97 compared to PYO2014. Using next generation sequencing and metagenomics analysis, we were able to characterize and compare the content of PYO cocktails separated by 17 years in time. Even though the cocktail composition is upgraded every six months, we found it to remain relatively stable over the years.
| S-EPMC5707535 | biostudies-literature
Project description:BackgroundColorectal cancer incidence and mortality have declined with increased screening and scientific advances in treatment. However, improvement in colorectal cancer outcomes has not been equal for all groups and disparities have persisted over time.MethodsData from the California Cancer Registry were used to estimate changes in 5-year colorectal cancer-specific survival over three diagnostic time periods: 1997-2002, 2003-2008, and 2009-2014. Analyses included all patients in California with colorectal cancer as a first primary malignancy. Multivariable Cox proportional hazard regression models were used to evaluate the effect of race/ethnicity, insurance status, and neighborhood socioeconomic status (nSES) on 5-year colorectal cancer-specific survival.ResultsOn the basis of a population-based sample of 197,060 colorectal cancer cases, racial/ethnic survival disparities decreased over time among non-Hispanic Blacks (NHB) compared with non-Hispanic Whites (NHW), after adjusting for demographic, clinical, and treatment characteristics. For cases diagnosed 1997-2002, colorectal cancer-specific hazard rates were higher for NHB [HR, 1.12; 95% confidence interval (CI), 1.06-1.19] and lower for Asians/Pacific Islanders (HR, 0.92; 95% CI, 0.87-0.96) and Hispanics (HR, 0.94; 95% CI, 0.90-0.99) compared with NHW. In 2009-2014, colorectal cancer-specific HR for NHB was not significantly different to the rate observed for NHW (HR, 1.03; 95% CI, 0.97-1.10). There were no changes in disparities in nSES, but increasing disparities by health insurance status.ConclusionsWe found a decrease in survival disparities over time by race/ethnicity, but a persistence of disparities by neighborhood socioeconomic status and health insurance status.ImpactFurther investigation into the drivers for these disparities can help direct policy and practice toward health equity for all groups.
| S-EPMC7269803 | biostudies-literature
Project description:BackgroundResistance to isoniazid is the most common form of drug-resistance in tuberculosis. However only a tiny proportion of TB patients in the world have access to isoniazid drug susceptibility testing-the widely implemented Xpert MTB/RIF technology only tests for resistance to rifampicin. Patients with isoniazid mono resistance that is not identified at baseline are treated with a standard regimen that effectively results in rifampicin mono-therapy during the latter four months of the six month treatment course, exposing remaining viable organisms to a single agent and greatly increasing the risk of development of multi drug-resistant TB. Unusually, Peru has pioneered universal pre-treatment drug susceptibility testing with methods that identify isoniazid resistance and has thus identified a large number of individuals requiring tailored therapy. Since 2010, treatment in Peru for isoniazid-resistant tuberculosis without multidrug-resistant tuberculosis (Hr-TB) has been with a standardized nine-month regimen of levofloxacin, rifampicin, ethambutol and pyrazinamide. The objectives of this study were to evaluate the outcomes of treatment for patients with Hr-TB initiating treatment with this regimen between January 2012 and December 2014 and to determine factors affecting these outcomes.MethodsRetrospective cross-sectional study; case data were obtained from the national registry of drug-resistant tuberculosis. Patients diagnosed with isoniazid resistant TB without resistance to rifampicin, pyrazinamide, ethambutol and quinolones as determined by either a rapid drug susceptibility testing (DST) (nitrate reductase test, MODS, Genotype MTBDRplus) or by the proportion method were included.FindingsA total of 947 cases were evaluated (a further 403 without treatment end date were excluded), with treatment success in 77.2% (731 cases), loss to follow-up in 19.7% (186 cases), treatment failure in 1.2% (12 cases), and death in 1.9% (18 cases). Unfavorable outcomes were associated in multivariate analysis with male gender (OR 0.50, 95% CI 0.34-0.72, p<0.05), lack of rapid DST (OR 0.67, 95% CI 0.50-0.91, p = 0.01), additional use of an injectable second-line anti-tuberculous drug (OR 0.46, 95% CI 0.31-0.70, p<0.05), and treatment initiation in 2014 (OR 0.77, 95% CI 0.62-0.94, p = 0.01).InterpretationThe treatment regimen implemented in Peru for isoniazid resistant TB is effective for TB cure and is not improved by addition of an injectable second-line agent. Access to rapid DST and treatment adherence need to be strengthened to increase favorable results.
| S-EPMC6279036 | biostudies-literature
Project description:ObjectiveTo determine the extent of substandard and falsified medicines in the UK.DesignA retrospective review of drug alerts and company-led recalls.SettingThe Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011.Eligibility criteriaDrug alerts related to quality defect in medicinal products.Main outcome measureRelevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert.ResultsThere were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11-year period. The number of defective medicines reported by the MHRA increased 10-fold from 5 in 2001 to 50 in 2011.ConclusionsSubstandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicines.
| S-EPMC3731779 | biostudies-literature
Project description:IntroductionMediterranean spotted fever (MSF) is a zoonotic disease caused by Rickettsia conorii. In Spain, deficiencies in the official reporting result in misreporting of this disease. This study aims to describe the clinical and temporal-spatial characteristics of MSF hospitalizations between 1997 and 2014.Materials and methodsWe performed a retrospective descriptive study using the Hospitalization Minimum Data Set (CMBD). All CMBD's hospital discharges with ICD-9 CM code 082.1 were analyzed. Hospitalization rates were calculated and clinical characteristics were described. Spatial distribution of cases and their temporal behavior were also assessed.ResultsA total of 4,735 hospitalizations with MSF diagnosis were recorded during the study period, out of which 62.2% were male, mean age of 48. Diabetes mellitus, alcohol dependence syndrome, and chronic liver disease occurred in 10.8%, 2.4% and 2.8% hospitalizations, respectively. The median annual hospitalization rate showed a decreasing trend from a maximum of 12.9 in 1997 to a minimum rate of 3.1 in 2014. Most admissions occurred during the summer, showing a significant annual seasonal behavior. Important regional differences were found.DiscussionAlthough MSF hospitalization rates have decreased considerably, it remains a public health problem due to its severity and economic impact. Therefore, it would be desirable to improve its oversight and surveillance.
| S-EPMC5371374 | biostudies-literature
Project description:BackgroundCurrently, there is no comprehensive presentation of trends in oral diseases in the German general population over the last 20 years.ObjectivesHow did prevalences of caries, periodontitis, and tooth loss and their determinants change in Germany between 1997 and 2014?Materials and methodsWe analysed data from 35- to 44-year-olds and 65- to 74-year-olds from the German Oral Health Studies ("Deutsche Mundgesundheitsstudien" [DMS]) III to V and of 25- to 74-year-olds from the Studies of Health in Pomerania (SHIP‑0 and SHIP-Trend-0). The decayed, missing, filled teeth index (DMFT), the number of sound teeth, the community periodontal index (CPI), and data on tooth count and edentulism were analysed.ResultsRegarding determinants, an increase in subjects with high school education, a slight decrease in smokers, and an increase in better oral hygiene patterns was observed in both studies. In 35- to 44-year-olds, the number of sound teeth increased from 11.9 in DMS III to 16.8 in DMS V, while in 65- to 74-year-olds the number of sound teeth increased by 5.9. A similar trend was observed in SHIP. In DMS, the prevalence of the highest CPI score of 4 decreased from 9.3% to 3.5% in 35- to 44-year-olds; in 65- to 74-year-olds, the 2014 prevalence was at the same level as in 1997 (10.5% and 9.8%). In parallel, the percentage of edentulous 65- to 74-year-olds halved in both studies. The number of teeth increased across all age strata.ConclusionsDMS and SHIP consistently showed an increase in the number of healthy teeth free of fillings, a slight reduction of subjects with a CPI score of 4, more tooth retention, and less edentulism. Because of more tooth retention and current demographic changes, higher periodontal treatment needs might be expected for the future.
| S-EPMC8241795 | biostudies-literature