Device-related outcomes following hypoglossal nerve stimulator implantation.

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. METHODS: Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. RESULTS: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with 3-year postimplantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). CONCLUSIONS: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology. CITATION: Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation. J Clin Sleep Med. 2024;20(9):1497-1503.

Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis.

Introduction: Considering the need for effective postmarketing surveillance of disease-modifying therapies (DMTs) in multiple sclerosis (MS), we analyzed the potential of the spontaneous reports for safety signal detection, verifying the completeness of the reports in the FDA Adverse Event Reporting System (FAERS).Methods: All reports with DMTs for MS considered the primary suspect cause of ADRs and registered between January 2004 and June 2019 were selected. The vigiGrade completeness score was applied and reports with a score greater than 0.80 were considered well documented. Descriptive statistical analysis and comparisons of well-documented reports by DMTs were performed.Results: A total of 297,926 reports were analyzed. The lowest completeness rates were observed for type of report (13.5%), dose (62.7%), and time from treatment start to the ADR (79.0%). Overall, 80.8% of reports were classified as well documented and those related to natalizumab had the highest proportion (92.4%, p < 0.001), while the lowest was observed for reports sent in 2017 (53.1%, p < 0.001) and for teriflunomide (48.5%, p < 0.001).Conclusions: The high proportion of well-documented reports for DMTs indicates that they can be a valuable source for safety signal detection. A more careful analysis should be performed for data from the groups identified with low completeness to avoid the disclosure of spurious results.

Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review.

BACKGROUND: Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems. These have limited utility for maternal immunization pharmacovigilance in LMIC settings and need to be supplemented with active surveillance. Our study's main objective was to identify existing perinatal data collection systems in LMICs that collect individual information on maternal and neonatal health outcomes and could be developed to inform active safety surveillance of novel vaccines for use during pregnancy. METHODS: A scoping review was performed following the Arksey and O'Malley six-stage approach. We included studies describing electronic or mixed paper-electronic data collection systems in LMICs, including research networks, electronic medical records, and custom software platforms for health information systems. Medline PubMed, EMBASE, Global Health, Cochrane Library, LILACS, Bibliography of Asian Studies (BAS), and CINAHL were searched through August 2019. We also searched grey literature including through Google and websites of existing relevant perinatal data collection systems, as well as contacted authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information. RESULTS: A total of 11,817 records were identified. The full texts of 264 records describing 96 data collection systems were assessed for eligibility. Eight perinatal data collection systems met our inclusion criteria: Global Network's Maternal Newborn Health Registry, International Network for the Demographic Evaluation of Populations and their Health; Perinatal Informatic System; Pregnancy Exposure Registry & Birth Defects Surveillance; SmartCare; Open Medical Record System; Open Smart Register Platform and District Health Information Software 2. These selected systems were qualitatively characterized according to seven different domains: governance; system design; system management; data management; data sources, outcomes and data quality. CONCLUSION: This review provides a list of active maternal and neonatal data collection systems in LMICs and their characteristics as well as their outreach, strengths, and limitations. Findings could potentially help further understand where to obtain population-based high-quality information on outcomes to inform the conduct of maternal immunization active vaccine safety surveillance activities and research in LMICs.

Predictors of adverse drug reactions associated with ribavirin in direct-acting antiviral therapies for chronic hepatitis C.

PURPOSE: To identify factors associated with the development of adverse drug reactions (ADR) in ribavirin therapeutic regimens. METHODS: A multicenter, prospective study was conducted in three public health hospitals in Rio de Janeiro between November 2015 and March 2018. Inclusion criteria were defined by patient follow-up at pharmaceutical consultation at the time of drug dispensing as those who used sofosbuvir in combination with simeprevir, daclatasvir, and/or ribavirin. All patients were invited to participate in the study during the first interview. Adverse drug reactions were reported according to the treatment regimen and frequency of occurrence. Statistical analysis was used to compare adverse reactions between treatments and their associated factors. RESULTS: A total of 405 patients were included in the study (mean age 59.6 ± 9.6 years); 61.0% were female, 88.1% were infected with genotype 1, and 65.4% were cirrhotic. The most prescribed treatment was the combination of sofosbuvir, daclatasvir, and ribavirin (55.3%). The majority of patients reported at least one ADR during treatment (83.2%), of which fatigue, anemia, and headache were the most common. Being female (OR = 1.86, [1.08-3.20]) and use of ribavirin (OR: 2.39; 95% CI [1.38-4.13]) were predictors for the development of ADR, which was also associated with development of anemia (OR: 10.28; 95% CI: [5.78-18.30]). Treatment efficacy was 98.1%. CONCLUSIONS: Direct-acting antiviral has been shown to be safe and effective. Therefore, use of ribavirin is questionable due to associated adverse reactions and similar efficacy to other treatments.

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis.

Analysis of advertising material distributed through pharmacies and drugstores.

A documental analysis was conducted to evaluate advertising material distributed through pharmacies and drugstores according to their compliance with Resolutions n. 102/2000 and 96/2008 of the Collegiate Board of Brazil's National Agency for Sanitary Surveillance. Brochures distributed through five pharmacies and drugstores in the city of Tubarão, Southern Brazil, were collected between May and November 2008. The 17 analyzed brochures advertised 2,444 products, of which 680 were medicines. Of these, 13.7% were controlled drugs, half of them had no registration number with the Ministry of Health and 77.9% had a registration number that did not match. Information on drug indications and safety were omitted. The results showed that the drug advertising materials were not in accordance with the aforementioned resolutions.

Strategies to increase the sensitivity of pharmacovigilance in Portugal.

OBJECTIVE: To evaluate the results of an intervention to improve the number and relevance of reports of adverse drug reactions. METHODS: A cluster-randomized controlled trial was conducted with pharmacists working in Northern Portugal, in 2007. After randomization, 364 individuals were placed into the intervention group (261 in telephone interviews and 103 in workshops), while the control group was comprised of 1,103 pharmacists. The following were approached in the educational intervention: the problem of adverse drug reaction, the impact on public health and spontaneous reporting. With regard to relevance, adverse reactions were classified into severe and unexpected. Statistical analysis was performed, based on the intention-to-treat principle; generalized linear mixed models were applied, using the penalized quasi-likelihood method. The pharmacists studied were followed during a period of 20 months. RESULTS: The intervention increased the rate of spontaneous reporting of adverse reactions three times (RR = 3.22; 95% CI 1.33;7.80), when compared to the control group. The relevance of reporting rose, with an increase in severe adverse reactions by approximately four times (RR = 3.87; 95% CI 1.29;11.61) and in unexpected adverse reactions by five times (RR = 5.02; 95% CI 1.33;18.93), compared to the control group. CONCLUSIONS: During a period of up to four months, educational interventions significantly increased the number and relevance of spontaneous reporting of adverse drug reactions by pharmacists in Northern Portugal.

Aspartame: scientific evaluation in the postmarketing period.

Prior to marketing, the safety of the high-intensity sweetener aspartame for its intended uses as a sweetener and flavor enhancer was demonstrated by the results of over 100 scientific studies in animals and humans. In the postmarketing period, the safety of aspartame was further evaluated through extensive monitoring of intake, postmarketing surveillance of anecdotal reports of alleged health effects, and additional research to evaluate these anecdotal reports and other scientific issues. The results of the extensive intake evaluation in the United States, which was done over an 8-year period, and the results of studies done in other countries demonstrated intakes which were well below the acceptable daily intakes set by the FDA and regulatory bodies in other countries, as well as the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of the anecdotal reports of adverse health effects, the first such system for a food additive, revealed that the reported effects were generally mild and also common in the general population and that there was no consistent or unique pattern of symptoms that could be causally linked to consumption of aspartame. Finally, the results of the extensive scientific research done to evaluate these allegations did not show a causal relationship between aspartame and adverse effects. Thus, the weight of scientific evidence confirms that, even in amounts many times what people typically consume, aspartame is safe for its intended uses as a sweetener and flavor enhancer.

Mercury poisoning associated with a Mexican beauty cream.

OBJECTIVES: To describe demographic characteristics, patterns of use, and symptoms associated with mercury poisoning among persons who used a Mexican beauty cream containing mercurous chloride and to estimate the prevalence of cream use in Texas near the Mexico border. DESIGN: Case series and cross-sectional survey. SETTING: Border communities of Arizona, California, New Mexico, and Texas. PARTICIPANTS: Persons who used the cream and contacted a health department in response to announcements about the cream and households that participated in the Survey of Health and Environmental Conditions in Texas Border Counties and Colonias, 1997. MAIN OUTCOME MEASURES: Urine mercury concentrations, self-reported symptoms, and prevalence of cream use among households. RESULTS: Of 330 cream users who contacted their health department, 96% were women, and 95% were Hispanic. The mean urine mercury concentration was 146.7 microg/L (reference range : 0-20 microg/L). In 5% of 2,194 randomly selected Texas households near the Mexico border, at least 1 person had used "Crema de Belleza-Manning" (Laboratorios Vida Natural, S.A., Tampico, Tamaulipas, Mexico) in the previous year. CONCLUSIONS: Most cream users had increased urine mercury concentrations. Cream use was common in Texas near the Mexico border. Physicians should consider toxicity in patients with neurologic symptoms of unclear cause and use public health departments when investigating unusual illnesses.

[Surveillance and the costs related to the prescription of antimicrobials in a pediatric hospital]. / Vigilancia y costos relacionados con la prescripción de antimicrobianos en un hospital pediátrico.

INTRODUCTION: Important considerations in the selection of an antimicrobial agent include the indications for its prescription, its efficacy, toxicity and cost. However, is has been observed that up to 50% of these prescriptions are inappropriate. OBJECTIVE: To evaluate the utilization patterns and costs of restricted antimicrobial agents requiring authorization of the infectious diseases service for their prescription, in a tertiary care pediatric hospital through the use of a computer software antimicrobial use surveillance program designed by the investigators. MATERIAL AND METHODS: A one-year longitudinal descriptive and prolective survey was conducted in all patients requiring antimicrobial therapy during their hospitalization. Information on the prescription and costs of antimicrobial agents was recorded from both the medical chart and pharmacy registers. RESULTS: A total of 748 patients were prescribed at least one restricted antimicrobial agent, corresponding to 9.6% of the total number of patients hospitalized and 63.4% of the antibiotic expenditures during the study. CONCLUSIONS: Hospital surveillance of antimicrobial prescription is useful for detecting antimicrobial prescription patterns and costs. These types of studies are inexpensive and of easy access when a computerized register is available in the pharmacy.

Vigilancia y costos relacionados con la prescripción de antimicrobianos en un hospital pediátrico / Vigilance and costs related with the prescription of antimicrobians in a pediatric hospital

Introducción. En la práctica médica, la selección de antimicrobianos, debe de incluir consideraciones sobre su indicación, eficacia, toxicidad y costos. Sin embargo, se ha observado que hasta 50 por ciento de las prescripciones de estos fármacos son inapropiados. Objetivo. Conocer el patrón de prescripción y los costos de fármacos antimicrobianos, bajo control de prescripción por el servicio de infectología en un hospital pediátrico, mediante la utilización de un programa de cómputo para la vigilancia de fármacos diseñados por los investigadores. Material y métodos. Mediante una encuesta longitudinal descriptiva y prolectiva, a lo largo de un año, se capturo toda la información sobre consumo y costos de antibióticos, tomando en cuenta el expediente clínico y los registros de farmacia en la que se incluyeron todos los pacientes que requirieron tratamiento anti-microbiano durante su internamiento. Resultados. Un total de 748 pacientes recibieron la prescripción de al menos un antimicrobiano bajo control, correspondiendo esto a 9.6 por ciento del total de pacientes ingresados y 63.4 por ciento del gasto en antibióticos en el hospital donde se realizó el estudio. Conclusiones. La evaluación de costos es de utilidad para detectar tendencia en el consumo y patrón de prescripción de antimicrobiano, es además barato y rápido cuando se cuenta con un registro computarizado en la farmacia

Perú: estadísticas de producción, tráfico y consumo de drogas, 1994-96 / Peru: statistics on production, trafic and drugs consumption, 1994-96

Información estadística proporcionada por las principales instituciones públicas y privadas que trabajan en el campo del uso indebido y el tráfico ilícito de drogas

[The post-licensing efficacy of VA-MENGOC-BC in children under 6 in Holguín, Cuba. The first year of observation]. / Eficacia poslicenciamiento de VA-MENGOC-BC en menores de 6 años en Holguín, Cuba. Primer año de observación.

The assessment of the after-licensing efficacy of the Cuban vaccine VA-MENGOC-BC was performed one year after the mass immunization campaign was completed in children under 6 years of age in the Province of Holguín which had the second highest incidence rate of meningococcal disease during 1988 in Cuba. In the design of the study the following aspects were taking into account: case definition; case detection, determination of the state of vaccination, and comparability of exposure. The utilization of 2 case definitions with different sensitivity and specificity is introduced within the methodology, as well as 2 estimation methods. Incidence rates from exposed and nonexposed subjects, as well as the ratio of cases and of the vaccinated population are used. The impact of this prophylactic intervention was determined by the estimation of the percentual preventive population fraction. Among outstanding results, the high efficacy of more than 98% found in both variants of case definition is to be mentioned. It is evidenced that the effect of the vaccine accounts for more than 80% of the observed case reduction. Such reduction in the number of cases was obtained without changing diagnostic criteria since the isolation of the agents was hept at levels similar to the ones from previous years.

[Community educational interventions against inappropriate drug use]. / Intervenciones educativas populares contra el uso inadecuado de medicamentos.

In the present study, which was carried out in peri-urban areas of Lima and Chimbote, Peru, and La Paz, Bolivia, the household survey method was used to investigate the manner in which drugs are used in treating the most common diseases in each locality. The objectives were to detect inappropriate practices, correct them through educational interventions, and determine the interventions' effectiveness. Simple random sampling was used to select the residences surveyed, which were then divided into study groups and control groups. A preliminary survey determined that the most frequent illnesses were the common cold, diarrhea, and dietary deficiency diseases and that their treatment often involved the inappropriate use of drugs. Educational interventions of varying duration were carried out, and subsequently a second survey was performed using the same instrument in order to determine the effectiveness of the interventions. Although there was an increased tendency not to treat the aforementioned diseases, the responses directly related to the use of drugs did not reveal any significant changes in behavior. Various factors were identified that influence the consumption of drugs.