WorldWideScience

Sample records for drug administration compliance

  1. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Science.gov (United States)

    2011-05-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0366] Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...

  2. 27 CFR 17.136 - Compliance with Food and Drug Administration requirements.

    Science.gov (United States)

    2010-04-01

    ... Compliance with Food and Drug Administration requirements. A product is not a medicine, medicinal preparation, food product, flavor, flavoring extract, or perfume for nonbeverage drawback if its formula would... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Compliance with Food and...

  3. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    International Nuclear Information System (INIS)

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  4. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 85). Section 4. Medical and radiological devices

    International Nuclear Information System (INIS)

    1985-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  5. The role of personal opinions and experiences in compliance with mass drug administration for lymphatic filariasis elimination in Kenya.

    Directory of Open Access Journals (Sweden)

    Doris W Njomo

    Full Text Available The main strategy adopted for Lymphatic Filariasis (LF elimination globally is annual mass drug administration (MDA for 4 to 6 rounds. At least 65% of the population at risk should be treated in each round for LF elimination to occur. In Kenya, MDA using diethylcarbamazine citrate (DEC and albendazole data shows declining compliance (proportion of eligible populations who receive and swallow the drugs levels (85%-62.8%. The present study's aim was to determine the role of personal opinions and experiences in compliance with MDA.This was a retrospective cross-sectional study conducted between January and September 2009 in two districts based on December 2008 MDA round. In each district, one location with high and one with low compliance was selected. Through systematic sampling, nine villages were selected and interviewer-based questionnaires administered to 965 household heads or adult representatives also systematically sampled. The qualitative data were generated from opinion leaders, LF patients with clinical signs and community drug distributors (CDDs all purposively selected and interviewed. Sixteen focus group discussions (FGDs were also conducted with single-sex adult and youth male and female groups. Chi square test was used to assess the statistical significance of differences in compliance with treatment based on the records reviewed. The house-to-house method of drug distribution influenced compliance. Over one-quarter (27% in low compared to 15% in high compliance villages disliked this method. Problems related to size, number and taste of the drugs were more common in low (16.4% than in high (14.4% compliance villages. Reasons for failure to take the drugs were associated with compliance (p0.05.Community sensitization on treatment, drugs used, their regimen and distribution method involving all leaders should be strengthened by the Programme Implementers. The communities need to be made aware of the potential side effects of the

  6. The importance of patient compliance in repeated rounds of mass drug administration (MDA) for the elimination of intestinal helminth transmission.

    Science.gov (United States)

    Farrell, Sam H; Truscott, James E; Anderson, Roy M

    2017-06-12

    Systematic non-compliance to chemotherapeutic treatment among a portion of the eligible population is thought to be a major obstacle to the elimination of helminth infections by mass drug administration (MDA). MDA for helminths is repeated at defined intervals such as yearly or every 2 years, as a consequence of the inability of the human host to develop fully protective immunity to reinfection. As such, how an individual complies to these repeated rounds of MDA can have a significant impact on parasite transmission. The importance of this factor is poorly understood at present. Few epidemiological studies have examined longitudinal trends in compliance in the many communities in areas of endemic helminth infection that are undergoing MDA. Reducing systematic non-compliance will obviously increase the number of individuals treated, but it may also alter the dynamics of parasite transmission. Here we develop an individual-based stochastic model of helminth transmission and MDA treatment to investigate how different patterns of compliance influence the impact of MDA for two groups of helminths, the soil transmitted nematode infections and the schistosome parasites. We study the effect of several alternative treatment and compliance patterns on the dynamics of transmission. We find that the impact of different compliance patterns, ranging from random treatment at each round of chemotherapy to systematic non-compliance by a proportion of the population, is very dependent on both transmission intensity in a defined setting and the type of infection that the treatment is targeted at. Systematic non-compliance has a greater impact on the potential for elimination of Schistosoma mansoni transmission by intensive MDA, than it does on Ascaris lumbricoides. We discuss the implications of our findings for the prioritisation of resources in MDA programmes and for monitoring and evaluation programme design. The key message generated by the analyses is that great care must be

  7. Coverage and Compliance of Mass Drug Administration in Lymphatic Filariasis: A Comparative Analysis in a District of West Bengal, India

    Directory of Open Access Journals (Sweden)

    Tanmay Kanti Panja

    2012-01-01

    Full Text Available Background: Despite several rounds of Mass Drug Administration (MDA as an elimination strategy of Lymphatic Filariasis (LF from India, still the coverage is far behind the required level of 85%.Objectives: The present study was carried out with the objectives to assess the coverage and compliance of MDA and their possible determinants. Methods: A cross-sectional community based study was conducted in Paschim Midnapur district of West Bengal, India for consecutive two years following MDA. Study participants were chosen by 30-cluster sampling technique. Data was collected by using pre-tested semi-structured proforma to assess the coverage and compliance of MDA along with possible determinants for non-attaining the expected coverage. Results: In the year 2009, coverage, compliance, coverage compliance gap (CCG and effective coverage was seen to be 84.1%, 70.5%, 29.5% and 59.3% respectively. In 2010, the results further deteriorated to 78.5%, 66.9%, 33.3% and 57% respectively. The poor coverage and compliance were attributed to improper training of service providers and lack of community awareness regarding MDA.Conclusion: The study emphasized supervised consumption, retraining of service providers before MDA activities, strengthening behaviour change communication strategy for community awareness. Advocacy by the program managers and policy makers towards prioritization of MDA program will make the story of filaria elimination a success.

  8. FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

    International Nuclear Information System (INIS)

    1986-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  9. [Autonomy attitudes in the treatment compliance of a cohort of subjects with continuous psychotropic drug administration].

    Science.gov (United States)

    Baumann, M; Trincard, M

    2002-01-01

    Prescriptions for psychotropic drugs are part of a general practitioner's daily routine. As with all drugs, they need to be controlled by a phenomenon of observance. Respecting prescriptions is in fact a major public health concern. Our problematic is centred on the analysis of the association between observance and autonomy in order to gain a better understanding of the links between the drug, how it is to be taken, and how the patients adapt and control it. Identifying and comparing autonomous practices psychotrope users associated with attitudes put into play by those who claim to observe or not to observe their treatment is the aim of this project. The qualitative analysis of the speech is based on the categorial analysis of the contents of 46 transcriptions of 23 women et 23 men continuous (regular monthly intake for at least 5 years), aged between 50 and 65. The majority live in couples, have professional activities, and are executives. The psychotropes with the largest consumption are: anxiolytics and antidepressors. The average duration of their consumption is more than 17 years. Two types of attitude can be distinguished through the qualitative analyse. The attitudes of non-observers towards the psychotropic drug and dependence show controlled, autonomous acts. Autonomy is an influencing factor in their observation of the prescribed treatment, it is a major component of their non-observance regarding psychotropes; thus our hypothesis is confirmed. The strategy adopted around the medication arises from autonomy of action. Organising the treatment is seen as a sign of autonomy, as taking an initiative in relation to the medical prescription, and not as rebellious, or carefree behaviour, or as a sign of inconsistency. Non-observers seem more to be involved in a step towards self-regulation. Active taking verbs such as stop, diminish, increase , and success verbs succeed the I is greatly used, reinforced in some cases by myself ; this vocabulary situates the

  10. An evaluation of coverage and compliance of mass drug administration 2006 for elimination of lymphatic filariasis in endemic areas of Gujarat

    Directory of Open Access Journals (Sweden)

    Kumar Pradeep

    2008-01-01

    Full Text Available Background: Mass drug administration (MDA means once-in-a-year administration of diethyl carbamazine (DEC tablet to all people (excluding children under 2 years, pregnant women and severely ill persons in identified endemic areas. It aims at cessation of transmission of lymphatic filariasis. Objective: What has been the coverage and compliance of MDA in Gujarat during the campaign in December 2006? Study Design: Cross-sectional population based house-to-house visit. Setting: Urban and rural areas in Gujarat identified as endemic for filariasis where MDA 2006 was undertaken. Study Variables: Exploratory - Rural and urban districts; Outcome - coverage, compliance, actual coverage, side effects. Analysis: Percentage and proportions. Results: Twenty-six clusters, each comprising 32 households from six endemic districts, yielded an eligible population of 4164. The coverage rate was 85.2% with variation across different areas. The compliance with drug ingestion was 89% with a gap of 11% to be targeted by intensive IEC. The effective coverage (75.8% was much below the target (85%. Side effects of DEC were minimum, transient and drug-specific. Overall coverage was marginally better in rural areas. The causes of poor coverage and compliance have been discussed and relevant suggestions have been made.

  11. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

  12. [Intrathecal administration of drugs].

    Science.gov (United States)

    Lebedev, I A; Levitina, E V; Akimzhanova, A K; Rakhmanina, O A; Shtork, T E

    2016-01-01

    The article summarizes the introduction of drugs into the cerebrospinal fluid. Indications and contraindications for the administration of pharmaceuticals in the cerebrospinal fluid spaces are presented. Main groups of pharmacological agents used for endolumbar introduction and conditions under which they are used, as well as advantages and disadvantages of this treatment are considered. The authors describe a method of administration of antibiotics for bacterial and fungal infections of the central nervous system. The need to assess the intracranial pressure prior to cisternal puncture and exclude blocking of cerebrospinal fluid pathways is emphasized. Information about intrathecal administration of anticancer and cytostatic drugs in primary and metastatic brain lesions as well as data on the significant positive effect of oxygen-ozone mixture in the treatment of victims of traumatic brain injury in its acute period are presented. Of interest are the results of the study, which showed a statistically significant reduction in the severity of neurological deficit after the introduction of cerebrolysin in the lumbar space in the first days after the onset of cerebral infarction. Possible complications of the described method of drug delivery, measures taken against them and methods of preventionare described.

  13. Drug Enforcement Administration.

    Science.gov (United States)

    Department of Justice, Washington, DC.

    This fact sheet contains information relating to drug abuse and abusers; drug traffic legislation; law enforcement; and descriptions of commonly used narcotics, stimulants, depressants, and hallucinogens. Also included is a short but explicit listing of audiovisual aids, an annotated bibliography, and drug identification pictures. The booklet…

  14. 77 FR 18830 - Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug...

    Science.gov (United States)

    2012-03-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0121] Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug... Food and Drug Administration to Incorporate Tobacco Products--Small Entity Compliance Guide'' to the...

  15. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Science.gov (United States)

    2010-04-28

    ...] Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug... ``FDA/Xavier University Global Outsourcing Conference.'' This 3-day public conference for the.... The conference will focus on global compliance challenges associated with pharmaceutical outsourcing...

  16. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug...

  17. Drug compliance among hypertensive patients in Port Harcourt, Nigeria.

    Science.gov (United States)

    Akpa, M R; Agomuoh, D I; Odia, O J

    2005-01-01

    Hypertension contributes significantly to cardiovascular morbidity and mortality. Adequate blood pressure control would therefore reduce cardiovascular morbidity and mortality, however adequate blood pressure control requires good treatment compliance. One hundred consecutive patients aged 30-79 years attending the cardiac clinic of the medical out-patients clinic of the University of Port Harcourt Teaching Hospital were directly questioned about compliance with their antihypertensive drugs and results entered into the questionnaire designed for the study. Compliance was good in sixty percent (60%) of respondents, fair in twenty nine percent (29%) and poor in eleven percent (11%). Compliance was also found to be good in sixty-seven percent (67%) of patients with tertiary education, good in forty one percent (41%) of those with primary education. Compliance was good in seventy four percent (74%) of those taking one drug, good in only thirty three percent (33%) of those taking four drugs. Patients taking single daily dose drugs had good compliance in seventy percent (70%), twice daily dosing had good compliance in fifty five percent (55%) and among those taking thrice daily dosage, compliance was good in only seventeen percent (17%). The study shows that good compliance with anti-hypertensive therapy is best achieved with monotherapy given as single dosage. It also shows the role of education in the level of compliance.

  18. Compliance with national guidelines for the management of drug-drug interactions in Dutch community pharmacies.

    NARCIS (Netherlands)

    Buurma, H.; Schalekamp, T.; Egberts, A.C.G.; Smet, P.A.G.M. de

    2007-01-01

    BACKGROUND: Pharmacists contribute to the detection and prevention of drug therapy-related problems, including drug-drug interactions. Little is known about compliance with pharmacy practice guidelines for the management of drug-drug interaction alerts. OBJECTIVE: To measure the compliance of

  19. How Parental Drug Use and Drug Treatment Compliance Relate to Family Reunification.

    Science.gov (United States)

    Smith, Brenda D.

    2003-01-01

    Cox regression was used to assess the relationships among parental drug use, drug treatment compliance, and reunification from substitute care. Findings indicated that drug treatment compliance was associated with faster reunification, even when accounting for ongoing drug use and three parenting measures. Findings were consistent with a…

  20. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  1. 78 FR 69133 - Drug Enforcement Administration

    Science.gov (United States)

    2013-11-18

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered... Diversion Control, Drug Enforcement Administration. [FR Doc. 2013-27486 Filed 11-15-13; 8:45 am] BILLING...

  2. Intravenous Smart Pump Drug Library Compliance: A Descriptive Study of 44 Hospitals.

    Science.gov (United States)

    Giuliano, Karen K; Su, Wan-Ting; Degnan, Daniel D; Fitzgerald, Kristy; Zink, Richard J; DeLaurentis, Poching

    2017-06-01

    Although intravenous (IV) smart pumps with built-in dose-error reduction systems (DERS) can reduce IV medication administration error, most serious adverse events still occur during IV medication administration. Sources of error include overriding DERS and manually bypassing drug libraries and the DERS. Our purpose was to use the Regenstrief National Center for Medical Device Informatics data set to better understand IV smart pump drug library and DERS compliance. Our sample consisted of 12 months of data from 7 hospital systems, 44 individual hospitals, and descriptive data from the American Hospital Directory (AHD) for 2015. The aims of the study were (1) to determine whether there are differences in IV smart pump drug library compliance between hospital systems and (2) to provide a broad descriptive overview of relevant trends related to IV smart pump compliance. For aim 1, we found 3 significant relationships among the 7 hospital systems: systems 3 (P pump compliance and the IV smart pump type used was significantly correlated (P = 0.013) with IV smart pump compliance. Our findings support that there are differences in IV smart pump compliance both within and between hospital systems and that IV smart pump type and the number of drug library profiles may be influencing factors. Further research is required to more accurately identify the impact of these factors in this very important area of patient safety.

  3. Compliance of Nigerians with drug treatment of systemic hypertension

    African Journals Online (AJOL)

    Patient's compliance (PC) is a very vital link between the medical process and treatment outcome. Many factors that affect it such as cost of drugs, adverse effect of drugs and perhaps inconvenient dosing have been addressed at different times, either by the drug manufacturers or the physician in hypertension management.

  4. Patient compliance with antimicrobial drugs: A Chinese survey.

    Science.gov (United States)

    Tong, Shuangmei; Pan, Jiaqian; Lu, Shan; Tang, Jing

    2018-04-01

    Antimicrobial therapy is among the mainstream treatment modalities employed in clinical settings. Antimicrobial sensitivity of the pathogen and patient compliance are key determinants of the efficacy of antimicrobial therapy. In this study, we sought to investigate the factors that affect patient compliance to antimicrobial therapy in a Chinese teaching hospital to enhance patient compliance and to prevent abuse and misuse of antibiotics by patients. A questionnaire survey was conducted among patients willing to answer all the questions who were prescribed antimicrobial drugs orally, and for whom at least half of the duration of therapy was not under the supervision of a doctor or nurse. Data analyses were performed using Kruskal-Wallis test and multivariate logistic regression. A total of 720 patients participated in the survey; of these, 714 patients provided complete data and were included in the analysis. Up to 86.97% of patients showed noncompliance to antimicrobial therapy (total compliance score compliance (total compliance score = 8). On multivariate analyses, understanding of the treatment was an important factor associated with compliance. A range of factors were associated with compliance to antimicrobial therapy, including understanding of the treatment, gender, age, home address, education level, and family income. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  5. Patient compliance with drug therapy for postmenopausal osteoporosis

    International Nuclear Information System (INIS)

    Ahmad, A.; Khan, M.Y.

    2007-01-01

    To determine compliance and factors affecting compliance to antiresorptive drugs in osteoporosis, and to compare compliant and non compliant groups in a tertiary care setting. A total of 800 patients with postmenopausal osteoporosis were included in the study. The demographic and reproductive characteristics of all the patients were recorded. Type of antiresorptive drugs prescribed, degree of compliance, time and reasons for discontinuation were studied and analyzed. The mean age of the patients was 64 (+-9) years and their mean duration of follow-up 18 (+-5) months. The prevalence of risk factors for osteoporosis were evenly distributed among treatment groups; 73% patients had a co-morbidity besides osteoporosis while 27% were osteoporotic alone. One or more previous vertebral fractures due to osteoporosis was reported by 14.5% of patients, whereas 35.5% had at least one non-vertebral fracture in their medical history. Out of the total patients 21.5% discontinued the prescribed drug before attending the bone mass re-evaluations, more than half of these within first six months of starting the drugs. The medication that was most frequently discontinued within one year was calcium and vitamin-D (33.7%, p<0.01) while the least discontinued medication was Alendronate (5.9%, p < 0.01) which is taken once a week. In this study the most important determinant of compliance was the type of drug prescribed and its dose frequency, with a definite preference for Alendronate once a week. Treatment compliance was particularly poor for calcium and vitamin-D regimen, thereby emphasizing the need to find new ways of administering supplements, particularly for vitamin-D. (author)

  6. Expand classical drug administration ways by emerging routes using dendrimer drug delivery systems: a concise overview.

    Science.gov (United States)

    Mignani, Serge; El Kazzouli, Saïd; Bousmina, Mosto; Majoral, Jean-Pierre

    2013-10-01

    Drugs are introduced into the body by numerous routes such as enteral (oral, sublingual and rectum administration), parenteral (intravascular, intramuscular, subcutaneous and inhalation administration), or topical (skin and mucosal membranes). Each route has specific purposes, advantages and disadvantages. Today, the oral route remains the preferred one for different reasons such as ease and compliance by patients. Several nanoformulated drugs have been already approved by the FDA, such as Abelcet®, Doxil®, Abraxane® or Vivagel®(Starpharma) which is an anionic G4-poly(L-lysine)-type dendrimer showing potent topical vaginal microbicide activity. Numerous biochemical studies, as well as biological and pharmacological applications of both dendrimer based products (dendrimers as therapeutic compounds per se, like Vivagel®) and dendrimers as drug carriers (covalent conjugation or noncovalent encapsulation of drugs) were described. It is widely known that due to their outstanding physical and chemical properties, dendrimers afforded improvement of corresponding carried-drugs as dendrimer-drug complexes or conjugates (versus plain drug) such as biodistribution and pharmacokinetic behaviors. The purpose of this manuscript is to review the recent progresses of dendrimers as nanoscale drug delivery systems for the delivery of drugs using enteral, parenteral and topical routes. In particular, we focus our attention on the emerging and promising routes such as oral, transdermal, ocular and transmucosal routes using dendrimers as delivery systems. Copyright © 2013 Elsevier B.V. All rights reserved.

  7. Nurse compliance with a protocol for safe injectable medication administration: comparison of two multicentre observational studies

    Science.gov (United States)

    Schutijser, Bernadette; Jongerden, Irene; Spreeuwenberg, Peter; Wagner, Cordula; de Bruijne, Martine

    2018-01-01

    Objectives Medication administration errors with injectable medication have a high risk of causing patient harm. To reduce this risk, all Dutch hospitals implemented a protocol for safe injectable medication administration. Nurse compliance with this protocol was evaluated as low as 19% in 2012. The aim of this second evaluation study was to determine whether nurse compliance had changed over a 4-year period, what factors were associated over time with protocol compliance and which strategies have been implemented by hospitals to increase protocol compliance. Methods In this prospective observational study, conducted between November 2015 and September 2016, nurses from 16 Dutch hospitals were directly observed during intravenous medication administration. Protocol compliance was complete if nine protocol proceedings were conducted correctly. Protocol compliance was compared with results from the first evaluation. Multilevel logistic regression analyses were used to assess the associations over time between explanatory variables and complete protocol compliance. Implemented strategies were classified according to the five components of the Systems Engineering Initiative for Patient Safety (SEIPS) model. Results A total of 372 intravenous medication administrations were observed. In comparison with 2012, more proceedings per administration were conducted (mean 7.6, 95% CI 7.5 to 7.7 vs mean 7.3, 95% CI 7.3 to 7.4). No significant change was seen in complete protocol compliance (22% in 2016); compliance with the proceedings ‘hand hygiene’ and ‘check by a second nurse’ remained low. In contrast to 2012, the majority of the variance was caused by differences between wards rather than between hospitals. Most implemented improvement strategies targeted the organisation component of the SEIPS model. Conclusions Compliance with ‘hand hygiene’ and ‘check by a second nurse’ needs to be further improved in order to increase complete protocol compliance. To do

  8. Rectal drug administration: clinical pharmacokinetic considerations.

    Science.gov (United States)

    de Boer, A G; Moolenaar, F; de Leede, L G; Breimer, D D

    1982-01-01

    The human rectum represents a body cavity in which drugs can be easily introduced and retained and from which absorption is well possible. There are important therapeutic reasons why it is sometimes preferable to give a drug rectally rather than orally, e.g. in cases of nausea and vomiting. Drawbacks of rectal drug administration include the interruption of absorption by defaecation and lack of patient acceptability. The mechanism of drug absorption from the rectum is probably no different to that in the upper part of the gastrointestinal tract, despite the fact that the physiological circumstances (e.g. pH, fluid content) differ substantially, Absorption from aqueous and alcoholic solutions may occur very rapidly, which has proved to be of considerable therapeutic value in the rapid suppression of acute convulsive attacks by diazepam (e.g. in children), but absorption from suppositories is generally slower and very much dependent on the nature of the suppository base, the use of surfactants or other additives, particle size of the active ingredient, etc. There is some evidence that hepatic first-pass elimination of high clearance drugs is partially avoided after rectal administration, e.g. lignocaine. This can be explained by the rectal venous blood supply: the upper part is connected with the portal system, whereas the lower part is directly connected with the systemic circulation. Plasma concentration data following rectal administration of representatives of several classes of drugs are reviewed: anticonvulsants, non-narcotic analgesics and non-steroidal anti-inflammatory agents, hypnosedatives and anaesthetics, strong analgesics, theophylline and derivatives, corticosteroids, antibacterial agents, thiazinamium, promethazine, hyoscine-N-butyl-bromide, streptokinase, progesterone, ergotamine tartrate and levodopa. Only limited number of cases has it been adequately shown that the rectal route of administration gives plasma concentrations which are comparable to

  9. Mass drug administration: the importance of synchrony.

    Science.gov (United States)

    Gao, Daozhou; Lietman, Thomas M; Dong, Chao-Ping; Porco, Travis C

    2017-06-01

    Mass drug administration, a strategy in which all individuals in a population are subject to treatment without individual diagnosis, has been recommended by the World Health Organization for controlling and eliminating several neglected tropical diseases, including trachoma and soil-transmitted helminths. In this article, we derive effective reproduction numbers and average post-treatment disease prevalences of a simple susceptible-infectious-susceptible epidemic model with constant, impulsive synchronized and non-synchronized drug administration strategies. In the non-synchronized model, the individuals in the population are treated at most once per period and their treatment times are uniformly distributed. Mathematically, the set of pulses for the non-synchronized model has the cardinality of the continuum. We show that synchronized and constant strategies are, respectively, the most and least effective treatments in disease control. Elimination through synchronized treatment is always possible when adequate drug efficacy and coverage are fulfilled and sustained. For a strategy with multiple rounds of synchronized treatment per period, the average post-treatment prevalence is irrelevant what the time differences between treatments are, as long as there are the same number of treatments per period. © The authors 2016. Published by Oxford University Press on behalf of the Institute of Mathematics and its Applications. All rights reserved.

  10. [Treatment with tuberculostatic drugs: compliance at a general hospital].

    Science.gov (United States)

    Polo Friz, H; Kremer, L; Acosta, H; Abdala, O; Canova, S; Rojo, S; Roca, G; Daín, A

    1997-01-01

    The purpose of this study was to assess the compliance with tuberculostatic drugs treatment in a public hospital from Córdoba City and to establish the causes of noncompliance. All the patients to which treatment with tuberculostatic drugs was indicated from January 1991 up to December 1994 were included. 45 patients were included: 18 females (40%) and 29 males. Sixteen (35.6%) did not complete the time of treatment indicated. Nine (56.3%) abandoned the treatment 2 months after having initiated it. In the group that did not complete the treatment there was a higher percentage of female patients (62.5%) than in the group that did complete it (27.6%), p = 0.02. There were not statistically significant differences in age, percentages of pulmonar and extrapulmonar tuberculosis and months of treatment indicated between both groups. Thirty-six percent of the patients who abandoned the treatment referred having interrupted it due to their own negligency, knowing the risk of such behavior; 36% suffered side effects and did not come back to hospital; 21% referred having consulted another physician who indicated to interrupt the treatment without performing other tests; and 7% misunderstood the indications. It is concluded that in a general hospital from Córdoba City, the percentage of patients who abandoned tuberculostatic treatment is high. In most cases the cause was related to failures in the conduct of patients, physicians or both.

  11. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Science.gov (United States)

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

  12. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  13. Drug Brand Response and Its Impact on Compliance and Efficacy in Depression Patients.

    Science.gov (United States)

    Li, Mingming; Cai, Jian; Zhang, Ping; Fei, Chunhua; Xu, Feng

    2016-01-01

    Introduction: Patient's response to drug brand is a comprehensive physiological and psychological effect which might impact the compliance and efficacy of drugs. Whether the therapeutic outcome altered on patients with brand response after they experience drug switch is not clear. Methods: 459 outpatients with mild-to-moderate depression were divided into the imported (joint venture) drug group and the domestic drug group according to their current drug application. Two groups of patients were assessed by drug brand preference questionnaire and medication compliance questionnaire. Patients with brand preference in imported (joint venture) drugs group received rational use of limited medical resource and pharmacoeconomics education, and then switched with domestic drug for 8 weeks. Safety and efficacy were evaluated both before and after the drug switch. Results: Overall, there were 27% of patients in imported drug group and 35% of patients in domestic drug group have brand response, respectively. About 2/3 patients in both groups showed low or no brand response. The compliance was similar in both groups with no significant difference (6.04 ± 2.08 vs. 4.74 ± 2.13, respectively, P > 0.05). The efficacy of imported drug group was significantly better than of the domestic drug group. Correlation analysis showed that in imported (joint venture) drugs group, medication compliance was closely related with brand response, but negatively correlated with age and duration. In domestic drugs group, medication compliance was independent of brand response, but closely related with education, age, and duration. After drug switch with domestic drug on patients with brand response, patients continued to maintain good antidepressant effect, and no severe adverse reaction occurred. Conclusion: The results suggested that domestic drugs switch might be feasible for patients using imported drugs with brand response, while providing patients with rational use of drug education and

  14. Drug Brand Response and Its Impact on Compliance and Efficacy in Depression Patients

    OpenAIRE

    Li, Mingming; Cai, Jian; Zhang, Ping; Fei, Chunhua; Xu, Feng

    2017-01-01

    Introduction: Patient's response to drug brand is a comprehensive physiological and psychological effect which might impact the compliance and efficacy of drugs. Whether the therapeutic outcome altered on patients with brand response after they experience drug switch is not clear. Methods: 459 outpatients with mild-to-moderate depression were divided into the imported (joint venture) drug group and the domestic drug group according to their current drug application. Two groups of patients ...

  15. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Science.gov (United States)

    2012-12-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080] Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  16. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Science.gov (United States)

    2012-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080] Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  17. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality and...: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with Parenteral...

  18. 76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

    Science.gov (United States)

    2011-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

  19. Drug Delivery Innovations to Address Global Health Challenges for Pediatric and Geriatric Populations (Through Improvements in Patient Compliance).

    Science.gov (United States)

    Boateng, Joshua

    2017-11-01

    Despite significant advances in pharmaceutical and biotechnological drug discovery, the global population is plagued with many challenging diseases. These are further compounded by anticipated explosion in an ageing population, which presents several problems such as polypharmacy, dysphagia, and neurologic conditions, resulting in noncompliance and disease complications. For antibiotics, poor compliance, can result in development of drug-resistant infections which can be fatal. Furthermore, children, especially, in developing countries die unnecessarily from easily treatable diseases (e.g., malaria), due to poor compliance arising from bitter taste and inability to swallow currently available medication. Although some of these challenges require the discovery of new drug compounds, a significant number can be resolved by employing pharmaceutics approaches to reduce the incidence of poor patient compliance. Such solutions are expected to make swallowing easier and reduce the need to swallow several solid medications, which is difficult for vulnerable pediatric and geriatric patients. This commentary will explore the current state of the art in the use of drug delivery innovations to overcome some of these challenges, taking cues from relevant regulatory agencies such as the Food and Drug Administration, the European Medicines Agency, World Health Organization, and the peer-reviewed scientific and clinical literature. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  20. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  1. 78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

    Science.gov (United States)

    2013-01-31

    ... Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035...

  2. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0226...) audit report provides FDA a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices. \\1\\ The GHTF founding members auditing systems include...

  3. A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis.

    Science.gov (United States)

    Frogel, Michael P; Stewart, Dan L; Hoopes, Michael; Fernandes, Ancilla W; Mahadevia, Parthiv J

    2010-01-01

    ;and an abstract database, Medical Intelligence Solution, for citations through April 2008. Specific search terms used were palivizumab with patient compliance, patient adherence, or patient persistence. Twenty-five articles and abstracts met the inclusion criteria. Available studies were mostly retrospective or observational prospective.Compliance, defined in various ways across the studies, varied between 25% and 100%, and 12 studies identified some of the factors related to noncompliance. Compliance generally was lower among Medicaid patients,African American patients, and other minorities. Ten studies (3 manuscripts and 7 abstracts) investigated the association of administration of prophylaxis through monthly home visits by a health professional with parental compliance with therapy. Most of the home-based programs were associated with higher compliance rates compared with clinic or office programs.Rates as high as 94% and 64% were achieved when Medicaid infants and infants of minority descent, respectively, received their doses through a home health program. When these infants received their doses at a clinic or office, depending on the definition of compliance, rates were 61%-100% for Medicaid infants and 44% for infants of minority descent. Reminder telephone calls to parents or caregivers, comprehensive multidisciplinary programs that included extensive counseling of parents, calendars with sticker reminders, and education in the language native to parents also were associated with increased compliance, although statistical significance was reported in only 1 study. Several studies recommended educating parents on the benefits of RSV prophylaxis, alleviating transportation and language difficulties, recognizing cultural differences and biases, and clarifying misperception of RSV illness severity. Home health programs had lower rates of RSV hospitalizations than office-based programs in 3 analyses conducted in 2 studies. In 4 other abstracts, the rates of RSV

  4. Evaluation of drug administration errors in a teaching hospital

    OpenAIRE

    Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

    2012-01-01

    Abstract Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs...

  5. 38 CFR 52.180 - Administration of drugs.

    Science.gov (United States)

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  6. Patients’ compliance with different administration routes for allergen immunotherapy in Germany

    Directory of Open Access Journals (Sweden)

    Egert-Schmidt AM

    2014-10-01

    Full Text Available Anne-Marie Egert-Schmidt, Jan-Marcel Kolbe, Sabine Mussler, Susanne Thum-Oltmer Allergopharma GmbH & Co. KG, Reinbek, Germany Background: Allergen immunotherapy (AIT is the practice of administering gradually increasing quantities of an allergen extract to an allergic subject to ameliorate the symptoms associated with the subsequent exposure to the causative allergen. It is the only treatment that may alter the natural course of allergic diseases. According to AIT guidelines and summary of product characteristics (SmPCs, the treatment should be carried out for at least 3 years. It is controversially discussed whether subcutaneous or sublingual administration routes cause higher patients’ compliance.Methods: German sales data for different preparations of the allergen manufacturer Allergopharma GmbH & Co. KG were retrospectively evaluated for 5 consecutive years, based on prescriptions per patient: pollen sublingual immunotherapy (SLIT and high-dose hypoallergenic (allergoid or unmodified depot pollen and mite preparations for subcutaneous immunotherapy (SCIT. To identify patients’ compliance, “completed treatment years” were determined. A completed treatment year was defined by the required number of prescribed allergen preparations according to the recommended dosage scheme given in the respective SmPCs.Results: Prescription data of 85,241 patients receiving pollen or mite SCIT and 706 patients receiving pollen SLIT were included in this analysis. Patients’ compliance for at least 3 treatment years with high-dose hypoallergenic pollen SCIT was higher when administered perennially (60% compared to preseasonally (27%. Prescriptions for at least 3 years were received from 42% of patients with pollen SCIT and from 45% of patients with mite SCIT. Compliance with SLIT was lowest with only 16% of patients receiving prescriptions for at least 3 treatment years. Children and adolescents were more compliant than adults, independent of whether

  7. Evaluation of drug administration errors in a teaching hospital.

    Science.gov (United States)

    Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

    2012-03-12

    Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

  8. Evaluation of drug administration errors in a teaching hospital

    Directory of Open Access Journals (Sweden)

    Berdot Sarah

    2012-03-01

    Full Text Available Abstract Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds. A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors with one or more errors were detected (27.6%. There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501. The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%. The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission. In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

  9. Nurses' experiences of drug administration errors

    OpenAIRE

    Schelbred, Anne‐Berit; Nord, Randi

    2007-01-01

    Beskriver en kvalitativ studie hvor hensikten var å beskrive erfaringer hos sykepleiere som har begått alvorlige feil med hensyn til legemiddelhåndtering. This paper is a report of a study to describe the experiences of nurses who had committed serious medication errors, the meaning these experiences carry, and what kind of help and support they received after committing their error. Medication administration is an important nursing task. Work overload, combined with increased numbers and ...

  10. Olfactory Transfer of Analgesic Drugs After Nasal Administration

    OpenAIRE

    Espefält Westin, Ulrika

    2007-01-01

    Nasal administration of analgesics for achieving rapid pain relief is currently a topic of great interest. The blood-brain barrier (BBB) restricts access to the central nervous system (CNS) for several central-acting drugs, such as morphine and dihydroergotamine, which results in a substantial effect delay. Evidence for the olfactory transfer of drugs from the nasal cavity to the CNS after nasal administration, bypassing the BBB, is available for both animals and humans. The aims of this thes...

  11. Tobacco advertising and sales practices in licensed retail outlets after the Food and Drug Administration regulations.

    Science.gov (United States)

    Frick, Ryan G; Klein, Elizabeth G; Ferketich, Amy K; Wewers, Mary Ellen

    2012-10-01

    To assess retailer compliance with Food and Drug Administration (FDA) regulations on tobacco sales and advertising practices, including point-of-sale advertisements, in two distinct Columbus, Ohio neighborhood groups by income. Data were gathered from a random sample of 129 licensed tobacco retailers, which included data on both exterior and interior advertisements as well as sales practices. Descriptive analyses compared retail outlets by high and low income neighborhood locations. Compliance with FDA regulations was high in the random sample of urban tobacco retail outlets. None of the retail outlets sold loose cigarettes or offered free items with purchase. Less than 10% of the outlets surveyed offered self-service access to cigarettes or smokeless tobacco products. From all surveyed retail outlets 95% had cigarette, 57% had smokeless, and 57% had cigar advertisements at the point-of-sale. There were no significant differences in compliance by income, but the mean number of advertisements on the building and self-service access to cigars was significantly different by neighborhood income. There was a high degree of compliance with the new FDA regulation on tobacco marketing and sales practices in urban retail tobacco outlets in Columbus, Ohio. Tobacco advertising and marketing remain highly prevalent in retail outlets, with some significant differences between high and low income neighborhoods.

  12. MODELING OF TARGETED DRUG DELIVERY PART II. MULTIPLE DRUG ADMINISTRATION

    Directory of Open Access Journals (Sweden)

    A. V. Zaborovskiy

    2017-01-01

    Full Text Available In oncology practice, despite significant advances in early cancer detection, surgery, radiotherapy, laser therapy, targeted therapy, etc., chemotherapy is unlikely to lose its relevance in the near future. In this context, the development of new antitumor agents is one of the most important problems of cancer research. In spite of the importance of searching for new compounds with antitumor activity, the possibilities of the “old” agents have not been fully exhausted. Targeted delivery of antitumor agents can give them a “second life”. When developing new targeted drugs and their further introduction into clinical practice, the change in their pharmacodynamics and pharmacokinetics plays a special role. The paper describes a pharmacokinetic model of the targeted drug delivery. The conditions under which it is meaningful to search for a delivery vehicle for the active substance were described. Primary screening of antitumor agents was undertaken to modify them for the targeted delivery based on underlying assumptions of the model.

  13. [Evaluation of administration errors of injectable drugs in neonatology].

    Science.gov (United States)

    Cherif, A; Sayadi, M; Ben Hmida, H; Ben Ameur, K; Mestiri, K

    2015-11-01

    Use of injectable drugs in newborns represents more than 90% of prescriptions and requires special precautions in order to ensure more safety and efficiency. The aim of this study is to gather errors relating to the administration of injectable drugs and to suggest corrective actions. This descriptive and transversal study has evaluated 300 injectable drug administrations in a neonatology unit. Two hundred and sixty-one administrations have contained an error. Data are collected by direct observations of administrative act. Errors observed are: an inappropriate mixture (2.6% of cases); an incorrect delivery rate (33.7% of cases); incorrect dilutions (26.7% of cases); error in calculation of the dose to be injected (16.7% of cases); error while sampling small volumes (6.3% of cases); error or omission of administration schedule (1% of cases). These data have enabled us to evaluate administration of injectable drugs in neonatology. Different types of errors observed could be a source of therapeutic inefficiency, extended lengths of stay or iatrogenic drug. Following these observations, corrective actions have been undertaken by pharmacists and consist of: organizing training sessions for nursing; developing an explanatory guide for dilution and administration of injectable medicines, which was made available to the clinical service. Collaborative strategies doctor-nurse-pharmacist can help to reduce errors in the medication process especially during his administration. It permits improvement of injectable drugs use, offering more security and better efficiency and contribute to guarantee ideal therapy for patients. Copyright © 2015. Published by Elsevier Masson SAS.

  14. 76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

    Science.gov (United States)

    2011-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

  15. Formulation approaches in mitigating toxicity of orally administrated drugs.

    Science.gov (United States)

    Kadiyala, Irina; Tan, Elijah

    2013-01-01

    This paper provides an overview of current formulation approaches to mitigate toxicity of orally administrated drugs. The formulation approaches are characterized by their intended impact on a drug's pharmacokinetic parameters, pharmacological properties or metabolic pathways. Regulatory opportunities and constraints with focus on U.S. regulations in optimizing a drug's safety or efficacy profile are reviewed. The following formulation approaches are described: (i) pharmacokinetic-modulating and (ii) pharmacodynamic-modulating. In the pharmacokinetic-modulating approach, the pharmacokinetic profile of drug release is modified by, for example, a reduction in peak drug plasma concentration while preserving or improving AUC, thereby potentially reducing toxic effects that may be related to C(max). In the pharmacodynamic-modulating approach, the drug is co-dosed with pharmacologically active or nonpharmacologically active agent or agents intended for mitigation of the drug's toxicity. The pharmacodynamic-modulating approach requires information on the specificity of drug interactions with other compounds and also on metabolic pathways. Examples demonstrating successful formulation work in reducing drug toxicity are provided. The in-depth knowledge of the drug's PK and PD properties combined with a greater understanding of the biology of diseases are necessary for successful drug product formulation leading to optimized in vivo exposure and minimized toxicity.

  16. The effects of heroin administration and drug cues on impulsivity.

    Science.gov (United States)

    Jones, Jermaine D; Vadhan, Nehal P; Luba, Rachel R; Comer, Sandra D

    2016-08-01

    Drug addiction is a chronic relapsing disorder characterized by compulsive drug seeking and continued use despite negative consequences. Behavioral impulsivity is a strong predictor of the initiation and maintenance of drug addiction. Preclinical data suggest that heroin may exacerbate impulsive characteristics in an individual but this has yet to be assessed in clinical samples. The current secondary data analysis sought to investigate the effects of heroin on impulsivity along with the effects of exposure to drug cues. Using the current data set, we also tentatively assessed the etiological relationship between impulsivity and heroin abuse. Sixteen heroin-dependent participants were recruited to complete Immediate Memory Task/Delayed Memory Task (IMT/DMT) and GoStop tasks following repeated heroin administration, following acute heroin administration, and following a drug cue exposure session. Four preceding days of active heroin availability, compared to four preceding days of placebo drug availability, increased impulsivity assessed using the IMT and DMT. Presentation of drug cues similarly acted to increase impulsivity assessments on all three tasks. It also appears that heavier users were more susceptible to the influence of drug cues on impulsivity. The present study represents a step toward a more comprehensive understanding of the interaction between opioid abuse and impulsivity. A better understanding of these factors could provide critical insight into the maintenance of heroin use and relapse.

  17. Diffusion of treatment in social networks and mass drug administration

    OpenAIRE

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2017-01-01

    Information, behaviors, and technologies spread when people interact. Understanding these interactions is critical for achieving the greatest diffusion of public interventions. Yet, little is known about the performance of starting points (seed nodes) for diffusion. We track routine mass drug administration-the large-scale distribution of deworming drugs-in Uganda. We observe friendship networks, socioeconomic factors, and treatment delivery outcomes for 16,357 individuals in 3491 households ...

  18. Drug Administration Errors in Hospital Inpatients: A Systematic Review

    OpenAIRE

    Berdot, Sarah; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre; Sabatier, Brigitte

    2013-01-01

    CONTEXT: Drug administration in the hospital setting is the last barrier before a possible error reaches the patient. OBJECTIVES: We aimed to analyze the prevalence and nature of administration error rate detected by the observation method. DATA SOURCES: Embase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies. STUDY SELECTION: Observational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured th...

  19. Food and Drug Administration Drug Approval Process: A History and Overview.

    Science.gov (United States)

    Williams, Christopher Ty

    2016-03-01

    In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. 1 Impact of praziquantel mass drug administration campaign on ...

    African Journals Online (AJOL)

    Abstract: As part of the Tanzania National Schistosomiasis Control Programme, Bahi district in central Tanzania, received two annual rounds of praziquantel mass drug administration (MDA) to control urinary schistosomiasis in schoolchildren. The objectives of this study were to assess the impact of the two rounds of MDA ...

  1. Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

    Science.gov (United States)

    Kaufman, Annette R.; Waters, Erika A.; Parascandola, Mark; Augustson, Erik M.; Bansal-Travers, Maansi; Hyland, Andrew; Cummings, K. Michael

    2011-01-01

    Objectives: To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. Methods: A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. Results: Smokers reporting that the FDA does not evaluate cigarettes for…

  2. Drug Testing and College Athletes: A Dilemma for Institutional Administration.

    Science.gov (United States)

    Gibbs, Annette

    1991-01-01

    A discussion of mandatory drug testing for college athletes reviews the National Collegiate Athletic Association's policy, arguments for and against such testing, the results of relevant court litigation, and the legal ramifications for college administration. The testing of employees in both public and private sectors is also briefly addressed.…

  3. 75 FR 13766 - Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and...

    Science.gov (United States)

    2010-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration--Partnering With Industry; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION...

  4. Adverse drug events caused by serious medication administration errors.

    Science.gov (United States)

    Kale, Abhivyakti; Keohane, Carol A; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2012-11-01

    To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting. Retrospective chart review of clinical events following observed medication administration errors. Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often. In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error. Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives. Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.

  5. Orbitofrontal response to drug-related stimuli after heroin administration.

    Science.gov (United States)

    Walter, Marc; Denier, Niklaus; Gerber, Hana; Schmid, Otto; Lanz, Christian; Brenneisen, Rudolf; Riecher-Rössler, Anita; Wiesbeck, Gerhard A; Scheffler, Klaus; Seifritz, Erich; McGuire, Philip; Fusar-Poli, Paolo; Borgwardt, Stefan

    2015-05-01

    The compulsion to seek and use heroin is frequently driven by stress and craving during drug-cue exposure. Although previous neuroimaging studies have indicated that craving is mediated by increased prefrontal cortex activity, it remains unknown how heroin administration modulates the prefrontal cortex response. This study examines the acute effects of heroin on brain function in heroin-maintained patients. Using a crossover, double-blind, placebo-controlled design, 27 heroin-maintained patients performed functional magnetic resonance imaging 20 minutes after the administration of heroin or placebo (saline) while drug-related and neutral stimuli were presented. Images were processed and analysed with statistical parametric mapping. Plasma concentrations of heroin and its main metabolites were assessed using high-performance liquid chromatography. Region of interest analyses showed a drug-related cue-associated blood-oxygen-level-dependent activation in the orbitofrontal cortex (OFC) in heroin-dependent patients during both treatment conditions (heroin and placebo). This activation of the OFC was significantly higher after heroin than after placebo administration. These findings may indicate the importance of OFC activity for impulse control and decision-making after regular heroin administration and may emphasize the benefit of the heroin-assisted treatment in heroin dependence. © 2014 Society for the Study of Addiction.

  6. [Drug advertising and promotion: regulations and extent of compliance in five Latin American countries].

    Science.gov (United States)

    Vacca, Claudia; Vargas, Claudia; Cañás, Martín; Reveiz, Ludovic

    2011-02-01

    To analyze differing regulations regarding drug promotion, and the extent of compliance as seen in samples of advertising directed to the public in Argentina, Colombia, Ecuador, Nicaragua, and Peru. A total of 683 pieces of promotional material on display in health facilities, pharmacies, and on the street were collected, 132 of which were randomly selected for analysis. The regulations governing pharmaceutical advertising, taken from official websites and interviews with regulatory officials and Ministry of Health staff in the five countries covered, were reviewed, along with their adherence to the ethical criteria of the World Health Organization (WHO). The contents of the materials in the sample were evaluated to determine their degree of compliance with national regulations and WHO recommendations on drug promotion. The countries have regulations incorporating WHO ethical criteria. Over 80% of the material analyzed included the indications for the drug, while over 70% omitted information on adverse effects. Fifty percent of the advertisements for over-the-counter (OTC) drugs on display in pharmacies listed indications not approved by the relevant health authority. In advertising in pharmacies, the risks from inadequate information were not found to differ significantly for OTC or prescription medications. Compared with materials provided in health facilities, the relative risk of the absence of information on dosage in the material distributed in pharmacies was 2.08 (confidence interval 95% 1.32-3.39). Although regulations on drug promotion and advertising in the five countries studied generally incorporate the WHO recommendations, promotional materials often fail to reflect the fact.

  7. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Science.gov (United States)

    2010-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food products...

  8. Community-directed mass drug administration is undermined by status seeking in friendship networks and inadequate trust in health advice networks

    NARCIS (Netherlands)

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2017-01-01

    Over 1.9 billion individuals require preventive chemotherapy through mass drug administration (MDA). Community-directed MDA relies on volunteer community medicine distributors (CMDs) and their achievement of high coverage and compliance. Yet, it is unknown if village social networks influence

  9. Community-directed mass drug administration is undermined by status seeking in friendship networks and inadequate trust in health advice networks

    NARCIS (Netherlands)

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2017-01-01

    Over 1.9 billion individuals require preventive chemotherapy through mass drug administration (MDA). Community-directed MDA relies on volunteer community medicine distributors (CMDs) and their achievement of high coverage and compliance. Yet, it is unknown if village social networks influence

  10. Lipid nanoparticles for administration of poorly water soluble neuroactive drugs.

    Science.gov (United States)

    Esposito, Elisabetta; Drechsler, Markus; Mariani, Paolo; Carducci, Federica; Servadio, Michela; Melancia, Francesca; Ratano, Patrizia; Campolongo, Patrizia; Trezza, Viviana; Cortesi, Rita; Nastruzzi, Claudio

    2017-09-01

    This study describes the potential of solid lipid nanoparticles and nanostructured lipid carriers as nano-formulations to administer to the central nervous system poorly water soluble drugs. Different neuroactive drugs, i.e. dimethylfumarate, retinyl palmitate, progesterone and the endocannabinoid hydrolysis inhibitor URB597 have been studied. Lipid nanoparticles constituted of tristearin or tristearin in association with gliceryl monoolein were produced. The nanoencapsulation strategy allowed to obtain biocompatible and non-toxic vehicles, able to increase the solubility of the considered neuroactive drugs. To improve URB597 targeting to the brain, stealth nanoparticles were produced modifying the SLN surface with polysorbate 80. A behavioural study was conducted in rats to test the ability of SLN containing URB597 given by intranasal administration to alter behaviours relevant to psychiatric disorders. URB597 maintained its activity after nanoencapsulation, suggesting the possibility to propose this kind of vehicle as alternative to unphysiological mixtures usually employed for animal and clinical studies.

  11. Examining the Relationships between Family Drug Court Program Compliance and Child Welfare Outcomes.

    Science.gov (United States)

    Child, Holly; McIntyre, Dara

    2015-01-01

    Although the evidence is accumulating to substantiate the successes of Family Drug Courts (FDC), there is little research on the relationship between parent compliance and successful reunification of children with their parent(s). This study looked at data from 206 families participating in a FDC in Sacramento County, California. Four compliance measures were examined individually and collectively, after controlling for participant characteristics, using logistic regression models to determine how FDC participation benchmarks impact child reunification. This study found the best predictors of reunification was participation in support group meetings and negative tests for substance use. These findings indicate that initiatives designed to address the needs of families affected by child maltreatment and substance use should take into account and support engagement in informal, community-based activities as well as formal, clinically focused interventions.

  12. Optimizing urine drug testing for monitoring medication compliance in pain management.

    Science.gov (United States)

    Melanson, Stacy E F; Ptolemy, Adam S; Wasan, Ajay D

    2013-12-01

    It can be challenging to successfully monitor medication compliance in pain management. Clinicians and laboratorians need to collaborate to optimize patient care and maximize operational efficiency. The test menu, assay cutoffs, and testing algorithms utilized in the urine drug testing panels should be periodically reviewed and tailored to the patient population to effectively assess compliance and avoid unnecessary testing and cost to the patient. Pain management and pathology collaborated on an important quality improvement initiative to optimize urine drug testing for monitoring medication compliance in pain management. We retrospectively reviewed 18 months of data from our pain management center. We gathered data on test volumes, positivity rates, and the frequency of false positive results. We also reviewed the clinical utility of our testing algorithms, assay cutoffs, and adulterant panel. In addition, the cost of each component was calculated. The positivity rate for ethanol and 3,4-methylenedioxymethamphetamine were <1% so we eliminated this testing from our panel. We also lowered the screening cutoff for cocaine to meet the clinical needs of the pain management center. In addition, we changed our testing algorithm for 6-acetylmorphine, benzodiazepines, and methadone. For example, due the high rate of false negative results using our immunoassay-based benzodiazepine screen, we removed the screening portion of the algorithm and now perform benzodiazepine confirmation up front in all specimens by liquid chromatography-tandem mass spectrometry. Conducting an interdisciplinary quality improvement project allowed us to optimize our testing panel for monitoring medication compliance in pain management and reduce cost. Wiley Periodicals, Inc.

  13. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  14. 78 FR 15953 - Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration...

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010] Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  15. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Science.gov (United States)

    2010-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

  16. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Science.gov (United States)

    2011-02-07

    ... as a cause of respiratory allergic reactions; (2) rhinitis, conjunctivitis, and dyspnea; (3... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  17. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration Advisory... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and... that a meeting of the Science Board to the Food and Drug Administration would be held on February 27...

  18. 78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

    Science.gov (United States)

    2013-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0365] Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of...

  19. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Science.gov (United States)

    2013-06-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket Nos. FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685] Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of...

  20. Opioid analgesic administration in patients with suspected drug use.

    Science.gov (United States)

    Kreling, Maria Clara Giorio Dutra; Mattos-Pimenta, Cibele Andrucioli de

    2017-01-01

    To identify the prevalence of patients suspected of drug use according to the nursing professionals' judgement, and compare the behavior of these professionals in opioid administration when there is or there is no suspicion that patient is a drug user. A cross-sectional study with 507 patients and 199 nursing professionals responsible for administering drugs to these patients. The Chi-Square test, Fisher's Exact and a significance level of 5% were used for the analyzes. The prevalence of suspected patients was 6.7%. The prevalence ratio of administration of opioid analgesics 'if necessary' is twice higher among patients suspected of drug use compared to patients not suspected of drug use (p = 0.037). The prevalence of patients suspected of drug use was similar to that of studies performed in emergency departments. Patients suspected of drug use receive more opioids than patients not suspected of drug use. Identificar a prevalência de pacientes com suspeita de uso de drogas conforme opinião de profissionais de enfermagem e comparar a conduta desses profissionais na administração de opioides quando há ou não suspeita de que o paciente seja usuário de drogas. Estudo transversal com 507 pacientes e 199 profissionais de enfermagem responsáveis pela administração de medicamentos a esses pacientes. Para as análises foram utilizados os testes de Qui-Quadrado, Exato de Fisher e um nível de significância de 5%. A prevalência de pacientes suspeitos foi 6,7%. A razão de prevalência de administração de analgésicos opioides "se necessário" é duas vezes maior entre os pacientes suspeitos em relação aos não suspeitos (p=0,037). A prevalência de suspeitos foi semelhante à de estudos realizados em departamentos de emergência. Os suspeitos de serem usuários de drogas recebem mais opioides do que os não suspeitos.

  1. Mass drug administration and the sustainable control of schistosomiasis: Community health workers are vital for global elimination efforts.

    Science.gov (United States)

    Inobaya, Marianette T; Chau, Thao N; Ng, Shu-Kay; MacDougall, Colin; Olveda, Remigio M; Tallo, Veronica L; Landicho, Jhoys M; Malacad, Carol M; Aligato, Mila F; Guevarra, Jerric R; Ross, Allen G

    2018-01-01

    Schistosomiasis control is centred on preventive chemotherapy through mass drug administration (MDA). However, endemic countries continue to struggle to attain target coverage rates and patient compliance. In the Philippines, barangay health workers (BHWs) play a vital role in the coordination of MDA, acting as advocates, implementers, and educators. The aim of this study was to determine whether BHW knowledge and attitudes towards schistosomiasis and MDA is sufficient and correlated with resident knowledge and drug compliance. A cross-sectional survey was conducted in 2015 among 2186 residents and 224 BHWs in the province of Northern Samar, the Philippines using a structured survey questionnaire. BHWs showed good familiarity on how schistosomiasis is acquired and diagnosed. Nevertheless, both BHWs and residents had poor awareness of the signs and symptoms of schistosomiasis, disease prevention, and treatment options. There was no correlation between the knowledge scores of the BHWs and the residents (r=0.080, p=0.722). Kruskal-Wallis analysis revealed significant differences in BHW knowledge scores between the low (3.29, 95% confidence interval 3.16-3.36), moderate (3.61, 95% confidence interval 3.49-3.69), and high (4.05, 95% confidence interval 3.77-4.13) compliance village groups (p=0.002), with the high compliance areas having the highest mean knowledge scores. This study highlights the importance of community health workers in obtaining the World Health Organization drug coverage rate of 75% and improving compliance with MDA in the community. Investing in the education of community health workers with appropriate disease-specific training is crucial if disease elimination is ultimately to be achieved. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  2. TAX ADMINISTRATION: Impact of Compliance and Collection Program Declines on Taxpayers

    National Research Council Canada - National Science Library

    2002-01-01

    ...) compliance and collection programs. Many view these programs-such as audits to determine whether taxpayers have accurately reported the amount of taxes that they owe and collection follow-up with taxpayers who have not...

  3. Diffusion of treatment in social networks and mass drug administration.

    Science.gov (United States)

    Chami, Goylette F; Kontoleon, Andreas A; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B; Tukahebwa, Edridah M; Dunne, David W

    2017-12-05

    Information, behaviors, and technologies spread when people interact. Understanding these interactions is critical for achieving the greatest diffusion of public interventions. Yet, little is known about the performance of starting points (seed nodes) for diffusion. We track routine mass drug administration-the large-scale distribution of deworming drugs-in Uganda. We observe friendship networks, socioeconomic factors, and treatment delivery outcomes for 16,357 individuals in 3491 households of 17 rural villages. Each village has two community medicine distributors (CMDs), who are the seed nodes and responsible for administering treatments. Here, we show that CMDs with tightly knit (clustered) friendship connections achieve the greatest reach and speed of treatment coverage. Importantly, we demonstrate that clustering predicts diffusion through social networks when spreading relies on contact with seed nodes while centrality is unrelated to diffusion. Clustering should be considered when selecting seed nodes for large-scale treatment campaigns.

  4. Acute antidepressant drug administration and autobiographical memory recall

    DEFF Research Database (Denmark)

    Papadatou-Pastou, Marietta; Miskowiak, Kamilla W; Williams, J Mark G

    2012-01-01

    Antidepressants affect memory and neural responses to emotionally valenced stimuli in healthy volunteers. However, it is unclear whether this extends to autobiographical memory for personally experienced events. The current study investigated the effects of acute administration of the antidepress...... of reboxetine on emotional memory extends to recall of personally experienced events. Such effects may be relevant to the cognitive improvements found with recovery from depression and with the mechanism of action of contemporary antidepressant drugs.......Antidepressants affect memory and neural responses to emotionally valenced stimuli in healthy volunteers. However, it is unclear whether this extends to autobiographical memory for personally experienced events. The current study investigated the effects of acute administration...... in the processing of positive versus negative memories was reduced following reboxetine compared with placebo in the left frontal lobe (extending into the insula) and the right superior temporal gyrus. This was paired with increased memory speed in volunteers given reboxetine versus placebo. The effect...

  5. The effect of physical, social and psychological factors on drug compliance in patients with mild hypertension.

    Science.gov (United States)

    Okken, V S; Niemeijer, M G; Dijkstra, A; Baars, M W; Said, S; Hoogenberg, K; Orfgen, H; Otten, S; Cleophas, T J

    2008-06-01

    In patients with hypertension noncompliance with drug treatment is between 15 to 54%, and has been recognised as a relevant contributor to the burden of cardiovascular morbidity. Up to 92% of patients experience unpleasant symptoms with their condition and, particularly in these patients, the symptoms experienced may enhance compliance. To simultaneously assess the effects of physical, social and psychological factors on noncompliance. Patients with mild hypertension despite drug treatment, from the departments of cardiology and internal medicine, were requested to answer a self-administered questionnaire addressing the presence of physical symptoms as well as psychosocial factors. The questionnaire was based on previously used test batteries and consisted of two lists of physical complaints and four lists addressing the four domains of planned behaviour regarding medical non-adherence according to Baron and Byrne. These domains mainly assess psychosocial factors. Each list consisted of three or more items and each item was scored on fiveto seven-point scales. Mean scores were used for assessment. The lists were also separately assessed for internal consistency and reliability using Cronbach's alphas. One-way analysis of variance and multivariate analysis of variance (MANOVA) with compliance as outcome variable and the physical, social and psychological variables as indicator variables were used for data analysis. MANOVA was adjusted for multiple testing. Many patients experienced physical symptoms due to hypertension, such as tiredness (31%), hot flushes (28%), headache (24%), reduced daily life energy (23%), palpitations (22%), with 95% confidence intervals between 16 to 38%. Scores for physical symptoms and social factors did not differ between self-reported adherers (n=165) and nonadherers (n=11). However, the score for psychological factors was significantly larger in the adherers than in the non-adherers, 5.05 versus 3.06, ppsychological factors. Conclusion

  6. 77 FR 23485 - Food and Drug Administration Patient Network Annual Meeting; Input Into Food and Drug...

    Science.gov (United States)

    2012-04-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-N-0001... consists of other activities, including the: FDA Patient Network Web site--A new, patient-centered Web site... committee meetings? Patient input to medical device companies during clinical trial design? Who (FDA...

  7. Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

    Science.gov (United States)

    Jonvallen, Petra

    2009-12-01

    Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

  8. Drug administration errors in hospital inpatients: a systematic review.

    Science.gov (United States)

    Berdot, Sarah; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre; Sabatier, Brigitte

    2013-01-01

    Drug administration in the hospital setting is the last barrier before a possible error reaches the patient. We aimed to analyze the prevalence and nature of administration error rate detected by the observation method. Embase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies. Observational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured the rate of administration errors in inpatients were included. Two reviewers (senior pharmacists) independently identified studies for inclusion. One reviewer extracted the data; the second reviewer checked the data. The main outcome was the error rate calculated as being the number of errors without wrong time errors divided by the Total Opportunity for Errors (TOE, sum of the total number of doses ordered plus the unordered doses given), and multiplied by 100. For studies that reported it, clinical impact was reclassified into four categories from fatal to minor or no impact. Due to a large heterogeneity, results were expressed as median values (interquartile range, IQR), according to their study design. Among 2088 studies, a total of 52 reported TOE. Most of the studies were cross-sectional studies (N=46). The median error rate without wrong time errors for the cross-sectional studies using TOE was 10.5% [IQR: 7.3%-21.7%]. No fatal error was observed and most errors were classified as minor in the 18 studies in which clinical impact was analyzed. We did not find any evidence of publication bias. Administration errors are frequent among inpatients. The median error rate without wrong time errors for the cross-sectional studies using TOE was about 10%. A standardization of administration error rate using the same denominator (TOE), numerator and types of errors is essential for further publications.

  9. Drug Administration Errors in Hospital Inpatients: A Systematic Review

    Science.gov (United States)

    Berdot, Sarah; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre; Sabatier, Brigitte

    2013-01-01

    Context Drug administration in the hospital setting is the last barrier before a possible error reaches the patient. Objectives We aimed to analyze the prevalence and nature of administration error rate detected by the observation method. Data Sources Embase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies. Study Selection Observational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured the rate of administration errors in inpatients were included. Data Extraction Two reviewers (senior pharmacists) independently identified studies for inclusion. One reviewer extracted the data; the second reviewer checked the data. The main outcome was the error rate calculated as being the number of errors without wrong time errors divided by the Total Opportunity for Errors (TOE, sum of the total number of doses ordered plus the unordered doses given), and multiplied by 100. For studies that reported it, clinical impact was reclassified into four categories from fatal to minor or no impact. Due to a large heterogeneity, results were expressed as median values (interquartile range, IQR), according to their study design. Results Among 2088 studies, a total of 52 reported TOE. Most of the studies were cross-sectional studies (N=46). The median error rate without wrong time errors for the cross-sectional studies using TOE was 10.5% [IQR: 7.3%-21.7%]. No fatal error was observed and most errors were classified as minor in the 18 studies in which clinical impact was analyzed. We did not find any evidence of publication bias. Conclusions Administration errors are frequent among inpatients. The median error rate without wrong time errors for the cross-sectional studies using TOE was about 10%. A standardization of administration error rate using the same denominator (TOE), numerator and types of errors is essential for further publications. PMID:23818992

  10. Drug administration errors in hospital inpatients: a systematic review.

    Directory of Open Access Journals (Sweden)

    Sarah Berdot

    Full Text Available CONTEXT: Drug administration in the hospital setting is the last barrier before a possible error reaches the patient. OBJECTIVES: We aimed to analyze the prevalence and nature of administration error rate detected by the observation method. DATA SOURCES: Embase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies. STUDY SELECTION: Observational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured the rate of administration errors in inpatients were included. DATA EXTRACTION: Two reviewers (senior pharmacists independently identified studies for inclusion. One reviewer extracted the data; the second reviewer checked the data. The main outcome was the error rate calculated as being the number of errors without wrong time errors divided by the Total Opportunity for Errors (TOE, sum of the total number of doses ordered plus the unordered doses given, and multiplied by 100. For studies that reported it, clinical impact was reclassified into four categories from fatal to minor or no impact. Due to a large heterogeneity, results were expressed as median values (interquartile range, IQR, according to their study design. RESULTS: Among 2088 studies, a total of 52 reported TOE. Most of the studies were cross-sectional studies (N=46. The median error rate without wrong time errors for the cross-sectional studies using TOE was 10.5% [IQR: 7.3%-21.7%]. No fatal error was observed and most errors were classified as minor in the 18 studies in which clinical impact was analyzed. We did not find any evidence of publication bias. CONCLUSIONS: Administration errors are frequent among inpatients. The median error rate without wrong time errors for the cross-sectional studies using TOE was about 10%. A standardization of administration error rate using the same denominator (TOE, numerator and types of errors is essential for further publications.

  11. Modeling of corneal and retinal pharmacokinetics after periocular drug administration.

    Science.gov (United States)

    Amrite, Aniruddha C; Edelhauser, Henry F; Kompella, Uday B

    2008-01-01

    the SD rat corneas. Similar pharmacokinetics models explain drug delivery to the cornea in rat and rabbit animal models. Retinal pharmacokinetics after periocular drug administration can be explained with a four-compartment (periocular space, choroid-containing transfer compartment, retina, and distribution compartment) model with elimination from the periocular space, retina, and choroid compartment. Inclusion of a dissolution-release step before the drug is available for absorption or elimination better explains retinal t(max). Good fits were obtained in both the BN (r = 0.99) and SD (r = 0.99) rats for retinal celecoxib using the same model; however, the parameter estimates differed. Corneal and retinal pharmacokinetics of small lipophilic molecules after periocular administration can be described by compartment models. The modeling analysis shows that (1) leak-back from the site of administration most likely contributes to the apparent lack of an increase phase in corneal concentrations; (2) elimination via the conjunctival or periocular blood and lymphatic systems contributes significantly to drug clearance after periocular injection; (3) corneal pharmacokinetics of small lipophilic molecules can be explained by using similar models in rats and rabbits; and (4) although there are differences in some retinal pharmacokinetics parameters between the pigmented and nonpigmented rats, the physiological basis of these differences has yet to be ascertained.

  12. 76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

    Science.gov (United States)

    2011-04-11

    ..., as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) legislation, Congress... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0012] Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program AGENCY...

  13. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  14. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  15. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Science.gov (United States)

    2011-01-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  16. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  17. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

  18. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  19. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  20. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  1. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0916] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. [[Page 126...

  2. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  3. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  4. 76 FR 28046 - Memorandum of Understanding Between the Food and Drug Administration and the International...

    Science.gov (United States)

    2011-05-13

    ... Tots Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0005; FDA 225-09-0014] Memorandum of Understanding Between the Food and Drug Administration and the...

  5. 78 FR 54901 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

    Science.gov (United States)

    2013-09-06

    ... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

  6. 78 FR 76842 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

    Science.gov (United States)

    2013-12-19

    ... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``FDA... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

  7. 78 FR 49988 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Science.gov (United States)

    2013-08-16

    .../Certification Bodies; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 [Docket...

  8. 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Science.gov (United States)

    2013-01-31

    ... AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110...

  9. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Science.gov (United States)

    2013-09-18

    .../Certification Bodies; Public Meetings AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meetings. SUMMARY: The Food and Drug Administration (FDA or we) is announcing two public meetings to... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 [Docket...

  10. 78 FR 277 - Food and Drug Administration Actions Related to Nicotine Replacement Therapies and Smoking...

    Science.gov (United States)

    2013-01-03

    ... Dependence; Public Hearing; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; Extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No...

  11. 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Science.gov (United States)

    2013-02-13

    ... AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110...

  12. 75 FR 4407 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2010-01-27

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food...

  13. 77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2012-04-11

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food...

  14. 77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2012-08-23

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food...

  15. 78 FR 26375 - Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship...

    Science.gov (United States)

    2013-05-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship..., Implementing, and Sustaining a Culture of Quality AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  16. 78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2013-05-22

    ... 24, 2013, from approximately 1 p.m. to 3:45 p.m. Location: Food and Drug Administration, White Oak..., Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, White Oak Bldg... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

  17. 75 FR 79379 - Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo...

    Science.gov (United States)

    2010-12-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Defense Advanced Research Projects Agency and Food and Drug Administration Expanding In Vivo Biomarker Detection Devices Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

  18. 75 FR 17418 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Science.gov (United States)

    2010-04-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004... Human Services and the National Alliance for Hispanic Health AGENCY: Food and Drug Administration, HHS... understanding (MOU) between the Food and Drug Administration, U.S. Department of Health and Human Services and...

  19. Transdermal and Topical Drug Administration in the Treatment of Pain

    Directory of Open Access Journals (Sweden)

    Wojciech Leppert

    2018-03-01

    Full Text Available The comprehensive treatment of pain is multidimodal, with pharmacotherapy playing a key role. An effective therapy for pain depends on the intensity and type of pain, the patients’ age, comorbidities, and appropriate choice of analgesic, its dose and route of administration. This review is aimed at presenting current knowledge on analgesics administered by transdermal and topical routes for physicians, nurses, pharmacists, and other health care professionals dealing with patients suffering from pain. Analgesics administered transdermally or topically act through different mechanisms. Opioids administered transdermally are absorbed into vessels located in subcutaneous tissue and, subsequently, are conveyed in the blood to opioid receptors localized in the central and peripheral nervous system. Non–steroidal anti–inflammatory drugs (NSAIDs applied topically render analgesia mainly through a high concentration in the structures of the joint and a provision of local anti–inflammatory effects. Topically administered drugs such as lidocaine and capsaicin in patches, capsaicin in cream, EMLA cream, and creams containing antidepressants (i.e., doxepin, amitriptyline act mainly locally in tissues through receptors and/or ion channels. Transdermal and topical routes offer some advantages over systemic analgesic administration. Analgesics administered topically have a much better profile for adverse effects as they relieve local pain with minimal systemic effects. The transdermal route apart from the above-mentioned advantages and provision of long period of analgesia may be more convenient, especially for patients who are unable to take drugs orally. Topically and transdermally administered opioids are characterised by a lower risk of addiction compared to oral and parenteral routes.

  20. DEWORMING DELUSIONS? MASS DRUG ADMINISTRATION IN EAST AFRICAN SCHOOLS.

    Science.gov (United States)

    Allen, Tim; Parker, Melissa

    2016-09-01

    Recent debates about deworming school-aged children in East Africa have been described as the 'Worm Wars'. The stakes are high. Deworming has become one of the top priorities in the fight against infectious diseases. Staff at the World Health Organization, the Gates Foundation and the World Bank (among other institutions) have endorsed the approach, and school-based treatments are a key component of large-scale mass drug administration programmes. Drawing on field research in Uganda and Tanzania, and engaging with both biological and social evidence, this article shows that assertions about the effects of school-based deworming are over-optimistic. The results of a much-cited study on deworming Kenyan school children, which has been used to promote the intervention, are flawed, and a systematic review of randomized controlled trials demonstrates that deworming is unlikely to improve overall public health. Also, confusions arise by applying the term deworming to a variety of very different helminth infections and to different treatment regimes, while local-level research in schools reveals that drug coverage usually falls below target levels. In most places where data exist, infection levels remain disappointingly high. Without indefinite free deworming, any declines in endemicity are likely to be reversed. Moreover, there are social problems arising from mass drug administration that have generally been ignored. Notably, there are serious ethical and practical issues arising from the widespread practice of giving tablets to children without actively consulting parents. There is no doubt that curative therapy for children infected with debilitating parasitic infections is appropriate, but overly positive evaluations of indiscriminate deworming are counter-productive.

  1. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms, and Explosives, Bureau of Prisons, Federal... Administrative Matters § 0.138 Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of...

  2. US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

    Science.gov (United States)

    Lathrop, Julia Tait; Jeffery, Douglas A; Shea, Yvonne R; Scholl, Peter F; Chan, Maria M

    2016-01-01

    Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic. © 2015 American Association for Clinical Chemistry.

  3. Monitoring compliance with standards of care for chronic diseases using healthcare administrative databases in Italy: Strengths and limitations.

    Directory of Open Access Journals (Sweden)

    Rosa Gini

    Full Text Available A recent comprehensive report on healthcare quality in Italy published by the Organization of Economic Co-operation and Development (OECD recommended that regular monitoring of quality of primary care by means of compliance with standards of care for chronic diseases is performed. A previous ecological study demonstrated that compliance with standards of care could be reliably estimated on regional level using administrative databases. This study compares estimates based on administrative data with estimates based on GP records for the same persons, to understand whether ecological fallacy played a role in the results of the previous study.We compared estimates of compliance with diagnostic and therapeutic standards of care for type 2 diabetes (T2DM, hypertension and ischaemic heart disease (IHD from administrative data (IAD with estimates from medical records (MR for the same persons registered with 24 GP's in 2012. Data were linked at an individual level.32,688 persons entered the study, 12,673 having at least one of the three diseases according to at least one data source. Patients not detected by IAD were many, for all three conditions: adding MR increased the number of cases of T2DM, hypertension, and IHD by +40%, +42%, and +104%, respectively. IAD had imperfect sensitivity in detecting population compliance with therapies (adding MR increased the estimate, from +11.5% for statins to +14.7% for antithrombotics, and, more substantially, with diagnostic recommendations (adding MR increased the estimate, from +23.7% in glycated hemoglobin tests, to +50.5% in electrocardiogram. Patients not detected by IAD were less compliant with respect to those that IAD correctly identified (from -4.8 percentage points in proportion of IHD patients compliant with a yearly glycated hemoglobin test, to -40.1 points in the proportion of T2DM patients compliant with the same recommendation. IAD overestimated indicators of compliance with therapeutic standards

  4. Human soil-transmitted helminths: implications of mass drug administration.

    Science.gov (United States)

    Vercruysse, Jozef; Levecke, Bruno; Prichard, Roger

    2012-12-01

    With the London Declaration on neglected tropical disease (NTD), we are entering a new era of combating NTDs. However, the worldwide prospects of increased mass drug administration (MDA) treatments warrant caution on the development of anthelmintic resistance. In this review, we discuss the practical implications of MDA programs on the development of anthelmintic resistance in human soil-transmitted helminths (STH). There is poor evidence of anthelmintic resistance in human STH. Moreover, there is presumptive evidence that the refugia in MDA programs to control human STH is currently large, suggesting that the development of anthelmintic resistance in STH will be slow or may not occur. It remains unclear whether the current MDA strategy to control STH will sufficiently delay or prevent the development of anthelmintic resistance. First, differences in efficacy across and within STH species, and seasonal transmission of STH have not yet been considered. Second, any surveillance system to monitor drug efficacy is lacking. Finally, there is still no agreed strategy on how to deal with anthelmintic resistance once it emerges. Although anthelmintic resistance in human STH is currently of limited concern, various actions should be put in place for its delay and monitoring, and strategies should be developed in case anthelmintic resistance occurs.

  5. A comparison of medication administration errors from original medication packaging and multi-compartment compliance aids in care homes: A prospective observational study.

    Science.gov (United States)

    Gilmartin-Thomas, Julia Fiona-Maree; Smith, Felicity; Wolfe, Rory; Jani, Yogini

    2017-07-01

    No published study has been specifically designed to compare medication administration errors between original medication packaging and multi-compartment compliance aids in care homes, using direct observation. Compare the effect of original medication packaging and multi-compartment compliance aids on medication administration accuracy. Prospective observational. Ten Greater London care homes. Nurses and carers administering medications. Between October 2014 and June 2015, a pharmacist researcher directly observed solid, orally administered medications in tablet or capsule form at ten purposively sampled care homes (five only used original medication packaging and five used both multi-compartment compliance aids and original medication packaging). The medication administration error rate was calculated as the number of observed doses administered (or omitted) in error according to medication administration records, compared to the opportunities for error (total number of observed doses plus omitted doses). Over 108.4h, 41 different staff (35 nurses, 6 carers) were observed to administer medications to 823 residents during 90 medication administration rounds. A total of 2452 medication doses were observed (1385 from original medication packaging, 1067 from multi-compartment compliance aids). One hundred and seventy eight medication administration errors were identified from 2493 opportunities for error (7.1% overall medication administration error rate). A greater medication administration error rate was seen for original medication packaging than multi-compartment compliance aids (9.3% and 3.1% respectively, risk ratio (RR)=3.9, 95% confidence interval (CI) 2.4 to 6.1, ppackaging (from original medication packaging-only care homes) and multi-compartment compliance aids (RR=2.3, 95%CI 1.1 to 4.9, p=0.03), and between original medication packaging and multi-compartment compliance aids within care homes that used a combination of both medication administration

  6. 77 FR 47652 - Second Annual Food and Drug Administration Health Professional Organizations Conference

    Science.gov (United States)

    2012-08-09

    ... patients from counterfeit and other substandard drugs/supply chain threats, and others. The goal of the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Second Annual Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and...

  7. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  8. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  9. 78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

    Science.gov (United States)

    2013-07-15

    ..., until the Food and Drug Administration (FDA) has had time to consider what action it should take... Vol. 78 Monday, No. 135 July 15, 2013 Part IV Department of Health and Human Services Food and... SERVICES Food and Drug Administration 21 CFR Parts 1 and 16 [Docket No. FDA-2013-N-0365] Administrative...

  10. 77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Science.gov (United States)

    2012-07-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563... Labeled for Human Use; Enforcement Action Dates; Correction AGENCY: Food and Drug Administration, HHS... contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who...

  11. Community-directed mass drug administration is undermined by status seeking in friendship networks and inadequate trust in health advice networks

    OpenAIRE

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2017-01-01

    Over 1.9 billion individuals require preventive chemotherapy through mass drug administration (MDA). Community-directed MDA relies on volunteer community medicine distributors (CMDs) and their achievement of high coverage and compliance. Yet, it is unknown if village social networks influence effective MDA implementation by CMDs. In Mayuge District, Uganda, census-style surveys were conducted for 16,357 individuals from 3,491 households in 17 villages. Praziquantel, albendazole, and ivermecti...

  12. Food and Drug Administration tobacco regulation and product judgments.

    Science.gov (United States)

    Kaufman, Annette R; Finney Rutten, Lila J; Parascandola, Mark; Blake, Kelly D; Augustson, Erik M

    2015-04-01

    The Family Smoking Prevention and Tobacco Control Act granted the Food and Drug Administration (FDA) the authority to regulate tobacco products in the U.S. However, little is known about how regulation may be related to judgments about tobacco product-related risks. To understand how FDA tobacco regulation beliefs are associated with judgments about tobacco product-related risks. The Health Information National Trends Survey is a national survey of the U.S. adult population. Data used in this analysis were collected from October 2012 through January 2013 (N=3,630) by mailed questionnaire and analyzed in 2013. Weighted bivariate chi-square analyses were used to assess associations among FDA regulation belief, tobacco harm judgments, sociodemographics, and smoking status. A weighted multinomial logistic regression was conducted where FDA regulation belief was regressed on tobacco product judgments, controlling for sociodemographic variables and smoking status. About 41% believed that the FDA regulates tobacco products in the U.S., 23.6% reported the FDA does not, and 35.3% did not know. Chi-square analyses showed that smoking status was significantly related to harm judgments about electronic cigarettes (pFDA regulation was associated with tobacco product harm judgment uncertainty. Tobacco product harm perceptions are associated with beliefs about tobacco product regulation by the FDA. These findings suggest the need for increased public awareness and understanding of the role of tobacco product regulation in protecting public health. Copyright © 2015. Published by Elsevier Inc.

  13. The U.S. food and drug administration's dosimetry program

    International Nuclear Information System (INIS)

    Baratta, E.

    2005-01-01

    Full text: The U. S. Public Health Service's (PHS) Food and Drug Administration (FDA) (part of the PHS) has had a Dosimetry Program at the Winchester Engineering and Analytical Center (WEAC) (formerly the Northeastern Radiological Health Laboratory). This Dosimetry Program has been in place since 1961. In 1967 it was augmented by the construction of a Whole Body Counter at WEAC for measuring internal dose. The FDA's Center for Medical Devices and Radiological Health had been handling these dosimeters since 1961 and in 2000 the WEAC took over total responsibility for this program for the FDA's Office of Regulatory affairs. This program was originally setup for the radiation workers (analysts and support personnel) and later included investigators personnel working in the medical and dental x-ray field. The field laboratories began using radionuclides in 1972 and were also issued radiation dosimeters. Investigators station at border import station alter 2003 were issued as well as radiation pages as a precaution when checking imported food and other FDA regulated products. This paper will discuss the results of radiation exposure received by analyst (including whole body measurements) at WEAC and field laboratories. Also discussed will be exposures to investigators in the medical and dental field. The exposure to the investigators at the import border stations will be included even though they have not been carrying dosimeters for slightly more than a year. In general, the exposures have been well below the Nuclear Regulatory Commission regulations for radiation workers. (author)

  14. Caregivers' perception of drug administration safety for pediatric oncology patients.

    Science.gov (United States)

    Harris, Nariman; Badr, Lina Kurdahi; Saab, Raya; Khalidi, Aziza

    2014-01-01

    Medication errors (MEs) are reported to be between 1.5% and 90% depending on many factors, such as type of the institution where data were collected and the method to identify the errors. More significantly, the risk for errors with potential for harm is 3 times higher for children, especially those receiving chemotherapy. Few studies have been published on averting such errors with children and none on how caregivers perceive their role in preventing such errors. The purpose of this study was to evaluate pediatric oncology patient's caregivers' perception of drug administration safety and their willingness to be involved in averting such errors. A cross-sectional design was used to study a nonrandomized sample of 100 caregivers of pediatric oncology patients. Ninety-six of the caregivers surveyed were well informed about the medications their children receive and were ready to participate in error prevention strategies. However, an underestimation of potential errors uncovered a high level of "trust" for the staff. Caregivers echoed their apprehension for being responsible for potential errors. Caregivers are a valuable resource to intercept medication errors. However, caregivers may be hesitant to actively communicate their fears with health professionals. Interventions that aim at encouraging caregivers to engage in the safety of their children are recommended.

  15. Immunoassay-Based Drug Tests Are Inadequately Sensitive for Medication Compliance Monitoring in Patients Treated for Chronic Pain.

    Science.gov (United States)

    Snyder, Marion L; Fantz, Corrine R; Melanson, Stacy

    2017-02-01

    Enzyme immunoassays (EIA) have notable limitations for monitoring therapeutic compliance in pain management. Chromatography coupled with mass spectrometry provides definitive results and superior sensitivity and specificity over traditional EIA testing. To analyze and compare the sensitivity of EIA results together with known prescriptions to liquid chromatography-tandem mass spectrometry (LC-MS/MS) for monitoring drug use (and abuse) in patients treated for chronic pain. A total of 530 urine samples from patients being treated for chronic pain were studied. Pain management clinic in the United States. The samples were tested for a profile of chronic pain medications and illicit drugs with commercially available EIA kits followed by analysis with Agilent LC-MS/MS system. The EIAs exhibited poor sensitivity and high rates of false negative results in the pain management setting. For example, 21% of EIA for opiates show false negative results. Mass spectrometry methods were more sensitive, detected a broader range of drugs and metabolites, and could detect non-prescribed drug use and simulations in compliance. Patients do not always accurately report drug use information, and some drugs do not have EIA methods available for comparative purposes. Mass spectrometry is a more robust and reliable method for detection of drugs used in the pain management setting. Due to the extent of undisclosed use and abuse of medications and illicit drugs, LC-MS/MS testing is necessary for adequate and accurate drug detection. In addition, LC-MS/MS methods are superior in terms of sensitivity and number of compounds that can be screened, making this a better method for use in pain management. Key words: Pain management, enzyme immunoassays, mass spectrometry, urine drug testing, prescription status, compliance.

  16. [An alarming threat to secondary prevention: low compliance (lifestyle) and poor adherence (drugs)].

    Science.gov (United States)

    Fuster, Valentín

    2012-07-01

    The deteriorating health of the general population and the increasing prevalence of chronic disease combine to present a problem of global proportions whose causes are both multifactorial and complex. The consumer society we live in does not encourage healthy living, and the consequences are even most devastating when social inequalities, the economic situation and the population explosion in recent decades are taken into account. The growth of poor eating habits, obesity, and hypertension are relentlessly contributing to the development of an epidemic of cardiovascular disease. In this context, the ability of national and international bodies and regulatory agencies to have an effect on commercial interests is very limited and alternative ways of reducing the disease burden are needed. Recent studies on patient compliance with lifestyle changes and on adherence to prescribed medication have produced alarming findings. Over 50% of patients, on average, choose to abandon the treatment they have been prescribed, and the percentage that achieve the targets proposed for improving habitual behaviors (e.g. quitting smoking, losing weight or increasing physical activity) is similar or lower. It is essential that solutions to these problems are found because, in addition to their implications for the health of the individual, poor compliance and adherence threaten to undermine the relevance of clinical study findings and are associated with substantial economic costs, given that they result in the failure to achieve therapeutic goals and increase rates of hospitalization and death. Improved communication between doctors and patients, the active participation of other health professionals and the development of combination drug formulations (e.g. the polypill) appear to be the most promising strategies for improving patient adherence to treatment and reducing the economic burden. Copyright © 2012. Published by Elsevier Espana.

  17. Automated anesthesia carts reduce drug recording errors in medication administrations - A single center study in the largest tertiary referral hospital in China.

    Science.gov (United States)

    Wang, Ying; Du, Yingying; Zhao, Yingying; Ren, Yang; Zhang, Wei

    2017-08-01

    To clinically evaluate a type of patented automated anesthesia cart in medication administrations in anesthesia. This was a prospectively randomized open label clinical trial. In 10 designated operating suits in the First Affiliated Hospital of Zhengzhou University, in China. 1066 cases originated from 10,812 medication administrations in anesthesia were randomized. 78 registered anesthesiologists managed the medication. The patients received medication administrations in anesthesia with either an automated or a conventional manual cart. American Society of Anesthesiologists (ASA) score, sex, duration of anesthesia and surgical specialty, errors in administration of medications (incorrect medication given (substitution), medication not given (omission) and drug recordings errors"), compliance and satisfaction were recorded. The total error rate was 7.3% with the automated anesthesia carts (1 in 14 administrations) and 11.9% with conventional manual carts (1 in 8 administrations). Automated anesthesia carts significantly reduced the drug recording error rate compared to conventional manual carts (Perrors omission errors was found between groups of automated anesthesia carts and conventional manual carts. The anesthesiologists' compliance with the automated anesthesia carts was unsatisfactory, and all the errors in medication recordings with the automated anesthesia carts were due to the incorrect use of the carts. Most of the participating anesthesiologists preferred the automated anesthesia carts (Perrors in medication administrations of anesthesia. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. 76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

    Science.gov (United States)

    2011-09-09

    ...] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug... conference for representatives of Health Professional Organizations. Dr. Margaret Hamburg, Commissioner of... person attending, the name of the organization, address, and telephone number. There is no registration...

  19. Systematic evaluation of "compliance" to prescribed treatment medications and "abstinence" from psychoactive drug abuse in chemical dependence programs: data from the comprehensive analysis of reported drugs.

    Science.gov (United States)

    Blum, Kenneth; Han, David; Femino, John; Smith, David E; Saunders, Scott; Simpatico, Thomas; Schoenthaler, Stephen J; Oscar-Berman, Marlene; Gold, Mark S

    2014-01-01

    This is the first quantitative analysis of data from urine drug tests for compliance to treatment medications and abstinence from drug abuse across "levels of care" in six eastern states of America. Comprehensive Analysis of Reported Drugs (CARD) data was used in this post-hoc retrospective observational study from 10,570 patients, filtered to include a total of 2,919 patients prescribed at least one treatment medication during 2010 and 2011. The first and last urine samples (5,838 specimens) were analyzed; compliance to treatment medications and abstinence from drugs of abuse supported treatment effectiveness for many. Compared to non-compliant patients, compliant patients were marginally less likely to abuse opioids, cannabinoids, and ethanol during treatment although more likely to abuse benzodiazepines. Almost 17% of the non-abstinent patients used benzodiazepines, 15% used opiates, and 10% used cocaine during treatment. Compliance was significantly higher in residential than in the non-residential treatment facilities. Independent of level of care, 67.2% of the patients (n = 1963; Pabuse detected in either the first or last urine samples (abstinence). Moreover, in 2010, 16.9% of the patients (n = 57) were abstinent at first but not at last urine (deteriorating abstinence), the percentage dropped to 13.3% (n = 174) in 2011; this improvement over years was statistically significant. A longitudinal analysis for abstinence and compliance was studied in a randomized subset from 2011, (n = 511) representing 17.5% of the total cohort. A statistically significant upward trend (p = 2.353×10-8) of abstinence rates as well as a similar but stronger trend for compliance ((p = 2.200×10-16) was found. Being cognizant of the trend toward drug urine testing being linked to medical necessity eliminating abusive screening, the interpretation of these valuable results require further intensive investigation.

  20. Accuracy of manual entry of drug administration data into an anesthesia information management system.

    Science.gov (United States)

    Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

    2014-11-01

    Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

  1. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  2. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-09-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0285] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  3. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  4. A systematic review of factors that shape implementation of mass drug administration for lymphatic filariasis in sub-Saharan Africa

    Directory of Open Access Journals (Sweden)

    Adam Silumbwe

    2017-05-01

    Full Text Available Abstract Background Understanding factors surrounding the implementation process of mass drug administration for lymphatic filariasis (MDA for LF elimination programmes is critical for successful implementation of similar interventions. The sub-Saharan Africa (SSA region records the second highest prevalence of the disease and subsequently several countries have initiated and implemented MDA for LF. Systematic reviews have largely focused on factors that affect coverage and compliance, with less attention on the implementation of MDA for LF activities. This review therefore seeks to document facilitators and barriers to implementation of MDA for LF in sub-Saharan Africa. Methods A systematic search of databases PubMed, Science Direct and Google Scholar was conducted. English peer-reviewed publications focusing on implementation of MDA for LF from 2000 to 2016 were considered for analysis. Using thematic analysis, we synthesized the final 18 articles to identify key facilitators and barriers to MDA for LF programme implementation. Results The main factors facilitating implementation of MDA for LF programmes were awareness creation through innovative community health education programmes, creation of partnerships and collaborations, integration with existing programmes, creation of morbidity management programmes, motivation of community drug distributors (CDDs through incentives and training, and management of adverse effects. Barriers to implementation included the lack of geographical demarcations and unregistered migrations into rapidly urbanizing areas, major disease outbreaks like the Ebola virus disease in West Africa, delayed drug deliveries at both country and community levels, inappropriate drug delivery strategies, limited number of drug distributors and the large number of households allocated for drug distribution. Conclusion Mass drug administration for lymphatic filariasis elimination programmes should design their implementation

  5. A systematic review of factors that shape implementation of mass drug administration for lymphatic filariasis in sub-Saharan Africa.

    Science.gov (United States)

    Silumbwe, Adam; Zulu, Joseph Mumba; Halwindi, Hikabasa; Jacobs, Choolwe; Zgambo, Jessy; Dambe, Rosalia; Chola, Mumbi; Chongwe, Gershom; Michelo, Charles

    2017-05-22

    Understanding factors surrounding the implementation process of mass drug administration for lymphatic filariasis (MDA for LF) elimination programmes is critical for successful implementation of similar interventions. The sub-Saharan Africa (SSA) region records the second highest prevalence of the disease and subsequently several countries have initiated and implemented MDA for LF. Systematic reviews have largely focused on factors that affect coverage and compliance, with less attention on the implementation of MDA for LF activities. This review therefore seeks to document facilitators and barriers to implementation of MDA for LF in sub-Saharan Africa. A systematic search of databases PubMed, Science Direct and Google Scholar was conducted. English peer-reviewed publications focusing on implementation of MDA for LF from 2000 to 2016 were considered for analysis. Using thematic analysis, we synthesized the final 18 articles to identify key facilitators and barriers to MDA for LF programme implementation. The main factors facilitating implementation of MDA for LF programmes were awareness creation through innovative community health education programmes, creation of partnerships and collaborations, integration with existing programmes, creation of morbidity management programmes, motivation of community drug distributors (CDDs) through incentives and training, and management of adverse effects. Barriers to implementation included the lack of geographical demarcations and unregistered migrations into rapidly urbanizing areas, major disease outbreaks like the Ebola virus disease in West Africa, delayed drug deliveries at both country and community levels, inappropriate drug delivery strategies, limited number of drug distributors and the large number of households allocated for drug distribution. Mass drug administration for lymphatic filariasis elimination programmes should design their implementation strategies differently based on specific contextual factors to

  6. Energy Research and Development Administration, Division of Safety, Standards, and Compliance respirator manual

    Energy Technology Data Exchange (ETDEWEB)

    Douglas, D.D.; Hack, A.L.; Held, B.J.; Revoir, W.H.

    1976-05-01

    The manual has been prepared to provide technical information for contractors of the Energy Research and Development Administration (ERDA) on the application of respiratory protective devices for protection against airborne contaminants, both radioactive and nonradioactive. The various elements of a respirator program including selection and maintenance of equipment and training of personnel are described to assist in establishing adequate programs.

  7. Energy Research and Development Administration, Division of Safety, Standards, and Compliance respirator manual

    International Nuclear Information System (INIS)

    Douglas, D.D.; Hack, A.L.; Held, B.J.; Revoir, W.H.

    1976-05-01

    The manual has been prepared to provide technical information for contractors of the Energy Research and Development Administration (ERDA) on the application of respiratory protective devices for protection against airborne contaminants, both radioactive and nonradioactive. The various elements of a respirator program including selection and maintenance of equipment and training of personnel are described to assist in establishing adequate programs

  8. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Science.gov (United States)

    2012-07-26

    ... Workshop; Notice of Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device development...

  9. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

  10. 77 FR 16971 - Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other...

    Science.gov (United States)

    2012-03-23

    ... agreements and MOUs relating to activities of our Office of Criminal Investigations, which are addressed in.... FDA-2012-N-0205] Agreements and Memoranda of Understanding Between the Food and Drug Administration... ``Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments...

  11. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Science.gov (United States)

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of... provides advice to the Agency on keeping pace with technical and scientific evolutions in the fields of... center or product area. Please call the Information Line for up-to-date information on this meeting. A...

  12. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Science.gov (United States)

    2011-07-01

    ..., FDA must stay abreast of the latest developments in research and also communicate with stakeholders... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0012] Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab...

  13. 75 FR 17423 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

    Science.gov (United States)

    2010-04-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-10-0007] Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services and the Association of Minority Health Profession Schools, Inc...

  14. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0386] Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human...

  15. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0787] Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies...

  16. Systematic evaluation of "compliance" to prescribed treatment medications and "abstinence" from psychoactive drug abuse in chemical dependence programs: data from the comprehensive analysis of reported drugs.

    Directory of Open Access Journals (Sweden)

    Kenneth Blum

    Full Text Available This is the first quantitative analysis of data from urine drug tests for compliance to treatment medications and abstinence from drug abuse across "levels of care" in six eastern states of America. Comprehensive Analysis of Reported Drugs (CARD data was used in this post-hoc retrospective observational study from 10,570 patients, filtered to include a total of 2,919 patients prescribed at least one treatment medication during 2010 and 2011. The first and last urine samples (5,838 specimens were analyzed; compliance to treatment medications and abstinence from drugs of abuse supported treatment effectiveness for many. Compared to non-compliant patients, compliant patients were marginally less likely to abuse opioids, cannabinoids, and ethanol during treatment although more likely to abuse benzodiazepines. Almost 17% of the non-abstinent patients used benzodiazepines, 15% used opiates, and 10% used cocaine during treatment. Compliance was significantly higher in residential than in the non-residential treatment facilities. Independent of level of care, 67.2% of the patients (n = 1963; P<.001 had every treatment medication found in both first and last urine specimens (compliance. In addition, 39.2% of the patients (n = 1143; P<.001 had no substance of abuse detected in either the first or last urine samples (abstinence. Moreover, in 2010, 16.9% of the patients (n = 57 were abstinent at first but not at last urine (deteriorating abstinence, the percentage dropped to 13.3% (n = 174 in 2011; this improvement over years was statistically significant. A longitudinal analysis for abstinence and compliance was studied in a randomized subset from 2011, (n = 511 representing 17.5% of the total cohort. A statistically significant upward trend (p = 2.353×10-8 of abstinence rates as well as a similar but stronger trend for compliance ((p = 2.200×10-16 was found. Being cognizant of the trend toward drug urine testing being linked

  17. ALTERNATIVE ROUTES OF DRUG ADMINISTRATION: ADVANTAGES AND DISADVANTAGES (SUBJECT REVIEW OF AMERICAN ACADEMY OF PEDIATRICS

    Directory of Open Access Journals (Sweden)

    article editorial

    2006-01-01

    Full Text Available During the past 20 years advances in drug formulations and innovative routes of administration have been made. Our understanding of drug transport across tissues has increased. These changes have often resulted in improved patient adherence to the therapeutic regiment and pharmacologic response. The administration of drugs by transdermal or transmucosal routes offers the advantage of being relatively painless. Also, the potential for greater flexibility in a variety of clinical situations exists, often precluding the need to establish intravinus access which is a particular benefit for children. This statement focuses on the advantages and disadvantages of alternative routes of drug administration. Issues of particular importance in the care of pediatric patients especially factors that could lead to drug-relaxed toxicity or adverse responses are emphasized.Key words: drug formulation, pharmacoKINETICS, pharmacodynamics, drug, children.

  18. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance... single copies of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug... available at http://www.regulations.gov . To receive ``Draft Guidance for Industry and Food and Drug...

  19. Frequency and determinants of drug administration errors in the intensive care unit

    NARCIS (Netherlands)

    van den Bemt, PMLA; Fijn, R; van der Voort, PHJ; Gossen, AA; Egberts, TCG; Brouwers, JRBJ

    Objective., The study aimed to identify both the frequency and the determinants of drug administration errors in the intensive care unit. Design: Administration errors were detected by using the disguised-observation technique (observation of medication administrations by nurses, without revealing

  20. 28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA)-limited access.

    Science.gov (United States)

    2010-07-01

    ... Administration (DEA)-limited access. 16.98 Section 16.98 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION... Exemption of the Drug Enforcement Administration (DEA)—limited access. (a) The following systems of records.../Diversion Analysis and Detection System (ARCOS/DADS) (Justice/DEA-003) (2) Controlled Substances Act...

  1. Diffusion of treatment in social networks and mass drug administration

    NARCIS (Netherlands)

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2017-01-01

    Information, behaviors, and technologies spread when people interact. Understanding these interactions is critical for achieving the greatest diffusion of public interventions. Yet, little is known about the performance of starting points (seed nodes) for diffusion. We track routine mass drug

  2. Can oral fluid cannabinoid testing monitor medication compliance and/or cannabis smoking during oral THC and oromucosal Sativex administration?

    Science.gov (United States)

    Lee, Dayong; Karschner, Erin L; Milman, Garry; Barnes, Allan J; Goodwin, Robert S; Huestis, Marilyn A

    2013-06-01

    We characterize cannabinoid disposition in oral fluid (OF) after dronabinol, synthetic oral Δ(9)-tetrahydrocannabinol (THC), and Sativex, a cannabis-extract oromucosal spray, and evaluate whether smoked cannabis relapse or Sativex compliance can be identified with OF cannabinoid monitoring. 5 and 15 mg synthetic oral THC, low (5.4 mg THC, 5.0 mg cannabidiol (CBD)) and high (16.2 mg THC, 15.0 mg CBD) dose Sativex, and placebo were administered in random order (n=14). Oral fluid specimens were collected for 10.5 h after dosing and analyzed for THC, CBD, cannabinol (CBN), and 11-nor-9-carboxy-THC (THCCOOH). After oral THC, OF THC concentrations decreased over time from baseline, reflecting residual THC excretion from previously self-administered smoked cannabis. CBD and CBN also were rarely detected. After Sativex, THC, CBD and CBN increased greatly, peaking at 0.25-1 h. Median CBD/THC and CBN/THC ratios were 0.82-1.34 and 0.04-0.06, respectively, reflecting cannabinoids' composition in Sativex. THCCOOH/THC ratios within 4.5 h post Sativex were ≤ 1.6 pg/ng, always lower than after oral THC and placebo. THCCOOH/THC ratios increased throughout each dosing session. Lack of measurable THC, CBD and CBN in OF following oral THC, and high OF CBD/THC ratios after Sativex distinguish oral and sublingual drug delivery routes from cannabis smoking. Low THCCOOH/THC ratios suggest recent Sativex and smoked cannabis exposure. These data indicate that OF cannabinoid monitoring can document compliance with Sativex pharmacotherapy, and identify relapse to smoked cannabis during oral THC medication but not Sativex treatment, unless samples were collected shortly after smoking. Published by Elsevier Ireland Ltd.

  3. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  4. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  5. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Science.gov (United States)

    2013-08-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

  6. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  7. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  8. Community-directed mass drug administration is undermined by status seeking in friendship networks and inadequate trust in health advice networks.

    Science.gov (United States)

    Chami, Goylette F; Kontoleon, Andreas A; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B; Tukahebwa, Edridah M; Dunne, David W

    2017-06-01

    Over 1.9 billion individuals require preventive chemotherapy through mass drug administration (MDA). Community-directed MDA relies on volunteer community medicine distributors (CMDs) and their achievement of high coverage and compliance. Yet, it is unknown if village social networks influence effective MDA implementation by CMDs. In Mayuge District, Uganda, census-style surveys were conducted for 16,357 individuals from 3,491 households in 17 villages. Praziquantel, albendazole, and ivermectin were administered for one month in community-directed MDA to treat Schistosoma mansoni, hookworm, and lymphatic filariasis. Self-reported treatment outcomes, socioeconomic characteristics, friendship networks, and health advice networks were collected. We investigated systematically missed coverage and noncompliance. Coverage was defined as an eligible person being offered at least one drug by CMDs; compliance included ingesting at least one of the offered drugs. These outcomes were analyzed as a two-stage process using a Heckman selection model. To further assess if MDA through CMDs was working as intended, we examined the probability of accurate drug administration of 1) praziquantel, 2) both albendazole and ivermectin, and 3) all drugs. This analysis was conducted using bivariate Probit regression. Four indicators from each social network were examined: degree, betweenness centrality, closeness centrality, and the presence of a direct connection to CMDs. All models accounted for nested household and village standard errors. CMDs were more likely to offer medicines, and to accurately administer the drugs as trained by the national control programme, to individuals with high friendship degree (many connections) and high friendship closeness centrality (households that were only a short number of steps away from all other households in the network). Though high (88.59%), additional compliance was associated with directly trusting CMDs for health advice. Effective treatment

  9. Long-term administration of antipsychotic drugs in schizophrenia and influence of substance and drug abuse on the disease outcome.

    Science.gov (United States)

    Werner, F-M; Coveñas, Rafael

    2017-10-20

    Many schizophrenic patients with a long-term administration of antipsychotic drugs do not regularly adhere to the prescribed pharmacotherapy. Antipsychotic drugs constitute a palliative, but not a curative treatment, and the long-term effect of these drugs is not secure. Patients tend to consume nicotine and alcohol, as well as some patients consume drugs such as cannabis and amphetamines. The objective of this mini-review is to examine the reasons for the high tendency of schizophrenic patients to consume alcohol, nicotine and drugs and in addition to suggest measures to reduce the abuse of substances and drugs. The effects of substances such as alcohol and nicotine and drugs such as cannabis and amphetamines on the disease outcome will be mentioned. Previous reviews on the psychotic disorders and the pharmacological treatment were used to examine the effects of substances and drugs on schizophrenic symptoms and to investigate appropriate measures to improve medication adherence and the renouncement of consuming substances and drugs. A possible coherence between the function of single susceptibility genes and the alteration of neurotransmitters is mentioned. The mechanism of action of the most important second-generation antipsychotic drugs and their indications are described. The tendency of schizophrenic patients to consume alcohol and nicotine and in addition the effect of both substances to possibly worsen psychotic symptoms are pointed out. The effect of nicotinergic agonists to support smoking cessation is described. The different compounds of cannabis, tetrahydrocannabidiol (a psychotomimetic) and cannabidiol (exerts antipsychotic actions), are mentioned. Because a reduced adherence to the pharmacotherapy is frequently combined with the abuse of substances, additional drugs, psychoeducation and the administration of long-acting injectable antipsychotic drugs could reduce the abuse of substances and drugs; these strategies could help to maintain the

  10. Demystifying the U.S. Food and Drug Administration: understanding regulatory pathways.

    Science.gov (United States)

    Naghshineh, Nima; Brown, Spencer; Cederna, Paul S; Levi, Benjamin; Lisiecki, Jeffrey; D'Amico, Richard A; Hume, Keith M; Seward, William; Rubin, J Peter

    2014-09-01

    The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon. The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained. The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced. The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

  11. Technology assessment and the Food and Drug Administration

    Science.gov (United States)

    Kaplan, A. H.; Becker, R. H.

    1972-01-01

    The statutory standards underlying the activities of the FDA, and the problems the Agency faces in decision making are discussed from a legal point of view. The premarketing clearance of new drugs and of food additives, the two most publicized and criticized areas of FDA activity, are used as illustrations. The importance of statutory standards in technology assessment in a regulatory setting is developed. The difficulties inherent in the formulation of meaningful standards are recognized. For foods, the words of the statute are inadequate, and for drugs, a statutory recognition of the various other objectives would be useful to the regulator and the regulated.

  12. Errors in drug administration by anaesthetists in public hospitals in ...

    African Journals Online (AJOL)

    Objective. To investigate errors in administering drugs by anaesthetists working in public hospitals in the Free State province. Methods. Anonymous questionnaires were distributed to doctors performing anaesthesia in public hospitals in the Free State, i.e. 188 doctors at 22 public sector hospitals. Outcomes included ...

  13. Drug Administration Errors by South African Anaesthetists – a Survey

    African Journals Online (AJOL)

    Adele

    TRAVEL FELLOWSHIP. Objectives. To investigate the incidence, nature of and factors contributing towards “wrong drug administrations” by South African anaesthetists. Design. A confidential, self-reporting survey was sent out to the 720 anaesthetists on the database of the South African Society of. Anaesthesiologists.

  14. Risk of Clinically Relevant Pharmacokinetic-based Drug-drug Interactions with Drugs Approved by the U.S. Food and Drug Administration Between 2013 and 2016.

    Science.gov (United States)

    Yu, Jingjing; Zhou, Zhu; Tay-Sontheimer, Jessica; Levy, Rene H; Ragueneau-Majlessi, Isabelle

    2018-03-23

    A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions. When considered as victims, eight new molecular entities (NMEs; cobimetinib, ibrutnib, isavuconazole, ivabradine, naloxegol, paritaprevir, simeprevir, and venetoclax) were identified as sensitive substrates of CYP3A, two NMEs (pirfenidone and tasimelteon) were sensitive substrates of CYP1A2, one NME (dasabuvir) was a sensitive substrate of CYP2C8, one NME (eliglustat) was a sensitive substrate of CYP2D6, and one NME (grazoprevir) was a sensitive substrate of OATP1B1/3 (with changes in exposure greater than 5-fold when co-administered with a strong inhibitor). Interestingly, approximately 75% of identified CYP3A substrates were also substrates of P-gp. As perpetrators, most clinical DDIs involved weak-to-moderate inhibition or induction, with only two drugs (Viekira Pak and idelalisib) showing strong inhibition of CYP3A, and one NME (lumacaftor) considered as a strong CYP3A inducer. Among drugs with large changes in exposure (≥ 5-fold), whether as victim or perpetrator, the most represented therapeutic classes were antivirals and oncology drugs, suggesting a significant risk of clinical DDIs in these patient populations. The American Society for Pharmacology and Experimental Therapeutics.

  15. Self-assessment of treatment compliance with antimuscarinic drugs and lower urinary tract condition among women with urinary incontinence.

    Science.gov (United States)

    Kosilov, Kirill; Loparev, Sergey; Kuzina, Irina; Shakirova, Olga; Zhuravskaya, Natalya; Lobodenko, Alexandra

    2017-11-01

    Our aim was to determine the efficiency of the Medication Compliance Self-Report Inventory (MASRI) in self-reporting antimuscarinic drug treatment compliance among women with urinary incontinence (UI). The study assessed 347 women aged 18-65 (averaging 49.7) years with more than one urinary incontinence (UI) episode per day. Treatment compliance was tested at the beginning and at weeks 4, 8, and 12 using the MASRI, the Brief Medication Questionnaire (BMQ), and visual pill counts. The MASRI's constructive, concurrent, and discriminate validity was studied in comparison with an external standard that uses the chi-square and Spearman coefficient. Receiver operating characteristic (ROC) analysis was performed to identify optimum MASRI cutoffs that would predict noncompliance. Furthermore, the functional condition of the lower urinary tract was tested using voiding diaries, uroflowmetry, and cystometry. The correlation between the percentage of noncompliant women according to the MASRI, and individuals with a belief barrier with respect to the BMQ screen was r = 0.81 (p ≤0.05), r = 0.84 (p ≤0.05), and r = 0.79 (p ≤0.05). The correlation between the percentage of noncompliant women according to the MASRI and of women who missed >20% of their doses according to the Regimen Screen of the BMQ was r = 0.79, p ≤0.05, r = 0.82, p ≤0.01, r = 0.77, and p ≤0.05 at the control points. Finally, the percentage of noncompliant patients who self-reported correctly according to the MASRI data compared with the BMQ was 95.6%, 95.7%, and 96.6% at the control points. The MASRI entails acceptable validity for accurately predicting treatment compliance with antimuscarinic drugs among women who have had UI for >3 months.

  16. Enhancing food safety: the role of the Food and Drug Administration

    National Research Council Canada - National Science Library

    Wallace, Robert B; Oria, Maria

    2010-01-01

    .... Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources...

  17. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2013-04-04

    ... Environment.'' The conference will cover current issues affecting the industry as well as explore strategies... compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the.... to 12:15 p.m. Location: The public conference will be held at the Renaissance Washington Hotel, 999...

  18. Preventing errors in administration of parenteral drugs: the results of a four-year national patient safety program.

    NARCIS (Netherlands)

    Blok, C. de; Schilp, J.; Wagner, C.

    2013-01-01

    Objectives: To evaluate the implementation of a four-year national patient safety program concerning the parenteral drug administration process in the Netherlands. Methods: Structuring the preparation and administration process of parenteral drugs reduces the number of medication errors. A

  19. Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment.

    Science.gov (United States)

    Siena, Giampaolo; Mari, Andrea; Canale, Aude; Mondaini, Nicola; Chindemi, Andrea; Greco, Isabella; Saleh, Omar; Serni, Sergio; Nicita, Giulio; Minervini, Andrea; Carini, Marco

    2018-02-01

    In December 2006, the region of Tuscany (Italy) authorized the free-of-charge provision of phosphodiesterase type 5 inhibitors (PDE5I) for all patients with Tuscan citizenship who undergo nerve-sparing radical prostatectomy (NSRP). To compare sexual rehabilitation outcomes in patients with low risk of erectile dysfunction and minimal comorbidities who received PDE5Is free of charge (PDE5I-F) with those who paid for PDE5Is (PDE5I-P) after bilateral NSRP. We reviewed prospectively recorded clinical data of 2,368 patients with Tuscan (PDE5I-F) and non-Tuscan (PDE5I-P) citizenship treated with NSRP at 3 different institutions in Tuscany from 2008 to 2013. Inclusion criteria for the final analysis were open or robot-assisted bilateral NSRP; low risk of postoperative erectile dysfunction according to the Briganti risk stratification tool; no smoking and no drug and alcohol abuse; no cardiovascular risk factors; no major surgery before and after NSRP; no neoadjuvant or adjuvant treatment; and no biochemical relapse. Dropout was defined as an interruption longer than 40 days of the treatment protocol indicated in the inclusion criteria. Treatment compliance was defined as more than 90% consumption of the prescribed PDE5I. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Italian version of the University of California-Los Angeles Prostate Cancer Index sexual function (UCLA-PCI-s) questionnaires were administered to assess patients' satisfaction with PDE5I treatment and sexual function. Overall, 648 patients in the PDE5I-F group and 182 in the PDE5I-P group met the inclusion criteria and were eligible for the study. Patients had comparable preoperative and surgical characteristics. The PDE5I-F group had a significantly higher early rehabilitation onset (P < .001), lower treatment dropout at 12, 24, and 36 months (P < .001 for all comparisons), and higher compliance to the treatment protocol at 6 and 12 months (P = .01 and P < .001, respectively

  20. Role of mass drug administration in elimination of Plasmodium falciparum malaria: a consensus modelling study.

    Science.gov (United States)

    Brady, Oliver J; Slater, Hannah C; Pemberton-Ross, Peter; Wenger, Edward; Maude, Richard J; Ghani, Azra C; Penny, Melissa A; Gerardin, Jaline; White, Lisa J; Chitnis, Nakul; Aguas, Ricardo; Hay, Simon I; Smith, David L; Stuckey, Erin M; Okiro, Emelda A; Smith, Thomas A; Okell, Lucy C

    2017-07-01

    Mass drug administration for elimination of Plasmodium falciparum malaria is recommended by WHO in some settings. We used consensus modelling to understand how to optimise the effects of mass drug administration in areas with low malaria transmission. We collaborated with researchers doing field trials to establish a standard intervention scenario and standard transmission setting, and we input these parameters into four previously published models. We then varied the number of rounds of mass drug administration, coverage, duration, timing, importation of infection, and pre-administration transmission levels. The outcome of interest was the percentage reduction in annual mean prevalence of P falciparum parasite rate as measured by PCR in the third year after the final round of mass drug administration. The models predicted differing magnitude of the effects of mass drug administration, but consensus answers were reached for several factors. Mass drug administration was predicted to reduce transmission over a longer timescale than accounted for by the prophylactic effect alone. Percentage reduction in transmission was predicted to be higher and last longer at lower baseline transmission levels. Reduction in transmission resulting from mass drug administration was predicted to be temporary, and in the absence of scale-up of other interventions, such as vector control, transmission would return to pre-administration levels. The proportion of the population treated in a year was a key determinant of simulated effectiveness, irrespective of whether people are treated through high coverage in a single round or new individuals are reached by implementation of several rounds. Mass drug administration was predicted to be more effective if continued over 2 years rather than 1 year, and if done at the time of year when transmission is lowest. Mass drug administration has the potential to reduce transmission for a limited time, but is not an effective replacement for existing

  1. The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

    Science.gov (United States)

    Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

    2015-10-01

    Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable Food and Drug Administration regulations. While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board. We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the Food and Drug Administration. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk pragmatic clinical trials. We recommend that the Food and Drug Administration establish a risk-based approach to obtaining informed consent in pragmatic clinical trials that would facilitate the conduct of pragmatic clinical trials without compromising the protection of enrolled individuals or the integrity of the resulting data. © The Author

  2. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited... also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) as outreach activities by Government Agencies to small businesses. Dated: August 8, 2012. Leslie Kux...

  3. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-03-28

    ... expenses, including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit... stakeholders and the public. The public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) as outreach activities by Government Agencies to small...

  4. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-12-20

    ... will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are... stakeholders and the public. The public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as outreach activities by Government Agencies to small...

  5. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ..., lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as... information to stakeholders and the public. The public workshop also is consistent with the Small Business... to small businesses. Dated: August 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc...

  6. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-03-25

    ... actual expenses, including refreshments, lunch, materials, and speaker expenses. Seats are limited... stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as an outreach activity by Government agencies to small...

  7. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-08-17

    ....) Registration: The registration fee covers the cost of actual expenses, including refreshments, lunch, materials... information to stakeholders and the public. The public workshop also is consistent with the Small Business... to small businesses. Dated: August 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy...

  8. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-08-23

    ... education (CME) and continuing nursing education (CNE) credit. CME for Physicians: SoCRA is accredited by... physicians. CNE for Nurses: SoCRA is an approved provider of continuing nursing education by the Pennsylvania....htm . (FDA has verified the Web site address, but we are not responsible for any subsequent changes to...

  9. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2012-02-15

    ...: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled...

  10. U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

    Science.gov (United States)

    Wing, Deborah A; Powers, Barbara; Hickok, Durlin

    2010-04-01

    The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical-legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.

  11. 76 FR 74791 - Memorandum of Understanding Between the Food and Drug Administration and the U.S. Department of...

    Science.gov (United States)

    2011-12-01

    ... HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug Administration and the U.S. Department of Agriculture's Agricultural and Marketing Service, Farm Service Agency... Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the...

  12. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  13. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration...

  14. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  15. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  16. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  17. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  18. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  19. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  20. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Science.gov (United States)

    2011-12-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0817] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  1. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  2. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  3. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  4. 75 FR 60767 - Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year...

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES Food and Drug Administration Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic Priorities Document; Request for Comments... Drug Administration (FDA) is seeking public comment on its draft Strategic Priorities FY 2011-2015. FDA...

  5. 76 FR 49775 - Food and Drug Administration/National Heart, Lung, and Blood Institute/National Science...

    Science.gov (United States)

    2011-08-11

    ... Public Workshop on Computer Methods for Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002...

  6. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Science.gov (United States)

    2012-11-23

    ...; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1090...

  7. 75 FR 18849 - Food and Drug Administration/National Heart Lung and Blood Institute/National Science Foundation...

    Science.gov (United States)

    2010-04-13

    ...; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/NHLBI/NSF... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001...

  8. 75 FR 31450 - Memorandum of Understanding by and Between the United States Food and Drug Administration and the...

    Science.gov (United States)

    2010-06-03

    ... Administration and the International Anesthesia Research Society for the Safety of Key Inhaled and Intravenous Drugs in Pediatrics Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004...

  9. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  10. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  11. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  12. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability AGENCY: Food and Drug Administration, HHS...

  13. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  14. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  15. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  16. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  17. 78 FR 20666 - Food and Drug Administration/National Institutes of Health/National Science Foundation Public...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0345] Food and Drug Administration/National Institutes of Health/ National Science Foundation Public Workshop... public workshop; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing its...

  18. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  19. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Science.gov (United States)

    2011-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability... and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical...

  20. Effects of chronic administration of drugs of abuse on impulsive choice (delay discounting) in animal models.

    Science.gov (United States)

    Setlow, Barry; Mendez, Ian A; Mitchell, Marci R; Simon, Nicholas W

    2009-09-01

    Drug-addicted individuals show high levels of impulsive choice, characterized by preference for small immediate over larger but delayed rewards. Although the causal relationship between chronic drug use and elevated impulsive choice in humans has been unclear, a small but growing body of literature over the past decade has shown that chronic drug administration in animal models can cause increases in impulsive choice, suggesting that a similar causal relationship may exist in human drug users. This article reviews this literature, with a particular focus on the effects of chronic cocaine administration, which have been most thoroughly characterized. The potential mechanisms of these effects are described in terms of drug-induced neural alterations in ventral striatal and prefrontal cortical brain systems. Some implications of this research for pharmacological treatment of drug-induced increases in impulsive choice are discussed, along with suggestions for future research in this area.

  1. Drug administration errors in an institution for individuals with intellectual disability : an observational study

    NARCIS (Netherlands)

    van den Bemt, P M L A; Robertz, R; de Jong, A L; van Roon, E N; Leufkens, H G M

    BACKGROUND: Medication errors can result in harm, unless barriers to prevent them are present. Drug administration errors are less likely to be prevented, because they occur in the last stage of the drug distribution process. This is especially the case in non-alert patients, as patients often form

  2. Drug Administration Errors in an Institution for Individuals with Intellectual Disability: An Observational Study

    Science.gov (United States)

    van den Bemt, P. M. L. A.; Robertz, R.; de Jong, A. L.; van Roon, E. N.; Leufkens, H. G. M.

    2007-01-01

    Background: Medication errors can result in harm, unless barriers to prevent them are present. Drug administration errors are less likely to be prevented, because they occur in the last stage of the drug distribution process. This is especially the case in non-alert patients, as patients often form the final barrier to prevention of errors.…

  3. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2011-03-22

    ...] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug... ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes.... Combination Products Panel. Update on Quality System Regulations. Warning Letter and Enforcement Action Trends...

  4. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  5. Enhancing topical analgesic administration: review and prospect for transdermal and transbuccal drug delivery systems.

    Science.gov (United States)

    Sanz, Roser; Calpena, Ana C; Mallandrich, Mireia; Clares, Beatriz

    2015-01-01

    Topical administration is an appealing method for drug delivery due to its non-invasiveness, self-controlled application, avoidance of first-pass metabolism in the liver and reduction of systemic side effects compared to other conventional routes such as oral and parenteral. However, topical administration must overcome the permeable barriers that skin and mucosa represent for the drug to achieve its desired therapeutic effect. Penetration of drugs through human skin is mainly impaired by the stratum corneum- the uppermost keratinized skin layer. In contrast, the stratified squamous epithelium (a nonkeratinized tissue) represents the major physical barrier for transbuccal drug administration in humans. Different technologies have been studied to enhance the bioavailability or local effects of drugs administered through skin and buccal mucosa. Those technologies involve the use of physical or chemical enhancers and new dosage forms such as vesicles, cyclodextrins, nanoparticles and other complex systems. Combinations of these technologies may further increase drug delivery in some cases. As analgesia is one of the main therapeutic effects sought through topical administration, this paper focuses on the review of drug delivery systems to improve the topical and transdermal/transbuccal drug delivery of substances with known analgesic action. A discussion of their possibilities and limitations is also included.

  6. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    Science.gov (United States)

    James, J S

    1998-03-06

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  7. Whistleblowing – a Mechanism for Collecting Data on Non-Compliance with the Principles of Administrative Law in Order to Mitigate Risks

    Directory of Open Access Journals (Sweden)

    Emil BALAN

    2017-03-01

    Full Text Available Clear, consistent and predictable rules applicable to the administrative activities of the EU institutions, as well as deepening the EU integration are crucial in order to create a European administrative space. Building on the need to achieving this goal, the paper analyses the object, the procedure applicable, the legal regime and the safeguards granted to whistleblowers, as well as the role of the whistleblowing as a preventive or risk mitigation mechanism for those situations in which noncompliance with the principles of administrative law may affect the validity of documents, the performance of the legal competencies of the institution or citizens` rights. It raises awareness on risks and costs of non-compliance with the principles of the administrative law and good administration standards, as well as on the vulnerabilities and effects it can generate. The document also places whistleblowing in the context of control mechanism available for verifying the compliance of concrete administrative activities with these principles, as a solution to identify and retrieve breaches from within the institution. To draw conclusions, this paper builds on the above analysis and the current Romanian good practice in the field, and frames a series of recommendations for improving the procedure applicable to whistleblowing.

  8. Factors influencing drug uptake during mass drug administration for control of lymphatic filariasis in rural and urban Tanzania.

    Directory of Open Access Journals (Sweden)

    William J Kisoka

    Full Text Available BACKGROUND: In most countries of Sub-Saharan Africa, control of lymphatic filariasis (LF is based on annual mass drug administration (MDA with a combination of ivermectin and albendazole. Treatment coverages are however often suboptimal for programmes to reach the goal of transmission interruption within reasonable time. The present study aimed to identify predictors and barriers to individual drug uptake during MDA implementation by the National LF Elimination Programme in Tanzania. METHODS: A questionnaire based cross sectional household survey was carried out in two rural and two urban districts in Lindi and Morogoro regions shortly after the 2011 MDA. 3279 adults (≥15 years were interviewed about personal characteristics, socio-economic status, MDA drug uptake among themselves and their children, reasons for taking/not taking drugs, and participation in previous MDA activities for LF control. FINDINGS: The overall drug uptake rate was 55.1% (range of 44.5-75.6% between districts. There was no overall major difference between children (54.8% and adults (55.2% or between females (54.9% and males (55.8%, but the role of these and other predictors varied to some extent between study sites. Major overall predictors of drug uptake among the interviewed adults were increasing age and history of previous drug uptake. Being absent from home during drug distribution was the main reason for not taking the drugs (50.2% followed by clinical contraindications to treatment (10.8%, missing household visits of drug distributors (10.6%, and households not being informed about the distribution (9.0%. CONCLUSION: Drug uptake relied more on easily modifiable provider-related factors than on individual perceptions and practices in the target population. Limited investments in appropriate timing, dissemination of accurate timing information to recipients and motivation of drug distributors to visit all households (repeatedly when residents are absent are likely

  9. Compliance to antihypertensive drugs, salt restriction, exercise and control of systemic hypertension in hypertensive patients at abbottabad

    International Nuclear Information System (INIS)

    Ahmed, N.; Waqas, A.; Khaliq, M.A.

    2008-01-01

    Hypertension is one of the most important cardiovascular risk factor but its control is still a challenge for physicians all around the world. Control of blood pressure can reduce cardiovascular morbidity and mortality, so the compliance to antihypertensive drugs and life style modification play an important role for the control of hypertension. This analytical (cross-sectional) study was conducted to assess prevalence of control of hypertension among hypertensive patients and to assess the relationship of control of hypertension with factors like compliance to antihypertensive drugs, salt restriction and exercise among the hypertensive patients. This study was conducted at outpatient clinic of medicine at Shahina Jamil Hospital Abbottabad from April 2007 to September 2007. Eighty-nine patients seen in the outpatient clinic of medicine were enrolled in the study. All the patients with age 15 years or above, diagnosed as a case of systemic hypertension were included. Among eighty nine patients, 67 were female and 22 were male with mean age of 55.8+-13.4 years, mean systolic and diastolic blood pressure of 160+-28.6 and 97.8+-14.1 mm Hg respectively, and pulse rate of 85.9+-11.4 per minutes. Out of 89 patients, 25.8% were having controlled hypertension, 48.3% were compliant and 51.7% were not compliant to antihypertensive drugs, 55.1% were having salt restriction and 44.9% were having no salt restriction and 23.6% were used to do physical activity while 76.4% were not used to do physical activity. In group A consisted of patients with controlled hypertension, 95.7% patients were compliant to antihypertensive patients, 95.7% were having salt restriction and 43.5% were used to do physical activity. In group B consisted of patients with uncontrolled hypertension, only 31.8% were compliant to antihypertensive drugs, 40.9% were having salt restriction, 16.7% were used to do physical activity. Hypertension can be controlled if the hypertensive patients have good compliance

  10. The role of gender relations in uptake of mass drug administration for lymphatic filariasis in Alor District, Indonesia.

    Science.gov (United States)

    Krentel, Alison; Wellings, Kaye

    2018-03-12

    The Global Programme to Eliminate Lymphatic Filariasis has set 2020 as a target to eliminate lymphatic filariasis (LF) as a public health problem through mass drug administration (MDA) to all eligible people living in endemic areas. To obtain a better understanding of compliance with LF treatment, a qualitative study using 43 in-depth interviews was carried out in Alor District, Indonesia to explore factors that motivate uptake of LF treatment, including the social and behavioural differences between compliant and non-compliant individuals. In this paper, we report on the findings specific to the role of family and gender relations and how they affect compliance. The sample comprised 21 men and 22 women; 24 complied with treatment while 19 did not. Gender relations emerged as a key theme in access, uptake and compliance with MDA. The view that the husband, as head of household, had the power, control, and in some cases the responsibility to influence whether his wife took the medication was common among both men and women. Gender also affected priorities for health care provision in the household as well as overall decision making regarding health in the household. Four models of responsibility for health decision making emerged: (i) responsibility resting primarily with the husband; (ii) responsibility resting primarily with the wife; (iii) responsibility shared equally by both husband and wife; and (iv) responsibility autonomously assumed by each individual for his or her own self, regardless of the course of action of the other spouse. (i) Gender relations and social hierarchy influence compliance with LF treatment because they inherently affect decisions taken within the household regarding health; (ii) health care interventions need to take account of the complexity of gender roles; (iii) the fact that women's power tends to be implicit and not overtly recognised in the household or the community has important implications for health care interventions; (iv

  11. The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation

    OpenAIRE

    Kalam, Murad

    2002-01-01

    This paper offers a brief model of FDA regulation of currently illegal narcotics in the United States. Given that nearly three out of four Americans believe that the drug war has failed, recent calls from prominent liberal and conservative thinkers to legalize drugs, and state “compassionate use†ballot initiatives, future drug legalization is at least conceivable in the United States. Yet, how would the FDA regulate NLD’s under its current st...

  12. Drug-Free Schools and Communities Act Compliance at Michigan Community Colleges

    Science.gov (United States)

    Custer, Bradley D.

    2018-01-01

    In 1989, Congress passed the Drug-Free Schools and Communities Act Amendments to address illegal alcohol and drug abuse on college campuses. To receive federal funding, each college must comply by implementing an alcohol and drug prevention program, but the federal government and some colleges have paid little attention to this policy. Recently,…

  13. Systematic review of drug administration costs and implications for biopharmaceutical manufacturing.

    Science.gov (United States)

    Tetteh, Ebenezer; Morris, Stephen

    2013-10-01

    The acquisition costs of biologic drugs are often considered to be relatively high compared with those of nonbiologics. However, the total costs of delivering these drugs also depend on the cost of administration. Ignoring drug administration costs may distort resource allocation decisions because these affect cost effectiveness. The objectives of this systematic review were to develop a framework of drug administration costs that considers both the costs of physical administration and the associated proximal costs; and, as a case example, to use this framework to evaluate administration costs for biologics within the UK National Health Service (NHS). We reviewed literature that reported estimates of administration costs for biologics within the UK NHS to identify how these costs were quantified and to examine how differences in dosage forms and regimens influenced administration costs. The literature reviewed were identified by searching the Centre for Review and Dissemination Databases (DARE, NHS EED and HTA); EMBASE (The Excerpta Medica Database); MEDLINE (using the OVID interface); Econlit (EBSCO); Tufts Medical Center Cost Effectiveness Analysis (CEA) Registry; and Google Scholar. We identified 4,344 potentially relevant studies, of which 43 studies were selected for this systematic review. We extracted estimates of the administration costs of biologics from these studies. We found evidence of variation in the way that administration costs were measured, and that this affected the magnitude of costs reported, which could then influence cost effectiveness. Our findings suggested that manufacturers of biologic medicines should pay attention to formulation issues and their impact on administration costs, because these affect the total costs of healthcare delivery and cost effectiveness.

  14. Drug distribution in man: a positron emission tomography study after oral administration of the labelled neuroprotective drug vinpocetine

    International Nuclear Information System (INIS)

    Gulyas, Balazs; Halldin, Christer; Sandell, Johan; Farde, Lars; Sovago, Judit; Cselenyi, Zsolt; Vas, Adam; Kiss, Bela; Karpati, Egon

    2002-01-01

    Direct information on the distribution of a drug requires measurements in various tissues. Such data have until now been obtained in animals, or have indirectly been calculated from plasma measurements in humans using mathematical models. Here we suggest the use of positron emission tomography (PET) as a method to obtain direct measurements of drug distribution in the human body. The distribution in body and brain of vinpocetine, a neuroprotective drug widely used in the prevention and treatment of cerebrovascular diseases, was followed after oral administration. Vinpocetine was labelled with carbon-11 and radioactivity was measured by PET in stomach, liver, brain and kidney in six healthy volunteers. The radioactivity in blood and urine as well as the fractions of [ 11 C]vinpocetine and labelled metabolites in plasma were also determined. After oral administration, [ 11 C]vinpocetine appeared immediately in the stomach and within minutes in the liver and the blood. In the blood the level of radioactivity continuously increased until the end of the measurement period, whereas the fraction of the unchanged mother compound decreased. Radioactivity uptake and distribution in the brain were demonstrable from the tenth minute after the administration of the labelled drug. Brain distribution was heterogeneous, similar to the distribution previously reported after intravenous administration. These findings indicate that vinpocetine, administered orally in humans, readily enters the bloodstream from the stomach and gastrointestinal tract and, consequently, passes the blood-brain barrier and enters the brain. Radioactivity from [ 11 C]vinpocetine was also demonstrated in the kidneys and in urine, indicating that at least a part of the radioactive drug and labelled metabolites is eliminated from the body through the kidneys. This study is the first to demonstrate that PET might be a useful, direct and non-invasive tool to study the distribution and pharmacokinetics of orally

  15. Laser-acoustic transcutaneous drug delivery: A new trend in administration of drugs

    Science.gov (United States)

    Zharov, Vladimir P.; Latyshev, Alexei S.

    1999-03-01

    This work deals with the principles of transcutaneous drug delivery technique which uses optoacoustic (OA) effect. Laser OA impregnation, enhanced laser OA impregnation, simple laser and laser OA injections are presented. Drug impregnation mathematical model and preliminary experiments on laser injection are described.

  16. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0432... Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to... other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major...

  17. Prescriber compliance with black box warnings in older adult patients.

    Science.gov (United States)

    Ricci, Judith R; Coulen, Charmaine; Berger, Jan E; Moore, Marsha C; McQueen, Angela; Jan, Saira A

    2009-11-01

    Patients prescribed medications with US Food and Drug Administration-issued black box warnings (BBWs) warrant additional vigilance by prescribers because these drugs can cause serious adverse drug events. Seniors are at greater risk for adverse drug events due to increased medication burden and greater health vulnerability. To improve our understanding of the prescribing and patient-monitoring practices of physicians prescribing medications with a BBW to patients age >or=65 years in an ambulatory care setting. A retrospective cohort study of administrative pharmacy and medical claims identified 58,190 patients age >or=65 years in the Horizon Blue Cross Blue Shield of New Jersey beneficiary population with >or=1 claim for >or=1 of the 8 targeted medications between January 1, 2005, and December 31, 2005. Medications included carbamazepine, amiodarone, ketoconazole, loop diuretics, methotrexate, cyclosporine, metformin and combinations, and cilostazol. Patients were followed 12 months from the index prescription date to evaluate prescriber compliance with BBWs using operationalized definitions of compliance. Patients prescribed drugs with a drug-laboratory warning had lower rates of prescriber BBW compliance (0.7%-24.9%) than patients prescribed drugs with a drug-disease warning (84.7%-90.2%). Administrative claims analysis identified low rates of prescriber compliance with BBWs in managing patients age >or=65 years. Claims analysis may be a cost-effective strategy to monitor prescriber compliance with BBWs in older patients at higher risk.

  18. 77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay...

    Science.gov (United States)

    2012-05-11

    ... Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; delay of compliance dates; request for comments... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 310...

  19. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

    Science.gov (United States)

    Sullivan, Helen W; Aikin, Kathryn J; Chung-Davies, Eunice; Wade, Michael

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.

  20. Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

    Directory of Open Access Journals (Sweden)

    Helen W Sullivan

    Full Text Available The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA. Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.

  1. Association between the evaluation by a patient care team and compliance with the claim of drugs in pharmacy

    Directory of Open Access Journals (Sweden)

    Robinson Herrera Marín

    2015-01-01

    Full Text Available Context: currently is recognized the achieving challenge a adequate adherence. There are multiple methods to detect whether a patient is non-adherent, including claims history of drugs in pharmacy. This method has been considered adequate. Objective: To determine the association between care by an patient care team (including an pharmacist and compliance with the claim of medicines in pharmacy. Method: case-control study in patients with asthma, chronic obstructive pulmonary disease or allergic rhinitis, they claimed their medicines in pharmacies between October of 2012 and November 2013 (n = 526 .was defined as a case the patients that during the observation period claimed their drugs in pharmacy >95% of the time (n: 263. For univariate analysis absolute and relative frequencies and summary measures were used. For binary analysis, contingency tables, chi-square tests, t-Student (Mann-Whitney U and ANOVA (Kruskal-Wallis H. The statistical measure of force used was the odds ratio. Was performed multivariate logistic regression. Results: 78.3% of cases and 47.1% of controls had been treated by an interdisciplinary group (p<0,001, which had an exposure time of 1.75 (interquartile range 0.79 to 2.34 and 0.32 years (interquartile range 0.24 to 1.02 years, respectively (p<0,001. The cases claimed their drugs in pharmacy 2.52 times more than controls (ORajusted 2.52 [1.17 to 5.42]. Conclusions: be attended by an patient care team was associated with greater compliance with the claim of medicines in pharmacy

  2. The use of sonophoresis in the administration of drugs throughout the skin.

    Science.gov (United States)

    Escobar-Chávez, José Juan; Bonilla-Martínez, Dalia; Villegas-González, Martha Angélica; Rodríguez-Cruz, Isabel Marlen; Domínguez-Delgado, Clara Luisa

    2009-01-01

    Transdermal drug delivery offers an attractive alternative to the conventional drug delivery methods of oral administration and injection. However, the stratum corneum acts as a barrier that limits the penetration of substances through the skin. Application of ultrasound to the skin increases its permeability (sonophoresis) and enables the delivery of various substances into and through the skin. Ultrasound has been used extensively for medical diagnostics and to a certain extent in medical therapy (physiotherapy, ultrasonic surgery, hyperthermia). Nevertheless, it has only recently become popular as a technique to enhance drug release from drug delivery systems. A number of studies suggest the use of ultrasound as an external mean of delivering drugs at increased rates and at desired times. This review presents the main findings in the field of sonophoresis, namely transdermal drug delivery and transdermal monitoring. Particular attention is paid to proposed enhancement mechanisms and trends in the field of topical and transdermal delivery.

  3. DILEMMAS OF COMMUNITY-DIRECTED MASS DRUG ADMINISTRATION FOR LYMPHATIC FILARIASIS CONTROL

    DEFF Research Database (Denmark)

    Kisoka, William; Mushi, Declare; Meyrowitsch, Dan W.

    2017-01-01

    There has in recent years been a growing interest in the social significance of global health policy and associated interventions. This paper is concerned with neglected tropical disease control, which prescribes annual mass drug administration to interrupt transmission of, among others, lymphatic...... filariasis. In Tanzania, this intervention is conducted through community-directed distribution, which aims to improve drug uptake by promoting community participation and local ownership in the intervention. However, the average uptake of drugs often remains too low to achieve the intended interruption...... of transmission. The qualitative research presented here followed the implementation of mass drug administration in Lindi and Morogoro Regions, Tanzania, in 2011 to understand the different forms of involvement in the campaign and the experiences of stakeholders of their part in community-directed distribution...

  4. Sex differences in the self-administration of cannabinoids and other drugs of abuse.

    Science.gov (United States)

    Fattore, Liana; Fadda, Paola; Fratta, Walter

    2009-12-01

    Many studies have provided evidence for important sex-dependent differences in the origins, outcomes and treatment of drug abuse and dependence. Preclinical studies typically have employed animal models of addiction, such as oral or intravenous self-administration, to untangle the environmental, neurobiological and genetic factors that contribute to the shift from occasional, recreational use to compulsive, uncontrolled intake of drugs. Craving and relapse of drug seeking in abstinent individuals have also been found to differ between men and women. Identification of the neurobiological basis of craving and drug dependence continues to pose a challenge to addiction research. Significant sex differences are emerging in substance-abuse-related behavior, which has increased the demand for research on how drug consumption may have different causes, progression and consequences in men and women. In keeping with epidemiological data in humans, differences between the two sexes in drug seeking and intake have been well-documented in animal studies, with most recent findings related to abuse of cannabinoids. Clinical and preclinical findings indicate that sex and gonadal hormones may account for individual differences in susceptibility to the reinforcing effects of addictive substances, and that differences in vulnerability to drug abuse may be mediated by the same biological mechanisms. This review focuses on the differences between males and females in relation to drug self-administration and how such behavior may be affected by hormonal status.

  5. Investigation of the mechanisms of action behind Electromotive Drug Administration (EMDA)

    DEFF Research Database (Denmark)

    Kos, Bor; Vasquez, Juan Luis; Miklavčič, D

    2016-01-01

    Objective. Bladder cancer is a cause of considerable morbidity worldwide. Electromotive Drug Administration is a method that combines intravesical chemotherapy with local electric field application. Electroporation has been suggested among other mechanisms as having a possible role in the therapy......, so the goal of the present study was to investigate the electric fields present in the bladder wall during the treatment to determine which mechanisms might be involved. Material and Methods. Electromotive Drug Administration involves applying intravesical mitomycin C with direct current of 20 m...

  6. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  7. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

  8. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

  9. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

  10. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and research...

  11. 28 CFR Appendix B to Part 61 - Drug Enforcement Administration Procedures Relating to the Implementation of the National...

    Science.gov (United States)

    2010-07-01

    ... ENVIRONMENTAL POLICY ACT Pt. 61, App. B Appendix B to Part 61—Drug Enforcement Administration Procedures... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug Enforcement Administration Procedures Relating to the Implementation of the National Environmental Policy Act B Appendix B to Part 61...

  12. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

  13. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

  14. Factors influencing drug uptake during mass drug administration for control of lymphatic filariasis in rural and urban Tanzania

    DEFF Research Database (Denmark)

    Kisoka, William J.; Simonsen, Paul Erik; Malecela, Mwelecele N.

    2014-01-01

    BACKGROUND: In most countries of Sub-Saharan Africa, control of lymphatic filariasis (LF) is based on annual mass drug administration (MDA) with a combination of ivermectin and albendazole. Treatment coverages are however often suboptimal for programmes to reach the goal of transmission...... control. FINDINGS: The overall drug uptake rate was 55.1% (range of 44.5-75.6% between districts). There was no overall major difference between children (54.8%) and adults (55.2%) or between females (54.9%) and males (55.8%), but the role of these and other predictors varied to some extent between study...

  15. Hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform: an advanced vehicle for topical delivery of antiglaucoma drugs and a likely solution to improving compliance and adherence in glaucoma management.

    Science.gov (United States)

    Yang, Hu; Leffler, Christopher T

    2013-03-01

    Glaucoma therapy typically begins with topical medications, of which there are 4 major classes in common use in the United States: beta-adrenergic antagonists, alpha-agonists, carbonic anhydrase inhibitors, and prostaglandin analogs. Unfortunately, all 4 classes require at least daily dosing, and 3 of the 4 classes are approved to be administered 2 or 3 times daily. This need for frequent dosing with multiple medications makes compliance difficult. Longer-acting formulations and combinations that require less frequent administration might improve compliance and therefore medication effectiveness. Recently, we developed an ocular drug delivery system, a hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform for delivering glaucoma therapeutics topically. This platform is designed to deliver glaucoma drugs to the eye efficiently and release the drug in a slow fashion. Furthermore, this delivery platform is designed to be compatible with many of the glaucoma drugs that are currently approved for use. In this article, we review this new delivery system with in-depth discussion of its structural features, properties, and preclinical application in glaucoma treatment. In addition, future directions and translational efforts for marketing this technology are elaborated.

  16. Personalized drug administration for cancer treatment using Model Reference Adaptive Control.

    Science.gov (United States)

    Babaei, Naser; Salamci, Metin U

    2015-04-21

    A new Model Reference Adaptive Control (MRAC) approach is proposed for the nonlinear regulation problem of cancer treatment via chemotherapy. We suggest an approach for determining an optimal anticancer drug delivery scenario for cancer patients without prior knowledge of nonlinear model structure and parameters by compounding State Dependent Riccati Equation (SDRE) and MRAC which will lead to personalized drug administration. Several approaches have been proposed for eradicating cancerous cells in nonlinear tumor growth model. The main difficulty in these approaches is the requirement of nonlinear model parameters, which are unknown to physicians in reality. To cope with this shortage, we first determine the drug delivery scenario for a reference patient with known mathematical model and parameters via SDRE technique, and by using the proposed approach we adapt the drug administration scenario for another cancer patient despite unknown nonlinear model structure and model parameters. We propose an efficient approach to determine drug administration which will help physicians for prescribing a chemotherapy protocol for a cancer patient by regulating the drug delivery scenario of the reference patient. Stabilizing the tumor growth nonlinear model has been achieved via full state feedback techniques and yields a near optimal solution to cancer treatment problem. Numerical simulations show the effectiveness of the proposed algorithm for eradicating tumor lumps with different sizes in different patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Errors in preparation and administration of parenteral drugs in neonatology: evaluation and corrective actions.

    Science.gov (United States)

    Hasni, Nesrine; Ben Hamida, Emira; Ben Jeddou, Khouloud; Ben Hamida, Sarra; Ayadi, Imene; Ouahchi, Zeineb; Marrakchi, Zahra

    2016-12-01

    The medication iatrogenic risk is quite unevaluated in neonatology Objective: Assessment of errors that occurred during the preparation and administration of injectable medicines in a neonatal unit in order to implement corrective actions to reduce the occurrence of these errors. A prospective, observational study was performed in a neonatal unit over a period of one month. The practice of preparing and administering injectable medications were identified through a standardized data collection form. These practices were compared with summaries of the characteristics of each product (RCP) and the bibliography. One hundred preparations were observed of 13 different drugs. 85 errors during preparations and administration steps were detected. These errors were divided into preparation errors in 59% of cases such as changing the dilution protocol (32%), the use of bad solvent (11%) and administration errors in 41% of cases as errors timing of administration (18%) or omission of administration (9%). This study showed a high rate of errors during stages of preparation and administration of injectable drugs. In order to optimize the care of newborns and reduce the risk of medication errors, corrective actions have been implemented through the establishment of a quality assurance system which consisted of the development of injectable drugs preparation procedures, the introduction of a labeling system and staff training.

  18. 75 FR 59105 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

    Science.gov (United States)

    2010-09-27

    ... 2105-AE03 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug..., Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590; 202... Part 40 Administrative practice and procedures, Alcohol abuse, Alcohol testing, Drug abuse, Drug...

  19. Quantification of drug-loaded magnetic nanoparticles in rabbit liver and tumor after in vivo administration

    Energy Technology Data Exchange (ETDEWEB)

    Tietze, Rainer; Jurgons, Roland; Lyer, Stefan; Schreiber, Eveline [Department of Otorhinolaryngology, Head and Neck Surgery, Friedrich-Alexander-University Erlangen-Nuernberg, Waldstr. 1, 91054 Erlangen (Germany); Wiekhorst, Frank; Eberbeck, Dietmar; Richter, Heike; Steinhoff, Uwe; Trahms, Lutz [Physikalisch-Technische Bundesanstalt, Berlin (Germany); Alexiou, Christoph [Department of Otorhinolaryngology, Head and Neck Surgery, Friedrich-Alexander-University Erlangen-Nuernberg, Waldstr. 1, 91054 Erlangen (Germany)], E-mail: C.Alexiou@web.de

    2009-05-15

    Magnetic nanoparticles have been investigated for biomedical applications for more than 30 years. The development of biocompatible nanosized drug delivery systems for specific targeting of therapeutics is imminent in medical research, especially for treating cancer and vascular diseases. We used drug-labeled magnetic iron oxide nanoparticles, which were attracted to an experimental tumor in rabbits with an external magnetic field (magnetic drug targeting, MDT). Aim of this study was to detect and quantify the biodistribution of the magnetic nanoparticles by magnetorelaxometry. The study shows higher amount of nanoparticles in the tumor after intraarterial application and MDT compared to intravenous administration.

  20. P.L. 94-142 Compliance and Management of Youth Services Administration. Report to Congressional Requesters.

    Science.gov (United States)

    General Accounting Office, Washington, DC. General Government Div.

    The document consists of a letter (and associated appendices) to members of the House of Representatives Committee on the District of Columbia from the Assistant Comptroller General concerning the District's compliance with legislation mandating special education services to handicapped delinquents. The letter reports that requirements of Public…

  1. Ensuring safe drug administration to pediatric patients with renal dysfunction: a multicenter study.

    Science.gov (United States)

    Harada, Ryoko; Ishikura, Kenji; Shinozuka, Shunsuke; Mikami, Naoaki; Hamada, Riku; Hataya, Hiroshi; Morikawa, Yoshihiko; Omori, Tae; Takahashi, Hirotaka; Hamasaki, Yuko; Kaneko, Tetsuji; Iijima, Kazumoto; Honda, Masataka

    2018-02-06

    In pediatric patients, due to variations in baseline serum creatinine (Cr) reference values, renal dysfunctions sometimes go unnoticed. In addition, renally excreted drugs need dose adjustment while nephrotoxic drugs should be avoided altogether in patients with impaired renal function. However, most physicians are apparently unaware of these facts and may administer these drugs to vulnerable patients. We administered a questionnaire to all physicians and pharmacists specializing in pediatric medical care at six Tokyo metropolitan government-run hospitals in Japan. 276 (59%) of 470 physicians and pharmacists participated. The rate of correct answers given by physicians who were asked to state the serum Cr reference range for 4-year-olds and 8-year-olds was 83 and 74%, respectively. On the other hand, the rate of correct answers given by pharmacists to the same question was only 27 and 24%, respectively. Only about 50% of physicians were aware that histamine H 2 -receptor antagonists and oseltamivir are renally excreted or that acyclovir and angiotensin II receptor blocker are nephrotoxic. However, most of the pharmacists recognized that histamine H 2 -receptor antagonists and oseltamivir are renally excreted drugs. For the majority of the investigated drugs, the awareness that we need to reduce dosages for patients with renal dysfunction was insufficient. To ensure safe drug administration, communication between physicians and pharmacists is paramount. There is an urgent need for the creation of a safe drug administration protocol for pediatric patients with renal dysfunction.

  2. Drug policy and administration affecting quality of life of the poor in Thailand.

    Science.gov (United States)

    Prutipinyo, Chardsumon; Sirichotiratana, Nithat

    2011-09-01

    This study aims to analyze drug policy and administration affecting quality of life of the poor in Thailand. Review of official reports and related documents, for the past 10 years (from 2000-2010). By imposing compulsory licensing, the Thai government maintains negotiating power over the price of pharmaceutical products with the patent holders of the original drugs. This gives an opportunity for relevant government agencies to produce or import patented drugs. At present, there are many problems and obstacles. The findings show that developing countries need to strengthen their negotiating power so that the pharmaceutical manufacturers cannot take advantage through mechanisms provided for such as compulsory licensing and provisions for flexibility in Trade-Related Intellectual Property Rights (TRIPS) agreement. Furthermore, these countries must support and empower the local pharmaceutical manufacturers to produce generic drugs. Developing countries should ensure that their populations have confidence in universal coverage service and medical systems regarding the quality of generic drugs.

  3. Drug overprescription in nursing homes: an empirical evaluation of administrative data.

    Science.gov (United States)

    Stroka, Magdalena A

    2016-04-01

    A widely discussed shortcoming of long-term care in nursing homes for the elderly is the inappropriate or suboptimal drug utilization, particularly of psychotropic drugs. Using administrative data from the largest sickness fund in Germany, this study was designed to estimate the effect of institutionalization on the drug intake of the frail elderly. Difference-in-differences propensity score matching techniques were used to compare drug prescriptions for the frail elderly who entered a nursing home with those who remained in the outpatient care system; findings suggest that nursing home residents receive more doses of antipsychotics, antidepressants, and analgesics. The potential overprescription correlates with estimated drug costs of about €87 million per year.

  4. Oral antidiabetic therapy in a large Italian sample: drug supply and compliance for different therapeutic regimens

    CERN Document Server

    Vittorino Gaddi, A; Capello, F; Di Pietro, C; Cinconze, E; Rossi, E; De Sando, V; Cevenini, M; D'Alò, G

    2014-01-01

    Objectives: To define the main features of patients treated with oral antidiabetics, evaluating monotherapy (MT), loose-dose combination therapy (LDCT) and fixed-dose combination therapy (FDCT); to describe medication adherence to the different therapies; and to evaluate the differences in compliance with the prescribed therapy regimen among prevalent and incident patient cohorts. Study design: This study was a retrospective cohort analysis based on the ARNO database, a national record that tracks reimbursable prescription claims submitted from selected pharmacies to the Italian national health system. In total, 169,375 subjects, from an overall population of 4,040,624 were included in this study. The patients represented 12 different local health units. Each patient had at least one oral antidiabetic prescription claim (A10B ATC code). Methods: Patients were divided into four groups according to their treatment regimen during the recruitment period (1 January 2008-31 December 2008): MT, FDCT, LDCT and swi...

  5. Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump.

    Science.gov (United States)

    Jin, Su-Eon; You, Siwon; Jeon, Seungho; Byon, Hyo-Jin; Hwang, Sung-Joo

    2017-03-11

    Administration sets are delivery tools for the direct application of drugs into the body and are composed of a spike, a drip chamber, tubes, Luer adapters (connectors), a needle cover for protection, and other accessories. Drug sorption to tubes of administration sets is a critical issue in terms of safety and efficacy. Although drug sorption is an important factor in the quality of an administration set, there are no standard evaluation methods for the regulation of drug sorption to the tubes. Here, we describe an evaluation protocol for drug sorption to tubes of administration sets. Tubes made of polyvinyl chloride (PVC)- and non-PVC-based polymeric materials were cut to 1 m in length. Diazepam and tacrolimus were used as model drugs. In the kinetic sorption study, we selected the drug concentration and flow rate based on the clinical usage of these drugs. After the dilution of each drug in a glass bottle, the diluted drug solution was delivered through tubes of administration sets using a pump. Samples were collected in amber vials at appropriate time points and the drugs were analyzed using high-performance liquid chromatography. Drug concentrations and sorption levels to tubes of the administration sets were calculated. Acceptable criteria to ensure the quality of administration sets are recommended.

  6. Rethinking the Food and Drug Administration's 2013 guidance on developing drugs for early-stage Alzheimer's disease.

    Science.gov (United States)

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  7. Obstetric Neuraxial Drug Administration Errors: A Quantitative and Qualitative Analytical Review.

    Science.gov (United States)

    Patel, Santosh; Loveridge, Robert

    2015-12-01

    Drug administration errors in obstetric neuraxial anesthesia can have devastating consequences. Although fully recognizing that they represent "only the tip of the iceberg," published case reports/series of these errors were reviewed in detail with the aim of estimating the frequency and the nature of these errors. We identified case reports and case series from MEDLINE and performed a quantitative analysis of the involved drugs, error setting, source of error, the observed complications, and any therapeutic interventions. We subsequently performed a qualitative analysis of the human factors involved and proposed modifications to practice. Twenty-nine cases were identified. Various drugs were given in error, but no direct effects on the course of labor, mode of delivery, or neonatal outcome were reported. Four maternal deaths from the accidental intrathecal administration of tranexamic acid were reported, all occurring after delivery of the fetus. A range of hemodynamic and neurologic signs and symptoms were noted, but the most commonly reported complication was the failure of the intended neuraxial anesthetic technique. Several human factors were present; most common factors were drug storage issues and similar drug appearance. Four practice recommendations were identified as being likely to have prevented the errors. The reported errors exposed latent conditions within health care systems. We suggest that the implementation of the following processes may decrease the risk of these types of drug errors: (1) Careful reading of the label on any drug ampule or syringe before the drug is drawn up or injected; (2) labeling all syringes; (3) checking labels with a second person or a device (such as a barcode reader linked to a computer) before the drug is drawn up or administered; and (4) use of non-Luer lock connectors on all epidural/spinal/combined spinal-epidural devices. Further study is required to determine whether routine use of these processes will reduce drug

  8. 75 FR 22819 - Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...

    Science.gov (United States)

    2010-04-30

    ...] Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare... Americans, no approved therapies exist. To optimize the means by which FDA considers articles for people... surveillance of, articles for rare diseases. The scope of such presentations may include non-clinical testing...

  9. Transmission assessment surveys (TAS) to define endpoints for lymphatic filariasis mass drug administration

    DEFF Research Database (Denmark)

    Chu, Brian K.; Deming, Michael; Biritwum, Nana-Kwadwo

    2013-01-01

    Lymphatic filariasis (LF) is targeted for global elimination through treatment of entire at-risk populations with repeated annual mass drug administration (MDA). Essential for program success is defining and confirming the appropriate endpoint for MDA when transmission is presumed to have reached...

  10. Prospects for the control of neglected tropical diseases by mass drug administration

    NARCIS (Netherlands)

    Smits, Henk L.

    2009-01-01

    The prospects for the control of neglected tropical diseases, including soil-transmitted helminthiasis, shistosomiasis, lymphatic filariasis, onchocerciasis and trachoma, through mass drug administration, are exemplified by the elimination of the trachoma as a public-health problem in Morocco. In

  11. 76 FR 12563 - Amendments to General Regulations of the Food and Drug Administration; Confirmation of Effective...

    Science.gov (United States)

    2011-03-08

    ... certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA's... revising the Agency's regulations to require tobacco products to be subject to the same general... General Regulations of the Food and Drug Administration; Confirmation of Effective Date AGENCY: Food and...

  12. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ... Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA...-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION...-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER...

  13. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Science.gov (United States)

    2013-06-07

    ... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...

  14. Modeling the Impact and Costs of Semiannual Mass Drug Administration for Accelerated Elimination of Lymphatic Filariasis

    NARCIS (Netherlands)

    W.A. Stolk (Wilma); Q.A. ten Bosch (Quirine); S.J. de Vlas (Sake); P.U. Fischer (Peter); G.J. Weil (Gary); A.S. Goldman (Ann)

    2013-01-01

    textabstractThe Global Program to Eliminate Lymphatic Filariasis (LF) has a target date of 2020. This program is progressing well in many countries. However, progress has been slow in some countries, and others have not yet started their mass drug administration (MDA) programs. Acceleration is

  15. Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children.

    Science.gov (United States)

    Bijarania, Sunil Kumar; Saini, Sushma Kumari; Verma, Sanjay; Kaur, Sukhwinder

    2017-05-01

    To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP. In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs. The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach's alpha was calculated as 0.94. All the nurses felt that the SOP is useful. Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.

  16. 75 FR 11893 - Food and Drug Administration Transparency Task Force; Request for Comments

    Science.gov (United States)

    2010-03-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247... regulated industry. DATES: Submit electronic or written comments by April 12, 2010. ADDRESSES: Submit... Transparency Initiative into three phases: (1) Creating a Web-based resource called ``FDA Basics,'' that...

  17. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Science.gov (United States)

    2013-09-25

    ...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is... to apply its regulatory authorities to select software applications intended for use on mobile...

  18. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Science.gov (United States)

    2010-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0559... Approval (PMA) Applications.'' It does not create or confer any rights for or on any person and does not... a copy of the draft guidance may do so by using the Internet. To receive ``Heart Valves...

  19. 78 FR 20326 - Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food...

    Science.gov (United States)

    2013-04-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0126] Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration--Human and Animal Food; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  20. Effects of sharing information on drug administration errors in pediatric wards: a pre-post intervention study.

    Science.gov (United States)

    Chua, Siew-Siang; Choo, Sim-Mei; Sulaiman, Che Zuraini; Omar, Asma; Thong, Meow-Keong

    2017-01-01

    Drug administration errors are more likely to reach the patient than other medication errors. The main aim of this study was to determine whether the sharing of information on drug administration errors among health care providers would reduce such problems. This study involved direct, undisguised observations of drug administrations in two pediatric wards of a major teaching hospital in Kuala Lumpur, Malaysia. This study consisted of two phases: Phase 1 (pre-intervention) and Phase 2 (post-intervention). Data were collected by two observers over a 40-day period in both Phase 1 and Phase 2 of the study. Both observers were pharmacy graduates: Observer 1 just completed her undergraduate pharmacy degree, whereas Observer 2 was doing her one-year internship as a provisionally registered pharmacist in the hospital under study. A drug administration error was defined as a discrepancy between the drug regimen received by the patient and that intended by the prescriber and also drug administration procedures that did not follow standard hospital policies and procedures. Results from Phase 1 of the study were analyzed, presented and discussed with the ward staff before commencement of data collection in Phase 2. A total of 1,284 and 1,401 doses of drugs were administered in Phase 1 and Phase 2, respectively. The rate of drug administration errors reduced significantly from Phase 1 to Phase 2 (44.3% versus 28.6%, respectively; P <0.001). Logistic regression analysis showed that the adjusted odds of drug administration errors in Phase 1 of the study were almost three times that in Phase 2 ( P <0.001). The most common types of errors were incorrect administration technique and incorrect drug preparation. Nasogastric and intravenous routes of drug administration contributed significantly to the rate of drug administration errors. This study showed that sharing of the types of errors that had occurred was significantly associated with a reduction in drug administration errors.

  1. Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration.

    Science.gov (United States)

    Oram, Matthew

    2016-09-01

    Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration's regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development. © The Author(s) 2016.

  2. 75 FR 61148 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

    Science.gov (United States)

    2010-10-04

    ...: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA... (Reaffirmed 2003) Reaffirmation (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric...

  3. [Drug administration to pediatric patients: Evaluation of the nurses' preparation habits in pediatric units].

    Science.gov (United States)

    Ménétré, S; Weber, M; Socha, M; Le Tacon, S; May, I; Schweitzer, C; Demoré, B

    2018-01-29

    In hospitals, the nursing staff is often confronted with the problem of the preparation and administration of drugs for their pediatric patients because of the lack of indication, pediatric dosage, and appropriate galenic form. The goal of this study was to give an overview of the nurses' preparation habits in pediatric units and highlight their daily problems. This single-center prospective study was conducted through an observation of the nursing staff during the drug preparation process in medicine, surgery and intensive care units. We included 91 patients (55 boys and 36 girls), with an average age of 6.3 years (youngest child, 10 days old; oldest child, 18 years old). We observed a mean 2.16 drug preparations per patient [1-5]. We collected 197 observation reports regarding 66 injectable drugs and 131 oral drugs (71 liquid forms and 60 solid forms). The majority of these reports concerned central nervous system drugs (63/197), metabolism and digestive system drugs (50/197), and anti-infective drugs (46/197). The study highlights the nurses' difficulties: modification of the solid galenic forms, lack of knowledge on oral liquid form preservation or reconstitution methods, withdrawal of small volumes, and vague and noncompliant labeling. This study led to the creation of a specific working group for pediatrics. This multidisciplinary team meets on a regular basis to work toward improving the current habits to both simplify and secure drug administration to hospitalized children. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  4. Mass drug administration and the sustainable control of schistosomiasis: Community health workers are vital for global elimination efforts

    Directory of Open Access Journals (Sweden)

    Marianette T. Inobaya

    2018-01-01

    Conclusions: This study highlights the importance of community health workers in obtaining the World Health Organization drug coverage rate of 75% and improving compliance with MDA in the community. Investing in the education of community health workers with appropriate disease-specific training is crucial if disease elimination is ultimately to be achieved.

  5. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Science.gov (United States)

    2011-04-25

    ... Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco...://www.regulations.gov ] and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation... Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February...

  6. 76 FR 67197 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

    Science.gov (United States)

    2011-10-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0739] Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements; Availability... for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that...

  7. Approaches to Increasing Ethical Compliance in China with Drug Trial Standards of Practice

    DEFF Research Database (Denmark)

    Rosenberg, Jacob

    2016-01-01

    researchers, and strong reinforcement by Chinese journal editors not to publish studies with these flaws, then research ethics and publication standards will probably improve. Other solutions to foster ethical practice of drug trials are discussed including Chinese initiatives directed at managing conflict......Zeng et al.'s Ethics Review highlights some of the challenges associated with clinical research in China. They found that only a minority of published clinical trials of anti-dementia drugs reported that they fulfilled the basic ethical principles as outlined in the Declaration of Helsinki....... With recent reports of scientific misconduct from China, there is an urgent need to find approaches to compel researchers to adhere to ethical research practices. This problem does not call for a simple solution, but if forces are joined with governmental regulations, education in ethics issues for medical...

  8. [Designing a software for drug management in special situations at a hospital's drug administration service].

    Science.gov (United States)

    Sánchez Cuervo, Marina; Muñoz García, María; Gómez de Salazar López de Silanes, María Esther; Bermejo Vicedo, Teresa

    2015-03-01

    to describe the features of a computer program for management of drugs in special situations (off-label and compassionate use) in a Department of Hospital Pharmacy (PD). To describe the methodology followed for its implementation in the Medical Services. To evaluate their use after 2 years of practice. the design was carried out by pharmacists of the PD. The stages of the process were: selection of a software development company, establishment of a working group, selection of a development platform, design of an interactive Viewer, definition of functionality and data processing, creation of databases, connection, installation and configuration, application testing and improvements development. A directed sequential strategy was used for implementation in the Medical Services. The program's utility and experience of use were evaluated after 2 years. a multidisciplinary working group was formed and developed Pk_Usos®. The program works in web environment with a common viewer for all users enabling real time checking of the request files' status and that adapts to the management of medications in special situations procedure. Pk_Usos® was introduced first in the Oncology Department, with 15 oncologists as users of the program. 343 patients had 384 treatment requests managed, of which 363 are authorized throughout two years. PK_Usos® is the first software designed for the management of drugs in special situations in the PD. It is a dynamic and efficient tool for all professionals involved in the process by optimization of times. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  9. Dramatyping: a generic algorithm for detecting reasonable temporal correlations between drug administration and lab value alterations

    Directory of Open Access Journals (Sweden)

    Axel Newe

    2016-03-01

    Full Text Available According to the World Health Organization, one of the criteria for the standardized assessment of case causality in adverse drug reactions is the temporal relationship between the intake of a drug and the occurrence of a reaction or a laboratory test abnormality. This article presents and describes an algorithm for the detection of a reasonable temporal correlation between the administration of a drug and the alteration of a laboratory value course. The algorithm is designed to process normalized lab values and is therefore universally applicable. It has a sensitivity of 0.932 for the detection of lab value courses that show changes in temporal correlation with the administration of a drug and it has a specificity of 0.967 for the detection of lab value courses that show no changes. Therefore, the algorithm is appropriate to screen the data of electronic health records and to support human experts in revealing adverse drug reactions. A reference implementation in Python programming language is available.

  10. A history of biopharmaceutics in the Food and Drug Administration 1968-1993.

    Science.gov (United States)

    Skelly, Jerome Philip

    2010-03-01

    The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions it was to have, and the implementation of that authority are described. The determination of bioequivalence, the bioavailability decision rules, pharmacokinetics, and drug metabolism are explained. The reason for the development of the Scale-Up and Post Approval Regulations and how they were developed are also explained.

  11. [Diffuse large B-cell lymphoma complicated with drug-induced vasculitis during administration of pegfilgrastim].

    Science.gov (United States)

    Ito, Yuta; Noda, Kentaro; Aiba, Keisuke; Yano, Shingo; Fujii, Tsunehiro

    A 59-year-old female with diffuse large B-cell lymphoma was treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) regimen. In addition, we administered pegfilgrastim for treating chemotherapy-induced febrile neutropenia. She complained of fever and neck and chest pain a few days after pegfilgrastim administration during the third and fourth courses of R-CHOP. Radiological imaging revealed an inflammation of large vessels, which led to the diagnosis of drug-associated vasculitis. We confirmed that vasculitis observed in this case was caused by pegfilgrastim administration because similar symptoms appeared with both injections of pegfilgrastim.

  12. Model-based drug administration : current status of target-controlled infusion and closed-loop control

    NARCIS (Netherlands)

    Kuizenga, Merel H.; Vereecke, Hugo E. M.; Struys, Michel M. R. F.

    Purpose of review Drug administration might be optimized by incorporating pharmacokinetic-dynamic (PK/PD) principles and control engineering theories. This review gives an update of the actual status of target-controlled infusion (TCI) and closed-loop computer-controlled drug administration and the

  13. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...

  14. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise explicitly...

  15. 76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

    Science.gov (United States)

    2011-10-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular...

  16. Economic evaluations of mass drug administration: The importance of economies of scale and scope.

    Science.gov (United States)

    Turner, Hugo C; Toor, Jaspreet; Hollingsworth, T Déirdre; Anderson, Roy M

    2017-11-08

    It is recognised that changing the current approaches for the control of the neglected tropical diseases will be needed to reach the World Health Organization's (WHO) 2020 goals. Consequently, it is important that economic evaluations of the alternative approaches are conducted. A vital component of such evaluations is the issue of how the intervention's costs should be incorporated. We discuss this issue - focusing on mass drug administration. We argue that the common approach of assuming an intervention's cost per treatment is constant, regardless of the number of individuals treated, is a misleading way to consider the delivery costs of mass drug administration due to the occurrence of economies/diseconomies of scale and scope. Greater care and consideration are required when the costs are incorporated into such analyses. Without this, these economic evaluations could potentially lead to incorrect policy recommendations. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  17. Iontophoresis as a non-invasive enhancement technique for the administration of drugs across biological membranes

    OpenAIRE

    Tratta, Elena

    2015-01-01

    Iontophoresis, a technique that consists in applying low density current to a membrane, has been widely investigated in order to enhance the permeation of drugs through different biological barriers such as the skin, the buccal mucosa and the sclera in order to obtain a systemic or local (in case of trans-scleral administration) effect without the need of an injection. The aim of this thesis was to investigate the effect of iontophoresis on these three barriers, considering the different s...

  18. A case for tobacco content regulation by the U.S. Food and Drug Administration

    OpenAIRE

    du Toit, J.A.

    2010-01-01

    Although many people welcome the recent move by the United States to give its Food and Drug Administration (fda) the authority to regulate the content of tobacco, some worry that such regulation constitutes unwarranted interference with the freedom of competent adult tobacco consumers. The concern for protecting the autonomy of individuals is valuable indeed, but given the highly addictive nature of tobacco products (and especially the nicotine in tobacco products), the continued use of tobac...

  19. Administration

    DEFF Research Database (Denmark)

    Bogen handler om den praksis, vi kalder administration. Vi er i den offentlige sektor i Danmark hos kontorfolkene med deres sagsmapper, computere, telefoner,, lovsamlinger,, retningslinier og regneark. I bogen udfoldes en mangfoldighed af konkrete historier om det administrative arbejde fra...... forskellige områder i den offentlige sektor. Hensigten er at forstå den praksis og faglighed der knytter sig til det administrative arbejde...

  20. Profile of drug administration errors in anesthesia among anesthesiologists from Santa Catarina

    Directory of Open Access Journals (Sweden)

    Thomas Rolf Erdmann

    2016-02-01

    Full Text Available INTRODUCTION: Anesthesiology is the only medical specialty that prescribes, dilutes, and administers drugs without conferral by another professional. Adding to the high frequency of drug administration, a propitious scenario to errors is created. OBJECTIVE: Access the prevalence of drug administration errors during anesthesia among anesthesiologists from Santa Catarina, the circumstances in which they occurred, and possible associated factors. MATERIALS AND METHODS: An electronic questionnaire was sent to all anesthesiologists from Sociedade de Anestesiologia do Estado de Santa Catarina, with direct or multiple choice questions on responder demographics and anesthesia practice profile; prevalence of errors, type and consequence of error; and factors that may have contributed to the errors. RESULTS: Of the respondents, 91.8% reported they had committed administration errors, adding the total error of 274 and mean of 4.7 (6.9 errors per respondent. The most common error was replacement (68.4%, followed by dose error (49.1%, and omission (35%. Only 7% of respondents reported neuraxial administration error. Regarding circumstances of errors, they mainly occurred in the morning (32.7%, in anesthesia maintenance (49%, with 47.8% without harm to the patient and 1.75% with the highest morbidity and irreversible damage, and 87.3% of cases with immediate identification. As for possible contributing factors, the most frequent were distraction and fatigue (64.9% and misreading of labels, ampoules, or syringes (54.4%. CONCLUSION: Most respondents committed more than one error in anesthesia administration, mainly justified as a distraction or fatigue, and of low gravity.

  1. [Profile of drug administration errors in anesthesia among anesthesiologists from Santa Catarina].

    Science.gov (United States)

    Erdmann, Thomas Rolf; Garcia, Jorge Hamilton Soares; Loureiro, Marcos Lázaro; Monteiro, Marcelo Petruccelli; Brunharo, Guilherme Muriano

    2016-01-01

    Anesthesiology is the only medical specialty that prescribes, dilutes, and administers drugs without conferral by another professional. Adding to the high frequency of drug administration, a propitious scenario to errors is created. Access the prevalence of drug administration errors during anesthesia among anesthesiologists from Santa Catarina, the circumstances in which they occurred, and possible associated factors. An electronic questionnaire was sent to all anesthesiologists from Sociedade de Anestesiologia do Estado de Santa Catarina, with direct or multiple choice questions on responder demographics and anesthesia practice profile; prevalence of errors, type and consequence of error; and factors that may have contributed to the errors. Of the respondents, 91.8% reported they had committed administration errors, adding the total error of 274 and mean of 4.7 (6.9) errors per respondent. The most common error was replacement (68.4%), followed by dose error (49.1%), and omission (35%). Only 7% of respondents reported neuraxial administration error. Regarding circumstances of errors, they mainly occurred in the morning (32.7%), in anesthesia maintenance (49%), with 47.8% without harm to the patient and 1.75% with the highest morbidity and irreversible damage, and 87.3% of cases with immediate identification. As for possible contributing factors, the most frequent were: distraction and fatigue (64.9%) and misreading of labels, ampoules, or syringes (54.4%). Most respondents committed more than one error in anesthesia administration, mainly justified as a distraction or fatigue, and of low gravity. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  2. Profile of drug administration errors in anesthesia among anesthesiologists from Santa Catarina.

    Science.gov (United States)

    Erdmann, Thomas Rolf; Garcia, Jorge Hamilton Soares; Loureiro, Marcos Lázaro; Monteiro, Marcelo Petruccelli; Brunharo, Guilherme Muriano

    2016-01-01

    Anesthesiology is the only medical specialty that prescribes, dilutes, and administers drugs without conferral by another professional. Adding to the high frequency of drug administration, a propitious scenario to errors is created. Access the prevalence of drug administration errors during anesthesia among anesthesiologists from Santa Catarina, the circumstances in which they occurred, and possible associated factors. An electronic questionnaire was sent to all anesthesiologists from Sociedade de Anestesiologia do Estado de Santa Catarina, with direct or multiple choice questions on responder demographics and anesthesia practice profile; prevalence of errors, type and consequence of error; and factors that may have contributed to the errors. Of the respondents, 91.8% reported they had committed administration errors, adding the total error of 274 and mean of 4.7 (6.9) errors per respondent. The most common error was replacement (68.4%), followed by dose error (49.1%), and omission (35%). Only 7% of respondents reported neuraxial administration error. Regarding circumstances of errors, they mainly occurred in the morning (32.7%), in anesthesia maintenance (49%), with 47.8% without harm to the patient and 1.75% with the highest morbidity and irreversible damage, and 87.3% of cases with immediate identification. As for possible contributing factors, the most frequent were distraction and fatigue (64.9%) and misreading of labels, ampoules, or syringes (54.4%). Most respondents committed more than one error in anesthesia administration, mainly justified as a distraction or fatigue, and of low gravity. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  3. Chiron Vision files FDA application to market intraocular implant for CMV retinitis. Food and Drug Administration.

    Science.gov (United States)

    1995-07-01

    Chiron Corporation and Hoffman-LaRoche announced a filing of a New Drug Application with the Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of CMV retinitis. Clinical trials show that Vitrasert offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye. One study reported that the median time to progression of CMV retinitis was 186 days for eyes receiving Vitrasert compared to 72 days for eyes receiving intravenous ganciclovir therapy. Chiron's intraocular implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug into the eye for up to eight months. Two additional trials are underway. For further information contact the Professional Services Group at Chiron Corporation at (800) 244-7668, select 2.

  4. The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy.

    Science.gov (United States)

    Obias-Manno, Dulce; Scott, Pamela E; Kaczmarczyk, Joseph; Miller, Margaret; Pinnow, Ellen; Lee-Bishop, Lynda; Jones-London, Michelle; Chapman, Kennerly; Kallgren, Deborah; Uhl, Kathleen

    2007-01-01

    In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program for women's health research, promoting the development of sound policy and regulation. In a little over a decade, the program has provided approximately 14 million dollars to fund more than 100 women's health research studies covering a broad range of health topics affecting women across their lifespan. Some studies, such as those elucidating drug effects on QT prolongation in women and drug-dietary supplement interaction, have had significant influence on regulatory decisions. Other studies have provided sound scientific data on sex and gender differences supporting FDA guidelines to protect women's health. This paper describes the science program at the FDA-OWH, providing examples of how funded research impacts regulatory policy.

  5. Mass administration of the antimalarial drug mefloquine to Guantánamo detainees: a critical analysis.

    Science.gov (United States)

    Nevin, Remington L

    2012-10-01

    Recently, evidence has emerged from an unusual form of mass drug administration practised among detainees held at US Naval Station Guantánamo Bay, Cuba ('Guantánamo'), ostensibly as a public health measure. Mefloquine, an antimalarial drug originally developed by the US military, whose use is associated with a range of severe neuropsychiatric adverse effects, was administered at treatment doses to detainees immediately upon their arrival at Guantánamo, prior to laboratory testing for malaria and irrespective of symptoms of disease. In this analysis, the history of mefloquine's development is reviewed and the indications for its administration at treatment doses are discussed. The stated rationale for the use of mefloquine among Guantánamo detainees is then evaluated in the context of accepted forms of population-based malaria control. It is concluded that there was no plausible public health indication for the use of mefloquine at Guantánamo and that based on prevailing standards of care, the clinical indications for its use are decidedly unclear. This analysis suggests the troubling possibility that the use of mefloquine at Guantánamo may have been motivated in part by knowledge of the drug's adverse effects, and points to a critical need for further investigation to resolve unanswered questions regarding the drug's potentially inappropriate use. Published 2012. This article is a US Government work and is in the public domain in the USA.

  6. Combined Transcriptomics and Metabolomics in a Rhesus Macaque Drug Administration Study

    Directory of Open Access Journals (Sweden)

    Kevin J. Lee

    2014-10-01

    Full Text Available We describe a multi-omic approach to understanding the effects that the anti-malarial drug pyrimethamine has on immune physiology in rhesus macaques (Macaca mulatta. Whole blood and bone marrow RNA-Seq and plasma metabolome profiles (each with over 15,000 features have been generated for five naïve individuals at up to seven time-points before, during and after three rounds of drug administration. Linear modelling and Bayesian network analyses are both considered, alongside investigations of the impact of statistical modeling strategies on biological inference. Individual macaques were found to be a major source of variance for both omic data types, and factoring individuals into subsequent modelling increases power to detect temporal effects. A major component of the whole blood transcriptome follows the bone marrow with a time-delay, while other components of variation are unique to each compartment. We demonstrate that pyrimethamine administration does impact both compartments throughout the experiment, but very limited perturbation of transcript or metabolite abundance following each round of drug exposure is observed. New insights into the mode of action of the drug are presented in the context of pyrimethamine’s predicted effect on suppression of cell division and metabolism in the immune system.

  7. Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.

    Science.gov (United States)

    Winiecki, Scott K; Tejero-Taldo, M Isabel; Avant, Debbie; Murphy, Dianne; McMahon, Ann W

    2016-05-01

    To determine aspects of the design of pediatric registries that contribute to the success of registries conducted as a postmarketing study following approval of drugs or biological products by the US Food and Drug Administration. Pediatric registries for drugs and biological products were identified by searching the US Food and Drug Administration Postmarketing Requirements and Commitments database. Based on the recruitment of patients, the meeting of predetermined deadlines, and the submission of data, we classified studies as successful, unsuccessful, or unevaluable. Design aspects of successful and unsuccessful registries were examined for commonalities. Thirty-eight studies were identified, and ten registries met the criteria for successful. Four (40%) successful registries utilized a registry established prior to product approval, and six (60%) were disease-based. Among unsuccessful registries, none were disease-based or utilized a pre-existing registry. Characteristics identified as more common to successful registries included utilizing a disease-based registry and a registry established prior to product approval. Future studies might examine a larger sample of registries to see if these aspects consistently result in successful studies. Published 2015. This article is a U.S. Government work and is in the public domain in the USA. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  8. Effects of sharing information on drug administration errors in pediatric wards: a pre–post intervention study

    Directory of Open Access Journals (Sweden)

    Chua SS

    2017-03-01

    Full Text Available Siew-Siang Chua,1 Sim-Mei Choo,1 Che Zuraini Sulaiman,2 Asma Omar,3 Meow-Keong Thong3 1Department of Pharmacy, Faculty of Medicine, University of Malaya, 2Pharmacy Department, University Malaya Medical Centre, 3Department of Paediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia Background and purpose: Drug administration errors are more likely to reach the patient than other medication errors. The main aim of this study was to determine whether the sharing of information on drug administration errors among health care providers would reduce such problems. Patients and methods: This study involved direct, undisguised observations of drug administrations in two pediatric wards of a major teaching hospital in Kuala Lumpur, Malaysia. This study consisted of two phases: Phase 1 (pre-intervention and Phase 2 (post-intervention. Data were collected by two observers over a 40-day period in both Phase 1 and Phase 2 of the study. Both observers were pharmacy graduates: Observer 1 just completed her undergraduate pharmacy degree, whereas Observer 2 was doing her one-year internship as a provisionally registered pharmacist in the hospital under study. A drug administration error was defined as a discrepancy between the drug regimen received by the patient and that intended by the prescriber and also drug administration procedures that did not follow standard hospital policies and procedures. Results from Phase 1 of the study were analyzed, presented and discussed with the ward staff before commencement of data collection in Phase 2. Results: A total of 1,284 and 1,401 doses of drugs were administered in Phase 1 and Phase 2, respectively. The rate of drug administration errors reduced significantly from Phase 1 to Phase 2 (44.3% versus 28.6%, respectively; P<0.001. Logistic regression analysis showed that the adjusted odds of drug administration errors in Phase 1 of the study were almost three times that in Phase 2 (P<0.001. The most

  9. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  10. Administration

    OpenAIRE

    2009-01-01

    Cet imposant volume constitue un registre des cours magistraux tenus par l’auteur à l’École supérieure allemande des sciences administratives de Spire, enrichis des résultats de travaux scientifiques menés principalement à l'Institut Allemand de Recherche en Administration Publique (Deutsches Forschungsinstitut für öffentliche Verwaltung Speyer, FÖV). Il s’agit donc d’une entreprise au long cours, destinée à apporter un nouvel éclairage (quasi ?) exhaustif sur l’administration publique : son ...

  11. Design of a RESTful web information system for drug prescription and administration.

    Science.gov (United States)

    Bianchi, Lorenzo; Paganelli, Federica; Pettenati, Maria Chiara; Turchi, Stefano; Ciofi, Lucia; Iadanza, Ernesto; Giuli, Dino

    2014-05-01

    Drug prescription and administration processes strongly impact on the occurrence of risks in medical settings for they can be sources of adverse drug events (ADEs). A properly engineered use of information and communication technologies has proven to be a promising approach to reduce these risks. In this study, we propose PHARMA, a web information system which supports healthcare staff in the secure cooperative execution of drug prescription, transcription and registration tasks. PHARMA allows the easy sharing and management of documents containing drug-related information (i.e., drug prescriptions, medical reports, screening), which is often inconsistent and scattered across different information systems and heterogeneous organization domains (e.g., departments, other hospital facilities). PHARMA enables users to access such information in a consistent and secure way, through the adoption of REST and web-oriented design paradigms and protocols. We describe the implementation of the PHARMA prototype, and we discuss the results of the usability evaluation that we carried out with the staff of a hospital in Florence, Italy.

  12. Long-term drug administration in the adult zebrafish using oral gavage for cancer preclinical studies

    Directory of Open Access Journals (Sweden)

    Michelle Dang

    2016-07-01

    Full Text Available Zebrafish are a major model for chemical genetics, and most studies use embryos when investigating small molecules that cause interesting phenotypes or that can rescue disease models. Limited studies have dosed adults with small molecules by means of water-borne exposure or injection techniques. Challenges in the form of drug delivery-related trauma and anesthesia-related toxicity have excluded the adult zebrafish from long-term drug efficacy studies. Here, we introduce a novel anesthetic combination of MS-222 and isoflurane to an oral gavage technique for a non-toxic, non-invasive and long-term drug administration platform. As a proof of principle, we established drug efficacy of the FDA-approved BRAFV600E inhibitor, Vemurafenib, in adult zebrafish harboring BRAFV600E melanoma tumors. In the model, adult casper zebrafish intraperitoneally transplanted with a zebrafish melanoma cell line (ZMEL1 and exposed to daily sub-lethal dosing at 100 mg/kg of Vemurafenib for 2 weeks via oral gavage resulted in an average 65% decrease in tumor burden and a 15% mortality rate. In contrast, Vemurafenib-resistant ZMEL1 cell lines, generated in culture from low-dose drug exposure for 4 months, did not respond to the oral gavage treatment regimen. Similarly, this drug treatment regimen can be applied for treatment of primary melanoma tumors in the zebrafish. Taken together, we developed an effective long-term drug treatment system that will allow the adult zebrafish to be used to identify more effective anti-melanoma combination therapies and opens up possibilities for treating adult models of other diseases.

  13. [Professional practice evaluation of injectable drug preparation and administration in neonatology].

    Science.gov (United States)

    Morin, P; Guillois, B; Gloanec, L; Chatelier, N; Saint-Lorant, G

    2017-09-01

    Adverse drug events are a daily concern in neonatology departments. The aim of this study was to assess the professional practices of preparation and administration of injectable forms of medications in neonatology. A professional practice evaluation with regard to the preparation and administration of various injectable forms of medications in different neonatology units within a given department was conducted by a pharmacy intern based on an assessment grid comprising ten criteria. Following an initial assessment, the results were presented to the care team, which validated the corrective measures put forward by a multiprofessional work group. A second assessment was conducted following the same methodology. Fifty of the department's 76 pediatric nurses were assessed during the first round of the audit and 21 during the second round. Two improvement priorities were identified: taking account of the dead volume of medication in needles and syringe hubs, together with complete identification of syringes used to administer medication. During the second round, these two aspects were improved, progressing from 38% to 100% and from 59% to 89%, respectively. To improve drug administration in neonatology and consequently, to improve patient safety, professional practice evaluation is an essential tool that requires close collaboration between the paramedical team, physicians and pharmacists. Its main value lies in the mobilization of the entire team around the subject in question, hence generating improved understanding and application of corrective measures. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  14. Effects of sharing information on drug administration errors in pediatric wards: a pre–post intervention study

    Science.gov (United States)

    Chua, Siew-Siang; Choo, Sim-Mei; Sulaiman, Che Zuraini; Omar, Asma; Thong, Meow-Keong

    2017-01-01

    Background and purpose Drug administration errors are more likely to reach the patient than other medication errors. The main aim of this study was to determine whether the sharing of information on drug administration errors among health care providers would reduce such problems. Patients and methods This study involved direct, undisguised observations of drug administrations in two pediatric wards of a major teaching hospital in Kuala Lumpur, Malaysia. This study consisted of two phases: Phase 1 (pre-intervention) and Phase 2 (post-intervention). Data were collected by two observers over a 40-day period in both Phase 1 and Phase 2 of the study. Both observers were pharmacy graduates: Observer 1 just completed her undergraduate pharmacy degree, whereas Observer 2 was doing her one-year internship as a provisionally registered pharmacist in the hospital under study. A drug administration error was defined as a discrepancy between the drug regimen received by the patient and that intended by the prescriber and also drug administration procedures that did not follow standard hospital policies and procedures. Results from Phase 1 of the study were analyzed, presented and discussed with the ward staff before commencement of data collection in Phase 2. Results A total of 1,284 and 1,401 doses of drugs were administered in Phase 1 and Phase 2, respectively. The rate of drug administration errors reduced significantly from Phase 1 to Phase 2 (44.3% versus 28.6%, respectively; P<0.001). Logistic regression analysis showed that the adjusted odds of drug administration errors in Phase 1 of the study were almost three times that in Phase 2 (P<0.001). The most common types of errors were incorrect administration technique and incorrect drug preparation. Nasogastric and intravenous routes of drug administration contributed significantly to the rate of drug administration errors. Conclusion This study showed that sharing of the types of errors that had occurred was significantly

  15. Applying Representative Bureaucracy Theory to Academia: Representation of Women in Faculty and Administration and Title IX Compliance in Intercollegiate Athletics

    Science.gov (United States)

    Lee, Young-joo; Won, Doyeon

    2016-01-01

    The representative bureaucracy theory posits that the passive representation of women in an organization leads to their active representation in terms of gender equity in policy implementation. The present study examines how women's representation in administration and faculty positions may explain gender equity-oriented policy outcomes, focusing…

  16. The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

    Science.gov (United States)

    Diehl, David L; Tierney, William M; Adler, Douglas G; Conway, Jason D; Farraye, Francis A; Kantsevoy, Sergey V; Kaul, Vivek; Kethu, Sripathi R; Kwon, Richard S; Mamula, Petar; Pedrosa, Marcos C; Rodriguez, Sarah A

    2010-07-01

    The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  17. Route of administration for illicit prescription opioids: a comparison of rural and urban drug users

    Directory of Open Access Journals (Sweden)

    Havens Jennifer R

    2010-10-01

    Full Text Available Abstract Background Nonmedical prescription opioid use has emerged as a major public health concern in recent years, particularly in rural Appalachia. Little is known about the routes of administration (ROA involved in nonmedical prescription opioid use among rural and urban drug users. The purpose of this study was to describe rural-urban differences in ROA for nonmedical prescription opioid use. Methods A purposive sample of 212 prescription drug users was recruited from a rural Appalachian county (n = 101 and a major metropolitan area (n = 111 in Kentucky. Consenting participants were given an interviewer-administered questionnaire examining sociodemographics, psychiatric disorders, and self-reported nonmedical use and ROA (swallowing, snorting, injecting for the following prescription drugs: buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, OxyContin® and other oxycodone. Results Among urban participants, swallowing was the most common ROA, contrasting sharply with substance-specific variation in ROA among rural participants. Among rural participants, snorting was the most frequent ROA for hydrocodone, methadone, OxyContin®, and oxycodone, while injection was most common for hydromorphone and morphine. In age-, gender-, and race-adjusted analyses, rural participants had significantly higher odds of snorting hydrocodone, OxyContin®, and oxycodone than urban participants. Urban participants had significantly higher odds of swallowing hydrocodone and oxycodone than did rural participants. Notably, among rural participants, 67% of hydromorphone users and 63% of morphine users had injected the drugs. Conclusions Alternative ROA are common among rural drug users. This finding has implications for rural substance abuse treatment and harm reduction, in which interventions should incorporate methods to prevent and reduce route-specific health complications of drug use.

  18. Multiple model predictive control for optimal drug administration of mixed immunotherapy and chemotherapy of tumours.

    Science.gov (United States)

    Sharifi, N; Ozgoli, S; Ramezani, A

    2017-06-01

    Mixed immunotherapy and chemotherapy of tumours is one of the most efficient ways to improve cancer treatment strategies. However, it is important to 'design' an effective treatment programme which can optimize the ways of combining immunotherapy and chemotherapy to diminish their imminent side effects. Control engineering techniques could be used for this. The method of multiple model predictive controller (MMPC) is applied to the modified Stepanova model to induce the best combination of drugs scheduling under a better health criteria profile. The proposed MMPC is a feedback scheme that can perform global optimization for both tumour volume and immune competent cell density by performing multiple constraints. Although current studies usually assume that immunotherapy has no side effect, this paper presents a new method of mixed drug administration by employing MMPC, which implements several constraints for chemotherapy and immunotherapy by considering both drug toxicity and autoimmune. With designed controller we need maximum 57% and 28% of full dosage of drugs for chemotherapy and immunotherapy in some instances, respectively. Therefore, through the proposed controller less dosage of drugs are needed, which contribute to suitable results with a perceptible reduction in medicine side effects. It is observed that in the presence of MMPC, the amount of required drugs is minimized, while the tumour volume is reduced. The efficiency of the presented method has been illustrated through simulations, as the system from an initial condition in the malignant region of the state space (macroscopic tumour volume) transfers into the benign region (microscopic tumour volume) in which the immune system can control tumour growth. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Regulatory aspects of teratology: role of the Food and Drug Administration

    International Nuclear Information System (INIS)

    Kelsey, F.O.

    1982-01-01

    The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products

  20. Improvement in Hemodynamics After Methylene Blue Administration in Drug-Induced Vasodilatory Shock: A Case Report.

    Science.gov (United States)

    Laes, JoAn R; Williams, David M; Cole, Jon B

    2015-12-01

    The purpose of this study is to describe a case where methylene blue improved hemodynamics in a poisoned patient. This is a single case report where a poisoned patient developed vasodilatory shock following ingestion of atenolol, amlodipine, and valsartan. Shock persisted after multiple therapies including vasopressors, high-dose insulin, hemodialysis, and 20% intravenous fat emulsion. Methylene blue (2 mg/kg IV over 30 min) was administered in the ICU with temporal improvement as measured by pulmonary artery catheter hemodynamic data pre- and post-methylene blue administration. Within 1 h of methylene blue administration, systemic vascular resistance improved (240 dyn s/cm5 increased to 1204 dyn s/cm5), and vasopressor requirements decreased with maintenance of mean arterial pressure 60 mmHg. Methylene blue may improve hemodynamics in drug-induced vasodilatory shock and should be considered in critically ill patients poisoned with vasodilatory medications refractory to standard therapies.

  1. Safety of fluralaner, a novel systemic antiparasitic drug, in MDR1(-/-) Collies after oral administration.

    Science.gov (United States)

    Walther, Feli M; Paul, Allan J; Allan, Mark J; Roepke, Rainer K A; Nuernberger, Martin C

    2014-03-06

    Fluralaner is a novel systemic ectoparasiticide for dogs providing long-acting flea- and tick-control after a single oral dose. This study investigated the safety of oral administration of fluralaner at 3 times the highest expected clinical dose to Multi Drug Resistance Protein 1 (MDR1(-/-)) gene defect Collies. Sixteen Collies homozygous for the MDR1 deletion mutation were included in the study. Eight Collies received fluralaner chewable tablets once at a dose of 168 mg/kg; eight sham dosed Collies served as controls. All Collies were clinically observed until 28 days following treatment. No adverse events were observed subsequent to fluralaner treatment of MDR1(-/-) Collies at three times the highest expected clinical dose. Fluralaner chewable tablets are well tolerated in MDR1(-/-) Collies following oral administration.

  2. Methodological Study to Develop Standard Operational Protocol on Intramuscular (IM, Intradermal (ID and Subcutaneous Drug Administration for Children

    Directory of Open Access Journals (Sweden)

    Sunil Kumar Bijarania

    2017-10-01

    Full Text Available Introduction: Medicine administration is a major role played by registered nurses. Medicines are prescribed by the physician and dispensed by the pharmacist but responsibility for meticulous administration rests with the registered nurse. It becomes even more important when drugs are to be administered to children. Drug administration via Intramuscular (IM, Intradermal (ID and Subcutaneous route is a complex process. Errors are associated with medicine administration. Aim: The objective of this study was to develop Standard Operational Protocol (SOP for IM, ID and Subcutaneous drug administration and checklist to assess the implementation of the developed SOP. Materials and Methods: A methodological research design adapted to carry out the present study to develop standard operational protocol for IM, ID and subcutaneous drug administration for children, admitted in Advanced Paediatric Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India. The study included 58 bedside nurses and 90 observations of medicine administration procedure. Results: The Content Validity Index (CVI was prepared to assess the validity of content (items of SOPs and checklists. Over all Cronbach's-alpha values was calculated to assess the internal consistency of Items in SOPs and checklists. CVI of SOP and checklists were 98.51%, 97.83% and 99.03%. Over all Cronbach'salpha values were calculated 0.96, 0.82 and 0.95. All the nurses felt that SOPs are useful. Conclusion: Valid and feasible SOPs for drug administration in children along with valid and reliable checklists were developed. It is recommended to use this document for drug administration in children to prevent any possible error during drug administration to children.

  3. Amendments to general regulations of the Food and Drug Administration. Direct final rule.

    Science.gov (United States)

    2010-11-30

    The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

  4. 76 FR 14030 - Extension of Memorandum of Understanding Between the Food and Drug Administration and Servicio...

    Science.gov (United States)

    2011-03-15

    ...The Food and Drug Administration (FDA) is providing notice of an extension of memorandum of understanding (MOU) between FDA and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States. The purpose of the MOU is to establish, and build confidence in, a system that increases the likelihood that cantaloupes from Mexico offered for import into the United States comply with U.S. law. This MOU also establishes a risk-based classification system for firms in Mexico producing cantaloupes for import into the United States to protect the public health.

  5. Nuclear methods for food analysis at the U.S. Food and Drug Administration

    International Nuclear Information System (INIS)

    Anderson, D.L.; Cunningham, W.C.; Capar, S.G.; Baratta, E.J.; Mackill, P.

    2001-01-01

    An overview radioanalytical techniques used in support of research, monitoring programs, and field assignments directed by the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) is presented. The Winchester Engineering and Analytical Center annually determines radionuclide concentrations in 260 Total Diet Study foods, approximately 80 imported foods, and a selection of domestic foods collected near U.S. nuclear power plants. Radioanalytical techniques used at CFSAN's neutron analysis laboratory at the National Institute of Standards and Technology are discussed along with applications for research, quality control, and special projects. (author)

  6. Chronic modafinil effects on drug-seeking following methamphetamine self-administration in rats

    Science.gov (United States)

    Reichel, Carmela M.; See, Ronald E.

    2011-01-01

    Acute administration of the cognitive enhancing drug, modafinil (Provigil®), reduces methamphetamine (meth) seeking following withdrawal from daily self-administration. However, the more clinically relevant effects of modafinil on meth-seeking after chronic treatment have not been explored. Here, we determined the impact of modafinil on meth-seeking after chronic daily treatment during extinction or abstinence following meth self-administration. Rats self-administered intravenous meth during daily 2-h sessions for 14 days, followed by extinction sessions or abstinence. During this period, rats received daily injections of vehicle, 30, or 100 mg/kg modafinil and were then tested for meth-seeking via cue, meth-primed, and context-induced reinstatement at early and late withdrawal time points. We found that chronic modafinil attenuated relapse to a meth-paired context, decreased conditioned cue-induced and meth-primed reinstatement, and resulted in enduring reductions in meth-seeking even after discontinuation of treatment. Additionally, we determined that only a very high dose of modafinil (300 mg/kg) during maintenance of self-administration had an impact on meth intake. These results validate and extend clinical and preclinical findings that modafinil may be a viable treatment option for meth addiction. PMID:21733228

  7. 77 FR 74582 - Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities...

    Science.gov (United States)

    2012-12-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No FDA-2012-D-1003] Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities... ``What You Need To Know About Registration of Food Facilities--Small Entity Compliance Guide.'' FDA has...

  8. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Science.gov (United States)

    2013-12-04

    ... Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in... of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville...

  9. 76 FR 19373 - The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational...

    Science.gov (United States)

    2011-04-07

    ... in Irvine, California: New Regulatory Challenges AGENCY: Food and Drug Administration, HHS. ACTION..., 2011, from 7:30 a.m. to 5 p.m. Location: The conference will be held at the Irvine Marriott Hotel...

  10. Mass Drug Administration for Scabies Control in a Population with Endemic Disease.

    Science.gov (United States)

    Romani, Lucia; Whitfeld, Margot J; Koroivueta, Josefa; Kama, Mike; Wand, Handan; Tikoduadua, Lisi; Tuicakau, Meciusela; Koroi, Aminiasi; Andrews, Ross; Kaldor, John M; Steer, Andrew C

    2015-12-10

    Scabies is an underrecognized cause of illness in many developing countries. It is associated with impetigo, which can lead to serious systemic complications. We conducted a trial of mass drug administration for scabies control in Fiji. We randomly assigned three island communities to one of three different interventions for scabies control: standard care involving the administration of permethrin to affected persons and their contacts (standard-care group), mass administration of permethrin (permethrin group), or mass administration of ivermectin (ivermectin group). The primary outcome was the change in the prevalence of scabies and of impetigo from baseline to 12 months. A total of 2051 participants were enrolled; 803 were in the standard-care group, 532 in the permethrin group, and 716 in the ivermectin group. From baseline to 12 months, the prevalence of scabies declined significantly in all groups, with the greatest reduction seen in the ivermectin group. The prevalence declined from 36.6% to 18.8% in the standard-care group (relative reduction in prevalence, 49%; 95% confidence interval [CI], 37 to 60), from 41.7% to 15.8% in the permethrin group (relative reduction, 62%; 95% CI, 49 to 75), and from 32.1% to 1.9% in the ivermectin group (relative reduction, 94%; 95% CI, 83 to 100). The prevalence of impetigo also declined in all groups, with the greatest reduction seen in the ivermectin group. The prevalence declined from 21.4% to 14.6% in the standard-care group (relative reduction, 32%; 95% CI, 14 to 50), from 24.6% to 11.4% in the permethrin group (relative reduction, 54%; 95% CI, 35 to 73), and from 24.6% to 8.0% in the ivermectin group (relative reduction, 67%; 95% CI, 52 to 83). Adverse events were mild and were reported more frequently in the ivermectin group than in the permethrin group (15.6% vs. 6.8%). Mass drug administration, particularly the administration of ivermectin, was efficacious for the control of scabies and impetigo. (Funded by the

  11. A novel method to calculate the extent and amount of drug transported into CSF after intranasal administration.

    Science.gov (United States)

    Shi, Zhenqi; Zhang, Qizhi; Jiang, Xinguo

    2005-01-31

    The aim of this paper is to establish a novel method to calculate the extent and amount of drug transported to brain after administration. The cerebrospinal fluid (CSF) was chosen as the target region. The intranasal administration of meptazinol hydrochloride (MEP) was chosen as the model administration and intravenous administration was selected as reference. According to formula transform, the extent was measured by the equation of X(A)CSF, infinity/X0 = Cl(CSF) AUC(0-->infinity)CSF/X0 and the drug amount was calculated by multiplying the dose with the extent. The drug clearance in CSF (Cl(CSF)) was calculated by a method, in which a certain volume of MEP solution was injected directly into rat cistern magna and then clearance was assessed as the reciprocal of the zeroth moment of a CSF level-time curve normalized for dose. In order to testify the accurateness of the method, 14C-sucrose was chosen as reference because of its impermeable characteristic across blood-brain barrier (BBB). It was found out that the MEP concentrations in plasma and CSF after intranasal administration did not show significant difference with those after intravenous administration. However, the extent and amount of MEP transported to CSF was significantly lower compared with those to plasma after these two administrations. In conclusion, the method can be applied to measure the extent and amount of drug transported to CSF, which would be useful to evaluate brain-targeting drug delivery.

  12. 77 FR 67820 - Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System

    Science.gov (United States)

    2012-11-14

    ... HUMAN SERVICES Food and Drug Administration Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System AGENCY: Food and Drug Administration, HHS. ACTION: Notice of a new system of records. SUMMARY: In accordance with the requirements of the Privacy Act of 1974 and the...

  13. Peer influences on drug self-administration: an econometric analysis in socially housed rats.

    Science.gov (United States)

    Peitz, Geoffrey W; Strickland, Justin C; Pitts, Elizabeth G; Foley, Mark; Tonidandel, Scott; Smith, Mark A

    2013-04-01

    Social-learning theories of substance use propose that members of peer groups influence the drug use of other members by selectively modeling, reinforcing, and punishing either abstinence-related or drug-related behaviors. The objective of the present study was to examine the social influences on cocaine self-administration in isolated and socially housed rats, under conditions where the socially housed rats were tested simultaneously with their partner in the same chamber. To this end, male rats were obtained at weaning and housed in isolated or pair-housed conditions for 6 weeks. Rats were then implanted with intravenous catheters and cocaine self-administration was examined in custom-built operant conditioning chambers that allowed two rats to be tested simultaneously. For some socially housed subjects, both rats had simultaneous access to cocaine; for others, only one rat of the pair had access to cocaine. An econometric analysis was applied to the data, and the reinforcing strength of cocaine was measured by examining consumption (i.e. quantity demanded) and elasticity of demand as a function of price, which was manipulated by varying the dose and ratio requirements on a fixed ratio schedule of reinforcement. Cocaine consumption decreased as a function of price in all groups. Elasticity of demand did not vary across groups, but consumption was significantly lower in socially housed rats paired with a rat without access to cocaine. These data suggest that the presence of an abstaining peer decreases the reinforcing strength of cocaine, thus supporting the development of social interventions in drug abuse prevention and treatment programs.

  14. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

  15. 76 FR 41267 - Memorandum of Understanding Between the Food and Drug Administration and MEDSCAPE, LLC and WEBMD LLC

    Science.gov (United States)

    2011-07-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug... educate and communicate with health care professionals. It will also promote the timely dissemination to...

  16. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Science.gov (United States)

    2013-05-14

    ... does not address real-time active safety surveillance studies, as this field is still rapidly evolving... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057..., MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding human drug products: Judy Staffa, Center for...

  17. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Science.gov (United States)

    2011-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Availability AGENCY: Food and Drug... technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket...

  18. Costs of Integrated Mass Drug Administration for Neglected Tropical Diseases in Haiti

    Science.gov (United States)

    Goldman, Ann S.; Brady, Molly A.; Direny, Abdel; Desir, Luccene; Oscard, Roland; Vely, Jean-Francois; Linehan, Mary; Baker, Margaret

    2011-01-01

    We conducted a cost analysis of Haiti's Ministry of Public Health and Population neglected tropical disease program, Projet des Maladies Tropicales Negligées and collected data for 9 of 55 communes participating in the May 2008–April 2009 mass drug administration (MDA). The Projet des Maladies Tropicales Negligées Program partnered with IMA World Health and Hôpital Ste. Croix to implement MDA for treatment of lymphatic filariasis and soil-transmitted helminthiasis by using once a year treatment with albendazole and diethylcarbamazine in a population of approximately 8 million persons. Methods included analyzing partner financial records and conducting retrospective surveys of personnel. In the nine communes, 633,261 persons were treated at a cost of U.S. $0.64 per person, which included the cost of donated drugs, and at a cost of U.S. $0.42 per person treated, when excluding donated drug costs. The MDA for lymphatic filariasis in Haiti began in 2000, with the treatment of 105,750 persons at a cost per person of U.S. $2.23. The decrease in cost per person treated is the result of cumulative implementation experience and economies of scale. PMID:22049035

  19. Pictorial prescribing reduces fentanyl drug administration errors: a simulated controlled study.

    Science.gov (United States)

    Booth, Stephen W; Gloag, Maria; Kinna, Sara; Bell, Andrew; Wheble, Joanna L C; Wheeler, Daniel W

    2017-06-01

    Transmucosal fentanyl is used to treat transient exacerbations of cancer pain. Several immediate release products are available, presented as intranasal sprays, sublingual and buccal tablets, or lozenges. These are not interchangeable, creating potential for medication errors. We compared the incidence of medication errors in a simulated scenario using handwritten drug charts and charts labelled with preprinted self-adhesive stickers with full pictorial fentanyl prescriptions. 54 nurses were shown 5 handwritten drug charts and 5 with self-adhesive pictorial labels. Nurses indicated which preparation and dose they would administer from boxes of Instanyl, Abstral, Effentora and Actiq (Nycomed, ProStrakan, Cephalon and Teva, respectively). We measured the frequency of drug administration errors and asked them to rate the prescriptions for clarity on four-point Likert items. The use of pictorial self-adhesive prescriptions significantly reduced errors in choice of preparation, from 20 with traditional handwritten charts to 6 with self-adhesive labels (OR 3.52, 95% CI 1.39 to 8.90, p=0.006), but the incidence of dose error was not significantly different (OR 1.47, 95% CI 0.80 to 2.70, p=0.281). Analysis of Likert items showed using pictorial printed labels significantly improved nurses' understanding of choice of preparation, dose and maximum four hourly dose (p<0.0001, p=0.006 and p=0.028, respectively). The use of pictorial prescribing appears to be a promising strategy that could reduce medication errors in choice of fentanyl preparations. There may be a wider use for pictorial prescribing where non-interchangeable preparations of the same drug exist. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  20. Adverse event management in mass drug administration for neglected tropical diseases.

    Science.gov (United States)

    Caplan, Arthur; Zink, Amanda

    2014-03-01

    The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of

  1. Vegetable Oil-Loaded Nanocapsules: Innovative Alternative for Incorporating Drugs for Parenteral Administration.

    Science.gov (United States)

    Venturinil, C G; Bruinsmann, A; Oliveira, C P; Contri, R V; Pohlmann, A R; Guterres, S S

    2016-02-01

    An innovative nanocapsule formulation for parenteral administration using selected vegetable oils (mango, jojoba, pequi, oat, annatto, calendula, and chamomile) was developed that has the potential to encapsulate various drugs. The vegetable oil-loaded nanocapsules were prepared by interfacial deposition and compared with capric/caprylic triglyceride-loaded lipid core nanocapsules. The major objective was to investigate the effect of vegetable oils on particle size distribution and physical stability and to determine the hemolytic potential of the nanocapsules, considering their applicability for intravenous administration. Taking into account the importance of accurately determining particle size for the selected route of administration, different size characterization techniques were employed, such as Laser Diffraction, Dynamic Light Scattering, Multiple Light Scattering, Nanoparticle Tracking Analysis, and Transmission Electronic Microscopy. Laser diffraction studies indicated that the mean particle size of all nanocapsules was below 300 nm. For smaller particles, the laser diffraction and multiple light scattering data were in agreement (D[3,2]-130 nm). Dynamic light scattering and nanoparticle tracking analysis, two powerful techniques that complement each other, exhibited size values between 180 and 259 nm for all nanoparticles. Stability studies demonstrated a tendency of particle creaming for jojoba-nanocapsules and sedimentation for the other nanoparticles; however, no size variation occurred over 30 days. The hemolysis test proved the hemocompatibility of all nanosystems, irrespective of the type of oil. Although all developed nanocapsules presented the potential for parenteral administration, jojoba oil-loaded nanocapsules were selected as the most promising nanoformulation due to their low average size and high particle size homogeneity.

  2. Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers.

    Science.gov (United States)

    Park, Sang-In; Oh, Jaeseong; Jang, Kyungho; Yoon, Jangsoo; Moon, Seol Ju; Park, Jong Sun; Lee, Jae Ho; Song, Junghan; Jang, In-Jin; Yu, Kyung-Sang; Chung, Jae-Yong

    2015-08-01

    Therapeutic drug monitoring (TDM) of second-line antituberculosis drugs would allow for optimal individualized dosage adjustments and improve drug safety and therapeutic outcomes. To evaluate the pharmacokinetic (PK) characteristics of clinically relevant, multidrug treatment regimens and to improve the feasibility of TDM, we conducted an open-label, multiple-dosing study with 16 healthy subjects who were divided into two groups. Cycloserine (250 mg), p-aminosalicylic acid (PAS) (5.28 g), and prothionamide (250 mg) twice daily and pyrazinamide (1,500 mg) once daily were administered to both groups. Additionally, levofloxacin (750 mg) and streptomycin (1 g) once daily were administered to group 1 and moxifloxacin (400 mg) and kanamycin (1 g) once daily were administered to group 2. Blood samples for PK analysis were collected up to 24 h following the 5 days of drug administration. The PK parameters, including the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve during a dosing interval at steady state (AUCτ), were evaluated. The correlations between the PK parameters and the concentrations at each time point were analyzed. The mean Cmax and AUCτ, respectively, for each drug were as follows: cycloserine, 24.9 mg/liter and 242.3 mg · h/liter; PAS, 65.9 mg/liter and 326.5 mg · h/liter; prothionamide, 5.3 mg/liter and 22.1 mg · h/liter; levofloxacin, 6.6 mg/liter and 64.4 mg · h/liter; moxifloxacin, 4.7 mg/liter and 54.2 mg · h/liter; streptomycin, 42.0 mg/liter and 196.7 mg · h/liter; kanamycin, 34.5 mg/liter and 153.5 mg · h/liter. The results indicated that sampling at 1, 2.5, and 6 h postdosing is needed for TDM when all seven drugs are administered concomitantly. This study indicates that PK characteristics must be considered when prescribing optimal treatments for patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT02128308.). Copyright © 2015, American Society for

  3. Pharmacokinetic, pharmacodynamic and biodistribution following oral administration of nanocarriers containing peptide and protein drugs.

    Science.gov (United States)

    Griffin, Brendan T; Guo, Jianfeng; Presas, Elena; Donovan, Maria D; Alonso, María J; O'Driscoll, Caitriona M

    2016-11-15

    The influence of nanoparticle (NP) formulations on the pharmacokinetic, pharmacodynamic and biodistribution profiles of peptide- and protein-like drugs following oral administration is critically reviewed. The possible mechanisms of absorption enhancement and the effects of the physicochemical properties of the NP are examined. The potential advantages and challenges of physiologically-based pharmacokinetic (PBPK) modelling to help predict efficacy in man are discussed. The importance of developing and expanding the regulatory framework to help translate the technology into the clinic and accelerate the availability of oral nanoparticulate formulations is emphasized. In conclusion, opportunities for future work to improve the state of the art of oral nanomedicines are identified. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Mass drug administration for trachoma: how long is not long enough?

    Directory of Open Access Journals (Sweden)

    Violeta Jimenez

    2015-03-01

    Full Text Available Blinding trachoma is targeted for elimination by 2020 using the SAFE strategy (Surgery, Antibiotics, Facial cleanliness, and Environmental improvements. Annual mass drug administration (MDA with azithromycin is a cornerstone of this strategy. If baseline prevalence of clinical signs of trachomatous inflammation - follicular among 1-9 year-olds (TF1-9 is ≥ 10% but 30%, 7 or more annual MDAs may be required to achieve the target. There are five years left before the 2020 deadline to eliminate blinding trachoma. Low endemic settings are poised to succeed in their elimination goals. However, newly-identified high prevalence districts warrant immediate inclusion in the global program. Intensified application of the SAFE strategy is needed in order to guarantee blinding trachoma elimination by 2020.

  5. Urban lymphatic filariasis in the city of Tanga, Tanzania, after seven rounds of mass drug administration

    DEFF Research Database (Denmark)

    Mwakitalu, Mbutolwe E.; Malecela, Mwele N.; Pedersen, Erling Møller

    2013-01-01

    Urban lymphatic filariasis (LF) has been listed among the challenges to the ongoing global efforts to eliminate LF. This is partly because the control strategies developed for rural areas - where most LF occurs - do not easily comply with human organization and behaviour in urban areas, and partly...... because the urban vectors thrive and proliferate in poorly planned urban settlements. This study investigated LF infection, disease and transmission in the medium-sized city of Tanga (approx. 300,000 inhabitants), Tanzania, after seven rounds of mass drug administration (MDA). Three representative sites...... of mosquito proofing measures including bed nets, environmental sanitation to prevent vector breeding) in order to reach successful LF control in the city. The high LF disease burden noted, despite the reduction in infection and transmission, moreover emphasizes the importance of allocating resources...

  6. A case for tobacco content regulation by the U.S. Food and Drug Administration.

    Science.gov (United States)

    du Toit, J A

    2010-08-01

    Although many people welcome the recent move by the United States to give its Food and Drug Administration (FDA) the authority to regulate the content of tobacco, some worry that such regulation constitutes unwarranted interference with the freedom of competent adult tobacco consumers. The concern for protecting the autonomy of individuals is valuable indeed, but given the highly addictive nature of tobacco products (and especially the nicotine in tobacco products), the continued use of tobacco by smokers cannot -without straining credulity-be said to be autonomous. This fact, combined with a proper construal of the FDA's role and an appreciation of the substantial morbidity and mortality associated with tobacco use, makes a strong case for content regulation.

  7. Breaking ground for psychological science: The U.S. Food and Drug Administration.

    Science.gov (United States)

    Fischhoff, Baruch

    2017-01-01

    The U.S. Food and Drug Administration (FDA) regulates products accounting for 20% of U.S. consumer spending. Many of its actions depend on assumptions about behavior. Will people heed food recall notices? Will they follow medication schedules? Will they have realistic expectations regarding the benefits and risks of new products? Over time, FDA has increasingly made psychology integral to its processes for answering such questions. That progress has come when windows of opportunity have found psychologists with science relevant to FDA's needs, FDA with staff who can translate that research into agency terms, and a regulatory arena that can accommodate behavioral evidence. These experiences suggest opportunities and obstacles for psychologists hoping to apply their science to the public good. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  8. Testosterone therapy in the new era of Food and Drug Administration oversight.

    Science.gov (United States)

    Desroches, Bethany; Kohn, Taylor P; Welliver, Charles; Pastuszak, Alexander W

    2016-04-01

    The Food and Drug Administration (FDA) introduced changes in labeling and indications for use to testosterone products in 2015 due to a possible increased risk of cardiovascular (CV) events. This decision was made based on six clinical studies-some that supported an increased CV risk, and some that did not. Since this decision, additional studies have been published examining the interplay between hypogonadism, CV risk, and testosterone, demonstrating that the risk may be lower than originally estimated. Clinicians are placed in a difficult position, as studies support an increased mortality risk in hypogonadal men, but also an increased risk of CV events in men on testosterone therapy. As a result, many clinicians will be more selective in their prescribing of testosterone. In this review, we examine how these new guidelines arose and how they may affect prescribing habits.

  9. Kombucha brewing under the Food and Drug Administration model Food Code: risk analysis and processing guidance.

    Science.gov (United States)

    Nummer, Brian A

    2013-11-01

    Kombucha is a fermented beverage made from brewed tea and sugar. The taste is slightly sweet and acidic and it may have residual carbon dioxide. Kombucha is consumed in many countries as a health beverage and it is gaining in popularity in the U.S. Consequently, many retailers and food service operators are seeking to brew this beverage on site. As a fermented beverage, kombucha would be categorized in the Food and Drug Administration model Food Code as a specialized process and would require a variance with submission of a food safety plan. This special report was created to assist both operators and regulators in preparing or reviewing a kombucha food safety plan.

  10. Food and drug administration. Radiation protection standards and recommendations for electronic products: the development process

    International Nuclear Information System (INIS)

    Little, M.S.

    1980-01-01

    The Food and Drug Administration is responsible for maintaining a national program to protect the public health from unnecessary and harmful radiation emitted by radiation products. This program involves the promulgation and implementation of mandatory and voluntary standards to promote safe and effective design and use of such products. This paper describes the process by which electronic product radiation safety standards and recommendations are developed. To assist the agency in the development effort and to achieve a sound technological and scientific basis and risk/benefit assessment, it is important that knowledgeable professionals, industrial representatives, and consumers participate in that process. This paper is designed to provide useful information to aid anyone wishing to participate more effectively. (author)

  11. Inspector Perceptions of the Food and Drug Administration's Newest Recommended Food Facility Inspection Format: Training Matters.

    Science.gov (United States)

    Ma, Jing; Kim, Jooho; Almanza, Barbara

    2017-06-01

    The Food and Drug Administration publishes the Food Code to guide restaurant inspections. The most recent version proposes a three-tier system categorizing violations as priority, priority foundation, and core. This study used a scenario-based questionnaire to examine inspector perceptions and preferences for inspection formats. Results suggest that inspectors would be able to maintain consistent evaluations when changing to the three-tier system, although the classifying terms under the three-tier system were confusing. Additionally, inspectors were not very positive about the new system; they were concerned that the new system would not be easy to understand and use, inspections would take a longer time, it would not accurately reflect the amount of risk associated with violations, and it would not be easy for consumers and managers to understand and use. The results suggest the need for additional training for inspectors before adoption, especially on the rationale and benefits of changing to a three-tier system.

  12. Short time administration of antirheumatic drugs - Methotrexate as a strong inhibitor of osteoblast's proliferation in vitro

    Directory of Open Access Journals (Sweden)

    Annussek Tobias

    2012-09-01

    Full Text Available Abstract Introduction Due to increasing use of disease modifying antirheumatic drugs (DMARDs as first line therapy in rheumatic diseases, dental and maxillofacial practitioner should be aware of drug related adverse events. Especially effects on bone-metabolism and its cells are discussed controversially. Therefore we investigate the in vitro effect of short time administration of low dose methotrexate (MTX on osteoblasts as essential part of bone remodelling cells. Methods Primary bovine osteoblasts (OBs were incubated with various concentrations of MTX, related to tissue concentrations, over a period of fourteen days by using a previously established standard protocol. The effect on cell proliferation as well as mitochondrial activity was assessed by using 3-(4, 5-dimethylthiazol-2-yl 2, 5-diphenyltetrazolium bromide (MTT assay, imaging and counting of living cells. Additionally, immunostaining of extracellular matrix proteins was used to survey osteogenic differentiation. Results All methods indicate a strong inhibition of osteoblast`s proliferation by short time administration of low dose MTX within therapeutically relevant concentrations of 1 to 1000nM, without affecting cell differentiation of middle-stage differentiated OBs in general. More over a significant decrease of cell numbers and mitochondrial activity was found at these MTX concentrations. The most sensitive method seems to be the MTT-assay. MTX-concentration of 0,01nM and concentrations below had no inhibitory effects anymore. Conclusion Even low dose methotrexate acts as a potent inhibitor of osteoblast’s proliferation and mitochondrial metabolism in vitro, without affecting main differentiation of pre-differentiated osteoblasts. These results suggest possible negative effects of DMARDs concerning bone healing and for example osseointegration of dental implants. Especially the specifics of the jaw bone with its high vascularisation and physiological high tissue metabolism

  13. Role of health education and self-action plan in improving the drug compliance in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Gajanan S Gaude

    2014-01-01

    Full Text Available Background: Considering the prevalence and associated burden of disease due to bronchial asthma, it is mandatory to obtain an optimal control of the disease and to improve outcomes for these patients. But it has been observed that there is very poor adherence to the inhalational therapy which leads to the suboptimal control of the disease. Objectives of the Study: To study the adherence for aerosol therapy in bronchial asthma patients and to assess the impact of health education and self-action plan in improving the compliance to the therapy. Methodology: A prospective study was done in a total of 500 bronchial asthma patients over a period of 2 years. Once included in the study, the patients were followed-up for a total of 12 weeks for calculation of nonadherence to the aerosol therapy. In nonadherent patients, we employed various health education strategies to improve the compliance in these cases. Results: A total of 500 patients of bronchial asthma who were started on aerosol therapy over duration of 2 years were included in the study. At the end of 12 weeks, it was observed that, only 193 patients (38.6% had regular compliance and 307 patients (61.4% were noncompliant to aerosol therapy as prescribed for bronchial asthma. Factors that were associated with poor compliance were: Lower educational level status, poor socioeconomic status, cumbersome regimens, dislike of medication, and distant pharmacies. Nondrug factors that reduced the compliance were: Fears about side effects, anger about condition or its treatment, forgetfulness or complacency, and patient′s ill attitudes toward health. After employing the various strategies for improving the compliance in these patients, the compliance increased in 176 patients (57.3% among the earlier defaulted patients, while the remaining 131 patients (42.7% were found to be noncompliant even after various educational techniques. Conclusion: Noncompliance in asthma management is a fact of life and no

  14. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

    Science.gov (United States)

    Sinha, Michael S; Freifeld, Clark C; Brownstein, John S; Donneyong, Macarius M; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Dal Pan, Gerald J; Pawar, Ajinkya M; Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S

    2018-01-05

    The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, and the public when safety issues emerge related to FDA-approved drug products. These safety messages are disseminated through social media to ensure broad uptake. The objective of this study was to assess the social media dissemination of 2 DSCs released in 2013 for the sleep aid zolpidem. We used the MedWatcher Social program and the DataSift historic query tool to aggregate Twitter and Facebook posts from October 1, 2012 through August 31, 2013, a period beginning approximately 3 months before the first DSC and ending 3 months after the second. Posts were categorized as (1) junk, (2) mention, and (3) adverse event (AE) based on a score between -0.2 (completely unrelated) to 1 (perfectly related). We also looked at Google Trends data and Wikipedia edits for the same time period. Google Trends search volume is scaled on a range of 0 to 100 and includes "Related queries" during the relevant time periods. An interrupted time series (ITS) analysis assessed the impact of DSCs on the counts of posts with specific mention of zolpidem-containing products. Chow tests for known structural breaks were conducted on data from Twitter, Facebook, and Google Trends. Finally, Wikipedia edits were pulled from the website's editorial history, which lists all revisions to a given page and the editor's identity. In total, 174,286 Twitter posts and 59,641 Facebook posts met entry criteria. Of those, 16.63% (28,989/174,286) of Twitter posts and 25.91% (15,453/59,641) of Facebook posts were labeled as junk and excluded. AEs and mentions represented 9.21% (16,051/174,286) and 74.16% (129,246/174,286) of Twitter posts and 5.11% (3,050/59,641) and 68.98% (41,138/59,641) of Facebook posts, respectively. Total daily counts of posts about zolpidem-containing products increased on Twitter and Facebook on the day of the first DSC; Google searches increased on the week of the

  15. 77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

    Science.gov (United States)

    2012-05-07

    .... Topics for discussion include the following: (1) The Business Case For Change; (2) Quality Risk Management--When, What, and How; (3) Sustaining Compliance Consistency Throughout Your Company and Supplier...

  16. Perceptions of the Food and Drug Administration as a Tobacco Regulator.

    Science.gov (United States)

    Jarman, Kristen L; Ranney, Leah M; Baker, Hannah M; Vallejos, Quirina M; Goldstein, Adam O

    2017-04-01

    The U. S. Food and Drug Administration (FDA) now has regulatory authority over all tobacco products. Little is known about public awareness and perceptions of FDA in their new role as a tobacco regulator. This research utilizes focus groups to examine perceptions of FDA as a tobacco regulator so that FDA can better communicate with the public about this role. We conducted 6 focus groups in 2014 among a diverse sample of smokers and non-smokers. Participants were asked if they had heard of FDA, what they knew about FDA, if they associated FDA with tobacco, and their thoughts about this FDA role. A total of 41 individuals participated. Although nearly all participants had heard of FDA, most were not aware of FDA's regulatory authority over tobacco products, did not associate the role of FDA with tobacco, and some drew comparisons between FDA's work in tobacco and their work regulating food and drugs. Data suggest that although public awareness of FDA regulatory authority over tobacco is low, with proper public education, the public may find FDA to be a trustworthy source of tobacco regulation.

  17. Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories

    International Nuclear Information System (INIS)

    McDonald, M.J.; Bourcier, S.C.; Talley, D.G.

    1997-01-01

    Prior to 1989 99 Mo was produced in the US by a single supplier, Cintichem Inc., Tuxedo, NY. Because of problems associated with operating its facility, in 1989 Cintichem elected to decommission the facility rather than incur the costs for repair. The demise of the 99 Mo capability at Cintichem left the US totally reliant upon a single foreign source, Nordion International, located in Ottawa Canada. In 1992 the DOE purchased the Cintichem 99 Mo Production Process and Drug Master File (DMF). In 1994 the DOE funded Sandia National Laboratories (SNL) to produce 99 Mo. Although Cintichem produced 99 Mo and 99m Tc generators for many years, there was no requirement for process validation which is now required by the Food and Drug Administration (FDA). In addition to the validation requirement, the requirements for current Good manufacturing Practices were codified into law. The purpose of this paper is to describe the process validation being conducted at SNL for the qualification of SNL as a supplier of 99 Mo to US pharmaceutical companies

  18. The impact of repeated rounds of mass drug administration with diethylcarbamazine plus albendazole on bancroftian filariasis in Papua New Guinea.

    Directory of Open Access Journals (Sweden)

    Gary J Weil

    Full Text Available This study employed various monitoring methods to assess the impact of repeated rounds of mass drug administration (MDA on bancroftian filariasis in Papua New Guinea, which has the largest filariasis problem in the Pacific region.Residents of rural villages near Madang were studied prior to and one year after each of three rounds of MDA with diethylcarbamazine plus albendazole administered per World Health Organization (WHO guidelines. The mean MDA compliance rate was 72.9%. Three rounds of MDA decreased microfilaremia rates (Mf, 1 ml night blood by filter from 18.6% pre-MDA to 1.3% after the third MDA (a 94% decrease. Mf clearance rates in infected persons were 71%, 90.7%, and 98.1% after 1, 2, and 3 rounds of MDA. Rates of filarial antigenemia assessed by card test (a marker for adult worm infection decreased from 47.5% to 17.1% (a 64% decrease after 3 rounds of MDA. The filarial antibody rate (IgG(4 antibodies to Bm14, an indicator of filarial infection status and/or exposure to mosquito-borne infective larvae decreased from 59.3% to 25.1% (a 54.6% decrease. Mf, antigen, and antibody rates decreased more rapidly in children <11 years of age (by 100%, 84.2%, and 76.8%, respectively relative to older individuals, perhaps reflecting their lighter infections and shorter durations of exposure/infection prior to MDA. Incidence rates for microfilaremia, filarial antigenemia, and antifilarial antibodies also decreased significantly after MDA. Filarial DNA rates in Anopheles punctulatus mosquitoes that had recently taken a blood meal decreased from 15.1% to 1.0% (a 92.3% decrease.MDA had dramatic effects on all filariasis parameters in the study area and also reduced incidence rates. Follow-up studies will be needed to determine whether residual infection rates in residents of these villages are sufficient to support sustained transmission by the An. punctulatus vector. Lymphatic filariasis elimination should be feasible in Papua New Guinea if MDA can

  19. Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes

    Directory of Open Access Journals (Sweden)

    Jessica L Norman

    2017-05-01

    Full Text Available Background: Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release or 6.25 mg (controlled release per night in women. Objectives: The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Methods: Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change. Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release or 6.25 mg (controlled release daily or less. Documentation of potentially related serious adverse events within the patients’ records was also evaluated. Results: A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020. In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%–50%, p = 0.23, elderly men (34%–40%, p = 0.53, and elderly women (60%–74%, p = 0.14, but the change was only significant in young women (42%–70%, p = 0.0045. Conclusion: After Food and Drug Administration–mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health

  20. Symptom experience associated with immunosuppressive drugs after liver transplantation in adults : possible relationship with medication non-compliance?

    NARCIS (Netherlands)

    Drent, Gerda; Moons, P.; De Geest, S.; Kleibeuker, J. H.; Haagsma, E. B.

    2008-01-01

    Symptom experience (occurrence and perceived distress) associated with side effects of immunosuppressive medications in organ transplant patients may well be associated with poorer quality of life and medication non-compliance. The aims of this study were: first, to assess symptom experience in

  1. Wireless Technologies, Ubiquitous Computing and Mobile Health: Application to Drug Abuse Treatment and Compliance with HIV Therapies.

    Science.gov (United States)

    Boyer, Edward W; Smelson, David; Fletcher, Richard; Ziedonis, Douglas; Picard, Rosalind W

    2010-06-01

    Beneficial advances in the treatment of substance abuse and compliance with medical therapies, including HAART, are possible with new mobile technologies related to personal physiological sensing and computational methods. When incorporated into mobile platforms that allow for ubiquitous computing, these technologies have great potential for extending the reach of behavioral interventions from clinical settings where they are learned into natural environments.

  2. A Controlled Trial of Mass Drug Administration to Interrupt Transmission of Multi Drug Resistant Falciparum Malaria in Cambodian Villages.

    Science.gov (United States)

    Tripura, Rupam; Peto, Thomas J; Nguon, Chea; Davoeung, Chan; Mukaka, Mavuto; Sirithiranont, Pasathorn; Dhorda, Mehul; Promnarate, Cholrawee; Imwong, Mallika; von Seidlein, Lorenz; Duanguppama, Jureeporn; Patumrat, Krittaya; Rekol, Huy; Grobusch, Martin P; Day, Nicholas P J; White, Nicholas J; Dondorp, Arjen M

    2018-03-07

    The increase in multidrug resistant Plasmodium falciparum in Southeast Asia suggests a need for acceleration of malaria elimination. We evaluated the effectiveness and safety of mass drug administrations (MDA) to interrupt malaria transmission. Four malaria-endemic villages in western Cambodia were randomized to three rounds of MDA (a three-day course of dihydroartemisinin with piperaquine-phosphate), administered in either early or at the end of the study-period. Comprehensive malaria treatment records were collected during 2014-2017. Subclinical parasite prevalence was estimated by ultra-sensitive quantitative polymerase chain reaction (uPCR) quarterly over 12 months. MDA coverage with at least one complete round was 88% (1999/2268), ≥2-rounds 73% (1645/2268), and all 3-rounds 58% (1310/2268). P.falciparum incidence in intervention and control villages was similar over the 12 months prior to the study: 39/1000 person-years vs 45/1000 person-years (p=0.50). The primary outcome, P.falciparum incidence in the 12 months after MDA, was lower in intervention villages (1.5/1,000 person-years vs 37.1/1,000 person-years; incidence rate ratio 24.5, 95%CI 3.4-177; p=0.002). Following MDA in 2016, there were no clinical falciparum malaria cases over 12 months (0/2044 person-years) in all 4 villages. After an initial decrease of P.vivax prevalence in intervention villages, P.vivaxprevalence had returned to approximately half of the baseline prevalence by 12 months, and was no longer significantly lower than in control villages. No severe adverse events were attributed to treatment. MDAs with high coverage were safe, and associated with the absence of clinical P.falciparum cases for at least one year. Registered on clinicaltrials.gov (NCT01872702).

  3. 28 CFR 811.11 - Compliance.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Compliance. 811.11 Section 811.11... OFFENDER REGISTRATION § 811.11 Compliance. (a) A sex offender may be excused from strict compliance with... circumstances that will interfere with compliance and makes alternative arrangements to satisfy the requirements...

  4. Methodological framework to identify possible adverse drug reactions using population-based administrative data.

    Science.gov (United States)

    Sauer, Brian; Nebeker, Jonathan; Shen, Shuying; Rupper, Randall; West, Suzanne; Shinogle, Judith A; Xu, Wu; Lohr, Kathleen N; Samore, Matthew

    2014-01-01

    We present a framework for detecting possible adverse drug reactions (ADRs) using the Utah Medicaid administrative data. We examined four classes of ADRs associated with treatment of dementia by acetylcholinesterase inhibitors (AChEIs): known reactions (gastrointestinal, psychological disturbances), potential reactions (respiratory disturbance), novel reactions (hepatic, hematological disturbances), and death. Our cohort design linked drug utilization data to medical claims from Utah Medicaid recipients. We restricted the analysis to 50 years-old and older beneficiaries diagnosed with dementia-related diseases. We compared patients treated with AChEI to patients untreated with anti-dementia medication therapy. We attempted to remove confounding by establishing propensity-score-matched cohorts for each outcome investigated; we then evaluated the effects of drug treatment by conditional multivariable Cox-proportional-hazard regression. Acute and transient effects were evaluated by a crossover design using conditional logistic regression. Propensity-matched analysis of expected reactions revealed that AChEI treatment was associated with gastrointestinal episodes (Hazard Ratio [HR]: 2.02; 95%CI: 1.28-3.2), but not psychological episodes, respiratory disturbance, or death. Among the unexpected reactions, the risk of hematological episodes was higher (HR: 2.32; 95%CI: 1.47-3.6) in patients exposed to AChEI. AChEI exposure was not associated with an increase in hepatic episodes. We also noted a trend, identified in the case-crossover design, toward increase odds of experiencing acute hematological events during AChEI exposure (Odds Ratio: 3.0; 95% CI: 0.97 - 9.3). We observed an expected association between AChEIs treatment and gastrointestinal disturbances and detected a signal of possible hematological ADR after treatment with AChEIs in this pilot study. Using this analytic framework may raise awareness of potential ADEs and generate hypotheses for future investigations

  5. Stevens-Johnson syndrome/toxic epidermal necrolysis and erythema multiforme drug-related hospitalisations in a national administrative database.

    Science.gov (United States)

    Sousa-Pinto, Bernardo; Araújo, Luís; Freitas, Alberto; Correia, Osvaldo; Delgado, Luís

    2018-01-01

    Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and erythema multiforme (EM) are immunologically-mediated dermatological disorders commonly triggered by drug exposure and/or other external agents. We aimed to characterise SJS/TEN- and EM-drug-related hospitalisations in a nationwide administrative database, focusing on demographic and clinical characteristics, and in the most frequently implicated drug classes. We analysed all drug-related hospitalisations with associated diagnosis of SJS/TEN or EM in Portuguese hospitals between 2009 and 2014. We compared gender, age, comorbidities, length of stay, and in-hospital mortality and estimated the number of episodes per million packages sold of drug classes. Predictors of in-hospital mortality were investigated in both conditions by logistic regression. There were 132 SJS/TEN-related and 122 EM-related hospitalisations. Incidence and in-hospital mortality of SJS/TEN episodes (24.2%) were consistent with previous studies. HIV co-infection was more common among SJS/TEN hospitalisations (9 vs. 2% with EM; P  = 0.009). Liver disease, advanced age, and a TEN diagnosis, were significantly associated with higher risk of mortality in patients with SJS/TEN. The highest numbers of SJS/TEN and EM episodes per million drug packages sold were observed for antivirals (8.7 and 1.5, respectively), antineoplastic/immunosuppressive drugs (5.6 and 3.9, respectively) and hypouricaemic drugs (5.0 and 2.4, respectively). SJS/TEN in-hospital mortality is high, and its risk factors include advanced age, liver disease, and TEN diagnosis. The drug classes most frequently associated with these conditions include antivirals, hypouricaemic drugs and antineoplastic/immunosuppressive drugs. Administrative databases seem useful in the study of SJS/TEN drug-related hospitalisations, yielding results consistent with previous studies and on a nationwide basis.

  6. Metabolic profile of amphetamine and methamphetamine following administration of the drug famprofazone.

    Science.gov (United States)

    Greenhill, Brandy; Valtier, Sandra; Cody, John T

    2003-10-01

    There are a several drugs that lead to the production of methamphetamine and/or amphetamine in the body which are subsequently excreted in the urine. These drugs raise obvious concerns when interpreting positive amphetamine drug testing results. Famprofazone is an analgesic found in a multi-ingredient medication (Gewodin) used for pain relief. Two Gewodin tablets (50 mg of famprofazone) were administered orally to healthy volunteers with no history of amphetamine, methamphetamine, or famprofazone use. Following administration, urine samples were collected ad lib for up to six days, and pH, specific gravity, and creatinine values were determined. In order to determine the quantitative excretion profile of amphetamine and methamphetamine, samples were extracted using liquid-liquid extraction, derivatized with heptafluorobutyric anhydride, and analyzed by gas chromatography-mass spectrometry (GC-MS). The ions monitored were 91, 118, 240 for amphetamine and 254, 210, 118 for methamphetamine. Amphetamine-d(6) and methamphetamine-d(11) were used as internal standards. Peak concentrations for amphetamine ranged from 148 to 2271 ng/mL and for methamphetamine 615 to 7361 ng/mL. Concentrations of both compounds peaked between 3 and 7 h post-dose. Amphetamine and methamphetamine could be detected (limit of detection = 5 ng/mL) at 121 and 143 h post-dose, respectively. Using a cutoff of 500 ng/mL, all subjects had individual urine samples that tested positive. One subject had 14 samples above the cutoff with the last positive being detected over 48 h post-dose. The profile of methamphetamine and amphetamine enantiomers was also determined using liquid-liquid extraction, derivatization with N-trifluoroacetyl-l-prolyl chloride and analysis by GC-MS. Data showed the famprofazone metabolites amphetamine and methamphetamine to be both d- and l-enantiomers. The proportion of l-methamphetamine exceeded that of its d-enantiomer from the first sample collected. Initially, the

  7. Effects of first-pass metabolism on metabolite mean residence time determination after oral administration of parent drug.

    Science.gov (United States)

    Chan, K K; Gibaldi, M

    1990-01-01

    Metabolite kinetics after oral drug administration can be determined, without separate metabolite administration, using the concepts of mean residence time (MRT). The MRT of parent drug and metabolite after oral administration of the parent drug, MRTp,p(oral) and MRTm,p(oral), can be calculated directly from the drug and metabolite profiles. The difference between MRTm,p(oral) and MRTp,p(oral), termed Delta MRT, yields an estimate of MRT of metabolite when the metabolite is given as an iv bolus, MRTm,m(iv). The calculation is simple for drugs that are known to undergo, negligible first-pass metabolism. Correction can also be made when extent of first-pass metabolism is known. Ambiguity is encountered, however, when the degree of first-pass metabolism is unknown. When the delta MRT is negative, then first-pass metabolism must be considered. A positive value of delta MRT, on the other hand, is not a definitive indication of the absence of first-pass metabolism. It may occur in the presence or absence of first-pass metabolism. Ignoring the possibility of first-pass metabolism when a positive value of delta MRT occurs may lead to an incorrect estimate of MRTm,m(iv). The estimation error is relatively small, however, when MRTm,m(iv) much greater than MRTp,p(iv), even when first-pass metabolism is extensive. This situation may apply to the administration of a prodrug.

  8. Food and Drug Administration warning on anesthesia and brain development: implications for obstetric and fetal surgery.

    Science.gov (United States)

    Olutoye, Olutoyin A; Baker, Byron Wycke; Belfort, Michael A; Olutoye, Oluyinka O

    2018-01-01

    There has been growing concern about the detrimental effects of certain anesthetic agents on the developing brain. Preclinical studies in small animal models as well as nonhuman primates suggested loss or death of brain cells and consequent impaired neurocognitive function following anesthetic exposure in neonates and late gestation fetuses. Human studies in this area are limited and currently inconclusive. On Dec. 14, 2016, the US Food and Drug Administration issued a warning regarding impaired brain development in children following exposure to certain anesthetic agents used for general anesthesia, namely the inhalational anesthetics isoflurane, sevoflurane, and desflurane, and the intravenous agents propofol and midazolam, in the third trimester of pregnancy. Furthermore, this warning recommends that health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against potential risks, especially for procedures that may last >3 hours or if multiple procedures are required in children fetal exposure to general anesthesia during cesarean delivery has not been associated with learning disabilities. However, the fetus can also be exposed to both intravenous and inhalation anesthetics during nonobstetric or fetal surgery in the second and third trimester; this exposure is typically longer than that for cesarean delivery. Very few studies address the effect of anesthetic exposure on the fetus in the second trimester when most nonobstetric and fetal surgical procedures are performed. It is also unclear how the plasticity of the fetal brain at this stage of development will modulate the consequences of anesthetic exposure. Strategies that may circumvent possible untoward long-term neurologic effects of anesthesia in the baby include: (1) use of nonimplicated (nongamma-aminobutyric acid agonist) agents for sedation such as opioids (remifentanil, fentanyl) or the alpha-2 agonist, dexmedetomidine, when appropriate; (2

  9. Modeling the impact and costs of semiannual mass drug administration for accelerated elimination of lymphatic filariasis.

    Directory of Open Access Journals (Sweden)

    Wilma A Stolk

    Full Text Available The Global Program to Eliminate Lymphatic Filariasis (LF has a target date of 2020. This program is progressing well in many countries. However, progress has been slow in some countries, and others have not yet started their mass drug administration (MDA programs. Acceleration is needed. We studied how increasing MDA frequency from once to twice per year would affect program duration and costs by using computer simulation modeling and cost projections. We used the LYMFASIM simulation model to estimate how many annual or semiannual MDA rounds would be required to eliminate LF for Indian and West African scenarios with varied pre-control endemicity and coverage levels. Results were used to estimate total program costs assuming a target population of 100,000 eligibles, a 3% discount rate, and not counting the costs of donated drugs. A sensitivity analysis was done to investigate the robustness of these results with varied assumptions for key parameters. Model predictions suggested that semiannual MDA will require the same number of MDA rounds to achieve LF elimination as annual MDA in most scenarios. Thus semiannual MDA programs should achieve this goal in half of the time required for annual programs. Due to efficiency gains, total program costs for semiannual MDA programs are projected to be lower than those for annual MDA programs in most scenarios. A sensitivity analysis showed that this conclusion is robust. Semiannual MDA is likely to shorten the time and lower the cost required for LF elimination in countries where it can be implemented. This strategy may improve prospects for global elimination of LF by the target year 2020.

  10. Bioadhesive drug delivery system using glyceryl monooleate for the intravesical administration of paclitaxel.

    Science.gov (United States)

    Lee, Seung-Ju; Kim, Sae Woong; Chung, Hesson; Park, Yeong Taek; Choi, Young Wook; Cho, Yong-Hyun; Yoon, Moon Soo

    2005-10-01

    Many reports have shown that the efficacy of intravesical therapy for bladder cancer is in part limited by the poor penetration of drugs into the urothelium. The present study evaluated the effect of glyceryl monooleate (GMO) on the absorption of intravesically administered paclitaxel in a rabbit model of bladder cancer. Urine, plasma, and tissue pharmacokinetics were determined in rabbits treated for 120 min with paclitaxel (500 microg/20 ml) by intravesical instillation. Two formulations of GMO/paclitaxel were evaluated using different proportions of water, 15 and 30%, and Taxol was used as a control. Animals were observed for clinical signs of toxicity and necropsy was performed. 120 min after instillation, the bladder was emptied and excised. In the urine, paclitaxel concentration was decreased by 39.6 and 41.2% in the two experimental groups and by 25.2% in the control group. The paclitaxel concentrations in the urothelium were 53 and 56% of the urine concentration in both experimental groups, but 11% in the control group. The concentration then declined exponentially in the underlying capillary-perfused tissues, reaching equilibrium at a depth of 1,400-1,700 microm. The plasma concentrations were extremely low compared with concentrations in urine and bladder tissues and were not associated with clinical toxicity. We conclude that GMO has a significantly increased bioadhesiveness to bladder mucosa. Therefore, intravesical administration of GMO/paclitaxel/water provides a significant advantage for drugs targeting the bladder tissue, and paclitaxel represents a viable option for intravesical bladder cancer therapy. Copyright 2005 S. Karger AG, Basel.

  11. Antibody formation after drug administration during cardiac surgery: parameters for aprotinin use.

    Science.gov (United States)

    Levy, J H

    1993-01-01

    Patients who require cardiac surgery or heart-lung transplantation may have been previously sensitized to drugs and blood products to which they may be reexposed during their current surgery. Reexposure may produce an anaphylactic reaction, a life-threatening allergic response. The presence of immunospecific immunoglobulin (Ig)E antibodies and, perhaps, certain classes of IgG antibodies may increase the risk of anaphylaxis. The substances that most commonly lead to anaphylaxis during cardiac surgery include antibiotics, blood products, colloid volume expanders, cyclosporine, and protamine. The anaphylactic potentials of several drugs commonly given in the perioperative setting are well known. Unlike oral cyclosporine for example, the intravenous form is solubilized in cremophor, a fatty-acid derivative that can directly activate the complement cascade. Protamine, whose anaphylactic potential during cardiac surgery is best understood, has been the subject of two studies in which risk of anaphylaxis was evaluated in approximately 5000 patients who received protamine reversal of systemic heparinization after cardiac surgery. This agent is a small polypeptide, derived from a fish source, with a molecular weight of approximately 5000; it is not particularly immunogenic, perhaps because it resembles human histone proteins. The risk of anaphylaxis after protamine administration is much higher among neutral protamine Hagedorn insulin-dependent diabetic patients (0.6% to 2%) than among non-neutral protamine Hagedorn insulin-dependent diabetic patients (0.06%). However, patients with pulmonary hypertension or prior exposure to protamine from previous cardiac surgery were not at an increased risk for anaphylaxis after protamine exposure. The presence of preexisting IgE antibodies has been shown to be highly predictive of the development of anaphylaxis.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.

    Science.gov (United States)

    Mathis, Mitchell V; Muoio, Brendan M; Andreason, Paul; Avila, Amy M; Farchione, Tiffany; Atrakchi, Aisar; Temple, Robert J

    2017-06-01

    To summarize the US Food and Drug Administration's (FDA's) review of the safety and effectiveness for pimavanserin, an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. We describe the regulatory and clinical issues important to the FDA's approval of this New Drug Application, with special focus on the risk-benefit balance. We also describe a new labeling feature that presents additional efficacy data to clinicians. Data sets for all relevant clinical trials of pimavanserin and the Applicant's and FDA's analyses of these data were considered in this review. Data were available from 616 patients with Parkinson's disease with hallucinations and delusions who received at least 1 dose of pimavanserin, with a total exposure of 825 patient-years in the Parkinson's disease psychosis population. Pimavanserin 34 mg/d was effective in treating hallucinations and delusions associated with Parkinson's disease. In the Applicant's single pivotal trial, 80.5% of pimavanserin patients experienced at least some improvement in symptoms compared to 58.1% of patients taking placebo. Pimavanserin did not worsen motor function, an adverse effect commonly observed with other antipsychotics, probably because of a lack of consequential dopamine binding. Pimavanserin is the only FDA-approved treatment for the hallucinations and delusions seen in patients with psychosis of Parkinson's disease. Although pimavanserin appears to have a pharmacologic mechanism that is different from other atypical antipsychotics, concern remained that the increased risk of death seen with antipsychotic use in elderly demented patients, and described in all approved antipsychotic labels, would also occur with pimavanserin. Pimavanserin bears the same boxed warning about the risk of death associated with antipsychotic use in elderly patients with dementia. © Copyright 2017 Physicians Postgraduate Press, Inc.

  13. Social preference and drug self-administration: a preclinical model of social choice within peer groups.

    Science.gov (United States)

    Smith, Mark A; Pitts, Elizabeth G

    2014-02-01

    selection models of substance use propose that individuals choose or self-select into peer groups based on shared substance use histories. Few experimental studies have examined the role of selection in substance use, possibly because few preclinical models allow subjects to choose or select individuals based on a shared self-administration history. In the present study, we used custom-built, three-compartment, operant conditioning chambers that permitted multiple rats to self-administer cocaine simultaneously in the same session. Rats assigned to the center compartment had access to two response levers, each in close physical proximity to one of its partners. In one group, a rat with access to cocaine was assigned to the center compartment and flanked by one rat with access to cocaine and one rat without access. In a second group, a rat without access to cocaine was assigned to the center compartment and flanked by one rat with access to cocaine and one rat without access. In the first group, rats with access to cocaine emitted more responses on the lever in close proximity to the other rat with access to cocaine; in the second group, rats without access to cocaine emitted more responses on the lever in close proximity to the other rat without access. These preferences were not apparent immediately but developed gradually over the course of several days of testing. These data suggest that rats prefer to be in close physical proximity to another rat with a shared behavioral history during periods of drug self-administration. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  14. Pluripotent stem cells in translation: a Food and Drug Administration-National Institutes of Health collaboration.

    Science.gov (United States)

    Kleitman, Naomi; Rao, Mahendra S; Owens, David F

    2013-07-01

    Recently, the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health, and the stem cell research community have collaborated on a series of workshops that address moving pluripotent stem cell therapies into the clinic. The first two workshops in the series focused on preclinical science, and a third, future workshop will focus on clinical trials. This summary addresses major points from both of the recent preclinically focused meetings. When entering into a therapeutics developmental program based on pluripotent cells, investigators must make decisions at the very early stages that will have major ramifications during later phases of development. Presentations and discussions from both invited participants and FDA staff described the need to characterize and document the quality, variability, and suitability of the cells and commercial reagents used at every translational stage. This requires consideration of future regulatory requirements, ranging from donor eligibility of the original source material to the late-stage manufacturing protocols. Federal, industrial, and academic participants agreed that planning backward is the best way to anticipate what evidence will be needed to justify human testing of novel therapeutics and to eliminate wasted efforts.

  15. Cessation of mass drug administration for lymphatic filariasis in Zanzibar in 2006: was transmission interrupted?

    Directory of Open Access Journals (Sweden)

    Maria P Rebollo

    2015-03-01

    Full Text Available Lymphatic filariasis (LF is targeted for elimination through annual mass drug administration (MDA for 4-6 years. In 2006, Zanzibar stopped MDA against LF after five rounds of MDA revealed no microfilaraemic individuals during surveys at selected sentinel sites. We asked the question if LF transmission was truly interrupted in 2006 when MDA was stopped.In line with ongoing efforts to shrink the LF map, we performed the WHO recommended transmission assessment surveys (TAS in January 2012 to verify the absence of LF transmission on the main Zanzibar islands of Unguja and Pemba. Altogether, 3275 children were tested on both islands and 89 were found to be CFA positive; 70 in Pemba and 19 in Unguja. The distribution of schools with positive children was heterogeneous with pronounced spatial variation on both islands. Based on the calculated TAS cut-offs of 18 and 20 CFA positive children for Pemba and Unguja respectively, we demonstrated that transmission was still ongoing in Pemba where the cut-off was exceeded.Our findings indicated ongoing transmission of LF on Pemba in 2012. Moreover, we presented evidence from previous studies that LF transmission was also active on Unguja shortly after stopping MDA in 2006. Based on these observations the government of Zanzibar decided to resume MDA against LF on both islands in 2013.

  16. Cessation of mass drug administration for lymphatic filariasis in Zanzibar in 2006: was transmission interrupted?

    Science.gov (United States)

    Rebollo, Maria P; Mohammed, Khalfan A; Thomas, Brent; Ame, Shaali; Ali, Said Mohammed; Cano, Jorge; Escalada, Alba Gonzalez; Bockarie, Moses J

    2015-03-01

    Lymphatic filariasis (LF) is targeted for elimination through annual mass drug administration (MDA) for 4-6 years. In 2006, Zanzibar stopped MDA against LF after five rounds of MDA revealed no microfilaraemic individuals during surveys at selected sentinel sites. We asked the question if LF transmission was truly interrupted in 2006 when MDA was stopped. In line with ongoing efforts to shrink the LF map, we performed the WHO recommended transmission assessment surveys (TAS) in January 2012 to verify the absence of LF transmission on the main Zanzibar islands of Unguja and Pemba. Altogether, 3275 children were tested on both islands and 89 were found to be CFA positive; 70 in Pemba and 19 in Unguja. The distribution of schools with positive children was heterogeneous with pronounced spatial variation on both islands. Based on the calculated TAS cut-offs of 18 and 20 CFA positive children for Pemba and Unguja respectively, we demonstrated that transmission was still ongoing in Pemba where the cut-off was exceeded. Our findings indicated ongoing transmission of LF on Pemba in 2012. Moreover, we presented evidence from previous studies that LF transmission was also active on Unguja shortly after stopping MDA in 2006. Based on these observations the government of Zanzibar decided to resume MDA against LF on both islands in 2013.

  17. Office bladder distention with Electromotive Drug Administration (EMDA is equivalent to distention under General Anesthesia (GA

    Directory of Open Access Journals (Sweden)

    Azevedo Kathryn J

    2005-11-01

    Full Text Available Abstract Background Bladder distention is commonly used in diagnosis and treatment of interstitial cystitis (IC. Traditionally performed in the operating room under general or spinal anesthesia (GA, it is expensive and associated with short term morbidity. Office bladder distention using electromotive drug administration (EMDA has been suggested as an alternative that is well tolerated by patients. We report the first comparative findings of patients undergoing both office distention with EMDA and distention in the operating room (OR with GA. Methods This retrospective chart review identified 11 patients participating in two protocols of EMDA bladder distention who also underwent bladder distention under GA either prior to or after the EMDA procedure. Results The median absolute difference in bladder capacity between GA and EMDA was only 25 cc; the median percent difference was 5%. Cystoscopic findings, while not prospectively compiled, appear to have been similar. Conclusion This study represents the first comparison between distention with EMDA versus GA and confirms the technical feasibility of performing bladder distention in an office setting. The distention capacity achieved in the office was nearly identical to that in the OR and the cystoscopic findings very similar. Further investigation into the comparative morbidity, cost, and other outcome measures is warranted to define the ultimate role of EMDA bladder distention in the clinical evaluation and care of patients with IC.

  18. U.S. Food and Drug Administration's dioxin monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    South, P.; S. Kathleen Egan; Troxell, T.; P. Michael Bolger [U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park (United States)

    2004-09-15

    Dioxin-like compounds (DLCs) are a group of environmental contaminants whose primary route of human exposure occurs via the consumption of fatty foods of animal origin. Recent safety risk assessments conducted by national and international organizations broadly agree that risk management actions should be developed to decrease DLC exposure. Since the mid-1990s, the U.S. Food and Drug Administration (FDA) has tested specific foods with the goal of describing and reducing DLC exposure. In 2001, FDA developed a strategy for DLCs (http://vm.cfsan.fda.gov/{proportional_to}lrd/dioxstra.html) and substantially expanded its dioxin monitoring program to obtain more comprehensive data on background levels of DLCs in specific food and feed samples as well as to identify and reduce pathways of DLC contamination. FDA's dioxin monitoring program analyzes food collected under its Total Diet Study (TDS) and food and feed from targeted sampling. The TDS is FDA's ongoing market basket survey of approximately 280 core foods in the U.S. food supply. FDA targeted sampling collects and analyzes foods suspected of having both higher DLC levels and more variability in those levels than other foods. The contribution of dietary DLCs to overall exposure and the possible introduction of DLCs in animalbased food via the use of particular feed components was recently identified by the National Academy of Sciences Committee on the Implications of Dioxin in the Food Supply and confirmed FDA's approach articulated in its dioxin strategy.

  19. Electromotive drug administration for treatment of therapy-refractory overactive bladder

    Directory of Open Access Journals (Sweden)

    A. Gauruder Burmester

    2008-12-01

    Full Text Available PURPOSE: Evaluate the benefits of electromotive drug administration (EMDA as an alternative technique in patients with chronic overactive bladder in terms of improvement of symptoms, quality of life, and sexuality. MATERIAL AND METHODS: A total of 72 patients with therapy-refractory overactive bladder according to the ICS (International Continence Society definition, were treated by EMDA. The regimen consisted of three treatment cycles, each with 3 instillations at 2-week intervals. The solution instilled consisted of 100 mL 4% lidocaine, 100 mL distilled water, 40 mg dexamethasone, and 2 mL epinephrine. Peri-interventionally, a urine test and close circulatory monitoring were performed. All women underwent urodynamic testing and cystoscopy and kept a voiding diary. A comprehensive history was obtained, a quality of life questionnaire administered, and a gynecologic examination performed before initiation of therapy. The women underwent follow-up at 12 months after the end of therapy. RESULTS: The patients had a mean age of 63 (± 11.2 years. Bladder capacity improved significantly by 109 mL (± 55 mL in 51 (71% patients (p = 0.021. The number of micturitions/day decreased significantly to 7 (± 2 (p = 0.013. Quality of life was improved in 54 patients (75%; p = 0.024 and sexuality in 39 (54%; p = 0.020. CONCLUSIONS: The results suggest that EMDA can improve both quality of life and sexuality in patients with therapy-refractory chronic overactive bladder.

  20. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Science.gov (United States)

    2013-03-08

    ...-Risk Assessment Ensuring the safety, effectiveness, and quality of human drugs is a complicated... assessment framework that is designed to make explicit the consideration of the various benefit-risk factors...-risk assessment in the human drug and biologic review process and the opportunity for public comment on...

  1. Criminal Compliance

    Directory of Open Access Journals (Sweden)

    Cristina Antonella Andretta

    2015-10-01

    The article discusses the concepts of both compliance and criminal compliance, its main components and structure as well as the main rules relating to its global application, and finally his emergence in the Ecuadorian legal system.

  2. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Science.gov (United States)

    2010-05-07

    ... http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatory... Tobacco.'' This guidance document discusses FDA's intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco...

  3. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Science.gov (United States)

    2011-09-09

    ... Internet at http://www.regulations.gov and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatory... Tobacco Control Act (21 U.S.C. 387e(j) and 387j)). In this draft guidance, FDA provides responses to... being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft...

  4. Determinants of prescribed drug use among pregnant women in Bahir Dar city administration, Northwest Ethiopia: a cross sectional study.

    Science.gov (United States)

    Admasie, Chanie; Wasie, Belaynew; Abeje, Gedefaw

    2014-09-18

    Drug use during pregnancy may be dangerous to the fetus. There is high consumption of prescribed drugs among pregnant women. This condition may be much higher in developing countries. There is no sufficient evidence on prescribed drug use among pregnant women in Bahir Dar town. The aim of this study was to assess the level of prescribed drug use and associated factors among pregnant women attending antenatal care (ANC) service at government health centers in Bahir Dar city administration. Institution based cross sectional study was used. Data were collected from randomly selected 510 pregnant women. Data were analyzed using SPSS version 16.0. Back ward stepwise logistic regression model was used and p-values pregnant women were included in the study of which 88.4% were prescribed at least one drug during pregnancy. Nearly 11% of the pregnant women were prescribed with drugs from category D or X of the US-FDA risk classification.Prescribed drug use among pregnant women was more likely when the pregnancy is wanted, (AOR = 2.4, 95% CI: 1.3 - 4.6), if the mother had maternal illness (AOR = 8.5, 95% CI: 5.4-13.4), when the educational level of ANC provider is diploma (AOR = 2.7, 95% CI: 1.5-4.7) and when number of pregnancies is more (AOR =2.1, 95% CI: 1.3-3.3). Prescribed drug use including those with potential harm to the fetus during pregnancy was very high in Bahir Dar city administration. Prescribed drug use is more when the woman had illness, when the woman was multi gravida and when the educational level of ANC provider was low (diploma). It is important to upgrade providers' educational level and institute prevention of diseases like malaria to reduce the level of prescribed drug use during pregnancy.

  5. 21 CFR 203.32 - Drug sample storage and handling requirements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug sample storage and handling requirements. 203.32 Section 203.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... contamination, deterioration, and adulteration. (b) Compliance with compendial and labeling requirements...

  6. Further amendments to general regulations of the Food and Drug Administration to incorporate tobacco products. Final rule.

    Science.gov (United States)

    2012-02-02

    The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.

  7. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Science.gov (United States)

    2010-08-31

    ...] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no...

  8. 76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

    Science.gov (United States)

    2011-04-25

    ...] Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No... entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document describes FDA's current policies with respect to civil money penalties and no-tobacco-sale orders...

  9. Comparison and validation of two mathematical models for the impact of mass drug administration on Ascaris lumbricoides and hookworm infection

    NARCIS (Netherlands)

    L.E. Coffeng (Luc); J. Truscott (James); S.H. Farrell (Sam H.); H.C. Turner (Hugo C.); R. Sarkar (Rajiv); G. Kang (Gagandeep); S.J. de Vlas (Sake); R.M. Anderson (Roy)

    2017-01-01

    textabstractThe predictions of two mathematical models of the transmission dynamics of Ascaris lumbricoides and hookworm infection and the impact of mass drug administration (MDA) are compared, using data from India. One model has an age structured partial differential equation (PDE) deterministic

  10. 77 FR 56650 - Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and...

    Science.gov (United States)

    2012-09-13

    .../validate new diagnostic technologies and their associated claims as well as factors that affect the quality...] Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and... entitled ``FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of...

  11. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Report Submission Program'' to the Division of Small Manufacturers, International, and Consumer... this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... Ministry of Health, Labour and Welfare system. This notice of availability and draft guidance satisfy the...

  12. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Science.gov (United States)

    2010-04-26

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... the Internet. To receive ``Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k...

  13. 75 FR 25869 - The National Institutes of Health and the Food and Drug Administration Joint Leadership Council...

    Science.gov (United States)

    2010-05-10

    ...] The National Institutes of Health and the Food and Drug Administration Joint Leadership Council... evaluation tools used for regulatory review. A newly formed NIH-FDA Joint Leadership Council will help ensure... Leadership Council. The NIH-FDA Joint Leadership Council provides a forum for the leadership of both agencies...

  14. The behavioral economics of drug self-administration: a review and new analytical approach for within-session procedures.

    Science.gov (United States)

    Bentzley, Brandon S; Fender, Kimberly M; Aston-Jones, Gary

    2013-03-01

    Behavioral-economic demand curve analysis offers several useful measures of drug self-administration. Although generation of demand curves previously required multiple days, recent within-session procedures allow curve construction from a single 110-min cocaine self-administration session, making behavioral-economic analyses available to a broad range of self-administration experiments. However, a mathematical approach of curve fitting has not been reported for the within-session threshold procedure. We review demand curve analysis in drug self-administration experiments and provide a quantitative method for fitting curves to single-session data that incorporates relative stability of brain drug concentration. Sprague-Dawley rats were trained to self-administer cocaine, and then tested with the threshold procedure in which the cocaine dose was sequentially decreased on a fixed ratio-1 schedule. Price points (responses/mg cocaine) outside of relatively stable brain cocaine concentrations were removed before curves were fit. Curve-fit accuracy was determined by the degree of correlation between graphical and calculated parameters for cocaine consumption at low price (Q(0)) and the price at which maximal responding occurred (P(max)). Removing price points that occurred at relatively unstable brain cocaine concentrations generated precise estimates of Q(0) and resulted in P (max) values with significantly closer agreement with graphical P(max) than conventional methods. The exponential demand equation can be fit to single-session data using the threshold procedure for cocaine self-administration. Removing data points that occur during relatively unstable brain cocaine concentrations resulted in more accurate estimates of demand curve slope than graphical methods, permitting a more comprehensive analysis of drug self-administration via a behavioral-economic framework.

  15. Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration.

    Science.gov (United States)

    Kao, David P; Haigney, Mark C P; Mehler, Philip S; Krantz, Mori J

    2015-09-01

    To assess the relative frequency of reporting of adverse events involving ventricular arrhythmia, cardiac arrest, corrected QT interval (QTc) prolongation or torsade de pointes to the US Food and Drug Administration (FDA) between buprenorphine and methadone. Retrospective pharmacoepidemiological study. Adverse drug events reported spontaneously to the FDA between 1969 and June 2011 originating in 196 countries (71% events from the United States). Adverse event cases mentioning methadone (n = 14 915) or buprenorphine (n = 7283) were evaluated against all other adverse event cases (n = 4 796 017). The primary outcome was the composite of ventricular arrhythmia or cardiac arrest. The secondary outcome was the composite of QTc prolongation or torsade de pointes. The proportional reporting ratio (PRR) was used to identify disproportionate reporting defined as a PRR > 2, χ(2) error > 4, with ≥ 3 cases. There were 132 (1.8%) ventricular arrhythmia/cardiac arrest and 19 (0.3%) QTc prolongation/torsade de pointes cases associated with buprenorphine compared with 1729 (11.6%) ventricular arrhythmia/cardiac arrest and 390 (2.6%) QTc prolongation/torsade de pointes cases involving methadone. PRRs associated with buprenorphine were not significant for ventricular arrhythmia/cardiac arrest (1.10, 95%, confidence interval (0.93-1.31, χ(2)  = 1.2) or QTc prolongation/torsade de pointes (1.03, 95% CI = 0.66-1.62, χ(2)  = 0.01), but were for methadone (7.20, 95% CI = 6.88-7.52, χ(2)  = 8027; 10.7, 95% CI = 9.66-11.8, χ(2)  = 1538, respectively). In spontaneously reported adverse events, methadone is associated with disproportionate reporting of cardiac arrhythmias, whereas buprenorphine is not. Although these findings probably reflect clinically relevant differences, a causal connection cannot be presumed and disproportionality analysis cannot quantify absolute risk per treatment episode. Population-based studies to

  16. 76 FR 58398 - Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New...

    Science.gov (United States)

    2011-09-21

    ... for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are... discussed in it do not apply to newly introduced unapproved drugs, delayed implementation of revised CPG 440...

  17. Design of lipid-based formulations for oral administration of poorly water-soluble drugs: precipitation of drug after dispersion of formulations in aqueous solution.

    Science.gov (United States)

    Mohsin, Kazi; Long, Michelle A; Pouton, Colin W

    2009-10-01

    This study was designed to investigate the precipitation of a lipophilic drug following dispersion of lipid formulations in water. The model drug fenofibrate was formulated in representative lipid delivery systems designed for oral administration, using medium chain glycerides, polysorbates, and propylene glycol as excipients. Aqueous dispersion of water-insoluble self-emulsifying lipid formulations resulted in turbid emulsions, followed subsequently by very slow precipitation of 3-7% of the dose of fenofibrate. Self-emulsifying formulations that included water-soluble surfactants, which dissolved a lower mass of drug in solution at equilibrium, nevertheless typically maintained drugs in a metastable state, following dilution with water, for several hours or even days. Formulations with higher contents of hydrophilic materials resulted in more rapid precipitation. Extensive precipitation of fenofibrate from oil-free formulations, comprising of only surfactants and cosolvents, took place within 30 min. The results indicated that most of the lipid systems were supersaturated with respect to the drug on dilution, but the extent of precipitation varied significantly between formulations and was influenced by the extent of supersaturation after dilution. The study suggests that the use of hydrophilic formulations for delivery of lipophilic drugs may result in a greater extent of drug precipitation in the stomach.

  18. Analysis of automated external defibrillator device failures reported to the Food and Drug Administration.

    Science.gov (United States)

    DeLuca, Lawrence A; Simpson, Allan; Beskind, Dan; Grall, Kristi; Stoneking, Lisa; Stolz, Uwe; Spaite, Daniel W; Panchal, Ashish R; Denninghoff, Kurt R

    2012-02-01

    Automated external defibrillators are essential for treatment of cardiac arrest by lay rescuers and must determine when to shock and if they are functioning correctly. We seek to characterize automated external defibrillator failures reported to the Food and Drug Administration (FDA) and whether battery failures are properly detected by automated external defibrillators. FDA adverse event reports are catalogued in the Manufacturer and User Device Experience (MAUDE) database. We developed and internally validated an instrument for analyzing MAUDE data, reviewing all reports in which a fatality occurred. Two trained reviewers independently analyzed each report, and a third resolved discrepancies or passed them to a committee for resolution. One thousand two hundred eighty-four adverse events were reported between June 1993 and October 2008, of which 1,150 were failed defibrillation attempts. Thirty-seven automated external defibrillators never powered on, 252 failed to complete rhythm analysis, and 524 failed to deliver a recommended shock. In 149 cases, the operator disagreed with the device's rhythm analysis. In 54 cases, the defibrillator stated the batteries were low and in 110 other instances powered off unexpectedly. Interrater agreement between reviewers 1 and 2 ranged by question from 69.0% to 98.6% and for most likely cause was 55.9%. Agreement was obtained for 93.7% to 99.6% of questions by the third reviewer. Remaining discrepancies were resolved by the arbitration committee. MAUDE information is often incomplete and frequently no corroborating data are available. Some conditions not detected by automated external defibrillators during self-test cause units to power off unexpectedly, causing defibrillation delays. Backup units frequently provide shocks to patients. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  19. Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine.

    Science.gov (United States)

    Witten, Celia M; McFarland, Richard D; Simek, Stephanie L

    2015-12-01

    Regenerative medicine (RM) is a popular term for a field of scientific and medical research. There is not one universally accepted definition of RM, but it is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. RM products have the potential to provide treatments for a number of unmet needs but have substantial scientific and regulatory challenges that need to be addressed for this potential to be fully realized. FDA has established formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. Regenerative medicine products regulated by FDA are classified on the basis of these definitions, and the classification forms the basis for determining the regulatory requirements to each specific product. FDA regulations are generally written to allow the agency flexibility to accommodate new scientific questions raised by novel and evolving technologies. FDA efforts to facilitate product development in this novel and promising area include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance. Regenerative medicine is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. This article provides an overview of the efforts of the U.S. Food and Drug Administration (FDA) to facilitate product development in the field commonly known was regenerative medicine. It provides an introduction to the processes by which FDA works with individual sponsors, interacts with the scientific and industry communities, participates in standards development, and develops formal FDA policy and guidance. ©AlphaMed Press.

  20. Impact of an Ivermectin Mass Drug Administration on Scabies Prevalence in a Remote Australian Aboriginal Community.

    Science.gov (United States)

    Kearns, Thérèse M; Speare, Richard; Cheng, Allen C; McCarthy, James; Carapetis, Jonathan R; Holt, Deborah C; Currie, Bart J; Page, Wendy; Shield, Jennifer; Gundjirryirr, Roslyn; Bundhala, Leanne; Mulholland, Eddie; Chatfield, Mark; Andrews, Ross M

    2015-10-01

    Scabies is endemic in many Aboriginal and Torres Strait Islander communities, with 69% of infants infected in the first year of life. We report the outcomes against scabies of two oral ivermectin mass drug administrations (MDAs) delivered 12 months apart in a remote Australian Aboriginal community. Utilizing a before and after study design, we measured scabies prevalence through population census with sequential MDAs at baseline and month 12. Surveys at months 6 and 18 determined disease acquisition and treatment failures. Scabies infestations were diagnosed clinically with additional laboratory investigations for crusted scabies. Non-pregnant participants weighing ≥15 kg were administered a single 200 μg/kg ivermectin dose, repeated after 2-3 weeks if scabies was diagnosed, others followed a standard alternative algorithm. We saw >1000 participants at each population census. Scabies prevalence fell from 4% at baseline to 1% at month 6. Prevalence rose to 9% at month 12 amongst the baseline cohort in association with an identified exposure to a presumptive crusted scabies case with a higher prevalence of 14% amongst new entries to the cohort. At month 18, scabies prevalence fell to 2%. Scabies acquisitions six months after each MDA were 1% and 2% whilst treatment failures were 6% and 5% respectively. Scabies prevalence reduced in the six months after each MDA with a low risk of acquisition (1-2%). However, in a setting where living conditions are conducive to high scabies transmissibility, exposure to presumptive crusted scabies and population mobility, a sustained reduction in prevalence was not achieved. Australian New Zealand Clinical Trial Register (ACTRN-12609000654257).

  1. Scabies community prevalence and mass drug administration in two Fijian villages.

    Science.gov (United States)

    Haar, Karin; Romani, Lucia; Filimone, Raikanikoda; Kishore, Kamal; Tuicakau, Meciusela; Koroivueta, Josefa; Kaldor, John M; Wand, Handan; Steer, Andrew; Whitfeld, Margot

    2014-06-01

    Scabies has been estimated to affect approximately 300 million people worldwide each year. Scabies rates are high and pose a significant public health problem in Fiji. Community-based comparison treatment trials have not been undertaken. We estimated scabies prevalence and compared the efficacy and tolerability of mass drug administration (MDA) of benzyl benzoate lotion (BB) or oral ivermectin (IVM) in two villages in Fiji. A prospective MDA trial was undertaken in two Fijian villages, comparing three daily applications of BB with single dose IVM or permethrin cream for those aged under two years. The therapies were offered to all community members regardless of the presence of scabies or its symptoms. The difference in prevalence was measured before and after the intervention and absolute risk reduction (ARR) and relative risk (RR) calculated. In the BB group, there were 572 eligible participants, of whom 435 (76%) enrolled and 201 (46%) returned for follow-up. In the IVM group, there were 667 eligible participants, of whom 325 (49%) enrolled and 126 (39%) returned. Scabies prevalence was lower after the intervention in both groups. It fell from 37.9 to 20.0% (ARR 18.0%; RR 0.52) in the BB group and from 23.7 to 9.5% (ARR 14.2%; RR 0.40) in the IVM group. Our study provides proof of principle that MDA for scabies can reduce scabies prevalence at the community level, and that there was no significant difference in this trial between BB and oral IVM. © 2013 The Authors. International Journal of Dermatology published by John Wiley & Sons Ltd on behalf of The International Society of Dermatology.

  2. Optimising strategies for Plasmodium falciparum malaria elimination in Cambodia: primaquine, mass drug administration and artemisinin resistance.

    Directory of Open Access Journals (Sweden)

    Richard J Maude

    Full Text Available Malaria elimination requires a variety of approaches individually optimized for different transmission settings. A recent field study in an area of low seasonal transmission in South West Cambodia demonstrated dramatic reductions in malaria parasite prevalence following both mass drug administration (MDA and high treatment coverage of symptomatic patients with artemisinin-piperaquine plus primaquine. This study employed multiple combined strategies and it was unclear what contribution each made to the reductions in malaria.A mathematical model fitted to the trial results was used to assess the effects of the various components of these interventions, design optimal elimination strategies, and explore their interactions with artemisinin resistance, which has recently been discovered in Western Cambodia. The modelling indicated that most of the initial reduction of P. falciparum malaria resulted from MDA with artemisinin-piperaquine. The subsequent continued decline and near elimination resulted mainly from high coverage with artemisinin-piperaquine treatment. Both these strategies were more effective with the addition of primaquine. MDA with artemisinin combination therapy (ACT increased the proportion of artemisinin resistant infections, although much less than treatment of symptomatic cases with ACT, and this increase was slowed by adding primaquine. Artemisinin resistance reduced the effectiveness of interventions using ACT when the prevalence of resistance was very high. The main results were robust to assumptions about primaquine action, and immunity.The key messages of these modelling results for policy makers were: high coverage with ACT treatment can produce a long-term reduction in malaria whereas the impact of MDA is generally only short-term; primaquine enhances the effect of ACT in eliminating malaria and reduces the increase in proportion of artemisinin resistant infections; parasite prevalence is a better surveillance measure for

  3. U.s. Food and Drug Administration approval: carfilzomib for the treatment of multiple myeloma.

    Science.gov (United States)

    Herndon, Thomas M; Deisseroth, Albert; Kaminskas, Edvardas; Kane, Robert C; Koti, Kallappa M; Rothmann, Mark D; Habtemariam, Bahru; Bullock, Julie; Bray, Jeffrey D; Hawes, Jessica; Palmby, Todd R; Jee, Josephine; Adams, William; Mahayni, Houda; Brown, Janice; Dorantes, Angelica; Sridhara, Rajeshwari; Farrell, Ann T; Pazdur, Richard

    2013-09-01

    The U.S. Food and Drug Administration (FDA) review leading to accelerated approval of carfilzomib is described. A single-arm trial enrolled 266 patients with multiple myeloma refractory to the most recent therapy who had received prior treatment with bortezomib and an immunomodulatory agent (IMID). Patients received carfilzomib by intravenous infusion over 2 to 10 minutes at a dose of 20 mg/m2 on days 1, 2, 8, 9, 15, and 16 of the 28 days of cycle 1, and at a dose of 27 mg/m2 on the same schedule in cycle 2 and subsequent cycles. The primary efficacy endpoint was overall response rate (ORR) as determined by an independent review committee using International Myeloma Working Group Uniform Response Criteria. The safety of carfilzomib was evaluated in 526 patients with multiple myeloma treated with various dosing regimens. The ORR was 23%. The median duration of response was 7.8 months. The most common adverse reactions associated with carfilzomib infusion were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and fever. The most common serious adverse events were pneumonia, acute renal failure, fever, and congestive heart failure. Infusion reactions to carfilzomib could be reduced by pretreatment with dexamethasone and intravenous fluids. On July 20, 2012, the FDA granted accelerated approval of carfilzomib for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an IMID and who have shown disease progression while on therapy or within 60 days of completion of the last therapy. ©2013 AACR.

  4. STABILITY AND COMPATIBILITY OF TAXOL WITH VARIOUS DRUGS DURING SIMULATED Y-SITE ADMINISTRATION

    Directory of Open Access Journals (Sweden)

    JIN PIL BURM

    2005-01-01

    Full Text Available This study evaluates the compatibility and stability of Taxol with ondansetron, ranitidine, vancomycin and cephalosporins in 5% dextrose injection and 0.9% sodium chloride injection during simulated Y-site administration. Two stock solutions of Taxol 0.3 and 1.2 mg/mL and each stock solutions of ondansetron 0.03, 0.1 and 0.3 mg/mL, ranitidine 0.5 and 2 mg/mL, vancomycin 1, 5 and 10 mg/mL and cephalosporins 20 mg/mL were prepared in glass bottles. Two mL of Taxol stock solution was mixed with 2 mL of each stock solution. Samples were removed at room temperature at time zero, one, two, four and 12 hours for immediate assay. Taxol concentrations were analyzed by High Performance Liquid Chromatography. All solutions were prepared in triplicate, and each drug was assayed in duplicate. At the time of sampling assay and before any dilution, each sample was visually inspected for clarity, color and precipitation. The pH was also determined. Taxol in concentrations of 0.3 and 1.2 mg/mL was stable when mixed with either ondansetron (0.03, 0.1 or 0.3 mg/mL, as the hydrochloride salt, ranitidine (0.5 or 2.0 mg/mL, as the hydrochloride salt, vancomycin (1, 5 or 10 mg/mL, as the hydrochloride salt or cephalosporins 20 mg/mL and stored in glass containers for 12 hours. No precipitates, color changes, or haziness was seen. The changes in pH were minor.

  5. Sulfites--a food and drug administration review of recalls and reported adverse events.

    Science.gov (United States)

    Timbo, Babgaleh; Koehler, Kathleen M; Wolyniak, Cecilia; Klontz, Karl C

    2004-08-01

    Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested > or = 10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

  6. Regulation and Device Development: Tips for Optimizing Your Experience With the Food and Drug Administration.

    Science.gov (United States)

    Brooks, Steven S

    2017-06-01

    Physician-inventors are in a unique position to identify unserved patient needs, and innovate solutions to clinical problems. These solutions may also have associated commercial opportunities. The logistics of developing these medical products, however, can seem a daunting task. One of the primary barriers in the United States is the regulatory process of the Food and Drug Administration (FDA). In this article, we will explore the risk-based approach used by the FDA which forms a framework to consider the regulatory pathway and the process to gain regulatory clearance or approval for medical devices. Inherent device properties and the procedural risk of the devices will determine the rigor with which they are scrutinized by FDA, and the evidentiary requirements to legally market them. Data and evidentiary development will vary depending on risk and regulatory precedent and may or may not require clinical data This regulatory paradigm will determine into which risk-based device class they fit, and whether they are regulated under the 510(k) or premarket approval application pathways. The FDA, although gatekeeper of the US market and tasked with determining which products are safe and effective, can be a powerful ally for product development. They have significant scientific and medical expertise, and mechanisms to both provide guidance, and also to consider novel approaches to product development and evidence development. Early interaction for routine and novel products alike can result in expedited and efficient development. This collaborative approach can be best practice to most expeditiously develop the next generation of products, getting them into the hands of US doctors and into the treatment of US patients. Copyright © 2017. Published by Elsevier Inc.

  7. Hair analysis does not allow to discriminate between acute and chronic administrations of a drug in young children.

    Science.gov (United States)

    Alvarez, Jean Claude; Lasne, Laetitia; Etting, Isabelle; Chéron, Gérard; Abadie, Véronique; Fabresse, Nicolas; Larabi, Islam Amine

    2018-01-01

    There are many differences between the hair from children and that of adult subjects, the hair being thinner, more porous with a different growth rate from the usual 1 cm/month observed in adults. In order to determine whether hair analysis could discriminate between chronic use and acute administration of a drug in children like in adults, we analyzed hair from 18 children aged between 1 day and 15 years in whom the administration of different drugs was known (single therapeutic administration or acute intoxication). A strand of hair was sampled within 1 to 45 days after treatment or intoxication. Analysis was conducted using LC/MS/MS. In the 10 youngest children, aged between 1 day and 29 months, the compounds administered in hospital or responsible for intoxication (lidocaine, ropivacaine, diazepam, midazolam, levetiracetam, morphine, ketamine, methadone, buprenorphine, THC, MDMA) were found in all segments of the hair independently of the time of sampling (1-45 days after ingestion). The concentrations detected were similar along the hair shaft, showing a radial diffusion and incorporation of the analytes in the hair of young children from the sebum. Concentrations could be very high when sampled shortly after administration (72 ng/mg for methadone, 75 ng/mg for MDMA after 3 days) and lower when sampling later (1.2 ng/mg for MDMA after 45 days). In these cases, hair analysis allowed to highlight the compounds responsible for intoxication even when they had disappeared from the blood or urine but should not be used to discriminate long-term exposure to a drug. In the eight remaining children aged from 34 months to 15 years, the drugs used in hospital (lidocaine, diazepam, morphine) or responsible for intoxication (THC, codeine, buprenorphine) were not found in any analyzed segments sampled 1 to 5 days after administration of the drugs, in agreement with the non-incorporation of the drugs from the sebum into the hair. For those children aged over

  8. William Bennett and the "Good War" against Drugs: Doublespeak and the Bush Administration's Hidden Agenda.

    Science.gov (United States)

    Massey, Tom

    This paper contends that former Secretary of Education William Bennett's "war on drugs" (he now directs the government's campaign against drugs) is not being waged against those who sell and use drugs, but against the civil liberties of everyone. The paper maintains that under the guise of ridding society of what President Bush called…

  9. Time-course measurements of drug concentrations in hair and toenails after single administrations of pharmaceutical products.

    Science.gov (United States)

    Kuwayama, Kenji; Miyaguchi, Hajime; Iwata, Yuko T; Kanamori, Tatsuyuki; Tsujikawa, Kenji; Yamamuro, Tadashi; Segawa, Hiroki; Inoue, Hiroyuki

    2017-04-01

    Hair and nails are often used to prove long-term intake of drugs in forensic drug testing. The aim of this study was to evaluate the effectiveness of drug testing using hair and nails and the feasibility of determining when drugs were ingested by measuring the time-courses of drug concentrations in hair and toenails after single administrations of various drugs. Healthy subjects ingested four pharmaceutical products containing eight active ingredients in single doses. Hair and toenails were collected at predetermined intervals, and drug concentrations in hair and nails were measured for 12 months. The administered drugs and their main metabolites were extracted using micropulverized extraction with a stainless steel bullet and were analyzed using liquid chromatography/tandem mass spectrometry. Acidic compounds such as ibuprofen and its metabolites were not detected in both specimens. Acetaminophen, a weakly acidic compound, was detected in nails more frequently than in hair. The maximum concentration of allyl isopropyl acetylurea, a neutral compound, in nails was significantly higher than in hair. Nails are an effective specimen to detect neutral and weakly acidic compounds. For fexofenadine, a zwitterionic compound, and for most basic compounds, the maximum concentrations in hair segments tended to be higher than those in nails. The hair segments showing the maximum concentrations varied between drugs, samples, and subjects. Drug concentrations in hair segments greatly depended on the selection of the hair. Careful interpretation of analytical results is required to predict the time of drug intake. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  10. Compliance notices – A new tool in environmental enforcement ...

    African Journals Online (AJOL)

    This note examines compliance notices, a new administrative remedy that has been created to assist in compliance and enforcement of environmental laws. The note considers the aim and scope of compliance and the process of issuing a compliance notice. In addition, it reflects on objections to compliance notices as well ...

  11. Community perceptions of targeted anti-malarial mass drug administrations in two provinces in Vietnam: a quantitative survey.

    Science.gov (United States)

    Nguyen, Thuy-Nhien; Thu, Pham N Huong; Hung, Ngo Trong; Son, Do Hung; Tien, Nguyen Thanh; Van Dung, Nguyen; Quang, Huynh Hong; Seidlein, Lorenz von; Cheah, Phaik Yeong; Dondorp, Arjen M; Day, Nicholas P J; White, Nicholas J; Hien, Tran Tinh

    2017-01-06

    As part of a targeted malaria elimination project, mass drug administrations (MDAs) were conducted in Vietnam. The impact of MDAs on malaria transmission depends largely on the efficacy of the anti-malarial drug regimen, the malaria epidemiology in the site and the population coverage. To explore why some people participate in MDAs and others do not, a quantitative survey of the villagers' perceptions was undertaken in Vietnam. In 2013/2014 MDAs were conducted in a village in Binh Phuoc province and a village in Ninh Thuan province. Within three months of the drug administration, 59 respondents in a village in Binh Phuoc and 79 respondents in a village in Ninh Thuan were randomly selected and interviewed. Comprehension of the purpose of the intervention was of paramount importance for participation in the intervention. Respondents aware that the intervention aims to protect against malaria were significantly more likely to participate than respondents who were unaware of the MDA's purpose. Secondly, how and by whom villagers were informed was critical for participation. There was a strong association between sensitization by an informant such as a member of the local health team with participation in the intervention. The study suggests several approaches to increase participation in mass drug administration campaigns. Training trustworthy informants to sensitize the study population is critical to maximize village participation in this setting. To achieve high coverage the entire community must understand and agree with the intervention.

  12. Administration of Drug Induce Liver Injury to the Inpatients with Liver Disease

    Directory of Open Access Journals (Sweden)

    Sindy E. Cinthya

    2012-06-01

    Full Text Available Drug induced liver injury is a serious human health problems. Pre-existing liver diseases are risk factor of liver injury by the drugs. The study was conducted to evaluate the use of drug induced liver injury in patients hospitalized with liver disease at one hospital in Kota Tasikmalaya. Informations were collected retrospectively in the period 2010-2011 from the patient’s medical record. A total of 52 patients research subjects were discovered 50 patients (96% using drug induced liver injury and 2 patients (4% did not use it. Drug induced liver injury most widely used were ranitidine (31.3%, ceftriaxone (23.1%, and paracetamol (16.4%. Level of the DILI usage in patient with liver disease was relative high (96%. Further research is needed to determine the effect of the drug induced liver injury to liver injury.

  13. Strongyloides seroprevalence before and after an ivermectin mass drug administration in a remote Australian Aboriginal community.

    Directory of Open Access Journals (Sweden)

    Therese M Kearns

    2017-05-01

    Full Text Available Strongyloides seroprevalence is hyper-endemic in many Australian Aboriginal and Torres Strait Islander communities, ranging from 35-60%. We report the impact on Strongyloides seroprevalence after two oral ivermectin mass drug administrations (MDAs delivered 12 months apart in a remote Australian Aboriginal community.Utilizing a before and after study design, we measured Strongyloides seroprevalence through population census with sequential MDAs at baseline and month 12. Surveys at months 6 and 18 determined changes in serostatus. Serodiagnosis was undertaken by ELISA that used sonicated Strongyloides ratti antigen to detect anti-Strongyloides IgG. Non-pregnant participants weighing ≥15 kg were administered a single 200 μg/kg ivermectin dose, repeated after 10-42 days if Strongyloides and/or scabies was diagnosed; others followed a standard alternative algorithm. A questionnaire on clinical symptoms was administered to identify adverse events from treatment and self-reported symptoms associated with serostatus.We surveyed 1013 participants at the baseline population census and 1060 (n = 700 from baseline cohort and 360 new entrants at month 12. Strongyloides seroprevalence fell from 21% (175/818 at baseline to 5% at month 6. For participants from the baseline cohort this reduction was sustained at month 12 (34/618, 6%, falling to 2% at month 18 after the second MDA. For new entrants to the cohort at month 12, seroprevalence reduced from 25% (75/297 to 7% at month 18. Strongyloides positive seroconversions for the baseline cohort six months after each MDA were 2.5% (4/157 at month 6 and 1% at month 18, whilst failure to serorevert remained unchanged at 18%. At 12 months, eosinophilia was identified in 59% of baseline seropositive participants and 89% of seropositive new entrants, compared with 47%baseline seronegative participants and 51% seronegative new entrants. Seropositivity was not correlated with haemoglobin or any self-reported clinical

  14. Is mass drug administration against lymphatic filariasis required in urban settings? The experience in Kano, Nigeria.

    Science.gov (United States)

    Pam, Dung D; de Souza, Dziedzom K; D'Souza, Susan; Opoku, Millicent; Sanda, Safiya; Nazaradden, Ibrahim; Anagbogu, Ifeoma N; Okoronkwo, Chukwu; Davies, Emmanuel; Elhassan, Elisabeth; Molyneux, David H; Bockarie, Moses J; Koudou, Benjamin G

    2017-10-01

    The Global Programme to Eliminate Lymphatic Filariasis (GPELF), launched in 2000, has the target of eliminating the disease as a public health problem by the year 2020. The strategy adopted is mass drug administration (MDA) to all eligible individuals in endemic communities and the implementation of measures to reduce the morbidity of those suffering from chronic disease. Success has been recorded in many rural endemic communities in which elimination efforts have centered. However, implementation has been challenging in several urban African cities. The large cities of West Africa, exemplified in Nigeria in Kano are challenging for LF elimination program because reaching 65% therapeutic coverage during MDA is difficult. There is therefore a need to define a strategy which could complement MDA. Thus, in Kano State, Nigeria, while LF MDA had reached 33 of the 44 Local Government Areas (LGAs) there remained eleven 'urban' LGAs which had not been covered by MDA. Given the challenges of achieving at least 65% coverage during MDA implementation over several years in order to achieve elimination, it may be challenging to eliminate LF in such settings. In order to plan the LF control activities, this study was undertaken to confirm the LF infection prevalence in the human and mosquito populations in three urban LGAs. The prevalence of circulating filarial antigen (CFA) of Wuchereria bancrofti was assessed by an immuno-chromatography test (ICT) in 981 people in three urban LGAs of Kano state, Nigeria. Mosquitoes were collected over a period of 4 months from May to August 2015 using exit traps, gravid traps and pyrethrum knock-down spray sheet collections (PSC) in different households. A proportion of mosquitoes were analyzed for W. bancrofti, using dissection, loop-mediated isothermal amplification (LAMP) assay and conventional polymerase chain reaction (PCR). The results showed that none of the 981 subjects (constituted of West Africa may not be of significant importance

  15. Maintaining effective mass drug administration for lymphatic filariasis through in-process monitoring in Sierra Leone

    Directory of Open Access Journals (Sweden)

    Hodges Mary H

    2012-10-01

    Full Text Available Abstract Background Since 2007 Sierra Leone has conducted mass drug administration (MDA for the elimination of lymphatic filariasis (LF implemented by unpaid community health volunteers (CHVs. Other health campaigns such as Mother and Child Health Weeks (MCHW pay for services to be implemented at community level and these persons are then known as community health workers (CHWs. In 2010, the LF MDA in the 12 districts of the Southern, Northern and Eastern Provinces un-expectantly coincided with universal distribution of Long Lasting Insecticide Treated Nets (LLITNs during the MCHW. In-process monitoring of LF MDA was performed to ensure effective coverage was attained in hard to reach sites (HTR in both urban and rural locations where vulnerable populations reside. Methods Independent monitors interviewed individuals eligible for LF MDA and tallied those who recalled having taken ivermectin and albendazole, calculated program coverage and reported results daily by phone. Monitoring of coverage in HTR sites in the 4 most rapidly urbanizing towns was performed after 4 weeks of LF MDA and again after 8 weeks throughout all 12 districts. End process monitoring was performed in randomly selected HTR sites not previously sampled throughout all 12 districts and compared to coverage calculated from the pre-MDA census and reported treatments. Results Only one town had reached effective program coverage (≥80% after 4 weeks following which CHWs were recruited for LF MDA in all district headquarter towns. After 8 weeks only 4 of 12 districts had reached effective coverage so LF MDA was extended for a further month in all districts. By 12 weeks effective program coverage had been reached in all districts except Port Loko and there was no significant difference between those interviewed in communities versus households or by sex. Effective epidemiological coverage (≥65% was reported in all districts and overall was significantly higher in males versus

  16. Individual and contextual determinants of regional variation in prescription drug use: an analysis of administrative data from British Columbia.

    Directory of Open Access Journals (Sweden)

    Steven G Morgan

    2010-12-01

    Full Text Available Increasing attention is being paid to variations in the use of prescription drugs because their role in health care has grown to the point where their use can be considered a proxy for health system performance. Studies have shown that prescription drug use varies across regions in the US, UK, and Canada by more than would be predicted based on age and health status alone. In this paper, we explore the determinants of variations in the use of prescription drugs, drawing on health services theories of access to care.We conducted a cross-sectional analysis using population-based administrative health care data for British Columbia (BC, Canada. We used logistic and hierarchical regressions to analyze the effects of individual- and area-level determinants of use of prescriptions overall and rates of purchase of prescriptions from five therapeutic categories representing a range of indications: antihypertensives, statins, acid reducing drugs, opioid drugs, and antidepressants. To indicate the relative scale of regional variations and the importance of individual- and area-level variables in explaining them, we computed standardized rates of utilization for 49 local health areas in BC.We found that characteristics of individuals and the areas in which they live affect likelihood of prescription drug purchase. Individual-level factors influenced prescription drug purchases in ways generally consistent with behavioral models of health services use. Contextual variables exerted influences that differed by type of drug studied. Population health, education levels, and ethnic composition of local areas were associated with significant differences in the likelihood of purchasing medications. Relatively modest regional variations remained after both individual-level and area-level determinants were taken into account.The results of this study suggest that individual- and area-level factors should be considered when studying variations in the use of

  17. Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors

    OpenAIRE

    Lu, Christine Y.; Zhang, Fang; Lakoma, Matthew D.; Butler, Melissa G.; Fung, Vicki; Larkin, Emma K.; Kharbanda, Elyse O.; Vollmer, William M.; Lieu, Tracy; Soumerai, Stephen B.; Wu, Ann Chen

    2015-01-01

    Purpose In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods We analyzed data (2005–2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and L...

  18. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Science.gov (United States)

    2010-02-01

    ... regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate... the Federal Food, Drug, and Cosmetic Act as a nonprescription drug (21 U.S.C. 802(45)(A), 21 CFR 1300... requirements, which were promulgated in 21 CFR, part 1314, include, but are not limited to: Packaging...

  19. 75 FR 49552 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-08-13

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... Bluewater Michigan Chapter, Inc. National Railway Historical Society (Bluewater), requests a waiver from...

  20. Physical compatibility of tedizolid phosphate with selected i.v. drugs during simulated Y-site administration.

    Science.gov (United States)

    Ghazi, Islam; Hamada, Yukihiro; Nicolau, David P

    2016-11-01

    The physical compatibility of commonly used agents that could be coadministered in the clinical setting with tedizolid phosphate during Y-site administration was evaluated. Tedizolid phosphate vials were reconstituted to a final concentration of 0.8 mg/mL. All other drugs were prepared according to manufacturers' recommendations and diluted with 0.9% sodium chloride injection (where applicable) to the highest standard concentrations used clinically. Y-site conditions were simulated in culture tubes by mixing 5 mL of tedizolid phosphate solution with 5 mL of the test drug solutions. The physical characteristics, turbidity, and pH of all admixtures were examined immediately after mixing and at 15, 60, and 120 minutes. Incompatibility was defined as gross precipitation, a positive Tyndall beam test, color changes, or increases in turbidity. With simulated Y-site administration, tedizolid phosphate was compatible with 69 of 86 drugs in 0.9% sodium chloride injection, including 24 of 31 antimicrobial agents. Of note, incompatibility was observed immediately after mixing except with ceftaroline and diphenhydramine, whose incompatibility with tedizolid phosphate was apparent after 15 and 60 minutes, respectively. Among the drug classes tested, tedizolid phosphate was compatible only with 1 aminoglycoside (amikacin) and incompatible with 1 echinocandin (caspofungin) and 1 cephalosporin (ceftaroline). In addition, tedizolid phosphate was incompatible with divalent cations (calcium chloride, calcium gluconate, and magnesium sulfate), probably due to precipitation with the phosphate component. A pH change of >1 unit occurred only with epinephrine (at 120 minutes). Tedizolid phosphate 0.8 mg/mL in 0.9% sodium chloride injection was physically compatible with 69 of 86 study drugs during simulated Y-site administration. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  1. ANALYSIS OF DISEASE MODIFYING DRUGS ADMINISTRATION FREGUENCY AND CAUSES OF THEIR WITHDRAWAL IN RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    E V Pavlova

    2000-01-01

    Full Text Available Aim of studdy: To assess the frequency of practical application of different basic drugs in rheumatoid arthritis (RA. Material and methods: Tlxe study was conducted basing of questionner of pts and analysis of ycases by randomized sampling among 103 consequent pts (M:F= 13:90 with reliable RA (ARA, 1987 in rheumatologic department of Clinical Hospital Nol in Ekaterinburg. 74% of pts under study demonstrated systemic manifestations: anemia (in 47 pts, lymphadenopathy (in 34, rheumatoid nodules (in 15, Sjogren s syndrome (in 4, nephropathy (in 4, vascular disturbances including Raynaud s phenomenon, capillarites (by 1 pt. Results: In the course of disease basic therapy was prescribed to 88 out of103 (85.4% pts and one and the same patient could take different basic drugs. Aminochinoline drugs prevailed, after them more frequent were immunodepressants and gold preparations. More rarely pts had sulfasalazin, cuprenil and wobenzym. In general, in 133 out of 184 cases of prescribing basic drugs they were canceled. The reason for cancellation were: prevalently absence of the drug in the pharmaceutical stores (in 48 cases averagely in 8 months of taking the drug; then they insufficient efficacy (44 cases averagely in 1.3 year. In 18 cases pts themselves stopped treatment averagely in 3.5 months of drug taking. Conclusion: In the majority of cases of basic drugs cancellation in RA the cause is their absence in sail especially on free of charge prescription. Cases ofself-cancellation of the drug demonstrate the need of explaining to pts the necessity> of long-term taking disease-modifying drugs.

  2. Dopamine D1 and D3 receptors mediate reconsolidation of cocaine memories in mouse models of drug self-administration.

    Science.gov (United States)

    Yan, Y; Newman, A H; Xu, M

    2014-10-10

    Memories of drug experience and drug-associated environmental cues can elicit drug-seeking and taking behaviors in humans. Disruption of reconsolidation of drug memories dampens previous memories and therefore may provide a useful way to treat drug abuse. We and others previously demonstrated that dopamine D1 and D3 receptors play differential roles in acquiring cocaine-induced behaviors. Moreover, D3 receptors contribute to the reconsolidation of cocaine-induced conditioned place preference. In the present study, we examined effects of manipulating D1 or D3 receptors on reconsolidation of cocaine memories in mouse models of drug self-administration. We found that pharmacological blockade of D1 receptors or a genetic mutation of the D3 receptor gene attenuated reconsolidation that lasted for at least 1week after the memory retrieval. In contrast, with no memory retrieval, pharmacological antagonism of D1 receptors or the D3 receptor gene mutation did not significantly affect reconsolidation of cocaine memories. Pharmacological blockade of D3 receptors also attenuated reconsolidation in wild-type mice that lasted for at least 1week after the memory retrieval. These results suggest that D1 and D3 receptors and related signaling mechanisms play key roles in reconsolidation of cocaine memories in mice, and that these receptors may serve as novel targets for the treatment of cocaine abuse in humans. Copyright © 2014 IBRO. All rights reserved.

  3. Factors related to compliance to anti-malarial drug combination: example of amodiaquine/sulphadoxine-pyrimethamine among children in rural Senegal

    Directory of Open Access Journals (Sweden)

    Sow Diarietou

    2009-06-01

    Full Text Available Abstract Background The introduction of new anti-malarial treatment that is effective, but more expensive, raises questions about whether the high level of effectiveness observed in clinical trials can be found in a context of family use. The objective of this study was to determine the factors related to adherence, when using the amodiaquine/sulphadoxine-pyrimethamine (AQ/SP association, a transitory strategy before ACT implementation in Senegal. Methods The study was conducted in five rural dispensaries. Children, between two and 10 years of age, who presented mild malaria were recruited at the time of the consultation and were prescribed AQ/SP. The child's primary caretaker was questioned at home on D3 about treatment compliance and factors that could have influenced his or her adherence to treatment. A logistic regression model was used for the analyses. Results The study sample included 289 children. The adherence rate was 64.7%. Two risks factors for non-adherence were identified: the children's age (8–10 years (ORa = 3.07 [1.49–6.29]; p = 0.004; and the profession of the head of household (retailer/employee versus farmer (ORa = 2.71 [1.34–5.48]; p = 0.006. Previously seeking care (ORa = 0.28 [0.105–0.736], p=0.001] satisfaction with received information (ORa = 0.45 [0.24–0.84]; p = 0.013, and the quality of history taking (ORa = 0.38 [0.21–0.69]; p = 0.001 were significantly associated with good compliance. Conclusion The results of the study show the importance of information and communication between caregivers and health center staff. The experience gained from this therapeutic transition emphasizes the importance of information given to the patients at the time of the consultation and drug delivery in order to improve drug use and thus prevent the emergence of rapid drug resistance.

  4. No Pharmacokinetic Drug-Drug Interaction Between Prasugrel and Vorapaxar Following Multiple-Dose Administration in Healthy Volunteers.

    Science.gov (United States)

    Anderson, Matt S; Kosoglou, Teddy; Statkevich, Paul; Li, Jing; Rotonda, Jennifer; Meehan, Alan G; Cutler, David L

    2018-02-01

    Vorapaxar is a first-in-class antagonist of the protease-activated receptor-1, the primary thrombin receptor on human platelets, which mediates the downstream effects of thrombin in hemostasis and thrombosis. Prasugrel is a platelet inhibitor that acts as a P2Y12 receptor antagonist through an active metabolite, R-138727. This study investigated the interaction of these 2 platelet antagonists when coadministered. This was a randomized, open-label, multiple-dose study in 54 healthy volunteers consisting of a fixed-sequence crossover and a parallel group design. In sequence 1, 36 subjects received prasugrel 60 mg on day 1 and then prasugrel 10 mg once daily on days 2 to 7, followed by vorapaxar 40 mg and prasugrel 10 mg on day 8 and then vorapaxar 2.5 mg and prasugrel 10 mg orally once daily on days 9 to 28. In sequence 2, 18 subjects received vorapaxar 40 mg on day 1 and then vorapaxar 2.5 mg once daily on days 2 to 21. The geometric mean ratios (90% confidence intervals) for AUCτ and C max of coadministration/monotherapy for vorapaxar (0.93 ng·h/mL[0.85-1.02 ng·h/mL] and 0.95 ng/mL [0.86-1.05 ng/mL]) and R-138727 (0.91 ng·h/mL [0.85- 0.99 ng·h/mL] and 1.02 ng/mL [0.89-1.17 ng/mL]) were within prespecified bounds, demonstrating the absence of a pharmacokinetic interaction between vorapaxar and prasugrel. There was no specific safety or tolerability risk associated with multiple-dose coadministration of vorapaxar and prasugrel. In conclusion, in this study in healthy volunteers, there was no pharmacokinetic drug-drug interaction between vorapaxar and prasugrel. Multiple-dose coadministration of the 2 drugs was generally well tolerated. © 2017, The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  5. Investigations on Clonazepam Loaded Polymeric Micelle-like Nanoparticles for Safe Drug Administration During Pregnancy.

    Science.gov (United States)

    Sezgin-Bayindir, Zerrin; Elcin, Ayse Eser; Parmaksiz, Mahmut; Elcin, Yasar Murat; Yuksel, Nilufer

    2018-03-01

    Medication during pregnancy is often a necessity for women to treat their acute or chronic diseases. The goal of this study is to evaluate the potential of micelle-like nanoparticles (MNP) for providing safe drug usage in pregnancy and protect both fetus and mother from medication side effects. Clonazepam loaded MNP were prepared from copolymers (polystyrene-poly(acrylic acid) (PS-PAA), poly(ethylene glycol)-b-poly(lactic acid) (PEG-PLA) and distearyl-sn-glycero-3-phosphoethanolamine-N-[methoxy-poly(ethylene glycol) (PEG-DSPE)) with varying monomer ratios and their drug loading efficiency, drug release ratio, particle size, surface charge and morphology were characterized. The cellular transport and cytotoxicity experiments were conducted on clonazepam and MNP formulations using placenta-choriocarcinoma-BeWo and brain-endothelial-bEnd3 cells. Clonazepam loaded PEG 5000 -PLA 4500 MNP reduced the drug transport through BeWo cells demonstrating that MNP may lower fetal drug exposure, thus reduce the drug side effects. However, lipofectamine modified MNP improved the transport of clonazepam and found to be promising for brain and in-utero specific drug treatment.

  6. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Abdel-Sattar, Maher; Bero, Lisa

    2015-01-01

    OBJECTIVES: To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports. STUDY DESIGN AND SETTING: This is a cross-sectional study. All new molecular drugs approved between Janua...

  7. USE OF INTERFERON BETA-1A FOR INTRAMUSCULAR ADMINISTRATION IN CHILDREN AND ADOLESCENTS WITH MULTIPLE SCLEROSIS: EFFICACY, SAFETY AND ADHERENCE TO THERAPY

    Directory of Open Access Journals (Sweden)

    O.V. Bykova

    2009-01-01

    Full Text Available Immunomodulatory drugs reduce relapse rate and disease progression in relapsing-remitting multiple sclerosis but extensive data are not available on the effectiveness and tolerability of these drugs in childhood or adolescence. Interferon beta tolerability biased by frequency and method of drug administration. Drug administration has great impact on treatment compliance and adherence. That’s why we discuss moreover interferon beta 1a intramuscular as perspective immunomodulative medication in pediatric MS cohort.Key words: immunomodulatory drugs, interferon beta, multiple sclerosis, compliance, adherence, adolescence, childhood.

  8. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0277... Adolescents'' is available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatory... Tobacco to Protect Children and Adolescents.'' It does not create or confer any rights for or on any...

  9. Pentobarbital self-administration in rhesus monkeys: drug concentration and fixed-ratio size interactions.

    OpenAIRE

    Lemaire, G A; Meisch, R A

    1984-01-01

    Performances of three rhesus monkeys were reinforced by the oral delivery of pentobarbital and studied as functions of fixed-ratio size and drug concentration. Pentobarbital solutions and water were concurrently available on identical reinforcement schedules from separate liquid-delivery systems during 3-hour sessions. Under a fixed-ratio 16 schedule of drug availability, a descending series of drug concentrations was tested (4, 2, 1, 0.5, 0.25, 0.125, and 0.0625 mg/ml, followed by a retest a...

  10. Performing compliance

    DEFF Research Database (Denmark)

    Wimmelmann, Camilla Lawaetz

    2017-01-01

    the local policy workers front-staged some practices in the implementation process and back-staged others. The local policy workers deliberately performed ‘guideline compliance’ by using information control and impression management techniques. The findings suggest that local guideline compliance should...... be regarded as a staged performance in which deliberate techniques are used to produce and manage certain impressions of compliance....

  11. Compliance status

    International Nuclear Information System (INIS)

    Black, D.G.

    1995-01-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford's compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute

  12. Is mass drug administration against lymphatic filariasis required in urban settings? The experience in Kano, Nigeria.

    Directory of Open Access Journals (Sweden)

    Dung D Pam

    2017-10-01

    Full Text Available The Global Programme to Eliminate Lymphatic Filariasis (GPELF, launched in 2000, has the target of eliminating the disease as a public health problem by the year 2020. The strategy adopted is mass drug administration (MDA to all eligible individuals in endemic communities and the implementation of measures to reduce the morbidity of those suffering from chronic disease. Success has been recorded in many rural endemic communities in which elimination efforts have centered. However, implementation has been challenging in several urban African cities. The large cities of West Africa, exemplified in Nigeria in Kano are challenging for LF elimination program because reaching 65% therapeutic coverage during MDA is difficult. There is therefore a need to define a strategy which could complement MDA. Thus, in Kano State, Nigeria, while LF MDA had reached 33 of the 44 Local Government Areas (LGAs there remained eleven 'urban' LGAs which had not been covered by MDA. Given the challenges of achieving at least 65% coverage during MDA implementation over several years in order to achieve elimination, it may be challenging to eliminate LF in such settings. In order to plan the LF control activities, this study was undertaken to confirm the LF infection prevalence in the human and mosquito populations in three urban LGAs.The prevalence of circulating filarial antigen (CFA of Wuchereria bancrofti was assessed by an immuno-chromatography test (ICT in 981 people in three urban LGAs of Kano state, Nigeria. Mosquitoes were collected over a period of 4 months from May to August 2015 using exit traps, gravid traps and pyrethrum knock-down spray sheet collections (PSC in different households. A proportion of mosquitoes were analyzed for W. bancrofti, using dissection, loop-mediated isothermal amplification (LAMP assay and conventional polymerase chain reaction (PCR.The results showed that none of the 981 subjects (constituted of <21% of children 5-10 years old tested

  13. 5 CFR 2424.41 - Compliance.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Compliance. 2424.41 Section 2424.41... FEDERAL LABOR RELATIONS AUTHORITY NEGOTIABILITY PROCEEDINGS Decision and Order § 2424.41 Compliance. The... compliance with its order, including enforcement under 5 U.S.C. 7123(b). ...

  14. 5 CFR 900.604 - Compliance.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Compliance. 900.604 Section 900.604... Compliance. (a) Certification by Chief Executives. (1) Certification of agreement by a chief executive of a... of certification by the chief executive, compliance with the Standards may be certified by the heads...

  15. 10 CFR 850.13 - Compliance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Compliance. 850.13 Section 850.13 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Administrative Requirements § 850.13 Compliance. (a) The responsible employer must conduct activities in compliance with its CBDPP. (b) The responsible...

  16. 5 CFR 304.108 - Compliance.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Compliance. 304.108 Section 304.108... APPOINTMENTS § 304.108 Compliance. (a) Each agency using 5 U.S.C. 3109 must establish and maintain a system of controls and oversight necessary to assure compliance with 5 U.S.C. 3109 and these regulations. The system...

  17. 22 CFR 209.6 - Compliance information.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Compliance information. 209.6 Section 209.6... § 209.6 Compliance information. (a) Cooperation and assistance. The Administrator shall to the fullest... and accurate compliance reports at such times, and in such form and containing such information, as...

  18. A Practical Methodology for Disaggregating the Drivers of Drug Costs Using Administrative Data.

    Science.gov (United States)

    Lungu, Elena R; Manti, Orlando J; Levine, Mitchell A H; Clark, Douglas A; Potashnik, Tanya M; McKinley, Carol I

    2017-09-01

    Prescription drug expenditures represent a significant component of health care costs in Canada, with estimates of $28.8 billion spent in 2014. Identifying the major cost drivers and the effect they have on prescription drug expenditures allows policy makers and researchers to interpret current cost pressures and anticipate future expenditure levels. To identify the major drivers of prescription drug costs and to develop a methodology to disaggregate the impact of each of the individual drivers. The methodology proposed in this study uses the Laspeyres approach for cost decomposition. This approach isolates the effect of the change in a specific factor (e.g., price) by holding the other factor(s) (e.g., quantity) constant at the base-period value. The Laspeyres approach is expanded to a multi-factorial framework to isolate and quantify several factors that drive prescription drug cost. Three broad categories of effects are considered: volume, price and drug-mix effects. For each category, important sub-effects are quantified. This study presents a new and comprehensive methodology for decomposing the change in prescription drug costs over time including step-by-step demonstrations of how the formulas were derived. This methodology has practical applications for health policy decision makers and can aid researchers in conducting cost driver analyses. The methodology can be adjusted depending on the purpose and analytical depth of the research and data availability. © 2017 Journal of Population Therapeutics and Clinical Pharmacology. All rights reserved.

  19. Intranasal administration of carbamazepine-loaded carboxymethyl chitosan nanoparticles for drug delivery to the brain

    Directory of Open Access Journals (Sweden)

    Shanshan Liu

    2018-01-01

    Full Text Available Epilepsy is considered as a common and diverse set of chronic neurological disorders and its symptoms can be controlled by antiepileptic drugs (AEDs. The presence of p-glycoprotein and multi-drug resistance transporters in the blood-brain barrier could prevent the entry of AEDs into the brain, causing drug resistant epilepsy. To overcome this problem, we propose using carboxymethyl chitosan nanoparticles as a carrier to deliver carbamazepine (CBZ intra-nasally with the purpose to bypass the blood-brain barrier thus to enhance the brain drug concentration and the treatment efficacy. Results so far indicate that the developed CBZ-NPs have small particle size (218.76 ± 2.41 nm with high drug loading (around 35% and high entrapment efficiency (around 80%. The in vitro release profiles of CBZ from the NPs are in accordance with the Korsmeyer-peppas model. The in vivo results show that both encapsulation of CBZ in nanoparticles and the nasal route determined the enhancement of the drug bioavailability and brain targeting characteristics.

  20. Evaluation of brain targeting and mucosal integrity of nasally administrated nanostructured carriers of a CNS active drug, clonazepam.

    Science.gov (United States)

    Abdel-Bar, Hend Mohamed; Abdel-Reheem, Amal Youssef; Awad, Gehanne Abdel Samie; Mortada, Nahed Daoud

    2013-01-01

    The aim of the study was to target clonazepam, a CNS active drug, to the brain through the non-invasive intranasal (in) route using of nanocarriers with proven safety in clonazepam nanocarriers were prepared by mixing isopropyl myristate, Tween 80, Cremophor EL or lecithin, polyethylene glycol 200, propylene glycol or ethanol in different ratios with water. in-vitro characterization of the nanocarriers was done by various methods including: polarized light microscopy, particle size determination, viscosity measurements and drug release studies. in-vivo study comparing intranasal and intravenous administration was performed. The drug targeting efficiency (DTE %) and direct nose to brain transport percentage (DTP %) were calculated and nasal integrity assessment was carried out. The obtained formulae had particle size below 100 nm favoring rapid direct nose to brain transport and the time for 100% drug release (T100%) depended on systems composition. Plasma Tmax of clonazepam nanostructured carriers varied from 10-30 min., while their brain Tmax did not exceed 10 min, in comparison with 30 min for iv solution. Although there was no significant difference (p>0.05) between the plasma AUC0-∞ of the different tested nanocarriers and intravenous one, the increase in brain AUC 0 -∞ of different nasal formulations in comparison to that of iv administration (3.6 -7.2 fold) confirms direct nose to brain transport via olfactory region. Furthermore, DTE and DTP% confirmed brain targeting of clonazepam following intranasal administration. The results confirmed that intranasal nanocarriers were proved to be safe alternative for iv clonazepam delivery with rapid nose to brain transport.

  1. Physical compatibility of various drugs with neonatal total parenteral nutrient solution during simulated Y-site administration.

    Science.gov (United States)

    Fox, Laura M; Wilder, Alyson G; Foushee, Jaime A

    2013-03-15

    The physical compatibility of various drugs with neonatal total parenteral nutrient (TPN) solution during simulated Y-site administration was evaluated. Study drugs were selected based on the lack of compatibility data with them and neonatal TPN solution and the frequency of use in a local neonatal unit. These drugs included amiodarone, caffeine citrate, clindamycin, enalaprilat, epinephrine, fluconazole, fosphenytoin sodium, hydrocortisone, metoclopramide, midazolam, pentobarbital, phenobarbital, and rifampin. Equal volumes of neonatal TPN solution or sterile water for injection were combined with study drugs or sterile water for injection at concentrations used clinically in neonates. Each test was performed in triplicate. The samples were examined via turbidimetric analysis and visually against light and dark backgrounds immediately after mixing and at 0.25, 0.5, 1, 2, and 3 hours after mixing. Analysis of variance was used to determine statistically significant differences between the test and control solutions. Many of the drugs studied exhibited no visual or turbidimetric evidence of incompatibility when combined with neonatal TPN solution for up to three hours in a simulated Y-site injection. Pentobarbital, phenobarbital, and rifampin formed visible precipitation immediately after mixing with the neonatal TPN solution. Caffeine citrate, clindamycin, enalaprilat, epinephrine, fluconazole, fosphenytoin sodium, hydrocortisone, metoclopramide, and midazolam exhibited no visual or turbidimetric evidence of incompatibility when combined with a neonatal TPN solution for up to three hours in a simulated Y-site injection. Amiodarone, pentobarbital, phenobarbital, and rifampin were not compatible with the neonatal TPN solution and should not be coadministered via Y-site injection.

  2. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  4. Analysis of the regional pharmaceutical market of hypoglycemic drugs of oral administration

    Directory of Open Access Journals (Sweden)

    Orlova T.S.

    2017-06-01

    Full Text Available Aim: to study the regional pharmaceutical market of oral antidiabetic drugs for 2013-2016 according to the example of the pharmacy network of "Yuniver" (Arkhangelsk, not realizing the program of preferential home. Material and Methods. The study was conducted on the basis of reports on the movement of goods in "Yuniver OOO "for the period from 2013 to 2016 were analyzed range of oral antidiabetic drugs on international nonproprietary names, and trade names, dynamic oral antidiabetic drugs sales (number of dispensed packages. Results. On the basis of data on the movement of goods showed an annual expansion of assortment of oral antidiabetic drugs in the pharmacy network, not realizing the program of preferential home. Conclusion. The assortment of oral hypoglycemic preparations on the example of a pharmacy network that does not realize a program of preferential leave for people with diabetes mellitus testifies to the use of modern medicines that prevent the occurrence of microcirculatory disorders of target organs included in the list of vital and essential drugs and in accordance with clinical recommendations on therapy this pathology.

  5. Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

    Science.gov (United States)

    Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

    2014-11-01

    The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

  6. Drugs targeting 5-hydroxytryptamine receptors in acute treatments of migraine attacks. A review of new drugs and new administration forms of established drugs

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer C; Pihl, Thomas Peter Boye; Hougaard, Anders

    2014-01-01

    Introduction: The development of sumatriptan, more than 20 years ago, added substantially to the characterization of 5-hydroxytryptamine (5-HT) receptors and their relevance to acute migraine therapy. Recently, 5-HT1F receptor agonists, with no vascular effects, have shown efficacy in the treatme...... in a low incidence of recurrence. None of these reviewed treatments are likely to fulfill patients' expectations, and the advancement of acute migraine drugs should likely depend on different mechanisms from current 5-HT-related drugs....

  7. Dissolution Enhancement of Drugs. Part II: Effect of Carriers ...

    African Journals Online (AJOL)

    Recent high throughput screening and combinatorial and parallel synthesis are increasing the number of drug molecules which are highly lipophilic. The oral route is the most preferred route of drug administration due to its convenience, good patient compliance and low medicine production costs. The challenges to ...

  8. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Science.gov (United States)

    2010-11-30

    ... dissemination of Patient Medication Information (PMI). With this FOA, FDA proposes to further expand the scope... paragraphs. Patient Medication Information (PMI) To be able to use prescription medications safely, consumers... Guides. Such changes to the delivery of PMI may require changes to the Federal Food, Drug, and Cosmetics...

  9. 77 FR 40069 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Science.gov (United States)

    2012-07-06

    ... being manufactured and distributed. In 2009, the Agency sent warning letters to companies manufacturing... opportunity to assess the adequacy of their chemistry, manufacturing, and controls specifications before...), have the potential to be highly addictive, and are extremely popular drugs of abuse. The particular...

  10. Lipid-based formulations for oral administration of poorly water-soluble drugs

    DEFF Research Database (Denmark)

    Mu, Huiling; Holm, René; Müllertz, Anette

    2013-01-01

    /dissolution step, which is a potential rate limiting factor for oral absorption of poorly water-soluble drugs. Lipids not only vary in structures and physiochemical properties, but also in their digestibility and absorption pathway; therefore selection of lipid excipients and dosage form has a pronounced effect...

  11. 75 FR 57233 - 340B Drug Pricing Program Administrative Dispute Resolution Process

    Science.gov (United States)

    2010-09-20

    ... of proof; evidence; and post-hearing briefs. (5) Decision-making Official or Body HRSA expects to... establish a decision making official or decision- making body within the Department of Health and Human... administrative official or body responsible for adjudicating such claim; (iv) Require that a manufacturer conduct...

  12. 77 FR 19425 - Prescription Drugs Not Administered During Treatment; Update to Administrative Cost for Calendar...

    Science.gov (United States)

    2012-03-30

    ... veteran is entitled to care (or the payment of expenses of care) under a health plan contract; a... care (or the payment of expenses of care) under a health plan contract; (2) a nonservice-connected... accounting system. Under this accounting system, the national average administrative cost is determined by...

  13. USE OF INTERFERON BETA-1A FOR INTRAMUSCULAR ADMINISTRATION IN CHILDREN AND ADOLESCENTS WITH MULTIPLE SCLEROSIS: EFFICACY, SAFETY AND ADHERENCE TO THERAPY

    OpenAIRE

    O.V. Bykova; T.V. Sidorenko; A.N. Platonova; N.V. Gol’tsova; L.M. Kuzenkova; A.N. Boiko

    2009-01-01

    Immunomodulatory drugs reduce relapse rate and disease progression in relapsing-remitting multiple sclerosis but extensive data are not available on the effectiveness and tolerability of these drugs in childhood or adolescence. Interferon beta tolerability biased by frequency and method of drug administration. Drug administration has great impact on treatment compliance and adherence. That’s why we discuss moreover interferon beta 1a intramuscular as perspective immunomodulative medication in...

  14. Chemical Leukoderma Associated with Methylphenidate Transdermal System: Data From the US Food and Drug Administration Adverse Event Reporting System.

    Science.gov (United States)

    Cheng, Carmen; La Grenade, Lois; Diak, Ida-Lina; Brinker, Allen; Levin, Robert L

    2017-01-01

    To identify and characterize cases of chemical leukoderma, an underrecognized adverse event, associated with the methylphenidate transdermal system (MTS) reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS). We searched the Food and Drug Administration Adverse Event Reporting System for reports of chemical leukoderma associated with MTS, received by the Food and Drug Administration from April 6, 2006 to December 23, 2014. We identified 51 cases of chemical leukoderma reported with the use of MTS. The median age was 11 years; 43 cases reported leukoderma at or near the application site only, and 7 reported leukoderma at other parts of the body in addition to the application site; 1 case did not provide enough information to confirm the affected site. The time to onset ranged from 2 months to 4 years after the initiation of MTS. MTS was discontinued in 31 cases. Thirteen patients were prescribed treatment for repigmentation. Three cases reported continued spread of leukoderma after MTS was discontinued. Nineteen cases were diagnosed as vitiligo, including 5 cases reporting histologic features consistent with vitiligo. Leukoderma was persistent in all cases. The median follow-up interval after the discontinuation of MTS in 23 cases was 14 months. As outlined in recent changes to the prescribing information for MTS, health care professionals need to be aware of the potential risk of chemical leukoderma caused by MTS, especially given that chemical leukoderma is often misdiagnosed as idiopathic vitiligo. MTS should be discontinued at the earliest sign of pigment loss and other treatment options considered. Published by Elsevier Inc.

  15. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.

    Directory of Open Access Journals (Sweden)

    Irving Kirsch

    2008-02-01

    Full Text Available Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug-placebo difference scores. Drug-placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.

  16. Amelioration of Carcinogen-Induced Toxicity in Mice by Administration of a Potentized Homeopathic Drug, Natrum Sulphuricum 200

    Directory of Open Access Journals (Sweden)

    Nandini Bhattacharjee

    2009-01-01

    Full Text Available To examine if a potentized homeopathic drug, Natrum Sulphuricum 200 (Nat Sulph-200 has protective potentials against hepatocarcinogenesis, liver tumors were induced in mice through chronic feeding of P-dimethylaminoazobenzene (p-DAB; initiator of hepatocarcinogenesis and phenobarbital (PB; promoter. Mice were divided into five sub-groups: fed normal low protein diet (Gr. I, normal control; fed normal low protein plus alcohol-200 (vehicle of the homeopathic remedy (Gr. II; fed diet mixed with 0.06% p-DAB plus 0.05% PB (Gr. III; fed diet and carcinogens like Gr.III, plus alcohol 200 (positive control for drug fed mice (Gr. IV and fed diet and carcinogens like Gr. III, plus Natrum Sulphuiricum-200 (Gr. V; drug fed. Mice were sacrificed at day 7, 15, 30, 60, 90 and day 120 for study of cytogenetical endpoints like chromosome aberrations (CA, micronuclei (MN, mitotic index (MI and sperm head anomaly (SHA and biochemical toxicity parameters like aspartate amino transferase (AST, alanine amino transferase (ALT, acid (AcP and alkaline (AlkP phosphatases, lipid peroxidation (LPO and reduced glutathione (GSH content. Less number of liver tumors were observed in Gr. V (drug fed mice. Administration of Nat Sulph 200 reduced genomic damage, activities of AcP, AlkP, AST, ALT, LPO and increased GSH content. Therefore, independent replication of the study by others is encouraged.

  17. Community members' perceptions of mass drug administration for control of lymphatic filariasis in rural rural and urban Tanzania

    DEFF Research Database (Denmark)

    Kisoka, William J.; Tersbøl, Britt Pinkowski; Meyrowitsch, Dan Wolf

    2016-01-01

    public health care is often deeply troubled and fails to meet the basic health needs of impoverished populations. This presents particular challenges for the implementation of mass drug administration (MDA), which currently is the principal means of control and eventual elimination. Several MDA...... and marginalization by the health care system and political authorities. However, the results suggest that if the communities are brought on board with genuine respect for their integrity and informed self-determination, there is scope for major improvements in community support for MDA-based control activities....

  18. Reassessment of areas with persistent Lymphatic Filariasis nine years after cessation of mass drug administration in Sri Lanka.

    Science.gov (United States)

    Rao, Ramakrishna U; Samarasekera, Sandhya D; Nagodavithana, Kumara C; Dassanayaka, Tharanga D M; Punchihewa, Manjula W; Ranasinghe, Udaya S B; Weil, Gary J

    2017-10-01

    Sri Lanka was one of the first countries to initiate a lymphatic filariasis (LF) elimination program based on WHO guidelines. The Anti-Filariasis Campaign provided 5 annual rounds of mass drug administration (MDA) with diethylcarbamazine plus albendazole in all 8 endemic districts from 2002-2006. Microfilaremia (Mf) prevalences have been consistently Sri Lanka with efficient transmission by Culex. Test and treat or other programs targeting adult males plus bed net promotion may be more effective than MDA for clearing remaining hotspots of transmission in Sri Lanka.

  19. Long-lasting insecticidal nets are synergistic with mass drug administration for interruption of lymphatic filariasis transmission in Nigeria.

    Directory of Open Access Journals (Sweden)

    Abel Eigege

    Full Text Available In central Nigeria Anopheles mosquitoes transmit malaria and lymphatic filariasis (LF. The strategy used for interrupting LF transmission in this area is annual mass drug administration (MDA with albendazole and ivermectin, but after 8 years of MDA, entomological evaluations in sentinel villages showed continued low-grade mosquito infection rates of 0.32%. After long-lasting insecticidal net (LLIN distribution by the national malaria program in late 2010, however, we were no longer able to detect infected vectors over a 24-month period. This is evidence that LLINs are synergistic with MDA in interrupting LF transmission.

  20. Relevance of the Updated Food and Drug Administration Alteplase Label for Acute Ischemic Stroke: The Estimated Impact and Current Guidelines.

    Science.gov (United States)

    Shiue, Harn J; Albright, Karen C; Sands, Kara A

    2018-04-01

    In 2015, the Food and Drug Administration updated the contraindications for the use of alteplase in acute ischemic stroke (AIS), potentially creating a greater impact on treatment. A history of intracranial hemorrhage and recent stroke within 3 months were removed as contraindications, increasing the number of patients eligible for alteplase. The aim of this commentary is to call attention to the updates and discuss them relative to current American Heart Association/American Stroke Association guidelines. Additionally, we estimate the clinical impact of the updates by analyzing AIS admissions to a large-volume Comprehensive Stroke Center.

  1. Implications of the new Food and Drug Administration draft guidance on human factors engineering for diabetes device manufacturers.

    Science.gov (United States)

    Wilcox, Stephen B; Drucker, Daniel

    2012-03-01

    This article discusses the implications of the new Food and Drug Administration's draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use environments. Another important consideration is that diabetes-related devices, unlike many other medical devices, are used constantly as part of the user's lifestyle--adding complexity to the focus on human factors and ease of use emphasized by the draft guidance. © 2012 Diabetes Technology Society.

  2. Brain Tumor Targeting of Magnetic Nanoparticles for Potential Drug Delivery: Effect of Administration Route and Magnetic Field Topography

    Science.gov (United States)

    Chertok, Beata; David, Allan E.; Yang, Victor C.

    2011-01-01

    Our previous studies demonstrated feasibility of magnetically-mediated retention of iron-oxide nanoparticles in brain tumors after intravascular administration. The purpose of this study was to elucidate strategies for further improvement of this promising approach. In particular, we explored administration of the nanoparticles via a non-occluded carotid artery as a way to increase the passive exposure of tumor vasculature to nanoparticles for subsequent magnetic entrapment. However, aggregation of nanoparticles in the afferent vasculature interfered with tumor targeting. The magnetic setup employed in our experiments was found to generate a relatively uniform magnetic flux density over a broad range, exposing the region of the afferent vasculature to high magnetic force. To overcome this problem, the magnetic setup was modified with a 9-mm diameter cylindrical NdFeB magnet to exhibit steeper magnetic field topography. Six-fold reduction of the magnetic force at the injection site, achieved with this modification, alleviated the aggregation problem under the conditions of intact carotid blood flow. Using this setup, carotid administration was found to present 1.8-fold increase in nanoparticle accumulation in glioma compared to the intravenous route at 350 mT. This increase was found to be in reasonable agreement with the theoretically estimated 1.9-fold advantage of carotid administration, Rd. The developed approach is expected to present an even greater advantage when applied to drug-loaded nanoparticles exhibiting higher values of Rd. PMID:21763736

  3. Towards a better prediction of peak concentration, volume of distribution and half-life after oral drug administration in man, using allometry.

    Science.gov (United States)

    Sinha, Vikash K; Vaarties, Karin; De Buck, Stefan S; Fenu, Luca A; Nijsen, Marjoleen; Gilissen, Ron A H J; Sanderson, Wendy; Van Uytsel, Kelly; Hoeben, Eva; Van Peer, Achiel; Mackie, Claire E; Smit, Johan W

    2011-05-01

    It is imperative that new drugs demonstrate adequate pharmacokinetic properties, allowing an optimal safety margin and convenient dosing regimens in clinical practice, which then lead to better patient compliance. Such pharmacokinetic properties include suitable peak (maximum) plasma drug concentration (C(max)), area under the plasma concentration-time curve (AUC) and a suitable half-life (t(½)). The C(max) and t(½) following oral drug administration are functions of the oral clearance (CL/F) and apparent volume of distribution during the terminal phase by the oral route (V(z)/F), each of which may be predicted and combined to estimate C(max) and t(½). Allometric scaling is a widely used methodology in the pharmaceutical industry to predict human pharmacokinetic parameters such as clearance and volume of distribution. In our previous published work, we have evaluated the use of allometry for prediction of CL/F and AUC. In this paper we describe the evaluation of different allometric scaling approaches for the prediction of C(max), V(z)/F and t(½) after oral drug administration in man. Twenty-nine compounds developed at Janssen Research and Development (a division of Janssen Pharmaceutica NV), covering a wide range of physicochemical and pharmacokinetic properties, were selected. The C(max) following oral dosing of a compound was predicted using (i) simple allometry alone; (ii) simple allometry along with correction factors such as plasma protein binding (PPB), maximum life-span potential or brain weight (reverse rule of exponents, unbound C(max) approach); and (iii) an indirect approach using allometrically predicted CL/F and V(z)/F and absorption rate constant (k(a)). The k(a) was estimated from (i) in vivo pharmacokinetic experiments in preclinical species; and (ii) predicted effective permeability in man (P(eff)), using a Caco-2 permeability assay. The V(z)/F was predicted using allometric scaling with or without PPB correction. The t(½) was estimated from

  4. Alendronate-Loaded Modified Drug Delivery Lipid Particles Intended for Improved Oral and Topical Administration

    OpenAIRE

    Lacramioara Ochiuz; Cristian Grigoras; Marcel Popa; Iulian Stoleriu; Corneliu Munteanu; Daniel Timofte; Lenuta Profire; Anca Giorgiana Grigoras

    2016-01-01

    The present paper focuses on solid lipid particles (SLPs), described in the literature as the most effective lipid drug delivery systems that have been introduced in the last decades, as they actually combine the advantages of polymeric particles, hydrophilic/lipophilic emulsions and liposomes. In the current study, we present our most recent advances in the preparation of alendronate (AL)-loaded SLPs prepared by hot homogenization and ultrasonication using various ratios of a self-emulsifyin...

  5. Serotonergic systems associated with arousal and vigilance behaviors following administration of anxiogenic drugs

    DEFF Research Database (Denmark)

    Abrams, J K; Johnson, P L; Hay-Schmidt, Anders

    2005-01-01

    Serotonergic systems play important roles in modulating behavioral arousal, including behavioral arousal and vigilance associated with anxiety states. To further our understanding of the neural systems associated with increases in anxiety states, we investigated the effects of multiple anxiogenic...... drugs have selective actions on a subpopulation of serotonergic neurons projecting to a distributed central autonomic and emotional motor control system regulating anxiety states and anxiety-related physiological and behavioral responses....

  6. A systematic review of adverse drug events associated with administration of common asthma medications in children

    Science.gov (United States)

    Johnson, David W.; Sperou, Arissa J.; Crotts, Jennifer; Saude, Erik; Hartling, Lisa; Stang, Antonia

    2017-01-01

    Objective To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications. Methods Following PRISMA guidelines, we systematically searched six bibliographic databases between January 1991 and January 2017. Study eligibility, data extraction and quality assessment were independently completed and verified by two reviewers. We included randomized control trials (RCT), case-control, cohort, or quasi-experimental studies where the primary objective was identifying ADE in children 1 month– 18 years old exposed to commercial asthma medications. The primary outcome was ADE frequency. Findings Our search identified 14,540 citations. 46 studies were included: 24 RCT, 15 cohort, 4 RCT pooled analyses, 1 case-control, 1 open-label trial and 1 quasi-experimental study. Studies examined the following drug classes: inhaled corticosteroids (ICS) (n = 24), short-acting beta-agonists (n = 10), long-acting beta-agonists (LABA) (n = 3), ICS + LABA (n = 3), Leukotriene Receptor Antagonists (n = 3) and others (n = 3). 29 studies occurred in North America, and 29 were industry funded. We report a detailed index of 406 ADE descriptions and frequencies organized by drug class. The majority of data focuses on ICS, with 174 ADE affecting 13 organ systems including adrenal and growth suppression. We observed serious ADE, although they were rare, with frequency ranging between 0.9–6% per drug. There were no confirmed deaths, except for 13 potential deaths in a LABA study including combined adult and pediatric participants. We identified substantial methodological concerns, particularly with identifying ADE and determining severity. No studies utilized available standardized causality, severity or preventability assessments. Conclusion The majority of studies focus on ICS, with adrenal and growth suppression described. Serious ADE are relatively uncommon, with no confirmed pediatric deaths. We identify substantial

  7. Scientometrics of anesthetic drugs and their techniques of administration, 1984–2013

    Directory of Open Access Journals (Sweden)

    Vlassakov KV

    2014-12-01

    Full Text Available Kamen V Vlassakov, Igor Kissin Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Abstract: The aim of this study was to assess progress in the field of anesthetic drugs over the past 30 years using scientometric indices: popularity indices (general and specific, representing the proportion of articles on a drug relative to all articles in the field of anesthetics (general index or the subfield of a specific class of anesthetics (specific index; index of change, representing the degree of growth in publications on a topic from one period to the next; index of expectations, representing the ratio of the number of articles on a topic in the top 20 journals relative to the number of articles in all (>5,000 biomedical journals covered by PubMed; and index of ultimate success, representing a publication outcome when a new drug takes the place of a common drug previously used for the same purpose. Publications on 58 topics were assessed during six 5-year periods from 1984 to 2013. Our analysis showed that during 2009–2013, out of seven anesthetics with a high general popularity index (≥2.0, only two were introduced after 1980, ie, the inhaled anesthetic sevoflurane and the local anesthetic ropivacaine; however, only sevoflurane had a high index of expectations (12.1. Among anesthetic adjuncts, in 2009–2013, only one agent, sugammadex, had both an extremely high index of change (>100 and a high index of expectations (25.0, reflecting the novelty of its mechanism of action. The index of ultimate success was positive with three anesthetics, ie, lidocaine, isoflurane, and propofol, all of which were introduced much longer than 30 years ago. For the past 30 years, there were no new anesthetics that have produced changes in scientometric indices indicating real progress. Keywords: anesthetics, anesthetic adjuvants, mortality, safety margins, therapeutic indices

  8. Alendronate-Loaded Modified Drug Delivery Lipid Particles Intended for Improved Oral and Topical Administration

    Directory of Open Access Journals (Sweden)

    Lacramioara Ochiuz

    2016-06-01

    Full Text Available The present paper focuses on solid lipid particles (SLPs, described in the literature as the most effective lipid drug delivery systems that have been introduced in the last decades, as they actually combine the advantages of polymeric particles, hydrophilic/lipophilic emulsions and liposomes. In the current study, we present our most recent advances in the preparation of alendronate (AL-loaded SLPs prepared by hot homogenization and ultrasonication using various ratios of a self-emulsifying lipidic mixture of Compritol 888, Gelucire 44/14, and Cremophor A 25. The prepared AL-loaded SLPs were investigated for their physicochemical, morphological and structural characteristics by dynamic light scattering, differential scanning calorimetry, thermogravimetric and powder X-ray diffraction analysis, infrared spectroscopy, optical and scanning electron microscopy. Entrapment efficacy and actual drug content were assessed by a validated HPLC method. In vitro dissolution tests performed in simulated gastro-intestinal fluids and phosphate buffer solution pH 7.4 revealed a prolonged release of AL of 70 h. Additionally, release kinetics analysis showed that both in simulated gastrointestinal fluids and in phosphate buffer solution, AL is released from SLPs based on equal ratios of lipid excipients following zero-order kinetics, which characterizes prolonged-release drug systems.

  9. Evaluation of mass drug administration in the program to control imported lymphatic filariasis in Thailand.

    Science.gov (United States)

    Toothong, Tanaporn; Tipayamongkholgul, Mathuros; Suwannapong, Nawarat; Suvannadabba, Saravudh

    2015-09-28

    Migration plays a major role in the emergence and resurgence of lymphatic filariasis (LF) in many countries. Because of the high prevalence of Imported Bancroftian Filariasis (IBF) caused by nocturnally periodic Wuchereria bancrofti and the intensive movement of immigrant workers from endemic areas, Thailand has implemented two doses of 6 mg/kg diethylcarbamazine (DEC) with interval of 6 months to prevent IBF. In areas where immigrants are very mobile, the administration of DEC may be compromised. This study aimed to evaluate DEC administration and its barriers in such areas. A cross-sectional study with two-stage stratified cluster sampling was conducted. We selected Myanmar immigrants aged >18 years from factory and fishery areas of Samut Sakhon Province for interview with a structured questionnaire. We also interviewed health personnel regarding the functions of the LF program and practice of DEC delivery among immigrants. Associations were measured by multiple logistic regression, at P Incorrect perceptions about the side-effects of DEC also obstructed DEC access for Myanmar immigrants. All positive LF antigenic immigrants reported visiting and emigrating from LF-endemic areas. Hospital-based DEC administration was an inappropriate approach to DEC delivery in areas with highly mobile Myanmar immigrants. Incorporating health-center personnel in DEC delivery twice yearly and improving the perceptions of DEC side effects would likely increase DEC coverage among Myanmar immigrants.

  10. Profiling Nonrecipients of Mass Drug Administration for Schistosomiasis and Hookworm Infections : A Comprehensive Analysis of Praziquantel and Albendazole Coverage in Community-Directed Treatment in Uganda

    NARCIS (Netherlands)

    Chami, Goylette F.; Kontoleon, Andreas A.; Bulte, Erwin|info:eu-repo/dai/nl/141315245; Fenwick, Alan; Kabatereine, Narcis B.; Tukahebwa, Edridah M.; Dunne, David W.

    2016-01-01

    Background. Repeated mass drug administration (MDA) with preventive chemotherapies is the mainstay of morbidity control for schistosomiasis and soil-transmitted helminths, yet the World Health Organization recently reported that less than one-third of individuals who required preventive

  11. 5 CFR 724.105 - Compliance.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Compliance. 724.105 Section 724.105 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED... 2002 Reimbursement of Judgement Fund § 724.105 Compliance. An agency's failure to reimburse the...

  12. Inhaled pulmonary vasodilators for persistent pulmonary hypertension of the newborn: safety issues relating to drug administration and delivery devices

    Directory of Open Access Journals (Sweden)

    Cosa N

    2016-04-01

    Full Text Available Nathan Cosa,1 Edward Costa Jr2 1Department of Respiratory Care, Banner Desert Medical Center, Cardon Children's Medical Center, Mesa, AZ, 2Department of Medical Affairs, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA Abstract: Treatment for persistent pulmonary hypertension of the newborn (PPHN aims to reduce pulmonary vascular resistance while maintaining systemic vascular resistance. Selective pulmonary vasodilation may be achieved by targeting pulmonary-specific pathways or by delivering vasodilators directly to the lungs. Abrupt withdrawal of a pulmonary vasodilator can cause rebound pulmonary hypertension. Therefore, use of consistent delivery systems that allow for careful monitoring of drug delivery is important. This manuscript reviews published studies of inhaled vasodilators used for treatment of PPHN and provides an overview of safety issues associated with drug delivery and delivery devices as they relate to the risk of rebound pulmonary hypertension. Off-label use of aerosolized prostacyclins and an aerosolized prostaglandin in neonates with PPHN has been reported; however, evidence from large randomized clinical trials is lacking. The amount of a given dose of aerosolized drug that is actually delivered to the lungs is often unknown, and the actual amount of drug deposited in the lungs can be affected by several factors, including patient size, nebulizer used, and placement of the nebulizer within the breathing circuit. Inhaled nitric oxide (iNO is the only pulmonary vasodilator approved by the US Food and Drug Administration for the treatment of PPHN. The iNO delivery device, INOmax DSIR®, is designed to constantly monitor NO, NO2, and O2 deliveries and is equipped with audible and visual alarms to alert providers of abrupt discontinuation and incorrect drug concentration. Other safety features of this device include two independent backup delivery systems, a backup drug cylinder, a battery that provides up to 6 hours of

  13. Neoliberal technocracy: explaining how and why the US Food and Drug Administration has championed pharmacogenomics.

    Science.gov (United States)

    Hogarth, Stuart

    2015-04-01

    By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when the agency released a wide-ranging report which positioned pharmacogenomics at the heart of a broader regulatory reform agenda. The Critical Path initiative addressed declining productivity of drug development by suggesting that the problem was a mismatch between the rapid pace of discovery in post-genomic biomedicine and the antiquated development process for new drugs. Framing their work in this context, FDA officials reconceptualised their role in the innovation process, in what was the first programmatic statement of a shift from a strictly gate-keeping role to a more collaborative or facilitative role as enablers of innovation. This paper situates the FDA's emergence as a champion of pharmacogenomics in the broader politics of pharmaceutical regulation in the USA. In making a contribution to the pharmaceuticalisation literature this paper will draw on the work of John Abraham who has argued that one of the primary drivers of pharmaceuticalisation has been "deregulatory state policies" and on Williams and colleagues who have argued that the changing relationship between regulatory agencies and the pharmaceutical industry is an important dimension of pharmaceuticalisation. This paper links this to the promotion of pharmaceutical futures such as pharmacogenomics and explores how this shift is also closely related to the trend towards a risk management approach to pharmaceutical regulation. The role of Bush appointees in the development and promotion of the Critical Path agenda is also examined. Copyright © 2015. Published by Elsevier Ltd.

  14. Safety of fluralaner chewable tablets (Bravecto), a novel systemic antiparasitic drug, in dogs after oral administration.

    Science.gov (United States)

    Walther, Feli M; Allan, Mark J; Roepke, Rainer K A; Nuernberger, Martin C

    2014-03-07

    Fluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment. This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose. Thirty-two (16 male and 16 female) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study. Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56, 168, and 280 mg fluralaner/kg body weight, equivalent to 1, 3, and 5 times the highest recommended treatment dose of fluralaner; sham dosed dogs served as controls.During the study, all dogs were clinically observed, and their health was carefully monitored including body weight development, food consumption and measurement of hematology, coagulation, clinical chemistry (including measurement of levels of ACTH and C-reactive protein) and urinalysis. Following euthanasia of the dogs, complete gross post mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted. There were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights; none of these findings were considered to be of clinical relevance. Oral administration of fluralaner at the highest recommended treatment dose (56 mg/kg) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg.

  15. FDA 2011 process validation guidance: lifecycle compliance model.

    Science.gov (United States)

    Campbell, Cliff

    2014-01-01

    This article has been written as a contribution to the industry's efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related "system qualities". The article represents a structured interpretation of the U.S. Food and Drug Administration's 2011 Guidance for Industry on Process Validation and is based on the author's educational background and his manufacturing/consulting experience in the validation field. The U.S. Food and Drug Administration's Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20(th) century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully "roadworthy" and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.

  16. Effect of the Implementation of Barcode Technology and an Electronic Medication Administration Record on Adverse Drug Events.

    Science.gov (United States)

    Truitt, Erin; Thompson, Ross; Blazey-Martin, Deborah; NiSai, Danna; Salem, Deeb

    2016-06-01

    Hospitals have attempted to reduce adverse drug events (ADEs) by investing in new technologies, but data regarding their efficacy are lacking. This study evaluates the effects of the implementation of barcode medication administration (BCMA) and electronic medication administration record (eMAR) technology on the profile of ADEs in a hospital setting. We conducted a before-and-after study examining the effects of the implementation of BCMA and eMAR technology on the profile of ADEs at a 400-bed academic medical center by using incident reports. We compared reported ADEs in pre- and post-implementation periods of 5 months to determine whether there was a reduction in the rate of ADEs within medication use phases. We further examined the severity of errors and described changes in the distribution of types of errors. A total of 775 electronic error-reporting system reports were included in this study: 397 (51%) in the pre-implementation period and 378 (49%) in the post-implementation period. The rate of ADEs significantly decreased from 0.26% to 0.20% after implementation of the technology (relative risk [RR], 0.78; 95% CI, 0.67-0.89). The rate of transcription errors decreased from 0.089% to 0.036% (RR, 0.40; 95% CI, 0.30-0.54), which was largely attributed to reduction of "wrong time" errors. The rate of administration errors was identical in both groups at 0.017% (RR, 0.98; 95% CI 0.58-1.66). The mean severity level of administration errors significantly decreased from 4.44 to 3.23 (p = .005). The implementation of eMAR and BCMA technology improved patient safety by decreasing the overall rate of ADEs and the rate of transcription errors. These technologies also reduced the harmful impact to patients caused by administration errors.

  17. A comparison of two mathematical models of the impact of mass drug administration on the transmission and control of schistosomiasis.

    Science.gov (United States)

    Truscott, J E; Gurarie, D; Alsallaq, R; Toor, J; Yoon, N; Farrell, S H; Turner, H C; Phillips, A E; Aurelio, H O; Ferro, J; King, C H; Anderson, R M

    2017-03-01

    The predictions of two mathematical models describing the transmission dynamics of schistosome infection and the impact of mass drug administration are compared. The models differ in their description of the dynamics of the parasites within the host population and in their representation of the stages of the parasite lifecycle outside of the host. Key parameters are estimated from data collected in northern Mozambique from 2011 to 2015. This type of data set is valuable for model validation as treatment prior to the study was minimal. Predictions from both models are compared with each other and with epidemiological observations. Both models have difficulty matching both the intensity and prevalence of disease in the datasets and are only partially successful at predicting the impact of treatment. The models also differ from each other in their predictions, both quantitatively and qualitatively, of the long-term impact of 10 years' school-based mass drug administration. We trace the dynamical differences back to basic assumptions about worm aggregation, force of infection and the dynamics of the parasite in the snail population in the two models and suggest data which could discriminate between them. We also discuss limitations with the datasets used and ways in which data collection could be improved. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Moving Clinical Deliberations on Administrative Discharge in Drug Addiction Treatment Beyond Moral Rhetoric to Empirical Ethics.

    Science.gov (United States)

    Williams, Izaak L

    2016-01-01

    Patients' admission to modern substance use disorder treatment comes with the attendant risk of being discharged from treatment-a widespread practice. This article describes the three mainstream theories of addiction that operate as a reference point for clinicians in reasoning about a decision to discharge a patient from treatment. The extant literature is reviewed to highlight the pathways that patients follow after administrative discharge. Little scientific research has been done to investigate claims and hypotheses about the therapeutic function of AD, which points to the need for empirical ethics to inform clinical addictions practice. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  19. Colistin administration for extensive drug-resistant Pseudomonas aeruginosa pneumonia in intensive care unit: case report

    Directory of Open Access Journals (Sweden)

    Cetin Kilinc

    2016-03-01

    Full Text Available Pseudomonas aeruginosa strains may develop the resistance to antibiotics via different mechanisms such as, alteration of protein binders of penicillin, porin mutations, DNA-gyrase mutation and active expulsion pumps. Especially, multi-drug resistant P.aeruginosa strains, are known to be most important cause of mortality in the intensive care units. Special antibiotic therapy is required, because of having the multiple antibiotic resistances. The case reports a 67-year-old male patient who had a history of 6 years paraplegia. He admitted to the emergency department with impaired general condition, including a week ongoing nausea,chest pain, cough, phlegm, wheezing and fatigue. Widespread crepitant rales were detected up to the middle and lower zones of both lungs. Besides, there was CRP elevation, hyperuricemia, a consolidated infiltration compatible with increased opacity at lower zone of right lung and reticulonodular style increased opacity at upper zone of right lung on chest .On disk diffusion, there was resistance to all antibiotics except colistin. Although colistin treatment was initiated, the patient was lost due to cardiac arrest at the 3rd day of treatment. This case is reported to be observed for the first time of P. aeruginosa infection that was extensively drug-resistant to antibiotics except colistin in our hospital, and to highlight importance of true treatment arrangements according to antibiotic susceptibility. [Cukurova Med J 2016; 41(1.000: 178-182

  20. Drug distribution in spinal cord during administration with spinal loop dialysis probes in anaesthetized rats

    DEFF Research Database (Denmark)

    Uustalu, Maria; Abelson, Klas S P

    2007-01-01

    The present investigation aimed to study two methodological concerns of an experimental model, where a spinal loop dialysis probe is used for administration of substances to the spinal cord and sampling of neurotransmitters by microdialysis from the same area of anaesthetized rats. [(3)H]Epibatid......The present investigation aimed to study two methodological concerns of an experimental model, where a spinal loop dialysis probe is used for administration of substances to the spinal cord and sampling of neurotransmitters by microdialysis from the same area of anaesthetized rats. [(3)H......]Epibatidine in concentrations of 1, 10 and 100 nM was dissolved in Ringer's solution and administered through the dialysis membrane into the dorsal region of the cervical spinal cord. First, the outflow of [(3)H]epibatidine from the probe into the spinal cord was examined with respect to different concentrations and changes....... The administered [(3)H]epibatidine was found to be distributed to the area closest to the dialysis probe and not dispersed along the spinal cord, and the distribution was equal for all concentrations. The data presented in this investigation provide information, which is important for interpretation of data from...

  1. Acetaldehyde as a drug of abuse: insight into AM281 administration on operant-conflict paradigm in rats.

    Directory of Open Access Journals (Sweden)

    Fulvio ePlescia

    2013-06-01

    Full Text Available Increasing evidence focuses on acetaldehyde (ACD as the mediator of the rewarding and motivational properties of ethanol. Indeed, ACD stimulates dopamine release in the nucleus accumbens and it is self-administered under different conditions. Besides the dopaminergic transmission, the endocannabinoid system has been reported to play an important role in ethanol central effects, modulating primary alcohol rewarding effect, drug-seeking and relapse behaviour. Drug motivational properties are highlighted in operant paradigms which include response-contingent punishment, a behavioural equivalent of compulsive drug use despite adverse consequences.The aim of this study was thus to characterize ACD motivational and rewarding properties employing an operant-conflict paradigm in which rats, trained to lever press in order to get ACD solution (0.9%, undergo extinction, reinstatement and conflict sessions, according to a modified Geller-Seifter procedur. Furthermore the role played by CB1 receptor system in modulating ACD-induced effects were investigated through the administration of CB1 receptor antagonist, AM281 (1 mg/kg, i.p. during the extinction-, relapse- and conflict experiments.Our results indicate that ACD is able to induce and maintain an operant behaviour, a high number of responses during extinction, an increase in the lever presses during the reinstatement phase, and a higher emission of punished responses during the conflict experiments, when compared to controls.The administration of AM281 is able to decrease ACD-seeking behaviour during extinction, the number of lever presses during reinstatement and to strongly decrease the punished responses for ACD. Our data strengthen the idea that ACD may be responsible for the central effects of ethanol, and pinpoint at the CB1 system as one of the neural substrates underlying its addictive properties.

  2. An exploration of alcohol use severity and route of drug administration among persons that use heroin and cocaine.

    Science.gov (United States)

    Scherer, Michael; Harrell, Paul T; Trenz, Rebecca C; Canham, Sarah; Latimer, William W

    2016-01-01

    Alcohol use is prevalent among populations of persons that use illicit drugs. Problematic alcohol use among persons that use heroin and cocaine has been associated with poor treatment adherence, abstinence maintenance, and mental health concerns. Fully exploring how alcohol use severity interacts with route of administration (ROA) may be of notable importance in development of treatment protocols for persons that use heroin and cocaine. Data from a neurological and sociobehavioral assessment of risk factors among injection and noninjection drug users known as the NEURO-HIV Epidemiologic Study was used in the analyses. Participants (N = 551) included those who reported their level of past-30-day alcohol use and past-6-month heroin and cocaine use. Multiple logistic regression analyses found that both problematic and moderate alcohol users were significantly less likely than abstainers to report injecting heroin and cocaine. Both problematic and moderate alcohol users were significantly more likely than abstainers to snort substances. Alcohol use may play a role in promoting or impeding the use of substances through certain ROAs. Treatment protocols that transition persons that use injection heroin and cocaine to noninjection use of these substances may be used in conjunction with treatments that reduce alcohol consumption as a means to reduce noninjection drug use.

  3. First intramuscular administration in the U.S. space program. [of motion sickness drugs

    Science.gov (United States)

    Bagian, James P.

    1991-01-01

    In the past, the only kind of medicines used for symptomatic treatment of space motion sickness (SMS) in space had been oral, transdermal, or suppositories. This paper describes the effect of the first intramuscular (IM) administration of Phenergan (50-mg in single dose) on SMS in one subject who exhibited grade-3 symptoms and signs which persisted unabated throughout the first and the second flight days aboard the Space Shuttle. Thirty minutes after the injection, the subject had completely recovered. His symptoms were gone, his appetite was back, and he had no recurrences for the remainder of the flight. Since that experiment, intramuscular injections have been given nine more times on subsequent flights, with similar results.

  4. Pharmacokinetics of Repeated Melatonin Drug Administrations Prior to and After Surgery

    DEFF Research Database (Denmark)

    Harpsøe, Nathja Groth; Andersen, Lars Peter Kloster; Mielke, Louise Vennegaard

    2016-01-01

    BACKGROUND: Recent clinical studies have documented the analgesic, anti-inflammatory, antioxidative and anxiolytic effects of exogenous melatonin. The pharmacokinetic properties of melatonin have primarily been investigated in experimental studies. OBJECTIVE: The aim of this study was to estimate...... the pharmacokinetics of melatonin in patients undergoing surgery and general anesthesia. METHODS: The study was designed as a prospective, two-phase cohort study. Patients were candidates for subpectoral breast augmentation surgery, and surgical procedures were performed by a single surgeon. The perioperative...... treatment protocol was standardized between patients. During the study, each patient received two separate oral administrations of melatonin 10 mg. Melatonin was administered 60 min before surgery, and at 9:00 p.m. the evening after surgery. The pharmacokinetic variables absorption half-life (t ½ absorption...

  5. Administration of phospholipide hepatoprotective drug Phosphogliv in patients with psoriatic arthritis (preliminary results

    Directory of Open Access Journals (Sweden)

    T. V. Korotaeva

    2004-01-01

    Full Text Available Considering membrane-reparative properties of a new phospholipid hepatoprotector Phosphogliv (FG its therapeutic efficacy was assessed in 9 pts with psoriatic arthritis (PA accompanied by prominent disturbances of blood rheology. FG was given 0,6 g a day during 3 months. Significant decrease of erythrocyte aggregation resulting in increase of erythrocyte aggregation formation time and diminishment of their hydrodynamic resistance without changes of whole blood general caisson viscosity was achieved. Significant improvement of Richie index, tender joint count and pt assessment was noted. The results prove availability of PG administration in PA therapy and possibility of enlargement PG application area owing to membrane-reparative properties of contained in it polyunsaturated phosphatidilcholin in combination with immunomodulating and anti-inflammatory action of glycyrrhizinic acid.

  6. Priority-based assessment of food additives database of the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition.

    OpenAIRE

    Benz, R D; Irausquin, H

    1991-01-01

    The priority-based assessment of food additives (PAFA) is a database maintained by the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition. PAFA contains extensive administrative, chemical, and toxicological information on 1685 regulated direct food additives. The database also has limited administrative and chemical information on an additional 1236 direct additives. The total 2921 substances represent everything added to food in the United States. PAFA conta...

  7. 75 FR 65397 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-10-22

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) received a request for a waiver of compliance with certain... of compliance with the Locomotive Safety Standards, 49 CFR 229.21, 229.23(d), 229.27(a)(3), and 229...

  8. 75 FR 82139 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-12-29

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain...-0143] The Grand Canyon Railway, Inc. (GRCX) seeks a waiver of compliance with the Steam Locomotive...

  9. 75 FR 82138 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-12-29

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) received a request for a waiver of compliance with certain...-2010-0170] The City of Vancouver, WA (City), seeks a permanent waiver of compliance from a certain...

  10. 75 FR 39616 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-07-09

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... Pan Am Railways (Pan Am) seeks a waiver of compliance with the Locomotive Safety Standards, 49 CFR 229...

  11. 76 FR 8810 - Petition for Waiver of Compliance

    Science.gov (United States)

    2011-02-15

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... compliance from certain provisions of 49 CFR for certain portions of its light-rail transit operations...

  12. 75 FR 39615 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-07-09

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain...-0102] The Orange Empire Railway Museum (OERM) seeks a waiver of compliance from certain provisions of...

  13. 75 FR 80108 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-12-21

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... petitioned for a permanent waiver of compliance for five cabooses from the requirements of the Railroad...

  14. 75 FR 65399 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-10-22

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain...-2010-0145] The Union Pacific Railroad Company (UP) seeks a waiver of compliance from certain provisions...

  15. 75 FR 20035 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-04-16

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... safety requirements. Jasper petitioned FRA for a waiver of compliance from certain provisions of the...

  16. 75 FR 39617 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-07-09

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain...-2010-0105] The Middletown & Hummelstown Railroad (MIDH) has petitioned FRA for a waiver of compliance...

  17. 75 FR 20037 - Petition for Waiver of Compliance

    Science.gov (United States)

    2010-04-16

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... compliance from the requirements of the Fire Safety Standard, 49 CFR 238.103, which requires materials used...

  18. Accuracy of Coverage Survey Recall following an Integrated Mass Drug Administration for Lymphatic Filariasis, Schistosomiasis, and Soil-Transmitted Helminthiasis.

    Directory of Open Access Journals (Sweden)

    Philip J Budge

    2016-01-01

    Full Text Available Achieving target coverage levels for mass drug administration (MDA is essential to elimination and control efforts for several neglected tropical diseases (NTD. To ensure program goals are met, coverage reported by drug distributors may be validated through household coverage surveys that rely on respondent recall. This is the first study to assess accuracy in such surveys.Recall accuracy was tested in a series of coverage surveys conducted at 1, 6, and 12 months after an integrated MDA in Togo during which three drugs (albendazole, ivermectin, and praziquantel were distributed. Drug distribution was observed during the MDA to ensure accurate recording of persons treated during the MDA. Information was obtained for 506, 1131, and 947 persons surveyed at 1, 6, and 12 months, respectively. Coverage (defined as the percentage of persons taking at least one of the MDA medications within these groups was respectively 88.3%, 87.4%, and 80.0%, according to the treatment registers; it was 87.9%, 91.4% and 89.4%, according to survey responses. Concordance between respondents and registers on swallowing at least one pill was >95% at 1 month and >86% at 12 months; the lower concordance at 12 months was more likely due to difficulty matching survey respondents with the year-old treatment register rather than inaccurate responses. Respondents generally distinguished between pills similar in appearance; concordance for recall of which pills were taken was over 80% in each survey.In this population, coverage surveys provided remarkably consistent coverage estimates for up to one year following an integrated MDA. It is not clear if similar consistency will be seen in other settings, however, these data suggest that in some settings coverage surveys might be conducted as much as one year following an MDA without compromising results. This might enable integration of post-MDA coverage measurement into large, multipurpose, periodic surveys, thereby conserving

  19. Brief intermittent cocaine self-administration and abstinence sensitizes cocaine effects on the dopamine transporter and increases drug seeking.

    Science.gov (United States)

    Calipari, Erin S; Siciliano, Cody A; Zimmer, Benjamin A; Jones, Sara R

    2015-02-01

    Although traditional sensitization paradigms, which result in an augmentation of cocaine-induced locomotor behavior and dopamine (DA) overflow following repeated experimenter-delivered cocaine injections, are often used as a model to study drug addiction, similar effects have been difficult to demonstrate following cocaine self-administration. We have recently shown that intermittent access (IntA) to cocaine can result in increased cocaine potency at the DA transporter (DAT); however, traditional sensitization paradigms often show enhanced effects following withdrawal/abstinence periods. Therefore, we determined a time course of IntA-induced sensitization by examining the effects of 1 or 3 days of IntA, as well as a 7-day abstinence period on DA function, cocaine potency, and reinforcement. Here we show that cocaine potency is increased following as little as 3 days of IntA and further augmented following an abstinence period. In addition, IntA plus abstinence produced greater evoked DA release in the presence of cocaine as compared with all other groups, demonstrating that following abstinence, both cocaine's ability to increase DA release and inhibit uptake at the DAT, two separate mechanisms for increasing DA levels, are enhanced. Finally, we found that IntA-induced sensitization of the DA system resulted in an increased reinforcing efficacy of cocaine, an effect that was augmented after the 7-day abstinence period. These results suggest that sensitization of the DA system may have an important role in the early stages of drug abuse and may drive the increased drug seeking and taking that characterize the transition to uncontrolled drug use. Human data suggest that intermittency, sensitization, and periods of abstinence have an integral role in the process of addiction, highlighting the importance of utilizing pre-clinical models that integrate these phenomena, and suggesting that IntA paradigms may serve as novel models of human addiction.

  20. Methotrexate: Revisited efficiency and safety of drug administration in psoriasis patients

    Directory of Open Access Journals (Sweden)

    A. L. Bakulev

    2017-01-01

    Full Text Available The article presents the current data of the literature on methotrexate, which is now one of the most commonly used preparation for the systemic treatment of patients with moderate to severe psoriasis. The following problems are under consideration: estimation by specialists of response to systemic psoriasis therapy and possible therapeutic strategies; selecting initial doses of methotrexate for the treatment of patients with psoriasis; the possibilities of combined use with genetically engineered biological agents and monitoring of therapy. The data from randomized clinical trials on the long-term continuous treatment with methotrexate (efficacy, safety; methods of its administration to patients and time and criteria for long-term effecasy are reported. There are presented the data on the mechanisms of methotrexate action and the new data about the impact on the adenosine metabolism and the ability of the preparation to modulate the inflammatory response in the skin of patients by inhibiting the cellular components of the inflammatory infiltrate in the skin (dendritic antigen-producing cells and T-lymphocytes, as well as the suppression of expression of some proinflammatory cytokines (IFN-y and IL17A.