How the elderly and young adults differ in the decision making process of nonprescription medication purchases.

PubMed

Sansgiry, S S; Cady, P S

1996-01-01

The study compared elderly and young adults in their behavior and involvement in the decision making process of over-the-counter (OTC) medication purchases. Elderly subjects were more involved in the decision making process to purchase OTC medications compared to young adults. The elderly not only purchase and spend more money on medications but also read OTC labels completely. They requested help from the pharmacist more frequently than young adults. Needs of the elderly in making an OTC medication purchase were different compared to young adults. The two age groups differed on importance rating for several attributes regarding OTC medications, such as; ease of opening the package, child resistant package, side effects of medicine, manufacturer of medicine, print size on package labels, and greater choice of medicine.

Receipt and use of spoken and written over-the-counter medicine information: insights into Australian and UK consumers' experiences.

PubMed

Tong, Vivien; Raynor, David K; Aslani, Parisa

2018-04-01

To explore Australian and UK consumers' receipt and use of spoken and written medicine information and examine the role of leaflets for consumers of over-the-counter (OTC) medicines. Semistructured interviews were conducted with 37 Australian and 39 UK consumers to explore information received with their most recent OTC medicine purchase, and how information was used at different times post-purchase. Interviews were audio-recorded, transcribed verbatim and thematically analysed. Similarities were evident between the key themes identified from Australian and UK consumers' experiences. Consumers infrequently sought spoken information and reported that pharmacy staff provided minimal spoken information for OTC medicines. Leaflets were not always received or wanted and had a less salient role as an information source for repeat OTC purchases. Consumers tended not to read OTC labels or leaflets. Product familiarity led to consumers tending not to seek information on labels or leaflets. When labels were consulted, directions for use were commonly read. However, OTC medicine information in general was infrequently revisited. As familiarity is not an infallible proxy for safe and effective medication use, strategies to promote the value and use of these OTC medicine information sources are important and needed. Minimal spoken information provision coupled with limited written information use may adversely impact medication safety in self-management. © 2017 Royal Pharmaceutical Society.

Lack of pregnancy warnings on over-the-counter dermatologic products containing potentially harmful hydroquinone.

PubMed

Bio, L L; Cies, J J

2017-07-01

To determine the presence of pregnancy warnings on over-the-counter (OTC) dermatologic products with hydroquinone, a potentially harmful ingredient. Data were obtained from the Food and Drug Administration National Drug Code Directory and Label Repository to identify OTC dermatologic products containing hydroquinone. Products were stratified based on pregnancy or general warning presence (WP) or absence (WA). Product characteristics were compared between groups: hydroquinone concentration, presence of external packaging, indication and warning statements. Of the 112 products studied, 21 had a pregnancy warning and 3 included a general warning against use: WP (n=24) and WA (n=88) group. External packaging was more prevalent in the WP group compared to WA (62.5% vs 29.5%, P=0.004). Majority of OTC dermatologic products containing hydroquinone did not have a pregnancy warning. This highlights the need for improved labeling and informs providers caring for pregnant women of OTC labeling limitations.

76 FR 35619 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

...The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

Effect of Warning Placement on the Information Processing of College Students Reading an OTC Drug Facts Panel

ERIC Educational Resources Information Center

Bhansali, Archita H.; Sangani, Darshan S.; Mhatre, Shivani K.; Sansgiry, Sujit S.

2018-01-01

Objective: To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students.Participants: University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010.Methods: A current FDA label was compared to two experimental labels developed using the…

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2011 CFR

2011-04-01

... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...

Novel label-free and high-throughput microchip electrophoresis platform for multiplex antibiotic residues detection based on aptamer probes and target catalyzed hairpin assembly for signal amplification.

PubMed

Wang, Ye; Gan, Ning; Zhou, You; Li, Tianhua; Hu, Futao; Cao, Yuting; Chen, Yinji

2017-11-15

Novel label-free and multiplex aptasensors have been developed for simultaneous detection of several antibiotics based on a microchip electrophoresis (MCE) platform and target catalyzed hairpin assembly (CHA) for signal amplification. Kanamycin (Kana) and oxytetracycline (OTC) were employed as models for testing the system. These aptasensors contained six DNA strands termed as Kana aptamer-catalysis strand (Kana apt-C), Kana inhibit strand (Kana inh), OTC aptamer-catalysis strand (OTC apt-C), OTC inhibit strand (OTC inh), hairpin structures H1 and H2 which were partially complementary. Upon the addition of Kana or OTC, the binding event of aptamer and target triggered the self-assembly between H1 and H2, resulting in the formation of many H1-H2 complexes. They could show strong signals which represented the concentration of Kana or OTC respectively in the MCE system. With the help of the well-designed and high-quality CHA amplification, the assay could yield 300-fold amplified signal comparing that from non-amplified system. Under optimal conditions, this assay exhibited a linear correlation in the ranges from 0.001ngmL -1 to 10ngmL -1 , with the detection limits of 0.7pgmL -1 and 0.9pgmL -1 (S/N=3) toward Kana and OTC, respectively. The platform has the following advantages: firstly, the aptamer probes can be fabricated easily without labeling signal tags for MCE detection; Secondly, the targets can just react with probes and produce the amplified signal in one-pot. Finally, the targets can be simultaneously detected within 10min in different channels, thus high-throughput measurement can be achieved. Based on this work, it is estimated that this detection platform will be universally served as a simple, sensitive and portable platform for antibiotic contaminants detection in biological and environmental samples. Copyright © 2017 Elsevier B.V. All rights reserved.

Examining the conspicuousness and prominence of two required warnings on OTC pain relievers

PubMed Central

Bix, Laura; Bello, Nora M.; Auras, Rafael; Ranger, Jon; Lapinski, Maria K.

2009-01-01

The labeling of over-the-counter (OTC) drugs is critical to their safe and effective use, and certain warnings are meant to be read at the point of purchase (POP). Examples include (i) warnings that alert consumers to the fact that the package is not child-resistant and (ii) warnings that alert consumers to potential product tampering. U.S. law mandates these warnings be “conspicuous” and “prominent” so that it is likely that consumers will read them before leaving the store. Our objective was to quantify the relative prominence and conspicuousness of these warnings. Sixty-one participants reviewed the packages of 5 commercially available analgesics to evaluate the prominence and conspicuousness of these warnings. Evaluated data included (i) the time spent examining the warnings compared with other areas of the label (using a bright pupil eye tracker), (ii) the ability to recall information from the OTCs viewed, and (iii) the legibility of the warnings relative to other elements of the labels (as measured by ASTM D7298-06). Eye-tracking data indicated that warnings were viewed by fewer participants and for less time than other elements of the packages. Recall and legibility data also indicated that the warning statements compared unfavorably with other elements of the labels tested. Evidence presented in this study suggests that 2 required warnings on 5 different OTCs are not prominent or conspicuous when compared with other elements of tested labels. PMID:19332798

17 CFR 240.36a1-1 - Exemption from Section 7 for OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OTC derivatives dealers. 240.36a1-1 Section 240.36a1-1 Commodity and Securities Exchanges SECURITIES... Information Filed Under the Act § 240.36a1-1 Exemption from Section 7 for OTC derivatives dealers. Preliminary Note: OTC derivatives dealers are a special class of broker-dealers that are exempt from certain broker...

21 CFR 201.72 - Potassium labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

21 CFR 201.72 - Potassium labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

21 CFR 201.72 - Potassium labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

Code of Federal Regulations, 2010 CFR

2010-04-01

... promulgation of a monograph. (b) On and after April 20, 1972, a number of notices were published in the Federal... classes of OTC drugs. At such time as an applicable OTC drug monograph becomes effective, the interim...

21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

Code of Federal Regulations, 2011 CFR

2011-04-01

... promulgation of a monograph. (b) On and after April 20, 1972, a number of notices were published in the Federal... classes of OTC drugs. At such time as an applicable OTC drug monograph becomes effective, the interim...

Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage.

PubMed

Goyal, R K; Rajan, S S; Essien, E J; Sansgiry, S S

2012-12-01

The Food and Drug Administration (FDA) issued new organ-specific warning label requirements for over-the-counter (OTC) analgesic products in order to make consumers aware of the risk of liver damage when using acetaminophen. However, awareness of a health risk alone cannot ensure consumers' engagement in safe and preventive behaviour. In this study, we attempted to: (i) measure consumer risk perception of liver damage due to the OTC acetaminophen products and (ii) analyse the effectiveness of the new organ-specific warning label in improving consumer risk perception of liver damage and intention to perform protective behaviours while using OTC acetaminophen products. This within-subject experimental study used a convenience sample of English-speaking adults visiting OTC segments of selected pharmacy stores in Houston. Participants were randomly exposed to the old and new warning labels and their respective risk perception (measured on a visual analogue scale, 0%, no risk, to 100%, extreme risk) and behavioural intention (measured on a 7-point Likert scale) were recorded using a validated, self-administered questionnaire. Descriptive statistics and non-parametric Wilcoxon signed-rank tests were performed using sas statistical software (v 9.2) at a priori significance level of 0.05. Majority of participants (74.4%) were not aware of the new warnings; however, majority (67.8%) had prior knowledge of the risk. The mean risk perception score for the new warning label was found to be significantly higher (72.2% vs. 65.9%, P < 0.0001) than the old warning label. Similarly, the average intention score for the new warning label was significantly higher (5.06 vs. 4.86, P < 0.0001) than the old warning label. The new warning label mandated by FDA is effective in improving consumer risk perception of potential liver damage and may encourage protective behaviour. However, future studies are essential to assess the impact of the new label on actual changes in consumer behaviour and subsequent reduction in acetaminophen-related morbidity and mortality. © 2012 Blackwell Publishing Ltd.

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... sections of the applicable OTC drug monographs. For a combination drug product that does not have an... combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b... monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... sections of the applicable OTC drug monographs. For a combination drug product that does not have an... combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b... monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements...

21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... combination, as established in the statement of identity sections of the applicable OTC drug monographs. If... drug monographs, unless otherwise stated in this paragraph (a). (1) For permitted combinations... established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this...

Medicines in My Home: Information for Students on the Safe Use of Over-the-Counter Medicines

MedlinePlus

... are safer when you follow directions. The active ingredients in OTC medicines can be harmful if you don’t use them as directed on the label. Take for example, the active ingredients in OTC fever and pain medicines.... • Acetaminophen can ...

Current Over-the-Counter Medicine Label: Take a Look

MedlinePlus

... of OTC medicines sometimes make changes to their products or labeling (new ingredients, dosages, or warnings). Make sure to read the label each time you use the product. Always look for special "flags" or "banners" on ...

21 CFR 201.64 - Sodium labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

21 CFR 201.64 - Sodium labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

21 CFR 201.64 - Sodium labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

21 CFR 201.64 - Sodium labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

21 CFR 201.64 - Sodium labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

76 FR 35678 - SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

... [Docket No. FDA-2011-N-0449] SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the... testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and... techniques, when appropriate, and other forms of information technology. SPF Labeling and Testing...

21 CFR 349.80 - Professional labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... labeling. The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 349.80 Section 349.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... general pharmacological category(ies) or the principal intended action(s) of the drug or, where the drug... actions of each active ingredient. When an OTC drug monograph contains a statement of identity, the pharmacological action described in the statement of identity shall also be stated as the purpose of the active...

Rapid screening test for detection of oxytetracycline residues in milk using lateral flow assay.

PubMed

Naik, Laxmana; Sharma, Rajan; Mann, Bimlesh; Lata, Kiran; Rajput, Y S; Surendra Nath, B

2017-03-15

A rapid, semi-quantitative lateral flow assay (LFA) was developed to screen the oxytetracycline (OTC) antibiotics residues in milk samples. In this study a competitive immuno-assay format was established. Colloidal gold nano-particles (GNP) were prepared and used as labelling material in LFA. Polyclonal antibodies were generated against OTC molecule (anti-OTC), purified and the quality was assessed by enzyme linked immuno sorbet assay. For the first time membrane components required for LFA in milk system was optimized. GNP and anti-OTC stable conjugate preparation method was standardized, and then these components were placed over the conjugate pad. OTC coupled with carrier protein was placed on test line; species specific secondary antibodies were placed on the control line of the membrane matrix. Assay was validated by spiking OTC to antibiotic free milk samples and results could be accomplished within 5min. without need of any equipment. The visual detection limit was 30ppb. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be... is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication...

21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be... is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication...

21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be... is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication...

21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be... is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication...

21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be... is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication...

Residue depletion of oxytetracycline from fillet tissues of northern pike and walleye

USGS Publications Warehouse

Bernardy, Jeffry A.; Vue, Chue; Gaikowski, Mark P.; Stehly, Guy R.; Gingerich, William H.; Moore, Allen

2003-01-01

The broad-spectrum antibacterial drug oxytetracycline (OTC) is used in the U.S. to treat certain diseases in salmonids and catfish. This study was conducted to support an extension of the OTC label to include all cool-water fish species cultured at U.S. public aquaculture facilities by satisfying human food safety requirements. Juvenile northern pike (Esox lucius; mean weight: 117 g) and walleye (Stizostedion vitreum; mean weight: 59 g) were fed OTC-medicated diets near the maximum legal treatment rate (82.7 mg OTC-HCl/kg fish/day for 10 days) and near the lower limit of the water temperature range for most disease outbreaks in these species (14 and 16 °C, respectively). Two trials were conducted simultaneously with northern pike, one using commercially medicated feed and the other using on-site OTC top-coated feed. A third trial was performed with walleye using on-site OTC top-coated feed. Fillet tissues were collected and OTC free base (OTC-base) concentrations were determined by high performance liquid chromatography. The maximum mean OTC-base concentrations in the fillet tissue were 319 ng/g in northern pike (skinless) and 721 ng/g in walleye (skin-on), both well below the current tolerance limit of 2000 ng/g OTC-base. The log-linear loss of OTC-base from the fillet tissues was monophasic, with terminal phase half-lives of 5.9 days in northern pike fed commercial medicated feed, 6.7 days in northern pike fed top-coated feed, and 10.5 days in walleye fed top-coated feed. The data supported a zero withdrawal time in juvenile northern pike and walleye fed OTC at the approved dose level for 10 days at water temperatures down to 14 and 16 °C respectively.

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

...” heading. (7) Graphical images (e.g., the UPC symbol) and information not described in paragraphs (c)(1... established and identified in an applicable OTC drug monograph or by regulation. The terms listed in § 330.1(j...) and (j) of this chapter shall not be used to change in any way the specific title, headings, and...

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

...” heading. (7) Graphical images (e.g., the UPC symbol) and information not described in paragraphs (c)(1... established and identified in an applicable OTC drug monograph or by regulation. The terms listed in § 330.1(j...) and (j) of this chapter shall not be used to change in any way the specific title, headings, and...

Testing of Candidate Icons to Identify Acetaminophen-Containing Medicines

PubMed Central

Shiffman, Saul; Cotton, Helene; Jessurun, Christina; Sembower, Mark A.; Pype, Steve; Phillips, Jerry

2016-01-01

Adding icons on labels of acetaminophen-containing medicines could help users identify the active ingredient and avoid concomitant use of multiple medicines containing acetaminophen. We evaluated five icons for communication effectiveness. Adults (n = 300) were randomized to view a prescription container label or over-the-counter labels with either one or two icons. Participants saw two icon candidates, and reported their interpretation; experts judged whether these reflected critical confusions that might cause harm. Participants rated how effectively each icon communicated key messages. Icons based on abbreviations of “acetaminophen” (“Ac”, “Ace”, “Acm”) were rated less confusing and more effective in communicating the active ingredient than icons based on “APAP” or an abstract symbol. Icons did not result in critical confusion when seen on a readable medicine label. Icon implementation on prescription labels was more effective at communicating the warning against concomitant use than implementation on over-the-counter (OTC) labels. Adding an icon to a second location on OTC labels did not consistently enhance this communication, but reduced rated effectiveness of acetaminophen ingredient communication among participants with limited health literacy. The abbreviation-based icons seem most suitable for labeling acetaminophen-containing medications to enable users to identify acetaminophen-containing products. PMID:28970383

Oxytetracycline depletion from skin-on fillet tissue of coho salmon fed oxytetracycline medicated feed in freshwater at temperatures less than 9°C

USGS Publications Warehouse

Meinertz, Jeffery R.; Gaikowski, Mark P.; Stehly, Guy R.; Gingerich, William H.; Evered, Joy A.

2001-01-01

Oxytetracycline (OTC) is a broad spectrum antibacterial agent approved in the USA for treating certain bacterial diseases in salmonids cultured in freshwater at temperatures greater than or equal to 9°C. This study was conducted to provide the information necessary to expand the OTC label to include treatment of diseased salmonids cultured in freshwater at temperatures below 9°C. The study was designed to treat juvenile coho salmon (Oncorhynchus kisutch) with OTC-medicated feed and determine the depletion of OTC from the skin-on fillet tissue. Oxytetracycline depletion was evaluated in juvenile coho salmon (weight range, 13–62 g) fed OTC-medicated feed at a rate of 88.2 mg OTC/kg body weight/day for 10 days. Pairs of skin-on fillets were taken from individual fish on days 4 and 10 during the treatment phase and on days 1, 4, 8, 14, and 19 during the depletion phase. Water temperatures during the study period ranged from 4.1°C to 8.5°C. The OTC concentrations in medicated feed and skin-on fillets were determined with high-performance liquid chromatography methods. The maximum mean OTC concentration in fillet tissue was 932 ng/g, 1 day after the last treatment and decreased to 32 ng/g 19 days after the last treatment. The log-linear loss of OTC from the fillet tissue was biphasic with a terminal phase half-life of 4.9 days.

The Effect of Water Hardness on Mortality of Zebrafish (Danio rerio) During Exposure to Oxytetracycline.

PubMed

Hundt, Matthias; Schreiber, Benjamin; Eckmann, Reiner; Lunestad, Bjørn Tore; Wünneman, Hannah; Schulz, Ralf

2016-02-01

Marking of fish otoliths with oxytetracycline and tetracycline is a widely used method to evaluate the effectiveness of stocking operations. Available protocols for the labeling of fish specify a number of factors influencing mark quality and potential risk for fish during marking. This study investigates the influence of water hardness on mortality of freshwater fish during marking with OTC. In order to pursue this question complexation of OTC with Mg(2+) and Ca(2+) cations was measured spectrophotometrically. Furthermore, zebrafish (Danio rerio) were immersed in OTC solutions (1200 mg/L; 48 h immersion) combined with varying levels of water hardness (5.5, 15.5, 25.5, 32.5°dH). The amount of OTC-Mg-Ca-complexes was positively correlated to water hardness. Moreover, it could be demonstrated that mortality of zebrafish during marking varied as a factor of water hardness. Highest mortalities occurred at the lowest (5.5°dH) and the highest (32.5°dH) tested levels during marking with OTC.

Clinical Pharmacology and Cardiovascular Safety of Naproxen.

PubMed

Angiolillo, Dominick J; Weisman, Steven M

2017-04-01

The voluntary withdrawal of Vioxx (rofecoxib) from the market in 2004, as well as the 2005 and 2014 US FDA Advisory Committee meetings about non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk, have raised questions surrounding the use of NSAIDs in at-risk populations. This paper discusses the cardiovascular safety profile of naproxen in the context of the NSAID class. The balance of evidence suggests that cardiovascular risk correlates with cyclooxygenase (COX)-2 selectivity, and the low COX-2 selectivity of naproxen results in a lower cardiovascular risk than that of other NSAIDs. The over-the-counter (OTC) use of naproxen is expected to pose minimal cardiovascular risk; however, the benefit-risk ratio and appropriate use should be considered at an individual patient level, particularly to assess underlying conditions that may increase the risk of events. Likewise, regulatory authorities should revisit label information periodically to ensure labeling reflects the current understanding of benefits and risks.

Developing consumer-centered, nonprescription drug labeling a study in acetaminophen.

PubMed

King, Jennifer P; Davis, Terry C; Bailey, Stacy Cooper; Jacobson, Kara L; Hedlund, Laurie A; Di Francesco, Lorenzo; Parker, Ruth M; Wolf, Michael S

2011-06-01

In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Residue depletion of oxytetracycline from fillet tissues of northern pike and walleye

USGS Publications Warehouse

Bernardy, J.A.; Vue, C.; Gaikowski, M.P.; Stehly, G.R.; Gingerich, W.H.; Moore, A.

2003-01-01

Iowa Department of Natural Resources Fisheries Bureau,Rathbun Research,15053 Hatchery Place,Moravia, IA 52571-8933,USA The broad-spectrum antibacterial drug oxytetracycline (OTC) is used in the U.S. to treat certain diseases in salmonids and catfish. This study was conducted to support an extension of the OTC label to include all cool-water fish species cultured at U.S. public aquaculture facilities by satisfying human food safety requirements. Juvenile northern pike (Esox lucius; mean weight: 117 g) and walleye (Stizostedion vitreum; mean weight: 59 g) were fed OTC-medicated diets near the maximum legal treatment rate (82.7 mg OTC-HCl/kg fish/day for 10 days) and near the lower limit of the water temperature range for most disease outbreaks in these species (14 and 16??C, respectively). Two trials were conducted simultaneously with northern pike, one using commercially medicated feed and the other using on-site OTC top-coated feed. A third trial was performed with walleye using on-site OTC top-coated feed. Fillet tissues were collected and OTC free base (OTC-base) concentrations were determined by high performance liquid chromatography. The maximum mean OTC-base concentrations in the fillet tissue were 319 ng/g in northern pike (skinless) and 721 ng/g in walleye (skin-on), both well below the current tolerance limit of 2000 ng/g OTC-base. The log-linear loss of OTC-base from the fillet tissues was monophasic, with terminal phase half-lives of 5.9 days in northern pike fed commercial medicated feed, 6.7 days in northern pike fed top-coated feed, and 10.5 days in walleye fed top-coated feed. The data supported a zero withdrawal time in juvenile northern pike and walleye fed OTC at the approved dose level for 10 days at water temperatures down to 14 and 16??C respectively. Published by Elsevier Science B.V.

[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database].

PubMed

Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Motooka, Yumi; Fukuda, Akiho; Naganuma, Misa; Umetsu, Ryogo; Nakao, Satoshi; Shimauchi, Akari; Ueda, Natsumi; Hirade, Kouseki; Iguchi, Kazuhiro; Nakamura, Mitsuhiro

2018-01-01

 OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for "skin and subcutaneous tissue disorders", "hepatobiliary disorders", and "immune system disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for "hepatobiliary disorders" than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.

A bridging study for oxytetracycline in the edible fillet of rainbow trout: Analysis by a liquid chromatographic method and the official microbial inhibition assay

USGS Publications Warehouse

Stehly, G.R.; Gingerich, W.H.; Kiessling, C.R.; Cutting, J.H.

1999-01-01

Oxytetracycline (OTC) is a drug approved by the U.S. Food and Drug Administration (FDA) to control certain diseases in salmonids and catfish. OTC is also a likely control agent for diseases of other fish species and for other diseases of salmonids and catfish not currently on the label. One requirement for FDA to extend and expand the approval of this antibacterial agent to other fish species is residue depletion studies. The current regulatory method for OTC in fish tissue, based on microbial inhibition, lacks sensitivity and specificity. To conduct residue depletion studies for OTC in fish with a liquid chromatographic method, a bridging study was required to determine its relationship with the official microbial inhibition assay. Triplicate samples of rainbow trout fillet tissue fortified with OTC at 0.3, 0.6, 1.2, 2.4, 4.8, and 9.6 ppm and fillet tissue with incurred OTC at approximately 0.75, 1.5, and 3.75 ppm were analyzed by high-performance liquid chromatography (HPLC) and the microbial inhibition assay. The results indicated that the 2 methods are essentially identical in the tested range, with mean coefficients of variation of 1.05% for the HPLC method and 3.94% for the microbial inhibition assay.

Surgery, Hospitals, and Medications

MedlinePlus

... products that are not commonly stocked in hospital pharmacies. Examples include: Salagen ® , Evoxac ® , and Restasis ® Eye drops, ... prescription and OTC medications/products in their labeled pharmacy container or packaging. This is important in case ...

ELISA testing for common food antigens in four dry dog foods used in dietary elimination trials.

PubMed

Raditic, D M; Remillard, R L; Tater, K C

2011-02-01

This study evaluated four over the counter venison dry dog foods available from one on-line retail vendor for potential contamination with common known food allergens: soy, poultry or beef. An amplified, double sandwich type enzyme linked immunosorbent assay (ELISA) test of soy, poultry and beef proteins were performed by an independent accredited food laboratory. The ELISA test for poultry protein was found to be unreliable when testing in dry dog foods because false negatives occurred. ELISA testing of control diets for both soy and beef proteins performed as expected and could be useful in antigen testing in dry dog foods. Three of the four over the counter (OTC) venison canine dry foods with no soy products named in the ingredient list were ELISA positive for soy; additionally one OTC diet tested positive for beef protein with no beef products listed as an ingredient list. One OTC venison diet was not found to be positive for soy, poultry or beef proteins. However, none of the four OTC venison diets could be considered suitable for a diagnostic elimination trial as they all contained common pet food proteins, some of which were readily identifiable on the label and some that were only detected by ELISA. Therefore, if the four OTC venison products selected in this study are representative of OTC products in general, then the use of OTC venison dry dog foods should not be used during elimination trials in suspected food allergy patients. © 2010 Blackwell Verlag GmbH.

An electrochemical aptasensor for multiplex antibiotics detection based on metal ions doped nanoscale MOFs as signal tracers and RecJf exonuclease-assisted targets recycling amplification.

PubMed

Chen, Meng; Gan, Ning; Zhou, You; Li, Tianhua; Xu, Qing; Cao, Yuting; Chen, Yinji

2016-12-01

An ultrasensitive electrochemical aptasensor for simultaneous detection of oxytetracycline (OTC) and kanamycin (KAN) has been developed based on metal ions doped metal organic frame materials (MOFs) as signal tracers and RecJ f exonuclease-catalyzed targets recycling amplification. The aptasensor consists of capture beads (the anti-single-stranded DNA Antibody, as anti-ssDNA Ab, labeled on Dynabeads) and nanoscale MOF (NMOF) based signal tracers (simplified as Apts-MNM, the NMOF labeled with metal ions and the aptamers). Particularly, the MOF (UiO-66-NH 2 ), with large internal surface areas, ultrahigh porosity and abundant amine groups in the pores, was employed as substrates to carry plenty of metal ions (Pb 2+ or Cd 2+ ) and label aptamers of OTC or KAN. Thus, the aptasensor is formed by the specific recognition between anti-ssDNA Ab and aptamers. In the presence of targets (OTC and KAN), aptamers prefer to form targets-Apts-MNM complexes in lieu of anti-ssDNA Ab-aptamer complexes, which results in the dissociation of Apts-MNM from capture beads. With the employment of RecJ f exonuclease, targets-Apts-MNM in supernatant was digested into mononucleotides and liberated the target, which can further participate in the next reaction cycling to produce more signal tracers. After magnetic separation, the enhanced square wave voltammetry (SWV) signals were produced from signal tracers. The aptasensor exhibited a linear correlation in the range from 0.5pM to 50nM, with detection limits of 0.18pM and 0.15pM (S/N=3) toward OTC and KAN respectively. This strategy provides specificity and sensitive approach for multiplex antibiotics detection and has promising applications in food analysis. Copyright © 2016 Elsevier B.V. All rights reserved.

Can consumers self-select for appropriate use of an over-the-counter statin? The Self Evaluation of Lovastatin to Enhance Cholesterol Treatment Study.

PubMed

Brass, Eric P; Vassil, Theodore; Replogle, Amy; Hwang, Peggy; Rusche, Steven; Shiffman, Saul; Levine, Jeffrey G

2008-05-15

Access to over-the-counter (OTC) statins has the potential to improve public health by reducing cardiovascular events. The Self Evaluation of Lovastatin to Enhance Cholesterol Treatment (SELECT) Study was designed to assess consumers' ability to self-select for treatment with lovastatin in an unsupervised setting. Subjects examined proposed OTC lovastatin cartons with labels that detailed an algorithm for self-selection based on age, lipid profile, and cardiovascular risk factors. Subjects viewed a carton with either a low-density lipoprotein cholesterol-based self-selection algorithm or one based on total cholesterol. Labels also contained warnings against use based on health conditions that might increase the risk of adverse events. Subjects were asked if the drug was appropriate for their use (self-assessment) and whether they would like to purchase the drug (purchase decision). A total of 1,326 consumers provided self-assessment decisions. After viewing the low-density lipoprotein cholesterol-based label, 82%, 36%, and 82% of those who self-assessed that the drug was appropriate for their use were correct with respect to the age, lipid, and risk-factor criteria, respectively. Corresponding numbers for the total cholesterol algorithm were 85%, 50% and 75%. Almost 90% of women aged <55 years who evaluated the drug indicated the drug was not right for them, and women in this age group made up only 9% of the total group of subjects who believed the drug was appropriate for their use. The label was also effective in discouraging use by women who were or may become pregnant, consumers with liver disease, and those with potential drug interactions. In conclusion, SELECT showed that consumers could use an OTC drug label in an unsupervised setting to appropriately self-select for self-management of their cholesterol with lovastatin.

Over-the-Counter Medicines: What's Right for You?

MedlinePlus

... Contents: Advice for Americans about Self-Care: Access + Knowledge = Power OTC Know-How: It's on the Label Drug ... Tampering Advice for Americans about Self-Care: Access + Knowledge = Power American medicine cabinets contain a growing choice of ...

Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule.

PubMed

2007-12-19

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.

75 FR 17297 - Account Class

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

...'') (CL01). \\10\\ The Futures Industry Association (representing the commodity futures and options industry... clearing through a Futures Commission Merchant * * * to a Derivatives Clearing Organization.'' 73 FR 65514... cleared OTC derivative (and relevant collateral) to be included in the futures account class rather than...

Substances used in completed suicide by overdose in Toronto: an observational study of coroner's data.

PubMed

Sinyor, Mark; Howlett, Andrew; Cheung, Amy H; Schaffer, Ayal

2012-03-01

To identify the substances used by people who die from suicide by overdose in Toronto and to determine the correlates of specific categories of substances used. Coroner's records for all cases of suicide by overdose in Toronto, Ontario, during a 10-year period (1998 to 2007) were examined. Data collected included demographic data, all substances detected, and those determined by the coroner to have caused death. Logistic regression analyses were used to examine demographic and clinical factors associated with suicide by different drug types. There were 397 documented suicides by overdose (mean age 49.1 years, 50% female). Most substances detected were psychotropic prescription medications (n = 245), followed by other prescription medications (n = 143) and over-the-counter (OTC) medications (n = 83). More than one-half of all suicides by overdose were determined to have only one specific substance as the cause of death (n = 206). In suicides where only one class of substance was present in lethal amounts, OTC medication (n = 48), opioid analgesics (n = 44), and tricyclic antidepressants (n = 44) were most common. Suicides by overdose involved the use of different classes of substances, including psychotropic prescription medication, other prescription medications, as well as OTC medications. Physicians and pharmacists should be aware of commonly used prescription and OTC medications in overdose and exercise increased vigilance in prescribing or dispensing them to at-risk patients.

A review of over-the-counter drug therapy.

PubMed

Esmay, J B; Wertheimer, A I

1979-01-01

The authors review the extent of the use of nonprescription drugs as well as possible variables influencing such consumption. Various studies indicate that age, sex, personality characteristics, perceptions of health status, socioeconomic factors, parental example, and pharmacists all play parts in determining over-the-counter (OTC) drug utilization. Several sources express concern about the inaccessibility of accurate OTC drug information to the consumer. Indeed, even the FDA has occasional difficulty obtaining reliable facts on both the numbers and formulae of such products. Several studies indicate that consumers acquire information about their home remedies through advertising, friends and relatives, physicians, pharmacists, and product labels. By far the most influential of these is advertising, and much concern has been voiced over consumers' unquestioning faith in drug ads. Examples are cited of deceptive, inaccurate, and unfair advertising practices used by some OTC drug manufacturers. The pros and cons of the "drug-oriented society" theory are discussed, including an analysis of its underlying origins. Testing of the safety and efficacy of nonrescription remedies has proved to be controversial, especially when considering the ramifications of the placebo effect. Different surveys report widespread misuse of OTC's by consumers through overuse, taking several drugs concurrently, and using home remedies to treat potentially serious diseases.

Misunderstanding and Potential Unintended Misuse of Acetaminophen among Adolescents and Young Adults

PubMed Central

Shone, Laura P.; King, Jennifer P.; Doane, Cindy; Wilson, Karen M.; Wolf, Michael S.

2013-01-01

Purpose Acetaminophen is highly accessible yet potentially dangerous when used incorrectly. In attempts to address concerns about acetaminophen, The U.S. Food and Drug Administration (FDA) has identified gaps in evidence about unintentional misuse among adolescents. Therefore, our objectives were to assess: adolescents’: 1) health literacy; 2) knowledge about acetaminophen; 3) recent use of over-the-counter (OTC) medicines; 4) and use of medication dosing instructions to understand the medicine and how to use it (‘acetaminophen skills’). Methods Subjects and Setting: We conducted a cross-sectional survey of adolescents and young adults (ages 16–23 years) recruited from education settings and health care sites in Monroe County, New York, from 11/08–9/09. Measures: Using structured in-person interviews, we assessed acetaminophen knowledge and recent use of over-the-counter (OTC) medicines. We assessed participants’ ability to identify acetaminophen in OTC products and answer questions about instructions for acetaminophen use through role-plays of everyday health scenarios. We measured health literacy with the Rapid Estimate of Adult Literacy in Medicine (REALM) for participants >18, and the REALM-Teen for those <18. Results Confusion about acetaminophen and its use was common. Limited health literacy was an independent risk factor for poor knowledge, misunderstanding, and potential unsafe use of acetaminophen-containing medicines, however, most participants at all health literacy levels erred dangerously in ‘unsafe’ understanding of acetaminophen use from label instructions. Conclusions Individuals with limited health literacy may face disproportionate risk of unsafe use of acetaminophen due to confusion and misunderstanding of label information. Better labeling, public health programs, and educational efforts could facilitate safer use of acetaminophen. PMID:21951256

Organotin intake through fish consumption in Finland

DOE Office of Scientific and Technical Information (OSTI.GOV)

Airaksinen, Riikka, E-mail: Riikka.Airaksinen@thl.fi; Rantakokko, Panu; Turunen, Anu W.

Background: Organotin compounds (OTCs) are a large class of synthetic chemicals with widely varying properties. Due to their potential adverse health effects, their use has been restricted in many countries. Humans are exposed to OTCs mostly through fish consumption. Objectives: The aim of this study was to describe OTC exposure through fish consumption and to assess the associated potential health risks in a Finnish population. Methods: An extensive sampling of Finnish domestic fish was carried out in the Baltic Sea and freshwater areas in 2005-2007. In addition, samples of imported seafood were collected in 2008. The chemical analysis was performedmore » in an accredited testing laboratory during 2005-2008. Average daily intake of the sum of dibutyltin (DBT), tributyltin (TBT), triphenyltin (TPhT) and dioctyltin (DOT) ({Sigma}OTCs) for the Finnish population was calculated on the basis of the measured concentrations and fish consumption rates. Results: The average daily intake of {Sigma}OTCs through fish consumption was 3.2 ng/kg bw day{sup -1}, which is 1.3% from the Tolerable Daily Intake (TDI) of 250 ng/kg bw day{sup -1} set by the European Food Safety Authority. In total, domestic wild fish accounted for 61% of the {Sigma}OTC intake, while the intake through domestic farmed fish was 4.0% and the intake through imported fish was 35%. The most important species were domestic perch and imported salmon and rainbow trout. Conclusions: The Finnish consumers are not likely to exceed the threshold level for adverse health effects due to OTC intake through fish consumption.« less

U.S. EPA, Pesticide Product Label, , 04/02/1982

EPA Pesticide Factsheets

2011-04-13

... (~ .. t. , ... Do ret ~p'~ """ w ,pt"¥'Ii cl ,"1, pro.;!~C' i'" Cf'l'\\dv'h "'O'Ot ""ev,'r::l' It"'c'!o" al'ld , .... ... foy":->Q,.t .. t"r ., ,t." ~ ",otc" 0" p'I,I~9 •• ,te"'" In '''f' ...

Don't Double Up on Acetaminophen

MedlinePlus

... re at the store deciding which product to buy, check the 'Drug Facts' label of OTC cold, cough and flu ... If you’re still not sure which to buy, ask the pharmacist for advice. FDA has an ... medicines containing acetaminophen accounted for nearly half of all ...

Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

PubMed Central

Moore, Nicholas; Pollack, Charles; Butkerait, Paul

2015-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC) analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs) including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs) between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. PMID:26203254

Department of Health and Human Services Semiannual Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88 Operations for Dietary Supplements 341 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products 0910-AF34 342... repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical...

21 CFR 341.70 - Labeling of OTC drug products containing ingredients that are used for treating concurrent...

Code of Federal Regulations, 2011 CFR

2011-04-01

... name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part...

21 CFR 341.70 - Labeling of OTC drug products containing ingredients that are used for treating concurrent...

Code of Federal Regulations, 2010 CFR

2010-04-01

... name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part...

21 CFR 341.70 - Labeling of OTC drug products containing ingredients that are used for treating concurrent...

Code of Federal Regulations, 2014 CFR

2014-04-01

... name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part...

21 CFR 341.70 - Labeling of OTC drug products containing ingredients that are used for treating concurrent...

Code of Federal Regulations, 2012 CFR

2012-04-01

... name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part...

21 CFR 341.70 - Labeling of OTC drug products containing ingredients that are used for treating concurrent...

Code of Federal Regulations, 2013 CFR

2013-04-01

... name of the drug, if any, and identifies the product as a “cough suppressant/oral anesthetic” or “antitussive (cough suppressant)/oral anesthetic.” The indications shall be combined from § 341.74(b) and part...

Pharmacy student decision making in over-the-counter medicine supply: A critical incident study.

PubMed

McMillan, Sara S; Thangarajah, Thachaayini; Anderson, Claire; Kelly, Fiona

2017-09-28

Various factors influence decision making in over-the-counter (OTC) medicine consultations, yet limited studies have focused, in-depth, on the thought process of pharmacy staff. This includes pharmacy students as pharmacists-in-training. To explore the factors that influence pharmacy students' decisions in relation to OTC consultations and choice of OTC medicine/s. Semi-structured interviews using the critical incident technique were undertaken with ten pharmacy students in Australia, who also worked as part-time pharmacy staff. Nine key themes were identified to influence pharmacy student decision making in OTC consultations, including customer response, confidence and scope of practice. Product requests were reported as more challenging due to customer expectations and experiences in other pharmacies, states or countries. Although negative customer response influenced some students to supply medicines in contradiction of evidence, an overarching concern for safety meant that a medicine was only supplied if unlikely to cause harm. Students reported developing confidence in OTC decision making more from real-life practice than university training; greater confidence was identified for inquiries more frequently experienced in the pharmacy. Students perceived that customers had assumptions around support staff, and were happier to talk to students than assistants. This study further identified that OTC decision making is a complex process for pharmacy students. Additional opportunities for experiential learning within this area are suggested, such as work-based placements or in-class activities such as role-plays with simulated patients. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

... products containing specified active ingredients and marketed without approved applications. It also amends... certain OTC sunscreen products containing specified active ingredients and marketed without approved... risk of skin cancer and early skin aging caused by the sun. If the timeline for implementation...

A study to examine the relationship between metritis severity and depletion of oxytetracycline in plasma and milk after intrauterine infusion.

PubMed

Gorden, P J; Ydstie, J A; Kleinhenz, M D; Wulf, L W; Gehring, R; Lee, C J; Wang, C; Coetzee, J F

2016-10-01

Metritis is a frequent problem in postpartum dairy cows. Intrauterine therapy with the antimicrobial oxytetracycline (OTC) is often used, although this therapy has not been shown to be superior to systemic therapy. The objectives of this study were to (1) determine the plasma and milk concentrations of OTC following intrauterine infusion in postpartum dairy cows with varying degrees of metritis severity; (2) determine the depletion time of OTC in an attempt to provide veterinarians withdrawal guidelines, should they use this therapy; and (3) correlate metritis severity scores with OTC concentrations in plasma and milk. Our hypothesis was that cows with more severe metritis would have higher OTC concentrations in milk following intrauterine therapy. Thirty-two cows were selected to participate in the study after farm personnel had determined that they had metritis based on evaluation of vaginal discharge between 4 and 14 DIM, in accordance with the farm's treatment protocols. Metritis scores (1-4) were assigned based on a published scheme: 1 represented yellow-to-orange thick discharge or translucent mucus with no fetid smell; 2 represented blood-tinged vaginal mucus, slightly watery, with little or no fetid smell; 3 represented red to red/brown watery discharge with moderate fetid smell; and 4 represented red to red/brown watery discharge containing pieces of placenta and an intense fetid smell. Trial cows received a single treatment of 4g of OTC (approximately 6.7mg/kg) via intrauterine infusion. Blood samples were collected over 96h, and milk samples were collected before intrauterine therapy and 3 times a day for 4 d following infusion. Following treatment, OTC rapidly diffused to plasma and subsequently to milk. Maximum OTC concentrations in plasma and milk occurred within the first 24h following intrauterine infusion, and 25 of the 32 cows had detectable OTC concentrations in milk at 4 d after intrauterine infusion. Cows with clinical metritis (metritis severity scores of 3 or 4) at the initiation of treatment were significantly and positively correlated with higher milk OTC concentrations at the second [time (T)9 h; r=0.43], fourth (T25 h; r=0.42), and fifth milking following treatment (T33 h; r=0.38) compared with cows with normal vaginal discharge. We also observed a positive correlation between initial metritis score and milk maximum concentration (r=0.36) and milk area under the concentration curve (r=0.36). Given that intrauterine administration of OTC is an extra-label therapy, dairy producers should consult with their veterinarian to ensure that milk is being tested at or below the established tolerance for OTC. This will ensure that violative drug residues do not enter the human food supply. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Obstruction of critical information on over-the-counter medication packages by external tags.

PubMed

Sansgiry, Sujit S; Pawaskar, Manjiri D

2005-02-01

Over-the-counter (OTC) medication packages are important sources of information for consumers during product selection and use. Consumers may not be able to access information from OTC packages if external tags, namely price or anti-theft tags, are improperly placed. To determine the amount and type of information concealed by anti-theft tags and price tags affixed on OTC drug packages. A field study was performed by evaluating packages containing acetaminophen and combinations of acetaminophen in stores located in Houston. Five packages for 4 products selected from each store after an initial survey for presence of an external tag were examined. A data collection sheet was prepared that extracted the type and amount of information concealed by these tags. Data were analyzed by performing descriptive analyses to provide an understanding of the information obscured. A total of 24 stores were considered in the study, and 67 products and 285 packages were evaluated. External tags, both anti-theft and price tags, obscured significant amounts of information on the principal display panel (53.4%) and the Drug Facts panel (47.7%) of OTC packages. These tags concealed crucial information on various aspects of labels such as brand names (42.3%), product description (36.3%), warnings (51.5%), uses (10.4%), and purposes (7.2%). Results suggest that improper use of external tags clearly obscured important information on OTC medication packages necessary for consumers to make informed decisions regarding product selection and use. Tagging practices should be altered to allow consumers full access to drug information on the product.

Time-lapse imaging reveals highly dynamic structural maturation of postnatally born dentate granule cells in organotypic entorhino-hippocampal slice cultures

PubMed Central

Radic, Tijana; Jungenitz, Tassilo; Singer, Mathias; Beining, Marcel; Cuntz, Hermann; Vlachos, Andreas; Deller, Thomas; Schwarzacher, Stephan W.

2017-01-01

Neurogenesis of hippocampal granule cells (GCs) persists throughout mammalian life and is important for learning and memory. How newborn GCs differentiate and mature into an existing circuit during this time period is not yet fully understood. We established a method to visualize postnatally generated GCs in organotypic entorhino-hippocampal slice cultures (OTCs) using retroviral (RV) GFP-labeling and performed time-lapse imaging to study their morphological development in vitro. Using anterograde tracing we could, furthermore, demonstrate that the postnatally generated GCs in OTCs, similar to adult born GCs, grow into an existing entorhino-dentate circuitry. RV-labeled GCs were identified and individual cells were followed for up to four weeks post injection. Postnatally born GCs exhibited highly dynamic structural changes, including dendritic growth spurts but also retraction of dendrites and phases of dendritic stabilization. In contrast, older, presumably prenatally born GCs labeled with an adeno-associated virus (AAV), were far less dynamic. We propose that the high degree of structural flexibility seen in our preparations is necessary for the integration of newborn granule cells into an already existing neuronal circuit of the dentate gyrus in which they have to compete for entorhinal input with cells generated and integrated earlier. PMID:28256620

21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

Code of Federal Regulations, 2014 CFR

2014-04-01

... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... to establish general recognition of the safety and effectiveness of quinine sulfate, vitamin E, or.... (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented...

21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

Code of Federal Regulations, 2013 CFR

2013-04-01

... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... to establish general recognition of the safety and effectiveness of quinine sulfate, vitamin E, or.... (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented...

21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... to establish general recognition of the safety and effectiveness of quinine sulfate, vitamin E, or.... (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented...

Over the counter (OTC) artificial tear drops for dry eye syndrome.

PubMed

Pucker, Andrew D; Ng, Sueko M; Nichols, Jason J

2016-02-23

Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears. To evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo. We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches. This review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy. We followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text. We included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias. OTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.

Correlates of Abusing and Misusing Over-the-Counter Pain Relievers Among Adult Population of Wrocław (Poland).

PubMed

Wójta-Kempa, Monika; Krzyżanowski, Dominik M

2016-01-01

Almost 90% of households in Poland buy medicines on their own initiative. The most popular OTC medicines bought by Polish consumers are painkillers and non-steroid-anti-inflammatory drugs. The aim of this article was to recognize and describe the most important predictive factors of the abuse and misuse of over-the-counter pain relievers among adults in Wrocław (Poland). The groups of users were selected and described. Some examples of misuse were analyzed. Three hundred eighty six adult inhabitants of Wrocław took part in the survey. The quota sample was representative referring to the most important socio-demographic factors (sex and median age). Almost 91% of participants declare taking OTC pain relievers, and 1.3% of them are their daily users. Only 6.2% of adult inhabitants of Wrocław never take OTC pain relievers. The category of "heavy users" embraces 11% of participants. The most important risk factors of overusing OTC pain relievers are sex (female), age over 55 years and the low health status. Only half of participants read the box label regularly and 25% of users admit they have modified recommended doses. Over 60% shortened recommended intervals between doses and 16% took two or more different pain medications (containing different substances). The non-medical purposes of using OTC pain relievers were: tiredness (7%), stressful situations (5.4%), and discomfort (18.4%). Some users take pain medications to cure hangovers (26%), or instead of the appropriate medicine (7%). About 20% take pain medications without a doctor's advice for longer than the recommended 3 days, and 10% never consult taking such medications with doctors. Pain should be treated aggressively and successfully, especially among chronically ill patients. We should monitor the consumption of OTC pain relievers and limit their current excessively supply and high availability.

21 CFR 872.3570 - OTC denture repair kit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

21 CFR 872.3570 - OTC denture repair kit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

21 CFR 872.3570 - OTC denture repair kit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

21 CFR 872.3570 - OTC denture repair kit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

21 CFR 872.3570 - OTC denture repair kit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

21 CFR 872.3540 - OTC denture cushion or pad.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-counter. (b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the... denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended...

21 CFR 872.3540 - OTC denture cushion or pad.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-counter. (b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the... denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended...

21 CFR 872.3540 - OTC denture cushion or pad.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-counter. (b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the... denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended...

21 CFR 872.3540 - OTC denture cushion or pad.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-counter. (b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the... denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended...

21 CFR 872.3540 - OTC denture cushion or pad.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-counter. (b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the... denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended...

Reading about over-the-counter medications.

PubMed

Nabors, Laura A; Lehmkuhl, Heather D; Parkins, Irina S; Drury, Anna M

2004-01-01

Many adolescents and young adults purchase and use over-the-counter (OTC) medications, and some may take these medications without reading about how to use them. Most do read package inserts and labels to learn about the medication, but studies examining what influences label reading for youth are needed. This study assessed factors related to label reading for young people, including demographic variables (gender, health status) and the types of information they were seeking about the medication. Eight hundred and seventy-six high school and college students participated, and most reported reading labels or package inserts to learn about medications. Participants experiencing pain were more likely to read labels, except for those experiencing headaches who reported being less likely to read labels. When reading labels, participants were interested in information about side effects, ingredients, dosage instructions, and symptoms treated by the medication. Future research should examine whether youth take medications as directed and what factors make labels and inserts easier to read and understand.

21 CFR 328.50 - Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

Code of Federal Regulations, 2011 CFR

2011-04-01

... intended for oral ingestion that contain alcohol. 328.50 Section 328.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Labeling § 328.50 Principal display panel of all...

21 CFR 328.50 - Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... intended for oral ingestion that contain alcohol. 328.50 Section 328.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Labeling § 328.50 Principal display panel of all...

21 CFR 328.50 - Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

Code of Federal Regulations, 2012 CFR

2012-04-01

... intended for oral ingestion that contain alcohol. 328.50 Section 328.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Labeling § 328.50 Principal display panel of all...

21 CFR 328.50 - Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

Code of Federal Regulations, 2013 CFR

2013-04-01

... intended for oral ingestion that contain alcohol. 328.50 Section 328.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Labeling § 328.50 Principal display panel of all...

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: “[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088.” The telephone number... means any component that is intended to furnish pharmacological activity or other direct effect in the... specified activity or effect. (3) Approved drug application means a new drug (NDA) or abbreviated new drug...

21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: “[Bullet] side effects occur. You may report side effects to FDA at 1-800-FDA-1088.” The telephone number... means any component that is intended to furnish pharmacological activity or other direct effect in the... specified activity or effect. (3) Approved drug application means a new drug (NDA) or abbreviated new drug...

Over the counter (OTC) artificial tear drops for dry eye syndrome

PubMed Central

Pucker, Andrew D; Ng, Sueko M; Nichols, Jason J

2016-01-01

Background Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears. Objectives To evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches. Selection criteria This review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy. Data collection and analysis We followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text. Main results We included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias. Authors’ conclusions OTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations. PMID:26905373

Over the Counter, under the Radar: Inequitably Distributing New York City's Late-Enrolling High School Students

ERIC Educational Resources Information Center

Arvidsson, Toi Sin; Fruchter, Norm; Mokhtar, Christina

2013-01-01

Every year, some 36,000 students who enroll in New York City high schools without participating in the high school choice process are labeled as "over-the-counter" or OTC students and are assigned a school by the New York City Department of Education (DOE). These young people are among the school system's highest-needs students: new…

Over the Counter, under the Radar: Inequitably Distributing New York City's Late-Enrolling High School Students. Executive Summary

ERIC Educational Resources Information Center

Arvidsson, Toi Sin; Fruchter, Norm; Mokhtar, Christina

2013-01-01

Every year, some 36,000 students who enroll in New York City high schools without participating in the high school choice process are labeled as "over-the-counter" or OTC students and are assigned a school by the New York City Department of Education (DOE). These young people are among the school system's highest-needs students: new…

Diagnosis of EGFR exon21 L858R point mutation as lung cancer biomarker by electrochemical DNA biosensor based on reduced graphene oxide /functionalized ordered mesoporous carbon/Ni-oxytetracycline metallopolymer nanoparticles modified pencil graphite electrode.

PubMed

Shoja, Yalda; Kermanpur, Ahmad; Karimzadeh, Fathallah

2018-08-15

In this present work we made a novel, fast, selective and sensitive electrochemical genobiosensor to detection of EGFR exon 21 point mutation based on two step electropolymerization of Ni(II)-oxytetracycline conducting metallopolymer nanoparticles (Ni-OTC NPs) on the surface of pencil graphite electrode (PGE) which was modified by reduced graphene oxide/carboxyl functionalized ordered mesoporous carbon (rGO/f-OMC) nanocomposite. ssDNA capture probe with amine groups at the5' end which applied as recognition element was immobilized on the rGO/f-OMC/PGE surface via the strong amide bond. Ni-OTC metallopolymer NPs were electropolymerized to rGO/ssDNA-OMC/PGE surface and then hybridization fallows through the peak current change in differential pulse voltammetry (DPV) using Ni-OTC NPs as a redox label. The biosensor was characterized by field emission scanning electron microscopy (FE-SEM), X-ray diffraction (XRD), FT-IR spectroscopy, energy dispersive X-ray spectroscopy (EDX), cyclic voltammetry and Nitrogen adsorption-desorption analysis. The Ni-OTC current response verified only the complementary sequence indicating a significant reduction current signal in comparison to single point mismatched and non-complementary and sequences. Under optimal conditions, the prepared biosensor showed long-term stability (21 days) with a wide linear range from 0.1 µM to 3 µM with high sensitivity (0.0188 mA/µM) and low detection limit (120 nM). Copyright © 2018 Elsevier B.V. All rights reserved.

Herbal Energizers: Speed By Any Other Name.

ERIC Educational Resources Information Center

Jenkins, Andrew P.

This guide focuses on over-the-counter (OTC) stimulants sold to high school aged athletes and dieters as "herbal energizers," food supplements, and fatigue reducers. While advertising often makes them appear healthful and harmless, all of these stimulants belong in the class "sympathomimetic amines," so called because they…

Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers†

PubMed Central

Klein-Schwartz, Wendy; Sorkin, John David; Doyon, Suzanne

2015-01-01

SUMMARY Purpose To assess the impact of a voluntary withdrawal of over-the-counter cough and cold medications (OTC CCMs) labeled for children under age 2 years on pediatric ingestions reported to the American Association of Poison Control Centers. Methods Trend analysis of OTC CCMs ingestions in children under the age 6 years resulting from therapeutic errors or unintentional poisonings for 27 months before (pre-) and 15 months after (post-) the October 2007 voluntary withdrawal was conducted. The rates and outcome severity were examined. Results The mean annual rate of therapeutic errors involving OTC CCMs post-withdrawal, in children less than 2-years of age, 45.2/100 000 (95%CI 30.7–66.6) was 54% of the rate pre-withdrawal, 83.8/100 000 (95%CI 67.6–104.0). The decrease was statistically significant p < 0.02. In this age group, there was no difference in the frequency of severe outcomes resulting from therapeutic errors post-withdrawal. There was no significant difference in unintentional poisoning rates post-withdrawal 82.1/100 000 (66.0–102.2) vs. pre-withdrawal 98.3/100 000 (84.4–114.3) (p < 0.21) in children less than 2-years of age. There were no significant reductions in rates of therapeutic errors and unintentional poisonings in children ages 2–5 years, who were not targeted by the withdrawal. Conclusions A significant decrease in annual rates of therapeutic errors in children under 2-years reported to Poison Centers followed the voluntary withdrawal of OTC CCMs for children under age 2-years. Concerns that withdrawal of pediatric medications would paradoxically increase poisonings from parents giving products intended for older age groups to young children are not supported. PMID:20533537

Comparison of oxytetracycline degradation behavior in pig manure with different antibiotic addition methods.

PubMed

Wang, Yan; Chen, Guixiu; Liang, Juanboo; Zou, Yongde; Wen, Xin; Liao, Xindi; Wu, Yinbao

2015-12-01

Using manure collected from swine fed with diet containing antibiotics and antibiotic-free swine manure spiked with antibiotics are the two common methods of studying the degradation behavior of veterinary antibiotic in manure in the environment. However, few studies had been conducted to co-compare these two different antibiotic addition methods. This study used oxytetracycline (OTC) as a model antibiotic to study antibiotic degradation behavior in manure under the above two OTC addition methods. In addition, the role of microorganisms present in the manure on degradation behavior was also examined. The results showed that degradation half-life of OTC in manure from swine fed OTC (9.04 days) was significantly shorter than that of the manure directly treated with OTC (9.65 days). Concentration of 4-epi-OTC in manure from swine fed OTC peaked earlier than that in manure spiked with OTC, and the degradation rates of 4-epi-OTC and α-apo-OTC in the manure from swine fed OTC were faster, but the peak concentrations were lower, than those in manure spiked with OTC. Bacterial diversity and relative abundance of Bacillus cereus data demonstrated that sterilization of the manure before experiment significantly decreased OTC degradation rate in both of the addition methods. Results of the present study demonstrated that the presence of the metabolites (especially 4-epi-OTC) and microorganisms had significant influence on OTC degradation.

76 FR 30418 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... securities. The marketplaces operated by OTC Markets Group Inc. include OTCQX, OTCQB and OTC Pink. II. Self... Premises in Certain OTC Bulletin Board and OTC Markets Securities May 19, 2011. Pursuant to Section 19(b)(1... approved booth premises in certain OTC Bulletin Board (``OTCBB'') and OTC Markets \\4\\ securities. The text...

76 FR 30415 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... marketplaces operated by OTC Markets Group Inc. include OTCQX, OTCQB and OTC Pink. II. Self-Regulatory... Premises in Certain OTC Bulletin Board and OTC Markets Securities May 19, 2011. Pursuant to Section 19(b)(1... premises in certain OTC Bulletin Board (``OTCBB'') and OTC Markets \\4\\ securities. The text of the proposed...

Immunological characterization of plant ornithine transcarbamylases

NASA Technical Reports Server (NTRS)

Slocum, R. D.; Williamson, C. L.; Poggenburg, C. A.; Lynes, M. A.

1990-01-01

Pea (Pisum sativum L.) ornithine transcarbamylase (OTC) antisera were used to investigate the immunological relatedness of several plant and animal OTC enzymes. The antisera immunoprecipitated OTC activity in all monocot and dicot species tested, and sodium dodecyl sulfate polyacrylamide gel electrophoresis analysis of immunoprecipitated protein revealed monomeric proteins ranging from 35,200 to 36,800 daltons in size. Pea OTC antisera did not recognize mammalian OTC protein. OTC activity and protein levels detected on sodium dodecyl sulfate polyacrylamide gel electrophoresis immunoblots from homogenates of green leaf, etiolated epicotyl and cotyledon, and root tissues of pea were poorly correlated. This might result from differences in amounts of enzymatically active OTC protein in the homogenates. Alternatively, the antisera may fail to recognize different isozyme forms of OTC, which have been reported for some plant species. A putative cytosolic precursor OTC (pOTC) polypeptide exhibiting and Mr = 39,500 to 40,000 daltons was immunoprecipitated from in vitro translation mixtures of total pea leaf poly(A)+ RNA. The size of the pOTC polypeptide, as compared with mature OTC monomer (36,000 daltons), suggests that a 4 kilodalton N-terminal leader sequence, like that responsible for mitochondrial targeting of the mammalian enzyme, may be involved in organellar import of the plant enzyme.

Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom.

PubMed

Tobin, Claire L; Dobbin, Malcolm; McAvoy, Brian

2013-10-01

Analysis of the policy response by Australia's National Drugs and Poisons Schedule Committee (NDPSC) and comparison with recommendations by expert advisory committees in New Zealand and the United Kingdom. Analysis of public policy documents of relevant regulatory authorities was conducted. Data were extracted regarding changes to over-the-counter (OTC) codeine analgesic scheduling, indications, maximum unit dose, maximum daily dose, maximum pack size, warning labels, consumer medicine information and advertising. Where available, public submissions and other issues considered by the committees and rationale for their recommendations were recorded and thematically analysed. Expert advisory committees in Australia, NZ and the UK defined the policy problem of OTC codeine misuse and harm as small relative to total use and responded by restricting availability. Pharmacist supervision was required at the point-of-sale and pack sizes were reduced to short-term use. Comparison with recommendations by expert advisory committees in NZ and the UK suggests the NDPSC's actions in response to OTC codeine misuse were appropriate given the available evidence of misuse and harm, but highlights opportunities to utilise additional regulatory levers. Framing policy problems as matters of public health in the context of limited evidence may support decision makers to implement cautionary incremental policy change. © 2013 The Authors. ANZJPH © 2013 Public Health Association of Australia.

Non-NSAID over-the-counter (OTC) remedies for arthritis: good, bad or indifferent?

PubMed

Whitehouse, M W; Butters, D E

1999-01-01

This overview looks at some of the issues involved with the ever-increasing availability of marketed non-prescription products, specifically claiming to treat the pain and inflammation of arthritis and other musculoskeletal problems.The question of whether the buyer is getting (any) value for their money cannot be answered without considering several key issues. These include: (a) reliability of claims; (b) placebo effect (but for how long?); (c) reliability of composition, and reproducibility (especially of natural products); (d) general safety; (e) interactions with other medications; (f) honest labelling (in the absence of stricter guidelines).A particularly difficult problem is to know how to recognise a 'drug of choice', particularly for such a multi-faceted disease as chronic arthritis, when there is so little information about the actual pharmacology/potential toxicity of these OTC products in the standard drug compendia and other readily available reference texts.This grey area can only be illuminated by (i) further introduction (and enforcement) of adequate standards/quality controls for products offered OTC; (ii) earliest prosecution of clinical trials to supercede unverified testimonial claims; (iii) appropriate funding to research/establish basic pharmacology of the active principles.In summary, more research, more regulation, and more realistic investment will be required to dispel present uncertainty about which non-NSAID drugs/nutriceuticals are indeed effective against arthritis/other forms of inflammation, and which are not.

Antidiarrheal Medicines: OTC Relief for Diarrhea

MedlinePlus

... types of OTC medicines treat diarrhea? You can buy over-the-counter (OTC) medicines without a prescription from your doctor. Some OTC ... short for "over-the-counter." OTC drugs are medicines you can buy without a prescription from your doctor. About Support ...

Effects of oxytetracycline on the abundance and community structure of nitrogen-fixing bacteria during cattle manure composting.

PubMed

Sun, Jiajun; Qian, Xun; Gu, Jie; Wang, Xiaojuan; Gao, Hua

2016-09-01

The effects of oxytetracycline (OTC) on nitrogen-fixing bacterial communities were investigated during cattle manure composting. The abundance and community structure of nitrogen-fixing bacteria were determined by qPCR and denaturing gradient gel electrophoresis (DGGE), respectively. The matrix was spiked with OTC at four levels: no OTC, 10mg/kg dry weight (DW) OTC (L), 60mg/kg DW OTC (M), and 200mg/kg DW OTC (H). The high temperature period of composting was shorter with M and H, and the decline in temperature during the cooling stage was accelerated by OTC. OTC had a concentration-dependent inhibitory effect on the nitrogenase activity during early composting, and the nifH gene abundance declined significantly during the later composting stage. The DGGE profile and statistical analysis showed that OTC changed the nitrogen-fixing bacterial community succession and reduced the community richness and dominance. The nitrogen-fixing bacterial community structure was affected greatly by the high level of OTC. Copyright © 2016. Published by Elsevier Ltd.

76 FR 80422 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

...-dealers would have been unable to accurately determine the market depth of, and demand for, securities in... inter-dealer quotation system, such as the OTC Bulletin Board (``OTCBB'') or OTC Link (formerly ``Pink Sheets''), operated by OTC Markets Group Inc. (``OTC Link''). According to representatives of both OTC...

Patient-Centered Research Abstracts

PubMed Central

Thorndike, AN; Biener, L; Rigotti, NA

2000-01-01

PURPOSE Nicotine replacement therapy (NRT) sales switched from prescription to over-the-counter (OTC) status in April 1996. The change was expected to benefit public health by increasing smokers' access to NRT, and industry data show a doubling of NRT sales since the switch. We used a population-based sample to assess whether OTC availability increased smokers' rates of 1) NRT use, 2) quit attempts, and 3) cessation. METHODS We analyzed data from the Massachusetts Tobacco Surveys, telephone surveys of a probability sample of Massachusetts (MA) residents (response rates 68%–78%). We compared responses from past-year smokers in 1993 (pre-OTC; N = 1784) to those from 1997–99 (post-OTC; N = 1240), using multiple logistic regression. We also compared the demographic characteristics of NRT users before and after the OTC switch among smokers who had made a quit attempt in the past year. RESULTS There was no significant change over time in the proportion of respondents using NRT at a quit attempt in the past year (20.1% pre-OTC vs. 19.9% post-OTC) and no significant change in the proportion of smokers who made a quit attempt or who quit smoking. Half of smokers who used NRT post-OTC used it to "delay or cut down" their smoking but not to make a quit attempt. Fewer non-whites used NRT post-OTC (3.3%) compared to pre-OTC (20.7%) (adjusted p = .002), but the proportion of whites using NRT did not change (20.6% pre-OTC to 21.9% post-OTC). A higher proportion of 18–30 year-olds and a lower proportion openface>45 year-olds used NRT post-OTC compared to pre-OTC (adjusted p = .0004). CONCLUSION We find no evidence that the OTC switch was associated with increased NRT use, quit attempts, or cessation rates among MA smokers, and one explanation may be that smokers purchase OTC NRT for reasons other than cessation. Since the switch, access to NRT appears to have increased for young adults but decreased for older and minority smokers. Even though NRT is now sold OTC, it remains important for physicians to encourage and monitor its use.

Determination and fate of oxytetracycline and related compounds in oxytetracycline production wastewater and the receiving river.

PubMed

Li, Dong; Yang, Min; Hu, Jianying; Ren, Liren; Zhang, Yu; Li, Kuiziao

2008-01-01

This study investigated the occurrence and fate of oxytetracycline (OTC) and its related substances, 4-epi-oxytetracycline (EOTC), alpha-apo-oxytetracycline (alpha-apo-OTC), and beta-apo-oxytetracycline (beta-apo-OTC), in a wastewater treatment plant (WWTP) treating OTC production wastewater and a river receiving the effluent from the WWTP using liquid chromatography electrospray ionization mass spectrometry (LC-ESI-MS). The percent removal of OTC in the WWTP was 38.0 +/- 10.5%, and the concentration of OTC was still up to 19.5 +/- 2.9 mg/L in the treated outflow. The concentration slightly decreased along the river, from 641 +/- 118 microg/L at site R2 (discharging point) to 377 +/- 142 microg/L at site R4 ( approximately 20 km from site R2), which was still higher than the minimal inhibition concentration of OTC reported ( approximately 250 microg/L). On the other hand, the total amount of its related substances in the treated effluent was less than 5% of OTC. Concentrations of alpha-apo-OTC and beta-apo-OTC increased along the river, from 5.76 +/- 0.63 and 2.08 +/- 0.30 microg/L at site R2 to 11.9 +/- 4.9 and 12.0 +/- 4.6 microg/L at R4, respectively, although EOTC decreased from 31.5 +/- 3.8 to 12.9 +/- 1.1 microg/L, respectively. The mean concentration of beta-apo-OTC in river sediments was 20.8 +/- 7.8 mg/kg, and its ratio to OTC was approximately 0.11, nearly twice the ratio of alpha-apo-OTC and EOTC to OTC (0.058 +/- 0.014 and 0.061 +/- 0.015, respectively).

75 FR 37488 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

..., Commission, from R. Cromwell Coulson, Chief Executive Officer, Pink OTC Markets, Inc., dated September 23... Coulson, Chief Executive Officer, Pink OTC Markets, Inc., dated January 6, 2010 (``Pink OTC 2 Letter..., Chief Executive Officer, Pink OTC Markets Inc., dated April 9, 2010 (``Pink OTC 3 Letter''). II...

The effect of Cu(2+) chelation on the direct photolysis of oxytetracycline: A study assisted by spectroscopy analysis and DFT calculation.

PubMed

Jin, Xin; Qiu, Shanshan; Wu, Ke; Jia, Mingyun; Wang, Fang; Gu, Chenggang; Zhang, Aiqian; Jiang, Xin

2016-07-01

The extensive usage of OTC and Cu(2+) in livestock and poultry industry caused high residues in natural environment. Co-contamination of OTC and Cu(2+) was a considerable environmental problem in surface waters. In this study, Cu(2+) mediated direct photolysis of OTC was studied. Cu(2+) chelating with OTC was found to greatly inhibit OTC photodegradation. To reveal the chelation mechanism of OTC-Cu complexes, multiple methods including UV-Vis absorption spectra, Infrared (IR) spectra, mass spectroscopy, and density functional theoretical (DFT) modeling were performed. Four OTC-Cu complexes were proposed. Cu(2+) preferably bond to O11O12 site with the binding constants logK = 8.19 and 7.86 for CuHL+ and CuL±, respectively. The second chelating site was suggested to be O2O3 with the binding constants of logK = 4.41 and 4.62 for Cu2HL3+ and Cu2L2+, respectively. The suppressed quantum yield of OTC by Cu2+ chelation was accused for their intra-/inter-molecular electron transfer, by which the energy in activated states was distributed. The occurrence of electron transfer between BCD ring and A ring also from BCD ring to Cu was evidenced by the TD-DFT result only for the OTC-Cu complexes. Besides, the cyclic voltammetry measurement also suggested one OTC-Cu(II)/OTC-Cu(I) redox couple. These results suggested that the persistence of OTC in environmental surface waters will probably be underestimated for neglecting the chelating effect of Cu2+. The photolysis quantum yield of OTC-Cu complexes, as well as the specific molar absorption constants, the equilibrium binding constants of Cu2+ with OTC could contribute to more accurate kinetic models of OTC. Copyright © 2016 Elsevier Ltd. All rights reserved.

Understanding older adults' medication decision making and behavior: A study on over-the-counter (OTC) anticholinergic medications.

PubMed

Holden, Richard J; Srinivas, Preethi; Campbell, Noll L; Clark, Daniel O; Bodke, Kunal S; Hong, Youngbok; Boustani, Malaz A; Ferguson, Denisha; Callahan, Christopher M

2018-03-06

Older adults purchase and use over-the-counter (OTC) medications with potentially significant adverse effects. Some OTC medications, such as those with anticholinergic effects, are relatively contraindicated for use by older adults due to evidence of impaired cognition and other adverse effects. To inform the design of future OTC medication safety interventions for older adults, this study investigated consumers' decision making and behavior related to OTC medication purchasing and use, with a focus on OTC anticholinergic medications. The study had a cross-sectional design with multiple methods. A total of 84 adults participated in qualitative research interviews (n = 24), in-store shopper observations (n = 39), and laboratory-based simulated OTC shopping tasks (n = 21). Simulated shopping participants also rank-ordered eight factors on their importance for OTC decision making. Findings revealed that many participants had concerns about medication adverse effects, generally, but were not aware of age-related risk associated with the use of anticholinergic medications. Analyses produced a map of the workflow of OTC-related behavior and decision making as well as related barriers such as difficulty locating medications or comparing them to an alternative. Participants reported effectiveness, adverse effects or health risks, and price as most important to their OTC medication purchase and use decisions. A persona analysis identified two types of consumers: the habit follower, who frequently purchased OTC medications and considered them safe; and the deliberator, who was more likely to weigh their options and consider alternatives to OTC medications. A conceptual model of OTC medication purchase and use is presented. Drawing on study findings and behavioral theories, the model depicts dual processes for OTC medication decision making - habit-based and deliberation-based - as well as the antecedents and consequences of decision making. This model suggests several design directions for consumer-oriented interventions to promote OTC medication safety. Copyright © 2018 Elsevier Inc. All rights reserved.

Self-medication.

PubMed

Lottier, W I

1978-10-01

Self-medication and drug interaction have been a problem in recent years. Pharmacists in ethical pharmacies and neighborhood establishments can best monitor these problems through use of patient profile records and consultations. The pharmacist should advise the public on over-the-counter (OTC) purchases. Auxiliary labels are recommended for use on containers to prevent drug interactions. Members of the black community have some specific problems with respect to self medications. These are addressed in this article. Self-medication, under supervision, is proper and can be controlled.

Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.

PubMed

Kohli, Erol; Buller, Allison

2013-02-01

US consumers spend more than $20 billion/year on over-the-counter (OTC) drugs. Although generic and brand name OTC drugs share the same active ingredients and undergo the same rigorous Food and Drug Administration approval process, brand name formulations continue to lead the OTC drug market with a higher market share. There is a limited amount of publicly available information regarding consumer perceptions and awareness about generic and brand name OTC drugs. The main objective of this research was to understand what factors influence US consumers to purchase generic versus brand name OTC drugs. The researchers used a 20-question, self-administered, multiple-choice survey to collect data on the factors influencing consumers' preferences for generic versus brand name OTC drugs. Results revealed that the single most influential factor for participants when purchasing OTC drugs was lower cost. Although economic factors play an important role in influencing consumers to choose generic formulations, a variety of other factors including advertisements, duration of the OTC effectiveness, severity of sickness, preferable form of OTC medication, safety of the OTC, relief of multiple symptoms, and preferred company will persuade others to pay more for brand name drugs. Ultimately, increased awareness and use of generic OTC drugs may result in substantial cost savings for consumers.

Avoidance behavior of Eisenia fetida in oxytetracycline- and heavy metal-contaminated soils.

PubMed

Gao, Minling; Lv, Mengting; Han, Meng; Song, Wenhua; Wang, Dong

2016-10-01

To determine the behavior of oxytetracycline (OTC) and heavy metals in soil, this study assessed the pollutant-induced avoidance behavior of earthworms (E. fetida) exposed to zinc (Zn 2+ ), lead (Pb 2+ ), and OTC in soil. The results showed a clear avoidance response within 48h of exposure to the highest concentrations of pollutants. Moreover, E. fetida was shown to be more sensitive to Zn 2+ than to Pb 2+ and OTC. Compared with OTC alone, the net response of earthworms increased in the OTC-Zn 2+ and OTC-Pb 2+ combined treatments, indicating a synergistic effect. Moreover, the net response (NR) of the earthworms was higher for OTC-Zn 2+ than it was for OTC-Pb 2+ , possibly reflecting the differences in essential characteristics of Zn and Pb. Copyright © 2016 Elsevier B.V. All rights reserved.

[Degradation of oxytetracycline in chicken feces aerobic-composting and its effects on their related parameters].

PubMed

Wang, Gui-Zhen; Li, Zhao-Jun; Zhang, Shu-Qing; Ma, Xiao-Tong; Liang, Yong-Chao

2013-02-01

In order to illustrate the degradation of tetracyclines (TCs) and their influences on process parameters during the period of chicken feces aerobic-composting, the degradation of oxytetracycline (OTC), a kind of TCs and its effects on parameters during the period of chick feces aerobic-composting including temperature, pH, and germination index were investigated using the method of aerobic-composting. The contents of OTC decreased gradually with composting time. The degradation rate was high before 10 d, and then decreased gradually. The differences in OTC degradation among the OTC treatments were also found. The degradation rate of OTC was higher at the level of 25 mg.kg-1, than that of other levels. The degradation curve of OTC could be described by the first-order kinetic model, and the correlation coefficients ranged from 0. 911 1 to 0. 9913. The impacts of OTC on chick feces composting were found. OTC could decrease the rising rate of composting temperature and make the high temperature (> or =50 degrees C) period shorter than that of the control. The values of pH, TN, WSC, and the content of NH: -N of composting were 4.58%, 12.62%, 49.06%, and 35.30% higher than those of the control. The impacts of OTC on maturity of chicken feces composting was not found when the OTC addition contents were lower than 50 mg.kg-1. However, the strong impacts of OTC on maturity of chicken feces composting were found when the OTC addition contents were higher than 50 mg.kg-1. The rates of NH+4 -N to NO-3 -N, and GI were much higher than 0. 5 and lower than 80% , respectively. Theses results suggest that OTC have strong impacts on chicken feces composting when the contents of TOC was higher than 50 mg.kg-1, although OTC have the short half-life period ranged from 1.79-4.88 d.

Factors associated with intention to engage in self-protective behavior: The case of over-the-counter acetaminophen products.

PubMed

Sawant, R V; Goyal, R K; Rajan, S S; Patel, H K; Essien, E J; Sansgiry, S S

2016-01-01

Inappropriate use of acetaminophen products is a concern due to the severe liver damage associated with intentional or accidental overdose of these products. In 2009, the U.S. Food and Drug Administration (FDA) issued more severe organ-specific warnings for the acetaminophen Drug Facts label to improve protective behavior among patients. However, it is not clear how patients react to such interventions by the FDA. The objective of this study was to evaluate the factors influencing patients' intention to engage in protective behavior while using acetaminophen products after reading the Drug Facts label. The study specifically looked at the relationship between four Protection Motivation Theory-based risk cognition factors and the intention to engage in protective behavior. An experimental, cross-sectional, field study was conducted using self-administered questionnaires at four community pharmacies in Houston, TX. Two hundred surveys were collected from adults visiting the selected pharmacy stores. Participants were exposed to a simulated label (i.e. Drug Facts label) containing organ-specific warnings for over-the-counter (OTC) acetaminophen products. Risk cognition measures (i.e. measures of perceived severity, perceived vulnerability, response efficacy, and self-efficacy) and measures of intention to engage in protective behavior (always reading warnings, using products with more caution, and consulting a pharmacist/physician) were recorded. Pearson correlation and multiple linear regression analyses, controlling for demographic and behavioral characteristics of the participants, were performed. Bivariate analyses indicated that an increase in perceived severity, perceived vulnerability and response efficacy were associated with a higher intention to engage in protective behavior. Findings from the multiple regression indicated that increase in perceived severity of liver damage, belonging to a non-healthcare occupation, no history of acetaminophen use and no history of alcohol consumption were associated with a higher intention to engage in protective behavior. Higher risk cognition of liver damage associated with inappropriate use of OTC acetaminophen products leads to greater intention to engage in protective behavior while using such products. Developing interventions targeted towards improving reading and adhering to the Drug Facts label could improve risk cognition, and thus improve patients' intention to engage in protective behavior. Regular acetaminophen users, heavy alcohol consumers and healthcare professionals might need other interventions apart from the Drug Facts label to improve their likelihood to engage in protective behavior. Copyright © 2016 Elsevier Inc. All rights reserved.

Systems Architectures for a Tactical Naval Command and Control System

DTIC Science & Technology

2009-03-01

Supplement TST Time-sensitive Targeting TTP Tactics, Techniques, and Procedures WTP Weapons-target pairing xix GLOSSARY Analysis...target pairings ( WTPs ) and are presented to OTC [a]. 24. OTC conducts risk assessment of engagement options [a]. 25. OTC orders confirmed surface...engagement options are generated through weapon- target pairings ( WTPs ) and are presented to OTC [a]. 24. OTC conducts risk assessment of engagement

Consumer behavior in the setting of over-the-counter statin availability: lessons from the consumer use study of OTC Mevacor.

PubMed

Brass, Eric P

2004-11-04

Despite the proven benefits of statins, large numbers of patients meeting guideline criteria for therapy are not receiving these drugs. It has been suggested that over-the-counter (OTC) availability of statins would allow more consumers to use statins and achieve cardiovascular risk reduction. However, concerns have been raised as to the consumers' ability to self-manage hyperlipidemia and use statins safely. The Consumer Use Study of OTC Mevacor (CUSTOM) was designed to define consumer behaviors in the setting of OTC statin availability. The study was conducted in a simulated OTC setting and allowed consumers to purchase once-daily lovastatin 20 mg. The CUSTOM dataset includes >3,300 consumers who evaluated OTC lovastatin for potential purchase at study sites and follow-up information on purchasers for up to 6 months of self-managed therapy. These data have been analyzed to address consumers' knowledge of their cholesterol concentrations as well as their ability to make OTC use decisions based on their cardiovascular risk, avoid drug-drug interactions, self-manage their cholesterol treatment after deciding to use the OTC product, and maintain interactions with physicians while using lovastatin OTC. The results showed that most study participants appropriately self-selected OTC statin therapy and managed their treatment. Use of OTC statins by consumers needing more intensive statin therapy or facing the risk of potential drug-drug interactions remains an area of concern but occurred infrequently in CUSTOM. These data are important for making an informed risk-benefit decision concerning OTC statin availability.

Effect of different oxytetracycline addition methods on its degradation behavior in soil.

PubMed

Chen, Gui-Xiu; He, Wei-Wei; Wang, Yan; Zou, Yong-De; Liang, Juan-Boo; Liao, Xin-Di; Wu, Yin-Bao

2014-05-01

The degradation behavior of veterinary antibiotics in soil is commonly studied using the following methods of adding antibiotics to the soil: (i) adding manure collected from animals fed with a diet containing antibiotics, (ii) adding antibiotic-free animal manure spiked with antibiotics and (iii) directly adding antibiotics. No research simultaneously comparing different antibiotic addition methods was found. Oxytetracycline (OTC) was used as a model antibiotic to compare the effect of the three commonly used antibiotic addition methods on OTC degradation behavior in soil. The three treatment methods have similar trends, though OTC degradation half-lives show the following significant differences (P<0.05): manure from swine fed OTC (treatment A)

Efficacy of a twice-daily, 3-step, over-the-counter skincare regimen for the treatment of acne vulgaris.

PubMed

Rodan, Katie; Fields, Kathy; Falla, Timothy J

2017-01-01

Acne vulgaris (acne) is the most common skin disorder producing physical and emotional scars that can persist for years. An estimated 83% of acne sufferers self-treat, but there is lack of studies documenting the effectiveness of over-the-counter (OTC) acne treatment products. This study was conducted to determine the effectiveness of an OTC, 3-step, anti-acne skincare regimen in treating acne and improving the appearance of red/inflamed facial skin. This 6-week, open-label clinical study included both genders aged between 12 and 35 years with mild-to-moderate acne. All subjects were required to have an acne score of 1-3 (Cook's acne grading scale: 0=clear to 7=very severe) and a moderate redness score of ≥2 (0=none and 4=severe). Subjects completed a 3-step facial treatment regimen every morning and evening using an OTC cleanser, toner, and acne treatment. Evaluations for effectiveness and safety were done at baseline and weeks 2, 4, and 6 using digital photographs (Visia-CR ® digital imaging system) of the face and analyzed using Image-Pro ® software for the grading of acne, red/inflamed skin, and the number and type of lesions. Thirty subjects (12 males and 18 females) were enrolled (mean age of 19 years; range 12-34 years). This skincare regimen resulted in statistically significant improvements in acne grading scores after 2 weeks of use, with mean scores continuing to improve after 4 and 6 weeks of use ( P <0.001). Statistically significant improvements from baseline in red/inflamed skin, open and closed comedones, and papules were detected at all time points and for nodules at week 6, compared to their respective baselines ( P <0.05). This clinical study demonstrated the effectiveness of an OTC 3-step, anti-acne skincare regimen in significantly improving acne and the overall appearance of skin in the majority of subjects who had mild-to-moderate acne.

Probing the In Vitro Cytotoxicity of the Veterinary Drug Oxytetracycline

PubMed Central

Chi, Zhenxing; Liu, Rutao; You, Hong; Ma, Shanshan; Cui, Hao; Zhang, Qiang

2014-01-01

The study investigated the effect of oxytetracycline (OTC) on the anti-oxidative defense system, the structure (hemolysis rate and morphology) and function (ATP enzyme activity) of human red blood cells (hRBCs) to investigate the possible toxic mechanism of OTC to hRBCs. The experimental results indicate that OTC can cause a decline in the function of the antioxidant defense system of hRBCs, resulting in oxidative stress. OTC can bring about morphological changes to hRBCs, and further leads to hemolysis, when the concentration of OTC is over 8×10−5 M (about 164 µg/ml). At a low OTC concentration, below 4×10−5 M (82 µg/ml), OTC can enhance the activity of ATP enzyme of hRBCs, known as hormesis. However, at a high concentration, above 4×10−5 M (about 82 µg/ml), the ATP enzymatic activity was inhibited, affecting the function of hRBCs. The estalished mechanism of toxicity of OTC to hRBCs can facilitate a deeper understanding of the toxicity of OTC in vivo. PMID:25019386

Passive warming effect on soil microbial community and humic substance degradation in maritime Antarctic region.

PubMed

Kim, Dockyu; Park, Ha Ju; Kim, Jung Ho; Youn, Ui Joung; Yang, Yung Hun; Casanova-Katny, Angélica; Vargas, Cristina Muñoz; Venegas, Erick Zagal; Park, Hyun; Hong, Soon Gyu

2018-06-01

Although the maritime Antarctic has undergone rapid warming, the effects on indigenous soil-inhabiting microorganisms are not well known. Passive warming experiments using open-top chamber (OTC) have been performed on the Fildes Peninsula in the maritime Antarctic since 2008. When the soil temperature was measured at a depth of 2-5 cm during the 2013-2015 summer seasons, the mean temperature inside OTC (OTC-In) increased by approximately 0.8 °C compared with outside OTC (OTC-Out), while soil chemical and physical characteristics did not change. Soils (2015 summer) from OTC-In and OTC-Out were subjected to analysis for change in microbial community and degradation rate of humic substances (HS, the largest pool of recalcitrant organic carbon in soil). Archaeal and bacterial communities in OTC-In were minimally affected by warming compared with those in OTC-Out, with archaeal methanogenic Thermoplasmata slightly increased in abundance. The abundance of heterotrophic fungi Ascomycota was significantly altered in OTC-In. Total bacterial and fungal biomass in OTC-In increased by 20% compared to OTC-Out, indicating that this may be due to increased microbial degradation activity for soil organic matter (SOM) including HS, which would result in the release of more low-molecular-weight growth substrates from SOM. Despite the effects of warming on the microbial community over the 8-years-experiments warming did not induce any detectable change in content or structure of polymeric HS. These results suggest that increased temperature may have significant and direct effects on soil microbial communities inhabiting maritime Antarctic and that soil microbes would subsequently provide more available carbon sources for other indigenous microbes. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Over-the-counter but out of reach: a pharmacy-based survey of OTC syringe sales in Tijuana, Mexico.

PubMed

Pollini, Robin A; Gallardo, Manuel; Ruiz, Serena; Case, Patricia; Zaller, Nickolas; Lozada, Remedios

2014-05-01

Sterile syringe access is critical to HIV prevention efforts targeting injection drug users (IDUs) but some pharmacies do not sell syringes over-the-counter (OTC) even where such sales are legal. We conducted a pharmacy survey in Tijuana, Mexico (where OTC sales are legal) to characterize attitudes toward syringe sales and to explore support for expanding pharmacy-based HIV prevention efforts. Of 203 respondents, 28% supported OTC syringe sales to IDUs and 74% said their pharmacy required a prescription for at least some syringe sales. Support for OTC syringe sales was independently associated with selling OTC syringes, understanding the role of sterile syringes in HIV prevention, and recognizing pharmacies as an important health resource for IDUs. Most respondents supported an expanded role for pharmacies in HIV prevention, exclusive of OTC syringe sales. Our study provides information for developing interventions to promote OTC syringe sales and expanding pharmacy-based distribution of HIV-related information and resources.

Copper/Zinc-Superoxide Dismutase Is Required for Oxytetracycline Resistance of Saccharomyces cerevisiae

PubMed Central

Avery, Simon V.; Malkapuram, Srividya; Mateus, Carolina; Babb, Kimberly S.

2000-01-01

Saccharomyces cerevisiae, along with other eukaryotes, is resistant to tetracyclines. We found that deletion of SOD1 (encoding Cu/Zn superoxide dismutase) rendered S. cerevisiae hypersensitive to oxytetracycline (OTC): a sod1Δ mutant exhibited a >95% reduction in colony-forming ability at an OTC concentration of 20 μg ml−1, whereas concentrations of up to 1,000 μg ml−1 had no effect on the growth of the wild type. OTC resistance was restored in the sod1Δ mutant by complementation with wild-type SOD1. The effect of OTC appeared to be cytotoxic and was not evident in a ctt1Δ (cytosolic catalase) mutant or in the presence of tetracycline. SOD1 transcription was not induced by OTC, suggesting that constitutive SOD1 expression is sufficient for wild-type OTC resistance. OTC uptake levels in wild-type and sod1Δ strains were similar. However, lipid peroxidation and protein oxidation were both enhanced during exposure of the sod1Δ mutant, but not the wild type, to OTC. We propose that Sod1p protects S. cerevisiae against a mode of OTC action that is dependent on oxidative damage. PMID:10613865

75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

..., Commission, from Liz Heese, Managing Director, Issuer Services, Pink OTC Markets, Inc. (``Pink OTC''), dated January 20, 2010 (``Pink OTC Letter''), and Letter to Elizabeth M. Murphy, Secretary, Commission, from...'') market. FINRA currently operates the OTC Bulletin Board (``OTCBB''), which provides a mechanism for FINRA...

17 CFR 240.3b-12 - Definition of OTC derivatives dealer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to options, forwards, futures, swap agreements, or collars involving currencies, interest or other... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Definition of OTC derivatives... Securities Exchange Act of 1934 Definitions § 240.3b-12 Definition of OTC derivatives dealer. The term OTC...

17 CFR 240.15a-1 - Securities activities of OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... derivatives dealers. 240.15a-1 Section 240.15a-1 Commodity and Securities Exchanges SECURITIES AND EXCHANGE... Under the Securities Exchange Act of 1934 Exemption of Certain Otc Derivatives Dealers § 240.15a-1 Securities activities of OTC derivatives dealers. Preliminary Note: OTC derivatives dealers are a special...

Removal of oxytetracycline (OTC) in a synthetic pharmaceutical wastewater by a sequential anaerobic multichamber bed reactor (AMCBR)/completely stirred tank reactor (CSTR) system: biodegradation and inhibition kinetics.

PubMed

Sponza, Delia Teresa; Çelebi, Hakan

2012-01-01

An anaerobic multichamber bed reactor (AMCBR) was effective in removing both molasses-chemical oxygen demand (COD), and the antibiotic oxytetracycline (OTC). The maximum COD and OTC removals were 99% in sequential AMCBR/completely stirred tank reactor (CSTR) at an OTC concentration of 300 mg L(-1). 51%, 29% and 9% of the total volatile fatty acid (TVFA) was composed of acetic, propionic acid and butyric acids, respectively. The OTC loading rates at between 22.22 and 133.33 g OTC m(-3) d(-1) improved the hydrolysis of molasses-COD (k), the maximum specific utilization of molasses-COD (k(mh)) and the maximum specific utilization rate of TVFA (k(TVFA)). The direct effect of high OTC loadings (155.56 and -177.78 g OTC m(-3) d(-1)) on acidogens and methanogens were evaluated with Haldane inhibition kinetic. A significant decrease of the Haldane inhibition constant was indicative of increases in toxicity at increasing loading rates. Copyright © 2011 Elsevier Ltd. All rights reserved.

Expanding the application scope of on-farm biopurification systems: Effect and removal of oxytetracycline in a biomixture.

PubMed

Jiménez-Gamboa, David; Castro-Gutiérrez, Víctor; Fernández-Fernández, Ericka; Briceño-Guevara, Susana; Masís-Mora, Mario; Chin-Pampillo, Juan Salvador; Mora-López, Marielos; Carazo-Rojas, Elizabeth; Rodríguez-Rodríguez, Carlos E

2018-01-15

Antibiotic-containing wastewaters produced in agricultural activities may depress the pesticide-degrading capacity of biomixtures contained in biopurification systems. This work aimed to assay the effect of oxytetracycline (OTC) on the removal of carbofuran (CFN) in an optimized biomixture, and to determine the capacity of the system to dissipate OTC. During co-application of CFN+OTC, CFN removal and its accelerated degradation were not negatively affected. Similarly, different doses of OTC (10-500mgkg -1 ) did not significantly affect CFN mineralization, and the process even exhibited a hormetic-like effect. Moreover, the biomixture was able to remove OTC with a half-life of 34.0 d. DGGE-cluster analyses indicated that fungal and bacterial communities remained relatively stable during OTC application and CFN+OTC co-application, with similarities of over 70% (bacteria) and 80% (fungi). Overall, these findings support the potential use of this matrix to discard OTC-containing wastewater in this system originally intended for CFN removal. Copyright © 2017 Elsevier B.V. All rights reserved.

Prevalence and predictors of over-the-counter medication use among adolescents in the United Arab Emirates.

PubMed

Barakat-Haddad, Caroline; Siddiqua, Ayesha

2018-01-02

The patterns of over-the-counter medication (OTC) usage among adolescents living in the United Arab Emirates (UAE) remains largely understudied. The objectives of this study are: (1) to determine the profile of OTC use among UAE adolescents; and (2) to determine the biological or physical, psychological or behavioural, and social predictors of OTC use among the UAE adolescent population. Using a cross-sectional study design, data were collected on the prevalence of OTC use for a sample of 6363 adolescents. Overall, 51% of participants in this study reported OTC use. The most common form of OTC used was acetaminophen. Significant predictors of OTC use were: nationality (UAE, GCC, Arab / Middle East, Arab / Africa, Western, other); needed health care but did not receive it; sex (female); age (15-18 years); any medical diagnosis; unconventional drug use; spending more than 5 hours using TV and computer daily; and using prescription medicines. Thus, there is a need to develop public health policies and strategies that promote appropriate use of OTC in the population.

Over-the-Counter Hearing Aids: A Lost Decade for Change

PubMed Central

Chan, Zoe Yee Ting; McPherson, Bradley

2015-01-01

Background. Hearing aids sold directly to consumers in retail stores or through the internet, without individual prescription by audiological professionals, are termed over-the-counter (OTC) devices. This study aimed to determine whether there was any change in the electroacoustic characteristics of OTC devices compared to research carried out a decade earlier. The previous results indicated that most OTC devices were low-frequency-emphasis devices and were unsuitable for elderly people with presbycusis, who were likely to be the major consumers of these products. Methods. Ten OTC devices were selected and their electroacoustic performance was measured. Appropriate clients for the OTC devices were derived, using four linear prescription formulae, and OTC suitability for elderly persons with presbycusis was investigated. Results. OTC electroacoustic characteristics were similar to those in the earlier study. Most OTC devices were not acoustically appropriate for potential consumers with presbycusis. Although several of the devices could match prescriptive targets for individuals with presbycusis, their poor electroacoustic performance—including ineffective volume control function, high equivalent input noise, and irregular frequency response—may override their potential benefit. Conclusion. The low-cost OTC devices were generally not suitable for the main consumers of these products, and there has been little improvement in the appropriateness of these devices over the past decade. PMID:26557701

49 CFR 172.446 - CLASS 9 label.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the six white spaces between them. The lower half of the label must be white with the class number “9... 49 Transportation 2 2010-10-01 2010-10-01 false CLASS 9 label. 172.446 Section 172.446... SECURITY PLANS Labeling § 172.446 CLASS 9 label. (a) Except for size and color, the “CLASS 9...

In vitro assessment of commercial sunscreens available in Latin America.

PubMed

Castanedo-Cázares, Juan Pablo; Martínez-Rosales, Karla; Hernández-Blanco, Diana; Valdés-Rodríguez, Guillermo; Torres-Alvarez, Bertha

2014-06-01

In Latin America, people have largely abandoned the practice of wearing hats and traditional clothing that provided skin protection. Sunscreen application has therefore become essential to protect against the increased sun exposure. The physician-prescribed medical-grade sunscreens provide sufficient sun protection but the requirement for regular use puts a financial burden on the patient that is often not sustainable. An appropriate sunscreen should provide a high and broad ultraviolet (UV) protection against UVB and UVA. Several over-the-counter (OTC) sunscreens have been developed for sale at affordable prices and are available for purchase in convenient locations, such as local grocery stores. The aim of this study was to assess the in vitro UV protection of 34 popular OTC sunscreens found in the Latin American market. UV absorbance/transmittance was quantified by diffusion transmission spectroscopy using coarse silica plaques. Photostability was tested by irradiating them with simulated solar light and calculating the sun protection factor (SPF), critical length of absorption (C lambda ), UVA/UVB ratio, and the spectral uniformity index (SUI). The results indicated that the in vitro SPFs were significantly lower than the value declared on the labels, particularly for those claiming high SPF values; however, the majority of these sunscreens offered high levels of UV protection. Considering the advantages of low cost and ample accessibility, we concluded that this sample of OTC sunscreens can be beneficial to the general public by providing some level of skin protection from solar radiation, and may be promoted to improve compliance with recommended photoprotection behavior.

77 FR 59431 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

... rule filing defines ``OTC option'' and ``OTC index option'' generically in order to simplify future... future OTC options accepted for clearing, OCC intends that such future OTC options will conform to the... index options that OCC may in the future clear may be fixed at such value as OCC determines and provides...

Nonprescription bronchodilator medication use in asthma.

PubMed

Kuschner, W G; Hankinson, T C; Wong, H H; Blanc, P D

1997-10-01

Many persons with asthma self-medicate with widely available and potentially hazardous nonprescription medicines. This study assessed the demographic and clinical covariates of self-treatment with over-the-counter asthma medications (OTCs). We conducted an analytical investigation using questionnaires and measures of lung function, comparing OTC and prescription medication users. We recruited adults with asthma by public advertisement. We studied 22 exclusive prescription asthma medication users, 15 exclusive OTC users, and 13 other subjects who combined prescription medication use with self-treatment with asthma OTCs. All but one OTC user self-medicated with a nonselective, sympathomimetic metered-dose inhaler. Taking income, access to care, and self-assessed disease severity into account, male gender was strongly associated with exclusive OTC use alone (odds ratio [OR]=8.9, 95% confidence interval [CI]= 1.3 to 61) and mixed OTC-prescription medication use (OR=9.7, 95% CI=1.1 to 83). The covariates of income, access to care, and self-assessed disease severity provided significant additional explanatory power to the model of exclusive OTC use (model chi2 difference 11.3, 5 df, p<0.05). Pulmonary function was similar among OTC and prescription medication users. However, prescription medication users' self-assessed asthma severity (mild compared to more severe) was associated with postbronchodilator reversibility of FEV1 obstruction (6% vs 18% reversibility, p<0.05) while exclusive OTC users' self-assessed severity showed the reverse pattern (19% vs 8%, p=0.2). Asthma education programs attempting to discourage unregulated bronchodilator use should give consideration to this profile of the "asthmatic-at-risk."

Liquid chromatographic determination of oxytetracycline in edible fish fillets from six species of fish

USGS Publications Warehouse

Meinertz, J.R.; Stehly, G.R.; Gingerich, W.H.

1998-01-01

The approved use of oxytetracycline (OTC) in U.S. Aquaculture is limited to specific diseases in salmonids and channel catfish. OTC may also be effective in controlling diseases in other fish species important to public aquaculture, but before approved use of OTC can be augmented, an analytical method for determining OTC in fillet tissue from multiple species of fish will be required to support residue depletion studies. The objective of this study was to develop and validate a liquid chromatographic (LC) method that is accurate, precise, and sensitive for OTC in edible fillets from multiple species of fish. Homogenized fillet tissues from walleye, Atlantic salmon, striped bass, white sturgeon, rainbow trout, and channel catfish were fortified with OTC at nominal concentrations of 10, 20, 100, 1000, and 5000 ng/g. In tissues fortified with OTC at 100, 1000, and 5000 ng/g, mean recoveries ranged from 83 to 90%, and relative standard deviations (RSDs) ranged from 0.9 to 5.8%. In all other tissues, mean recoveries ranged from 59 to 98%, and RSDs ranged from 3.3 to 20%. Method quantitation limits ranged from 6 to 22 ng/g for the 6 species. The LC parameters produced easily integratable OTC peaks without coelution of endogenous compounds. The method is accurate, precise, and sensitive for OTC in fillet tissue from 6 species of fish from 5 phylogenetically diverse groups.

Seasonal patterns of oral antihistamine and intranasal corticosteroid purchases from Australian community pharmacies: a retrospective observational study

PubMed Central

Carney, A Simon; Price, David B; Smith, Pete K; Harvey, Richard; Kritikos, Vicky; Bosnic-Anticevich, Sinthia Z; Christian, Louise; Skinner, Derek A; Carter, Victoria; Durieux, Alice MS

2017-01-01

Purpose To explore patterns in the purchase of prescription and over-the-counter (OTC) oral antihistamines (OAHs) and intranasal corticosteroids (INCSs) by patients, from pharmacies in different geographical regions of Australia. Patients and methods Retrospective observational study using a database containing anonymous pharmacy transaction data from 20.0% of the pharmacies in Australia that link doctor prescriptions and OTC information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment during 2013 and 2014 were assessed. Results In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 12 months. Of treatments purchased, 75.9% were OAHs and 16.6% were INCSs. OTC purchases of both treatments exceeded purchases through prescription. OTC OAHs purchasing patterns were seasonal and almost identical in the Australian Capital Territory, Victoria, Western Australia, South Australia, and New South Wales, and similar seasonal patterns for OTC INCSs were noted in most regions except for South Australia and Tasmania. Prescription purchasing patterns of both OAHs and INCSs remained unchanged throughout the year in most regions. Conclusion This large-scale retrospective observational study identified seasonal purchasing patterns of OTC and prescription OAHs and INCSs in a real-world setting. It highlighted that seasonality only affects OTC purchasing patterns of OAHs and INCSs across Australia and that practitioner prescribing remains unchanged, suggesting that it is only for persistent disease. PMID:28919832

Seasonal patterns of oral antihistamine and intranasal corticosteroid purchases from Australian community pharmacies: a retrospective observational study.

PubMed

Carney, A Simon; Price, David B; Smith, Pete K; Harvey, Richard; Kritikos, Vicky; Bosnic-Anticevich, Sinthia Z; Christian, Louise; Skinner, Derek A; Carter, Victoria; Durieux, Alice Ms

2017-01-01

To explore patterns in the purchase of prescription and over-the-counter (OTC) oral antihistamines (OAHs) and intranasal corticosteroids (INCSs) by patients, from pharmacies in different geographical regions of Australia. Retrospective observational study using a database containing anonymous pharmacy transaction data from 20.0% of the pharmacies in Australia that link doctor prescriptions and OTC information. Pharmacy purchases of at least one prescription or OTC rhinitis treatment during 2013 and 2014 were assessed. In total, 4,247,193 prescription and OTC rhinitis treatments were purchased from 909 pharmacies over 12 months. Of treatments purchased, 75.9% were OAHs and 16.6% were INCSs. OTC purchases of both treatments exceeded purchases through prescription. OTC OAHs purchasing patterns were seasonal and almost identical in the Australian Capital Territory, Victoria, Western Australia, South Australia, and New South Wales, and similar seasonal patterns for OTC INCSs were noted in most regions except for South Australia and Tasmania. Prescription purchasing patterns of both OAHs and INCSs remained unchanged throughout the year in most regions. This large-scale retrospective observational study identified seasonal purchasing patterns of OTC and prescription OAHs and INCSs in a real-world setting. It highlighted that seasonality only affects OTC purchasing patterns of OAHs and INCSs across Australia and that practitioner prescribing remains unchanged, suggesting that it is only for persistent disease.

Bioremediation of oxytetracycline in seawater by living and dead biomass of the microalga Phaeodactylum tricornutum.

PubMed

Santaeufemia, Sergio; Torres, Enrique; Mera, Roi; Abalde, Julio

2016-12-15

Due to its use, a large amount of Oxytetracycline (OTC) is released into water, which has a detrimental impact on aquatic ecosystems and human health. Although there are different physicochemical methods (mainly photodegradation) to remove OTC, there is increasing interest in the use of bioremediation. The sorption characteristics of OTC using living and dead biomass of the microalga Phaeodactylum tricornutum have been investigated in this study. Kinetics, isotherms and maximum elimination capacity were tested and discussed. Kinetic studies showed that the OTC removal by living biomass followed a sigmoidal model. However, the dead biomass followed a pseudo-first order model. The living biomass showed higher efficiency than the dead biomass with maximum sorption capacities of 29.18mgg -1 and 4.54mgg -1 , respectively. Combination of living biomass and photodegradation under the culture conditions eliminated 13.2mgL -1 of OTC during 11h of culture and with an initial OTC concentration of 15mgL -1 . With an initial OTC concentration of 2.5mgL -1 , 97% of OTC was removed. This removal was mainly caused by bioremediation than by photodegradation. The results proved the potential practical application of the living P. tricornutum biomass for a low-cost and efficient removal of OTC from seawater. Copyright © 2016 Elsevier B.V. All rights reserved.

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false OTC test sample collection systems for drugs of... Instrumentation and Accessories § 864.3260 OTC test sample collection systems for drugs of abuse testing. (a) Identification. An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device...

17 CFR 240.15b9-2 - Exemption from SRO membership for OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Exemption from SRO membership for OTC derivatives dealers. 240.15b9-2 Section 240.15b9-2 Commodity and Securities Exchanges... § 240.15b9-2 Exemption from SRO membership for OTC derivatives dealers. An OTC derivatives dealer, as...

21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

Code of Federal Regulations, 2014 CFR

2014-04-01

...-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life...

21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

Code of Federal Regulations, 2013 CFR

2013-04-01

...-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life...

21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

Code of Federal Regulations, 2012 CFR

2012-04-01

...-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life...

21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

Code of Federal Regulations, 2011 CFR

2011-04-01

...-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life...

21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

Code of Federal Regulations, 2010 CFR

2010-04-01

...-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts have been used OTC for the treatment and/or prevention of malaria, a serious and potentially life...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

Improvement of oxytetracycline production mediated via cooperation of resistance genes in Streptomyces rimosus.

PubMed

Yin, Shouliang; Wang, Xuefeng; Shi, Mingxin; Yuan, Fang; Wang, Huizhuan; Jia, Xiaole; Yuan, Fang; Sun, Jinliang; Liu, Tiejun; Yang, Keqian; Zhang, Yuxiu; Fan, Keqiang; Li, Zilong

2017-09-01

Increasing the self-resistance levels of Streptomyces is an effective strategy to improve the production of antibiotics. To increase the oxytetracycline (OTC) production in Streptomyces rimosus, we investigated the cooperative effect of three co-overexpressing OTC resistance genes: one gene encodes a ribosomal protection protein (otrA) and the other two express efflux proteins (otrB and otrC). Results indicated that combinational overexpression of otrA, otrB, and otrC (MKABC) exerted a synergetic effect. OTC production increased by 179% in the recombinant strain compared with that of the wild-type strain M4018. The resistance level to OTC was increased by approximately two-fold relative to the parental strain, thereby indicating that applying the cooperative effect of self-resistance genes is useful to improve OTC production. Furthermore, the previously identified cluster-situated activator OtcR was overexpressed in MKABC in constructing the recombinant strain MKRABC; such strain can produce OTC of approximately 7.49 g L -1 , which represents an increase of 19% in comparison with that of the OtcR-overexpressing strain alone. Our work showed that the cooperative overexpression of self-resistance genes is a promising strategy to enhance the antibiotics production in Streptomyces.

Flower evolution of alpine forbs in the open top chambers (OTCs) from the Qinghai-Tibet Plateau.

PubMed

Zhang, Chan; Wang, Lin-Lin; Yang, Yong-Ping; Duan, Yuan-Wen

2015-05-22

Effects of global changes on biodiversity have been paid more and more attention world widely, and the open top chambers (OTCs) are the most common tools to study the effects of climatic warming on plant diversity. However, it remains unclear how flowers evolve under environmental changes, which could help us to understand the changes of plant diversity in the OTCs. We compared the insect diversity and pollen:ovule (P/O) ratio of eight outcrossing species with different life histories inside and outside the OTCs on the Qinghai-Tibet Plateau, to examine the effects induced by OTCs on the evolution of floral traits. In the OTCs, P/O ratio decreased in annuals, but increased in perennials, indicating an overall trend toward selfing in annuals. We found that the insect diversity differed significantly inside and outside the OTCS, with decreases of dipteran insects and bees. We concluded that changes of P/O ratio in the studied plant species might result from pollination failure, which might be the results of mismatch between flowering time and pollinator activities. We also suggested annuals might be in a more extinction risk than perennials in OTCs, if strong inbreeding depression occurs in these annual outcrossing plants.

Sirt3 promotes the urea cycle and fatty acid oxidation during dietary restriction

PubMed Central

Hallows, William C.; Yu, Wei; Smith, Brian C.; Devries, Mark K.; Ellinger, James J.; Someya, Shinichi; Shortreed, Michael R.; Prolla, Tomas; Markley, John L.; Smith, Lloyd M.; Zhao, Shimin; Guan, Kun-Liang; Denu, John M.

2011-01-01

Summary Emerging evidence suggests that protein acetylation is a broad-ranging regulatory mechanism. Here we utilize acetyl-peptide arrays and metabolomic analyses to identify substrates of mitochondrial deacetylase Sirt3. We identified ornithine transcarbamoylase (OTC) from the urea cycle, and enzymes involved in β-oxidation. Metabolomic analyses of fasted mice lacking Sirt3 (sirt3−/−) revealed alterations in β-oxidation and the urea cycle. Biochemical analysis demonstrated that Sirt3 directly deacetylates OTC and stimulates its activity. Mice under caloric restriction (CR) increased Sirt3 protein levels, leading to deacetylation and stimulation of OTC activity. In contrast, sirt3−/− mice failed to deacetylate OTC in response to CR. Inability to stimulate OTC under CR led to a failure to reduce orotic acid levels, a known outcome of OTC deficiency. Thus, Sirt3 directly regulates OTC activity and promotes the urea cycle during CR, and the results suggest that under low energy input, Sirt3 modulates mitochondria by promoting amino-acid catabolism and β-oxidation. PMID:21255725

Heterologous expression of oxytetracycline biosynthetic gene cluster in Streptomyces venezuelae WVR2006 to improve production level and to alter fermentation process.

PubMed

Yin, Shouliang; Li, Zilong; Wang, Xuefeng; Wang, Huizhuan; Jia, Xiaole; Ai, Guomin; Bai, Zishang; Shi, Mingxin; Yuan, Fang; Liu, Tiejun; Wang, Weishan; Yang, Keqian

2016-12-01

Heterologous expression is an important strategy to activate biosynthetic gene clusters of secondary metabolites. Here, it is employed to activate and manipulate the oxytetracycline (OTC) gene cluster and to alter OTC fermentation process. To achieve these goals, a fast-growing heterologous host Streptomyces venezuelae WVR2006 was rationally selected among several potential hosts. It shows rapid and dispersed growth and intrinsic high resistance to OTC. By manipulating the expression of two cluster-situated regulators (CSR) OtcR and OtrR and precursor supply, the OTC production level was significantly increased in this heterologous host from 75 to 431 mg/l only in 48 h, a level comparable to the native producer Streptomyces rimosus M4018 in 8 days. This work shows that S. venezuelae WVR2006 is a promising chassis for the production of secondary metabolites, and the engineered heterologous OTC producer has the potential to completely alter the fermentation process of OTC production.

21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

Code of Federal Regulations, 2011 CFR

2011-04-01

... proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11... proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective...

21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

Code of Federal Regulations, 2010 CFR

2010-04-01

... proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11... proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective...

17 CFR 240.11a1-6 - Transactions for certain accounts of OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... accounts of OTC derivatives dealers. 240.11a1-6 Section 240.11a1-6 Commodity and Securities Exchanges... (rule 11a-1) § 240.11a1-6 Transactions for certain accounts of OTC derivatives dealers. A transaction effected by a member of a national securities exchange for the account of an OTC derivatives dealer that is...

21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

Code of Federal Regulations, 2013 CFR

2013-04-01

... proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11... proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective...

21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

Code of Federal Regulations, 2012 CFR

2012-04-01

... proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11... proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective...

21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

Code of Federal Regulations, 2014 CFR

2014-04-01

... proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11... proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective...

Consumer views on safety of over-the-counter drugs, preferred retailers and information sources in Sweden: after re-regulation of the pharmacy market.

PubMed

Westerlund, Tommy; Barzi, Sahra; Bernsten, Cecilia

2017-01-01

The availability of over-the-counter drugs (OTCs) has increased in Sweden since a re-regulation of the pharmacy market in 2009, through which non-pharmacy retailers became permitted to provide certain OTCs. To examine the adult general public's views on safety, purchasing and information channels, storage and disposal of OTCs in Sweden, three years after the re-regulation of the pharmacy market. A questionnaire study in 2012-13 in a stratified, random sample of all inhabitants in Sweden ≥ 18 years old. Totally 8,302 people (42%) answered the questionnaire. Seven percent found OTCs completely harmless regardless of how they are being used, 18% felt they should be used only on health professionals' recommendation. Differences in how OTCs are perceived were however found with regards to respondents' country of birth, family type, educational level and income. The pharmacy was still the preferred OTC drug retailer by 83% of the respondents and preferred information source by 80% Reasons for preferred retailers were primarily due to out of habit (45%), counseling provided (35%), the product range (34%) and the confidence in staff (27%). Analgesics are the most common OTCs to have at home (90%). The bathroom cabinet is the primary site for storage (42%) and 16% throw their OTC leftovers in the trash. The study population does not consider OTCs as harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals' recommendation only. The pharmacy is still the preferred retailer and information source, and there is room for further improvement in the storage and disposal of OTCs. A return of OTC drug leftovers to the pharmacy should be further encouraged. Due to several limitations, great caution should however be observed when generalizing the results to the adult population of Sweden.

Transport via SLC5A8 (SMCT1) Is Obligatory for 2-Oxothiazolidine-4-Carboxylate to Enhance Glutathione Production in Retinal Pigment Epithelial Cells

PubMed Central

Babu, Ellappan; Ananth, Sudha; Veeranan-Karmegam, Rajalakshmi; Coothankandaswamy, Veena; Smith, Sylvia B.; Boettger, Thomas; Ganapathy, Vadivel

2011-01-01

Purpose. To evaluate the role of SLC5A8 in the transport of 2-oxothiazolidine-4-carboxylate (OTC) and to determine whether OTC augments glutathione production in RPE cells, thereby providing protection against oxidative stress. Methods. SLC5A8-mediated transport of OTC was monitored in Xenopus laevis oocytes by electrophysiological means. Saturation kinetics, Na+-activation kinetics, and inhibition by ibuprofen were analyzed by monitoring OTC-induced currents as a measure of transport activity. Oxidative stress was induced in ARPE-19 cells and primary RPE cells isolated from wild type and Slc5a8-/- mouse retinas using H2O2, and the effects of OTC on cell death and intracellular glutathione concentration were examined. Results. Heterologous expression of human SLC5A8 in X. laevis oocytes induced Na+-dependent inward currents in the presence of OTC under voltage-clamp conditions. The transport of OTC via SLC5A8 was saturable, with a Kt of 104 ± 3 μM. The Na+-activation kinetics was sigmoidal with a Hill coefficient of 1.9 ± 0.1, suggesting involvement of two Na+ in the activation process. Ibuprofen, a blocker of SLC5A8, inhibited SLC5A8-mediated OTC transport; the concentration necessary for half-maximal inhibition was 17 ± 1 μM. OTC increased glutathione levels and protected ARPE-19 and primary RPE cells isolated from wild type mouse retinas from H2O2-induced cell death. These effects were abolished in primary RPE isolated from Slc5a8-/- mouse retinas. Conclusions. OTC is a transportable substrate for SLC5A8. OTC augments glutathione production in RPE cells, thereby protecting them from oxidative damage. Transport via SLC5A8 is obligatory for this process. PMID:21508099

Consumer views on safety of over-the-counter drugs, preferred retailers and information sources in Sweden: after re-regulation of the pharmacy market

PubMed Central

2016-01-01

Background: The availability of over-the-counter drugs (OTCs) has increased in Sweden since a re-regulation of the pharmacy market in 2009, through which non-pharmacy retailers became permitted to provide certain OTCs. Objective: To examine the adult general public’s views on safety, purchasing and information channels, storage and disposal of OTCs in Sweden, three years after the re-regulation of the pharmacy market. Methods: A questionnaire study in 2012-13 in a stratified, random sample of all inhabitants in Sweden ≥ 18 years old. Results: Totally 8,302 people (42%) answered the questionnaire. Seven percent found OTCs completely harmless regardless of how they are being used, 18% felt they should be used only on health professionals’ recommendation. Differences in how OTCs are perceived were however found with regards to respondents’ country of birth, family type, educational level and income. The pharmacy was still the preferred OTC drug retailer by 83% of the respondents and preferred information source by 80% Reasons for preferred retailers were primarily due to out of habit (45%), counseling provided (35%), the product range (34%) and the confidence in staff (27%). Analgesics are the most common OTCs to have at home (90%). The bathroom cabinet is the primary site for storage (42%) and 16% throw their OTC leftovers in the trash. Conclusions: The study population does not consider OTCs as harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals’ recommendation only. The pharmacy is still the preferred retailer and information source, and there is room for further improvement in the storage and disposal of OTCs. A return of OTC drug leftovers to the pharmacy should be further encouraged. Due to several limitations, great caution should however be observed when generalizing the results to the adult population of Sweden. PMID:28503226

Occurrence of tetracycline resistance genes in aquaculture facilities with varying use of oxytetracycline

PubMed Central

Seyfried, Erin E.; Newton, Ryan J.; Rubert, Kennedy F.; Pedersen, Joel A.; McMahon, Katherine D.

2014-01-01

The contribution of human activities to environmental reservoirs of antibiotic resistance is poorly understood. The purpose of this study was to determine if oxytetracycline (OTC) use in aquaculture facilities increased the detection frequency (i.e. prevalence) of tetracycline resistance genes relative to facilities with no recent OTC treatment. We used PCR to screen water and sediment from four non-commercial fish farms in northwestern Wisconsin for the presence of ten tetracycline resistance determinants (tetR): tet(A), tet(B), tet(D), tet(E), tet(G), tet(M), tet(O), tet(Q), tet(S) and tet(W). Water from farms with recent OTC use had significantly higher tetR detection frequencies than did water from farms without recent OTC use, with prevalence in raceways and rearing ponds of farms with recent OTC use exceeded by more than two-fold that of farms not using OTC. Effluent from all farms, regardless of treatment regime, had higher tetR detection frequencies than their corresponding influent for all genes, but the specific combinations of tetR genes detected in a sample were not different from their corresponding influent. Although OTC use was associated with the increased occurrence and diversity of tetR genes in water samples, it was not found to relate to tetR gene occurrence in sediment samples. Sediment samples from facilities with no recent OTC use had significantly higher frequencies of tetR gene detection than did samples from facilities with recent OTC use. All of the tetR genes were detected in both the medicated and non-medicated feed samples analyzed in this study. These findings suggest that both OTC treatment in aquaculture facilities, and the farms themselves, may be sources of tetR gene introduction to the environment. To our knowledge, this is the first study to use genotypic and cultivation-independent methods to examine tetR gene occurrence associated with OTC use in aquaculture. PMID:20217406

An investigation of prescription and over-the-counter supply of ophthalmic chloramphenicol in Wales in the 5 years following reclassification.

PubMed

Du, Hank C T; John, Dai N; Walker, Roger

2014-02-01

The aims of the study were to (i) quantify the sales of over-the-counter (OTC) ophthalmic chloramphenicol from all community pharmacies in Wales and investigate the impact on primary care prescriptions up to 5 years after reclassification and (ii) investigate the temporal relationship between items supplied OTC and on NHS primary care prescriptions. Primary care prescription data (2004-2010) and OTC sales data (2005-2010) for ophthalmic chloramphenicol were obtained. The quantity sold OTC was calculated from pharmacy wholesale records and sales data from a large pharmacy multiple. Spearman's rank correlation for prescription and OTC supplies of ophthalmic chloramphenicol was calculated for data from January 2008 to December 2010. OTC supply of chloramphenicol eye drops and ointment were both highest in 2007-2008 and represented 68% (57,708/84,304) and 48% (22,875/47,192) of the corresponding prescription volume, respectively. There was a steady year-on-year increase in the combined supply of OTC ophthalmic chloramphenicol and that dispensed on prescription from 144,367 items in 2004-2005 to 210,589 in 2007-2008 before stabilising in 2008-2009 and 2009-2010. A significant positive correlation was observed between prescription items and OTC sales of chloramphenicol eye drops and ointment combined (r=0.7, P<0.001). OTC availability increased the total quantity of ophthalmic chloramphenicol supplied in primary care compared to that seen prior to reclassification. Although growth in the sales of ophthalmic chloramphenicol OTC has stabilised and the supply pattern mirrors primary care prescribers, further work is required to investigate whether use is appropriate and whether the publication of updated practice guidance has changed this. © 2013 The Authors. IJPP © 2013 Royal Pharmaceutical Society.

A bacterial model for expression of mutations in the human ornithine transcarbamylase (OTC) gene

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tuchman, M.; McCann, M.T.; Qureshi, A.A.

1994-09-01

OTC is a mitochondrial enzyme catalyzing the formation of citrulline from carbamyl phosphate and ornithine. X-linked deficiency of OTC is the most prevalent genetic defect of ureagenesis. Mutations and polymorphisms in the OTC gene identified in deficient patients have indicated the occurrence of many family-specific, unique alleles. Due to the low frequency of recurrent mutations, distinguishing between deleterious mutations and polymorphisms is difficult. Using a human OTC gene containing plasmid driven by a tac promoter, we have devised a simple and efficient method for expressing mutations in the mature human OTC enzyme. To demonstrate this method, PCR engineered site-directed mutagenesismore » was employed to generated cDNA fragments which contained either the R151Q or R277W known mutations found in patients with neonatal and late-onset OTC deficiency, respectively. The normal allele for each mutation was also generated by an identical PCR procedure. Digestion with Bgl II- and Sty I-generated mutant and normal replacement cassettes containing the respective mutant and wild type sequences. Upon transformation of JM109 E.coli cells, OTC enzymatic activity was measured at log and stationary phases of growth using a radiochromatographic method. The R141Q mutation abolished enzymatic activity (<0.02% of normal), whereas the R277W mutation expressed partial activity (2.3% of normal). In addition, a PCR-generated mutation, A280V, resulted in 73% loss of catalytic activity. This OTC expression system is clinically applicable for distinguishing between mutations and polymorphisms, and it can be used to investigate the effects of mutations on various domains of the OTC gene.« less

BWTG3 hepatoma cells can acquire phenylalanine hydroxylase, cystathionine synthase and CPS-I without genetic manipulation, but activation of the silent OTC gene requires cell fusion with hepatocytes.

PubMed

Farmer, A A; Goss, S J

1991-04-01

The mouse hepatoma BWTG3 has been tested for its ability to grow in three different media that select for traits normally expressed in adult liver: homocysteine medium to select for cystathionine synthase (CS), tyrosine-free medium for phenylalanine hydroxylase (PH), and ornithine medium for carbamylphosphate synthetase-I (CPS-I) and ornithine transcarbamylase (OTC). In no case were the cells immediately capable of bulk growth, showing that all these traits were in some degree deficient. However, the cultures in homocysteine medium and in tyrosine-free medium both gave rise, spontaneously, to growing clones with frequencies of approximately 10(-3) and 10(-5), respectively. The deficiencies of CS and PH were accordingly excluded from further study, in view of their inherent instability. In contrast, no colonies ever formed in ornithine medium. Though neither CPS-I nor OTC were detectable in stock BWTG3 cells, it was found that CPS-I was readily inducible by hormones. The deficiency of OTC, however, appeared to be totally stable showing no reversion in response either to hormones or to azacytidine treatment. This deficiency was investigated by fusing the hepatoma to OTC+ liver cells prepared from normal or sparse-fur (spf) mice. Sparse-fur mice were used because their OTC is mutant and has a distinctive pH-dependence. OTC+ hybrids were readily produced, without the need for any specific selection for OTC, and, in one case at least, with only minimal chromosome segregation. In all the OTC+ hybrids made with spf cells, there was clear reactivation of the wild-type, hepatoma-derived OTC gene.(ABSTRACT TRUNCATED AT 250 WORDS)

Residue depletion of oxytetracycline (OTC) and 4-epi-oxytetracycline (4-epi-OTC) in broiler chicken's claws by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

PubMed

Cornejo, J; Pokrant, E; Araya, D; Briceño, C; Hidalgo, H; Maddaleno, A; Araya-Jordán, C; San Martin, B

2017-04-01

Antibiotics are widely used in poultry production for the treatment of bacterial diseases. However, residues may remain in products and by-products destined for human consumption or animal feeding. The claws of chickens, which are a by-product of the poultry industry, can directly or indirectly enter the food chain as meals destined to feed other productive animals. Thus, it becomes necessary to determine and quantify antimicrobial residues present in this matrix. The objective of the study was to assess the depletion of oxytetracycline (OTC) and its metabolite 4-epi-OTC in broiler chicken's claws. Claws of 32 broilers treated with a therapeutic dosage of 10% OTC during 7 days were analysed. Samples were taken at days 3, 9, 15 and 19 post-treatment. As for the control group, eight broiler chickens were raised under the same conditions. Extraction was carried out through EDTA-McIlvaine buffer, and clean-up employed a SPE C-18 Sep-Pak®. Instrumental analysis was performed through LC-MS/MS. The concentrations of both analytes were determined in claw samples until day 19 post-treatment. Average concentrations were within the LOD (20 μg kg - 1 ) and LOQ (22 µg kg - 1 ) for OTC and 84 μg kg - 1 for 4-epi-OTC. Withdrawal times (WDTs) of 39 days for OTC and 54 days for 4-epi-OTC were established in claws based on 95% confidence. These findings demonstrate that claws can be a source of antimicrobial residue entry into the food chain, since the results showed that OTC and its metabolite can be found in chicken's claws for long periods, even exceeding the average lifespan of a broiler chicken.

Cough Medicine: Understanding Your OTC Options

MedlinePlus

... and expectorants. A common antitussive is dextromethorphan (some brand names: Triaminic Cold and Cough, Robitussin Cough, Vicks ... expectorant available in OTC products is guaifenesin (2 brand names: Mucinex, Robitussin Chest Congestion). How do OTC ...

Questions and Answers on Unapproved Chelation Products

MedlinePlus

... OTC) to prevent or treat diseases. Companies are marketing unapproved OTC chelation therapy products to patients with ... 4. Why did FDA take this action? Companies marketing unapproved OTC chelation products with unsubstantiated treatment claims ...

Antibacterial activity of oxytetracycline photoproducts in marine aquaculture's water.

PubMed

Leal, J F; Henriques, I S; Correia, A; Santos, E B H; Esteves, V I

2017-01-01

Oxytetracycline (OTC) is one of the most used antibiotics in aquaculture. The main concern related to its use is the bacterial resistance, when ineffective treatments are applied for its removal or inactivation. OTC photo-degradation has been suggested as an efficient complementary process to conventional methods used in intensive fish production (e.g.: ozonation). Despite this, and knowing that the complete mineralization of OTC is difficult, few studies have examined the antibacterial activity of OTC photoproducts. Thus, the main aim of this work is to assess whether the OTC photoproducts retain the antibacterial activity of its parent compound (OTC) after its irradiation, using simulated sunlight. For that, three Gram-negative bacteria (Escherichia coli, Vibrio sp. and Aeromonas sp.) and different synthetic and natural aqueous matrices (phosphate buffered solutions at different salinities, 0 and 21‰, and three different samples from marine aquaculture industries) were tested. The microbiological assays were made using the well-diffusion method before and after OTC has been exposed to sunlight. The results revealed a clear effect of simulated sunlight, resulting on the decrease or elimination of the antibacterial activity for all strains and in all aqueous matrices due to OTC photo-degradation. For E. coli, it was also observed that the antibacterial activity of OTC is lower in the presence of sea-salts, as demonstrated by comparison of halos in aqueous matrices containing or not sea-salts. Copyright © 2016 Elsevier Ltd. All rights reserved.

Predictors of over-the-counter medication: A cross-sectional Indian study.

PubMed

Panda, Abinash; Pradhan, Supriya; Mohapatro, Gurukrushna; Kshatri, Jaya Singh

2017-01-01

The determinants of over-the-counter (OTC) medication need to be understood to design adequate drug information policies. To determine the prevalence and predictors of OTC medication among the adult population of Berhampur town in Odisha, India. It was a prospective, cross-sectional, observational study carried out in the private retail pharmacy on a convenience sample of 880 adults over a period of 6 months at Berhampur, Odisha, India. Medication use behavior was explored using a data collection form that had three parts. The first part captured data on the sociodemographic characteristics of drug consumers. The second and third part collected data on drug history and attitude toward the available health-care facility, respectively. Descriptive statistics was used to represent the prevalence of OTC medication. Odds ratio and 95% confidence intervals (CIs) were used to determine the predictors of OTC medication. The overall prevalence of OTC medication use was 18.72% (95% CI: 15.34-47.16%). Younger age, male gender, lower income, and poor lifestyle were the predictors of OTC medication. Perception of poor accessibility to health care, the presence of chronic diseases and having a symptom count of more than two significantly increased the likelihood of OTC medication ( P < 0.05). Sociodemographic profile, drug history, and attitude toward health-care availability in the locality can predict OTC medication behavior. Interventions aimed at changing the perceptions of the public regarding accessibility, affordability of the health care is likely to influence OTC medication behavior and make it safer.

[Evaluation of Dissolution Profiles of Famotidine from Over-the-counter Drugs].

PubMed

Saito, Yuji; Adachi, Naoki; Kato, Miki; Nadai, Masayuki

2018-03-27

  In recent years, self-medication has started to receive more attention in Japan owing to increasing medical costs and health awareness among people. One of the main roles of pharmacists in self-medication is to provide appropriate information regarding over-the-counter (OTC) drugs. However, pharmacists promoting the proper use of OTC drugs have little information on their formulation properties. In this study, we performed dissolution tests on both OTC drugs and ethical drug (ED) containing famotidine, and evaluated the differences in their dissolution profiles. Marked differences in dissolution profiles of OTC drugs were observed in test solutions at pH 1.2, 4.0, and 6.8 and in water. To evaluate the differences quantitatively, we calculated the lag time and dissolution rate constant from the dissolution profiles. Significant differences in lag times and dissolution rate constants between some OTC drugs and ED were observed. We also used similarity factor (f2), to quantify the similarity between dissolution profiles of OTC drugs and ED. f2 values less than 42 were observed in some OTC drugs, suggesting that these differences might influence absorption in vivo resulting in differences in their onset time and efficacy. The findings of this study will provide useful information for the promotion of proper use of OTC drugs.

Flower evolution of alpine forbs in the open top chambers (OTCs) from the Qinghai-Tibet Plateau

PubMed Central

Zhang, Chan; Wang, Lin-Lin; Yang, Yong-Ping; Duan, Yuan-Wen

2015-01-01

Effects of global changes on biodiversity have been paid more and more attention world widely, and the open top chambers (OTCs) are the most common tools to study the effects of climatic warming on plant diversity. However, it remains unclear how flowers evolve under environmental changes, which could help us to understand the changes of plant diversity in the OTCs. We compared the insect diversity and pollen:ovule (P/O) ratio of eight outcrossing species with different life histories inside and outside the OTCs on the Qinghai-Tibet Plateau, to examine the effects induced by OTCs on the evolution of floral traits. In the OTCs, P/O ratio decreased in annuals, but increased in perennials, indicating an overall trend toward selfing in annuals. We found that the insect diversity differed significantly inside and outside the OTCS, with decreases of dipteran insects and bees. We concluded that changes of P/O ratio in the studied plant species might result from pollination failure, which might be the results of mismatch between flowering time and pollinator activities. We also suggested annuals might be in a more extinction risk than perennials in OTCs, if strong inbreeding depression occurs in these annual outcrossing plants. PMID:25998558

Efficacy of a twice-daily, 3-step, over-the-counter skincare regimen for the treatment of acne vulgaris

PubMed Central

Rodan, Katie; Fields, Kathy; Falla, Timothy J

2017-01-01

Background Acne vulgaris (acne) is the most common skin disorder producing physical and emotional scars that can persist for years. An estimated 83% of acne sufferers self-treat, but there is lack of studies documenting the effectiveness of over-the-counter (OTC) acne treatment products. Objective This study was conducted to determine the effectiveness of an OTC, 3-step, anti-acne skincare regimen in treating acne and improving the appearance of red/inflamed facial skin. Methods This 6-week, open-label clinical study included both genders aged between 12 and 35 years with mild-to-moderate acne. All subjects were required to have an acne score of 1–3 (Cook’s acne grading scale: 0=clear to 7=very severe) and a moderate redness score of ≥2 (0=none and 4=severe). Subjects completed a 3-step facial treatment regimen every morning and evening using an OTC cleanser, toner, and acne treatment. Evaluations for effectiveness and safety were done at baseline and weeks 2, 4, and 6 using digital photographs (Visia-CR® digital imaging system) of the face and analyzed using Image-Pro® software for the grading of acne, red/inflamed skin, and the number and type of lesions. Results Thirty subjects (12 males and 18 females) were enrolled (mean age of 19 years; range 12–34 years). This skincare regimen resulted in statistically significant improvements in acne grading scores after 2 weeks of use, with mean scores continuing to improve after 4 and 6 weeks of use (P<0.001). Statistically significant improvements from baseline in red/inflamed skin, open and closed comedones, and papules were detected at all time points and for nodules at week 6, compared to their respective baselines (P<0.05). Conclusion This clinical study demonstrated the effectiveness of an OTC 3-step, anti-acne skincare regimen in significantly improving acne and the overall appearance of skin in the majority of subjects who had mild-to-moderate acne. PMID:28115862

Anti-fibrotic effects of L-2-oxothiazolidine-4-carboxylic acid via modulation of nuclear factor erythroid 2-related factor 2 in rats.

PubMed

Kim, In Hee; Kim, Dae-Ghon; Hao, Peipei; Wang, Yunpeng; Kim, Seong Hun; Kim, Sang Wook; Lee, Seung Ok; Lee, Soo Teik

2012-06-01

L-2-Oxothiazolidine-4-carboxylic acid (OTC) is a cysteine prodrug that maintains glutathione in tissues. The present study was designed to investigate anti-fibrotic and anti-oxidative effects of OTC via modulation of nuclear factor erythroid 2-related factor 2 (Nrf2) in an in vivo thioacetamide (TAA)-induced hepatic fibrosis model. Treatment with OTC (80 or 160 mg/kg) improved serum liver function parameters and significantly ameliorated liver fibrosis. The OTC treatment groups exhibited significantly lower expression of α-smooth muscle actin, transforming growth factor-β 1, and collagen α 1 mRNA than that in the TAA model group. Furthermore, the OTC treatment groups showed a significant decrease in hepatic malondialdehyde level compared to that in the TAA model group. Nrf2 and heme oxygenase-1 expression increased significantly in the OTC treatment groups compared with that in the TAA model group. Taken together, these results suggest that OTC restores the anti- oxidative system by upregulating Nrf2; thus, ameliorating liver injury and a fibrotic reaction.

Cold medicines and children

MedlinePlus

... ingredient. Avoid giving more than one OTC cold medicine to your child. It may cause an overdose with severe side ... the dosage instructions strictly while giving an OTC medicine to your child. When giving OTC cold medicines to your child: ...

Evaluation of the efficacy, tolerability, and safety of an over-the-counter acne regimen containing benzoyl peroxide and salicylic acid in subjects with acne.

PubMed

Kircik, Leon H; Gwazdauskas, Jennifer; Butners, Victoria; Eastern, Joseph; Green, Lawrence J

2013-03-01

Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. MaxClarity™ is an OTC acne treatment system comprising BPO and SA in an aqueous foam delivery vehicle, VersaFoam AF™. This paper describes 2 open-label, single-arm studies conducted to assess the efficacy, safety, tolerability, and patient preference of MaxClarity in the treatment of mild, moderate, and severe acne. Subjects applied MaxClarity twice daily for 8 weeks in study 402 and for 12 weeks in study 405. Reductions in all lesion types were seen throughout both studies. At week 8 (study 402), there was a mean reduction from baseline of -56.9 ± 32.7% in total lesions in subjects with mild, moderate, or severe acne. At week 12 (study 405), there was a reduction from baseline of -61.6 ± 22.0% in total lesions in subjects with moderate or severe acne. Overall, both studies demonstrated that MaxClarity is a generally well tolerated and effective treatment for mild, moderate, and severe acne.

Effects of Nigella sativa oil and ascorbic acid against oxytetracycline-induced hepato-renal toxicity in rabbits.

PubMed

Abdel-Daim, Mohamed M; Ghazy, Emad W

2015-03-01

Oxytetracycline (OTC) is a broad spectrum antibiotic widely used for treatment of a wide range of infections. However, its improper human and animal use leads to toxic effects, including hepatonephrotoxicity. Our objective was to evaluate protective effects of Nigella sativa oil (NSO) and/or ascorbic acid (AA), against OTC-induced hepatonephrotoxicity in rabbits. Forty male white New Zealand rabbits were divided into 5 groups of eight each. The 1(st) group (control) was given saline. The 2(nd) group was given OTC (200 mg/kg, orally). The 3(rd) and 4(th) groups were orally administered NSO and AA (2 ml/kg and 200 mg/kg respectively) 1 hr before OTC administration at the same dose regimen used for the 2(nd) group. Both NSO and AA were given in combination for the 5(th) group along with OTC administration. Serum biochemical parameters related to liver and kidney injury were evaluated, and lipid peroxidation as well as antioxidant markers in hepatic and renal tissues were examined. OTC-treated animals revealed significant alterations in serum biochemical hepato-renal injury markers, and showed a markedly increase in hepato-renal lipid peroxidation and inhibition in tissue antioxidant biomarkers. NSO and AA protect against OTC-induced serum and tissue biochemical alterations when each of them is used alone or in combination along with OTC treatment. Furthermore, both NSO and AA produced synergetic hepatoprotective and antioxidant properties. The present study revealed the preventive role of NSO and/or AA against the toxic effects of OTC through their free radical-scavenging and potent antioxidant activities.

Adsorption-desorption of oxytetracycline on marine sediments: Kinetics and influencing factors.

PubMed

Li, Jia; Zhang, Hua

2016-12-01

To reveal the kinetics and mechanisms of antibiotic adsorption/desorption processes, batch and stirred flow chamber (SFC) experiments were carried out with oxytetracycline (OTC) on two marine sediments. The OTC adsorption capacities of the marine sediments were relatively weak and related to their organic carbon (OC) and contents of fine particles. Sorption isotherms of OTC on marine sediment can be well described by both the Langmuir and Freundlich models. Langmuir adsorption maxima (q max ) and Freundlich distribution coefficients (K f ) increased with the decrease of salinity and pH, which indicated the importance of variable charged sites on sediment surfaces. A second order kinetic model successfully described adsorption and desorption kinetics of OTC and well reproduced the concentration change during stop-flow. The adsorption kinetic rates (k a ) for OTC under different experimental conditions ranged from 2.00 × 10 -4 to 1.97 × 10 -3  L (mg min) -1 . Results of SFC experiments indicated that diffusive mass transfer was the dominant mechanism of the time-dependent adsorption of OTC and its release from marine sediment was mildly hysteretic. The high desorption percentage (43-75% for LZB and 58-75% for BHB) implied that binding strength of OTC on two marine sediments was weak. In conclusion, marine sediment characteristics and environmental factors such as salinity, pH, and flow rate are critical factors determine extent of OTC sorption on marine sediment and need to be incorporated in modeling fate and transport of OTC in marine environment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Over-the-counter treatments and perineal hygiene in postmenopausal women.

PubMed

Erekson, Elisabeth A; Martin, Deanna K; Brousseau, E Christine; Yip, Sallis O; Fried, Terri R

2014-03-01

The objective of this descriptive study was to quantify the personal hygiene habits/practices of, as well as the over-the-counter (OTC) products used by, postmenopausal women. Specifically, we were interested in any product that would contact the vulva or vagina. We performed a cross-sectional study of postmenopausal women seeking routine gynecologic care. We developed a questionnaire on their personal hygiene habits/practices and the OTC products that they use that would contact the vulva or vagina. We recruited postmenopausal women seeking gynecologic care from two separate gynecology practices. Descriptive statistics were performed as appropriate to characterize the frequency of reported treatments and practices. The questionnaire on OTC treatments and perineal hygiene was completed by 114 postmenopausal women. Fifty-eight women (50.9%) reported using at least one OTC vulvovaginal treatment in the last 3 months, including barrier treatments, topical anesthetics, powders, and antifungals. Women often used more than one OTC product. Thirty-seven women (32.5%) reported the use of two or more OTC products. Powders were used by 34 women (29.8%). Talcum powder was the most commonly used powder (26 of 34; 76.5%). Nine postmenopausal women (7.9%) reported douching in the last 3 months. We found that more than half of postmenopausal women seeking gynecologic care have used an OTC product for vulvovaginal symptoms in the last 3 months and that one third of women use two or more products. Because the use of OTC products is very common, our study highlights the need for a detailed history inquiry about OTC product use and perineal hygiene practices.

Interest in over-the-counter access to oral contraceptives among women in the United States.

PubMed

Grossman, Daniel; Grindlay, Kate; Li, Rick; Potter, Joseph E; Trussell, James; Blanchard, Kelly

2013-10-01

A growing body of evidence indicates that over-the-counter (OTC) access to oral contraceptive pills (OCPs) is safe and effective. We performed a nationally representative survey of adult women at risk of unintended pregnancy using a probability-based online panel. In November-December 2011, 2046 eligible women completed the survey. Weighted proportions were calculated, and logistic regression was used to identify covariates associated with support for and interest in using an OTC OCP. A total of 62.2% said they were strongly (31.4%) or somewhat (30.9%) in favor of OCPs being available OTC. A total of 37.1% of participants reported being likely to use OCPs if available OTC, including 58.7% of current users, 28.0% using no method and 32.7% using a less effective method. Covariates associated with a higher odds of reporting interest in using OTC OCPs were younger age; being divorced, being separated or living with a partner (versus married); being uninsured or having private insurance (versus public insurance); living in the south (versus northeast); and current use of OCPs or less effective methods, or nonuse of contraception (versus use of another hormonal method or intrauterine device). Among respondents who said they were likely to use OTC OCPs, the highest amount they were willing to pay was on average $20. US women are supportive of OTC access to OCPs, and many would obtain refills OTC or start using OCPs if they were available OTC. Copyright © 2013. Published by Elsevier Inc.

A survey of the availability in Canadian pharmacy chains of over-the-counter natural health products for menopause symptoms.

PubMed

Croden, Jennifer; Ross, Sue; Yuksel, Nese; Sydora, Beate C

2015-03-27

Menopause is a natural phase in a woman's aging process, characterized by the cessation of menstruation. Women who are going through the menopause transition can experience physiological symptoms that significantly impact their quality of life. Concern about adverse effects of traditional hormone therapy often leads women to purchase over-the-counter (OTC) natural health products (NHPs). The goal of this study was toinvestigate the range of OTC NHPs for menopause available to Canadian women, and the packaging information they can access to make self-management decisions. Edmonton stores belonging to each of nine Canadian pharmacy chains were visited to identify NHPs marketed for the relief of menopausal symptoms. Details were extracted from the packaging: a) product name and manufacturer, b) Health Canada license number, c) medically active ingredients, d) claims of efficacy, e) contra-indications and warnings, and f) daily cost. Data were entered and analyzed using Microsoft Excel. We identified 20 OTC NHP menopausal products, 19 of which had Health Canada license numbers. Twenty-eight medically active ingredients were identified, with the most common being black cohosh (in 14 products) and soy isoflavones (n = 7), chaste tree (n = 5), and dong quai (n = 3). Most products claimed they would relieve vasomotor symptoms, including hot flashes (n = 14) and night sweats (n = 10). Each product had a labeled contraindication for at least one specific condition. Costs per recommended daily dose ranged from $0.07 to a maximum of $2.50 (CAD$). Natural health products for menopausal symptoms are easily available to Canadian women. The lack of clear evidence of product efficacy makes the need for easily accessible, balanced information on this topic important for women to make well informed choices.

78 FR 73197 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-05

... Federal Register final rule that required all OTC drug products marketed under the OTC monograph system to... marketplace under new drug applications, abbreviated new drug applications, or an OTC drug monograph, except...

Over-the-Counter Access to Oral Contraceptives.

PubMed

Grossman, Daniel

2015-12-01

Making oral contraceptives (OCs) available over the counter (OTC) could help to reduce the high rate of unintended pregnancy in the United States. Surveys show widespread support for OTC access to OCs among US women. Studies indicate that women can accurately use checklists to identify contraindications to OCs. Continuation is as good or better among OTC users compared with women using OCs obtained by prescription. Women and clinicians have expressed concerns related to making OCs available OTC. These concerns can be addressed by existing data or through research required by the Food and Drug Administration as part of the application to make OCs available OTC. Copyright © 2015 Elsevier Inc. All rights reserved.

Transfer of oxytetracycline from swine manure to three different aquatic plants: implications for human exposure.

PubMed

Boonsaner, Maliwan; Hawker, Darryl W

2015-03-01

Little is known regarding the potential for pharmaceuticals including antibiotics to be accumulated in edible aquatic plants and enter the human food chain. This work investigates the transfer of a widely used veterinary antibiotic, oxytetracycline (OTC), from swine manure to aquatic plants by firstly characterizing desorption from swine manure to water and fitting data to both nonlinear and linear isotherms. Bioconcentration of OTC from water was then quantified with aquatic plants of contrasting morphology and growth habit viz. watermeal (Wolffia globosa Hartog and Plas), cabomba (Cabomba caroliniana A. Gray) and water spinach (Ipomoea aquatica Forsk.). Watermeal and water spinach are widely consumed in Southeast Asia. The OTC desorption and bioconcentration data were used to provide the first quantitative estimates of human exposure to OTC from a manure-water-aquatic plant route. Results show that under certain conditions (plants growing for 15d in undiluted swine manure effluent (2% w/v solids) and an initial OTC swine manure concentration of 43mgkg(-1) (dry weight)), this pathway could provide a significant fraction (>48%) of the acceptable daily intake (ADI) for OTC. While effluent dilution, lower OTC manure concentrations and not all plant material consumed being contaminated would be expected to diminish the proportion of the ADI accumulated, uptake from aquatic plants should not be ignored when determining human exposure to antibiotics such as OTC. Copyright © 2014 Elsevier Ltd. All rights reserved.

Nonprescription medications for respiratory symptoms: Facts and marketing fictions.

PubMed

Weinberger, Miles; Hendeles, Leslie

2018-05-01

There are many nonprescription (over-the-counter [OTC]) medications available on pharmacy shelves marketed for relief of respiratory symptoms. The number of such medications has been increasing. This review provides an evidence-based examination of OTC products used for respiratory symptoms. Antihistamines, decongestants, mucolytics, antitussives, and intranasal steroids were selected as the most common OTC medications taken by adults and children for various respiratory symptoms. Controlled clinical trials of efficacy were identified by searching a medical literature data base. Those trials and key publications related to the pharmacokinetics and pharmacodynamics of the products were reviewed. Comparisons of the various OTC antihistamines' ability to suppress the effects of histamine were related to their clinical benefit. Intranasal corticosteroids are the preferred agents for maintenance therapy of persistent nasal congestion and are highly effective for symptoms of inhalant allergy other than allergic conjunctivitis. The disconnect between marketing claims and evidence was demonstrated for antihistamines and oral alpha-1 adrenergic agonist decongestants. Data for OTC mucolytics and antitussives were insufficient to justify their use based on the evidence. There was little relationship between marketing claims and evidence regarding OTC medications used for respiratory symptoms. Analysis of data supported cetirizine, levocetirizine, and fexofenadine as the most effective of the OTC antihistamines. There were no data that supported the use of oral phenylephrine as a decongestant. Neither OTC mucolytics or antitussives provided sufficient evidence to justify their use.

Consumer preferences for over-the-counter drug retailers in the reregulated Swedish pharmacy market.

PubMed

Håkonsen, Helle; Sundell, Karolina Andersson; Martinsson, Johan; Hedenrud, Tove

2016-03-01

Following a large regulatory reform in 2009, which ended the state's pharmacy monopoly, non-pharmacy retailers in Sweden today sell certain over-the-counter (OTC) drugs. The aim of this study was to investigate consumer preferences regarding OTC drug retailers and the reasons for choosing a pharmacy versus non-pharmacy retailer. We conducted a web survey aimed at Swedish adults. Out of a stratified sample of 4058 persons, 2594 agreed to take part (48% women; mean age: 50.3 years). Questions related to OTC drug use, retailer choice and factors affecting the participants' preferences for OTC drug retailers. Logistic regression was conducted to analyse OTC drug use and reasons for retailer choice in relation to sex, age and education. Nine in ten participants reported OTC drug use in the 6 months prior to the study. For their last OTC purchase, 76% had gone to a pharmacy, 20% to a grocery shop and 4% to a convenience store, gas station or online. Geographic proximity, opening hours and product range were reported as the most important factors in retailer choice. Counselling by trained staff was important to 57% of participants. The end of the state's pharmacy monopoly and the increase in number of pharmacies seem to have impacted more on Swedish consumers' purchase behaviours compared with the deregulation of OTC drug sales. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Demographic, Risk, and Spatial Factors Associated With Over-the-Counter Syringe Purchase Among Injection Drug Users

PubMed Central

Stopka, Thomas J.; Lutnick, Alexandra; Wenger, Lynn D.; DeRiemer, Kathryn; Geraghty, Estella M.; Kral, Alex H.

2012-01-01

Since 2005, California law allowed over-the-counter (OTC) syringe sales pending local authorization. Although pharmacy sales of OTC syringes are associated with reduced injection-mediated risks and decreases in human immunodeficiency virus infection rates, little is known about the factors associated with syringe purchase among injection drug users (IDUs). Using a cross-sectional design, the authors applied targeted sampling to collect quantitative survey data from IDUs (n = 563) recruited in San Francisco, California, during 2008. They also compiled a comprehensive list of retail pharmacies, their location, and whether they sell OTC syringes. They used a novel combination of geographic information system and statistical analyses to determine the demographic, behavioral, and spatial factors associated with OTC syringe purchase by IDUs. In multivariate analyses, age, race, injection frequency, the type of drug injected, and the source of syringe supply were independently associated with OTC syringe purchases. Notably, the prevalence of OTC syringe purchase was 53% lower among African-American IDUs (adjusted prevalence ratio = 0.47, 95% confidence interval: 0.33, 0.67) and higher among injectors of methamphetamine (adjusted prevalence ratio = 1.35, 95% confidence interval: 1.07, 1.70). Two neighborhoods with high densities of IDUs had limited access to OTC syringes. Increased access to OTC syringes would potentially prevent blood-borne infectious diseases among IDUs. PMID:22562660

A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

PubMed

Patel, Mira; Slack, Marion; Cooley, Janet; Bhattacharjee, Sandipan

2016-01-01

Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p < 0.001). Pharmacists who have expertise in medications were shown to prefer using generic OTC medications rather than brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide consumers the evidence needed to make well-informed choices when choosing between brand and generic medications.

Chronic impacts of oxytetracycline on mesophilic anaerobic digestion of excess sludge: Inhibition of hydrolytic acidification and enrichment of antibiotic resistome.

PubMed

Tian, Zhe; Zhang, Yu; Yang, Min

2018-07-01

We evaluated the chronic impact of oxytetracycline (OTC) on performance and antibiotic resistance development during the mesophilic anaerobic digestion (AD) of antibiotic-containing biomass. Mesophilic AD was conducted in a completely stirred tank reactor by constantly feeding municipal excess sludge spiked with increasing concentrations of OTC (0-1000 mg L -1 ) under a solid retention time of 20 days over a period of 265 days. Results showed that methane generation of mesophilic AD was inhibited when the OTC concentration in digested sludge was increased to around 18,000 mg kg -1 (OTC dose, 1000 mg L -1 ), due to the inhibition of fermenting and acidogenic bacteria. Metagenomic sequencing and high-throughput quantitative PCR analysis demonstrated that tetracycline resistance genes were the most dominant type (38.47-43.76%) in the resistome, with tetG, tetX, tetM, tetR, tetQ, tetO, and tetL as the dominant resistant subtypes throughout the whole experimental period. The relative abundance of these tet genes increased from 2.10 × 10 -1 before spiking OTC (OTC concentration in digested sludge, 8.97 mg kg -1 ) to 2.83 × 10 -1 (p < 0.05) after spiking OTC at a dose of 40 mg L -1 (OTC concentration in digested sludge, 528.52 mg kg -1 ). Furthermore, mobile genetic elements, including integrons, transposons, and plasmids, were also enriched with the increase in OTC dose. Based on partial canonical correspondence analysis, the contributions of horizontal (mobile element alteration) and vertical (bacterial community shift) gene transfer to antibiotic resistome variation were 29.35% and 21.51%, respectively. Thus, considering the inhibition of hydrolytic acidification and enrichment of antibiotic resistome, mesophilic AD is not suggested to directly treat the biomass containing OTC concentration higher than 200 mg L -1 . Copyright © 2018 Elsevier Ltd. All rights reserved.

Popularity and customer preferences for over-the-counter Chinese medicines perceived by community pharmacists in Shanghai and Guangzhou: a questionnaire survey study.

PubMed

Ge, Shuai; He, Tian-Tian; Hu, Hao

2014-01-01

This study interviewed community pharmacists in Shanghai and Guangzhou for their perception of the popular categories of over-the-counter (OTC) Chinese medicines and the factors affecting customer preferences for OTC Chinese medicines. A cross-sectional survey was carried out in six main administrative districts in Guangzhou and eight main administrative districts in Shanghai, China. Descriptive statistical analysis was conducted in this study. OTC Chinese medicines contributed 21-50% among all the pharmaceutical sales by the community pharmacies. The prevalent categories of OTC Chinese medicines were common cold medicines, respiratory system medicines, digestive system agents, gynecological medicines, health tonic medicines, and qing re (heat-clearing) and qu du (detoxifying) medicines. Customers were more concerned about medical factors of OTC Chinese medicines than business factors. Among the medical factors, the most important was drug safety, followed by efficacy, contraindications, indications, and side effects. Among the business factors, the most important were brand and price. This study identified the top sales categories of OTC Chinese medicines in Shanghai and Guangzhou and the important factors such as drug safety, efficacy, period of validity, contraindications, and indications that are affecting the customer preferences for OTC Chinese medicines.

Purification and characterization of ornithine transcarbamylase from pea (Pisum sativum L.)

NASA Technical Reports Server (NTRS)

Slocum, R. D.; Richardson, D. P.

1991-01-01

Pea (Pisum sativum) ornithine transcarbamylase (OTC) was purified to homogeneity from leaf homogenates in a single-step procedure, using delta-N-(phosphonacetyl)-L-ornithine-Sepharose 6B affinity chromatography. The 1581-fold purified OTC enzyme exhibited a specific activity of 139 micromoles citrulline per minute per milligram of protein at 37 degrees C, pH 8.5. Pea OTC represents approximately 0.05% of the total soluble protein in the leaf. The molecular weight of the native enzyme was approximately 108,200, as estimated by Sephacryl S-200 gel filtration chromatography. The purified protein ran as a single molecular weight band of 36,500 in sodium dodecyl sulfate-polyacrylamide gel electrophoresis. These results suggest that the pea OTC is a trimer of identical subunits. The overall amino acid composition of pea OTC is similar to that found in other eukaryotic and prokaryotic OTCs, but the number of arginine residues is approximately twofold higher. The increased number of arginine residues probably accounts for the observed isoelectric point of 7.6 for the pea enzyme, which is considerably more basic than isoelectric point values that have been reported for other OTCs.

Effect on smoking cessation of switching nicotine replacement therapy to over-the-counter status.

PubMed

Thorndike, Anne N; Biener, Lois; Rigotti, Nancy A

2002-03-01

This study examined whether the change in nicotine replacement therapy sales from prescription to over the counter (OTC) status affected smoking cessation. We used the 1993-1999 Massachusetts Tobacco Surveys to compare data from adult current smokers and recent quitters before and after the OTC switch. No significant change over time occurred in the proportion of smokers who used nicotine replacement therapy at a quit attempt in the past year (20.1% pre-OTC vs 21.4% post-OTC), made a quit attempt in the past year (48.1% vs 45.2%), or quit smoking in the past year (8.1% vs 11.1%). Fewer non-Whites used nicotine replacement therapy after the switch (20.7% pre-OTC vs 3.2% post-OTC, P =.002), but the proportion of Whites using nicotine replacement therapy did not change significantly (20.6% vs 24.0%). We observed no increase in Massachusetts smokers' rates of using nicotine replacement therapy, making a quit attempt, or stopping smoking after nicotine replacement therapy became available for OTC sale. There appear to be other barriers to the use of nicotine replacement therapy besides visiting a physician, especially among minority smokers.

Probabilistic cluster labeling of imagery data

NASA Technical Reports Server (NTRS)

Chittineni, C. B. (Principal Investigator)

1980-01-01

The problem of obtaining the probabilities of class labels for the clusters using spectral and spatial information from a given set of labeled patterns and their neighbors is considered. A relationship is developed between class and clusters conditional densities in terms of probabilities of class labels for the clusters. Expressions are presented for updating the a posteriori probabilities of the classes of a pixel using information from its local neighborhood. Fixed-point iteration schemes are developed for obtaining the optimal probabilities of class labels for the clusters. These schemes utilize spatial information and also the probabilities of label imperfections. Experimental results from the processing of remotely sensed multispectral scanner imagery data are presented.

Medicine reclassification processes and regulations for proper use of over-the-counter self-care medicines in Japan.

PubMed

Nomura, Kaori; Kitagawa, Yuki; Yuda, Yasukatsu; Takano-Ohmuro, Hiromi

2016-01-01

Japan has actively reclassified substances ranging from prescription drugs to over-the-counter (OTC) drugs in recent years. The sale of most OTC drugs was deregulated several times and pharmacists' supervision was deemed no longer mandatory. Japan established a new OTC evaluation system in 2015 to hear opinions from various stakeholders regarding medicine types to be reclassified. This study aimed to examine the new framework to identify candidate substances for reclassification. Moreover, we examined how to manage the safe, self-care use of OTC drugs in Japan. The necessary regulatory information on OTC approvals as of January 2015 was collected using an Internet search and relevant databases. To highlight the characteristics of OTC drugs in Japan, the UK was selected as a comparison country because it too was actively promoting the reclassification of medicines from prescription to nonprescription status, and because of economic similarity. Japan and the UK have a risk-based classification for nonprescription medicines. Japan has made OTC drugs available with mandatory pharmacists' supervision, face-to-face with pharmacists, or online instruction, which is similar to the "pharmacy medicine" practiced in the UK. Japan recently reformed the reclassification process to involve physicians and the public in the process; some interactions were back to "prescription-only medicine" in the UK. It is expected that the opinion of marketers, medical professionals, and the public will improve the discussion that will greatly contribute to the safe use of drugs. Monitoring the new system will be noteworthy to ensure that OTC drug users are managing their self-care properly and visiting a doctor only when necessary. The supply methods are similar in Japan and the UK; however, the expected growth in the Japanese OTC market by the Cabinet and the industry is still uncertain.

Improvement of the soil nitrogen content and maize growth by earthworms and arbuscular mycorrhizal fungi in soils polluted by oxytetracycline.

PubMed

Cao, Jia; Wang, Chong; Ji, Dingge

2016-11-15

Interactions between earthworms (Eisenia fetida) and arbuscular mycorrhizal fungi (Rhizophagus intraradices, AM fungi) have been suggested to improve the maize nitrogen (N) content and biomass and were studied in soils polluted by oxytetracycline (OTC). Maize was planted and amended with AMF and/or earthworms (E) in the soil with low (1mgkg(-1) soil DM) or high (100mgkg(-1) soil DM) amounts of OTC pollution in comparison to soil without OTC. The root colonization, shoot and root biomass, shoot and root N contents, soil nitrogen forms, ammonia-oxidizing bacteria (AOB) and archaea (AOA) were measured at harvest. The results indicated that OTC decreased maize shoot and root biomass (p<0.05) by mediating the soil urease activity and AOB and AOA abundance, which resulted in a lower N availability for maize roots and shoots. There was a significant interaction between earthworms and AM fungi on the urease activity in soil polluted by OTC (p<0.05). Adding earthworms or AM fungi could increase the maize biomass and N content (p<0.05) in OTC polluted soil by increasing the urease activity and relieving the stress from OTC on the soil N cycle. AM fungi and earthworms interactively increased maize shoot and root biomass (p<0.05) in the OTC polluted soils through their regulation of the urease activity and the abundance of ammonia oxidizers, resulting in different soil NH4(+)-N and NO3(-)-N contents, which may contribute to the N content of maize shoots and roots. Earthworms and AM fungi could be used as an efficient method to relieve the OTC stress in agro-ecosystems. Copyright © 2016 Elsevier B.V. All rights reserved.

Removal of herbicides in a biopurification system is not negatively affected by oxytetracycline or fungally pretreated oxytetracycline.

PubMed

Cambronero-Heinrichs, Juan Carlos; Masís-Mora, Mario; Quirós-Fournier, José Pablo; Lizano-Fallas, Verónica; Mata-Araya, Iray; Rodríguez-Rodríguez, Carlos E

2018-05-01

The disposal of agricultural antibiotic-containing wastewater in biopurification systems (BPS) employed in the treatment of pesticides, may negatively affect the removal capacity of these devices. This work aimed to employ a fungal pretreatment of oxytetracycline (OTC)-rich wastewater, before its disposal in a BPS used for the treatment of two pesticides. The fungal treatment at reactor scale (stirred tank reactor, 3L) with biomass of Trametes versicolor efficiently removed 100 mg L -1 OTC in only 60 h. However, ecotoxicity tests on seed germination with Lactuca sativa revealed that antibiotic elimination did not correlate with a decrease in toxicity. After the pretreatment, treated OTC was discarded in biomixtures used for the elimination of the herbicides ametryn and terbutryn. The co-application of treated or untreated OTC did not inhibit the removal of the herbicides; moreover, in both cases their removal seemed to be slightly enhanced in the presence of OTC or its residues, with respect to antibiotic-free biomixtures. Estimated half-lives ranged from 28.4 to 34.8 d for ametryn, and 34.0-51.0 d for terbutryn. In addition, the biomixture was also able to remove OTC in the presence of the herbicides, with an estimated half-life of 38 d. Remarkably, the toxicity of the wastewater containing OTC or treated OTC was mostly eliminated after its disposal in the biomixture. Overall results suggest that, given the high efficiency of the biomixture, the fungal pretreatment of OTC-containing wastewater is not mandatory before its disposal in the BPS. Copyright © 2018 Elsevier Ltd. All rights reserved.

Toxic responses of swimming crab (Portunus trituberculatus) larvae exposed to environmentally realistic concentrations of oxytetracycline.

PubMed

Ren, Xianyun; Wang, Zhuqing; Gao, Baoquan; Liu, Ping; Li, Jian

2017-04-01

Oxytetracycline (OTC) is the most commonly used antibiotics for bacterial treatment in crustacean farming in China, and because of their intensive use, the potential harmful effects on aquatic organisms are of great concern. The aim of this study was to investigate the effects of oxytetracycline (OTC) on the antioxidant system, detoxification progress, and biomolecule damage in Portunus trituberculatus larvae. In this study, larvae that belonged to four zoeal stages were exposed to four different concentrations of OTC (0, 0.3, 3, and 30 μg/L) for 3 days. The results showed that the exposure to OTC significantly suppressed the antioxidant system of, especially, zoea I (Z1) and zoea II (Z2) larvae. OTC inhibited the transcriptional expression of phase I (CYP2 and CYP3) and phase II detoxification genes (GST) in a dose-dependent manner and altered the expressions of their corresponding enzymes, namely, aminopyrine N-demethylase, erythromycin N-demethylase, and glutathione S-transferase. Moreover, 0.3 μg/L OTC activated the transcription of ATP-binding cassette (ABC) transporter subfamily B (ABCB) and subfamily G (ABCG) in the Z1 and Z2 larvae, while 3 and 30 μg/L OTC suppressed all of them. Additionally, malondialdehyde content exhibited a dose- and zoea-effect relationship to some extent, but no significant differences were observed in the F values of the Z3 and Z4 larvae, except for the 30 μg/L OTC treatment. Thus, the Z3 and Z4 larvae were less sensitive to OTC exposure than the Z1 and Z2 larvae. Copyright © 2017 Elsevier Ltd. All rights reserved.

Is crime associated with over-the-counter pharmacy syringe sales? Findings from Los Angeles, California.

PubMed

Stopka, Thomas J; Geraghty, Estella M; Azari, Rahman; Gold, Ellen B; DeRiemer, Kathryn

2014-03-01

More than 50,000 new HIV infections occur annually in the United States. Injection drug users represent twelve percent of incident HIV infections each year. Pharmacy sales of over-the-counter (OTC) syringes have helped prevent HIV transmission among injection drug users in many states throughout the United States. However, concerns exist among some law enforcement officials, policymakers, pharmacists, and community members about potential links between OTC syringe sales and crime. We used a geographic information system and novel spatial and longitudinal analyses to determine whether implementation of pharmacy-based OTC syringe sales were associated with reported crime between January 2006 and December 2008 in Los Angeles Police Department Reporting Districts. We assessed reported crime pre- and post-OTC syringe sales initiation as well as longitudinal associations between crime and OTC syringe-selling pharmacies. By December 2008, 9.3% (94/1010) of Los Angeles Police Department Reporting Districts had at least one OTC syringe-selling pharmacy. Overall reported crime counts and reported crime rates decreased between 2006 and 2008 in all 1010 Reporting Districts. Using generalized estimating equations and adjusting for potential confounders, reported crime rates were negatively associated with OTC syringe sales (adjusted rate ratio: 0.89; 95% confidence interval: 0.81, 0.99). Our findings demonstrate that OTC pharmacy syringe sales were not associated with increases in reported crime in local communities in Los Angeles during 2006-2008. Copyright © 2014 Elsevier B.V. All rights reserved.

Effect from low-level exposure of oxytetracycline on abundance of tetracycline resistance genes in arable soils.

PubMed

Shentu, Jia-Li; Zhang, Kun; Shen, Dong-Sheng; Wang, Mei-Zhen; Feng, Hua-Jun

2015-09-01

To evaluate the effect from low-level exposure of antibiotics on the abundance of antibiotic resistance genes, unpolluted arable soils were treated with oxytetracycline (OTC)-containing manure, with OTC (0, 2, 20, or 70 μg kg(-1)) added every 2 weeks on 10 occasions. Six tetracycline resistance genes [TRGs-tet(A), tet(L), tet(M), tet(Q), tet(O), and tet(W)] and the 16S ribosomal RNA (rRNA) gene were monitored using real-time quantitative polymerase chain reaction. The relative abundance of tet(A), tet(L), tet(M), and tet(Q) genes in soil increased 10-1000 times after application of OTC-containing manure. Tet(A) abundance per unit of residual OTC on day 140 was 1.53-4.42 times higher than that on day 28, while tet(L) abundance was 1.04-1.74 times higher. Treatment with >40 μg kg(-1) OTC significantly increased abundance of tet(A) and tet(L), while tet(M) and tet(Q) abundance was positively correlated (R (2) = 0.965 and 0.932, p < 0.01) with residual OTC concentrations. There was a significant accumulation of TRGs associated with low-level OTC exposure in arable soils. Besides OTC residual, the effects from exposure time and application frequencies should also be considered to limit the increase in abundance of tet(A) and tet(L).

Evaluation of the Spatiotemporal Dynamics of Oxytetracycline and Its Control Effect Against Citrus Huanglongbing via Trunk Injection.

PubMed

Hu, Jiahuai; Wang, Nian

2016-12-01

Citrus huanglongbing (HLB) or greening is a devastating bacterial disease that has destroyed millions of trees and is associated with phloem-residing 'Candidatus Liberibacter asiaticus' (Las) in Florida. In this study, we evaluated the spatiotemporal dynamics of oxytetracycline in planta and its control effect against HLB via trunk injection. Las-infected 'Hamlin' sweet orange trees on 'Swingle' citrumelo rootstock at the early stage of decline were treated with oxytetracycline hydrochloride (OTC) using trunk injection with varying number of injection ports. Spatiotemporal distribution of OTC and dynamics of Las populations were monitored by high-performance liquid chromatography method and qPCR assay, respectively. Uniform distribution of OTC throughout tree canopies and root system was achieved 2 days postinjection. High levels of OTC (>850 µg/kg) were maintained in leaf and root for at least 1 month and moderate OTC (>500 µg/kg) persisted for more than 9 months. Reduction of Las populations in root system and leaves of OTC-treated trees were over 95% and 99% (i.e., 1.76 and 2.19 log reduction) between 2 and 28 days postinjection. Conditions of trees receiving OTC treatment were improved, fruit yield was increased, and juice acidity was lowered than water-injected control even though their differences were not statistically significant during the test period. Our study demonstrated that trunk injection of OTC could be used as an effective measure for integrated management of citrus HLB.

Using over-the-counter medicines safely

MedlinePlus

... about OTC drugs. About OTC Medicines You can buy OTC medicines without a prescription in: Drug stores Grocery stores ... Safely You should: Examine the package before you buy it. Make sure it has not been tampered with. Never use medicine you have bought that does not look the ...

49 CFR 172.402 - Additional labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 30, 2001, such as, a label without the hazard class or division number displayed in the lower corner... this section); and (2)For other than Class 1 or Class 2 materials (for subsidiary labeling requirements for Class 1 or Class 2 materials see paragraph (e) or paragraphs (f) and (g), respectively, of this...

Measurement of oxytetracycline and emamectin benzoate in freshwater sediments downstream of land based aquaculture facilities in the Atlantic Region of Canada.

PubMed

Lalonde, Benoit A; Ernst, William; Greenwood, Lyndsay

2012-09-01

This study investigated the occurrence of oxytetracycline (OTC) and emamectin benzoate (EB) in sediments located near the effluent outfall from four freshwater aquaculture facilities in Atlantic Canada. While two facilities had no detectable concentrations of EB or OTC, two facilities had detectable concentrations of one or both of these chemicals. Concentrations ranged from <0.05-18 mg/kg to <0.01-2.5 mg/kg for OTC and EB respectively. Although these values could not be compared with freshwater toxicant values, some of the concentrations of EB and OTC detected were higher than LC(50) values calculated for marine invertebrates. OTC concentrations measured in this study are also of a magnitude which has been known to produce resistant bacteria.

Popularity and customer preferences for over-the-counter Chinese medicines perceived by community pharmacists in Shanghai and Guangzhou: a questionnaire survey study

PubMed Central

2014-01-01

Background This study interviewed community pharmacists in Shanghai and Guangzhou for their perception of the popular categories of over-the-counter (OTC) Chinese medicines and the factors affecting customer preferences for OTC Chinese medicines. Methods A cross-sectional survey was carried out in six main administrative districts in Guangzhou and eight main administrative districts in Shanghai, China. Descriptive statistical analysis was conducted in this study. Results OTC Chinese medicines contributed 21–50% among all the pharmaceutical sales by the community pharmacies. The prevalent categories of OTC Chinese medicines were common cold medicines, respiratory system medicines, digestive system agents, gynecological medicines, health tonic medicines, and qing re (heat-clearing) and qu du (detoxifying) medicines. Customers were more concerned about medical factors of OTC Chinese medicines than business factors. Among the medical factors, the most important was drug safety, followed by efficacy, contraindications, indications, and side effects. Among the business factors, the most important were brand and price. Conclusions This study identified the top sales categories of OTC Chinese medicines in Shanghai and Guangzhou and the important factors such as drug safety, efficacy, period of validity, contraindications, and indications that are affecting the customer preferences for OTC Chinese medicines. PMID:25243017

Effect on Smoking Cessation of Switching Nicotine Replacement Therapy to Over-the-Counter Status

PubMed Central

Thorndike, Anne N.; Biener, Lois; Rigotti, Nancy A.

2002-01-01

Objectives. This study examined whether the change in nicotine replacement therapy sales from prescription to over the counter (OTC) status affected smoking cessation. Methods. We used the 1993–1999 Massachusetts Tobacco Surveys to compare data from adult current smokers and recent quitters before and after the OTC switch. Results. No significant change over time occurred in the proportion of smokers who used nicotine replacement therapy at a quit attempt in the past year (20.1% pre-OTC vs 21.4% post-OTC), made a quit attempt in the past year (48.1% vs 45.2%), or quit smoking in the past year (8.1% vs 11.1%). Fewer non-Whites used nicotine replacement therapy after the switch (20.7% pre-OTC vs 3.2% post-OTC, P = .002), but the proportion of Whites using nicotine replacement therapy did not change significantly (20.6% vs 24.0%). Conclusions. We observed no increase in Massachusetts smokers' rates of using nicotine replacement therapy, making a quit attempt, or stopping smoking after nicotine replacement therapy became available for OTC sale. There appear to be other barriers to the use of nicotine replacement therapy besides visiting a physician, especially among minority smokers. (Am J Public Health. 2002;92:437–442) PMID:11867326

Effects of oxytetracycline on archaeal community, and tetracycline resistance genes in anaerobic co-digestion of pig manure and wheat straw.

PubMed

Wang, Xiaojuan; Pan, Hongjia; Gu, Jie; Qian, Xun; Gao, Hua; Qin, Qingjun

2016-12-01

In this study, the effects of different concentrations of oxytetracycline (OTC) on biogas production, archaeal community structure, and the levels of tetracycline resistance genes (TRGs) were investigated in the anaerobic co-digestion products of pig manure and wheat straw. PCR denaturing gradient gel electrophoresis analysis and real-time quantitative polymerase chain reaction (RT-qPCR) (PCR) were used to detect the archaeal community structure and the levels of four TRGs: tet(M), tet(Q), tet(W), and tet(C). The results showed that anaerobic co-digestion with OTC at concentrations of 60, 100, and 140 mg/kg (dry weight of pig manure) reduced the cumulative biogas production levels by 9.9%, 10.4%, and 14.1%, respectively, compared with that produced by the control, which lacked the antibiotic. The addition of OTC substantially modified the structure of the archaeal community. Two orders were identified by phylogenetic analysis, that is, Pseudomonadales and Methanomicrobiales, and the methanogen present during anaerobic co-digestion with OTC may have been resistant to OTC. The abundances of tet(Q) and tet(W) genes increased as the OTC concentration increased, whereas the abundances of tet(M) and tet(C) genes decreased as the OTC concentration increased.

Community pharmacists' perceptions about pharmaceutical service of over-the-counter traditional Chinese medicine: a survey study in Harbin of China.

PubMed

Song, Menghuan; Ung, Carolina Oi Lam; Lee, Vivian Wing-Yan; Hu, Yuanjia; Zhao, Jing; Li, Peng; Hu, Hao

2017-01-05

This study aims to investigate community pharmacist's perception on the provision of over-the-counter (OTC) traditional Chinese medicine (TCM) pharmaceutical services; focusing on the areas of their attitude, general practice, perceived barriers and suggested improvements. Questionnaire survey targeting community pharmacists in Harbin of China was applied in this study. Questionnaires were distributed and collected at community pharmacies. Data was analyzed by combining descriptive analysis and Chi-test. 280 valid questionnaires were collected, giving a response rate of 78%. Respondents generally showed positive attitude towards OTC TCM pharmaceutical services. However, they were uncertain about whether such pharmaceutical services should be considered as their primary responsibility. Respondents indicated that they acted proactively to find out all the medicines taken by their patients and to remind consumers of possible OTC TCM adverse reactions. However, they were less keen on recommending or re-directing consumers to suitable OTC TCM. The three main barriers hindering the provision of OTC TCM pharmaceutical service identified in this study were "insufficient professional knowledge" (54.6%), "ambiguity of the professional role of pharmacists" (54.6%) and "lack of scientific evidence of OTC TCM" (45.4%). The three main actions considered most relevant to improving pharmaceutical service of OTC TCM were "formulating or refining legislation to clarify the legal and professional role of pharmacists with respect to TCM" (60.7%), "strengthening training of pharmacists with respect to TCM" (57.9%), and "promoting public awareness of the pharmacist's role" (53.6%). According to the results of Chi-test, respondents' perceptions about the attitude, practice, perceived barriers, and improvement suggestions were significantly different depending on the education levels, certificate types and workloads of western medicine. The community pharmacists in Harbin, China were positive about the provision of OTC TCM pharmaceutical services. However, they were less certain about taking this duty as their primary responsibility. Insufficient knowledge and lack of role definition in the area of OTC TCM were found to be the major factors discouraging the provision of pharmaceutical service on OTC TCM by community pharmacists.

Perspectives among a Diverse Sample of Women on the Possibility of Obtaining Oral Contraceptives Over the Counter: A Qualitative Study.

PubMed

Baum, Sarah; Burns, Bridgit; Davis, Laura; Yeung, Miriam; Scott, Cherisse; Grindlay, Kate; Grossman, Daniel

2016-01-01

There is increasing support among stakeholders in the United States to make oral contraceptives (OCs) available over the counter (OTC). Previous research on the topic has focused on representative samples of U.S. women, Latina women, low-income women, and abortion clients. However, little is known about the perspectives of African American women, Asian American women, and young women. We conducted 14 focus group discussions with 138 women. Twenty-three percent of participants were ages 18 or younger, 61% were African American, and 26% were Asian American/Pacific Islander. Community organizations recruited participants through convenience sampling and hosted the discussions. Focus groups were transcribed and coded thematically. Women reported potential benefits of OTC access, including convenience and privacy. Many believed OTC availability of OCs would help to reduce unintended pregnancy and help to destigmatize birth control. Participants also expressed concerns about OTC access, such as worry that first-time users and young adolescents would not have enough information to use the pill safely and effectively, as well as concerns about whether women would still obtain preventive screenings. Women were also worried that the cost of OTC OCs would be higher if insurance no longer covered them. Overall, women were interested in the option of obtaining the pill OTC. Future research and advocacy efforts should explore women's concerns, including whether adolescents can effectively use OTC pills and ensuring insurance coverage for OTC contraception. Copyright © 2016 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

21 CFR 25.31 - Human drugs and biologics.

Code of Federal Regulations, 2011 CFR

2011-04-01

... approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the... a supplement to such applications, or action on an OTC monograph, if the action increases the use of... an OTC monograph, for substances that occur naturally in the environment when the action does not...

12 CFR 217.34 - OTC derivative contracts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... net present value of the amount of unpaid premiums. Table 1 to § 217.34—Conversion Factor Matrix for... single OTC derivative contract is the greater of the mark-to-fair value of the OTC derivative contract or... with a negative mark-to-fair value, is calculated by multiplying the notional principal amount of the...

12 CFR 324.34 - OTC derivative contracts.

Code of Federal Regulations, 2014 CFR

2014-01-01

... calculating PFE. (E) The PFE of the protection provider of a credit derivative is capped at the net present... single OTC derivative contract is the greater of the mark-to-fair value of the OTC derivative contract or... with a negative mark-to-fair value, is calculated by multiplying the notional principal amount of the...

21 CFR 872.3560 - OTC denture reliner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false OTC denture reliner. 872.3560 Section 872.3560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be...

21 CFR 872.3560 - OTC denture reliner.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false OTC denture reliner. 872.3560 Section 872.3560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be...

21 CFR 872.3560 - OTC denture reliner.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false OTC denture reliner. 872.3560 Section 872.3560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be...

21 CFR 872.3560 - OTC denture reliner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false OTC denture reliner. 872.3560 Section 872.3560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be...

Rx for OTC Users: Improved Health Education.

ERIC Educational Resources Information Center

Shands, Virginia P.; And Others

A self-administered survey was given to 152 college students to test their knowledge and understanding of some basic health facts and terminology commonly found in printed materials affixed to or accompanying common over-the-counter (OTC) drug preparations. The results indicated that 96% of the sample had used OTC medications as college students.…

Consumer behavior in OTC medicines market.

PubMed

Woźniak-Holecka, Joanna; Grajek, Mateusz; Siwozad, Karolina; Mazgaj, Kamila; Czech, Elzbieta

2012-01-01

Over-the-counter (OTC) drugs are pharmaceuticals sold without a medical prescription. The goal of the paper was to evaluate the awareness in the studied group of people concerning purchasing and usage of the OTC drugs. The essence of the research was to determine whether factors as: education, income, type and place of work influence purchase and use of OTC drugs. Four equal groups (100 people each) were studied by an anonymous questionnaire. Two occupational groups: nurses and people working outside the medical sector, and also 2 student groups--from medical and non-medical schools living in Silesia. Respondents answered 47 questions. Data received from the questionnaire were statistically analyzed by means of the Chi2 test (p < 0.05). More than half of the respondents use OTC drugs. The respondents mainly buy the medicines in pharmacies. People connected with medical sector more often take pharmacists' advice and opinion than people from non-medical sector. The majority of the respondents are not familiar with chemical composition of the OTC drugs they take. Among them medical staff and medical schools students are to be found.

Oxytetracycline removal from water by novel microbial embedding gel beads

NASA Astrophysics Data System (ADS)

Wu, Nan; Pan, Peng; Zeng, Ming; Wang, Wei; Xu, Chenshan; Zhang, Zongpeng; Liu, Xinyuan; Wang, Yichao

2018-01-01

As a common antibiotic in aquatic environment, excessive oxytetracycline (OTC) is urgent to be removed due to its great biological toxicity. Compared with the traditional activated sludge, microbial embedding can enhance the treating efficiency. In this study, novel microbial embedding gel beads were produced with the additional agent of cyclodextrin (CD). Results show that CD could increase the mass transfer of OTC into gel beads, possibly because of its strong affinity for organic matters. In terms of OTC biodegradation, gel beads with CD were comparable to gel beads without CD, while the former’s sucrose removal efficiency was higher than the latter. The biodegradation of OTC only occurred in the presence of sucrose. The respiration test also confirmed these findings. Overall, the produced novel gel beads modified with CD could improve the removal performance of OTC.

Medicine reclassification processes and regulations for proper use of over-the-counter self-care medicines in Japan

PubMed Central

Nomura, Kaori; Kitagawa, Yuki; Yuda, Yasukatsu; Takano-Ohmuro, Hiromi

2016-01-01

Objectives Japan has actively reclassified substances ranging from prescription drugs to over-the-counter (OTC) drugs in recent years. The sale of most OTC drugs was deregulated several times and pharmacists’ supervision was deemed no longer mandatory. Japan established a new OTC evaluation system in 2015 to hear opinions from various stakeholders regarding medicine types to be reclassified. This study aimed to examine the new framework to identify candidate substances for reclassification. Moreover, we examined how to manage the safe, self-care use of OTC drugs in Japan. Methods The necessary regulatory information on OTC approvals as of January 2015 was collected using an Internet search and relevant databases. To highlight the characteristics of OTC drugs in Japan, the UK was selected as a comparison country because it too was actively promoting the reclassification of medicines from prescription to nonprescription status, and because of economic similarity. Results Japan and the UK have a risk-based classification for nonprescription medicines. Japan has made OTC drugs available with mandatory pharmacists’ supervision, face-to-face with pharmacists, or online instruction, which is similar to the “pharmacy medicine” practiced in the UK. Japan recently reformed the reclassification process to involve physicians and the public in the process; some interactions were back to “prescription-only medicine” in the UK. Conclusion It is expected that the opinion of marketers, medical professionals, and the public will improve the discussion that will greatly contribute to the safe use of drugs. Monitoring the new system will be noteworthy to ensure that OTC drug users are managing their self-care properly and visiting a doctor only when necessary. The supply methods are similar in Japan and the UK; however, the expected growth in the Japanese OTC market by the Cabinet and the industry is still uncertain. PMID:27555801

A case of sudden cardiac death following Domperidone self-medication.

PubMed

Fais, Paolo; Vermiglio, Elisa; Laposata, Chiara; Lockwood, Robert; Gottardo, Rossella; De Leo, Domenico

2015-09-01

The phenomenon of sudden cardiac death is usually related to the worsening of existing heart conditions leading to ventricular arrhythmia (VA). One of the well-known triggers of SCD is drug-induced prolongation of the QT interval, such as that caused by Domperidone (D). Despite its risk to prolong the QT interval and associated narrow therapeutic index, D is available as an over-the-counter (OTC) drug in many countries such as Italy, Ireland, Netherlands, China, South Africa, Mexico, New Zealand and Chile to treat gastroesophageal reflux and functional dyspepsia. The present paper reports a case of SCD that occurred some hours after D self-administration in a 47-year-old female subject with mitral valve prolapse, thus, predisposed to both VA and SCD. Despite the risks related to D administration, to the best of our knowledge, this particular issue has not been discussed in the medico-legal literature. For this reason, the forensic implications of D administration are discussed focusing on issues related to the self-administration as an OTC drug (as seen in this case), administration to incapacitated subjects, prescription to patients with contraindications and the off-label drug use of D at high and hazardous concentrations to stimulate lactation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Investigating Occipito-Temporal Contributions to Reading with TMS

ERIC Educational Resources Information Center

Duncan, Keith J.; Pattamadilok, Chotiga; Devlin, Joseph T.

2010-01-01

The debate regarding the role of ventral occipito-temporal cortex (vOTC) in visual word recognition arises, in part, from difficulty delineating the functional contributions of vOTC as separate from other areas of the reading network. Here, we investigated the feasibility of using TMS to interfere with vOTC processing in order to explore its…

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Instrumentation and Accessories § 864.3260 OTC test sample collection systems for drugs of abuse testing. (a) Identification. An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device...

21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Instrumentation and Accessories § 864.3260 OTC test sample collection systems for drugs of abuse testing. (a) Identification. An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device...

21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Instrumentation and Accessories § 864.3260 OTC test sample collection systems for drugs of abuse testing. (a) Identification. An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device...

21 CFR 864.3260 - OTC test sample collection systems for drugs of abuse testing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... abuse testing. 864.3260 Section 864.3260 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Instrumentation and Accessories § 864.3260 OTC test sample collection systems for drugs of abuse testing. (a) Identification. An over-the-counter (OTC) test sample collection system for drugs of abuse testing is a device...

17 CFR 240.36a1-2 - Exemption from SIPA for OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... derivatives dealers. 240.36a1-2 Section 240.36a1-2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE... § 240.36a1-2 Exemption from SIPA for OTC derivatives dealers. Preliminary Note: OTC derivatives dealers... derivative dealers are subject to special requirements, including limitations on the scope of their...

17 CFR 240.15c3-4 - Internal risk management control systems for OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Internal risk management...-Counter Markets § 240.15c3-4 Internal risk management control systems for OTC derivatives dealers. (a) An OTC derivatives dealer shall establish, document, and maintain a system of internal risk management...

Rapid and sensitive analytical method for monitoring of 12 organotin compounds in natural waters.

PubMed

Vahčič, Mitja; Milačič, Radmila; Sčančar, Janez

2011-03-01

A rapid analytical method for the simultaneous determination of 12 different organotin compounds (OTC): methyl-, butyl-, phenyl- and octyl-tins in natural water samples was developed. It comprises of in situ derivatisation (by using NaBEt4) of OTC in salty or fresh water sample matrix adjusted to pH 6 with Tris-citrate buffer, extraction of ethylated OTC into hexane, separation of OTC in organic phase on 15 m GC column and subsequent quantitative determination of separated OTC by ICP-MS. To optimise the pH of ethylation, phosphate, carbonate and Tris-citrate buffer were investigated alternatively to commonly applied sodium acetate - acetic acid buffer. The ethylation yields in Tris-citrate buffer were found to be better for TBT, MOcT and DOcT in comparison to commonly used acetate buffer. Iso-octane and hexane were examined as organic phase for extraction of ethylated OTC. The advantage of hexane was in its ability for quantitative determination of TMeT. GC column of 15 m in length was used for separation of studied OTC under the optimised separation conditions and its performances compared to 30 m column. The analytical method developed enables sensitive simultaneous determination of 12 different OTC and appreciably shortened analysis time in larger series of water samples. LOD's obtained for the newly developed method ranged from 0.05-0.06 ng Sn L-1 for methyl-, 0.11-0.45 ng Sn L-1 for butyl-, 0.11-0.16 ng Sn L-1 for phenyl-, and 0.07-0.10 ng Sn L-1 for octyl-tins. By applying the developed analytical method, marine water samples from the Northern Adriatic Sea containing mainly butyl- and methyl-tin species were analysed to confirm the proposed method's applicability.

Usage patterns of 'over-the-counter' vs. prescription-strength nonsteroidal anti-inflammatory drugs in France.

PubMed

Duong, Mai; Salvo, Francesco; Pariente, Antoine; Abouelfath, Abdelilah; Lassalle, Regis; Droz, Cecile; Blin, Patrick; Moore, Nicholas

2014-05-01

Most risks of nonsteroidal anti-inflammatory drugs (NSAIDs) are pharmacological, dose and duration dependent. Usage patterns of prescription-only (POM) or 'over-the-counter (OTC)' NSAIDs may influence risks, but are not commonly described. The Echantillon Généraliste de Bénéficiaires database, the permanent 1/97 representative sample from the French national healthcare insurance systems, was queried over 2009-2010 to identify usage patterns, concomitant chronic diseases and cardiovascular medication in OTC and POM NSAID users. Over 2 years, 229 477 of 526 108 patients had at least one NSAID dispensation; 44 484 patients (19%) were dispensed only OTC NSAIDs (93% ibuprofen) and 121 208 (53%) only POM NSAIDs. The OTC users were younger (39.9 vs. 47.4 years old) and more often female (57 vs. 53%); 69% of OTC users and 49% of POM users had only one dispensation. A mean of 14.6 defined daily doses (DDD) were dispensed over 2 years for OTC vs. 53 for POM; 93% OTC vs. 60% POM patients bought ≤ 30 DDD over 2 years, and 1.5 vs. 12% bought ≥ 90 DDD. Chronic comorbidities were found in 19% of OTC users vs. 28% of POM users; 24 vs. 37% had at least one dispensation of a cardiovascular drug over the 2 years. Most of the use of NSAIDs appears to be short term, especially for OTC-type NSAIDs, such as ibuprofen. The validity of risk estimates for NSAIDs extrapolated from clinical trials or from observational studies not including OTC-type usage may need to be revised. © 2013 The British Pharmacological Society.

Association of over-the-counter pharmaceutical sales with influenza-like-illnesses to patient volume in an urgent care setting.

PubMed

Liu, Timothy Y; Sanders, Jason L; Tsui, Fu-Chiang; Espino, Jeremy U; Dato, Virginia M; Suyama, Joe

2013-01-01

We studied the association between OTC pharmaceutical sales and volume of patients with influenza-like-illnesses (ILI) at an urgent care center over one year. OTC pharmaceutical sales explain 36% of the variance in the patient volume, and each standard deviation increase is associated with 4.7 more patient visits to the urgent care center (p<0.0001). Cross-correlation function analysis demonstrated that OTC pharmaceutical sales are significantly associated with patient volume during non-flu season (p<0.0001), but only the sales of cough and cold (p<0.0001) and thermometer (p<0.0001) categories were significant during flu season with a lag of two and one days, respectively. Our study is the first study to demonstrate and measure the relationship between OTC pharmaceutical sales and urgent care center patient volume, and presents strong evidence that OTC sales predict urgent care center patient volume year round.

Adsorption and desorption of oxytetracycline and carbamazepine by multiwalled carbon nanotubes.

PubMed

Oleszczuk, Patryk; Pan, Bo; Xing, Baoshan

2009-12-15

We investigated the adsorption-desorption by multiwalled carbon nanotubes (MWCNTs) of two pharmaceuticals, oxytetracycline (OTC) and carbamazepine (CBZ). The pharmaceuticals demonstrated relatively fast sorption kinetics on MWCNTs. All adsorption isotherms were nonlinear and fit the Polanyi-Manes model (PMM). The single point adsorption coefficient (K) values for OTC were more than 1 order of magnitude higher than those for CBZ on corresponding MWCNTs. The adsorbed volume capacity (Q(0)) and K values of PMM showed a significant relationship with surface areas and the meso- and micropore volume of MWCNTs for both chemicals. Depending on the MWCNT outer diameter, 13.8-25.2% and 62.7-90.6% of initially adsorbed OTC and CBZ, respectively, were desorbed after 200 h. The rate of desorption of both OTC and CBZ depended upon pH and the quantity of initially adsorbed pharmaceuticals, as well as aggregation in the case of OTC.

Laws prohibiting over-the-counter syringe sales to injection drug users: relations to population density, HIV prevalence, and HIV incidence.

PubMed

Friedman, S R; Perlis, T; Des Jarlais, D C

2001-05-01

This study sought to assess relations of laws prohibiting over-the-counter syringe sales (anti-OTC laws) to population prevalence of injection drug users and HIV prevalence or incidence among 96 US metropolitan areas. A cross-sectional analysis was used. Metropolitan areas with anti-OTC laws had a higher mean HIV prevalence (13.8% vs 6.7%) than other metropolitan areas (pseudo-P < .001). In 83 metropolitan areas with HIV prevalence of less than 20%, anti-OTC laws were associated with HIV incidence rates of 1% or greater (pseudo-P < .001). Population proportions of injection drug users did not vary by presence of anti-OTC laws. Anti-OTC laws are not associated with lower population proportions of injection drug users. Laws restricting syringe access are associated with HIV transmission and should be repealed.

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2011 CFR

2011-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2013 CFR

2013-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2010 CFR

2010-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2012 CFR

2012-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2014 CFR

2014-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 520.1660d - Oxytetracycline powder.

Code of Federal Regulations, 2011 CFR

2011-04-01

....14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs...

21 CFR 520.1660d - Oxytetracycline powder.

Code of Federal Regulations, 2013 CFR

2013-04-01

....14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs...

21 CFR 520.1660d - Oxytetracycline powder.

Code of Federal Regulations, 2014 CFR

2014-04-01

....14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs...

21 CFR 520.1660d - Oxytetracycline powder.

Code of Federal Regulations, 2010 CFR

2010-04-01

....14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs...

21 CFR 520.1660d - Oxytetracycline powder.

Code of Federal Regulations, 2012 CFR

2012-04-01

....14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs...

75 FR 7606 - Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the... effectiveness of 13 active ingredients found eligible for possible addition to an OTC drug monograph via the TEA... ingredients found eligible for inclusion in an OTC drug monograph under the TEA process on the basis of...

17 CFR 240.15c3-1f - Optional market and credit risk requirements for OTC derivatives dealers (Appendix F to 17 CFR...

Code of Federal Regulations, 2010 CFR

2010-04-01

... charges. An OTC derivatives dealer shall provide a description of all statistical models used for pricing... controls over those models, and a statement regarding whether the firm has developed its own internal VAR models. If the OTC derivatives dealer's VAR model incorporates empirical correlations across risk...

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and... in OTC drug products for external use as hair growers or for hair loss prevention. There is a lack of...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

17 CFR 240.11a1-6 - Transactions for certain accounts of OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Transactions for certain accounts of OTC derivatives dealers. 240.11a1-6 Section 240.11a1-6 Commodity and Securities Exchanges... effected by a member of a national securities exchange for the account of an OTC derivatives dealer that is...

76 FR 41551 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... an index-based or derivative security (e.g., a right or warrant) that is quoted on the OTCBB or OTC... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64843; File No. SR-NYSE-2011-22] Self... Premises in Certain OTC Bulletin Board and OTC Markets Securities July 8, 2011. I. Introduction On May 11...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2010 CFR

2010-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

The efficacy of mass-marking channel catfish fingerlings by immersion in oxytetracycline

USGS Publications Warehouse

Stewart, David R.

2011-01-01

Oxytetracycline (OTC) has been extensively used for marking a variety of fish species, but has never been successfully used to mark channel catfish Ictalurus punctatus. Channel catfish fingerlings (~ 25 mm TL) obtained from the Oklahoma Department of Wildlife Conservation at Byron Fish Hatchery were kept in Living Streams (791 to 1,018 L) equipped with recirculation units. Marking trials consisted of immersing channel catfish in one of three concentrations (250, 450, and 700 mg/L) OTC hydrochloride [HCl] for 6 hours. Samples of channel catfish were obtained from each group at 1-week and 4-week postimmersion. Lapilli otoliths and pectoral spines were removed to assess mark presence with an epi-fluorescent compound microscope. After one week, no marks were detected on pectoral spines for all treatments, mark detection on otoliths depended on concentration, but never exceeded 43% (700 mg/L). After four weeks, all otoliths and pectoral spines were determined marked for 700 mg/L OTC, 20% for fish immersed in 450 mg/L OTC, and 0% were marked after four weeks at the 250 mg/L OTC. Results show, channel catfish fingerlings can be successfully marked with immersion in OTC at 700 mg/L for at least 6 hours.

Development of a quantum dot-based immunochromatography test strip for rapid screening of oxytetracycline and 4-epi-oxytetracycline in edible animal tissues.

PubMed

Xie, Yong; Zhang, Lei; Yang, Xian; Le, Tao

2017-03-01

A rapid and sensitive immunochromatographic test strip (ICTS) was developed in a competitive format with the quantum dot-conjugated monoclonal antibody specifically to determine the residues of oxytetracycline (OTC) and its metabolite 4-epi-oxytetracycline (4-epi-OTC). Using an ICTS reader, the 50% inhibition concentration (IC 50 ) was found to be 3.41 ± 0.29 ng ml - 1 of OTC in phosphate-buffered saline samples and the detection limit was 0.44 ± 0.05 ng ml - 1 . The visual cut-off level of the ICTS is 25 ng ml - 1 . The recoveries from tissue samples spiked with OTC of 50-600 μg kg - 1 were 74.2-107.2%, with coefficients of variation below 15%. The method was used to analyse incurred tissue samples, and there was good correlation (R 2  = 0.999) between the ICTS and high-performance liquid chromatography. These results indicate that ICTS is suitable for the rapid and quantitative detection of OTC and 4-epi-OTC residues in edible animal tissues.

The effect on social welfare of a switch of second-generation antihistamines from prescription to over-the-counter status: a microeconomic analysis.

PubMed

Shih, Ya-Chen Tina; Prasad, Manishi; Luce, Bryan R

2002-04-01

The US Food and Drug Administration (FDA) recently held a meeting to determine whether the status of second-generation antihistamines (SGAs) should be switched from prescription (Rx) to over-the-counter (OTC) status. This article provides a conceptual microeconomic framework for addressing issues regarding the impact of such a switch on social welfare. A review of the economic literature on Rx-to-OTC switches was conducted. Relevant articles published in English between 1990 and 2001 were identified through searches of ABI Info, EconLit, PsychInfo, MEDLINE, CANCERLIT, AIDSLINE, and HealthStar, as well as a general Internet search for statements in the press or on the FDA Web site. The search terms used were Rx, prescription, OTC, over-the-counter, second-generation antihistamines, nonsedating antihistamines, first-generation antihistamines, and sedating antihistamines. Microeconomic models focusing on consumer surplus were employed to determine the potential price response and social-welfare implications of a switch of SGAs to OTC status. Unlike the agents involved in previous Rx-to-OTC switches, SGAs are still under patent protection. Economic theory suggests that a firm that is protected by a patent will price aggressively. The market for OTC SGAs is likely to be more elastic due to a lack of insurance coverage for OTC products; hence, drug manufacturers would be likely to charge a lower price if SGAs were sold OTC. However, a lower price does not necessarily guarantee an improvement in social welfare; the net impact is determined by whether the increase in consumer surplus outweighs the deadweight loss (losses of consumer and producer surplus not transferred to other parties). Additionally, the assumption of a price reduction would be called into question if there were inequalities in marginal costs between the Rx and OTC markets. In this situation, the postswitch price might increase or not be reduced significantly. It is uncertain whether granting OTC status to SGAs would be cost saving to society, particularly as these drugs are patent protected. The social-welfare implications of such a switch would depend heavily on pricing strategies and consumer behavior. Further analyses are needed to determine how both factors influence social welfare; only then can the costs and benefits of a switch be understood completely.

Advertising of OTC products in a Nigerian urban setting: content analysis for indications, targets, and advertising appeal.

PubMed

Yusuff, Kazeem B; Yusuf, Akeem

2009-01-01

To identify the indications for which treatments were promoted, the segments of population targeted, and the type and extent of advertising appeal used for over-the-counter (OTC) products in a Nigerian urban setting. Using a cross-sectional design, the content of advertisements for OTC products on radio, television, and billboards in a city in southwestern Nigeria were assessed during a 3-month period. Two coders independently assessed 1,492 advertisements for 49 brands of OTC products (interrater reliability [Cohen's kappa] = 0.83 [95% CI 0.80-0.90]). The most frequent indications for OTC products were aches and pain (42.9%), anemia/malnutrition (34.8%), and malaria (22.2%). Of advertisements, 92% were targeted at the primary end user. Use of appeal related to efficacy (100%), psychosocial enhancement (80%), and ease of use (40%) in visual, written, and audio messages was highest in ads on billboards. Efficacy appeal had the highest frequency across the three advertising media (100%); ease-of-use and safety appeal had the lowest frequency (40% and 7.4%, respectively). Nigerian movie stars were used as brand icons in advertisements of OTC products on radio (59.5%), television (52.9%), and billboards (49.6%). The majority of advertisements for OTC products in a Nigerian urban setting used advertising appeal related to efficacy and psychosocial enhancement. Promotional efforts by pharmaceutical manufacturers appear to focus on positive emotional appeal to influence drug purchase and use decisions.

Australian pharmacies prevent potential adverse reactions in patients taking warfarin requesting over-the-counter analgesia.

PubMed

MacFarlane, Brett V; Bergin, Jenny K; Reeves, Peter; Matthews, Andrew

2015-06-01

The objective of this article was to assess if Australian pharmacy staff prevent potential adverse reactions in warfarin patients requesting over-the-counter (OTC) analgesia. Mystery shoppers entered 170 pharmacies across Australia to request OTC analgesia for a hypothetical patient with a wrist injury who currently takes warfarin following a heart valve replacement. The request was made to the first pharmacist or non-pharmacist staff member to approach the mystery shopper. The interaction was audio-taped and assessed by a pharmacist. The OTC analgesic recommended was assessed for the potential to cause an adverse bleeding event. The quality of advice given with the OTC analgesic was assessed against determined criteria. Results were compared with scenarios of similar request type where the hypothetical patient was not taking warfarin. Mystery shoppers enquiring about taking OTC analgesics concomitantly with warfarin had access to the pharmacist in 97.0% of cases. All 170 pharmacies recommended OTC analgesics that were less likely to cause adverse events when taken with warfarin. The advice given and the communication between pharmacy staff and mystery shoppers were of high quality. Australian pharmacies support the quality use of medicines by patients taking warfarin by providing expeditious access to the pharmacist, appropriate recommendations of OTC analgesics, high standards of quality of advice and they communicate in a way to ensure ease of understanding by the consumer. The protocols used by pharmacy staff help prevent potentially serious adverse drug events. © 2014 Royal Pharmaceutical Society.

17 CFR 240.15c3-4 - Internal risk management control systems for OTC derivatives dealers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... unenforceable; (6) Procedures are in place to identify and address any deficiencies in the operating systems and... control systems for OTC derivatives dealers. 240.15c3-4 Section 240.15c3-4 Commodity and Securities...-Counter Markets § 240.15c3-4 Internal risk management control systems for OTC derivatives dealers. (a) An...

17 CFR 240.15c3-4 - Internal risk management control systems for OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... unenforceable; (6) Procedures are in place to identify and address any deficiencies in the operating systems and... control systems for OTC derivatives dealers. 240.15c3-4 Section 240.15c3-4 Commodity and Securities...-Counter Markets § 240.15c3-4 Internal risk management control systems for OTC derivatives dealers. (a) An...

17 CFR 240.15c3-4 - Internal risk management control systems for OTC derivatives dealers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... unenforceable; (6) Procedures are in place to identify and address any deficiencies in the operating systems and... control systems for OTC derivatives dealers. 240.15c3-4 Section 240.15c3-4 Commodity and Securities...-Counter Markets § 240.15c3-4 Internal risk management control systems for OTC derivatives dealers. (a) An...

10 CFR 61.57 - Labeling.

Code of Federal Regulations, 2012 CFR

2012-01-01

... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

10 CFR 61.57 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-01-01

... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

10 CFR 61.57 - Labeling.

Code of Federal Regulations, 2011 CFR

2011-01-01

... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

10 CFR 61.57 - Labeling.

Code of Federal Regulations, 2014 CFR

2014-01-01

... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

10 CFR 61.57 - Labeling.

Code of Federal Regulations, 2013 CFR

2013-01-01

... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

L-2-oxothiazolidine-4-carboxylic acid attenuates oxidative stress and inflammation in retinal pigment epithelium

PubMed Central

Promsote, Wanwisa; Veeranan-Karmegam, Rajalakshmi; Ananth, Sudha; Shen, Defen; Chan, Chi-Chao; Lambert, Nevin A.; Ganapathy, Vadivel

2014-01-01

Purpose Oxidant- and inflammation-induced damage to retinal pigment epithelial (RPE) cells is central to the pathogenesis of age-related macular degeneration (AMD). Thus, developing novel strategies to protect these cells is important. We reported previously on the robust antioxidant and therefore cell-protective effects of the cysteine pro-drug L-2-oxothiazolidine-4-carboxylic acid (OTC) in cultured human RPE cells. New reports citing a novel anti-inflammatory role for OTC in addition to the known glutathione-stimulating and antioxidant properties emerged recently; however, this role has not been evaluated in RPE cells or in intact retina. Given the crucial causative roles of oxidative stress and inflammation in AMD pathogenesis, knowing whether OTC might exhibit a similar benefit in this cell and tissue type has high clinical relevance; thus, we evaluated OTC in the present study. Methods ARPE-19 and primary RPE cells isolated from wild-type, Gpr109a−/−, or Slc5a8−/− mouse eyes were exposed to TNF-α in the presence or absence of OTC, followed by analysis of IL-6 and Ccl2 expression with real-time quantitative polymerase chain reaction or enzyme-linked immunosorbent assay. Cellular and molecular markers of inflammation and oxidative stress (i.e., IL-1β, TGF-β, ABCG1, ABCA1, reduced glutathione, and dihydroethidium) were evaluated in Ccl2−/−/Cx3cr1−/− double knockout mice on rd8 background (DKO rd8) treated with OTC (10 mg/ml) in drinking water for a period of 5 months. Results OTC treatment significantly inhibited the expression and secretion of IL-6 and Ccl2 in TNF-α-stimulated ARPE-19 cells. Studies conducted using DKO rd8 animals treated with OTC in drinking water confirmed these findings. Cellular and molecular markers of inflammation were significantly suppressed in the retinas of the OTC-treated DKO rd8 animals. Subsequent in vitro and in vivo studies of the possible mechanism(s) to explain these actions revealed that although OTC is an agonist of the anti-inflammatory G-protein coupled receptor GPR109A and a transportable substrate of the sodium-coupled monocarboxylate transporter SMCT1 (SLC5A8), these properties may play a role but do not explain entirely the anti-inflammatory effects this compound elicits in cultured RPE cells and the intact mouse retina. Conclusions This study represents, to our knowledge, the first report of the suppressive effects of OTC on inflammation in cultured RPE cells and on inflammation and oxidative stress in the retina in vivo. PMID:24426777

Rejection of Tetracycline and Oxytetracycline in Water by a Nanofiltration Membrane

NASA Astrophysics Data System (ADS)

Li, Weiying; Sun, Xiuli; Wang, Qing; Xu, Jingjing; Lu, Junyu

2010-11-01

The removal of tetracycline (TC) and oxytetracycline (OTC) by a nanofiltration (NF) membrane was studied using synthetic solutions. The effects of operation parameters (recovery and flux), feed concentration and salinity on the rejection of tetracyclines and their adsorption on membranes were investigated. TC was observed to show a high adsorptive affinity for the membrane. Almost 80% of TC and 70% of OTC were adsorbed on the membrane surface after stirring for 2000 min and over 50% of them had been adsorbed just 120 min after stir. High removal efficiencies (>90%) were observed for TC and OTC with NF membrane. Rejection ratio of OTC by NF was slightly higher than that of TC.

Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss.

PubMed

Sacco, Guillaume; Gonfrier, Sébastien; Teboul, Bernard; Gahide, Ivan; Prate, Fredéric; Demory-Zory, Mathilde; Turpin, Jean-Michel; Vuagnoux, Claire; Genovese, Philippe; Schneider, Stéphane; Guérin, Olivier; Guevara, Nicolas

2016-07-09

Presbycusis has a direct influence on autonomy of the elderly but hearing aids lack of affordability. Moreover a recent review demonstrate that electroacoustic characteristics of OTC hearing aids were generally not suitable for the elderly people. In our study, we assessed the clinical value of a new over-the-counter (OTC) hearing aid device (TEO First®) in the elderly. This prospective monocentric open label study included patients over 60 years of age with a mild to moderate presbycusis. Patients were assessed with acceptable noise level test (ANL), pure tone (PTA) and speech (SA) audiometry in silent and noisy environment, with and without TEO First®. A Glasgow Hearing Aid Benefit Profile, acceptability and satisfaction surveys were completed after one month of using the device. Thirty one patients were included. There was an improvement of hearing with TEO First® in silence (SA: +39.2 %, p < 0.01; PTA: -9.04 dB, p < 0.01) or in noise (SA +47.7 %, p < 0.01; PTA: -5.23 dB, p < 0.05). After one month of use of the device, quality of life has improved with regards to the following parameters: decrease of perceived hearing difficulties during conversation without background noise (-9.6 % p = 0.018), in conversation with several people (-16.2 % p = 0.0076), decrease of negative emotions while watching TV (-18.5 % p = 0.011), during conversation without background noise (-16.5 % p = 0.0024), during conversation in noisy background (-17.1 % p = 0.027) and during conversation with several people (-20 % p = 0.014). The acceptability of the device was low to moderate. TEO First® is an effective OTC hearing aid that improves the patient's quality of life. Current Controlled Trials NCT01815788.

A fluorescent aptasensor for sensitive analysis oxytetracycline based on silver nanoclusters.

PubMed

Hosseini, Morteza; Mehrabi, Fatemeh; Ganjali, Mohammad Reza; Norouzi, Parviz

2016-11-01

A fluorescent aptasensor for detection of oxytetracycline (OTC) was presented based on fluorescence quenching of DNA aptamer-templated silver nanoclusters (AgNCs). The specific DNA scaffolds with two different nucleotides fragments were used: one was enriched with a cytosine sequence fragment (C12) that could produce DNA-AgNCs via a chemical reduction method, and another was the OTC aptamer fragment that could selectively bind to the OTC antibiotic. Thus, the as-prepared AgNCs could exhibit quenched fluorescence after binding to the target OTC. The fluorescence ratio of the DNA-AgNCs was quenched in a linearly proportional manner to the concentration of the target in the range of 0.5 nM to 100 nM with a detection limit of 0.1 nM. This proposed nanobiosensor was demonstrated to be sensitive, selective, and simple, introducing a viable alternative for rapid determination of toxin OTC in honey and water samples. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Association of Over-The-Counter Pharmaceutical Sales with Influenza-Like-Illnesses to Patient Volume in an Urgent Care Setting

PubMed Central

Liu, Timothy Y.; Sanders, Jason L.; Tsui, Fu-Chiang; Espino, Jeremy U.; Dato, Virginia M.; Suyama, Joe

2013-01-01

We studied the association between OTC pharmaceutical sales and volume of patients with influenza-like-illnesses (ILI) at an urgent care center over one year. OTC pharmaceutical sales explain 36% of the variance in the patient volume, and each standard deviation increase is associated with 4.7 more patient visits to the urgent care center (p<0.0001). Cross-correlation function analysis demonstrated that OTC pharmaceutical sales are significantly associated with patient volume during non-flu season (p<0.0001), but only the sales of cough and cold (p<0.0001) and thermometer (p<0.0001) categories were significant during flu season with a lag of two and one days, respectively. Our study is the first study to demonstrate and measure the relationship between OTC pharmaceutical sales and urgent care center patient volume, and presents strong evidence that OTC sales predict urgent care center patient volume year round. PMID:23555647

7 CFR 201.74 - Labeling of all classes of certified seed.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Labeling of all classes of certified seed. 201.74... SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Certified Seed § 201.74 Labeling of all classes of certified seed. (a...

7 CFR 201.74 - Labeling of all classes of certified seed.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Labeling of all classes of certified seed. 201.74... SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) FEDERAL SEED ACT FEDERAL SEED ACT REGULATIONS Certified Seed § 201.74 Labeling of all classes of certified seed. (a...

Ozonation performance of WWTP secondary effluent of antibiotic manufacturing wastewater.

PubMed

Zheng, Shaokui; Cui, Cancan; Liang, Qianjin; Xia, Xinghui; Yang, Fan

2010-11-01

The ozonation performance of wastewater treatment plant secondary effluent of oxytetracycline (OTC) manufacturing wastewater was investigated in terms of ozone dosage and initial pH levels when OTC contributed to a negligible fraction in the chemical oxygen demand (COD) ingredients of the medium-organic-strength wastewater with low biodegradability. A particular emphasis was placed on ammonia, OTC, and residual antibacterial activity (RAA) (evaluated using the objective pathogenic bacterium Staphylococcus aureus). It appears that an ozone dosage of 657 mg L⁻¹ (120 min of reaction) was enough to achieve an OTC abatement of 96%, and COD and biochemical oxygen demand removals of 29% and 33%, respectively, at initial levels of 10.4, 1360, and 300 mg L⁻¹ , respectively. There is a clear correlation between complete OTC depletion and complete RAA disappearance with an increase of ozone dosage. The presence of plentiful non-antibiotic refractory substances influenced the determination of the optimum ozone dosage for biodegradability enhancement and OTC/RAA reduction as well as the ozonation transformation of NH(3). The initial pH adjustment from the original level (pH 9) to pH 11 significantly reduced COD removal while RAA and NH(3) levels were not significantly influenced. Copyright © 2010 Elsevier Ltd. All rights reserved.

The power of the patient question: A secret shopper study.

PubMed

Peters, Joanne; Desai, Karishma; Ricci, Daniel; Chen, Dan; Singh, Monny; Chewning, Betty

2016-09-01

To examine the effect of one standardized patient question on the length, number and type of new topics pharmacists addressed. To explore how community pharmacists counsel secret shoppers on two types of over-the-counter (OTC) medications-ibuprofen (IB) and emergency contraceptives (EC). 25 pharmacists from 7 independent, midwestern community pharmacies consented to have secret shoppers purchase an OTC medication and to have their consultations audio-recorded. Following standardized scenarios, 5 secret shoppers audio-recorded 73 encounters. At the end of 36 encounters secret shoppers asked one standard question, "What else should I know before taking this product?" Role Theory informed the study design with apriori hypotheses that topics assessed, topics discussed, and consultation length would vary by the OTC medication (IB or EC) and whether secret shoppers asked a question. Audio-recording coding had high inter-rater reliability (kappa=0.94). Length of encounter was significantly associated with patients asking the question (p<0.05), but not type of OTC medication. On average 1.22 new topics were discussed with a patient question. New topics included information about safe and efficacious use of the OTC's. Results highlight the importance of encouraging patients to ask pharmacists their questions about OTC products for safe use and thorough consultations. Copyright © 2016. Published by Elsevier Ireland Ltd.

A preliminary examination of over-the-counter medication misuse rates in older adults.

PubMed

Stone, Jamie A; Lester, Corey A; Aboneh, Ephrem A; Phelan, Cynthia H; Welch, Lauren L; Chui, Michelle A

Older adults are the largest consumers of over the counter (OTC) medications. Of the older adults who are at risk of a major adverse drug event, more than 50% of these events involve an OTC medication. To explore how older adults select and hypothetically use OTC medications and if the selected medications would be considered safe for use. Walking interviews were conducted with 20 community-dwelling older adults in a community pharmacy. Each participant selected an OTC medication for a hypothetical pain and sleep scenario. Data were analyzed for four types of misuse: drug-drug interaction, drug-disease interaction, drug-age interaction, and excess usage. At least one instance of potential misuse was found in 95% of participants. For sleep medications, drug-drug interactions and drug-age interactions were more common, affecting 50% and 65% of participants respectively. The most common type of misuse noted in the pain products selected was that of drug-drug interaction, with a total of 39 occurrences, affecting 60% of the participants. OTC misuse is common among older adults, and it is important for older adults to seek out resources, such as a pharmacist, to help them make safe OTC decisions. Copyright © 2016 Elsevier Inc. All rights reserved.

Interactions of oxytetracycline with a smectite clay: a spectroscopic study with molecular simulations.

PubMed

Aristilde, Ludmilla; Marichal, Claire; Miéhé-Brendlé, Jocelyne; Lanson, Bruno; Charlet, Laurent

2010-10-15

Binding of antibiotics to clay minerals can decrease both their physical and biological availability in soils. To elucidate the binding mechanisms of tetracycline antibiotics on smectite clays as a function of pH, we probed the interactions of oxytetracycline (OTC) with Na-montmorillonite (MONT) using X-ray diffraction (XRD), infrared (IR), and solid-state nuclear magnetic resonance (NMR) spectroscopies, and Monte Carlo molecular simulations. The XRD patterns demonstrate the presence of OTC in the MONT interlayer space at acidic pH whereas complexation of OTC by external basal and edge sites seems to prevail at pH 8. At both pH, the (1)H-(13)C NMR profile indicates restricted mobility of the adsorbed OTC species; and, -CH(3) deformation and C-N stretching IR vibration bands confirm a binding mechanism involving the protonated dimethylamino group of OTC. Changes in the (23)Na NMR environments are consistent with cation-exchange and cation complexation reactions at the different sites of adsorption. Molecular simulations indicate that MONT interlayer spacing and structural charge localization dictate favorable binding conformations of the intercalated OTC, facilitating multiple interactions in agreement with the spectroscopic data. Our results present complementary insights into the mechanisms of adsorption of TETs on smectites important for their retention in natural and engineered soil environments.

Electrode Modification and Optimization in Air-Cathode Single-Chamber Microbial Fuel Cells.

PubMed

Wang, Yanhua; Wu, Jiayan; Yang, Shengke; Li, Huihui; Li, Xiaoping

2018-06-27

Due to the known problems of microbial fuel cells (MFCs), such as low electricity generation performance and high cost of operation, we modified the electrode with graphene and polyaniline (PANI) is a single-chamber air-cathode MFC and then evaluated the effects of electrode modification on MFC electricity generation performance. Carbon cloth electrodes (unmodified, CC; graphene-modified, G/CC; and polyaniline-graphene-modified, PANI-G/CC) were prepared using the impregnation method. Sulfonated cobalt phthalocyanine (CoPcS) was then introduced as a cathode catalyst. The Co-PANI-G/CC cathode showed higher catalytic activity toward oxygen reduction compared with other electrodes. The maximum power density of the MFC with Co-PANI-G/CC cathode was 32.2 mW/m², which was 1.8 and 6.1 times higher than the value obtained with Co-G/CC and Co/CC cathodes, respectively. This indicates a significant improvement in the electricity generation of single-chamber MFCs and provides a simple, effective cathode modification method. Furthermore, we constructed single-chamber MFCs using the modified anode and cathode and analyzed electricity generation and oxytetracycline (OTC) degradation with different concentrations of OTC as the fuel. With increasing added OTC concentration, the MFC performance in both electricity generation and OTC degradation gradually decreased. However, when less than 50 mg/L OTC was added, the 5-day degradation rate of OTC reached more than 90%. It is thus feasible to process OTC-containing wastewater and produce electricity using single-chamber MFCs, which provides a new concept for wastewater treatment.

Prices of over-the-counter drugs used by 15-year-old adolescents in Germany and their association with socioeconomic background.

PubMed

Italia, Salvatore; Wolfenstetter, Silke B; Brüske, Irene; Heinrich, Joachim; Berdel, Dietrich; von Berg, Andrea; Lehmann, Irina; Standl, Marie; Teuner, Christina M

2017-11-25

In Germany, over-the-counter (OTC) drugs are normally reimbursed up to the age of 12 years only. The aim of this study was to analyse prices of over-the-counter drugs used by adolescents in Germany and their association with socioeconomic factors. Based on the German GINIplus and LISAplus birth cohorts, data on drug utilization among 15-year-old adolescents (n = 4677) were collected using a self-administered questionnaire. The reported drugs were subdivided into prescription drugs and OTC drugs. The drugs' prices were tracked by the pharmaceutical identification numbers. Overall, 1499 OTC drugs with clearly identifiable prices were eligible for analysis. Their mean price was €9.75 (95% confidence interval: €9.27-10.22). About 75% of the OTC drugs cost less than €10. Higher mean prices were associated with residing in Munich (€10.74; 95% confidence interval: €9.97-11.52) and with higher paternal education (e.g. highest education level: €10.17; 95% confidence interval: €9.47-10.86). Adolescents residing in Munich (in comparison with the less wealthy region of Wesel) and adolescents with higher educated fathers were also significantly more likely to use OTC drugs costing ≥ €10 or ≥ €25, respectively. The price of €10 for non-reimbursable OTC drugs may represent a (psychological) threshold. Higher prices could discourage especially adolescents from a lower socioeconomic background from taking medically advisable but non-reimbursable OTC drugs.

Potential public sector cost-savings from over-the-counter access to oral contraceptives.

PubMed

Foster, Diana G; Biggs, M Antonia; Phillips, Kathryn A; Grindlay, Kate; Grossman, Daniel

2015-05-01

This study estimates how making oral contraceptive pills (OCPs) available without a prescription may affect contraceptive use, unintended pregnancies and associated contraceptive and pregnancy costs among low-income women. Based on published figures, we estimate two scenarios [low over-the-counter (OTC) use and high OTC use] of the proportion of low-income women likely to switch to an OTC pill and predict adoption of OCPs according to the out-of-pocket costs per pill pack. We then estimate cost-savings of each scenario by comparing the total public sector cost of providing OCPs OTC and medical care for unintended pregnancy. Twenty-one percent of low-income women at risk for unintended pregnancy are very likely to use OCPs if they were available without a prescription. Women's use of OTC OCPs varies widely by the out-of-pocket pill pack cost. In a scenario assuming no out-of-pocket costs for the over-the counter pill, an additional 11-21% of low-income women will use the pill, resulting in a 20-36% decrease in the number of women using no method or a method less effective than the pill, and a 7-25% decrease in the number of unintended pregnancies, depending on the level of use and any effect on contraceptive failure rates. If out-of-pocket costs for such pills are low, OTC access could have a significant effect on use of effective contraceptives and unintended pregnancy. Public health plans may reduce expenditures on pregnancy and contraceptive healthcare services by covering oral contraceptives as an OTC product. Interest in OTC access to oral contraceptives is high. Removing the prescription barrier, particularly if pill packs are available at low or zero out-of-pocket cost, could increase the use of effective methods of contraception and reduce unintended pregnancy and healthcare costs for contraceptive and pregnancy care. Copyright © 2015 Elsevier Inc. All rights reserved.

"Just Advil": Harm reduction and identity construction in the consumption of over-the-counter medication for chronic pain.

PubMed

Eaves, Emery R

2015-12-01

Direct-to-consumer marketing has sparked ongoing debate concerning whether ads empower consumers to be agents of their own care or shift greater control to the pharmaceutical industry. Ads for over-the-counter (OTC) medications in particular portend to offer simple, harmless solutions for meeting the demands of social life. Rather than join the longstanding debate between consumer agency and social control in pharmaceutical advertising, I approach self-medication with over-the-counter (OTC) analgesics using Harm Reduction as a framework. From this perspective, consumption of OTC analgesics by chronic pain sufferers is a means of seeking some level of relief while also avoiding the stigma associated with prescription pain medication. Qualitative methods are used to analyze data from two sources: (1) semi-structured qualitative interviews with 95 participants in a trial examining the effectiveness of Traditional Chinese Medicine for Temporomandibular Disorders (TMD) from 2006 to 2011 in Tucson, AZ and Portland, OR; and (2) print, online, and television advertisements for three major brands of OTC pain medication. Participants described their use of OTC medications as minimal, responsible, and justified by the severity of their pain. OTC medication advertising, while ostensibly ambiguous and targeting all forms of pain, effectively lends support to the consumption of these medications as part of the self-projects of chronic pain sufferers, allowing them to reconcile conflicting demands for pain relief while being stoic and maintaining a positive moral identity. Describing OTC medication as "just over-the-counter" or "not real pain medication," sufferers engage in ideological harm reduction, distinguishing themselves from "those people who like taking pain medication" while still seeking relief. Justifying one's use of OTC medication as minimal and "normal," regardless of intake, avoids association with the addictive potential of prescription pain medications and aligns the identity of the chronic pain sufferer with a culturally sanctioned identity as stoic bearer of pain. Copyright © 2015 Elsevier Ltd. All rights reserved.

“Just Advil”: Harm reduction and identity construction in the consumption of Over-The-Counter medication for chronic pain Social Science & Medicine

PubMed Central

2015-01-01

Direct-to-consumer marketing has sparked ongoing debate concerning whether ads empower consumers to be agents of their own care or shift greater control to the pharmaceutical industry. Ads for over-the-counter (OTC) medications in particular portend to offer simple, harmless solutions for meeting the demands of social life. Rather than join the longstanding debate between consumer agency and social control in pharmaceutical advertising, I approach self-medication with over-the-counter (OTC) analgesics using Harm Reduction as a framework. From this perspective, consumption of OTC analgesics by chronic pain sufferers is a means of seeking some level of relief while also avoiding the stigma associated with prescription pain medication. Qualitative methods are used to analyze data from two sources: (1) semi-structured qualitative interviews with 95 participants in a trial examining the effectiveness of Traditional Chinese Medicine for Temporomandibular Disorders (TMD) from 2006 to 2011 in Tucson, AZ and Portland, OR; and (2) print, online, and television advertisements for three major brands of OTC pain medication. Participants described their use of OTC medications as minimal, responsible, and justified by the severity of their pain. OTC medication advertising, while ostensibly ambiguous and targeting all forms of pain, effectively lends support to the consumption of these medication as part of the self-projects of chronic pain sufferers, allowing them to reconcile conflicting demands for pain relief while being stoic and maintaining a positive moral identity. Describing OTC medication as “just over-the-counter” or “not real pain medication,” sufferers engage in ideological harm reduction, distinguishing themselves from “those people who like taking pain medication” while still seeking relief. Justifying one’s use of OTC medication as minimal and “normal,” regardless of intake, avoids association with the addictive potential of prescription pain medications and aligns the identity of the chronic pain sufferer with a culturally sanctioned identity as stoic bearer of pain. PMID:26517291

Purchasing Over-the-counter medicines from Australian pharmacy: What do the pharmacy customers value and expect?

PubMed

Chan, Vincent; Tran, Hung

2016-01-01

Over-the-counter medicines (OTC) are widely available and can be purchased without a prescription. Their availability means that a customer may choose to purchase them without the involvement of a pharmacy/pharmacist. It is important to understand customer OTC purchasing perceptions and behaviour from a pharmacy to better understand the needs and opportunities in this space. This study aimed to examine customers' key expectations and what they value when purchasing OTC and how the effect of health status/stress and perceived risks/benefits of purchasing OTCs from a pharmacy may influence their OTC shopping behaviour. Customers from two metropolitan pharmacies across two different suburbs in Brisbane, Queensland, Australia completed a self-administered questionnaire. Data collection was conducted over a six-week period. The questionnaire examined demographics, current level of health and stress, as well as a range of questions (seven-point Likert-scale) examining perceived benefits and risks, what they value, trust and expect when purchasing OTC. A total of 86 customers from a broad range of demographics were captured in this study. When asked about their current health state, 41% and 23% respectively indicated that they were stressed and tense when they arrived at the pharmacy but many were feeling well (38%). Most customers strongly agreed/agreed that trust in the advice from a pharmacy (96%), trust in the products (73%), and the altruistic approach of a pharmacy (95%) were critical to them. Further, 82% and 78% respectively disagreed that time pressures or costs were concerns, despite many feeling tense and stressed when they came in. When asked where they intend to buy their future OTC, 89% indicated pharmacy instead of a supermarket. High levels of trust, confidence and sense of altruism and care were key factors for customers buying OTC from a pharmacy, regardless of time pressures, costs or existing levels of stress and health.

Significant role of UV and carbonate radical on the degradation of oxytetracycline in UV-AOPs: Kinetics and mechanism.

PubMed

Liu, Yiqing; He, Xuexiang; Duan, Xiaodi; Fu, Yongsheng; Fatta-Kassinos, Despo; Dionysiou, Dionysios D

2016-05-15

Carbonate radical (CO3(•-)), a selective oxidant, reacts readily with electron-rich compounds through electron transfer and/or hydrogen abstraction. In this study, the role of CO3(•-) in degrading oxytetracycline (OTC) by UV only, UV/H2O2 and UV/persulfate (UV/PS) advanced oxidation processes (AOPs) in the presence of HCO3(-) or CO3(2-) was investigated. For UV only process, the presence of photosensitizers, i.e., nitrate (NO3(-)) and natural organic matter (NOM), had different impacts on OTC degradation, i.e., an enhancing effect by NO3(-) due to the generation of HO(•) and a slight inhibiting effect by NOM possibly due to a light scattering effect. Differently for UV/H2O2 and UV/PS processes, the presence of NO3(-) hardly influenced the destruction of OTC. Generation of CO3(•-) presented a positive role on OTC degradation by UV/NO3(-)/HCO3(-). Such influence was also observed in the two studied AOPs in the presence of both bicarbonate and other natural water constituents. When various natural water samples from different sources were used as reaction matrices, UV only and UV/H2O2 showed an inhibiting effect while UV/PS demonstrated a comparable or even promoting effect in OTC decomposition. After elucidating the potential contribution of UV direct photolysis via excited state OTC* at an elevated reaction pH condition, putative OTC transformation byproducts via CO3(•-) reaction were identified by ultra-high definition accurate-mass quadrupole time-of-flight tandem mass spectrometry (QTOF/MS). Five different reaction pathways were subsequently proposed, including hydroxylation (+16 Da), quinonization (+14 Da), demethylation (-14 Da), decarbonylation (-28 Da) and dehydration (-18 Da). The significant role of UV at high pH and CO3(•-) on OTC removal from contaminated water was therefore demonstrated both kinetically and mechanistically. Copyright © 2016 Elsevier Ltd. All rights reserved.

Purchasing Over-the-counter medicines from Australian pharmacy: What do the pharmacy customers value and expect?

PubMed Central

2016-01-01

Background: Over-the-counter medicines (OTC) are widely available and can be purchased without a prescription. Their availability means that a customer may choose to purchase them without the involvement of a pharmacy/pharmacist. It is important to understand customer OTC purchasing perceptions and behaviour from a pharmacy to better understand the needs and opportunities in this space. Objective: This study aimed to examine customers’ key expectations and what they value when purchasing OTC and how the effect of health status/stress and perceived risks/benefits of purchasing OTCs from a pharmacy may influence their OTC shopping behaviour. Methods: Customers from two metropolitan pharmacies across two different suburbs in Brisbane, Queensland, Australia completed a self-administered questionnaire. Data collection was conducted over a six-week period. The questionnaire examined demographics, current level of health and stress, as well as a range of questions (seven-point Likert-scale) examining perceived benefits and risks, what they value, trust and expect when purchasing OTC. Results: A total of 86 customers from a broad range of demographics were captured in this study. When asked about their current health state, 41% and 23% respectively indicated that they were stressed and tense when they arrived at the pharmacy but many were feeling well (38%). Most customers strongly agreed/agreed that trust in the advice from a pharmacy (96%), trust in the products (73%), and the altruistic approach of a pharmacy (95%) were critical to them. Further, 82% and 78% respectively disagreed that time pressures or costs were concerns, despite many feeling tense and stressed when they came in. When asked where they intend to buy their future OTC, 89% indicated pharmacy instead of a supermarket. Conclusions: High levels of trust, confidence and sense of altruism and care were key factors for customers buying OTC from a pharmacy, regardless of time pressures, costs or existing levels of stress and health. PMID:27785164

Dietary administration of the probiotic SpPdp11: Effects on the intestinal microbiota and immune-related gene expression of farmed Solea senegalensis treated with oxytetracycline.

PubMed

Tapia-Paniagua, S T; Vidal, S; Lobo, C; García de la Banda, I; Esteban, M A; Balebona, M C; Moriñigo, M A

2015-10-01

Few antimicrobials are currently authorised in the aquaculture industry to treat infectious diseases. Among them, oxytetracycline (OTC) is one of the first-choice drugs for nearly all bacterial diseases. The objective of this study was to evaluate the effect of the dietary administration of OTC both alone and jointly with the probiotic Shewanella putrefaciens Pdp11 (SpPdp11) on the intestinal microbiota and hepatic expression of genes related to immunity in Senegalese sole (Solea senegalensis) juveniles. The results demonstrated that the richness and diversity of the intestinal microbiota of fish treated with OTC decreased compared with those of the control group but that these effects were lessened by the simultaneous administration of SpPdp11. In addition, specimens that received OTC and SpPdp11 jointly showed a decreased intensity of the Denaturing Gradient Gel Electrophoresis (DGGE) bands related to Vibrio genus and the presence of DGGE bands related to Lactobacillus and Shewanella genera. The relationship among the intestinal microbiota of fish fed with control and OTC diets and the expression of the NADPH oxidase and CASPASE-6 genes was demonstrated by a Principal Components Analysis (PCA) carried out in this study. In contrast, a close relationship between the transcription of genes, such as NKEF, IGF-β, HSP70 and GP96, and the DGGE bands of fish treated jointly with OTC and SpPdp11 was observed in the PCA study. In summary, the results obtained in this study demonstrate that the administration of OTC results in the up-regulation of genes related to apoptosis but that the joint administration of OTC and S. putrefaciens Pdp11 increases the transcription of genes related to antiapoptotic effects and oxidative stress regulation. Further, a clear relationship between these changes and those detected in the intestinal microbiota is established. Copyright © 2015 Elsevier Ltd. All rights reserved.

Increasing taurine intake and taurine synthesis improves skeletal muscle function in the mdx mouse model for Duchenne muscular dystrophy

PubMed Central

Pinniger, Gavin J.; Graves, Jamie A.; Grounds, Miranda D.; Arthur, Peter G.

2016-01-01

Key points Duchenne muscular dystrophy (DMD) is a fatal muscle wasting disease associated with increased inflammation, oxidative stress and myofibre necrosis.Cysteine precursor antioxidants such as N‐acetyl cysteine (NAC) and l‐2‐oxothiazolidine‐4‐carboxylate (OTC) reduce dystropathology in the mdx mouse model for DMD, and we propose this is via increased synthesis of the amino acid taurine.We compared the capacity of OTC and taurine treatment to increase taurine content of mdx muscle, as well as effects on in vivo and ex vivo muscle function, inflammation and oxidative stress.Both treatments increased taurine in muscles, and improved many aspects of muscle function and reduced inflammation. Taurine treatment also reduced protein thiol oxidation and was overall more effective, as OTC treatment reduced body and muscle weight, suggesting some adverse effects of this drug.These data suggest that increasing dietary taurine is a better candidate for a therapeutic intervention for DMD. Abstract Duchenne muscular dystrophy (DMD) is a fatal muscle wasting disease for which there is no widely available cure. Whilst the mechanism of loss of muscle function in DMD and the mdx mouse model are not fully understood, disruptions in intracellular calcium homeostasis, inflammation and oxidative stress are implicated. We have shown that protein thiol oxidation is increased in mdx muscle, and that the indirect thiol antioxidant l‐2‐oxothiazolidine‐4‐carboxylate (OTC), which increases cysteine availability, decreases pathology and increases in vivo strength. We propose that the protective effects of OTC are a consequence of conversion of cysteine to taurine, which has itself been shown to be beneficial to mdx pathology. This study compares the efficacy of taurine with OTC in decreasing dystropathology in mdx mice by measuring in vivo and ex vivo contractile function and measurements of inflammation and protein thiol oxidation. Increasing the taurine content of mdx muscle improved both in vivo and ex vivo muscle strength and function, potentially via anti‐inflammatory and antioxidant effects of taurine. OTC treatment increased taurine synthesis in the liver and taurine content of mdx muscle, improved muscle function and decreased inflammation. However, OTC was less effective than taurine treatment, with OTC also decreasing body and EDL muscle weights, suggesting that OTC had some detrimental effects. These data support continued research into the use of taurine as a therapeutic intervention for DMD, and suggest that increasing dietary taurine is the better strategy for increasing taurine content and decreasing severity of dystropathology. PMID:26659826

Increasing taurine intake and taurine synthesis improves skeletal muscle function in the mdx mouse model for Duchenne muscular dystrophy.

PubMed

Terrill, Jessica R; Pinniger, Gavin J; Graves, Jamie A; Grounds, Miranda D; Arthur, Peter G

2016-06-01

Duchenne muscular dystrophy (DMD) is a fatal muscle wasting disease associated with increased inflammation, oxidative stress and myofibre necrosis. Cysteine precursor antioxidants such as N-acetyl cysteine (NAC) and l-2-oxothiazolidine-4-carboxylate (OTC) reduce dystropathology in the mdx mouse model for DMD, and we propose this is via increased synthesis of the amino acid taurine. We compared the capacity of OTC and taurine treatment to increase taurine content of mdx muscle, as well as effects on in vivo and ex vivo muscle function, inflammation and oxidative stress. Both treatments increased taurine in muscles, and improved many aspects of muscle function and reduced inflammation. Taurine treatment also reduced protein thiol oxidation and was overall more effective, as OTC treatment reduced body and muscle weight, suggesting some adverse effects of this drug. These data suggest that increasing dietary taurine is a better candidate for a therapeutic intervention for DMD. Duchenne muscular dystrophy (DMD) is a fatal muscle wasting disease for which there is no widely available cure. Whilst the mechanism of loss of muscle function in DMD and the mdx mouse model are not fully understood, disruptions in intracellular calcium homeostasis, inflammation and oxidative stress are implicated. We have shown that protein thiol oxidation is increased in mdx muscle, and that the indirect thiol antioxidant l-2-oxothiazolidine-4-carboxylate (OTC), which increases cysteine availability, decreases pathology and increases in vivo strength. We propose that the protective effects of OTC are a consequence of conversion of cysteine to taurine, which has itself been shown to be beneficial to mdx pathology. This study compares the efficacy of taurine with OTC in decreasing dystropathology in mdx mice by measuring in vivo and ex vivo contractile function and measurements of inflammation and protein thiol oxidation. Increasing the taurine content of mdx muscle improved both in vivo and ex vivo muscle strength and function, potentially via anti-inflammatory and antioxidant effects of taurine. OTC treatment increased taurine synthesis in the liver and taurine content of mdx muscle, improved muscle function and decreased inflammation. However, OTC was less effective than taurine treatment, with OTC also decreasing body and EDL muscle weights, suggesting that OTC had some detrimental effects. These data support continued research into the use of taurine as a therapeutic intervention for DMD, and suggest that increasing dietary taurine is the better strategy for increasing taurine content and decreasing severity of dystropathology. © 2015 The Authors. The Journal of Physiology © 2015 The Physiological Society.

Assessment of oxytetracycline baths as therapeutic treatment for the control of the agent of withering syndrome (WS) in red abalone (Haliotis rufescens).

PubMed

Winkler, Federico M; García, Ricardo; Valdivia, María Vicenta; Lohrmann, Karin B

2018-03-01

Withering Syndrome (WS) is a lethal disease that affects abalone species in both wild and farmed populations. This infection, caused by the rickettsial-like intracellular organism (RLO) Candidatus Xenohaliotis californiensis, can severely impair the normal development of affected animals, and ultimately, their survival. The most common line of action against the WS has been the use of antibiotics, specifically oxytetracycline (OTC), administered via intramuscular injection and per os via medicated feed. In the present study, we have assessed the effectiveness of OTC baths as therapeutic treatment for the control of the WS agent in H. rufescens. Clinical signs of infection were monitored for 11 months in treated juveniles, in addition to feed consumption rate, growth patterns and gonad development. Abalones were asymptomatic until the end of the experiment, when a small number of non-treated animals exhibited clinical signs of infection. Gonad maturity was not observed. OTC treated animals grew significantly less than their non-treated counterparts, being 4.3% shorter and 13.6% lighter at the end of the experiment. They also displayed negative allometry, i.e. for the same shell length, they were lighter than non-treated groups. Furthermore, the weight of muscle and soft tissues in OTC treated animals was lighter than in the other groups, while no differences were found in shell weight. The feed consumption rate was the same for all groups, thus the observed growth patterns cannot be attributed to a decreased feed intake. One possible explanation is that antibiotic treatment may have impacted gut microflora, thus preventing efficient nutrient digestion and absorption and, indirectly, reducing growth. Prevalence of RLOs causing WS (WS-RLO) and the variant form (RLOv), infected with a bacteriophague and non virulent, were significantly lower in the OTC-treated group than in the other groups. Similar results were observed for the mean intensity of RLOv, while for WS-RLO, the intensity in the OTC-treated group was higher, although not statistically significant, than the rest of the groups. These observations may be the consequence of an increased bacterial sensitivity to OTC effects associated with the phage infection or faster reproduction of WS-RLOs than RLOv after OTC treatment. Our results let us infer that the prophylactic use of OTC in abalone to avoid the negative effects of WS on abalone farms could have an undesired negative effect on the biological control exerted by the phage on the bacteria after OTC treatment. Copyright © 2018 Elsevier Inc. All rights reserved.

An open-label, randomized, four-treatment crossover study evaluating the effects of salt form, acetaminophen, and food on the pharmacokinetics of phenylephrine.

PubMed

Gelotte, Cathy K

2018-06-01

Phenylephrine hydrochloride (HCl) is a decongestant available in over-the-counter (OTC) medicines. Previously marketed prescription products contained phenylephrine tannate, an extended-release salt, which allowed dosing every 8-12 h. Given the regulatory history that cold medicines marketed before 1962 had limited supporting clinical data, and with widespread replacement of pseudoephedrine by phenylephrine in OTC products over the last ten years, the need for contemporary studies grew. This exploratory crossover study evaluated effects of salt form, acetaminophen, and food on phenylephrine pharmacokinetics and metabolites in healthy adults. Test treatments were 25 mg phenylephrine tannate (equivalent to 10 mg phenylephrine HCl) combined with 200 mg guaifenesin, fasted; 10 mg phenylephrine HCl combined with 650 mg acetaminophen, fasted; and 10 mg phenylephrine HCl, fed. The reference treatment was 10 mg phenylephrine HCl, fasted. Plasma phenylephrine pharmacokinetics and urine metabolites were determined. Although the tannate salt slowed phenylephrine absorption compared with the HCl salt, terminal concentrations were similar, suggesting that products containing the tannate salt should not be dosed less frequently than those containing the HCl salt. The premise that acetaminophen increases phenylephrine bioavailability by competition for presystemic sulfation was corroborated by increased phenylephrine sulfate in urine. Food delayed phenylephrine absorption, but not the total amount absorbed. Copyright © 2018. Published by Elsevier Inc.

Impact of Dry Eye Disease on Work Productivity, and Patients' Satisfaction With Over-the-Counter Dry Eye Treatments.

PubMed

Nichols, Kelly K; Bacharach, Jason; Holland, Edward; Kislan, Thomas; Shettle, Lee; Lunacsek, Orsolya; Lennert, Barb; Burk, Caroline; Patel, Vaishali

2016-06-01

To assess the effect of dry eye disease on work productivity and performance of non-work-related activities, and patients' satisfaction with over-the-counter (OTC) dry eye treatments. In this prospective, noninterventional, cross-sectional study, conducted at 10 U.S. optometry/ophthalmology practices, 158 symptomatic dry eye patients naïve to prescription medication underwent standard dry eye diagnostic tests and completed Work Productivity and Activity Impairment (WPAI) and Ocular Surface Disease Index (OSDI) questionnaires. Use of OTC dry eye medication, and satisfaction with OTC medication and symptom relief were also assessed. On average, dry eye resulted in loss of 0.36% of work time (∼5 minutes over 7 days) and ∼30% impairment of workplace performance (presenteeism), work productivity, and non-job-related activities. Presenteeism and productivity impairment scores showed significant correlation with OSDI total (r = 0.55) and symptom domain (r = 0.50) scores, but not with dry eye clinical signs. Activity impairment score showed stronger correlation with OSDI total (r = 0.61) and symptom domain (r = 0.53) scores than with clinical signs (r ≤ 0.20). Almost 75% of patients used OTC dry eye medication. Levels of patient satisfaction with OTC medication (64.2%) and symptom relief from OTC (37.3%) were unaffected by administration frequency (≥3 vs. ≤2 times daily). Dry eye causes negligible absenteeism, but markedly reduces workplace and non-job-related performances. Impairment of work performance is more closely linked to dry eye symptoms than to clinical signs. Patients' perceptions of OTC dry eye medication tend to be more positive than their perceptions of symptom relief.

A sensitive electrochemical aptasensor for multiplex antibiotics detection based on high-capacity magnetic hollow porous nanotracers coupling exonuclease-assisted cascade target recycling.

PubMed

Yan, Zhongdan; Gan, Ning; Li, Tianhua; Cao, Yuting; Chen, Yinji

2016-04-15

A multiplex electrochemical aptasensor was developed for simultaneous detection of two antibiotics such as chloramphenicol (CAP) and oxytetracycline (OTC), and high-capacity magnetic hollow porous nanotracers coupling exonuclease-assisted target recycling was used to improve sensitivity. The cascade amplification process consists of the exonuclease-assisted target recycling amplification and metal ions encoded magnetic hollow porous nanoparticles (MHPs) to produce voltammetry signals. Upon the specific recognition of aptamers to targets (CAP and OTC), exonuclease I (Exo I) selectively digested the aptamers which were bound with CAP and OTC, then the released CAP and OTC participated new cycling to produce more single DNA, which can act as trigger strands to hybrid with nanotracers to generate further signal amplification. MHPs were used as carriers to load more amounts of metal ions and coupling with Exo I assisted cascade target recycling can amplify the signal for about 12 folds compared with silica based nanotracers. Owing to the dual signal amplification, the linear range between signals and the concentrations of CAP and OTC were obtained in the range of 0.0005-50 ng mL(-1). The detection limits of CAP and OTC were 0.15 and 0.10 ng mL(-1) (S/N=3) which is more than 2 orders lower than commercial enzyme-linked immunosorbent immunoassay (ELISA) method, respectively. The proposed method was successfully applied to simultaneously detection of CAP and OTC in milk samples. Besides, this aptasensor can be applied to other antibiotics detection by changing the corresponding aptamer. The whole scheme is facile, selective and sensitive enough for antibiotics screening in food safety. Copyright © 2015 Elsevier B.V. All rights reserved.

Ovarian tissue cryopreservation (OTC) in prepubertal girls and young women: an analysis of parents' and patients' decision-making.

PubMed

Sullivan-Pyke, Chantae S; Carlson, Claire A; Prewitt, Maureen; Gracia, Clarisa R; Ginsberg, Jill P

2018-04-01

The purpose of this study was to explore the decision-making influences, perceived level of control over decision-making, and mood states of parents and patients who were offered OTC prior to gonadotoxic therapy. Parents and patients, at least 12 years old, who required gonadotoxic therapy and were offered OTC prior to therapy, were asked to complete questionnaires. Two validated instruments were also used: the Decision-Making Control Instrument (DMCI) and the Profile of Mood States (POMS). The factors that influenced decision-making were compared using Student's t test, and the scores of DMCI and POMS were compared using the Mann-Whitney test. Thirty-six parents and 16 patients who elected ovarian tissue cryopreservation (OTC) completed questionnaires. Five parents who declined OTC also completed questionnaires. Accepters thought OTC was a good idea and that, in the future, science would enable cryopreserved ovarian tissue to be used to restore fertility (100% parents, 93.8% patients). Among accepters, the desire for genetically related children and prevention of the stress of infertility drove parents' and patients' decisions (90.9 and 100%, respectively). The desire to prevent the stress of infertility was important to parents, but patients were less likely to report that a desire to prevent the stress of infertility factored into their decision-making (66.7 vs. 50.0%; p < 0.001). All respondents felt in control of their decision and displayed low levels of mood disturbance. Though the decision to undergo experimental OTC is difficult and often urgent, this study suggests that families feel in control of their decision-making and report little emotional disturbance.

Treatment with the cysteine precursor l-2-oxothiazolidine-4-carboxylate (OTC) implicates taurine deficiency in severity of dystropathology in mdx mice.

PubMed

Terrill, Jessica R; Boyatzis, Amber; Grounds, Miranda D; Arthur, Peter G

2013-09-01

Oxidative stress has been implicated in the pathology of the lethal skeletal muscle disease Duchenne muscular dystrophy (DMD), and various antioxidants have been investigated as a potential therapy. Recently, treatment of the mdx mouse model for DMD with the antioxidant and cysteine and glutathione (GSH) precursor n-acetylcysteine (NAC) was shown to decrease protein thiol oxidation and improve muscle pathology and ex vivo muscle strength. This study further investigates the mechanism for the benefits of NAC on dystrophic muscle by administering l-2-oxothiazolidine-4-carboxylate (OTC) which also upregulates intracellular cysteine and GSH, but does not directly function as an antioxidant. We observed that OTC, like NAC, decreases protein thiol oxidation, decreases pathology and increases strength, suggesting that the both NAC and OTC function via increasing cysteine and GSH content of dystrophic muscle. We demonstrate that mdx muscle is not deficient in either cysteine or GSH and that these are not increased by OTC treatment. However, we show that dystrophic muscle of 12 week old mdx mice is deficient in taurine, a by-product of disposal of excess cysteine, a deficiency that is ameliorated by OTC treatment. These data suggest that in dystrophic muscles, apart from the strong association of increased oxidative stress and protein thiol oxidation with dystropathology, another major issue is an insufficiency in taurine that can be corrected by increasing the availability of cysteine. This study provides new insight into the molecular mechanism underlying the benefits of NAC in muscular dystrophy and supports the use of OTC as an alternative drug for potential clinical applications to DMD. Copyright © 2013 Elsevier Ltd. All rights reserved.

Chinese Character and English Word processing in children's ventral occipitotemporal cortex: fMRI evidence for script invariance.

PubMed

Krafnick, Anthony J; Tan, Li-Hai; Flowers, D Lynn; Luetje, Megan M; Napoliello, Eileen M; Siok, Wai-Ting; Perfetti, Charles; Eden, Guinevere F

2016-06-01

Learning to read is thought to involve the recruitment of left hemisphere ventral occipitotemporal cortex (OTC) by a process of "neuronal recycling", whereby object processing mechanisms are co-opted for reading. Under the same theoretical framework, it has been proposed that the visual word form area (VWFA) within OTC processes orthographic stimuli independent of culture and writing systems, suggesting that it is universally involved in written language. However, this "script invariance" has yet to be demonstrated in monolingual readers of two different writing systems studied under the same experimental conditions. Here, using functional magnetic resonance imaging (fMRI), we examined activity in response to English Words and Chinese Characters in 1st graders in the United States and China, respectively. We examined each group separately and found the readers of English as well as the readers of Chinese to activate the left ventral OTC for their respective native writing systems (using both a whole-brain and a bilateral OTC-restricted analysis). Critically, a conjunction analysis of the two groups revealed significant overlap between them for native writing system processing, located in the VWFA and therefore supporting the hypothesis of script invariance. In the second part of the study, we further examined the left OTC region responsive to each group's native writing system and found that it responded equally to Object stimuli (line drawings) in the Chinese-reading children. In English-reading children, the OTC responded much more to Objects than to English Words. Together, these results support the script invariant role of the VWFA and also support the idea that the areas recruited for character or word processing are rooted in object processing mechanisms of the left OTC. Copyright © 2016 Elsevier Inc. All rights reserved.

Chinese Character and English Word processing in children’s ventral occipitotemporal cortex: fMRI evidence for script invariance

PubMed Central

Krafnick, Anthony J.; Tan, Li-Hai; Flowers, D. Lynn; Luetje, Megan M.; Napoliello, Eileen M.; Siok, Wai-Ting; Perfetti, Charles; Eden, Guinevere F.

2016-01-01

Learning to read is thought to involve the recruitment of left hemisphere ventral occipitotemporal cortex (OTC) by a process of “neuronal recycling”, whereby object processing mechanisms are co-opted for reading. Under the same theoretical framework, it has been proposed that the visual word form area (VWFA) within the OTC processes orthographic stimuli independent of culture and writing systems, suggesting that it is universally involved in written language. However, this “script invariance” has yet to be demonstrated in monolingual readers of two different writing systems studied under the same experimental conditions. Here, using functional magnetic resonance imaging (fMRI), we examined activity in response to English Words and Chinese Characters in 1st graders in the United States and China, respectively. We examined each group separately and found the readers of English as well as the readers of Chinese to activate the left ventral OTC for their respective native writing systems (using both a whole-brain and a bilateral OTC-restricted analysis). Critically, a conjunction analysis of the two groups revealed significant overlap between them for native writing system processing, located in the VWFA and therefore supporting the hypothesis of script invariance. In the second part of the study, we further examined the left OTC region responsive to each group’s native writing system and found it responded equally to Object stimuli (line drawings) in the Chinese-reading children. In English-reading children, the OTC responded much more to Objects than to English Words. Together, these results support the script invariant role of the VWFA and also support the idea that the areas recruited for character or word processing are rooted in object processing mechanisms of the left OTC. PMID:27012502

Misuse of OTC drugs in Poland.

PubMed

Zaprutko, Tomasz; Koligat, Dorota; Michalak, Michał; Wieczorek, Marta; Józiak, Malwina; Ratajczak, Monika; Szydłowska, Kinga; Miazek, Joanna; Kus, Krzysztof; Nowakowska, Elżbieta

2016-08-01

The misuse of over-the-counter (OTC) drugs became a global public health concern. Although abuse with dextrometorphan (DXM), pseudoefedrine (PSD), codeine (COD) or benzydamine (BND) may lead even to psychosis, drugs containing these substances are relatively cheap and freely available. In Poland the Act on Counteracting Drug Addiction was amended in 2015, however it seems that there are still some points which could be improved. Study was conducted between October 2014 and June 2015 using a specially designed questionnaire delivered to pharmacists from the Greater Poland region. Questionnaire consisting of 11 closed questions was distributed by direct contact and via the Internet. From over 2500 distributed questionnaires, we received 761 sheets and 680 were included. The misuse of OTC drugs is increasing in Poland from pharmacists point of view. The most popular substance was PSD followed by COD and DXM. The main reason of misuse of these drugs could be related to the use of Internet and free access to these medications. In respondents (58.2%) opinion OTC drugs containing analyzed substances should be moved into the prescription status. The misuse of OTC drugs should be considered as a very dangerous phenomenon. Although the Act on Counteracting Drug Addiction was amended in Poland in 2015, there are some facets requiring improvement. Social education may play a key role in the limitation of misuse of OTC drugs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Oxytetracycline induces DNA damage and epigenetic changes: a possible risk for human and animal health?

PubMed

Gallo, Adriana; Landi, Rosaria; Rubino, Valentina; Di Cerbo, Alessandro; Giovazzino, Angela; Palatucci, Anna Teresa; Centenaro, Sara; Guidetti, Gianandrea; Canello, Sergio; Cortese, Laura; Ruggiero, Giuseppina; Alessandrini, Andrea; Terrazzano, Giuseppe

2017-01-01

Oxytetracycline (OTC), which is largely employed in zootechnical and veterinary practices to ensure wellness of farmed animals, is partially absorbed within the gastrointestinal tract depositing in several tissues. Therefore, the potential OTC toxicity is relevant when considering the putative risk derived by the entry and accumulation of such drug in human and pet food chain supply. Despite scientific literature highlights several OTC-dependent toxic effects on human and animal health, the molecular mechanisms of such toxicity are still poorly understood. Here, we evaluated DNA damages and epigenetic alterations by quantitative reverse transcription polymerase chain reaction, quantitative polymerase chain reaction, chromatin immuno-precipitation and Western blot analysis. We observed that human peripheral blood mononuclear cells (PBMCs) expressed DNA damage features (activation of ATM and p53, phosphorylation of H2AX and modifications of histone H3 methylation of lysine K4 in the chromatin) after the in vitro exposure to OTC. These changes are linked to a robust inflammatory response indicated by an increased expression of Interferon (IFN)- γ and type 1 superoxide dismutase (SOD1). Our data reveal an unexpected biological in vitro activity of OTC able to modify DNA and chromatin in cultured human PBMC. In this regard, OTC presence in foods of animal origin could represent a potential risk for both the human and animal health.

Effects of oxytetracycline on the performance and activity of biomixtures: Removal of herbicides and mineralization of chlorpyrifos.

PubMed

Huete-Soto, Alejandra; Castillo-González, Humberto; Masís-Mora, Mario; Chin-Pampillo, Juan Salvador; Rodríguez-Rodríguez, Carlos E

2017-01-05

Biopurification systems (BPS) are design to remove pesticides from agricultural wastewater. This work assays for the first time the potential effect of an antibiotic of agricultural use (oxytetracycline, OTC) on the performance of a biomixture (biologically active core of BPS), considering that antibiotic-containing wastewaters are also produced in agricultural labors. The respiration of the biomixture was stimulated in the presence of increasing doses of OTC (≥100mgkg -1 ), and only slightly increased with lower doses (≤10mgkg -1 ). When co-applied during the removal of chlorpyrifos, OTC increased chlorpyrifos mineralization rates at low doses, resembling a hormetic effect. The biomixture was also able to remove three herbicides (atrazine, ametryn and linuron) with half-lives of 24.3 d, 43.9 d and 30.7 d; during co-application of OTC at a biomixture-relevant concentration, only the removal of ametryn was significantly inhibited, increasing its half-life to 92.4 d. Ecotoxicological assays revealed that detoxification takes place in the biomixture during the removal of herbicides in the presence of OTC. Overall results suggest that co-application of OTC in a biomixture does not negatively affect the performance of the matrix in every case; moreover, the co-application of this antibiotic could improve the mineralization of some pesticides. Copyright © 2016 Elsevier B.V. All rights reserved.

Kinetics and mechanism investigation on the destruction of oxytetracycline by UV-254nm activation of persulfate.

PubMed

Liu, Yiqing; He, Xuexiang; Fu, Yongsheng; Dionysiou, Dionysios D

2016-03-15

Oxytetracycline (OTC), an important broad-spectrum antibiotic, has been detected extensively in various environmental systems, which may have a detrimental impact on ecosystem and human health through the development of drug resistant bacteria and pathogens. In this study, the degradation of OTC was evaluated by UV-254nm activated persulfate (PS). The observed UV fluence based pseudo first-order rate constant (kobs) was found to be the highest at near neutral pH conditions (pH 5.5-8.5). Presence of various natural water constituents had different effects on OTC degradation, with a significant enhancement in the presence of bicarbonate or Cu(2+). Limited elimination of total organic carbon (TOC) and PS was observed during the mineralization of OTC. Transformation byproducts in the presence and absence of hydroxyl radical scavenging agent tert-butanol (t-BuOH) were identified using ultra-high definition accurate-mass quadrupole time-of-flight liquid chromatography/mass spectrometer (LC-QTOF/MS). Potential OTC degradation mechanism was subsequently proposed revealing four different reaction pathways by SO4(-) reaction including hydroxylation (+16Da), demethylation (-14Da), decarbonylation (-28Da) and dehydration (-18Da). This study suggests that UV-254nm/PS is a promising treatment technology for the control of water pollution caused by emerging contaminants such as OTC. Copyright © 2015 Elsevier B.V. All rights reserved.

Phosphate Control of Oxytetracycline Production by Streptomyces rimosus Is at the Level of Transcription from Promoters Overlapped by Tandem Repeats Similar to Those of the DNA-Binding Sites of the OmpR Family

PubMed Central

McDowall, Kenneth J.; Thamchaipenet, Arinthip; Hunter, Iain S.

1999-01-01

Physiological studies have shown that Streptomyces rimosus produces the polyketide antibiotic oxytetracycline abundantly when its mycelial growth is limited by phosphate starvation. We show here that transcripts originating from the promoter for one of the biosynthetic genes, otcC (encoding anhydrotetracycline oxygenase), and from a promoter for the divergent otcX genes peak in abundance at the onset of antibiotic production induced by phosphate starvation, indicating that the synthesis of oxytetracycline is controlled, at least in part, at the level of transcription. Furthermore, analysis of the sequences of the promoters for otcC, otcX, and the polyketide synthase (otcY) genes revealed tandem repeats having significant similarity to the DNA-binding sites of ActII-Orf4 and DnrI, which are Streptomyces antibiotic regulatory proteins (SARPs) related to the OmpR family of transcription activators. Together, the above results suggest that oxytetracycline production by S. rimosus requires a SARP-like transcription factor that is either produced or activated or both under conditions of low phosphate concentrations. We also provide evidence consistent with the otrA resistance gene being cotranscribed with otcC as part of a polycistronic message, suggesting a simple mechanism of coordinate regulation which ensures that resistance to the antibiotic increases in proportion to production. PMID:10322002

Molecular Insights into the pH-Dependent Adsorption and Removal of Ionizable Antibiotic Oxytetracycline by Adsorbent Cyclodextrin Polymers

PubMed Central

Zhang, Yu; Cai, Xiyun; Xiong, Weina; Jiang, Hao; Zhao, Haitong; Yang, Xianhai; Li, Chao; Fu, Zhiqiang; Chen, Jingwen

2014-01-01

Effects of pH on adsorption and removal efficiency of ionizable organic compounds (IOCs) by environmental adsorbents are an area of debate, because of its dual mediation towards adsorbents and adsorbate. Here, we probe the pH-dependent adsorption of ionizable antibiotic oxytetracycline (comprising OTCH2 +, OTCH±, OTC−, and OTC2−) onto cyclodextrin polymers (CDPs) with the nature of molecular recognition and pH inertness. OTCH± commonly has high adsorption affinity, OTC− exhibits moderate affinity, and the other two species have negligible affinity. These species are evidenced to selectively interact with structural units (e.g., CD cavity, pore channel, and network) of the polymers and thus immobilized onto the adsorbents to different extents. The differences in adsorption affinity and mechanisms of the species account for the pH-dependent adsorption of OTC. The mathematical equations are derived from the multiple linear regression (MLR) analysis of quantitatively relating adsorption affinity of OTC at varying pH to adsorbent properties. A combination of the MLR analysis for OTC and molecular recognition of adsorption of the species illustrates the nature of the pH-dependent adsorption of OTC. Based on this finding, γ-HP-CDP is chosen to adsorb and remove OTC at pH 5.0 and 7.0, showing high removal efficiency and strong resistance to the interference of coexisting components. PMID:24465975

Adsorption Property and Mechanism of Oxytetracycline onto Willow Residues

PubMed Central

Wang, Di; Xu, Haiyang; Yang, Shengke; Wang, Wenke; Wang, Yanhua

2017-01-01

To elucidate the adsorption property and the mechanism of plant residues to reduce oxytetracycline (OTC), the adsorption of OTC onto raw willow roots (WR-R), stems (WS-R), leaves (WL-R), and adsorption onto desugared willow roots (WR-D), stems (WS-D), and leaves (WL-D) were investigated. The structural characterization was analyzed by scanning electron microscopy, Fourier-transform infrared spectra, and an elemental analyzer. OTC adsorption onto the different tissues of willow residues was compared and correlated with their structures. The adsorption kinetics of OTC onto willow residues was found to follow the pseudo-first-order model. The isothermal adsorption process of OTC onto the different tissues of willow residues followed the Langmuir and Freundlich model and the process was also a spontaneous endothermic reaction, which was mainly physical adsorption. After the willow residues were desugared, the polarity decreased and the aromaticity increased, which explained why the adsorption amounts of the desugared willow residues were higher than those of the unmodified residues. These observations suggest that the raw and modified willow residues have great potential as adsorbents to remove organic pollutants. PMID:29271892

Otolith marking of juvenile shortnose gar by immersion in oxytetracycline

USGS Publications Warehouse

Snow, Richard A.; Long, James M.

2017-01-01

Oxytetracycline (OTC) has been used to mark a variety of fish species at multiple developmental stages; however, there is little information on batch-marking Lepisosteidae. Juvenile Shortnose Gar Lepisosteus platostomus (53 ± 3 mm TL) were seined from an Oklahoma State University research pond and transported to the Oklahoma Fishery Research Lab. Juvenile Shortnose Gar were exposed to a range of OTC concentrations—0, 500, 600, and 700 mg/L—for 4, 5, or 6 h. Lapillus and sagitta otoliths were examined 14 d postexposure for mark presence and evaluation using fluorescent microscopy. Overall, 93.3% of otoliths exposed to OTC exhibited a mark. Concentration of OTC affected the mean mark quality, whereas duration and otolith type examined did not. However, as concentration increased, so did mortality, suggesting a balance is needed to achieve marking goals. Based on our findings, batch marking of Shortnose Gar can be successful at OTC concentrations from 500 to 700 mg/L for 4–6 h, although mark quality may vary and mortality rates increase at the higher concentrations and longer durations.

Economic impact of a triptan Rx-to-OTC switch in six EU countries.

PubMed

Millier, Aurelie; Cohen, Joshua; Toumi, Mondher

2013-01-01

Triptans have been safely and effectively used in the management of migraine for more than fifteen years, and it seems reasonable to wonder what would be the economic impact of moving a specific triptan to OTC availability. The objective of this study was then to examine the economic impact of payer policies of a triptan Rx-to-OTC switch in six EU countries (France, UK, Spain, Italy, Germany and Poland). A decision model was used to model the budgetary impact of a triptan Rx-to-OTC switch from the third-party payer (TPP) and the societal perspectives, using a one-year timeframe. From the TPP perspective, it is estimated that the current overall direct spending on the management of migraine attacks across the 6 EU Member States is €582 million annually, and that the savings would reach €75 million (13% of the overall direct economic burden of migraine). From the societal perspective, €86 million annually would be added. Given evidence of effectiveness and safety, and given the potential savings, a triptan Rx-to-OTC switch is a reasonable public policy decision.

Changes in microbial community structures due to varying operational conditions in the anaerobic digestion of oxytetracycline-medicated cow manure.

PubMed

Turker, Gokhan; Aydin, Sevcan; Akyol, Çağrı; Yenigun, Orhan; Ince, Orhan; Ince, Bahar

2016-07-01

Management of manure containing veterinary antibiotics is a major concern in anaerobic treatment systems because of their possible adverse effects on microbial communities. Therefore, the aim of study was to investigate how oxytetracycline (OTC) influences bacteria and acetoclastic and hydrogenotrophic methanogens under varying operational conditions in OTC-medicated and non-medicated anaerobic cow manure digesters. Concentrations of OTC and its metabolites throughout the anaerobic digestion were determined using ultraviolet-high-performance liquid chromatography (UV-HPLC) and tandem liquid chromatography-mass spectrometry (LC/MS/MS), respectively. Fluorescent in situ hybridization, denaturing gradient gel electrophoresis, cloning, and sequencing analyses were used to monitor changes in microbial community structures. According to the results of analytical and molecular approaches, operating conditions highly influence active microbial community dynamics and associate with biogas production and elimination of OTC and its metabolites during anaerobic digestion of cow manure in the presence of an average initial concentration of 2.2 mg OTC/L. The impact of operating conditions has a drastic effect on acetoclastic methanogens than hydrogenotrophic methanogens and bacteria.

Adsorption mechanisms and impact factors of oxytetracycline on activated sludge

NASA Astrophysics Data System (ADS)

Xiancai, Song; Dongfang, Liu; Lejun, Zhao

2017-03-01

The adsorption mechanisms and the effect of Oxytetracycline (OTC) onto activated sludge were studied. The results show that the adsorption of Oxytetracycline (OTC) onto activated sludge was coincident with the Pseudo-second-order kinetic model which suggested that chemical adsorption mechanism was dominant. The influences including pH and metal ions on the OTC were examined. It was demonstrated that the adsorption process was highly pH-dependant, which indicate that cationic exchange mechanisms may play an important role in the adsorption process. Na+, K+, Ca2+, Mg2+ and Cd2+ ions more or less inhibited the adsorption of OTC on activated sludge while Cu2+ enhanced the adsorption ability. The phenomenon may reflect the result that a surface complexation mechanism could involved in the adsorption.

Comparison of the incipient lesion enamel fluoride uptake from various prescription and OTC fluoride toothpastes and gels.

PubMed

Schemehorn, B R; DiMarino, J C; Movahed, N

2014-01-01

The objective of this in vitro study was to compare the fluoride uptake into incipient enamel lesions of a novel 970 ppm F- ion SnF2 over-the-counter (OTC) gel (Enamelon Preventive Treatment Gel) and a novel 1150 ppm F- ion OTC toothpaste (Enamelon), each delivering amorphous calcium phosphate (ACP), to the uptake from two different prescription strength, 5000 ppm F- ion dentifrices containing tri-calcium phosphate (TCP) and a prescription 900 ppm F- ion paste containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP). The test procedure followed method #40 in the US-FDA Anticaries Drug Products for OTC Human Use, Final Monograph testing procedures. Eight sets of twelve incisor enamel cores were mounted in Plexiglas rods and the exposed surfaces were polished. The indigenous fluoride levels of each specimen were determined prior to treatment. The treatments were performed using slurries of a negative control (water) and the following products applied to a set of sound enamel cores: 5000 ppm F- ion, sodium fluoride (NaF) prescription (Rx) dentifrice "A" containing TCP; 5000 ppm F- ion, NaF Rx dentifrice "B" containing TCP; 900 ppm F- ion, NaF Rx paste with CPP-ACP; 1150 ppm F- ion, NaF OTC toothpaste; 1150 ppm F- ion, stannous fluoride (SnF2) OTC toothpaste delivering ACP (Enamelon); 1100 ppm F- ion, SnF2 OTC toothpaste; and 970 ppm F- ion, SnF2 OTC gel delivering ACP (Enamelon Preventive Treatment Gel). The twelve specimens of each group were immersed into 25 ml of their assigned slurry with constant stirring (350 rpm) for 30 minutes. Following treatment, one layer of enamel was removed from each specimen and analyzed for fluoride and calcium. The pre-treatment fluoride (indigenous) level of each specimen was subtracted from the post-treatment value to determine the change in enamel fluoride due to the test treatment. The increase in the average fluoride uptake for treated enamel cores was: 10,263 ± 295 ppm for the 970 ppm F- ion, Enamelon Preventive Treatment Gel; 7,016 ± 353 ppm for the 1150 ppm F- ion Enamelon Toothpaste; 4,138 ± 120 ppm for the 5000 ppm F- ion, NaF prescription dentifrice "A" with TCP; 3801 ± 121 ppm for the 5000 ppm F- ion, NaF prescription dentifrice "B" with TCP; 2,647 ± 57 ppm for the 1100 ppm F- ion, SnF2 OTC toothpaste; 1470 ± 40 ppm for the 1150 ppm F- ion, NaF OTC toothpaste; and 316 ± 9 ppm for the 900 ppm F- ion, NaF paste with CPP-ACP. The differences among all the products tested were statistically significant (p < 0.05), except for the two 5000 ppm F- ion products with TCP that were not statistically different from one another, and the 900 ppm F ion, NaF paste with CPP-ACP that was not statistically different from the negative water control. The Enamelon products (970 ppm and 150 ppm F ion, SnF2OTC dentifrices) delivering ACP provide statistically significantly more fluoride to incipient enamel lesions than two prescription strength 5000 ppm F- ion toothpastes containing TCP, the 900 ppm F- ion prescription paste containing CPP-ACP, and the other OTC toothpastes compared in this study.

Effectiveness and cost-effectiveness of salicylic acid and cryotherapy for cutaneous warts. An economic decision model.

PubMed

Thomas, K S; Keogh-Brown, M R; Chalmers, J R; Fordham, R J; Holland, R C; Armstrong, S J; Bachmann, M O; Howe, A H; Rodgers, S; Avery, A J; Harvey, I; Williams, H C

2006-08-01

To estimate the costs of commonly used treatments for cutaneous warts, as well as their health benefits and risk. To create an economic decision model to evaluate the cost-effectiveness of these treatments, and, as a result, assess whether a randomised controlled trial (RCT) would be feasible and cost-effective. Focus groups, structured interviews and observation of practice. Postal survey sent to 723 patients. A recently updated Cochrane systematic review and published cost and prescribing data. Primary and secondary data collection methods were used to inform the development of an economic decision model. Data from the postal survey provided estimates of the effectiveness of wart treatments in a primary care setting. These estimates were compared with outcomes reported in the Cochrane review of wart treatment, which were largely obtained from RCTs conducted in secondary care. A decision model was developed including a variety of over-the-counter (OTC) and GP-prescribed treatments. The model simulated 10,000 patients and adopted a societal perspective. OTC treatments were used by a substantial number of patients (57%) before attending the GP surgery. By far the most commonly used OTC preparation was salicylic acid (SA). The results of the economic model suggested that of the treatments prescribed by a GP, the most cost-effective treatment was SA, with an incremental cost-effectiveness ratio (ICER) of 2.20 pound/% cured. The ICERs for cryotherapy varied widely (from 1.95 to 7.06 pound/% cured) depending on the frequency of applications and the mode of delivery. The most cost-effective mode of delivery was through nurse-led cryotherapy clinics (ICER = 1.95 pound/% cured) and this could be a cost-effective alternative to GP-prescribed SA. Overall, the OTC therapies were the most cost-effective treatment options. ICERs ranged from 0.22 pound/% cured for OTC duct tape and 0.76 pound/% cured for OTC cryotherapy to 1.12 pound/% cured for OTC SA. However, evidence in support of OTC duct tape and OTC cryotherapy is very limited. Side-effects were commonly reported for both SA and cryotherapy, particularly a burning sensation, pain and blistering. Cryotherapy delivered by a doctor is an expensive option for the treatment of warts in primary care. Alternative options such as GP-prescribed SA and nurse-led cryotherapy clinics provide more cost-effective alternatives, but are still expensive compared with self-treatment. Given the minor nature of most cutaneous warts, coupled with the fact that the majority spontaneously resolve in time, it may be concluded that a shift towards self-treatment is warranted. Although both duct tape and OTC cryotherapy appear promising new self-treatment options from both a cost and an effectiveness perspective, more research is required to confirm the efficacy of these two methods of wart treatment. If these treatments are shown to be as cost-effective as or more cost-effective than conventional treatments, then a shift in service delivery away from primary care towards more OTC treatment is likely. A public awareness campaign would be useful to educate patients about the self-limiting nature of warts and the possible alternative OTC treatment options available. Two future RCTs are recommended for consideration: a trial of SA compared with nurse-led cryotherapy in primary care, and a trial of home treatments. Greater understanding of the efficacy of these home treatments will give doctors a wider choice of treatment options, and may help to reduce the overall demand for cryotherapy in primary care.

Efficacy of ovarian tissue cryopreservation for fertility preservation: lessons learned from 545 cases.

PubMed

Jadoul, P; Guilmain, A; Squifflet, J; Luyckx, M; Votino, R; Wyns, C; Dolmans, M M

2017-05-01

How effective is ovarian tissue cryopreservation (OTC)? In our cohort of patients who underwent OTC, premature ovarian failure (POF) rates, return rates and pregnancy rates after autotransplantation were 31.5, 4.4 and 33%, respectively. OTC for fertility purposes has been performed for >20 years now. With over 86 live births reported worldwide and success rates of ~30% after autotransplantation of frozen-thawed ovarian cortex, the procedure should no longer be considered experimental. However, very few publications report the efficacy of this procedure. Cases of ovarian tissue cryobanking for fertility preservation performed between 1997 and 2013 in a single institution were reviewed by analysis of the cryobank database and a prospective questionnaire sent out in March 2015. There were 545 patients who underwent OTC during this period. The analysis included indications for OTC, survival rates, ovarian function and spontaneous pregnancies after OTC, come-back rates for ovarian tissue transplantation, pregnancy rates after transplantation, and complication and satisfaction rates. OTC was performed in this cohort at a mean age of 22.3 ± 8.8 years for oncological indications (79%), benign gynecological pathologies (17.5%) and genetic risks of POF (3.5%). Of the 545 patients, 29% were under 18 years of age at the time of OTC and 15% were prepubertal. While 10% of patients died from their disease, 21 patients (3.9%) underwent autotransplantation, 7 of whom delivered a healthy baby, yielding a post-transplantation live birth rate of 33%. Of 451 patients who were sent the questionnaire, 143 agreed to respond (32%). Nevertheless, ovarian function could not be evaluated in 36% of those who answered. Of 92 evaluable patients, 31.5% were menopausal and 68.5% showed persistent ovarian function. Of 52 women who attempted to conceive naturally, 37 were successful (71%). Among 140 patients who answered the questionnaire, 96% were satisfied with the procedure and only 1 major complication (intra-abdominal hemorrhage) was encountered. Among all the patients, 12% have donated their ovarian cortex for research purposes or have had it destroyed. The questionnaire participation rate (32%), limited follow-up (mean 7.6 ± 3.5 years) and use of only clinical criteria for evaluation of ovarian function made it difficult to accurately assess the risk of POF and efficiency of OTC. Our findings confirm a 30% pregnancy rate after ovarian cortex autotransplantation but also stress the difficulties of evaluating the real efficacy of OTC. No funding was sought for this study and none of the authors have any conflict of interest. ClinicalTrials.gov Registration ID: CRYOFONOV01. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs.

PubMed

Hoshino, Tatsuro; Muto, Nanami; Tsukada, Shinsuke; Nakamura, Takatoshi; Maegawa, Hikoichiro

2018-01-06

Since the publication of "Application Guideline for Western Traditional Herbal Medicines as OTC Drugs" in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved.

European Ethnopharmaceuticals for Self-Medication in Japan: Review Experience of Vitis vinifera L., Folium Extract and Vitex agnus-castus L., Fructus Extract as OTC Drugs

PubMed Central

Hoshino, Tatsuro; Muto, Nanami; Tsukada, Shinsuke; Nakamura, Takatoshi; Maegawa, Hikoichiro

2018-01-01

Since the publication of “Application Guideline for Western Traditional Herbal Medicines as OTC Drugs” in 2007, only two European ethnopharmaceuticals, Vitis vinifera L., folium extract (Antistax) and Vitex agnus-castus L., fructus extract (Prefemin), have been approved as OTC drugs in Japan. In this review, we describe the current regulation of Western ethnopharmaceuticals in Japan, summarize our regulatory experiences and discuss the scientific and regulatory issues involved. PMID:29316611

Disentangling Intracycle Interferences in Photoelectron Momentum Distributions Using Orthogonal Two-Color Laser Fields

NASA Astrophysics Data System (ADS)

Xie, Xinhua; Wang, Tian; Yu, ShaoGang; Lai, XuanYang; Roither, Stefan; Kartashov, Daniil; Baltuška, Andrius; Liu, XiaoJun; Staudte, André; Kitzler, Markus

2017-12-01

We use orthogonally polarized two-color (OTC) laser pulses to separate quantum paths in the multiphoton ionization of Ar atoms. Our OTC pulses consist of 400 and 800 nm light at a relative intensity ratio of 10 ∶1 . We find a hitherto unobserved interference in the photoelectron momentum distribution, which exhibits a strong dependence on the relative phase of the OTC pulse. Analysis of model calculations reveals that the interference is caused by quantum pathways from nonadjacent quarter cycles.

76 FR 65221 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... (formerly, ``Pink Sheets''), operated by OTC Markets Group Inc. (``OTC Link''). According to representatives...-dealers would have been unable to accurately determine the market depth of, and demand for, securities in...

Concentrations of organotin compounds in various fish species in the Finnish lake waters and Finnish coast of the Baltic Sea.

PubMed

Rantakokko, Panu; Hallikainen, Anja; Airaksinen, Riikka; Vuorinen, Pekka J; Lappalainen, Antti; Mannio, Jaakko; Vartiainen, Terttu

2010-05-15

Organotin compounds (OTCs) leaching from the antifouling paints used in boats and ships have contaminated many water areas worldwide. The purpose of this study was to obtain a general view of the organotin contamination in fish in Finnish lake areas and Finnish coast of the Baltic Sea using perch as the main indicator species. Perch sampling covered areas presumed as less contaminated and areas suspected as more contaminated. Besides perch, 12 other species were sampled from sites presumed as less contaminated. OTCs measured were mono-, di- and tributyltin, mono-, di-, and triphenyltin and dioctyltin. The sum concentration of OTCs (SigmaOTCs) in perch in the least contaminated areas of the Baltic Sea were around 20 ng/g fresh weight (fw) and less than 10 ng/g fw in lake areas. In heavily contaminated areas of the Baltic Sea 150-500 ng/g fw in perch were detected. In lake areas the maximum SigmaOTCs in perch was only 30 ng/g fw. With regard to the other species in the Baltic Sea, salmon, sprat, flounder, whitefish, vendace and lamprey contained low concentrations (SigmaOTCs mainly less than 20 ng/g fw), whereas in pike, pike-perch, burbot and bream concentrations were higher. SigmaOTCs in lake fish were generally lower than in the Baltic Sea. In a distance gradient study, SigmaOTCs in perch decreased quickly from nearly 200 ng/g fw at a contaminated harbor area to 35 ng/g fw during a distance of 5 km. Further decrease was slower and reached 15 ng/g fw at 100 km. In a size dependence study triphenyltin showed better correlation with the fish length than tributyltin for all species studied, i.e. for perch (0.16 vs 0.26), pike-perch (0.13 vs 0.24) and roach (0.46 vs 0.80). High correlation for roach may be partly explained by smaller number of samples collected and small length range. Copyright 2010 Elsevier B.V. All rights reserved.

Urticarial vasculitis induced by OTC diet pills: a case report.

PubMed

Chérrez Ojeda, Iván; Loayza, Enrique; Greiding, Leonardo; Calderón, Juan Carlos; Cherrez, Annia; Adum, Farid

2015-01-01

Urticarial Vasculitis (UV) is in most of the cases idiopathic; however it has been associated with several conditions and drugs. Over the counter (OTC) diet pills are widely available, even on-line, but they are rarely regulated by pharmaceutical control. We present the case of a 35-year-old female patient suffering of pruriginous and painful wheals more than 1 cm in diameter, with a burning sensation. The eruption lasted more than 24 hours and was accompanied by angioedema, headache and myalgia. No remarkable medical history was found, except for previous intake of OTC diet pills. UV diagnosis was confirmed by the skin biopsy of a lesion. OTC diet pills are widely available worldwide, and due to its widespread use, allergologists and dermatologist should be able to recognize symptoms and lesions of cutaneous vasculitis, which may be under reported.

From prescription-only (Rx) to over-the-counter (OTC) status in Germany 2006-2015: pharmacological perspectives on regulatory decisions.

PubMed

Barrenberg, Eva; Garbe, Edeltraut

2017-07-01

Little is known about the extent of switches from prescription-only (Rx) to over-the-counter (OTC) status in Europe and about the pharmacological properties of the switched substances. The objectives of this study were to provide an overview of the substances that were switched from Rx to OTC status in Germany between 2006 and 2015 and to assess their pharmacological properties. Session minutes of the German Expert Advisory Committee for Prescription-Only Issues, changes to the German Ordinance on Prescription-Only Medicines and the Summary of Product Characteristics of the switched substances were analysed. Pharmacological properties were studied in relation to the EU Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use (the 'EU switch guide'). Between 2006 and 2015, seven substances (almotriptan, omeprazole, benzydamine, ibuprofen/pseudoephedrine, racecadotril, ketotifen and levonorgestrel) were switched from Rx to OTC status in Germany. In all cases, the OTC status was restricted to certain indications, doses, pack sizes, or other limitations. Notwithstanding recommendations of the EU switch guide, some of the switched substances might interact with commonly used drugs potentially resulting in serious adverse drug reactions or have contraindications or warnings regarding substantial parts of the population. The stipulations of the EU switch guide were fully met for only some switches, while this was not completely the case for others. Further development of guidance on balancing risks and benefits of OTC availability is recommended.

[Use and potential risks of over-the-counter analgesics].

PubMed

Freytag, A; Quinzler, R; Freitag, M; Bickel, H; Fuchs, A; Hansen, H; Hoefels, S; König, H-H; Mergenthal, K; Riedel-Heller, S G; Schön, G; Weyerer, S; Wegscheider, K; Scherer, M; van den Bussche, H; Haefeli, W E; Gensichen, J

2014-04-01

We investigated the use of prescription and non-prescription (over-the-counter, OTC) analgesics and the associated risks in elderly patients with multiple morbidities. Pain medication use was evaluated from the baseline data (2008/2009) of the MultiCare cohort enrolling elderly patients with multiple morbidities who were treated by primary care physicians (trial registration: ISRCTN89818205). We considered opioids (N02A), other analgesics, and antipyretics (N02B) as well as nonsteroidal anti-inflammatory drugs (NSAIDs; M01A). OTC use, duplicate prescription, dosages, and interactions were examined for acetylsalicylic acid, diclofenac, (dex)ibuprofen, naproxen, and acetaminophen. Of 3,189 patients with multiple morbidities aged 65-85 years, 1,170 patients reported to have taken at least one prescription or non-prescription analgesic within the last 3 months (36.7 %). Of these, 289 patients (24.7 % of 1,170) took at least one OTC analgesic. Duplicate prescription was observed in 86 cases; 15 of these cases took the analgesics regularly. In two cases, the maximum daily dose of diclofenac was exceeded due to duplicate prescription. In 235 cases, patients concurrently took a drug with a potentially clinically relevant interaction. In 43 cases (18.3 % of 235) an OTC analgesic, usually ibuprofen, was involved. About one third of the elderly patients took analgesics regularly or as needed. Despite the relatively high use of OTC analgesics, the proportions of duplicate prescription, medication overdoses, and adverse interactions due to OTC products was low.

Genetic characterization of enzymes involved in the priming steps of oxytetracycline biosynthesis in Streptomyces rimosus.

PubMed

Wang, Peng; Gao, Xue; Chooi, Yit-Heng; Deng, Zixin; Tang, Yi

2011-08-01

Tetracyclines are clinically important aromatic polyketides whose biosynthesis is catalysed by bacterial type II polyketide synthases (PKSs). Tetracyclines are biosynthesized starting with an amide-containing malonamate starter unit and the resulting C-2 carboxyamide is critical for the antibiotic activities. In this work, we genetically verified that an amidotransferase, OxyD, and a thiolase, OxyP, are involved in the biosynthesis and incorporation of the starter unit. First, two mutations, R248T and D268N, were found to be present in OxyD* encoded in Streptomyces rimosus ATCC 13224, a strain that produces the acetate-primed 2-acetyl-2-decarboxyamido-oxytetracycline (ADOTC) instead of the malonamate-primed oxytetracycline (OTC). Homology modelling suggested that in particular D268N may inactivate OxyD. Complementation of S. rimosus ATCC 13224 with wild-type OxyD restored OTC biosynthesis, thereby confirming the essential role of OxyD in the synthesis of the amide starter unit. Second, using a series of knockout and complementation approaches, we demonstrated that OxyP is most likely involved in maintaining fidelity of the amide-priming process via hydrolysis of the competing acetate priming starter units. While the inactivation of OxyP does not eliminate OTC biosynthesis, the ratio of acetate-primed ADOTC to malonamate-primed OTC is significantly increased. This suggests that OxyP plays an ancillary role in OTC biosynthesis and is important for minimizing the levels of ADOTC, a shunt product that has much weaker antibiotic activities than OTC.

Nitric oxide is involved in the oxytetracycline-induced suppression of root growth through inhibiting hydrogen peroxide accumulation in the root meristem

NASA Astrophysics Data System (ADS)

Yu, Qing-Xiang; Ahammed, Golam Jalal; Zhou, Yan-Hong; Shi, Kai; Zhou, Jie; Yu, Yunlong; Yu, Jing-Quan; Xia, Xiao-Jian

2017-02-01

Use of antibiotic-contaminated manure in crop production poses a severe threat to soil and plant health. However, few studies have studied the mechanism by which plant development is affected by antibiotics. Here, we used microscopy, flow cytometry, gene expression analysis and fluorescent dyes to study the effects of oxytetracycline (OTC), a widely used antibiotic in agriculture, on root meristem activity and the accumulation of hydrogen peroxide (H2O2) and nitric oxide (NO) in the root tips of tomato seedlings. We found that OTC caused cell cycle arrest, decreased the size of root meristem and inhibited root growth. Interestingly, the inhibition of root growth by OTC was associated with a decline in H2O2 levels but an increase in NO levels in the root tips. Diphenyliodonium (DPI), an inhibitor of H2O2 production, showed similar effects on root growth as those of OTC. However, exogenous H2O2 partially reversed the effects on the cell cycle, meristem size and root growth. Importantly, cPTIO (the NO scavenger) and tungstate (an inhibitor of nitrate reductase) significantly increased H2O2 levels in the root tips and reversed the inhibition of root growth by OTC. Out results suggest that OTC-induced NO production inhibits H2O2 accumulation in the root tips, thus leading to cell cycle arrest and suppression of root growth.

Oxidative degradation of the antibiotic oxytetracycline by Cu@Fe3O4 core-shell nanoparticles.

PubMed

Pham, Van Luan; Kim, Do-Gun; Ko, Seok-Oh

2018-08-01

A core-shell nanostructure composed of zero-valent Cu (core) and Fe 3 O 4 (shell) (Cu@Fe 3 O 4 ) was prepared by a simple reduction method and was evaluated for the degradation of oxytetracycline (OTC), an antibiotic. The Cu core and the Fe 3 O 4 shell were verified by X-ray diffractometry (XRD) and transmission electron microscopy. The optimal molar ratio of [Cu]/[Fe] (1/1) in Cu@Fe 3 O 4 created an outstanding synergic effect, leading to >99% OTC degradation as well as H 2 O 2 decomposition within 10min at the reaction conditions of 1g/L Cu@Fe 3 O 4 , 20mg/L OTC, 20mM H 2 O 2 , and pH3.0 (and even at pH9.0). The OTC degradation rate by Cu@Fe 3 O 4 was higher than obtained using single nanoparticle of Cu or Fe 3 O 4 . The results of the study using radical scavengers showed that OH is the major reactive oxygen species contributing to the OTC degradation. Finally, good stability, reusability, and magnetic separation were obtained with approximately 97% OTC degradation and no notable change in XRD patterns after the Cu@Fe 3 O 4 catalyst was reused five times. These results demonstrate that Cu@Fe 3 O 4 is a novel prospective candidate for the pharmaceutical and personal care products degradation in the aqueous phase. Copyright © 2018 Elsevier B.V. All rights reserved.

Oxytetracycline recovery from aqueous media using computationally designed molecularly imprinted polymers.

PubMed

Rodríguez-Dorado, Rosalía; Carro, Antonia M; Chianella, Iva; Karim, Kal; Concheiro, Angel; Lorenzo, Rosa A; Piletsky, Sergey; Alvarez-Lorenzo, Carmen

2016-09-01

Polymers for recovery/removal of the antimicrobial agent oxytetracycline (OTC) from aqueous media were developed with use of computational design and molecular imprinting. 2-Hydroxyethyl methacrylate, 2-acrylamide-2-methylpropane sulfonic acid (AMPS), and mixtures of the two were chosen according to their predicted affinity for OTC and evaluated as functional monomers in molecularly imprinted polymers and nonimprinted polymers. Two levels of AMPS were tested. After bulk polymerization, the polymers were crushed into particles (200-1000 μm). Pressurized liquid extraction was implemented for template removal with a low amount of methanol (less than 20 mL in each extraction) and a few extractions (12-18 for each polymer) in a short period (20 min per extraction). Particle size distribution, microporous structure, and capacity to rebind OTC from aqueous media were evaluated. Adsorption isotherms obtained from OTC solutions (30-110 mg L(-1)) revealed that the polymers prepared with AMPS had the highest affinity for OTC. The uptake capacity depended on the ionic strength as follows: purified water > saline solution (0.9 % NaCl) > seawater (3.5 % NaCl). Polymer particles containing AMPS as a functional monomer showed a remarkable ability to clean water contaminated with OTC. The usefulness of the stationary phase developed for molecularly imprinted solid-phase extraction was also demonstrated. Graphical Abstract Selection of functional monomers by molecular modeling renders polymer networks suitable for removal of pollutants from contaminated aqueous environments, under either dynamic or static conditions.

[Knowledge, attitudes, and behaviour of the population of the Czech Republic to self-medication. III: behaviour in the area of drugs and self-medication].

PubMed

Drhová, L

2005-09-01

A large survey carried out from June to September 2002 in the territory of the Czech Republic found and analyzed the knowledge of the population of the Czech Republic in relation to self-medication and o-t-c drugs and revealed the main problematic areas from the viewpoint of the public. The survey was particularly focused on the behaviour of people in relation to packaging of OTC drugs and drug information sheets, expiration period of medicaments-advertisements for OTC drugs in the media, most frequently selected indications for self-medication, self-medication in small children, financial participation in self-medication and the resultant compliance or non-compliance, and the price of the OTC drug and dosage. The results show that 68% of respondents are able to take a medicine after its expiration period. An o-t-c drug would be bought just on the basis of television advertising by 7% of respondents, and more than a half of the respondents (57%) stated they would first consult their physician or pharmacist. In the case of a sudden ailment of a one-year-old child, 80% of respondents stated that they would contact the physician, 8% opted for self-medication. Under the assumption that an OTC drug is covered by health insurance, 27% of respondents would go to the physician, though they could buy it themselves.

Classification with asymmetric label noise: Consistency and maximal denoising

DOE PAGES

Blanchard, Gilles; Flaska, Marek; Handy, Gregory; ...

2016-09-20

In many real-world classification problems, the labels of training examples are randomly corrupted. Most previous theoretical work on classification with label noise assumes that the two classes are separable, that the label noise is independent of the true class label, or that the noise proportions for each class are known. In this work, we give conditions that are necessary and sufficient for the true class-conditional distributions to be identifiable. These conditions are weaker than those analyzed previously, and allow for the classes to be nonseparable and the noise levels to be asymmetric and unknown. The conditions essentially state that amore » majority of the observed labels are correct and that the true class-conditional distributions are “mutually irreducible,” a concept we introduce that limits the similarity of the two distributions. For any label noise problem, there is a unique pair of true class-conditional distributions satisfying the proposed conditions, and we argue that this pair corresponds in a certain sense to maximal denoising of the observed distributions. Our results are facilitated by a connection to “mixture proportion estimation,” which is the problem of estimating the maximal proportion of one distribution that is present in another. We establish a novel rate of convergence result for mixture proportion estimation, and apply this to obtain consistency of a discrimination rule based on surrogate loss minimization. Experimental results on benchmark data and a nuclear particle classification problem demonstrate the efficacy of our approach. MSC 2010 subject classifications: Primary 62H30; secondary 68T10. Keywords and phrases: Classification, label noise, mixture proportion estimation, surrogate loss, consistency.« less

Classification with asymmetric label noise: Consistency and maximal denoising

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blanchard, Gilles; Flaska, Marek; Handy, Gregory

In many real-world classification problems, the labels of training examples are randomly corrupted. Most previous theoretical work on classification with label noise assumes that the two classes are separable, that the label noise is independent of the true class label, or that the noise proportions for each class are known. In this work, we give conditions that are necessary and sufficient for the true class-conditional distributions to be identifiable. These conditions are weaker than those analyzed previously, and allow for the classes to be nonseparable and the noise levels to be asymmetric and unknown. The conditions essentially state that amore » majority of the observed labels are correct and that the true class-conditional distributions are “mutually irreducible,” a concept we introduce that limits the similarity of the two distributions. For any label noise problem, there is a unique pair of true class-conditional distributions satisfying the proposed conditions, and we argue that this pair corresponds in a certain sense to maximal denoising of the observed distributions. Our results are facilitated by a connection to “mixture proportion estimation,” which is the problem of estimating the maximal proportion of one distribution that is present in another. We establish a novel rate of convergence result for mixture proportion estimation, and apply this to obtain consistency of a discrimination rule based on surrogate loss minimization. Experimental results on benchmark data and a nuclear particle classification problem demonstrate the efficacy of our approach. MSC 2010 subject classifications: Primary 62H30; secondary 68T10. Keywords and phrases: Classification, label noise, mixture proportion estimation, surrogate loss, consistency.« less

Loosely bound oxytetracycline in riverine sediments from two tributaries of the Chesapeake Bay

USGS Publications Warehouse

Simon, N.S.

2005-01-01

The fate of antibiotics that bind to riverine sediment is not well understood. A solution used in geochemical extraction schemes to determine loosely bound species in sediments, 1 M MgCl2 (pH 8), was chosen to determine loosely bound, and potentially bioavailable, tetracycline antibiotics (TCs), including oxytetracycline (5-OH tetracycline) (OTC) in sediment samples from two rivers on the eastern shore of the Chesapeake Bay. Bottom sediments were collected at sites upstream from, at, and downstream from municipal sewage-treatment plants (STPs) situated on two natural waterways, Yellow Bank Stream, MD, and the Pocomoke River, MD. Concentrations of easily desorbed OTC ranged from 0.6 to approximately 1.2 ??g g-1 dry wt sediment in Yellow Bank Stream and from 0.7 to approximately 3.3 ??g g-1 dry wt sediment in the Pocomoke River. Concentrations of easily desorbable OTC were generally smaller in sediment upstream than in sediment downstream from the STP in the Pocomoke River. STPs and poultry manure are both potential sources of OTC to these streams. OTC that is loosely bound to sediment is subject to desorption. Other researchers have found desorbed TCs to be biologically active compounds.

Application for oxytetracycline wastewater pretreatment by Fenton iron mud based cathodic-anodic-electrolysis ceramic granular fillers.

PubMed

Zhang, Feilong; Yue, Qinyan; Gao, Yuan; Gao, Baoyu; Xu, Xing; Ren, Zhongfei; Jin, Yang

2017-09-01

In this study, Fenton iron mud applied as main raw material of cathodic-anodic-electrolysis ceramic granular fillers (ICMF) in a continuous reactor, which were used to pretreat oxytetracycline (OTC) wastewater. The ICMF was characterized by Scanning Electron Microscope and Energy Dispersive Spectrometer analysis. The effects of pH value, hydraulic retention time, OTC concentrations and aeration on removal efficiency of total organic carbon (TOC) and OTC were studied. The degradation byproducts of OTC were analyzed by UV-2450, High Performance Liquid Chromatography and Liquid Chromatography-mass Spectrometry. The SEM images showed that the surface ICMF was porous. This system had a higher stability, and good removal efficiency of TOC of 80.5% and OTC of 98.5% under the optimal conditions, which were influent pH of 3, HRT of 4 h, and anaerobic condition. After running for 60 d, the removal efficiency of TOC was stable and the ICMF did not become hardened. The reactor was back washed by acid solution (pH: 1) in 20 d approximately. This paper provides useful information for approaching in wastewater pretreatment and recycling the Fenton iron mud. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Effects of simulated warming on the growth, leaf phenology, and leaf traits of Salix eriostachya in sub-alpine timberline ecotone of western Sichuan, China].

PubMed

Xu, Zhen-feng; Hu, Ting-xing; Zhang, Li; Zhang, Yuan-bin; Xian, Jun-ren; Wang, Kai-yun

2009-01-01

By using open-top chamber (OTC), the effects of simulated warming on the growth, leaf phenology, and leaf traits of Salix eriostachya in sub-alpine timberline ecotone of Western Sichuan were studied. The results showed that comparing with the control, the mean air temperature at 1.2 m above the ground throughout S. eriostachya growth season in OTC increased by 2.9 degrees C, while the soil temperature at the depth of 5 cm only increased by 0.4 degrees C. The temperature increase in OTC made S. eriostachya budding advanced and defoliation postponed obviously, and the leaf life-span longer. The leaf and branch growth rates as well as the specific leaf area in OTC increased obviously, whereas the leaf nitrogen concentration decreased significantly. In OTC, the stomata conductance, net photosynthetic rate, photorespiration, and dark respiration rate of S. eriostachya all exhibited an increasing trend. It was suggested that S. eriostachya had stronger capability to adapt to warming, and, under the background of future global climate change, the elevation of S. eriostachya distribution in the timberline ecotone would be likely to ascend.

Assessing the economic impact of Rx-to-OTC switches: systematic review and guidelines for future development.

PubMed

Cohen, J; Millier, A; Karray, S; Toumi, M

2013-01-01

Switching drugs from prescription to non-prescription status (Rx-to-OTC) presents a unique set of challenges and opportunities to policy-makers and the industry in terms of managing health outcomes, pharmaceutical spending, and steering of consumer choices of therapy. Decision-analytic models are used to address uncertainty and produce reasonable estimates of the economic impact of switches for payers. This article presents a critical literature review of existing models which assess the economic impact of Rx-to-OTC switches, and provides guidelines in which future economic evaluations of Rx-to-OTC switches could be improved. A comprehensive search strategy was implemented in Medline and Embase, to retrieve published economic evaluations on Rx-to-OTC switches from 1995-2010. The research digest of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) was reviewed for potentially relevant abstracts for the past 3 years. Each model used was critically evaluated in terms of structure, relevance of inputs, methodology used, and robustness of results. Worldwide, the economic impact of Rx-to-OTC switches has only been evaluated in a total of 12 peer-reviewed publications. Ten out of 12 studies were US-based, and two European-based. The models covered various disease categories, including allergy, hypercholesterolemia, gastroenterology, contraception, pulmonology, and virology. Seventy-five per cent of the models predicted cost savings for payers and patients. Limitations of the models mainly included use of strong assumptions and non-inclusion of specific populations due to lack of data. Guidelines were developed to help future model development. They cover structural issues on decision context, health states, and clinical outcomes, and other considerations for model specifications. Although reviewed studies lacked quality, this review of economic evidence of Rx-to-OTC switches suggests that switches may produce cost savings to public and private payers. This is especially important in light of the trend towards more switches.

[Effects of soil trituration size on adsorption of oxytetracycline on soils].

PubMed

Qi, Rui-Huan; Li, Zhao-Jun; Long, Jian; Fan, Fei-Fei; Liang, Yong-Chao

2011-02-01

In order to understand the effects of soil trituration size on adsorption of oxytetracycline (OTC) on soils, two contrasting soils including moisture soil and purplish soil were selected to investigate adsorption of OTC on these soils, at the scales of no more than 0.20 mm, 0.84 mm, 0.25 mm and 0.15 mm, using the method of batch equilibrium experiments respectively. The results presented as the following: (1) Adsorption amount of OTC on moisture soil and purplish soil increased with the sampling time, and reached to equilibration at 24 h. First-order kinetic model, second-order kinetic model, parabolic-diffusion kinetic model, Elovich kinetic model, and two-constant kinetic model could be used to fit the changes in adsorption on soils with sampling time. Adsorption of OTC on two soils consisted of two processes such as quick adsorption and slow adsorption. Quick adsorption process happened during the period of 0-0.5 h. The adsorption rates of OTC on soils were higher at the small trituration size than those at the large trituration size, and at the same trituration size, the k(f) of purplish soil was about two times higher than those of moisture soil. (2) Adsorption isotherms of OTC on two soils with different trituration sizes were deviated from the linear model. The data were fitted well to Freundlich and Langmuir models, with the correlation coefficients between 0.956 and 0.999. The values of k(f) and q(m) for purplish soil were higher than those for moisture soil. At the same soil, adsorption amount of OTC increased with the decreases of soil trituration size. The results suggested that it is important to select the appropriate trituration size, based on the physical and chemical properties such as soil particle composition and so on, when the fate of antibiotics on soils was investigated.

A dose-response relationship for marketable yield reduction of two lettuce (Lactuca sativa L.) cultivars exposed to tropospheric ozone in Southern Europe.

PubMed

Marzuoli, Riccardo; Finco, Angelo; Chiesa, Maria; Gerosa, Giacomo

2017-12-01

The present study investigated the response to ozone (O 3 ) of two cultivars (cv.'Romana' and cv. 'Canasta') of irrigated lettuce grown in an open-top chamber (OTC) experiment in Mediterranean conditions. Two different levels of O 3 were applied, ambient O 3 in non-filtered OTCs (NF-OTCs) and -40% of ambient O 3 in charcoal-filtered OTCs (CF-OTCs), during four consecutive growing cycles. At the end of each growing cycle, the marketable yield (fresh biomass) was assessed while during the growing periods, measurements of the stomatal conductance at leaf level were performed and used to define a stomatal conductance model for calculation of the phytotoxic ozone dose (POD) absorbed by the plants.Results showed that O 3 caused statistically significant yield reductions in the first and in the last growing cycle. In general, the marketable yield of the NF-OTC plants was always lower than the CF-OTC plants for both cultivars, with mean reductions of -18.5 and -14.5% for 'Romana' and 'Canasta', respectively. On the contrary, there was no statistically significant difference in marketable yield due to the cultivar factor or to the interaction between O 3 and cultivar in any of the growing cycle performed.Dose-response relationships for the marketable relative yield based on the POD values were calculated according to different flux threshold values (Y). The best regression fit was obtained using an instantaneous flux threshold of 6 nmol O 3 m -2  s -1 (POD 6 ); the same value was obtained also for other crops. According to the generic lettuce dose-response relationship, an O 3 critical level of 1 mmol O 3 m -2 of POD 6 for a 15% of marketable yield loss was found.

Total tin and organotin speciation in historic layers of antifouling paint on leisure boat hulls.

PubMed

Lagerström, Maria; Strand, Jakob; Eklund, Britta; Ytreberg, Erik

2017-01-01

Despite their ban on small vessels in 1989 in the EU, organotin compounds (OTCs) are still being released into the environment due to their presence in historic paint layers on leisure boats. 23 paint samples scraped from recreational boats from three countries around the Baltic Sea were analyzed for total tin (Sn) and OTCs. Two antifouling paint products were also subjected to the same analyses. A new method for the detection of Sn in paint flake samples was developed and found to yield more accurate results compared to four different acid digestion methods. A new method was also developed for the extraction of OTCs from ground paint flakes. This endeavor revealed that existing methods for organotin analysis of sediment may not have full recoveries of OTCs if paint flakes are present in the sample. The hull paint samples had Sn concentrations ranging from 25 to 18,000 mg/kg paint and results showed that tributyltin (TBT) was detected in all samples with concentrations as high as 4.7 g (as Sn)/kg paint. TBT was however not always the major OTC. Triphenyltin (TPhT) was abundant in many samples, especially in those originating from Finland. Several other compounds such as monobutyltin (MBT), dibutyltin (DBT), tetrabutyltin (TeBT), monophenyltin (MPhT) and diphenyltin (DPhT) were also detected. These could be the result of degradation occurring on the hull or of impurities in the paint products as they were also identified in the two analyzed paint products. A linear correlation (r 2  = 0.934) was found between the total tin content and the sum of all detected OTCs. The detection of tin can therefore be used to indicate the presence of OTCs on leisure boats. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Experimental surveillance using data on sales of over-the-counter medications--Japan, November 2003-April 2004.

PubMed

Ohkusa, Yasushi; Shigematsu, M; Taniguchi, K; Okabe, N

2005-08-26

This report describes a study to explore the possibility of using data on sales of over-the- counter (OTC) medications as part of a routine syndromic surveillance system aimed at early detection of infections of public health concern. A retrospective evaluation was conducted of sales of OTC medications used to treat the common cold. This report discusses the correlation of these data to influenza activity in Japan during the 2003-04 influenza season and evaluates the potential of using such data to predict influenza epidemics. Data from approximately 1,100 pharmacies throughout Japan collected during November 2003-April 2004 were analyzed. OTC sales data were compared with influenza incidence data (one weekly and two daily data sets) to determine correlations and predictability. Adjusted R-square was used as an index of goodness of-fit in the estimation. Data reflecting daily influenza activity were obtained from the National Surveillance of Daily Influenza Outpatients and the Mailing List-Based Influenza Epidemic Database. National sentinel surveillance data for influenza from approximately 5,000 sites nationwide also were analyzed. Although a correlation was demonstrated between sales of OTC medications used to treat the common cold and concurrent influenza activity, analysis of sales data alone was not sufficient to determine influenza activity in advance even when sales promotion effects were excluded from the analysis. Because visiting a health-care provider costs more than purchasing OTC medications, the hypothesis was formed that an ill person will purchase OTC medications first and visit a physician only if the condition does not resolve or worsens. The results of this study do not provide any clear evidence to support this hypothesis. For this reason, OTC sales do not appear to be a good candidate for a national real-time detection system for influenza epidemics in Japan.

Using partially labeled data for normal mixture identification with application to class definition

NASA Technical Reports Server (NTRS)

Shahshahani, Behzad M.; Landgrebe, David A.

1992-01-01

The problem of estimating the parameters of a normal mixture density when, in addition to the unlabeled samples, sets of partially labeled samples are available is addressed. The density of the multidimensional feature space is modeled with a normal mixture. It is assumed that the set of components of the mixture can be partitioned into several classes and that training samples are available from each class. Since for any training sample the class of origin is known but the exact component of origin within the corresponding class is unknown, the training samples as considered to be partially labeled. The EM iterative equations are derived for estimating the parameters of the normal mixture in the presence of partially labeled samples. These equations can be used to combine the supervised and nonsupervised learning processes.

OTC Medicines: Know Your Risks, and Reduce Them

MedlinePlus

... something for just a short time. Include any herbal supplements, vitamins, and minerals you take. Once a year, ... you take. This includes OTC medicines, vitamins, and herbal supplements. Your doctor can tell you whether you are ...

Hypertension among Oral Contraceptive Users in El Paso, Texas

PubMed Central

White, Kari; Potter, Joseph E.; Hopkins, Kristine; Amastae, Jon; Grossman, Daniel

2015-01-01

On the U.S.-Mexico border, residents frequently cross into Mexico to obtain medications or medical care. We previously reported relatively high prevalence of hypertension among Latina oral contraceptive users in El Paso, particularly those obtaining pills over the counter (OTC) in Mexico. Here, we examine factors associated with having hypertension among 411 OTC users and 399 clinic users. We also assess hypertension awareness and interest in using blood pressure kiosks. Women age 35 to 44 and who had BMI ≥ 30 kg/m2 had higher odds of having hypertension. 59% of hypertensive women had unrecognized hypertension, and 77% of all participants would use a blood pressure kiosk; there were no significant differences between clinic and OTC users. Alternative approaches to increase access to health screenings are needed in this setting, where OTC pill use among women with unrecognized hypertension confers unique health risks. PMID:24185148

OTC analgesics and drug interactions: clinical implications

PubMed Central

Fendrick, A Mark; Pan, Deborah E; Johnson, Grace E

2008-01-01

The risk of drug interactions with concurrent use of multiple medications is a clinically relevant issue. Many patients are unaware that over-the-counter (OTC) analgesics can cause potentially serious adverse effects when used in combination with other common medications such as anticoagulants, corticosteroids, or antihypertensive agents. Of particular significance is the increased risk of upper abdominal gastrointestinal adverse events in patients who take traditional nonsteroidal anti-inflammatory drugs (NSAIDs). This risk is dose dependent and further increased in patients who take more than one NSAID or use NSAIDs in combination with certain other medications. Some NSAIDs may also mitigate the antiplatelet benefits of aspirin and may increase blood pressure in patients with hypertension. Clinicians should be aware of potential drug interactions with OTC analgesics when prescribing new medications. Additionally, patients should be properly counseled on the appropriate and safe use of OTC analgesics. PMID:18257920

Evaluation of the diffusion coefficient for controlled release of oxytetracycline from alginate/chitosan/poly(ethylene glycol) microbeads in simulated gastrointestinal environments.

PubMed

Cruz, Maria C Pinto; Ravagnani, Sergio P; Brogna, Fabio M S; Campana, Sérgio P; Triviño, Galo Cardenas; Lisboa, Antonio C Luz; Mei, Lucia H Innocentini

2004-12-01

Diffusion studies of OTC (oxytetracycline) entrapped in microbeads of calcium alginate, calcium alginate coacervated with chitosan (of high, medium and low viscosity) and calcium alginate coacervated with chitosan of low viscosity, covered with PEG [poly(ethylene glycol) of molecular mass 2, 4.6 and 10 kDa, were carried out at 37+/-0.5 degrees C, in pH 7.4 and pH 1.2 buffer solutions - conditions similar to those found in the gastrointestinal system. The diffusion coefficient, or diffusivity (D), of OTC was calculated by equations provided by Crank [(1975) Mathematics in Diffusion, p. 85, Clarendon Press, Oxford] for diffusion, which follows Fick's [(1855) Ann. Physik (Leipzig) 170, 59] second law, considering the diffusion from the inner parts to the surface of the microbeads. The least-squares and the Newton-Raphson [Carnahan, Luther and Wilkes (1969) Applied Numerical Methods, p. 319, John Wiley & Sons, New York] methods were used to obtain the diffusion coefficients. The microbead swelling at pH 7.4 and OTC diffusion is classically Fickian, suggesting that the OTC transport, in this case, is controlled by the exchange rates of free water and relaxation of calcium alginate chains. In case of acid media, it was observed that the phenomenon did not follow Fick's law, owing, probably, to the high solubility of the OTC in this environment. It was possible to modulate the release rate of OTC in several types of microbeads. The presence of cracks formed during the process of drying the microbeads was observed by scanning electron microscopy.

[Comparison in dissolution behavior of ethical and over-the counter scopolamine butylbromide].

PubMed

Suzuki, Ichie; Miyazaki, Yasunori; Uchino, Tomonobu; Kagawa, Yoshiyuki

2011-01-01

Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a prescription drug to OTC, pharmacists can acquire that information from the corresponding ethical drug (ED) through the package insert, interview form, and so on. However, the pharmaceutical equivalence between ED and OTC is unclear. In this study, we examined the drug dissolution behavior of both ED and OTCs containing scopolamine butylbromide. Dissolution tests were performed by the paddle method using Japanese Pharmacopeia (JP) XV test fluids at pH 1.2, 4.0 and 6.8 and water based on the guidelines for bioequivalence studies of generic products. The dissolution profiles of OTCs differed significantly from ED showing a similarity factor (f2) value ranging from 8.9 to 42.9. Time until 85% dissolution ranged from 23 to 95 min and from 17 to 174 min at pH 1.2 and pH 6.8, respectively. Then JP XV disintegration tests were conducted to investigate differences in the disintegration process. The disintegration time of preparations showing delayed dissolution was prolonged compared to that of others, suggesting that the disintegration of the tablet or capsule is one of the important factors affecting the drug dissolution. These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug. For patient safety, more detailed product information of OTCs should be supplied by the manufacturer, and not be assumed from that of corresponding ED.

Variable X-chromosome inactivation and enlargement of pericentral glutamine synthetase zones in the liver of heterozygous females with OTC deficiency.

PubMed

Musalkova, Dita; Sticova, Eva; Reboun, Martin; Sokolova, Jitka; Krijt, Jakub; Honzikova, Jitka; Gurka, Jiri; Neroldova, Magdalena; Honzik, Tomas; Zeman, Jiri; Jirsa, Milan; Dvorakova, Lenka; Hrebicek, Martin

2018-06-01

Ornithine transcarbamylase (OTC) deficiency is an X-linked disorder that causes recurrent and life-threatening episodes of hyperammonemia. The clinical picture in heterozygous females is highly diverse and derives from the genotype and the degree of inactivation of the mutated X chromosome in hepatocytes. Here, we describe molecular genetic, biochemical, and histopathological findings in the livers explanted from two female patients with late-onset OTC deficiency. Analysis of X-inactivation ratios by DNA methylation-based assays showed remarkable intra-organ variation ranging from 46:54 to 82:18 (average 70:30, n = 37), in favor of the active X chromosome carrying the mutation c.583G>C (p.G195R), in the first patient and from 75:25 to 90:10 (average 82:18, n = 20) in favor of the active X chromosome carrying the splicing mutation c.663+1G>A in the second patient. The X-inactivation ratios in liver samples correlated highly with the proportions of OTC-positive hepatocytes calculated from high-resolution image analyses of the immunohistochemically detected OTC in frozen sections that was performed on total area > 5 cm 2 . X-inactivation ratios in blood in both female patients corresponded to the lower limit of the liver values. Our data indicate that the proportion of about 20-30% of hepatocytes expressing the functional OTC protein is not sufficient to maintain metabolic stability. X-inactivation ratios assessed in liver biopsies taken from heterozygous females with X-linked disorders should not be considered representative of the whole liver.

Predictors of recall of over-the-counter and prescription non-steroidal anti-inflammatory drug exposure.

PubMed

Lewis, James D; Strom, Brian L; Kimmel, Stephen E; Farrar, John; Metz, David C; Brensinger, Colleen; Nessel, Lisa; Localio, A Russell

2006-01-01

Because of the difficulty in establishing a gold standard, data on accuracy of recall of over-the-counter (OTC) medication use are sparse. We studied a cohort of 1889 persons living in the Philadelphia area to assess recall of non-aspirin non-steroidal anti-inflammatory drug (NANSAID) use during the preceding 8 weeks. Our analyses were based on the assumption that among the group of subjects, on average, the reported usage of NANSAIDs should not vary over the previous 8 weeks. To model the effect of time on reported usage while allowing for the inherent correlation of responses within subjects over time, we employed alternating logistic regression. We documented a significant decline in reported use of OTC NANSAIDs but not prescription NANSAIDs during the 8-week study period (p = 0.3 for frequent prescription NANSAIDs, p = 0.2 for infrequent prescription NANSAIDs, p < 0.001 for frequent OTC NANSAIDs, and p < 0.001 for infrequent OTC NANSAIDs). Reported rates of frequent and infrequent OTC NANSAID consumption declined from 6.3 to 4.6% and from 17.1 to 12.8% between the most recent week and eight weeks prior, respectively. Interviews focusing on medications used on an as needed basis should be performed as close as possible to the index date. Likewise, data on frequent use of OTC NANSAIDs may be more reliable than that on infrequent use, particularly when subjects are asked to recall more than a few weeks back in time. (c) 2005 John Wiley & Sons, Ltd.

[The knowledge of students and teachers of selected groups about the OTC drugs containing codeine and pseudoephedrine--an alternative to "legal highs"?].

PubMed

Sliwińska-Mossoń, Mariola; Marcinkiewicz, Marcin; Marciniak, Katarzyna; Milnerowicz, Halina

2015-01-01

Currently the youth to intoxication increasingly used drugs generally available over the counter (OTC, Over-The-Counter drug) containing psychotropic substances. The knowledge on the subject among parents and teachers is inadequate. The aim of the study is to assess the knowledge of students and teachers about OTC drugs containing codeine or pseudoephedrine and their consequences on the use and popularity of these drugs. The study was conducted from December 2014 to March 2015 of 93 respondents. In conducting the study used research tool in the form of an anonymous questionnaire consisting of 21 questions for the students and teachers of 16 questions, the questions relate knowledge of the studied group persons on the OTC drugs containing codeine or pseudoephedrine and the effects of their use. Among the students participating in the study, the majority of respondents are aware that using drugs containing codeine or pseudoephedrine can be addicted to them. Higher knowledge on this subject have demonstrated high school students, but less teachers. Most of the respondents had knowledge about the health effects that result from an overdose of these drugs. Among the students most frequently reported sources of knowledge about OTC drugs containing codeine or pseudoephedrine were friends and the Internet. The general knowledge of high school students and teachers on the effects of OTC medications containing codeine or pseudoephedrine is not sufficient. There is a need to conduct preventive and educational action aimed at increasing knowledge among youth and adults on the health effects of these drugs.

76 FR 20744 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

...-Transaction Fees for Executions Against a Public Quotation in an OTC Equity Security April 8, 2011. On... disclose on its website any fees imposed against its published quotation in any OTC Equity Security...

Over-the-Counter Medicines

MedlinePlus

Over-the-counter (OTC) medicines are drugs you can buy without a prescription. Some OTC medicines relieve aches, pains and itches. Some prevent or cure ... the Food and Drug Administration decides whether a medicine is safe enough to sell over-the-counter. ...

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

Code of Federal Regulations, 2011 CFR

2011-04-01

..., eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of... such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil...

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

Code of Federal Regulations, 2013 CFR

2013-04-01

..., eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of... such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil...

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

Code of Federal Regulations, 2010 CFR

2010-04-01

..., eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of... such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil...

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

Code of Federal Regulations, 2014 CFR

2014-04-01

..., eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of... such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil...

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

Code of Federal Regulations, 2012 CFR

2012-04-01

..., eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lobeline (in the form of... such OTC drug product containing cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil...

49 CFR 177.842 - Class 7 (radioactive) material.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the labels on the individual packages and overpacks in the group. This provision does not apply to... Class 7 (radioactive) material bearing “RADIOACTIVE YELLOW-II” or “RADIOACTIVE YELLOW-III” labels may... transport index number determined by adding together the transport index number on the labels on the...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2010 CFR

2010-04-01

... recognition of the safety and effectiveness of these or any other orally administered ingredients for OTC use... is required for marketing. In the absence of an approved application, such product is also misbranded...

Use of Over-the-Counter Medication among Pregnant Women in Sharjah, United Arab Emirates

PubMed Central

Mustafa, Hafsa

2017-01-01

Background Over-the-counter medications are widely available in pharmacies Their safety profile, however, does not extend to pregnant women. Accordingly, there should be educational programs developed for pregnant women to protect them from the harms of the side effects. Aim This study was planned and designed with the aim of exploring the awareness and assessing the usage of OTC medications among pregnant women in Sharjah, UAE. Method A cross-sectional survey using a self-administered questionnaire. Results More than three-quarters (75.7%) reported that they are familiar with the term “over-the-counter drugs.” Interestingly, 40% of the respondents reported that they took OTC drugs during pregnancy, and the majority (94.2%) agreed with the survey statement “not all OTC medications are safe to be taken during pregnancy.” Constipation was the most frequent side effect that most of the participants reported during the study period. Folic acid (36%), calcium (28.6%), and iron (35.1%) were the most common supplements used by the pregnant women responding. Conclusion The reported 40% usage of OTC medications among pregnant women in this study is worrisome and calls for the need to educate, counsel, and increase awareness among pregnant women regarding the dangers of OTC drugs usage while pregnant in Sharjah, UAE. PMID:28804652

Development of the extraction method for the simultaneous determination of butyl-, phenyl- and octyltin compounds in sewage sludge.

PubMed

Zuliani, Tea; Lespes, Gaetane; Milacic, Radmila; Scancar, Janez

2010-03-15

The toxicity and bioaccumulation of organotin compounds (OTCs) led to the development of sensitive and selective analytical methods for their determination. In the past much attention was assigned to the study of OTCs in biological samples, water and sediments, coming mostly from marine environment. Little information about OTCs pollution of terrestrial ecosystems is available. In order to optimise the extraction method for simultaneous determination of butyl-, phenyl- and octyltin compounds in sewage sludge five different extractants (tetramethylammonium hydroxide, HCl in methanol, glacial acetic acid, mixture of acetic acid and methanol (3:1), and mixture of acetic acid, methanol and water (1:1:1)), the presence or not of a complexing agent (tropolone), and the use of different modes of extraction (mechanical stirring, microwave and ultrasonic assisted extraction) were tested. Extracted OTCs were derivatised with sodium tetraethylborate and determined by gas chromatography coupled with mass spectrometer. Quantitative extraction of butyl-, phenyl- and octyltin compounds was obtained by the use of glacial acetic acid as extractant and mechanical stirring for 16h or sonication for 30 min. The limits of detection and quantification for OTCs investigated in sewage sludge were in the ng S ng(-1) range. Copyright (c) 2009 Elsevier B.V. All rights reserved.

Barriers and Facilitators for Information Exchange during Over-The-Counter Consultations in Community Pharmacy: A Focus Group Study

PubMed Central

Seubert, Liza J; Boeni, Fabienne; Hattingh, Laetitia; Clifford, Rhonda M

2017-01-01

Consumers are confident managing minor ailments through self-care, often self-medicating from a range of over-the-counter (OTC) medicines available from community pharmacies. To minimise risks, pharmacy personnel endeavour to engage in a consultation when consumers present with OTC enquiries however they find consumers resistant. The aim was to determine stakeholder perspectives regarding barriers and facilitators for information exchange during OTC consultations in community pharmacies and to understand the elicited themes in behavioural terms. Focus groups were undertaken with community pharmacist, pharmacy assistant and consumer participants. Independent duplicate analysis of transcription data was conducted using inductive and framework methods. Eight focus groups involving 60 participants were conducted. Themes that emerged indicated consumers did not understand pharmacists’ professional role, they were less likely to exchange information if asking for a specific product than if asking about symptom treatment, and they wanted privacy. Consumers were confident to self-diagnose and did not understand OTC medicine risks. Pharmacy personnel felt a duty of care to ensure consumer safety, and that with experience communication skills developed to better engage consumers in consultations. They also identified the need for privacy. Consumers need education about community pharmacists’ role and responsibilities to motivate them to engage in OTC consultations. They also require privacy when doing so. PMID:29211054

Evaluation of two over-the-counter natural thyroid hormone preparations in human volunteers.

PubMed

Csako, G; Corso, D M; Kestner, J; Bokser, A D; Kennedy, P E; Pucino, F

1992-04-01

To determine the pharmacologic activity of over-the-counter (OTC) thyroid preparations. In vitro analysis and a prospective, crossover study in vivo. Tertiary care center. Two healthy adult volunteers. Three OTC preparations (Thyrotrophin PMG [bovine thyroid PMG extract], Thyro Forte [thyroid lymphogland concentrate with synergistic complex], and Thyro Complex [thyroid lyophilized gland concentrate with synergistic complex]) were analyzed in vitro. Volunteers were administered two times the manufacturer's maximum recommended daily dose of either Thyrotrophin PMG or Thyro Forte for one week, washed out for four to five weeks, and crossed over to receive the opposite tablet preparation for an additional week. The triiodothyronine (T3) and thyroxine (T4) contents of OTC preparations were measured by HPLC. Vital signs, serum total and free T4, total T3, thyroid stimulating hormone, thyroxine binding globulin, thyroglobulin, and general chemistry tests (including glucose and cholesterol) were monitored before, during, and between administration of the products. HPLC analysis of the three OTC preparations showed no T4 but did show possible T3 in two of these products. We found no definite clinical or laboratory evidence of thyroid hormone excess with either product. Healthcare professionals should advise against the use of these scientifically unsound and relatively expensive OTC thyroid preparations, of which the therapeutic efficacy is unknown.

Magnetic resonance spectroscopy and molecular studies in ornithine transcarbamylase deficiency novel mutation c.802A>G in exon 8 (p.Met268Val).

PubMed

Jamroz, E; Paprocka, J; Sokół, M; Popowska, E; Ciara, E

2013-01-01

Ornithine transcarbamylase (OTC) deficiency, an X-linked, semidominant disorder, is the most common inherited de-fect in ureagenesis, resulting in hyperammonaemia type II. The OTC gene, localised on chromosome X, has been mapp-ed to band Xp21.1, proximate to the Duchenne muscular dystrophy (DMD) gene. More than 350 different mutations, including missense, nonsense, splice-site changes, small de-letions or insertions and gross deletions, have been describ-ed so far. Almost all mutations in consensus splicing sites confer a neonatal phenotype. Most mutations in the OTC gene are 'private' and are distributed throughout the gene with a paucity of mutation in the sequence encoding the leader peptide (exon 1 and beginning of exon 2) and in exon 7. They have familial origin or occur de novo. Even with sequencing of the entire reading frame and exon/intron boundaries, only about 80% of the mutations are detected in patients with proven OTC deficiency. The remainder probably occur within the introns or in regulatory domains. The authors present a 4-year-old boy with the unreported missense mutation c.802A>G. The nucleotide transition leads to amino acid substitution Met to Val at codon 268 of the OTC protein.

Determination of Oxytetracycline and 4-Epi-Oxytetracycline Residues in Feathers and Edible Tissues of Broiler Chickens Using Liquid Chromatography Coupled with Tandem Mass Spectrometry.

PubMed

Cornejo, Javiera; Pokrant, Ekaterina; Krogh, Magdalena; Briceño, Cristóbal; Hidalgo, Héctor; Maddaleno, Aldo; Araya-Jordán, Carolina; Martín, Betty San

2017-04-01

Antibiotics have been widely used in poultry production for the treatment of bacterial diseases. However, drug residues can remain in products derived from animals after the cessation of the drug therapies. Feathers, in particular, have shown an affinity for antibiotics such as tetracycline, suggesting the persistence of these drugs in nonedible tissue. After the birds are slaughtered, feathers are ground into feather meals, which are used as organic fertilizer or an ingredient in animal diets, thereby entering into the food chain and becoming a potential risk for public health. To evaluate the depletion of oxytetracycline (OTC) and its metabolite 4-epi-oxytetracycline (4-epi-OTC) in the muscles, liver, and feathers, 64 broiler chickens, bred under controlled conditions, were treated orally with a commercial formulation of 10% OTC for 7 days. The analytes were quantified using liquid chromatography-tandem mass spectrometry. OTC and 4-epi-OTC were found in the feathers for 46 days, whereas they were found in the muscle and liver for only 12 and 6 days, respectively. These results prove that the analytes remain in feathers in higher concentrations than they do in edible tissues after treatment with tetracyclines. Thus, feather meals represent a potential source of antimicrobial residue contamination in the food chain.

The use of nonsteroidal anti-inflammatory drugs and analgesics by liver transplant recipients.

PubMed

Mulka-Gierek, Maria; Foroncewicz, Bartosz; Florczak, Michał; Pączek, Leszek; Krawczyk, Marek; Mucha, Krzysztof

2016-04-01

This study aimed to assess the reasons and the frequency of the use of over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics by liver transplant recipients (LTR). Patient awareness of possible drug-related side-effects was also assessed. NSAIDs and analgesics available without prescription belong to the most commonly used class of drugs. However, use of these drugs might be complicated by toxic adverse effects (AEs). Patients at risk for AEs include the transplant recipients. This was a descriptive study. An anonymous survey was carried out in 73 randomly selected LTR, who represented 10% of all LTR at our centre. There were 64% of the patients who confirmed taking NSAIDs or analgesics; 16% of these patients took these drugs at least several times a week and 10% took them daily. For 39% of patients, the only way to manage their pain were OTC NSAIDs or analgesics. As many as 36% of patients were unaware of the risks associated with the use of these drugs. Ninety per cent of LTR consider physicians the most trusted source of drugs information. Our study shows that two-thirds of LTR take OTC NSAIDs or analgesics and one-third are unaware of the AEs associated with these drugs. Therefore, both transplant nurses and doctors should educate their patients about the use and possible AE of these drugs. Considering the high NSAIDs consumption rates, the side effects of these drugs should always be suspected. Especially in patients taking these drugs and referring to medical advisors with specific symptoms, such as: abdominal pain, anaemia, elevated serum creatinine concentration or liver enzymes activity. Awareness of the scale of the problem enables health professionals to cooperate in educating patients. Such practices may reduce uncontrolled abuse of these drugs and related health care costs. © 2016 John Wiley & Sons Ltd.

77 FR 12310 - Drugs for Human Use; Drug Efficacy Study Implementation; Prescription Drugs That Contained...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-29

...) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this... an OTC monograph (21 CFR 310.6(f)). Any person who wishes to determine whether a specific product is...

78 FR 48536 - In the Matter of Hutech21 Co., Ltd.; Order of Suspension of Trading

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

...''). Hutech21 is a British Virgin Islands corporation based in Rathwell, Manitoba, and its stock is currently quoted on OTC Link, operated by OTC Markets Group, Inc. under the symbol CLGZF. Questions have arisen...

Degradation of selected agrochemicals by the white rot fungus Trametes versicolor.

PubMed

Mir-Tutusaus, Josep Anton; Masís-Mora, Mario; Corcellas, Cayo; Eljarrat, Ethel; Barceló, Damià; Sarrà, Montserrat; Caminal, Glòria; Vicent, Teresa; Rodríguez-Rodríguez, Carlos E

2014-12-01

Use of agrochemicals is a worldwide practice that exerts an important effect on the environment; therefore the search of approaches for the elimination of such pollutants should be encouraged. The degradation of the insecticides imiprothrin (IP) and cypermethrin (CP), the insecticide/nematicide carbofuran (CBF) and the antibiotic of agricultural use oxytetracycline (OTC) were assayed with the white rot fungus Trametes versicolor. Experiments with fungal pellets demonstrated extensive degradation of the four tested agrochemicals, at rates that followed the pattern IP>OTC>CP>CBF. In vitro assays with laccase-mediator systems showed that this extracellular enzyme participates in the transformation of IP but not in the cases of CBF and OTC. On the other hand, in vivo studies with inhibitors of cytochrome P450 revealed that this intracellular system plays an important role in the degradation of IP, OTC and CBF, but not for CP. The compounds 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylic acid (DCCA) and 3-phenoxybenzoic acid (PBA) were detected as transformation products of CP, as a result of the breakdown of the molecule. Meanwhile, 3-hydroxycarbofuran was detected as a transformation product of CBF; this metabolite tended to accumulate during the process, nonetheless, the toxicity of the system was effectively reduced. Simultaneous degradation of CBF and OTC showed a reduction in toxicity; similarly, when successive additions of OTC were done during the slower degradation of CBF, the fungal pellets were able to degrade both compounds. The simultaneous degradation of the four compounds successfully took place with minimal inhibition of fungal activity and resulted in the reduction of the global toxicity, thus supporting the potential use of T. versicolor for the treatment of diverse agrochemicals. Copyright © 2014 Elsevier B.V. All rights reserved.

The influence of evidence-based medicine training on decision-making in relation to over-the-counter medicines: a qualitative study.

PubMed

Hanna, Lezley-Anne; Hughes, Carmel

2012-12-01

To explore the role of evidence of effectiveness when making decisions about over-the-counter (OTC) medication and to ascertain whether evidence-based medicine training raised awareness in decision-making. Additionally, this work aimed to complement the findings of a previous study because all participants in this current study had received training in evidence-based medicine (unlike the previous participants). Following ethical approval and an e-mailed invitation, face-to-face, semi-structured interviews were conducted with newly registered pharmacists (who had received training in evidence-based medicine as part of their MPharm degree) to discuss the role of evidence of effectiveness with OTC medicines. Interviews were recorded and transcribed verbatim. Following transcription, all data were entered into the NVivo software package (version 8). Data were coded and analysed using a constant comparison approach. Twenty-five pharmacists (7 males and 18 females; registered for less than 4 months) were recruited and all participated in the study. Their primary focus with OTC medicines was safety; sales of products (including those that lack evidence of effectiveness) were justified provided they did no harm. Meeting patient expectation was also an important consideration and often superseded evidence. Despite knowledge of the concept, and an awareness of ethical requirements, an evidence-based approach was not routinely implemented by these pharmacists. Pharmacists did not routinely utilize evidence-based resources when making decisions about OTC medicines and some felt uncomfortable discussing the evidence-base for OTC products with patients. The evidence-based medicine training that these pharmacists received appeared to have limited influence on OTC decision-making. More work could be conducted to ensure that an evidence-based approach is routinely implemented in practice. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

A re-evaluation of the taste and odour of methyl tertiary butyl ether (MTBE) in drinking water.

PubMed

Suffet, I H

2007-01-01

Methyl tertiary butyl ether (MTBE) is a gasoline additive that has been found in groundwater when an underground gasoline storage tank leaks. Although dependent on the clean-up standards that are applied, clean-up costs have been estimated in the US alone to be in the billions of dollars. MTBE is considered primarily a taste and odour concern and not a toxicity issue at concentrations found in drinking water. Thus, the clean-up of MTBE problems is controlled by the MTBE odour threshold concentration (OTC). The level of clean-up and associated differential of millions of dollars is a matter of concern for water purveyors and well owners. A 1993 study of nine OTC studies showed the OTC of MTBE in water to be between 0.04 and 0.06 microg/L, a level over two orders of magnitude less than eight other studies. This 1993 study was repeated at the original laboratory in 2004 and is reported in this paper. The laboratory's quality control programme and ability to repeat one of the eight other studies indicated the laboratory was qualified to repeat its original OTC study. The flavour and odour detection threshold range in the 1993 study, however, could not be confirmed by trained assessors repeating the original study in 2004. The inconsistencies in the data and the high detection on water blanks indicate that the dilution series of the test solutions for the 1993 study were mainly at subthreshold levels. Therefore, the original study of 1993 is not a valid OTC study for MTBE and should not be used to develop drinking water and clean-up standards. The OTC of MTBE is over 15 microg/L for the eight valid studies.

Liver failure with coagulopathy, hyperammonemia and cyclic vomiting in a toddler revealed to have combined heterozygosity for genes involved with ornithine transcarbamylase deficiency and Wilson disease.

PubMed

Mira, Valerie; Boles, Richard G

2012-01-01

A girl with a 2 month history of cyclic episodes of vomiting, diarrhea, and lethargy lasting 2-3 days each presented with acute hepatopathy (ALT 3,500 IU/L) with coagulopathy (PT 55 s) and hyperammonemia (207 μmol/L) at age 1½ years. Biochemical and molecular analyzes revealed ornithine transcarbamylase (OTC) deficiency. While laboratory signs of mild hepatocellular dysfunction are common in OTC deficiency, substantial liver failure with coagulopathy is generally not seen, although four others cases have been reported, three of which presented with cyclic vomiting. Further evaluation in our case revealed elevated urine (198.8 μg/g creatinine) and liver (103 μg/g dry weight) copper content, and a heterozygous mutation in the Wilson disease gene, ATP7B. Our patient, now aged 5 years, has remained in excellent health with normal growth and development on fasting avoidance, a modified vegan diet, and sodium phenylbutyrate.These five cases demonstrate that generalized liver dysfunction/failure is a potential serious complication of OTC deficiency, although not a common one, and suggests that an ALT and PT should be obtained in OTC patients during episodes of hyperammonemia. Cyclic vomiting is a known presentation of OTC deficiency; it is not known if comorbid liver failure predisposes toward this phenotype. We propose that the heterozygote state in ATP7B increases the liver copper content, thus predisposing our patient with OTC deficiency to develop liver failure during a hyperammonemic episode. Our present case is an example of the opportunity of molecular diagnostics to identify putative modifier genes in patients with atypical presentations of genetic disorders.

Lack of gender effect on the pharmacokinetics of oxytetracycline in Fenneropenaeus chinensis after intramuscular administration

NASA Astrophysics Data System (ADS)

Sun, Ming; Li, Jian; Chang, Zhiqiang; Guo, Wenting; Zhao, Fazhen; Li, Jitao

2015-04-01

Fenneropenaeus chinensis, an economically important shrimp species, currently suffers from epizootic diseases due to high density stocking and bacterial infections. Oxytetracycline (OTC) has been widely used to treat various systemic bacterial infections in shrimp farming. In the present study, the effect of gender on pharmacokinetics of OTC in F. chinensis was investigated. The OTC concentrations in hemolymph of shrimp after single intramuscular administration (75 mg OTC per kg body weight) were analyzed by high performance liquid chromatography and best described with a two-compartment open model which is characterized by a short elimination half-life, low clearance, and a relatively large apparent volume of distribution. The pharmacokinetic equations were C t = 58.54e-0.38 t + 11.67e-0.04 t for females; and C t = 27.94e-0.28 t + 14.87e-0.04 t for males. The distribution and elimination half-lives of OTC were 1.82 and 19.58 h, respectively, in females and 2.50 and 16.11 h, respectively, in males at 22°C. The areas under the drug concentration curve were 480 mg L-1 h-1 in females and 430 mg L-1 h-1 in males. The total body clearance of the drug was 157.11 mL kg-1 h-1 in females and 172.47 mL kg-1 h-1 in males. The apparent volume distribution was 4.44 in females and 4.01 L kg-1 in males. There was no significant difference in pharmacokinetic parameters between female and male shrimps, indicating that there is no need to consider the gender effect in clinical use of OTC in F. chinensis farming.

Now you see it. Now you don't: fair balance and adequate provision in advertisements for drugs before and after the switch from prescription to over-the-counter.

PubMed

Faerber, Adrienne E; Kreling, David H

2012-01-01

The objective of this study was to measure differences in fair balance (benefit and risk statements) and adequate provision (toll-free numbers, Internet URLs, print ad references, and medical professional references) in advertising content for drugs that have switched from prescription to over-the-counter (OTC). The Vanderbilt TV News Archive was used to select products to study, to measure the frequency and placement of ads for those products, and to view advertising content for those products. Unique advertisements (n = 108) for loratadine (Claritin), citirizine (Zyrtec), and omeprazole (Prilosec) were analyzed for the presence of adequate provision statements and for the frequency of benefit, risk, and other statements. OTC ads were shorter than prescription ads by 10.6 seconds but contained the same total number of statements. Most prescription ads (n (RX) = 31) contained toll-free numbers (97%), Internet URLs (94%), medical professional references (100%) and print ad references (68%). Few OTC ads (n (OTC) = 77) contained adequate provision statements: 4% contained toll-free numbers and 10% contained Internet URLs. Prescription ads had similar numbers of benefits (1.5) and risks (1.8) per 30 seconds of ad time, and OTC ads had more benefits (6.6) than risks (1.2) per 30 seconds of ad time. Prescription drug ads contained risk statements that listed specific side effects and explicit harms from taking the product, but OTC ads contained nonspecific risk information and statements that implied risk rather than directly identifying risk. Differences in the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulation of advertising affected the balance of risk and benefit information that appeared and the specificity of risk information available.

A randomised clinical trial on the efficacy of oxytetracycline dose through water medication of nursery pigs on diarrhoea, faecal shedding of Lawsonia intracellularis and average daily weight gain.

PubMed

Larsen, Inge; Hjulsager, Charlotte Kristiane; Holm, Anders; Olsen, John Elmerdahl; Nielsen, Søren Saxmose; Nielsen, Jens Peter

2016-01-01

Oral treatment with antimicrobials is widely used in pig production for the control of gastrointestinal infections. Lawsonia intracellularis (LI) causes enteritis in pigs older than six weeks of age and is commonly treated with antimicrobials. The objective of this study was to evaluate the efficacy of three oral dosage regimens (5, 10 and 20mg/kg body weight) of oxytetracycline (OTC) in drinking water over a five-day period on diarrhoea, faecal shedding of LI and average daily weight gain (ADG). A randomised clinical trial was carried out in four Danish pig herds. In total, 539 animals from 37 batches of nursery pigs were included in the study. The dosage regimens were randomly allocated to each batch and initiated at presence of assumed LI-related diarrhoea. In general, all OTC doses used for the treatment of LI infection resulted in reduced diarrhoea and LI shedding after treatment. Treatment with a low dose of 5mg/kg OTC per kg body weight, however, tended to cause more watery faeces and resulted in higher odds of pigs shedding LI above detection level when compared to medium and high doses (with odds ratios of 5.5 and 8.4, respectively). No association was found between the dose of OTC and the ADG. In conclusion, a dose of 5mg OTC per kg body weight was adequate for reducing the high-level LI shedding associated with enteropathy, but a dose of 10mg OTC per kg body weight was necessary to obtain a maximum reduction in LI shedding. Copyright © 2015 Elsevier B.V. All rights reserved.

Acute over-the-counter pharmacological intervention does not adversely affect behavioral outcome following diffuse traumatic brain injury in the mouse.

PubMed

Harrison, Jordan L; Rowe, Rachel K; O'Hara, Bruce F; Adelson, P David; Lifshitz, Jonathan

2014-09-01

Following mild traumatic brain injury (TBI), patients may self-treat symptoms of concussion, including post-traumatic headache, taking over-the-counter (OTC) analgesics. Administering one dose of OTC analgesics immediately following experimental brain injury mimics the at-home treated population of concussed patients and may accelerate the understanding of the relationship between brain injury and OTC pharmacological intervention. In the current study, we investigate the effect of acute administration of OTC analgesics on neurological function and cortical cytokine levels after experimental diffuse TBI in the mouse. Adult, male C57BL/6 mice were injured using a midline fluid percussion (mFPI) injury model of concussion (6-10 min righting reflex time for brain-injured mice). Experimental groups included mFPI paired with either ibuprofen (60 mg/kg, i.p.; n = 16), acetaminophen (40 mg/kg, i.p.; n = 9), or vehicle (15% ethanol (v/v) in 0.9% saline; n = 13) and sham injury paired OTC medicine or vehicle (n = 7-10 per group). At 24 h after injury, functional outcome was assessed using the rotarod task and a modified neurological severity score. Following behavior assessment, cortical cytokine levels were measured by multiplex ELISA at 24 h post-injury. To evaluate efficacy on acute inflammation, cortical cytokine levels were measured also at 6 h post-injury. In the diffuse brain-injured mouse, immediate pharmacological intervention did not attenuate or exacerbate TBI-induced functional deficits. Cortical cytokine levels were affected by injury, time, or their interaction. However, levels were not affected by treatment at 6 or 24 h post-injury. These data indicate that acute administration of OTC analgesics did not exacerbate or attenuate brain-injury deficits which may inform clinical recommendations for the at-home treated mildly concussed patient.

Dos and Don'ts of Giving OTC Cough and Cold Medicines to Your Child

MedlinePlus

... workers, extended family members, or babysitters) knows what medicines your child is taking and when he or she should ... ts Don’t give OTC cough and cold medicines to a child younger than 4 years of age unless your ...

21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

Code of Federal Regulations, 2010 CFR

2010-04-01

... of the safety and effectiveness of these or any other ingredients for OTC use for ingrown toenail... is required for marketing. In the absence of an approved new drug application or abbreviated new drug...

Use Over-the-Counter Medicines Wisely

MedlinePlus

... correctly. Simply put, this means that when you buy or use an OTC medicine, remember to: ● Respect that OTCs are serious medicines ... simple steps: ● Read the label—every time you buy or use a nonprescription medicine pay special attention to the ingredients, and directions ...

Determination of adenosine disodium triphosphate (ATP) using oxytetracycline-Eu 3+ as a fluorescence probe by spectrofluorimetry

NASA Astrophysics Data System (ADS)

Hou, Faju; Miao, Yanhong; Jiang, Chongqiu

2005-10-01

A new spectrofluorimetric method was developed for determination of adenosine disodium triphosphate (ATP). We studied the interactions between oxytetracycline (OTC)-Eu 3+ complex and adenosine disodium triphosphate (ATP) by using UV-vis absorption and fluorescence spectra. Using oxytetracycline (OTC)-Eu 3+ as a fluorescence probe, under the optimum conditions, ATP can remarkably enhance the fluorescence intensity of the OTC-Eu 3+ complex at λ = 612 nm and the enhanced fluorescence intensity of Eu 3+ ion is in proportion to the concentration of ATP. Optimum conditions for the determination of ATP were also investigated. The linear ranges for ATP are 8.00 × 10 -8-1.50 × 10 -6 mol L -1 with detection limits of 2.67 × 10 -9 mol L -1. This method is simple, practical and relatively free interference from coexisting substances and can be successfully applied to determination of ATP in samples. The mechanism of fluorescence enhancement between oxytetracycline (OTC)-Eu 3+ complex and ATP was also studied.

Toxicological Implications and Inflammatory Response in Human Lymphocytes Challenged with Oxytetracycline.

PubMed

Di Cerbo, A; Palatucci, A T; Rubino, V; Centenaro, S; Giovazzino, A; Fraccaroli, E; Cortese, L; Ruggiero, G; Guidetti, G; Canello, S; Terrazzano, G

2016-04-01

Antibiotics are widely used in zoo technical and veterinary practices as feed supplementation to ensure wellness of farmed animals and livestock. Several evidences have been suggesting both the toxic role for tetracyclines, particularly for oxytetracycline (OTC). This potential toxicity appears of great relevance for human nutrition and for domestic animals. This study aimed to extend the evaluation of such toxicity. The biologic impact of the drug was assessed by evaluating the proinflammatory effect of OTC and their bone residues on cytokine secretion by in vitro human peripheral blood lymphocytes. Our results showed that both OTC and OTC-bone residues significantly induced the T lymphocyte and non-T cell secretion of interferon (IFN)-γ, as cytokine involved in inflammatory responses in humans as well as in animals. These results may suggest a possible implication for new potential human and animal health risks depending on the entry of tetracyclines in the food-processing chain. © 2015 The Authors Journal of Biochemical and Molecular Toxicology Published Wiley Periodicals, Inc.

Nephrogenic systemic fibrosis and class labeling of gadolinium-based contrast agents by the Food and Drug Administration.

PubMed

Yang, Lucie; Krefting, Ira; Gorovets, Alex; Marzella, Louis; Kaiser, James; Boucher, Robert; Rieves, Dwaine

2012-10-01

In 2007, the Food and Drug Administration requested that manufacturers of all approved gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, use nearly identical text in their product labeling to describe the risk of nephrogenic systemic fibrosis (NSF). Accumulating information about NSF risks led to revision of the labeling text for all of these drugs in 2010. The present report summarizes the basis and purpose of this class-labeling approach and describes some of the related challenges, given the evolutionary nature of the NSF risk evidence. The class-labeling approach for presentation of product risk is designed to decrease the occurrence of NSF and to enhance the safe use of GBCAs in radiologic practice. © RSNA, 2012.

Cell-selective metabolic labeling of biomolecules with bioorthogonal functionalities.

PubMed

Xie, Ran; Hong, Senlian; Chen, Xing

2013-10-01

Metabolic labeling of biomolecules with bioorthogonal functionalities enables visualization, enrichment, and analysis of the biomolecules of interest in their physiological environments. This versatile strategy has found utility in probing various classes of biomolecules in a broad range of biological processes. On the other hand, metabolic labeling is nonselective with respect to cell type, which imposes limitations for studies performed in complex biological systems. Herein, we review the recent methodological developments aiming to endow metabolic labeling strategies with cell-type selectivity. The cell-selective metabolic labeling strategies have emerged from protein and glycan labeling. We envision that these strategies can be readily extended to labeling of other classes of biomolecules. Copyright © 2013 Elsevier Ltd. All rights reserved.

Nonsteroidal Anti-Inflammatory Drugs and Analgesics Use by Kidney Transplant Recipients.

PubMed

Mulka-Gierek, Maria; Foroncewicz, Bartosz; Pączek, Leszek; Wawiórko, Elżbieta; Kamińska, Joanna; Kosieradzki, Maciej; Małkowski, Piotr; Małczuk, Bianka; Nazarewski, Sławomir; Mucha, Krzysztof

2018-03-02

BACKGROUND Nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics are the most commonly used drugs and are increasingly available over-the-counter (OTC). In certain groups of patients, including kidney transplant recipients, their use may be complicated by adverse effects or drug interactions. The aim of our study was to assess the causes and frequency of OTC NSAIDs or analgesics use, as well as the awareness of related side effects. MATERIAL AND METHODS We enrolled 94 randomly selected kidney transplant recipients, who represented 5% of all kidney transplant recipients at our center. An anonymous survey consisting of 23 multiple-choice questions was administered voluntarily and anonymously. RESULTS In all, 63% of study patients confirmed taking the OTC painkillers; 22% of these patients took these drugs at least several times a week, and 4% took these drugs daily. For 38% of the study kidney transplant recipients, NSAIDs or analgesics were reported to be the only way to manage their pain. In addition, 30% of study patients were unaware of the risks associated with these drugs, despite the fact that 89% of the study patients consider physicians the best source of information. CONCLUSIONS Our study found that 63% of kidney transplant recipients regularly took OTC painkillers and 30% were unaware of the potential adverse effects. This necessitates continuous, ongoing education of kidney transplant recipients about the risks of OTC NSAIDs or analgesics use.

Adsorption in a Fixed-Bed Column and Stability of the Antibiotic Oxytetracycline Supported on Zn(II)-[2-Methylimidazolate] Frameworks in Aqueous Media

PubMed Central

Anceski Bataglion, Giovana; Nogueira Eberlin, Marcos; Machado Ronconi, Célia

2015-01-01

A metal-organic framework, Zn-[2-methylimidazolate] frameworks (ZIF-8), was used as adsorbent material to remove different concentrations of oxytetracycline (OTC) antibiotic in a fixed-bed column. The OTC was studied at concentrations of 10, 25 and 40 mg L-1. At 40 mg L-1, the breakthrough point was reached after approximately 10 minutes, while at 10 and 25 mg L-1 this point was reached in about 30 minutes. The highest removal rate of 60% for the 10 mg L-1 concentration was reached after 200 minutes. The highest adsorption capacity (28.3 mg g-1) was attained for 25 mg L-1 of OTC. After the adsorption process, a band shift was observed in the UV-Vis spectrum of the eluate. Additional studies were carried out to determine the cause of this band shift, involving a mass spectrometry (MS) analysis of the supernatant liquid during the process. This investigation revealed that the main route of adsorption consisted of the coordination of OTC with the metallic zinc centers of ZIF-8. The materials were characterized by thermal analysis (TA), scanning electron microscopy (SEM), powder X-ray diffraction (XRD), and infrared spectroscopy (IR) before and after adsorption, confirming the presence of OTC in the ZIF-8 and the latter’s structural stability after the adsorption process. PMID:26057121

Hyperthermostable binding molecules on phage: Assay components for point-of-care diagnostics for active tuberculosis infection.

PubMed

Zhao, Ning; Spencer, John; Schmitt, Margaret A; Fisk, John D

2017-03-15

Tuberculosis is the leading cause of death from infectious disease worldwide. The low sensitivity, extended processing time, and high expense of current diagnostics are major challenges to the detection and treatment of tuberculosis. Mycobacterium tuberculosis ornithine transcarbamylase (Mtb OTC, Rv1656) has been identified in the urine of patients with active TB infection and is a promising target for point-of-care diagnostics. Specific binding proteins with low nanomolar affinities for Mtb OTC were selected from a phage display library built upon a hyperthermostable Sso7d scaffold. Phage particles displaying Sso7d variants were utilized to generate a sandwich ELISA-based assay for Mtb OTC. The assay response is linear between 2 ng/mL and 125 ng/mL recombinant Mtb OTC and has a limit of detection of 400 pg/mL recombinant Mtb OTC. The assay employing a phage-based detection reagent is comparable to commercially-available antibody-based biosensors. Importantly, the assay maintains functionality at both neutral and basic pH in presence of salt and urea over the range of concentrations typical for human urine. Phage-based diagnostic systems may feature improved physical stability and cost of production relative to traditional antibody-based reagents, without sacrificing specificity and sensitivity. Copyright © 2017 Elsevier Inc. All rights reserved.

In Vitro Effects of Some Botanicals with Anti-Inflammatory and Antitoxic Activity

PubMed Central

Guidetti, Gianandrea; Giovazzino, Angela; Rubino, Valentina; Palatucci, Anna Teresa; Centenaro, Sara; Fraccaroli, Elena; Cortese, Laura; Bonomo, Maria Grazia; Ruggiero, Giuseppina; Canello, Sergio; Terrazzano, Giuseppe

2016-01-01

Several extrinsic factors, like drugs and chemicals, can foster autoimmunity. Tetracyclines, in particular oxytetracycline (OTC), appear to correlate with the emergence of immune-mediated diseases. Accumulation of OTC, the elective drug for gastrointestinal and respiratory infectious disease treatment in broiler chickens, was reported in chicken edible tissues and could represent a potential risk for pets and humans that could assume this antibiotic as residue in meat or in meat-derived byproducts. We investigated the in vitro anti-inflammatory properties of a pool of thirteen botanicals as a part of a nutraceutical diet, with proven immunomodulatory activity. In addition, we evaluated the effect of such botanicals in contrasting the in vitro proinflammatory toxicity of OTC. Our results showed a significant reduction in interferon- (INF-) γ production by human and canine lymphocytes in presence of botanicals (⁎ p < 0.05). Increased INF-γ production, dependent on 24-hour OTC-incubation of T lymphocytes, was significantly reduced by the coincubation with Haematococcus pluvialis, with Glycine max, and with the mix of all botanicals (⁎ p < 0.05). In conclusion, the use of these botanicals was shown to be able to contrast OTC-toxicity and could represent a new approach for the development of functional foods useful to enhance the standard pharmacological treatment in infections as well as in preventing or reducing the emergence of inflammatory diseases. PMID:27597982

75 FR 3765 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... time for the annual audit report is 100 hours per OTC derivatives dealer, for a total of 180 hours per... Financial and Operational Combined Uniform Single (``FOCUS'') Report, is the basic document for reporting...). Rule 17a-12 requires registered OTC derivatives dealers to file Part IIB of the FOCUS Report quarterly...

77 FR 66182 - TRICARE Over-the-Counter Drug Demonstration Project

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-02

... costs/benefits and beneficiary satisfaction of providing OTC drugs under the pharmacy benefits program... (TPharm) which was on November 4, 2009. In order to more thoroughly evaluate the clinical and cost effectiveness of OTC drugs as well as beneficiary satisfaction with the project, the Department published a...

78 FR 9963 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... to amend FINRA trade reporting rules to require that members report over-the-counter (``OTC... through the Alternative Display Facility (``ADF'') or a Trade Reporting Facility (``TRF''), and... Proposed Rule Change 1. Purpose FINRA trade reporting rules require that members report OTC transactions in...

Substance Abuse and Teacher Stress.

ERIC Educational Resources Information Center

Fimian, Michael J.; And Others

1985-01-01

Examined on-the-job stress in relationship with need to use and frequency of use of over-the-counter (OTC) and prescription (P) drugs and alcohol (A), across five teacher samples (N=1,788). Results showed high stress frequencies were significantly related to the frequent use of OTC, P, and A substances. (Author/BH)

17 CFR 240.3b-12 - Definition of OTC derivatives dealer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Definition of OTC derivatives dealer. 240.3b-12 Section 240.3b-12 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION... to options, forwards, futures, swap agreements, or collars involving currencies, interest or other...

75 FR 17806 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

...) require that members report secondary market transactions in non-exchange-listed direct participation...., OTC Bulletin Board and Pink Sheets securities), which are reported through the OTC Reporting Facility...) (``Cancellations Order''). This new requirement would include trades executed during normal market hours and...

21 CFR 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a...

Code of Federal Regulations, 2010 CFR

2010-04-01

... safety and effectiveness of these and any other ingredients (e.g., cayenne pepper) for OTC use as a... 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved...

Over the counter drugs (and dietary supplement) exercise: a team-based introduction to biochemistry for health professional students.

PubMed

Phadtare, Sangita; Abali, Emine; Brodsky, Barbara

2013-01-01

For successful delivery of basic science topics for health-professional students, it is critical to reduce apprehension and illustrate relevance to clinical settings and everyday life. At the beginning of the Biochemistry course for Physician Assistants, a team-based assignment was designed to develop an understanding of the mechanism of action, effectiveness, and toxicity of five common over the counter (OTC) drugs and dietary supplements, and place these familiar medicines in a political and historical context. The objectives of this exercise were to stimulate interest in biochemistry; to provide basic information on enzymes and enzyme inhibitors related to these drugs to be expanded upon later in the course; and to encourage active and interactive learning. Teams of five students were formed, and each student was given an information sheet on aspirin, alpha-galactosidase, orlistat, dextromethorphan, or simvastatin, a low dose statin, which was previously available without prescription at pharmacies in the UK. After each member of the team acquired information on one OTC drug/dietary supplement by reading an assigned information sheet, the team was asked to go through a series of questions, and then submit answers to a quiz as a group. A high rate of success on the quiz, an overwhelmingly positive response on formal course evaluations, and enthusiastic exchanges during class suggested this team-based session accomplished its goals. Copyright © 2013 Wiley-Liss, Inc.

Active learning in the presence of unlabelable examples

NASA Technical Reports Server (NTRS)

Mazzoni, Dominic; Wagstaff, Kiri

2004-01-01

We propose a new active learning framework where the expert labeler is allowed to decline to label any example. This may be necessary because the true label is unknown or because the example belongs to a class that is not part of the real training problem. We show that within this framework, popular active learning algorithms (such as Simple) may perform worse than random selection because they make so many queries to the unlabelable class. We present a method by which any active learning algorithm can be modified to avoid unlabelable examples by training a second classifier to distinguish between the labelable and unlabelable classes. We also demonstrate the effectiveness of the method on two benchmark data sets and a real-world problem.

Classification without labels: learning from mixed samples in high energy physics

NASA Astrophysics Data System (ADS)

Metodiev, Eric M.; Nachman, Benjamin; Thaler, Jesse

2017-10-01

Modern machine learning techniques can be used to construct powerful models for difficult collider physics problems. In many applications, however, these models are trained on imperfect simulations due to a lack of truth-level information in the data, which risks the model learning artifacts of the simulation. In this paper, we introduce the paradigm of classification without labels (CWoLa) in which a classifier is trained to distinguish statistical mixtures of classes, which are common in collider physics. Crucially, neither individual labels nor class proportions are required, yet we prove that the optimal classifier in the CWoLa paradigm is also the optimal classifier in the traditional fully-supervised case where all label information is available. After demonstrating the power of this method in an analytical toy example, we consider a realistic benchmark for collider physics: distinguishing quark- versus gluon-initiated jets using mixed quark/gluon training samples. More generally, CWoLa can be applied to any classification problem where labels or class proportions are unknown or simulations are unreliable, but statistical mixtures of the classes are available.

Classification without labels: learning from mixed samples in high energy physics

DOE PAGES

Metodiev, Eric M.; Nachman, Benjamin; Thaler, Jesse

2017-10-25

Modern machine learning techniques can be used to construct powerful models for difficult collider physics problems. In many applications, however, these models are trained on imperfect simulations due to a lack of truth-level information in the data, which risks the model learning artifacts of the simulation. In this paper, we introduce the paradigm of classification without labels (CWoLa) in which a classifier is trained to distinguish statistical mixtures of classes, which are common in collider physics. Crucially, neither individual labels nor class proportions are required, yet we prove that the optimal classifier in the CWoLa paradigm is also the optimalmore » classifier in the traditional fully-supervised case where all label information is available. After demonstrating the power of this method in an analytical toy example, we consider a realistic benchmark for collider physics: distinguishing quark- versus gluon-initiated jets using mixed quark/gluon training samples. More generally, CWoLa can be applied to any classification problem where labels or class proportions are unknown or simulations are unreliable, but statistical mixtures of the classes are available.« less

Classification without labels: learning from mixed samples in high energy physics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Metodiev, Eric M.; Nachman, Benjamin; Thaler, Jesse

Modern machine learning techniques can be used to construct powerful models for difficult collider physics problems. In many applications, however, these models are trained on imperfect simulations due to a lack of truth-level information in the data, which risks the model learning artifacts of the simulation. In this paper, we introduce the paradigm of classification without labels (CWoLa) in which a classifier is trained to distinguish statistical mixtures of classes, which are common in collider physics. Crucially, neither individual labels nor class proportions are required, yet we prove that the optimal classifier in the CWoLa paradigm is also the optimalmore » classifier in the traditional fully-supervised case where all label information is available. After demonstrating the power of this method in an analytical toy example, we consider a realistic benchmark for collider physics: distinguishing quark- versus gluon-initiated jets using mixed quark/gluon training samples. More generally, CWoLa can be applied to any classification problem where labels or class proportions are unknown or simulations are unreliable, but statistical mixtures of the classes are available.« less

MOVING PLANT TOXICOLOGY FROM THE GREENHOUSE TO THE FIELD: A METHOD THAT INCORPORATES THE POSITIVE ATTRIBUTES OF EACH

EPA Science Inventory

Open top chambers (OTC) have been used to study effects of air pollutants on plants for over 25 years. Many of those studies have used potted plants, producing environmental and ecological rooting conditions that are unrealistic. Others have placed OTC over existing vegetation, ...

17 CFR 240.15a-1 - Securities activities of OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... options, forwards, futures, swap agreements, or collars involving currencies, interest or other rates... derivatives dealers. 240.15a-1 Section 240.15a-1 Commodity and Securities Exchanges SECURITIES AND EXCHANGE... Under the Securities Exchange Act of 1934 Exemption of Certain Otc Derivatives Dealers § 240.15a-1...

76 FR 27123 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

... references to ``OTC Bulletin Board'' and ``OTCBB'' with ``Non-NMS Quotation Service'' and ``NNQS.'' The text... filing the proposed rule change to rename the OTC Bulletin Board (``OTCBB'') as the Non-NMS Quotation... OTCBB assets do not include the technology comprising the interdealer quotation system operated by FINRA...

Analysis of Dextromethorphan in Cough Drops and Syrups: A Medicinal Chemistry Laboratory

ERIC Educational Resources Information Center

Hamilton, Todd M.; Wiseman, Frank L., Jr.

2009-01-01

Fluorescence spectroscopy is used to determine the quantity of dextromethorphan hydrobromide (DM) in over-the-counter (OTC) cough drops and syrups. This experiment is appropriate for an undergraduate medicinal chemistry laboratory course when studying OTC medicines and active ingredients. Students prepare the cough drops and syrups for analysis,…

21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin... potential for serious risk to patients using these drug products. The bioavailability of pancreatic enzymes... included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for treating...

21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin... potential for serious risk to patients using these drug products. The bioavailability of pancreatic enzymes... included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for treating...

21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin... potential for serious risk to patients using these drug products. The bioavailability of pancreatic enzymes... included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for treating...

17 CFR 240.3b-13 - Definition of eligible OTC derivative instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... interest in, one or more commodities, securities, currencies, interest or other rates, indices... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Definition of eligible OTC derivative instrument. 240.3b-13 Section 240.3b-13 Commodity and Securities Exchanges SECURITIES AND EXCHANGE...

17 CFR 240.3b-13 - Definition of eligible OTC derivative instrument.

Code of Federal Regulations, 2011 CFR

2011-04-01

... interest in, one or more commodities, securities, currencies, interest or other rates, indices... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Definition of eligible OTC derivative instrument. 240.3b-13 Section 240.3b-13 Commodity and Securities Exchanges SECURITIES AND EXCHANGE...

76 FR 12916 - Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... endpoint. Reports purporting to be two studies by Collipp (one published and one unpublished) were..., OTC weight control drug products containing benzocaine will require an approved NDA or ANDA. Studies...., a manufacturer of OTC weight control drug products, submitted two citizen petitions, one in 1990 and...

76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug... overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or... because of ongoing concerns about potentially serious accidental drug overdoses that can result from the...

Effect of canopy structure and open-top chamber techniques on micrometeorological parameters and the gradients and transport of water vapor, carbon dioxide and ozone in the canopies of plum trees (`prunus salicina`) in the San Joaquin valley. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grantz, D.A.; Vaughn, D.L.; Metheny, P.A.

1995-03-15

Plum trees (Prunus salicina cv. Casselman) were exposed to ozone in open-top chambers (OTC) or chamberless plots, and trace gas concentrations and microenvironmental conditions were monitored within tree canopies inside the outside the OTC. Concentrations of ozone, carbon dioxide and water vapor, leaf and air temperature, light intensity, and wind speed were measured at nine positions in the tree canopies. The objectives were to: (1) map the distribution of microenvironmental parameters within the canopies inside and outside the OTC; (2) determine transport parameters for gas exchange, and (3) calculate ozone flux. Significant vertical and horizontal gradients were observed; gradients weremore » diminished and often inverted inside relative to outside the OTC due to air distribution at the bottom of the OCT. Ozone flux was readily modeled from measures of stomatal conductance, nonstomatal conductance and ozone concentration at the leaf surface.« less

Chlortetracycline and Oxytetracycline Residues in Poultry Tissues and Eggs

PubMed Central

Meredith, W. E.; Weiser, H. H.; Winter, A. R.

1965-01-01

A pad-plate method of assaying residual amounts of chlortetracycline (CTC) and oxytetracycline (OTC) using Bacillus cereus 213 was used to determine amounts of antibiotic left in tissues and eggs of poultry fed 1,000 and 200 ppm of CTC and OTC in basal feed mixtures. The effects of various methods of cooking the tissues and eggs and the potentiating effect of terephthalic acid (TPA) were studied. It was found that normal methods of roasting, frying, and autoclaving poultry tissue destroyed all residual CTC and OTC, even with the potentiating effect of TPA. The largest amounts of residual antibiotic were found in the liver, then breast, and then thigh tissue when assayed for CTC. Tissue assays for CTC revealed that it was not taken up as extensively as CTC and the largest amounts were found in the liver, then breast. OTC residue was seldom found in the thigh tissue. Terephthalic acid in 0.5% concentration increased the concentration found in all cases. Cooking by poaching and scrambling eggs did not destroy the antibiotic in all cases. PMID:14264853

Analysis of oxytetracycline in water using a portable analyzer

NASA Astrophysics Data System (ADS)

Chen, Guoying; Braden, Susan; Qin, Feng

2006-10-01

Oxytetracycline (OTC) is extensively used in aquaculture worldwide for preventive and therapeutic purposes. Most of the drug, however, is discharged into the marine environment due to leaching from medicated feed and poor gastrointestinal (GI) absorption. Without exposure to sun light OTC has a long lifetime in the marine environment, therefore it is important to monitor and study its occurrence, distribution, fate and impact on the ecosystem. A portable tetracycline (TC) analyzer was developed in this laboratory for this purpose based on europium-sensitized luminescence. In this study, an assay method is developed for OTC analysis in water using this instrument. Water samples are filtered with glass wool; and solid phase extraction (SPE) is performed using Oasis HLB cartridges for OTC extraction and cleanup. Following reagent application, the samples are excited by 385 nm LED pulses; and time-resolved luminescence (TRL) is measured at 610 nm by a photomultiplier tube. A 0-3 ppm linear dynamic range (r2 = 0.9988) and a 0.021 ppb limit of detection were achieved with a typical <5% relative standard deviation.

Oxytetracycline analysis in honey using a specific portable analyzer

NASA Astrophysics Data System (ADS)

Chen, Guoying; Schwartz, Daniel; Braden, S.; Nunez, Alberto

2007-09-01

Oxytetracycline (OTC) residue in honey is detected using a portable analyzer designed to specifically target tetracycline (TC) drugs based on europium-sensitized luminescence (ESL). A 385 nm light emitting diode (LED) is used as the excitation source and a photomultiplier tube as the light detector. OTC is extracted from honey and cleaned up by solid phase extraction (SPE) using Strata X-WC weak cation exchange cartridges. To the eluate Eu(III) is added to form a Eu-TC chelate at pH 8.5. Efficient intrachelate energy transfer allows sensitive OTC detection at λ ex=385 nm and λ em=610 nm. After a 25-µs time delay, the ESL signal is integrated over a 25-1000 µs interval. The signal intensity reveals a linear relationship (R2=0.972) to OTC concentrations in the 10-200 ng/g range. The limit-of-detection is 6.7 ng/g with an average 5.8% relative standard deviation. The background signal corresponds to ~10 ppb. This instrumentation and method combination enables field analysis that is especially useful for beekeeping industry.

Antibiotic degradation and microbial community structures during acidification and methanogenesis of swine manure containing chlortetracycline or oxytetracycline.

PubMed

Yin, Fubin; Dong, Hongmin; Zhang, Wanqin; Zhu, Zhiping; Shang, Bin

2018-02-01

Anaerobic digestion (AD) has been applied to animal manure stabilization, and antibiotics is frequently found in animal manure. However, antibiotic degradation and microbial community structures during two-stage AD (acidification and methanogenesis) remain poorly understood. This experiments on two-stage anaerobic swine manure digesters were performed to investigate the degradation mechanisms and effects of chlortetracycline (CTC) and oxytetracycline (OTC) on microbial community structures. Results showed that acidification and methanogenesis showed good degradation performance for manure containing CTC and OTC at 60 and 40 mg/kg·TS, respectively. CTC and OTC were degraded by 59.8% and 41.3% in the acidogenic stage and by 76.3% and 78.3% in the methanogenic stage, respectively. CTC and OTC negatively affected bacterial community in methanogenic and acidogenic stages, respectively. They also adversely influenced the archaeal species in the methanogenic stage. Two-stage AD was proposed to treat manure containing antibiotics and to reduce the negative effects of antibiotics on AD. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of anaerobic digestion on chlortetracycline and oxytetracycline degradation efficiency for swine manure.

PubMed

Yin, Fubin; Dong, Hongmin; Ji, Chao; Tao, Xiuping; Chen, Yongxing

2016-10-01

Manure containing antibiotics is considered a hazardous substance that poses a serious health risk to the environment and to human health. Anaerobic digestion (AD) could not only treatment animal waste but also generate valuable biogas. However, the interaction between antibiotics in manure and the AD process has not been clearly understood. In this study, experiments on biochemical methane potential (BMP) were conducted to determine the inhibition of the AD process from antibiotics and the threshold of complete antibiotic removal. The thresholds of the complete antibiotic removal were 60 and 40mg/kg·TS for CTC and OTC, respectively. CTC and OTC with concentrations below thresholds could increase the BMP of manure. When the CTC and OTC concentrations exceeded the thresholds, they inhibited manure fermentation, and the CTC removal rate declined exponentially with concentration (60-500mg/kg·TS). The relationship between OTC antibiotic concentration and its removal rate in AD treatment was described with exponential (40-100mg/kg·TS) and linear equations (100-500mg/kg·TS). Copyright © 2016 Elsevier Ltd. All rights reserved.

Learning classification with auxiliary probabilistic information

PubMed Central

Nguyen, Quang; Valizadegan, Hamed; Hauskrecht, Milos

2012-01-01

Finding ways of incorporating auxiliary information or auxiliary data into the learning process has been the topic of active data mining and machine learning research in recent years. In this work we study and develop a new framework for classification learning problem in which, in addition to class labels, the learner is provided with an auxiliary (probabilistic) information that reflects how strong the expert feels about the class label. This approach can be extremely useful for many practical classification tasks that rely on subjective label assessment and where the cost of acquiring additional auxiliary information is negligible when compared to the cost of the example analysis and labelling. We develop classification algorithms capable of using the auxiliary information to make the learning process more efficient in terms of the sample complexity. We demonstrate the benefit of the approach on a number of synthetic and real world data sets by comparing it to the learning with class labels only. PMID:25309141

Safety and efficacy of over-the-counter cough and cold medicines for use in children.

PubMed

Vassilev, Zdravko P; Kabadi, Shaum; Villa, Raul

2010-03-01

Over-the-counter (OTC) cough and cold medications have been used widely for years and continue to be a preferred choice for temporary relief of symptoms of upper respiratory tract infections in children. These medications are being placed under extraordinary scrutiny in the pediatric population due to the lack of conclusive evidence about their therapeutic efficacy and increased reports of associations with serious adverse events and even mortality. A PubMed search was conducted to identify articles published up to August 2009 describing the efficacy and safety of OTC cough and cold medications in children. The objective was to provide an overview of the relevant literature and regulatory history and to comment on the available data on this important topic. The paper provides a detailed up-to-date review of the key efficacy and safety studies published on the subject. In addition, the reader is presented with an overview of the regulatory history and recent developments surrounding the use of OTC cough and cold medications in children in the US. This review confirms the lack of efficacy of OTC cough and cold products in children and reaffirms that although the overall incidence of related serious adverse events is low, such events continue to occur. The conclusions in this paper support a recommendation that OTC cough and cold medications should not be given to infants and very young children. Furthermore, additional research is needed to evaluate the safety and efficacy of these medicines in the broader pediatric population.

A single exposure of sediment sulphate-reducing bacteria to oxytetracycline concentrations relevant to aquaculture enduringly disturbed their activity, abundance and community structure.

PubMed

Fernández, M L; Granados-Chinchilla, F; Rodríguez, C

2015-08-01

Although feed medicated with antibiotics is widely used in animal production to prevent and treat bacterial infections, the effect of these drugs on nontarget anaerobic bacteria is unknown. We aimed to clarify whether a single exposure of sulphate-reducing bacteria (SRB) from a tilapia pond to oxytetracycline (OTC) concentrations relevant to aquaculture impacts their function, abundance and community structure. To demonstrate changes in SO4(2-) content, SRB abundance, dsrB copy number and SRB diversity, sediment mesocosms were spiked with 5, 25, 50 and 75 mg OTC kg(-1) and examined for 30 days by means of ion chromatography, qPCR, cultivation and fluorescent in situ hybridization (FISH). On day 3, we measured higher SO4(2-) concentrations (ca. two-fold) and a reduction in dsrB copy numbers of approximately 50% in the treatments compared to the controls. After 30 days, a subtle yet measurable enrichment of bacteria from the order Desulfovibrionales occurred in mesocosms receiving ≥ 50 mg OTC kg(-1), notwithstanding that SRB counts decreased two orders of magnitude. OTC was dynamically and reversibly converted into 4-epioxytetracycline and other related compounds in a dose-dependent manner during the experiment. A single exposure to rather high OTC concentrations triggered functional and structural changes in a SRB community that manifested quickly and persisted for a month. This study improves our limited knowledge on the ecotoxicology of antibiotics in anaerobic environments. © 2015 The Society for Applied Microbiology.

Variable effects of oxytetracycline on antibiotic resistance gene abundance and the bacterial community during aerobic composting of cow manure.

PubMed

Qian, Xun; Sun, Wei; Gu, Jie; Wang, Xiao-Juan; Sun, Jia-Jun; Yin, Ya-Nan; Duan, Man-Li

2016-09-05

Livestock manure is often subjected to aerobic composting but little is known about the variation in antibiotic resistance genes (ARGs) during the composting process under different concentrations of antibiotics. This study compared the effects of three concentrations of oxytetracycline (OTC; 10, 60, and 200mg/kg) on ARGs and the succession of the bacterial community during composting. Very similar trends were observed in the relative abundances (RAs) of each ARG among the OTC treatments and the control during composting. After composting, the RAs of tetC, tetX, sul1, sul2, and intI1 increased 2-43 times, whereas those of tetQ, tetM, and tetW declined by 44-99%. OTC addition significantly increased the absolute abundances and RAs of tetC and intI1, while 200mg/kg OTC also enhanced those of tetM, tetQ, and drfA7. The bacterial community could be grouped according to the composting time under different treatments. The highest concentration of OTC had a more persistent effect on the bacterial community. In the present study, the succession of the bacterial community appeared to have a greater influence on the variation of ARGs during composting than the presence of antibiotics. Aerobic composting was not effective in reducing most of the ARGs, and thus the compost product should be considered as an important reservoir for ARGs. Copyright © 2016 Elsevier B.V. All rights reserved.

Disposition of a long-acting oxytetracycline formulation in Thai swamp buffaloes (Bubalus bubalis).

PubMed

Poapolathep, S; Wongpanit, K; Imsilp, K; Tanhan, P; Klangkaew, N; Giorgi, M; Poapolathep, A

2017-04-01

The present study aimed to characterize the pharmacokinetic profile of oxytetracycline long-acting formulation (OTC-LA) in Thai swamp buffaloes, Bubalus bubalis, following single intramuscular administration at two dosages of 20 and 30 mg/kg body weight (b.w.). Blood samples were collected at assigned times up to 504 h. The plasma concentrations of OTC were measured by high-performance liquid chromatography (HPLC). The concentrations of OTC in the plasma were determined up to 264 h and 432 h after i.m. administration at doses of 20 and 30 mg/kg b.w., respectively. The C max values of OTC were 12.11 ± 1.87 μg/mL and 12.27 ± 1.92 μg/mL at doses of 20 and 30 mg/kg, respectively. The AUC last values increased in a dose-dependent fashion. The half-life values were 52.00 ± 14.26 h and 66.80 ± 10.91 h at doses of 20 and 30 mg/kg b.w, respectively. Based on the pharmacokinetic data and PK-PD index (T > MIC), i.m. administration of OTC at a dose of 30 mg/kg b.w once per week might be appropriate for the treatment of susceptible bacterial infection in Thai swamp buffaloes. © 2016 John Wiley & Sons Ltd.

Safeguarding older adults from inappropriate over-the-counter medications: the role of community pharmacists.

PubMed

Chui, Michelle A; Stone, Jamie A; Martin, Beth A; Croes, Kenneth D; Thorpe, Joshua M

2014-12-01

To elicit the thought process or mental model that community pharmacists use when making recommendations on over-the-counter (OTC) medications to older adults and to elicit the current practices of community pharmacists in providing information, advice, and counseling to older adults about potentially inappropriate OTC medications. Three separate focus groups with pharmacists were conducted with 5 to 8 pharmacists per group. A vignette about an elderly woman seeking an OTC sleep aid was used to elicit information that pharmacists seek to establish when making a recommendation. Focus groups were recorded, transcribed verbatim, and analyzed for themes using the initial and focused coding methods of grounded theory. Community pharmacists' mental models were characterized by 2 similarities: a similarity in what community pharmacists seek to establish about patients and a similarity in when community pharmacists seek to establish it--the sequence in which they try to learn key details about patients. It was identified that pharmacists gather specific information about the patient's medication profile, health conditions, characteristics of the problem, and past treatments in order to make a recommendation. Community pharmacists recommended behavioral modifications and seeing their physician prior to recommending an OTC sleep aid, primarily due to medication safety concerns. Pharmacists can play a key role in assisting older adults to select and use OTC medications. © The Author 2013. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Preferential coding of eye/hand motor actions in the human ventral occipito-temporal cortex.

PubMed

Tosoni, Annalisa; Guidotti, Roberto; Del Gratta, Cosimo; Committeri, Giorgia; Sestieri, Carlo

2016-12-01

The human ventral occipito-temporal cortex (OTC) contains areas specialized for particular perceptual/semantic categories, such as faces (fusiform face area, FFA) and places (parahippocampal place area, PPA). This organization has been interpreted as reflecting the visual structure of the world, i.e. perceptual similarity and/or eccentricity biases. However, recent functional magnetic resonance imaging (fMRI) studies have shown not only that regions of the OTC are modulated by non-visual, action-related object properties but also by motor planning and execution, although the functional role and specificity of this motor-related activity are still unclear. Here, through a reanalysis of previously published data, we tested whether the selectivity for perceptual/semantic categories in the OTC corresponds to a preference for particular motor actions. The results demonstrate for the first time that face- and place-selective regions of the OTC exhibit preferential BOLD response to the execution of hand pointing and saccadic eye movements, respectively. Moreover, multivariate analyses provide novel evidence for the consistency across neural representations of stimulus category and movement effector in OTC. According to a 'spatial hypothesis', this pattern of results originates from the match between the region eccentricity bias and the typical action space of the motor effectors. Alternatively, the double dissociation may be caused by the different effect produced by hand vs. eye movements on regions coding for body representation. Overall, the present findings offer novel insights on the coupling between visual and motor cortical representations. Copyright © 2016. Published by Elsevier Ltd.

Simple heuristics in over-the-counter drug choices: a new hint for medical education and practice.

PubMed

Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

Over-the-counter (OTC) drugs are widely available and often purchased by consumers without advice from a health care provider. Many people rely on self-management of medications to treat common medical conditions. Although OTC medications are regulated by the National and the International Health and Drug Administration, many people are unaware of proper dosing, side effects, adverse drug reactions, and possible medication interactions. This study examined how subjects make their decisions to select an OTC drug, evaluating the role of cognitive heuristics which are simple and adaptive rules that help the decision-making process of people in everyday contexts. By analyzing 70 subjects' information-search and decision-making behavior when selecting OTC drugs, we examined the heuristics they applied in order to assess whether simple decision-making processes were also accurate and relevant. Subjects were tested with a sequence of two experimental tests based on a computerized Java system devised to analyze participants' choices in a virtual environment. We found that subjects' information-search behavior reflected the use of fast and frugal heuristics. In addition, although the heuristics which correctly predicted subjects' decisions implied significantly fewer cues on average than the subjects did in the information-search task, they were accurate in describing order of information search. A simple combination of a fast and frugal tree and a tallying rule predicted more than 78% of subjects' decisions. The current emphasis in health care is to shift some responsibility onto the consumer through expansion of self medication. To know which cognitive mechanisms are behind the choice of OTC drugs is becoming a relevant purpose of current medical education. These findings have implications both for the validity of simple heuristics describing information searches in the field of OTC drug choices and for current medical education, which has to prepare competent health specialists to orientate and support the choices of their patients.

Simple heuristics in over-the-counter drug choices: a new hint for medical education and practice

PubMed Central

Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

Introduction Over-the-counter (OTC) drugs are widely available and often purchased by consumers without advice from a health care provider. Many people rely on self-management of medications to treat common medical conditions. Although OTC medications are regulated by the National and the International Health and Drug Administration, many people are unaware of proper dosing, side effects, adverse drug reactions, and possible medication interactions. Purpose This study examined how subjects make their decisions to select an OTC drug, evaluating the role of cognitive heuristics which are simple and adaptive rules that help the decision-making process of people in everyday contexts. Subjects and methods By analyzing 70 subjects’ information-search and decision-making behavior when selecting OTC drugs, we examined the heuristics they applied in order to assess whether simple decision-making processes were also accurate and relevant. Subjects were tested with a sequence of two experimental tests based on a computerized Java system devised to analyze participants’ choices in a virtual environment. Results We found that subjects’ information-search behavior reflected the use of fast and frugal heuristics. In addition, although the heuristics which correctly predicted subjects’ decisions implied significantly fewer cues on average than the subjects did in the information-search task, they were accurate in describing order of information search. A simple combination of a fast and frugal tree and a tallying rule predicted more than 78% of subjects’ decisions. Conclusion The current emphasis in health care is to shift some responsibility onto the consumer through expansion of self medication. To know which cognitive mechanisms are behind the choice of OTC drugs is becoming a relevant purpose of current medical education. These findings have implications both for the validity of simple heuristics describing information searches in the field of OTC drug choices and for current medical education, which has to prepare competent health specialists to orientate and support the choices of their patients. PMID:23745077

Assessment of some cultural experimental methods to study the effects of antibiotics on microbial activities in a soil: An incubation study

PubMed Central

Molaei, Ali; Haghnia, Gholamhosain; Astaraei, Alireza; Rasouli-Sadaghiani, MirHassan; Teresa Ceccherini, Maria; Datta, Rahul

2017-01-01

Oxytetracycline (OTC) and sulfamethoxazole (SMX) are two of most widely used antibiotics in livestock and poultry industry. After consumption of antibiotics, a major portion of these compounds is excreted through the feces and urine of animals. Land application of antibiotic-treated animal wastes has caused increasing concern about their adverse effects on ecosystem health. In this regard, inconsistent results have been reported regarding the effects of antibiotics on soil microbial activities. This study was conducted based on the completely randomized design to the measure microbial biomass carbon, cumulative respiration and iron (III) reduction bioassays. Concentrations of OTC and SMX including 0, 1, 10, 25, 50, and 100 mg/kg were spiked in triplicate to a sandy loam soil and incubated for 21 days at 25°C. Results showed that the effects of OTC and SMX antibiotics on cumulative respiration and microbial biomass carbon were different. SMX antibiotic significantly affected soil microbial biomass carbon and cumulative respiration at different treatments compared to control with increasing incubation time. OTC antibiotic, on the other hand, negatively affected cumulative respiration compared to control treatment throughout the incubation period. Although OTC antibiotic positively affected microbial biomass carbon at day one of incubation, there was no clear trend in microbial biomass carbon between different treatments of this antibiotic after that time period. Nevertheless, sulfamethoxazole and oxytetracycline antibiotics had similar effects on iron (III) reduction such that they considerably affected iron (III) reduction at 1 and 10 mg/kg, and iron (III) reduction was completely inhibited at concentrations above 10 mg/kg. Hence, according to our results, microbial biomass carbon and cumulative respiration experiments are not able alone to exhibit the effect of antibiotics on soil microbial activity, but combination of these two experiments with iron (III) reduction test could well display the effects of sulfamethoxazole (SMX) and oxytetracycline (OTC) antibiotics on soil biochemical activities. PMID:28683144

Orthopaedic trauma care in Haiti: a cost-effectiveness analysis of an innovative surgical residency program.

PubMed

Carlson, Lucas C; Slobogean, Gerard P; Pollak, Andrew N

2012-01-01

In an effort to sustainably strengthen orthopaedic trauma care in Haiti, a 2-year Orthopaedic Trauma Care Specialist (OTCS) program for Haitian physicians has been developed. The program will provide focused training in orthopaedic trauma surgery and fracture care utilizing a train-the-trainer approach. The purpose of this analysis was to calculate the cost-effectiveness of the program relative to its potential to decrease disability in the Haitian population. Using established methodology originally outlined in the World Health Organization's Global Burden of Disease project, a cost-effectiveness analysis was performed for the OTCS program in Haiti. Costs and disability-adjusted life-years (DALYs) averted were estimated per fellow trained in the OTCS program by using a 20-year career time horizon. Probabilistic sensitivity analysis was used to simultaneously test the joint uncertainty of the cost and averted DALY estimates. A willingness-to-pay threshold of $1200 per DALY averted, equal to the gross domestic product per capita in Haiti, was selected on the basis of World Health Organization's definition of highly cost-effective health interventions. The OTCS program results in an incremental cost of $1,542,544 ± $109,134 and 12,213 ± 2,983 DALYs averted per fellow trained. The cost-effectiveness ratio of $133.97 ± $34.71 per DALY averted is well below the threshold of $1200 per DALY averted. Furthermore, sensitivity analysis suggests that implementing the OTCS program is the economically preferred strategy with more than 95% probability at a willingness-to-pay threshold of $200 per DALY averted and across the entire range of potential variable inputs. The current economic analysis suggests the OTCS program to be a highly cost-effective intervention. Probabilistic sensitivity analysis demonstrates that the conclusions remain stable even when considering the joint uncertainty of the cost and DALY estimates. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Molecular and Cellular Effects Induced in Mytilus galloprovincialis Treated with Oxytetracycline at Different Temperatures

PubMed Central

Banni, Mohamed; Sforzini, Susanna; Franzellitti, Silvia; Oliveri, Caterina; Viarengo, Aldo; Fabbri, Elena

2015-01-01

The present study evaluatedthe interactive effects of temperature (16°C and 24°C) and a 4-day treatment with the antibiotic oxytetracycline (OTC) at 1 and 100μg/L on cellular and molecular parameters in the mussel Mytilus galloprovincialis. Lysosomal membrane stability (LMS), a sensitive biomarker of impaired health status in this organism, was assessed in the digestive glands. In addition, oxidative stress markers and the expression of mRNAs encoding proteins involved in antioxidant defense (catalase (cat) and glutathione-S-transferase (gst)) and the heat shock response (hsp90, hsp70, and hsp27) were evaluated in the gills, the target tissue of soluble chemicals. Finally, cAMP levels, which represent an important cell signaling pathway related to oxidative stress and the response to temperature challenges, were also determined in the gills. Exposure to heat stress as well as to OTC rendered a decrease in LMS and an increase in malonedialdehyde accumulation (MDA). CAT activity was not significantly modified, whereas GST activity decreased at 24°C. Cat and gst expression levels were reduced in animals kept at 24°C compared to 16°C in the presence or absence of OTC. At 16°C, treatment with OTC caused a significant increase in cat and gst transcript levels. Hsp27 mRNA was significantly up-regulated at all conditions compared to controls at 16°C. cAMP levels were increased at 24°C independent of the presence of OTC. PCA analysis showed that 37.21% and 25.89% of the total variance was explained by temperature and OTC treatment, respectively. Interestingly, a clear interaction was observed in animals exposed to both stressors increasing LMS and MDA accumulation and reducing hsp27 gene expression regulation. These interactions may suggest a risk for the organisms due to temperature increases in contaminated seawaters. PMID:26067465

Rapid synthesis of Ti-MCM-41 by microwave-assisted hydrothermal method towards photocatalytic degradation of oxytetracycline.

PubMed

Chen, Hanlin; Peng, Yen-Ping; Chen, Ku-Fan; Lai, Chia-Hsiang; Lin, Yung-Chang

2016-06-01

This study employed microwave-assisted hydrothermal method to synthesize Ti-MCM-41, which are mesoporous materials with a high surface area and excellent photocatalytic ability. Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), X-ray photoelectron spectroscopy (XPS), transmission electron microscopy (TEM), and ultraviolet-visible spectroscopy (UV-Vis) were employed. The XRD findings showed that Ti-MCM-41 exhibited a peak at 2θ of 2.2°, which was attributed to the hexagonal MCM-41 structure. The BET (Brunauer-Emmett-Teller) results agreed with the TEM findings that Ti-MCM-41 has a pore size of about 3-5nm and a high surface area of 883m(2)/g. FTIR results illustrated the existence of Si-O-Si and Si-O-Ti bonds in Ti-MCM-41. The appearance of Ti 2p peaks in the XPS results confirmed the FTIR findings that the Ti was successfully doped into the MCM-41 structure. Zeta (ζ)-potential results indicated that the iso-electric point (IEP) of Ti-MCM-41 was at about pH3.02. In this study, the photocatalytic degradation of oxytetracycline (OTC) at different pH was investigated under Hg lamp irradiation (wavelength 365nm). The rate constant (K'obs) for OTC degradation was 0.012min(-1) at pH3. Furthermore, TOC (total organic carbon) and high resolution LC-MS (liquid chromatography-mass spectrometry) analyses were conducted to elucidate the possible intermediate products and degradation pathway for OTC. The TOC removal efficiency of OTC degradation was 87.0%, 74.4% and 50.9% at pH3, 7 and 10, respectively. LC-MS analysis results showed that the degradation products from OTC resulted from the removal of functional groups from the OTC ring. Copyright © 2016. Published by Elsevier B.V.

Effect of elevated CO2 on degradation of azoxystrobin and soil microbial activity in rice soil.

PubMed

Manna, Suman; Singh, Neera; Singh, V P

2013-04-01

An experiment was conducted in open-top chambers (OTC) to study the effect of elevated CO2 (580 ± 20 μmol mol(-1)) on azoxystrobin degradation and soil microbial activities. Results indicated that elevated CO2 did not have any significant effect on the persistence of azoxystrobin in rice-planted soil. The half-life values for the azoxystrobin in rice soils were 20.3 days in control (rice grown at ambient CO2 outdoors), 19.3 days in rice grown under ambient CO2 atmosphere in OTC, and 17.5 days in rice grown under elevated CO2 atmosphere in OTC. Azoxystrobin acid was recovered as the only metabolite of azoxystrobin, but it did not accumulate in the soil/water and was further metabolized. Elevated CO2 enhanced soil microbial biomass (MBC) and alkaline phosphatase activity of soil. Compared with rice grown at ambient CO2 (both outdoors and in OTC), the soil MBC at elevated CO2 increased by twofold. Elevated CO2 did not affect dehydrogenase, fluorescein diacetate, and acid phosphatase activity. Azoxystrobin application to soils, both ambient and elevated CO2, inhibited alkaline phosphates activity, while no effect was observed on other enzymes. Slight increase (1.8-2 °C) in temperature inside OTC did not affect microbial parameters, as similar activities were recorded in rice grown outdoors and in OTC at ambient CO2. Higher MBC in soil at elevated CO2 could be attributed to increased carbon availability in the rhizosphere via plant metabolism and root secretion; however, it did not significantly increase azoxystrobin degradation, suggesting that pesticide degradation was not the result of soil MBC alone. Study suggested that increased CO2 levels following global warming might not adversely affect azoxystrobin degradation. However, global warming is a continuous and cumulative process, therefore, long-term studies are necessary to get more realistic assessment of global warming on fate of pesticide.

Monitoring over-the-counter medication sales for early detection of disease outbreaks--New York City.

PubMed

Das, Debjani; Metzger, K; Heffernan, R; Balter, S; Weiss, D; Mostashari, F

2005-08-26

Over-the-counter (OTC) medications are frequently used during the initial phase of illness, and increases in their sales might serve as an early indicator of communitywide disease outbreaks. Since August 2002, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has tracked OTC medication sales to enhance detection of natural and intentional infectious disease outbreaks. This report describes the surveillance system and presents results from retrospective analyses and a comparison between citywide trends in OTC medication sales and emergency department (ED) visits. Sales data transmitted daily to DOHMH are categorized into two groups: influenza-like illness (ILI), which includes cough and influenza medications, and gastrointestinal illness (GI), which includes major brand and generic antidiarrheals. Cyclical, linear regression models were used to identify significant (p<0.05) increases in the daily ratio of ILI to analgesics sales (analgesics are used as a denominator in the absence of total sales). Daily and weekly average ratios of GI to analgesic sales were analyzed. Citywide trends in OTC ILI and GI medication sales were compared with ED visits for fever/influenza and diarrhea syndromes. Citywide ILI drug sales were highest during annual influenza epidemics and elevated during spring and fall allergy seasons, similar to trends in the ED fever/influenza syndrome. ILI sales did not consistently provide earlier warning than the ED system of communitywide influenza. GI drug sales increased during the fall and peaked during early winter and after the blackout of August 2003. Unlike ED diarrheal visits, GI medication sales did not substantially increase during late winter (February-March). Citywide OTC medication sales can provide indications of communitywide illness, including annual influenza epidemics. Antidiarrheal medication sales were more sensitive to increases in GI caused by norovirus and influenza than illness caused by rotavirus. OTC medication sales can be considered as an adjunct syndromic surveillance system but might not be as sensitive as ED systems.

Inter-class sparsity based discriminative least square regression.

PubMed

Wen, Jie; Xu, Yong; Li, Zuoyong; Ma, Zhongli; Xu, Yuanrong

2018-06-01

Least square regression is a very popular supervised classification method. However, two main issues greatly limit its performance. The first one is that it only focuses on fitting the input features to the corresponding output labels while ignoring the correlations among samples. The second one is that the used label matrix, i.e., zero-one label matrix is inappropriate for classification. To solve these problems and improve the performance, this paper presents a novel method, i.e., inter-class sparsity based discriminative least square regression (ICS_DLSR), for multi-class classification. Different from other methods, the proposed method pursues that the transformed samples have a common sparsity structure in each class. For this goal, an inter-class sparsity constraint is introduced to the least square regression model such that the margins of samples from the same class can be greatly reduced while those of samples from different classes can be enlarged. In addition, an error term with row-sparsity constraint is introduced to relax the strict zero-one label matrix, which allows the method to be more flexible in learning the discriminative transformation matrix. These factors encourage the method to learn a more compact and discriminative transformation for regression and thus has the potential to perform better than other methods. Extensive experimental results show that the proposed method achieves the best performance in comparison with other methods for multi-class classification. Copyright © 2018 Elsevier Ltd. All rights reserved.

Representational Similarity of Body Parts in Human Occipitotemporal Cortex.

PubMed

Bracci, Stefania; Caramazza, Alfonso; Peelen, Marius V

2015-09-23

Regions in human lateral and ventral occipitotemporal cortices (OTC) respond selectively to pictures of the human body and its parts. What are the organizational principles underlying body part responses in these regions? Here we used representational similarity analysis (RSA) of fMRI data to test multiple possible organizational principles: shape similarity, physical proximity, cortical homunculus proximity, and semantic similarity. Participants viewed pictures of whole persons, chairs, and eight body parts (hands, arms, legs, feet, chests, waists, upper faces, and lower faces). The similarity of multivoxel activity patterns for all body part pairs was established in whole person-selective OTC regions. The resulting neural similarity matrices were then compared with similarity matrices capturing the hypothesized organizational principles. Results showed that the semantic similarity model best captured the neural similarity of body parts in lateral and ventral OTC, which followed an organization in three clusters: (1) body parts used as action effectors (hands, feet, arms, and legs), (2) noneffector body parts (chests and waists), and (3) face parts (upper and lower faces). Whole-brain RSA revealed, in addition to OTC, regions in parietal and frontal cortex in which neural similarity was related to semantic similarity. In contrast, neural similarity in occipital cortex was best predicted by shape similarity models. We suggest that the semantic organization of body parts in high-level visual cortex relates to the different functions associated with the three body part clusters, reflecting the unique processing and connectivity demands associated with the different types of information (e.g., action, social) different body parts (e.g., limbs, faces) convey. Significance statement: While the organization of body part representations in motor and somatosensory cortices has been well characterized, the principles underlying body part representations in visual cortex have not yet been explored. In the present fMRI study we used multivoxel pattern analysis and representational similarity analysis to characterize the organization of body maps in human occipitotemporal cortex (OTC). Results indicate that visual and shape dimensions do not fully account for the organization of body part representations in OTC. Instead, the representational structure of body maps in OTC appears strongly related to functional-semantic properties of body parts. We suggest that this organization reflects the unique processing and connectivity demands associated with the different types of information different body parts convey. Copyright © 2015 the authors 0270-6474/15/3512977-09$15.00/0.

Method for automatic determination of soybean actual evapotranspiration under open top chambers (OTC) subjected to effects of water stress and air ozone concentration.

PubMed

Rana, Gianfranco; Katerji, Nader; Mastrorilli, Marcello

2012-10-01

The present study describes an operational method, based on the Katerji et al. (Eur J Agron 33:218-230, 2010) model, for determining the daily evapotranspiration (ET) for soybean inside open top chambers (OTCs). It includes two functions, calculated day par day, making it possible to separately take into account the effects of concentrations of air ozone and plant water stress. This last function was calibrated in function of the daily values of actual water reserve in the soil. The input variables of the method are (a) the diurnal values of global radiation and temperature, usually measured routinely in a standard weather station; (b) the daily values of the AOT40 index accumulated (accumulated ozone over a threshold of 40 ppb during daylight hours, when global radiation exceeds 50 Wm(-2)) determined inside the OTC; and (c) the actual water reserve in the soil, at the beginning of the trial. The ensemble of these input variables can be automatable; thus, the proposed method could be applied in routine. The ability of the method to take into account contrasting conditions of ozone air concentration and water stress was evaluated over three successive years, for 513 days, in ten crop growth cycles, excluding the days employed to calibrate the method. Tests were carried out in several chambers for each year and take into account the intra- and inter-year variability of ET measured inside the OTCs. On the daily scale, the slope of the linear regression between the ET measured by the soil water balance and that calculated by the proposed method, under different water conditions, are 0.98 and 1.05 for the filtered and unfiltered (or enriched) OTCs with root mean square error (RMSE) equal to 0.77 and 1.07 mm, respectively. On the seasonal scale, the mean difference between measured and calculated ET is equal to +5% and +11% for the filtered and unfiltered OTCs, respectively. The ability of the proposed method to estimate the daily and seasonal ET inside the OTCs is therefore satisfactory following inter- and intra-annual tests. Finally, suggestions about the applications of the proposed method for other species, different from soybean, were also discussed.

Metal ion-oxytetracycline pharmacokinetic interactions after oral co-administration in broiler chickens.

PubMed

Ziółkowski, H; Jasiecka, A; Zuśka-Prot, M; Przybysz, J; Grabowski, T; Jaroszewski, J J

2016-08-01

The influence of the composition of calcium (Ca(2+)), magnesium (Mg(2+)), and iron (Fe(3+)) ions in two concentration levels (low-500 mg/L of CaCl2, 125 mg/L of MgCl2, and 10 mg/L of FeCl3 and high-2,500 mg/L of CaCl2, 625 mg/L of MgCl2, and 50 mg/L of FeCl3) contained in water on the pharmacokinetics (PK) of oxytetracycline (OTC) was determined. OTC hydrochloride was administered at a dose of 25 mg/kg of body weight to broiler chickens divided into four groups of nine birds each, including 3 oral groups (in deionized water -control, in water with low ion concentration, and in water with high ion concentration) and 1 intravenous group. OTC concentrations in plasma were determined using liquid chromatography-tandem mass spectrometry, after which non-compartmental pharmacokinetic analysis was conducted.The absolute bioavailability of OTC in the group of birds exposed to higher ions concentration was reduced (8.68% ± 2.56) as compared to the control (13.71% ± 2.60). Additionally, in this group, decrease in PK parameters such as: area under the concentration-time curve from 0 to infinity (15.36 μg × h/mL ± 4.36), from 0 to t (14.78 μg × h/mL ± 4.37), area under the first moment of curve from 0 to t (107.54 μg × h/mL ± 36.48), and maximum plasma concentration (2.13 μg/mL ± 0.32) were also observed. It is noteworthy, all mentioned parameters demonstrated a downward trend with high correlation coefficient (P = 0.004, P = 0.002, P = 0.005, P = 0.004, P = 0.011, respectively), reflecting the influence of increasing concentrations of Ca(2+), Mg(2+), and Fe(3+) ions on the decreasing absorption rate of OTC.Based on the current research results, it can be assumed that high concentrations of several ions applied concomitantly are able to decrease the absorption of OTC from gastrointestinal tract in broiler chickens. This occurrence might impair the drug's clinical efficacy toward some pathogenic microorganisms. It implies that using OTC on a farm may require administration of higher doses than the routine one when infections are caused by less sensitive pathogens. © 2016 Poultry Science Association Inc.

77 FR 57602 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-18

... options on other indices and on individual equity securities in the future, subject to Commission approval... ``OTC index option'' generically in order to simplify future amendments to provide for additional... proposed Section 6 of Article XVII of the By-Laws. With respect to future OTC options accepted for clearing...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores... the treatment of fever blisters and cold sores. (a) l-lysine (lysine, lysine hydrochloride... products to treat fever blisters and cold sores. There is a lack of adequate data to establish general...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores... the treatment of fever blisters and cold sores. (a) l-lysine (lysine, lysine hydrochloride... products to treat fever blisters and cold sores. There is a lack of adequate data to establish general...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores... the treatment of fever blisters and cold sores. (a) l-lysine (lysine, lysine hydrochloride... products to treat fever blisters and cold sores. There is a lack of adequate data to establish general...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores... the treatment of fever blisters and cold sores. (a) l-lysine (lysine, lysine hydrochloride... products to treat fever blisters and cold sores. There is a lack of adequate data to establish general...

77 FR 23770 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-20

... to Proposed Rule Change To Amend FINRA Rule 6433 (Minimum Quotation Size Requirements for OTC Equity... proposed rule change to amend FINRA Rule 6433 (Minimum Quotation Size Requirements for OTC Equity... investors, three from an inter-dealer quotation system and two from a member firm.\\4\\ FINRA responded to...

75 FR 62404 - Agency Information Collection Activities; Proposed Collection; Comment Request; Additional...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

... TEA final rule). The regulations in Sec. 330.14 state that OTC drug products introduced into the U.S... and extent'' application (TEA) to be submitted to us by any party for our consideration to include new conditions in the OTC drug monograph system. TEAs must provide evidence described in Sec. 330.14(c...

78 FR 10655 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... occurred or is ongoing that has had a material effect on the market for the OTC Equity Security or has... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68874; File No. SR-FINRA-2012-010] Self... Change To Amend FINRA Rule 6440 (Trading and Quotation Halt in OTC Equity Securities) February 8, 2013. I...

Use of a portable time-resolved fluorometer to determine oxytetracycline residue in four fruit crops

USDA-ARS?s Scientific Manuscript database

Worldwide, oxytetracycline (OTC) is used in fruit and vegetable crops to prevent and treat bacteria diseases. In the U.S., the Environmental Protection Agency approved its use in apple, pear, peach, and nectarine, and set tolerance at 350 ng/g. OTC residues in 12 varieties of these fruits are determ...

76 FR 9386 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-17

..., Pink OTC Markets Inc., dated January 18, 2010 (``Pink OTC Letter''); Letter to Elizabeth M. Murphy..., Knight Equity Markets, L.P., dated February 22, 2010 (``Knight Letter''). \\5\\ See Letter to Elizabeth M... remove the requirement that a member assign and use a unique market participant identifier (MPID) for its...

75 FR 51863 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change Relating to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

... weight, were non-NMS stocks that trade either on the OTC Bulletin Board or the Pink OTC Markets. \\8\\ 17... Total Market Index\\SM\\ (the ``Wilshire 5000''). The Index represents a float-adjusted, market capitalization-weighted index of the issues ranked below 2500 by market capitalization of the Wilshire 5000. As...

17 CFR 240.17a-12 - Reports to be made by certain OTC derivatives dealers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... available for use by any official or employee of the United States or by any other person to whom the... in future engagements; or (ii) The OTC derivatives dealer has notified a certified public accountant...) of this section that the engagement has been terminated; or (iii) A certified public accountant has...

12 CFR 3.34 - OTC derivative contracts.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., notional principal amount is the net receipts to each party falling due on each value date in each currency... calculating PFE. (E) The PFE of the protection provider of a credit derivative is capped at the net present... the greater of the mark-to-fair value of the OTC derivative contract or zero. (ii) PFE. (A) The PFE...

17 CFR 240.36a1-1 - Exemption from Section 7 for OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from Section 7 for OTC derivatives dealers. 240.36a1-1 Section 240.36a1-1 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934...

17 CFR 240.15b9-2 - Exemption from SRO membership for OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from SRO membership for OTC derivatives dealers. 240.15b9-2 Section 240.15b9-2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934...

17 CFR 240.36a1-2 - Exemption from SIPA for OTC derivatives dealers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from SIPA for OTC derivatives dealers. 240.36a1-2 Section 240.36a1-2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934 Rules and Regulations...

78 FR 330 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

... Rule Change To Amend SPAN Margin Parameters for ICE OTC Natural Gas Liquids Contracts December 27, 2012... Rule Change The purpose of the change is to amend SPAN Margin Parameters for ICE OTC Natural Gas Liquids (NGL) Contracts. All capitalized terms not defined herein are defined in the ICE Clear Europe...

21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

Code of Federal Regulations, 2014 CFR

2014-04-01

... in the Federal Register of November 19, 1972 (37 FR 25249). (xii) Certain OTC Multiple-Vitamin Preparations for Oral Use containing excessive amounts of vitamin D and/or vitamin A (DESI 97), for which... the products into conformity with current medical knowledge and experience. (d) Manufacturers and...

21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

Code of Federal Regulations, 2013 CFR

2013-04-01

... in the Federal Register of November 19, 1972 (37 FR 25249). (xii) Certain OTC Multiple-Vitamin Preparations for Oral Use containing excessive amounts of vitamin D and/or vitamin A (DESI 97), for which... the products into conformity with current medical knowledge and experience. (d) Manufacturers and...

21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

Code of Federal Regulations, 2012 CFR

2012-04-01

... in the Federal Register of November 19, 1972 (37 FR 25249). (xii) Certain OTC Multiple-Vitamin Preparations for Oral Use containing excessive amounts of vitamin D and/or vitamin A (DESI 97), for which... the products into conformity with current medical knowledge and experience. (d) Manufacturers and...

Mirror-image discrimination in the literate brain: a causal role for the left occpitotemporal cortex.

PubMed

Nakamura, Kimihiro; Makuuchi, Michiru; Nakajima, Yasoichi

2014-01-01

Previous studies show that the primate and human visual system automatically generates a common and invariant representation from a visual object image and its mirror reflection. For humans, however, this mirror-image generalization seems to be partially suppressed through literacy acquisition, since literate adults have greater difficulty in recognizing mirror images of letters than those of other visual objects. At the neural level, such category-specific effect on mirror-image processing has been associated with the left occpitotemporal cortex (L-OTC), but it remains unclear whether the apparent "inhibition" on mirror letters is mediated by suppressing mirror-image representations covertly generated from normal letter stimuli. Using transcranial magnetic stimulation (TMS), we examined how transient disruption of the L-OTC affects mirror-image recognition during a same-different judgment task, while varying the semantic category (letters and non-letter objects), identity (same or different), and orientation (same or mirror-reversed) of the first and second stimuli. We found that magnetic stimulation of the L-OTC produced a significant delay in mirror-image recognition for letter-strings but not for other objects. By contrast, this category specific impact was not observed when TMS was applied to other control sites, including the right homologous area and vertex. These results thus demonstrate a causal link between the L-OTC and mirror-image discrimination in literate people. We further suggest that left-right sensitivity for letters is not achieved by a local inhibitory mechanism in the L-OTC but probably relies on the inter-regional coupling with other orientation-sensitive occipito-parietal regions.

Over-the-Counter Medicines and Diabetes Care.

PubMed

Taylor, Jeff

2017-12-01

People with diabetes turn to over-the-counter (OTC) medicines for many ailments. The focus of this brief review is the impact common OTC medicines might have on this group of patients. Three types of OTC medicines were selected as most deserving of attention: 3 herbal agents, nonsteroidal anti-inflammatory drugs (NSAIDs) and cough/cold products. Existing literature was used to determine precautions that might be in order. Herbal/natural agents with the potential to impact blood sugar have been identified in various reports. In discussing 3, glucosamine and cinnamon (at doses recommended on commercial products) should have minimal impact on diabetic management, whereas St. John's wort is a concern involving potential drug interactions. For colds, of about 11 active ingredients, only decongestants (primarily oral) need be considered for their possible effects on blood sugar. Finally, NSAIDs (even at OTC doses) must be used with caution, given their cardiovascular, renal and gastrointestinal risks. Care guidelines do encourage patients to take ownership of their condition. Yet the ability to self-medicate safely is not a certainty. In spite of easy access and a reasonable level of safety, OTC medicines still can negatively impact a user. NSAIDs available without prescription continue to cause concern. Before the use of any medicine, a person must ensure it will be safe. A health-care provider can be asked for assistance, but that option may not always be employed. Package information is there to provide critical information in lieu of that, something the self-medicating patient will, it is hoped, embrace. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

The oxidative stress response of oxytetracycline in the ciliate Pseudocohnilembus persalinus.

PubMed

Wang, Chongnv; Pan, Xuming; Fan, Yawen; Chen, Ying; Mu, Weijie

2017-12-01

Oxytetracycline (OTC) is commonly employed in fish farms to prevent bacterial infections in China, and because of their widely and intensive use, the potential harmful effects on organisms in aquatic environment are of great concern. Ciliates play an important role in aquatic food webs as secondary producers, and Pseudocohnilembus persalinus, is one kind of them which are easily found in fish farms, surviving in polluted water. Therefore, using P. persalinus as experimental models, this study investigated the effects of oxytetracycline (OTC) on the growth, antioxidant system and morphological damage in pollution-resistant ciliates species. Our results showed that the 96-h EC 50 values for OTC of P. persalinus was 21.38mgL -1 . The increased level of SOD and GSH during 96h OTC stress was related to an adaptive response under oxidative stress induced in ciliates. Additionally, sod1, sod2 and sod3 exhibited a significant increased expression level compared to control group at 24h treatment, indicating a promoting of dense system in ciliates at this exposure time. However, only sod1 and sod2 showed raised expression level at 48h stress, showing the different sensitive of gene isoforms to some extent. With OTC treatment, damage of regular wrinkles, shrunk, twisted on the cell surface, even forming cyst of scuticociliatid ciliate cells were firstly observed by SEM (scanning electron microscope) in this study. Overall, physiological, molecular and morphological information on the toxicological studies of ciliates and more information on possibility of ciliates as indicators of contamination were provided in this study. Copyright © 2017. Published by Elsevier B.V.

Development and application of a multiroute physiologically based pharmacokinetic model for oxytetracycline in dogs and humans.

PubMed

Lin, Zhoumeng; Li, Mengjie; Gehring, Ronette; Riviere, Jim E

2015-01-01

Oxytetracycline (OTC) is a commonly used tetracycline antibiotic in veterinary and human medicine. To establish a quantitative model for predicting OTC plasma and tissue exposure, a permeability-limited multiroute physiologically based pharmacokinetic model was developed in dogs. The model was calibrated with plasma pharmacokinetic data in beagle dogs following single intravenous (5 mg/kg), oral (100 mg/kg), and intramuscular (20 mg/kg) administrations. The model predicted other available dog data well, including drug concentrations in the liver, kidney, and muscle after repeated exposure, and data in the mixed-breed dog. The model was extrapolated to humans and the human model adequately simulated measured plasma OTC concentrations after intravenous (7.14 mg/kg) and oral exposures (6.67 mg/kg). The dog model was applied to predict 24-h OTC area-under-the-curve after three therapeutic treatments. Results were 27.75, 51.76, and 64.17 μg/mL*h in the plasma, and 120.93, 225.64, and 279.67 μg/mL*h in the kidney for oral (100 mg/kg), intravenous (10 mg/kg), and intramuscular (20 mg/kg) administrations, respectively. This model can be used to predict plasma and tissue concentrations to aid in designing optimal therapeutic regimens with OTC in veterinary, and potentially, human medicine; and as a foundation for scaling to other tetracycline antibiotics and to other animal species. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:233-243, 2015. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Successful early management of a female patient with a metabolic stroke due to ornithine transcarbamylase deficiency.

PubMed

Tummolo, Albina; Favia, Vito; Bellantuono, Rosa; Bellino, Vito; Ranieri, Antonio; Morrone, Amelia; De Palo, Tommaso; Papadia, Francesco

2013-05-01

Ornithine transcarbamylase deficiency (OTC-D) is a urea cycle disorder caused by dysfunction of ornithine transcarbamylase, which frequently leads to hyperammonemia. Hyperammonemia represents a medical emergency requiring prompt treatment to reduce plasma ammonia levels and prevent severe neurological damage, coma, and death, particularly in patients with acute decompensation-related coma. The clinical symptoms of OTC-D can manifest themselves either at an early stage, which is often associated with severe symptoms, or in later life (late-onset OTC-D), when symptoms may be less severe. There is currently little agreement over diagnostic signs of the condition or the most appropriate therapeutic approach. Hyperammonemia is usually treated with ammonia scavengers, continuous venovenous hemodialysis, and dietary changes. N-carbamylglutamate is approved for the treatment of hyperammonemia in N-acetylglutamate synthetase deficiency and may have efficacy in other urea cycle disorders. Here, we report a 13-year-old girl who was diagnosed with OTC-D at the age of 3 years. On this occasion, the patient presented with vomiting, lethargy, and mental confusion. Despite biochemical parameters being within normal ranges, she was comatose within a few hours. She was promptly treated with a combined therapy of continuous venovenous hemodialysis and N-carbamylglutamate, resulting in a gradual normalization of clinical symptoms within 30 hours. No neurological damage was apparent at 18 months after treatment. This case demonstrates that clinical benefits can be obtained by beginning aggressive treatment of OTC-D within a few hours of the onset of severe neurological symptoms even in the absence of altered biochemical markers.

Use of over-the-counter medicines for young children in Australia.

PubMed

Trajanovska, Misel; Manias, Elizabeth; Cranswick, Noel; Johnston, Linda

2010-01-01

To describe over-the-counter (OTC) medicine use by Australian parents for children aged birth to 24 months; types of medicines used and indications for use. A cross-sectional survey of parents was conducted using a self-administered over-the-counter medicine use questionnaire. A total of 640 questionnaires were distributed to parents of children who attended a hospital outpatient clinic, maternal and child health centre, or a childcare service in Melbourne, Australia. A total of 325 questionnaires were completed (50.1%). Of these, 98.2% of parents had reportedly purchased at least one OTC medicine for their child in the previous 12 months. The most commonly purchased medicines were: paracetamol (acetaminophen) (95.9%), choline salicylate (47.3%), ibuprofen (36.4%), and cough and cold products (46.7%). Paracetamol was commonly used for a high temperature (82.4%) and non-specific pain (62.3%). Over 40% of parents had used cough and cold products to treat cold and flu symptoms. Nineteen (6.1%) parents had used OTC medicines to induce sleep or settle their child. Most parents had used at least one OTC medicine to manage childhood symptoms. Of concern is that over 40% of parents had used cough and cold products for their young child, despite a lack of evidence surrounding their efficacy. In order to minimise risks associated with OTC medicine use, particularly cough and cold products, health-care providers need to continue the provision of current evidence-based information to parents regarding safe and appropriate use of medicines for their child.

76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

... intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph... establish a final monograph for OTC sunscreen products. These products are not yet the subject of an effective final monograph. \\1\\ See section 505 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355...

21 CFR 330.14 - Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... conditions regulated as a cosmetic or dietary supplement in a foreign country that would be regulated as OTC... without the personal involvement of a pharmacist; dietary supplement; or cosmetic). If the condition has... concerns about the condition's toxicity or other potentiality for harmful effect, the method of its use, or...

Parent, Teacher, and School Factors Associated with Over-the-Counter Drug Use among Multiracial Youth

ERIC Educational Resources Information Center

Vidourek, Rebecca A.; King, Keith A.

2013-01-01

Background: Over-the-counter (OTC) drug use is an increasing health issue among adolescents. Purpose: This study investigated OTC drug use among 7th through 12th grade multiracial students in one metropolitan area. Methods: A total of 2134 students completed the PRIDE Questionnaire, which examines alcohol and other drug use. Results: A total of…

21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a chemical...

21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a chemical...

75 FR 11221 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-10

... traded either on the OTC Bulletin Board or the Pink OTC Markets. The Exchange represents that: (1) Except... Change Relating to Listing of Wilshire 5000 Total Market ETF and the Wilshire 4500 Completion ETF March 3... proposes to list and trade the shares of the Wilshire 5000 Total Market ETF and the Wilshire 4500...

75 FR 41252 - Self-Regulatory Organizations; Notice of Filing of Proposed Rule Change by NYSE Arca, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-15

... a market capitalization greater than $75 million. In addition, as of April 21, 2010, the Index... or portfolio (excluding such Derivative Securities Products) each shall have a minimum market value... 12(g) of the Act. \\8\\ Non-NMS stocks are traded either on the OTC Bulletin Board or the Pink OTC...

76 FR 41539 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Amending...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... organization could not trade in an index-based or derivative security (e.g., a right or warrant) that is quoted... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64844; File No. SR-NYSEAmex-2011-34] Self... Premises in Certain OTC Bulletin Board and OTC Markets Securities July 8, 2011. I. Introduction On May 11...

75 FR 34983 - Order (1) Pursuant to Section 4(c) of the Commodity Exchange Act, Permitting the Kansas City...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... Act, Permitting the Kansas City Board of Trade Clearing Corporation To Clear Over-the-Counter Wheat...-the-counter (OTC) swap agreements (swaps) in wheat. Authority for granting this request is found in... grant KCBTCC approval to clear OTC wheat calendar swaps, and it would permit KCBT to list those products...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2012 CFR

2012-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2013 CFR

2013-04-01

... setting forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2011 CFR

2011-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2010 CFR

2010-04-01

... forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual active... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Procedures for classifying OTC drugs as generally...

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Code of Federal Regulations, 2014 CFR

2014-04-01

... setting forth the quantities of active ingredients of the drug. III. Animal safety data. A. Individual... paragraph (a)(6)(iii) of this section), all clinical testing has been conducted pursuant to a new drug... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Procedures for classifying OTC drugs as generally...

Evaluation of food chain transfer of the antibiotic oxytetracycline and human risk assessment.

PubMed

Boonsaner, Maliwan; Hawker, Darryl W

2013-10-01

There has been recent concern regarding the possibility of antibiotics entering the aquatic food chain and impacting human consumers. This work reports experimental results of the bioconcentration of the antibiotic oxytetracycline (OTC) by the Asian watermeal plant (Wolffia globosa Hartog & Plas) and bioaccumulation of OTC in watermeal and water by the seven-striped carp (Probarbus jullieni). They show, for the first time, the extent to which OTC is able to transfer from water to plant to fish and enter the food chain. The mean bioconcentration factor (dry weight basis) with watermeal was 1.28 × 10(3) L kg(-1). Separate experiments were undertaken to characterize accumulation of OTC by carp from water and watermeal. These showed the latter pathway to be dominant under the conditions employed. The bioconcentration and biomagnification factors for these processes were 1.75 L kg(-1) and 2 × 10(-4) kg g(-1) respectively. Using an aqueous concentration range of 0.34-3.0 μg L(-1), hazard quotients for human consumption of contaminated fish of 1.3 × 10(-2) to 1.15 × 10(-1) were derived. Copyright © 2013 Elsevier Ltd. All rights reserved.

Developing and applying a site-specific multimedia fate model to address ecological risk of oxytetracycline discharged with aquaculture effluent in coastal waters off Jangheung, Korea.

PubMed

Kim, Woojung; Lee, Yunho; Kim, Sang Don

2017-11-01

The overuse of oxytetracycline (OTC) in aquaculture has become a problem because of its chronic toxic effects on marine ecosystems. The present study assessed the ecological risk of OTC in the coastal waters near the Jangheung Flatfish Farm using a site-specific multimedia fate model to analyze exposure. Before the model was applied, its performance was validated by comparing it with field data. The coastal waters in the testbed were sampled and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) followed by solid-phase extraction (SPE). The concentrations of OTC measured varied from 7.05 to 95.39ng/L. The results of validating the models showed that the site-specific multimedia fate model performed better (root mean square error (RMSE): 24.217, index of agreement (IOA): 0.739) than conventional fugacity approaches. This result demonstrated the utility of this model in supporting effective future management of aquaculture effluent. The results of probabilistic risk assessment indicated that OTC from aquaculture effluent did not cause adverse effects, even in a maximum-use scenario. Copyright © 2017 Elsevier Inc. All rights reserved.

Survey of medical ethnobotanicals for dental and oral medicine conditions and pathologies.

PubMed

Colvard, Michael D; Cordell, Geoffrey A; Villalobos, Rodrigo; Sancho, Gina; Soejarto, Doel D; Pestle, William; Echeverri, Tatiana Lobo; Perkowitz, Kathleen M; Michel, Joanna

2006-08-11

Ethnomedical questionnaires were distributed in Chicago, Costa Rica, and Colombia to identify the most common over-the-counter (OTC) plant or plant-based products advocated for treating oral pain, ulcerative conditions, and cancer within these locations. Over 100 plants or plant-based herbal preparations and commercial products, purchased from local botanical markets and pharmacies, were advocated for the treatment of oral medicine conditions. Locally familiar and common language names were attributed to the plant products at the time of purchase. Plant products or plant-based commercial products containing plant-based essential oils, anesthetic constituents, and or chemical compounds recommended as OTC oral medicine preparations were systematized, tabulated, and correlated with the published phytotherapeutic literature. Though pharmacognostic research is available for some of the species collected, further ethnographic research is needed to correlate common names with the accurate taxonomic identification for each plant species. Furthermore, epidemiological research is needed to verify the use and standardized dosage for OTC ethnomedicine preparations for oral medicine conditions. Pharmacognostic research and clinical trails which can verify taxonomy, dose, safety, active principles, and efficacy of these OTC oral medicine products must be enhanced in order to verify the claimed validity in contemporary, global, oral medicine practice.

OTC polyethylene glycol 3350 and pharmacists' role in managing constipation.

PubMed

Horn, John R; Mantione, Maria Marzella; Johanson, John F

2012-01-01

To define constipation, assess the pharmacist's role in identifying and treating constipation, and review clinical evidence for the efficacy, safety, and tolerability of polyethylene glycol (PEG) 3350 (MiraLAX-Merck Consumer Care), an osmotic laxative now available over the counter (OTC), across a variety of patient populations routinely encountered in pharmacy settings. Systematic PubMed search of the primary literature for constipation treatment guidelines and clinical trial results for PEG 3350. Pharmacists have a unique role in assisting patients with identifying and managing constipation. Multiple controlled clinical trials have established the efficacy, safety, and tolerability of PEG 3350 at its recommended dose of 17 g once daily. On the basis of this evidence, various professional groups have recommended PEG 3350 for use in improving stool frequency and consistency in patients with constipation. PEG 3350 is approved for short-term use, including treatment of constipation caused by medications. Pharmacists can play an important role in managing constipation with OTC agents. Compared with other available OTC agents, PEG 3350 can be recommended to patients suffering from constipation on the basis of a large body of clinical evidence supporting its efficacy and safety, as well as the high patient acceptance shown for its palatability and once-daily dosing.