Science.gov

Sample records for over-the-counter whitening agents

  1. Over-the-counter whitening agents: a concise review.

    PubMed

    Demarco, Flávio Fernando; Meireles, Sônia Saeger; Masotti, Alexandre Severo

    2009-01-01

    Tooth discoloration is commonly found in the dental clinic and tooth bleaching has been considered the preferred esthetic alternative, being more conservative, safe and with predictable results. Supervised home-use of 10% Carbamide Peroxide (CP) bleaching with custom-trays is the most common bleaching procedure dispensed by dentists to their patients. The good results obtained with this technique stimulated the flourishing of new products and techniques. Over-the-counter (OTC) bleaching products appeared as a low-cost alternative to bleach discolored teeth without dentist supervision. Different OTC products are available in supermarkets, drug stores or on the Internet, including rinses, paint-on brushes, toothpastes, chewing guns, dental floss, and whitening strips. There is lack of clinical evidence regarding the safety and effectiveness of these products, being most of the studies supported by the manufacturers'. Basically, toothpastes, chewing gums, and dental floss are removal agents of superficial stains. Rinses and paint-on brushes with low levels of hydrogen peroxide have some whitening effect, but without clinical relevance. Strips present similar esthetic results and side-effects, compared to bleaching with 10% CP using trays; however, the studies have financial support from the manufacturers and were based on short term evaluations. Legislation varies widely in different countries regarding OTC dental bleaching. Concerns have appeared due to the potential abusive use of these self-medication agents, especially in young patients, with potential harmful results. Dentists should be acquainted with this kind of products to be able to inform their patients. In conclusion, there is a need for independent clinical trials to provide sufficient evidence regarding the use of OTC bleaching products.

  2. In Vitro Evaluation of the Efficacy of Different Over-the-Counter Products on Tooth Whitening.

    PubMed

    Karadas, Muhammet; Duymus, Zeynep Yesil

    2015-01-01

    This in vitro study evaluated the whitening effect of four different over-the-counter products compared with a 10% carbamide peroxide (CP) bleaching gel. Specimens obtained from bovine incisors were stained in a tea solution and randomly divided into six groups according to the product used (n=10): CT: conventional toothpaste (negative control); CWT: Crest 3D White toothpaste; CWR: Crest 3D White mouth rinse; CWS: Crest 3D White strips; DW: Dazzling White (paint-on gel); and OP: Opalescence PF 10% CP (at-home bleaching gel, positive control). Over-the-counter products and 10% CP were used according to the manufacturer's recommendations. Color measurements were performed according to the CIELab system using spectrophotometer after staining, and after 4 and 8 weeks of the treatment procedure. The ∆E, ∆L, ∆a, and ∆b values were calculated. The data obtained were analyzed by repeated-measures ANOVA. Tukey's test for multiple comparisons was applied (p<0.05). All groups, except CWT, were effective in tooth whitening in comparison with conventional toothpaste. There was no significant difference in tooth whitening between CWT and CT (p=0.93). CWS, DW and OP groups presented significantly higher color changes than the CWR group. DW and CWS showed similar tooth whitening to OP.

  3. Effect of four over-the-counter tooth-whitening products on enamel microhardness.

    PubMed

    Majeed, A; Grobler, S R; Moola, M H; Oberholzer, T G

    2011-10-01

    This in vitro study evaluated the effect of four over-the-counter tooth-whitening products on enamel microhardness. Fifty enamel blocks were prepared from extracted human molar teeth. The enamel surfaces were polished up to 1200 grit fineness and the specimens randomly divided into five groups. Enamel blocks were exposed to: Rapid White (n=10); Absolute White (n=10); Speed White (n=10) and White Glo (n=10) whitening products, according to the manufacturers' instructions. As control, ten enamel blocks were kept in artificial saliva at 37 degrees C without any treatment. Microhardness values were obtained before exposure (baseline) and after 1, 7 and 14-day treatment periods using a digital hardness tester with a Vickers diamond indenter. Data were analysed using Wilcoxon Signed Rank Sum Test, one-way ANOVA and Tukey-Kramer Multiple Comparison Test (p<0.05). Both Rapid White and Absolute White reduced enamel microhardness. Speed White increased the microhardness of enamel, while White Glo and artificial saliva had no effect on hardness. Over-the-counter tooth-whitening products might decrease enamel microhardness depending on the type of product.

  4. Comparison of two over-the-counter tooth whitening products using a novel system.

    PubMed

    Cronin, Matthew J; Charles, Christine A; Zhao, Qian; Dembling, Wayne Z

    2005-02-01

    Tooth whitening is one of the most widely accepted esthetic procedures in dentistry. Various treatment options include in-office and prescribed at-home bleaching procedures, over-the-counter bleaching kits, and whitening dentifrices. This study evaluated and compared a 6% hydrogen peroxide tooth bleaching gel delivered on polyethylene film (HP) with an 18% carbamide peroxide brush-applied liquid gel (CP). A total of 59 subjects completed this 2-week, examiner blind, randomized, parallel group study. Both treatments were applied twice daily for 2 weeks according to the manufacturer's instructions. Evaluations for oral safety and Vita tooth shade were conducted by a dental examiner at baseline and 2 weeks after product use. In addition, the ShadeVision System was used to determine changes in Vita shade and L*a*b* values. Based on both the examiner and ShadeVision System assessments, both treatments significantly improved tooth shade. Improvements in Vita tooth shade based on the adjusted mean for HP were 2.64 (P < 0.001) and 2.33 (P < 0.001) for the examiner and ShadeVision System assessments, respectively, compared with improvements of 1.04 (P = .004) and 0.42 (P = 0.029) for CP users, respectively. The difference between treatments was found to be significant for both the examiner (P = .005) and ShadeVision (P = .001) assessments. Findings from the L*a*b* data derived from the ShadeVision System were in agreement with Vita assessments, with significant differences for changes in L*, a*, and b* in favor of HP users (P = .001). In this study, the ShadeVision method of color analysis was relatively easy to use and demonstrated significant differences between 2 OTC whitening products using both Vitapan and L*a*b* means of assessment.

  5. Use and abuse of over-the-counter analgesic agents.

    PubMed Central

    Abbott, F V; Fraser, M I

    1998-01-01

    Pain and discomfort in everyday life are often treated with over-the-counter (OTC) analgesic medications. These drugs are remarkably safe, but serious side effects can occur. Up to 70% of the population in Western countries uses analgesics regularly, primarily for headaches, other specific pains and febrile illness. It is not known whether the patterns of use are consistent with good pain management practices. OTC analgesics are also widely used to treat dysphoric mood states and sleep disturbances, and high levels of OTC analgesic medication use are associated with psychiatric illness, particularly depressive symptoms, and the use of alcohol, nicotine and caffeine. More than 4 g per day of acetylsalicylic acid (ASA) or acetaminophen over long periods is considered abuse. People using excessive amounts of OTC analgesics may need more effective treatments for chronic pain, depression or dysthymia. The possibility that these drugs have subtle reinforcing properties needs to be investigated. Certainly phenacetin, which was taken off the market in the 1970s, had intoxicating effects. A better understanding of patterns of use is needed to determine the extent of problem use of OTC analgesics, and whether health could be improved by educating people about the appropriate use of these drugs. PMID:9505057

  6. Efficacy and safety of over-the-counter whitening strips as compared to home-whitening with 10 % carbamide peroxide gel--systematic review of RCTs and metanalysis.

    PubMed

    Serraglio, Carla Regina; Zanella, Luana; Dalla-Vecchia, Karine Battestin; Rodrigues-Junior, Sinval Adalberto

    2016-01-01

    The study aims to compare the efficacy and safety of over-the-counter whitestrips with the American Dental Association (ADA)-recommended home-whitening using the 10 % carbamide peroxide gel. Randomized controlled trials (RCTs) comparing the clinical efficacy and safety of the whitestrips with the 10 % carbamide peroxide (10 % CP) gel applied on tray for tooth whitening in adults were searched at PubMed and Cochrane Central Register of Controlled Trials databases and selected up to October 2014. Efficacy of the whitening techniques was assessed through ∆E, ∆L, and ∆b parameters, while side effects were analyzed as dichotomous variables. Data was extracted independently by two reviewers. Metanalysis was performed using random- and fixed-effect models (RevMan 5.3). Eight studies were included in the metanalysis. The metanalysis revealed no significant difference between the intervention groups for tooth-whitening efficacy measured as ΔE (mean difference [MD]-0.53; 95 % CI [-1.72;0.66]; Z = 0.88; p = 0.38) and ΔL (MD-0.22; 95 % CI [-0.81;0.36]; z = 0.75; p = 0.45); reduction of yellowing was higher with the whitestrips (MD-0.47; 95 % CI [-0.89; -0.06]; Z = 2.25; p = 0.02). Tooth sensitivity (risk ratio [RR] 1.17; 95 % CI [0.81-1.69]; Z = 0.81; p = 0.42) and gingival sensitivity (RR 0.76; 95 % CI [0.53-1.10]; Z = 1.44; p = 0.15) were similar, regardless of the whitening method used. The observed gingival irritation was higher when the 10 % CP gel was applied on tray (RR 0.43; 95 % CI [0.20-0.93]; Z = 2.14; p = 0.03). The quality of evidence generated was rated very low for all outcomes. There is no sound evidence to support the use of the whitening strips in detriment of the ADA-recommended technique based on the 10 % carbamide peroxide gel applied on tray. To the moment, there is no sound evidence in dental literature to suggest that the ADA-recommended whitening technique based on 10 % carbamide peroxide gel could be substituted by the whitening strips. The

  7. Oral Adverse Reactions Caused by Over-the-Counter Oral Agents

    PubMed Central

    Andabak Rogulj, Ana; Vidovic Juras, Danica; Gabric, Dragana; Vrdoljak, Danko Velimir

    2015-01-01

    Over-the-counter products rarely cause unwanted reactions in the oral cavity. Oral reactions to these agents are not specific and might present with various clinical oral findings. Detailed medical history is a key to the proper diagnosis of these lesions and fortunately other diagnostic procedures are rarely needed. Lesions are usually managed with elimination of the offending agent and with topical steroids. In more severe cases systemic steroids should be applied. PMID:25883811

  8. Adverse drug interactions involving common prescription and over-the-counter analgesic agents.

    PubMed

    Hersh, Elliot V; Pinto, Andres; Moore, Paul A

    2007-01-01

    Eight analgesic preparations with approved indications for acute pain were among the top 200 drugs prescribed in the United States in 2006. In addition, an estimated 36 million Americans use over-the-counter (OTC) analgesics daily. Given this volume of use, it is not surprising that a number of drug interactions involving analgesic drugs have been reported. This article examines the pharmacologic factors that enhance the clinical relevance of potential drug interactions and reviews the literature on drug interactions involving the most commonly used analgesic preparations in the United States. A PubMed search was conducted for English-language articles published between January 1967 and July 2007. Among the search terms were drug interactions, acetaminophen, aspirin, ibuprofen, naproxen, celecoxib, NSAIDs, hydrocodone, oxycodone, codeine, tramadol, OTC analgesics, alcohol, ethanol, antihypertensive drugs, methotrexate, warfarin, SSRIs, paroxetine, fluoxetine, sertraline, citalopram, serotonin syndrome, MAOIs, and overdose. Controlled clinical trials, case-control studies, and case reports were included in the review. A number of case reports and well-controlled clinical trials were identified that provided evidence of the relatively well known drug-drug interactions between prescription/OTC NSAIDs and alcohol, antihypertensive drugs, high-dose methotrexate, and lithium, as well as between frequently prescribed narcotics and other central nervous system depressants. In contrast, the ability of recent alcohol ingestion to exacerbate the hepatotoxic potential of therapeutic doses of acetaminophen is not supported by either case reports or clinical research. Use of ibuprofen according to OTC guidelines in patients taking cardioprotective doses of aspirin does not appear to interfere with aspirin's antiplatelet activity, whereas chronic prescription use of ibuprofen and other NSAIDs may interfere. Low-dose aspirin intake appears to abolish the gastroprotective effects

  9. The Hunt for Natural Skin Whitening Agents

    PubMed Central

    Smit, Nico; Vicanova, Jana; Pavel, Stan

    2009-01-01

    Skin whitening products are commercially available for cosmetic purposes in order to obtain a lighter skin appearance. They are also utilized for clinical treatment of pigmentary disorders such as melasma or postinflammatory hyperpigmentation. Whitening agents act at various levels of melanin production in the skin. Many of them are known as competitive inhibitors of tyrosinase, the key enzyme in melanogenesis. Others inhibit the maturation of this enzyme or the transport of pigment granules (melanosomes) from melanocytes to surrounding keratinocytes. In this review we present an overview of (natural) whitening products that may decrease skin pigmentation by their interference with the pigmentary processes. PMID:20054473

  10. Over-the-counter anti-ageing topical agents and their ability to protect and repair photoaged skin.

    PubMed

    Bradley, Eleanor J; Griffiths, Christopher E M; Sherratt, Michael J; Bell, Mike; Watson, Rachel E B

    2015-03-01

    Ultraviolet radiation (UVR)-induced photoageing of the skin is associated with characteristic clinical features including a sallow complexion, deep, coarse wrinkles and a loss of elasticity. Remodelling of the dermal extracellular matrix (ECM) with changes to fibrillar collagens, elastic fibres and glycosaminoglycans is likely to be a major contributing factor to these particular clinical signs. Over-the-counter (OTC) topical formulations are one popular management strategy for preventing and/or repairing photoaged skin, most commonly targeting wrinkles as these are often the most concerning clinical feature. Due to the cosmetic nature of such formulations, evidence of their clinical efficacy and mechanism of action is often limited. However, these formulations usually contain putative active ingredients which individually have been subject to in vitro and in vivo investigation for efficacy as photoageing interventions. This review highlights commonly found ingredients within OTC formulations and assesses the evidence for: (i) their efficacy in clinically and histologically improving photoaged skin; (ii) the potential mechanisms of action; and (iii) their ability to act synergistically with complementary ingredients to enhance the clinical outcome.

  11. Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety

    PubMed Central

    Culpepper, Larry; Wingertzahn, Mark A.

    2015-01-01

    Objective: To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia. Data sources: A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials. Study selection: Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia. Results: Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects. Conclusions: A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety. PMID:27057416

  12. Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.

    PubMed

    Culpepper, Larry; Wingertzahn, Mark A

    2015-01-01

    To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia. A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials. Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia. Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects. A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety.

  13. Over-the-Counter Medicines

    MedlinePlus

    Over-the-counter (OTC) medicines are drugs you can buy without a prescription. Some OTC medicines relieve aches, pains ... Others help manage recurring problems, like migraines. In the United States, the Food and Drug Administration decides ...

  14. [Laboratory evaluation of tooth whitening agents in hydroxyapatite samples].

    PubMed

    Poiurovskaia, I Ia; D'iakonenko, E E; Pozharkova, M E

    2013-01-01

    The paper presents laboratory model for evaluation of the effectiveness of tooth whitening agents on pure and technical hydroxyapatite (HAP) samples. HAP samples were exposed in distilled water, and colour measurements were taken after coloration in tea extract and using of "Blend-a-med delicate bleaching" ("Procter & Gamble", Germany) toothpaste. The proposed laboratory model allows imitating discoloration by food dye (tea) and measure the whitening toothpaste effect by significant change in colour characteristics in the CIE L*a*b* system.

  15. Tooth whitening today.

    PubMed

    Sarrett, David C

    2002-11-01

    Methods to improve the esthetics of the dentition by tooth whitening are of interest to dentists, their patients and the public. In the past 20 years, research on bleaching and other methods of removing tooth discolorations has dramatically increased. Dentist-supervised and over-the-counter products now are available to solve a variety of tooth discoloration problems without restorative intervention. The indications for appropriate use of tooth-whitening methods and products are dependent on correct diagnosis of the discoloration. Tooth-whitening methods include the use of peroxide bleaching agents to remove internal discolorations or abrasive products to remove external stains. Peroxide bleaching procedures are completed by the dentist in single or multiple appointments, or by the patient over a period of weeks to months using custom trays loaded with a bleaching agent. Both methods are safe and effective when supervised by the dentist. Microabrasion is indicated for the removal of isolated discolorations that often are associated with fluorosis. Whitening toothpastes remove surface stains only through the polishing effect of the abrasives they contain. Tooth whitening is a form of dental treatment and should be completed as part of a comprehensive treatment plan developed by a dentist after an oral examination. When used appropriately, tooth-whitening methods are safe and effective.

  16. Over-the-Counter Medicines - Multiple Languages

    MedlinePlus

    ... Guide to Over the Counter Medications - العربية (Arabic) MP3 Global Health Center University of Louisville Division of ... to Over the Counter Medications - فارسی (Farsi (Persian)) MP3 Global Health Center University of Louisville Division of ...

  17. Over-the-counter Acne Treatments

    PubMed Central

    Graber, Emmy M.

    2012-01-01

    Acne is a common dermatological disorder that most frequently affects adolescents; however, individuals may be affected at all ages. Many people who suffer from acne seek treatment from both prescription and over-the-counter acne medications. Due to convenience, lower cost, and difficulty getting an appointment with a dermatologist, the use of over-the-counter acne treatments is on the rise. As the plethora of over-the-counter acne treatment options can be overwhelming, it is important that dermatologists are well-versed on this subject to provide appropriate information about treatment regimens and potential drug interactions and that their patients see them as well-informed. This article reviews the efficacy of various over-the-counter acne treatments based on the current literature. A thorough literature review revealed there are many types of over-the-counter acne treatments and each are designed to target at least one of the pathogenic pathways that are reported to be involved in the development of acne lesions. Many of the key over-the-counter ingredients are incorporated in different formulations to broaden the spectrum and consumer appeal of available products. Unfortunately, many over-the-counter products are not well-supported by clinical studies, with a conspicuous absence of double-blind or investigator-blind, randomized, vehicle-controlled studies. Most studies that do exist on over-the-counter acne products are often funded by the manufacturer. Use of over-the-counter acne treatments is a mainstay in our society and it is important that dermatologists are knowledgeable about the different options, including potential benefits and limitations. Overall, over-the-counter acne therapies can be classified into the following five major groups: cleansers, leave-on products, mechanical treatments, essential oils, and vitamins. PMID:22808307

  18. Using over-the-counter medicines safely

    MedlinePlus

    ... ency/patientinstructions/000882.htm Using over-the-counter medicines safely To use the sharing features on this ... need to know about OTC drugs. About OTC Medicines You can buy OTC medicines without a prescription ...

  19. Clinical evaluation of two carbamide peroxide tooth-whitening agents.

    PubMed

    Heymann, H O; Swift, E J; Bayne, S C; May, K N; Wilder, A D; Mann, G B; Peterson, C A

    1998-04-01

    A blinded study was conducted to evaluate the efficacy and safety of a dentist-prescribed, accelerated carbamide peroxide tooth-whitening system. Fifty-one patients with discolored teeth completed a clinical trial using an overnight bleaching regimen. One group used an experimental bleaching (whitening) regimen with 10% carbamide peroxide bleaching paste, and another group used the Colgate Platinum Professional Overnight Whitening System. The study included an initial 1-week control/compliance phase using a placebo gel, followed by a 1-week active phase using the assigned bleaching agent. The shade of each participant's maxillary anterior teeth was evaluated by 2 trained and calibrated evaluators at the start of the control/compliance phase, the beginning of the active phase, and days 3, 5, and 7 of the active phase. A value-oriented Vita shade guide with 16 rankings was used to measure color changes, and the number of shade guide units of change (delta sgu) was calculated. Potential side effects, such as tooth hypersensitivity and gingival irritation, also were assessed at each recall examination, as well as recorded by the patients in their daily diaries. At the end of the 7-day active phase, the mean delta sgu for the group using the experimental bleaching agent was 7.1 +/- 2.4, and for the Colgate Platinum Overnight group, the delta sgu was 7.5 +/- 2.2. There were no statistically significant (p > or = 0.05) differences between the results of both groups at the 0-, 3-, 5-, and 7-day evaluations. After 7 days, the change in shade guide units for both groups ranged from 3 to 13 units, far exceeding the minimum required change by the American Dental Association Guidelines (delta sgu = 2 units) for demonstrating efficacy. There was no statistical difference in the whitening achieved at day 5 vs. day 7 for either tooth-whitening group. There were no notable changes in any gingival, bleeding, or plaque indexes for the 50 patients completing the active phase. The

  20. Toxicoses from over-the-counter human drugs.

    PubMed

    Papich, M G

    1990-03-01

    This article describes the mechanisms, recognition, and management of toxicoses from human over-the-counter (OTC) drugs. Drugs that have been included were chosen because of their potential for toxicosis and the incidence of exposure. Drug groups discussed are cough, cold, and allergy medications, laxatives and cathartics, antacids, antidiarrheal agents, topicals, and vitamin and iron supplements.

  1. Clinical study of the safety and effectiveness of a novel over-the-counter bleaching tray system.

    PubMed

    Ghalili, K Michael; Khawaled, Kamal; Rozen, Doran; Afsahi, Veda

    2014-01-01

    We investigated color change, gingival irritation, and tooth sensitivity in patients undergoing at-home vital tooth bleaching with a novel over-the-counter bleaching tray system. Tooth color shade in anterior teeth, supragingival plaque and gingivitis in Ramfjord teeth, as well as visual assessment of teeth gingival tissues and mucosa were evaluated in-office prior to treatment, after two consecutive applications of the 9% hydrogen peroxide bleaching product, after eight applications (10 minutes/day for 3 days at home), and after ten applications (50 minutes exposure over 5 days). Color stability was evaluated at 3 months after completing the treatment regimen. Over-the-counter bleaching products can be used by the patient at home without dentist supervision, but are frequently associated with gingival irritation and tooth sensitivity despite low concentrations of peroxide agents. Our investigations showed that the treatment is tolerable and safe with a low incidence of adverse effects. Any adverse effects associated with use of the whitening gel and tray are temporary, easily controlled, and often disappear within minutes of treatment. Statistical analysis revealed significant improvement in teeth whitening following treatment (mean color change of seven shades) and at three months after treatment.

  2. Clinical study of the safety and effectiveness of a novel over-the-counter bleaching tray system

    PubMed Central

    Ghalili, K Michael; Khawaled, Kamal; Rozen, Doran; Afsahi, Veda

    2014-01-01

    We investigated color change, gingival irritation, and tooth sensitivity in patients undergoing at-home vital tooth bleaching with a novel over-the-counter bleaching tray system. Tooth color shade in anterior teeth, supragingival plaque and gingivitis in Ramfjord teeth, as well as visual assessment of teeth gingival tissues and mucosa were evaluated in-office prior to treatment, after two consecutive applications of the 9% hydrogen peroxide bleaching product, after eight applications (10 minutes/day for 3 days at home), and after ten applications (50 minutes exposure over 5 days). Color stability was evaluated at 3 months after completing the treatment regimen. Over-the-counter bleaching products can be used by the patient at home without dentist supervision, but are frequently associated with gingival irritation and tooth sensitivity despite low concentrations of peroxide agents. Our investigations showed that the treatment is tolerable and safe with a low incidence of adverse effects. Any adverse effects associated with use of the whitening gel and tray are temporary, easily controlled, and often disappear within minutes of treatment. Statistical analysis revealed significant improvement in teeth whitening following treatment (mean color change of seven shades) and at three months after treatment. PMID:24591847

  3. Comparison of efficacy of an in-office whitening system used with and without a whitening priming agent.

    PubMed

    Da Costa, Juliana; Lubisich, Erinne; Ferracane, Jack; Hilton, Thomas

    2011-04-01

    The purpose of this study was to compare the whitening efficacy of an in-office whitening system with and without the whitening primer application and evaluate tooth and soft tissue sensitivity. This was a randomized, split-mouth design, single-blinded, clinical study. Twenty-five patients received a whitening priming agent (Power Swabs, Power Swabs Corporation, Beaverton, OR, USA) on right or left maxillary incisors prior to in-office tooth whitening with Opalescence Boost (38% hydrogen peroxide; Ultradent Products, Inc., South Jordan, UT, USA). Color was evaluated with the Bleachedguide 3D Master (Vita Zahnfabrik, Bad Sackingen, Germany) and Vita Easyshade spectrophotometer (Vident, Brea, CA, USA), after 30 minutes, 1 day, and 15 days postwhitening. After each tooth color measurement, the subjects were asked to rate their tooth and soft tissue sensitivity experience using a visual analog scale (1-10 categories). Results were analyzed by two-way repeated measurements analysis of variance/Tukey's (p<0.05); Mann-Whitney rank sum test and Kruskal-Wallis. The teeth that were treated with the primer prior to tooth whitening did not show significant difference in ΔL*, Δa*, Δb*, ΔE* and delta shade guide from the teeth that were not treated with the primer, at the three time points evaluated (baseline versus 30 minutes after in-office treatment, baseline versus 1 day, and baseline versus 15 days). None of the subjects experienced soft tissue sensitivity, and those who experienced tooth sensitivity said it was not noticeable after 15 days postwhitening. The primer neither enhanced the whitening effect nor decreased tooth sensitivity when used before vital bleaching with Opalescence Boost (Ultradent Products, Inc., South Jordan, UT, USA). None of the subjects experienced soft tissue sensitivity, and some experienced transient tooth sensitivity. © 2011, COPYRIGHT THE AUTHORS. JOURNAL COMPILATION © 2011, WILEY PERIODICALS, INC.

  4. Artocarpus plants as a potential source of skin whitening agents.

    PubMed

    Arung, Enos Tangke; Shimizu, Kuniyoshi; Kondo, Ryuichiro

    2011-09-01

    Artocarpus plants have been a focus of constant attention due to the potential for skin whitening agents. In the in vitro experiment, compounds from the Artocarpus plants, such as artocarpanone, norartocarpetin, artocarpesin, artogomezianol, andalasin, artocarbene, and chlorophorin showed tyrosinase inhibitory activity. Structure-activity investigations revealed that the 4-substituted resorcinol moiety in these compounds was responsible for their potent inhibitory activities on tyrosinase. In the in vitro assay, using B16 melanoma cells, the prenylated polyphenols isolated from Artocarpus plants, such as artocarpin, cudraflavone C, 6-prenylapigenin, kuwanon C, norartocarpin, albanin A, cudraflavone B, and brosimone I showed potent inhibitory activity on melanin formation. Structure-activity investigations revealed that the introduction of an isoprenoid moiety to a non-isoprenoid-substituted polyphenol enhanced the inhibitory activity of melanin production in B16 melanoma cells. In the in vivo investigation, the extract of the wood of Artocarpus incisus and a representative isolated compound from it, artocarpin had a lightening effect on the skin of guinea pigs' backs. Other in vivo experiments using human volunteers have shown that water extract of Artocarpus lakoocha reduced the melanin formation in the skin of volunteers. These results indicate that the extracts of Artocarpus plants are potential sources for skin whitening agents.

  5. Soft-tissue alterations following exposure to tooth-whitening agents.

    PubMed

    Lucier, Rebekah N; Etienne, Olivier; Ferreira, Susana; Garlick, Jonathan A; Kugel, Gerard; Egles, Christophe

    2013-04-01

    Tooth-whitening agents are widely used, either as self-application products or under the supervision of a dentist. These products may be associated with transient gross morphologic changes in oral soft tissues. However, their potential effects on human keratinocytes and fibroblasts in a stratified squamous epithelium have yet to be elucidated. In this study, three-dimensional human tissue equivalents are exposed to varying concentrations of tooth-whitening agents for increasing time periods. Tissue alterations are investigated in terms of morphology, proliferation, apoptosis, and protein expression. All whitening agents tested altered tissue morphology, induced proliferation of basal keratinocytes, and caused apoptosis of cells in all epithelial strata. In addition, whitening agents induced alterations in the expression of cytokines that are linked to inflammation. These results suggest that whitening agents may induce similar changes in vivo and that these products should be used for limited periods of time or under the supervision of a dental professional.

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

    MedlinePlus

    ... Over-the-Counter Medicines The Over-the-Counter Medicine Label: Take a Look Share Tweet Linkedin Pin ... your family when using over-the-counter (OTC) medicines (available without a prescription). This is especially true ...

  7. Effect of a whitening agent application on enamel bond strength of self-etching primer systems.

    PubMed

    Miyazaki, Masashi; Sato, Hikaru; Sato, Tomomi; Moore, B Keith; Platt, Jeffrey A

    2004-06-01

    Though reduction in bond strength after tooth whitening has been reported, little is known about it's effect on enamel bond strength of two-step bonding systems that exclude phosphoric acid etching prior to bonding agent application. The purpose of this study was to determine the effect of whitening procedure using an in-office whitening agent on enamel bond strength of self-etching primer systems. Three self-etching primer systems, Imperva Fluoro Bond, Mac Bond II, Clearfil SE Bond, and a one-bottle adhesive system Single Bond as a control material, were used. Bovine mandibular incisors were mounted in self-curing resin and the facial enamel or dentin surfaces were ground wet on 600-grit SiC paper. An in-office whitening agent, Hi-Lite was applied on the tooth surface according to the manufacturer's instruction. Bonding procedures were done soon after rinsing off the whitening agent or after 24 hours storage in distilled water. Specimens without whitening procedure were prepared as controls. Fifteen specimens per test group were stored in 37 degrees C distilled water for 24 hours, then shear tested at a crosshead speed of 1.0 mm/minute. One-way ANOVA followed by Duncan multiple range test were used for statistical analysis of the results. For the specimens made soon after rinsing off the whitening agent, a significant decrease in enamel bond strength was observed for all the bonding systems used. For the specimens made after 24 hours storage in water, a small decrease in enamel bond strength was observed and no significant differences were found compared to those of controls (without whitening). From the results of this study, enamel bond strengths of the self-etching primer systems might be affected to a lesser degree after rinsing with water followed by 24 hours storage in water.

  8. Characterization of dentifrices containing desensitizing agents, triclosan or whitening agents: EDX and SEM analysis.

    PubMed

    Pinto, Shelon Cristina Souza; Hilgenberg, Sérgio Paulo; Wambier, Denise Stadler; Farago, Paulo Vitor; Bandéca, Matheus Coelho; Santos, Fábio André

    2014-01-01

    Dentifrices with different compositions are available on the market, but there is limited information about their properties. The aim of this in vitro study was to evaluate the physicochemical characteristics of 12 dentifrices divided into three categories, as containing desensitizing agents, Triclosan or whitening agents. Desiccation loss/residue analysis: 5 g of dentifrice was weighed five times for each group. pH analysis: 5 g of dentifrice were diluted in three parts of distilled water and analyzed using a digital potentiometer. Scanning electron microscopy (SEM): analysis of ashes, shape and size of the particles. Energy-dispersive x-ray spectroscopy (EDX): identification of the abrasive elements. Data were analyzed using ANOVA, Bonferroni post hoc test (α=0.05). Desiccation loss: 38.21% to 65.83%. Dentifrices containing Triclosan and desensitizing agents showed statistically significant differences among them (p<0.05). Whitening dentifrices showed statistically significant differences between Close-Up Whitening and Sensodyne Branqueador (44.72%, 65.83%, respectively). Most dentifrices presented neutral or basic pH. Different shape and size particles were observed in the SEM analysis. Abrasive elements were identified in the EDX. These results demonstrate that the evaluated dentifrices had different properties and their composition influences directly their characteristics, thus resulting in a more or less abrasive action on tooth surface. Knowing the characteristics of the dentifrices is important to indicate the ideal product for each case.

  9. Overview of skin whitening agents with an insight into the illegal cosmetic market in Europe.

    PubMed

    Desmedt, B; Courselle, P; De Beer, J O; Rogiers, V; Grosber, M; Deconinck, E; De Paepe, K

    2016-06-01

    Lightening skin tone is an ancient and well-documented practice, and remains common practice among many cultures. Whitening agents such as corticosteroids, tretinoin and hydroquinone are medically applied to effectively lighten the skin tone of hyperpigmented lesions. However, when these agents are used cosmetically, they are associated with a variety of side-effect. Alternative agents, such as arbutin and its derivatives kojic acid and nicotinamide have been subsequently developed for cosmetic purposes. Unfortunately, some cosmetics contain whitening agents that are banned for use in cosmetic products. This article provides an overview of the mode of action and potential side-effects of cosmetic legal and illegal whitening agents, and the pattern of use of these types of products. Finally, an EU analysis of the health problems due to the presence of illegal products on the market is summarized. © 2016 European Academy of Dermatology and Venereology.

  10. 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.

  11. Over-the-Counter Medications in Pregnancy.

    PubMed

    Servey, Jessica; Chang, Jennifer

    2014-10-15

    Many pregnant women take over-the-counter (OTC) medications despite the absence of randomized controlled trials to guide their use during pregnancy. Most data come from case-control and cohort studies. In 1979, the U.S. Food and Drug Administration began reviewing all prescription and OTC medications to develop risk categories for use in pregnancy. Most OTC medications taken during pregnancy are for allergy, respiratory, gastrointestinal, or skin conditions, as well as for general analgesia. Acetaminophen, which is used by about 65% of pregnant women, is generally considered safe during any trimester. Cold medications are also commonly used and are considered safe for short-term use outside of the first trimester. Many gastrointestinal medications are now available OTC. Histamine H2 blockers and proton pump inhibitors have not demonstrated significant fetal effects. Nonsteroidal anti-inflammatory drugs are generally not recommended in pregnancy, especially during organogenesis and in the third trimester. There are even fewer data regarding use of individual herbal supplements. Ginger is considered safe and effective for treating nausea in pregnancy. Topical creams are considered safe based on small studies and previous practice. All OTC medication use should be discussed with patients, and the effects of the symptoms should be balanced with the risks and benefits of each medication. Because of the expanding OTC market, formalized studies are warranted for patients to make a safe and informed decision about OTC medication use during pregnancy.

  12. Vital tooth whitening.

    PubMed

    Kihn, Patricia W

    2007-04-01

    Vital tooth whitening, when administered correctly, is by all accounts one of the safest, most conservative, least expensive, and most effective aesthetic procedures currently available to patients. This article traces the evolution of the technology, describes what is known about the mechanism of action and explores such issues as toxicology and side effects associated with tooth whitening. The article also describes the various tooth-whitening systems, which include dentist-supervised night-guard bleaching, in-office or power bleaching, and bleaching with over-the-counter bleaching products. Combination treatments and light-activated treatments are also discussed. Finally, the article summarizes the areas of research needed in this field.

  13. Determination of fluorescent whitening agent in emulsion paint based on fluorescence spectrophotometry

    NASA Astrophysics Data System (ADS)

    Zhang, Lin; Zhao, Youlin

    2017-06-01

    Fluorescence spectrophotometry was applied to the determination of fluorescent whitening agent in emulsion paint. At temperature of 30°C, linear relationship was found between fluorescence intensity and concentration of fluorescent whitening agent in the range of 0.025-0.25mg/ml when the emission wavelength was 437nm and excitation wavelength was 347nm, correlation conefficient was 0.998, detection limit was 0.0007mg/ml, relative standard deviation ranged from 0.49% to 0.72%, recovery of standard addition ranged from 98.3% to 104.5%. The influence of storage time and exposure time were also studied here. Measurement results indicated the feasibility and precision of using this method for quantitative analysis of fluorescent whitening agent.

  14. Over-the-counter cough medicines: New approaches.

    PubMed

    Morice, Alyn H

    2015-12-01

    The global market for over-the-counter (OTC) medicines in the category cough/cold is enormous amounting to 5.77 billion euro in 2014 (source IMS). Despite this enormous healthcare investment, mainly by direct consumer purchase, evidence for efficacy is poor by modern standards. Because of a lack of new drug development existing OTC medicines are supported by trials of inadequate design. This has led to the claim that cough medicines are inefficacious. Recent developments in measuring cough support some existing agents but investment in modern studies to provide comprehensive proof of efficacy has not happened. The switch from prescription medicine to OTC which has occurred in other markets will not occur in antitussives since novel therapies have yet to be developed. One area, that of herbal derived medicines, has seen innovation because it is less hampered by regulatory constraints.

  15. Color measurements on prints containing fluorescent whitening agents

    NASA Astrophysics Data System (ADS)

    Andersson, Mattias; Norberg, Ole

    2007-01-01

    Papers with a slightly blue shade are, at least among a majority of observers being perceived as whiter than papers having a more neutral color1. Therefore, practically all commercially available printing papers contain bluish dyes and fluorescent whitening agents (FWA) to give the paper a whiter appearance. Furthermore, in the paper industry, the most frequently used measure for paper whiteness is the CIE-whiteness. The CIE Whiteness formula, does in turn, also favor slightly bluish papers. Excessive examples of high CIE-whiteness values can be observed in the office-paper segment where a high CIE-whiteness value is an important sales argument. As an effect of the FWA, spectrophotometer measurements of optical properties such as paper whiteness are sensitive to the ultraviolet (UV) content of the light source used in the instrument. To address this, the standard spectrophotometers used in the paper industry are equipped with an adjustable filter for calibrating the UV-content of the illumination. In the paper industry, spectrophotometers with d/0 measurement geometry and a light source of type C are used. The graphical arts industry on the other hand, typically measures with spectrophotometers having 45/0 geometry and a light source of type A. Moreover, these instruments have only limited possibilities to adjust the UV-content by the use of different weighting filters. The standard for color measurements in the paper industry governs that measurements should be carried out using D65 standard illumination and the 10 ° standard observer. The corresponding standard for the graphic arts industry specify D50 standard illumination and the 2 ° standard observer. In both cases, the standard illuminants are simulated from the original light source by spectral weighting functions. However, the activation of FWA, which will impact the measured spectral reflectance, depends on the actual UV-content of the illumination used. Therefore, comparisons between measurements on

  16. [Development of low-concentration hydrogen peroxide whitening agent using visible light-responsive titania photocatalyst].

    PubMed

    Arai, Hiroshi

    2010-06-01

    Although highly concentrated hydrogen peroxide (HP) has been used to bleach vital discolored teeth during office whitening, low-concentration HP was recognized to have insufficient whitening ability. We demonstrated that using a visible light-responsive titania photocatalyst (VLRTP) and a vis-Nd : YAG laser, 3 wt% HP-bleached oxytetracycline (OTC)-stained teeth models were more efficient than 30 wt% HP. The stained samples were prepared by soaking synthetic hydroxyapatite ceramic disks in OTC aqueous solutions. Color images of the OTC-stained models before and after whitening were taken with a conventional flatbed scanner and calibrated using a photocell colorimeter. By VLRTP treatment with vis-Nd : YAG laser irradiation, the lightness value (L*) significantly increased and the yellowness index (b*) significantly approached zero. This suggests that a diluted HP agent with VLRTP can more efficiently decolorize stained teeth by visible light irradiation.

  17. Tooth whitening: facts and fallacies.

    PubMed

    Heymann, H O

    2005-04-23

    Since the introduction of nightguard vital bleaching (tray bleaching) in 1989, dentistry has witnessed an astronomical rise in the interest in tooth whitening.(1) As a result, the most frequently asked question is, 'what bleaching technique works best?' Virtually all of today's whitening approaches work, because bleach is bleach. Whether a nightguard bleach is used with only 10% carbamide peroxide (which contains only 3% hydrogen peroxide), over-the-counter (OTC) whitening strips are applied containing 6% hydrogen peroxide, or an in-office bleach is employed using 25-35% hydrogen peroxide, the end results can potentially be the same. Similarity of results is possible because the mechanism of action is the same: oxidation of organic pigments or chromogens in the tooth. Granted, some bleaching approaches are more expeditious than others, owing to differences in concentration or exposure time. But as just noted, the most important factors in the efficacy of any bleaching treatment are concentration of the bleaching agent and duration of the exposure time.

  18. Clinical evaluation of 16% and 35% carbamide peroxide as in-office vital tooth whitening agents.

    PubMed

    Onwudiwe, U V; Umesi, D C; Orenuga, O O; Shaba, O P

    2013-01-01

    Tooth bleaching (whitening) is a conservative and cost effective treatment of discoloured teeth. The purpose of this study was to evaluate the clinical efficacy and safety of 16% and 35% carbamide peroxide as in-office bleaching agents. Thirty adult subjects who desired to whiten their discoloured teeth were enrolled in the study. Carbamide bleaching agents, in concentrations of 16% and 35%, were used to whiten their teeth employing the spilt-arch technique/half-mouth design using vacuum formed half-arch matrix seated over the maxillary teeth for a one-hour session per week for two weeks. Outcome was monitored with Vita shade guide and photographs. Twenty females and ten males, ages 18-43 years, with mean age 27.83 years, participated in the study. Tooth whitening was obtained in all subjects. Shade tab movement of 2-4 shades and 4-6 shades was recorded at first sessions then 3-5 and 5-9 shades at second sessions for 16% and 35% concentrations of carbamide peroxide respectively. The bleaching outcome was significantly better with the 35% concentration of carbamide peroxide while transient tooth sensitivity was observed in both concentrations ofthe bleaching agents. Carbamide peroxide in 16% and 35% concentration are effective and safe for bleaching discoloured vital teeth, however, 35% concentration gave significantly more lightening effect without additional side effects compared to 16% concentration.

  19. [Study of the effect of fluoride removal agent and microabrasion technology in LED teeth whitening of dental fluorosis].

    PubMed

    Jia, Yan; Zhang, Rong; Luo, Hong-Xia; Li, Ping; Zhang, Chun-Lei

    2016-10-01

    To evaluate the effect of fluoride removal agent and microabrasion technology in LED teeth whitening of dental fluorosis. One hundred and twelve patients with moderate dental fluorosis treated from August 2012 to July 2015 were divided into experimental group and control group according to random number table, with 61 cases in each group. In addition to pretreatment for all patients, patients in the control group were given combined treatment of Beyond LED whitening and fluoride removal agent; while patients in the experimental group were given microabrasion before LED whitening, with the same subsequent treatment process as that in the control group. The whitening effect and tooth sensitivity during whitening were compared between the two groups at the completion of treatment, 1 month and 6 months after treatment. SPSS 19.0 software package was employed for statistical analysis. There were no ineffective or lost patients in 2 groups. The effective rate of whitening for patients in the experimental group at completion of treatment, 1 month and 6 months after treatment was significantly higher than that in the control group (P<0.05). There was no case with tooth sensitivity during treatment. There was no significant difference in non-significant sensitivity rate or significant sensitivity rate between the 2 groups (P>0.05). Combined treatment with fluoride removal agent and microabrasion technology in LED teeth whitening for dental fluorosis can significantly improve the whitening effect and will not interfered by significantly increased tooth sensitivity.

  20. Toothpastes containing abrasive and chemical whitening agents: efficacy in reducing extrinsic dental staining.

    PubMed

    Soares, Cristina Neves Girao Salgado; Amaral, Flavia Lucisano Botelho do; Mesquita, Marcelo Ferraz; Franca, Fabiana Mantovani Gomes; Basting, Roberta Tarkany; Turssi, Cecilia Pedroso

    2015-01-01

    This in vitro study evaluated the efficacy of toothpastes containing abrasive and chemical whitening agents in reducing the extrinsic discoloration of dental enamel. Sixty slabs of dentin from human teeth were sealed so that only the enamel surface was exposed. The enamel surfaces were photographed for initial color assessment. Staining was performed by immersing the dental slabs in 0.2% chlorhexidine solution for 2 minutes and then in black tea for 60 minutes. This process was repeated 15 times. Photographs were taken at the end of the staining process, and the slabs were divided into 5 groups (n = 12), 3 to be brushed with toothpastes containing chemical whitening agents (2 containing phosphate salts and 1 containing phosphate salts plus hydrogen peroxide) and 2 to represent control groups (ordinary/nonwhitening toothpaste and distilled water). The dental slabs were subjected to mechanical toothbrushing with toothpaste slurry or distilled water, according to each group's specifications. After brushing, more photographs were taken for color analysis. The results showed a significant reduction in luminosity after the staining process in addition to an increase in the colors red and yellow (P < 0.001). After brushing, there was a significant increase in luminosity and a reduction in both red and yellow (P < 0.001). However, there was no observed difference between the changes in color values in dental enamel slabs brushed with whitening toothpastes and the changes found in slabs brushed with ordinary toothpaste. The whitening toothpastes did not outperform an ordinary toothpaste in the removal of extrinsic staining.

  1. Desensitizing agent efficacy during whitening in an at-risk population.

    PubMed

    Leonard, Ralph H; Smith, Lynn R; Garland, Glenn E; Caplan, Daniel J

    2004-01-01

    Nightguard vital bleaching (NGVB) has gained acceptance among dentists and patients as a simple and effective procedure to lighten discolored teeth. Although the efficacy and predictability of NGVB have been well established, it has been documented that patients undergoing the procedure may experience side effects such as tooth sensitivity (TS) and gingival irritation (GI). A previous NGVB study suggested that selected participants might benefit from a regimen of a desensitizing agent (DSA) to decrease or prevent TS during whitening. The purpose of this study was to determine whether the daily use of an active DSA (UltraEZ, Ultradent Products Inc., South Jordan, UT, USA) during NGVB would decrease TS in a population at risk for TS when compared with a placebo. Forty subjects participated in this single-blind randomized clinical trial. All participants had indicated that they had preexisting TS or other risk factors for TS during NGVB. To evaluate TS caused by the tray alone, participants wore custom-fitted maxillary whitening trays containing no DSA or whitening solution during week 1. Next, participants were randomly assigned to apply either the active DSA or placebo daily for 14 days in the trays for 30 minutes prior to whitening. The placebo was the same formulation as UltraEZ but without the desensitizing agents (3% potassium nitrate and 0.11% by weight fluoride ion). The bleaching solution was a 10% carbamide peroxide whitening solution (Opalescence, Ultradent Inc.). Post treatment, participants were followed up for 1 week, during which time they used neither trays nor solutions. Throughout the study, participants completed a daily diary to record their perceptions of TS and the time spent wearing the tray with the whitening solution. Forty-one percent of the active group had at least 1 day of TS during treatment compared with 78% of the placebo group. The difference was statistically significant (p = .027) using the two-tailed Fisher exact test. This study

  2. Dental whitening--revisiting the myths.

    PubMed

    Perdigão, Jorge

    2010-01-01

    The popularity of dental bleaching has increased with the introduction of at-home whitening. Currently available whitening methods include those prescribed by a dental professional for use at home, those applied by the professional in the dental office, a combination of the two, or systems available over the counter. This article reviews the effect, efficacy, and safety of bleaching techniques and materials. Most whitening techniques are considered effective and safe when carried out under the supervision of a dental professional. This article also compares the efficacy and safety of some of the most popular bleaching techniques, including at-home whitening with carbamide peroxide, over-the-counter (OTC) systems, and in-office whitening. Some of these whitening techniques are illustrated in this article.

  3. Sinus Pain: Can Over-the-Counter Medications Help?

    MedlinePlus

    ... requests or policy questions to our media and public relations staff at newsroom@entnet.org . Why Do We ... over-the-counter (OTC) medications. What Is The Role Of OTC Medication For Sinus Pain? There are ...

  4. Over-the-counter treatments for acne and rosacea.

    PubMed

    Rosamilia, Lorraine Larsen

    2016-06-01

    Acne and rosacea are common inflammatory processes historically classified in the same disease category, but evolving understanding of their disparate pathophysiology and exacerbating factors have generated an enormous armamentarium of therapeutic possibilities. Patients seek over-the-counter therapies first when managing cutaneous disease; therefore, this review defines ingredients considered to be effective over-the-counter acne and rosacea products, their mechanisms, and safe formulations, including botanical components, oral supplements, and other anecdotal options in this vast skin care domain.

  5. Calcium release rates from tooth enamel treated with dentifrices containing whitening agents and abrasives.

    PubMed

    Araujo, Danilo Barral; Silva, Luciana Rodrigues; de Araujo, Roberto Paulo Correia

    2010-01-01

    Tooth whitening agents containing hydrogen peroxide and carbamide peroxide are used frequently in esthetic dental procedures. However, lesions on the enamel surface have been attributed to the action of these products. Using conventional procedures for separating and isolating biological structures, powdered enamel was obtained and treated with hydrogen peroxide, carbamide peroxide, and sodium bicarbonate, ingredients typically found in dentifrices. The enamel was exposed to different pH levels, and atomic emission spectrometry was used to determine calcium release rates. As the pH level increased, the rate of calcium release from enamel treated with dentifrices containing whitening agents decreased. Carbamide peroxide produced the lowest amount of decalcification, while sodium bicarbonate produced the highest release rates at all pH levels.

  6. Investigating the Stability of Benzoyl Peroxide in Over-the-Counter Acne Medications

    ERIC Educational Resources Information Center

    Kittredge, Marina Canepa; Kittredge, Kevin W.; Sokol, Melissa S.; Sarquis, Arlyne M.; Sennet, Laura M.

    2008-01-01

    One of the most commonly used ingredients in over-the-counter acne treatments in cream, gel, and wash form is benzoyl peroxide. It is an anti-bacterial agent that kills the bacterium ("Propionibacterium acne") involved in the formation of acne. The formulation of these products is extremely difficult owing to the instability of benzoyl peroxide.…

  7. Investigating the Stability of Benzoyl Peroxide in Over-the-Counter Acne Medications

    ERIC Educational Resources Information Center

    Kittredge, Marina Canepa; Kittredge, Kevin W.; Sokol, Melissa S.; Sarquis, Arlyne M.; Sennet, Laura M.

    2008-01-01

    One of the most commonly used ingredients in over-the-counter acne treatments in cream, gel, and wash form is benzoyl peroxide. It is an anti-bacterial agent that kills the bacterium ("Propionibacterium acne") involved in the formation of acne. The formulation of these products is extremely difficult owing to the instability of benzoyl peroxide.…

  8. Tooth whitening: current status.

    PubMed

    Marshall, Kimberly; Berry, Thomas G; Woolum, James

    2010-09-01

    This article reviews the history of tooth whitening and its rapid evolution and briefly discusses tooth whitening agents and protocols. The active ingredients and mode of action during the whitening process are explained. The factors affecting the speed of whitening and its final results are discussed, as well as adverse effects and safety precautions. Protocols are explained in detail, and the predicted outcomes, including those for tetracycline-stained teeth, are covered.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. The effect of whitening agents on caries susceptibility of human enamel.

    PubMed

    Al-Qunaian, Talal A

    2005-01-01

    This in vitro study evaluated whether the treatment of human enamel with whitening agents containing different concentrations of carbamide or hydrogen peroxide changes the susceptibility of enamel to caries. Twenty-four sound human incisors were selected for this study. For each tooth, the crown was sectioned into two halves in the cervical-incisal direction. One half of the sectioned tooth was treated and the other half was used as a control specimen. Each half was randomly divided into three treatment groups (eight two-halves/group). The whitening agents were 10% carbamide peroxide, 20% carbamide peroxide with fluoride and 35% hydrogen peroxide. Following pretreatment, the specimens were demineralized for four days in an in vitro microbial caries model and then analyzed using a confocal laser scanning microscope (CLSM). Results showed that there were no significant differences between the treated and controlled specimens for teeth treated with 10% carbamide peroxide or 35% hydrogen peroxide. However, specimens treated with 20% carbamide peroxide with FP (0.11% fluoride and potassium nitrate) were less susceptible to caries than their controls at p < or = 0.05. In conclusion, application of bleaching agents does not increase the caries susceptibility of human enamel.

  15. [Effects of tooth whitening agents and acidic drinks on the surface properties of dental enamel].

    PubMed

    Chen, Xiaoling; Chen, Zhiqun; Lin, Yao; Shao, Jinquan; Yin, Lu

    2013-10-01

    Using tooth whitening agents (bleaching clip) in vitro and acidic drinks, we conducted a comparative study of the changes in enamel surface morphology, Ca/P content, and hardness. Tooth whitening glue pieces, cola, and orange juice were used to soak teeth in artificial saliva in vitro. Physiological saline was used as a control treatment. The morphology of the four groups was observed under a scanning electron microscope (SEM) immediately after the teeth were soaked for 7 and 14 d. The changes in Ca/P content and microhardness were analyzed. The enamel surfaces of the teeth in the three test groups were demineralized. The Ca/P ratio and the average microhardness were significantly lower than those of the control group immediately after the teeth were soaked (P < 0.05). The Ca/P ratio and microhardness gradually increased after 7 d. No significant difference was observed between the control group and the test groups after 14 d (P > 0.05). Bleaching agents caused transient demineralization of human enamel, but these agents could induce re-mineralization and repair of enamel over time. Demineralization caused by bleaching covered a relatively normal range compared with acidic drinks and daily drinking.

  16. Aspirin and acetaminophen: should they be available over the counter?

    PubMed

    Brune, Kay; Hinz, Burkhard; Otterness, Ivan

    2009-02-01

    Traditional nonsteroidal anti-inflammatory drugs block cyclooxygenase (COX). They are the most widely used drugs for pain relief. They are indispensable for their effects but are condemned for their adverse drug reactions. Two COX inhibitors, acetaminophen and aspirin, are the most widely used over-the-counter drugs. They have low (but useful) therapeutic activity, but they are endowed with specific risks that are not seen with most other COX inhibitors. Both are lethal if taken in overdose. Each is stigmatized by severe adverse effects. Aspirin results in prolonged inhibition of blood coagulation, and acetaminophen can result in liver toxicity at normal dose and liver failure at higher dose. Both drugs cause many deaths every year. We recommend that the status of both drugs be changed to prescription only. Their continued availability over the counter poses an unacceptable risk to the general population.

  17. Clinical evaluation of a new 10% carbamide peroxide tooth-whitening agent.

    PubMed

    Barnes, D M; Kihn, P W; Romberg, E; George, D; DePaola, L; Medina, E

    1998-10-01

    NUPRO Gold Tooth Whitening System was evaluated for efficacy according to the proposed ADA guidelines for acceptance. Sixty participants with discolored anterior teeth participated in a 14-day, double-blind, clinical trial. The participants were matched for age, gender, and oral health status and were given either a placebo gel without the active agent or the NUPRO Gold active gel, which they wore in a custom-fabricated mouth guard for home use. The shade of each participant's maxillary anterior teeth was evaluated using a value-oriented Vita Lumin Vacuum Shade Guide before the study. The same shade guide was used to determine shade changes. Time of use of the agent and potential side effects, such as tooth and gingival hypersensitivity and tissue irritation, were assessed at all recall examinations and were recorded by participants in daily diaries. The average shade change for the placebo users was less than one shade. The average shade change for the NUPRO Gold users was 6.96 shades. Tooth hypersensitivity varied from none to severe. Tissue irritation was minimal. The results of these evaluations indicate that NUPRO Gold is effective as a tooth-whitening system, when administered properly under the supervision of a dentist, with commonly reported side effects of transient tooth sensitivity and minimal gingival sensitivity. Little or no change in tissue health was noted. This study was supported by Dentsply Preventive Care (York, Pennsylvania).

  18. 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.

  19. Detection of whitening agents in illegal cosmetics using attenuated total reflectance-infrared spectroscopy.

    PubMed

    Deconinck, E; Bothy, J L; Desmedt, B; Courselle, P; De Beer, J O

    2014-09-01

    Cosmetic products containing illegal whitening agents are still found on the European market. They represent a considerable risk to public health, since they are often characterised by severe side effects when used chronically. The detection of such products at customs is not always simple, due to misleading packaging and the existence of products containing only legal components. Therefore there is a need for easy to use equipment and techniques to perform an initial screening of samples. The use of attenuated total reflectance-infrared (ATR-IR) spectroscopy, combined with chemometrics, was evaluated for that purpose. It was found that the combination of ATR-IR with the simple chemometric technique k-nearest neighbours gave good results. A model was obtained in which a minimum of illegal samples was categorised as legal. The correctly classified illegal samples could be attributed to the illegal components present.

  20. Physician attitudes toward over the counter availability for oral contraceptives.

    PubMed

    Howard, David L; Wall, Jeffrey; Strickland, Julie L

    2013-12-01

    To assess physician attitude towards making oral contraceptives available over the counter in the United States (US). We assessed physician attitudes towards a transition from prescription only to over-the-counter availability (rx-OTC) for oral contraceptive pills by disseminating an electronic survey directed primarily to residents training in Obstetrics and Gynecology (OBGYN) and Family Practice in the US. An overwhelming majority of 638 respondents (71 %) were against an rx-OTC switch for combined oral contraceptives and among this subset of respondents the primary concern was safety (92.3 %). Overall, respondents were evenly divided on the issue of an rx-OTC switch for progestin-only-pills but of those who opposed, 73.2 % cited safety as their primary concern. For progestin-only-pills female respondents were more likely to support OTC availability. Most OBGYN and Family Practice residents opposed to OTC availability for oral contraceptives cite safety as their primary concern. Considering the abundant evidence as to the overall safety of oral contraceptives, especially progestin-only-pills, there appears to be a knowledge deficit among OBGYN and Family Practice residents regarding the safety of oral contraceptives.

  1. Development of a quantitative method to monitor the effect of a tooth whitening agent.

    PubMed

    Amaechi, Bennett T; Higham, Susan M

    2002-01-01

    This study demonstrated a quantitative method for assessing the effect of a tooth whitening agent. Forty human teeth were stained with a tea solution, and randomly assigned to two groups (A, B) of twenty teeth. The teeth were subsequently treated with either sodium hypochlorite (NaOCL) or deionized distilled water (DDW) by intermittent immersion (60 seconds on each occasion) in a 1:10 dilution of NaOCL (group A) or DDW (group B). Prior to whitening and following each immersion, the color of the teeth at the stained spot was measured using ShadeEye-Ex Dental Chroma Meter and quantitative light-induced fluorescence (QLF). ShadeEye-Ex instantly gave a numerical value for the stain intensity, chroma (C), which is the average of three measurements taken automatically by the machine. QLF gave a quantitative value for the stain, delta Q (% mm2), following analysis of the fluorescence image of the tooth. Immersion was stopped after four readings when one specimen, in group A, was observed to have regained its natural color. There was a good correlation between C and delta Q with either NaOCL (Pearson correlation coefficient (r) = 0.974; p < 0.05) or DDW (r = 0.978; p < 0.05). With NaOCL, an inverse relationship observed between stain measurements, C (Linear fit correlation (R) = -0.982; p < 0.05) or delta Q (R = -0.988; p < 0.05) and exposure time correlated to a linear fit, but not with DDW. ANOVA showed a significant difference between the means (n = 20) of the reading at the measurement intervals (0, 60, 120 and 180 seconds) for both C (p < 0.001) and delta Q (p < 0.001) with NaOCL but not with DDW. In conclusion, the study highlighted the potential of ShadeEye-Ex Dental Chroma Meter as a tool for the quantitative assessment of the gradual change in shade of discolored teeth by tooth whitening products.

  2. [In vitro tests of internal tooth whitening agents on colored solutions do not replace tests on teeth].

    PubMed

    Bäumler, Marc A; Schug, Jens; Schmidlin, PatrickR; Imfeld, Thomas

    2006-01-01

    Two in vitro tests for the assessment of whitening agents were evaluated. A simple, reproducible and cost-effective model using coloured solutions was compared to a tooth model. The following bleaching agents were investigated: 1) Sodium perborate tetrahydrate/30% H2O2, 2) sodium perborate tetrahydrate/3% H2O2, 3) thermocatalytic procedure with 30% H2O2 and 4) Opal-escence Endo. In the model using coloured solutions, the light absorption of the solutions was assessed one and 24 hours after application of the whitening agents. In discoloured teeth, whitening agents were placed in a simulated access cavity. In groups 1, 2, and 4, the agents were left in the cavity for three days, whereas in group 3 the substance was applied three times for 30 seconds. Bleaching processes were repeated three times. All bleaching agents proved effective in the model with coloured solutions, as well as in the tooth model. The effect was most pronounced after the first bleaching step. The results showed, however, that the simplified experiment with coloured solutions cannot replace the tooth model.

  3. Evaluation of an over-the-counter medication program.

    PubMed

    Huntzinger, Paul Evan

    2004-07-01

    Nonprescription medication (i.e., "over-the-counter") programs have historically been popular at many military treatment facilities. These programs were developed to provide a mechanism through which active duty members could obtain certain nonprescription medications without seeing a health care provider. The goal of such programs was to reduce demand on health care provider appointments and operational costs associated with such visits. Coast Guard military treatment facilities are encouraged to provide the service. The purpose of this paper was to evaluate whether the nonprescription medication program offered at the Coast Guard Alameda pharmacy reduced demand on health care provider appointments for self-limiting conditions and reduced costs associated with such visits.

  4. Drug interactions between prescribed and over-the-counter medication.

    PubMed

    Honig, P K; Gillespie, B K

    1995-11-01

    The use and availability of over-the-counter (OTC) medication is increasing. Although regulatory agencies take care to assure than nonprescription medications are safe and effective, these drugs still have the potential to have clinically significant interactions with prescription medicines. The major classes of OTC medication to be considered in this light include antacids, histamine H2 receptor antagonists, NSAIDs, cough and cold preparations and the antiasthma products. Healthcare providers and patients/consumers should be educated regarding possible drug interactions, patient drug regimens should be simplified where possible, and all therapeutic failures and adverse reactions should be investigated with regard to the potential contribution of OTC drug products. Regulatory agencies and pharmaceutical manufacturers should ensure that nonprescription drug labelling is complete and intelligible to meet these objectives. Consideration should be given to improving the postmarketing surveillance of OTC medications.

  5. Toxicity of over-the-counter cough and cold medications.

    PubMed

    Gunn, V L; Taha, S H; Liebelt, E L; Serwint, J R

    2001-09-01

    Over-the-counter (OTC) cough and cold medications are marketed widely for relief of common cold symptoms, and yet studies have failed to demonstrate a benefit of these medications for young children. In addition, OTC medications can be associated with significant morbidity and even mortality in both acute overdoses and when administered in correct doses for chronic periods of time. Physicians often do not inquire about OTC medication use, and parents (or other caregivers) often do not perceive OTCs as medications. We present 3 cases of adverse outcomes over a 13-month period-including 1 death-as a result of OTC cough and cold medication use. We explore the toxicities of OTC cough and cold medications, discuss mechanisms of dosing errors, and suggest why physicians should be more vigilant in specifically inquiring about OTCs when evaluating an ill child.

  6. Over-the-counter medications: Risk and safety in pregnancy.

    PubMed

    Chambers, Christina

    2015-11-01

    Over-the-counter (OTC) medications are among the most commonly used products in pregnancy. Similar to prescription medications, for many products there is a lack of adequate data on safety of use in pregnancy. Assumptions of safety for these products based on long experience and OTC status, in the absence of data, may be ill founded. Examples of four OTC products used to treat common conditions in pregnancy are described. Potential links to adverse short- and long-term infant outcomes for these products are reviewed, and the strengths and limitations of data to support these. Research to detect or rule out these risks is essential. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. [Health care consumers about over-the-counter drugs].

    PubMed

    Burger, David M

    2014-01-01

    Dutch consumers can now purchase 'over-the-counter drugs' (OTCs) at three distribution channels: (a) the pharmacy; (b) the chemist; (c) other sales outlets such as supermarkets and petrol stations. However, little is known about whether consumers consider themselves and others to have adequate knowledge to purchase OTCs in relative freedom. During a recent study, members of the Healthcare Consumer Panel of the Netherlands Institute for Health Services Research completed a survey on freely available analgesics. These consumers were very confident of their personal skills in handling OTCs responsibly. However, they had less confidence in how others would deal with OTCs. Regarding the wider availability of OTCs, only 1-8% believed it would be preferable to have these drugs available in the supermarket or petrol station, depending on the type and frequency of side effects of the medication. The government would be wise in conducting this type of qualitative study before measures are taken for wider availability of medicines.

  8. Best Way to Take Your Over-the-Counter Pain Reliever? Seriously.

    MedlinePlus

    ... best way to take your over-the-counter pain reliever? Seriously. Share Tweet Linkedin Pin it More sharing ... Print (PDF version - 6MB) Over-the-counter (OTC) pain relievers/fever reducers (the kind you can buy without ...

  9. Abuse of the over-the-counter antispasmodic butylscopolamine for the home synthesis of psychoactive scopolamine.

    PubMed

    Kummer, Sebastian; Rickert, Annette; Daldrup, Thomas; Mayatepek, Ertan

    2016-07-01

    We report on two patients who ingested psychoactive scopolamine that was synthesized at home from butylscopolamine (Buscopan®), which is available as over-the-counter antispasmodic in nearly 100 countries worldwide. Patient 1 presented with severe central anticholinergic toxidrome, while patient 2 suffered from minor symptoms. An empty blister of Buscopan® was found in the patients' home, but initially was not suspected to be causative for the observed central anticholinergic symptoms, as Buscopan® is not able to pass the blood-brain barrier in its native form. Only later, the information by third parties and a Google search helped to identify homemade scopolamine derived from Buscopan® as the responsible agent in these two cases. Retrospectively, scopolamine could be detected in serum and urine of both patients, while it was absent in one control after ingestion of native Buscopan®. Over-the-counter drugs can be used to synthesize psychoactives with means that are available in every household. Such knowledge can spread via social media and internet discussion boards long before appearing in medical literature. While typical clinical presentation often enables clinicians to adequately identify and treat specific toxidromes, these sources of information need to be increasingly taken into account by medical professionals for identification of its causative agent. This potential of Buscopan® might gain importance as an easily accessible source of psychoactive scopolamine. • Substances with central anticholinergic effects are known for their hallucinogenic potential and may be used as psychoactives. What is New: • The over-the-counter antispasmodic butylscopolamine (Buscopan®) can be abused to synthesize anticholinergic, psychoactive scopolamine at home with means that are available in every household.

  10. 78 FR 57623 - TRICARE Over-the-Counter Drug Demonstration Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... of the Secretary TRICARE Over-the-Counter Drug Demonstration Project AGENCY: Office of the Secretary, DoD. ACTION: Notice of modification to the TRICARE Over-the-Counter Drug Demonstration Project... which the Department of Defense (DoD) evaluates allowing selected over-the-counter (OTC) drugs to...

  11. [Determination of fluorescent whitening agents in plastic food contact materials by high performance liquid chromatography with fluorescence detector].

    PubMed

    Jiao, Yanna; Ding, Li; Zhu, Shaohua; Fu, Shanliang; Gong, Qiang; Li, Hui; Wang, Libing

    2013-01-01

    A method for the determination of fluorescent whitening agents in plastic food contact materials by high performance liquid chromatography (HPLC) with fluorescence detector was developed. The samples were extracted with trichloromethane by sonication for 30 min at 40 degrees C. The HPLC method was performed on a column of Eclipse XDB-C18 (250 mm x 4.6 mm, 5 microm) by gradient elution using 5 mmol/L ammonium acetate and acetonitrile as the mobile phases, and detected by the fluorescence detector at an excitation wavelength of 350 nm and an emission wavelength of 430 nm. The experimental results indicated that the four fluorescent whitening agents were separated well. The limits of detection (LOD) (S/N = 3) were 0.3, 0.1, 0.05, 0.14 mg/L, and the limits of quantification (LOQ) (S/N = 10) were 1.0, 0.4, 0.2, 0.5 mg/L for 1,4-bis (4-cyanostyryl) benzene (C. I. 199), 1,4-bis (2-benzoxazolyl) naphthalene (C. I. 367), 4,4'-bis(2-methoxystyryl) biphenyl (C. I. 378) and 2,5-thiophenediylbis (5-tert-butyl-1,3-benzoxazole) (C. I. 184), respectively. Good linearities with correlation coefficients (r2) not less than 0.991 were obtained. The proposed method is simple, accurate, sensitive and can meet the requirements of the routine determination of fluorescent whitening agents in entry-exit products.

  12. Over-the-counter medicines: professional expertise and consumer discourses.

    PubMed

    Stevenson, Fiona A; Leontowitsch, Miranda; Duggan, Catherine

    2008-09-01

    Ideas of participation and partnership in health care consultations have attracted increasing attention in recent years; however the consequences in terms of the necessary shifts in existing relationships are often overlooked. We examine how pharmacists work to maintain their professional expertise against the rise of health-care consumerism. We draw on the following data from a UK study of consultations for over-the-counter (OTC) medicines in two pharmacies: (i) an outline of the pharmacy owners' views of their practice model, (ii) data from observations and tape recorded consultations (iii) interviews with customers and pharmacists and (iv) views expressed in two feedback sessions discussing vignettes developed from observational and interview-based fieldwork. There was no suggestion that attempts to engage customers in discussions about their treatment necessitated a diminution of the importance of pharmaceutical expertise. Indeed, both pharmacists and customers acknowledged the importance of the asymmetry of knowledge between pharmacists and customers. Pharmaceutical expertise was however not always perceived to be necessary and transactions in pharmacies may be treated like those in any other retail environment. Further research using a larger dataset to investigate problems in interactions resulting from tensions between pharmaceutical expertise and consumerism is indicated.

  13. Aluminium in over-the-counter drugs: risks outweigh benefits?

    PubMed

    Reinke, Claudia M; Breitkreutz, Jörg; Leuenberger, Hans

    2003-01-01

    In the early 1970s, aluminium toxicity was first implicated in the pathogenesis of clinical disorders in patients with chronic renal failure involving bone (renal osteomalacia) or brain tissue (dialysis encephalopathy). Before that time the toxic effects of aluminium ingestion were not considered to be a major concern because absorption seemed unlikely to occur. Meanwhile, aluminium toxicity has been investigated in countless epidemiological and clinical studies as well as in animal experiments and many papers have been published on the subject. It is now commonly acknowledged that aluminium toxicity can be induced by infusion of aluminium-contaminated dialysis fluids, by parenteral nutrition solutions, and by oral exposure as a result of aluminium-containing pharmaceutical products such as aluminium-based phosphate binders or antacid intake. Over-the-counter antacids are the most important source for human aluminium exposure from a quantitative point of view. However, aluminium can act as a powerful neurological toxicant and provoke embryonic and fetal toxic effects in animals and humans after gestational exposure. Despite these facts, the patient information leaflets from European antacids that are available OTC show substantial differences regarding warnings from aluminium toxicity. It seems advisable that all patients should receive the same information on aluminium toxicity from patient information leaflets, in particular with regard to the increased absorption through concomitant administration with citrate-containing beverages and the use of such antacids during pregnancy.

  14. 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.

  15. Over-the-counter-drug-induced thyroid disorders.

    PubMed

    Hoang, Thanh D; Mai, Vinh Q; Clyde, Patrick W; Shakir, Mohamed K M

    2013-01-01

    Excessive iodine ingestion may cause thyroid dysfunction. In this case series, we report four patients who developed significant thyroid dysfunction after ingesting over-the-counter (OTC) drugs containing large concentrations of iodine. Four patients from a tertiary medical center are reported. Case 1 involved acute exacerbation of thyrotoxicosis induced by taking OTC Tri-iodine™ in a 35-year-old woman while still on methimazole therapy. Case 2 involved thyroid-extract-induced thyrotoxicosis following ingestion of Thyromine™, and was confirmed by laboratory studies and ¹³¹I thyroid uptake. Cases 3 and 4 involved severe, symptomatic hypothyroidism induced in 2 patients with underlying autoimmune thyroiditis (Hashimoto's disease) following ingestion of Iodoral™. In all cases, thyroid dysfunction resolved with appropriate management and discontinuation of the OTC drugs. These case reports demonstrate the significant risks associated with OTC preparations containing iodine in patients predisposed to thyroid dysfunction. There is no valid reason for taking high-dose OTC iodine supplements, which have been shown to cause harm and have no known benefit.

  16. Enhanced eyelashes: prescription and over-the-counter options.

    PubMed

    Jones, Derek

    2011-02-01

    Women have long strived to possess long, thick, and dark eyelashes. Prominent eyes and eyelashes are often considered a sign of beauty and can be associated with increased levels of attractiveness, confidence, and well-being. Numerous options may improve the appearance of eyelashes. Mascara aims to temporarily darken, lengthen, and thicken eyelashes using a combination of waxes, pigments, and resins. Artificial eyelashes can be adhered either to the dermal margin or to individual eyelashes. Individuals may even use eyelash transplantations to improve the appearance of their eyelashes. The unique properties of eyelashes (e.g., relatively long telogen and short anagen phases compared with scalp hairs, slow rate of growth, and a lack of influence by androgens) may allow for specific aesthetic interventions to improve the appearance of natural eyelashes. Some over-the-counter (OTC) products may contain prostaglandin analogs that can affect eyelash growth, but neither the safety nor efficacy of these OTC cosmetics has been fully studied. Originally indicated for the reduction of intraocular pressure, the synthetic prostaglandin analog bimatoprost was recently approved for the treatment of hypotrichosis of the eyelashes. In a double-blinded, randomized, vehicle-controlled trial, bimatoprost safely and effectively grew natural eyelashes, making them longer, thicker, and darker. Bimatoprost was generally safe and well tolerated and appears to provide an additional option for individuals looking to improve the appearance of their eyelashes.

  17. Photodegradation-based detection of fluorescent whitening agents in a mountain river.

    PubMed

    Assaad, Aziz; Pontvianne, Steve; Pons, Marie-Noëlle

    2014-04-01

    Fluorescent whitening agents (FWAs) are highly soluble and poorly biodegradable ingredients used in laundry detergents and in industries (paper, textile, plastic manufacturing). They are likely to pass through biological wastewater treatment systems. The presence of FWAs in a mountain river was detected by monitoring the decay of synchronous fluorescence intensity at λ(ex)=360 nm after exposing samples to ultraviolet (UV) light (365 nm), for mimicking sunlight, for 15 min. The method was first validated on four commercial FWAs (DAS-1, FB28, DMA-X and CBS-X) in different water matrices (deionized water and pristine river water in the presence of humic acid and dyes). A 40% decay was observed after 15 min for the least photosensitive FWA (CBS-X). A field application was then performed on samples collected along a mountain river in which impacts of FWAs from domestic sources (laundry greywater) and industrial sources (paper and textile mills) were suspected. Variations of fluorescence decay at λ(ex)=360 nm could be explained by these potential sources of pollution. It is suggested that the fluorescence decay at λ(ex)=280 nm also be considered as an indicator, as some FWAs can exhibit fluorescence at that excitation wavelength.

  18. [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.

  19. Abuse of prescription and over-the-counter medications.

    PubMed

    Lessenger, James E; Feinberg, Steven D

    2008-01-01

    The nonmedical use of prescription or over-the-counter (OTC) medications implies that the user is using them for reasons other than those indicated in the prescribing literature or on the box label. The abuse of these medications is a national issue. Intentional drug abuse of prescribed and OTC medicines has climbed steadily. Data from the 2005 National Survey on Drug Use and Health demonstrated that 6.4 million (2.6%) people aged 12 or older had used prescription drugs for nonmedical reasons during the past month. Of these, 4.7 million used pain relievers, 1.8 million used tranquilizers, and 1.1 million used stimulants. The nonmedical use of prescription drugs in the past month among young adults aged 18 to 25 increased from 5.4% in 2002 to 6.3% in 2005, primarily because of an increase in the abusive use of pain relievers. Physicians need to watch for prescription and OTC medication abuse. Treatment strategies include (1) inquiring about prescription, OTC, and herbal drug use at the initial examination (even though many individuals are drug-abuse savvy, some are naive and do not realize that OTC medications can be problematic); (2) inquiring about drug use during office visits; (3) providing disposal containers that patients can use to dispose of their unused or unneeded prescription or OTC medications; (4) treating pain aggressively and appropriately; (5) practicing careful record keeping of prescription refills and controls over prescription blanks; (6) referring patients who are addicted to medications to 12-step programs such as Alcoholic Anonymous, Narcotics Anonymous, and Pills Anonymous; and (7) considering detoxification.

  20. [Over the counter drugs--a new era in Israel].

    PubMed

    Abadi-Korek, Ifat; Vaknin, Sharona; Marom, Eli; Shemer, Joshua; Luxenburg, Osnat

    2011-01-01

    The reformation in the marketing of non-prescription medicinal products has been launched. As of May 10th 2005, the pharmacist regulations 2004 (marketing of over-the-counter (OTC) drugs outside of pharmacies, as well as not by a pharmacist) will be in effect. This change aLlows the marketing of medicines outside of pharmacies, as has been the custom in the U.S.A., England and some of the European Union countries for many years. This reformation is incorporated in a policy that encourages self-medication by the use of non-prescription drugs. The self-medication policy originates from the point of view of the consumers who wish to be responsible for their own health and save precious time wasted on doctor visits; and the government's assumption that self-medication of OTC medicines by citizens wiLL decrease expenses for the HMOs in both doctor's billings as well as medication costs. In order to regulate the marketing terms of these medicinal products, regulations and complimentary guidelines were written and published. These documents encompass the following issues: the list of OTC medicines, marketing reguLations, packaging regulations, Licensed marketing Locations, storage regulations as well as display regulations, advertising regulations, monitoring and control. The medicinal products in this category only included medicines containing "safe" active ingredients with restrictions regarding the strength/concentration and packaging size; this category does not include medicines requiring special storage conditions (such as refrigeration or freezing), medicines containing an active ingredient that is addictive, medicines containing an active ingredient with danger of poisoning if misused, and medicines containing an active ingredient that has the potential to harm. The implementation of the regulations and guidelines will improve the consumer's ability to diagnose and treat oneself when sick with minor ailments, without consulting a doctor.

  1. Pharmacy consultation and over-the-counter medication purchasing outcomes. Over-the-Counter Medication Intervention Project Team.

    PubMed

    Sclar, D A; Robison, L M; Skaer, T L

    1996-06-01

    A demonstration project was conducted within 23 community pharmacies located throughout the state of Washington to: (1) assess the effects of pharmacy consultation on over-the-counter (OTC) medication purchasing decisions and costs, (2) to identify factors influencing those intending to purchase a brand name medication to change to a generic or private label product, or to a different brand name product, and (3) to quantify prevented adverse medication outcomes. Pharmacy students in their final year of training provided consultation to 745 consumers intending to purchase an OTC product. The consultations averaged 4.6 min in length, and resulted in 42.6% of consumers changing their intended purchase. These changes reduced OTC expenditures by an average of US $1.53 per customer, primarily as a result of movement from brand name products to lower priced generic or private label equivalents. Nearly 8% of consumers made no purchase after consultation, and 4.3% were referred to a physician. Logistic regression analysis identified gender of the consultant being female (odds ratio = 3.87, 95% CI = 1.58-9.45), and an increasing length of consultation (odds ratio = 1.30, 95% CI = 1.08-1.57) as being significant factors influencing consumers to change their final purchase from a brand name OTC product to a generic or private label, or to a different brand name product. Potential adverse outcomes (disease-medication interaction; medication-medication interaction; additive side-effects; or duplication in therapeutic category) were prevented in 7.1% of the study population. This study documents consumer need for pharmacy consultation in order to optimize both the therapeutic appropriateness of, and pharmaceutical expenditures for OTC medication.

  2. [Removal of fluorescent whitening agent by hydrogen peroxide oxidation catalyzed by activated carbon].

    PubMed

    Liu, Hai-Long; Zhang, Zhong-Min; Zhao, Xia; Jiao, Ru-Yuan

    2014-06-01

    Degradation of fluorescent whitening agent VBL in the processes of activated carbon (AC) and activated carbon modified (ACM) adsorptions, hydrogen peroxide (H2O2) oxidation, and hydrogen peroxide oxidation catalyzed by activated carbon were studied. Mechanism of the above catalytic oxidation was also investigated by adding tert-Butyl alcohol (TBA), the free radical scavenger, and detecting the released gases. The results showed that: the activated carbon modified by Fe (NO3)3 (ACM)exhibited better adsorption removal than AC. Catalytic oxidation showed efficient removal of VBL, and the catalytic removal of AC (up to 95%) was significantly higher than that of ACM (58% only). Catalytic oxidation was inhibited by TBA, which indicates that the above reaction involved *OH radicals and atom oxygen generated by hydrogen peroxide with the presence of AC. The results of H2O2 decomposition and released gases detection involved in the process showed that activated carbon enhanced the decomposition of H2O2 which released oxygen and heat. More O2 was produced and higher temperature of the reactor was achieved, which indicated that H2O2 decomposition catalyzed by ACM was significantly faster than that of AC. Combining the results of VBL removal, it could be concluded that the rate of active intermediates (*OH radicals and atom oxygen) production by ACM catalytic reaction was faster than that of AC. These intermediates consumed themselves and produced O2 instead of degrading VBL. It seemed that the improper mutual matching of the forming rate of activating intermediates and the supply rate of reactants was an important reason for the lower efficiency of ACM catalytic reaction comparing with AC.

  3. Syndromic Surveillance of Norovirus using Over-the-counter Sales of Medications Related to Gastrointestinal Illness

    PubMed Central

    Edge, Victoria L; Pollari, Frank; Ng, Lai King; Michel, Pascal; McEwen, Scott A; Wilson, Jeffrey B; Jerrett, Michael; Sockett, Paul N; Martin, S Wayne

    2006-01-01

    Objective To assess whether over-the-counter (OTC) sales of gastrointestinal illness (GI)-related medications are associated with temporal trends of reportable community viral, bacterial and parasitic infections. Methods The temporal patterns in weekly and seasonal sales of nonprescription products related to GI were compared with those of reportable viral, bacterial and parasitic infections in a Canadian province. Results Temporal patterns of OTC product sales and Norovirus activity were similar, both having highest activity in the winter months. In contrast, GI cases from both bacterial and parasitic agents were highest from late spring through to early fall. Conclusions Nonprescription sales of antidiarrheal and antinauseant products are a good predictor of community Norovirus activity. Syndromic surveillance through monitoring of OTC product sales could be useful as an early indicator of the Norovirus season, allowing for appropriate interventions to reduce the number of infections. PMID:18382634

  4. The whitening effect of bleaching agents on tetracycline-stained rat teeth.

    PubMed

    Shin, D H; Summitt, J B

    2002-01-01

    This study compared the whitening effect of three bleaching agents on the teeth of rats and demonstrated differences in bleaching where dentin was exposed or enamel was thin. Thirty Albino rats were peritoneally injected with tetracycline solution daily for two weeks. Thirty-two disc-shaped specimens were cut from the crowns of incisors removed from sacrificed rats and were irradiated with UV light for 16 hours. Sections were stored in saline. Eight sections served as controls and were not bleached. Three bleaching agents (Opalescence, Rembrandt and Nite White) were applied to eight specimens each, five times a day for two weeks, and images of the sections were recorded at the following times: before bleaching (baseline), day 1, day 3, day 5, day 7, day 9, day 11 and day 14. Mean colors to demonstrate any change (deltaE) from baseline for each time period were as follows: control-9.78 (baseline), 9.17, 9.36, 9.65, 9.40, 9.99, 10.57, 11.36; Opalescence-10.08, (baseline) 7.63, 6.72, 6.04, 5.10, 4.87, 4.89, 4.27; Rembrandt-9.83 (baseline), 11.27, 9.55, 8.36, 7.75, 6.94, 7.11, 7.04; Nite White-10.44 (baseline), 9.92, 7.58, 6.80, 5.45, 5.05, 4.73, 4.01. All bleached teeth were lightened (p<.01). Another 56 tetracycline-stained rat incisors were UV irradiated for three days. Three different penetration depths were tested: penetration through lingual dentin and labial enamel (DN group), penetration through labial enamel only (RE group) and penetration through labial enamel covered with 1.0 mm human enamel (HE group). Specimens were bleached with Opalescence for one hour five times a day for one week or four weeks. A control group of unbleached teeth was also examined. Results (deltaE) were as follows: control--11.67; 1-week DN--13.55; 1-week RE--12.80; 1-week HE--12.07; 4-week DN--7.48; 4-week RE--7.50; 4-week HE--11.69. The color change in the 4-week DN and the 4-week RE groups showed the greatest reduction (p<.01).

  5. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Over-the-counter drugs for minor sore throats... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements for Specific Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and...

  6. Ionic liquid as a mobile phase additive in high-performance liquid chromatography for the simultaneous determination of eleven fluorescent whitening agents in paper materials.

    PubMed

    Wang, Qing; Chen, Xianbo; Qiu, Bin; Zhou, Liang; Zhang, Hui; Xie, Juan; Luo, Yan; Wang, Bin

    2016-04-01

    In the present study, 11 4,4'-diaminostilbene-2,2'-disulfonic acid based fluorescent whitening agents with different numbers of sulfonic acid groups were separated by using an ionic liquid as a mobile phase additive in high-performance liquid chromatography with fluorescence detection. The effects of ionic liquid concentration, pH of mobile phase B, and composition of mobile phase A on the separation of fluorescent whitening agents were systematically investigated. The ionic liquid tetrabutylammonium tetrafluoroborate is superior to tetrabutylammomnium bromide for the separation of the fluorescent whitening agents. The optimal separation conditions were an ionic liquid concentration at 8 mM and the pH of mobile phase B at 8.5 with methanol as mobile phase A. The established method exhibited low limits of detection (0.04-0.07 ng/mL) and wide linearity ranges (0.30-20 ng/mL) with high linear correlation coefficients from 0.9994 to 0.9998. The optimized procedure was applied to analyze target analytes in paper samples with satisfactory results. Eleven target analytes were quantified, and the recoveries of spiked paper samples were in the range of 85-105% with the relative standard deviations from 2.1 to 5.1%. The obtained results indicated that the method was efficient for detection of 11 fluorescent whitening agents.

  7. Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

    MedlinePlus

    ... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

  8. What Diabetics Need to Know about Over-The-Counter Meds

    MedlinePlus

    ... medlineplus.gov/news/fullstory_167630.html What Diabetics Need to Know About Over-the-Counter Meds Many ... or not they contain carbohydrates -- if you just need them for a few days," she said. Read ...

  9. Informational and symbolic content of over-the-counter drug advertising on television.

    PubMed

    Tsao, J C

    1997-01-01

    The informational and symbolic content of 150 over-the-counter drug commercials on television are empirically analyzed in this study. Results on the informational content suggest that over-the-counter drug ads tend to focus on the concern of what the drug will do for the consumer, rather than on the reasons why the drug should be ingested. Accordingly, advertising strategy is centered on consumer awareness of the product as the primary goal. Educational commitment, however, did not seem to be blended into the promotional efforts for over-the-counter drugs. Findings on the symbolic content of over-the-counter drug ads reveal that drug images have been distorted. Performance of most drugs has been portrayed to be simple resolutions to relieve the symptom. Moreover, a casual attitude toward drug usage is encouraged in the commercials, while time lapse of drug effects is overlooked.

  10. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over the counter for the relief of minor irritations of the mouth or throat. It will not object to the labeling of...

  11. Readability and comprehensibility of over-the-counter medication labels.

    PubMed

    Trivedi, Hariprasad; Trivedi, Akshaya; Hannan, Mary F

    2014-04-01

    Nonprescription medications are relatively safe, but not risk-free and can lead to serious adverse events, particularly if used contrary to directions or without attention to depicted warnings. The question arises whether the information presented on the product label is readable and comprehensible to the average lay person. We examined the product labels of nonprescription medications for readability and comprehensibility characteristics using the Flesch-Kincaid method. The Flesch-Kincaid reading ease scores and grade level scores were derived. We further validated the grade level scores using the Gunning-Fog method. Qualitative assessment of select labels found severe deficiencies such as poor organization and inundation with technical terms. By quantitative assessment the average reading ease score of 40 nonprescription medication labels (including nonsteroidal anti-inflammatory agents, antacids, laxative preparations, anti-allergy medications, H-2 blockers, proton pump inhibitors, sleep aids, an antiasthmatic, and cough and cold remedies) was 38 ± 12. The average Flesch-Kincaid grade level score was 16 ± 5. All labels except one were at reading grade level greater than the eighth grade. The average grade level of education necessary to understand the material according to the Gunning-Fog method was 17 ± 5 and all labels were above the eighth grade reading level. Nonprescription medication labels are written in a language that is not comprehensible to the average member of the general public. There is a need for considerable improvement in the readability of these labels.

  12. Toxicity and use of over-the-counter cough and cold medication in the pediatric population.

    PubMed

    Montgomery, Emily J; Wasserman, Gary S

    2008-01-01

    Discussions of the efficacy and toxicity of over-the-counter cough and cold medication have been circulating in the pediatric literature for years. Adverse effects of these medications and the lack of evidence of their efficacy in children make their use a serious matter. An additional consideration for physicians is the recreational use of over-the-counter medications, including adolescent abuse of dextromethorphan. The recent increase in media attention to these issues warrants further review.

  13. Assessing the relationship between pharmacists' job satisfaction and over-the-counter counselling at community pharmacies.

    PubMed

    Urbonas, Gvidas; Kubilienė, Loreta

    2016-04-01

    Community pharmacies have an increasing role in self-medication and community health is dependent on the quality of counselling services provided to patients. Some studies show that pharmacists' job satisfaction affects their work quality; other studies found that higher involvement in clinical services increases pharmacists' job satisfaction. To test the relationship between job satisfaction and over-the-counter counselling practice at community pharmacies. Community pharmacies in Lithuania. A convenience sample (n = 305) of community pharmacists participated in the cross-sectional survey where they expressed satisfaction with job and reported on their over-the-counter counselling behaviour on self-report scales. The Partial Least Squares Structural Equation Modelling approach was employed for data analysis. The strength of the relationship between job satisfaction and over-the-counter counselling service. A bidirectional relationship between job satisfaction and over-the-counter counselling service was found. In addition, job satisfaction and over-the-counter counselling quality depended on pharmacists' age. Organizations were recommended to create a counselling friendly environment that would increase pharmacists' job satisfaction and, in return, counselling quality. Also, additional motivation of the retired pharmacists, as well as development of counselling skills of the younger pharmacy workforce, were seen as a means to improve both organizational climate and counselling quality over the counter.

  14. Prediction of gastrointestinal disease with over-the-counter diarrheal remedy sales records in the San Francisco Bay Area.

    PubMed

    Kirian, Michelle L; Weintraub, June M

    2010-07-20

    Water utilities continue to be interested in implementing syndromic surveillance for the enhanced detection of waterborne disease outbreaks. The authors evaluated the ability of sales of over-the-counter diarrheal remedies available from the National Retail Data Monitor to predict endemic and epidemic gastrointestinal disease in the San Francisco Bay Area. Time series models were fit to weekly diarrheal remedy sales and diarrheal illness case counts. Cross-correlations between the pre-whitened residual series were calculated. Diarrheal remedy sales model residuals were regressed on the number of weekly outbreaks and outbreak-associated cases. Diarrheal remedy sales models were used to auto-forecast one week-ahead sales. The sensitivity and specificity of signals, generated by observed diarrheal remedy sales exceeding the upper 95% forecast confidence interval, in predicting weekly outbreaks were calculated. No significant correlations were identified between weekly diarrheal remedy sales and diarrhea illness case counts, outbreak counts, or the number of outbreak-associated cases. Signals generated by forecasting with the diarrheal remedy sales model did not coincide with outbreak weeks more reliably than signals chosen randomly. This work does not support the implementation of syndromic surveillance for gastrointestinal disease with data available though the National Retail Data Monitor.

  15. Prediction of gastrointestinal disease with over-the-counter diarrheal remedy sales records in the San Francisco Bay Area

    PubMed Central

    2010-01-01

    Background Water utilities continue to be interested in implementing syndromic surveillance for the enhanced detection of waterborne disease outbreaks. The authors evaluated the ability of sales of over-the-counter diarrheal remedies available from the National Retail Data Monitor to predict endemic and epidemic gastrointestinal disease in the San Francisco Bay Area. Methods Time series models were fit to weekly diarrheal remedy sales and diarrheal illness case counts. Cross-correlations between the pre-whitened residual series were calculated. Diarrheal remedy sales model residuals were regressed on the number of weekly outbreaks and outbreak-associated cases. Diarrheal remedy sales models were used to auto-forecast one week-ahead sales. The sensitivity and specificity of signals, generated by observed diarrheal remedy sales exceeding the upper 95% forecast confidence interval, in predicting weekly outbreaks were calculated. Results No significant correlations were identified between weekly diarrheal remedy sales and diarrhea illness case counts, outbreak counts, or the number of outbreak-associated cases. Signals generated by forecasting with the diarrheal remedy sales model did not coincide with outbreak weeks more reliably than signals chosen randomly. Conclusions This work does not support the implementation of syndromic surveillance for gastrointestinal disease with data available though the National Retail Data Monitor. PMID:20646311

  16. Use of over-the-counter medications and herbal remedies in pregnancy.

    PubMed

    Refuerzo, Jerrie S; Blackwell, Sean C; Sokol, Robert J; Lajeunesse, Lorraine; Firchau, Katherine; Kruger, Michael; Sorokin, Yoram

    2005-08-01

    The purpose of this study was to determine the frequency of prescription and over-the-counter (OTC) medications, and herbal remedies used by pregnant women. A prospective observational study was performed at a single tertiary-care hospital. Postpartum women completed a questionnaire that included a list of more than 120 medications, herbal remedies, and alternative therapies listed by both brand and common name. Patients were asked to identify any and all medications or treatments used during pregnancy. Of 418 patients who completed questionnaires, 96.9% took at least one medication during their pregnancy. After excluding prenatal vitamins and iron supplements, 76.5% took at least one other medication; 62.8% used OTC medications, and 4.1% used herbal and/or alternative remedies. Multiple drug use occurred in 33.5% of patients, with up to 13.6% consuming four or more medications. The use of prescribed and OTC, medications, and herbal/alternative therapy, is common in pregnancy, with many patients consuming more than one agent at a time.

  17. A Survey of Teenagers' Attitudes Toward Moving Oral Contraceptives Over the Counter.

    PubMed

    Manski, Ruth; Kottke, Melissa

    2015-09-01

    Evidence suggests that over-the-counter access to oral contraceptives may help expand use among adult women. Teenagers may particularly benefit from this approach, as they experience disproportionately high rates of unintended pregnancy and face unique challenges accessing contraceptives. However, limited research has explored teenagers' attitudes toward over-the-counter access. In 2014, a sample of 348 females aged 14-17, recruited via Facebook advertisements, participated in an online survey assessing teenagers' attitudes toward over-the-counter access and their understanding of how to use oral contraceptives after reading a prototype over-the-counter product label. Differences by participants' characteristics were assessed in bivariate analyses (Pearson chi-square and Fisher's exact tests for categorical measures, and independent t tests and one-way analyses of variance for continuous measures). Seventy-three percent of participants supported over-the-counter access, and 61% reported that they would likely use oral contraceptives available through this approach. Few subgroup differences were found. Notably, sexually experienced participants were significantly more likely than others both to support this approach (85% vs. 63%) and to be interested in obtaining oral contraceptives this way (77% vs. 48%). Participants understood an average of 7.1 of eight key concepts that the prototype product label was intended to convey; no significant differences were found among subgroups. Over-the-counter access may be a promising approach for providing oral contraceptives to teenagers. Additional research is needed to evaluate whether teenagers can screen themselves for contraindications to oral contraceptive use and correctly use oral contraceptives obtained over the counter. Copyright © 2015 by the Guttmacher Institute.

  18. "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

  19. Implementing an over-the-counter medication administration policy in an elementary school.

    PubMed

    Foster, Lori S; Keele, Rebecca

    2006-04-01

    A major focus of school nursing interventions is to improve school attendance. In many schools, parents are required to leave work and/or to arrange transportation to bring their children over-the-counter medicines. Many times these children went home, missing class and making it difficult to keep up with class work. The purpose of this study was to examine the impact of a new policy and procedure allowing school nurses to administer certain over-the-counter medications in elementary schools in a southern New Mexico public school district. "Sent home" rates before implementation of the new policy were compared with sent home rates for 2 years following implementation. Although not statistically significant, findings indicated that over-the-counter medication administration by school nurses does show a trend toward sending fewer students home and, therefore, keeping them in the learning environment.

  20. HPLC-UV Method for the Identification and Screening of Hydroquinone, Ethers of Hydroquinone and Corticosteroids Possibly Used as Skin-Whitening Agents in Illicit Cosmetic Products.

    PubMed

    Gimeno, Pascal; Maggio, Annie-Françoise; Bancilhon, Marjorie; Lassu, Nelly; Gornes, Hervé; Brenier, Charlotte; Lempereur, Laurent

    2016-03-01

    Corticosteroids, hydroquinone and its ethers are regulated in cosmetics by the Regulation 1223/2009. As corticosteroids are forbidden to be used in cosmetics and cannot be present as contaminants or impurities, an identification of one of these illicit compounds deliberately introduced in these types of cosmetics is enough for market survey control. In order to quickly identify skin-whitening agents present in illegal cosmetics, this article proposes an HPLC-UV method for the identification and screening of hydroquinone, 3 ethers of hydroquinone and 39 corticosteroids that may be found in skin-whitening products. Two elution gradients were developed to separate all compounds. The main solvent gradient (A) allows the separation of 39 compounds among the 43 compounds considered in 50 min. Limits of detection on skin-whitening cosmetics are given. For compounds not separated, a complementary gradient elution (B) using the same solvents is proposed. Between 2004 and 2009, a market survey on "skin-whitening cosmetic" was performed on 150 samples and highlights that more than half of the products tested do not comply with the Cosmetic Regulation 1223/2009 (amending the Council Directive 76/768/EEC). © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Over-the-counter sales of antibiotics from community pharmacies in Abu Dhabi.

    PubMed

    Dameh, Majd; Green, James; Norris, Pauline

    2010-10-01

    The aim of this study is to investigate over-the-counter sale of antibiotics from community pharmacies in Abu Dhabi city, focusing on the extent, demographic and socioeconomic determinants of this practice. The study was conducted in the capital of the United Arab Emirates, Abu Dhabi, and involved 17 randomly selected private pharmacies. A cross-sectional design using structured observations of 30 clients purchasing antibiotics from a pharmacy staff (either a pharmacist or pharmacy assistant) at each selected pharmacy. A total of 510 interactions were observed. Statistical analysis was performed using SPSS. The extent and types of antibiotics sold over-the-counter in Abu Dhabi city as observed in the selected sample of community pharmacies, and the demographic and socioeconomic factors that contributed to this practice. Sixty eight percent (68.4%) of the observed antibiotic sales were sold over-the-counter without prescriptions. Injection antibiotics constituted 2.2% of the antibiotics sold, 45.5% of which were sold over-the-counter. Combination of penicillins including β-lactamase inhibitors (34.0%), penicillins with extended spectrum (22.3%) and second generation cephalosporins (11.2%) were the mostly commonly sold antibiotic groups. Respiratory conditions (63.1%) were the most frequent reason for purchasing antibiotics. Over-the-counter sales of antibiotics were related to client ethnicity and age, gender of pharmacy staff and health complaint. Our study revealed high sales of over-the-counter antibiotics, despite this being illegal. The ineffectiveness of antibiotics in treating respiratory conditions of viral origin and effects of such practice on the emergence of bacterial resistance necessitates prompt action.

  2. Availability of Over-the-Counter Emergency Contraception in 2 Disparate New York City Neighborhoods

    PubMed Central

    Bakshi, Salina; Keyhani, Salomeh; Howell, Elizabeth A.

    2012-01-01

    We conducted a telephone survey of pharmacies in 2 New York City neighborhoods on same-day availability, type, and cost of over-the-counter emergency contraception. There was no difference in availability of over-the-counter emergency contraception between Upper East Side and East Harlem pharmacies (93% vs 94%; P = .71). Average cost of medication was less in East Harlem than in the Upper East Side ($45.16 vs $51.64; P < .001). Efforts should accentuate overcoming cost and knowledge barriers associated with the use of emergency contraception. PMID:22994248

  3. Ineffectiveness of over-the-counter total-release foggers against the bed bug (Heteroptera: Cimicidae).

    PubMed

    Jones, Susan C; Bryant, Joshua L

    2012-06-01

    Field-collected bed bugs (Cimex lectularius L.) showed little, if any, adverse effects after 2-h direct exposure to the aerosolized pyrethroid(s) from three over-the-counter total-release foggers ('bug bombs' or 'foggers'); Hotshot Bedbug and Flea Fogger, Spectracide Bug Stop Indoor Fogger, and Eliminator Indoor Fogger. One field-collected population, EPM, was an exception in that there was significant mortality at 5-7 d when bugs out in the open had been exposed to the Spectracide Fogger; mortality was low when these bugs had access to an optional harborage, a situation observed for all field-collected populations when exposed to the three foggers. Even the Harlan strain, the long-term laboratory population that is susceptible to pyrethroids and that served as an internal control in these experiments, was unaffected if the bugs were covered by a thin cloth layer that provided harborage. In residences and other settings, the majority of bed bugs hide in protected sites where they will not be directly contracted by the insecticide mist from foggers. This study provides the first scientific data supporting the position that total-release foggers should not be recommended for control of bed bugs, because 1) many field-collected bed bugs are resistant to pyrethroids, and they are not affected by brief exposure to low concentrations of pyrethrins and/or pyrethroids provided by foggers; and 2) there is minimal, if any, insecticide penetration into typical bed bug harborage sites. This study provides strong evidence that Hotshot Bedbug and Flea Fogger, Spectracide Bug Stop Indoor Fogger, and Eliminator Indoor Fogger were ineffective as bed bug control agents.

  4. [Determination of four fluorescent whitening agents in laundry detergents by solid phase extraction combined with ultra-high performance liquid chromatography].

    PubMed

    Xian, Yanping; Guo, Xindong; Luo, Haiying; Wu, Yuluan; Chen, Yiguang; Luo, Donghui; Wu, Wenhai

    2013-02-01

    A new method was established to determine three stilbene-type disulfonate and one distyrylbiphenyl-type fluorescent whitening agents (FWA351, FWA85, FWA28 and FWA71) in laundry detergents by solid phase extraction (SPE) and ultra-high performance liquid chromatography with a diode array detector (UPLC-DAD). The fluorescent whitening agents were extracted from laundry detergents with 2% formic acid aqueous solution and methanol, and purified by WAX SPE column, and analyzed by UPLC-DAD on a Phenomenex Synergi Max-RP column (150 mm x 2.0 mm), employing acetonitrile-10 mmol/L ammonium acetate as the mobile phase in a gradient elution mode. The fluorescent whitening agents were qualitatively determined by retention time, and confirmed by the ultraviolet spectrum. The results indicated that the target analytes were in the range of 0.05-180 mg/L with the correlation coefficients (r) greater than 0. 999 3, and the method limits of quantification (MLOQ) of target analytes were ranged from 1.5 mg/kg to 15 mg/kg (S/N = 10). The feasibility of this method was demonstrated by the determination of FWAs in samples with spiked recoveries. The recoveries were in the range between 84.9% and 105%, and the precision (relative standard deviation, RSD) ranged from 3.2% to 6.1% (n = 6). Among the 15 samples analyzed, the rate of positive samples was 53.3%, over 1 000 mg/kg of FWA351 and FWA71 were detected. The method is simple, precise and has high recoveries for the determination of fluorescent whitening agents in laundry detergent samples.

  5. Facile synthesis of α-Fe{sub 2}O{sub 3}@ porous hollow yeast-based carbonaceous microspheres for fluorescent whitening agent-VBL wastewater treatment

    SciTech Connect

    Zheng, Pei; Tong, Zhiqing; Bai, Bo

    2016-03-15

    Porous hollow carbonaceous microspheres (PHCMs) fabricated from yeast cells by hydrothermal treatment have stimulated interest because of their outstanding chemical and physical properties. Herein, the functionalizations of PHCMs by further coating of α-Fe{sub 2}O{sub 3} nanoparticles onto the surface were carried out. The structure of resulted α-Fe{sub 2}O{sub 3}@PHCMs products were characterized by field emission scanning electron microscopy (FE-SEM), energy dispersive spectrometry (EDS), X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), and BET specific surface area measurements (BET), respectively. Its promising application was evaluated by the Fenton-like degradation of fluorescent whitening agent-VBL from aqueous solutions. - Graphical abstract: In this work, novel α-Fe{sub 2}O{sub 3}@porous hollow carbonaceous microspheres (α-Fe{sub 2}O{sub 3}@PHCMs) were synthesized through a combination of hydrothermal method and calcinations route and achieved excellent removal efficiency for fluorescent whitening Agent-VBL. - Highlights: • The hybrid α-Fe{sub 2}O{sub 3}@ porous hollow microspheres (PHCMs) were firstly fabricated. • The formation mechanism of α-Fe{sub 2}O{sub 3}@PHCMs microspheres was proposed and verified. • Dithizone played a key role in the synthesis of α-Fe{sub 2}O{sub 3}@PHCMs composites. • A favorable removal for the fluorescent whitening agent-VBL were achieved.

  6. Long chain ionic liquid based mixed hemimicelles and magnetic dispersed solid-phase extraction for the extraction of fluorescent whitening agents in paper materials.

    PubMed

    Wang, Qing; Qiu, Bin; Chen, Xianbo; Wang, Bin; Zhang, Hui; Zhang, Xiaoyuan

    2017-04-12

    A novel mixed hemimicelles and magnetic dispersive solid-phase extraction method based on long-chain ionic liquids for the extraction of five fluorescent whitening agents was established. The factors influenced on extraction efficiency were investigated. Under the optimal conditions, namely, the pH of sample solution at 8.0, the concentration of long chain ionic liquid at 0.5 mmol/L, the amount of Fe3 O4 nanoparticle at 12 mg, extraction time at 10 min, pH 6.0 of methanol as eluent and the desorption time at 1 min, satisfactory results were obtained. Wide linear ranges (0.02-10 ng/mL) and good linearity were attained (0.9997-0.9999). The intra-day and inter-day RSDs were 2.1-8.3%. Limits of detection were 0.004-0.01 ng/mL, which was decreased by almost an order of magnitude compared to direct detection without extraction. The present method was applied to extract the fluorescent whitening agents in two kinds of paper samples, obtaining satisfactory results. All showed results illustrated that the detection sensitivity was improved and the proposed method was a good choice for the enriching and monitoring of trace fluorescent whitening agents. This article is protected by copyright. All rights reserved.

  7. Over-the-Counter Drug Advertising in Gender Oriented Popular Magazines.

    ERIC Educational Resources Information Center

    Vener, A. M.; Krupka, L. R.

    1986-01-01

    Survey of 64 popular men's magazines and 47 women's magazines revealed that almost seven times as many over-the-counter drug advertisements were found in the latter than in the former. Most advertisements directed toward women concerned appearance; most directed toward men were for stimulants. Suggests enhanced regulatory efforts against…

  8. Informational and Symbolic Content of Over-the-Counter Drug Advertising on Television.

    ERIC Educational Resources Information Center

    Tsao, James C.

    1997-01-01

    Empirically analyzed the informational and symbolic content of 150 over-the-counter drug commercials on television. Results suggest that these ads tend to focus on what the drug will do for the consumer, rather than on the reasons why the drug should be ingested. Educational commitment seemed absent in promotional efforts. (RJM)

  9. Implementing an Over-the-Counter Medication Administration Policy in an Elementary School

    ERIC Educational Resources Information Center

    Foster, Lori S.; Keele, Rebecca

    2006-01-01

    A major focus of school nursing interventions is to improve school attendance. In many schools, parents are required to leave work and/or to arrange transportation to bring their children over-the-counter medicines. Many times these children went home, missing class and making it difficult to keep up with class work. The purpose of this study was…

  10. Remedy or cure? Lay beliefs about over-the-counter medicines for coughs and colds.

    PubMed Central

    Johnson, Gina; Helman, Cecil

    2004-01-01

    BACKGROUND: Over 500 million is spent in the United Kingdom every year on over-the-counter medicines for coughs and colds. Evidence for their pharmacological efficacy is lacking. AIM: To examine lay beliefs about over-the-counter medicines for coughs and colds. To explore whether the distinction between symptom relief and cure has the same relevance to lay people as it does to medical professionals. DESIGN OF STUDY: Small pilot study using qualitative techniques. SETTING: Variety sample of 11 patients attending the National Health Service walk-in centre, Birmingham, England. METHOD: In-depth semi-structured interviews, including pile-sorting and fictional case histories, were used to explore participants' beliefs about the effects of over-the-counter medicines on coughs and colds. RESULTS: Eight of the 11 participants believed that at least one over the-counter cough medicine (most frequently Benylin for Chesty Coughs) could shorten, or "cure", an illness. Five participants thought that the majority of the medicines that they recognised would speed recovery rather than just relieve symptoms. CONCLUSIONS: There is a common confusion in the lay person's mind between the ability of a medicine to relieve symptoms, and its ability to cure a disease or to hasten recovery. This misunderstanding may affect the demand for primary care consultations. PMID:14965387

  11. 77 FR 66182 - TRICARE Over-the-Counter Drug Demonstration Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... which the Department of Defense (DoD) evaluates allowing selected over-the-counter (OTC) drugs to be included on the TRICARE uniform formulary. The Department will continue to evaluate the costs/benefits and..., 2009. In order to more thoroughly evaluate the clinical and cost effectiveness of OTC drugs as well as...

  12. Over-the-Counter Data's Impact on Educators' Data Analysis Accuracy

    ERIC Educational Resources Information Center

    Rankin, Jenny Grant

    2013-01-01

    There is extensive research on the benefits of making data-informed decisions, but research also contains evidence many educators incorrectly interpret student data. Meanwhile, the types of detailed labeling on over-the-counter medication have been shown to improve use of non-medication products, as well. However, data systems most educators use…

  13. Over-the-Counter Data's Impact on Educators' Data Analysis Accuracy

    ERIC Educational Resources Information Center

    Rankin, Jenny Grant

    2013-01-01

    There is extensive research on the benefits of making data-informed decisions, but research also contains evidence many educators incorrectly interpret student data. Meanwhile, the types of detailed labeling on over-the-counter medication have been shown to improve use of "non"-medication products, as well. However, data systems most…

  14. Exploring Ovulation & Pregnancy Using Over-the-Counter Products: A Novel Guided Inquiry

    ERIC Educational Resources Information Center

    Venditti, Jennifer J.; Surmacz, Cynthia A.

    2012-01-01

    In this guided inquiry, students explore the complex hormonal regulation of the female reproductive cycle using inexpensive ovulation and pregnancy detection kits that are readily available over the counter. This hands-on activity engages students in the practice of doing science as highlighted by the "National Science Education Standards." The…

  15. 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…

  16. Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

    MedlinePlus

    ... herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products Now playing: E-mail to a friend ... care provider says it’s OK. Not all drugs, herbal products or supplements are safe to take during pregnancy. If you’ ...

  17. Developing a Nursing Protocol for Over-the-Counter Medications in High School

    ERIC Educational Resources Information Center

    Awbrey, Lucinda Mejdell; Juarez, Sandra M.

    2003-01-01

    Management of medications in school is one of the critical roles that school nurses carry out in the school setting. In recent years, parents have come to question the medication procedures that school districts follow. Parents question why a physician's order is required for school personnel to provide over-the-counter (OTC) medications to their…

  18. Implementing an Over-the-Counter Medication Administration Policy in an Elementary School

    ERIC Educational Resources Information Center

    Foster, Lori S.; Keele, Rebecca

    2006-01-01

    A major focus of school nursing interventions is to improve school attendance. In many schools, parents are required to leave work and/or to arrange transportation to bring their children over-the-counter medicines. Many times these children went home, missing class and making it difficult to keep up with class work. The purpose of this study was…

  19. Developing a Nursing Protocol for Over-the-Counter Medications in High School

    ERIC Educational Resources Information Center

    Awbrey, Lucinda Mejdell; Juarez, Sandra M.

    2003-01-01

    Management of medications in school is one of the critical roles that school nurses carry out in the school setting. In recent years, parents have come to question the medication procedures that school districts follow. Parents question why a physician's order is required for school personnel to provide over-the-counter (OTC) medications to their…

  20. Exploring Ovulation & Pregnancy Using Over-the-Counter Products: A Novel Guided Inquiry

    ERIC Educational Resources Information Center

    Venditti, Jennifer J.; Surmacz, Cynthia A.

    2012-01-01

    In this guided inquiry, students explore the complex hormonal regulation of the female reproductive cycle using inexpensive ovulation and pregnancy detection kits that are readily available over the counter. This hands-on activity engages students in the practice of doing science as highlighted by the "National Science Education Standards." The…

  1. 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…

  2. Over-the-Counter Data's Impact on Educators' Data Analysis Accuracy

    ERIC Educational Resources Information Center

    Rankin, Jenny Grant

    2013-01-01

    There is extensive research on the benefits of making data-informed decisions, but research also contains evidence many educators incorrectly interpret student data. Meanwhile, the types of detailed labeling on over-the-counter medication have been shown to improve use of "non"-medication products, as well. However, data systems most…

  3. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Over-the-counter drugs for minor sore throats; suggested warning. 201.315 Section 201.315 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements for Specific...

  4. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Over-the-counter drugs for minor sore throats; suggested warning. 201.315 Section 201.315 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements for Specific...

  5. Over-the-counter (OTC) medications for acute cough in children and adults in community settings.

    PubMed

    Smith, Susan M; Schroeder, Knut; Fahey, Tom

    2014-11-24

    and found conflicting results. Four studies compared other combinations of drugs with placebo and indicated some benefit in reducing cough symptoms. Three trials found that antihistamines were no more effective than placebo in relieving cough symptoms.In the child studies, antitussives (data from three studies), antihistamines (data from three studies), antihistamine-decongestants (two studies) and antitussive/bronchodilator combinations (one study) were no more effective than placebo. No studies using expectorants met our inclusion criteria. The results of one trial favoured active treatment with mucolytics over placebo. One trial tested two paediatric cough syrups and both preparations showed a 'satisfactory response' in 46% and 56% of children compared to 21% of children in the placebo group. One new trial indicated that three types of honey were more effective than placebo over a three-day period.Twenty-one studies reported adverse effects. There was a wide range across studies, with higher numbers of adverse effects in participants taking preparations containing antihistamines and dextromethorphan. The results of this review have to be interpreted with caution because the number of studies in each category of cough preparations was small. Availability, dosing and duration of use of over-the-counter cough medicines vary significantly in different countries. Many studies were poorly reported making assessment of risk of bias difficult and studies were also very different from each other, making evaluation of overall efficacy difficult. There is no good evidence for or against the effectiveness of OTC medicines in acute cough. This should be taken into account when considering prescribing antihistamines and centrally active antitussive agents in children; drugs that are known to have the potential to cause serious harm.

  6. Optical properties and surface structure comparison of tooth whitening using four laser systems and chemical action agents

    NASA Astrophysics Data System (ADS)

    Dostalova, Tatjana; Jelinkova, Helena; Koranda, Pavel; Nemec, Michal; Sulc, Jan; Housova, Devana; Miyagi, Mitsunobu; Kokta, Milan R.

    2003-06-01

    The purpose of the study is to evaluate the effect of various laser techniques for bleaching teeth in office vital whitening. Hydrogen peroxide (30% concentration) and carbamide peroxide (10% solution) were used for chemical activation of bleaching process. Extracted non-carcious upper central incisors were exposed to laser radiation. Four different laser systems (Nd:YAG laser SHG, wavelength 0.53 μm, CTE:YAG laser, wavelength 2.7 μm, Nd:YAG laser, wavelength 1.06 μm, and alexandrite laser, wavelength 0.75 μm) were applied to accelerate the speed of the process. The end of chemical exposition was verified by the change of bleaching agent color. The color change was determined by stereomicroscope (Nikon SMZ 2T, Japan), the quality of surface structure was checked by scanning electron microscope Joel, Japan). The speed of bleaching rnaged from 630 s (chemical methods only) to 250-340 s (chemicals + alexandrite laser radiation). The Alexandrite laser application was considered an elective process to decrease the time of bleaching without modifying the surface.

  7. Organic pollutant removal versus toxicity reduction in industrial wastewater treatment: the example of wastewater from fluorescent whitening agent production.

    PubMed

    Köhler, Annette; Hellweg, Stefanie; Escher, Beate I; Hungerbühler, Konrad

    2006-05-15

    Industrial wastewater treatment in the chemical industry aims at eliminating organic contaminants, as these pollutants may be persistent and ecotoxic. In a case study performed in collaboration with the chemical industry, we investigated the removal of a fluorescent whitening agent and its side products in the wastewater-treatment system. Adsorption to activated carbon and biological treatment were simulated in laboratory tests. Algae toxicity tests were performed to quantify the toxicity of the wastewater mixture and of single components. The contaminants identified accounted for up to 82% of the wastewater's total organic carbon (TOC). Adsorption to activated carbon eliminated the TOC and the single contaminants only slightly. Nevertheless, the toxicity of the wastewater decreased by 40%. In contrast, biological treatment reduced the TOC by up to 80%, and the whole effluent toxicity increased. These results indicate that new ecotoxic metabolites were formed during the biological treatment. They also illustrate that mere reduction of the TOC in the wastewater-treatment system is not sufficient for ensuring a reduction of environmental impact. Therefore, simultaneously conducting TOC measurements and toxicity tests, as demonstrated in the current work, is recommended.

  8. Performance and membrane fouling characteristics of a combined biofilm and membrane bioreactor for treatment of fluorescent whitening agent wastewater.

    PubMed

    Liang, Zhiwei; Du, Ping; Yang, Shangyuan; Li, Xin; Qian, Yichao

    2014-01-01

    A full-scale system, composed of one anoxic fixed biofilm reactor, four oxic fixed biofilm reactors and an activated sludge membrane bioreactor, was used to treat heavily organic loaded, high toxic and saline fluorescent whitening agent wastewater. This system was running steady during the experimental period of three months. Treatment performance and membrane fouling characteristics were investigated. The concentrations of chemical oxygen demand (COD), NH4+, NO3- and total nitrogen (TN) in effluent were 447, 27, 14 and 114 mg L(-1), corresponding to the removal rates of 89%, 76%, 68% and 64%, respectively. A series of analyses, including Fourier transform infrared spectroscopy, energy-dispersive X-ray spectroscopy, confocal laser scanning microscopy, scanning electron microscopy and protein and polysaccharide concentration measurements, represented that the sludge layer formed on the membrane surface contained both organic and inorganic foulants. Polysaccharides in bound extracellullar polymeric substances in mixed liquor were the main contributor to membrane fouling. Off-line tap water rinsing was proved to be a cost-effective method of fouling control.

  9. Development and validation of a fast chromatographic method for screening and quantification of legal and illegal skin whitening agents.

    PubMed

    Desmedt, B; Rogiers, V; Courselle, P; De Beer, J O; De Paepe, K; Deconinck, E

    2013-09-01

    During the last years, the EU market is flooded by illegal cosmetics via the Internet and a so-called "black market". Among these, skin-bleaching products represent an important group. They contain, according to the current European cosmetic legislation (Directive 76/768/EEC), a number of illegal active substances including hydroquinone, tretinoin and corticosteroids. These may provoke as well local as systemic toxic effects, being the reason for their banning from the EU market. To control this market there is a need for a fast screening method capable of detecting illegal ingredients in the wide variety of existing bleaching cosmetic formulations. In this paper the development and validation of an ultra high pressure liquid chromatographic (UHPLC) method is described. The proposed method makes use of a Waters Acquity BEH shield RP18 column with a gradient using 25 mM ammonium borate buffer (pH 10) and acetonitrile. This method is not only able to detect the major illegal (hydroquinone, tretinoin and six dermatologic active corticosteroids) and legal whitening agents, the latter having restrictions with respect to concentration and application (kojic acid, arbutin, nicotinamide and salicylic acid), but can also quantify these in a run time of 12 min. The method was successfully validated using the "total error" approach in accordance with the validation requirements of ISO-17025. During the validation a variety of cosmetic matrices including creams, lotions and soaps were taken into consideration.

  10. Efficacy of do-it-yourself whitening as compared to conventional tooth whitening modalities: an in vitro study.

    PubMed

    Kwon, S R; Meharry, M; Oyoyo, U; Li, Y

    2015-01-01

    To evaluate the efficacy of do-it-yourself (DIY) whitening as compared to conventional tooth whitening modalities using different shade assessment tools. Extracted human molars (120) were randomly distributed to six groups (n=20). Whitening was performed according to manufacturer's directions for over-the-counter, dentist-dispensed for home use, and in-office whitening. DIY whitening consisted of a strawberry and baking soda mix. Additionally, negative and positive controls were used. Two evaluators used the Vita Classical (VC) and Vita Bleachedguide 3D-Master with interpolated numbers (BGi) for visual assessment at baseline and one-week, one-month, and three-month postwhitening. Instrumental measurements were performed with a spectrophotometer. Kruskal-Wallis procedure was used to assess color changes among groups and intraclass correlation (ICC) to evaluate agreement between evaluators. DIY exhibited lower color change (ΔSGUVC, ΔSGUBGi, ΔE*, where SGU = shade guide unit and E = overall color change) compared to other whitening groups at all time points (p<0.05). ICC demonstrated very good agreement between evaluators with VC and BGi at each time point. Both shade guides were related with each other and strongly related to instrumental measurements (p<0.05). DIY whitening was the least effective whitening modality. Both VC and BGi are related with each other and have good correlation with instrumental measurements.

  11. Women's use of over-the-counter antifungal medications for gynecologic symptoms.

    PubMed

    Ferris, D G; Dekle, C; Litaker, M S

    1996-06-01

    Over-the-counter (OTC) antifungal products for vulvovaginal candidiasis (VVC) have gained tremendous popularity, as evidenced by staggering increases in sales since the products were switched from prescription-only to OTC status. The rapid escalation in the sale of these products may imply that women are using them inappropriately. The purposes of this study were to determine (1) whether women could correctly diagnose VVC and common genitourinary tract problems after reading classic case scenarios, (2) whether women could correctly select the appropriate treatment for these cases, and (3) whether a previous diagnosis of VVC by a clinician had any effect on a woman's ability to self-diagnose and self-treat VVC. Women 16 years of age and older were recruited from medical and community sites to complete a 63-question survey instrument designed to assess their knowledge of the symptoms and signs of pelvic inflammatory disease, bacterial vaginosis, acute cystitis, vaginal trichomoniasis, and vulvovaginal candidiasis after reading classic case scenarios. A total of 601 women completed the questionnaire, 552 subjects and 49 medically trained women who served as a criterion standard for comparison. Of the 552 subjects, 365 reported a prior diagnosis of VCC and 154 reported no such prior diagnosis. The medically trained cohort was more accurate in diagnosing VVC (83.7% correct) than were subjects who had received a prior diagnosis of VVC (34.5% correct), and more accurate than subjects without a previous diagnosis of VVC (11.0% correct, P < .001). A greater percentage of subjects in whom VVC had been previously diagnosed, as compared with the medically trained cohort, would use OTC agents inappropriately for pelvic inflammatory disease (6.7% vs 4.3%, respectively; P = NS), bacterial vaginosis (14.6% vs 6.4%, respectively; P = .028), urinary tract infection (2.0% vs 0%, respectively; P < .001), and vaginal trichomoniasis (11.8% vs 6.6%, respectively; P = .048). A minority of

  12. A research agenda for moving early medical pregnancy termination over the counter.

    PubMed

    Kapp, N; Grossman, D; Jackson, E; Castleman, L; Brahmi, D

    2017-10-01

    Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone-misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over-the-counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self-use of medical termination, the critical elements missing are the label comprehension, self-selection and actual use studies. Considering medical pregnancy termination through the over-the-counter regulatory lens clarifies critical evidence gaps. © 2017 Ipas. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

  13. The Use of Over-The-Counter Medications to Facilitate Sexual Assault.

    PubMed

    Jenkins, A J; Stillwell, M E

    2010-01-01

    Over-the-counter drugs are medications that are available without the requirement of a prescription. They are considered relatively safe and well-tolerated when taken in accordance with the dosing instructions on the package label. However, when taken alone or in combination with other drugs, they possess pharmacological properties that have the potential to facilitate sexual assault. This chapter reviews the chemistry and pharmacology of these drugs. Additionally, a brief overview of analytical methodology is presented.

  14. Over-the-Counter and Prescription Sleep Medication and Incident Stroke: The REGARDS Study

    PubMed Central

    Petrov, Megan E. Ruiter; Howard, Virginia J.; Kleindorfer, Dawn; Grandner, Michael A.; Molano, Jennifer R.; Howard, George

    2014-01-01

    Purpose Preliminary evidence suggests sleep medications are associated with risk of vascular events; however, the long-term vascular consequences are understudied. This study investigated the relation between sleep medication use and incident stroke. Methods Within the REasons for Geographic And Racial Differences in Stroke study, 21,678 black and white participants (≥45yrs) with no history of stroke were studied. Participants were recruited from 2003−2007. From 2008−2010, participants self-reported their prescription and over-the-counter sleep medication use over the past month. Suspected stroke events were identified by telephone contact at 6-month intervals, and associated medical records were retrieved and physician-adjudicated. Proportional hazards analysis was used to the estimate hazard ratios for incident stroke associated with sleeping medication use (0, 1−14, and 15+ days per month) controlling for sociodemographics, stroke risk factors, mental health symptoms, and sleep apnea risk. Results At the sleep assessment, 9.6% of the sample used prescription sleep medication and 11.1% used over-the-counter sleep aids. Over an average follow-up of 3.3±1.0 years, 297 stroke events occurred. Over-the-counter sleep medication use was associated with increased risk for incident stroke in a frequency-response relationship (p-trend = 0.014), with a 46% increased risk for 1–14 days of use per month (HR=1.46; 95%CI: 0.99–2.15) and a 65% increased risk for 15+ days (HR=1.65; 95%CI: 0.96–2.85). There was no significant association with prescription sleep medications (p = 0.80). Conclusions Over-the-counter sleep medication use may independently increase the risk of stroke beyond other risk factors in middle-aged to older individuals with no history of stroke. PMID:25113086

  15. Ion mobility spectrometry for the rapid analysis of over-the-counter drugs and beverages

    PubMed Central

    Fernández-Maestre, Roberto

    2009-01-01

    In the pharmaceutical industry, there are increasing requirements for analytical methods in quality assessment for the production of drugs. In this investigation, ion mobility spectrometry (IMS) was used for the rapid qualitative separation and identification of active ingredients in generic over-the-counter drugs and food additives in beverages. The active ingredients determined in drugs were acetaminophen, aspartame, bisacodyl, caffeine, dextromethorphan, diphenhydramine, famotidine, glucosamine, guaifenesin, loratadine, niacin, phenylephrine, pyridoxine, thiamin, and tetrahydrozoline. Aspartame and caffeine were determined in beverages. Fourteen over-the-counter drugs and beverages were analyzed. Analysis times below 10 s were obtained for IMS, and reduced mobilities were reported for the first time for 12 compounds. A quadrupole mass spectrometer coupled to a mobility spectrometer was used to assure a correct peak assignation. The combination of fast analysis, low cost, and inexpensive maintenance of IMS instruments makes IMS an attractive technique for the qualitative determination of the active ingredients in over-the-counter drugs and food additives in manufacture quality control and cleaning verification for the drug and food industries. PMID:20835390

  16. Ion mobility spectrometry for the rapid analysis of over-the-counter drugs and beverages.

    PubMed

    Fernández-Maestre, Roberto; Hill, Herbert H

    2009-08-01

    In the pharmaceutical industry, there are increasing requirements for analytical methods in quality assessment for the production of drugs. In this investigation, ion mobility spectrometry (IMS) was used for the rapid qualitative separation and identification of active ingredients in generic over-the-counter drugs and food additives in beverages. The active ingredients determined in drugs were acetaminophen, aspartame, bisacodyl, caffeine, dextromethorphan, diphenhydramine, famotidine, glucosamine, guaifenesin, loratadine, niacin, phenylephrine, pyridoxine, thiamin, and tetrahydrozoline. Aspartame and caffeine were determined in beverages. Fourteen over-the-counter drugs and beverages were analyzed. Analysis times below 10 s were obtained for IMS, and reduced mobilities were reported for the first time for 12 compounds. A quadrupole mass spectrometer coupled to a mobility spectrometer was used to assure a correct peak assignation. The combination of fast analysis, low cost, and inexpensive maintenance of IMS instruments makes IMS an attractive technique for the qualitative determination of the active ingredients in over-the-counter drugs and food additives in manufacture quality control and cleaning verification for the drug and food industries.

  17. History of whitening.

    PubMed

    Anliker, R

    1975-01-01

    Man's earliest endeavours to enhance the brightness of white objects in everyday use, especially clothing, led to the invention of various bleaching processes. KRAIS'S discovery in 1929 that the natural substance esculin could be applied to textiles to give whites of unprecedented brilliance led to the industrial development of fluorescent whitening agents (FWA's). The limited effectiveness of esculin, a glycoside of 6,7-dihydroxycoumarin prompted research which led to the synthesis of other compounds of the same class, many of which have proved useful as whiteners; though the really broad developments of the 1940's stemmed from the synthesis of the 4,4'-diaminostilbene-2,2'disulfonic acid derivatives which are sill the most important groups of FWAs.

  18. 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 acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  19. 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 acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  20. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  1. 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 acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  2. 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 acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  3. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  4. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  5. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  6. 76 FR 56682 - Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ...-ZA40 Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding... on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved..., 2011, ANPRM), FDA published an ANPRM that requested data and information on OTC sunscreen...

  7. Glutathione as a skin whitening agent: Facts, myths, evidence and controversies.

    PubMed

    Sonthalia, Sidharth; Daulatabad, Deepashree; Sarkar, Rashmi

    2016-01-01

    Glutathione is a low molecular weight thiol-tripeptide that plays a prominent role in maintaining intracellular redox balance. In addition to its remarkable antioxidant properties, the discovery of its antimelanogenic properties has led to its promotion as a skin-lightening agent. It is widely used for this indication in some ethnic populations. However, there is a dichotomy between evidence to support its efficacy and safety. The hype around its depigmentary properties may be a marketing gimmick of pharma-cosmeceutical companies. This review focuses on the various aspects of glutathione: its metabolism, mechanism of action and the scientific evidence to evaluate its efficacy as a systemic skin-lightening agent. Glutathione is present intracellularly in its reduced form and plays an important role in various physiological functions. Its skin-lightening effects result from direct as well as indirect inhibition of the tyrosinase enzyme and switching from eumelanin to phaeomelanin production. It is available in oral, parenteral and topical forms. Although the use of intravenous glutathione injections is popular, there is no evidence to prove its efficacy. In fact, the adverse effects caused by intravenous glutathione have led the Food and Drug Administration of Philippines to issue a public warning condemning its use for off-label indications such as skin lightening. Currently, there are three randomized controlled trials that support the skin-lightening effect and good safety profile of topical and oral glutathione. However, key questions such as the duration of treatment, longevity of skin-lightening effect and maintenance protocols remain unanswered. More randomized, double-blind, placebo-controlled trials with larger sample size, long-term follow-up and well-defined efficacy outcomes are warranted to establish the relevance of this molecule in disorders of hyperpigmentation and skin lightening.

  8. Facile synthesis of α-Fe2O3@ porous hollow yeast-based carbonaceous microspheres for fluorescent whitening agent-VBL wastewater treatment

    NASA Astrophysics Data System (ADS)

    Zheng, Pei; Tong, Zhiqing; Bai, Bo

    2016-03-01

    Porous hollow carbonaceous microspheres (PHCMs) fabricated from yeast cells by hydrothermal treatment have stimulated interest because of their outstanding chemical and physical properties. Herein, the functionalizations of PHCMs by further coating of α-Fe2O3 nanoparticles onto the surface were carried out. The structure of resulted α-Fe2O3@PHCMs products were characterized by field emission scanning electron microscopy (FE-SEM), energy dispersive spectrometry (EDS), X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), and BET specific surface area measurements (BET), respectively. Its promising application was evaluated by the Fenton-like degradation of fluorescent whitening agent-VBL from aqueous solutions.

  9. Effect of bleaching agents and whitening dentifrices on the surface roughness of human teeth enamel.

    PubMed

    Özkan, Pelin; Kansu, Gülay; Özak, Sule Tuğba; Kurtulmuş-Yilmaz, Sevcan; Kansu, Pelin

    2013-01-01

    The aim of this in vitro study was to evaluate the surface roughness of human enamel bleached with 10% carbamide peroxide or 10% hydrogen peroxide bleaching agents at different times and also subjected to different superficial cleaning treatments. One hundred and forty flat enamel samples were divided into 14 groups, Group 1-Group 14 (G1-G14). G1-G7 were treated with 10% carbamide peroxide and different dentifrices, G8-G14 were treated with 10% hydrogen peroxide and different dentifrices (G1 and G8: not brushed as control groups; G2 and G9: brushed with Ipana® toothpaste; G3 and G10: brushed with Clinomyn® toothpaste; G4 and G11: brushed with Moos Dent® toothpaste; G5 and G12: brushed with Signal® toothpaste; G6 and G13: brushed with Colgate® toothpaste; G7 and G14: brushed without dentifrice). A profilometer was used to measure average roughness values of the initial surface roughness and at each 7-day-interval. The bleaching was performed for 6 h a day and the surface cleaning treatment was performed 3-times a day, 2 min each time, for 4 weeks. The samples were stored in distilled water during the test period. Statistical analysis revealed significant differences in surface roughness values over time for all groups except G1 and G8 (not brushed). The results of the surface roughness of all groups were nearly the same. The bleaching with 10% hydrogen peroxide and 10% carbamide peroxide did not alter the enamel surface roughness, but when the bleaching treatment was performed combined with abrasive dentifrices, a significant increase in roughness values was observed.

  10. Access to Emergency Contraception in the Over-the-Counter Era.

    PubMed

    Cleland, Kelly; Bass, Jamie; Doci, Florida; Foster, Angel M

    After years of complex regulatory changes, levonorgestrel (LNG) emergency contraception (EC) is now approved for unrestricted sale in the United States. Timely access to EC pills is critical because they are more likely to work the sooner they are taken. This study assesses whether LNG EC is sold in accordance with current Food and Drug Administration regulations. We distributed an online questionnaire through an EC-focused listserv for reproductive health professionals, asking data collectors to visit local stores and document product names, price, over-the-counter shelf availability, and misinformation about age restrictions. We used χ(2) analysis to assess bivariate associations and t tests and Wilcoxon rank-sum tests to determine differences in means. We collected information about 220 stores. The majority (65%) stocked EC on over-the-counter shelves, although only 22% of these displayed it without a locked security enclosure. Chain pharmacies were more likely to shelf-stock EC than independent pharmacies (77% vs. 5%; p = .000), but variation existed among stores within the same chain. Among stores that were asked, 40% incorrectly reported an age restriction for non-prescription purchase of LNG EC, whereas 95% correctly reported that men can buy LNG EC. The average price of branded and generic LNG EC was $49.64 and $40.05, respectively. Changes in the regulatory status of LNG EC have resulted in widespread confusion about how EC can be sold, and its high price contributes to access barriers. Retailers should ensure that consumers can access LNG EC quickly and easily by stocking the product on over-the-counter shelves and educating staff about current regulations. Copyright © 2016 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

  11. Over-the-counter analgesic use by urban Aboriginal people in South Australia.

    PubMed

    Cusack, Lynette; de Crespigny, Charlotte; Wilson, Coral

    2013-07-01

    Despite recent health gains for Australian Aboriginal people their significantly poorer health status compared with that of non-Aboriginal Australians remains significant. Within the context of high levels of mortality and morbidity, research highlights significant barriers to timely health-care, access and safe use of prescribed and over-the-counter medicines. The risks to Aboriginal people's health due to unsafe medication use are preventable. The purpose of this article is to present the findings from qualitative research focused on Aboriginal people's knowledge, use and experience of over-the-counter analgesics. The study was conducted in the north-western metropolitan area of Adelaide, which has the largest urban Aboriginal population in South Australia. The employment of an Aboriginal Elder as Cultural Advisor enabled engagement with Aboriginal participants. Purposive 'snow ball' sampling was used to recruit participants for four focus groups [n = 30] and one participant opting for a personal semi-structured interview. Participants worked with the researchers to develop the findings and formulate recommendations. The 25 women and 6 men, aged 20-80 years reported various chronic medical conditions. Focus groups/interview elicited accounts of critical issues concerning safe selection and use of over-the-counter analgesics. Serious health risks were evident due to limited knowledge about safe analgesic use and over-reliance on information from family, friends and advertising. Extremely poor access was reported by participants to culturally and linguistically appropriate information, education and advice from a range of doctors and other health professionals including Aboriginal health workers. © 2013 Blackwell Publishing Ltd.

  12. Analysis of Marketing Strategy for Food Supplements and Over-The-Counter Medicines.

    PubMed

    Dzeparoski, Marjan; Trajkovic-Jolevska, Suzana

    2016-09-15

    Marketing strategy is correlated with the regulations for the corresponding product category. Accordingly, there is a big difference in the marketing strategy of food supplements and over-the-counter medicines. In this paper are presented 2 different marketing strategies of a new small pharmaceutical company in two studies. The findings of studies analysis can be used for developing marketing strategies in the wider sense and other products, for other small to medium sized companies in other countries of interest with similar regulations and help them understand how to position and promote themselves and their products.

  13. Drug facilitated sexual assault using an over-the-counter ocular solution containing tetrahydrozoline (Visine).

    PubMed

    Spiller, Henry A; Rogers, Jacqualine; Sawyer, Tama S

    2007-07-01

    Drug facilitated sexual assault (DFSA) has been defined as sexual activity occurring where consent is invalid or absent due to the effects of drugs and or alcohol. We report the use of a commonly available over-the-counter drug to induce an obtunded compliant victim with no memory of the period during the sexual assault. An adult male repeatedly used tetrahydrozoline to induce a comatose state in an adult female and four female children for the purposes of sexual assault. It may be warranted to include imidazoline derivatives in the testing for cases of DFSA.

  14. Over-the-counter availability of Plan B emergency contraception: further discussion and commentary.

    PubMed

    Fincham, Jack E; Harris, Curtis E; Fassett, William E; Richards, Warren

    2005-02-01

    The controversy surrounding the potential switch of the Plan B emergency contraceptive therapy from prescription to over-the-counter status has been unprecedented. Regulatory, professional, and societal aspects of this issue have been discussed recently and will no doubt continue to be debated. In this editorial, members of the Medicine, Law, and Ethics panel of The Annals of Pharmacotherapy's Editorial Board offer a sampling of viewpoints touching on varying aspects of the controversy. Readers may wish to consider the ramifications of their professional decisions in this and similar situations in advance of having to make such decisions.

  15. Antiperspirant drug products for over-the-counter human use; final monograph. Final rule.

    PubMed

    2003-06-09

    The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.

  16. Analysis of Marketing Strategy for Food Supplements and Over-The-Counter Medicines

    PubMed Central

    Dzeparoski, Marjan; Trajkovic-Jolevska, Suzana

    2016-01-01

    Marketing strategy is correlated with the regulations for the corresponding product category. Accordingly, there is a big difference in the marketing strategy of food supplements and over-the-counter medicines. In this paper are presented 2 different marketing strategies of a new small pharmaceutical company in two studies. The findings of studies analysis can be used for developing marketing strategies in the wider sense and other products, for other small to medium sized companies in other countries of interest with similar regulations and help them understand how to position and promote themselves and their products. PMID:27703582

  17. Unsupervised clustering of over-the-counter healthcare products into product categories.

    PubMed

    Wallstrom, Garrick L; Hogan, William R

    2007-12-01

    A general problem in biosurveillance is finding appropriate aggregates of elemental data to monitor for the detection of disease outbreaks. We developed an unsupervised clustering algorithm for aggregating over-the-counter healthcare (OTC) products into categories. This algorithm employs MCMC over hundreds of parameters in a Bayesian model to place products into clusters. Despite the high dimensionality, it still performs fast on hundreds of time series. The procedure was able to uncover a clinically significant distinction between OTC products intended for the treatment of allergy and OTC products intended for the treatment of cough, cold, and influenza symptoms.

  18. A comparison of different over-the-counter foot orthotic devices on multi-segment foot biomechanics.

    PubMed

    Ferber, Reed; Hettinga, Blayne A

    2016-12-01

    Over-the-counter foot orthoses are a cost-effective alternative to custom-made devices. However, few studies have compared over-the-counter devices and most biomechanical research involving orthoses has focused on rearfoot biomechanics. To determine changes in multi-segment foot biomechanics during shod walking in three commercially available over-the-counter devices: SOLE, SuperFeet and Powerstep when compared to no orthotic. Repeated measures, cross-sectional study. Retroreflective markers were placed on the right limb of 18 participants representing forefoot, midfoot, rearfoot and shank segments. Three-dimensional kinematics were recorded using an eight-camera motion capture system while participants walked on a treadmill and the order of condition was randomized between four conditions: SOLE, SuperFeet, Powerstep and no orthotic. All over-the-counter devices exhibited significant decreases in plantar fascia strain compared to no orthotic and only Powerstep exhibited significant decreases in peak rearfoot eversion. Medial longitudinal arch deformation was not reduced for any over-the-counter device. Different over-the-counter devices exhibited specific alterations in rearfoot kinematics and all reduced plantar fascia strain by varying amounts. These over-the-counter-specific kinematic changes should be taken into consideration when recommending these devices as a treatment option. Over-the-counter orthoses are a cost-effective alternative to custom-made devices. We demonstrated that three commonly used over-the-counter devices influence foot kinematics and plantar fascia strain differently. Clinicians can use these results to provide more tailored treatment options for their patients. © The International Society for Prosthetics and Orthotics 2015.

  19. In vitro evaluation of variances between real and declared concentration of hydrogen peroxide in various tooth-whitening products.

    PubMed

    Majeed, Abdul; Farooq, Imran; Grobler, Sias R; Moola, M H

    2015-07-01

    The aim of this in vitro study was to analyze the real hydrogen peroxide (HP) concentration in various commercially available tooth-whitening products containing HP and/or carbamide peroxide (CP). Sixteen commercially available tooth-whitening products containing various concentrations of CP or HP were investigated. The products were divided into four groups: dentist-supervised home bleaching products (Group 1, n = 5), in-office bleaching products (Group 2, n = 4), over-the-counter bleaching products (Group 3, n = 3) and whitening toothpastes and rinses (Group 4, n = 4). The peroxide concentration was determined using the oxy-reduction titration method. All the reagents used in the study were of analytic grade and freshly prepared before the experiment. The HP concentration in various dentist-supervised home bleaching products and in-office bleaching products ranged from 3.02-37.08% (expected range = 3-38%). The HP concentration of over-the-counter whitening products ranged from 1.24-5.57% (expected range cannot be estimated as no concentration of active ingredient was provided). Among whitening toothpastes and rinses, Colgate Plax whitening rinse showed more than 1% HP concentration, whereas it was lower than 0.05% in other whitening toothpastes and oral rinses (expected range cannot be estimated as no active ingredient was mentioned). HP concentration of most of the professional tooth-whitening products was different from the expected concentrations, although the deviations were small and most of the products were close to the expected concentration. No concentration of active ingredient was provided for over-the-counter whitening products and no active ingredient was mentioned for whitening toothpastes and rinses.

  20. Atrial Fibrillation Due to Over The Counter Stimulant Drugs in A Young Adult.

    PubMed

    Thyagarajan, Braghadheeswar; Alagusundaramoorthy, Sayee Sundar; Agrawal, Abhinav

    2015-08-01

    The usage of over the counter stimulant drugs and energy drinks is increasing on a day to day basis for various purposes including work, sports and leisure among individuals in all age groups. Multiple formulations are available in the market including pills, liquid capsules and drinks in various flavours. Many of them contain excessively high doses of caffeine along with a variety of stimulant compounds that have multiple effects in different parts of the human body. The consumption of such high amounts of caffeine itself has shown to have caused cardiac arrhythmias in healthy individuals and when it is mixed with a number of stimulant compounds can be associated with a number of adverse effects in the human body. However, the awareness of such life threatening complications associated with these energy drinks does not exist among people who consume it on a day to day basis. We report a case of 25-year-old Caucasian male with no significant past medical history for cardiac diseases, no risk factors for atrial fibrillation, non smoker, occasional alcohol drinker who presents with new onset atrial fibrillation with rapid ventricular response due to the consumption of over the counter stimulant energy capsule which had high doses of caffeine.

  1. Gastrointestinal tolerability of ibuprofen compared with paracetamol and aspirin at over-the-counter doses.

    PubMed

    Rampal, P; Moore, N; Van Ganse, E; Le Parc, J M; Wall, R; Schneid, H; Verrière, F

    2002-01-01

    This multicentre, randomized, investigator-blinded, parallel-group study compared the gastrointestinal (GI) tolerability of ibuprofen, paracetamol and aspirin at over-the-counter doses for common pain indications. Patients (of whom 8633 were evaluable) took either ibuprofen up to 1200 mg daily, or paracetamol or aspirin, each up to 3000 mg daily, for 1-7 days. The main outcome was the proportion of patients with GI adverse events. There were significantly more patients who suffered GI adverse events, principally abdominal pain, dyspepsia, nausea and diarrhoea, with aspirin (18.5%) than with ibuprofen (11.5%), but the difference between ibuprofen and paracetamol (13.1%) was not significant. Significantly more of those patients with a history of non-ulcer GI disease (n = 371) developed GI adverse events than did those with no such history; the incidence of GI adverse events in both groups was lowest with ibuprofen. More women than men experienced GI adverse events (15.5% versus 12.8%). The higher incidence of GI adverse events with aspirin was evident from the first day of treatment. In conclusion, the GI tolerability of ibuprofen, at over-the-counter doses of up to 1200 mg daily for up to 7 days, was at least as good as that of paracetamol and significantly better than that of aspirin.

  2. Atrial Fibrillation Due to Over The Counter Stimulant Drugs in A Young Adult

    PubMed Central

    Alagusundaramoorthy, Sayee Sundar; Agrawal, Abhinav

    2015-01-01

    The usage of over the counter stimulant drugs and energy drinks is increasing on a day to day basis for various purposes including work, sports and leisure among individuals in all age groups. Multiple formulations are available in the market including pills, liquid capsules and drinks in various flavours. Many of them contain excessively high doses of caffeine along with a variety of stimulant compounds that have multiple effects in different parts of the human body. The consumption of such high amounts of caffeine itself has shown to have caused cardiac arrhythmias in healthy individuals and when it is mixed with a number of stimulant compounds can be associated with a number of adverse effects in the human body. However, the awareness of such life threatening complications associated with these energy drinks does not exist among people who consume it on a day to day basis. We report a case of 25-year-old Caucasian male with no significant past medical history for cardiac diseases, no risk factors for atrial fibrillation, non smoker, occasional alcohol drinker who presents with new onset atrial fibrillation with rapid ventricular response due to the consumption of over the counter stimulant energy capsule which had high doses of caffeine. PMID:26435989

  3. The use of over-the-counter medication by elderly medical in-patients.

    PubMed Central

    Batty, G. M.; Oborne, C. A.; Swift, C. G.; Jackson, S. H.

    1997-01-01

    Use of over-the-counter (OTC) medications by elderly patients is often not identified. This survey was performed to study the use of OTCs by medical in-patients aged 65 and over. Data on the use of OTC medications before and during hospital admission were collected by questioning patients and case notes were examined for documentation of their use of OTC medications. OTC medications were used by 44 of 138 (32%) patients interviewed. Patients used a total of 70 OTC medications before admission and six OTC medications were being used during hospital admission. There was no documentation of pre-admission and in-hospital OTC medicine use in the clinical notes and patients had little knowledge of the potential harm some products can cause. As more products become available over the counter, doctors should record their use in patients' notes and patients should be encouraged to seek professional advice before purchasing OTC medicines and to read the product information leaflets. Images Figure PMID:9519186

  4. Effects of Bleaching Agents Combined with Regular and Whitening Toothpastes on Surface Roughness and Mineral Content of Enamel.

    PubMed

    Attia, Mariana Lerner; Cavalli, Vanessa; do Espírito Santo, Ana Maria; Martin, Airton Abrahão; D'Arce, Maria Beatriz Freitas; Aguiar, Flávio Henrique Baggio; Lovadino, José Roberto; do Rego, Marcos Augusto; Cavalcanti, Andréa Nóbrega; Liporoni, Priscila Christiane Suzy

    2015-07-01

    The purpose of this study was to evaluate surface roughness and changes in the composition of enamel submitted to different bleaching protocols and toothbrushing with regular and whitening toothpastes. Bleaching treatment could promote morphological and chemical changes in enamel surface. Enamel blocks were randomized into nine groups (n=10) according to the bleaching treatment (no bleaching, control group; 6% hydrogen peroxide, HP; or 10% carbamide peroxide, CP) and toothpaste used (placebo, PL; regular, R; or whitening dentifrice, W). Bleaching was performed according to manufacturers' instructions and all groups were submitted to 30,000 cycles of simulated toothbrushing with toothpaste (PL, R, or W). Mineral content evaluation and enamel roughness were evaluated initially (T1), after bleaching (T2), and after toothbrushing (T3), using an energy-dispersive micro X-ray fluorescence spectrometer and profilometry, respectively. Data were statistically analyzed with two way ANOVA, Tukey, and Dunnett tests (5%). Enamel surface roughness was influenced by bleaching and toothbrushing. Surface roughness increased for the groups that brushed with the placebo dentifrice (CP+PL, HP+PL, C+PL) and for the control group that brushed with whitening dentifrice (C+W). Enamel Ca/P ratio decreased after bleaching, but toothbrushing, regardless of the dentifrice used, did not reduce the enamel mineral content. The bleaching treatment resulted in a decrease of enamel mineral content, but the studied dentifrices did not contribute to surface mineral loss.

  5. Evaluating the evidence for over-the-counter alternatives for relief of hot flashes in menopausal women.

    PubMed

    Kelley, Kristi W; Carroll, Dana G

    2010-01-01

    To review the literature on alternative over-the-counter (OTC) therapies for the treatment of hot flashes in menopausal women. A literature search was conducted using PubMed, International Pharmaceutical Abstracts, and Medline from inception to June 2010, combining the term hot flash individually with black cohosh, isoflavones, red clover, soy, vitamin E, ginseng, dong quai, evening primrose oil, wild yam, kava, and melatonin. All publication types including human participants and published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. Clinical trials comparing the above single-ingredient agents with placebo or active treatment were selected. In addition, only studies assessing the effects of these single-ingredient agents on vasomotor symptoms in menopausal women were included. Since the Women's Health Initiative and Heart and Estrogen/Progestin Replacement Study II, women have sought lifestyle changes and other drug therapies as alternatives to menopausal hormone therapy to relieve hot flashes associated with menopause. The currently available literature is conflicting in regard to efficacy and does not support the use of alternative OTC therapies for hot flash management associated with menopause. In addition, long-term safety data are lacking for any of these therapies. Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management. Based on the current literature, alternative OTC therapies do not have consistent, beneficial data to support their use in hot flash management.

  6. Over-the-counter sleeping pills: a survey of use in Hong Kong and a review of their constituents.

    PubMed

    Chung, Ka Fai; Lee, Claire K Y

    2002-01-01

    This study examined the composition of over-the-counter (OTC) sleeping pills in Hong Kong and reviewed the current knowledge about the hypnotic efficacy and safety of their major herbal and dietary supplement constituents. We conducted a cross-sectional survey of OTC sleep aids at drug stores in a residential district of 0.3 million population and literature search using MEDLINE, EMBASE, PsycINFO, China Journal Net, China Biomedical Database and relevant English and Chinese literature. We identified 17 brands of OTC sleeping pill: eleven of them were composed of mixtures of Chinese and Western herbal agents and six brands contained 3 mg of melatonin. The Chinese herbal mixture suanzaorentang, comprising zizyphi spinosi semen, poria cocos, ligusticum wallichii, anemarrhenae rhizoma and glycyrrhizae radix in ratio of 7:5:2:1:1, was the most common OTC sleeping pill available in the survey. Our literature review showed that kava, valerian and melatonin were the better-researched herbs and dietary supplements, however, the data on hypnotic efficacy and safety was inadequate to support their clinical use. More rigorous investigations of the risk-benefit relationship of herbal agents and dietary supplements used for insomnia are needed.

  7. Tooth Whitening: What We Now Know

    PubMed Central

    Carey, Clifton M.

    2014-01-01

    Declarative Title Current research about tooth whitening shows that it is safe and effective when manufacturer’s protocol is followed, yet there are risks of which the profession and users should be aware. This update provides a summary of current research and assessment of the safety and efficacy of tooth whitening regimens. Background Tooth whitening has become one of the most frequently requested dental procedures by the public. The public has come to demand whiter, more perfect smiles and in response many choices for tooth whitening have been made available. These include home-based products such as toothpastes, gels, and films, as well as in-office based systems where products containing highly concentrated bleaching agents are applied under professional supervision. The profession and public have been aware of certain risks related to tooth whitening such as increased tooth sensitivity and gingival irritation. New research has shown that there are other risks such as tooth surface roughening and softening, increased potential for demineralization, degradation of dental restorations, and unacceptable color change of dental restorations. The new research is also focused on optimizing whitening procedures to reduce tooth sensitivity and to increase the persistence of the whitening. Methods Current reports in the literature are reviewed that are related to the use of peroxide based whitening methods. These reports include in vitro studies for method optimization and mechanism as well as clinical studies on effects of various whitening regimens. Conclusions When manufacturer’s instructions are followed, hydrogen peroxide and carbamide peroxide based tooth whitening is safe and effective. Patients should be informed of the risks associated with tooth whitening and instructed on identification of adverse occurrences so that they may seek professional help asneeded. PMID:24929591

  8. Tooth whitening: what we now know.

    PubMed

    Carey, Clifton M

    2014-06-01

    Current research about tooth whitening shows that it is safe and effective when manufacturer's protocol is followed, yet there are risks of which the profession and users should be aware. This update provides a summary of current research and assessment of the safety and efficacy of tooth whitening regimens. Tooth whitening has become one of the most frequently requested dental procedures by the public. The public has come to demand whiter, more perfect smiles and in response many choices for tooth whitening have been made available. These include home-based products such as toothpastes, gels, and films, as well as in-office based systems where products containing highly concentrated bleaching agents are applied under professional supervision. The profession and public have been aware of certain risks related to tooth whitening such as increased tooth sensitivity and gingival irritation. New research has shown that there are other risks such as tooth surface roughening and softening, increased potential for demineralization, degradation of dental restorations, and unacceptable color change of dental restorations. The new research is also focused on optimizing whitening procedures to reduce tooth sensitivity and to increase the persistence of the whitening. Current reports in the literature are reviewed that are related to the use of peroxide based whitening methods. These reports include in vitro studies for method optimization and mechanism as well as clinical studies on effects of various whitening regimens. When manufacturer's instructions are followed, hydrogen peroxide and carbamide peroxide based tooth whitening is safe and effective. Patients should be informed of the risks associated with tooth whitening and instructed on identification of adverse occurrences so that they may seek professional help as needed. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... over-the-counter (OTC) for the treatment of boils. (a) Aminacrine hydrochloride, benzocaine, bismuth..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... aminacrine hydrochloride, bismuth subnitrate, calomel, camphor, cholesterol, ergot fluid...

  10. High use of over-the-counter analgesic; possible warnings of reduced quality of life in adolescents - a qualitative study.

    PubMed

    Skarstein, Siv; Lagerløv, Per; Kvarme, Lisbeth Gravdal; Helseth, Sølvi

    2016-01-01

    Use of over-the-counter analgesics among adolescents has increased markedly. High consumption of over-the-counter analgesics among adolescents is associated with frequent pain, lower self-esteem, reduced sleep, lower educational ambition, binge drinking, higher caffeine consumption, and part-time employment. Knowledge about life experiences of adolescents who frequently use over-the-counter analgesics may be useful to prevent health problems. The purpose of the study was to increase knowledge about adolescents who suffer from frequent pain and have a high consumption of over-the-counter analgesics. A qualitative study, employing one-on-one, in-depth interviews using a thematic interview guide. Data were collected in Norway in 2013-2014. Three boys and sixteen girls; aged 14-16 years, who continuously consumed over-the-counter analgesics were recruited from ten high schools in urban and suburban districts. Candidate participants were excluded if they were medically diagnosed with an acute or chronic illness, requiring extended use of over-the-counter analgesics within the last year. The interviews were taped, transcribed and analysed as text according to Kvale's three contexts of interpretation: self-understanding, common sense and theory. All participants disclosed unresolved physical and psychosocial distress characterized as pain. Frequent pain from various body parts made everyday life challenging. Methods of pain self-appraisal and over-the-counter analgesics use often mimicked maternal patterns. Participants reported being raised under unpredictable circumstances that contributed to long lasting family conflicts and peer-group problems. Participants wanted to feel appreciated and to be socially and academically successful. However, pain reduced their ability to manage everyday life, hampered experienced possibilities for success, and made social settings difficult. Childhood experiences influence how adolescents experience pain and use over-the-counter

  11. The pH of various tooth-whitening products on the South African market.

    PubMed

    Majeed, A; Grobler, S R; Moola, M H

    2011-07-01

    The purpose of this in vitro study was to investigate the pH of 21 commercially available tooth-whitening products. Tooth-whitening products were divided into four categories: dentist supervised-home bleaching products (n = 5); in-office bleaching products (n = 5); over-the-counter bleaching products (n = 4) and whitening toothpastes and rinses (n = 7). The pH of three samples of each product was measured using an Orion Expandable Ion Analyzer EA940 with a Sure-Flow, Epoxy-body combination pH electrode. The group data were analysed using one way ANOVA (significant at p < 0.05). The five dentist supervised-home bleaching products had a mean pH of 6.21 +/- 0.76 and ranged from 4.88 to 6.81. The five in-office bleaching products had a mean pH of 6.26 +/- 1.19 and ranged from 5.30 to 7.85. The four over-the-counter whitening products had a mean pH of 5.07 +/- 1.74 and ranged from 3.76 to 8.03 and the seven whitening toothpastes had a mean pH of 7.66 +/- 1.19 and ranged from 6.61 to 9.68. The pH of the over-the-counter category was significantly lower (more acidic) than all other categories (p < 0.05). The whitening gel of Rapid-White had the lowest acidic pH of 3.76 and Colgate Advanced Whitening toothpaste showed the highest alkaline pH of 9.68. The pH of all tooth-whitening products showed a wide range from 3.76 (highly acidic) to 9.68 (highly alkaline). Over-the-counter whitening products showed the lowest pH levels and in general these can be expected to damage enamel more than the other products. Dentists should be vigilant with regards to products used outside their surgeries and should warn their patients accordingly. The acidic pH of many of the whitening products other than in-office bleaching products is of concern and the general public should be better informed by the dental professionals of the dangers of these products.

  12. Rosacea Patient Perspectives on Homeopathic and Over-the-counter Therapies.

    PubMed

    Alinia, Hossein; Lan, Lucy; Kuo, Sandy; Huang, Karen E; Taylor, Sarah L; Feldman, Steven R

    2015-10-01

    Rosacea patients commonly employ nonprescription therapies. The authors' aim was to understand rosacea patients' perceptions of over-the-counter products, complementary and alternative medicine, and homeopathic therapies. A public, online discussion forum comprising 3,350 members and 27,051 posts provided a source of 346 posts on patient perceptions on alternative rosacea treatments. Three major themes of nonprescription treatment were identified-motivation for use, patient-provider discussions, and experience with these treatments. Perceived medication failure, barriers to treatment, and distrust of physicians drive patients to seek nonprescription therapies. Still, patients prefer to consult a physician on incorporating nonprescription therapies into treatment. Complementary and alternative medicine natural products (19.4% of posts), complementary and alternative medicine practices (16.5%), and homeopathic medicine (3.8%) were commonly discussed. Physicians have an opportunity to be a trusted source of information on the strengths and weaknesses of skin care products and other complementary treatments for rosacea.

  13. A Model of Consumer Response to Over-the-Counter Drug Advertising: Antecedents and Influencing Factors.

    PubMed

    Huh, Jisu; Delorme, Denise E; Reid, Leonard N

    2016-01-01

    Given the importance of over-the-counter (OTC) drugs in the health care marketplace and lack of systematic research on OTC drug advertising (OTCA) effects, this study tested a theory-based, product category-specific OTCA effects model. Structural equation modeling analysis of data for 1 OTC drug category, analgesics, supported the proposed model, explaining the OTCA effect process from key consumer antecedents to ad involvement, from ad involvement to ad attention, from ad attention to cognitive responses, then to affective/evaluative responses, leading to the final behavioral outcome. Several noteworthy patterns also emerged: (a) Product involvement was directly linked to ad attention, rather than exerting an indirect influence through ad involvement; (b) ad attention was significantly related to both cognitive and affective/evaluative responses to different degrees, with stronger links to cognitive responses; and

  14. Consumer involvement: effects on information processing from over-the-counter medication labels.

    PubMed

    Sansgiry, S S; Cady, P S; Sansgiry, S

    2001-01-01

    The objective of this study was to evaluate the effects of consumer involvement on information processing from over-the-counter (OTC) medication labels. A sample of 256 students evaluated simulated OTC product labels for two product categories (headache and cold) in random order. Each participant evaluated labels after reading a scenario to simulate high and low involvement respectively. A questionnaire was used to collect data on variables such as label comprehension, attitude-towards-product label, product evaluation, and purchase intention. The results indicate that when consumers are involved in their purchase of OTC medications they are significantly more likely to understand information from the label and evaluate it accordingly. However, involvement does not affect attitude-towards-product label nor does it enhance purchase intention.

  15. Prescription to over-the-counter switches in the United States

    PubMed Central

    Chang, Jongwha; Lizer, Allison; Patel, Isha; Bhatia, Deepak; Tan, Xi; Balkrishnan, Rajesh

    2016-01-01

    As the role of the pharmacist becomes more patient and counseling-centered, the healthcare market is changing to keep pace with more modern needs, such as self-treatment. Self-treatment provides patients the ability to diagnose their own condition and pick an appropriate medication from the pharmacy to treat their symptoms. This process allows a certain freedom for consumers to actively engage in their own health. In order for patients to self-treat, access to over-the-counter (OTC) medication is of prime importance. Many medications that are available as OTC today were previously labeled as prescription medications. As more safety studies and trials are conducted for different drugs, they can be deemed appropriate for use without a prescription. This review study discusses the process of switching of prescription medications to OTC medications in the United States and the implications of switching on patients, practitioners, drug makers, and insurers. PMID:27512703

  16. Obstetric-gynecology resident education regarding barrier and over-the-counter contraceptives: a national study.

    PubMed

    Miklavcic, Amie Y; Isaacs, Christine R

    2012-11-01

    The study was conducted to assess obstetrics-gynecology resident knowledge about barrier and over-the-counter (OTC) contraceptives and identify strengths and weaknesses in resident education. We developed a survey for distribution among 50 randomly selected U.S. obstetrics-gynecology residency programs. Of 202 respondents, only 57% and 36% of residents reported adequate knowledge to counsel patients regarding latex vs. nonlatex condom use, respectively. Ninety-six percent knew spermicides were nonprotective against sexually transmitted diseases (STDs); however, there was limited knowledge about delivery options. Only 17% had ever fit or prescribed a diaphragm, and 30% reported knowledge in performing a fitting. Greater than 80% of residents stated they received no formal didactics addressing the use of condoms, spermicides, or diaphragms. Limited experience regarding Cycle Beads and natural family planning was expressed. Obstetrics-gynecology residents receive little formal training about barrier and OTC contraceptive options and seek more education because of their awareness of inadequate knowledge.

  17. Prescription to over-the-counter switches in the United States.

    PubMed

    Chang, Jongwha; Lizer, Allison; Patel, Isha; Bhatia, Deepak; Tan, Xi; Balkrishnan, Rajesh

    2016-01-01

    As the role of the pharmacist becomes more patient and counseling-centered, the healthcare market is changing to keep pace with more modern needs, such as self-treatment. Self-treatment provides patients the ability to diagnose their own condition and pick an appropriate medication from the pharmacy to treat their symptoms. This process allows a certain freedom for consumers to actively engage in their own health. In order for patients to self-treat, access to over-the-counter (OTC) medication is of prime importance. Many medications that are available as OTC today were previously labeled as prescription medications. As more safety studies and trials are conducted for different drugs, they can be deemed appropriate for use without a prescription. This review study discusses the process of switching of prescription medications to OTC medications in the United States and the implications of switching on patients, practitioners, drug makers, and insurers.

  18. Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012.

    PubMed

    Both, Leonard; Botgros, Radu; Cavaleri, Marco

    2015-01-01

    Antimicrobial resistance is recognised as a growing problem that seriously threatens public health and requires prompt action. Concerns have therefore been raised about the potential harmful effects of making antibiotics available without prescription. Because of the very serious concerns regarding further spread of resistance, the over-the-counter (OTC) availability of antibiotics was analysed here. Topical and systemic OTC antibiotics and their indications were determined across 26 European Union (EU) countries and Norway by means of a European survey. We identified a total of 48 OTC products containing 20 different single antibiotics and three antibiotic combinations as active substances, used mainly as topical preparations in short treatment courses. Given the relevance of these medicines and the increasing risk of antimicrobial resistance, it is important to limit the availability of OTC antibiotics and to monitor their use.

  19. Implications of a switch from prescription to over-the-counter status for allergy drugs.

    PubMed

    Brass, Eric P

    2004-05-01

    Several drugs for the treatment of allergic conditions, previously available only by prescription, can now be purchased over-the-counter (OTC). The OTC availability of allergy drugs has the potential to increase patient access to these medications. At the same time, OTC availability transfers a number of decisions from the health care provider to the patient and might alter the role of the physician in allergy management. For example, patients must correctly self-diagnosis that their symptoms are due to an allergy, and identify the appropriate type of allergy medication to use. OTC drug availability has economic implications for the patient and physician, as well as for the health care insurance and pharmaceutical industries. Therefore, although OTC access to allergy medications facilitates treatment of allergies by consumers, more research is required to understand the true public health and economic impacts of OTC availability of these drugs.

  20. The benefits and risks of over-the-counter availability of levonorgestrel emergency contraception.

    PubMed

    Camp, S L; Wilkerson, D S; Raine, T R

    2003-11-01

    Removing the prescription requirement for Plan B will help ensure that the product plays a larger role nationally in the reduction of unintended pregnancy and abortion-important public health goals. Over-the-counter (OTC) sale of Plan B should present no serious safety issues. OTC consumers are able to understand and follow the instructions for proper use of Plan B. Efficacy of the OTC product is likely to be the same as, or better than, the prescription product, given more timely access to treatment. Based on the results of a growing body of literature and foreign marketing experience, the risk of unintended health consequences also appears to be minimal. There is no evidence to suggest that American women will abuse Plan B as an OTC product.

  1. Sulbutiamine, an 'innocent' over the counter drug, interferes with therapeutic outcome of bipolar disorder.

    PubMed

    Douzenis, Athanasios; Michopoulos, Ioannis; Lykouras, Lefteris

    2006-01-01

    A case of a patient with bipolar disorder with a history of hospitalizations and addiction to sulbutiamine is presented. Sulbutiamine is a precursor of thiamine that crosses the blood-brain barrier and is widely available without prescription in most countries or over the internet. Because of this patient's need to consume ever increasing quantities of sulbutiamine, his psychiatric care was severely compromised through him defaulting appointments and frequent changes of psychiatrists. This paper reviews the current scientific knowledge about sulbutiamine, and some of the information and claims available on the web about its use and potential. It is argued that doctors need to be aware of the potential misuse of medication available over the counter or on the internet and its potential harmful influence.

  2. 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.

  3. Over-the-counter cough and cold medications in children: are they helpful?

    PubMed

    Bell, Edward A; Tunkel, David E

    2010-05-01

    Over-the-counter cough/cold medications are commonly used in children. Recent recommendations by the Food and Drug Administration and changes to product labeling by cough/cold product manufacturers have reduced use of these products in children younger than four years of age. Data from controlled clinical trials of cough/cold product ingredients do not support their efficacy in young children. Serious adverse effects have been reported from cough/cold product use in infants and children, which largely result from inappropriate use by caregivers. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over cough/cold product use for infants and children. Otolaryngologists should educate caregivers of children on the safe and effective use of these products and therapies.

  4. Access of over-the-counter nicotine replacement therapy products to minors.

    PubMed

    Johnson, Karen C; Klesges, Lisa M; Somes, Grant W; Coday, Mace C; DeBon, Margaret

    2004-03-01

    Public health policy guidelines recommend that health care providers (eg, physicians, nurses, others) counsel adolescent smokers to quit and that nicotine replacement therapy (NRT) may be considered to aid in smoking cessation for nicotine-dependent youth. This recommendation is discrepant with Food and Drug Administration-approved labeling of NRT products, stating that they not be sold to persons younger than 18 years. It is not clear how easily minors are able to purchase NRT products in retail markets. To explore youth access to NRT by conducting the first study, to our knowledge, to determine the ability of minors to purchase over-the-counter NRT products. Observational case series of NRT purchase attempts and survey description of store characteristics. Retail businesses in Memphis, Tenn. Population-based sample of 165 stores that sold over-the-counter medications. Successfully completed purchase attempts of NRT by the minor buyer. In most stores that stocked NRT products, the age of the minor was not queried at any time during the purchase attempt (79%) and the minor was able to successfully purchase the product (81%). If the minor was asked her age, the store was much less likely to sell the NRT product. Stores in which a cash register gave an age query prompt or in which alcohol was sold were more likely to inquire about the minor's age and less likely to sell NRT products. Nicotine replacement therapy products were successfully obtained in most purchases by a minor buyer without proof of age. While ease of purchasing NRT products is potentially beneficial to young smokers attempting to quit, these purchases are discrepant with Food and Drug Administration labeling regarding the sale of NRT products to minors.

  5. The benefits and risks of over-the-counter availability of nicotine polacrilex ("nicotine gum").

    PubMed

    Oster, G; Delea, T E; Huse, D M; Regan, M M; Colditz, G A

    1996-05-01

    Nicotine polacrilex ("nicotine gum") is effective in helping persons to quit smoking cigarettes. Because many persons try to quit without formal assistance, it may be an appropriate product for over-the-counter (OTC) purchase. Some smokers, however, might use such a product in lieu of more effective methods of cessation, and still others might use it to cope with enforced periods of nicotine abstinence (eg, at the work place) and thereby delay their decision to quit. The study's objective was to assess the public health benefits and risks of OTC availability of nicotine gum. A Markov model was developed and used to contrast two alternative policy scenarios: one in which nicotine gum was assumed to remain available only by prescription, and another in which it was assumed to be made available for OTC purchase. Various data sources were used to estimate the model, including the Health Promotion and Disease Prevention Supplement to the 1991 National Health Interview Survey and the 1986 Adult Use of Tobacco Survey. Primary outcome measures included the numbers of persons who would try to quit smoking, the numbers who would use various methods of smoking cessation, including OTC nicotine gum, and the numbers of current adult smokers who would be abstinent at the end of 10 years. Findings suggest that an average of 3 million persons each year would use OTC nicotine gum. As a consequence of OTC availability, an additional 450,000 smokers would be abstinent at the end of 10 years. These results are sensitive to assumptions regarding the effectiveness of OTC nicotine gum, as well as to the effect of OTC availability on the use of other methods of smoking cessation. The number of persons who would quit smoking, however, increases under a fairly wide range of assumptions. Over-the-counter availability of nicotine gum may confer significant public health benefits.

  6. The use during pregnancy of prescription, over-the-counter, and alternative medications among Hispanic women.

    PubMed

    Bercaw, Jennifer; Maheshwari, Bani; Sangi-Haghpeykar, Haleh

    2010-09-01

    Despite lack of scientific evidence about the safety of complementary and alternative medicines, the reported use of such remedies during pregnancies has increased. This study was undertaken to investigate the use of herbs, vitamins, and over-the-counter and prescription medications among pregnant Hispanic women and reasons for use, and to assess physician-patient level of communication about women's use. A total of 485 Hispanic women were surveyed by means of a self-administered questionnaire immediately postpartum in a public hospital in Houston, Texas. The primary outcome was use of alternative therapies during the prenatal period. During their pregnancies, 19 percent of the participants took herbs and 47 percent took vitamin supplements, other than prenatal vitamins. The most common reason for using herbs and vitamins was to improve the woman's general health and energy level (59%); a few women (12%) had used them for specific pregnancy-related problems. Overall, 77 percent took prenatal vitamins and 21 percent supplemented with folic acid. The rates of use of over-the-counter and prescription medications were 23 and 29 percent, respectively. The use of prescription medication was two-and-a-half times higher among women with history of medical problems (adjusted OR = 2.59, 95% CI = 1.59-4.25, p = 0.0001). No other factor studied was independently associated with supplement or medication use. One in five women (20%) believed that herbs and vitamins were safer to use than prescription medication or were better at treating medical problems than prescription medicine, and one-third had not disclosed information about supplement use to their physicians. Use of herbal remedies does not appear to be a replacement for conventional medicine among most pregnant Hispanic women. Patient education about the risks of alternative therapies may lead to a reduction in intake of alternative medicines and greater disclosure to medical practitioners among this ethnic group.

  7. 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.

  8. Review of the Mechanism of Tooth Whitening.

    PubMed

    Kwon, So Ran; Wertz, Philip W

    2015-01-01

    This review integrated the current literature on diffusion of whitening agents, their interactions with stain molecules, and changes to the surface, with the aim of establishing a better understanding of the mechanism underlying tooth whitening. An electronic PubMed database search, with combinations of the following terms was performed: Tooth Bleaching, Tooth Bleaching Agent, Hydrogen Peroxide, Pharmacokinetics, Tooth Permeability, Oxidation-Reduction, Tooth Demineralization, and Color. Tooth whitening is a dynamic process that involves diffusion of the whitening material to interact with stain molecules and also involves micromorphologic alterations on the surface and changes within the tooth that affect its optical properties. The interaction seems not to be limited to stain molecules, but rather an affinity-based interaction process that also accompanies effects on sound enamel and dentin structures. This review underlines that supervision by dental health professionals as recommended by the American Dental Association (ADA) Council on Scientific Affairs is critical to achieving a successful and safe whitening outcome. The mechanism that underlies tooth whitening with the use of peroxide-based materials is a complex phenomenon encompassing diffusion, interaction, and surfaces changes within the tooth. Therefore, supervision by dental health professionals as recommended by the ADA Council on Scientific Affairs is imperative to achieve a successful and safe whitening outcome. © 2015 Wiley Periodicals, Inc.

  9. Hand-Held Instrument Fights Acne, Tops Over-the-Counter Market

    NASA Technical Reports Server (NTRS)

    2007-01-01

    Tyrell Inc., a Houston-based medical technologies company, was able to access engineering support in redesigning a heating element for a hand-held acne-fighting device through SATOP, NASA's Space Alliance Technology Outreach Program. SATOP put Tyrell in contact with The Boeing Company, which assessed the design and made several major contributions. The product, named Zeno, is now the highest selling over-the-counter medical device for the treatment of acne, and in 2006, Zeno was named the "SATOP Texas, Success Story of the Year." Zeno employs proprietary ClearPoint technology to provide relief of mild to moderate inflammatory acne by delivering a precisely controlled low-level dosage of heat to the blemish, causing the bacteria at the root of more than 90 percent of acne to self-destruct. Within its first year on the market, Zeno was cited by various publications for several awards, including Allure's 2005 "Best of Beauty," Marie Claire's "10 Best Gadgets for Girls," and Popular Science's 2005 "Best of What's New." A variation of the Zeno for use in treating herpetic lesions such as cold sores, by killing the virus that causes them, is currently undergoing FDA trials.

  10. 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.

  11. 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

  12. 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

  13. Rosacea Patient Perspectives on Homeopathic and Over-the-counter Therapies

    PubMed Central

    Lan, Lucy; Kuo, Sandy; Huang, Karen E.; Taylor, Sarah L.; Feldman, Steven R.

    2015-01-01

    Background: Rosacea patients commonly employ nonprescription therapies. The authors’ aim was to understand rosacea patients’ perceptions of over-the-counter products, complementary and alternative medicine, and homeopathic therapies. Method: A public, online discussion forum comprising 3,350 members and 27,051 posts provided a source of 346 posts on patient perceptions on alternative rosacea treatments. Results: Three major themes of nonprescription treatment were identified—motivation for use, patient-provider discussions, and experience with these treatments. Perceived medication failure, barriers to treatment, and distrust of physicians drive patients to seek nonprescription therapies. Still, patients prefer to consult a physician on incorporating nonprescription therapies into treatment. Complementary and alternative medicine natural products (19.4% of posts), complementary and alternative medicine practices (16.5%), and homeopathic medicine (3.8%) were commonly discussed. Conclusion: Physicians have an opportunity to be a trusted source of information on the strengths and weaknesses of skin care products and other complementary treatments for rosacea. PMID:26557217

  14. The impact of over-the-counter availability of "Plan B" on teens' contraceptive decision making.

    PubMed

    Krishnamurti, Tamar; Eggers, Sara L; Fischhoff, Baruch

    2008-08-01

    In ruling on the over-the-counter status (OTC) of the emergency contraceptive, "Plan B", the US Food and Drug Administration (FDA) questioned whether younger adolescent females could adequately self-select and self-medicate. That determination requires a judgment of fact, regarding how increased emergency contraceptive availability would affect adolescents' behavior, and a judgment of values, regarding the acceptability of different outcomes. We present a general approach to such problems, using analytical and empirical methods grounded in behavioral decision research. We illustrate it with findings from 30 in-depth interviews and follow-up surveys, with adolescent females aged 13-19 in the Pittsburgh area reporting how Plan B availability would affect three decisions (having sex, choosing contraceptives, using Plan B). Although the FDA expressed concern about younger teens using Plan B as their primary form of contraception, neither younger nor older teens revealed such an intention. However, teens preferred easier availability, should emergency contraceptive be needed. Incorporating an understanding of teens' decision-related perspectives can make such policies more predictable and transparent.

  15. 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.

  16. The risks of do-it-yourself and over-the-counter devices for tattoo removal.

    PubMed

    Kluger, Nicolas

    2015-01-01

    The tattoo removal market has boomed over the years following the increased prevalence of tattooed individuals around the world. Surgery and laser are currently the gold standards for tattoo removal. However, both of them have drawbacks. Surgery is better suited for small tattoos in areas of adequate skin laxity but leave a scar, while laser removal is a long and painful procedure, with no guarantee of a complete efficacy. Both are expensive procedures, and not all individuals are ready to fund them privately. Consequently, some individuals are in the search of faster, easier, and cheaper procedures that can be performed either by themselves or by laypeople. The unregulated market of internet provides a favorable ground for many websites to offer various tattoo removal methods. Besides, some tattooists and other non-medical laypeople have started to get interested by such a growing market, especially as some laser devices manufactured in Asia are now available at competitive prices, and due to weaknesses in the EU legislation regarding the use of lasers for cosmetic procedures by non-medical laypeople. We review here different do-it-yourself and over-the-counter tattoo removal methods. We discuss the potential risks for tattooed individuals and stress the importance of a better regulation of such a market.

  17. Over-the-counter cough and cold medication use in young children.

    PubMed

    Ryan, Teresa; Brewer, Melanie; Small, Leigh

    2008-01-01

    During a 2-year period from 2004 and 2005, emergency departments treated over 1,500 children under the age of 2 years for adverse events related to over-the-counter (OTC) cough and cold medication use; these incidents include 3 infant deaths. The risk of overdose, incorrect dosing and adverse events is increased in young children due to the greater number of colds they acquire each year. Lack of evidence to support the use of OTC medications in young children is well documented in the literature; however, people continue to use OTC medications with young children. The common cold is generally a mild, self-limited illness that usually improves with time. Recommended care and treatment for the common cold includes symptomatic treatment. This article presents and reviews the available evidence regarding the use of OTC cough and cold medications for pediatric healthcare providers. This review of the evidence will be helpful for healthcare providers to minimize risks to young children who intentionally or unintentionally ingest these medications and to educate child caregivers regarding proper use of OTC cough and cold medications with children.

  18. Perioperative Use of Herbal, Complementary, and Over the Counter Medicines in Plastic Surgery Patients

    PubMed Central

    Collins, Declan; Oakey, Steve; Ramakrishnan, Venkat

    2011-01-01

    Objective: Over the last 50 years, there has been a surge of interest by both the public and medical practitioners in therapies and disciplines that are not considered part of mainstream medical care. The title given to these is complementary and alternative medicine. Of all these branches, our interest is the increasing use of herbal medicines, traditional medicines (such as Chinese or Indian), homeopathy and “dietary supplements,” and the influence they may have on our practice. Our objective was to examine the prevalence and reasons for use of complementary and alternative medicines, the current regulations, and proposed policy changes affecting the licensing of these products. In addition, we highlight some of the problems that have been experienced with herbal and traditional medicines. Methods: A prospective analysis of herbal and over the counter medicines used by elective plastic surgery patients. Results: Of 100 elective plastic surgery patients undergoing procedures at St Andrew's Centre for Burns and Plastic Surgery, 44% of patients were taking a dietary supplement, herbal, or homeopathic remedy. In none of the patients was this documented in the notes by either the surgeon or anesthetist. Conclusions: We recommend that clear documentation of the use of nonprescribed medicines becomes part of standard practice and, furthermore, that patients stop all such medications 2 weeks prior to surgery until the efficacy, interactions, and safety profiles are clearly established. PMID:21625528

  19. Over-the-counter medicine abuse – a review of the literature

    PubMed Central

    2013-01-01

    Background: The sale of over-the-counter (OTC) medicines from pharmacies can help individuals self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognised. This review describes the current knowledge and understanding of OTC medicine abuse. Approach: Comprehensive search of international empirical and review literature between 1990 and 2011. Findings: OTC medicine abuse was identified in many countries and although implicated products varied, five key groups emerged: codeine-based (especially compound analgesic) medicines, cough products (particularly dextromethorphan), sedative antihistamines, decongestants and laxatives. No clear patterns relating to those affected or their experiences were identified and they may represent a hard-to-reach group, which coupled with heterogeneous data, makes estimating the scale of abuse problematic. Associated harms included direct physiological or psychological harm (e.g. opiate addiction), harm from another ingredient (e.g. ibuprofen-related gastric bleeding) and associated social and economic problems. Strategies and interventions included limiting supplies, raising public and professional awareness and using existing services and Internet support groups, although associated evaluations were lacking. Terminological variations were identified. Conclusions: OTC medicine abuse is a recognised problem internationally but is currently incompletely understood. Research is needed to quantify scale of abuse, evaluate interventions and capture individual experiences, to inform policy, regulation and interventions. PMID:23525509

  20. Community pharmacists' experience of over-the-counter medicine misuse in Scotland.

    PubMed

    MacFadyen, L; Eadie, D; McGowan, T

    2001-09-01

    Over the last decade Britain has observed a trend towards the re-regulation of 'prescription only medicines' in favour of pharmacy status drugs. This move towards self-treatment to reduce pressures on general practitioner drug budgets and workloads has focused attention on the need for community pharmacists to extend their patient education and screening roles. In response to these changes, this study was conducted to explore: the type of over-the-counter (OTC) medicine being misused in Scotland; pharmacists' professional attitudes and management of OTC misuse; and the training and support needs of pharmacists. A postal questionnaire was designed. This was informed by an earlier stage of qualitative research and the available literature. It was then piloted and administered to all 110 pharmacies in the study area. A 79% response rate was achieved. The research found that OTC misuse, particularly of certain analgesics, sleeping prescriptions, products containing codeine or pseudoephedrine, caffeine, cough mixtures, and laxatives was common. The estimated mean number of patients suspected of misusing medicines in a typical week was 5.63. Pharmacies in urban areas were more likely than those in rural areas to report suspected misuse. The research identified a number of intervention strategies relating to: patient/pharmacist interaction; information provision; removal of products from the point of sale; sharing of information with other local pharmacists; and referral to other members of the primary care team. Pharmacists expressed a need for support in managing OTC misuse and in organising 'early warning systems' to share information locally.

  1. 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.

  2. Implications of over-the-counter proton pump inhibitors for patient counseling by pharmacists.

    PubMed

    Simonson, William

    2013-01-01

    The article reviews the literature on the role of the pharmacist in patient counseling and discusses how that role may apply to patients with frequent heartburn who are seeking an over-the-counter (OTC) treatment. Searches of the National Library of Medicine PubMed database were conducted using the terms "heartburn," "nonprescription," "therapy," "pharmacist," and "counseling," supplemented by additional searches on counseling for prescription products, and by the author's knowledge of pharmacy practice and the scientific literature. Accurate recognition of the signs of heartburn are an important first step in counseling a patient on the appropriate OTC medication; immediate referral to a health care provider is mandatory if cardiac pain or certain gastrointestinal symptoms are present. When counseling a patient about treatments for heartburn, the pharmacist should practice effective listening in an environment that is conducive to communication by the patient. Proton pump inhibitors are effective for the treatment of heartburn; the histamine2 receptor antagonists and antacids should also be considered for appropriate patients. Adverse events have been noted with proton pump inhibitors; however, overall the benefits significantly outweigh the risks and problems are unlikely to arise during the 2-week duration of OTC treatment of heartburn. Pharmacists can provide valuable services to patients with frequent heartburn, particularly with regard to counseling about the condition and appropriate OTC therapy. The availability of numerous OTC products, including antacids, histamine2 receptor antagonists, and proton pump inhibitors, enables pharmacists to fulfill an important clinical role and improve patient satisfaction.

  3. Socioeconomic impact of seasonal (epidemic) influenza and the role of over-the-counter medicines.

    PubMed

    Klepser, Michael E

    2014-09-01

    The substantial economic impact of influenza on society results primarily from lost work time and reduced productivity of patients and caregivers and increased use of medical resources. Additionally, since the 1980s, aging of the US population has meant rising influenza-related morbidity and mortality. According to the most current published data on this topic, in 2003 the total economic burden of influenza epidemics in the USA across all age groups was US$87.1 billion. As of February 2013, overall vaccine effectiveness for the 2012/2013 season was estimated to be 56 %. The Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases has concluded that more effective vaccines and vaccination strategies are needed. Moderate efficacy of the influenza vaccine, continued questions regarding the value of treatment with antivirals, and a growing self-care movement have led to increased use of over-the-counter (OTC) medicines, which play a vital role in managing symptoms associated with mild to moderate influenza and provide an estimated US$102 billion in annual savings for the US healthcare system. A primary benefit to society of using OTC medicines to manage influenza is decreased use of the healthcare system, thereby mitigating the socioeconomic burden of influenza. Considering the stresses placed on the US healthcare system and the substantial productivity losses resulting from seasonal influenza as well as the growing self-care movement, OTC medicines will play an important role in the course of future influenza epidemics.

  4. Management of common cold symptoms with over-the-counter medications: clearing the confusion.

    PubMed

    Jackson Allen, Patricia; Simenson, Steven

    2013-01-01

    The common cold, an acute upper respiratory tract infection of viral origin, is among the most widespread ailments in the world. Although the general public usually relies on over-the-counter (OTC) medication(s) to treat cough/cold symptoms, reliable guidance is needed to help select the appropriate OTC medication for each individual. Consumers may be confused by the wide variety of products available, containing ≥ 1 active pharmaceutical ingredient. Health care professionals are in a position to help people identify the most bothersome symptom(s), evaluate underlying medical conditions and medications, and recommend the most appropriate OTC active ingredient(s) for treatment. Patients should be educated about available OTC medications to manage cough/cold symptoms and the importance of learning to read the package labeling for appropriate dosing and administration. In addition, potentially serious causes of cough/cold symptoms (eg, influenza, asthma, bronchitis) or underlying medical conditions that put the individual at increased risk for complications should be ruled out when symptoms do not resolve within a typical cold timeline. This review article discusses the active ingredients found in OTC medications and the clinical evidence supporting their use. The need to educate health care professionals and patients on the safe and effective use of OTC medications is addressed, and we offer a guide for the management of symptoms that appear during the timeline of a typical common cold.

  5. Over-the-counter stimulant, depressant, and nootropic use by veterinary students.

    PubMed

    Hofmeister, Erik H; Muilenburg, Jessica L; Kogan, Lori; Elrod, Susan M

    2010-01-01

    US veterinary students are subject to significant stress throughout their veterinary education. In this article, the authors characterize the use of over-the-counter (OTC) medications and relate their use to stress in a veterinary student population. Of the students sampled, 35% were OTC medication users; 33% of these were regular OTC medication users. Forty-three percent of students were energy drink (ED) users; 45% of these were regular ED users. OTC medication users had significantly higher stress scores than non-OTC medication users, and ED users had significantly higher anxiety scores than non-ED users. The most common reasons for use given by OTC medication users were to help with studying and to fall asleep at night. Depression scores were significantly higher for juniors and sophomores than for freshmen. Depression, stress, and anxiety scores were all lower in the Colorado State University students when compared with the University of Georgia students. OTC medication and ED veterinary student users had distinct characteristics that differed from those of nonusers. Users suffered from more stress and anxiety and had more difficulties with sleep, which may have affected their overall health and academic performance. Educating veterinary students about the consequences of using OTC medication and ED and providing counseling support may be of benefit to veterinary students' psychological well-being.

  6. Newborn chemical exposure from over-the-counter skin care products.

    PubMed

    Cetta, F; Lambert, G H; Ros, S P

    1991-05-01

    Human exposure to potentially toxic environmental chemicals is a major concern to our society. Over-the-counter (OTC) skin care products are a potential source of environmental chemical exposure to newborns. A prospective study was undertaken to define existing newborn bathing practices and quantitate environmental chemical exposure from OTC skin care products. One hundred-ninety six mothers of infants discharged from our newborn nursery were asked to respond to a questionnaire concerning newborn bathing practices and OTC skin care product usage. Complete questionnaires were returned by 23% of the mothers. The average newborn had 8 +/- 3 (+/- SEM) skin care products applied with the resultant exposure to 48 +/- 18 different environmental chemicals. Forty-seven percent of our respondents used a baby powder. The average one month old was bathed 4 times a week and was shampooed 3 times weekly. Seventy-eight percent of the respondents reported that their newborn had a rash but only 45% of those reporting a rash sought professional medical advice. Thirty-seven percent of the mothers reporting a rash made a change in bathing practice or product selection. In view of our findings, the human newborn is exposed to a large number of environmental chemicals thorough topical OTC preparations. The efficacy, transcutaneous absorption and potential toxicity of these products should be investigated.

  7. 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.

  8. Prescription and over-the-counter drug treatment admissions to the California public treatment system

    PubMed Central

    Gonzales, Rachel; Brecht, Mary-Lynn; Mooney, Larissa; Rawson, Richard A.

    2014-01-01

    Prescription and over-the-counter (OTC) drug abuse has become a focal point of public health policy, prevention, and control efforts. Adolescents represent one of the fastest growing segments of the general population abusing prescription and OTC drugs as represented by national surveys. This article reports on treatment admission data to the California addiction public system for prescription and OTC drugs among two age subgroups: adolescents 12–17 years and adults 18 years and older. Of the 6,841 admissions for primary abuse of prescription and OTC drugs in California (during 2006–2007), most adolescent admissions (12–17) were for stimulant prescription and OTC drugs (45.3% and 32.1%, respectively), whereas opioid prescription drugs (88.9%) were most common for adults 18 years and older. Differences in psychosocial, treatment, and substance use characteristics between these two age subgroups are described. Results from this study offer useful treatment admission information about prescription and OTC drug abuse within the California public addiction treatment system. PMID:21193282

  9. 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

  10. Prescription and over-the-counter drug treatment admissions to the California public treatment system.

    PubMed

    Gonzales, Rachel; Brecht, Mary-Lynn; Mooney, Larissa; Rawson, Richard A

    2011-04-01

    Prescription and over-the-counter (OTC) drug abuse has become a focal point of public health policy, prevention, and control efforts. Adolescents represent one of the fastest growing segments of the general population abusing prescription and OTC drugs as represented by national surveys. This article reports on treatment admission data to the California addiction public system for prescription and OTC drugs among two age subgroups: adolescents 12-17 years and adults 18 years and older. Of the 6,841 admissions for primary abuse of prescription and OTC drugs in California (during 2006-2007), most adolescent admissions (12-17) were for stimulant prescription and OTC drugs (45.3% and 32.1%, respectively), whereas opioid prescription drugs (88.9%) were most common for adults 18 years and older. Differences in psychosocial, treatment, and substance use characteristics between these two age subgroups are described. Results from this study offer useful treatment admission information about prescription and OTC drug abuse within the California public addiction treatment system. Published by Elsevier Inc.

  11. Ibuprofen: a journey from prescription to over-the-counter use.

    PubMed

    Moore, Nicholas

    2007-01-01

    Ibuprofen was the first non-aspirin non-steroidal antiinflammatory drug (NSAID) to be approved for over-the-counter (OTC) use and is widely considered to be the best tolerated drug of its class. Low-dose, OTC ibuprofen has been used for pain relief for over 30 years without any obvious major health issues. However, there is no clear differentiation between the OTC and prescription doses of ibuprofen, and their respective effects. Adverse reactions to ibuprofen appear to be dose and duration dependent, and this may be the reason for the observed tolerability of the drug at OTC doses. OTC ibuprofen is at least as effective as aspirin and more effective than paracetamol. The tolerability concerns associated with higher dose NSAIDs currently do not apply to low-dose, short-term use of ibuprofen for common pain. Ibuprofen is associated with the least risk of GI complications compared with other NSAIDs and is considered relatively benign in overdose. This review will aim to distinguish the safety of OTC or non-prescription use of ibuprofen from its prescription use.

  12. Prescription requirements and over-the-counter access to oral contraceptives: a global review.

    PubMed

    Grindlay, Kate; Burns, Bridgit; Grossman, Daniel

    2013-07-01

    Since the prescription requirement for oral contraceptives (OCs) can act as a barrier for some women, over-the-counter (OTC) access may improve uptake and continuation. The goal of this study was to ascertain the prescription requirements and informal OTC availability of OCs worldwide. From April 2011 to September 2012, we researched official documentation and conducted an online survey with government officials and pharmaceutical and reproductive health specialists on OC availability in countries worldwide. Results were compiled in a database and entered into a map for analysis of regional patterns. Data were obtained for 147 countries. OCs were informally available without prescription in 38% of countries, legally available without prescription (no screening by a health professional required) in 24% of countries, legally available without prescription (screening required) in 8% of countries and available only by prescription in 31% of countries. Notable regional patterns in OC prescription requirements emerged. OCs are available without prescription in the majority of countries. Country experiences with OTC provision may provide evidence about the safety and effectiveness of OTC provision as a strategy to improve access to effective family planning. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Effectiveness of Over-the-Counter Nicotine Replacement Therapy: A Qualitative Review of Nonrandomized Trials

    PubMed Central

    Peters, Erica N.; Naud, Shelly

    2011-01-01

    Aim: Randomized trials conducted in over-the-counter (OTC) settings have shown that nicotine replacement therapy (NRT) is effective. This paper reviews nonrandomized tests of the effectiveness of OTC NRT. Methods: Literature search via computer and other methods located (a) retrospective cohort studies of users versus nonusers of OTC NRT and (b) studies of quit rates before versus after NRT went OTC or before versus after NRT was given free to quitline callers. The methods were too heterogeneous to allow meta-analysis. Results: The results were similar for cohort and pre- versus post-studies. Most of the studies found numerically greater quitting among NRT users than nonusers. Often when NRT was not found effective, other assumed effective treatments (e.g., phone counseling) were also not found effective, suggesting biased or insensitive study methods. Only about half of the studies found statistically greater quitting among NRT users, and the most rigorous studies did not find greater quitting among users. Many studies found selection bias, for example, NRT users are more dependent smokers. Conclusions: Some lines of evidence appear to confirm the effectiveness of OTC NRT, but others do not. We believe further secondary analyses using nonrandomized comparisons are unlikely to resolve this issue due to sensitivity, specificity, and selection bias problems. PMID:21471303

  14. Opportunities and challenges: over-the-counter codeine supply from the codeine consumer's perspective.

    PubMed

    Nielsen, Suzanne; Cameron, Jacqui; Pahoki, Sanja

    2013-06-01

    This study aimed to gain a better understanding on perspectives of over-the-counter (OTC) codeine users and issues relating to codeine dependence in the community pharmacy setting. Examining OTC codeine users' experiences aimed to promote better understanding of OTC codeine dependence, and inform pharmacy practices. Utilising a qualitative research methodology we conducted interviews with 20 participants who were OTC codeine users and met DSM IV criteria for codeine dependence. Key themes identified included experience of participants acquiring OTC codeine and participants' interactions with pharmacists. The OTC codeine-dependent participants found it generally easy to access OTC codeine, describing 'standard' questioning, minimal intervention from pharmacists and only occasional refusal to supply. A better appearance and presentation was generally linked to easy codeine supply. The experiences of participants suggest a number of barriers exist to effective intervention for OTC codeine dependence in the community pharmacy setting. Identification of these barriers will provide an opportunity to more effectively target interventions to reduce harm related to OTC codeine products. Increased involvement of pharmacists in OTC codeine sales was associated with help-seeking by codeine users. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

  15. Pharmacotherapy and over-the-counter drug use among elderly in Belgrade, Serbia.

    PubMed

    Gazibara, Tatjana; Nurkovic, Selmina; Kisic-Tepavcevic, Darija; Kurtagic, Ilma; Kovacevic, Nikolina; Gazibara, Teodora; Pekmezovic, Tatjana

    2013-01-01

    From November 2012 to January 2013, 480 seniors were recruited at the Pubic Health Center in Belgrade, Serbia. The patients' records were validated by four independent investigators. Data on over-the-counter (OTC) drug use were collected through a questionnaire. Polypharmacy, an intake of ≥5 prescribed medications, reported in 10.4% of seniors, was associated with cardiovascular (odds ratio [OR] = 3.07; 95% confidence interval [CI] = 1.12-8.39) and endocrine diseases (OR = 2.25; 95% CI = 1.05-4.84) as well as with the number of treated chronic conditions (OR = 2.45; 95% CI = 1.75-3.44). The most frequently used OTC drugs were analgesics (metamizole, diclofenac and acetaminophen) and vitamins (vitamin C and vitamin B complex). The number of treated chronic conditions was associated with use of OTC drugs (OR = 1.17; 95% CI = 1.01-1.36). Multiple chronic conditions correlated with multiple OTC drug use (ρ = 0.125, p = 0.019). Our analysis indicated that the prevalence of polypharmacy and OTC drug use in the elderly are comparable to those in industrialized countries.

  16. Over-the-counter topical skin products--a common component of skin disease management.

    PubMed

    Vogel, Curt A; Balkrishnan, Rajesh; Fleischer, Alan B; Cayce, Kimberly A; Feldman, Steven R

    2004-07-01

    Over-the-counter (OTC) products are widely recommended by physicians and utilized by the public for the treatment and prevention of disease. The use of OTC drugs has been studied extensively, but the patterns of physician recommendations for OTC topical skin products and the characteristics associated with patients receiving such recommendations remain unclear. We aimed to look at patterns of OTC topical skin product recommendations by physician specialty, patient demographics, geographical region, diagnosis, and metropolitan status to determine whether there are differences in the utilization of these products in the treatment of dermatologic conditions. We analyzed office-based physician visits for OTC topical skin product recommendations recorded in the 1995 to 2000 National Ambulatory Medical Care Survey (NAMCS). From 1995 to 2000, there were an estimated 36 million physician recommendations for OTC topical skin products. Although dermatologists were responsible for 53.8% of recommendations, pediatricians had the largest proportion of recommendations per prescription recommendation (OTC/Rx=0.58). Women patients, white patients, patients younger than 20 years, urban residents, and those living in the Southern United States received greater numbers of OTC topical skin product recommendations. Of the leading products recommended, hydrocortisone (27.6%), anti-infectives (23.4%), and moisturizers (13.4%) were the most common. OTC topical skin product recommendations by US physicians are substantial, particularly among dermatologists and primary care physicians. Physician specialty, gender, race, and age appear to be factors associated with those recommendations.

  17. Over-the-counter hearing aids: electroacoustic characteristics and possible target client groups.

    PubMed

    Cheng, C M; McPherson, B

    2000-01-01

    Over-the-counter hearing aids (OTCs) are those directly purchased from retail outlets, without the benefit of prior professional hearing health care. They are particularly common in developing countries. This study examined the amplification characteristics of a selected sample of OTCs to determine if any target client group or groups were suitable for the OTCs. The electroacoustical performance of 10 OTCs was measured. The measurements included saturated sound pressure level curve, high-frequency average full-on gain, frequency response, total harmonic distortion, equivalent input noise level, and input-output curve. The full-on gain curve of each hearing aid was used to estimate the hypothetical hearing loss of target clients for each aid as it would be calculated by four hearing aid prescription formulae. Real-ear probe tube measurements were also performed on 10 adult subjects to determine the amplification that could be achieved by the OTCs before audible feedback occurred. The OTC hearing aids were not able to meet the prescription gain requirements of the majority of elderly clients who usually purchased them.

  18. Safeguarding Older Adults From Inappropriate Over-the-Counter Medications: The Role of Community Pharmacists

    PubMed Central

    Chui, Michelle A.; Stone, Jamie A.; Martin, Beth A.; Croes, Kenneth D.; Thorpe, Joshua M.

    2014-01-01

    Purpose of the Study: 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. Design and Methods: 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. Results: 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. Implications: Pharmacists can play a key role in assisting older adults to select and use OTC medications. PMID:24197014

  19. Displacement of optical centers in over-the-counter readers: a potential cause of diplopia.

    PubMed

    West, Constance E; Hunter, David G

    2014-06-01

    Induced prism in spectacle lenses, which may result from inadvertent displacement of optical centers, may worsen an existing heterophoria or even cause diplopia, yet over-the-counter reading glasses (OTC readers) are not always assessed by clinicians when evaluating patients with diplopia or asthenopia. To gauge the magnitude of this potential problem, we used a focimeter and prescription aligner to assess the frequency and extent of clinically significant manufacturing variations in a random selection of 160 OTC readers. The optical centers were vertically displaced by ≥3 mm in 11%, with a maximum displacement of 7 mm in 1 pair. Average interpupillary distance was 64 mm (range, 58-74.5 mm), with interpupillary distance outside the normal range of 60-70 mm in 5%. Monocular pupillary distance was asymmetric by ≥5 mm in 4%. A 0.75 D power difference between lenses was measured in one pair of OTC readers. Some OTC readers have misaligned optical centers and other manufacturing defects that are of a magnitude sufficient to exacerbate a heterophoria and cause asthenopia or diplopia.

  20. 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.

  1. Patients' Preferences for Generic and Branded Over-the-Counter Medicines: An Adaptive Conjoint Analysis Approach.

    PubMed

    Halme, Merja; Linden, Kari; Kääriä, Kimmo

    2009-12-01

    : Despite increased use of generic medicines, little is known about either the attitudes of patients towards them or the decision-making process surrounding them. Young adults use over-the-counter (OTC) analgesics relatively often. : To assess the preferences of patients for generic and branded OTC pain medicines, to identify clusters with different preference structures, and to estimate the price elasticity of a generic alternative among university students. : Finnish university students (n = 256; students in courses at the Helsinki School of Economics) responded to an adaptive conjoint analysis (ACA) questionnaire on the choice between branded and generic OTC ibuprofen products. Product attributes of price, brand, onset time of effect, place of purchase and source of information were included in the questionnaire on the basis of the literature, a focus group and a previous pilot study. Several socioeconomic and health behavior descriptors were employed. Individual-level utility functions were estimated, preference clusters were identified, and the price elasticity of the generic medicine was assessed. : Five clusters with characteristic individual-level preferences and price elasticity but few differences in socioeconomic background were detected. Approximately half of the respondents were strongly price sensitive while the others had other preferences such as brand or an opportunity to buy the medicine at a pharmacy or to have a physician or a pharmacist as an information source. : The study provided new information on the concomitant effects of brand, price and other essential product attributes on the choice by patients between branded and generic medicines.

  2. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults

    PubMed Central

    Schroeder, Knut; Fahey, Tom

    2002-01-01

    Objectives To determine whether over the counter cough medicines are effective for acute cough in adults. Design Systematic review of randomised controlled trials. Data sources Search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register in all languages. Included studies All randomised controlled trials that compared oral over the counter cough preparations with placebo in adults with acute cough due to upper respiratory tract infection in ambulatory settings and that had cough symptoms as an outcome. Results 15 trials involving 2166 participants met all the inclusion criteria. Antihistamines seemed to be no better than placebo. There was conflicting evidence on the effectiveness of antitussives, expectorants, antihistamine-decongestant combinations, and other drug combinations compared with placebo. Conclusion Over the counter cough medicines for acute cough cannot be recommended because there is no good evidence for their effectiveness. Even when trials had significant results, the effect sizes were small and of doubtful clinical relevance. Because of the small number of trials in each category, the results have to be interpreted cautiously. What is already know on this topicThe NHS encourages self treatment of acute self limiting illnessesOver the counter cough medicines are commonly used as first line treatment for acute coughWhat this study addsThere is little evidence for or against the effectiveness of over the counter cough medicinesAlthough cough medicines are generally well tolerated, they may be an unnecessary expenseRecommendation of over the counter cough medicines to patients is not justified by current evidence PMID:11834560

  3. Whitening toothpastes: a review of the literature.

    PubMed

    Joiner, Andrew

    2010-01-01

    To review and summarise the whitening agents contained within tooth whitening toothpaste formulations, their mode of action in tooth whitening, and the in vitro and clinical methods used to evaluate and demonstrate their efficacy. Original scientific full papers or reviews listed in ISI Web of Science and Medline were included in this review using the search terms white*, toothpaste and dentifrice. Due to the reported consumer and patient dissatisfaction with their perceived tooth color, toothpaste manufacturers have responded by developing a vast array of contemporary whitening toothpastes. One of the key functional ingredients in whitening toothpastes is the abrasive system. In general, these have been designed to give effective removal of extrinsic stains and help prevent tooth stains from reforming without undue abrasivity towards the dental hard tissues. Whitening toothpastes may contain additional agents that augment the abrasive cleaning by aiding the removal and/or prevention of extrinsic stains, for examples, peroxide, enzymes, citrate, pyrophosphate and hexametaphosphate, or optical agents such as blue covarine which can improve tooth whiteness following tooth brushing. In vitro methods used to evaluate tooth whitening efficacy typically determine the ability of a toothpaste formulation to remove/prevent model extrinsic stains on substrates such as enamel or hydroxyapatite or changes in the intrinsic color of tooth specimens. Clinical protocols for evaluating the efficacy of whitening toothpastes typically determine either stain removal or prevention, where changes in natural stain or chlorhexidine/tea induced stain are measured typically over 2-6 weeks. In some clinical studies the overall tooth color change was measured using techniques such as Vita shade guides, colorimeters and image analysis of digital photographs of teeth. Copyright © 2010 Elsevier Ltd. All rights reserved.

  4. Switching of prescription drugs to over-the-counter status: is it a good thing for the elderly?

    PubMed

    Francis, Sally-Anne; Barnett, Nina; Denham, Michael

    2005-01-01

    Prescription medicines are increasingly being switched to over-the-counter (OTC, nonprescription) status in the developed world, with the support of government policy. These changes may provide greater choice for individuals and offer potential savings in government spending on health while expanding the market for pharmaceutical companies. However, there is concern regarding the safety of these reclassifications. Elderly people are the largest consumers of prescription and OTC medicines and are more vulnerable to drug adverse effects and the risks of multiple or inappropriate medications. Commonly purchased agents such as NSAIDs have recognised adverse effects which have been shown to be more common in the elderly. Furthermore, all sedatives, including antihistamines, have a propensity to cause falls in older people. As many doctors do not ask patients about OTC medicine use, problems related to use of these drugs may go undetected. Furthermore, the increased availability of OTCs may result in a delay in patients consulting medical practitioners for potentially serious conditions, although this has not so far been investigated. In the UK, the recent switch of a low-dose HMG-CoA reductase inhibitor (statin) to OTC status has caused concern. Although there might theoretically be some benefits from improved access to medications used in primary and secondary prevention of heart disease, the actual outcomes of use of this reduced dose of the statin will be difficult or impossible for patients or practitioners to monitor. OTC drug use implies a mutual responsibility for communication between patients and health professionals that in practice is not always achieved. Epidemiological research is needed to investigate patterns of OTC use and evaluate the potential risks of OTC medicines in elderly people. Governments, regulatory bodies, professionals and the drug industry have a responsibility to ensure that robust systems are in place if the increased use of OTC medicines

  5. Over-the-counter antibiotics in Saudi Arabia, an urgent call for policy makers.

    PubMed

    Bin Nafisah, Sharafaldeen; Bin Nafesa, Salahaldin; Alamery, Aliyah H; Alhumaid, Mazen A; AlMuhaidib, Haitham M; Al-Eidan, Fahad A

    2017-02-02

    Antibiotics over-consumption is a pandemic that has a tremendous cost on the overwhelmed healthcare system. The accessibility of antibiotics coupled with the misconception of public toward those drugs both of which implicated in the use and misuse of antibiotics. The aim of this study was to investigate the perception of the community toward antibiotics, its purpose and harmfulness, in addition to the accessibility of those drugs as over the counter and without prescriptions. We also investigated the behavior toward antibiotic prescriptions when perceived unnecessary. This is a cross-sectional study in Riyadh-Saudi Arabia based upon a structured self-administered questionnaire. The study included 473 individuals with a mean age of 27 years old. Forty eight percent (n=227) of the participants obtain antibiotics without prescriptions. Ninety two percent (n=208) of those noted pharmacist counseling as their method of acquisition. Self-prescription noted in 8.4% (n=19). Viral illnesses accounted for the highest percentage for seeking antibiotics in 35.5% (n=166) more commonly among females. Thirty one point eight percent (n=149) used antibiotics for analgesia while 13.7% (n=64) believed in their prophylactic use. We also noted that the prevalence of sharing antibiotics is 19.7%. The perceived unnecessary prescriptions uncovered 122 of the participants who reported throwing the prescribed antibiotics away after acquisition. Dispensing antibiotics without prescription is an issue that mandates a political intervention and implementation of the existing laws that prohibit dispensing without proper prescription. We advocate public health measures targeting both healthcare providers and the public on the use and misuse of antibiotics.

  6. Chlorpheniramine, selective serotonin-reuptake inhibitors (SSRIs) and over-the-counter (OTC) treatment.

    PubMed

    Hellbom, Einar

    2006-01-01

    Some old antihistamines were selective serotonin-reuptake inhibitors (SSRIs) and the SSRI effect was discovered by Nobel Laureate Professor Arvid Carlsson as early as 1969. Chlorpheniramine was the most active of the tested drugs, and it compares favourably with amitriptyline and imipramine with respect to actions on both serotonergic and noradrenergic neurons. Chlorpheniramine can be called a SSRI, since the blocking of 5HT is stronger than the effect on noradrenaline neurons; however it might also be called a selective serotonin and noradrenaline reuptake inhibitor (SSNRI) and be compared with new drugs, such as venlafaxine. Carlsson suggested the potential value of clinical studies of the antidepressant properties of this and related antihistamine drugs. But, in the event, no such trials were ever performed at the time. However, later clinical observations of the benefits of dex-chlorpheniramine treatment in panic disorder have been published. Clinical experience suggests that patients using chlorpheniramine, and having also a concomitant depression or panic disorder, may experience a return of symptoms when their old drug is changed to a new antihistamine lacking SSRI effects. Yet this phenomenon is not known to many doctors, and even less known to the large number of patients buying chlorpheniramine under various trade names over-the-counter (OTC) at a low price for self-treatment of hay fewer or as a cold remedy. Chlorpheniramine was introduced in USA under the name Chlor-Trimeton as long ago as July 1950, and is still on the market. Therefore, this SSRI is now over 50 years old. If chlorpheniramine had been tested in depression in the nineteen seventies, it is probable that a safe, inexpensive SSRI drug could have been used some 15 years earlier than fluoxetine - which became available in 1987. Chlorpheniramine might have been the first safe, non-cardiotoxic and well-tolerated antidepressant. Billions of dollars in the development and marketing costs would

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

    PubMed Central

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

    2013-01-01

    Objective The objective of this descriptive study was to quantify the personal hygiene habits/practices and over-the-counter (OTC) products used by postmenopausal women. Specifically, we were interested in any product that would contact the vulva or vagina. Methods We performed a cross-sectional study of postmenopausal women seeking routine gynecologic care. We developed questionnaire of personal hygiene habits/practices and OTC products used by women 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. Results 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 three 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 (76.5%, n/N = 26/34). Nine (7.9%) postmenopausal women reported douching in the last three months. Conclusions We found that over half of postmenopausal women seeking gynecologic care have used an OTC product for vulvovaginal symptoms in the last three months and 1/3 of women use 2 or more products. Because the use of OTC products is so common, our study highlights the need for detailed history inquiry about OTC product use and perineal hygiene practices. PMID:23880795

  8. Sales of over-the-counter remedies as an early warning system for winter bed crises.

    PubMed

    Davies, G R; Finch, R G

    2003-08-01

    To evaluate the pattern of emergency adult medical admissions during the winter period and the usefulness of sales of over-the-counter cough/cold remedies as a predictor of these. The databases of a single NHS trust acute unit and pharmacy outlets in its catchment area were analyzed retrospectively, comparing numbers of emergency admissions, ICD-10 discharge codes, local electronic point-of-sale (EPOS) and national sales data. Over nine consecutive winter periods from 1992/3, peak admissions always occurred within a defined ten-day period from 29th December to 9th January. Emergency admissions increased significantly during this period (P = 0.0002). Pharmaceutical/retail data were available for three consecutive winters 1998/99, 1999/2000 and 2000/2001, none of which coincided with increased influenza activity nationally. Acute respiratory illness as defined by International Classification of Diseases, 10th edition (ICD-10) discharge coding did not appear to contribute to the increase in admissions at the peak. However, National and Local EPOS sales were positively correlated with admissions and the rate of EPOS sales exceeded an empiric threshold of 1000 units per week two weeks prior to the admissions peak in each year. Emergency admissions over the winter period are increasing and can be expected within a period of only ten days each year. No firm relationship between acute respiratory illness and admissions could be defined but local EPOS data may give up to two weeks warning of the peak in admissions and merits further prospective evaluation.

  9. Over-the-counter (OTC) bruxism splints available on the Internet.

    PubMed

    Wassell, R W; Verhees, L; Lawrence, K; Davies, S; Lobbezoo, F

    2014-06-13

    Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential pitfalls that need to be highlighted. These include unevidenced claims of efficacy. To survey OTC bruxism splints available to individuals in the UK via the Internet, categorise their characteristics, and determine any web-based claims or safety warnings. An Internet search was made of OTC bruxism splints available in the UK. The following information was recorded for each OTC splint: the name of the manufacturer, name of the device, its UK price and any claims and safety warnings made either on a major UK retail website or via other UK web retail outlets. In addition, a note was made of any web-based mention of 'CE marking', indicating compliance with the EC Medical Devices Directive's requirements for safety, quality and performance. Safety information is notable for its paucity and is totally lacking on many Internet sites. However, manufacturers are not obliged to display safety information on the Internet, but it must be provided with the product. A search of the MAUDE database showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes. None of the splint designs assure full occlusal coverage. As with any partial coverage appliance, if worn for protracted periods there may be a risk of unwanted tooth movement. Dentists should report or assist patients with reporting suspected adverse events with OTC splints to the relevant competent authority. In the UK this is the Medicines and Healthcare Products Regulatory Agency (MHRA).

  10. Users and utilization patterns of over-the-counter acid inhibitors and antacids in The Netherlands.

    PubMed

    Van Vliet, Evelyn P M; Kuipers, Ernst J; Steyerberg, Ewout W; Siersema, Peter D

    2008-01-01

    General practitioners (GPs) are the first-line physicians who are consulted for upper digestive symptoms. Persons with symptoms may, however, prefer to buy acid inhibitors or antacids in drugstores or pharmacies and bypass a GP. The aim of this work was to study users, reasons for use, and utilization patterns of over-the-counter (OTC) acid inhibitors and antacids in The Netherlands. We also studied factors that were associated with the substitution of OTC acid inhibitors or antacid use for consultation with a GP. From July 2005 to January 2006, persons buying OTC acid inhibitors or antacids in 12 pharmacies and 4 drugstores were asked to complete a questionnaire. A total of 82/160 (51%) questionnaires were returned. Heartburn was the main symptom for buying an acid inhibitor or antacid. Seventy-one (87%) participants substituted OTC drug use for a GP consultation. The most commonly reported reason was the belief that symptoms were not serious enough to seek medical care. Exploratory analyses showed that substitution was less common in participants with comorbidity, a history of upper gastrointestinal disorder, use of an acid inhibitor or antacid previously prescribed by a physician, alarm symptoms (such as pain and nausea), and with being symptomatic for >4 days/week. Although the reasons for substitution of OTC acid inhibitor or antacid use for a GP consultation in The Netherlands do not suggest an a priori increased risk of an underlying serious disorder, it may be advisable for staff in drugstores and pharmacies to provide users with information on appropriate use and when to consult a GP.

  11. Dissolution rates of over-the-counter painkillers: a comparison among formulations.

    PubMed

    Alemanni, Matteo; Gatoulis, Sergio C; Voelker, Michael

    2016-06-01

    We wanted to compare the dissolution profile of several over-the-counter analgesics to understand whether the different formulation techniques employed to enhance absorption were associated with variations in the dissolution rate, a parameter known to affect drug absorption. We considered 5 formulations currently marketed in Italy: aspirin tablets (Aspirina Dolore e Infiammazione®), ibuprofen tablets and liquid capsules (Moment®), ibuprofen lysine tablets (Nurofenimmedia®) and dexketoprofen trometamol tablets (Enantyum®). Dissolution tests were performed according to the current USP/NF monograph dissolution procedure. Drug dissolution was evaluated at 1, 3, 6, 15, and 30 minutes since the start of the test. Dissolution was evaluated at three different pH: 1.2, 4.5 and 6.8. Every test was repeated 12 times. The aspirin formulation was by far the most rapid dissolving formulation, among those tested, with more than 80% of the tablet dissolved at 6 minutes for every pH considered. At pH 1.2 and 4.5, only the dexketoprofen formulation was able to reach the dissolution level of aspirin at 30 minutes, but had lower levels of dissolution at the previous time points. Instead, at pH 6.8, most of the formulations approached aspirin dissolution level, but only after 15 minutes. Ibuprofen capsules had the slowest kinetics, with a lag phase the first 6 minutes. Different formulation strategies can lead to great differences in the dissolution rates even among drugs of the same class, suggesting that enhancements in the formulation of painkillers can lead to improvements in drug absorption, and thus in the onset of analgesia.

  12. Swedish teenagers and over-the-counter analgesics - responsible, casual or careless use.

    PubMed

    Holmström, Inger K; Bastholm-Rahmner, Pia; Bernsten, Cecilia; Röing, Marta; Björkman, Ingeborg

    2014-01-01

    Teenagers in Sweden were given greater access as consumers of OTC drugs in 2009 after the reregulation of the pharmacy market, which allowed for the establishment of private pharmacies and sale of specific over-the-counter (OTC) drugs in retail stores and gas stations. Increased access to OTC drugs could provide new opportunities for self-care but attenuates the opportunity for the traditional expert surveillance of pharmacists, thus increasing the possibility of inappropriate OTC drug use. Views of 16-19 year old Swedish teenagers on OTC drugs, with special regard to analgesic drugs were explored and described, based on the following questions: How and where did they acquire their knowledge and attitudes regarding OTC drugs? What perceptions did they have about the use of OTC drugs? A qualitative approach with a descriptive design was chosen. Data were collected in 2011 with 10 focus group discussions with high school students aged 16-19 years from different parts of Sweden. A total of 77 teenagers participated, 33 males and 44 females. A manifest qualitative content analysis was performed. While most teenagers appeared to have responsible attitudes toward OTC drugs and their use, some teenagers had attitudes that ranged from casual to careless. The focus group discussions also revealed knowledge gaps among teenagers regarding OTC drugs, and the significant influence of parents and peers on their OTC drug use. This study provides insight into how vulnerable some teenagers could be as new consumers of OTC drugs and suggested that educational efforts could be geared toward parents as well as teenagers. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Self-medicated over the counter ophthalmic solutions in central Bangkok.

    PubMed

    Tayanithi, Pakitti; Aramwit, Pornanong

    2005-09-01

    There is a paucity of research about patients' attitudes, motivations and expectations towards self-medicated over the counter (OTC) ophthalmic solutions. To identify the attitudes, motivations and expectations of general population towards self-medicated OTC ophthalmic solutions. 200 consecutive participants who were studying or lived in Patumwan District of Bangkok filled in a questionnaire in a 3-months period. 67.5% (135/200) of the participants had an age range of 15-24 years old and 32.5% (65/200) were between 25-35 years old. Participants who were university graduates and currently university students were 53% and 35.5% respectively. Most history of illness was allergy (10/200). Half of the participants had normal vision and 40% (80/200) were near-sighted. The factor that most influenced the use of solution was dust in the eye (55%-111/200). Ocular allergic symptoms, such as eye itching, irritation and tearing, was the second. The most frequent symptom that induced the use of solutions was eye itching and irritation (48.5%-97/200). The symptom of red or pink eye was the second (33%-66/200). 48.5% (97/200) and 53.50% (107/200) of participants started using the solution at the time the influencing symptoms occurred and used for one day respectively. 46.5% (93/200) of the participants realized that the solution could be use only within 1 month after opening. From the data of this survey, more information and knowledge about the use of OTC products needs to be campaigned, even among highly educated citizens in the center of Bangkok. Better information for patients could improve the safety of OTC medicines. The ways of advising patients need to be found. The uncertainty is, therefore, how far this trend will go and how health care professionals and consumers will resspond.

  14. Over-the-counter nonsteroidal anti-inflammatory drugs and risk of gastrointestinal symptoms.

    PubMed

    Thomas, Joseph; Straus, Walter L; Bloom, Bernard S

    2002-09-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used medications. Although much is known about prescription NSAIDs and risk of GI side effects, little is known about over-the-counter (OTC) NSAIDs and their risk of GI side effects. The aim of this study was to estimate use of OTC NSAIDs, GI side effects, and professional and self-care for these side effects. We conducted a telephone survey of an age-stratified U.S. random sample of 535 persons at least 40 yr old, who used an OTC NSAID for 4 of the previous 7 days, and a matched comparison population of 1068 persons who used no NSAID within the previous 30 days. We measured current use of OTC NSAIDs, GI symptoms, diagnoses and their treatment, and prescription and OTC GI medications. The most commonly used OTC NSAID was aspirin (alone or in combination compounds). Prevention of myocardial infarction or stroke was the most common reason for use (43.2%), followed by all forms of pain relief (44.2%) and relief of arthritis symptoms (24.5%). NSAID users were twice as likely as nonusers to report GI side effects (19.6% vs 9.5%, p = 0.0001), and more than twice as likely to use an OTC GI medication when they had GI symptoms (46.7% vs 20.8%, p = 0.001). OTC NSAIDs are not a benign medication even at low dosages. Physicians may be unaware that patients self-medicate with OTC NSAIDs and for GI side effects with additional OTC GI medications. Therefore, physicians should routinely ask patients about all forms of self-treatment.

  15. Contraindications to combined oral contraceptives among over-the-counter compared with prescription users.

    PubMed

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

    2011-03-01

    To compare the estimated proportion of contraindications to combined oral contraceptives between women who obtained combined oral contraceptives in U.S. public clinics compared with women who obtained combined oral contraceptives over the counter (OTC) in Mexican pharmacies. We recruited a cohort of 501 women who were residents of El Paso, Texas, who obtained OTC combined oral contraceptives in Mexico and 514 women who obtained combined oral contraceptives from family planning clinics in El Paso. Based on self-report of World Health Organization category 3 and 4 contraindications and interviewer-measured blood pressure, we estimated the proportion of contraindications and, using multivariable-adjusted logistic regression, identified possible predictors of contraindications. The estimated proportion of any category 3 or 4 contraindication was 18%. Relative contraindications (category 3) were more common among OTC users (13% compared with 9% among clinic users, P=.006). Absolute contraindications (category 4) were not different between the groups (5% for clinic users compared with 7% for OTC users, P=.162). Hypertension was the most prevalent contraindication (5.6% of clinic users and 9.8% of OTC users). After multivariable adjustment, OTC users had higher odds of having contraindications compared with clinic users (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.11-2.29). Women aged 35 years or older (OR 5.30, 95% CI 3.59-7.81) and those with body mass index 30.0 or more (OR 2.24, 95% CI 1.40-3.56) also had higher odds of having contraindications. Relative combined oral contraceptive contraindications are more common among OTC users in this setting. Progestin-only pills might be a better candidate for the first OTC product given their fewer contraindications.

  16. Utilization of triptans in Sweden; analyses of over the counter and prescription sales.

    PubMed

    von Euler, Mia; Keshani, Sara; Baatz, Katarina; Wettermark, Bjorn

    2014-12-01

    To enable easier access to triptans, the drug of choice for moderate to severe migraine, some countries have made triptans available without prescription, that is, over the counter (OTC). Concern has been raised about this. The aim of this study was to describe the utilization pattern of triptans in Sweden before and after the OTC switch. Wholesaler and aggregated sales data from all Swedish pharmacies 1991 to 2011 and patient identity data on dispensed prescriptions 2007 and 2011 from the Swedish National Prescribed Drug Register were used to investigate volume and expenditure of triptans. The databases contain complete data for all drugs sold in Sweden or dispensed to all Swedish inhabitants (9.5 million in 2012). Volumes of triptans have increased to 7.0 million defined daily doses (DDD) on prescriptions and 0.7 million DDDs OTC in 2011. Prescriptions were dispensed to 10.0 and 10.1 per 1000 inhabitants in 2007 and 2011, respectively. Although half of those dispensed triptans in 2007 were not in 2011, the incidence remained stable at 2.8 patients per thousand person-years. In 2011, the 10% of the heaviest users accounted for 44% and 48% of dispensed triptans in women and men, respectively. Triptans OTC and the volumes dispensed on prescription have increased as has the DDD per patient purchasing triptans on prescription. However, the number of patient's dispensed triptans on prescription has remained stable. A concern is that almost half of prescribed triptans are purchased by 10% of the users. Copyright © 2014 John Wiley & Sons, Ltd.

  17. Using prescription claims data for drugs available over-the-counter (OTC).

    PubMed

    Yood, Marianne Ulcickas; Campbell, Ulka B; Rothman, Kenneth J; Jick, Susan S; Lang, Janet; Wells, Karen E; Jick, Hershel; Johnson, Christine C

    2007-09-01

    Many pharmacoepidemiologic studies use automated prescription claims data to estimate the association between exposure and disease. One limitation of automated data, when studying drugs that are also available via retail, is that over-the-counter (OTC) exposure is missed. The purpose of this study is to quantify the effect of misclassification of OTC use in research that uses prescription claims data as the sole source of exposure information. We conducted a sensitivity analysis in the context of studies of non-steroidal anti-inflammatory drugs (NSAIDs) and colorectal cancer. The following factors were widely varied to examine the impact on the validity of the effect estimate for NSAIDs and colorectal cancer: (1) the overall prevalence of NSAID exposure in the population, (2) the proportion of NSAID exposure due to OTC use (the prevalence of missed NSAID exposure in studies of prescription claims), and (3) the true risk ratio (RR(true)). We graphed the RR that would be observed (RR(observed)) as a function of overall prevalence of NSAID use and the prevalence of NSAID use that is OTC exposure. We found that when the true RR ranges from 0.25 to 0.75, missing OTC drug exposure is not a large source of bias in those situations in which the overall prevalence of drug use is relatively low (less than 35%) and the proportion of drug use that is OTC exposure is as high as 80%. Results from our sensitivity analysis indicate that, in many circumstances, prescription claims data can give valid estimates of association even though some of the drugs are available OTC. Copyright (c) 2007 John Wiley & Sons, Ltd.

  18. Intentional misuse of over-the-counter medications, mental health, and polysubstance use in young adults.

    PubMed

    Benotsch, Eric G; Koester, Stephen; Martin, Aaron M; Cejka, Anna; Luckman, Diana; Jeffers, Amy J

    2014-08-01

    In recent years, the non-medical use of prescription drugs (without a doctor's prescription) has increased dramatically. Less attention has been paid to the intentional misuse of over-the-counter (OTC) medications. Misuse of OTC medications has negative health consequences similar to those of illicit drugs, including psychosis, tachycardia, seizures and agitation. When mixed with alcohol or other drugs, these medications can also be dangerous: OTC-related emergency room visits increased 70% from 2004 to 2008. This study examined the intentional misuse of OTC medications, the non-medical use of prescription drugs, the use of alcohol and illicit drugs, and psychological factors in two samples of young adults (ages 18-25) from different areas of the United States (Total N = 1,197). Overall, 18.6% of the Colorado sample and 13.0% of the Virginia sample reported lifetime misuse of an OTC medication. Participants who reported misusing OTC medications were also significantly more likely to report using marijuana, ecstasy, cocaine, and non-medical use of prescription analgesics, stimulants, anxiolytics, and sedatives. Participants who reported misusing OTC medications were more than twice as likely to report hazardous alcohol use, relative to individuals who denied misusing OTC medications. Individuals who had misused OTC medications scored significantly higher in sensation seeking and hopelessness and reported more symptoms of depression, anxiety, and somatic distress, relative to those who denied OTC misuse. Results suggest that a considerable minority of young adults are jeopardizing their health with the misuse of OTC medications as part of a pattern of polysubstance use.

  19. Students' attitude toward use of over the counter medicines during exams in Saudi Arabia.

    PubMed

    Almalak, Haya; Albluwi, Ala'a Ibrahim; Alkhelb, Dalal Ahmed; Alsaleh, Hajar Mohmmed; Khan, Tahir Mehmood; Hassali, Mohamed Azmi Ahmad; Aljadhey, Hisham

    2014-04-01

    To explore the use of over the counter (OTC) medicines among students during exams in Riyadh City, Kingdom of Saudi Arabia. A cross-sectional study was designed; using a self-administered twenty-two item online questionnaire for the students' convenience and easy response disclosure. Data were analyzed using Statistical Package for Social Science (SPSS) version 13®. A total of N = 1596 students participated in this survey, of whom 829 (51.9%) were university students and 767 (48.1%) were high school students. Overall, 80.0% of the respondents disclosed the use of OTC non-steroidal anti-inflammatory drugs for headache and pain relief. In addition, other substances used during the exams were Energy Drinks (5.0%), Flu Medication (5.0%), Vitamins (5.0%) and Antibiotics (5.0%). Female students were found to be more knowledgeable about safety issues concerning the use of OTC medicines (5.11 ± 1.27, p = <0.001) than male students. Ease in access to OTC medicine, availability of pharmacist consultation and advertisement in print and electronic media were the main factors disclosed by the respondents that may result in an increase in the use of OTC products. The use of OTC medicines was generally higher among female students (p = 0.001). The use of OTC medication during exams was more among high school and university students. Gender, age and educational institution were found significantly affecting the use of OTC medicines during exams.

  20. The Impact of Restricting Over-the-Counter Sales of Antimicrobial Drugs

    PubMed Central

    Moura, Maria Luísa; Boszczowski, Icaro; Mortari, Naíma; Barrozo, Lígia Vizeu; Neto, Francisco Chiaravalloti; Lobo, Renata Desordi; Pedroso de Lima, Antonio Carlos; Levin, Anna S.

    2015-01-01

    Abstract To describe the nationwide impact of a restrictive law on over-the-counter sales of antimicrobial drugs, implemented in Brazil in November 2010. Approximately 75% of the population receives healthcare from the public health system and receives free-of-charge medication if prescribed. Total sales in private pharmacies as compared with other channels of sales of oral antibiotics were evaluated in this observational study before and after the law (2008–2012). Defined daily dose per 1000 inhabitants per day (DDD/TID) was used as standard unit. In private pharmacies the effect of the restrictive law was statistically significant (P < 0.001) with an estimated decrease in DDD/TID of 1.87 (s.e. =  0.18). In addition, the trend of DDD/TID before the restrictive law was greater than after the intervention (P < 0.001). Before November 2010, the slope for the trend line was estimated as 0.08 (s.e. = 0.01) whereas after the law, the estimated slope was 0.03 (s.e. = 0.01). As for the nonprivate channels, no difference in sales was observed (P = 0.643). The impact in the South and Southeast (more developed) regions was higher than in the North, Northeast, and Mid-West. The state capitals had a 19% decrease, compared with 0.8% increase in the rest of the states. Before the law, the sales of antimicrobial drugs were steadily increasing. From November 2010, with the restrictive law, there was an abrupt drop in sales followed by an increase albeit at a significantly lower rate. The impact was higher in regions with better socio-economic status. PMID:26402824

  1. Surveillance and uncertainty: community pharmacy responses to over the counter medicine abuse.

    PubMed

    Cooper, Richard

    2013-05-01

    The sale of over-the-counter (OTC) medicines from community pharmacies offers important opportunities for members of the public to access medicines and self-treat conditions. They are increasingly recognised, however, as having the potential for abuse and harm despite their perceived relative safety. This study reports on a qualitative study that explored the experiences and views of community pharmacy staff in relation to current practices and concerns, management and support relating to OTC medicine abuse. Semi-structured interviews were undertaken with a purposive sample of ten pharmacists and seven medicines counter assistants in the United Kingdom. Analysis of interviews indicated that a range of medicines was implicated, including opiates, sedative antihistamines, laxatives and decongestants. A surveillance role was apparent for assistants, who placed emphasis on regulations, procedure and monitoring frequency of purchases to manage abuse, with referral on to pharmacists. Frequency of purchase was central to assistants' definition of those suspected of OTC medicine abuse, which pharmacists also utilised as well as a distinction between intentional abuse and unintentional medicine misuse. A lack of information about customers, easy access to, and poor communication between community pharmacies were emergent barriers to pharmacists providing more support. Many appeared uncertain of referral options or how pharmacists could effectively stop the problem of abuse. The commercial environment was a particular concern, in relation to customer expectations, medicine advertising and easy access to different community pharmacies. A key tension emerged between providing medicine supplies that permitted consumer freedom, with the needs of healthcare professionals to understand more about those consumers qua patients. Policy implications include the need for improved knowledge for community pharmacy staff about signposting to relevant services, increased awareness of who

  2. Perception of pharmacists regarding over-the-counter medication: A survey

    PubMed Central

    Ravichandran, Abinaya; Basavareddy, Asha

    2016-01-01

    Objective: To assess knowledge, attitude, and practice of the pharmacists toward dispensing the over-the-counter (OTC) medications using questionnaire. Materials and Methods: cross-sectional questionnaire-based study was conducted to assess the knowledge, attitude, and practice among pharmacists regarding OTC medications. Eighty out of hundred filled questionnaires were received from various pharmacists from medical shops in and around Kolar. Data were analyzed using descriptive statistics. Results: A total of 74.6% responded to the questionnaire. Most of the dispensers (97.3%) at pharmacy were qualified with a D.Pharma/B.Pharma degree. Pharmacists with B.Pharma (80%) were able to define OTC. Majority of them had more than ten consumers taking OTC per week. Among the OTCs dispensed, common were analgesics (75%), antacids (48%), antihistaminics (40%), and others (35%). The choice of OTC brand was made by pharmacists (58.7%) and consumers (41.2%). Most of them (96.5%) asked the consumer's complaints before dispensing the drug, but only few (51%) counseled them regarding the instructions to administer medication. The brand of OTC was influenced by prescriptions of local doctor (60%), consumer's choice (31.2%), cost of the drug (16.7%), and medical representatives (5%). OTCs were safe to dispense, according to 90% of the pharmacists; however, among them, 50% expressed that the consumers should first consult doctor. Conclusion: Majority of the pharmacists were qualified to dispense medication, but only few knew about OTC drugs. Analgesics were most commonly used OTC. These drugs were safe to dispense, however, consulting doctor before taking medications was suggested by some of them. PMID:28066116

  3. Preclinical, Clinical, and Over-the-Counter Postmarketing Experience with a New Vaginal Cup: Menstrual Collection

    PubMed Central

    North, Barbara B.

    2011-01-01

    Abstract Background Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Methods Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. Results No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. Conclusions These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services. PMID

  4. Students’ attitude toward use of over the counter medicines during exams in Saudi Arabia

    PubMed Central

    Almalak, Haya; Albluwi, Ala’a Ibrahim; Alkhelb, Dalal Ahmed; Alsaleh, Hajar Mohmmed; Khan, Tahir Mehmood; Hassali, Mohamed Azmi Ahmad; Aljadhey, Hisham

    2013-01-01

    Purpose To explore the use of over the counter (OTC) medicines among students during exams in Riyadh City, Kingdom of Saudi Arabia. Method A cross-sectional study was designed; using a self-administered twenty-two item online questionnaire for the students’ convenience and easy response disclosure. Data were analyzed using Statistical Package for Social Science (SPSS) version 13®. Results A total of N = 1596 students participated in this survey, of whom 829 (51.9%) were university students and 767 (48.1%) were high school students. Overall, 80.0% of the respondents disclosed the use of OTC non-steroidal anti-inflammatory drugs for headache and pain relief. In addition, other substances used during the exams were Energy Drinks (5.0%), Flu Medication (5.0%), Vitamins (5.0%) and Antibiotics (5.0%). Female students were found to be more knowledgeable about safety issues concerning the use of OTC medicines (5.11 ± 1.27, p = <0.001) than male students. Ease in access to OTC medicine, availability of pharmacist consultation and advertisement in print and electronic media were the main factors disclosed by the respondents that may result in an increase in the use of OTC products. The use of OTC medicines was generally higher among female students (p = 0.001). Conclusion The use of OTC medication during exams was more among high school and university students. Gender, age and educational institution were found significantly affecting the use of OTC medicines during exams. PMID:24648821

  5. Management of over-the-counter insomnia complaints in Australian community pharmacies: a standardized patient study.

    PubMed

    Kashyap, Krishneeta C; Nissen, Lisa M; Smith, Simon S; Kyle, Greg

    2014-04-01

    To evaluate the current management of over-the-counter (OTC) insomnia complaints in Australian community pharmacies using standardized patient methodology. Trained standardized patients visited a sample of 100 randomly selected South East Queensland community pharmacies in June 2011. The standardized patients enacted two OTC insomnia scenarios: a direct product request (DPR) (n = 50) and a symptom-based request (SBR) (n = 50). Results of the interactions were documented immediately after each visit and evaluated using the Pharmaceutical Society of Australia's WHAT STOP GO protocol as a standard comparison. Of all DPRs, 30% were handled entirely by the pharmacist, 70% of staff enquired about specific symptoms and 28% investigated the cause of insomnia. No staff investigated the frequency of product use. The DPR scenario resulted in a 92% supply of the requested doxylamine product (Restavit). In the SBR scenario, 18% of requests were handled entirely by the pharmacist, 58% of staff enquired about specific symptoms and 44% investigated the cause of insomnia. Staff recommended medicated products (38%), or herbal (78%) or non-drug techniques (18%). Investigation into smoking and alcohol intake was not undertaken in DPR or SBR interactions, while questioning on caffeine intake was undertaken in 2 and 14% of cases respectively. There were no significant differences found in the handling of sleep requests by pharmacists compared to pharmacy assistants. The standardized patient methodology was a successful way to assess the community pharmacy counselling provided with OTC sleep requests and suboptimal staff responses were found when compared with recommended practice standards. © 2013 Royal Pharmaceutical Society.

  6. Compliance, behavior change, and weight loss with orlistat in an over-the-counter setting.

    PubMed

    Schwartz, Susan M; Bansal, Vidhu P; Hale, Cecilia; Rossi, Maureen; Engle, Janet P

    2008-03-01

    The study was conducted to provide information on how consumers would use orlistat 60 mg, especially in terms of product dosing, in a setting without physician supervision. A 3-month, open-label, naturalistic study was conducted in an over-the-counter (OTC) setting in 18 pharmacies. Consumers >/=18 years were allowed to purchase orlistat packages containing a bottle of orlistat 60 mg plus educational materials, which provided lifestyle information and tools to encourage successful weight loss. Data were collected at pharmacy visits and during telephone interviews at 14, 30, 60, and 90 days after enrollment. A total of 237 subjects purchased and used the product, and completed at least one interview. Most subjects followed the dosing directions and took two to three capsules per day with meals throughout the study. The majority of subjects took a daily multivitamin, as directed. Approximately, 80% of subjects used the educational materials and found them useful or very useful. Over the study duration, most subjects reported following a diet and 51% of subjects reported more frequent or longer exercise than at enrollment. Approximately, 80% of subjects indicated they were satisfied or very satisfied with the weight loss achieved; measured and self-reported relative median weight loss was approximately 5% after > or =60 days of using orlistat. Most common adverse events were gastrointestinal (GI), and majority of subjects did not interrupt or discontinue orlistat due to these GI events. These results demonstrate that orlistat 60 mg can be used appropriately and safely and with high consumer satisfaction without physician supervision or dietary counseling. Collectively, results indicate that orlistat 60 mg is an appropriate weight loss therapy in the OTC environment.

  7. Over-the-counter medication patterns in households in Sharjah, United Arab Emirates

    PubMed Central

    Zaghloul, Ashraf Ahmad; Elsergany, Moetaz; El-Enein, Nagwa Abou; Alsuwaidi, Hamda; Ayoub, Mohamed

    2014-01-01

    Background Self-medication and acquisition of over-the-counter (OTC) medications are emerging community health issues. Besides being a cheap alternative for treating common illnesses, the behavior entails serious ramifications, such as medication wastage, increasing pathogen resistance, and adverse drug reactions. The present study was conducted to explore the extent of OTC medications in households in Sharjah, United Arab Emirates (UAE), including native UAE and expatriate families. Methods The study employed a population-based, cross-sectional, analytical study design. The study population included native and expatriate households residing in the Emirate of Sharjah, UAE. The snowball sampling technique was used, and the sample included a total of 335 households. Results Expatriate households acquired more OTC medications than did native households (adjusted odds ratio [aOR]=1.7). The demographic determinants for expatriate households were number of family members (aOR=1.6), age of children in the family (aOR=1.8), and annual income (aOR=0.5). Expatriate households purchased more OTC medication practices than did native households (aOR=2.2). In the statistical sense, expatriate household practices were buying medication upon relatives’ advice (aOR=0.3), storage condition of medication (aOR=2.4), and disposal of expired medication (aOR=0.6). The highest percentages of OTC medications in native and expatriate households were those related to gastric and ear, nose, and throat illnesses. Conclusion The presence of OTC medications in expatriate households was two-fold more common than in native households in Sharjah, UAE. There were significant associations for behaviors related to the reasons why OTC medications were purchased and stored within the household for both native and expatriate families. PMID:24403846

  8. 21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Ipecac syrup; warnings and directions for use for over-the-counter sale. 201.308 Section 201.308 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

  9. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310...) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have... disease conditions. There are serious and complicating aspects to many of the diseases these...

  10. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310...) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have... disease conditions. There are serious and complicating aspects to many of the diseases these...

  11. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310...) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have... disease conditions. There are serious and complicating aspects to many of the diseases these...

  12. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310...) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have... disease conditions. There are serious and complicating aspects to many of the diseases these...

  13. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310...) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have... disease conditions. There are serious and complicating aspects to many of the diseases these...

  14. 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......

  15. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false May I purchase definitive Series I... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES I Definitive Series I Savings Bonds § 359.34 May I purchase definitive Series I savings bonds over-the-counter? You may purchase definitive bonds...

  16. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false May I purchase definitive Series I... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES I Definitive Series I Savings Bonds § 359.34 May I purchase definitive Series I savings bonds over-the-counter? Effective January 1, 2012, Treasury discontinued the...

  17. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false May I purchase definitive Series I... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES I Definitive Series I Savings Bonds § 359.34 May I purchase definitive Series I savings bonds over-the-counter? You may purchase definitive bonds...

  18. 31 CFR 351.46 - May I purchase definitive Series EE savings bonds over-the-counter?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May I purchase definitive Series EE savings bonds over-the-counter? You may purchase definitive bonds...

  19. 31 CFR 351.46 - May I purchase definitive Series EE savings bonds over-the-counter?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May I purchase definitive Series EE savings bonds over-the-counter? You may purchase definitive bonds...

  20. 31 CFR 351.46 - May I purchase definitive Series EE savings bonds over-the-counter?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May I purchase definitive Series EE savings bonds over-the-counter? Effective January 1, 2012,...

  1. 31 CFR 351.46 - May I purchase definitive Series EE savings bonds over-the-counter?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May I purchase definitive Series EE savings bonds over-the-counter? Effective January 1, 2012,...

  2. 31 CFR 351.46 - May I purchase definitive Series EE savings bonds over-the-counter?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May I purchase definitive Series EE savings bonds over-the-counter? Effective January 1, 2012,...

  3. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false May I purchase definitive Series I... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES I Definitive Series I Savings Bonds § 359.34 May I purchase definitive Series I savings bonds over-the-counter? Effective January 1, 2012, Treasury discontinued the...

  4. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false May I purchase definitive Series I... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES I Definitive Series I Savings Bonds § 359.34 May I purchase definitive Series I savings bonds over-the-counter? Effective January 1, 2012, Treasury discontinued the...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 310 SPF Labeling and Testing... solicits comments on SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products... of information technology. SPF Labeling and Testing Requirements for OTC Sunscreen Products...

  6. 76 FR 38975 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 201 (formerly Docket No. 1978N-0038) RIN 0910-AF43 Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human...

  7. 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…

  8. 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…

  9. 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

    ... the potential environmental impact of amending over-the-counter (OTC) drug monographs to include... been found eligible for potential inclusion in OTC drug monographs based on time and extent... found eligible for possible addition to an OTC drug monograph via the TEA process described in 21 CFR...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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

    ... human environment. Therefore, neither an environmental assessment nor an environmental impact statement... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 310 (Formerly Docket No. 1978N-0038) RIN 0910-AF43 Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human...

  15. To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Over-the-Counter Drug Advertising.

    ERIC Educational Resources Information Center

    Council on Children, Media, and Merchandising, Washington, DC.

    This report supports amending the proposed Federal Trade Commission (FTC) Rule on Over-the Counter (OTC) Drug Advertising to insure better protection for children, illiterate populations, the deaf and the blind, from advertising on the air-waves. Several points are addressed: (1) the difficulties of combining the rule making schedules of the Food…

  16. 78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency Use... Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public... Webcast location will be posted on the Web page at http://www.fda.gov/Drugs/NewsEvents/ucm356526.htm...

  17. The role of the pharmacist in the selection and use of over-the-counter proton-pump inhibitors.

    PubMed

    Boardman, Helen F; Heeley, Gordon

    2015-10-01

    Heartburn and other symptoms of gastro-oesophageal reflux occur in ~30% of survey respondents in multiple countries worldwide. Heartburn and acid regurgitation are common complaints in the pharmacy, where patients frequently seek relief through medication and advice. The growing number of proton-pump inhibitors available in the over-the-counter setting provides an efficacious choice to patients experiencing frequent heartburn. Pharmacists can assist patients in their treatment decisions whilst inquiring about alarm symptoms that should prompt a physician referral. Aim of the review Provide pharmacists with a review of current clinical research and expert guidelines on use of over-the-counter proton-pump inhibitors. This narrative review was conducted to identify publications relevant to the following themes: overview of available treatments for frequent episodes of heartburn/acid regurgitation; treatment algorithms providing guidance on when to use over-the-counter proton-pump inhibitors; and the role of the pharmacist in the use of over-the-counter proton-pump inhibitors. Frequent symptoms of acid reflux, such as heartburn and acid regurgitation, can interfere substantially with daily life activities. Proton-pump inhibitors are the most efficacious treatment for frequent reflux symptoms and are recommended as an appropriate initial treatment in uncomplicated cases. Proton-pump inhibitors have varying pharmacokinetics and pharmacodynamics across the class; 20 mg esomeprazole has higher bioavailability and exposure than over-the-counter omeprazole, for example. However, differences in clinical efficacy for symptom relief have not been demonstrated. The safety and tolerability of proton-pump inhibitors have been well established in clinical trial and post-marketing settings, and use of a short regimen is associated with a very low likelihood of missing a more serious condition. Pharmacists can assist patients with accurate self-diagnosis by asking short, simple

  18. Partnership in optimizing management of reflux symptoms: a treatment algorithm for over-the-counter proton-pump inhibitors.

    PubMed

    Boardman, Helen F; Delaney, Brendan C; Haag, Sebastian

    2015-01-01

    Uncomplicated heartburn and acid regurgitation are increasingly treated and managed using over-the-counter medications. However, with over-the-counter availability of antacids, alginates, histamine 2 receptor antagonists (H2RAs), and proton-pump inhibitors (PPIs), consumers need guidance as to appropriate options and how to use them. Relevant guidelines, studies, and reviews were identified via literature searches of PubMed/Medline and Google Scholar, as well as cross-referencing from the identified papers. Antacids, alginates, and H2RAs are best suited to management of occasional heartburn, taken either before provocative meals or other triggers or on demand when symptoms arise. Over-the-counter PPIs are appropriate options across the range of symptom severity/frequency typically encountered in the pharmacy, but may be particularly appropriate for treatment of those with frequent and/or very bothersome heartburn. A 2-4 week course of daily PPIs can lead to complete resolution of frequent heartburn. Counseling is important to ensure that patients understand that failure of symptoms to resolve or a rapid return of symptoms while taking a PPI is an indication to consult a doctor, whereas a return of symptoms after a period of months may be an indication for just another course of treatment. The need for effective communication and for ensuring use of the correct medication in the over-the-counter setting puts much of the responsibility for management of heartburn and acid regurgitation on the pharmacist. A proposed algorithm that details when and how to use available over-the-counter medications is presented. This algorithm also highlights alarm features and atypical symptoms indicative of other underlying conditions that should be referred directly to a physician. Implementation of a simple algorithm will empower pharmacists and consumers alike and ensure consistent and appropriate care.

  19. Relative impact of clinical evidence and over-the-counter prescribing on topical antibiotic use for acute infective conjunctivitis.

    PubMed

    Davis, Helen; Mant, David; Scott, Caroline; Lasserson, Daniel; Rose, Peter W

    2009-12-01

    Acute infective conjunctivitis is a common presentation in general practice. In 2005, three placebo-controlled clinical trials showed that use of topical antibiotics had a small effect on time to clinical resolution. In the same year, chloramphenicol eye drops were made available for sale over the counter. To compare the relative impact of clinical trial evidence and a change to over-the-counter availability on community use of topical chloramphenicol. Observational study using mainly routinely collected data for England. National prescribing data for England and local data from general practices in Oxfordshire, England. Data were collated from three sources: GP prescriptions from the Prescription Pricing Authority, wholesale supply to pharmacists from IMS Health, and an audit of delayed prescribing and non-prescribing from electronic consultation records for acute conjunctivitis, in four general practices. The number of general practice prescriptions for topical chloramphenicol fell from 2.3 million in 2004 to 1.9 million in 2007, a reduction of 15.5%. In contrast, over-the-counter sales by pharmacists have increased steadily. The net effect of these changes has been a 47.8% increase in total chloramphenicol use during 2005-2007, with 1.1 million additional packs being used in 2007 compared to 2004. Making an antibiotic available over the counter increases its use substantially. This is in conflict with the important public health message that antibiotic use needs to be reduced to combat resistance. These findings support the views of the Chief Medical Officer that no more antibiotics should currently be made available over the counter.

  20. Impact of Over-the-Counter Restrictions on Antibiotic Consumption in Brazil and Mexico

    PubMed Central

    Santa-Ana-Tellez, Yared; Mantel-Teeuwisse, Aukje K.; Dreser, Anahi; Leufkens, Hubert G. M.; Wirtz, Veronika J.

    2013-01-01

    Background In Latin American countries over-the-counter (OTC) dispensing of antibiotics is common. In 2010, both Mexico and Brazil implemented policies to enforce existing laws of restricting consumption of antibiotics only to patients presenting a prescription. The objective of the present study is therefore to evaluate the impact of OTC restrictions (2010) on antibiotics consumption in Brazil and Mexico. Methods and Findings Retail quarterly sales data in kilograms of oral and injectable antibiotics between January 2007 and June 2012 for Brazil and Mexico were obtained from IMS Health. The unit of analysis for antibiotics consumption was the defined daily dose per 1,000 inhabitants per day (DDD/TID) according to the WHO ATC classification system. Interrupted time series analysis was conducted using antihypertensives as reference group to account for changes occurring independently of the OTC restrictions directed at antibiotics. To reduce the effect of (a) seasonality and (b) autocorrelation, dummy variables and Prais-Winsten regression were used respectively. Between 2007 and 2012 total antibiotic usage increased in Brazil (from 5.7 to 8.5 DDD/TID, +49.3%) and decreased in Mexico (10.5 to 7.5 DDD/TID, −29.2%). Interrupted time series analysis showed a change in level of consumption of −1.35 DDD/TID (p<0.01) for Brazil and −1.17 DDD/TID (p<0.00) for Mexico. In Brazil the penicillins, sulfonamides and macrolides consumption had a decrease in level after the intervention of 0.64 DDD/TID (p = 0.02), 0.41 (p = 0.02) and 0.47 (p = 0.01) respectively. While in Mexico it was found that only penicillins and sulfonamides had significant changes in level of −0.86 DDD/TID (p<0.00) and −0.17 DDD/TID (p = 0.07). Conclusions Despite different overall usage patterns of antibiotics in Brazil and Mexico, the effect of the OTC restrictions on antibiotics usage was similar. In Brazil the trend of increased usage of antibiotics was tempered after the OTC

  1. Issues related to monitoring the safety of over-the-counter (OTC) medicines.

    PubMed

    Bond, Christine; Hannaford, Philip

    2003-01-01

    Pharmaceutical advances over the past 50 years have benefited many people in terms of disease prevention and management. However, probably without exception, most pharmaceutical products can cause adverse consequences of varying severity and frequency. In the last 10 years, many medicines that were originally prescription only have now become available over the counter (OTC), either from pharmacies or other general retail outlets. The volume and value of OTC medicine sales have increased accordingly. These switches have been well regulated and based on clear criteria and evidence of safety. Benefits of the changes include increased convenience to patients, greater self-management of minor ailments and a reduction in government drug expenditure.However, there are important differences between medicines supplied OTC and on medical prescription. With OTC medicines there is generally less healthcare professional input into the recommendation or ongoing monitoring of use. There is an absence of records per se, or linkage to other medication records elsewhere, and most countries allow direct-to-consumer advertising of the product. Taken together these differences can result in inappropriate expectations, demand and use of the OTC medicines, with limited opportunity for ongoing patient follow-up and monitoring of safety. Methodologies for pharmacy-based epidemiological studies of OTC medicines need to be developed. Studies should be large enough to detect associations that might exist, and to consider other explanations for associations such as chance, bias or confounding. There have already been some pilot studies with encouraging results with respect to follow-up rates. Outcome data however have usually been self-reported and the studies have lacked a suitable comparison group. Purchasers and suppliers of OTC medicines should also be made aware of, and encouraged to use, existing systems for spontaneous reporting of suspected adverse events, such as the Yellow Card

  2. Over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings.

    PubMed

    Smith, Susan M; Schroeder, Knut; Fahey, Tom

    2012-08-15

    Acute cough due to upper respiratory tract infection (URTI) is a common symptom. Non-prescription, over-the-counter (OTC) medicines are frequently recommended as a first-line treatment, but there is little evidence as to whether these drugs are effective. To assess the effects of oral OTC cough preparations for acute cough in children and adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2012 Issue 3 which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1966 to March week 1 2012), EMBASE (January 1974 to March 2012), CINAHL (January 2010 to March 2012), LILACS (January 2010 to March 2012), Web of Science (January 2010 to March 2012) and the UK Department of Health National Research Register (March 2010). Randomised controlled trials (RCTs) comparing oral OTC cough preparations with placebo in children and adults suffering from acute cough in ambulatory settings. We considered all cough outcomes and secondary outcomes of interest were adverse effects. Two review authors independently screened potentially relevant citations, extracted data and assessed study quality. We performed quantitative analysis where appropriate. Twenty-six trials (18 in adults, eight in children) involving 4037 people (3421 adults and 616 children) were included.In the adult studies six trials compared antitussives with placebo and had variable results. Two trials compared the expectorant guaifenesin with placebo; one indicated significant benefit whereas the other did not. One trial found that a mucolytic reduced cough frequency and symptom scores. Two studies examined antihistamine-decongestant combinations and found conflicting results. Four studies compared other combinations of drugs with placebo and indicated some benefit in reducing cough symptoms. Three trials found antihistamines were no more effective than placebo in relieving cough symptoms.In the children studies antitussives (two studies), antihistamines (two

  3. Designing an over-the-counter consumer decision-making tool for older adults.

    PubMed

    Martin-Hammond, Aqueasha M; Abegaz, Tamirat; Gilbert, Juan E

    2015-10-01

    Older adults are at increased risk of adverse drug events due to medication. Older adults tend to take more medication and are at higher risk of chronic illness. Over-the-counter (OTC) medication does not require healthcare provider oversight and understanding OTC information is heavily dependent on a consumer's ability to understand and use the medication appropriately. Coupling health technology with effective communication is one approach to address the challenge of communicating health and improving health related tasks. However, the success of many health technologies also depends on how well the technology is designed and how well it addresses users needs. This is especially true for the older adult population. This paper describes (1) a formative study performed to understand how to design novel health technology to assist older adults with OTC medication information, and (2) how a user-centered design process helped to refine the initial assumptions of user needs and help to conceptualize the technology. An iterative design process was used. The process included two brainstorming and review sessions with human-computer interaction researchers and design sessions with older adults in the form of semi-structured interviews. Methods and principles of user-centered research and design were used to inform the research design. Two researchers with expertise in human-computer interaction performed expert reviews of early system prototypes. After initial prototypes were developed, seven older adults were engaged in semi-structured interviews to understand usability concerns and features and functionality older adults may find useful for selecting appropriate OTC medication. Eight usability concerns were discovered and addressed in the two rounds of expert review, and nine additional usability concerns were discovered in design sessions with older adults. Five themes emerged from the interview transcripts as recommendations for design. These recommendations

  4. Impact of over-the-counter restrictions on antibiotic consumption in Brazil and Mexico.

    PubMed

    Santa-Ana-Tellez, Yared; Mantel-Teeuwisse, Aukje K; Dreser, Anahi; Leufkens, Hubert G M; Wirtz, Veronika J

    2013-01-01

    In Latin American countries over-the-counter (OTC) dispensing of antibiotics is common. In 2010, both Mexico and Brazil implemented policies to enforce existing laws of restricting consumption of antibiotics only to patients presenting a prescription. The objective of the present study is therefore to evaluate the impact of OTC restrictions (2010) on antibiotics consumption in Brazil and Mexico. Retail quarterly sales data in kilograms of oral and injectable antibiotics between January 2007 and June 2012 for Brazil and Mexico were obtained from IMS Health. The unit of analysis for antibiotics consumption was the defined daily dose per 1,000 inhabitants per day (DDD/TID) according to the WHO ATC classification system. Interrupted time series analysis was conducted using antihypertensives as reference group to account for changes occurring independently of the OTC restrictions directed at antibiotics. To reduce the effect of (a) seasonality and (b) autocorrelation, dummy variables and Prais-Winsten regression were used respectively. Between 2007 and 2012 total antibiotic usage increased in Brazil (from 5.7 to 8.5 DDD/TID, +49.3%) and decreased in Mexico (10.5 to 7.5 DDD/TID, -29.2%). Interrupted time series analysis showed a change in level of consumption of -1.35 DDD/TID (p<0.01) for Brazil and -1.17 DDD/TID (p<0.00) for Mexico. In Brazil the penicillins, sulfonamides and macrolides consumption had a decrease in level after the intervention of 0.64 DDD/TID (p = 0.02), 0.41 (p = 0.02) and 0.47 (p = 0.01) respectively. While in Mexico it was found that only penicillins and sulfonamides had significant changes in level of -0.86 DDD/TID (p<0.00) and -0.17 DDD/TID (p = 0.07). Despite different overall usage patterns of antibiotics in Brazil and Mexico, the effect of the OTC restrictions on antibiotics usage was similar. In Brazil the trend of increased usage of antibiotics was tempered after the OTC restrictions; in Mexico the trend of decreased usage was boosted.

  5. Effect of two in-office whitening agents on the enamel surface in vivo: a morphological and non-contact profilometric study.

    PubMed

    Cadenaro, Milena; Breschi, Lorenzo; Nucci, Cesare; Antoniolli, Francesca; Visintini, Erika; Prati, Carlo; Matis, Bruce A; Di Lenarda, Roberto

    2008-01-01

    This study evaluated the morphological effects produced in vivo by two in-office bleaching agents on enamel surface roughness using a noncontact profilometric analysis of epoxy replicas. The null hypothesis tested was that there would be no difference in the micromorphology of the enamel surface during or after bleaching with two different bleaching agents. Eighteen subjects were selected and randomly assigned to two treatment groups (n=9). The tooth whitening materials tested were 38% hydrogen peroxide (HP) (Opalescence Xtra Boost) and 35% carbamide peroxide (CP) (Rembrandt Quik Start). The bleaching agents were applied in accordance with manufacturer protocols. The treatments were repeated four times at one-week intervals. High precision impressions of the upper right incisor were taken at baseline as the control (CTRL) and after each bleaching treatment (T0: first application, T1: second application at one week, T2: third application at two weeks and T3: fourth application at three weeks). Epoxy resin replicas were poured from impressions, and the surface roughness was analyzed by means of a non-contact profilometer (Talysurf CLI 1000). Epoxy replicas were then observed using SEM. All data were statistically analyzed using ANOVA and differences were determined with a t-test. No significant differences in surface roughness were found on enamel replicas using either 38% hydrogen peroxide or 35% carbamide peroxide in vivo. This in vivo study supports the null hypothesis that two in-office bleaching agents, with either a high concentration of hydrogen or carbamide peroxide, do not alter enamel surface roughness, even after multiple applications.

  6. Multimedia educational interventions for consumers about prescribed and over-the-counter medications.

    PubMed

    Ciciriello, Sabina; Johnston, Renea V; Osborne, Richard H; Wicks, Ian; deKroo, Tanya; Clerehan, Rosemary; O'Neill, Clare; Buchbinder, Rachelle

    2013-04-30

    Health consumers increasingly want access to accurate, evidence-based information about their medications. Currently, education about medications (that is, information that is designed to achieve health or illness related learning) is provided predominantly via spoken communication between the health provider and consumer, sometimes supplemented with written materials. There is evidence, however, that current educational methods are not meeting consumer needs. Multimedia educational programs offer many potential advantages over traditional forms of education delivery. To assess the effects of multimedia patient education interventions about prescribed and over-the-counter medications in people of all ages, including children and carers. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2011, Issue 6), MEDLINE (1950 to June 2011), EMBASE (1974 to June 2011), CINAHL (1982 to June 2011), PsycINFO (1967 to June 2011), ERIC (1966 to June 2011), ProQuest Dissertation & Theses Database (to June 2011) and reference lists of articles. Randomised controlled trials (RCTs) and quasi-RCTs of multimedia-based patient education about prescribed or over-the-counter medications in people of all ages, including children and carers, if the intervention had been targeted for their use. Two review authors independently extracted data and assessed the risk of bias of included studies. Where possible, we contacted study authors to obtain missing information. We identified 24 studies that enrolled a total of 8112 participants. However, there was significant heterogeneity in the comparators used and the outcomes measured, which limited the ability to pool data. Many of the studies did not report sufficient information in their methods to allow judgment of their risk of bias. From the information that was reported, three of the studies had a high risk of selection bias and one was at high risk of bias due to lack of blinding of the outcome

  7. Tooth sensitivity and whitening.

    PubMed

    Swift, Edward J

    2005-09-01

    This article presents a review of the basic concepts of tooth sensitivity and how those concepts apply to cervical dentin hypersensitivity and the sensitivity frequently associated with tooth whitening. The etiology and treatment of cervical dentin hypersensitivity are described. The clinical presentation, incidence, and predisposing factors for sensitivity associated with tooth whitening also are discussed.

  8. Simultaneous determination of 11 fluorescent whitening agents in food-contact paper and board by ion-pairing high-performance liquid chromatography with fluorescence detection.

    PubMed

    Jiang, Dingguo; Chen, Lisong; Fu, Wusheng; Qiu, Hanquan

    2015-02-01

    4,4'-Diaminostilbene-2,2'-disulfonic acid based fluorescent whitening agents (DSD-FWAs) are prohibited in food-contact paper and board in many countries. In this work, a reliable high-performance liquid chromatography method was developed for the simultaneous determination of 11 common DSD-FWAs in paper material. Sample preparation and extraction as well as chromatographic separation of multicomponent DSD-FWAs were successfully optimized. DSD-FWAs in prepared samples were ultrasonically extracted with acetonitrile/water/triethylamine (40:60:1, v/v/v), separated on the C(18) column with the mobile phase containing tetrabutylammonium bromide, and then detected by a fluorescence detector. The limits of detection were 0.12-0.24 mg/kg, and the calibration curves showed the linear correlation (R(2) ≥ 0.9994) within the range of 8.0-100 ng/mL, which was equivalent to the range of 0.80-10 mg/kg in the sample. The average recoveries and the RSDs were 81-106% and 2-9% at two fortification levels (1.0 and 5.0 mg/kg) in paper bowls, respectively. The successful determination of 11 DSD-FWAs in food-contact paper and board obtained from local markets indicated that the newly developed method was rapid, accurate, and highly selective.

  9. Determination of fluorescent whitening agents in laundry detergents and surface waters by solid-phase extraction and ion-pair high-performance liquid chromatography.

    PubMed

    Shu, Wei-Chuan; Ding, Wang-Hsien

    2005-09-23

    A simple method was developed to detect four stilbene-type disulfonate and one distyrylbiphenyl-type fluorescent whitening agents (FWAs) in household laundry detergents and surface waters by ion-pair high-performance liquid chromatography. The FWA concentrations in detergents were measured directly. The contents of FWAs in water samples were extracted by solid-phase extraction (C18-SPE) with ion-pairing reagent, and were then determined by an isocratic ion-pair chromatography (IPC) using a C18 column, applying tetrabutylammonium hydrogensulfate (TBA) as the ion-pairing reagent in mobile phase, and equipped with fluorescence detection. Water samples at various pH conditions for SPE were evaluated. Experimental results indicate that the proposed method is precise and sensitive in analyzing FWAs, and enables quantitation of 0.01-0.1 microg/l in 100 ml water samples. The recovery rates of FWAs in spiked water samples were between 73 and 89%, and the precision (RSD) ranged from 2.6 to 8.9%. Over 7200 microg/g of 4,4'-bis(2-sulfostryl)-biphenyl (DSBP) and 2320 microg/g of 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazine-2-yl)-amino]stilbene-2,2'-disulfonate (DAS1) were detected in household laundry detergents. Trace amounts of DSBP were detected in surface water samples ranging from 0.2 to 3.7 microg/l.

  10. Diethylene glycol in health products sold over-the-counter and imported from Asian countries.

    PubMed

    Schier, Joshua G; Barr, Dana B; Li, Zheng; Wolkin, Amy F; Baker, Samuel E; Lewis, Lauren S; McGeehin, Michael A

    2011-03-01

    Diethylene glycol (DEG), a chemical that has been implicated in multiple medication-associated mass poisonings, can result in renal and neurological toxicity if ingested. Three previous such mass poisonings implicated Chinese manufacturers as the origin of contaminated ingredients. No literature exists on potential DEG or triethylene glycol (TEG), a related compound, contamination of health products imported from Asian countries to the USA. Our primary objective was to quantitatively assess the amount of DEG present in a convenience sampling of these health products. The study's secondary objectives were to: (1) evaluate for, and quantify TEG levels in these samples; (2) compare DEG and TEG levels in these products directly to levels in medications implicated in previous similar mass poisonings; and (3) to estimate DEG dose (in mg/kg) based on the manufacturer's instructions and compare these values to toxic doses from past mass poisonings and the literature. A quantitative assessment of DEG and TEG was performed in a convenience sampling of over-the-counter health products imported from Asian countries. Results were converted to volume to volume (v/v) % and compared with DEG levels in medications implicated in previous mass poisonings. Estimated doses (based on the manufacturer's instructions) of each product with detectable levels of DEG for a 70 kg adult were compared to toxic doses of DEG reported in the literature. Seventeen of 85 (20%) samples were not able to be analyzed for DEG or TEG due to technical reasons. Fifteen of 68 (22%) samples successfully tested had detectable levels of DEG (mean, 18.8 μg/ml; range, 0.791-110.1 μg/ml; and volume to volume (v/v) range, 0.00007-0.01%). Two of 68 (3%) samples had TEG levels of 12.8 and 20.2 μg/ml or 0.0012% and 0.0018% TEG v/v. The product with the highest DEG% by v/v was 810 times less than the product involved in the Panama DEG mass poisoning (8.1%). The lowest reported toxic dose from a past DEG mass

  11. A Guide to the Ingredients and Potential Benefits of Over-the-Counter Cleansers and Moisturizers for Rosacea Patients

    PubMed Central

    Miller, Richard

    2011-01-01

    It is difficult for rosacea patients to discern which products and ingredients will be beneficial to their skin and which products will lead to an exacerbation of the signs and symptoms of rosacea. In this paper, the authors provide a brief overview of rosacea, its pathogenesis, signs and symptoms, and the management of the two major rosacea subtypes—erythematotelangiectatic rosacea and papular pustular rosacea. Reviewed in greater detail are the common ingredients used in over-the-counter cleansers and moisturizers with discussion of how these ingredients potentially benefit or harm the skin of patients with rosacea. Clinical studies investigating the benefits of using certain over-the-counter cleansers and moisturizers in patients with erythematotelangiectatic rosacea and papular pustular rosacea with or without topical prescription therapy are also reviewed. The specific formulas used in the clinical studies include a sensitive skin synthetic detergent bar, a nonalkaline cleanser and moisturizer, polyhydroxy acid containing cleanser and moisturizer, and a ceramide-based cleanser and moisturizer formulated in a multivesicular emulsion. Based on review of available data, the authors conclude that the use of mild over-the-counter cleansers and moisturizers is beneficial for patients with erythematotelangiectatic rosacea and papular pustular rosacea. The properties of over-the-counter cleansers and moisturizers that contribute to their mildness include an acidic-neutral pH to minimize the flux in skin pH; surfactants or emulsifiers that will not strip the skin of its moisture or strip the lipids and proteins of the stratum corneum; moisturizing ingredients such as emollients, humectants, and occlusives; and formulas without potential irritants and allergens. The most consistent clinical benefits demonstrated in the reviewed studies were a subjectively perceived improvement in subjective symptoms of dryness and irritation as well as an objective improvement in

  12. A Guide to the Ingredients and Potential Benefits of Over-the-Counter Cleansers and Moisturizers for Rosacea Patients.

    PubMed

    Levin, Jacquelyn; Miller, Richard

    2011-08-01

    It is difficult for rosacea patients to discern which products and ingredients will be beneficial to their skin and which products will lead to an exacerbation of the signs and symptoms of rosacea. In this paper, the authors provide a brief overview of rosacea, its pathogenesis, signs and symptoms, and the management of the two major rosacea subtypes-erythematotelangiectatic rosacea and papular pustular rosacea. Reviewed in greater detail are the common ingredients used in over-the-counter cleansers and moisturizers with discussion of how these ingredients potentially benefit or harm the skin of patients with rosacea. Clinical studies investigating the benefits of using certain over-the-counter cleansers and moisturizers in patients with erythematotelangiectatic rosacea and papular pustular rosacea with or without topical prescription therapy are also reviewed. The specific formulas used in the clinical studies include a sensitive skin synthetic detergent bar, a nonalkaline cleanser and moisturizer, polyhydroxy acid containing cleanser and moisturizer, and a ceramide-based cleanser and moisturizer formulated in a multivesicular emulsion. Based on review of available data, the authors conclude that the use of mild over-the-counter cleansers and moisturizers is beneficial for patients with erythematotelangiectatic rosacea and papular pustular rosacea. The properties of over-the-counter cleansers and moisturizers that contribute to their mildness include an acidic-neutral pH to minimize the flux in skin pH; surfactants or emulsifiers that will not strip the skin of its moisture or strip the lipids and proteins of the stratum corneum; moisturizing ingredients such as emollients, humectants, and occlusives; and formulas without potential irritants and allergens. The most consistent clinical benefits demonstrated in the reviewed studies were a subjectively perceived improvement in subjective symptoms of dryness and irritation as well as an objective improvement in

  13. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications. Final rule.

    PubMed

    2016-11-23

    The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.

  14. Barriers to contraception and interest in over-the-counter access among low-income women: a qualitative study.

    PubMed

    Dennis, Amanda; Grossman, Daniel

    2012-06-01

    Barriers to contraceptive access encourage nonuse and gaps in use, which contribute to the high prevalence of unintended pregnancy in the United States. One strategy to improve access to oral contraceptives is to make them available without a prescription. From March 2007 to January 2009, focus group discussions and in-depth interviews were conducted with 45 low-income women in the Boston area to explore how they obtain contraceptives and their opinions about making oral contraceptives available over the counter. Transcripts of the discussions and interviews were deductively and inductively coded. Data were analyzed thematically, and illustrative quotes were extracted. Overall, participants reported ease in obtaining contraceptives, which were available at multiple accessible locations throughout Boston. However, various barriers-unaffordable copays and clinic visits, the time required for clinic visits, restrictions on the number of packs of prescription contraceptives (e.g., the ring, the pill) purchased monthly and the limited time frame in which to purchase them-deterred consistent use of preferred methods. Most participants supported over-the-counter access to oral contraceptives; however, they raised concerns about cost, as well as the safety of such access for minors, first-time users and women with medical conditions. Women's concerns about over-the-counter access to contraceptives must be addressed if this approach is to improve use and potentially help reduce the unintended pregnancy rate. Copyright © 2012 by the Guttmacher Institute.

  15. Factors influencing consumers' attitudinal and behavioral responses to direct-to-consumer and over-the-counter drug advertising.

    PubMed

    Lee, Mina; Whitehill King, Karen; Reid, Leonard N

    2015-04-01

    Using a model developed from the research literature, the authors compared consumers' attitudinal and behavioral responses to direct-to-consumer prescription drug advertising (DCTA) and over-the-counter nonprescription drug advertising (OTCA) of drugs. Adults 18 years of age and older who had taken any prescription drugs in the past 6 months completed online survey questionnaires. Variables measured included demographics (age, gender, race, education, and income), health-related characteristics (health status, prescription and over-the-counter drug use, health consciousness, and involvement with prescription or over-the-counter drugs), perceived amount of attention and exposure to DTCA and OTCA, attitudinal outcomes (skepticism toward DTCA/OTCA and attitude toward DTCA/OTCA), and behavioral outcomes triggered by DTCA and OTCA. The findings indicate that exposure to drug advertising is one of the most significant predictors of attitudinal and behavioral outcomes. Some audience factors such as health status, involvement with drugs, health consciousness, drug use, income, and age also were differentially associated with consumer responses to drug advertising.

  16. American and German students' knowledge, perceptions, and behaviors with respect to over-the-counter pain relievers.

    PubMed

    Hanoch, Yaniv; Katsikopoulos, Konstantinos V; Gummerum, Michaela; Brass, Eric P

    2007-11-01

    To better understand the knowledge base and perceptions involved in the decision to buy and use over-the-counter pain relievers (OTCPRs) by taking into account the environment in which these decisions are made. The authors expected that the differences in access and marketing would affect knowledge and decision making related to OTCPRs in the United States and Germany. A survey was given to 108 undergraduate university students in the United States and Germany (58 and 50 participants, respectively). The authors found that significantly more Americans than Germans take OTCPRs and that they also take significantly more OTCPRs. Americans exhibited less knowledge about side effects than their German counterparts. When asked when they consulted package labels, Americans reported they were more likely to do so before buying a product, whereas Germans reported consulting labels before taking OTCPRs for the first time. Package labels affected more Americans' decisions to purchase OTCPRs; Americans were also less likely to consult a doctor when feeling pain but more likely to take OTCPRs. Finally, Americans viewed OTCPRs as riskier after their status changed from prescription only to over the counter, whereas Germans believed they posed less risk. This study analyzed health-related behavior by looking at how environmental factors shape decision processes related to over-the-counter drug use. The results indicate that looking at environmental factors does help to explain differences in knowledge, perceptions, and behaviors among German and American students. (PsycINFO Database Record (c) 2007 APA, all rights reserved).

  17. Perceived stress levels among HIV/AIDS-infected mothers: the role of over-the-counter products.

    PubMed

    Ellis, Walter L

    2012-01-01

    The purpose of this study was to identify correlates of perceived stress levels among 49 HIV/AIDS-infected mothers enrolled in a social services agency that provides HIV/AIDS support services in North Carolina. The author found in an Ordinary Least Squares regression analysis that the CD4 t-cell count, receipt of advice or support from church pastor, annual household income, and employed were all negatively related to seropositive mothers' perceived stress scores. Conversely, the need to have borrowed money from family members or friends to help pay for over-the-counter products like nutritional drinks, vitamins, or minerals was found to be positively related to these scores. The accessibility of these over-the-counter products could not only help to lower seropositive mothers' perceived stress levels but also potentially improve the functioning of their body's immune system. Implications for the Medicaid Program's prescription drug policy that excludes these over-the-counter products and prescription drug representatives are discussed.

  18. 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

  19. 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

  20. “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

  1. Acylhydrazone bond dynamic covalent polymer gel monolithic column online coupling to high-performance liquid chromatography for analysis of sulfonamides and fluorescent whitening agents in food.

    PubMed

    Zhang, Chengjiang; Luo, Xialin; Wei, Tianfu; Hu, Yufei; Li, Gongke; Zhang, Zhuomin

    2017-10-13

    A new dynamic covalent polymer (DCP) gel was well designed and constructed based on imine chemistry. Polycondensation of 4,4'-biphenyldicarboxaldehyde and 1,3,5-benzenetricarbohydrazide via Schiff-base reaction resulted in an acylhydrazone bond gel (AB-gel) DCP. AB-gel DCP had three-dimensional network of interconnected nanoparticles with hierarchically porous structure. AB-gel DCP was successfully fabricated as a monolithic column by an in-situ chemical bonding method for online enrichment and separation purpose with excellent permeability. AB-gel DCP based monolithic column showed remarkable adsorption affinity towards target analytes including sulfonamides (SAs) and fluorescent whitening agents (FWAs) due to its strong π-π affinity, hydrophobic effect and hydrogen bonding interaction. Then, AB-gel DCP based monolithic column was applied for online separation and analysis of trace SAs and FWAs in food samples coupled with high-performance liquid chromatography (HPLC). Sulfathiazole (ST) and sulfadimidine (SM2) in one positive weever sample were actually found and determined with concentrations of 273.8 and 286.3μg/kg, respectively. 2,5-Bis(5-tert-butyl-2-benzoxazolyl) thiophene (FWA184) was actually quantified in one tea infusion sample with the concentration of 268.5ng/L. The spiked experiments suggested the good recoveries in range of 74.5-110% for SAs in weever and shrimp samples with relative standard deviations (RSDs) less than 9.7% and in range of 74.0-113% for FWAs in milk and tea infusion samples with RSDs less than 9.0%. AB-gel DCP monolithic column was proved to be a promising sample preparation medium for online separation and analysis of trace analytes in food samples with complex matrices. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Whitening techniques using the diode laser and halogen lamp in human devitalized primary teeth.

    PubMed

    Gontijo, Isa T; Navarro, Ricardo S; Ciamponi, Ana Lídia; Zezell, Denise Maria

    2008-01-01

    The aim of this study was to make an in vivo assessment of 2 whitening techniques in deciduous teeth, with the variable being the source of energy activation. Ten upper central incisors darkened by trauma were selected and whitening agent used was a 35% hydrogen peroxide. The teeth were distributed into 2 groups: group 1-activation with an infrared diode laser (GaAlAs), and group 2-activation with a halogen lamp. Assessment of whitening was done by color analysis with the Vita 3D scale at 3 different times: before whitening, immediately after whitening, and 1 week after whitening. A Kruskal-Wallace test showed that there were no significant difference between the 2 groups when comparing group 1 and 2 and comparing 2 and 3 immediately and after 1 week of treatment. Laser activation of the whitening agent was not more effective than halogen light activation for root canal-treated deciduous teeth.

  3. Exploration of over the counter sales of antibiotics in community pharmacies of Addis Ababa, Ethiopia: pharmacy professionals' perspective.

    PubMed

    Gebretekle, Gebremedhin Beedemariam; Serbessa, Mirgissa Kaba

    2016-01-01

    Over the counter sale of antibiotics is a global problem and it is increasingly recognized as a source of antibiotic misuse and is believed to increase treatment costs, adverse effects of treatment and emergence of resistance. The increasing trend of over the counter sale of antibiotics in Ethiopia calls for exploration of why such dispensing is practiced. This study aims to explore reasons for over the counter sale of antibiotics in the community pharmacies of Addis Ababa, Ethiopia. A phenomenological qualitative study was conducted in five randomly selected community pharmacies of Addis Ababa. One pharmacy professional from each pharmacy were interviewed at the spot using semi-structured, open-ended interview checklist. Besides, observation of professionals' dispensing practice was made for at least one hour in the same community pharmacies using an observation checklist. Findings were categorized into specific themes that were developed following the objectives. This was facilitated by use of OpenCode 3.6 software. All participants pointed out that antibiotics were frequently dispensed without prescription and contend that the trend of such dispensing has been increasing. The findings indicated that the nonprescription sales of antibiotics were common for Amoxicillin, Ciprofloxacin and Cotrimoxazole. The poor, less educated and younger groups of the population were reported to frequently request antibiotics without prescription. The main reasons for nonprescription sale of antibiotics by pharmacy professionals were found to be related to pharmacy owner's influence to maximize revenue, customer's pressure, weak regulatory mechanism and professional conflicts of interest. The study shows that nonprescription sale of antibiotics was common practice at least in Addis Ababa. The main reasons for this malpractice were the need to maximize revenue and weak regulatory mechanism. Hence, strong regulatory enforcement and community awareness campaign is called for to limit

  4. Intoxication with over-the-counter antitussive medication containing dihydrocodeine and chlorpheniramine causes generalized convulsion and mixed acidosis.

    PubMed

    Murao, Satoshi; Manabe, Hiroaki; Yamashita, Tetsuji; Sekikawa, Takashi

    2008-01-01

    We report a 35-year-old man who was referred to our hospital with generalized convulsion and mixed acidosis presumably caused by abuse of SS-BRON tablets, an over-the-counter (OTC) antitussive medication sold in Japan. These tablets contain dihydrocodeine phosphate, methylephedrine, chlorpheniramine, and caffeine. Although it is difficult to discern which component caused these symptoms, it seems that dihydrocodeine phosphate or methylephedrine was involved in the addiction to SS-BRON and chlorpheniramine may have caused the generalized convulsion. It should be recognized that an OTC antitussive, which is quite easy to obtain, can be abused and subsequently induce serious intoxication.

  5. Patient knowledge of the paracetamol content of over-the-counter (OTC) analgesics, cough/cold remedies and prescription medications.

    PubMed

    Wood, David M; English, Edward; Butt, Saera; Ovaska, Hanna; Garnham, Francesca; Dargan, Paul I

    2010-11-01

    To test, by completion of a simple questionnaire, patient knowledge of whether 15 commonly used over-the-counter and prescription analgesics and cough/cold remedies contained paracetamol and patient knowledge of the 4 g maximum daily dose of paracetamol. Patients in the emergency department triage waiting area of a busy London teaching hospital were asked to complete a standardised one-page questionnaire. From a list of 15 commonly used over-the-counter and prescription products, patients were asked which contained paracetamol, responding 'yes', 'no' or 'not sure' for each. They were also asked to state the recommended maximum daily dose of paracetamol. 910 patients were enrolled in the study (mean age 39 years, 53% women). The mean±SD score was 6.5±2.5. The maximum score was 14 (n=2) and the minimum score was 0 (n=11). For the recommended maximum daily dose, 93.7% (n=853) of patients gave an answer. Of these, 53.8% answered correctly, 4.7% quoted a supratherapeutic dose and 41.5% a subtherapeutic dose. Patient knowledge of paracetamol-containing products and of the maximum daily dose is currently insufficient to ensure safe use of the drug. Interventions are required to address these knowledge gaps to prevent unintentional repeated supratherapeutic ingestion of paracetamol. These interventions could include targeted public education and/or appropriate and effective medication labelling.

  6. Nonmedical use of over-the-counter medications is significantly associated with nonmedical use of prescription drugs among university students.

    PubMed

    Le, Vi T; Norris Turner, Abigail; McDaniel, Anne; Hale, Kenneth M; Athas, Christina; Kwiek, Nicole C

    2017-08-16

    To examine the association between nonmedical use of over-the-counter medications (NMUOTC) and nonmedical use of prescription drugs (NMUPD). University students surveyed on NMUOTC and NMUPD between August and December 2011 (N = 939). Cross-sectional data analysis of online survey. The majority of respondents were women, undergraduate, Caucasian, and not affiliated with Greek life. NMUPD and NMUOTC were reported by 21.4% and 11.2% of students, respectively. NMUOTC was significantly associated with NMUPD in unadjusted analyses and after adjustment for gender, age, race/ethnicity, and Greek membership (odds ratio: 3.37, 95% confidence interval: 2.17, 5.23). Secondary analyses showed a relationship between over-the-counter (OTC) cough medication misuse and NMUPD, OTC stimulant misuse and prescription stimulant misuse, and OTC sleep aid misuse with prescription depressant misuse. Results suggest the importance of both measuring the prevalence of OTC misuse and incorporating its misuse into assessments of polydrug use in the university population.

  7. Effect of various tooth whitening modalities on microhardness, surface roughness and surface morphology of the enamel.

    PubMed

    Kwon, So Ran; Kurti, Steven R; Oyoyo, Udochukwu; Li, Yiming

    2015-09-01

    The purpose of this study was to evaluate the effect of four whitening modalities on surface enamel as assessed with microhardness tester, profilometer, and scanning electron microscopy (SEM). Whitening was performed according to manufacturer's directions for over-the-counter (OTC), dentist dispensed for home use (HW) and in-office (OW) whitening. Do-it-yourself (DIY) whitening consisted of a strawberry and baking soda mix. Additionally, negative and positive controls were used. A total of 120 enamel specimens were used for microhardness testing at baseline and post-whitening. Following microhardness testing specimens were prepared for SEM observations. A total of 120 enamel specimens were used for surface roughness testing at baseline and post-whitening (n = 20 per group). Rank-based Analysis of Covariance was performed to compare microhardness and surface roughness changes. Tests of hypotheses were two-sided with α = 0.05. There was a significant difference in Knoop hardness changes (ΔKHN) among the groups (Kruskal-Wallis test, p < 0.0001). Significant hardness reduction was observed in the positive control and DIY group (p < 0.0001). Mean surface roughness changes (ΔRa) were significantly different among the groups (Kruskal-Wallis test, p < 0.0001). Surface roughness increased in the OTC group (p = 0.03) and in the positive control (p < 0.0001). The four whitening modalities-DIY, OTC, HW and OW induced minimal surface morphology changes when observed with SEM. It can be concluded that none of the four whitening modalities adversely affected enamel surface morphology. However, caution should be advised when using a DIY regimen as it may affect enamel microhardness and an OTC product as it has the potential to increase surface roughness.

  8. Do patients adhere to over-the-counter artemisinin combination therapy for malaria? evidence from an intervention study in Uganda

    PubMed Central

    2012-01-01

    Background Increasing affordability of artemisinin combination therapy (ACT) in the African retail sector could be critical to expanding access to effective malaria treatment, but must be balanced by efforts to protect the efficacy of these drugs. Previous research estimates ACT adherence rates among public sector patients, but adherence among retail sector purchasers could differ substantially. This study aimed to estimate adherence rates to subsidized, over-the-counter ACT in rural Uganda. Methods An intervention study was conducted with four licensed drug shops in Eastern Uganda in December 2009. Artemether-lumefantrine (AL) was made available for sale at a 95% subsidy over-the counter. Customers completed a brief survey at the time of purchase and then were randomly assigned to one of three study arms: no follow-up, follow-up after two days or follow-up after three days. Surveyors recorded the number of pills remaining through blister pack observation or through self-report if the pack was unavailable. The purpose of the three-day follow-up arm was to capture non-adherence in the sense of an incomplete treatment course ("under-dosing"). The purpose of the two-day follow-up arm was to capture whether participants completed the full course too soon ("over-dosing"). Results Of the 106 patients in the two-day follow-up sample, 14 (13.2%) had finished the entire treatment course by the second day. Of the 152 patients in the three-day follow-up sample, 49 (32.2%) were definitely non-adherent, three (2%) were probably non-adherent and 100 (65.8%) were probably adherent. Among the 52 who were non-adherent, 31 (59.6%) had more than a full day of treatment remaining. Conclusions Overall, adherence to subsidized ACT purchased over-the-counter was found to be moderate. Further, a non-trivial fraction of those who complete treatment are taking the full course too quickly. Strategies to increase adherence in the retail sector are needed in the context of increasing

  9. Over-the-counter medication use for childhood fever: a cross-sectional study of Australian parents.

    PubMed

    Walsh, Anne; Edwards, Helen; Fraser, Jenny

    2007-09-01

    To report Australian parents' medication (paracetamol, ibuprofen and homeopathic) use in childhood fever management. A cross-sectional survey of 401 Queensland parents of children aged between 6 months and 5 years recruited through advertising (48.4%), face-to-face (26.4%) and snowball (24.4%) methods was conducted. A 17-item instrument was developed; construct and content validity were determined by an expert panel; and item reliability by test-retest with nine parents. Areas targeted were medication use and influences on and barriers to medication use. Most participants were female, had tertiary education and lived in a major city (mean age 34.6 years). Reducing children's fever with over-the-counter medications was common (91%): 94% of parents reported using paracetamol and 77% reported using ibuprofen. A few (3.7%) used homeopathic remedies. Dosage was determined by weight (86.3%), age (84.3%), temperature (32.4%), illness severity (31.4%) and lethargy (20.9%). Frequency was determined by instructions on the medication label (55.3%), temperature (40.6%) and well-being (27.7%). Ibuprofen was administered too frequently by 31.5% (four hourly by 22.8%), and paracetamol by 3.8%. Fifty-two per cent had alternated medications, 65.8% of these for temperatures below 38.5 degrees C. Decisions to alternate were influenced by information from doctors/hospitals (49.5%) and children remaining febrile post-antipyretic (41.7%). Most parents reported over-the-counter medications as potentially harmful (73.2%), citing liver (38.2%), stomach (26.4%) and kidney (18.6%) damage and overdose (35.7%) as concerns. When medications were refused or spat out (44.0%), parents used force (62.4%), different methods (29.5%) or suppositories (20.8%). Most parents used over-the-counter medications to reduce fever, often below 38.5 degrees C. The belief that these medications were harmful was overridden by fears of harmful outcomes from fever.

  10. Home-based chemically-induced whitening of teeth in adults.

    PubMed

    Hasson, H; Ismail, A I; Neiva, G

    2006-10-18

    During the last decade tooth whitening products have become widely available in the USA for sale over-the-counter or dispensed by dentists for use at home. With the current rapid growth in demand for tooth whitening it is imperative that the dental community base its recommendations to patients on sound scientific evaluations conducted in well-designed and independent studies. To evaluate the effectiveness (versus a placebo or another active product) and side effects of over-the-counter or dentist-dispensed chemically-based tooth whitening products designed for home use. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, Issue 3); MEDLINE (January 1966 to September week 2 2005); and EMBASE (1988 to week 39 2005). The tables of content of selected dental journals published since 1995 were searched for additional references. Written requests for additional studies and information were mailed to experts in this area of research. After a final set of studies was identified, the list of references reported in the included reports was reviewed to identify additional studies. Studies published in English and non-English were considered in this review. Randomised controlled trials and quasi-randomised controlled trials of dentist-dispensed or over-the-counter tooth whitening products with a chemical action (rather than abrasive action), for home use. Screening of titles and abstracts, data extraction and quality assessment were undertaken independently and in duplicate. A total of 416 articles were identified, 25 of which met the inclusion criteria and presented data that could be used in the analysis. All included trials measured effectiveness immediately after 2 weeks of product application. Only 13 studies reported outcome data 1 week after the 2-week application period, and of those only six reported outcome data after 1 month or longer. Four of the included trials were assessed as at moderate risk of bias and the

  11. Usage of Over-the-Counter and Herbal Products in Common Cold in Poland: Findings from Consumer Survey.

    PubMed

    Karlowicz-Bodalska, K; Miśkiewicz, K; Kurpas, D; Han, S; Kowalczyk, A; Marciniak, D; Dryś, A; Glomb, T; Cedzich, S; Broniecka, U; Kuchar, E

    2016-01-01

    Upper respiratory tract infections are usually self-treated with synthetic and herbal over-the-counter products. The aim of the study was to assess the reasons for the purchase of those medications in Poland. We examined 413 adults, aged 18 and over (70.5% of them were women) using a questionnaire. The findings demonstrate that oral synthetic products were used by 76% of respondents, while herbal products by 30%. Synthetic products were used mainly by educated people under 65 years of age, students, and the employed. Herbal products were used mainly by older people. In conclusion, synthetic products against common cold are perceived as more effective. Such medications are used by people who probably would like to recover and return to professional activity as quickly as possible. As they generally use more medications, they are at increased risk of adverse effects resulting from drug interactions, and they should be a target group for health education programs.

  12. Safety implications of transferring the oral contraceptive from prescription-only to over-the-counter status.

    PubMed

    Potts, M; Denny, C

    1995-12-01

    The idea of making oral contraceptives available without prescription has a long history, and has been recently revived in the US and the UK. High dose oral contraceptives have generally been replaced by low dose formulations and, subsequently, most cardiovascular risks have been reduced and a protection against ovarian and uterine cancers has been consistently demonstrated. Oral contraceptive compliance, however, continues to be a problem, but there is no reason to assume that wise practice would be any more or less if oral contraceptives were available over-the-counter (OTC). Some countries have introduced alternatives to prescription-only oral contraceptives, whereby nurses, midwives, social workers and/or pharmacists are incorporated into the distribution process. This article concludes that the balance of risks and benefits is in favour of OTC access for oral contraceptives.

  13. 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.

  14. Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases.

    PubMed

    Frei, Matthew Y; Nielsen, Suzanne; Dobbin, Malcolm D H; Tobin, Claire L

    2010-09-06

    To investigate morbidity related to misuse of over-the-counter (OTC) codeine-ibuprofen analgesics. Prospective case series collected from Victorian hospital-based addiction medicine specialists between May 2005 and December 2008. Morbidity associated with codeine-ibuprofen misuse. Twenty-seven patients with serious morbidity were included, mainly with gastrointestinal haemorrhage and opioid dependence. The patients were taking mean daily doses of 435-602 mg of codeine phosphate and 6800-9400 mg ibuprofen. Most patients had no previous history of substance use disorder. The main treatment was opioid substitution treatment with buprenorphine-naloxone or methadone. Although codeine can be considered a relatively weak opioid analgesic, it is nevertheless addictive, and the significant morbidity and specific patient characteristics associated with overuse of codeine-ibuprofen analgesics support further awareness, investigation and monitoring of OTC codeine-ibuprofen analgesic use.

  15. Over-the-Counter and Out-of-Control: Legal Strategies to Protect Youths From Abusing Products for Weight Control

    PubMed Central

    Taylor, Lisa M.; Austin, S. Bryn

    2013-01-01

    Abuse of widely available, over-the-counter drugs and supplements such as laxatives and diet pills for weight control by youths is well documented in the epidemiological literature. Many such products are not medically recommended for healthy weight control or are especially susceptible to abuse, and their misuse can result in serious health consequences. We analyzed the government’s role in regulating these products to protect public health. We examined federal and state regulatory authority, and referred to international examples to inform our analysis. Several legal interventions are indicated to protect youths, including increased warnings and restrictions on access through behind-the-counter placement or age verification. We suggest future directions for governments internationally to address this pervasive public health problem. PMID:23237149

  16. Ex vivo effectiveness of French over-the-counter products against head lice (Pediculus humanus capitis De Geer, 1778).

    PubMed

    Combescot-Lang, Catherine; Vander Stichele, Robert H; Toubate, Berthine; Veirron, Emilie; Mumcuoglu, Kosta Y

    2015-05-01

    Head lice infestation is still a public health problem worldwide, with an intracountry and intercountry prevalence variation of 0.7 to 59%. There is a large variety of over-the-counter anti-louse products, but their efficacy is not always well assessed. Our objective was to test the pediculicidal and ovicidal efficacy of 21 over-the-counter head louse products, available in France during the period of 2008 to 2012. We tested children living in Tours City in central France and visiting preschools, primary schools, kindergarten, camps, and child care facilities, as well as children in their family houses, and were examined for the presence of lice. The products were collected from randomly selected pharmacies by covert investigators and then tested in the laboratory on an ex vivo sample of head lice and their eggs, collected from the hair of infested children. Living lice and unharmed eggs were collected from the scalps of 3-12 years old. The laboratory conditions for ex vivo testing mimicked the manufacturers' instructions for exposure time and application method. In 21 runs, 3919 living lice and 4321 undamaged living eggs were collected from the scalp of over 400 children. The 21 products were classified in three groups: 6 products in a group of potentially 100% pediculicidal activity and potentially 100% ovicidal activity, 8 products in a group of potentially 100% pediculicidal activity but insufficient ovicidal activity (including 2 products with claims of single application treatment), and 7 products in a group of insufficient pediculicidal activity and ovicidal activity. The pharmaceutical market for head lice products in France is swamped with poorly tested and ineffective products. Rigorous efficacy testing preregistration and periodic screening and testing of effectiveness in the post-registration period should be endorsed by the health authorities.

  17. Use of Over-the-Counter Analgesics Is Not Associated With Acute Decompensation in Patients With Cirrhosis

    PubMed Central

    KHALID, SAKIB K.; LANE, JILL; NAVARRO, VICTOR; GARCIA–TSAO, GUADALUPE

    2013-01-01

    BACKGROUND & AIMS Over-the-counter analgesics have been proposed to lead to decompensation of compensated cirrhosis or to further decompensation of an already decompensated patient. We performed a prospective, case-control study to investigate the effects of analgesics on acute hepatic decompensation. METHODS Data from consecutive cirrhotic patients hospitalized at 2 tertiary care hospitals for decompensation of cirrhosis (cases, n = 91) were compared with that from consecutive patients with compensated cirrhosis that were followed in the liver clinic (n = 153) and with randomly selected noncirrhotic patients concurrently hospitalized with the cases (n = 89). All patients were given a structured questionnaire to collect information on recent use of acetaminophen, nonsteroidal anti-inflammatory drugs and alcohol. RESULTS Only 32 (35%) of the cirrhotic patients used over-the-counter analgesics (19% acetaminophen, 16% nonsteroidal anti-inflammatory drugs), compared with 80 of the cirrhotic controls (52%; 25% acetaminophen, 31% nonsteroidal anti-inflammatory drugs), and 62 (70%) of the noncirrhotic controls. Acetaminophen use did not differ between groups, even for those with recent alcohol use. The doses and days of nonsteroidal anti-inflammatory drug use were higher among cirrhotic patients, compared with controls. Alcohol ingestion was significantly greater among patients with alcoholic cirrhosis, compared with controls. CONCLUSIONS In patients with cirrhosis, acetaminophen use at doses lower than those recommended is not associated with acute hepatic decompensation, even in patients with recent alcohol ingestion. Nonsteroidal anti-inflammatory drugs might be associated with deleterious effects on cirrhosis. Alcohol ingestion is associated with decompensation in patients with alcoholic cirrhosis. PMID:19394441

  18. Occurrence of phthalate esters in over-the-counter medicines from China and its implications for human exposure.

    PubMed

    Jia, Lu-Lu; Lou, Xiang-Ying; Guo, Ying; Leung, Kelvin Sze-Yin; Zeng, Eddy Y

    2017-01-01

    Food, air, personal care products and indoor dust have been recognized as the main routes of exposure to phthalates in Chinese population, but other sources may have been overlooked, e.g., medicines. To fill the knowledge gap, phthalate esters were measured in 96 over-the-counter medicines made in China, including selected 71 Chinese patented medicines and 25 western medicines. It was found that none of the medicines was free of phthalates. The mean concentrations of individual phthalates ranged from 0.001μg/g (dicyclohexyl phthalate) to 5.85μg/g (diethyl phthalate). Among 9 targeted phthalates, di-n-butyl phthalate was the dominant congener, accounting for >65% of the total phthalates in all medicine samples, followed by di-(2-ethylhexyl) phthalate and diethyl phthalate. Phthalates in medicines appeared to derive from gastroresistant film coatings, plastic packing materials or phthalate contaminated rural herbal plants (especially for Chinese patented medicines). Daily human exposure to phthalates was estimated for local patients for one treatment cycle (e.g., one week) based on suggested consumption dosage and phthalate concentrations. Almost all exposure levels were below the guidelines suggested by the United States Environmental Protection Agency or European Food Safety Authority, indicating low health risk with phthalates from consumption of the medicines. In addition, concentration levels of phthalates in patients would increase upon administration but are expected to decrease to the same values as those in patients before they took medicines in several days. Because the number of medicine samples was limited and the concentrations of phthalates varied in a large range, further investigations are needed to acquire more data for better assessment of human health effects for Chinese population. Capsule: Distribution of phthalate esters in over-the-counter medicines and related exposure for Chinese population are examined.

  19. An interactive technology approach to educate older adults about drug interactions arising from over-the-counter self-medication practices.

    PubMed

    Neafsey, Patricia J; Strickler, Zoe; Shellman, Juliette; Chartier, Virginia

    2002-01-01

    An interactive computer program (Personal Education Program [PEP]) designed for the learning styles and psychomotor skills of older adults was used to teach older adults about potential drug interactions that can result from self-medication with over-the-counter (OTC) agents and alcohol. Subjects used the PEP on notebook computers equipped with infrared sensitive touchscreens. Subjects were recruited from senior centers. Those who met age, vision, literacy, independence, and medication use criteria were randomly assigned to one of three groups: (1) PEP plus information booklet; (2) information booklet only; or (3) control. A repeated measures (three time periods 2 weeks apart), three-group design was used. Users of PEP had significantly greater knowledge and self-efficacy scores than both the conventional and control groups at all three time points. The PEP group reported fewer adverse self-medication behaviors over time. Reported self-medication behaviors did not change over time for either the conventional or control groups. Subjects indicated a high degree of satisfaction with the PEP and reported their intent to make specific changes in self-medication behaviors.

  20. 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

  1. Tooth whitening in children.

    PubMed

    Donly, Kevin J; Donly, Adriana Segura; Baharloo, Laila; Rojas-Candelas, Edith; Garcia-Godoy, Franklin; Zhou, Xiaojie; Gerlach, Robert W

    2002-01-01

    Although there are several case reports of vital tooth bleaching in children, there is limited clinical trial evidence of the safety or efficacy of this practice. Accordingly, a new clinical trial was conducted to evaluate the effects of 2 different bleaching systems, a 6.5% hydrogen peroxide strip system and a 10% carbamide peroxide tray system, in a population of preteens and teens. A total of 106 volunteers, aged 11 to 18 years, took part in this 8-week study. Patients were randomized by a ratio of 2:1 to the strip or tray groups, with each group treating the maxillary arch first and then the mandibular arch for 4 consecutive weeks each. Individuals assigned to the strip group used the system twice daily for 30 minutes (a total of 56 contact hours over the 8-week study). Those assigned to the tray group used that system overnight (approximately 448 contact hours). Digital images were obtained at baseline and after every 2-week treatment period. Average tooth color was determined in L*, a*, b* color space, where L* indicated lightness, a* indicated red-green, and b* indicated yellow-blue. Both systems significantly whitened teeth (P < 0.0001). While there were no significant differences between groups with respect to the primary whitening response (delta b*) on the maxillary teeth, 4 weeks of overnight treatment with the 10% carbamide peroxide tray (approximately 224 contact hours) yielded statistically significant whitening (P < 0.05) on the mandibular teeth compared with the 6.5% hydrogen peroxide strip used for 28 hours. Both tooth-whitening systems had similar sensitivity/irritation reported after instructed use. This research demonstrates that tooth whitening in teens may be safely accomplished using either the short-contact-time hydrogen peroxide bleaching strips or the overnight carbamide peroxide tray systems tested in this study.

  2. Anti-calculus and whitening toothpastes.

    PubMed

    van Loveren, Cor; Duckworth, Ralph M

    2013-01-01

    In terms of novel formulations, there seems to have been a shift in emphasis from anti-caries/anti-gingivitis to anti-calculus/whitening toothpastes in recent years. The anti-calculus and whitening effects of toothpastes are to some extent based on the same active ingredients: compounds of high affinity for tooth mineral. Due to this affinity, crystal growth may be hindered (anti-calculus) and chromophores be displaced (whitening). Besides these common ingredients, both types of toothpaste may contain agents specifically aimed at each condition. Clinical studies have shown that these active ingredients can be successfully formulated in fluoride toothpastes to give significant reductions in supragingival calculus and stain formation and facilitate their removal. Some of the ingredients are formulated in toothpastes that additionally contain anti-plaque and anti-gingivitis ingredients, making these toothpastes (together with the fluoride) truly multi-functional. The development of these products is not straightforward because of interaction between formulation components and because the active ingredients must maintain their beneficial characteristics during the shelf life of the paste. Neither a therapeutic benefit (in terms of less gingivitis or less caries) nor a societal benefit (in terms of less treatment demand) has been demonstrated as a result of the anti-calculus and whitening effects of toothpastes.

  3. Efficacy of mouth rinses and toothpaste on tooth whitening.

    PubMed

    Torres, C R G; Perote, L C C C; Gutierrez, N C; Pucci, C R; Borges, A B

    2013-01-01

    People increasingly desire tooth whitening. Considering the wide range of whitening products on the market, this study evaluated the efficacy of whitening toothpastes and mouth rinses compared with the 10% carbamide peroxide (CP) whitening gel. We obtained 120 cylindrical specimens from bovine teeth, which were darkened for 24 hours in a coffee solution. The color measurement was performed by a spectrophotometer using the CIE L*a*b* system, and specimens were divided into six groups according to the use of the following agents: group 1, conventional fluoridated toothpaste; group 2, Close Up White Now; group 3, Listerine Whitening; group 4, Colgate Plax Whitening; group 5, experimental mouth rinse with Plasdone; and group 6, 10% CP Whiteness Perfect. After the simulation of 12 weeks of treatment for groups 1 to 5 and 14 days of treatment for group 6, the specimens were subjected to a new color reading. Data were subjected to one-way analysis of variance (α=0.05), which showed significant differences among groups after 12 weeks for ΔE (p=0.001). Results of the Tukey test revealed that groups 3, 4, and 6 presented significantly higher color alteration than groups 1, 2, and 5. The whitening toothpaste Close Up White Now and the experimental mouth rinse with Plasdone showed similar color alteration as conventional toothpaste after a 12-week treatment simulation. These groups presented significantly lower color alteration compared with whitening mouth rinses Listerine and Colgate Plax Whitening, which showed similar results to those observed after 14 days of bleaching with 10% CP treatment.

  4. A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury.

    PubMed

    Scheiman, James M; Cryer, Byron; Kimmey, Michael B; Rothstein, Richard I; Riff, Dennis S; Wolfe, Michael M

    2004-04-01

    Ibuprofen is a well-tolerated nonsteroidal anti-inflammatory drug (NSAID), particularly at over-the-counter (OTC) doses. Cyclooxygenase 2 (COX-2)-selective inhibitors cause less ulceration than prescription-dose nonselective NSAIDs. We compared endoscopic injury related to nonprescription ibuprofen doses with celecoxib, also comparing prescription doses of naproxen with placebo as a positive control. The study was a randomized, placebo-controlled, double blind, double-dummy endoscopic evaluation with concealed allocation. A 2-way crossover with a 4-5-week washout period was used. Participants were healthy adults with normal baseline findings from endoscopy. Ninety-five subjects were randomly assigned, and 79 subjects completed both study phases. Age distribution was reflective of the target population of the OTC agent. Twenty percent were infected with Helicobacter pylori, and 79% and 67% had a current or past medical problem, respectively. Qualifying subjects, stratified by the presence or absence of H. pylori infection (n = 20), were randomly assigned to 1 of the 4 sequences (phase I/II) as follows: ibuprofen/celecoxib; celecoxib/ibuprofen, naproxen/placebo, or placebo/naproxen. Primary end points were the frequency of endoscopic ulcers and erosions in the groups administered: (1) celecoxib vs. ibuprofen and (2) naproxen vs. placebo. In celecoxib-treated subjects, 2.6% developed ulcers compared with 17.9% of those treated with ibuprofen (P = 0.056). Naproxen treatment was associated with a significantly greater ulceration rate compared with placebo. Short-term use of the nonselective COX inhibitors ibuprofen and naproxen is associated with a greater risk for endoscopic mucosal injury compared with the COX-2-selective inhibitor celecoxib or placebo. A prospective analysis appropriately powered to address the incidence of clinically significant gastroduodenal ulceration associated with the short-term use of these agents would be required to further define the

  5. Clinic versus over-the-counter access to oral contraception: choices women make along the US-Mexico border.

    PubMed

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

    2010-06-01

    As part of the Border Contraceptive Access Study, we interviewed oral contraceptive (OC) users living in El Paso, Texas, to assess motivations for patronizing a US clinic or a Mexican pharmacy with over-the-counter (OTC) pills and to determine which women were likely to use the OTC option. We surveyed 532 clinic users and 514 pharmacy users about background characteristics, motivations for choosing their OC source, and satisfaction with this source. Older women and women born and educated in Mexico were more likely to patronize pharmacies. Cost of pills was the main motivation for choosing their source for 40% of pharmacy users and 23% of clinic users. The main advantage cited by 49% of clinic users was availability of other health services. Bypassing the requirement to obtain a doctor's prescription was most important for 27% of pharmacy users. Both groups were very satisfied with their pill source. Women of different ages, parities, and educational levels would likely take advantage of an OTC option were OCs available at low cost. Improving clinic provision of OCs should be considered.

  6. JAAD online. Over-the-counter scar products for postsurgical patients: disparities between online advertised benefits and evidence regarding efficacy.

    PubMed

    Morganroth, Pamela; Wilmot, Alissa Cowden; Miller, Christopher

    2009-12-01

    Surgical patients frequently read about over-the-counter (OTC) scar products online and ask physicians for advice about product use. We summarized the characteristics of the 20 best-selling scar products on the Web site drugstore.com and reviewed the medical literature for data supporting the efficacy of OTC scar products used on fresh postsurgical wounds. Products had an average price of $16.25 (range $9.49-$59.99) and an average of 9.2 ingredients (range 1-29). Silicone, vitamin E, and onion extract were common ingredients. Although weak evidence indicates that silicone gel dressings may improve postsurgical scar appearance, published evidence does not support postoperative use of most scar products. However, many products have multiple ingredients, and few clinical trials assess the ingredient combinations of specific products. The practical information about OTC scar products and published efficacy data found in this review may help physicians to counsel patients about postsurgical product use and counter unrealistic expectations gained from online advertisements.

  7. 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.

  8. Evidence-based treatment of frequent heartburn: the benefits and limitations of over-the-counter medications.

    PubMed

    McRorie, Johnson W; Gibb, Roger D; Miner, Philip B

    2014-06-01

    This review summarizes the pharmacological effects of over-the-counter (OTC) heartburn drugs, and the implications for treating frequent heartburn. PubMed and SCOPUS were searched across all years to identify well-controlled, randomized clinical studies that assessed mechanism of action and efficacy. Antacids can transiently neutralize acid in the esophagus, but do not significantly affect gastric pH or prevent subsequent heartburn episodes. Histamine-2 receptor antagonists (H2 RAs) rapidly develop tolerance with repeat dosing, and exhibit an analgesic effect that may provide heartburn relief while leaving the esophagus exposed to acid. Proton pump inhibitors (PPIs) provide a sustained inhibition of gastric acid production, and are superior to antacids and H2 RAs for control of gastric acid and treatment of frequent heartburn. When recommending therapies for frequent heartburn, it is of particular importance to understand the strengths and weaknesses of available OTC medications. Antacids and H2 RAs are not recommended for treatment of frequent heartburn, while OTC PPIs are both indicated for, and effective for, treatment of frequent heartburn. A PPI dose of 20 mg is optimal for empiric treatment of frequent heartburn, and consistent with the 2013 treatment guidelines established by the American College of Gastroenterology (ACG) for treatment with a minimum effective dose. ©2014 The Author(s) ©2014 American Association of Nurse Practitioners.

  9. Demographic, risk, and spatial factors associated with over-the-counter syringe purchase among injection drug users.

    PubMed

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

    2012-07-01

    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.

  10. "Social medication" and the control of children: a qualitative study of over-the-counter medication among Australian children.

    PubMed

    Allotey, Pascale; Reidpath, Daniel Diamond; Elisha, Danielle

    2004-09-01

    The aim of the study was to identify the patterns of use of over-the-counter (OTC) medications among children. The study used a qualitative design, with in-depth interviews of 40 parents with children <5 years of age. There were 3 striking and readily apparent themes in the use of OTC medications among children. One was the administration of OTC medications as a form of "social medication," to give parents control over children's behavior that they perceived as fractious and irritating. A related theme was the use of OTC medications to reduce the inconvenience to the parents of having a sick child, again giving parents greater control and better time-management abilities. Finally, acetaminophen was considered by many parents to have almost miraculous properties in calming, sedating, and lifting the mood of children. The use of OTC medications for the treatment of minor ailments among children is widespread, despite the lack of evidence of efficacy of the most commonly used medications and the potential for toxicity. With the increasing propensity to look to medication as a means of supporting changing lifestyles, there is an urgent need to review the prevalence and effects of social medication.

  11. 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.

  12. 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

    2017-05-24

    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.

  13. Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis

    PubMed Central

    Weber, Teresa M.; Herndon, James H.; Ewer, Melissa; Stephens, Thomas J.; Flick, Iris; Filbry, Alexander; Neufang, Gitta; Schoelermann, Andrea M.

    2015-01-01

    ABSTRACT Background Two steroid-free, over-the-counter skin protectant products have been developed for the care and treatment of atopic dermatitis (AD)—Eucerin Eczema Relief Body Crème (Body Cream) for daily skin moisturization and Eucerin Eczema Relief Instant Therapy cream (Instant Therapy) for treatment of AD flare-ups. We tested the efficacy and tolerability of these formulations in infants and children with AD. Methods Study 1: Body Cream was applied twice daily to the lower legs of 64 children with a history of AD (aged 3 months to 12 years) for 14 days. Study 2: Instant Therapy was applied to active lesions and surrounding skin of 29 children (aged 3 months to 12 years) with active atopic lesions. Assessments were performed at baseline and Days 7 and 14. Symptoms were assessed using the Atopic Dermatitis Severity Index in Study 2. Results Body Cream significantly improved skin hydration and reduced itching, burning/stinging, erythema, and tactile roughness. Instant Therapy significantly improved skin hydration and AD symptoms, notably pruritus, erythema, and lichenification. Both products were safe and well tolerated. Discussion Body Cream and Instant Therapy were effective and well tolerated in the treatment of AD in children. These products provide steroid-free, nonprescription therapy for the maintenance and treatment of acute eczema and were proven effective and safe in infants as young as 3 months. PMID:25699134

  14. PHYSICIAN AND PARENT RESPONSE TO THE FDA ADVISORY ABOUT USE OF OVER THE COUNTER COUGH AND COLD MEDICATIONS

    PubMed Central

    Garbutt, Jane M.; Sterkel, Randall; Banister, Christina; Walbert, Carrie; Strunk, Robert C.

    2012-01-01

    OBJECTIVE To assess the likely impact of the Food and Drug Administration (FDA) advisory not to use over-the-counter (OTC) cough and cold products for children < 2 years old on care provided by pediatricians and parents METHODS One-hundred and five community pediatricians completed a mailed survey (53% response rate), and 1,265 parents with children < 12 years old completed a self-administered survey while waiting for an office visit. RESULTS All physicians were aware of the advisory; 75% agreed with it. Fifty-nine percent did not recommend OTC cough and cold products for children < 2 years old before the advisory and 35% were less likely to do so afterwards. Seventy-three percent of parents were aware of the advisory, 70% believed these products relieved symptoms, 68% did not believe they were dangerous, and 74% had them at home. After the advisory, 21% of parents were more likely to request an antibiotic from the doctor. 225 parents only had children < 2 years old and 695 only had children 2–11 years old. Among these parental groups respectively, 53% and 10% of parents did not use these products before the advisory, an additional 33% and 28% were less likely to do so afterwards, and 15% and 61% would continue use them. CONCLUSIONS Pediatricians must be prepared for requests from parents for antibiotics and other remedies for symptom relief for their children with colds. As no effective alternatives are available maybe non-treatment should be promoted. PMID:19819775

  15. Over-the-counter analgesics normalize blood glucose and body composition in mice fed a high fat diet.

    PubMed

    Kendig, Eric L; Schneider, Scott N; Clegg, Deborah J; Genter, Mary Beth; Shertzer, Howard G

    2008-07-15

    Type 2 diabetes (noninsulin-dependent diabetes mellitus) develops from a pre-diabetic condition that is characterized by insulin resistance and glucose intolerance, and is exacerbated by obesity. In this study, we compared the ability of over-the-counter analgesic drugs (OTCAD) [acetaminophen (APAP); ibuprofen (IBU); naproxen (NAP); aspirin (ASA)], to protect against the development of a pre-diabetic state in mice fed a high fat diet. After 10 weeks on the high fat diet, mice had normal fasting blood glucose (FBG) levels, but exhibited impaired glucose tolerance. Treatment with 20 mg OTCADs/kg body weight improved glucose tolerance, with the order of efficacy, APAP=ASA>IBU, while NAP proved ineffective. Mice fed the high fat diet also exhibited increases in weight gain associated with an increase in body fat. OTCADs prevented in part this increase in body fat, in the order of efficacy, APAP=IBU>NAP=ASA. In isolated liver mitochondria, OTCADs inhibited succinate-dependent H2O2 production, while in white adipose tissue, APAP inhibited NADPH-oxidase mediated H2O2 production and lipid peroxidation. Thus, OTCADs diminish pro-oxidant processes that might otherwise exacerbate inflammation and a pre-diabetic state. We conclude that OTCADs, especially APAP and IBU, may be valuable tools to delay or prevent the development of type 2 diabetes from a pre-diabetic condition.

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

    PubMed

    Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; Kato, Yamato; Nakayama, Yoko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Over-the-counter (OTC) drugs play an important role in self-medication. To ensure patient safety, pharmacists should ask patients to pay attention to possible adverse events (AE) associated with OTC drugs and educate patients about the symptoms related to those AEs. The aims of the present study were as follows: (1) to assess the tendency of AEs to occur with OTC drug use in Japan; (2) to detect a safety signal for OTC drugs using the reporting odds ratio (ROR); and (3) to evaluate clustery features, which include suspected drugs and therapeutic classifications, and safety signal indices (number of reports and the ROR), using cluster analysis. The number of reports of AEs following use of combination cold remedy, antipyretic and analgesic remedy, and herbal medicine was 1007, 566, and 221, respectively. We set the cluster number at five; clustery features obtained were as follows: (1) high reporting rate for skin and subcutaneous tissue disorder AEs was the largest group related to combination cold remedy; (2) high reporting rate for nervous system disorder AEs including dizziness was the second largest group. The same medicinal ingredient may demonstrate similar tendencies of the occurrence of AEs and similar clustery features in the Japanese Adverse Drug Event Report database. Our analysis of AEs associated with OTC drugs may be useful for pharmacists and patients alike. Further studies are required to draw better-informed conclusions.

  17. 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.

  18. "But it's just paracetamol": Caregivers' ability to administer over-the-counter painkillers to children with the information provided.

    PubMed

    Bennin, Fiona; Rother, Hanna-Andrea

    2015-03-01

    To determine whether caregivers are able to make informed decisions about their families' use of over-the-counter (OTC) painkillers through access to and use of three mechanisms of information provision. A cross sectional, face-to-face questionnaire was administered to 60 caregivers and seven pharmacists in Cape Town, South Africa. Caregivers answered questions related to paracetamol (acetaminophen) labels, inserts and Patient Information Leaflets (PIL). Most study caregivers received labels with the painkillers they purchased. Many pharmacists (43%) felt that the information provided was ineffective in preventing overdosing. Study caregivers found it difficult to understand the scientific terms in all three mechanisms of information provision. Most respondents (80%) found the PIL easiest to understand, yet few had received PILs with their purchase. Ten percent of literate respondents were unable to understand the dosage requirements for children. Most caregivers are not able to make informed decisions from the information provided with OTC painkillers. This is mostly attributable to limited provision of information and low health literacy. Written information with OTC medications in simple language and verbal counselling at dispensaries would play a significant role in increasing the health literacy of especially at risk populations of over-dosing their children. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  19. Over-the-Counter Relief From Pains and Pleasures Alike: Acetaminophen Blunts Evaluation Sensitivity to Both Negative and Positive Stimuli.

    PubMed

    Durso, Geoffrey R O; Luttrell, Andrew; Way, Baldwin M

    2015-06-01

    Acetaminophen, an effective and popular over-the-counter pain reliever (e.g., the active ingredient in Tylenol), has recently been shown to blunt individuals' reactivity to a range of negative stimuli in addition to physical pain. Because accumulating research has shown that individuals' reactivity to both negative and positive stimuli can be influenced by a single factor (an idea known as differential susceptibility), we conducted two experiments testing whether acetaminophen blunted individuals' evaluations of and emotional reactions to both negative and positive images from the International Affective Picture System. Participants who took acetaminophen evaluated unpleasant stimuli less negatively and pleasant stimuli less positively, compared with participants who took a placebo. Participants in the acetaminophen condition also rated both negative and positive stimuli as less emotionally arousing than did participants in the placebo condition (Studies 1 and 2), whereas nonevaluative ratings (extent of color saturation in each image; Study 2) were not affected by drug condition. These findings suggest that acetaminophen has a general blunting effect on individuals' evaluative and emotional processing, irrespective of negative or positive valence. © The Author(s) 2015.

  20. Over-the-Counter Relief From Pains and Pleasures Alike: Acetaminophen Blunts Evaluation Sensitivity to Both Negative and Positive Stimuli

    PubMed Central

    Durso, Geoffrey R. O.; Luttrell, Andrew; Way, Baldwin M.

    2015-01-01

    Acetaminophen, an effective and popular over-the-counter pain reliever (e.g., the active ingredient in Tylenol), has recently been shown to blunt individuals’ reactivity to a range of negative stimuli in addition to physical pain. Because accumulating research has shown that individuals’ reactivity to both negative and positive stimuli can be influenced by a single factor (an idea known as differential susceptibility), we conducted two experiments testing whether acetaminophen blunted individuals’ evaluations of and emotional reactions to both negative and positive images from the International Affective Picture System. Participants who took acetaminophen evaluated unpleasant stimuli less negatively and pleasant stimuli less positively, compared with participants who took a placebo. Participants in the acetaminophen condition also rated both negative and positive stimuli as less emotionally arousing than did participants in the placebo condition (Studies 1 and 2), whereas nonevaluative ratings (extent of color saturation in each image; Study 2) were not affected by drug condition. These findings suggest that acetaminophen has a general blunting effect on individuals’ evaluative and emotional processing, irrespective of negative or positive valence. PMID:25862546

  1. Investigation of social, demographic and health variations in the usage of prescribed and over-the-counter medicines within a large cohort (South Yorkshire, UK)

    PubMed Central

    Green, Mark A; Little, Emma; Cooper, Richard; Relton, Clare; Strong, Mark

    2016-01-01

    Objectives Prescribed and over-the-counter (non-prescribed) medicine usage has increased in recent years; however, there has been less investigation of the socioeconomic predictors of use. This has been due to a lack of data, especially for over-the-counter medicines. Our study aims to understand how prescribed and over-the-counter medicine patterns vary by demographic, social and health characteristics within a large population cohort. Design Cross-sectional data analysis. Setting South Yorkshire, UK. Participants 27 806 individuals from wave 1 of the Yorkshire Health Study (2010–2012). Measures Individuals self-reported each medicine they were taking and whether each was prescribed or not. The medicines were grouped into 14 categories (eg, cardiovascular system, infection, contraception). Negative binomial regression models were used to analyse the count of medicine usage. We included demographic (age, gender, ethnicity), social (education), health-related (body mass index, smoking, alcohol consumption, physical activity) factors and chronic health conditions (eg, stroke, anxiety and heart disease) in our analyses. Results 49% of men and 62% of women were taking medicine with the majority of this prescribed (88% and 83%, respectively). Health conditions were found to be positively associated with prescribed medicine usage, but mixed in their associated with over-the-counter medicines. Educational attainment was negatively associated with prescribed and positively associated with over-the-counter usage. Conclusions Our study addresses a dearth of evidence to provide new insights into how behaviours in medicine usage vary by demographic, social and health-related factors. Differences in over-the-counter medicine usage by educational attainment may help our understanding of the determinants of health inequalities. PMID:27683515

  2. Erosion Potential of Tooth Whitening Regimens as Evaluated with Polarized Light Microscopy.

    PubMed

    Brambert, Patrick; Qian, Fang; Kwon, So Ran

    2015-11-01

    Tooth whitening is a widely utilized esthetic treatment in dentistry. With increased access to over-the-counter (OTC) systems concerns have been raised as to potential adverse effects associated with overuse of whitening materials. Therefore, this study aimed to evaluate enamel erosion due to different whitening regimens when used in excess of recommended guidelines. Extracted human teeth (n = 66) were randomly divided into 11 groups (n = 6/group). Specimens were exposed to OTC products: Crest Whitestrips and 5-minute natural white and a do-it-yourself (DIY) strawberry whitening recipe. Within each regimen, groups were further divided per exposure time: specimens receiving the recommended product dosage; 5 times the recommended dosage; and 10 times the recommended dosage. Negative and positive controls were treated with grade 3 water and 1.0% citric acid, respectively. Specimens were nail-varnished to limit application to a 1 × 4 mm window. Following treatment, specimens were sectioned and erosion (drop in μm) measured using polarized light microscopy. Two-sample t-test was used to detect difference in amount of enamel erosion between negative and positive groups, while one-way analysis of variance (ANOVA), followed by post hoc Dunnett's test was used to detect difference between set of treatment groups and negative control groups or among all experimental groups. There was significant difference in mean amount of enamel erosion (p < 0.0001). Mean enamel erosion for positive control group was significantly greater than that for negative control group (23.50 vs 2.65 μm). There was significant effect for type of treatments on enamel erosion [F(9,50) = 25.19; p < 0.0001]. There was no significant difference between the negative control and each of treatment groups (p > 0.05 for all instances), except for Natural White_10 times treatment group (p < 0.0001) that was significantly greater than the negative control group (14.82 vs 2.65 μm). Caution is advised when

  3. Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: Paediatric deaths associated with over the counter cough and cold medicines.

    PubMed

    Deschler, Deanna; Judge, Bryan

    2014-02-01

    A short cut review was carried out to establish whether over the counter cough and cold medicines were associated with unexpected deaths in childhood. 115 papers were found using the reported searches, of which three presented the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of those best papers are tabulated. It is concluded that while over the counter cough and cold medications may be associated with unexpected paediatric deaths, the degree of risk is not clear.

  4. Characterization of suspected illegal skin whitening cosmetics.

    PubMed

    Desmedt, B; Van Hoeck, E; Rogiers, V; Courselle, P; De Beer, J O; De Paepe, K; Deconinck, E

    2014-03-01

    An important group of suspected illegal cosmetics consists of skin bleaching products, which are usually applied to the skin of the face, hands and décolleté for local depigmentation of hyper pigmented regions or more importantly, for a generalized reduction of the skin tone. These cosmetic products are suspected to contain illegal active substances that may provoke as well local as systemic toxic effects, being the reason for their banning from the EU market. In that respect, illegal and restricted substances in cosmetics, known to have bleaching properties, are in particular hydroquinone, tretinoin and corticosteroids. From a legislative point of view, all cosmetic products containing a prohibited whitening agent are illegal and must be taken off the EU market. A newly developed screening method using ultra high performance liquid chromatography-time off flight-mass spectrometry allows routine analysis of suspected products. 163 suspected skin whitening cosmetics, collected by Belgian inspectors at high risk sites such as airports and so-called ethnic cosmetic shops, were analyzed and 59% were classified as illegal. The whitening agents mostly detected were clobetasol propionate and hydroquinone, which represent a serious health risk when repeatedly and abundantly applied to the skin. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Safety and usage pattern of an over-the-counter ambroxol cough syrup: a community pharmacy-based cohort study.

    PubMed

    Schulz, M; Hämmerlein, A; Hinkel, U; Weis, G; Gillissen, A

    2006-09-01

    Mucoactive substances such as ambroxol, available in several countries as over-the-counter (OTC) medicines, are used for the treatment of acute and chronic bronchitis. This study was designed to evaluate the "real life" behavior of consumers with non-prescription access to an ambroxol cough syrup with special focus on tolerability and the pattern of product usage. Customers who bought the ambroxol syrup were recruited in 300 community pharmacies in Germany. Baseline data were collected from the participants in the pharmacy. Completing a self-administered questionnaire, participants provided information on tolerability, self-perceived effectiveness and usage pattern. 2,707 participants were recruited in 266 pharmacies. 2,664 questionnaires were evaluable. At baseline, the respondents reported a complex pattern of symptoms. Productive cough, congested airways, dry cough, cough irritation in the throat and soreness in the throat were the most common ones. 67 patients (2.5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9). No serious or unknown AE were reported. In general, 97% of the participants assessed the safety as "very good" (51%) or "good" (46%). Overall, the respondents complied with the indications for use and the recommended dosages, with only 0.7% of the participants using the maximum daily dose. 92% of the patients assessed the self-perceived effectiveness as "very good" (29%) or "good" (63%) and 89% were willing to purchase this ambroxol cough syrup again. This study confirms that ambroxol is used according to the advice given in the patients' leaflet and supports the already established safety and efficacy of this product in acute bronchitis. It also demonstrates that the use of an OTC cough medication can be successfully monitored in a pharmacy-based cohort study.

  6. Seasonal Variation in Penicillin Use in Mexico and Brazil: Analysis of the Impact of Over-the-Counter Restrictions

    PubMed Central

    Santa-Ana-Tellez, Yared; Mantel-Teeuwisse, Aukje K.; Leufkens, Hubert G. M.

    2014-01-01

    During 2010, Mexico and Brazil implemented policies to enforce existing laws of restricting over-the-counter sales of antibiotics. We determined if the enforcement led to more appropriate antibiotic use by measuring changes in seasonal variation of penicillin use. We used retail quarterly sales data in defined daily doses per 1,000 inhabitant-days (DDD/TID) from IMS Health from the private sector in Mexico and Brazil from the first quarter of 2007 to the first quarter of 2013. This database contains information on volume of antibiotics sold in retail pharmacies using information from wholesalers. We used interrupted time-series models controlling for external factors with the use of antihypertensives with interaction terms to assess changes in trend, level, and variation in use between quarters for total penicillin use and by active substance. The most used penicillin was amoxicillin, followed by amoxicillin-clavulanic acid and ampicillin (minimal use in Brazil). Before the restrictions, the seasonal variation in penicillin use was 1.1 DDD/TID in Mexico and 0.8 DDD/TID in Brazil. In Mexico, we estimated a significant decrease in the seasonal variation of 0.4 DDD/TID after the restriction, mainly due to changes in seasonal variation of amoxicillin and ampicillin. In Brazil, the seasonal variation did not change significantly, overall and in the breakdown by individual active substances. For Mexico, inappropriate penicillin use may have diminished after the restrictions were enforced. For Brazil, increasing use and no change in seasonal variation suggest that further efforts are needed to reduce inappropriate penicillin use. PMID:25313222

  7. Daytime intragastric acid control: post hoc analyses of esomeprazole 20 mg and over-the-counter proton-pump inhibitors

    PubMed Central

    Katz, Philip; Kahrilas, Peter J.; Johnson, David A.; Lind, Tore; Röhss, Kerstin; Traxler, Barry; Hugo, Vincent; Dent, John

    2015-01-01

    Objectives: In mild gastroesophageal reflux disease, which accounts for the great majority of cases, the major burden of reflux occurs during daytime hours, after food intake. The aim of these analyses was to evaluate intragastric pH control during the typical 14-hour daytime awake period by proton-pump inhibitors (PPIs) given at over-the-counter (OTC) dosages. Methods: In one double-blind and three open-label, randomized, crossover studies, intragastric pH was monitored for 24 hours on day 5 of treatment. The 24-hour data have been reported previously. Post hoc analyses reassessed these studies for the 14-hour daytime period, comparing esomeprazole 20 mg with currently available OTC PPIs omeprazole, pantoprazole (not available in the US) and lansoprazole. Results: Subjects maintained intragastric pH >4 for a significantly greater mean percentage of the 14-hour daytime period with esomeprazole 20 mg compared with any of the PPI comparators at OTC dosages. Geometric mean ratios (95% confidence intervals) for esomeprazole 20 mg versus the comparators were: 1.45 (1.14–1.85; p = 0.003) versus omeprazole 20 mg; 2.50 (2.01–3.11; p < 0.0001) versus pantoprazole 20 mg; and 1.69 (1.46–1.97; p < 0.0001) and 1.89 (1.05–3.37; p = 0.03) versus lansoprazole 15 mg. A greater proportion of subjects had better pH control with esomeprazole than with the other PPIs (range: 69–97%). Conclusions: Across the 14-hour daytime period, esomeprazole 20 mg once daily given 30 minutes before breakfast for 5 days provided acid control for a significantly greater average proportion of time versus the PPI comparators omeprazole, pantoprazole and lansoprazole at currently available OTC dosages. PMID:26557888

  8. The Impact of Restricting Over-the-Counter Sales of Antimicrobial Drugs: Preliminary Analysis of National Data.

    PubMed

    Moura, Maria Luísa; Boszczowski, Icaro; Mortari, Naíma; Barrozo, Lígia Vizeu; Chiaravalloti Neto, Francisco; Lobo, Renata Desordi; Pedroso de Lima, Antonio Carlos; Levin, Anna S

    2015-09-01

    To describe the nationwide impact of a restrictive law on over-the-counter sales of antimicrobial drugs, implemented in Brazil in November 2010. Approximately 75% of the population receives healthcare from the public health system and receives free-of-charge medication if prescribed. Total sales in private pharmacies as compared with other channels of sales of oral antibiotics were evaluated in this observational study before and after the law (2008-2012). Defined daily dose per 1000 inhabitants per day (DDD/TID) was used as standard unit. In private pharmacies the effect of the restrictive law was statistically significant (P < 0.001) with an estimated decrease in DDD/TID of 1.87 (s.e. =  0.18). In addition, the trend of DDD/TID before the restrictive law was greater than after the intervention (P < 0.001). Before November 2010, the slope for the trend line was estimated as 0.08 (s.e. = 0.01) whereas after the law, the estimated slope was 0.03 (s.e. = 0.01). As for the nonprivate channels, no difference in sales was observed (P = 0.643). The impact in the South and Southeast (more developed) regions was higher than in the North, Northeast, and Mid-West. The state capitals had a 19% decrease, compared with 0.8% increase in the rest of the states. Before the law, the sales of antimicrobial drugs were steadily increasing. From November 2010, with the restrictive law, there was an abrupt drop in sales followed by an increase albeit at a significantly lower rate. The impact was higher in regions with better socio-economic status.

  9. 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

  10. Parents' decision following the Food and Drug Administration recommendation: the case of over-the-counter cough and cold medication.

    PubMed

    Hanoch, Y; Gummerum, M; Miron-Shatz, T; Himmelstein, M

    2010-11-01

    In 2007, the Food and Drug Administration (FDA) recommended against parents administering over-the-counter cough and cold medications (OTC-CCM) to children under 2 years of age because serious and potentially life-threatening side effects can occur. This study examined the impact of FDA's recommendations against giving children under 2 years old OTC-CCM. We asked parents (n= 377) whether they knew of and trusted the FDA recommendations, as well as whether they intended to follow them. We also examined parents' knowledge, perceptions and behaviours with respect to OTC-CCM. About 33% of our sample had never heard of the FDA recommendations. Of those who were aware, 32.9% intended to continue administering OTC-CCM, and another 36.7% were not sure what to do. Our results indicate that parents who trust the FDA recommendations are significantly more likely to stop giving OTC-CCM to their children. However, almost half did not trust the FDA recommendations or were not sure whether to trust them. Our results indicate that parents who trust the FDA recommendation are significantly more likely to discontinue using OTC-CCM. Our data also reveal that many parents give more than one drug simultaneously (32.9%), cannot identify the active ingredient(s) (28.9%) or fail to store the medications in a safe place (86.1%). Parents' confidence in the FDA recommendations predicted whether they would continue or stop administering OTC-CCM to their children. Our findings illustrate the urgent need for widespread public education about OTC-CCM products to ensure children's safety. © 2010 Blackwell Publishing Ltd.

  11. Is Wetter Better? An Evaluation of Over-the-Counter Personal Lubricants for Safety and Anti-HIV-1 Activity

    PubMed Central

    Dezzutti, Charlene S.; Brown, Elizabeth R.; Moncla, Bernard; Russo, Julie; Cost, Marilyn; Wang, Lin; Uranker, Kevin; Kunjara Na Ayudhya, Ratiya P.; Pryke, Kara; Pickett, Jim; LeBlanc, Marc-André; Rohan, Lisa C.

    2012-01-01

    Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. Therefore, safety and anti-HIV-1 activity of over-the-counter (OTC) aqueous- (n = 10), lipid- (n = 2), and silicone-based (n = 2) products were tested. The rheological properties of the lipid-based lubricants precluded testing with the exception of explant safety testing. Six aqueous-based gels were hyperosmolar, two were nearly iso-osmolar, and two were hypo-osmolar. Evaluation of the panel of products showed Gynol II (a spermicidal gel containing 2% nonoxynol-9), KY Jelly, and Replens were toxic to Lactobacillus. Two nearly iso-osmolar aqueous- and both silicone-based gels were not toxic toward epithelial cell lines or ectocervical or colorectal explant tissues. Hyperosmolar lubricants demonstrated reduction of tissue viability and epithelial fracture/sloughing while the nearly iso-osmolar and silicon-based lubricants showed no significant changes in tissue viability or epithelial modifications. While most of the lubricants had no measurable anti-HIV-1 activity, three lubricants which retained cell viability did demonstrate modest anti-HIV-1 activity in vitro. To determine if this would result in protection of mucosal tissue or conversely determine if the epithelial damage associated with the hyperosmolar lubricants increased HIV-1 infection ex vivo, ectocervical tissue was exposed to selected lubricants and then challenged with HIV-1. None of the lubricants that had a moderate to high therapeutic index protected the mucosal tissue. These results show hyperosmolar lubricant gels were associated with cellular toxicity and epithelial damage while showing no anti-viral activity. The two iso-osmolar lubricants, Good Clean Love and PRÉ, and both silicone-based lubricants, Female Condom 2 lubricant and Wet Platinum, were the safest in our testing algorithm. PMID:23144863

  12. 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.

  13. Over-the-counter fish oil use in a county hospital: Medication use evaluation and efficacy analysis.

    PubMed

    Tatachar, Amulya; Pio, Margaret; Yeung, Denise; Moss, Elizabeth; Chow, Diem; Boatright, Steven; Quinones, Marissa; Mathew, Annie; Hulstein, Jeffrey; Adams-Huet, Beverley; Ahmad, Zahid

    2015-01-01

    Little is known about the use and effectiveness of over-the-counter (OTC) fish oil supplements for triglyceride (TG) lowering. To (1) perform a medication-use evaluation (MUE) and (2) assess the efficacy of OTC fish oil. Retrospective, observational cohort study using electronic medical records and the pharmacy database from Parkland Health and Hospital System in Dallas, Texas. Parkland is a tax-supported county institution that provides patients with single-brand OTC fish oil. Two separate analyses were conducted. Six hundred seventeen patients (prescribed fish oil between July 1, 2012, and August 31, 2012) were included in the MUE analysis and 235 patients (109 fish oil, 72 fenofibrate, and 54 gemfibrozil, prescribed between January 1, 2012, and July 31, 2013) were included in the efficacy analysis. The main outcome measure for the MUE was fish oil prescribing habits including dosages and patient adherence, as defined by medication possession ratio. The main outcome measure for the efficacy analysis was change in lipids measured using the last value before fish oil treatment and the first value after fish oil treatment. MUE: 617 patients received prescriptions for OTC fish oil. Sixty-four percent were prescribed a total daily dose of 2000 mg. Only 25% of patients were adherent. Efficacy analysis: despite being prescribed suboptimal doses, fish oil reduced TGs by 29% (95% confidence interval, 34.3-22.7). Compared with fish oil therapy, fibrate therapy resulted in a greater TG reduction: 48.5% (55.1-41.0) with fenofibrate and 49.8% (57.6-40.5) with gemfibrozil (P < .0001, both medications compared with fish oil). Health care providers prescribe suboptimal doses of fish oil, and adherence is poor. Even at low doses (2 g/d), though, fish oil lowers TGs by 29%. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  14. Over-the-counter fish oil use in a county hospital: Medication use evaluation and efficacy analysis

    PubMed Central

    Tatachar, Amulya; Pio, Margaret; Yeung, Denise; Moss, Elizabeth; Chow, Diem; Boatright, Steven; Quinones, Marissa; Mathew, Annie; Hulstein, Jeffrey; Adams-Huet, Beverley; Ahmad, Zahid

    2016-01-01

    BACKGROUND Little is known about the use and effectiveness of over-the-counter (OTC) fish oil supplements for triglyceride (TG) lowering. OBJECTIVES To (1) perform a medication-use evaluation (MUE) and (2) assess the efficacy of OTC fish oil. METHODS Retrospective, observational cohort study using electronic medical records and the pharmacy database from Parkland Health and Hospital System in Dallas, Texas. Parkland is a tax-supported county institution that provides patients with single-brand OTC fish oil. Two separate analyses were conducted. Six hundred seventeen patients (prescribed fish oil between July 1, 2012, and August 31, 2012) were included in the MUE analysis and 235 patients (109 fish oil, 72 fenofibrate, and 54 gemfibrozil, prescribed between January 1, 2012, and July 31, 2013) were included in the efficacy analysis. The main outcome measure for the MUE was fish oil prescribing habits including dosages and patient adherence, as defined by medication possession ratio. The main outcome measure for the efficacy analysis was change in lipids measured using the last value before fish oil treatment and the first value after fish oil treatment. RESULTS MUE: 617 patients received prescriptions for OTC fish oil. Sixty-four percent were prescribed a total daily dose of 2000 mg. Only 25% of patients were adherent. Efficacy analysis: despite being prescribed suboptimal doses, fish oil reduced TGs by 29% (95% confidence interval, 34.3–22.7). Compared with fish oil therapy, fibrate therapy resulted in a greater TG reduction: 48.5% (55.1–41.0) with fenofibrate and 49.8% (57.6–40.5) with gemfibrozil (P < 0001, both medications compared with fish oil). CONCLUSIONS Health care providers prescribe suboptimal doses of fish oil, and adherence is poor. Even at low doses (2 g/d), though, fish oil lowers TGs by 29%. PMID:26073390

  15. The drugs don't sell: DIY heart health and the over-the-counter statin experience.

    PubMed

    Will, Catherine M; Weiner, Kate

    2015-04-01

    This paper draws on a study of over-the-counter statins to provide a critical account of the figure of the 'pharmaceutical consumer' as a key actor in the pharmaceuticalisation literature. A low dose statin, promising to reduce cardiovascular risk, was reclassified to allow sale in pharmacies in the UK in 2004. We analysed professional and policy debates about the new product, promotional and sales information, and interviews with consumers and potential consumers conducted between 2008 and 2011, to consider the different consumer identities invoked by these diverse actors. While policymakers constructed an image of 'the citizen-consumer' who would take responsibility for heart health through exercising the choice to purchase a drug that was effectively rationed on the NHS and medical professionals raised concerns about 'a flawed consumer' who was likely to misuse the product, both these groups assumed that there would be a market for the drug. By contrast, those who bought the product or potentially fell within its target market might appear as 'health consumers', seeking out and paying for different food and lifestyle products and services, including those targeting high cholesterol. However, they were reluctant 'pharmaceutical consumers' who either preferred to take medication on the advice of a doctor, or sought to minimize medicine use. In comparison to previous studies, our analysis builds understanding of individual consumers in a market, rather than collective action for access to drugs (or, less commonly, compensation for adverse effects). Where some theories of pharmaceuticalisation have presented consumers as creating pressure for expanding markets, our data suggests that sociologists should be cautious about assuming there will be demand for new pharmaceutical products, especially those aimed at prevention or asymptomatic conditions, even in burgeoning health markets. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. How Do US Gastroenterologists Use Over-the-Counter and Prescription Medications in Patients With Gastroesophageal Reflux and Chronic Constipation?

    PubMed

    Menees, Stacy B; Guentner, Amanda; Chey, Samuel W; Saad, Richard; Chey, William D

    2015-11-01

    The aim of this study was to assess how US gastroenterologists perceive and utilize over-the-counter (OTC) and prescription medications for gastroesophageal reflux disease (GERD) and chronic constipation (CC). A total of 3,600 randomly selected American Gastroenterological Association (AGA) members were mailed a 27-question survey that assessed their perceptions and use of OTC and prescription medications. The χ(2) test and Student's t-test were utilized for bivariate analysis. A total of 830 gastroenterologists (23.1%) completed the survey. For the typical acid reflux patient, 50% of gastroenterologists recommended OTC proton pump inhibitors (PPIs), 13% recommended an OTC histamine2 receptor antagonist, whereas 33% recommended a prescription PPI. However, in the typical CC patient, 97% of gastroenterologists initially utilized OTC treatments. The vast majority of gastroenterologists felt that OTC brand name and store brand PPIs (76%) and polyethylene glycol (PEG 3350; 90%) were equally effective. Despite this, a minority "always" or "very often" directed their patients to purchase a store brand PPI (35%) or laxative (40%). In addition, gastroenterologists tended to underestimate the cost savings associated with store brand medicines and had limited knowledge regarding the regulation of store brands. Among US gastroenterologists, OTC medications now dominate primary therapy of GERD and CC. Despite feeling that name brand and store brand PPIs and laxatives are equally effective, the majority of gastroenterologists recommend brand name medicines and underestimate the cost savings associated with store brands. In this age of accountable care, greater efforts to help physicians and patients to better utilize their health-care dollars is warranted.

  1. 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.

  2. Utilisation of prescription and over-the-counter triptans: a cross-sectional study in Stockholm, Sweden.

    PubMed

    Frisk, Pia; Sporrong, Sofia K; Ljunggren, Gunnar; Wettermark, Björn; von Euler, Mia

    2016-06-01

    Triptans are widely used in acute migraine, and in some countries, they are also available over-the-counter (OTC). In Sweden, sales have increased for both prescription and OTC triptans. This study aimed to describe current prescribing and utilisation patterns of prescription and OTC triptans in Stockholm, Sweden. Register data from 4759 patients dispensed triptans in 2014 were used to study documented diagnosis of migraine, concomitant acute and preventive treatment for migraine, and contraindications. Survey data from 49 patients purchasing OTC triptans in three pharmacies were used to capture physician-diagnosed migraine, concomitant acute and preventive treatment for migraine, a behaviour of combining or alternating between prescription and OTC triptans, and pharmacy counselling rates. Among the prescription triptan users, 52 % had a recorded diagnosis of migraine, 48 % had no other acute treatment, preventive treatment was rare (12 %) and contraindications were found in 2 % of the patients. Among the OTC triptan users, the majority (63 %) had been diagnosed by a physician and had a history of prescription triptan use, but combining or alternating between OTC and prescription triptans was rare. Concomitant acute treatment was reported in 53 % and preventive treatment was rare (4 %), despite high self-reported migraine frequencies. Some off-label use was detected, despite moderate to high counselling rates. Triptans are prescribed with attention to safety but with poor recording of migraine diagnosis. OTC triptan users generally have a history of prescription triptan use. Preventive treatment rates are low in both groups. Strategies to discern patients who need other treatment options should be considered.

  3. Correlation between the use of 'over-the-counter' medicines and adherence in elderly patients on multiple medications.

    PubMed

    Olesen, Charlotte; Harbig, Philipp; Barat, Ishay; Damsgaard, Else Marie

    2013-10-12

    Background Medication adherence is a multifaceted issue that is influenced by various factors. One factor may be the concurrent use of over-the-counter (OTC) medicines. The use of OTC medicine has been reported as common amongst elderly patients. Objective To determine if a correlation exists between the use of OTC medicines and adherence to prescribed medications in elderly patients. Setting Non-institutionalised elderly patients in Denmark. Methods Elderly unassisted patients aged ≥65 prescribed five or more prescription drugs were included in the study. Information on the use of concurrent OTC medications (herbal medicines, dietary supplements, or non-prescribed drugs) was elicited during home visit interviews. Prescription drug adherence was determined by pill counts. A patient was categorised as non-adherent if the mean adherence rate for all drugs consumed was <80 %. Different sensitivity analyses were made where adherence was defined different. Main outcome measure Medication adherence based on pill-count. Results A total of 253 participants included 72 % who used OTC medicines and 11 % who did not adhere to their prescriptions. Users of OTC medicines, however, were significantly more likely to be adherent than were non-users (odds ratio 0.41; 95 % confidence interval 0.18-0.91). Sensitivity analyses where adherence was defined different show no relationship between adherence and use of OTC medicine. Furthermore, separate analyses of herbal medicines, dietary supplements, or non-prescribed drugs did not correlate with adherence to prescriptions. Conclusion Amongst elderly patients on multiple medications a positive relationship was found between the overall use of OTC medicines and adherence to prescription drugs, in contrast to none when adherence were defined different or herbal medicines, dietary supplements, or non-prescribed drugs were analysed separately.

  4. Use of over-the-counter (OTC) drugs and perceptions of OTC drug safety among German adults.

    PubMed

    Barrenberg, E; Garbe, E

    2015-11-01

    In Europe, little empirical evidence is available about over-the-counter (OTC) drug consumption and risk perceptions. The objective of this study was to describe consumers' OTC drug use and perceptions of OTC drug safety in Germany. An online survey based on a quota sample with combined strata for age, gender, and education of 300 adult German participants was conducted in June and July 2013. The survey questionnaire covered the participants' OTC and prescription drug use, risk perceptions of OTC and prescription drugs, package leaflet reading habits, and OTC drug off-label use. Seven day prevalences of OTC drug use were higher in women (52.0%) than in men (40.8%). The risk perception of specific OTC drugs was impacted by the route of administration, the indication, and the drugs' ingredients. Products for dermal application or plant-based products were considered 'rather not risky' by 82.7-96.6 of the participants, depending on the product. Products for oral use or chemically synthesized substances were considered less safe. While 48.0% of consumers reported always reading the package leaflet of OTC drugs, 44.5% reported not reading it if they knew the drug or believed the drug was very safe. People, 60 years and older, reported significantly lower levels of OTC drug off-label use (9.3%) than younger people (22.0%). The 7-day prevalence of OTC drug use in Germany is high, especially among women. Consumers generally have balanced perceptions regarding OTC drug safety. Behaviours and knowledge related to OTC drug use should be considered by health care providers and regulators.

  5. Factors associated with presence of pharmacies and pharmacies that sell syringes over-the-counter in Los Angeles County.

    PubMed

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

    2013-12-01

    Community pharmacies serve as key locations for public health services including interventions to enhance the availability of syringes sold over-the-counter (OTC), an important strategy to prevent injection-mediated HIV transmission. Little is known about the community characteristics associated with the availability of pharmacies and pharmacies that sell syringes OTC. We conducted multivariable regression analyses to determine whether the sociodemographic characteristics of census tract residents were associated with pharmacy presence in Los Angeles (LA) County during 2008. Using a geographic information system, we conducted hot-spot analyses to identify clusters of pharmacies, OTC syringe-selling pharmacies, sociodemographic variables, and their relationships. For LA County census tracts (N = 2,054), population size (adjusted odds ratio [AOR], 1.22; 95 % confidence interval [CI], 1.16, 1.28), median age of residents (AOR, 1.03; 95 % CI, 1.01, 1.05), and the percent of households receiving public assistance (AOR, 0.97; 95 % CI, 0.94, 0.99) were independently associated with the presence of all pharmacies. Only 12 % of census tracts had at least one OTC syringe-selling pharmacy and sociodemographic variables were not independently associated with the presence of OTC syringe-selling pharmacies. Clusters of pharmacies (p < 0.01) were located proximally to clusters of older populations and were distant from clusters of poorer populations. Our combined statistical and spatial analyses provided an innovative approach to assess the sociodemographic and geographic factors associated with the presence of community pharmacies and pharmacies that participate in OTC syringe sales.

  6. 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

  7. 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

  8. Seasonal variation in penicillin use in Mexico and Brazil: analysis of the impact of over-the-counter restrictions.

    PubMed

    Santa-Ana-Tellez, Yared; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Wirtz, Veronika J

    2015-01-01

    During 2010, Mexico and Brazil implemented policies to enforce existing laws of restricting over-the-counter sales of antibiotics. We determined if the enforcement led to more appropriate antibiotic use by measuring changes in seasonal variation of penicillin use. We used retail quarterly sales data in defined daily doses per 1,000 inhabitant-days (DDD/TID) from IMS Health from the private sector in Mexico and Brazil from the first quarter of 2007 to the first quarter of 2013. This database contains information on volume of antibiotics sold in retail pharmacies using information from wholesalers. We used interrupted time-series models controlling for external factors with the use of antihypertensives with interaction terms to assess changes in trend, level, and variation in use between quarters for total penicillin use and by active substance. The most used penicillin was amoxicillin, followed by amoxicillin-clavulanic acid and ampicillin (minimal use in Brazil). Before the restrictions, the seasonal variation in penicillin use was 1.1 DDD/TID in Mexico and 0.8 DDD/TID in Brazil. In Mexico, we estimated a significant decrease in the seasonal variation of 0.4 DDD/TID after the restriction, mainly due to changes in seasonal variation of amoxicillin and ampicillin. In Brazil, the seasonal variation did not change significantly, overall and in the breakdown by individual active substances. For Mexico, inappropriate penicillin use may have diminished after the restrictions were enforced. For Brazil, increasing use and no change in seasonal variation suggest that further efforts are needed to reduce inappropriate penicillin use.

  9. Self-medication with over-the-counter drugs and complementary medications in South Australia's elderly population

    PubMed Central

    2009-01-01

    Background A number of surveys have examined use of complementary and alternative medicines (CAM) in Australia. However, there are limited Australian data on use of CAM and over-the-counter (OTC) medicines in the elderly population. The main aims of this study were to examine self-medication practices with CAM and OTC medicines among older Australians and variables associated with their use. Methods The Australian Longitudinal Study of Ageing (ALSA) is an ongoing multidisciplinary prospective study of the older population which commenced in 1992 in South Australia. Data collected in 4 waves of ALSA between 1992 and 2004 were used in this study with a baseline sample of 2087 adults aged 65 years and over, living in the community or residential aged care. OTC medicines were classified according to the World Health Organization Anatomical Therapeutic Chemical (ATC) classification. CAM were classified according a modified version of the classification adopted by the Therapeutics Goods Administration (TGA) in Australia. Results The prevalence of CAM or OTC use ranged from 17.7% in 2000-2001 to 35.5% in 2003-2004. The top classes of CAM and OTC medicines used remained relatively constant over the study period. The most frequent classes of CAM used were vitamins and minerals, herbal medicines and nutritional supplements while the most commonly used OTC were analgesics, laxatives and low dose aspirin. Females and those of younger age were more likely to be CAM users but no variable was associated with OTC use. Conclusion Participants seemed to self-medicate in accordance with approved indications, suggesting they were informed consumers, actively looking after their own health. However, use of analgesics and aspirin are associated with an increased risk of adverse drug events in the elderly. Future work should examine how self-medication contributes to polypharmacy and increases the risk of adverse drug reactions. PMID:19906314

  10. Pharmacists' perceived integration into practice of over-the-counter simvastatin five years post reclassification.

    PubMed

    Paudyal, Vibhu; Hansford, Denise; Cunningham, Scott; Stewart, Derek

    2012-10-01

    Simvastatin 10 mg was reclassified in 2004 to over-the-counter (OTC) status in the UK, indicated for the prevention of a first major coronary event in individuals at moderate risk of the event. The primary reason behind the reclassification was to reduce the burden of disease management in general practice. Community pharmacists' adoption of OTC simvastatin into practice immediately post reclassification was reported to below but there has been no systematic update on current practice. The aim was to investigate pharmacists' adoption into practice, and attitudes to, OTC simvastatin 5 years post reclassification in the UK. Community pharmacists at all community pharmacies in Scotland. A pre-piloted postal questionnaire was distributed to all community pharmacies in Scotland (N = 1138). Self rated adoption was measured on a five point scale. Factors associated with decision making were investigated using a 24-item Likert-type agreement scale. Pharmacists' perceived integration of reclassified simvastatin; factors associated with decision making. Response rate was 49.5 % (n = 563). A high majority reported not supplying the reclassified medicine mainly owing to a perceived lack of evidence, low patient demand, customer complaints about the retail price and lack of access to patient medical records. A minority agreed to reclassification being an opportunity for their role development. Community Pharmacists' views of reclassified simvastatin supply 5 years post reclassification, as compared to the time it was newly reclassified, suggest low uptake. This lack of progress over time suggests that, against policy initiatives, OTC availability is unlikely to have impacted on the level of general practice led management of patients at risk of coronary events.

  11. 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.

  12. Face masks and basketball: NCAA division I consumer trends and a review of over-the-counter face masks.

    PubMed

    Gandy, Jessica R; Fossett, Lela; Wong, Brian J F

    2016-05-01

    This study aims to: 1) determine the current consumer trends of over-the-counter (OTC) and custom-made face mask usage among National Collegiate Athletic Association (NCAA) Division I athletic programs; and 2) provide a literature review of OTC face guards and a classified database. Literature review and survey. Consumer trends were obtained by contacting all 352 NCAA Division I programs. Athletic trainers present in the office when called answered the following questions: 1) "When an athlete breaks his or her nose, is a custom or generic face guard used?" and 2) "What brand is the generic face guard that is used?" Data was analyzed to determine trends among athletic programs. Also, a database of OTC devices available was generated using PubMed, Google, and manufacturer Web sites. Among the 352 NCAA Division I athletic programs, 254 programs participated in the survey (72% response rate). The majority preferred custom-made guards (46%). Disadvantages included high cost and slow manufacture turnaround time. Only 20% of the programs strictly used generic brands. For the face mask database, 10 OTC products were identified and classified into four categories based on design, with pricing ranging between $35.99 and $69.95. Only a handful of face masks exist for U.S. consumers, but none of them have been reviewed or classified by product design, sport application, price, and collegiate consumer use. This project details usage trends among NCAA Division I athletic programs and provides a list of available devices that can be purchased to protect the nose and face during sports. NA. Laryngoscope, 126:1054-1060, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  13. 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.

  14. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity.

    PubMed

    Dezzutti, Charlene S; Brown, Elizabeth R; Moncla, Bernard; Russo, Julie; Cost, Marilyn; Wang, Lin; Uranker, Kevin; Kunjara Na Ayudhya, Ratiya P; Pryke, Kara; Pickett, Jim; Leblanc, Marc-André; Rohan, Lisa C

    2012-01-01

    Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. Therefore, safety and anti-HIV-1 activity of over-the-counter (OTC) aqueous- (n = 10), lipid- (n = 2), and silicone-based (n = 2) products were tested. The rheological properties of the lipid-based lubricants precluded testing with the exception of explant safety testing. Six aqueous-based gels were hyperosmolar, two were nearly iso-osmolar, and two were hypo-osmolar. Evaluation of the panel of products showed Gynol II (a spermicidal gel containing 2% nonoxynol-9), KY Jelly, and Replens were toxic to Lactobacillus. Two nearly iso-osmolar aqueous- and both silicone-based gels were not toxic toward epithelial cell lines or ectocervical or colorectal explant tissues. Hyperosmolar lubricants demonstrated reduction of tissue viability and epithelial fracture/sloughing while the nearly iso-osmolar and silicon-based lubricants showed no significant changes in tissue viability or epithelial modifications. While most of the lubricants had no measurable anti-HIV-1 activity, three lubricants which retained cell viability did demonstrate modest anti-HIV-1 activity in vitro. To determine if this would result in protection of mucosal tissue or conversely determine if the epithelial damage associated with the hyperosmolar lubricants increased HIV-1 infection ex vivo, ectocervical tissue was exposed to selected lubricants and then challenged with HIV-1. None of the lubricants that had a moderate to high therapeutic index protected the mucosal tissue. These results show hyperosmolar lubricant gels were associated with cellular toxicity and epithelial damage while showing no anti-viral activity. The two iso-osmolar lubricants, Good Clean Love and PRÉ, and both silicone-based lubricants, Female Condom 2 lubricant and Wet Platinum, were the safest in our testing algorithm.

  15. Possible role of pseudoephedrine and other over-the-counter cold medications in the deaths of very young children.

    PubMed

    Wingert, William E; Mundy, Lisa A; Collins, Gary L; Chmara, Edward S

    2007-03-01

    The Philadelphia Medical Examiners Office has reported a series of 15 deaths between February 1999 and June 2005 of infants and toddlers 16 months and younger in which drugs commonly found in over-the-counter (OTC) cold medications were present. A total of 10 different drugs were detected: pseudoephedrine, dextromethorphan, acetaminophen, brompheniramine, carbinoxamine, chlorpheniramine, ethanol, doxylamine and the anticonvulsants, phenobarbital, and phenytoin. The drugs were confirmed and quantified by gas chromatography (GC)-mass spectrometry, with the exception of ethanol, which was analyzed by headspace GC and of phenobarbital and phenytoin that were quantified by GC with a nitrogen phosphorus detector. The most predominant drug was pseudoephedrine, which was found in all of the cases (blood concentration, n=14, range=0.10-17.0 mg/L, mean=3.34 mg/L) and was the sole drug detected in three cases. Acetaminophen was detected in blood from each of the five cases with sufficient sample. Other drugs (with frequency of detection) were dextromethorphan (five cases), carbinoxamine (four cases), chlorpheniramine (two cases) and brompheniramine, doxylamine, and ethanol (one case each). In the majority of the cases, toxicity from drugs found in easily available OTC medications was listed either as the direct cause of death or as a contributory factor. The manner of death was determined to be natural in only two of the cases. This postmortem study supports previous evidence that the administration of OTC cold medications to infants may, under some circumstances, be an unsafe practice and in some cases may even be fatal. The treating physicians and the general public need to be made more aware of the dangers of using OTC cold medications to treat very young children so that these types of tragedies might be avoided.

  16. Relationships between Perceptual Attributes and Rheology in Over-the-Counter Vaginal Products: A Potential Tool for Microbicide Development

    PubMed Central

    Mahan, Ellen D.; Zaveri, Toral; Ziegler, Gregory R.; Hayes, John E.

    2014-01-01

    Vaginal microbicides are believed to have substantial potential to empower women to protect themselves from HIV, although clinical trials to date have had mixed results at best. Issues with patient adherence in these trials suggest additional emphasis should be placed on optimizing acceptability. Acceptability is driven, in part, by the sensory properties of the microbicide, so better understanding of the relationships between sensory properties and the physical and rheological properties of microbicides should facilitate the simultaneous optimization of sensory properties in parallel with the biophysical properties required for drug deployment. Recently, we have applied standard methods to assess the potential acceptability of microbicide prototypes ex vivo and to quantify the sensory properties of microbicide surrogates. Here, we link quantitative perceptual data to the rheological properties of 6 over-the counter (OTC) vaginal products used as ex vivo microbicide surrogates. Shear-thinning behavior (n) and tan δ (10 rad/s) showed no relationship with any perceptual attributes while shear storage modulus, G’ (10 rad/s) was correlated with some attributes, but did not appear to be a strong predictor of sensory properties. Conversely, the storage loss modulus, G” (10 rad/s) and the consistency coefficient, K, were correlated with several sensory attributes: stickiness, rubberiness, and uniform thickness for G’’ and stickiness, rubberiness, and peaking for K. Although these relationships merit confirmation in later studies, this pilot study suggests rheological principles can be used to understand the sensory properties evoked by microbicide surrogates assessed ex vivo. Additional work is needed to determine if these findings would apply for microbicides in vivo. PMID:25188244

  17. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Products for Over-the- Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as...-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective... final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE)...

  18. A Reformulation of the Issue of Over-the-Counter Television Drug Advertising Using a Health-Related Locus of Control Scale.

    ERIC Educational Resources Information Center

    Jarvis, Dennis J.; And Others

    The issue of whether or not television should continue to air commercial announcements for over-the-counter (O-T-C) drugs has been debated in the United States. On 8 December 1976, the Federal Communications Commission denied a petition to ban such television commercials between 6 A.M. and 9 P.M. in part because it could find little scientific…

  19. Ibuprofen-Induced Hypokalemia and Distal Renal Tubular Acidosis: A Patient's Perceptions of Over-the-Counter Medications and Their Adverse Effects.

    PubMed

    Salter, Mark D

    2013-01-01

    We highlight a case of distal renal tubular acidosis secondary to ibuprofen and codeine use. Of particular interest in this case are the patient's perception of over-the-counter (OTC) medication use, her own OTC use prior to admission, and her knowledge of adverse reactions or side effects of these medications prior to taking them.

  20. Ibuprofen-Induced Hypokalemia and Distal Renal Tubular Acidosis: A Patient's Perceptions of Over-the-Counter Medications and Their Adverse Effects

    PubMed Central

    Salter, Mark D.

    2013-01-01

    We highlight a case of distal renal tubular acidosis secondary to ibuprofen and codeine use. Of particular interest in this case are the patient's perception of over-the-counter (OTC) medication use, her own OTC use prior to admission, and her knowledge of adverse reactions or side effects of these medications prior to taking them. PMID:24829833

  1. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... 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...

  2. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... 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...

  3. 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

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... 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...

  4. 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

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... 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...

  5. 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

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... 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...

  6. Emergency Contraceptive Pill (ECP) Use and Experiences at College Health Centers in the Mid-Atlantic United States: Changes since ECP Went Over-the-Counter

    ERIC Educational Resources Information Center

    Miller, Laura M.

    2011-01-01

    Objective: To investigate the availability of emergency contraceptive pills (ECPs) at college health centers since ECP went over-the-counter (OTC) in 2006. Related issues, such as distribution procedure, existence of a written protocol, personnel involved, contraindications, follow-up procedures, methods of advertising, and staff attitudes, were…

  7. Clinical studies of sweat rate reduction by an over-the-counter soft-solid antiperspirant and comparison with a prescription antiperspirant product in male panelists.

    PubMed

    Swaile, D F; Elstun, L T; Benzing, K W

    2012-03-01

    Individuals with axillary hyperhidrosis have much higher than average sweat rates and are often prescribed anhydrous aluminum chloride (AlCl(3)) solutions. Topical application of these solutions can be irritating to the skin, resulting in poor compliance and lower than desired efficacy. Demonstrate the efficacy of an over the counter "clinical strength" soft-solid antiperspirant using a night time application regimen and compare to a prescription aluminum chloride (6.5%) antiperspirant using male panelists. Gravimetric hot room efficacy testing (100 F and 35% Humidity) was performed comparing an over the counter soft-solid antiperspirant to placebo in a single test. Two separate gravimetric tests were placed comparing a prescription aluminum chloride (6.5%) antiperspirant to the same soft solid product using an intent to treat model. Skin irritation was assessed daily by a trained grader. Placebo testing resulted in 85% of panelists having a reduction in sweating rate greater than 50%. Comparison testing showed the over the counter soft solid reduced sweat rate by an average of 34% better than the prescription product while resulting significantly less skin irritation. Over the counter "clinical strength" soft-solid antiperspirants can be considered as an alternative treatment to aluminum chloride antiperspirants for the treatment of heavy sweating. © 2012 The Author. BJD © 2012 British Association of Dermatologists.

  8. Over-the-Counter Medication and Herbal or Dietary Supplement Use in College: Dose Frequency and Relationship to Self-Reported Distress

    ERIC Educational Resources Information Center

    Stasio, Michael J.; Curry, Kim; Sutton-Skinner, Kelly M.; Glassman, Destinee M.

    2008-01-01

    Objective: A growing number of researchers have examined the use of over-the-counter (OTC) medications and herbal or dietary supplements among college students. There is concern about the efficacy and safety of these products, particularly because students appear to use them at a higher rate than does the general public. Participants and Methods:…

  9. Emergency Contraceptive Pill (ECP) Use and Experiences at College Health Centers in the Mid-Atlantic United States: Changes since ECP Went Over-the-Counter

    ERIC Educational Resources Information Center

    Miller, Laura M.

    2011-01-01

    Objective: To investigate the availability of emergency contraceptive pills (ECPs) at college health centers since ECP went over-the-counter (OTC) in 2006. Related issues, such as distribution procedure, existence of a written protocol, personnel involved, contraindications, follow-up procedures, methods of advertising, and staff attitudes, were…

  10. Over-the-Counter Medication and Herbal or Dietary Supplement Use in College: Dose Frequency and Relationship to Self-Reported Distress

    ERIC Educational Resources Information Center

    Stasio, Michael J.; Curry, Kim; Sutton-Skinner, Kelly M.; Glassman, Destinee M.

    2008-01-01

    Objective: A growing number of researchers have examined the use of over-the-counter (OTC) medications and herbal or dietary supplements among college students. There is concern about the efficacy and safety of these products, particularly because students appear to use them at a higher rate than does the general public. Participants and Methods:…

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. Effects of carbamide peroxide whitening agents on enamel surfaces and caries-like lesion formation: an SEM and polarized light microscopic in vitro study.

    PubMed

    Flaitz, C M; Hicks, M J

    1996-01-01

    Whitening enamel with carbamide peroxide (CP) to remove cosmetically displeasing stains has become common-place in dental practice. This in vitro study evaluated CP treatment effects on enamel surface morphology and caries-like lesion susceptibility. Tooth quarters were prepared from 10 caries-free human molars following a fluoride-free prophylaxis. The tooth quarters were assigned to the following treatment groups: 1) Distobuccal-10 percent NW gel (Nite White, Discus Dental); 2) Distolingual-10 percent PL paste (Platinum, Colgate); 3) Mesiobuccal-16 percent NW gel; and 4) Mesiolingual-Control. Following the manufacturers' recommended treatment, each quarter was sectioned with one portion prepared for SEM and the other portion for caries-like lesion formation. Intact enamel surfaces were present with all treatments. Enamel prism markings with exaggerated prism peripheries and mild to moderate prism core loss were seen with both 10 percent NW and 16 percent NW gels, but was more prominent with 16 percent NW gel. Amorphous surface layers with occasional exposure of indistinct prism markings occurred with 10 percent PL paste. Body of lesion mean depths were 135 microns control, 159 microns 16 percent NW, 144 microns 10 percent NW, and 122 microns 10 percent PL. Lesion depths were significantly different (p < 0.05 DMR paired design) between 10 percent PL and 16 percent NW, and between control and 16 percent NW. Whitening enamel surfaces in vitro with 10 percent carbamide peroxide paste containing dicalcium phosphate dihydrate (Colgate-Platinum) produced an amorphous surface layer and reduced caries susceptibility when compared with 16 percent carbamide peroxide gel (Nite White).

  17. High-frequency use of over-the-counter analgesics among adolescents: reflections of an emerging difficult life, a cross-sectional study.

    PubMed

    Skarstein, Siv; Rosvold, Elin O; Helseth, Sølvi; Kvarme, Lisbeth G; Holager, Tanja; Småstuen, Milada C; Lagerløv, Per

    2014-03-01

    To examine characteristics of 15- to 16-year-old adolescents who used over-the-counter analgesics daily to weekly (high-frequency users) as compared to those who used less or no analgesics (low-frequency users). Further to analyse the differences in pain experience, lifestyle, self-esteem, school attendance and educational ambition. An anonymous cross-sectional questionnaire-based study. The questionnaire covered the use of over-the-counter analgesics, pain experience, sociodemographics, lifestyle factors, self-esteem, school absence and future educational plans. The study took place in the 10th grade in six junior high schools in a medium-sized town in Norway. The local sales data for analgesics and antipyretics were close to the national average. We invited 626 adolescents to participate. Of the 367 adolescents (59%) who responded, 51% were girls. Associations between the frequency of use of over-the-counter analgesic and the mentioned variables were analysed using multiple logistic regression. In total, 26% (42 boys and 48 girls) used over-the-counter analgesics daily to weekly. These high-frequency users experienced more widespread pain, slept less, had more paid spare-time work, drank more caffeinated drinks, participated more often in binge drinking, had lower self-esteem, less ambitious educational plans and more frequent school absence than did the low-frequency users. These associations remained significant when controlling for gender, cultural background and self-evaluated economic status. Adolescent, who are high-frequency users of over-the-counter analgesics, suffer more pain and have identifiable characteristics indicative of complex problems. Their ability to handle stress appears to be discordant with the kind of situations to which they are exposed. The wear and tear associated with allostatic mechanisms counteracting stress may heighten their pain experience. © 2013 Nordic College of Caring Science. Published by Blackwell Publishing Ltd.

  18. Clinical trial of tooth whitening with 6% hydrogen peroxide whitening strips and two whitening dentifrices.

    PubMed

    Yudhira, Rafael; Peumans, Marleen; Barker, Matthew L; Gerlach, Robert W

    2007-09-01

    To compare tooth whitening with 6% hydrogen peroxide whitening strips and two whitening dentifrices in a 12-week randomized controlled trial at a Belgian dental school. After informed consent, 46 healthy adults were randomly assigned to one of three strip + dentifrice treatment groups. Subjects received either 6% hydrogen peroxide whitening strips (Crest Whitestrips) and an anticavity toothpaste (Crest Cavity Protection), placebo strips and a sodium fluoride (NaF) whitening dentifrice (Mentadent Whitening Toothpaste) or placebo strips and a sodium monofluorophosphate (MFP) whitening dentifrice (Rembrandt Low Abrasion Whitening Toothpaste). Strip use (peroxide or placebo) was for 30 minutes, twice daily for 2 weeks, while dentifrice use was at least twice daily for 12 weeks. Efficacy was measured from standardized digital images of the maxillary facial tooth surfaces, while safety was evaluated from oral examination and interview. Treatments were compared after 2 weeks (strip use) and 12 weeks (dentifrice use) using analysis of covariance. All subjects completed the 12-week evaluation. Adjusting for baseline and age, the peroxide strip group had -2.45 Deltab*, 2.39 DeltaL*, and -0.96 Deltaa* at Week 2. Between-group comparisons demonstrated significant (P< 0.0001) reductions in yellowness and redness, and increased brightness favoring the peroxide strip group. The peroxide strip group demonstrated 95%+ color retention (Deltab* & DeltaL*) at Week 12, differing significantly (P< 0.0001) versus either of the continuously used whitening dentifrices. There were no significant (P> 0.18) differences between the whitening dentifrice groups at any timepoints. All treatments were well-tolerated, with minor tooth sensitivity and oral irritation representing the most common findings.

  19. 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

  20. Increase of urinary 5-hydroxyindoleacetic acid excretion but not serum chromogranin A following over-the-counter 5-hydroxytryptophan intake.

    PubMed

    Joy, Tisha; Walsh, Grace; Tokmakejian, Sonya; Van Uum, Stan Hm

    2008-01-01

    5-hydroxyindoleacetic acid (5-HIAA) excretion is commonly measured for biochemical detection of carcinoid tumours. A 77-year-old woman was referred for elevated 24 h urine 5-HIAA excretion (510 micromol/day; normal is less than 45 micromol/day) and serum chromogranin A (CgA) (72.1 U/L; normal is less than 18 U/L), both subsequently normalized after discontinuation of 5-hydroxytryptophan (5-HTP). 5-HTP, a precursor of serotonin, is not commonly listed as a substance that increases 5-HIAA levels in urine. The effect of 5-HTP on CgA has not been previously described. To determine whether, and to what extent, oral 5-HTP increases urine 5-HIAA excretion and serum CgA levels in healthy volunteers. A randomized, prospective, double-blind, placebo-controlled crossover study, with a four-day washout period, was performed in a general community setting. Eight healthy subjects aged 22 to 58 years were recruited by advertising. Bedtime ingestion of 5-HTP 100 mg/day was compared with placebo ingestion for 10 days. Twenty-four hour urine excretion of 5-HIAA and serum CgA were the main outcome measures. Median (range) urinary 5-HIAA excretion was 204 micromol/day (22 micromol/day to 459 micromol/day) during 5-HTP intake, compared with 18 micromol/day (12 micromol/day to 36 micromol/day) during placebo intake (P=0.017). 5-HTP did not affect clinical symptoms or serum CgA levels. Oral 5-HTP increases urinary 5-HIAA excretion with considerable interindividual variation. In a small number of subjects, oral 5-HTP did not affect serum CgA levels. Therefore, increased 5-HIAA levels with normal CgA levels may suggest 5-HTP ingestion. The use of over-the-counter 5-HTP should be excluded as the cause of increased urinary 5-HIAA levels before initiating diagnostic tests to search for a carcinoid tumour. 5-HTP should be added to popular references as a substance that may cause increased 5-HIAA excretion.

  1. Increase of urinary 5-hydroxyindoleacetic acid excretion but not serum chromogranin A following over-the-counter 5-hydroxytryptophan intake

    PubMed Central

    Joy, Tisha; Walsh, Grace; Tokmakejian, Sonya; Van Uum, Stan HM

    2008-01-01

    BACKGROUND: 5-hydroxyindoleacetic acid (5-HIAA) excretion is commonly measured for biochemical detection of carcinoid tumours. A 77-year-old woman was referred for elevated 24 h urine 5-HIAA excretion (510 μmol/day; normal is less than 45 μmol/day) and serum chromogranin A (CgA) (72.1 U/L; normal is less than 18 U/L), both subsequently normalized after discontinuation of 5-hydroxytryptophan (5-HTP). 5-HTP, a precursor of serotonin, is not commonly listed as a substance that increases 5-HIAA levels in urine. The effect of 5-HTP on CgA has not been previously described. OBJECTIVES: To determine whether, and to what extent, oral 5-HTP increases urine 5-HIAA excretion and serum CgA levels in healthy volunteers. PATIENTS AND METHODS: A randomized, prospective, double-blind, placebo-controlled crossover study, with a four-day washout period, was performed in a general community setting. Eight healthy subjects aged 22 to 58 years were recruited by advertising. Bedtime ingestion of 5-HTP 100 mg/day was compared with placebo ingestion for 10 days. Twenty-four hour urine excretion of 5-HIAA and serum CgA were the main outcome measures. RESULTS: Median (range) urinary 5-HIAA excretion was 204 μmol/day (22 μmol/day to 459 μmol/day) during 5-HTP intake, compared with 18 μmol/day (12 μmol/day to 36 μmol/day) during placebo intake (P=0.017). 5-HTP did not affect clinical symptoms or serum CgA levels. CONCLUSIONS: Oral 5-HTP increases urinary 5-HIAA excretion with considerable interindividual variation. In a small number of subjects, oral 5-HTP did not affect serum CgA levels. Therefore, increased 5-HIAA levels with normal CgA levels may suggest 5-HTP ingestion. The use of over-the-counter 5-HTP should be excluded as the cause of increased urinary 5-HIAA levels before initiating diagnostic tests to search for a carcinoid tumour. 5-HTP should be added to popular references as a substance that may cause increased 5-HIAA excretion. PMID:18209781

  2. A Study on the Dispensing Pattern of Over the Counter Drugs in Retail Pharmacies in Sarjapur Area, East Bangalore.

    PubMed

    Nagaraj, Manjushree; Chakraborty, Ananya; Srinivas, B N

    2015-06-01

    Over the counter drugs (OTC) are sold without the prescription of a registered medical practitioner. There are reports that OTC drug market in India is on the rise. This is attributed to the rising cost of health care, difficulty in accessing healthcare, and an alarming tendency to self manage symptoms. The outcome of this is OTC related adverse effects, abuse, and hospitalizations. Literature on OTC is sparse. Hence this study was undertaken to evaluate the dispensing pattern of OTC drugs in retail pharmacies in Sarjapur area, East Bangalore. The study was conducted in 3 retail pharmacies in Sarjapur area, Bangalore East. The duration of the study was for a period of 10 days from August 1st to August 10th 2014. The common complaints for which the patients frequented the pharmacies were observed and recorded .The investigator personally interviewed the patients between 6pm to 9pm, near the respective pharmacies. During this study period around 216 patients visited pharmacies without prescription. The drugs supplied to 216 patients by private pharmacies without prescription was recorded. Data was analysed by descriptive statistics using Microsoft Excel. Most commonly dispensed OTC drugs were analgesics (26.8%). The other categories of medications dispensed were antihistamines (15.2%), antacids (14.8%), antibiotics (10%), antipyretics (7.8%), Oral contraceptive (OC pills) (5.09%) and others (20%). The commonly dispensed antibiotics were Cefadroxil (250mg) for dental infection and Levofloxacin (500mg) for upper respiratory tract infection. The most common complaint for the use of OTC drugs was pain (25%). It was noted that 55.09% of the dispensed drugs belonged to schedule H. However, 13% patients were aware regarding the harmful effects of drugs. The use of OTC drugs is alarmingly high in Bangalore East. Pharmacists have to be trained and educated regarding rationale dispensing of drugs. The need for promoting the appropriate use of drugs in the Indian health care

  3. Key information providers, channels, and characteristics of Japanese consumers' informed choices of over-the-counter medications.

    PubMed

    Hayashi, Makiko; Masuda, Sachiko; Kimura, Hiromichi

    2015-01-01

    People need reliable information regarding over-the-counter medications (OTCs), so that they can independently make appropriate informed choices. The study aimed to identify the information providers and channels that have an impact on the purchase of OTCs, and to demonstrate the information needs of OTC purchasers, using these providers and channels, from the viewpoint of information characteristics such as specialty, objectivity, concreteness, comprehensiveness, individuality, and availability, focusing on the efficacy of OTCs and related safety information. A questionnaire survey of randomly sampled adults aged ≥20 was conducted at the Japan Drugstore Show 2012, hosted by the Japan Association of Chain Drug Stores. In this questionnaire, information was particularly limited to the efficacy and safety of OTCs. Multivariate logistic regression analysis was performed on data from 1743 respondents (1625 purchasers and 118 non-purchasers of OTCs) who obtained information on OTCs in their daily lives, to demonstrate the associations between the use of information providers and channels (predictor variables) and the purchase of OTCs (outcome variable), as well as between information characteristics valued by purchasers (predictor variables) and their use of these information providers or channels (outcome variables). Both the use of pharmacists as information providers and consultation at pharmacies as an information channel were positively associated with the purchase of OTCs (odds ratio [OR], 3.74; 95 % confidence interval [CI], 2.46-5.68; P < 0.001 and OR, 4.55; 95 % CI 2.92-7.11, P < 0.001, respectively), whereas both the use of family or friends using OTCs as information providers and family or friends as information channels were negatively associated with the purchase of OTCs (OR, 0.60; 95 % CI 0.40-0.90; P = 0.014 and OR, 0.55; 95 % CI 0.36-0.82; P = 0.004, respectively). OTC purchasers who valued individuality of information were more likely to

  4. Developing alternative over-the-counter medicine label formats: How do they compare when evaluated by consumers?

    PubMed

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

    2017-03-09

    In recent years, the Australian Therapeutic Goods Administration (TGA) has proposed implementing a standardized over-the-counter (OTC) medicine label. However, there were mixed consumer opinions regarding a label proposed in 2012 and limited evidence demonstrating the usability of the revised (2014) format. To develop and examine the usability of alternative OTC medicine label formats for standardization, and explore consumer perspectives on the labels. Four alternative labels were developed for the exemplar medicine diclofenac. One was based on the Medicine Information label proposed by the TGA ('Medicine Information'), one was based on the U.S. Drug Facts label ('Drug Facts'), and two were based on suggestions proposed by consumers in the earlier needs analysis phase of this research (referred to as the 'Medicine Facts' and 'Consumer Desires' label formats). Five cohorts of 10 participants were recruited. Each cohort was assigned to user test one of the alternative labels or an existing label for a proprietary diclofenac product (which acted as a comparator) for diagnostic purposes. Each participant then provided feedback on all 5 labels. Each interview consisted of the administration of a user testing questionnaire, measuring consumers' ability to find and understand key points of information, and a semi-structured interview exploring consumer perspectives. Overall, all 4 alternative label formats supported consumers' ability to find and understand key points. The existing comparator label was the poorer label with respect to participants' ability to find and understand key points. Factors such as perceived usability, color, design, content, and/or content ordering impacted consumer preferences. The 'Consumer Desires' or 'Drug Facts' label formats were most often preferred by consumers for use as the standardized OTC label over the TGA proposed format. All alternative label formats demonstrated satisfactory usability and could be considered for use in OTC label

  5. THYROSIM App for Education and Research Predicts Potential Health Risks of Over-the-Counter Thyroid Supplements.

    PubMed

    Han, Simon X; Eisenberg, Marisa; Larsen, P Reed; DiStefano, Joseph

    2016-04-01

    Computer simulation tools for education and research are making increasingly effective use of the Internet and personal devices. To facilitate these activities in endocrinology and metabolism, a mechanistically based simulator of human thyroid hormone and thyrotropin (TSH) regulation dynamics was developed and further validated, and it was implemented as a facile and freely accessible web-based and personal device application: the THYROSIM app. This study elucidates and demonstrates its utility in a research context by exploring key physiological effects of over-the-counter thyroid supplements. THYROSIM has a simple and intuitive user interface for teaching and conducting simulated "what-if" experiments. User-selectable "experimental" test-input dosages (oral, intravenous pulses, intravenous infusions) are represented by animated graphical icons integrated with a cartoon of the hypothalamic-pituitary-thyroid axis. Simulations of familiar triiodothyronine (T3), thyroxine (T4), and TSH temporal dynamic responses to these exogenous stimuli are reported graphically, along with normal ranges on the same single interface page; and multiple sets of simulated experimental results are superimposable to facilitate comparative analyses. This study shows that THYROSIM accurately reproduces a wide range of published clinical study data reporting hormonal kinetic responses to large and small oral hormone challenges. Simulation examples of partial thyroidectomies and malabsorption illustrate typical usage by optionally changing thyroid gland secretion and/or gut absorption rates--expressed as percentages of normal--as well as additions of oral hormone dosing, all directly on the interface, and visualizing the kinetic responses to these challenges. Classroom and patient education usage--with public health implications--is illustrated by predictive simulated responses to nonprescription thyroid health supplements analyzed previously for T3 and T4 content. Notably, it was found that

  6. 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

  7. 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

  8. Acute adverse events from over-the-counter Chinese herbal medicines: a population-based survey of Hong Kong Chinese

    PubMed Central

    2013-01-01

    Background Although over-the-counter traditional Chinese herbal medicine (COTC) is commonly used to treat everyday illness in many parts of the world, no population-based study has been done to examine the prevalence and factors associated with COTC-related adverse events. Methods A cross-sectional telephone survey was conducted among Hong Kong Chinese adults in 2011 (n = 1100) with informed verbal consent. Stepwise logistic regression of demographic, attitudinal and behavioral variables was used to determine factors associated with past-year adverse events. Results Of study respondents, 71.7% (789/1100) reported past-year COTC use and 2.3% (25/1100) reported at least one COTC-related adverse event in the past year. Of the 27 adverse events cases reported among COTC users, the most common were allergic reactions (n = 11) dizziness (n = 5), and gastro-intestinal problems (n = 4). Pills/capsules were the dosage form that caused the highest proportion of adverse events (n = 10), followed by plasters (n = 7), creams/ointments (n = 5), and ingestible powders (n = 2). Although COTC users reporting adverse events were more likely to report greater practices to avoid adverse events (OR = 6.47; 95% CI: 1.38-30.3); they were also more likely to possess lower education levels (OR = 9.64, 95% CI: 2.20-42.3) and to have received COTC information from non-reliable, mass-media information sources such as magazines (OR = 3.32; 95% CI: 1.01-8.50) or television (OR = 2.93; 95% CI: 1.03-10.7). Package labels were also felt to be unclear by 42.9% of COTC users. A large proportion of COTC users demonstrated low levels of COTC-related knowledge, while the main impediment to greater information-seeking was the belief that reliable COTC information is not obtainable from Western health professionals. Conclusions Despite global movements toward more stringent complementary medicine regulation, the limited accessibility of reliable information

  9. Quantitative determination of a-Arbutin, ß-Arbutin, Kojic acid, nicotinamide, hydroquinone, resorcinol, 4-methoxyphenol, 4-ethoxyphenol and ascorbic acid from skin whitening Products by HPLC-UV

    USDA-ARS?s Scientific Manuscript database

    Development of an analytical method for the simultaneous determination of multifarious skin whitening agents will provide an efficient tool to analyze skin whitening cosmetics. An HPLC-UV method was developed for quantitative analysis of six commonly used whitening agents, a-arbutin, ß-arbutin, koji...

  10. Whitening-dependent changes of fluorescence of extracted human teeth.

    PubMed

    Pereira Sanchez, Natalie; Aleksic, Aleksandar; Dramicanin, Miroslav; Paravina, Rade D

    2017-09-01

    To evaluate in vitro the fluorescence properties of extracted human teeth whitened with 40% hydrogen peroxide. A total of 28 extracted human teeth were pumiced for 1 minute using a low-speed dental handpiece and a disposable rubber cup. Pre-whitening fluorescence measurements (T0), maximum excitation (Exmax ), maximum emission (Emmax ), and maximum intensity (Imax 10(8) ), were performed using a spectrofluorometer. After T0 measurements, the teeth were whitened using the in-office method with 40% hydrogen peroxide, three times for 20 minutes. The fluorescence parameters were measured under the same conditions 7 and 14 days after bleaching (T1 and T2, respectively). Exmax exhibited a broader range 7 days after whitening and decreased after 14 days. The Emmax and Imax 10(8) displayed a narrower range after whitening. The mean Exmax differed significantly between the time points (F = 20.09. P < .001). The corresponding analysis for the mean Emmax differed significantly between the time points (F = 16.69, P < .001). The same was true for the mean Imax 10(8) (F = 9.69, P < .001). Within the limitations of this study, whitening provoked statistically significant changes in fluorescence of the intact teeth in vitro. The appearance of human teeth and dental materials and their changes upon aging and exposure to different agents (staining, whitening) is a topic of great relevance to esthetic dentistry. While some appearance parameters, such as color, translucency, and gloss, have been thoroughly studied, fluorescence and its influence on overall tooth appearance is still not well understood, yet it has influenced the development of fluorescence emitting restorative materials. © 2017 Wiley Periodicals, Inc.

  11. The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers.

    PubMed

    Oster, G; Huse, D M; Delea, T E; Colditz, G A; Richter, J M

    1990-09-01

    In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status by the U.S. Food and Drug Administration to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. This study explores the potential utility of techniques of decision analysis in evaluating the balance of these benefits and risks. Histamine H2 receptor antagonists (H2-blockers), which are currently available only by prescription, are presented as a case study and were examined to determine how OTC availability of these agents would alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders. Currently, about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would: 1) increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%; 2) increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% currently to 43.2%; 3) result in 14 additional cases of serious hematologic disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline; 4) cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care; and 5) decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia. On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the

  12. Acute generalised exanthematous pustulosis and other severe drug eruptions from over the counter medications: A case report and review of the literature.

    PubMed

    Kline, Amy; Fischer, Gayle

    2016-05-01

    We present a case of acute generalised exanthematous pustulosis in an 11-year-old girl who used Duro-Tuss, an over-the-counter cough mixture containing pholcodine, and present a comprehensive review of the literature on severe drug reactions resulting from using non-prescription medications. This case reinforces the importance of taking a complete medication history. © 2015 The Australasian College of Dermatologists.

  13. Over-the-counter and prescription sleep medication and incident stroke: the REasons for Geographic and Racial Differences in Stroke study.

    PubMed

    Petrov, Megan E; Howard, Virginia J; Kleindorfer, Dawn; Grandner, Michael A; Molano, Jennifer R; Howard, George

    2014-09-01

    Preliminary evidence suggests sleep medications are associated with risk of vascular events; however, the long-term vascular consequences are understudied. This study investigated the relation between sleep medication use and incident stroke. Within the REasons for Geographic And Racial Differences in Stroke study, 21,678 black participants and white participants (≥45 years) with no history of stroke were studied. Participants were recruited from 2003 to 2007. From 2008 to 2010, participants self reported their prescription and over-the-counter sleep medication use over the past month. Suspected stroke events were identified by telephone contact at 6-month intervals and associated medical records were retrieved and physician-adjudicated. Proportional hazards analysis was used to estimate hazard ratios for incident stroke associated with sleep medication use (0, 1-14, and 15+ days per month) controlling for sociodemographics, stroke risk factors, mental health symptoms, and sleep apnea risk. At the sleep assessment, 9.6% of the sample used prescription sleep medication and 11.1% used over-the-counter sleep aids. Over an average follow-up of 3.3 ± 1.0 years, 297 stroke events occurred. Over-the-counter sleep medication use was associated with increased risk of incident stroke in a frequency-response relationship (P = .014), with a 46% increased risk for 1-14 days of use per month (hazards ratio [HR] = 1.46; 95% confidence interval [CI], .99-2.15) and a 65% increased risk for 15+ days (HR = 1.65; 95% CI, .96-2.85). There was no significant association with prescription sleep medications (P = .80). Over-the-counter sleep medication use may independently increase the risk of stroke beyond other risk factors in middle-aged to older individuals with no history of stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  14. How adolescents experience and cope with pain in daily life: a qualitative study on ways to cope and the use of over-the-counter analgesics

    PubMed Central

    Lagerløv, Per; Rosvold, Elin Olaug; Holager, Tanja; Helseth, Sølvi

    2016-01-01

    Objective The aim of this study was to describe how different adolescents experience and manage pain in their daily life, with a focus on their use of over-the-counter analgesics. More specifically, the aim was to explore different patterns among the adolescents in pain descriptions, in the management of pain, in relationships with others, and in their daily life. Design Qualitative semistructured interviews on experiences with pain, pain management and involvement of family and friends during pain. Pain and stress management strategies and attachment theory will be in focus for interpretations. Participants and setting 25 participants aged 15–16-years from six different junior high schools, both genders, with and without immigrant background were interviewed at their local schools in Norway. Results We identified 4 groups of adolescents with similarities in attitudes and management strategies to pain: ‘pain is manageable’, ‘pain is communicable’, ‘pain is inevitable’ and ‘pain is all over’. The participants within each group differed in how they engaged their parents in pain; how they perceived, communicated and managed pain; and how they involved emotions and used over-the-counter analgesics. Conclusions The adolescents’ different involvement with the family during pain related to their pain perception and management. Knowledge of the different ways of approaching pain is important when supporting adolescents and may be a subject for further research on the use of over-the-counter analgesics in the family. PMID:26932141

  15. Evaluation of marketing claims, ingredients, and nutrient profiles of over-the-counter diets marketed for skin and coat health of dogs.

    PubMed

    Johnson, Lily N; Heinze, Cailin R; Linder, Deborah E; Freeman, Lisa M

    2015-06-15

    To evaluate marketing claims, ingredients, and nutrient profiles of over-the-counter diets marketed for skin and coat health of dogs. Cross-sectional study. 24 over-the-counter dry and canned diets marketed for skin and coat health of dogs. Data on marketing claims and ingredients were collected from diet packaging and manufacturer websites. Concentrations of selected nutrients were obtained by contacting the manufacturers and were compared against minimum values for Association of American Feed Control Officials Dog Food Nutrient Profiles for adult dog maintenance based on calorie content. Most diets incorporated marketing terms such as digestive health, sensitive, or premium that are poorly defined and may have limited relevance to skin, coat, or general health. The types and numbers of major ingredients (ie, potential to contribute protein to the diet) differed. The total number of unique major ingredients in each diet ranged from 3 to 8 (median, 5.5), but the total number of unique ingredients in each diet ranged from 28 to 68 (median, 38). Concentrations of nutrients associated with skin and coat condition also differed widely. Results indicated that the large variation among over-the-counter diets marketed for skin and coat health may cause confusion for owners during diet selection. Owners of a dog with dermatologic problems should consult their veterinarian to select a good-quality diet that meets specific nutrient goals.

  16. The influence of a novel in-office tooth whitening procedure using an Er,Cr:YSGG laser on enamel surface morphology.

    PubMed

    Dionysopoulos, Dimitrios; Strakas, Dimitrios; Koliniotou-Koumpia, Eugenia

    2015-08-01

    The purpose of this in vitro study was to evaluate the influence of a novel in-office tooth whitening procedure using Er,Cr:YSGG laser radiation on bovine enamel. Forty-eight enamel specimens were prepared from bovine canines and divided into four groups: Group 1 specimens (control) received no whitening treatment; Group 2 received whitening treatment with an at-home whitening agent (22% carbamide peroxide) for 7 days; Group 3 received whitening treatment with a novel in-office whitening agent (35% H(2)O(2)); Group 4 received the same in-office whitening therapy with Group 3 using Er,Cr:YSGG laser in order to accelerate the whitening procedure. The specimens were stored for 10 days after the whitening treatment in artificial saliva. Vickers hardness was determined using a microhardness tester and surface roughness was evaluated using a VSI microscope. Three specimens of each experimental group were examined under SEM and the mineral composition of the specimens was evaluated using EDS. Data were statistically analyzed using one-way ANOVA, Tukey's post-hoc test, Wilcoxon signed rank and Kruskal-Wallis tests (a = 0.05). The surface microhardness of the enamel was reduced after the in-office whitening treatments (P< 0.05), but not influenced after the at-home whitening treatment (P> 0.05). Moreover, the surface roughness was not significantly changed after tooth whitening. EDS analysis did not show alterations in the enamel mineral composition, while SEM observations indicated changes in the surface morphology, especially after in-office tooth whitening (P< 0.05). The laser-assisted whitening treatment with Er,Cr:YSGG laser did not affect the alterations in enamel surface compared with the conventional in-office whitening technique. © 2015 Wiley Periodicals, Inc.

  17. The effect of three whitening oral rinses on enamel micro-hardness.

    PubMed

    Potgieter, E; Osman, Y; Grobler, S R

    2014-05-01

    The purpose of this study was to determine the effect on human enamel micro-hardness of three over-the-counter whitening oral rinses available in South Africa. Enamel fragments were gathered into three groups of 15 each. One group was exposed to Colgate Plax Whitening Blancheur, the second group to White Glo 2 in 1 and the third to Plus White, in each case for periods recommended by the respective manufacturers. Surface micro-hardness of all groups was measured before and after a 14 day treatment period. pH levels of the oral rinses were also determined with a combination pH electrode. Pre- and post- treatment data were analysed by the Wilcoxon Signed Rank Sum Test. According to the micro-hardness values no significant (p > 0.05) enamel damage was found as a result of treatment. However, it was observed that Colgate Pax and White Glo decreased the enamel hardness, an early sign of enamel damage, while Plus White showed a small increase in hardness. The three whitening oral rinses on the South African market do not damage the tooth enamel significantly when used as recommended by the manufacturers. However, extending the contact period and increasing the frequency of application might lead to damage of enamel.

  18. Hot-water and solid-phase extraction of fluorescent whitening agents in paper materials and infant clothes followed by unequivocal determination with ion-pair chromatography-tandem mass spectrometry.

    PubMed

    Chen, Hsin-Chang; Ding, Wang-Hsien

    2006-03-10

    A comprehensive method for the determination of four stilbene-type disulfonate and one distyrylbiphenyl-type fluorescent whitening agents (FWAs) in paper materials (napkin and paper tissue) and infant clothes was developed. FWAs were extracted from paper material and cloth samples using a hot-water extraction, and the aqueous extracts were then preconcentrated with the newly developed Oasis WAX (mixed-mode of weak anion exchange and reversed-phase sorbent) solid-phase extraction cartridge. The analytes were unequivocal determined by ion pair chromatography coupled with negative electrospray ionization-tandem mass spectrometry (HPLC-ESI-MS-MS), applying a di-n-hexyl-ammonium acetate (DHAA) as the ion-pairing reagent in mobile phase. Limits of quantitation (LOQ) were established between 0.2 and 0.9 ng/g in 2 g of samples. Recovery of five FWAs in spiked commercial samples was between 42 and 95% and RSD (n = 3) ranging from 2 to 11%. The method was finally applied to commercial samples, showing that two stilbene-type disulfonates were predominant FWAs detected in napkin and infant cloth samples.

  19. Effect of chewing gum on tooth sensitivity following whitening.

    PubMed

    Tang, B; Millar, B J

    2010-06-01

    Transient sensitivity is the most common side-effect associated with tooth whitening. The purpose of this randomised, controlled clinical study was to determine if a chewing gum containing Recaldent (CPP-ACP) was effective in reducing tooth sensitivity associated with in-office whitening procedures. Eighty-eight patients were recruited and had their teeth lightened using a single-visit, in-office whitening treatment with 15% hydrogen peroxide augmented by light for a treatment period of one hour. Following the procedure, each patient was randomly assigned to one of three study groups: Group A, who used a sugar-free chewing gum with CPP-ACP; Group B, who did not use any desensitising agent; and Group C, who used a sugar-free chewing gum without CPP-ACP. The participants were requested to return for a 24 hour follow-up visit, at which the colour changes were measured using a value-oriented Vita classic shade guide. They also reported on the incidence, duration and intensity of tooth sensitivity experienced by completing a post-treatment questionnaire. The average Vita shade unit reduction was 4.8 and 88.6% of the patients were satisfied with their treatment outcomes. However, 85.2% of them experienced tooth sensitivity at some point following the whitening procedures. Both Group A and Group C experienced significantly less intense tooth sensitivity than Group B following the whitening procedures. However, Group A did not have a statistically significant reduction in the incidence, duration or intensity of sensitivity when compared to Group C. All sensitivity ceased at the 24 hour follow-up visits. This study suggested that using a sugar-free chewing gum (both with and without CPP-ACP) could reduce the intensity of tooth sensitivity associated with in-office whitening procedures. However, it failed to demonstrate conclusively that using a sugar-free chewing gum with CPP-ACP could provide additional therapeutic benefits.

  20. Tooth whitening and temperature rise with two bleaching activation methods

    NASA Astrophysics Data System (ADS)

    Abu-ElMagd, D. M.; El-Sayad, I. I.; Abd El-Gawad, L. M.

    2009-02-01

    Objectives: To measure the tooth whitening and the surface and intra-pulpal temperature increase in vitro on extracted upper human incisors after chemical, zoom light and diode laser activated bleaching. Materials and Methods: Thirty caries-free upper human incisors were selected. Teeth were divided into three equal groups according to the methods of activation of the bleaching agent (n=10). A whitening gel containing hydrogen peroxide was applied to the buccal surface of all teeth. Group I was bleached using chemically activated hydrogen peroxide gel. Group II was bleached with high intensity advanced power zoom activation light, for three applications of 15 min each. Group III was bleached with diode laser activation technique, where the teeth were irradiated with 2 watt diode laser for three applications of 30 sec each. Degree of whitening was assessed using an image analysis system, while temperature rise was recorded using a thermocouple on the external tooth surface and intrapulpal. Results: The degree of whitening increased significantly in all groups. However, the percentage of whitening was not statistically significantly different between the three groups. In addition, group II showed statistically significant higher mean rise in both surface and pulp temperatures than group I and group III. Conclusions: Chemical bleaching produces the same whitening effect as zoom AP light and laser, with no surface or pulpal temperature rise. Laser application is faster and produces less surface and pulp temperature increase than zoom AP light. Diode lasers used to activate bleaching gels are not considered dangerous to the vitality of dental pulps using power settings of 2W.

  1. Tooth Whitening And Temperature Rise With Two Bleaching Activation Methods

    SciTech Connect

    Abu-ElMagd, D. M.; El-Sayad, I. I.; Abd El-Gawad, L. M.

    2009-09-27

    To measure the tooth whitening and the surface and Intrapulpal temperature increase in vitro on freshly extracted upper human central incisors after chemical, Zoom AP light and diode laser activated bleaching. Thirty caries-free upper human incisors were selected. Teeth were divided into three equal groups according to the methods of activation of the bleaching agent (n = 10). A whitening gel containing hydrogen peroxide was applied to the buccal surface of all teeth. Group I was bleached using chemically activated hydrogen peroxide gel, for three applications of 15 min each. Group II was bleached with high intensity advanced power Zoom activation light (Zoom AP), for three applications of 15 min each. Group III was bleached with diode laser activation technique, where the teeth were irradiated with 2 Watt diode laser for three applications of 30 sec each. The whitening degree was assessed using an image analysis system, while temperature rise was recorded using a thermocouple on the external tooth surface and Intrapulpal. The degree of whitening increased significantly in all groups. However, the percentage of whitening was not statistically significantly different between the three groups. In addition, group II showed statistically significant higher mean rise in both surface and pulp temperatures than group I and group III. Chemical bleaching produces the same whitening effect as Zoom AP light and laser, with no surface or pulpal temperature rise. Laser application is faster and produces less surface and pulp temperature increase than Zoom AP light. Diode laser used to activate bleaching gels is not considered dangerous to the vitality of dental pulp using power settings of 2 W.

  2. Tooth Whitening And Temperature Rise With Two Bleaching Activation Methods

    NASA Astrophysics Data System (ADS)

    Abu-ElMagd, D. M.; El-Sayad, I. I.; Abd El-Gawad, L. M.

    2009-09-01

    To measure the tooth whitening and the surface and Intrapulpal temperature increase in vitro on freshly extracted upper human central incisors after chemical, Zoom AP light and diode laser activated bleaching. Thirty caries-free upper human incisors were selected. Teeth were divided into three equal groups according to the methods of activation of the bleaching agent (n = 10). A whitening gel containing hydrogen peroxide was applied to the buccal surface of all teeth. Group I was bleached using chemically activated hydrogen peroxide gel, for three applications of 15 min each. Group II was bleached with high intensity advanced power Zoom activation light (Zoom AP), for three applications of 15 min each. Group III was bleached with diode laser activation technique, where the teeth were irradiated with 2 Watt diode laser for three applications of 30 sec each. The whitening degree was assessed using an image analysis system, while temperature rise was recorded using a thermocouple on the external tooth surface and Intrapulpal. The degree of whitening increased significantly in all groups. However, the percentage of whitening was not statistically significantly different between the three groups. In addition, group II showed statistically significant higher mean rise in both surface and pulp temperatures than group I and group III. Chemical bleaching produces the same whitening effect as Zoom AP light and laser, with no surface or pulpal temperature rise. Laser application is faster and produces less surface and pulp temperature increase than Zoom AP light. Diode laser used to activate bleaching gels is not considered dangerous to the vitality of dental pulp using power settings of 2 W.

  3. How adolescents experience and cope with pain in daily life: a qualitative study on ways to cope and the use of over-the-counter analgesics.

    PubMed

    Lagerløv, Per; Rosvold, Elin Olaug; Holager, Tanja; Helseth, Sølvi

    2016-03-01

    The aim of this study was to describe how different adolescents experience and manage pain in their daily life, with a focus on their use of over-the-counter analgesics. More specifically, the aim was to explore different patterns among the adolescents in pain descriptions, in the management of pain, in relationships with others, and in their daily life. Qualitative semistructured interviews on experiences with pain, pain management and involvement of family and friends during pain. Pain and stress management strategies and attachment theory will be in focus for interpretations. 25 participants aged 15-16-years from six different junior high schools, both genders, with and without immigrant background were interviewed at their local schools in Norway. We identified 4 groups of adolescents with similarities in attitudes and management strategies to pain: 'pain is manageable', 'pain is communicable', 'pain is inevitable' and 'pain is all over'. The participants within each group differed in how they engaged their parents in pain; how they perceived, communicated and managed pain; and how they involved emotions and used over-the-counter analgesics. The adolescents' different involvement with the family during pain related to their pain perception and management. Knowledge of the different ways of approaching pain is important when supporting adolescents and may be a subject for further research on the use of over-the-counter analgesics in the family. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. What information for the patient? Large scale pilot study on experimental package inserts giving information on prescribed and over the counter drugs.

    PubMed Central

    1990-01-01

    OBJECTIVE--To compare the acceptability and the degree of understandability of two drug information leaflets on three over the counter and two prescribed drugs. DESIGN--Prospective observational study. SETTING--Random sample of municipal pharmacies throughout Italy. SUBJECTS--A total of 6992 clients of the pharmacies who requested the study drugs over a period of four months. INTERVENTION--Exposure of patients to two information leaflets, one approved by the Ministry of Health, and the other an experimental sheet prepared by the research working group. MAIN OUTCOME MEASURES--The degree of acceptability of the information was assessed by using a pretested questionnaire. Comments concerning information needs were also encouraged and collected. RESULTS--6992 Clients responded to the questionnaire. Non-metropolitan (urban and rural) areas had the highest rate of participation. The participants strongly preferred the experimental leaflets to the approved leaflets, both with respect to accessibility of the contents (overall preference 78.1% v 17.8%) and ease of understanding the contraindications of drug use (90.2% v 73.7%). Basic attitudes related to the use of written information were similar among clients of different age groups, educational levels (though emerging people with primary school or lower educational levels showed slightly lesser understanding), and geographic areas. Up to 50% of those who took over the counter drugs indicated a disposition to change their drug seeking behaviour on the basis of the information in the experimental leaflet. The comments provided a useful complementary set of data on the information needs expressed by participants. CONCLUSIONS--The results of this pilot study indicate that patients will enter active programmes to investigate the provision of problem oriented drug information. Their information needs seem to concern both prescribed and over the counter drugs. More extensive and systematic work is required to develop an

  5. Limited effectiveness of over-the-counter plant preparations used for the treatment of urinary tract infections as inhibitors of the urease activity from Staphylococcus saprophyticus.

    PubMed

    Deutch, C E

    2017-05-01

    Urease is a key virulence factor for the Gram-positive urinary tract pathogen Staphylococcus saprophyticus and a potential target for antimicrobial therapy. The enzyme from S. saprophyticus is unusual in that it does not contain cysteine at the active site. The aims of this study were to test 14 over-the-counter plant preparations as inhibitors of this urease and to determine whether they can prevent the increase in pH that normally occurs in bacterial cultures containing urea. Urease activity was measured colorimetrically by the formation of ammonium ions. The green tea and Uva-Ursi preparations reduced urease activity in a soluble extract of S. saprophyticus by more than 75%. Two herbal mixtures were weakly inhibitory and reduced activity by about 25%, but the other products had little or no effect. The green tea and Uva-Ursi extracts also inhibited urease activity in whole cells by more than 75%. One of the herbal products (WishGarden UTI) showed some inhibition of urease activity but the other (UTI Clear) did not. The green tea and Uva-Ursi preparations prevented the increase in pH that normally occurs when S. saprophyticus is grown in an artificial urine medium, but this was due primarily to bacterial death. The WishGarden UTI preparation could partially delay the pH increase while allowing some cells to remain viable. These results indicate that only a few of the commercially available over-the-counter plant preparations commonly used for the treatment of urinary tract infections (UTIs) can inhibit the urease activity from S. saprophyticus. While over-the-counter plant preparations may be considered an alternative to traditional antibiotics for the treatment of UTIs, they should be used with caution and a product should be matched to the properties of the virulence factors of the bacterial pathogen involved. © 2017 The Society for Applied Microbiology.

  6. Dandruff, seborrheic dermatitis, and psoriasis drug products containing coal tar and menthol for over-the-counter human use; amendment to the monograph. Final rule

    SciTech Connect

    2006-03-15

    The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.

  7. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Final rule.

    PubMed

    2009-04-29

    The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

  8. Tooth whitening clinical trials: a global perspective.

    PubMed

    Gerlach, Robert W

    2007-09-01

    Tooth whitening has been the subject of extensive clinical trials research since the introduction of the first hydrogen-peroxide whitening strips in 2000. Availability of digital image analysis, an unambiguous and reproducible method for assessing color change, has contributed to global clinical research and product development on whitening strips. The research has included a series of global randomized controlled trials in distinct sites and cultures, involving 6-6.5% hydrogen peroxide whitening strips used for 7-21 days. These studies, conducted at research hospitals, dental schools, and private dental practice, demonstrated significant color improvement with whitening strips relative to baseline and/or various controls without serious adverse events. This integrated clinical trials research provides important evidence of long-term safety and effectiveness of tooth whitening with 6-6.5% hydrogen peroxide whitening strips.

  9. Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials.

    PubMed Central

    Hays, J T; Croghan, I T; Schroeder, D R; Offord, K P; Hurt, R D; Wolter, T D; Nides, M A; Davidson, M

    1999-01-01

    OBJECTIVES: The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995. METHODS: Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. RESULTS: Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. CONCLUSIONS: In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment. PMID:10553392

  10. Hypercalcemia, hypervitaminosis A and 3-epi-25-OH-D3 levels after consumption of an "over the counter" vitamin D remedy. a case report.

    PubMed

    Granado-Lorencio, F; Rubio, E; Blanco-Navarro, I; Pérez-Sacristán, B; Rodríguez-Pena, R; García López, F J

    2012-06-01

    Intoxication from vitamin D supplements has been rarely reported but, nowadays, it occurs more frequently. 3-epi-25-OH-D(3) is highly prevalent in adults and it is considered of biological relevance. We report a case of vitamin D toxicity with hypercalcemia, acute renal failure and hypervitaminosis A after consuming an over-the-counter vitamin D supplement. Our data suggest that the contribution of 3-epi-25-OH-D(3) is not altered during vitamin D toxicity, although the serum levels of 25-OH-D(3) and 3-epi-25-OH-D(3) may display a different rate of clearance. The patient also displayed hypervitaminosis A unrelated to diet, possibly caused by renal failure related to the hypercalcemia induced by vitamin D toxicity. Because of the increasing use of over-the-counter vitamin D supplements and the potential iatrogenic hypercalcemia related to hypervitaminosis A, the present case highlights the importance of evaluating both the use of (non-) prescribed medication and vitamin A status during vitamin D toxicity. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. Skin Barrier Health: Regulation and Repair of the Stratum Corneum and the Role of Over-the-Counter Skin Care.

    PubMed

    Lee, Thomas; Friedman, Adam

    2016-09-01

    The epidermis functions as a physical barrier that separates the inner body from the outside environment. The outermost layer of the epidermis, the stratum corneum, plays a key role in maintaining this barrier. There are numerous biochemical changes that take place to and in the keratinocyte as it migrates from the bottom, or startum basale, to the top layer of the epidermis in order for this barrier to function appropriately. In addition, external and internal factors, such as irritants and underlying medical diseases, can also affect the stratum corneum, both of which can potentially lead to disruption of barrier function and ultimately skin pathology. In this article, we will review keratinocyte biology as it relates to the formation and function of the stratum corneum. We will also review stratum corneum structure, physiology, and the impact of chemical agents and defective stratum corneum components that can lead to skin disease. Finally, we will briefly discuss how moisturizers repair defects in the stratum corneum and restore barrier function.

    J Drugs Dermatol. 2016;15(9):1047-1051.

  12. The effects of a customized over-the-counter mouth guard on neuromuscular force and power production in trained men and women.

    PubMed

    Dunn-Lewis, Courtenay; Luk, Hui-Ying; Comstock, Brett A; Szivak, Tunde K; Hooper, David R; Kupchak, Brian R; Watts, Ashley M; Putney, Brendan J; Hydren, Jay R; Volek, Jeff S; Denegar, Craig R; Kraemer, William J

    2012-04-01

    Although mouth guards were originally designed for injury prevention, even elite athletes are now using performance mouth guards to improve athletic success. Both expensive custom models and over-the-counter models are available, but the efficacy is not well known. Some athletes remain wary of the perceived potential for detriments using a mouth guard to their performance. Thus, the purpose of this study was to examine various physical performance tests when using a mouth guard including a customized over-the-counter mouth guard. Twenty-six trained men (25 ± 4 years; 1.78 ± 0.07 m; 83.3 ± 11.4 kg) and 24 trained women (23 ± 3 years; 1.65 ± 0.08 m; 62.6 ± 7.8 kg) volunteered for the investigation. The subjects completed a familiarization period and then balanced and randomized treatment conditions that included: (a) a customized Power Balance performance mouth guard (PB MG); (b) a regular over the counter boil-and-bite mouth guard (Reg MG); and (c) a no mouth guard (No MG) treatment condition. At each visit, the subjects completed a testing protocol that was sequenced in the following order: sit-and-reach flexibility, medial-lateral balance, visual reaction time, vertical jump, 10-m sprint, bench throw, and plyo press power quotient (3PQ). Heart rate and rating of perceived exertion (RPE) were recorded around the 3PQ. Significance was set at p ≤ 0.05. Expected significant sex differences existed for all power, strength, and speed variables. Bench throw power (watts) and force (newtons) were significantly higher under PB MG than either Reg MG or No MG or in both men and women. The 3PQ power and force production were higher than that for the other 2 treatments for the PB MG for men only. There were no significant differences for treatment conditions in the heart rate or RPE after the 3PQ test. Men were better able to maintain significantly higher 3PQ power production under PB MG treatment condition compared with the other 2 treatment conditions. Rate of power

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

    PubMed Central

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

    2001-01-01

    OBJECTIVES: 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. METHODS: A cross-sectional analysis was used. RESULTS: 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. CONCLUSIONS: 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. PMID:11344889

  14. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011

    PubMed Central

    Qato, Dima M.; Wilder, Jocelyn; Schumm, L. Philip; Gillet, Victoria; Alexander, G. Caleb

    2016-01-01

    IMPORTANCE Prescription and over-the-counter medicines and dietary supplements are commonly used, alone and together, among older adults. However, the effect of recent regulatory and market forces on these patterns is not known. OBJECTIVES To characterize changes in the prevalence of medication use, including concurrent use of prescription and over-the-counter medications and dietary supplements, and to quantify the frequency and types of potential major drug-drug interactions. DESIGN, SETTING, AND PARTICIPANTS Descriptive analyses of a longitudinal, nationally representative sample of community-dwelling older adults 62 to 85 years old. In-home interviews with direct medication inspection were conducted in 2005–2006 and again in 2010–2011. The dates of the analysis were March to November 2015. We defined medication use as the use of at least 1 prescription or over-the-counter medication or dietary supplement at least daily or weekly and defined concurrent use as the regular use of at least 2 medications. We used Micromedex to identify potential major drug-drug interactions. MAIN OUTCOMES AND MEASURES Population estimates of the prevalence of medication use (in aggregate and by therapeutic class), concurrent use, and major drug-drug interactions. RESULTS The study cohort comprised 2351 participants in 2005–2006 and 2206 in 2010–2011. Their mean age was 70.9 years in 2005–2006 and 71.4 years in 2010–2011. Fifty-three percent of participants were female in 2005–2006, and 51.6% were female in 2010–2011. The use of at least 1 prescription medication slightly increased from 84.1% in 2005–2006 to 87.7% in 2010–2011 (P = .003). Concurrent use of at least 5 prescription medications increased from 30.6% to 35.8% (P = .02). While the use of over-the-counter medications declined from 44.4% to 37.9%, the use of dietary supplements increased from 51.8% to 63.7%(P < .001 for both). There were clinically significant increases in the use of statins (33.8% to 46

  15. Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople.

    PubMed

    Hellier, Elizabeth; Tucker, Mike; Kenny, Natalie; Rowntree, Anna; Edworthy, Judy

    2010-09-01

    This study aimed to examine the utility of using color and shape to differentiate drug strength information on over-the-counter medicine packages. Medication errors are an important threat to patient safety, and confusions between drug strengths are a significant source of medication error. A visual search paradigm required laypeople to search for medicine packages of a particular strength from among distracter packages of different strengths, and measures of reaction time and error were recorded. Using color to differentiate drug strength information conferred an advantage on search times and accuracy. Shape differentiation did not improve search times and had only a weak effect on search accuracy. Using color to differentiate drug strength information improves drug strength identification performance. Color differentiation of drug strength information may be a useful way of reducing medication errors and improving patient safety.

  16. A comparison of transdermal over-the-counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back pain and arthritis.

    PubMed

    Castro, Eric; Dent, David

    2017-08-14

    Transdermal lidocaine therapy has become a gold standard as part of a treatment regimen for patients who suffer from localized pain. We compared transdermal patches: over-the-counter (OTC) lidocaine 3.6% combined with menthol 1.25%, prescription lidocaine 5% (Rx) and placebo. In a double-blind, placebo-controlled trial, 87 patients were randomized to: OTC, Rx or placebo. OTC met primary end points of noninferiority compared with Rx for efficacy, side effects and quality of life. Versus placebo, OTC proved superiority for efficacy, general activity and normal work. Side effects were similar. It is theorized that menthol's ability to increase skin permeability facilitated more efficient drug delivery to the site of pain causing higher than expected efficacy. Decreased cost and resource utilization could benefit patients and payers.

  17. Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule.

    PubMed

    2002-01-23

    The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the- counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. The criteria and procedures address how OTC drugs initially marketed in the United States after the OTC drug review began in 1972, and OTC drugs without any U.S. marketing experience, can meet the statutory definition of marketing to a "material extent" and "for a material time" and become eligible. If found eligible, the condition would be evaluated for general recognition of safety and effectiveness in accordance with FDA's OTC drug monograph regulations. FDA is also changing the current OTC drug monograph procedures to streamline the process and provide additional information in the review.

  18. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011.

    PubMed

    Qato, Dima M; Wilder, Jocelyn; Schumm, L Philip; Gillet, Victoria; Alexander, G Caleb

    2016-04-01

    Prescription and over-the-counter medicines and dietary supplements are commonly used, alone and together, among older adults. However, the effect of recent regulatory and market forces on these patterns is not known. To characterize changes in the prevalence of medication use, including concurrent use of prescription and over-the-counter medications and dietary supplements, and to quantify the frequency and types of potential major drug-drug interactions. Descriptive analyses of a longitudinal, nationally representative sample of community-dwelling older adults 62 to 85 years old. In-home interviews with direct medication inspection were conducted in 2005-2006 and again in 2010-2011. The dates of the analysis were March to November 2015. We defined medication use as the use of at least 1 prescription or over-the-counter medication or dietary supplement at least daily or weekly and defined concurrent use as the regular use of at least 2 medications. We used Micromedex to identify potential major drug-drug interactions. Population estimates of the prevalence of medication use (in aggregate and by therapeutic class), concurrent use, and major drug-drug interactions. The study cohort comprised 2351 participants in 2005-2006 and 2206 in 2010-2011. Their mean age was 70.9 years in 2005-2006 and 71.4 years in 2010-2011. Fifty-three percent of participants were female in 2005-2006, and 51.6% were female in 2010-2011. The use of at least 1 prescription medication slightly increased from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P = .003). Concurrent use of at least 5 prescription medications increased from 30.6% to 35.8% (P = .02). While the use of over-the-counter medications declined from 44.4% to 37.9%, the use of dietary supplements increased from 51.8% to 63.7% (P < .001 for both). There were clinically significant increases in the use of statins (33.8% to 46.2%), antiplatelets (32.8% to 43.0%), and omega-3 fish oils (4.7% to 18.6%) (P < .05 for all

  19. Influence of whitening and regular dentifrices on orthodontic clear ligature color stability.

    PubMed

    Oliveira, Adauê S; Kaizer, Marina R; Salgado, Vinícius E; Soldati, Dener C; Silva, Roberta C; Moraes, Rafael R

    2015-01-01

    This study evaluated the effect of brushing orthodontic clear ligatures with a whitening dentifrice containing a blue pigment (Close Up White Now, Unilever, London, UK) on their color stability, when exposed to a staining agent. Ligatures from 3M Unitek (Monrovia, CA, USA) and Morelli (Sorocaba, SP, Brazil) were tested. Baseline color measurements were performed and nonstained groups (control) were stored in distilled water whereas test groups were exposed for 1 hour daily to red wine. Specimens were brushed daily using regular or whitening dentifrice. Color measurements were repeated after 7, 14, 21, and 28 days using a spectrophotometer based on the CIE L*a*b* system. Decreased luminosity (CIE L*), increased red discoloration (CIE a* axis), and increased yellow discoloration (CIE b* axis) were generally observed for ligatures exposed to the staining agent. Color variation was generally lower in specimens brushed with regular dentifrice, but ligatures brushed with whitening dentifrice were generally less red and less yellow than regular dentifrice. The whitening dentifrice led to blue discoloration trend, with visually detectable differences particularly apparent according to storage condition and ligature brand. The whitening dentifrice containing blue pigment did not improve the ligature color stability, but it decreased yellow discoloration and increased a blue coloration. The use of a whitening dentifrice containing blue pigment during orthodontic treatment might decrease the yellow discoloration of elastic ligatures. © 2015 Wiley Periodicals, Inc.

  20. Over-the-counter medicines

    MedlinePlus

    ... anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev . 2013;6:CD006362. PMID: 23733384 www. ... paracetamol) for the common cold in adults. Cochrane Database Syst Rev . 2013;7:CD008800. PMID: 23818046 www. ...

  1. Over-the-counter analgesics.

    PubMed

    Clarence, M

    The increasing availability of analgesic drugs from a variety of outlets may be seen as a welcome development by manufacturers and consumers, but there are poorly acknowledged dangers associated with injudicious usage. Maggie Clarence outlines the properties of the most common products on the market, and emphasises the need for sound patient education from suitably trained personnel.

  2. Utilization and Safety of Common Over-the-Counter Dietary/Nutritional Supplements, Herbal Agents, and Homeopathic Compounds for Disease Prevention.

    PubMed

    Trivedi, Ruchir; Salvo, Marissa C

    2016-09-01

    Dietary supplements are commonly used by patients as part of their medical care plan. Often clinicians may not be aware of their use, because patients do not always consider these to be medications. All clinicians need to continually ask patients about their use of dietary supplements when collecting a medication history. Dietary supplements and prescription medications often share similar enzymatic pathways for their metabolism. These interactions may lead to severe adverse reactions. This article reviews available evidence for a variety of dietary supplements in select disease categories.

  3. Whitening non vital teeth - a case report.

    PubMed

    Moraru, Iren; Tuculină, Mihaela; Bătăiosu, Marilena; Gheorghiţă, Lelia; Diaconu, Oana

    2012-07-01

    Commonly used in cosmetic dentistry teeth whitening can be used combined with other restorative techniques during dental treatment. Non-vital teeth whitening is necessary whenever we need an improvement of their aspect, as it's a known fact that these teeth can have a grey or pink-grey coloration when they are not correctly endodontical treated.

  4. Druggists and pharmacists as gatekeepers: sales routines and compliance with sales protocols for over-the-counter naproxen 275 mg medicines in the Netherlands.

    PubMed

    van Hoof, Joris J; Cents, Michel H G; Megens, Nicole M J; van der Tang, Sijbrand J

    2014-09-01

    Since for the sales of over-the-counter (OTC) medicines, prescribing physicians are not involved, and written instructions on/in the medicine boxes are inefficient, druggists and pharmacists are important gatekeepers in preventing customers' accidents. In this study we investigated the sales routines, and compliance with sales protocols, in order to evaluate that gatekeeper's function. By means of the mystery shopping method, 228 pharmacies and drugstores in The Netherlands were visited and a naproxen 275mg medium-risk medicine was requested for a (fictitious) patient who was suffering from severe back pains. According to the sales protocols the vendors should never sell the requested medicine, because the mystery shoppers only gave an answer to one of the four mandatory sales protocol questions. Furthermore, the requested medicine is not the right or best choice for back pains. Four different scenarios were used in a 2×2 design (8-year-old patient vs. 25-year-old patient, and 1 box with 12 pills vs. 3 boxes with 12 pills). Of the drugstores and pharmacies only 16.7% complied with the sales protocols and did not sell the specific (or comparable) medicine, after asking all four mandatory questions (or already after one, two or three questions). Most vendors (83.3%) did not comply and sold the requested medicine, a comparable medicine, or even a more risky medicine after no question at all (or after asking some or even all four questions). Although both score low, pharmacists show better compliance (23.9%) than druggists (10.1%). When it comes to OTC medicines, druggists and pharmacists largely commit sloppy sales. The expected gatekeeping function of pharmacists and druggists is very limited, and customers might be in danger of inappropriate medicine selection, quantity and usage. We call for thorough evaluation of the over-the-counter system, improvement of the educational programs for medicine providers, and national campaigns to inform the public. Copyright

  5. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet.

    PubMed

    Paluch, Edward; Jayawardena, Shyamalie; Wilson, Brenda; Farnsworth, Sarah

    2016-01-01

    The extent to which people comply with labeled instructions for use of long-acting over-the-counter analgesics is largely unknown; this study evaluated whether consumers can correctly select and use a new long-acting ibuprofen 600-mg immediate-release and extended-release (IR/ER) product. A single open-label study with participants randomly assigned to 2 substudies. Self-selection substudy: participants estimated duration of their last pain episode, then selected ibuprofen IR/ER or standard ibuprofen IR for a similar episode. Compliance substudy: participants purchased and recorded real-world use of ibuprofen IR/ER in daily diaries over 30 days. Eighteen U.S. pharmacies. Consumers age 12 years or older who used an average of ≥5 doses per month of an over-the-counter analgesic in the past 3 months. Self-selection: questionnaire only. Compliance: ibuprofen IR/ER as needed. Self-selection: percentage who correctly selected or avoided selecting ibuprofen IR/ER based on anticipated pain duration. Compliance: proportion who were excessive users (use for >10 of 30 days and averaging >1600 mg/d, or >20 tablets over ≤10 days and averaging >1600 mg/d). Self-selection substudy (N = 249): on the primary endpoint, 69.1% (95% confidence interval [CI], 63.3%-74.8%) overall made a correct selection-63.5% (95% CI, 57.5%-69.4%) correctly selected ibuprofen IR/ER for pain ≥6 hours and 5.6% (95% CI, 2.8%-8.5%) correctly avoided selecting ibuprofen IR/ER for shorter-lasting pain. Overall, 82.7% (95% CI, 77.6%-87.8%) chose correctly when subjects who picked ibuprofen IR for pain ≥6 hours (a "missed opportunity," not an incorrect selection) were excluded. Compliance substudy (N = 405): only 5 participants (1.2%; 95% CI, 0.2%-2.3%) were excessive users; all took ibuprofen IR/ER for >10 days, averaging 1821 mg/day (range, 1661.5-2072.7 mg/d). No excessive user experienced an adverse event. Although the study did not meet the a priori primary efficacy outcome target, the majority

  6. The relevance of the urinary concentration of ephedrines in anti-doping analysis: determination of pseudoephedrine, cathine, and ephedrine after administration of over-the-counter medicaments.

    PubMed

    Strano-Rossi, Sabina; Leone, Daniele; de la Torre, Xavier; Botrè, Francesco

    2009-08-01

    This article describes a method for the detection and quantitation of cathine, pseudoephedrine, ephedrine, and methylephedrine in urine, using their deuterated analogues as internal standards and derivatization to form the corresponding trimethylsilyl derivatives after a simple liquid-liquid extraction. The study was designed to evaluate whether the urinary cutoff values set by the World Anti-Doping Agency for the banned ephedrines (cathine >5 microg/mL, ephedrine and methylephedrine >10 microg/mL) can be exceeded after the normal self-administration of common over-the-counter medicaments containing nonbanned ephedrines. The present method, after validation, has been applied on real urine samples obtained from 9 healthy volunteers taking different doses of over-the-counter preparations containing ephedrines. Results obtained from excretion studies show high interindividual differences in the urinary concentrations of both pseudoephedrine and cathine, not dependent on body weight or sex nor, in some instances, on the administered dose. The same typical therapeutic dose of pseudoephedrine (60 mg) produced a urinary concentration of more than 5 microg/mL for cathine and of more than 100 microg/mL for pseudoephedrine in 2 of 9 subjects only. When a dose of 120 mg was administered, cathine concentration exceeded 5 microg/mL in 4 of 7 subject, and also concentrations of pseudoephedrine above 100 microg/mL. After administration of 5 x 120 mg of pseudoephedrine (120 mg administered every 7 days for 5 weeks) to one of the subjects exceeding the urinary threshold values, the urinary concentration of cathine and pseudoephedrine exceeded 5 microg/mL (peak concentration 14.8 microg/mL) and 100 microg/mL (peak concentration 275 microg/mL), respectively. When the same subject took 180 mg of pseudoephedrine, the urinary concentration values were below 5 microg/mL for ephedrine and 100 microg/mL for pseudoephedrine. In the case of ephedrine administration in a sustained

  7. Effect of whitening agents on dentin bonding.

    PubMed

    Spyrides, G M; Perdigão, J; Pagani, C; Araújo, M A; Spyrides, S M

    2000-01-01

    Several studies have shown a reduction in enamel bond strengths when the bonding procedure is carried out immediately after vital bleaching with peroxides. This reduction in bond strengths has become a concern in cosmetic dentistry with the introduction of new "in-office" and "waiting-room" bleaching techniques. The aim of this in vitro study was to evaluate the effect of three bleaching regimens: 35% hydrogen peroxide (HP), 35% carbamide peroxide (CP), and 10% CP, on dentin bond strengths. One hundred and twenty fresh bovine incisors were used in this study. The labial surface of each tooth was ground flat to expose dentin and was subsequently polished with 600-grit wet silicon carbide paper. The remaining dentin thickness was monitored and kept at an average of 2 mm. The teeth were randomly assigned to four bleaching regimens (n = 30): (A) control, no bleaching treatment; (B) 35% HP for 30 minutes; (C) 35% CP for 30 minutes; and (D) 10% CP for 6 hours. For each group, half of the specimens (n = 15) were bonded with Single Bond/Z100 immediately after the bleaching treatment, whereas the other half was bonded after the specimens were stored for 1 week in artificial saliva at 37 degrees C. The specimens were fractured in shear using an Instron machine. For the groups bonded immediately after bleaching, one-way analysis of variance (ANOVA) followed by the Duncan's post hoc test revealed a statistically significant reduction in bond strengths in a range from 71% to 76%. For the groups bonded at 1 week, one-way ANOVA showed that group B (35% HP for 30 min) resulted in the highest bond strengths, whereas 10% CP resulted in the lowest bond strengths. Student's t-test showed that delayed bonding resulted in a significant increase in bond strengths for groups B (35% HP) and C (35% CP); whereas the group bleached with 10% CP (group D) remained in the same range obtained for immediate bonding. Storage in artificial saliva also affected the control group, reducing its bond strengths to 53% of the original.

  8. The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study

    PubMed Central

    Medagama, Arjuna Bandara; Widanapahirana, Heshan; Prasanga, Tharindu

    2015-01-01

    Aims: There is an increase of over-the-counter (OTC) herbal products for use in diabetes mellitus. The aim of this study is to evaluate the safety information provided with OTC herbal remedies intended for diabetic patients in Sri Lanka and to assess the completeness of the information provided. Methods: Inclusion criteria consisted of OTC herbal remedies meant for use in diabetes. They were bought from local Sri Lankan supermarkets and non-ayurvedic pharmacies and product information regarding the risk of hypoglycemia, precautions for use, adverse events, dose, and interactions were assessed using a scoring system. The accuracy of the information was then compared against published data. Results: 11 products fulfilled the inclusion criteria. Five products contained a single constituent and five contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycemia. 9 out of 11 products (81.8%) carried ≤3 items of the five essential factual information we expected. Hypoglycemic coma, gastrointestinal symptoms, hepatotoxicity, carcinogenesis, and interactions causing elevated drug levels of Carbamazepine were some of the safety information that was missing. Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority. PMID:26649230

  9. Over-the-counter and Prescription Medications for Acne: A Cross-Sectional Survey in a Sample of University Students in Saudi Arabia

    PubMed Central

    Alshehri, Mohja D.; Almutairi, Abdulsalam T.; Alomran, Asma M.; Alrashed, Batool A.; Kaliyadan, Feroze

    2017-01-01

    Introduction and Background: Acne is a very common dermatological condition found among the adolescent population in Saudi Arabia. Many patients with acne try various forms of self-medication, over the counter medicines (OTC), and prescription medicines for the same. Materials and Methods: This was a cross-sectional study among university students in the Kingdom of Saudi Arabia (KSA). A validated questionnaire was distributed to a convenience sample of university students to evaluate their knowledge and attitudes towards OTC (mainly) as well as prescription medicine for acne. Chi-square and multiple logistic regression tests were used for comparisons between groups. Results: Four hundred and twenty valid, completed questionnaires were obtained. A total of 220 (52.4%) used some type of OTC medications at least once, where as 108 (25.7%) used prescription medicines and 92 (21.9%) used both. The most common OTC medications used were cleansers by 250 participants (41.9%). Among prescription medicines, the most common were topical and oral antibiotics (11.4%). Bivariate and multivariate analysis showed that females are statistically more likely to use OTC medicines compared to males (Odds ratio: 1.7). Conclusion: The use of self-medications and OTC medications is common among university students in KSA. The most common OTC medicine used for acne was cleanser. PMID:28405552

  10. Drugs involved in drug-facilitated crimes--part II: Drugs of abuse, prescription and over-the-counter medications. A review.

    PubMed

    Shbair, M K S; Eljabour, S; Bassyoni, I; Lhermitte, M

    2010-11-01

    In recent years, there has been a notable increase in the number of reports of drug-facilitated crimes. Usually, individuals report that they were robbed or assaulted while incapacitated by drugs. Most often, these cases have involved drugs that have the ability to produce an effect that leaves the victim in a semiconscious or unconscious state. It is reasonable to assume that the purpose of drug-induced incapacitation is probably largely unchanged with time. This covers the full range of property offences (particularly theft) and crimes against the person (often sexual assault). What have changed are the drugs themselves: the number; type; their accessibility; effects and detection. This review describes the different aspects related to the involvement and use of drugs of abuse, as well as prescription and over-the counter medications in drug-facilitated crimes, which may help people working in this field to expand their knowledge in order to better understand the nature of these crimes or offences.

  11. [Surveillance study on use of over-the-counter drug and health food by school pharmacist for grade-schooler, junior high school student, and high school students].

    PubMed

    Anraku, Makoto; Tomida, Hisao; Sato, Eiji; Tabuchi, Norihiko; Yoshitomi, Hironori; Okamura, Nobuyuki; Taguchi, Katsuhide; Kondo, Yuko; Murakami, Nobuyuki

    2011-01-01

    In recent years, it is necessary to acquire knowledge not only about medicine but also over-the-counter (OTC) drugs and health food for children, because lowering trend in the age of the health hazard by improper use of health food is reported. Therefore, in order to estimate the extent of use of OTC drugs and health food, the school pharmacists administered a questionnaire to students in grade-school (n=123), junior high school (n=303), and high school (n=115) in Fukuyama city. As a result of the questionnaire survey, surprisingly, the usage ratio of OTC drugs and health food showed the most increase in grade-schooler. The trigger of use of health food is "parents' recommendations" in the lower grades, otherwise the ratio of "use by themselves" was increased in the higher grades. Moreover, a remarkable difference was observed by the kinds of use in students with or without exercise. Interestingly, exercise group expected "physical strength" effects than no exercise group. In addition, the ratio of consultation to the pharmacist at the time of purchase of OTC drugs and health food was low in all grade students. In particular, the ratio of consultation to the pharmacist at the time of purchase of health food was very low in high school students. Therefore, to provide accurate information of medicine and health food for students, the school pharmacist should engage not only in routine work but also in positive guidance about OTC drugs and health food in the future.

  12. Study of the influence of over-the-counter vitamin supplement intake on urine fluorescence to optimize cancer detection by fluorescence cystoscopy

    NASA Astrophysics Data System (ADS)

    Zellweger, Matthieu; Martoccia, Carla; Mengin, Matthieu; Iselin, Christophe; Bergh, Hubert van den; Wagnières, Georges

    2015-06-01

    Fluorescence cystoscopy (FC) efficiently enhances the detection and improves the therapeutic management of early bladder cancer. During an FC, about 150 ml of water is needed to inflate the bladder. The water is quickly diluted by urine which can be fluorescent. If this bladder washout fluid (BWF) becomes fluorescent, the FC images are frequently degraded. Unfortunately, it is unclear which elements of the diet may contribute to this background fluorescence. We propose to start this exploration with over-the-counter (OTC) vitamin supplements. To this end, we measured excitation-emission matrices of urine samples and the kinetics of modifications of urine fluorescence obtained from nine healthy volunteers before, during, and after intake of a commercially available OTC vitamin supplement. The pharmacokinetics shows that the BWF fluorescence values reach a maximum 8 to 10 h after vitamin intake. They decrease in the half-day that follows and reach values close to baseline ˜1 day afterward. Based on these results, we conclude that, in order to avoid degradations of fluorescence images, it is likely best that the intake of OTC vitamin supplements be avoided during the week preceding an FC.

  13. Don’t Ask, Don’t Tell: Parental Nondisclosure of Complementary and Alternative Medicine and Over-the-Counter Medication Use in Children’s Asthma Management

    PubMed Central

    Sidora-Arcoleo, Kimberly; Yoos, H. Lorrie; Kitzman, Harriet; McMullen, Ann; Anson, Elizabeth

    2008-01-01

    Background Parent-healthcare provider (HCP) communication is an important component of pediatric asthma management. Given the high prevalence of complementary and alternative medicine (CAM) and over-the-counter (OTC) medication use among this population, it is important to examine parental nondisclosure of these asthma management strategies. Method One-time interview and one-year retrospective medical record review with 228 parents of 5–12 year old children with asthma enrolled from 6 pediatric primary care practices examining parental nondisclosure of CAM and OTC medication use, reasons for nondisclosure, medical record documentation of CAM usage, and association between parent-HCP relationship and nondisclosure. Results Seventy-one percent of parents reported using CAM and/or OTC medication for children’s asthma management and 54% of those parents did not disclose usage. Seventy-five percent “did not think” to discuss it. Better parent-HCP relationship led to decreased nondisclosure. Discussion HCPs can play an important role in creating an environment where parents feel comfortable sharing information about their children’s asthma management strategies in order to arrive at a shared asthma management plan for the child leading to improved asthma health outcomes. PMID:18590866

  14. Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product.

    PubMed

    Hermann, Anne C; Nafziger, Anne N; Victory, Jennifer; Kulawy, Robert; Rocci, Mario L; Bertino, Joseph S

    2005-06-01

    Progesterone products are available in prescription form as well as over-the-counter (OTC) topical preparations sold for "cosmetic" uses. In a randomized study design, the authors compared the drug exposure from an OTC progesterone cream to a Food and Drug Administration-approved oral preparation at the labeled daily doses recommended for each product. Twelve healthy postmenopausal women received 200-mg oral progesterone capsules once daily for 12 days or progesterone cream 40 mg twice daily for 12 days. At steady state (day 12 of each phase), whole-blood samples were collected over 24 hours (oral progesterone) or 12 hours (topical progesterone) and assayed for total progesterone concentration. No significant differences were found in dose-normalized 24-hour progesterone exposure comparing the cream to oral capsules (median AUC(0-24) 12.5 ng x h/mL vs 10.5 ng x h/mL, respectively; P = .81). In light of the potential risks associated with long-term progesterone use, the authors question whether topical progesterone products should be available OTC.

  15. Association of health-related quality of life with dual use of prescription and over-the-counter nonsteroidal antiinflammatory drugs.

    PubMed

    Kovac, Stacey H; Saag, Kenneth G; Curtis, Jeffrey R; Allison, Jeroan

    2008-02-15

    Inadequate prescription therapy pain management, lack of doctor-patient communication about over-the-counter (OTC) medications, and easy accessibility of OTC medications may contribute to patients using more than 1 medication to manage pain. It is well established that taking multiple nonsteroidal antiinflammatory drugs (NSAIDs) can lead to serious gastrointestinal problems. Little is known about whether use of more than 1 NSAID (i.e., dual use) is related to patient self-reported outcomes, specifically health-related quality of life (HRQOL). We hypothesized that dual use of NSAIDs would be associated with reduced HRQOL. Patients from a managed care organization who filled > or =1 NSAID prescription over a 6-month period were eligible for a telephone interview focusing on NSAID use, which included the Short Form 12 (SF-12) Health Survey. Dual use was defined as taking 2 NSAIDs, either prescription or OTC, at least twice weekly during the past month. A multivariable linear regression model examined the association between dual use and the Physical Component Summary score (PCS-12) from the SF-12. Dual use was associated with lower PCS-12 scores indicating poorer HRQOL, after controlling for clinical and demographic factors. Patients may self-manage their pain to improve their daily activities by taking more than 1 NSAID. However, by attempting to obtain symptom relief, patients may be putting themselves at risk for complications. Providers are likely unaware of patients' risk. Future research should evaluate the causal factors contributing to dual use.

  16. 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.

  17. Analysis of multiple end points in consumer research in support of switching drugs from prescription to over-the-counter status: the concept of end-point hierarchies.

    PubMed

    Brass, E P; Shay, L E; Leonard-Segal, A

    2009-04-01

    Clinical and regulatory decision making concerning over-the-counter (OTC) drugs requires research designed to understand how consumers will self-manage treatment using the candidate OTC drug. Consumer research for an OTC drug may include studies of label comprehension, self-selection, and actual use. Definition and analysis of end points for these trials have varied in the absence of consensus on optimal approaches. Research programs should prospectively prioritize the importance of label messages based on their roles in the safe and effective use of the drug. The assessment of messages for which failure to heed warnings will expose the consumer to increased risk or clinically relevant treatment failure should receive the highest priority as study end points. Based on the consequences of unheeded warnings, message-specific targets for appropriate response rates can be predefined. This prospective, hierarchical approach to end-point definition, combined with prespecification of targeted correct-response rates, has the potential to increase the scientific rigor and regulatory utility of these important research studies.

  18. Atmospheric identification of active ingredients in over-the-counter pharmaceuticals and drugs of abuse by atmospheric pressure glow discharge mass spectrometry (APGD-MS).

    PubMed

    Brewer, Tim M; Verkouteren, Jennifer R

    2011-09-15

    Atmospheric pressure glow discharge mass spectrometry was used to characterize the active ingredients in pharmaceutical over-the-counter (OTC) drug formulations (Tylenol Allergy, Alka-Seltzer Plus Nighttime, Sudafed, Aleve and Mucinex DM) and drugs of abuse (crack cocaine, methamphetamine, MDMA (ecstasy) and hydrocodone). Material was desorbed and directly ionized under atmospheric conditions by allowing the substance to come in direct contact with the plasma followed by mass spectrometric detection. With this technique, controlled substances and OTC medications were readily distinguished from one another. Characteristic mass spectra were identified for the active ingredients in the OTC and drugs of abuse. Importantly, all drug compounds studied here, both OTC and illicit, demonstrated signals for either molecular ions or protonated molecules as well as fragmentation patterns that are readily identified in the National Institute of Standards and Technology (NIST) electron ionization (EI) mass spectral library. It is believed that this technique holds promise for forensic and law enforcement communities for real-time atmospheric analysis of drugs with database-searchable spectra of controlled substances. Published in 2011 by John Wiley & Sons, Ltd.

  19. Damage of office supply, personal use items, and over-the-counter medical devices after sterilization by ethylene oxide gas, electron beam, and gamma radiation.

    PubMed

    Lucas, Anne D; Merritt, Katharine; Hitchins, Victoria M

    2004-01-01

    After letters containing Bacillus anthracis spores entered the U.S. mail in 2001, a problem emerged regarding how to decontaminate the letters, packages, and personal items in offices that received these letters. The effects of three sterilization methods (i.e. ethylene oxide gas [EO], electron beam [e-beam] radiation, and gamma radiation) were evaluated for a variety of office supply and equipment, personal use items, and over-the-counter medical devices. No single sterilization method was suitable for all items that could be mailed or found in an office. Damage or discoloration was evident for some items by each sterilization method. There were changes in the color of certain items, such as some of the packaging material, some pacifiers, some of the fabrics, and the nylon stockings after e-beam and gamma radiation. Both e-beam and gamma radiation damaged all film samples. Following EO sterilization and normal aeration, there were a number of samples with high (above 250 microg/g) levels of EO and samples with detectable ethylene chlorohydrin levels. The data would suggest that certain items exposed to EO sterilization must be further aerated prior to use, or discarded. Generic descriptions of products (such as plastics) or grouping of items (such as condoms) were not sufficient to predict what is safe in terms of EO residual levels remaining on an item. Successful decontamination of a wide variety of items will require careful selection of different sterilization methods.

  20. Gold nanoparticles bridging infra-red spectroscopy and laser desorption/ionization mass spectrometry for direct analysis of over-the-counter drug and botanical medicines.

    PubMed

    Chau, Siu-Leung; Tang, Ho-Wai; Ng, Kwan-Ming

    2016-05-05

    With a coating of gold nanoparticles (AuNPs), over-the-counter (OTC) drugs and Chinese herbal medicine granules in KBr pellets could be analyzed by Fourier Transform Infra-red (FT-IR) spectroscopy and Surface-assisted Laser Desorption/Ionization mass spectrometry (SALDI-MS). FT-IR spectroscopy allows fast detection of major active ingredient (e.g., acetaminophen) in OTC drugs in KBr pellets. Upon coating a thin layer of AuNPs on the KBr pellet, minor active ingredients (e.g., noscapine and loratadine) in OTC drugs, which were not revealed by FT-IR, could be detected unambiguously using AuNPs-assisted LDI-MS. Moreover, phytochemical markers of Coptidis Rhizoma (i.e. berberine, palmatine and coptisine) could be quantified in the concentrated Chinese medicine (CCM) granules by the SALDI-MS using standard addition method. The quantitative results matched with those determined by high-performance liquid chromatography with ultraviolet detection. Being strongly absorbing in UV yet transparent to IR, AuNPs successfully bridged FT-IR and SALDI-MS for direct analysis of active ingredients in the same solid sample. FT-IR allowed the fast analysis of major active ingredient in drugs, while SALDI-MS allowed the detection of minor active ingredient in the presence of excipient, and also quantitation of phytochemicals in herbal granules. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. 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.

  2. Influence of precursor solvent extraction on stable isotope signatures of methylamphetamine prepared from over-the-counter medicines using the Moscow and Hypophosphorous routes.

    PubMed

    NicDaéid, Niamh; Jayamana, Saravana; Kerr, William J; Meier-Augenstein, Wolfram; Kemp, Helen F

    2013-03-01

    A number of methods of clandestine manufacture of methylamphetamine involve the extraction and subsequent reaction of pseudoephedrine hydrochloride with other essential chemicals. The precursor can be easily extracted from over-the-counter medication widely available in the UK and elsewhere. Essential chemicals such as iodine and red phosphorous are also readily available and can be extracted from iodine tinctures and matchboxes, respectively. This work reports the repetitive preparation of methylamphetamine using two popular routes (the Moscow and Hypophosphorous synthesis). The focus was on the extraction solvent used for isolation of the precursor chemical and any consequential isotopic variation which may arise in the final product. Six batches of methylamphetamine were prepared under precisely controlled conditions for each synthetic route and for each of three different precursor extraction solvents. Synthesis of the final product from laboratory grade precursor using the synthetic methods described was used as a template for comparison. The resultant IRMS data from all 48 prepared samples suggests some underlying trends in the identification of the synthetic route which may aid in the interpretation of IRMS data derived from clandestine samples.

  3. [Surveillance study in collaboration with a university-daycare center for elderly people and nursery school for children on the use of over-the-counter drugs and health food in Fukuyama].

    PubMed

    Anraku, Makoto; Inoue, Hirofumi; Sato, Eiji; Hata, Toshiyuki; Tsuchiya, Daiju; Okamura, Nobuyuki; Yoshitomi, Hironori; Kondo, Yuko; Tanaka, Masataka; Tomida, Hisao

    2010-08-01

    To estimate the extent of use of over-the-counter (OTC) drugs and health food, we administered a questionnaire to the parents of children in a nursery school and to elderly people in a daycare center in Fukuyama city. The aim of the questionnaire was to determine the percentage of children and elderly people who use OTC drugs and health food, the purpose of using them, and the types of OTC drugs and health food used. Other questions concerned the person advising them on the use of OTC and health food, the side effects of OTC drugs and health food, and the awareness of children and elderly people regarding possible interactions between prescription drugs and OTC drugs. In children, the most frequently consumed OTC drugs were cold medicines (32.1%), followed by topical creams (22.6%) and eye lotion (14.3%). In elderly people, the most frequently consumed OTC products were eye lotion (18.0%), followed by laxatives (14.8%) and fomentation agents (13.1%). The purchase ratio of health food for children and elderly people were 4.8% and 11.5%, respectively. These results suggest that the need for OTC drugs and health food in children are very different from those in elderly people. In addition, in promoting self-medication, the demand for the opinion of a specialist occupied about 80% or 70% of the total specialist time among children and elderly people, respectively. Therefore, when providing information on health food and OTC drugs, the needs of each generation should be taken into account. The information obtained from the responses received will allow us to provide better pharmaceutical care for both children and elderly people in Fukuyama city.

  4. Physical-chemical characteristics of whitening toothpaste and evaluation of its effects on enamel roughness.

    PubMed

    Hilgenberg, Sérgio Paulo; Pinto, Shelon Cristina Souza; Farago, Paulo Vitor; Santos, Fábio André; Wambier, Denise Stadler

    2011-01-01

    This in vitro study evaluated the physical-chemical characteristics of whitening toothpastes and their effect on bovine enamel after application of a bleaching agent (16% carbamide peroxide). Physical-chemical analysis was made considering mass loss by desiccation, ash content and pH of the toothpastes. Thirty bovine dental enamel fragments were prepared for roughness measurements. The samples were subjected to bleaching treatments and simulated brushing: G1. Sorriso Dentes Brancos (Conventional toothpaste), G2. Close-UP Whitening (Whitening toothpaste), and G3. Sensodyne Branqueador (Whitening toothpaste). The average roughness (Ra) was evaluated prior to the bleaching treatment and after brushing. The results revealed differences in the physical-chemical characteristics of the toothpastes (p < 0.0001). The final Ra had higher values (p < 0.05) following the procedures. The mean of the Ra did not show significant differences, considering toothpaste groups and bleaching treatment. Interaction (toothpaste and bleaching treatment) showed significant difference (p < 0.0001). The whitening toothpastes showed differences in their physical-chemical properties. All toothpastes promoted changes to the enamel surface, probably by the use of a bleaching agent.

  5. ‘I can't be an addict. I am.’ Over-the-counter medicine abuse: a qualitative study

    PubMed Central

    Cooper, Richard J

    2013-01-01

    Objectives Over-the-counter (OTC) pharmacy medicines are considered relatively safe in contrast to prescribed and illicit substances, but their abuse and addiction potential is increasingly recognised. Those affected represent a hard to reach group, with little known about their experiences. Study objectives were to describe the experiences and views of those self-reporting OTC medicine abuse, and why medicines were taken, how they were obtained and associated treatment and support sought. Design Qualitative study using in-depth mainly telephone interviews. Participants A purposive sample of 25 adults, aged 20–60s, 13 women. Setting UK, via two internet support groups. Results Individuals considered themselves ‘addicted’, but socially and economically active and different from illicit substance misusers. They blamed themselves for losing control over their medicine use, which usually began for genuine medical reasons and not experimentation and was often linked to the cessation of, or ongoing, medical prescribing. Codeine, in compound analgesics, was the main medicine implicated with three distinct dose ranges emerging with decongestant and sedative antihistamine abuse also being reported. Subsequent use was for the ‘buzz’ or similar effects of the opiate, which was obtained unproblematically by having lists of pharmacies to visit and occasionally using internet suppliers. Perceived withdrawal symptoms were described for all three dose ranges, and work and health problems were reported with higher doses. Mixed views about different treatment and support options emerged with standard drug treatment services being considered inappropriate for OTC medicines and concerns that this ‘hidden addiction’ was recorded in medical notes. Most supported the continued availability of OTC medicines with appropriate addiction warnings. Conclusions Greater awareness of the addiction potential of OTC medicines is needed for the public, pharmacists and medical

  6. Socioeconomic Determinants of Antibiotic Consumption in the State of São Paulo, Brazil: The Effect of Restricting Over-The-Counter Sales.

    PubMed

    Kliemann, Breno S; Levin, Anna S; Moura, M Luísa; Boszczowski, Icaro; Lewis, James J

    2016-01-01

    Improper antibiotic use is one of the main drivers of bacterial resistance to antibiotics, increasing infectious diseases morbidity and mortality and raising costs of healthcare. The level of antibiotic consumption has been shown to vary according to socioeconomic determinants (SED) such as income and access to education. In many Latin American countries, antibiotics could be easily purchased without a medical prescription in private pharmacies before enforcement of restrictions on over-the-counter (OTC) sales in recent years. Brazil issued a law abolishing OTC sales in October 2010. This study seeks to find SED of antibiotic consumption in the Brazilian state of São Paulo (SSP) and to estimate the impact of the 2010 law. Data on all oral antibiotic sales having occurred in the private sector in SSP from 2008 to 2012 were pooled into the 645 municipalities of SSP. Linear regression was performed to estimate consumption levels that would have occurred in 2011 and 2012 if no law regulating OTC sales had been issued in 2010. These values were compared to actual observed levels, estimating the effect of this law. Linear regression was performed to find association of antibiotic consumption levels and of a greater effect of the law with municipality level data on SED obtained from a nationwide census. Oral antibiotic consumption in SSP rose from 8.44 defined daily doses per 1,000 inhabitants per day (DID) in 2008 to 9.95 in 2010, and fell to 8.06 DID in 2012. Determinants of a higher consumption were higher human development index, percentage of urban population, density of private health establishments, life expectancy and percentage of females; lower illiteracy levels and lower percentage of population between 5 and 15 years old. A higher percentage of females was associated with a stronger effect of the law. SSP had similar antibiotic consumption levels as the whole country of Brazil, and they were effectively reduced by the policy.

  7. Spatial and Temporal Algorithm Evaluation for Detecting Over-The-Counter Thermometer Sale Increases during 2009 H1N1 Pandemic

    PubMed Central

    Que, Jialan; Tsui, Fu-Chiang

    2012-01-01

    Background Spatial outbreak detection algorithms using routinely collected healthcare data have been developed since the late 90s to identify and locate disease outbreaks. However, current well-received spatial algorithms assume only one outbreak cluster present at the same point of time which may not be valid during a pandemic when several clusters of geographic areas concurrently occur. Based on a retrospective evaluation on time-series and spatial algorithms, this paper suggests that time series analysis in detection of pandemics is still a desirable process, which may achieve more sensitive performance with better timeliness. Methods In this paper, we first prove in theory that two existing spatial models, the likelihood ratio and the Bayesian spatial scan statistics, are not useful if multiple clusters occur at the same point of time in different geographic regions. Then we conduct a comparison between a spatial algorithm, the Bayesian Spatial Scan Statistic (BSS), and a time series algorithm, the wavelet anomaly detector (WAD), on the performance of detecting the increase of the over-the-counter (OTC) medicine sales during 2009 H1N1 pandemic. Results The experiments demonstrated that the Bayesian spatial algorithm responded to the increase of thermometer sales about 3 days later than the time series algorithm. Conclusion Time-series algorithms demonstrated an advantage for early outbreak detection, especially when multiple clusters occur at the same time in different geographic regions. Given spatial-temporal algorithms for outbreak detection are widely used, this paper suggests that epidemiologists or public health officials would benefit by applying time series algorithms as a complement to spatial algorithms for public health surveillance. PMID:23569624

  8. The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus.

    PubMed

    Johnson, David A; Katz, Philip O; Armstrong, David; Cohen, Henry; Delaney, Brendan C; Howden, Colin W; Katelaris, Peter; Tutuian, Radu I; Castell, Donald O

    2017-04-01

    The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare

  9. Prevalence and predictors of over-the-counter medication use among pregnant women: a cross-sectional study in the Netherlands.

    PubMed

    Verstappen, Gwenny Mpj; Smolders, Elise J; Munster, Janna M; Aarnoudse, Jan G; Hak, Eelko

    2013-03-02

    Over-the-counter-medication (OTC-medication) use during pregnancy can be potentially harmful for the fetus. To successfully counsel the patient it is important to know if the patient is at risk. In this study possible predictors for OTC-medication use were identified and a model was designed to predict OTC-medication use during pregnancy. We performed a post-hoc analysis on data collected for a clustered clinical trial to study a screening strategy for Query fever. Pregnant women under supervision of a midwife were eligible for inclusion. These women filled out questionnaires during their pregnancy and post-partum. These questionnaires were used to determine the prevalence and to select possible predictors for OTC-medication use. These predictors were included in a prediction model using multivariate analysis. The discrimination and calibration of the model were assessed with Receiver Operating Characteristic analysis and the Hosmer and Lemeshow test. Of the 1348 women enrolling in the clustered clinical trial, we included 1246 women in this analysis. The prevalence of OTC-medication use was 12.5%. The predictors for OTC-medication use in our cohort were: nulliparity, use of prescription medication, the presence of a comorbidity, Body Mass Index between 26 and 30 kg/m2 and General Practitioner visits. These predictors were used to design a prediction model for OTC-medication use. The area under the Receiver Operating Characteristic-curve of the prediction model was 0.667 (95% CI 0.620-0.714 P<0.001) and the predictive probabilities ranged from 6.6% to 57.4%. The Hosmer and Lemeshow goodness-of-fit test indicated good calibration of the model (P = 0.640). It is possible to indicate women at risk for OTC-medication use during pregnancy, using five maternal characteristics that independently contribute to the prediction model. The predictors are easy to estimate and the model is easy to implement in daily practice.

  10. Oxidation levels of North American over-the-counter n-3 (omega-3) supplements and the influence of supplement formulation and delivery form on evaluating oxidative safety.

    PubMed

    Jackowski, Stefan A; Alvi, Azhar Z; Mirajkar, Abdur; Imani, Zahabia; Gamalevych, Yuliya; Shaikh, Nisar A; Jackowski, George

    2015-01-01

    The aim of the present study was to evaluate the oxidation status of North American n-3 (omega-3) PUFA nutritional supplements commercially available in Canada and evaluate the influence of product formulation and delivery form on oxidative safety. A total of 171 North American over-the-counter n-3 PUFA nutritional supplements were analysed for oxidation safety. Primary and secondary oxidation and total oxidation (TOTOX) were determined using the American Oil Chemists' Society (AOCS) procedures. Comparisons between supplements' final forms, oil source and n-3 PUFA concentration quartiles, as measures of product formulations and delivery forms, were compared using ANOVA. Of the products successfully tested, 50 % exceeded the voluntary recommended levels for markers of oxidation. Another 18 % of products were approaching the limits with 1-3 years before expiration. Encapsulated products without flavour additives had significantly lower secondary and TOTOX levels than bulk oils and flavoured products (P < 0·05). Children's products had significantly higher primary, secondary and TOTOX levels compared with all other products (P < 0·05). Markers of oxidation did not differ between oil sources (P > 0·05), with the exception of krill oil products having higher secondary oxidation levels than plant-based products (P > 0·05). Markers of oxidation did not differ between n-3 PUFA supplement concentration quartiles. Consumers may be at risk of exposure to higher levels of oxidative products. New regulatory mandates need to be introduced to ensure that all n-3 PUFA products, used as nutritional supplements, regardless of their formulation or delivery form, can be tested for oxidative safety and compliance.

  11. Over-the-counter advice seeking about complementary and alternative medicines (CAM) in community pharmacies and health shops: an ethnographic study.

    PubMed

    Cramer, Helen; Shaw, Alison; Wye, Lesley; Weiss, Marjorie

    2010-01-01

    In many ways, consumers of complementary and alternative medicine (CAM) embody the values that current policies aim to encourage such as self-caring and private consumption. For example, the British Government's choice agenda suggests patient choice and self-management are key government priorities and state that good information should be at the heart of all services. However, research on community pharmacies suggests that there is a continued lack of knowledge about CAM, especially herbal medicines and the limited research on health shops indicates that advice about CAM products is varied and inconsistent. Recognising the underlying tension of community pharmacies and health shops which combine both retail roles and promotion of patient wellbeing, we set out to examine customer advice seeking about CAM. The settings included independent and chain stores, selling varying amounts and types of CAM products. Data collection was ethnographic involving observation of staff-customer interactions, and semi-structured interviews with counter staff and people who purchased CAM products. The findings identified six main types of staff-customer interactions regarding over-the-counter CAM products. This typology ranged from needing significant amounts of help to needing very little including: help with diagnosis; help finding a general remedy; help with a specific product; free advice; pastoral care; and 'just buying'. The implications of these findings are discussed in the light of ongoing debates about the place of CAM in UK mainstream medicine and the evidence base for CAM. Potentially a highly valuable community resource, there is a lack of support for community pharmacies and health shops despite the government's choice agenda.

  12. Use of, satisfaction with, and willingness to switch prescription and over-the-counter treatments for chronic urticaria: an online survey.

    PubMed

    Stull, Donald E; Gavriel, Sonia

    2009-09-01

    : Chronic urticaria (hives) affects a sizeable number of people worldwide, perhaps as much as 3%. It is often accompanied by angioedema. The negative effects of urticaria and angioedema, and any adverse effects of treatment, can result in significant patient burden. : To explore patients' use of, preferences for, and willingness to switch from prescription to over-the-counter (OTC) treatments for chronic urticaria. In addition, we compared treatment satisfaction with the treatment used most recently for their chronic urticaria. : Data were collected by an online survey using members of international consumer survey panels representative of the general populations in France and Germany. Panelists with urticaria were selected based on answers to screening questions. Respondents were asked, in their native language, questions about their typical course of treatment (prescription vs OTC), satisfaction with treatment, troublesomeness of their typical outbreak, whether their condition had improved or become worse over the past 12 months, and their willingness to try a new treatment if one became available. Descriptive analyses were performed on selected variables. Groups were compared using difference of means tests. Correlations and multiple regressions were performed to assess predictors of satisfaction with treatment and likelihood of switching treatment. : The final study sample consisted of 405 patients. Patients who used prescription treatments were more satisfied and reported greater treatment benefits with their treatment than those using OTC treatments. Patients who felt that their condition had become worse over the past 12 months were more likely to consider switching treatments. Respondents who used Aerius (desloratadine) most recently for treating their symptoms reported greater satisfaction with treatment than did those who used other commonly used prescription treatments most recently. : These results suggest that prescription treatments for chronic

  13. 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.

  14. Absence of 'over-the-counter' medicinal products in on-line prescription records: a risk factor of overlooking interactions in the elderly.

    PubMed

    Olesen, C; Harbig, P; Barat, I; Damsgaard, E M

    2013-02-01

    To assess possible origins of harmful interactions in elderly patients arising from the current absence of information on over-the-counter (OTC) medicines in the Danish 'on-line prescription record'. Information on current use of prescription drugs and OTC medicinal products (non-prescription drugs, herbal medicine, dietary supplements, and others) was collected by home visit interviews. The latter OTC products were not listed in an on-line prescription record that covered the previous two years. Information on interactions between OTC medicines and between OTC products and prescription drugs was obtained from the Danish National Drug Interaction Database. Of the 309 patients recruited (median age 75 years, interquartile range (IQR) 70-81), 229 (74%) used 568 OTC medicines not listed in the Danish 'on-line prescription record', amongst which we identified 166 potential interactions - between OTC treatments or between OTC and prescription drugs. Fifty percent of patients taking OTC medicines were exposed to potential interactions, i.e. one to three instances per patient. Twenty-five percent of patients exposed to interactions experienced interaction listed as 'Can be used with certain precautions'. The absence of information on OTC products in an on-line prescription record entails a risk of overlooking interactions in elderly patients. Such products should be included in on-line medication records to prevent adverse effects from interactions. However, online medication records are not available in all countries and as inclusion of data on OTC drugs seem not to be feasible presently. Still, it is highly recommended that the patient's drug list is reviewed on a regular basis. Copyright © 2012 John Wiley & Sons, Ltd.

  15. The impact of over-the-counter simvastatin on the number of statin prescriptions in the United Kingdom: a view from the General Practice Research Database.

    PubMed

    Filion, Kristian B; Delaney, J A Chris; Brophy, James M; Ernst, Pierre; Suissa, Samy

    2007-01-01

    The United Kingdom (UK) government changed the prescription policy of statins, making low-dose simvastatin (10 mg) available as an over-the-counter (OTC) drug in August 2004. We assessed the impact of this policy change on statin prescribing. We examined all statin prescriptions in the General Practice Research Database (GPRD), a well-validated database of approximately 3.5 million patients, from the first quarter of 2001 to the second quarter of 2005. From 2001, the number of statin prescriptions written for GPRD patients was increasing by approximately 437 prescriptions per 100,000 people per quarter until the time of the policy change. Over the four quarters post-policy implementation, however, this trend changed abruptly (p < 0.0001) with a decrease of 281 prescriptions per 100,000 people per quarter. This decrease was not restricted to prescriptions of 10 mg statins but was also observed for statin prescriptions of >or=20 mg. Several other cardiovascular medications displayed a similar trend as that observed in the number of statin prescriptions. This trend was not observed among non-cardiovascular control medications. Our study suggests that the policy allowing the OTC sale of 10 mg simvastatin has had a significant impact on statin prescriptions by general practitioners. However, this new policy may also be leading to less aggressive statin therapy. An alternative explanation for the observed decrease in statin prescriptions may be related to the unknown factors responsible for the overall decrease observed with other cardiovascular prescription drugs. Copyright (c) 2006 John Wiley & Sons, Ltd.

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

    PubMed

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

    2010-08-01

    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. 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. 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. 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. 2010 John Wiley & Sons, Ltd.

  17. 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

  18. Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine.

    PubMed

    Pires, Carla M; Cavaco, Afonso M

    2014-05-01

    To explore and compare the opinions of physicians, pharmacists and potential users on the readability of a package insert of an over-the-counter medicine. Exploratory study based on the administration of a semi-open questionnaire. This instrument was developed according to the readability guideline of the European Medicine Agency (EMA) and used to evaluate participants' accessibility to, and comprehensibility of, the package insert for diclofenac 12.5 mg tablets. Sixty-three participants were recruited from the Lisbon region and enrolled in three groups: physicians (Dg), pharmacists (Pg) and potential consumers (PCg), with a minimum of 20 participants each. Almost all (85 %) of the 20 PCg participants were educated above the 9th grade, although the majority of them (95 %) referred to, at least, one package insert interpretation issue, mainly related to the comprehension of technical terms. Amongst other differences between the groups, the Pg participants (n = 22) obtained a significantly less favourable opinion regarding the layout of the titles. Furthermore, the Pg and Dg (n = 21) participants proposed technical enhancements, such as the use of a table to explain the posology, precautions in case of renal failure, or the recommendation to take the tablets with meals. Differences in the way of using the diclofenac tablets are expected, considering the comprehension dissimilarities between health professionals and potential consumers. The package insert of diclofenac 12.5 mg could be enhanced for safer use. Regarding the readability assessment of this package insert, the method proposed in the EMA guidelines might not be as effective as expected. Future research is advisable.

  19. Counting the cost of over-the-counter codeine containing analgesic misuse: A retrospective review of hospital admissions over a 5 year period.

    PubMed

    Mill, Deanna; Johnson, Jacinta L; Cock, Victoria; Monaghan, Emily; Hotham, Elizabeth D

    2017-09-18

    Combination analgesics containing codeine (CACC) are currently available over-the-counter (OTC) in many countries following a pharmacist's advice. Published case reports detail life-threatening morbidities associated with OTC-CACC misuse, although the cost of treating such patients has not been quantified. This study aims to: (i) identify and detail patients admitted to an Australian tertiary teaching hospital over a 5 year period with sequelae of OTC-CACC misuse; and (ii) estimate the costs of identified hospital admissions. Using International Classification of Diseases (10th revision) diagnostic codes, a structured search was performed to identify admissions to a tertiary teaching hospital, relating to CACC misuse, over the defined period. A retrospective case note review provided data detailing patient characteristics, presenting morbidities and resultant interventions, and an approximate cost was calculated for identified admissions. Ninety-nine OTC-CACC-related admissions (for 30 individual patients) were identified. Most related to gastrointestinal morbidities secondary to ibuprofen/codeine misuse. Mean length of stay per admission was 5.9 days, with 10.1% of admissions requiring intensive care. Patients consumed a daily mean of 28 OTC-CACC tablets for a mean of 606 days prior to admission. These 99 admissions were estimated to cost the health system AU$1 008 082 with a mean cost per admission of AU$10 183. The outcomes of OTC-CACC misuse are serious and come at a significant cost to patient health and the Australian health-care system. Identification and management of this cohort appears sub-optimal with delays in diagnosis and high readmission rates. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  20. An ecological study of the extent and factors associated with the use of prescription and over-the-counter codeine in Australia.

    PubMed

    Gisev, Natasa; Nielsen, Suzanne; Cama, Elena; Larance, Briony; Bruno, Raimondo; Degenhardt, Louisa

    2016-04-01

    The extent and factors associated with codeine use in the community remain poorly understood despite the widespread global use of codeine. The aim of this study was to examine the use of prescription and over-the-counter (OTC) codeine in Australia and identify the geographic and socio-demographic characteristics associated with prescription and OTC codeine use. National sales data for prescription and OTC codeine (supplied by IMS Health) were used to estimate codeine utilisation (in pack sales and milligrammes) in Australia during 2013, mapped to Australian Bureau of Statistics (ABS) Statistical Local Areas (SLAs) and Remoteness Areas. Socio-demographic characteristics and total population estimates of SLAs were obtained from the ABS. SLA-level data on sex, age distribution, income, occupations involving physical labour and number of pharmacies were included in linear regression analyses to examine their association with total, prescription and OTC codeine use. In total, 27,780,234 packs of codeine were sold in Australia during 2013, equating to 12,376 kg. OTC codeine preparations accounted for 15,490,207 packs (55.8 %) or 4967.30 kg (40.1 %). Nationally, an estimated 1.24 packs (or 554.10 mg) of codeine were sold per person; utilisation was higher in more remote areas. SLAs with a higher percentage of low-income earning households had the highest rates of prescription codeine use (β 0.16, p < 0.001), whereas SLAs with a higher percentage of males had the highest rates of OTC codeine use (β 0.22, p < 0.001). Codeine use is common in Australia, with clear distinctions in the geographic and socio-demographic characteristics associated with prescription and OTC codeine use.

  1. A cross-sectional analysis of over-the-counter codeine use among an Australian sample of people who regularly inject drugs.

    PubMed

    Arora, Sheena; Roxburgh, Amanda; Bruno, Raimondo; Nielsen, Suzanne; Burns, Lucy

    2013-11-01

    The study aims to examine the medical and non-medical use of over-the-counter (OTC) codeine combination drugs in a sample of people who inject drugs; and to examine risk factors associated with exceeding the recommended dose of OTC codeine, including the experience of pain. This study analysed annual survey data from a convenience sample of people who inject drugs in Australia who are interviewed for the Illicit Drug Reporting System. People who have injected drugs (n = 902) on at least a monthly basis in the preceding six months across Australia were interviewed. Participants were asked about their use of OTC codeine and their experience of pain. One third (35%) of participants had used OTC codeine in the preceding six months and 52% (95% confidence interval 48.7-55.3) of this group had exceeded the recommended dose on their last occasion of use. This clearly places them at increased risk of harms associated with toxicity from the accompanying analgesic found in combination codeine products. Multivariate analyses demonstrated that those exceeding the recommended codeine dose of OTC codeine were more likely to be experiencing moderate to very severe pain. There is a need to evaluate the approach to pain management in this population. Greater pharmacist involvement, real-time monitoring of sales, the development of screening tools to identify those at risk of harm and further education of primary care practitioners could be beneficial in reducing the risk of harm associated with these medications for all users of OTC codeine, including people who inject drugs. © 2013 Australasian Professional Society on Alcohol and other Drugs.

  2. 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.

  3. 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

  4. User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines.

    PubMed

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

    User testing evaluates written medicine information (WMI) usability by examining participants' ability to find and understand information. It can also be an effective method to determine how consumers say they will act on information on an over-the-counter (OTC) label. To examine consumers' proposed behaviors regarding dosage and storage as a measure of a medicine label's usability and consumers' functional health literacy. User testing of 5 diclofenac OTC labels (by 50 subjects; 10 per label) measured consumers' ability to find and understand key points of information using a 13-item questionnaire. Consumers were required to elaborate on their behavior in regard to 2 additional questions: 1) when they would take diclofenac if they had constant back pain from 8 am (dosage-related) and; 2) where they would store it in their home (storage-related). Responses were transcribed verbatim, and coded by 2 pharmacists. Appropriate dosing for constant back pain was reported by 29 consumers. However, dosing intervals shorter than the specified 8 h were often reported (n = 19), due to adjusting intervals to accommodate up to the maximum of 8 tablets in 24 h, desire for pain relief, and/or pragmatic dosing (e.g. around bedtime). Only 29 consumers stated completely appropriate storage location examples (e.g. medicine cabinet). Consumers may act inappropriately on OTC label information about dosage and/or storage, which could potentially adversely impact medication use. User testing can contribute to the development of high quality WMI and help identify where label wordings are inappropriate for the health literacy levels of consumers. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Efficacy of chemical and botanical over-the-counter pediculicides available in Brazil, and off-label treatments, against head lice ex vivo.

    PubMed

    Asenov, André; Oliveira, Fabíola Araújo; Speare, Rick; Liesenfeld, Oliver; Hengge, Ulrich R; Heukelbach, Jorg

    2010-03-01

    There is a lack of reliable data on the efficacy of over-the-counter (OTC) pediculicides in Brazil. We performed ex vivo assays of eight marketed pediculicides: 1% permethrin (Kwell, Clean Hair, Keltrina, Nedax), 0.02% deltamethrin (Deltacid, Pediderm), and two "natural" products (Piolho e Lêndea, Pilogenio). We also tested 5% permethrin (Keltrina Plus), traditional home remedies and an ivermectin-based product used in veterinary medicine. Head lice (49-52 per group) were immersed in the compound for 3 min and washed after 20 min to simulate the typical in vivo treatment protocol. Lice were examined for activity up to 24 h using stringent criteria for survival. Of the permethrin containing products, highest mortality was observed with Kwell and Clean Hair (97.9 and 90.2% after 4 h). Keltrina, Nedax, Keltrina Plus, and the two deltamethrin-based products showed only a low efficacy of <60% after 4 h. With exception of pure coconut oil (80% mortality after 4 h), home remedies showed a very low efficacy, and both marketed products killed few lice. The ivermectin-based product caused a mortality of 100% after 4 h. Most Brazilian OTC products did not show a satisfactory efficacy against head lice. Resistance may be present. Ivermectin and coconut oil are promising compounds for topical treatment. Laboratory-based tests should be used to assess resistance patterns and to identify formulations of the active ingredient that increase the efficacy. Standardized testing should be performed before a product is licensed for head lice treatment.

  6. A Review of the Ingredients Contained in Over the Counter (OTC) Cough Syrup Formulations in Kenya. Are They Harmful to Infants?

    PubMed Central

    Kigen, Gabriel

    2015-01-01

    Background Cough syrups are widely used in the developing world, but safety of their use in infants and children less than two years has not been well documented. Some syrups contain multiple combinations of such drugs as promethazine, diphenhydramine and ephedrine; which are individually now contraindicated in children less than two years. Despite this, the syrups are available as over the counter drugs and may be dispensed to mothers who are unaware of the potentially hazardous effects to their infants. A descriptive cross-sectional study was used to investigate suitability of cough syrups sold within Eldoret municipality for use in children less than two years of age based on their formulations and available literature. Methods Two semi-structured questionnaires were administered to pharmacy attendants and mothers attending sick child clinic at a referral hospital to establish whether cough syrups containing more than one active ingredient of compounds, now contraindicated in children are administered to infants, and awareness of potential serious adverse effects. Data from labeled contents of cough syrups from retail pharmacies was recorded and corroborated with information from literature to determine those deemed to contain the ingredients. The second questionnaire was administered to mothers with children less than two years to ascertain whether they had used the identified syrups. A total of 260 mothers and 55 pharmacy attendants were interviewed. Results There was widespread use of the syrups in children, including infants, with 192 (74%) of the respondents having used identified syrups and over 90% of these on children less than 2 years including those less than three months.146 (76%) mothers had administered the syrup at double the recommended dose. Conclusion The regulatory authorities should make concerted efforts to discourage use of cough syrups containing ingredients that pose adverse events to infants, including campaigns to educate pharmacy

  7. Next-day residual sedative effect after nighttime administration of an over-the-counter antihistamine sleep aid, diphenhydramine, measured by positron emission tomography.

    PubMed

    Zhang, Dongying; Tashiro, Manabu; Shibuya, Katsuhiko; Okamura, Nobuyuki; Funaki, Yoshihito; Yoshikawa, Takeo; Kato, Masato; Yanai, Kazuhiko

    2010-12-01

    Antihistamines often are self-administered at night as over-the-counter (OTC) sleep aids, but their next-day residual sedative effect has never been evaluated using a reliable quantitative method such as positron emission tomography (PET). We performed a double-blind, placebo-controlled, crossover study in which we evaluated the residual effect the next day after nighttime administration of diphenhydramine, a commonly used OTC sleep aid, in terms of brain H₁ receptor occupancy (H₁RO) measured using ¹¹C-doxepin-PET. We also compared the results of diphenhydramine with those of bepotastine, a second-generation antihistamine. Eight healthy adult male subjects underwent PET measurement the morning (11:00) after random oral administration of diphenhydramine (50 mg), bepotastine (10 mg), or placebo the night before (23:00). Binding potential ratios and H₁ROs were calculated in different brain regions of interest such as the cingulate gyrus, frontotemporal cortex, and cerebellum. Subjective sleepiness and plasma drug concentration also were measured. Calculation of binding potential ratios revealed significantly lower values for diphenhydramine than for bepotastine or placebo in all regions of interest (P < 0.01). Cortical mean H₁RO after diphenhydramine treatment was 44.7% compared with 16.6% for bepotastine treatment (P < 0.01). Subjective sleepiness was not significantly different among the subjects treated with each test drug or the placebo. In conclusion, the next-day residual sedative effect after nighttime administration of the OTC sleep aid diphenhydramine was verified for the first time by direct PET measurement of H₁RO. Taking into account the possible hangover effect of OTC antihistamine sleep aids, care needs to be taken during their administration.

  8. Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial

    PubMed Central

    Chen, Q.-J.; Xiang, W.-P.; Zhang, D.-K.; Wang, R.-P.; Luo, Y.-F.; Kang, J.-Z.; Cheng, L.-N.

    2011-01-01

    BACKGROUND An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women. METHODS A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated. RESULTS Of 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously. CONCLUSIONS The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP. PMID:21672924

  9. Socioeconomic Determinants of Antibiotic Consumption in the State of São Paulo, Brazil: The Effect of Restricting Over-The-Counter Sales

    PubMed Central

    Levin, Anna S.; Moura, M. Luísa; Boszczowski, Icaro; Lewis, James J.

    2016-01-01

    Background Improper antibiotic use is one of the main drivers of bacterial resistance to antibiotics, increasing infectious diseases morbidity and mortality and raising costs of healthcare. The level of antibiotic consumption has been shown to vary according to socioeconomic determinants (SED) such as income and access to education. In many Latin American countries, antibiotics could be easily purchased without a medical prescription in private pharmacies before enforcement of restrictions on over-the-counter (OTC) sales in recent years. Brazil issued a law abolishing OTC sales in October 2010. This study seeks to find SED of antibiotic consumption in the Brazilian state of São Paulo (SSP) and to estimate the impact of the 2010 law. Methods Data on all oral antibiotic sales having occurred in the private sector in SSP from 2008 to 2012 were pooled into the 645 municipalities of SSP. Linear regression was performed to estimate consumption levels that would have occurred in 2011 and 2012 if no law regulating OTC sales had been issued in 2010. These values were compared to actual observed levels, estimating the effect of this law. Linear regression was performed to find association of antibiotic consumption levels and of a greater effect of the law with municipality level data on SED obtained from a nationwide census. Results Oral antibiotic consumption in SSP rose from 8.44 defined daily doses per 1,000 inhabitants per day (DID) in 2008 to 9.95 in 2010, and fell to 8.06 DID in 2012. Determinants of a higher consumption were higher human development index, percentage of urban population, density of private health establishments, life expectancy and percentage of females; lower illiteracy levels and lower percentage of population between 5 and 15 years old. A higher percentage of females was associated with a stronger effect of the law. Conclusions SSP had similar antibiotic consumption levels as the whole country of Brazil, and they were effectively reduced by the

  10. 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.

  11. Effect of Whitening Dentifrice on Micro Hardness, Colour Stability and Surface Roughness of Aesthetic Restorative Materials

    PubMed Central

    Basappa, N.; Prabhakar, AR; Raju, OS; Lamba, Gagandeep

    2016-01-01

    Introduction Whitening agents present in the novel whitening dentifrices may have deleterious effects over the aesthetic restorations. Aim The present study evaluated the invitro effect of whitening dentifrice on micro hardness, colour stability and surface roughness on aesthetic restorative materials. Materials and Methods Forty specimens each of compomer and of composite were prepared using brass mould. Specimens were equally divided into 4 groups. Group I (20 disks of compomer are subjected to brushing with conventional tooth paste) Group II (20 disks of composite subjected to brushing with conventional tooth paste), Group III (20 disks of compomer subjected to brushing with whitening tooth paste). Group IV (20 disks of composite subjected to brushing with whitening toothpaste). Each group was further divided into two subgroups, where 10 sample were subjected for two weeks of brushing with respective tooth paste and other 10 were subjected for four weeks of brushing. For the evaluation of micro hardness, colour stability and surface roughness, micro hardness testing machine, spectrophotometer and surface testing machine were used respectively. Initial and final readings were taken for each specimen and difference obtained was subjected to statistical analysis. One-way ANOVA was used for multiple group comparison followed by post-hoc Tukey’s-test. The paried t-test was used for intra group comparison and unpaired t-test for comparing independent sample groups. Results The compomer and composite showed no significant difference in micro hardness either with conventional or whitening tooth paste both at two and four weeks. Although there was a highly significant colour change observed after using whitening tooth paste for both compomer and composite. Regarding surface roughness, there was a significant change in roughness in both conventional and whitening tooth paste with compomer and composite. However, whitening tooth paste had a significant change in surface

  12. Effect of Whitening Dentifrice on Micro Hardness, Colour Stability and Surface Roughness of Aesthetic Restorative Materials.

    PubMed

    Roopa, K B; Basappa, N; Prabhakar, A R; Raju, O S; Lamba, Gagandeep

    2016-03-01

    Whitening agents present in the novel whitening dentifrices may have deleterious effects over the aesthetic restorations. The present study evaluated the invitro effect of whitening dentifrice on micro hardness, colour stability and surface roughness on aesthetic restorative materials. Forty specimens each of compomer and of composite were prepared using brass mould. Specimens were equally divided into 4 groups. Group I (20 disks of compomer are subjected to brushing with conventional tooth paste) Group II (20 disks of composite subjected to brushing with conventional tooth paste), Group III (20 disks of compomer subjected to brushing with whitening tooth paste). Group IV (20 disks of composite subjected to brushing with whitening toothpaste). Each group was further divided into two subgroups, where 10 sample were subjected for two weeks of brushing with respective tooth paste and other 10 were subjected for four weeks of brushing. For the evaluation of micro hardness, colour stability and surface roughness, micro hardness testing machine, spectrophotometer and surface testing machine were used respectively. Initial and final readings were taken for each specimen and difference obtained was subjected to statistical analysis. One-way ANOVA was used for multiple group comparison followed by post-hoc Tukey's-test. The paried t-test was used for intra group comparison and unpaired t-test for comparing independent sample groups. The compomer and composite showed no significant difference in micro hardness either with conventional or whitening tooth paste both at two and four weeks. Although there was a highly significant colour change observed after using whitening tooth paste for both compomer and composite. Regarding surface roughness, there was a significant change in roughness in both conventional and whitening tooth paste with compomer and composite. However, whitening tooth paste had a significant change in surface roughness compared with conventional tooth paste

  13. Overview of a professional tooth-whitening system containing 6.5% hydrogen peroxide whitening strips.

    PubMed

    Sagel, Paul A; Jeffers, Melissa E; Gibb, Roger D; Gerlach, Robert W

    2002-01-01

    Professionally dispensed, at-home tooth whitening began with 10% carbamide peroxide gels applied to the dentition with custom-made trays. In the 1990s, higher-concentration carbamide peroxide gels were introduced to achieve faster results. Today, 15% and 20% carbamide peroxide gels are commonly used. Recently, a new vital tooth-whitening technique that uses a flexible strip rather than a tray to apply a 5.3% hydrogen peroxide whitening gel was introduced. The new strip-based product was shown to provide whitening equivalent to a 10% carbamide peroxide tray with half the wear time. In addition, the strip eliminated the need to custom fabricate trays for each patient. This article provides an overview of a professionally distributed strip-based whitening system and reviews some of the clinical data which supports the efficacy of the product. This new whitening system includes 42 mandibular and 42 maxillary strips at a higher concentration of 6.5% hydrogen peroxide. In addition, the system also includes a novel dual-action whitening dentifrice to prevent future staining postbleaching and an extrasoft toothbrush. Clinically, the professionally distributed strip-based whitening system provided 96% more efficacy than a popular carbamide plus hydrogen peroxide (equivalent to 10% carbamide peroxide) tray system and 52% more whitening than the 5.3% hydrogen peroxide strip system.

  14. Safety and Efficacy of Over-the-Counter Drug Use by the Elderly. Hearing before the Subcommittee on Health and Long-Term Care of the Select Committee on Aging. House of Representatives, Ninety-Eighth Congress, First Session.

    ERIC Educational Resources Information Center

    Congress of the U.S., Washington, DC. House Select Committee on Aging.

    This document contains the prepared statements and panel testimony from the Congressional hearing on over-the-counter (OTC) drug use by the elderly. Opening statements are given by Representatives Claude Pepper (chairman), Ralph Regula, Mary Rose Oakar, Michael Bilirakis, Tom Lantos, and Hal Daub. Topics which are covered include the incidence and…

  15. Age estimation using level of eyebrow and eyelash whitening.

    PubMed

    Kantarcı, Feride Aylin; Kantarcı, Muhammed Nabi; Bilgi, Sefer

    2014-01-22

    The aim of this study was to determine whether eyebrow and eyelash whitening is an effective parameter in age estimation. We evaluated 1545 patients. Age groups were 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, and 81-90 years. Level of whitening was categorized as level 0: no whitening, level 1: 1-3 strands, level 2: 3-10 strands, level 3: 10 strands-2/3 whitening, level 4: >3/4 whitening. Mean age was 42.39 ± 20.01. While there was no eyebrow whitening in 87% of the subjects, level 4 whitening of eyebrows was observed in 0,8% of the subjects. There was no eyelash whitening in 97,7% of the subjects and no level 4 eyelash whitening was detected in any subject. Men had significantly more level 1, 2, 3, and 4 eyebrow whitening compared with women. There was no gender difference in terms of eyelash whitening level. There was no eyebrow and eyelash whitening in subjects age 1-40 years; whitening began in the 41-50 years age group and increased with age in other groups. Mean age was 39.59 ± 19.63 years in subjects with no eyebrow whitening; 59 years in level 1, 61 years in level 2, 63 years in level 3, and 69 years in level 4 eyebrow whitening. Mean age was 41.85 ± 19.87 in subjects with no eyelash whitening; and 63.57 ± 10.75 in those with whitening. Particularly after 41-50 years of age, level of eyebrow and eyelash whitening may be among a useful age estimation parameter.

  16. Age estimation using level of eyebrow and eyelash whitening

    PubMed Central

    Kantarcı, Feride Aylin; Kantarcı, Muhammed Nabi; Bilgi, Sefer

    2014-01-01

    Background The aim of this study was to determine whether eyebrow and eyelash whitening is an effective parameter in age estimation. Material/Methods We evaluated 1545 patients. Age groups were 1–10, 11–20, 21–30, 31–40, 41–50, 51–60, 61–70, 71–80, and 81–90 years. Level of whitening was categorized as lev