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Sample records for prescription drugs over-the-counter

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

    MedlinePlus

    ... premature birth 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 ...

  2. Prescription and Over-the-Counter Drug Abuse Prevention. Prevention Update

    ERIC Educational Resources Information Center

    Higher Education Center for Alcohol, Drug Abuse, and Violence Prevention, 2010

    2010-01-01

    According to the White House Office of National Drug Control Policy, "abuse of prescription drugs to get high has become increasingly prevalent among teens and young adults. Past year abuse of prescription pain killers now ranks second--only behind marijuana--as the Nation's most prevalent illegal drug problem." Use of prescription drugs without a…

  3. 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.

  4. Prescription and Over-the-Counter Medications

    MedlinePlus

    ... Naloxone Pain Prevention Treatment Trends & Statistics Women and Drugs Publications Funding Funding Opportunities Clinical Research Post-Award Concerns General Information Grant & Contract Application ...

  5. 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.

  6. 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.

  7. 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.

  8. [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.

  9. 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

  10. 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.

  11. Now you see it. Now you don't: fair balance and adequate provision in advertisements for drugs before and after the switch from prescription to over-the-counter.

    PubMed

    Faerber, Adrienne E; Kreling, David H

    2012-01-01

    The objective of this study was to measure differences in fair balance (benefit and risk statements) and adequate provision (toll-free numbers, Internet URLs, print ad references, and medical professional references) in advertising content for drugs that have switched from prescription to over-the-counter (OTC). The Vanderbilt TV News Archive was used to select products to study, to measure the frequency and placement of ads for those products, and to view advertising content for those products. Unique advertisements (n = 108) for loratadine (Claritin), citirizine (Zyrtec), and omeprazole (Prilosec) were analyzed for the presence of adequate provision statements and for the frequency of benefit, risk, and other statements. OTC ads were shorter than prescription ads by 10.6 seconds but contained the same total number of statements. Most prescription ads (n (RX) = 31) contained toll-free numbers (97%), Internet URLs (94%), medical professional references (100%) and print ad references (68%). Few OTC ads (n (OTC) = 77) contained adequate provision statements: 4% contained toll-free numbers and 10% contained Internet URLs. Prescription ads had similar numbers of benefits (1.5) and risks (1.8) per 30 seconds of ad time, and OTC ads had more benefits (6.6) than risks (1.2) per 30 seconds of ad time. Prescription drug ads contained risk statements that listed specific side effects and explicit harms from taking the product, but OTC ads contained nonspecific risk information and statements that implied risk rather than directly identifying risk. Differences in the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulation of advertising affected the balance of risk and benefit information that appeared and the specificity of risk information available.

  12. [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.

  13. 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...

  14. Over-the-Counter Medicines

    MedlinePlus

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

  15. 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

  16. 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...

  17. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 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...

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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…

  3. 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 ...

  4. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 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. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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...

  7. 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...

  8. 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...

  9. Prescription Drugs and Cold Medicines

    MedlinePlus

    ... Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription Drugs & Cold ... and over-the-counter (OTC) drugs are, after marijuana (and alcohol), the most commonly abused substances by ...

  10. 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

  11. 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

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

  12. 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

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

  13. 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

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

  14. 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

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

  15. 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.

  16. 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...

  17. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  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...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  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...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  1. 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...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data...

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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...

  10. 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.

  11. 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.

  12. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... is that the product will have a therapeutic or some other physiological effect on the body. Therefore... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Topically applied hormone-containing drug products for over-the-counter (OTC) human use. 310.530 Section 310.530 Food and Drugs FOOD AND...

  13. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... is that the product will have a therapeutic or some other physiological effect on the body. Therefore... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Topically applied hormone-containing drug products for over-the-counter (OTC) human use. 310.530 Section 310.530 Food and Drugs FOOD AND...

  14. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... is that the product will have a therapeutic or some other physiological effect on the body. Therefore... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Topically applied hormone-containing drug products for over-the-counter (OTC) human use. 310.530 Section 310.530 Food and Drugs FOOD AND...

  15. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... is that the product will have a therapeutic or some other physiological effect on the body. Therefore... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Topically applied hormone-containing drug products for over-the-counter (OTC) human use. 310.530 Section 310.530 Food and Drugs FOOD AND...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... demonstration project under 10 U.S.C. 1092 to allow certain over-the- counter (OTC) medications to be included... demonstration project continues to be authorized by 10 U.S.C. 1092. Dated: October 31, 2012. Aaron...

  18. 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.

  19. 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...

  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. 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......

  2. 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…

  3. 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.

  4. 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 ...

  5. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs... ingredients offered over-the-counter (OTC) for oral use as insect repellents. (a) Thiamine hydrochloride... insect repellent (an orally administered drug product intended to keep insects away). There is a lack...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. [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.

  12. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturers and distributors of all OTC drugs effect changes in their formulations and/or labeling to bring... give increased assurance that the drug will have its intended effect, yet not raise or contribute any... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Status of over-the-counter (OTC) drugs...

  13. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... manufacturers and distributors of all OTC drugs effect changes in their formulations and/or labeling to bring... give increased assurance that the drug will have its intended effect, yet not raise or contribute any... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Status of over-the-counter (OTC) drugs...

  14. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacturers and distributors of all OTC drugs effect changes in their formulations and/or labeling to bring... give increased assurance that the drug will have its intended effect, yet not raise or contribute any... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Status of over-the-counter (OTC) drugs...

  15. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacturers and distributors of all OTC drugs effect changes in their formulations and/or labeling to bring... give increased assurance that the drug will have its intended effect, yet not raise or contribute any... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Status of over-the-counter (OTC) drugs...

  16. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturers and distributors of all OTC drugs effect changes in their formulations and/or labeling to bring... give increased assurance that the drug will have its intended effect, yet not raise or contribute any... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Status of over-the-counter (OTC) drugs...

  17. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs... irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional...

  18. 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.

  19. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  1. Over-the-Counter Drugs and Complementary Medications Use among Children in Southern Italy.

    PubMed

    Pileggi, Claudia; Mascaro, Valentina; Bianco, Aida; Pavia, Maria

    2015-01-01

    The use of nonprescription medicines (NPDs) for children illnesses without a doctor's suggestion can lead to unnecessary medication use and is not free of risks. The aim of our study was to examine attitudes and practice of parents towards NPDs use for their children. We also investigated the conditions that may predict NPDs use. A cross-sectional survey was conducted on parents of children attending Community Based Pediatrician (CBP) consultation and data were collected through structured interviews. Positive attitude on NPDs use was reported by 71.4% of parents, and 61.5% of them had administered NPDs in the previous 6 months. Antipyretic drugs were the most frequently used medication class without the supervision of the CBP. A positive attitude towards NPDs was significantly more frequent in parents who did not use the CBP as the sole source of information about drugs. The study demonstrated a widespread use of NPDs in children in our context, supported by a substantial positive attitude towards their safety. However, considering potential harms related to some NPDs and the finding that most parents rely on CBP advice, role of CBP on appropriate use of NPDs by parents should be emphasized.

  2. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 333 Guidance for Industry on Topical Acne Drug... availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the... ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling...

  3. 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

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria. 310.547 Section 310.547 Food and Drugs FOOD...-threatening disease. Quinine is no longer the drug of choice for the treatment and/or prevention of most...

  4. 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...

  5. 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

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section... prostatic hypertrophy. (a) The amino acids glycine, alanine, and glutamic acid (alone or in combination) and... of benign prostatic hypertrophy, e.g., urinary urgency and frequency, excessive urinating at...

  11. 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), Lactobacillus acidophilus, and Lactobacillus bulgaricus have been present in orally administered OTC...

  12. 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... treatment or prevention of any disease. These ingredients and salts include, but are not limited to,...

  13. 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.

  14. 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).

  15. Over-the-counter pain relievers

    MedlinePlus

    ... Analgesics; Acetaminophen; NSAID; Nonsteroidal anti-inflammatory drug; Pain medicine - over-the-counter; Pain medicine - OTC ... Pain medicines are also called analgesics. Each kind of pain medicine has benefits and risks. Some types of pain ...

  16. 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.

  17. 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

  18. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Amyl nitrite inhalant as a prescription drug for... Prescription Status of Specific Drugs § 250.100 Amyl nitrite inhalant as a prescription drug for human use. (a) Amyl nitrite inhalant has been available over-the-counter for emergency use by the patient in...

  19. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Amyl nitrite inhalant as a prescription drug for... Prescription Status of Specific Drugs § 250.100 Amyl nitrite inhalant as a prescription drug for human use. (a) Amyl nitrite inhalant has been available over-the-counter for emergency use by the patient in...

  20. 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.

  1. 21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... is required for marketing. In the absence of an approved new drug application or abbreviated new drug... March 9, 1994, any such OTC drug product initially introduced or initially delivered for...

  2. 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

  3. 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.

  4. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin... potential for serious risk to patients using these drug products. The bioavailability of pancreatic enzymes... included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for...

  5. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla,...

  6. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla,...

  7. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla,...

  8. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla,...

  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

    ... applications (TEAs). We are currently evaluating the safety and effectiveness of these ingredients. DATES... found eligible for possible addition to an OTC drug monograph via the TEA process described in 21 CFR... inclusion in an OTC drug monograph under the TEA process on the basis of foreign marketing...

  10. 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.

  11. 21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... approved drug application for any product that requires a separate allergy warning. This warning shall follow the subheading “Allergy alert:” (C) Flammability warning, with appropriate flammability...

  12. 21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... approved drug application for any product that requires a separate allergy warning. This warning shall follow the subheading “Allergy alert:” (C) Flammability warning, with appropriate flammability...

  13. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... marketing. In the absence of an approved new drug application, such product is also misbranded under section... initially delivered for introduction into interstate commerce that is not in compliance with this section...

  14. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... chapter is required for marketing. In the absence of an approved application, such product is also..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  15. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and part 314 of this chapter is required for marketing. In the absence of an approved application..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  16. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and part 314 of this chapter is required for marketing. In the absence of an approved application..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  17. 21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5... stearate Zinc sulfide (2) Anticaries drug products—(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium... hydrochloride (B) Ingredients. Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride...

  18. 21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5... stearate Zinc sulfide (2) Anticaries drug products—(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium... hydrochloride (B) Ingredients. Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride...

  19. 21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5... stearate Zinc sulfide (2) Anticaries drug products—(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium... hydrochloride (B) Ingredients. Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride...

  20. 21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2 up to 5... stearate Zinc sulfide (2) Anticaries drug products—(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium... hydrochloride (B) Ingredients. Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride...

  1. [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.

  2. 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.

  3. 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…

  4. 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.

  5. Prescription Drug Abuse

    MedlinePlus

    ... from what the doctor prescribed, it is called prescription drug abuse. It could be Taking a medicine that was prescribed for someone else Taking a ... at higher doses or when taken with other medicines. NIH: National Institute on Drug Abuse

  6. Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule.

    PubMed

    2010-03-04

    We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products.

  7. Prescription Drug Abuse

    ERIC Educational Resources Information Center

    Hamilton, Gloria J.

    2009-01-01

    This article presents current statistics on nonmedical use of both categories of prescription medications by high school and college students. The incidence of nonmedical use of prescription medications continues to increase among high school and college students. Two categories of drugs that are commonly used for reasons other than those for…

  8. Prescription Drug Assistance Programs

    MedlinePlus

    ... Treatment & Support Finding and Paying for Treatment Understanding Health Insurance If You Have Trouble Paying a Bill Prescription ... income and no drug coverage If you have health insurance If your income is low: Look into Medicaid ...

  9. Abuse of prescription drugs.

    PubMed Central

    Wilford, B B

    1990-01-01

    An estimated 3% of the United States population deliberately misuse or abuse psychoactive medications, with severe consequences. According to the National Institute on Drug Abuse, more than half of patients who sought treatment or died of drug-related medical problems in 1989 were abusing prescription drugs. Physicians who contribute to this problem have been described by the American Medical Association as dishonest--willfully misprescribing for purposes of abuse, usually for profit; disabled by personal problems with drugs or alcohol; dated in their knowledge of current pharmacology or therapeutics; or deceived by various patient-initiated fraudulent approaches. Even physicians who do not meet any of these descriptions must guard against contributing to prescription drug abuse through injudicious prescribing, inadequate safeguarding of prescription forms or drug supplies, or acquiescing to the demands or ruses used to obtain drugs for other than medical purposes. PMID:2349801

  10. Medicare Prescription Drug Coverage

    MedlinePlus

    ... people also have to pay an additional monthly cost. Private companies provide Medicare prescription drug coverage. You choose the drug plan you like best. Whether or not you should sign up depends on how good your current coverage is. You need to sign up as ...

  11. Over-the-counter medicines

    MedlinePlus

    ... YS. Non-steroidal anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev . 2013;6:CD006362. PMID: ... Lin X, Wu T. Acetaminophen (paracetamol) for the common cold in adults. Cochrane Database Syst Rev . 2013;7: ...

  12. 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.

  13. Prescription Nonsteroidal Anti-Inflammatory Medicines

    MedlinePlus

    ... is called a drug-drug interaction. Vitamins and herbal supplements can affect the way your body processes drugs, ... over-the-counter and prescription medicines, vitamins and herbal supplements that you are taking. Also, talk to your ...

  14. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... lobeline sulfate or natural lobelia alkaloids or Lobelia inflata herb), menthol, methyl salicylate... drug product containing lobeline (in the form of lobeline sulfate or natural lobelia alkaloids...

  15. 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

    ... contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug... Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic....

  16. 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

    ... contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug... Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic....

  17. 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

    ... contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug... Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic....

  18. 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

    ... contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug... Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic....

  19. 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

    ... contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug... Atropa belladonna and Datura stramonium, are neither safe nor effective as an OTC anticholinergic....

  20. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos avoid you,” “bugs stay away,” “keep mosquitos away for 12 to 24 hours,” and “the newest way to fight mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect...

  1. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos avoid you,” “bugs stay away,” “keep mosquitos away for 12 to 24 hours,” and “the newest way to fight mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect...

  2. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos avoid you,” “bugs stay away,” “keep mosquitos away for 12 to 24 hours,” and “the newest way to fight mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect...

  3. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos avoid you,” “bugs stay away,” “keep mosquitos away for 12 to 24 hours,” and “the newest way to fight mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect...

  4. Adolescent Nonmedical Prescription Drug Use

    ERIC Educational Resources Information Center

    Ford, Jason A.; Watkins, William C.

    2012-01-01

    For many adolescents today, the most common form of substance use is nonmedical prescription drug use. Fittingly, many researchers, policy makers, and people who work with youth are concerned about the serious problems associated with nonmedical prescription drug use (NMPDU). In this article, authors Jason Ford and William Watkins provide an…

  5. Taking Medicines Safely After Alcohol or Drug Abuse Recovery

    MedlinePlus

    ... Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & Devices Over-the-counter Products Procedures & Devices Prescription Medicines Health Tools Dictionary Symptom Checker BMI Calculator myhealthfinder ...

  6. The prescription drug abuse epidemic.

    PubMed

    Yu, Hoi-Ying Elsie

    2012-09-01

    In the United States, the nonmedical use of prescription drugs is the second most common illicit drug use, behind only marijuana. This article discusses the abuse issues with three of the most widely abused prescription drugs: opioids, central nervous system (CNS) depressants (eg, benzodiazepines), and stimulants (eg, amphetamine-dextroamphetamine and methylphenideate) in the United States. Efforts to deal with the problem are described as well.

  7. Methadone and prescription drug overdose.

    PubMed

    Hendrikson, Hollie; Hansen, Melissa

    2014-12-01

    (1) Methadone accounted for 2 percent of painkiller prescriptions and more than 30 percent of prescription painkiller deaths in 2009. (2) Data suggest that the rise in deaths from methadone overdose is not related to its use in treating drug abuse but, rather, to its use for pain management. (3) Preferred drug lists in most Medicaid programs identify methadone as a preferred drug for managing chronic pain, but most experts do no recommend it as a first choice.

  8. 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.

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

    MedlinePlus

    ... Near You Sinus Pain: Can Over-the-Counter Medications Help? Sinus Pain: Can Over-the-Counter Medications ... OTC) medications. What Is The Role Of OTC Medication For Sinus Pain? There are many different OTC ...

  10. Prescription Drug Abuse

    MedlinePlus

    ... Whether they're using street drugs or medications, drug abusers often have trouble at school, at home, with ... a short period of time may make a drug abuser aggressive or paranoid. Although stimulant abuse might not ...

  11. Opioids: The Prescription Drug & Heroin Overdose Epidemic

    MedlinePlus

    ... Resources Law Enforcement Resources Opioids: The Prescription Drug & Heroin Overdose Epidemic Opioids are natural or synthetic chemicals ... in your brain or body. Common opioids include heroin and prescription drugs such as oxycodone, hydrocodone, and ...

  12. Prescription Drug Abuse and Youth. Information Brief.

    ERIC Educational Resources Information Center

    Department of Justice, Washington, DC. National Drug Intelligence Center.

    Prescription drugs, a category of psychotherapeutics that comprises prescription-type pain relievers, tranquilizers, stimulants, and sedatives, are among the substances most commonly abused by young people in the United States. Prescription drugs are readily available and can easily be obtained by teenagers who abuse these drugs to experience a…

  13. 76 FR 51310 - Branded Prescription Drug Fee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee AGENCY: Internal... issuing temporary regulations relating to the branded prescription drug fee imposed by the Affordable Care... certain branded prescription drugs. The text of the temporary regulations also serves as the text of...

  14. 76 FR 51245 - Branded Prescription Drug Fee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... Service 26 CFR Parts 51 and 602 RIN 1545-BK34 Branded Prescription Drug Fee AGENCY: Internal Revenue... manufacturing or importing branded prescription drugs. This fee was enacted by section 9008 of the Patient... certain branded prescription drugs. The text of the temporary regulations also serves as the text of...

  15. Prescription drug abuse: problem, policies, and implications.

    PubMed

    Phillips, Janice

    2013-01-01

    This article provides an overview on prescription drug abuse and highlights a number of related legislative bills introduced during the 112th Congress in response to this growing epidemic. Prescription drug abuse has emerged as the nation's fastest growing drug problem. Although prescription drugs have been used effectively and appropriately for decades, deaths from prescription pain medicine in particular have reached epidemic proportions. Bills related to prescription drug abuse introduced during the 112th Congress focus on strengthening provider and consumer education, tracking and monitoring prescription drug abuse, improving data collection on drug overdose fatalities, combating fraud and abuse in Medicare and Medicaid programs, reclassifying drugs to make them more difficult to prescribe and obtain, and enforcing stricter penalties for individuals who operate scam pain clinics and sell pain pills illegitimately. This article underscores the importance of a multifaceted approach to combating prescription drug abuse and concludes with implications for nursing.

  16. 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

  17. 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.

  18. Closing the Prescription Drug Coverage Gap

    MedlinePlus

    ... coverage gap discount work for brand-name drugs? Companies that make brand-name prescription drugs must sign ... Coverage Gap Discount Program. This program requires the companies to offer discounts on brand-name drugs to ...

  19. 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.

  20. 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.

  1. Doping in gymnasiums in Amman: the other side of prescription and nonprescription drug abuse.

    PubMed

    Wazaify, Mayyada; Bdair, Ahmad; Al-Hadidi, Kamal; Scott, Jenny

    2014-08-01

    This study investigated the abuse of over-the-counter (OTC) products (e.g., proteins, dietary supplements) and prescription drugs (e.g., hormones) in gymnasiums in Amman by random distribution of a structured questionnaire to 375 gym clients (November 2012-February 2013). Data were analyzed using SPSS for Windows (version 17.0). A total of 31 (8.8%) clients admitted to using 21 products (mentioned 71 times) of anabolic steroids and other hormones (e.g., growth hormone and thyroxine) to increase muscular power at the gym or build muscle mass. Abuse of different prescription and OTC drugs among gymnasium clients is present in Jordan, but current methods for controlling the problem are ineffective. Better methods should be developed. The study's limitations are noted.

  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. Are You Shopping Smart for Prescription Drugs?

    MedlinePlus

    ... best known for its ratings of cars, appliances, computers, and TVs, recently launched Consumer Reports Best Buy Drugs . The project compares prescription drugs based on their effectiveness, safety, side effects, and cost. The results are offered free at ...

  4. 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

  5. 77 FR 12310 - Drugs for Human Use; Drug Efficacy Study Implementation; Prescription Drugs That Contained...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is...; IRS drug products require an approved NDA or ANDA, as appropriate. Furthermore, labeling for drug... an approved NDA or ANDA is unlawful as of the effective date of this notice. This notice is...

  6. 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.

  7. The Conundrum of Online Prescription Drug Promotion

    PubMed Central

    Wanasika, Isaac

    2016-01-01

    This commentary discusses pertinent issues from Hyosun Kim’s paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration’s (FDA’s) decision to deregulate online advertising of prescription drugs. While Kim’s findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. PMID:27285519

  8. Prescription drug abuse in the elderly.

    PubMed

    Martin, Caren McHenry

    2008-12-01

    The increased use of prescription drugs has brought pain relief too many and often improved the quality of life of elderly patients. But the increase in use and availability of prescription medications-especially controlled substances-brings with it an increased potential for abuse. Studies have shown that intentional abuse of prescription drugs is increasing among all age groups. As the number of persons 65 years of age and older skyrockets with the aging of the baby boomers, experts predict that prescription drug abuse among the elderly also will rise significantly. Efforts to increase awareness of drug abuse among elderly patients, caregivers, and health care practitioners, as well as research into how best to prevent and treat the elderly drug abuser, will be necessary to thwart what could become a significant public health problem.

  9. 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...

  10. Patterns of prescription drug misuse among young injection drug users.

    PubMed

    Lankenau, Stephen E; Teti, Michelle; Silva, Karol; Bloom, Jennifer Jackson; Harocopos, Alex; Treese, Meghan

    2012-12-01

    Misuse of prescription drugs and injection drug use has increased among young adults in the USA. Despite these upward trends, few studies have examined prescription drug misuse among young injection drug users (IDUs). A qualitative study was undertaken to describe current patterns of prescription drug misuse among young IDUs. Young IDUs aged 16-25 years who had misused a prescription drug, e.g., opioids, tranquilizers, or stimulants, at least three times in the past 3 months were recruited in 2008 and 2009 in Los Angeles (n = 25) and New York (n = 25). Informed by an ethno-epidemiological approach, descriptive data from a semi-structured interview guide were analyzed both quantitatively and qualitatively. Most IDUs sampled were both homeless and transient. Heroin, prescription opioids, and prescription tranquilizers were frequently misused in the past 30 days. Qualitative results indicated that young IDUs used prescription opioids and tranquilizers: as substitutes for heroin when it was unavailable; to boost a heroin high; to self-medicate for health conditions, including untreated pain and heroin withdrawal; to curb heroin use; and to reduce risks associated with injecting heroin. Polydrug use involving heroin and prescription drugs resulted in an overdose in multiple cases. Findings point to contrasting availability of heroin in North American cities while indicating broad availability of prescription opioids among street-based drug users. The results highlight a variety of unmet service needs among this sample of young IDUs, such as overdose prevention, drug treatment programs, primary care clinics, and mental health services.

  11. Sale of prescription drugs over the Internet.

    PubMed

    Armstrong, K; Bloom, B S

    1999-01-01

    Online drugstores represent one of the hottest categories in electronic commerce. The Internet offers great promise in expanding access to prescription drugs for the disabled, the elderly, and people living in rural areas. But with this promise comes the danger of eliminating the safeguards that protect consumers from inappropriate use of medications and adverse drug events. This Issue Brief highlights two studies that investigate the availability of prescription drugs over the Internet, and focuses on the alarming ease with which consumers can obtain drugs without seeing a physician or a pharmacist.

  12. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * *...

  13. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * *...

  14. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * *...

  15. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (a)(1)...

  16. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * *...

  17. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (a)(1)...

  18. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (a)(1)...

  19. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Prescription-drug advertisements. 202.1 Section 202.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (a)(1)...

  20. Unapproved prescription cough, cold, and allergy drug products: recent US Food and Drug Administration regulatory action on unapproved cough, cold, and allergy medications.

    PubMed

    Ostroff, Craig; Lee, Charles E; McMeekin, Judith

    2011-08-01

    The US Food and Drug Administration (FDA) drug approval and over-the-counter drug monograph processes play an essential role in ensuring that all drugs are both safe and effective for their intended uses. Manufacturers of drugs that lack required approval have not provided the FDA with evidence demonstrating that their products are safe and effective. Some of these prescription drugs have been marketed for many years and have remained on the market despite changes to the Federal Food, Drug, and Cosmetic Act, which requires approval for safety and efficacy purposes. Many health-care providers may be unaware that unapproved drugs exist because the product labels of these drugs do not disclose that they lack FDA approval. The FDA recently took action against unapproved prescription oral cough, cold, and allergy drug products because of concerns about the potential risks of these products, particularly some extended-release formulations that have not been reviewed for quality. There is a potential for medication errors because product names and labeling have not been reviewed for potential confusion, with some products inappropriately labeled for use in children aged ≤ 2 years. FDA-approved prescription drugs or drugs appropriately marketed as over the counter remain available for treatment of cough, cold, and allergy symptoms. Such products are of known efficacy, safety, identity, quality, and purity. Removing unapproved drugs from the marketplace and encouraging manufacturers of unapproved products to seek FDA review and approval is a top priority for the FDA. Since the initiation of the Unapproved Drugs Initiative in 2006, the FDA has removed ~1,500 unapproved products from the market and has worked with firms to bring other unapproved drugs into the approval process. The FDA remains committed to its mission of ensuring that safe and effective drugs are available to American consumers.

  1. 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.

  2. Using Prescription Drug Monitoring Programs to Address Drug Abuse.

    PubMed

    Hansen, Melissa

    2015-03-01

    (1) Forty-nine states have established prescription drug monitoring programs (PDMPs) to address misuse and abuse of controlled substances. (2) Pilot programs have shown that connecting prescribers' PDMPs using health information technology results in improved patient care. (3) Legislators can access up-to-date information about their state PDMP at the Prescription Drug Monitoring Program Training and Technical Assistance Center.

  3. Universal prescription drug coverage in Canada

    PubMed Central

    Boothe, Katherine

    2016-01-01

    Canada’s universal public healthcare system is unique among developed countries insofar as it does not include universal coverage of prescription drugs. Universal, public coverage of prescription drugs has been recommended by major national commissions in Canada dating back to the 1960s. It has not, however, been implemented. In this article, we extend research on the failure of early proposals for universal drug coverage in Canada to explain failures of calls for reform over the past 20 years. We describe the confluence of barriers to reform stemming from Canadian policy institutions, ideas held by federal policy-makers, and electoral incentives for necessary reforms. Though universal “pharmacare” is once again on the policy agenda in Canada, arguably at higher levels of policy discourse than ever before, the frequently recommended option of universal, public coverage of prescription drugs remains unlikely to be implemented without political leadership necessary to overcome these policy barriers. PMID:27744279

  4. [Drug prescriptions: Adherence and understanding in Madagascar].

    PubMed

    Raharinjatovo, L; Ralandison, S

    2015-01-01

    Frequently ignored or neglected, poor adherence is an important cause of treatment failure and a major public health problem. We assessed the factors involved in adherence in a hospital in Madagascar. This long-term study evaluated two groups of variables: patients' level of understanding of their disease and drug prescriptions, and the information on the prescription written by the doctor. We interviewed 93 in-patients (mean age: 50 years) and found that 16% were illiterate. Overall, 27% did not know the name of their illness, 34% were unaware of the treatment objectives, and 14% did not understand the drug prescription. On 20% of the prescriptions, the patients' name was not included, and the daily dose information and schedule was omitted from 16%. A day after receiving the prescription, only 64% had purchased the medication and only 53% of all patients had taken any. A correlation was observed between illiteracy, knowledge of the disease/treatment goals, and non-purchase of drugs. The poor quality of information contained in the prescriptions and patients' poor understanding of what they were supposed to do are obvious. Using pre-completed health forms and text messages might improve adherence.

  5. The Prescription Drug Marketing Act of 1987.

    PubMed

    Greenberg, R B

    1988-10-01

    The Prescription Drug Marketing Act of 1987 is described, and its implications for hospitals and other health-care entities are discussed. The act, which became effective on July 21, 1988, is intended to reduce public health risks from adulterated, misbranded, and counterfeit drug products that enter the marketplace through drug diversion. The law provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Other distribution channels for samples specified in the law are permissible, provided records are maintained. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also identified. According to FDA's advisory guidelines on the statute, the law will permit hospitals to return drug products, provided the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (for manufacturers) or the goods were destroyed or returned to the manufacturer (for wholesalers). The final chapter on drug diversion must await issuance of final FDA regulations.

  6. 75 FR 12555 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Act; Public Meeting AGENCY: Food... Administration (FDA) is announcing a public meeting on the Prescription Drug User Fee Act (PDUFA). The... FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug,...

  7. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription-drug advertisements. 202.1 Section...) DRUGS: GENERAL PRESCRIPTION DRUG ADVERTISING § 202.1 Prescription-drug advertisements. (e) * * * (6... some particular when the difference has not been demonstrated by substantial evidence. An...

  8. Understanding Medicare Prescription Drug Coverage

    MedlinePlus

    ... Health ResourcesHealthcare Management End-of-Life Issues Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & ... Health ResourcesHealthcare Management End-of-Life Issues Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & ...

  9. Physician perceptions of prescription drug information.

    PubMed

    Evans, K R; Beltramini, R F

    1986-01-01

    This study reports the findings of an investigation designed to explore the importance of prescription drug information source characteristics among physicians. Differences were found to exist among the importance ratings both in aggregate, and between, categories of physician specialty and years in practice. Conclusions for pharmaceutical marketers and the implications for future research efforts are discussed.

  10. 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.

  11. 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.

  12. 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 ...

  13. [Drug design ideas and methods of Chinese herb prescriptions].

    PubMed

    Ren, Jun-guo; Liu, Jian-xun

    2015-09-01

    The new drug of Chinese herbal prescription, which is the best carrier for the syndrome differentiation and treatment of Chinese medicine and is the main form of the new drug research and development, plays a very important role in the new drug research and development. Although there are many sources of the prescriptions, whether it can become a new drug, the necessity, rationality and science of the prescriptions are the key to develop the new drug. In this article, aiming at the key issues in prescriptions design, the source, classification, composition design of new drug of Chinese herbal prescriptions are discussed, and provide a useful reference for research and development of new drugs.

  14. Women who doctor shop for prescription drugs.

    PubMed

    Worley, Julie; Thomas, Sandra P

    2014-04-01

    Doctor shopping is a term used to describe a form of diversion of prescription drugs when patients visit numerous prescribers to obtain controlled drugs for illicit use. Gender differences exist in regard to prescription drug abuse and methods of diversion. The purpose of this phenomenological study guided by the existential philosophy of Merleau-Ponty was to understand the lived experience of female doctor shoppers. Interviews were conducted with 14 women, which were recorded, transcribed, and analyzed. Included in the findings are figural aspects of the participants' experience of doctor shopping related to the existential grounds of world, time, body, and others. Four themes emerged from the data: (a) feeding the addiction, (b) networking with addicts, (c) playing the system, and (d) baiting the doctors. The findings suggest several measures that nurses can take to reduce the incidence of doctor shopping and to provide better care for female doctor shoppers.

  15. Patterns of Prescription Medication Diversion among Drug Dealers

    ERIC Educational Resources Information Center

    Rigg, Khary K.; Kurtz, Steven P.; Surratt, Hilary L.

    2012-01-01

    This research examined the following questions: (1) how do drug dealers acquire their inventories of prescription medications? and (2) which types of prescription medications do dealers most commonly sell? Data are drawn from a National Institute on Drug Abuse-funded research study that examined prescription drug diversion and abuse in South…

  16. Resonant Messages to Prevent Prescription Drug Misuse by Teens

    ERIC Educational Resources Information Center

    Twombly, Eric C.; Holtz, Kristen D.; Agnew, Christine B.

    2011-01-01

    Prescription drug misuse is a major health problem, particularly among teens. A key step in curbing misuse is the development of effective prescription drug prevention messages. This paper explores the elements of prescription drug misuse prevention messages that resonate with teens using data from focus groups with seventh and eighth grade…

  17. 76 FR 59897 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Internal Revenue Service 26 CFR Part 51 RIN 1545-BK34 Branded Prescription Drug Fee; Correction AGENCY... engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by..., 2011 and applies to any fee on branded prescription drug sales that is due on or after September...

  18. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a)...

  19. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions. For purposes of...

  20. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a)...

  1. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a)...

  2. 76 FR 59898 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee; Correction AGENCY... provides guidance relating to the branded prescription drug fee imposed by the Affordable Care Act. FOR... PART 51--BRANDED PRESCRIPTION DRUGS, the last line of the first paragraph, the language ``this issue...

  3. 76 FR 59897 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Internal Revenue Service 26 CFR Part 51 RIN 1545-BK34 Branded Prescription Drug Fee; Correction AGENCY... entities engaged in the business of manufacturing or importing branded prescription drugs. This fee was... September 28, 2011 and applies to any fee on branded prescription drug sales that is due on or...

  4. 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

  5. ENHANCING PRESCRIPTION DRUG INNOVATION AND ADOPTION

    PubMed Central

    Alexander, G. Caleb; O’Connor, Alec B.; Stafford, Randall S.

    2014-01-01

    The adoption and use of a new drug would ideally be guided by its Innovation and cost-effectiveness. The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a market place in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U.S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines. PMID:21690598

  6. Controlled prescription drug abuse at epidemic level.

    PubMed

    2006-01-01

    In July 2005, The National Center on Addiction and Substance Abuse (CASA) at Columbia University announced the results of a study indicating that the number of Americans who abuse controlled prescription drugs has nearly doubled from 7.8 million to 15.1 million from 1992 to 2003 and abuse among teens has more than tripled during that time. A summary of that study and information about the full report are presented.

  7. Quantitative Information on Oncology Prescription Drug Websites.

    PubMed

    Sullivan, Helen W; Aikin, Kathryn J; Squiers, Linda B

    2016-09-02

    Our objective was to determine whether and how quantitative information about drug benefits and risks is presented to consumers and healthcare professionals on cancer-related prescription drug websites. We analyzed the content of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). Websites were equally likely to present quantitative information for benefits (96.9 %) and risks (95.4 %). However, the amount of the information differed significantly: Both consumer-directed and healthcare-professional-directed webpages were more likely to have quantitative information for every benefit (consumer 38.5 %; healthcare professional 86.1 %) compared with every risk (consumer 3.1 %; healthcare professional 6.2 %). The numeric and graphic presentations also differed by audience and information type. Consumers have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs. Research has shown that using quantitative information to communicate treatment benefits and risks can increase patients' and physicians' understanding and can aid in treatment decision-making, although some numeric and graphic formats are more useful than others.

  8. Checklist for Choosing Over-the-Counter (OTC) Medicine for Adults

    MedlinePlus

    ... by the doctor: ____________________________________________________________________________ Other medicines (OTC and prescription), vitamins, ... the form of medicine (such as tablet, capsule, or liquid) wanted. Read the “ Drug Facts” label ...

  9. Abuse of Prescription (Rx) Drugs Affects Young Adults Most

    MedlinePlus

    ... Affects Young Adults Most Abuse of Prescription (Rx) Drugs Affects Young Adults Most Email Facebook Twitter Text Description of Infographic Young adults (age 18 to 25) are the biggest abusers of prescription (Rx) opioid pain relievers, ADHD stimulants, ...

  10. 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.

  11. 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.

  12. Prescription Drug Abuse: From Epidemiology to Public Policy

    PubMed Central

    McHugh, R. Kathryn; Nielsen, Suzanne; Weiss, Roger D.

    2014-01-01

    Prescription drug abuse has reached an epidemic level in the United States. The prevalence of prescription drug abuse escalated rapidly beginning in the late 1990s, requiring a significant increase in research to better understand the nature and treatment of this problem. Since this time, a research literature has begun to develop and has provided important information about how prescription drug abuse is similar to, and different from the abuse of other substances. This introduction to a special issue of the Journal of Substance Abuse Treatment on prescription drug abuse provides an overview of the current status of the research literature in this area. The papers in this special issue include a sampling of the latest research on the epidemiology, clinical correlates, treatment, and public policy considerations of prescription drug abuse. Although much has been learned about prescription drug abuse in recent years, this research remains in early stages, particularly with respect to understanding effective treatments for this population. Future research priorities include studies on the interaction of prescription drugs with other licit and illicit substances, the impact of prescription drug abuse across the lifespan, the optimal treatment for prescription drug abuse and co-occurring conditions, and effective public policy initiatives for reducing prescription drug abuse. PMID:25239857

  13. Prescription drug abuse: from epidemiology to public policy.

    PubMed

    McHugh, R Kathryn; Nielsen, Suzanne; Weiss, Roger D

    2015-01-01

    Prescription drug abuse has reached an epidemic level in the United States. The prevalence of prescription drug abuse escalated rapidly beginning in the late 1990s, requiring a significant increase in research to better understand the nature and treatment of this problem. Since this time, a research literature has begun to develop and has provided important information about how prescription drug abuse is similar to, and different from the abuse of other substances. This introduction to a special issue of the Journal of Substance Abuse Treatment on prescription drug abuse provides an overview of the current status of the research literature in this area. The papers in this special issue include a sampling of the latest research on the epidemiology, clinical correlates, treatment, and public policy considerations of prescription drug abuse. Although much has been learned about prescription drug abuse in recent years, this research remains in early stages, particularly with respect to understanding effective treatments for this population. Future research priorities include studies on the interaction of prescription drugs with other licit and illicit substances, the impact of prescription drug abuse across the lifespan, the optimal treatment for prescription drug abuse and co-occurring conditions, and effective public policy initiatives for reducing prescription drug abuse.

  14. Prescription Drug Misuse and Sexual Behavior Among Young Adults.

    PubMed

    Wells, Brooke E; Kelly, Brian C; Rendina, H Jonathon; Parsons, Jeffrey T

    2015-01-01

    Though research indicates a complex link between substance use and sexual risk behavior, there is limited research on the association between sexual risk behavior and prescription drug misuse. In light of alarming increases in prescription drug misuse and the role of demographic characteristics in sexual risk behavior and outcomes, the current study examined demographic differences (gender, sexual identity, age, relationship status, parental class background, and race/ethnicity) in sexual risk behavior, sexual behavior under the influence of prescription drugs, and sexual risk behavior under the influence of prescription drugs in a sample of 402 young adults (ages 18 to 29) who misused prescription drugs. Nearly half of the sexually active young adult prescription drug misusers in this sample reported recent sex under the influence of prescription drugs; more than three-quarters reported recent sex without a condom; and more than one-third reported recent sex without a condom after using prescription drugs. Zero-inflated Poisson regression models indicated that White race, younger age, higher parental class, and being a heterosexual man were all associated with sexual risk behavior, sex under the influence of prescription drugs, and sexual risk under the influence of prescription drugs. Findings have implications for the targeting of prevention and intervention efforts.

  15. Prevention of overlapping prescriptions of psychotropic drugs by community pharmacists.

    PubMed

    Shimane, Takuya; Matsumoto, Toshihiko; Wada, Kiyoshi

    2012-10-01

    The nonmedical use or abuse of prescription drugs, including psychotropic medicines, is a growing health problem in Japan. Patient access to psychotropic drugs, specifically from the oversupply of medications due to overlapping prescriptions, may increase the risk of drug abuse and dependence. However, very little is known about such overlapping prescriptions. Today, the dispensing of prescriptions is generally moving from inside to outside of hospitals, with psychotropic drugs mainly dispensed at community pharmacies. In this study, we used health insurance claims (i.e., receipts) for dispensing as the main source of information in an investigation of overlapping prescriptions of psychotropic drugs. A total of 119 patients were found to have received overlapping prescriptions, as identified by community pharmacists who were members of the Saitama Pharmaceutical Association, using patient medication records, followed by medication counseling and prescription notes for the patient. According to our findings, the most frequently overlapping medication was etizolam. Etizolam can be prescribed for more than 30 days since it is not regulated under Japanese law as a "psychotropic drug." Generally, when a drug can be prescribed for a greater number of days, it increases the likelihood of an overlapping prescription during the same period. As a result, the long-term prescription of etizolam increases the risk of overlapping prescriptions. We also found that the patients who received overlapping prescriptions of etizolam were mostly elderly and the most common pattern was prescription from both internal medicine and orthopedics physicians. Etizolam has wide range of indications that are covered by health insurance. Our results suggest that patients who received overlapping prescriptions of etizolam may receive prescriptions from different prescribers for different purposes. Therefore, it may be appropriate to regulate etizolam as a "psychotropic drug" under Japanese law

  16. 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.

  17. 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

  18. [Clinical practice guideline. Drug prescription in elderly].

    PubMed

    Peralta-Pedrero, María Luisa; Valdivia-Ibarra, Francisco Javier; Hernández-Manzano, Mario; Medina-Beltrán, Gustavo Rodrigo; Cordero-Guillén, Miguel Angel; Baca-Zúñiga, José; Cruz-Avelar, Agles; Aguilar-Salas, Ismael; Avalos-Mejía, Annia Marisol

    2013-01-01

    The process of prescribing a medication is complex and includes: deciding whether it is indicated, choosing the best option, determining the dose and the appropriate management scheme to the physiological condition of the patient, and monitoring effectiveness and toxicity. We have to inform patients about the expected side effects and indications for requesting a consultation. Specific clinical questions were designed based on the acronym PICOST. The search was made in the specific websites of clinical practice guidelines, was limited to the population of older adults, in English or Spanish. We used 10 related clinical practice guidelines, eight systematic reviews and five meta-analyses. Finally, we made a search of original articles or clinical reviews for specific topics. The development and validation of clinical practice guidelines for "rational drug prescriptions in the elderly" is intended to promote an improvement in the quality of prescription through the prevention and detection of inappropriate prescribing in the elderly and, as a result of this, a decrease in the adverse events by drugs, deterioration of health of patients and expenditure of resources.

  19. 45 CFR 156.122 - Prescription drug benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and...

  20. 45 CFR 156.122 - Prescription drug benefits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Prescription drug benefits. 156.122 Section 156... Essential Health Benefits Package § 156.122 Prescription drug benefits. (a) A health plan does not provide... at least the greater of: (i) One drug in every United States Pharmacopeia (USP) category and...

  1. Prescription Drug Abuse Information in D.A.R.E.

    ERIC Educational Resources Information Center

    Morris, Melissa C.; Cline, Rebecca J. Welch; Weiler, Robert M.; Broadway, S. Camille

    2006-01-01

    This investigation was designed to examine prescription drug-related content and learning objectives in Drug Abuse Resistance Education (D.A.R.E.) for upper elementary and middle schools. Specific prescription-drug topics and context associated with content and objectives were coded. The coding system for topics included 126 topics organized…

  2. Impact of a Mandatory Prescription Drug Monitoring Program on Prescription of Opioid Analgesics by Dentists.

    PubMed

    Rasubala, Linda; Pernapati, Lavanya; Velasquez, Ximena; Burk, James; Ren, Yan-Fang

    2015-01-01

    Prescription Drug Monitoring Programs (PDMP) are statewide databases that collect data on prescription of controlled substances. New York State mandates prescribers to consult the PDMP registry before prescribing a controlled substance such as opioid analgesics. The effect of mandatory PDMP on opioid drug prescriptions by dentists is not known. This study investigates the impact of mandatory PDMP on frequency and quantity of opioid prescriptions by dentists in a dental urgent care center. Based on the sample size estimate, we collected patient records of a 3-month period before and two consecutive 3-month periods after the mandatory PDMP implementation and analyzed the data on number of visits, treatment types and drug prescriptions using Chi-square tests. For patients who were prescribed pain medications, 452 (30.6%), 190 (14.1%), and 140 (9.6%) received opioid analgesics in the three study periods respectively, signifying a statistically significant reduction in the number of opioid prescriptions after implementation of the mandatory PDMP (p<0.05). Total numbers of prescribed opioid pills in a 3-month period decreased from 5096 to 1120, signifying a 78% reduction in absolute quantity. Prescriptions for non-opioid analgesics acetaminophen increased during the same periods (p<0.05). We conclude that the mandatory PDMP significantly affected the prescription pattern for pain medications by dentists. Such change in prescription pattern represents a shift towards the evidence-based prescription practices for acute postoperative pain.

  3. Impact of a Mandatory Prescription Drug Monitoring Program on Prescription of Opioid Analgesics by Dentists

    PubMed Central

    Rasubala, Linda; Pernapati, Lavanya; Velasquez, Ximena; Burk, James; Ren, Yan-Fang

    2015-01-01

    Prescription Drug Monitoring Programs (PDMP) are statewide databases that collect data on prescription of controlled substances. New York State mandates prescribers to consult the PDMP registry before prescribing a controlled substance such as opioid analgesics. The effect of mandatory PDMP on opioid drug prescriptions by dentists is not known. This study investigates the impact of mandatory PDMP on frequency and quantity of opioid prescriptions by dentists in a dental urgent care center. Based on the sample size estimate, we collected patient records of a 3-month period before and two consecutive 3-month periods after the mandatory PDMP implementation and analyzed the data on number of visits, treatment types and drug prescriptions using Chi-square tests. For patients who were prescribed pain medications, 452 (30.6%), 190 (14.1%), and 140 (9.6%) received opioid analgesics in the three study periods respectively, signifying a statistically significant reduction in the number of opioid prescriptions after implementation of the mandatory PDMP (p<0.05). Total numbers of prescribed opioid pills in a 3-month period decreased from 5096 to 1120, signifying a 78% reduction in absolute quantity. Prescriptions for non-opioid analgesics acetaminophen increased during the same periods (p<0.05). We conclude that the mandatory PDMP significantly affected the prescription pattern for pain medications by dentists. Such change in prescription pattern represents a shift towards the evidence-based prescription practices for acute postoperative pain. PMID:26274819

  4. 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.

  5. Prescription drug abuse information in D.A.R.E.

    PubMed

    Morris, Melissa C; Cline, Rebecca J Welch; Weiler, Robert M; Broadway, S Camille

    2006-01-01

    This investigation was designed to examine prescription drug-related content and learning objectives in Drug Abuse Resistance Education (D.A.R.E.) for upper elementary and middle schools. Specific prescription-drug topics and context associated with content and objectives were coded. The coding system for topics included 126 topics organized within 14 categories. A two-dimensional coding system for context identified Use versus Abuse and Explicit versus Implicit references to prescription drugs. Results indicated that content and objectives found in D.A.R.E. represent a very narrow breadth of prescription drug topics. Moreover, all prescription-drug related content and objectives were presented in an Abuse-Implicit context. Although some educational material in D.A.R.E. modules potentially is related to prescription drugs, none of the content or objectives explicitly identify drugs discussed as prescription drugs. If elementary and middle schools rely on D.A.R.E. modules to teach students about drug abuse, students are likely to be underinformed about prescription drug risks.

  6. "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

  7. 75 FR 12756 - Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... Collection; Comment Request; Prescription Drug Advertisements AGENCY: Food and Drug Administration, HHS..., contained in FDA's regulations on prescription drug advertisements. DATES: Submit written or electronic... of information technology. Prescription Drug Advertisements--21 CFR 202.1 (OMB Control Number...

  8. Agreement between patients' self-report and physicians' prescriptions on nonsteroidal anti-inflammatory drugs and other drugs used in musculoskeletal disorders: the international Pharmacoepidemiologic General Research eXtension database.

    PubMed

    Grimaldi-Bensouda, Lamiae; Rossignol, Michel; Aubrun, Elodie; Benichou, Jacques; Abenhaim, Lucien

    2012-07-01

    PURPOSE: The use of prescription records for the assessment of exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) does not capture over-the-counter drug use. This study compared patients' self-reported use to physician's prescriptions for NSAIDs and other drugs used to treat musculoskeletal disorders (MSDs). METHODS: The international Pharmacoepidemiologic General Research eXtension database includes a network of general practitioners recruiting patients without reference to diagnoses or prescriptions. Data on all drug use across France within the 2 years preceding the date of inclusion (index date) were obtained from both patients' self-reports (PSRs) and physicians' prescription reports (PPRs). Patients' reports were obtained using a structured telephone interview combined with an interview guide containing a list of drugs commonly used. Comparisons were made on exposure to four categories of MSD drugs and three time windows up to 24 months before the index date. RESULTS: Agreement between physician and patient reports was assessed on 4152 patient-physician pairs. Bias- and prevalence-adjusted kappa values showed fair agreement for nonaspirin NSAIDs, moderate to fair for nonnarcotic analgesics, high for osteoarthritis and moderate to substantial for muscle relaxants. Over-the-counter drug use was associated with greater disagreement (OR = 2.21, 95%CI = 1.05-1.38). Age was not associated with disagreement. CONCLUSION: Differences between PSR and PPR in estimating the prevalence of MSD drug use varied by the type of drug and the elapsed time from the index date. The patient-assisted interview method used in this study showed better agreement with PPR compared with standard interviews, especially for long time windows and patients older than 65 years. Copyright © 2012 John Wiley & Sons, Ltd.

  9. Teens and Prescription Drugs: An Analysis of Recent Trends on the Emerging Drug Threat

    ERIC Educational Resources Information Center

    Office of National Drug Control Policy, 2007

    2007-01-01

    This report synthesizes a number of national studies that show the intentional abuse of prescription drugs to get high is a growing concern, particularly among teens. The analysis shows that teens are turning away from street drugs and using prescription drugs to get high. New users of prescription drugs have caught up with new users of marijuana.…

  10. Strategies Used by Adults to Reduce Their Prescription Drug Costs

    MedlinePlus

    ... or private coverage to use strategies to save money on prescription drugs. Figure 3. Percentages of adults aged 18–64 ... doctor for a lower cost medication to save money …You bought prescription drugs from another country to save money …You ...

  11. Preventing Prescription Drug Abuse in Adolescence: A Collaborative Approach

    ERIC Educational Resources Information Center

    Jones, Beth A.; Fullwood, Harry; Hawthorn, Melissa

    2012-01-01

    With the growing awareness of adolescent prescription drug abuse, communities and schools are beginning to explore prevention and intervention strategies which are appropriate for their youth. This article provides a framework for developing a collaborative approach to prescription drug abuse prevention--called the Prevention Awareness Team--that…

  12. Non-Medical Prescription Drug Use among University Students

    ERIC Educational Resources Information Center

    Vidourek, Rebecca A.; King, Keith A.; Knopf, Ellen E.

    2010-01-01

    Background: Non-medical prescription drug use is an increasing problem among university students. Purpose: The present study investigated university students' involvement in non-medical prescription drug (NMPD) use and associations between use and other risky behaviors. Methods: A sample of 363 university students completed a four page survey…

  13. Nonmedical Prescription Drug Use among Midwestern Rural Adolescents

    ERIC Educational Resources Information Center

    Park, Nicholas K.; Melander, Lisa; Sanchez, Shanell

    2016-01-01

    Prescription drug misuse has been an increasing problem in the United States, yet few studies have examined the protective factors that reduce risk of prescription drug abuse among rural adolescents. Using social control theory as a theoretical framework, we test whether parent, school, and community attachment reduce the likelihood of lifetime…

  14. 77 FR 46653 - Branded Prescription Drug Fee; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee; Hearing AGENCY... proposed regulations relating to the branded prescription drug fee imposed by the Affordable Care...

  15. 77 FR 48111 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee; Correction AGENCY... prescription drug fee imposed by the Affordable Care Act. FOR FURTHER INFORMATION CONTACT: Concerning...

  16. Controversy in Purchasing Prescription Drugs Online in China.

    PubMed

    Yuan, Peng; Qi, Lin; Wang, Long

    2016-08-01

    China's government is considering legalization of online prescription drugs to increase the pharmaceutical market and enhance access to necessary medicines. However, challenges such as a shortage of licensed pharmacists and drug quality issues have raised concerns and delayed consensus on the proposal. China's government must address the most pressing issues so it can render a decision on online prescription sales.

  17. Future Challenges and Opportunities in Online Prescription Drug Promotion Research

    PubMed Central

    Southwell, Brian G.; Rupert, Douglas J.

    2016-01-01

    Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. PMID:26927597

  18. Influences of motivational contexts on prescription drug misuse and related drug problems.

    PubMed

    Kelly, Brian C; Rendina, H Jonathon; Vuolo, Mike; Wells, Brooke E; Parsons, Jeffrey T

    2015-01-01

    Prescription drug misuse has emerged as a significant problem among young adults. While the effects of motivational contexts have been demonstrated for illicit drugs, the role of motivational contexts in prescription drug misuse remains understudied. Using data from 400 young adults recruited via time-space sampling, we examined the role of motivational contexts in the frequency of misuse of three prescription drug types as well as drug-related problems and symptoms of dependency. Both negative and positive motivations to use drugs are associated with increases in prescription drug misuse frequency. Only negative motivations are associated directly with drug problems and drug dependence, as well as indirectly via prescription pain killer misuse. Addressing positive and negative motivational contexts of prescription drug misuse may not only provide a means to reduce misuse and implement harm reduction measures, but may also inform the content of treatment plans for young adults with prescription drug misuse problems.

  19. Prescription drugs: issues of cost, coverage, and quality.

    PubMed

    Copeland, C

    1999-04-01

    This Issue Brief closely examines expenditures on prescription drugs, and discusses their potential to substitute for other types of health care services. In addition, it describes employer coverage of prescription drugs, direct-to-consumer advertising of prescription drugs, and potential legislation affecting the prescription drug market. Prescription drug expenditures grew at double-digit rates during almost every year since 1980, accelerating to 14.1 percent in 1997. In contrast, total national health expenditures, hospital service expenditures, and physician service expenditures growth rates decreased from approximately 13 percent in 1980 to less than 5 percent in 1997. Private insurance payments for prescription drugs increased 17.7 percent in 1997, after growing 22.1 percent in 1995 and 18.3 percent in 1996. This growth in prescription drug payments compares with 4 percent or less overall annual growth in private insurance payments for each of those three years. From 1993 to 1997, the overwhelming majority of the increases in expenditures on prescription drugs were attributable to increased volume, mix, and availability of pharmaceutical products. In 1997, these factors accounted for more than 80 percent of the growth in prescription drug expenditures. A leading explanation for the sharp growth in drug expenditures is that prescription drugs are a substitute for other forms of health care. While it is difficult to determine the extent to which this substitution occurs, various studies have associated cost savings with the use of pharmaceutical products in treating specific diseases. Evidence suggests that more appropriate utilization of prescription drugs has the potential to lower total expenditures and improve the quality of care. Also, some studies indicate the U.S. health care system needs to improve the way patients use and physicians prescribe current medications. Prescription drug plans offered by employers are likely to undergo changes to ensure that

  20. The “Black Box” of Prescription Drug Diversion

    PubMed Central

    Inciardi, James A.; Surratt, Hilary L.; Cicero, Theodore J.; Kurtz, Steven P.; Martin, Steven S.; Parrino, Mark W.

    2009-01-01

    A variety of surveys and studies are examined in an effort to better understand the scope of prescription drug diversion and to determine if there are consistent patterns of diversion among various populations of prescription drug abusers. Data are drawn from the RADARS® System, the National Survey of Drug Use and Health (NSDUH), the Delaware School Survey, and a series of quantitative and qualitative studies conducted in Miami, Florida. The data suggest that the major sources of diversion include drug dealers, friends and relatives, smugglers, pain patients, and the elderly, but these vary by the population being targeted. In all of the studies examined, the use of the Internet as a source for prescription drugs is insignificant. Little is known about where drug dealers are obtaining their supplies, and as such, prescription drug diversion is a “black box” requiring concentrated systematic study. PMID:20155603

  1. Direct-to-consumer advertising of prescription drugs.

    PubMed

    Frosch, Dominick L; Grande, David

    2010-01-01

    In 2007, the pharmaceutical industry spent more than $4.9 billion on direct-to-consumer advertising (DTCA) of prescription drugs in the U.S. Controversy over DTCA has grown since the Food and Drug Administration liberalized its regulations in 1997. Proponents claim that such advertising educates consumers, promotes patient participation in clinical decisions, and improves patient adherence to medication instructions. Opponents argue that such advertising is meant to persuade, not educate, and that it promotes inappropriate use of prescription drugs, or diverts consumers from better alternatives. This Issue Brief summarizes the evidence about the effects of DTCA, and proposes guidelines for improving the utility of prescription drug advertising.

  2. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs for human use. 201.100 Section 201.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... for human use. A drug subject to the requirements of section 503(b)(1) of the act shall be exempt...

  3. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Prescription drugs for human use. 201.100 Section 201.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... for human use. A drug subject to the requirements of section 503(b)(1) of the act shall be exempt...

  4. Identification and management of prescription drug abuse in pregnancy.

    PubMed

    Worley, Julie

    2014-01-01

    Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing.

  5. 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.

  6. Recognizing Signs of Prescription Drug Abuse and Addiction, Part I.

    PubMed

    Felicilda-Reynaldo, Faye D

    2014-01-01

    Prescription drug abuse/misuse is increasing. Nonmedical use of prescription medications, especially opioid analgesics, now is considered an epidemic in the United States. Medical-surgical nurses are in a strategic position to help address substance abuse problems in patients.

  7. Patterns of prescription medication diversion among drug dealers

    PubMed Central

    Rigg, Khary K.; Kurtz, Steven P.; Surratt, Hilary L.

    2012-01-01

    This research examined the following questions: (1) how do drug dealers acquire their inventories of prescription medications? and (2) which types of prescription medications do dealers most commonly sell? Data are drawn from a National Institute on Drug Abuse-funded research study that examined prescription drug diversion and abuse in South Florida. In-depth semi-structured interviews (n = 50) were conducted with an ethnically diverse sample of prescription drug dealers from a variety of milieus to assess patterns of diversion. Audiotapes of the interviews were transcribed, coded, and thematically analysed using the NVivo 8 software program. Dealers relied on a wide array of diversion methods including visiting multiple pain clinics, working with pharmacy employees to steal medications from pharmacies, and purchasing medications from indigent patients. The type of medication most commonly sold by dealers was prescription opioid analgesics, and to a lesser extent benzodiazepines such as alprazolam. These findings inform public health policy makers, criminal justice officials, the pharmaceutical industry and government regulatory agencies in their efforts to reduce the availability of diverted prescription drugs in the illicit market. Specifically, these data support the need for statewide prescription drug monitoring programs and increased training for healthcare workers who have access to controlled medications. PMID:22665955

  8. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Prescription drugs for human use. 201.100 Section 201.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... without naming their components. (ii) Color additives may be designated as coloring without...

  9. 76 FR 56201 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed...

  10. Medicare program; Medicare Advantage and prescription drug benefit programs: negotiated pricing and remaining revisions; prescription drug benefit program: payments to sponsors of retiree prescription drug plans. Final rule.

    PubMed

    2012-01-12

    This final rule implements and finalizes provisions regarding the reporting of gross covered retiree plan-related prescription drug costs (gross retiree costs) and retained rebates by Retiree Drug Subsidy (RDS) sponsors; and the scope of our waiver authority under the Social Security Act (the Act).

  11. Combinations of Prescription Drug Misuse and Illicit Drugs among Young Adults

    PubMed Central

    Kelly, Brian C.; Wells, Brooke E.; Pawson, Mark; LeClair, Amy; Parsons, Jeffrey T.

    2014-01-01

    Background Prescription drug misuse remains a critical drug trend. Data indicate that young adults in nightlife scenes misuse prescription drugs at high rates. As such, continued surveillance of the patterns of prescription drug misuse among young adults is necessary, particularly assessments that spotlight specific areas of risk, such as polydrug use. Methods Prevalence and correlates of recent combinations of prescription drugs and other substances among urban young adults recruited at nightlife venues using time-space sampling are assessed via prevalence estimates and logistic regression analyses. Results Overall, 16.4% of the sample reported combining illicit drug use with prescription drug misuse. Of those who reported any prescription drug misuse, 65.9% used prescription drugs in combination with at least one of the illicit drugs assessed. The most common combination was marijuana, followed by alcohol, cocaine, ecstasy, and psychedelics. Being male and identifying as gay, lesbian, or bisexual predicted the combination of prescription drugs with ecstasy, cocaine, and psychedelics. Conclusions Rates of combining alcohol and illicit drug use with prescription drug misuse were high, especially among men and those identified as a sexual minority. These rates are alarming in light of the host of negative health outcomes associated with combining prescription and illicit drugs. PMID:24462348

  12. Pregnant? Drugs and Alcohol Can Hurt Your Unborn Baby.

    ERIC Educational Resources Information Center

    Department of Agriculture, Washington, DC.

    This brochure, directed towards pregnant women, describes the dangers of alcohol, street drugs, smoking, and prescription drugs or over-the-counter medicines. It presents a story (in the mother's words) of a woman who took drugs to get high while pregnant and the ill effects on her son. The brochure claims being drug free means being a better…

  13. The attitudes of consumers toward direct advertising of prescription drugs.

    PubMed

    Morris, L A; Brinberg, D; Klimberg, R; Rivera, C; Millstein, L G

    1986-01-01

    Attitudes about prescription drug advertising directed to consumers were assessed in 1,509 persons who had viewed prototypical advertisements for fictitious prescription drug products. Although many subjects were generally favorable toward the concept of drug advertising directed to consumers, strong reservations were also expressed, especially about television advertising. Prescription drug advertising did not appear to undermine the physician's authority, since respondents viewed the physician as the primary drug decision-maker. However, the physician was not perceived as the sole source of prescription drug information. Television advertising appeared to promote greater information-seeking about particular drugs; however, magazine ads were more fully accepted by subjects. Furthermore, magazine ads led to enhanced views of the patient's authority in drug decision-making. The greater information conveyed in magazine ads may have given subjects more confidence in their own ability to evaluate the drug and the ad. Ads that integrated risk information into the body of the advertisement were more positively viewed than ads that gave special emphasis to the risk information. The results suggest that consumer attitudes about prescription drug advertising are not firmly held and are capable of being influenced by the types of ads people view. Regulation of such ads may need to be flexed to adapt to the way different media are used and processed by consumers.

  14. 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

  15. 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.

  16. Prescription drug monitoring programs in the United States of America

    PubMed Central

    Félix, Sausan El Burai; Mack, Karin

    2015-01-01

    SYNOPSIS Since the late 1990s, the number of opioid analgesic overdose deaths has quadrupled in the United States of America (from 4 030 deaths in 1999 to 16 651 in 2010). The objectives of this article are to provide an overview of the problem of prescription drug overdose in the United States and to discuss actions that could help reduce the problem, with particular attention to the characteristics of prescription drug monitoring programs (PDMPs). These programs consist of state-level databases that monitor controlled substances. The information compiled in the databases is at the disposal of authorized persons (e.g., physicians, pharmacists, and other health-care providers) and may be used only for professional purposes. Suppliers can use such information to prevent interaction with other drugs or therapeutic duplication, or to identify drug-search behavior. Law enforcement agencies can use these programs to identify improper drug prescription or dispensing patterns, or drug diversion. PMID:25563153

  17. Prescription Drug Misuse among Young Adults: Looking Across Youth Cultures

    PubMed Central

    Kelly, Brian C; Wells, Brooke E; LeClair, Amy; Tracy, Daniel; Parsons, Jeffrey T; Golub, Sarit A

    2012-01-01

    Aims Youth cultures play a key role in the social organisation of drug trends among young people; the current prescription drug misuse trend is no different. The authors evaluated whether patterns of prescription drug misuse differed across several youth cultures. Methods Using field survey methods and time-space sampling during 2011, the authors assessed the patterns and prevalence of prescription drug misuse among young adults who are socially active in various urban youth cultures (n = 1781). Findings The prevalence of lifetime prescription drug misuse is highest within indie rock scenes (52.5%), electronic dance music scenes (52.1%), lesbian parties (53.8%) and alt scenes (50.9%). Prescription drug misuse was lowest among young adults in hip-hop scenes (25.0%). These findings were upheld in logistic regression analyses that accounted for demographic differences across youth cultures: indie rock scenes (adjusted odds ratio = 2.11), electronic dance music scenes (adjusted odds ratio = 2.20), lesbian parties (adjusted odds ratio = 2.30) and alt scenes (adjusted odds ratio = 2.65) all reported statistically significant (P < 0.05) higher odds of misuse than college bar scenes. Recent prescription drug misuse mirrored patterns for lifetime misuse. Conclusions: The differing prevalence of prescription drug misuse across distinct youth cultures suggests that the trend has not diffused equally among young people. The differing prevalence across youth cultures indicates that the most efficacious strategies for youth intervention may be targeted approaches that account for the subculturally rooted differences in attitudes and social norms. PMID:23190213

  18. Drug prescription appropriateness in the elderly: an Italian study

    PubMed Central

    Allegri, Nicola; Rossi, Federica; Del Signore, Federica; Bertazzoni, Paolo; Bellazzi, Roberto; Sandrini, Giorgio; Vecchi, Tomaso; Liccione, Davide; Pascale, Alessia; Govoni, Stefano

    2017-01-01

    Purpose Correct drug prescription in the elderly is a difficult task that requires careful survey of the current pharmacological therapies. In this article, we reviewed the drug prescriptions provided to 860 persons aged 65 years or over, residing in a small city of Lombardy, Italy. Methods Subjects were recruited from a local nursing home, the Pavia and Vigevano Neuropsychological Center for Alzheimer’s Disease, general practitioners’ offices, and the local University of the Third Age. For each patient, the amount of potentially inappropriate prescriptions (PIPs), sedative and anticholinergic load (SL and AL, respectively), and drug–drug interactions were evaluated. Results Widespread polypharmacy, giving rise to 10.06% of PIPs in the whole collection of prescriptions, was observed. In particular, PIPs mainly concern drugs acting at the central nervous system level, mostly benzodiazepines and antipsychotics. Moreover, approximately one-fourth of the subjects had an elevated SL and approximately one-tenth a high AL. Drug–drug interactions were frequent (266 requiring medical attention), up to five for each single patient. Of concern was the underuse of antidementia drugs: only 20 patients received a cholinesterase inhibitor or memantine, although 183 patients were potentially suitable for this treatment. Conclusion These results demonstrate the need to develop novel strategies aimed at improving the quality of drug prescription. PMID:28228653

  19. Prescription drug abuse among prisoners in rural Southwestern Virginia.

    PubMed

    Wunsch, Martha J; Nakamoto, Kent; Goswami, Anil; Schnoll, Sidney H

    2007-01-01

    Non-medical use of prescription medications is on the rise across the U.S., particularly in rural areas. In this study of 233 prisoners and probationers in southwestern Virginia, we add to an emerging profile of individuals abusing prescription medications. In this retrospective review of 2000-2004 augmented Addiction Severity Index data, those abusing prescription medications reported increased illicit drug and alcohol abuse, poly-drug abuse, psychiatric problems, and arrests for property crimes. Forty percent reported abuse of OxyContin, a drug implicated in a number of deaths in this region. Compared to non-users, OxyContin users were younger, more likely to be female, and more likely to abuse benzodiazepines, methadone, cocaine, and heroin. Longevity of abuse of these other drugs belies suggestions that OxyContin was acting as a "gateway" drug leading naïve users into addiction and risk of death.

  20. 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.

  1. Prevalence of the Prescription of Potentially Interacting Drugs

    PubMed Central

    Tragni, Elena; Casula, Manuela; Pieri, Vasco; Favato, Giampiero; Marcobelli, Alberico; Trotta, Maria Giovanna; Catapano, Alberico Luigi

    2013-01-01

    The use of multiple medications is becoming more common, with a correspondingly increased risk of untoward effects and drug-related morbidity and mortality. We aimed at estimating the prevalence of prescription of relevant potentially interacting drugs and at evaluating possible predictors of potentially interacting drug exposure. We retrospectively analyzed data on prescriptions dispensed from January 2004 to August 2005 to individuals of two Italian regions with a population of almost 2.1 million individuals. We identified 27 pairs of potentially interacting drugs by examining clinical relevance, documentation, and volume of use in Italy. Subjects who received at least one prescription of both drugs were selected. Co-prescribing denotes “two prescriptions in the same day”, and concomitant medication “the prescription of two drugs with overlapping coverage”. A logistic regression analysis was conducted to examine the predictors of potential Drug-Drug Interaction (pDDIs). 957,553 subjects (45.3% of study population) were exposed to at least one of the drugs/classes of the 27 pairs. Overall, pDDIs occurred 2,465,819 times. The highest rates of concomitant prescription and of co-prescription were for ACE inhibitors+NSAIDs (6,253 and 4,621/100,000 plan participants). Considering concomitance, the male/female ratio was <1 in 17/27 pairs (from 0.31 for NSAIDs-ASA+SSRI to 0.74 for omeprazole+clopidogrel). The mean age was lowest for methotrexate pairs (+omeprazole, 59.9 years; +NSAIDs-ASA, 59.1 years) and highest for digoxin+verapamil (75.4 years). In 13/27 pairs, the mean ages were ≥70 years. On average, subjects involved in pDDIs received ≥10 drugs. The odds of exposure were more frequently higher for age ≥65 years, males, and those taking a large number of drugs. A substantial number of clinically important pDDIs were observed, particularly among warfarin users. Awareness of the most prevalent pDDIs could help practitioners in preventing concomitant use

  2. Prescription of fixed dose combination drugs for diarrhoea.

    PubMed

    Chakrabarti, Amit

    2007-01-01

    Fixed-dose combinations (FDCs) of an antiprotozoal and an antibacterial, for treatment of diarrhoea, have been available in the Indian pharmaceutical market for about a decade. There is little evidence to substantiate this combination therapy. We evaluated 2,163 physician prescriptions for diarrhoea and found that 59 per cent of prescriptions were for FDCs. This is unethical because prescribing such combinations exposes a patient to higher risks of adverse drug reactions and also increases the chances of drug resistance. Physicians' prescribing practices in India are influenced by socioeconomic factors and the pharmaceutical industry's marketing techniques that include giving incentives to physicians to prescribe certain drugs.

  3. 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

  4. Americans' access to prescription drugs stabilizes, 2007-2010.

    PubMed

    Boukus, Ellyn R; Carrier, Emily R

    2011-12-01

    Despite the weak economy and more people lacking health insurance, the proportion of Americans reporting problems affording prescription drugs remained level between 2007 and 2010, with more than one in eight going without a prescribed drug in 2010, according to a new national study from the Center for Studying Health System Change (HSC). While remaining stable overall, access to prescription drugs improved for working-age, uninsured people, likely reflecting a decline in visits to health care providers, as well as changes in the composition of the uninsured population. Likewise, elderly people eligible for both Medicare and Medicaid saw a sharp drop in prescription drug access problems. The most vulnerable people--the uninsured, those with low incomes, people in fair or poor health, and those with multiple chronic conditions--continued to face the most unmet prescription needs. For example, 48 percent of uninsured people in fair or poor health went without a prescription drug because of cost concerns in 2010, almost double the rate of insured people with the same reported health status.

  5. The economics of prescription drug prices, government intervention, and the importation of drugs from Canada.

    PubMed

    Openshaw, Matthew S

    2005-01-01

    Popular attention has focused on the skyrocketing health care costs in the United States and specifically on increasing insurance and prescription drug prices. Individuals and some local governments have advocated importing price-controlled prescription drugs from Canada to help ease the financial burden. What effects would this have on consumer prices, drug companies' incentives, and the development of new medications?

  6. 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

  7. 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…

  8. 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…

  9. 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…

  10. 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…

  11. 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.…

  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…

  13. How Can Prescription Drug Addiction Be Treated?

    MedlinePlus

    ... Naloxone Pain Prevention Treatment Trends & Statistics Women and Drugs Publications Funding Funding Opportunities Clinical Research Post-Award Concerns General Information Grant & Contract Application ...

  14. How Can Prescription Drug Misuse Be Prevented?

    MedlinePlus

    ... Naloxone Pain Prevention Treatment Trends & Statistics Women and Drugs Publications Funding Funding Opportunities Clinical Research Post-Award Concerns General Information Grant & Contract Application ...

  15. Body pushing, prescription drugs and hospital admission.

    PubMed

    Byard, Roger W; Kenneally, Michaela

    2017-03-15

    A 39-year-old man died of multi-organ failure complicating mixed drug toxicity that included methadone, oxazepam, oxycodone and nitrazepam. His past medical history involved alcohol and poly-substance abuse with chronic self-harm and suicidal ideation. There had been multiple hospital admissions for drug overdoses. At autopsy the most unusual finding was of two packages of 10 tablets each, wrapped in thin plastic film within the rectum. The insertion of drugs into body orifices and cavities has been termed body pushing to distinguish it from body packing where illicit drugs are wrapped and swallowed for transport and smuggling, and body stuffing where small amounts of loosely wrapped or unwrapped drugs are swallowed to conceal evidence from police. This case demonstrates that body pushing may not always involve illicit drugs or attempted concealment from police or customs officials. It appears that the drugs had been hidden to ensure an additional supply during the time of residence in hospital. The extent to which body pushing is currently being used by patients to smuggle drugs into secure medical facilities is yet to be determined.

  16. A New Prescription for Fighting Drug Abuse

    ERIC Educational Resources Information Center

    Schachter, Ron

    2012-01-01

    It's a drug prevention conversation--and program--that was largely missing as recently as a decade ago in most middle and high schools. In those days, the principal concern of health educators and disciplinarians alike was to keep students from misusing alcohol and illegal street drugs such as ecstasy, cocaine and even heroine. But driven by the…

  17. Rural Adolescents' Nonmedical Prescription Drug Use: Implications for Intervention

    ERIC Educational Resources Information Center

    Young, April M.; Glover, Natalie; Havens, Jennifer R.

    2012-01-01

    Rural communities often have distinct contextual factors that impact residents' substance abuse behavior. However, most studies to date have focused either exclusively on urban populations or neglected to analyze data in a way that allows any rural/urban comparison. This is especially true for research examining nonmedical prescription drug use…

  18. A Political History of Medicare and Prescription Drug Coverage

    PubMed Central

    Oliver, Thomas R; Lee, Philip R; Lipton, Helene L

    2004-01-01

    This article examines the history of efforts to add prescription drug coverage to the Medicare program. It identifies several important patterns in policymaking over four decades. First, prescription drug coverage has usually been tied to the fate of broader proposals for Medicare reform. Second, action has been hampered by divided government, federal budget deficits, and ideological conflict between those seeking to expand the traditional Medicare program and those preferring a greater role for private health care companies. Third, the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 reflect earlier missed opportunities. Policymakers concluded from past episodes that participation in the new program should be voluntary, with Medicare beneficiaries and taxpayers sharing the costs. They ignored lessons from past episodes, however, about the need to match expanded benefits with adequate mechanisms for cost containment. Based on several new circumstances in 2003, the article demonstrates why there was a historic opportunity to add a Medicare prescription drug benefit and identify challenges to implementing an effective policy. PMID:15225331

  19. Justice Implications of a Proposed Medicare Prescription Drug Policy

    ERIC Educational Resources Information Center

    Larkin, Heather

    2004-01-01

    Social justice is a core value to the mission of social work. Older people are among the most vulnerable populations for whom social workers are called on to advocate. Although Medicare prescription drug coverage has been a top legislative issue over the past few years, such a benefit expansion has yet to be implemented. This article examines the…

  20. [Adverse drug reactions reporting is helping "non substituable" prescription!].

    PubMed

    Jacquot, Julien; Bagheri, Haleh; Montastruc, Jean-Louis

    2014-01-01

    In August 2012, general practitioners of Haute- Garonne received a letter from Health insurance system, informing that prescriptions could be endorsed by "not substituable" after reporting an adverse drug reactions (ADR). Compared to an equivalent period before this letter, we observed an increase of ADRs reports for generics, mainly concerning gastrointestinal ADR and lack of efficacy.

  1. An integrated drug prescription and distribution system: challenges and opportunities.

    PubMed

    Lanssiers, R; Everaert, E; De Win, M; Van De Velde, R; De Clercq, H

    2002-01-01

    Using the hospital's drug prescription and distribution system as a guide, benefits and drawbacks of a medical activity management system that is tightly integrated with the supply chain management of a hospital will be discussed from the point of view of various participating healthcare actors.

  2. [The evolution of principal drugs in prescription compatibility].

    PubMed

    Yuan, Bing; Shi, Dong-ping

    2009-01-01

    The principal drugs of principal, adjuvant, auxiliary and conductant compatiblity in prescriptions recorded in the ancient literatures had different meaning and quantities. According to the current literatures, Zhuangzi Xu Wugui took the one can cure diseases as the principal drug; The principal, adjuvant, auxiliary and conductant drugs in Shennong Bencao Jing (Shennong's Classic of Materia Medica) can be used to differentiate the good and bad of drugs; Yaoxing Lun (Treatise on medicinal property) of Zheng quan (Tang dynasty) stipulated some drugs as principal drugs; Zazhu Bencao of Jiang Xiaowan (Tang dynasty) took the one can cure yin diseases as the principal drugs; Yixue Qiyuan (the origination of medicine) of Zhang Yuansu (Jin dynasty) took the one of maximum dosage as principal drugs; Piwei Lun (Treatise on Spleen and Stomach) of LI gao (Jin dynasty) took the powerful one as the principal drug; The principal drugs in Yi Lun (medicine treatise) of Wang Kentang (Ming dynasty) changed according to different ages. The quantities of principal drugs can had two and three ingredients even took one prescription as principal drug instead of one ingredient.

  3. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... drug coverage. A Part D plan is always the primary payer relative to a State Pharmaceutical Assistance... prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription Drug Coverage §...

  4. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... drug coverage. A Part D plan is always the primary payer relative to a State Pharmaceutical Assistance... prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription Drug Coverage §...

  5. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... drug coverage. A Part D plan is always the primary payer relative to a State Pharmaceutical Assistance... prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription Drug Coverage §...

  6. 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

  7. Health Outcomes in Patients Using No-Prescription Online Pharmacies to Purchase Prescription Drugs

    PubMed Central

    2012-01-01

    Background Many prescription drugs are freely available for purchase on the Internet without a legitimate prescription from a physician. Objective This study focused on the motivations for using no-prescription online pharmacies (NPOPs) to purchase prescription drugs rather than using the traditional doctor-patient-pharmacy model. We also studied whether users of NPOP-purchased drugs had poorer health outcomes than those who obtain the same drug through legitimate health care channels. Methods We selected tramadol as a representative drug to address our objective because it is widely prescribed as an unscheduled opioid analgesic and can easily be purchased from NPOPs. Using search engine marketing (SEM), we placed advertisements on search result pages stemming from the keyword “tramadol” and related terms and phrases. Participants, who either used the traditional doctor-patient-pharmacy model to obtain tramadol (traditional users, n=349) or purchased it on the Web without a prescription from their local doctor (ie, nontraditional users, n=96), were then asked to complete an online survey. Results Respondents in both groups were primarily white, female, and in their mid-forties (nontraditional users) to upper forties (traditional users). Nearly all nontraditional users indicated that their tramadol use was motivated by a need to treat pain (95%, 91/96) that they perceived was not managed appropriately through legitimate health care channels. A majority of nontraditional users (55%, 41/75) indicated they used NPOPs because they did not have access to sufficient doses of tramadol to relieve pain. In addition, 29% (22/75) of nontraditional users indicated that the NPOPs were a far cheaper alternative than seeing a physician, paying for an office visit, and filling a prescription at a local pharmacy, which is often at noninsured rates for those who lack medical insurance (37%, 35/96, of NPOP users). The remainder of participants (16%, 12/96) cited other motivations

  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. State prescription drug price Web sites: how useful to consumers?

    PubMed

    Tu, Ha T; Corey, Catherine G

    2008-02-01

    To aid consumers in comparing prescription drug costs, many states have launched Web sites to publish drug prices offered by local retail pharmacies. The current push to make retail pharmacy prices accessible to consumers is part of a much broader movement to increase price transparency throughout the health-care sector. Efforts to encourage price-based shopping for hospital and physician services have encountered widespread concerns, both on grounds that prices for complex services are difficult to measure and compare accurately and that quality varies substantially across providers. Experts agree, however, that prescription drugs are much easier to shop for than other, more complex health services. However, extensive gaps in available price information--the result of relying on Medicaid data--seriously hamper the effectiveness of state drug price-comparison Web sites, according to a new study by the Center for Studying Health System Change (HSC). An alternative approach--requiring pharmacies to submit price lists to the states--would improve the usefulness of price information, but pharmacies typically oppose such a mandate. Another limitation of most state Web sites is that price information is restricted to local pharmacies, when online pharmacies, both U.S. and foreign, often sell prescription drugs at substantially lower prices. To further enhance consumer shopping tools, states might consider expanding the types of information provided, including online pharmacy comparison tools, lists of deeply discounted generic drugs offered by discount retailers, and lists of local pharmacies offering price matches.

  10. 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

  11. Searching for answers: proper prescribing of controlled prescription drugs.

    PubMed

    Brown, Martha E; Swiggart, William H; Dewey, Charlene M; Ghulyan, Marine V

    2012-01-01

    Prescription drug abuse is increasing at alarming rates in this country. Most often drugs are obtained through relatives or friends. An important step in addressing this problem is educating healthcare providers in the proper prescribing of scheduled drugs. Physicians and other healthcare workers receive little training in proper screening for substance abuse, proper prescribing of scheduled drugs, and referral for those needing treatment. Continuing medical education is one venue for addressing this problem. However, screening, brief intervention and referral for treatment (SBIRT) should be taught in medical school and residency.

  12. 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

  13. 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.

  14. How Medicare Prescription Drug Coverage Works with a Medicare Advantage Plan or Medicare Cost Plan

    MedlinePlus

    ... Medicare Prescription Drug Coverage Works with a Medicare Advantage Plan or Medicare Cost Plan Medicare offers prescription ... elect the drug coverage. 2. Join a Medicare Advantage Plan— like a Health Maintenance Organization (HMO), Preferred ...

  15. 77 FR 16973 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in... determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements... and Benefit Information in Direct-to-Consumer Prescription Drug Television...

  16. 76 FR 68295 - Reducing Prescription Drug Shortages

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to... with adequate notice of potential shortages. As part of my Administration's broader effort to work with... of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of...

  17. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... human use. 250.100 Section 250.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS New Drug or Prescription Status of Specific Drugs § 250.100 Amyl nitrite inhalant as a prescription drug for human use....

  18. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... human use. 250.100 Section 250.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS New Drug or Prescription Status of Specific Drugs § 250.100 Amyl nitrite inhalant as a prescription drug for human use....

  19. Medicare prescription drug coverage: Consumer information and preferences

    PubMed Central

    Winter, Joachim; Balza, Rowilma; Caro, Frank; Heiss, Florian; Jun, Byung-hill; Matzkin, Rosa; McFadden, Daniel

    2006-01-01

    We investigate prescription drug use, and information and enrollment intentions for the new Medicare Part D drug insurance program, using a sample of Medicare-eligible subjects surveyed before open enrollment began for this program. We find that, despite the complexity of competing plans offered by private insurers under Part D, a majority of the Medicare population had information on this program and a substantial majority planned to enroll. We find that virtually all elderly, even those with no current prescription drug use, can expect to benefit from enrollment in a Part D Standard plan at the low premiums available in the current market. However, there is a significant risk that many eligible seniors, particularly low-income elderly with poor health or cognitive impairment, will make poor enrollment and plan choices. PMID:16682629

  20. Potential of prescription registries to capture individual-level use of aspirin and other nonsteroidal anti-inflammatory drugs in Denmark: trends in utilization 1999–2012

    PubMed Central

    Schmidt, Morten; Hallas, Jesper; Friis, Søren

    2014-01-01

    Background Due to over-the-counter availability, no consensus exists on whether adequate information on nonsteroidal anti-inflammatory drug (NSAID) use can be obtained from prescription registries. Objectives To examine utilization of aspirin and nonaspirin NSAIDs in Denmark between 1999 and 2012 and to quantify the proportion of total sales that was sold on prescription. Method Based on nationwide data from the Danish Serum Institute and the Danish National Prescription Registry, we retrieved sales statistics for the Danish primary health care sector to calculate 1-year prevalences of prescription users of aspirin or nonaspirin NSAIDs, and to estimate the corresponding proportions of total sales dispensed on prescription. Results Both low-dose aspirin and nonaspirin NSAIDs were commonly used in the Danish population between 1999 and 2012, particularly among elderly individuals. The 1-year prevalence of prescribed low-dose aspirin increased throughout the study period, notably among men. Nonaspirin NSAID use was frequent in all age groups above 15 years and showed a female preponderance. Overall, the prevalence of prescribed nonaspirin NSAIDs decreased moderately after 2004, but substantial variation according to NSAID subtype was observed; ibuprofen use increased, use of all newer selective cyclooxygenase-2 inhibitors nearly ceased after 2004, diclofenac use decreased by nearly 50% after 2008, and naproxen use remained stable. As of 2012, the prescribed proportion of individual-level NSAID sales was 92% for low-dose aspirin, 66% for ibuprofen, and 100% for all other NSAIDs. Conclusion The potential for identifying NSAID use from prescription registries in Denmark is high. Low-dose aspirin and nonaspirin NSAID use varied substantially between 1999 and 2012. Notably, use of cyclooxygenase-2 inhibitors nearly ceased, use of diclofenac decreased markedly, and naproxen use remained unaltered. PMID:24872722

  1. A Primer on Prescription Drug Abuse and the Role of the Pharmacy Director

    PubMed Central

    Harvin, Andre; Weber, Robert J.

    2015-01-01

    Prescription drug abuse, or using a prescription drug in a way not intended by the provider, has become such an issue in the United States that in 2013 the US Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) classified it as a new epidemic. The goal of this article is to provide pharmacy directors with a primer on prescription drug abuse and its prevention. This article will cover the causes and societal impact of prescription drug abuse, review recent and proposed strategies to prevent prescription drug abuse, and discuss efforts within the health system to reduce the risks of narcotic diversion that can lead to prescription drug abuse. There are several health and societal factors that have contributed to the rise in prescription drug abuse. As there is no singular contributory factor to this epidemic, there is no easy solution for proper containment and monitoring of prescription drug use. Pharmacy directors play a vital role in the safe use of prescription medications by providing for fail-safe systems for accounting and controlling prescription drugs. In addition, pharmacists can play a role in educating patients and health care workers on the dangers of prescription drug abuse. Health systems should form teams to identify drug diversion and provide an intervention that demands accountability while helping the impaired professional. Health system pharmacy directors must play an integral role in these efforts and continue to seek opportunities to reduce any risks for prescription drug abuse. PMID:26405329

  2. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription Drug Coverage § 423.464 Coordination...

  3. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination of Part D Plans With Other Prescription Drug Coverage § 423.464 Coordination...

  4. 76 FR 54599 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ... 42 CFR Parts 417, 422, and 423 Medicare Program; Medicare Advantage and Prescription Drug Benefit... Prescription Drug Benefit Programs AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final... (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost...

  5. 76 FR 63017 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes... Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to... (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations...

  6. On the demand for prescription drugs: heterogeneity in price responses.

    PubMed

    Skipper, Niels

    2013-07-01

    This paper estimates the price elasticity of demand for prescription drugs using an exogenous shift in consumer co-payment caused by a reform in the Danish subsidy scheme for the general public. Using purchasing records for the entire Danish population, I show that the average price response for the most commonly used drug yields demand elasticities in the range of -0.36 to -0.5. The reform is shown to affect women, the elderly, and immigrants the most. Furthermore, this paper shows significant heterogeneity in the price response over different types of antibiotics, suggesting that the price elasticity of demand varies considerably even across relatively similar drugs.

  7. 76 FR 45831 - Prescription Drug User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2012. The Federal Food, Drug,...

  8. Women and Drugs: The Heroin Abuser and the Prescription Drug Abuser.

    ERIC Educational Resources Information Center

    Gutierres, Sara E.; And Others

    1984-01-01

    Reviewed the literature on female drug use/abuse and derived descriptions of the female heroin abuser and the female prescription drug abuser. Researchers suggest that problems of female drug abusers should be viewed in terms of the feminine role as well as the role of drug abuser. (BH)

  9. Prescription drug misuse/abuse in the elderly.

    PubMed

    Culberson, John W; Ziska, Martin

    2008-09-01

    One quarter of the prescription drugs sold in the United States are used by the elderly, often for problems such as chronic pain, insomnia, and anxiety. The prevalence of abuse may be as high as 11 percent with female gender, social isolation, depression, and history of substance abuse increasing risk. Screening instruments for prescription drug abuse have not been validated in the geriatric population. Benzodiazepines, opiate analgesics, and some skeletal muscle relaxants may result in physical dependence; however, tolerance, withdrawal syndrome, and dose escalation may be less common in the older patient. Lower doses may decrease the risk of abuse and dependence; however, fear of abuse often results in a failure to adequately treat symptoms such as anxiety, pain, and insomnia.

  10. Direct-to-consumer advertising of prescription drugs.

    PubMed

    Williams, J R; Hensel, P J

    1995-01-01

    Starting consumers off on the "path to purchase" by encouraging them to seek more information is a major goal of direct-to-consumer (DTC) advertising for prescription medications. But the authors found that a consumer's attitude toward DTC advertising can determine which of several paths he or she is likely to take. The attitudes of older adults are especially significant for pharmaceutical marketers because these consumers are heavy users of the drugs being advertised.

  11. National drug control policy and prescription drug abuse: facts and fallacies.

    PubMed

    Manchikanti, Laxmaiah

    2007-05-01

    In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects

  12. 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

  13. 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.

  14. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs; reminder advertisements and... Prescription Drug Consumer Price Listing § 200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers. (a) Prescription drug reminder advertisements...

  15. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine...

  16. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine...

  17. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine...

  18. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine...

  19. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Amphetamine and methamphetamine inhalers regarded... DRUGS New Drug or Prescription Status of Specific Drugs § 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs. (a) Recurring reports of abuse and misuse of methamphetamine...

  20. 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.

  1. Prescription Drug Diversion: Predictors of Illicit Acquisition and Redistribution in Three U.S. Metropolitan Areas

    PubMed Central

    Harris, Shana; Nikulina, Valentina; Gelpí-Acosta, Camila; Morton, Cory; Newsome, Valerie; Gunn, Alana; Hoefinger, Heidi; Aikins, Ross; Smith, Vivian; Barry, Victoria; Downing, Martin J.

    2015-01-01

    Objective Prescription drug diversion, the transfer of prescription drugs from lawful to unlawful channels for distribution or use, is a problem in the United States. Despite the pervasiveness of diversion, there are gaps in the literature regarding characteristics of individuals who participate in the illicit trade of prescription drugs. This study examines a range of predictors (e.g., demographics, prescription insurance coverage, perceived risk associated with prescription drug diversion) of membership in three distinct diverter groups: individuals who illicitly acquire prescription drugs, those who redistribute them, and those who engage in both behaviors. Methods Data were drawn from a cross-sectional Internet study (N = 846) of prescription drug use and diversion patterns in New York City, South Florida, and Washington, D.C.. Participants were classified into diversion categories based on their self-reported involvement in the trade of prescription drugs. Group differences in background characteristics of diverter groups were assessed by Chi-Square tests and followed up with multivariate logistic regressions. Results While individuals in all diversion groups were more likely to be younger and have a licit prescription for any of the assessed drugs in the past year than those who did not divert, individuals who both acquire and redistribute are more likely to live in New York City, not have prescription insurance coverage, and perceive fewer legal risks of prescription drug diversion. Conclusion Findings suggest that predictive characteristics vary according to diverter group. PMID:26690813

  2. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution § 203.50 Requirements for wholesale distribution of prescription drugs. (a) Identifying statement for sales by... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Requirements for wholesale distribution...

  3. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution § 203.50 Requirements for wholesale distribution of prescription drugs. (a) Identifying statement for sales by... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Requirements for wholesale distribution...

  4. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution § 203.50 Requirements for wholesale distribution of prescription drugs. (a) Identifying statement for sales by... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Requirements for wholesale distribution...

  5. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution § 203.50 Requirements for wholesale distribution of prescription drugs. (a) Identifying statement for sales by... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Requirements for wholesale distribution...

  6. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution § 203.50 Requirements for wholesale distribution of prescription drugs. (a) Identifying statement for sales by... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Requirements for wholesale distribution...

  7. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  8. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  9. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  10. How Parents of Teens Store and Monitor Prescription Drugs in the Home

    ERIC Educational Resources Information Center

    Friese, Bettina; Moore, Roland S.; Grube, Joel W.; Jennings, Vanessa K.

    2013-01-01

    Qualitative interviews were conducted with parents of teens to explore how parents store and monitor prescription drugs in the home. Most parents had prescription drugs in the house, but took few precautions against teens accessing these drugs. Strategies for monitoring included moving the drugs to different locations, remembering how many pills…

  11. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... committees for human prescription drugs. 14.160 Section 14.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees...

  12. 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.

  13. The rise in prescription drug abuse: raising awareness in the dental community.

    PubMed

    Oakley, Marnie; O'Donnell, Jean; Moore, Paul A; Martin, James

    2011-01-01

    Prescription drugs classified as controlled dangerous substances are essential therapeutic modalities in treating a variety of healthcare conditions; however, their pleasurable side effects can appeal to patients for uses other than their intent. As a result, unfortunate consequences of prescription drug use can arise. Misuse or abuse of prescription drugs can contribute to addictive behaviors, serious health risks, and potentially, death. It is imperative that the dental community remains educated and informed of nationwide healthcare trends, and prescription drug abuse is no exception. Ethically, dentists should be able to respond in a manner that addresses the best interests of their patients. To respond appropriately, dentists need to understand the terminology of prescription drug abuse; be able to identify and describe the drugs most often misused or abused; be able to identify individuals who may be at risk for prescription drug abuse; and be prepared to manage patients at risk in the dental setting.

  14. 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

  15. Prevalence and Patterns of Prescription Drug Misuse among Young Ketamine Injectors

    PubMed Central

    Lankenau, Stephen E.; Sanders, Bill; Bloom, Jennifer Jackson; Hathazi, Dodi S.; Alarcon, Erica; Tortu, Stephanie; Clatts, Michael

    2008-01-01

    In recent years, epidemiological monitoring data has indicated sharp increases in prescription drug misuse. Despite these increases, little is known about the context or patterns associated with prescription drug misuse, particularly among youth or young injection drug users (IDUs). A three-city study of 213 young IDUs found prescription drug misuse to be pervasive, specifically the use of opioids and benzodiazepines. Particular practices not commonly associated with prescription drugs were reported, such as sniffing, smoking, and injection. Associated health risks included initiation into injection drug use, polydrug use, drug overdose, and drug dependency. A greater awareness of the potential health risks associated with prescription drug misuse should be incorporated into services that target IDUs, including street outreach, syringe exchanges, and drug treatment. PMID:18612374

  16. 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.

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

    PubMed Central

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

    2014-01-01

    Aims 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. Methods 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. Results 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. Conclusions 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. PMID:24102791

  18. New use of prescription drugs prior to a cancer diagnosis

    PubMed Central

    Hallas, Jesper

    2016-01-01

    Abstract Purpose Cancers often have considerable induction periods. This confers a risk of reverse causation bias in studies of cancer risk associated with drug use, as early symptoms of a yet undiagnosed cancer might lead to drug treatment in the period leading up to the diagnosis. This bias can be alleviated by disregarding exposure for some time before the cancer diagnosis (lag time). We aimed at assessing the duration of lag time needed to avoid reverse causation bias. Methods We identified all Danish patients with incident cancer between 2000 and 2012 (n = 353 087). Incident use of prescription drugs was assessed prior to their cancer diagnosis as well as among population controls (n = 1 402 400). Analyses were conducted for all cancers and for breast, lung, colon and prostate cancer individually. Further, analyses were performed for a composite measure of all incident drug use as well as for nine pre‐specified individual drug classes, representing drug treatment likely to be prescribed for symptoms of the given cancers. Results The incidence rate for new drug treatment among cancer cases was stable around 130 per 1000 persons per month until 6 months prior to cancer diagnosis where it increased gradually and peaked at 434 in the month immediately preceding the cancer diagnosis. Considerable variation was observed among cancers, for example, breast cancer showed almost no such effect. The pre‐selected drug classes showed a stronger increase prior to cancer diagnoses than drugs overall. Conclusions Incident use of drugs increases in the months prior to a cancer diagnosis. To avoid reverse causation, 6 months' lag time would be sufficient for most drug‐cancer associations. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd. PMID:27889931

  19. Drugs, Strip Searches, and Educator Liability: Implications of "Safford v. Redding"

    ERIC Educational Resources Information Center

    Stader, David L.; Greicar, Margo B.; Stevens, David W.; Dowdy, Ray

    2010-01-01

    School administrators are expected to balance the need for school safety and good order with the rights of students to be free of unreasonable search of their person and property. This balance can be particularly difficult when over-the-counter or prescription drugs are involved. This article summarizes a recent U.S. Supreme Court decision that…

  20. 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.

  1. 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.

  2. Nonmedical Prescription Drug Use among Adolescents: The Influence of Bonds to Family and School

    ERIC Educational Resources Information Center

    Ford, Jason A.

    2009-01-01

    There has been a tremendous increase in the prevalence of nonmedical prescription drug use among adolescents in recent years. Research now indicates that the prevalence of nonmedical prescription drug use is greater than the prevalence of other illicit drug use, excluding marijuana. Despite these recent trends, there is a dearth of research in the…

  3. 78 FR 53152 - Prescription Drug User Fee Rates for Fiscal Year 2014; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Rates for Fiscal Year 2014... Administration is correcting a notice entitled ``Prescription Drug User Fee Rates for Fiscal Year 2014'' that appeared in the Federal Register of August 2, 2013 (78 FR 46980). The document announced the Fiscal...

  4. 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

  5. “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

  6. 77 FR 1877 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ...; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing and Remaining Revisions..., governing what was renamed the Medicare Advantage (MA) program (formerly Medicare+Choice). The MMA...

  7. 38 CFR 1.483 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS GENERAL PROVISIONS Disclosures Without Patient Consent § 1.483 Disclosure of information to participate in state prescription drug monitoring...

  8. 38 CFR 1.483 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS GENERAL PROVISIONS Disclosures Without Patient Consent § 1.483 Disclosure of information to participate in state prescription drug monitoring...

  9. Mechanisms of Prescription Drug Diversion Among Drug-Involved Club- and Street-Based Populations

    PubMed Central

    Inciardi, James A.; Surratt, Hilary L.; Kurtz, Steven P.; Cicero, Theodore J.

    2010-01-01

    Objective Prescription drug diversion involves the unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace, and can occur along all points in the drug delivery process, from the original manufacturing site to the wholesale distributor, the physician's office, the retail pharmacy, or the patient. However, empirical data on diversion are limited. Method In an attempt to develop a better understanding of how specific drug-using populations are diverting prescription opioids and other medications, or obtaining controlled drugs that have already been diverted, qualitative interviews and focus group data were collected on four separate populations of prescription drug abusers in Miami, Florida—club drug users, street-based illicit drug users, methadone maintenance patients, and HIV positive individuals who abuse and/or divert drugs. Results Sources of abused prescription drugs cited by focus group participants were extremely diverse, including their physicians and pharmacists; parents and relatives; “doctor shopping”; leftover supplies following an illness or injury; personal visits to Mexico, South America and the Caribbean; prescriptions intended for the treatment of mental illness; direct sales on the street and in nightclubs; pharmacy and hospital theft; through friends or acquaintances; under-the-door apartment flyers advertising telephone numbers to call; and “stealing from grandma's medicine cabinet.” Conclusion While doctor shoppers, physicians and the Internet receive much of the attention regarding diversion, the data reported in this paper suggest that there are numerous active street markets involving patients, Medicaid recipients and pharmacies as well. In addition, there are other data which suggest that the contributions of residential burglaries, pharmacy robberies and thefts, and “sneak thefts” to the diversion problem may be understated. PMID:17305688

  10. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Exemption for certain drugs limited by new-drug applications to prescription sale. 310.201 Section 310.201 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted...

  11. 76 FR 35672 - Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... far higher UV radiation doses than a consumer would ever receive even under the most severe sun... provided. Docket: For access to the docket to read background documents or comments received, go to http..., into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management,...

  12. 49 CFR 219.103 - Prescribed and over-the-counter drugs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... informed of all medications authorized or prescribed and has determined that use of the medications is... imposed with respect to use of the medications in combination). (b) This subpart does not restrict...

  13. 76 FR 12916 - Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... hunger actually resulted in a ``clinically ] significant benefit of the type claimed'' (i.e., weight loss... daily) Group 4: Glucose hard candy containing benzocaine, caffeine, and vitamins (benzocaine group... Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives...

  14. An Exploration of Social Circles and Prescription Drug Abuse Through Twitter

    PubMed Central

    2013-01-01

    Background Prescription drug abuse has become a major public health problem. Relationships and social context are important contributing factors. Social media provides online channels for people to build relationships that may influence attitudes and behaviors. Objective To determine whether people who show signs of prescription drug abuse connect online with others who reinforce this behavior, and to observe the conversation and engagement of these networks with regard to prescription drug abuse. Methods Twitter statuses mentioning prescription drugs were collected from November 2011 to November 2012. From this set, 25 Twitter users were selected who discussed topics indicative of prescription drug abuse. Social circles of 100 people were discovered around each of these Twitter users; the tweets of the Twitter users in these networks were collected and analyzed according to prescription drug abuse discussion and interaction with other users about the topic. Results From November 2011 to November 2012, 3,389,771 mentions of prescription drug terms were observed. For the 25 social circles (n=100 for each circle), on average 53.96% (SD 24.3) of the Twitter users used prescription drug terms at least once in their posts, and 37.76% (SD 20.8) mentioned another Twitter user by name in a post with a prescription drug term. Strong correlation was found between the kinds of drugs mentioned by the index user and his or her network (mean r=0.73), and between the amount of interaction about prescription drugs and a level of abusiveness shown by the network (r=0.85, P<.001). Conclusions Twitter users who discuss prescription drug abuse online are surrounded by others who also discuss it—potentially reinforcing a negative behavior and social norm. PMID:24014109

  15. Exploring the Etiologic Factors and Dynamics of Prescription Drug Abuse in Southwest Virginia

    PubMed Central

    Redican, Kerry J; Marek, Lydia I; Brock, Donna JP; McCance-Katz, Elinore F

    2012-01-01

    Background: Prescription drug abuse in Southwest Virginia is a serious problem affecting indi-viduals, families, and communities. The aim of this study was to characterize and understand the extent of the prescription drug abuse problem in Southwest, Virginia as well as the dynamics that surround that abuse. More specifically, the study focused on learning the extent of the problem along with which prescription drugs are typically used prior to entering treatment, reasons for prescription drug and methadone abuse, and the sources for prescription drug use, misuse and abuse. Methods: Mixed methodology was employed which included surveying methadone clinic con-sumers at two treatment clinics in Southwest, Virginia and seven focus field interviews of key community stakeholders. Results: The extent of prescription drug abuse is high and that the demographics of prescription drug users are getting younger and now involve more males than females. Oxycodone, hydroco¬done, methadone, and morphine were the most commonly used drugs prior to enrollment in the clinics with over one-half of methadone-maintained consumers reporting that they had abused benzodiazepines along with opioids. Focus groups and clinic consumer data highlighted the key etiological factors in prescription drug abuse: use (due to workforce related injuries) turning to abuse, wanting to get high, overprescribing and physician issues, lack of information, and cultural acceptance of drug taking as problem solving behavior. The two most common sources for the abused prescription drugs were physicians and street dealers. Conclusions: A constellation of conditions have led to the epidemic of prescription drug abuse in Southwest Virginia, including poverty, unemployment and work-related injuries, besides, public health education programs on the dangers of prescription opiate misuse and abuse are urgently needed. PMID:24688929

  16. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Amyl nitrite inhalant as a prescription drug for human use. 250.100 Section 250.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS New Drug...

  17. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Fixed-combination prescription drugs for humans. 300.50 Section 300.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... drugs for humans. The Food and Drug Administration's policy in administering the new-drug,...

  18. Back to School: Keeping Our Children Safe, Healthy, and Drug-Free in the New School Season. Fact Sheet

    ERIC Educational Resources Information Center

    Office of National Drug Control Policy, 2010

    2010-01-01

    Results of the 2009 "Monitoring the Future" (MTF) study document the disturbing prevalence among teens of abuse of prescription and over-the-counter drugs. The data show, for example, that seven of the substances most commonly abused by high school seniors are pharmaceuticals. Many parents believe they are powerless to influence their teens.…

  19. Motivations for Non-Medical Prescription Drug Use: A Mixed Methods Analysis

    PubMed Central

    Rigg, Khary K.; Ibañez, Gladys E.

    2010-01-01

    Despite a dramatic increase in the non-medical use of prescription drugs among illicit drug users, their motives for abusing prescription drugs are still largely unknown. The objective of this study was to 1) determine the motivations for engaging in the non-medical use of prescription opioids and sedatives among street-based illicit drug users, methadone maintenance patients, and residential drug treatment clients, 2) examine associations between prescription drug abuse motivations and gender, age, race/ethnicity, and user group, and 3) examine associations between specific motivations and prescription drug abuse patterns. Quantitative surveys (n = 684) and in-depth interviews (n = 45) were conducted with a diverse sample of prescription drug abusers in South Florida between March 2008 and November 2009. The three most common motivations reported were “to get high”, “to sleep”, and “for anxiety/stress”. There were age, race/ethnicity, and gender differences by motives. Prescription drug abuse patterns were also found to be associated with specific motivations. While additional research is needed, these findings serve to inform appropriate prevention and treatment initiatives for prescription drug abusers. PMID:20667680

  20. New Medicare-approved prescription drug discount card.

    PubMed

    James, John S

    2004-05-28

    Patients who are on Medicare and have income under 135% of Federal poverty level and are not on Medicaid probably should obtain one of the new Medicare discount cards that became available on June 1, 2004, because all these cards include $600 annual credit for prescription-drug purchases for persons within that income limit. Unfortunately this program is complex, no one yet knows how it will work in practice, and after choosing a card one is locked in and cannot change cards until November 15. The most difficult part of the choice of which card to get may involve how it interacts with other programs, including ADAP, and pharmaceutical company patient assistance programs.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. Misperceptions of Nonmedical Prescription Drug Use: A Web Survey of College Students

    PubMed Central

    McCabe, Sean Esteban

    2008-01-01

    Objectives This study compared undergraduate students’ perceived versus actual prevalence rates of nonmedical use of marijuana, prescription opioids and prescription stimulants. Methods In 2005, a randomly selected sample of 3,639 college students self-administered a Web survey regarding their substance use behaviors and attitudes (68% response rate). Results The majority of undergraduate students overestimated the prevalence of nonmedical use of prescription stimulants (70.2%) and prescription opioids (69.9%) and marijuana use (50.5%) among peers on their campus. The mean difference between perceived versus actual past year use was considerably greater for nonmedical use of prescription stimulants (mean difference = 12.2, 95% CI = 11.7 – 12.7) and prescription opioids (mean difference = 8.8, 95% CI = 8.3 – 9.2) than marijuana (mean difference = 2.9, 95% CI = 2.2 – 3.6). Multivariate regression analysis revealed overestimation of nonmedical use of prescription drugs was significantly associated with gender and medical use of prescription drugs. Conclusions The findings provided strong evidence of misperception of nonmedical prescription drug use among college students. Future research and prevention efforts should assess the impact of correcting misperceived norms on reducing nonmedical prescription drug use. PMID:18242002

  8. Use of prescription drugs and future delinquency among adolescent offenders.

    PubMed

    Drazdowski, Tess K; Jäggi, Lena; Borre, Alicia; Kliewer, Wendy L

    2015-01-01

    Non-medical use of prescription drugs (NMUPD) by adolescents is a significant public health concern. The present study investigated the profile of NMUPD in 1349 adolescent offenders from the Pathways to Desistance project, and whether NMUPD predicted future delinquency using longitudinal data. Results indicated that increased frequency and recency of NMUPD in adolescent offenders are related to some demographic factors, as well as increased risk for violence exposure, mental health diagnoses, other drug use, and previous delinquency, suggesting that severity of NMUPD is important to consider. However, ANCOVA analyses found that NMUPD was not a significant predictor of drug-related, non-aggressive, or aggressive delinquency 12 months later beyond other known correlates of delinquency. Age, sex, exposure to violence, lower socioeconomic status, more alcohol use, and having delinquency histories were more important than NMUPD in predicting future delinquency. These findings suggest that although NMUPD is an important risk factor relating to many correlates of delinquency, it does not predict future delinquency beyond other known risk factors.

  9. 77 FR 74827 - Working Group on Access to Information on Prescription Drug Container Labels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... TRANSPORTATION BARRIERS COMPLIANCE BOARD Working Group on Access to Information on Prescription Drug Container... container labels accessible to people who are blind or visually impaired. The working group will hold its... working group to develop best practices for making information on prescription drug container...

  10. 77 FR 32407 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for...; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year...), the final rule with comment period entitled ``Medicare Program; Changes to the Medicare Advantage...

  11. 75 FR 71064 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit... Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other... the Office of the Federal Register base the comment period closing date on the date the proposed...

  12. 77 FR 19425 - Prescription Drugs Not Administered During Treatment; Update to Administrative Cost for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... AFFAIRS Prescription Drugs Not Administered During Treatment; Update to Administrative Cost for Calendar... purposes of calculating VA's charges for prescription drugs that were not administered during treatment but... administered during treatment for: (1) A nonservice-connected disability for which the veteran is entitled...

  13. Nonmedical Use of Prescription Drugs by College Students with Minority Sexual Orientations

    ERIC Educational Resources Information Center

    Duryea, Daniel G.; Calleja, Nancy G.; MacDonald, Douglas A.

    2015-01-01

    Results from the 2009 "National College Health Assessment" were analyzed by gender and sexual orientation for college students' nonmedical use of prescription drugs. Male and female students identified as having a minority sexual orientation (gay or bisexual) were significantly more likely to use nonmedical prescription drugs than…

  14. Prescription Drug Misuse among University Staff and Students: A Survey of Motives, Nature and Extent

    ERIC Educational Resources Information Center

    Holloway, Katy; Bennett, Trevor

    2012-01-01

    Aims: To determine the prevalence and nature of prescription drug misuse among university staff and students in the UK. Methods: In 2009, an online questionnaire regarding non-medical use of prescription drugs was completed by 1614 students and 489 staff registered at a large university in Wales. The sample data were weighted to match the…

  15. The Impact of Science Education Games on Prescription Drug Abuse Attitudes among Teens: A Case Study

    ERIC Educational Resources Information Center

    Klisch, Yvonne; Bowling, Kristi G.; Miller, Leslie M.; Ramos, Miguel A.

    2013-01-01

    Two online science education games, in which players learn about the risks of prescription drug abuse in the context of investigating crimes, were evaluated to determine shifts of prescription drug abuse attitudes attributable to game exposure. High school students from grades 11 and 12 (n = 179) were assigned to one of the games and participated…

  16. Total and Out-of-Pocket Expenditures for Prescription Drugs among Older Persons

    ERIC Educational Resources Information Center

    Sambamoorthi, Usha; Shea, Dennis; Crystal, Stephen

    2003-01-01

    Purpose: The burden of prescription drug costs on Medicare beneficiaries has become a critical policy issue in improving the Medicare program, yet few studies have provided detailed and current information on that burden. The present study estimates total and out-of-pocket expenditures for prescription drugs and the burden of these costs in…

  17. An Exploration of the Relationship between the Use of Methamphetamine and Prescription Drugs

    ERIC Educational Resources Information Center

    Lamonica, Aukje K.; Boeri, Miriam

    2012-01-01

    This study examines patterns of use of prescription drugs and methamphetamine. We drew our sample from a study about 130 active and inactive methamphetamine users and focused on 16 participants with a recent history of methamphetamine and prescription drug use. We collected in-depth interviews to explore relationships in use trajectory patterns.…

  18. 21 CFR 250.105 - Gelsemium-containing preparations regarded as prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Gelsemium-containing preparations regarded as prescription drugs. 250.105 Section 250.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS New...

  19. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Fixed-combination prescription drugs for humans. 300.50 Section 300.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination...

  20. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Fixed-combination prescription drugs for humans. 300.50 Section 300.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination...

  1. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Fixed-combination prescription drugs for humans. 300.50 Section 300.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination...

  2. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Fixed-combination prescription drugs for humans. 300.50 Section 300.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination...

  3. 78 FR 28862 - Announcement of Requirements and Registration for “Propose New Ideas For Prescription Drugs Oral...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... abuse and the treatment of drug abusers. This Challenge is also in accordance with NIDA's strategic... New Ideas For Prescription Drugs Oral Overdose Protection'' Authority: 15 U.S.C. 3719. SUMMARY: Prescription drug abuse is a growing drug problem for America. The ``Propose New Ideas For Prescription...

  4. Pricing of prescription drugs and its impact on physicians' choice behavior.

    PubMed

    Miao-Sheng, Chen; Yu-Ti, Shih

    2008-09-01

    This research presents an analysis of Taiwan's health care market with the focus on the pricing of prescription drugs and its impact on physicians' choice behavior. Since the advent of Taiwan's national health insurance, with the competent authority being Bureau of National Health Insurance (BNHI), hospitals are allowed to sell prescription drugs to patients at prices above the purchasing prices, so each prescription drug has two prices: one at which drugs are sold to hospitals; the other which BNHI reimbursement to hospitals. The margin between the different prices is the sales discount that pharmaceutical companies offer to the hospitals. We find that sales discount has a great impact on physicians' choice behavior: i.e., physicians are price-sensitive to prescription drugs. In addition, it is found that too high a sales discount of a prescription drug would result in a too low weighted average price of that drug sold; thus BNHI would be more likely to adjust downward the rate it reimbursement to the hospital. This presents a sales strategy problem to pharmaceutical companies. To solve this, we use the distribution of physicians' evaluations of prescription drugs to establish a profit maximization model in hopes of helping companies to price drugs and find the optimal promotion expending. Ten popular prescription drugs are used in this research as examples.

  5. 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

  6. Racial-Ethnic Disparities in Opioid Prescriptions at Emergency Department Visits for Conditions Commonly Associated with Prescription Drug Abuse.

    PubMed

    Singhal, Astha; Tien, Yu-Yu; Hsia, Renee Y

    2016-01-01

    Prescription drug abuse is a growing problem nationally. In an effort to curb this problem, emergency physicians might rely on subjective cues such as race-ethnicity, often unknowingly, when prescribing opioids for pain-related complaints, especially for conditions that are often associated with drug-seeking behavior. Previous studies that examined racial-ethnic disparities in opioid dispensing at emergency departments (EDs) did not differentiate between prescriptions at discharge and drug administration in the ED. We examined racial-ethnic disparities in opioid prescription at ED visits for pain-related complaints often associated with drug-seeking behavior and contrasted them with conditions objectively associated with pain. We hypothesized a priori that racial-ethnic disparities will be present among opioid prescriptions for conditions associated with non-medical use, but not for objective pain-related conditions. Using data from the National Hospital Ambulatory Medical Care Survey for 5 years (2007-2011), the odds of opioid prescription during ED visits made by non-elderly adults aged 18-65 for 'non-definitive' conditions (toothache, back pain and abdominal pain) or 'definitive' conditions (long-bone fracture and kidney stones) were modeled. Opioid prescription at discharge and opioid administration at the ED were the primary outcomes. We found significant racial-ethnic disparities, with non-Hispanic Blacks being less likely (adjusted odds ratio ranging from 0.56-0.67, p-value < 0.05) to receive opioid prescription at discharge during ED visits for back pain and abdominal pain, but not for toothache, fractures and kidney stones, compared to non-Hispanic whites after adjusting for other covariates. Differential prescription of opioids by race-ethnicity could lead to widening of existing disparities in health, and may have implications for disproportionate burden of opioid abuse among whites. The findings have important implications for medical provider education

  7. Racial-Ethnic Disparities in Opioid Prescriptions at Emergency Department Visits for Conditions Commonly Associated with Prescription Drug Abuse

    PubMed Central

    Tien, Yu-Yu; Hsia, Renee Y.

    2016-01-01

    Prescription drug abuse is a growing problem nationally. In an effort to curb this problem, emergency physicians might rely on subjective cues such as race-ethnicity, often unknowingly, when prescribing opioids for pain-related complaints, especially for conditions that are often associated with drug-seeking behavior. Previous studies that examined racial-ethnic disparities in opioid dispensing at emergency departments (EDs) did not differentiate between prescriptions at discharge and drug administration in the ED. We examined racial-ethnic disparities in opioid prescription at ED visits for pain-related complaints often associated with drug-seeking behavior and contrasted them with conditions objectively associated with pain. We hypothesized a priori that racial-ethnic disparities will be present among opioid prescriptions for conditions associated with non-medical use, but not for objective pain-related conditions. Using data from the National Hospital Ambulatory Medical Care Survey for 5 years (2007–2011), the odds of opioid prescription during ED visits made by non-elderly adults aged 18–65 for ‘non-definitive’ conditions (toothache, back pain and abdominal pain) or ‘definitive’ conditions (long-bone fracture and kidney stones) were modeled. Opioid prescription at discharge and opioid administration at the ED were the primary outcomes. We found significant racial-ethnic disparities, with non-Hispanic Blacks being less likely (adjusted odds ratio ranging from 0.56–0.67, p-value < 0.05) to receive opioid prescription at discharge during ED visits for back pain and abdominal pain, but not for toothache, fractures and kidney stones, compared to non-Hispanic whites after adjusting for other covariates. Differential prescription of opioids by race-ethnicity could lead to widening of existing disparities in health, and may have implications for disproportionate burden of opioid abuse among whites. The findings have important implications for medical

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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…

  14. 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…

  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. Disease Information in Direct-to-Consumer Prescription Drug Print Ads.

    PubMed

    Aikin, Kathryn J; Sullivan, Helen W; Betts, Kevin R

    2016-01-01

    Direct-to-consumer (DTC) prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding. Participants (4,064 adults) viewed 1 of 15 DTC print ads for fictitious prescription drugs indicated to treat chronic obstructive pulmonary disease, anemia, or lymphoma that varied in disease information presence, type, and format. Participants answered questions that assessed risk and benefit memory, perception, and behavioral intention. Results indicate that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication.

  6. Awareness of and attitudes toward direct-to-consumer prescription drug advertising among young adults.

    PubMed

    Alperstein, Neil M

    2014-01-01

    This study examines awareness and knowledge of and attitudes toward direct-to-consumer (DTC) prescription drug advertising among young adults between 18 and 24 years of age. The study finds that young adults are not as aware of prescription drug advertising as older consumers, however, they are aware of specific heavily advertised drugs, especially those for allergy medications, birth control, and sleep aids. Young adults hold mixed to negative views about advertising in general, and they do not view DTC prescription drug advertising as a beneficial source of information, nor do they believe such advertising serves to educate consumers.

  7. Drug prescriptions in Danish out-of-hours primary care: a 1-yearpopulation-based study

    PubMed Central

    Christensen, Morten Bondo; Nørøxe, Karen Busk; Moth, Grete; Vedsted, Peter; Huibers, Linda

    2016-01-01

    Objective General practitioners are the first point of contact in Danish out-of-hours (OOH) primary care. The large number of contacts implies that prescribing behaviour may have considerable impact on health-care expenditures and quality of care. The aim of this study was to examine the prevailing practices for medication prescription in Danish OOH with a particular focus on patient characteristics and contact type. Design and setting A one-year population-based retrospective observational study was performed of all contacts to OOH primary care in the Central Denmark Region using registry data. Main outcome measures Prescriptions were categorised according to Anatomical Therapeutic Chemical Classification (ATC) codes and stratified for patient age, gender and contact type (telephone consultation, clinic consultation or home visit). Prescription rates were calculated as number of prescriptions per 100 contacts. Results Of 644,777 contacts, 154,668 (24.0%) involved medication prescriptions; 21.9% of telephone consultations, 32.9% of clinic consultations and 14.3% of home visits. Around 53% of all drug prescriptions were made in telephone consultations. Anti-infective medications for systemic use accounted for 45.5% of all prescriptions and were the most frequently prescribed drug group for all contact types, although accounting for less than 1/3 of telephone prescriptions. Other frequently prescribed drugs were ophthalmological anti-infectives (10.5%), NSAIDs (6.4%), opioids (3.9%), adrenergic inhalants (3.0%) and antihistamines (2.3%). Conclusion About 25% of all OOH contacts involved one or more medication prescriptions. The highest prescription rate was found for clinic consultations, but more than half of all prescriptions were made by telephone. KEY POINTSAs the out-of-hours (OOH) primary care services cover more than 75% of all hours during a normal week, insight into the extent and type of OOH drug prescription is important.General practitioners (GPs) are

  8. Prescription Drug Insurance Coverage and Patient Health Outcomes: A Systematic Review

    PubMed Central

    Huybrechts, Krista F.; Choudhry, Niteesh K.; Fulchino, Lisa A.; Isaman, Danielle L.; Kowal, Mary K.; Brennan, Troyen A.

    2015-01-01

    Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies demonstrating that broader prescription drug insurance reduces use of other health care services and has a positive impact on patient outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the Affordable Care Act expansions in drug coverage to improve the health of low-income patients receiving state-based health insurance. PMID:25521879

  9. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing...

  10. Emergency department utilization and subsequent prescription drug overdose death

    PubMed Central

    Brady, Joanne E.; DiMaggio, Charles J.; Keyes, Katherine M.; Doyle, John J.; Richardson, Lynne D.; Li, Guohua

    2015-01-01

    Purpose Prescription drug overdose (PDO) deaths are a critical public health problem in the United States. This study aims to assess the association between emergency department (ED) utilization patterns in a cohort of ED patients and the risk of subsequent unintentional PDO mortality. Methods Using data from the New York Statewide Planning and Research Cooperative System for 2006–2010, a nested case-control design was used to examine the relationship between ED utilization patterns in New York State residents of age 18–64 years and subsequent PDO death. Results The study sample consisted of 2732 case patients who died of PDO and 2732 control ED patients who were selected through incidence density sampling. With adjustment for demographic characteristics, and diagnoses of pain, substance abuse, and psychiatric disorders, the estimated odds ratios of PDO death relative to one ED visit or less in the previous year were 4.90 (95% confidence interval [CI]: 4.50–5.34) for those with two ED visits, 16.61 (95% CI: 14.72–18.75) for those with three ED visits, and 48.24 (95% CI: 43.23–53.83) for those with four ED visits or more. Conclusions Frequency of ED visits is strongly associated with the risk of subsequent PDO death. Intervention programs targeting frequent ED users are warranted to reduce PDO mortality. PMID:25935710

  11. Symbolic Boundaries, Subcultural Capital, and Prescription Drug Misuse across Youth Cultures

    PubMed Central

    Kelly, Brian C; Trimarco, James; LeClair, Amy; Pawson, Mark; Parsons, Jeffrey T; Golub, Sarit A

    2014-01-01

    Prescription drug misuse among young adults has surged over the past decade. Yet, the contexts surrounding this misuse remain unclear, particularly subcultural contexts. Many urban young adults participate in youth cultures. This paper describes the subcultural contexts of prescription drug misuse within youth subcultures. Drawing on ethnographic data collected over 12 months from different youth cultural scenes, the authors describe the subcultural bases of prescription drug misuse. The symbolic boundaries and subcultural capital inherent in these scenes shape the ways youth think about drugs and behave accordingly. While young adults are often lumped together, ethnographic data show considerable variation across these subcultures with regard to what may enable or inhibit prescription drug misuse. The broader subcultural ethos in each scene, as well as attitudes towards other types of drugs, frame the ways that prescription drugs are perceived and used within each of these scenes. In this regard, the findings highlight the role of symbolic boundaries and subcultural capital in drug use among young adults by shaping their routine practices. These data highlight that education campaigns about prescription drug misuse should account for the variability in youth cultural scenes to maximize the efficacy of these messages aimed at young adults. PMID:25529457

  12. Prescription drug abuse as a public health problem in Ohio: a case report.

    PubMed

    Winstanley, Erin L; Gay, Joe; Roberts, Lisa; Moseley, Judi; Hall, Orman; Beeghly, B Christine; Winhusen, Theresa; Somoza, Eugene

    2012-11-01

    Prescription drug overdose is the leading cause of injury death in Ohio, as well as in 16 other states. Responding to the prescription drug epidemic is particularly challenging given the fragmentation of the health care system and that the consequences of addiction span across systems that have not historically collaborated. This case study reports on how Ohio is responding to the prescription drug epidemic by developing cross-system collaboration from local public health nurses to the Governor's office. In summary, legal and regulatory policies can be implemented relatively quickly whereas changing the substance abuse treatment infrastructure requires significant financial investments.

  13. Income and the Use of Prescription Drugs by the Elderly: Evidence from the Notch Cohorts

    ERIC Educational Resources Information Center

    Moran, John R.; Simon, Kosali Ilayperuma

    2006-01-01

    We use exogenous variation in Social Security payments created by the Social Security benefits notch to estimate how retirees' use of prescription medications responds to changes in their incomes. Using data from the 1993 Wave of the AHEAD, we obtain instrumental variables estimates of the income elasticity of prescription drug use that are…

  14. The impact of science education games on prescription drug abuse attitudes among teens: a case study.

    PubMed

    Klisch, Yvonne; Bowling, Kristi G; Miller, Leslie M; Ramos, Miguel A

    2013-01-01

    Two online science education games, in which players learn about the risks of prescription drug abuse in the context of investigating crimes, were evaluated to determine shifts of prescription drug abuse attitudes attributable to game exposure. High school students from grades 11 and 12 (n = 179) were assigned to one of the games and participated in a pretest, two game-play sessions, and a delayed posttest. Students in both groups demonstrated more negative attitudes toward prescription drug abuse after playing the game, driven by changes of students' normative beliefs and their ability to make the connection between prescription drug abuse and illicit drugs. A secondary aim was to assess gains in science knowledge; however, due to low internal consistency reliabilities of content measures, students' knowledge acquisition could not be determined.

  15. A behavioral economic analysis of the nonmedical use of prescription drugs among young adults.

    PubMed

    Pickover, Alison M; Messina, Bryan G; Correia, Christopher J; Garza, Kimberly B; Murphy, James G

    2016-02-01

    The nonmedical use of prescription drugs is a widely recognized public health issue, and young adults are particularly vulnerable to their use. Behavioral economic drug purchase tasks capture an individual's strength of desire and motivation for a particular drug. We examined young adult prescription drug purchase and consumption patterns using hypothetical behavioral economic purchase tasks for prescription sedatives/tranquilizers, stimulants, and opiate pain relievers. We also examined relations between demand, use frequency, and Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) substance use disorder (SUD) symptoms, and sex differences in these relations. Undergraduate students who endorsed past-year prescription drug use (N = 393) completed an online questionnaire for course credit. Measures assessed substance use frequency and DSM-5 SUD symptoms. Hypothetical purchase tasks for sedatives, stimulants, and pain relievers assessed participants' consumption and expenditure patterns for these substances across 25 prices. Past-year prescription sedative, stimulant, and pain reliever use was endorsed by 138, 258, and 189 participants, respectively. Among these users, consumption for their respective substance decreased as a function of ascending price, as expected. Demand indices for a prescription drug were associated with each other and with use frequency and SUD symptoms, with variability across substances but largely not by sex. In addition, demand for prescription pain relievers differentially predicted symptoms independent of use, with differences for females and males. In conclusion, hypothetical consumption and expenditure patterns for prescription drugs were generally well described by behavioral economic demand curves, and the observed associations with use and SUD symptoms provide support for the utility of prescription drug purchase tasks.

  16. 76 FR 1182 - Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... supply chain. On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub... HUMAN SERVICES Food and Drug Administration Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION:...

  17. 76 FR 29765 - Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. ] SUMMARY: The Food and Drug Administration (FDA)...

  18. 76 FR 58020 - Prescription Drug User Fee Act IV Information Technology Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Act IV Information Technology Plan AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of an updated information technology (IT) plan...

  19. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... HUMAN SERVICES Food and Drug Administration Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for public comment of the...

  20. 76 FR 41434 - Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 203 Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing...

  1. An explanatory model for state Medicaid per capita prescription drug expenditures.

    PubMed

    Roy, Sanjoy; Madhavan, S Suresh

    2012-01-01

    Rising prescription drug expenditure is a growing concern for publicly funded drug benefit programs like Medicaid. To be able to contain drug expenditures in Medicaid, it is important that cause(s) for such increases are identified. This study attempts to establish an explanatory model for Medicaid prescription drugs expenditure based on the impacts of key influencers/predictors identified using a comprehensive framework of drug utilization. A modified Andersen's behavior model of health services utilization is employed to identify potential determinants of pharmaceutical expenditures in state Medicaid programs. Level of federal matching funds, access to primary care, severity of diseases, unemployment, and education levels were found to be key influencers of Medicaid prescription drug expenditure. Increases in all, except education levels, were found to result in increases in drug expenditures. Findings from this study could better inform intervention policies and cost-containment strategies for state Medicaid drug benefit programs.

  2. Direct-to-consumer ads can influence behavior. Advertising increases consumer knowledge and prescription drug requests.

    PubMed

    Peyrot, M; Alperstein, N M; Van Doren, D; Poli, L G

    1998-01-01

    This study examines the impact of direct-to-consumer (DTC) pharmaceutical advertising on prescription drug knowledge and the requesting behavior of consumers. The authors developed and tested a conceptual model of prescription drug knowledge and requests. Consumers' belief that drug advertising can educate them was associated with a greater amount of drug knowledge, and the belief they would upset physicians by asking for specific drugs was associated with less knowledge. The belief that drug advertising reduces prices was associated with greater probability of drug requests, and the belief that physicians should be the sole source of drug information was associated with lesser probability of request. Preference for generic drugs was associated with a lesser likelihood of requesting a specific drug. Media exposure and drug advertising awareness were associated with higher drug knowledge and a greater probability of drug requesting.

  3. Nonsteroidal Antiinflammatory Drug Use and Lower Urinary Tract Symptoms: Results From the Boston Area Community Health Survey

    PubMed Central

    Gates, Margaret A.; Hall, Susan A.; Chiu, Gretchen R.; Kupelian, Varant; FitzGerald, Mary P.; Link, Carol L.; McKinlay, John B.

    2011-01-01

    There is evidence for a role of inflammation in the etiology of lower urinary tract symptoms (LUTS), raising the possibility that use of nonsteroidal antiinflammatory drugs (NSAIDs) may inhibit the development or progression of LUTS. The authors examined the association between use of prescription and over-the-counter NSAIDs and LUTS among 1,974 men and 2,661 women in the Boston Area Community Health Survey (2002–2005). Multivariable-adjusted logistic regression was used to estimate odds ratios and 95% confidence intervals for LUTS, voiding symptoms, storage symptoms, and nocturia. There was no clear association between use of prescription or over-the-counter NSAIDs (compared with no NSAID use) and overall LUTS, voiding symptoms, or nocturia in men or women. However, over-the-counter NSAID use was positively associated with storage symptoms in women (odds ratio = 1.37, 95% confidence interval: 1.03, 1.83), and there was a positive association between over-the-counter NSAID use and overall LUTS among women with a history of arthritis (odds ratio = 2.09, 95% confidence interval: 1.20, 3.64). These results do not provide strong support for an association between NSAIDs and LUTS. However, the associations between over-the-counter NSAID use and certain urologic symptoms, particularly among women with arthritis, and the potential mechanisms involved should be evaluated in future studies. PMID:21357657

  4. 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

  5. What kind of patients and physicians value direct-to-consumer advertising of prescription drugs.

    PubMed

    Gönül, F F; Carter, F; Wind, J

    2000-06-01

    Direct-to-consumer (DTC) advertising of prescription drugs can enhance the physician-patient relationship, as well as benefiting its sponsor. However, overall benefits can only occur if the patients value the information enough to discuss it with their physicians and the physicians are not predisposed against the DTC information. We investigate the impact of demographics and exposure to marketing on consumers' and physicians' receptiveness to DTC advertising of prescription drugs, using data from two nationwide surveys. We find that consumers who have an ongoing need for health care, that is, those with children or with a chronic condition requiring medication, value prescription drug advertising more highly, while older consumers, consumers who have been sick recently, or more educated consumers are more likely to trust their physicians instead. We find that more experienced physicians, physicians who see more patients, or those who have more exposure to pharmaceutical advertisements are more accepting of DTC advertising of prescription drugs.

  6. Prescription drug samples--does this marketing strategy counteract policies for quality use of medicines?

    PubMed

    Groves, K E M; Sketris, I; Tett, S E

    2003-08-01

    Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.

  7. 76 FR 79194 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... Collection; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements AGENCY: Food... labeling, called Medications Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication. DATES: Submit either electronic...

  8. Acetylsalicylic-acid-containing drugs and nonsteroidal anti-inflammatory drugs available in Canada.

    PubMed

    Brigden, M; Smith, R E

    1997-04-01

    A large number of drugs containing acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter in Canada. The possibility of serious side effects and drug interactions is therefore high. The authors have compiled a comprehensive list of products containing these drugs from information supplied by pharmaceutical databases, independent marketing researchers and Health Canada's Drug Directorate. Physicians should ensure that additional ASA-containing drugs or NSAIDs are not inadvertently taken by patients, especially those receiving oral anticoagulant therapy or those with a qualitative platelet defect. Patients at risk should be cautioned to check with their physician before taking any new medication, even over-the-counter products.

  9. 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

  10. Motivations for prescription drug misuse among young men who have sex with men (YMSM) in Philadelphia

    PubMed Central

    Kecojevic, Aleksandar; Corliss, Heather L.; Lankenau, Stephen E.

    2015-01-01

    Background Prescription drug misuse (i.e. opioids, tranquilizers and stimulants) has become the fastest growing area of substance abuse among young adults. Limited studies focus on prescription drug misuse among young men who have sex with men (YMSM, aged 18–29 years). Furthermore, little is known about YMSM’s motivations for misuse. The purpose of this study was to explore personal motivations for prescription drug misuse among YMSM, including the possible connection between misuse and sexual behaviors. Methods As part of a larger mixed methods study of 191 YMSM recruited in Philadelphia during 2012–2013, we conducted semi-structured qualitative interviews with 25 of these participants to gather additional contextual information about their prescription drug misuse. We conducted thematic analysis of qualitative data. Results While our results corroborated previous literature on motives for misuse of prescription drugs, our data yielded some distinct motivations specific among YMSM. These motives included social/recreational motives, facilitating sex with other men (including motives such as use of opioids for less painful anal receptive sex), and psychological motives such as depression, stress management, coping with everyday hardships (opioids and tranquilizers) or feeling more energized (stimulants). Prescription drugs were commonly misused within the broader contexts of participants' polysubstance use, adding to the significance of this problem. Conclusions Our findings offer insights into YMSM’s motivations for prescription drug misuse, and point to the importance of recognizing and addressing them. While substance use is likely related to various psychosocial issues impacting YMSM, it also may lead to significant health consequences. Results support the need to include prescription drugs and polysubstance use in harm reduction messages and treatment approaches aimed at substance using YMSM. PMID:25936445

  11. Trends in Prescription Drug Use among Adults in the United States from 1999–2012

    PubMed Central

    Kantor, Elizabeth D.; Rehm, Colin D.; Haas, Jennifer S.; Chan, Andrew T.; Giovannucci, Edward L.

    2015-01-01

    Importance It is important to document patterns of prescription drug use to inform both clinical practice and research. Objective To evaluate trends in prescription drug use among adults living in the United States. Design, Setting, and Participants Temporal trends in prescription drug use were evaluated using nationally representative data from the National Health and Nutrition Examination Survey (NHANES). Participants include 37,959 non-institutionalized US adults, aged 20 years and older. Seven NHANES cycles were included (1999–2000 to 2011–2012), and the sample size per cycle ranged from 4,861 to 6,212. Exposures Calendar year, as represented by continuous NHANES cycle. Main Outcome(s) and Measure(s) Within each NHANES cycle, use of prescription drugs in the prior 30 days was assessed overall and by drug class. Temporal trends across cycles were evaluated. Analyses were weighted to represent the US adult population. Results Results indicate an increase in overall use of prescription drugs among US adults between 1999–2000 and 2011–2012 with an estimated 51% of US adults reporting use of any prescription drugs in 1999–2000 and an estimated 59% reporting use in 2011–2012 (Difference: 8%; 95% CI: 3.8%–12%; p-trend<0.001). The prevalence of polypharmacy (use of ≥5 prescription drugs) increased from an estimated 8.2% in 1999–2000 to 15% in 2011–2012 (Difference: 6.6%; 95% CI: 4.4%–8.2%; p-trend<0.001). These trends remained statistically significant with age adjustment. Among the 18 drug classes used by more than 2.5% of the population at any point over the study period, the prevalence of use increased in 11 drug classes including antihyperlipidemic agents, antidepressants, prescription proton-pump inhibitors, and muscle relaxants. Conclusions and Relevance In this nationally representative survey, significant increases in overall prescription drug use and polypharmacy were observed. These increases persisted after accounting for changes in the

  12. Distribution of certain drug products by registered blood establishments and comprehensive hemophilia diagnostic treatment centers that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements and administrative procedures. Final rule.

    PubMed

    2008-10-09

    The Food and Drug Administration (FDA) is amending its regulations to allow certain registered blood establishments and comprehensive hemophilia diagnostic treatment centers that are also health care entities to distribute certain drug products. The final rule amends limited provisions of the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA). These regulations, among other things, restrict the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs purchased by hospitals and other health care entities.

  13. Changes in drug utilization following the outpatient prescription drug cost-sharing program--evidence from Taiwan's elderly.

    PubMed

    Liu, Shuen-Zen; Romeis, James C

    2004-06-01

    This paper examines changes in drug utilization following Taiwan's newly implemented National Health Insurance (NHI) outpatient prescription drug cost-sharing program for persons over 65 years old. The study is a hospital outpatient prescription level analysis that adopts a pretest-posttest control group experiment design. Selected measures of outpatient prescription drug utilization are examined for cost-sharing and non cost-sharing groups in cost-sharing periods and pre cost-sharing periods. Additional analyses were conducted comparing older patients with and without chronic diseases and differences for essential and non-essential drugs. Patients over age 65 were drawn from 21 hospitals in the Taipei area using a stratified random sampling method. This paper yields several interesting findings. First, average prescription cost and prescription period increased for both the cost-sharing and non cost-sharing groups. However, the rate of increase was significantly less in the cost-sharing group when compared with the non cost-sharing group. Second, the elderly with non-chronic diseases were more sensitive (i.e., reducing drug utilization) to the drug cost-sharing program when compared with those with chronic diseases. Third, for the elderly with non-chronic diseases average drug cost per prescription experienced a smaller decrease in essential drugs but a moderate increase in non-essential drugs for the cost-sharing group. By contrast, for the non cost-sharing group, average drug cost per prescription increased sharply in non-essential drugs as well as essential drugs. Finally, there was a significant increase in the number of prescriptions as well as drug costs above the upper bound of the cost-sharing schedule. The outpatient drug cost-sharing program implemented by the NHI in Taiwan did not reverse the trend of prescription drug cost increases in hospitals. The significant increase in the number of prescriptions above the upper bound of the cost-sharing schedule

  14. Benzodiazepines: a major component in unintentional prescription drug overdoses with opioid analgesics.

    PubMed

    Jann, Michael; Kennedy, William Klugh; Lopez, Gaylord

    2014-02-01

    The misuse and abuse of prescription medications in the United States continues to increase despite interventions by health care professionals, regulatory, and law enforcement agencies. Opioid analgesics are the leading class of prescription drugs that have caused unintentional overdose deaths. Benzodiazepines when taken alone are relatively safe agents in overdose. However, a 5-fold increase in deaths attributed to benzodiazepines occurred from 1999 to 2009. Emergency department visits related to opioid analgesics increased by 111% followed by benzodiazepines 89%. During 2003 to 2009, the 2 prescriptions drugs with the highest increase in death rates were oxycodone 264.6% and alprazolam 233.8%. Therefore, benzodiazepines have a significant impact on prescription drug unintentional overdoses second only to the opioid analgesics. The combination prescribing of benzodiazepines and opioid analgesics commonly takes place. The pharmacokinetic drug interactions between benzodiazepines and opioid analgesics are complex. The pharmacodynamic actions of these agents differ as their combined effects produce significant respiratory depression. Physician and pharmacy shopping by patients occurs, and prescription drug-monitoring programs can provide important information on benzodiazepine and opioid analgesic prescribing patterns and patient usage. Health care professionals need to inform patients and work closely with regulatory agencies and legislatures to stem the increasing fatalities from prescription drug unintentional overdoses.

  15. Drugs and other product choices.

    PubMed

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature.

  16. Concomitant use of prescription medications and dietary supplements in menopausal women; an approach to provider preparedness

    PubMed Central

    Gardiner, Paula; Stargrove, Mitchell Bebel; Dog, Tieraona Low

    2010-01-01

    Dietary supplements are becoming increasingly popular as therapies for symptom relief among menopause-age women in the United States. However, a large gap exists between research in the concomitant use of prescription medications and dietary supplements and provider preparedness to guide patient decision making. Many menopausal women take prescription medications, over the counter medications, and herbs and dietary supplements for climactic symptoms or other health conditions. With any drug, there is the potential for interactions. Women taking medications with a narrow therapeutic index, such as anticoagulants, anticonvulsants, and drugs for the treatment of chronic diseases, are at particular risk. Patients should be queried regarding their use of dietary supplements when starting or stopping a prescription drug, or if unexpected reactions occur. When counseling patients, one must carefully consider the risks and benefits of each supplement and medication being taken by each individual. PMID:21168291

  17. Drug companies monitor prescriptions and sales to fine-tune their marketing strategies.

    PubMed

    2010-06-01

    Market research companies analyse drug prescriptions and sales in community and hospital pharmacies, thus enabling drug companies to refine their marketing strategies. Some information of interest to drug companies is provided directly by healthcare professionals, sometimes unwittingly, and sometimes in return for small "favours".

  18. Watching the monitors: "PAID" prescriptions, fiscal intermediaries and drug-utilization review.

    PubMed

    Morgan, J P

    1977-02-03

    Prescription monitoring evolved from the need of drug firms to obtain marketing information. Today, extensive monitoring is also done by fiscal intermediaries who administer prepaid drug benefit plans, both private and governmental, particularly Medicaid. The most important such agent is PAID Prescriptions. Under various contracts, PAID monitors physician, pharmacy, and patient behavior related to prescriptions and uses review processes that evaluate certain kinds of behavior for appropriateness. The criteria of appropriateness are essentially those that save money. PAID negotiates a program fee with the insurer (public or private) and applies constraints so that prescription and administrative costs do not overrun that fee. PAID and other monitors have contemplated expansion into the realm of defining and encouraging appropriate prescribing under the concept of "drugutilization review." The actual practices of PAID, particularly the background of fiscal enforcement, may impede the development of an actual drug-utilization review process.

  19. Prescription drug advertising: is it a driving force on drug pricing?

    PubMed

    Millstein, Lloyd G

    2003-01-01

    It has been shown that drug companies will sell more drugs when they use DTC advertising, but it is also true that many consumers who are suffering--unaware there is help for their symptoms--will learn from these ads that help is available. Advertising to consumers, like advertising to professionals, will continue to be one of the best methods of providing information. Of course, healthcare professionals also have the sales representatives, their colleagues, medical journals, and medical conventions as additional options for needed information. The consumer may or may not use other methods, such as the Internet, the library or friends or family, but the advertising is a starting point for a dialogue. If the DTC ad provides consumers with "information," which is different from "advertising," the drug company will be providing a worthwhile service to consumers and potential patients. No doubt consumers will begin demanding higher quality information from DTC ads and will frown upon the ads that are blatantly trying just to sell a drug. It will also reap the benefits of improved consumer awareness and patient compliance. A DTC ad that is consumer-friendly, does not use fear appeal, is educational in tone, and downplays the "hard sell" and hype will go a long way in offering important information to the casual observer. Oversight by the FDA will ensure the information meets the requirements they have set down for prescription drug advertising. That is, advertising will be truthful and fairly balanced and will meet what the government, consumers and, no doubt, the medical community wants. Attempting to control drug costs, by controlling advertising, will not be an easy task. This has an implication across all product areas, not just drugs. DTC advertising has become a lightening rod for cost containment issues, but is it alone driving demand for prescription products? I don't think so.

  20. Overview of the New York State program for prescription drug benefits.

    PubMed

    Lennard, E L; Feinberg, P E

    1994-12-01

    New York State's prescription drug benefits program is described. The Empire Plan, a part of the New York State Health Insurance Program, includes a prescription drug benefits program. The prescription drug program began in 1986 and covers more than 700,000 people. In 1988 the state started a therapeutic drug-use-evaluation (DUE) program in correct with the supplier, Health Information Designs, a subsidiary of ValueRx Pharmacy Program. In 1991 the partnership with ValueRx was expanded to include patient profilling and physician education. In 1993 the state implemented a prior-authorization program for certain high-technology drugs, also administered by ValueRx. New York's public work force is heavily unionized, and the unions have been deeply involved in program design and vendor selection. Program participants have access to a large network of community pharmacies. The program also provides mail-order service. Quality is at the center of the state's and the unions' prescription drug program philosophy. Saving money is also a major objective; savings totaling $19.5 million were realized from 1988 through 1993 under the partnership between the state and ValueRx. The Empire Plan's prescription drug benefits program is building quality and saving money by integrating DUE, prior authorization, education, community pharmacy, and mail-order service.

  1. Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004-2008.

    PubMed

    2010-06-18

    Rates of overdose deaths involving prescription drugs increased rapidly in the United States during 1999-2006. However, such mortality data do not portray the morbidity associated with prescription drug overdoses. Data from emergency department (ED) visits can represent this morbidity and can be accessed more quickly than mortality data. To better understand recent national trends in drug-related morbidity, CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA) reviewed the most recent 5 years of available data (2004-2008) on ED visits involving the nonmedical use of prescription drugs from SAMHSA's Drug Abuse Warning Network (DAWN). This report describes the results of that review, which showed that the estimated number of ED visits for nonmedical use of opioid analgesics increased 111% during 2004-2008 (from 144,600 to 305,900 visits) and increased 29% during 2007-2008. The highest numbers of ED visits were recorded for oxycodone, hydrocodone, and methadone, all of which showed statistically significant increases during the 5-year period. The estimated number of ED visits involving nonmedical use of benzodiazepines increased 89% during 2004-2008 (from 143,500 to 271,700 visits) and 24% during 2007-2008. These findings indicate substantial, increasing morbidity associated with the nonmedical use of prescription drugs in the United States during 2004-2008, despite recent efforts to control the problem. Stronger measures to reduce the diversion of prescription drugs to nonmedical purposes are warranted.

  2. 76 FR 24901 - Request for Input To Inform a Possible Surgeon General Action on Prescription Drug Abuse in Youth

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... Action on Prescription Drug Abuse in Youth AGENCY: National Institute on Drug Abuse, National Institutes...: The National Institute on Drug Abuse, a Research Institute of the National Institutes of Health, is... General response to the public health problem of prescription drug abuse among youth....

  3. Medical and Nonmedical Users of Prescription Drugs among College Students

    ERIC Educational Resources Information Center

    Rozenbroek, Katelyn; Rothstein, William G.

    2011-01-01

    Objectives: To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Participants: Undergraduates at an urban mid-Atlantic university with 12,000 students. Methods: A questionnaire administered in classes provided 413 responses, with a usable response…

  4. Medical Use, Illicit Use, and Diversion of Abusable Prescription Drugs

    ERIC Educational Resources Information Center

    McCabe, Sean Esteban; Teter, Christian J.; Boyd, Carol J.

    2006-01-01

    The authors investigated the medical use, illicit use, and diversion of 4 distinct classes of abusable prescription medication (sleeping medication, sedative or anxiety medication, stimulant medication, and pain medication) in a random sample of undergraduate students. In spring 2003, 9,161 undergraduate students attending a large, public,…

  5. Compliance of psychotropic drug prescription with clinical practice guidelines in older inpatients.

    PubMed

    Etchepare, Fanny; Pambrun, Elodie; Bégaud, Bernard; Verdoux, Hélène; Tournier, Marie

    2016-02-01

    Several practice guidelines were published by French regulatory agencies between 2006 and 2009 to improve psychotropic drug use in older patients. The objectives of the study were to assess compliance with these guidelines in older patients hospitalized in psychiatric units and to identify characteristics associated with compliance. A cross-sectional study was conducted in 117 patients aged 65 years and older hospitalized in two psychiatric departments of a public hospital, at three dates randomly chosen between January and May 2014. Medical and sociodemographic characteristics were collected from electronic medical records. In all, 8% of psychotropic prescriptions were compliant with guidelines. A total of 98% of antidepressant prescriptions complied with guidelines for product selection (no tricyclics) and 72% for initial dosage (half of that recommended for younger adults). Regarding benzodiazepines, short half-life drugs were chosen in 73% of treatments, low maintenance dosage was found in 64% of treatments, and a discontinuous administration rhythm was noted in 33% of treatments. Regarding antipsychotics, initial dosage was a quarter of the allowed initial dosage for younger adults in 39% of prescriptions and metabolic blood testing was performed in 17% of prescriptions. Neurological and cognitive tolerance was monitored in 41% and 61% of prescriptions, respectively. Few clinical factors were found to be associated with compliance or noncompliance with guidelines in older psychiatric inpatients. Practice guidelines on psychotropic drug prescription were partially respected in older inpatients. Practitioners should take into account the risks associated with non-recommended patterns of psychotropic drug use in this vulnerable population.

  6. Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites.

    PubMed

    Sullivan, Helen W; O'Donoghue, Amie C; Rupert, Douglas J; Willoughby, Jessica Fitts; Aikin, Kathryn J

    2017-02-01

    We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks. Participants (Internet panelists with high cholesterol [n = 2,609] or seasonal allergies [n = 2,637]) were randomly assigned to view a website promoting a fictitious prescription drug for their condition. The website presented risk information at the bottom of the homepage, or at the bottom of the homepage with a signal above indicating that the risk information was located below, or on a linked secondary page. We also varied the format of risk information (paragraph, checklist, bulleted list, highlighted box). Participants then answered questions on risk recall and perceptions. Participants recalled fewer drug risks when the risks were placed on a secondary page. The signal had little effect, and risk information format did not affect outcomes. The location of risk information on prescription drug websites can affect consumer knowledge of drug risks; however, signals and special formatting may not be necessary for websites to adequately inform consumers about drug risks. We recommend that prescription drug websites maintain risk information on their homepages to achieve "fair balance" as required by the U.S. Food and Drug Administration.

  7. 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.

  8. Characterizing the relationship between free drug samples and prescription patterns for acne vulgaris and rosacea

    PubMed Central

    Hurley, Michael P.; Stafford, Randall S.; Lane, Alfred T.

    2014-01-01

    Importance Describing the relationship between the availability of free prescription drug samples and dermatologists’ prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician’s office. Objective To investigate the relationships between free drug samples and dermatologists’ local and national prescribing patterns and between the availability of free drug samples and prescription costs. Design, Setting, and Participants Cross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of a nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of either acne vulgaris or acne rosacea in 2010. Main Outcome Measures National trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples. Results On a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase directly correlates with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs

  9. A Decade of Controversy: Balancing Policy With Evidence in the Regulation of Prescription Drug Advertising

    PubMed Central

    Grande, David; Tarn, Derjung M.; Kravitz, Richard L.

    2010-01-01

    Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA. This advertising has some benefits, but significant risks are evident as well, magnified by the prominence of DTCA in population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, the quality and quantity of information should be improved to enable consumers to better self-identify whether treatment is indicated, more realistically appraise the benefits, and better attend to the risks associated with prescription drugs. We propose guidelines for improving the utility of prescription drug advertising. PMID:19910354

  10. Herb-drug interactions. Interactions between saw palmetto and prescription medications.

    PubMed

    Bressler, Rubin

    2005-11-01

    Patients over age 50 typically present with one chronic disease per decade. Each chronic disease typically requires long-term drug therapy, meaning most older patients require several drugs to maintain health. Simultaneously, use of complementary and alternative medicine (CAM) has increased in the United States in the last 20 years, reaching 36% in 2002; herbal medicine use accounts for approximately 22% of all CAM use. Older adults often add herbal medicines to prescription medications, yet do not always inform their physicians. The drug metabolizing enzyme systems process all compounds foreign to the body, including prescription and herbal medications. Therefore use of both medicinals simultaneously has a potential for adverse interactions. This review, which discusses saw palmetto, is the last in a series covering the documented interactions among the top 5 efficacious herbal medicines and prescription drugs.

  11. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising.

    PubMed

    Frosch, Dominick L; Grande, David; Tarn, Derjung M; Kravitz, Richard L

    2010-01-01

    Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA. This advertising has some benefits, but significant risks are evident as well, magnified by the prominence of DTCA in population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, the quality and quantity of information should be improved to enable consumers to better self-identify whether treatment is indicated, more realistically appraise the benefits, and better attend to the risks associated with prescription drugs. We propose guidelines for improving the utility of prescription drug advertising.

  12. The Drug Facts Box: Improving the communication of prescription drug information

    PubMed Central

    Schwartz, Lisa M.; Woloshin, Steven

    2013-01-01

    Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130

  13. The Drug Facts Box: Improving the communication of prescription drug information.

    PubMed

    Schwartz, Lisa M; Woloshin, Steven

    2013-08-20

    Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

  14. Prescription Pain Medications (Opioids)

    MedlinePlus

    ... Drug Facts / Prescription Pain Medications (Opioids) Prescription Pain Medications (Opioids) Print What is prescription opioid misuse? Also ... Hillbilly Heroin, OC, or Vikes Prescription opioids are medications that are chemically similar to endorphins – opioids that ...

  15. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    PubMed Central

    2009-01-01

    Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD) and DDD/1000 persons/day/(DID). Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67) and average annual expense (€21.55 v. €41.14). Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID) being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline) and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities. PMID:19995453

  16. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All... concepts completed to date for each active ingredient associated with approved human prescription drug and... section of labeling. The current intent is to index the basic indication concepts without the...

  17. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Potassium permanganate preparations as... or Prescription Status of Specific Drugs § 250.108 Potassium permanganate preparations as... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports...

  18. 76 FR 77543 - Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Quantitative Summary of the Benefits and Risks of... ``Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review'' (literature review... FDA is announcing the availability of a draft report entitled ``Quantitative Summary of the...

  19. 76 FR 2691 - Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... To Reduce Liver Injury From Unintentional Overdose AGENCY: Food and Drug Administration, HHS. ACTION... safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem...-containing prescription drug products to address new safety information about the risk of liver damage....

  20. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... established to advise the Commissioner: (a) Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the... determination of safety and effectiveness in that class of drugs. (b) Specifically on any particular...

  1. Prescription Opioid Use and Non-fatal Overdose in a Cohort of Injection Drug Users

    PubMed Central

    Lake, Stephanie; Wood, Evan; Buxton, Jane; Dong, Huiru; Montaner, Julio; Kerr, Thomas

    2015-01-01

    Background There is growing concern regarding rising rates of prescription drug-related deaths among the general North American population as well as increasing availability of illicitly obtained prescription opioids. Concurrently among people who inject drugs (IDU), illicit prescription opioid use has increased while non-fatal overdose remains a major source of morbidity. Objectives This study aimed to evaluate whether the use of POs was associated with non-fatal overdose among IDU in Vancouver, Canada. Methods Data was obtained from two open prospective cohorts of IDU between December 2005 and May 2013. We used generalized estimating equation (GEE) logistic regression to evaluate the association between prescription opioid use and non-fatal overdose, adjusting for various social, demographic, and behavioral factors. Results There were 1,614 IDU, including 541 (33.5%) women, who were recruited and included in this analysis. At baseline, 526 (32.6%) reported using POs and 118 (7.3%) reported experiencing an overdose in the previous six months. In a multivariable analysis, prescription opioid use remained independently associated with non-fatal overdose (adjusted odds ratio: 1.61, 95% confidence interval: 1.32–1.95), after adjusting for confounders. Conclusion We observed relatively high rates of prescription opioid use among IDU in this setting, and found an independent association between prescription opioid use and non-fatal overdose. Our data is likely representative of riskier substance use associated with those who use prescription opioids within our sample. Interventions to prevent and respond to overdoses should consider the higher risk profiles of IDU who use prescription opioids. PMID:25699628

  2. 78 FR 26374 - An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ... HUMAN SERVICES Food and Drug Administration An Evaluation of the Prescription Drug User Fee Act Workload... on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an... identified with the docket number found in brackets in the heading of this document. FOR FURTHER...

  3. 78 FR 28860 - Announcement of Requirements and Registration for: “Data Rx: Prescription Drug Abuse Infographic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... abuse and the treatment of drug abusers. Consistent with this authority, one of NIDA's strategic goals... Rx: Prescription Drug Abuse Infographic Challenge'' Authority: 15 U.S.C. 3719. SUMMARY: The ``Data Rx: Prescription Drug Abuse Infographic Challenge Concept'' challenges the general public to create an...

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

    PubMed Central

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

    2016-01-01

    The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

  5. Nonmedical Use of Antihistaminergic Anxiolytics and Other Prescription Drugs among Persons with Opioid Dependence

    PubMed Central

    Abrahamsson, Tove; Kral, Alex H.

    2016-01-01

    Background. Nonmedical prescription drug use (NMPDU) is an increasing problem, insufficiently studied among people in opioid maintenance treatment (OMT). This study investigates the prevalence of and factors associated with NMPDU for drug classes insufficiently described in opioid-dependent populations, including antihistaminergic anxiolytics and central stimulants. Methods. Study participants were recruited at two OMT clinics in Malmo, Sweden, between October 2014 and December 2015 (N = 73) and interviewed about their use, motivations for use, and acquisition and administration of prescription drugs. Results. The majority of the sample reported lifetime NMPDU: 60% for benzodiazepine-like hypnotics (z-drugs), 21% for pregabalin, 19% for stimulants, and 12%–15% for antihistaminergic anxiolytics. Lower age was associated with nonmedical benzodiazepine use (Adjusted Odds Ratio = 0.89; 95% Confidence Interval = 0.82–0.97). Illicit acquisition was reported by 61% of people using z-drugs, 46% of people using pregabalin, and 38% of people using prescription stimulants, but only by 6–10% of people using antihistaminergic anxiolytics. Conclusions. The substantial nonmedical use of pregabalin, z-drugs, and prescription stimulants found in this study suggests that clinicians should prescribe these drugs with great caution. Nonmedical use of antihistaminergic anxiolytics does not seem to be a clinical issue among people in OMT in a Swedish setting, but we propose future studies to monitor their use. PMID:28097037

  6. Nonmedical Use of Antihistaminergic Anxiolytics and Other Prescription Drugs among Persons with Opioid Dependence.

    PubMed

    Dahlman, Disa; Abrahamsson, Tove; Kral, Alex H; Hakansson, Anders

    2016-01-01

    Background. Nonmedical prescription drug use (NMPDU) is an increasing problem, insufficiently studied among people in opioid maintenance treatment (OMT). This study investigates the prevalence of and factors associated with NMPDU for drug classes insufficiently described in opioid-dependent populations, including antihistaminergic anxiolytics and central stimulants. Methods. Study participants were recruited at two OMT clinics in Malmo, Sweden, between October 2014 and December 2015 (N = 73) and interviewed about their use, motivations for use, and acquisition and administration of prescription drugs. Results. The majority of the sample reported lifetime NMPDU: 60% for benzodiazepine-like hypnotics (z-drugs), 21% for pregabalin, 19% for stimulants, and 12%-15% for antihistaminergic anxiolytics. Lower age was associated with nonmedical benzodiazepine use (Adjusted Odds Ratio = 0.89; 95% Confidence Interval = 0.82-0.97). Illicit acquisition was reported by 61% of people using z-drugs, 46% of people using pregabalin, and 38% of people using prescription stimulants, but only by 6-10% of people using antihistaminergic anxiolytics. Conclusions. The substantial nonmedical use of pregabalin, z-drugs, and prescription stimulants found in this study suggests that clinicians should prescribe these drugs with great caution. Nonmedical use of antihistaminergic anxiolytics does not seem to be a clinical issue among people in OMT in a Swedish setting, but we propose future studies to monitor their use.

  7. Data-Driven Identification of Structural Alerts for Mitigating the Risk of Drug-Induced Human Liver Injuries

    DTIC Science & Technology

    2015-02-11

    RESEARCH ARTICLE Open Access Data-driven identification of structural alerts for mitigating the risk of drug-induced human liver injuries Ruifeng Liu...structural alerts before use. Method: To derive human liver toxicity structural alerts, we retrieved all small-molecule entries from LiverTox, a U.S...National Institutes of Health online resource for information on human liver injuries induced by prescription and over-the-counter drugs and dietary

  8. Motivations for Prescription Drug Misuse among Young Adults: Considering Social and Developmental Contexts

    PubMed Central

    LeClair, Amy; Kelly, Brian C.; Pawson, Mark; Wells, Brooke E.; Parsons, Jeffrey T.

    2015-01-01

    Aims As part of a larger study on prescription drug misuse among young adults active in urban nightlife scenes, we examined participants’ motivations for misuse. Prescription painkillers, stimulants and sedatives were the primary substances of interest. Methods Participants were recruited from nightlife venues in New York using time-space sampling. Subjects completed a mixed-methods assessment at project research offices. The data presented here are from a subsample of 70 qualitative interviews conducted during the baseline assessment. Findings We identified experimentation and a “work hard, play hard” ethos as key motivations for misusing prescription drugs and argue that these motivations are specific, though not necessarily unique, to the participants’ social location as young adults. These findings highlight the role of life stage and social context in the misuse of prescription drugs. Conclusion Future studies of prescription drug misuse should pay attention to the larger social contexts in which users are embedded and, therefore, make decisions about how and why to misuse. Moving beyond the very broad concepts of “recreation” and “self-medication” presently established in the research, policies targeting young adults may want to tailor intervention efforts based on motivations. PMID:26709337

  9. Branded prescription drug fee. Final regulations, temporary regulations, and removal of temporary regulations.

    PubMed

    2014-07-28

    This document contains final regulations that provide guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010. This document also withdraws the Branded Prescription Drug Fee temporary regulations and contains new temporary regulations regarding the definition of controlled group that apply beginning on January 1, 2015. The final regulations and the new temporary regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. The text of the temporary regulations in this document also serves as the text of proposed regulations set forth in a notice of proposed rulemaking (REG-123286-14) on this subject in the Proposed Rules section in this issue of the Federal Register.

  10. Supply and demand: negotiating the prescription drug labyrinth to reduce costs.

    PubMed

    DeStefino, Kevin

    2003-01-01

    Prescription drug costs are increasing at a rate of 15% to 17% a year and a look into the future does not bring much better news. Employers can expect to see more numbers like these as doctors more aggressively treat diseases using drug therapy, the population continues to age and pharmaceutical companies continue to spend billions of dollars on direct-to-consumer advertising aimed at consumers who are desensitized to the true costs of their prescriptions. In this environment, it is unlikely that companies can realistically expect to reverse costs of even to avoid cost increases. However, this article provides employers with a prudent approach to managing both the supply and demand sides of the prescription drug equation in order to reduce their level of increase. Supply-side management focuses on negotiations with vendors, while the demand side focuses on managing employee utilization.

  11. Mechanisms of Prescription Drug Diversion Among Impaired Physicians

    PubMed Central

    Cummings, Simone Marie; Merlo, Lisa; Cottler, Linda B.

    2014-01-01

    The diversion of medications by physicians is a seldom discussed problem in the United States. A better understanding of the mechanisms of diversion could assist decision-makers as they seek to develop preventive. To identify these mechanisms, nine focus groups of physicians undergoing monitoring for substance abuse by a state-based physician health program (PHP) were conducted. The content analysis revealed that physicians divert medications by stealing from the office or hospital, by defrauding patients and insurers, by using medication samples, and by misusing valid prescriptions. The implementation of policy interventions targeting these mechanisms has the potential to mitigate the amount of physician diversion that occurs. PMID:21745042

  12. [Rational and emotional appeals in prescription drug advertising: study of a weight loss drug].

    PubMed

    Huertas, Melby Karina Zuniga; Campomar, Marcos Cortez

    2008-04-01

    The Direct-to-Consumer (DTC) advertising of medicines encourages people to ask doctors for certain medicines and treatments that require medical prescription. In order to enhance their persuasive power, advertising models recommend matching the appeals (rational and/or emotional) to the consumer's attitude (cognitive and/ or affective) towards the product. This recommendation leads to controversies in the context of DTC advertising. Emotional appeals, although frequently used, would always be inadequate in that kind of advertising. In absence of empiric evidence of the consumer's perspective, a descriptive research was undertaken with the objective of evaluating: i) the components of the attitude toward medicines; ii) attitude and behavioral intentions in response to DTC ads (one appealing to reason and the other appealing to emotion). A prescription weight loss drug was chosen for this purpose. The results revealed a predominantly cognitive attitude toward the product and an attitude and behavioral intention more favorable to the rational ad. Negative cognition about the product played an outstanding role canceling the persuasive power of emotional appeals.

  13. [Evaluation of electronic drug prescriptions at a university hospital].

    PubMed

    Cassiani, Sílvia Helena; Gimenes, Fernanda Raphael; Freire, Cláudia Câmara

    2002-01-01

    The medical orders have an important role in the prevention of medication errors. The objective of this study is to identify and to analyse the causal factors of error in the medication related to electronic prescription in two different clinics of a university hospital of the interior of the state of São Paulo. A questionnaire related to the advantages and disadvantages of electronic prescription was applied to the professionals of these clinics. The data collected was grouped in accordance with the similarity of the answers. These professionals identified causal factors of errors in the medical orders, but they also mentioned the advantages of it when compared to the manual order, such as bigger readability, rapidity and organization of the first one. As we can see, the computerized system of medical order represents a great advance considering strategies to minimize errors from orders badly formulated. However, it does not eliminate the possibility of occurrence of causal factors of errors in the medication, which asks for some modifications in the system.

  14. A prescription for unemployment? Recessions and the demand for mental health drugs.

    PubMed

    Bradford, W David; Lastrapes, William D

    2014-11-01

    We estimate the relationship between mental health drug prescriptions and the level of labor market activity in the USA. Based on monthly data from the National Ambulatory Medical Care Survey of physicians and aggregated by US census regions, we find that the number of mental health drug prescriptions (those aimed at alleviating depression and anxiety) rises by about 10% when employment falls by 1% and when unemployment rises by 100 basis points, but only for patients in the Northeast region. This paper is one of the first to look at compensatory health behavior in response to the business cycle.

  15. Opportunities for Exploring and Reducing Prescription Drug Abuse Through Social Media.

    PubMed

    Scott, Kevin R; Nelson, Lewis; Meisel, Zachary; Perrone, Jeanmarie

    2015-01-01

    The rising toll of opioid overdoses in the past decade has been declared a prescription drug epidemic by the Centers for Disease Control. In that same period, Internet platforms, such as Facebook and Twitter, have grown exponentially, being used primarily by a population similar to new initiates of substance abuse. Researchers have utilized social media to gain insights into use patterns and prevailing attitudes about various substances. Social media has potential to enhance screening, prevention, and treatment of addiction. With future funding, they should be leveraged to advance understanding of prescription drug use and improve treatment and prevention of abuse.

  16. Insurance Coverage of Prescription Drugs and the Rural Elderly

    ERIC Educational Resources Information Center

    Mueller, Curt; Schur, Claudia

    2004-01-01

    Rural impacts of a Medicare drug benefit will ultimately depend on the number of elderly who are currently without drug coverage, new demand by those currently without coverage, the nature of the new benefit relative to current benefits, and benefit design. Purpose: To enhance understanding of drug coverage among rural elderly Medicare…

  17. Prescription Drugs Associated with Reports of Violence Towards Others

    PubMed Central

    Moore, Thomas J.; Glenmullen, Joseph; Furberg, Curt D.

    2010-01-01

    Context Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others. Objective To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association. Methodology From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms. Main Outcome Measures Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01). Results We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs. Conclusions Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional

  18. A computer-assisted drug prescription system: the model and its implementation in the ATM knowledge base.

    PubMed

    Riou, C; Pouliquen, B; Le Beux, P

    1999-03-01

    Informatisation of drug prescription is an important topic in medical informatics. For several years now, computerized drug databases have been implemented. Usually only a small part of the prescriptions can be stored in prescription systems because of the format of the included information; prescriptions contain essentially free text without any structure and homogeneity of the used vocabulary. In this article a model is presented for knowledge representation in a computerized drug prescription system. The model should be applicable to clinical practice and be didactic for medical students. The problem of standardization of terminology had to be solved. A computer-assisted drug prescription program has been developed. The next step is its validation by clinicians. The program can also be used in a consultation mode.

  19. Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches.

    PubMed

    Carnovale, Carla; Conti, Valentino; Perrone, Valentina; Antoniazzi, Stefania; Pozzi, Marco; Merlino, Luca; Venegoni, Mauro; Clementi, Emilio; Radice, Sonia

    2013-12-01

    The persistent lack of information on the paediatric use of most medicinal products is a major hindrance towards an optimal treatment of paediatric patients. Several studies have documented the high prevalence of off-label use in paediatric population. No comprehensive studies, however, exist that analyse in full all prescriptions for all dispensed drugs, especially in view of the recent intervention by the European Medicine Agency to tackle this issue. We have assessed the drug prescription pattern in the paediatric outpatient population of Lombardy, which has a reliable record of such prescriptions focusing on off-label drug use. We analysed all dispensed outpatient prescriptions to children aged 0-18 years and the proportion of off-label drug use in 2011, using data from the regional administrative prescriptions database. A total of 4,027,119 prescriptions were dispensed, of which 133,619 (3.3 %) were off-label. The anatomical therapeutic chemical classes most involved in off-label prescriptions were antibiotics for systemic use (33,629), alimentary tract and metabolism (31,739) and respiratory tract (31,458). The highest rate (8 %) of off-label drug prescriptions was observed in the age range 0-1. The study revealed also an inappropriate prescription pattern for fluoroquinolones and drugs targeting the cardiovascular and musculoskeletal systems. We identified inappropriate prescriptions for specific drug classes, highlighting the need of increasing pharmacological studies in the paediatric patients and specific critical drugs/drug classes in which such studies are particularly urgent. Depending on the region, inappropriate paediatric drug prescriptions may affect different drug classes, indicating the need of tailoring specific programmes of information.

  20. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  1. 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

  2. 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

  3. A qualitative exploration of prescription opioid injection among street-based drug users in Toronto: behaviours, preferences and drug availability

    PubMed Central

    Firestone, Michelle; Fischer, Benedikt

    2008-01-01

    Background There is evidence of a high prevalence of prescription opioid (PO) and crack use among street drug users in Toronto. The purpose of this qualitative study was to describe drug use behaviours and preferences as well as the social and environmental context surrounding the use of these drugs among young and old street-based drug injection drug users (IDUs). Methods In-depth interviews were conducted with 25 PO injectors. Topics covered included drug use history, types of drugs used, how drugs were purchased and transitions to PO use. Interviews were taped and transcribed. Content analysis was conducted to identify themes. Results Five prominent themes emerged from the interviews: 1) Combination of crack and prescription opioids, 2) First injection experience and transition to prescription opioids, 3) Drug preferences and availability, 4) Housing and income and 5) Obtaining drugs. There was consensus that OxyContin and crack were the most commonly available drugs on the streets of Toronto. Drug use preferences and behaviours were influenced by the availability of drugs, the desired effect, ease of administration and expectations around the purity of the drugs. Distinct experiences were observed among younger users as compared to older users. In particular, the initiation of injection drug use and experimentation with POs among younger users was influenced by their experiences on the street, their peers and general curiosity. Conclusion Given the current profile of street-based drug market in Toronto and the emergence of crack and POs as two predominant illicit drug groups, understanding drug use patterns and socio-economic factors among younger and older users in this population has important implications for preventive and therapeutic interventions. PMID:18928556

  4. Understanding the incomprehensible: a guide to the new Medicare prescription drug benefit for case managers.

    PubMed

    Marshall, Carter L

    2004-01-01

    Much of the health news over the last few months has centered on problems elderly patients encounter in obtaining and effectively using the prescription drug discount cards that became available on June 1 under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This article focuses on the next prescription drug newsmaker, Medicare Part D, that will supercede the discount cards on January 1, 2006. There are many complex issues that case managers must evaluate when assisting beneficiaries with queries about "what to do." This article attempts to clarify the "incomprehensible" twists and turns of these issues and provides access to a "Medicare Drug Prescription Benefit Calculator" that may assist the beneficiary and case manager in decision making. Case managers need to understand that there are many opposing viewpoints on this benefit, and it promises to become the subject of a major national debate. For this reason, substantial changes may occur prior to the launch of Part D. If you think discount drug cards are confusing, "you ain't seen nothin' yet!"

  5. Non-medical prescription drug and illicit street drug use among young Swiss men and associated mental health issues.

    PubMed

    Baggio, Stéphanie; Studer, Joseph; Mohler-Kuo, Meichun; Daeppen, Jean-Bernard; Gmel, Gerhard

    2014-01-01

    Non-medical use of prescription drugs (NMUPD) is increasing among the general population, particularly among teenagers and young adults. Although prescription drugs are considered safer than illicit street drugs, NMUPD can lead to detrimental consequences. The aim of the present study was to investigate the relationship between drug use (NMUPD on the one side, illicit street drugs on the other side) with mental health issues and then compare these associations. A representative sample of 5719 young Swiss men aged around 20 years filled in a questionnaire as part of the ongoing baseline Cohort Study on Substance Use Risk Factors (C-SURF). Drug use (16 illicit street drugs and 5 NMUPDs, including sleeping pills, sedatives, pain killers, antidepressants, stimulants) and mental health issues (depression, SF12) were assessed. Simple and multiple linear regressions were employed. In simple regressions, all illicit and prescription drugs were associated with poorer mental health. In multiple regressions, most of the NMUPDs, except for stimulants, were significantly associated with poorer mental health and with depression. On the contrary, the only associations that remained significant between illicit street drugs and mental health involved cannabis. NMUPD is of growing concern not only because of its increasing occurrence, but also because of its association with depression and mental health problems, which is stronger than the association observed between these problems and illicit street drug use, excepted for cannabis. Therefore, NMUPD must be considered in screening for substance use prevention purposes.

  6. Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    Southwell, Brian G; Rupert, Douglas J

    2016-01-16

    Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions.

  7. Structure-based discovery of prescription drugs that interact with the norepinephrine transporter, NET

    PubMed Central

    Schlessinger, Avner; Geier, Ethan; Fan, Hao; Irwin, John J.; Shoichet, Brian K.; Giacomini, Kathleen M.; Sali, Andrej

    2011-01-01

    The norepinephrine transporter (NET) transports norepinephrine from the synapse into presynaptic neurons, where norepinephrine regulates signaling pathways associated with cardiovascular effects and behavioral traits via binding to various receptors (e.g., β2-adrenergic receptor). NET is a known target for a variety of prescription drugs, including antidepressants and psychostimulants, and may mediate off-target effects of other prescription drugs. Here, we identify prescription drugs that bind NET, using virtual ligand screening followed by experimental validation of predicted ligands. We began by constructing a comparative structural model of NET based on its alignment to the atomic structure of a prokaryotic NET homolog, the leucine transporter LeuT. The modeled binding site was validated by confirming that known NET ligands can be docked favorably compared to nonbinding molecules. We then computationally screened 6,436 drugs from the Kyoto Encyclopedia of Genes and Genomes (KEGG DRUG) against the NET model. Ten of the 18 high-scoring drugs tested experimentally were found to be NET inhibitors; five of these were chemically novel ligands of NET. These results may rationalize the efficacy of several sympathetic (tuaminoheptane) and antidepressant (tranylcypromine) drugs, as well as side effects of diabetes (phenformin) and Alzheimer’s (talsaclidine) drugs. The observations highlight the utility of virtual screening against a comparative model, even when the target shares less than 30% sequence identity with its template structure and no known ligands in the primary binding site. PMID:21885739

  8. 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.

  9. 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.

  10. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    PubMed

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  11. FDA Approvals of Brand-Name Prescription Drugs in 2015

    PubMed Central

    2016-01-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products PMID:27668042

  12. Prescription for Drug Abuse Education: Managing the Mood Changers

    ERIC Educational Resources Information Center

    Yolles, Stanley F.

    1971-01-01

    This article emphasizes the need to prepare youth to make decisions about drug use. To do this it is essential to eliminate hypocrisy about the use of marihuana, to "infuse" the curriculum with drug information and to provide students with realistic learning experiences. (Author)

  13. Use of Antipsychotic Drugs in Individuals with Intellectual Disability (ID) in the Netherlands: Prevalence and Reasons for Prescription

    ERIC Educational Resources Information Center

    de Kuijper, G.; Hoekstra, P.; Visser, F.; Scholte, F. A.; Penning, C.; Evenhuis, H.

    2010-01-01

    Background: We investigated antipsychotic drug prescription practice of Dutch ID physicians, studying prevalence of antipsychotic drug use, reasons for prescription and the relationship between these reasons and patient characteristics. Methods: A cross-sectional study of medical and pharmaceutical records in a population living in residential…

  14. Use of the Internet to Obtain Drugs without a Prescription Among Treatment-involved Adolescents and Young Adults.

    PubMed

    Festinger, David S; Dugosh, Karen L; Clements, Nicolle; Flynn, Anna B; Falco, Mathea; McLellan, A Thomas; Arria, Amelia M

    2016-01-01

    Nonmedical use of prescription drugs is common and poses risks such as injury, overdose, and development of abuse and dependence. Internet pharmacies offer prescription drugs without a prescription, creating a source of illicit drugs accessible to anyone with an Internet connection. We examined this issue in a convenience sample of 1,860 adolescents and young adults from 24 residential and outpatient treatment programs. Few individuals obtained drugs from the Internet (n = 26, 2.3%). Pain relievers were the most frequently purchased type of drug. The majority of adolescents and young adult online purchasers made the purchases from their own or a friend's house.

  15. 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.

  16. 78 FR 9589 - Disclosures To Participate in State Prescription Drug Monitoring Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ...-risk individuals and trends that will assist in the prevention of the accidental or intentional misuse... misuse of prescription drugs and assist in avoiding negative health outcomes for VA patients, including... veteran population such as increased rates of homelessness, suicide attempts, and alcohol and...

  17. Utilizing Business, University, and Community Resources to Target Adolescent Prescription Drug Abuse

    ERIC Educational Resources Information Center

    Wade-Mdivanian, R.; Anderson-Butcher, D.; Hale, K.; Kwiek, N.; Smock, J.; Radigan, D.; Lineberger, J.

    2012-01-01

    "Generation Rx" is a prescription drug abuse prevention strategy which includes a "toolkit" designed to be used with youth. Developed by Cardinal Health Foundation and the Ohio State University, it provides health care providers (especially pharmacists), parents, teachers, youth workers, and other community leaders with…

  18. 45 CFR 156.295 - Prescription drug distribution and cost reporting.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... prescriptions that were provided under the QHP through retail pharmacies compared to mail order pharmacies, and... drugs dispensed, broken down by pharmacy type, which includes an independent pharmacy, supermarket pharmacy, or mass merchandiser pharmacy that is licensed as a pharmacy by the State and that...

  19. [Drugs used for cognitive impairment. Analysis of 1.5 million prescriptions in Argentina].

    PubMed

    Rojas, Galeno; Demey, Ignacio; Arizaga, Raúl L

    2013-01-01

    Cognitive impairment and dementia treatment costs are significant for health systems. According to national and international guidelines, recommended drugs for treatment of dementias are cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and memantine. Despite these guidelines recommendations, other nootropics, vasodilators and antioxidants are often used in Argentina. The purpose of this study was to describe and compare the prescription pattern of commonly used drugs for the treatment of cognitive disorders and dementia in different regions of Argentina. An observational, retrospective study of 1814108 recipes prescribed to National Institute of Social Services for Retired and Pensioners outpatients during the during the second half of 2008 and the first and second half of 2009 was performed, taking in count the whole country and also different Argentina's regions. Demographic variables, quantity and rate of prescriptions, dosage forms and strengths were analyzed. Considering the entire country, memantine was the most prescribed drug in these periods (570893 packages). An increase in the memantine, donepezil, rivastigmine and idebenone rates of prescription was observed. Prescription rate of memantine increased in the North-West and North-East regions, that of idebenone in the North-East region and Patagonia and donepezil in the North-East region. Non recommended drugs were highly prescribed in all the analyzed regions. Some of them were indicated to young and middle-aged patients.

  20. The Relationship between Health Professionals and the Elderly Patient Facing Drug Prescription: A Qualitative Approach

    ERIC Educational Resources Information Center

    Lefevre, Fernando; Teixeira, Jorge Juarez Vieira; Lefevre, Ana Maria Cavalcanti; de Castro, Lia Lusitana Cardozo; Spinola, Aracy Witt de Pinho

    2004-01-01

    Aiming at identifying the relationship between the elderly patient facing drug prescription and health professionals, an exploratory and descriptive study of a qualitative cut was carried out using semi-structured interviews. To this end, the Collective Subject Discourse analysis technique was employed. Thirty elderly patients living in the urban…