Science.gov

Sample records for prescription drugs over-the-counter

  1. Drug Knowledge (Prescription, Over-the-Counter, Social): Young Adult Consumers at Risk?

    ERIC Educational Resources Information Center

    Krupka, Lawrence R.; And Others

    1987-01-01

    Surveyed knowledge of 561 young adults concerning use and effects of various over-the-counter, prescription, and social drug products. College student respondents correctly answered, on the average, 71% of the questions on the Drug Knowledge Test, with women demonstrating somewhat greater knowledge than men. Suggests using this instrument in drug…

  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. Prescription and Over-the-Counter Medications

    MedlinePlus

    ... Charts Emerging Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine ... by acting on the same neurotransmitter systems as cocaine. Opioid pain relievers such as OxyContin ® attach to ...

  4. [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. PMID:21449153

  5. 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

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

    PubMed

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

    2016-01-01

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

  7. 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. PMID:21745037

  8. A review of over-the-counter drug therapy.

    PubMed

    Esmay, J B; Wertheimer, A I

    1979-01-01

    The authors review the extent of the use of nonprescription drugs as well as possible variables influencing such consumption. Various studies indicate that age, sex, personality characteristics, perceptions of health status, socioeconomic factors, parental example, and pharmacists all play parts in determining over-the-counter (OTC) drug utilization. Several sources express concern about the inaccessibility of accurate OTC drug information to the consumer. Indeed, even the FDA has occasional difficulty obtaining reliable facts on both the numbers and formulae of such products. Several studies indicate that consumers acquire information about their home remedies through advertising, friends and relatives, physicians, pharmacists, and product labels. By far the most influential of these is advertising, and much concern has been voiced over consumers' unquestioning faith in drug ads. Examples are cited of deceptive, inaccurate, and unfair advertising practices used by some OTC drug manufacturers. The pros and cons of the "drug-oriented society" theory are discussed, including an analysis of its underlying origins. Testing of the safety and efficacy of nonrescription remedies has proved to be controversial, especially when considering the ramifications of the placebo effect. Different surveys report widespread misuse of OTC's by consumers through overuse, taking several drugs concurrently, and using home remedies to treat potentially serious diseases. PMID:500849

  9. Use of Prescription and Over-the-counter Medications and Dietary Supplements Among Older Adults in the United States

    PubMed Central

    Qato, Dima M.; Alexander, G. Caleb; Conti, Rena M.; Johnson, Michael; Schumm, Phil; Lindau, Stacy Tessler

    2009-01-01

    Context Despite concerns about drug safety, current information on older adults’ use of prescription and over-the-counter medications and dietary supplements is limited. Objective To estimate the prevalence and patterns of medication use among older adults (including concurrent use), and potential major drug-drug interactions. Design, Setting, and Participants Three thousand five community-residing individuals, aged 57 through 85 years, were drawn from a cross-sectional, nationally representative probability sample of the United States. In-home interviews, including medication logs, were administered between June 2005 and March 2006. Medication use was defined as prescription, over-the-counter, and dietary supplements used “on a regular schedule, like every day or every week.” Concurrent use was defined as the regular use of at least 2 medications. Main Outcome Measure Population estimates of the prevalence of medication use, concurrent use, and potential major drug-drug interactions, stratified by age group and gender. Results The unweighted survey response rate was 74.8% (weighted response rate, 75.5%). Eighty-one percent (95% confidence interval [CI], 79.4%–83.5%) used at least 1 prescription medication, 42% (95% CI, 39.7%–44.8%) used at least 1 over-the-counter medication, and 49% (95% CI, 46.2%–52.7%) used a dietary supplement. Twenty-nine percent (95% CI, 26.6%–30.6%) used at least 5 prescription medications concurrently; this was highest among men (37.1%; 95% CI, 31.7%–42.4%) and women (36.0%; 95% CI, 30.2%–41.9%) aged 75 to 85 years. Among prescription medication users, concurrent use of over-the-counter medications was 46% (95% CI, 43.4%–49.1%) and concurrent use of dietary supplements was 52% (95% CI, 48.8%–55.5%). Overall, 4% of individuals were potentially at risk of having a major drug-drug interaction; half of these involved the use of nonprescription medications. These regimens were most prevalent among men in the oldest age

  10. 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. ...

  11. Over-the-counter drugs block heart accumulation of MIBG

    SciTech Connect

    Sherman, P.S.; Fisher, S.J.; Wieland, D.M.; Sisson, J.C.

    1985-05-01

    Previous work in the authors' laboratory using chemically sympathectomized animals showed that > 50% of meta-iodobenzyl-guanidine (MIBG) in the heart is localized in adrenergic nerves. In the present study, commonly used drugs known to alter the uptake and/or release of norepinephrine by adrenergic neurons have been evaluated for their effect on the biodistribution of MIBG. Pseudoephedrine (Sudafed), phenylpropanolamine (Dexatrim) and phenylephrine (Neosynephrine) were administered (5 mg/kg, i.p.) to rats; amphetamine was also evaluated (0.8mg/kg, i.p.). Thirty minutes later I-125-MIBG (0.2-0.4 Ci/mm) was injected i.v.; animals (N=3) were sacrificed 2 h following radiotracer. Compared to controls (N = 3), drug pretreatments resulted in large decreases in radiotracer concentration in adrenergic-rich tissues such as left atrium, left ventricle, spleen and parotid glands. Pseudoephedrine caused decreases (%) of 78, 57, 48 and 35 in the four tissues, respectively. Each of the four drugs caused a greater decrease in I-125-MIBG concentration in the left atrium than in the left ventricle. Comparative studies using H-3-norepinephrine are in progress. Entex, a nasal decongestant containing both phenylephrine and phenylpropanolamine, markedly diminished the heart and salivary gland accumulation of I-123-MIBG in a normal male volunteer. These preliminary studies suggest that commonly used sympathomimetic agents, including some over-the-counter preparations, decrease the accumulation of MIBG in adrenergic neurons. These results also suggest that patients should be carefully screened for drug usage prior to MIBG scintigraphy of the heart.

  12. Over-the-Counter Medicines

    MedlinePlus

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

  13. Adverse drug reactions and drug-drug interactions with over-the-counter NSAIDs.

    PubMed

    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

  14. 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...

  15. 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...

  16. Over-the-Counter Drugs: A Challenge for Drug Education

    ERIC Educational Resources Information Center

    Serrone, David M.

    1973-01-01

    Drug education should be a complete program including information on the all too frequently overused group of self medicaments. Misuse of these drugs by self medication may, in many circumstances, lead to serious consequences. Knowledge of their use should be an effort of every drug education program. (Author)

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Over-the-counter drugs for minor sore throats... Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and... anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over...

  18. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Over-the-counter drugs for minor sore throats... Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and... anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over...

  19. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Over-the-counter drugs for minor sore throats... Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and... anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over...

  20. Periconceptional Over-the-Counter Nonsteroidal Anti-inflammatory Drug Exposure and Risk for Spontaneous Abortion

    PubMed Central

    Velez Edwards, Digna R.; Aldridge, Tiara; Baird, Donna D.; Funk, Michele Jonsson; Savitz, David A.; Hartmann, Katherine E.

    2012-01-01

    Objective To estimate the association between over-the-counter nonsteroidal anti-inflammatory drug (NSAID) exposure during the early first-trimester and risk for spontaneous abortion (gestation prior to 20 weeks) in a prospective cohort. Methods Women were enrolled in the Right from the Start study (2004–2010). Exposure data regarding over-the-counter NSAID use from the last menstrual period through the 6th week of pregnancy were obtained from intake and first-trimester interviews. Pregnancy outcomes were self-reported and verified by medical records. Gestational age was determined from last menstrual period. Stage of development prior to loss was determined from study ultrasound. Cox proportional hazards regression models were used to estimate the association between NSAID exposure and pregnancy outcome, taking into account candidate confounders. Results Among 2,780 pregnancies, 367 women (13%) experienced an spontaneous abortion. NSAID exposure was reported by 1,185 (43%) women. NSAID exposure was not associated with spontaneous abortion risk in unadjusted models (hazard ratio [HR] = 1.01, 95% confidence interval [CI] 0.82, 1.24) or models adjusted for maternal age (adjusted [aHR] = 1.00, 95% CI 0.81, 1.23). Conclusions Our findings suggest that use of non-prescription over-the-counter NSAIDs in early pregnancy does not put women at increased risk of spontaneous abortion. PMID:22914399

  1. Hispanic youth involvement in over-the-counter drug use: parent, peer, and school factors.

    PubMed

    Vidourek, Rebecca A; King, Keith A; Fehr, Sara K

    2014-01-01

    Research on substance use among Hispanic youth is lacking. The purpose of this study was to examine over-the-counter drug use among Hispanic youth. Of Hispanic youth, 23.9% used an over-the-counter drug for the purpose of getting high. Involvement in prosocial behaviors was correlated with decreased over-the-counter use for females and high school students. Involvement in risky behaviors increased the risk of use for males, females, junior high school students, and high school students. Significant differences were found based on parent, peer, teacher, and school factors. Prevention and intervention programs should address over-the-counter drug use among Hispanic youth. PMID:25310268

  2. 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

  3. 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. PMID:25730505

  4. 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…

  5. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products marketed as over-the-counter (OTC) daytime sedatives. 310.519 Section 310.519 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.519 Drug products...

  6. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products marketed as over-the-counter (OTC) daytime sedatives. 310.519 Section 310.519 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.519 Drug products...

  7. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section... products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign... the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the...

  8. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section... products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign... the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the...

  9. 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 ...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    .... On June 15, 2007, the Department of Defense published a notice in the Federal Register (FR) (72 FR..., the Department published a notice in the FR (74 FR 66626- 66627) on December 16, 2009 that extended... of the Secretary TRICARE Over-the-Counter Drug Demonstration Project AGENCY: Office of the...

  11. 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

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Format and content requirements for over-the-counter (OTC) drug product labeling. 201.66 Section 201.66 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.66 Format...

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543... containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic... potential for serious risk to patients using these drug products. The bioavailability of pancreatic...

  19. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543... containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic... potential for serious risk to patients using these drug products. The bioavailability of pancreatic...

  20. 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. PMID:16861144

  1. 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 PMID:26312772

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

    PubMed

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

    2015-08-01

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

  3. 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

  4. 21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief. 310.538 Section 310.538 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs...

  5. 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

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  6. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527 Section 310.527 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  7. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  8. 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

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. 310.532 Section 310.532 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  9. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for...

  10. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. 310.543 Section 310.543 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  11. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. 310.542 Section 310.542 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for...

  12. 21 CFR 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent. 310.536 Section 310.536 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements...

  13. Skin protectant drug products for over-the-counter human use; final monograph. Final rule.

    PubMed

    2003-06-01

    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) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of the ongoing review of OTC drug products conducted by FDA. The final monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on skin protectant drug products for these specific uses that have come to the agency's attention. This final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC skin protectant ingredients that have been found to be not generally recognized as safe and effective. This final rule also lifts the stay of 21 CFR part 352 (published at 66 FR 67485, December 31, 2001) to amend the final monograph for OTC sunscreen drug products to include sunscreen-skin protectant combination drug products, and then stays Sec. 347.20(d) (21 CFR 347.20(d)) and part 352 until further notice in the Federal Register. PMID:12785379

  14. 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. PMID:26861972

  15. 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

    ... any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices §...

  16. 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

    ... any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices §...

  17. 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

    ... any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices §...

  18. 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

    ... any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices §...

  19. 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

    ... any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. 310... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices §...

  20. Over-the-counter drugs: factors in adult use of sedatives, tranquilizers, and stimulants.

    PubMed Central

    Bell, R

    1984-01-01

    Despite a growing research interest in over-the-counter (OTC) drug use, little information has been available about the determinants of use for this category of medications. The researcher examined the effects of demographic, need, and physician utilization measures on the use of 10 OTC drugs that were categorized as sedatives, tranquilizers, or stimulants. A statewide survey in 1975 of drug-using behavior in the previous year by Illinois adults ages 18-59 resulted in 2,738 questionnaires that could be analyzed. Thirteen variables, representing the demographic, need, and physician utilization characteristics of the respondents, were entered as predictors into logistic multiple regression models to estimate their effects on drug use. Only 10.37 percent of the respondents indicated that they had used any of the OTC drugs in the previous year. Sedative use was found to be increased in persons who were tense or were having trouble sleeping. Having trouble sleeping also increased the probability of using OTC tranquilizers and stimulants. Women had a much higher probability of using OTC tranquilizers than men, and men had a higher probability of using stimulants. Non-whites had a higher probability of using tranquilizers than did whites. Stimulants were more likely to be used by younger adults and unmarried adults. Physician utilization, measured by the number of visits to physicians, did not significantly affect OTC drug use. PMID:6429733

  1. 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

  2. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a...

  3. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a...

  4. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a...

  5. 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

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a...

  6. 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

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Topically applied hormone-containing drug products... for Specific New Drugs or Devices § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use. (a) The term “hormone” is used broadly to describe a...

  7. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule.

    PubMed

    2011-06-17

    The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004). PMID:21682059

  8. Accuracy of information on printed over-the-counter drug advertisements.

    PubMed

    Sansgiry, S; Sharp, W T; Sansgiry, S S

    1999-01-01

    Direct-to-consumer drug advertising is a useful medium for educating people and disseminating product information. Consumers make product purchase decisions based on the information gained from advertisements. If advertisements are misleading, consumers may not have adequate drug knowledge to detect this misinformation. The objective of this study was to evaluate print advertisements for over-the-counter (OTC) products. Five clinical pharmacists evaluated print advertisements appearing in three consumer periodicals. Advertisements were selected over a nine month period beginning January 1994. Accuracy of information on OTC advertisements was determined based on federal guidelines. Additionally, reviewers identified deficiencies in advertisements that may mislead consumers. According to reviewers, around 50% of advertisements lacked accurate statements. Side effects were indicated on only one advertisement. All advertisements were indicated by reviewers to be more promotional than educational. Reviewers indicated that more than 50% of advertisements lacked information essential for consumers to make an informed choice during self-medication decisions. This study indicates that OTC drug advertisements lack information necessary for consumers to make informed purchase decisions. Inaccurate information and lack of information on side effects could mislead consumers causing harmful adverse events. PMID:11010213

  9. 78 FR 57397 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Announcement of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash Products; Announcement of Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

  10. A Study on the Dispensing Pattern of Over the Counter Drugs in Retail Pharmacies in Sarjapur Area, East Bangalore

    PubMed Central

    Chakraborty, Ananya; Srinivas, B.N

    2015-01-01

    Background Over the counter drugs (OTC) are sold without the prescription of a registered medical practitioner. There are reports that OTC drug market in India is on the rise. This is attributed to the rising cost of health care, difficulty in accessing healthcare, and an alarming tendency to self manage symptoms. The outcome of this is OTC related adverse effects, abuse, and hospitalizations. Literature on OTC is sparse. Hence this study was undertaken to evaluate the dispensing pattern of OTC drugs in retail pharmacies in Sarjapur area, East Bangalore. Materials and Methods The study was conducted in 3 retail pharmacies in Sarjapur area, Bangalore East. The duration of the study was for a period of 10 days from August 1st to August 10th 2014. The common complaints for which the patients frequented the pharmacies were observed and recorded .The investigator personally interviewed the patients between 6pm to 9pm, near the respective pharmacies. During this study period around 216 patients visited pharmacies without prescription. The drugs supplied to 216 patients by private pharmacies without prescription was recorded. Data was analysed by descriptive statistics using Microsoft Excel. Results and Observations Most commonly dispensed OTC drugs were analgesics (26.8%). The other categories of medications dispensed were antihistamines (15.2%), antacids (14.8%), antibiotics (10%), antipyretics (7.8%), Oral contraceptive (OC pills) (5.09%) and others (20%). The commonly dispensed antibiotics were Cefadroxil (250mg) for dental infection and Levofloxacin (500mg) for upper respiratory tract infection. The most common complaint for the use of OTC drugs was pain (25%). It was noted that 55.09% of the dispensed drugs belonged to schedule H. However, 13% patients were aware regarding the harmful effects of drugs. Conclusion The use of OTC drugs is alarmingly high in Bangalore East. Pharmacists have to be trained and educated regarding rationale dispensing of drugs. The need

  11. 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

    ..., 2013 (78 FR 57397), FDA announced that it would hold a public hearing on December 4, 2013, to obtain... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency...

  12. 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. 310.537 Section 310.537 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or initially delivered for introduction into interstate commerce that is not in compliance with...

  13. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores. 310.537 Section 310.537 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or initially delivered for introduction into interstate commerce that is not in compliance with...

  14. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores. 310.537 Section 310.537 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or initially delivered for introduction into interstate commerce that is not in compliance with...

  15. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores. 310.537 Section 310.537 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... or initially delivered for introduction into interstate commerce that is not in compliance with...

  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

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. 310.542 Section 310.542 Food...) Hyperphosphatemia is a condition in which an abnormally high plasma level of phosphate occurs in the blood....

  17. 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

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and...) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood....

  18. 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...

  19. 21 CFR 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin... ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs... (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs...

  20. 21 CFR 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin... ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs... (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs...

  1. 21 CFR 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin... ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs... (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs...

  2. 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

  3. 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

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 17, 2011 (76 FR 35669) (the June 17... Effectiveness Testing final rule that published in the Federal Register of June 17, 2011 (76 FR 35620). FDA is...-ZA40 Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information...

  4. Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.

    PubMed

    2003-12-01

    The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM). PMID:14664244

  5. Over the counter drugs. The interface between the community pharmacist and patients.

    PubMed

    Bond, C M; Bradley, C

    1996-03-23

    Pharmacists play an important part in primary health care, and their accessibility is a key factor. Their NHS payments relate predominantly to the dispensing of prescribed medicines; to recognise the service element of their advisory role, an NHS funded professional fee could be built into the cost structure for pharmacy medicines. The increased number of medicines available over the counter has highlighted the need for training for counter assistants; it will become compulsory in July 1996, and some family health services authorities are providing this. The shift to care in the community could mean that pharmacists will have an even greater role in the primary health care team. Encouraging the public to seek advice from the community pharmacist may lead to a greater proportion of visits to doctors resulting from referrals from the pharmacist. Joint development by pharmacists and doctors of guidelines for advice on, and recommendation of, over the counter medicines is needed. PMID:8605465

  6. 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...

  7. 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

    ... 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...

  8. 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

    ... 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...

  9. 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

    ... 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...

  10. 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

    ... 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  16. 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

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific...

  17. 77 FR 66182 - TRICARE Over-the-Counter Drug Demonstration Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... a notice in the Federal Register (72 FR 33208-33210) implementing the demonstration project until... beneficiary satisfaction with the project, the Department published a notice in the Federal Register (74 FR... beneficiary satisfaction of providing OTC drugs under the pharmacy benefits program when the selected...

  18. 76 FR 12916 - Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... of gum, lozenges, or candy is an effective OTC drug product for weight control'' (47 FR 8466 at 8474... were published in the Federal Register as an ANPR for OTC weight control products in 1982 (47 FR 8466... daily) Group 4: Glucose hard candy containing benzocaine, caffeine, and vitamins (benzocaine...

  19. Prescription Drugs

    MedlinePlus

    ... body, especially in brain areas involved in the perception of pain and pleasure. Prescription stimulants , such as ... of drug that causes changes in your mood, perceptions, and behavior can affect judgment and willingness to ...

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

    PubMed Central

    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. PMID:26106606

  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. PMID:26106606

  2. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 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...

  4. 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...

  5. 21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  6. Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule.

    PubMed

    2007-03-29

    The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products. PMID:17450664

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

    Will, Catherine M; Weiner, Kate

    2015-04-01

    This paper draws on a study of over-the-counter statins to provide a critical account of the figure of the 'pharmaceutical consumer' as a key actor in the pharmaceuticalisation literature. A low dose statin, promising to reduce cardiovascular risk, was reclassified to allow sale in pharmacies in the UK in 2004. We analysed professional and policy debates about the new product, promotional and sales information, and interviews with consumers and potential consumers conducted between 2008 and 2011, to consider the different consumer identities invoked by these diverse actors. While policymakers constructed an image of 'the citizen-consumer' who would take responsibility for heart health through exercising the choice to purchase a drug that was effectively rationed on the NHS and medical professionals raised concerns about 'a flawed consumer' who was likely to misuse the product, both these groups assumed that there would be a market for the drug. By contrast, those who bought the product or potentially fell within its target market might appear as 'health consumers', seeking out and paying for different food and lifestyle products and services, including those targeting high cholesterol. However, they were reluctant 'pharmaceutical consumers' who either preferred to take medication on the advice of a doctor, or sought to minimize medicine use. In comparison to previous studies, our analysis builds understanding of individual consumers in a market, rather than collective action for access to drugs (or, less commonly, compensation for adverse effects). Where some theories of pharmaceuticalisation have presented consumers as creating pressure for expanding markets, our data suggests that sociologists should be cautious about assuming there will be demand for new pharmaceutical products, especially those aimed at prevention or asymptomatic conditions, even in burgeoning health markets. PMID:24954520

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

    PubMed

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

    2015-09-01

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

  10. 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...

  11. 21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores... the treatment of fever blisters and cold sores. (a) l-lysine (lysine, lysine hydrochloride... products to treat fever blisters and cold sores. There is a lack of adequate data to establish...

  16. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. 310.546... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in...

  17. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. 310.546... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in...

  18. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. 310.546... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in...

  19. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. 310.546... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in...

  20. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. 310.546... of nocturnal leg muscle cramps. (a) Quinine sulfate alone or in combination with vitamin E has been... muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in...

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

    MedlinePlus

    ... pain if they follow the directions on the product label. But taking too much can lead to liver ... pain if they follow the directions on the product label. But taking too much can lead to liver ...

  2. 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 ...

  3. 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.

  4. Medicare Prescription Drug Coverage

    MedlinePlus

    ... D is the name of Medicare's prescription drug coverage. It's insurance that helps people pay for prescription ... monthly cost. Private companies provide Medicare prescription drug coverage. You choose the drug plan you like best. ...

  5. 76 FR 35678 - SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... described in the May 21, 1999, final rule (64 FR 27666 at 27689 through 27693) or the SPF test method described in the August 27, 2007, proposed rule (72 FR 49070 at 49114 through 49119). We believe that the..., 1999 (64 FR 13254), we amended our regulations governing requirements for human drug products...

  6. Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (Over The Counter) in Surabaya, Indonesia

    PubMed Central

    2010-01-01

    Background Antimicrobial resistance is an increasing problem in developing countries and antibiotic use is widespread. Our previous surveys in Java, Indonesia, revealed that most antibiotic use was probably unnecessary or ineffective. The aim of this study was to explore a potential connection between resistance and substandard antibiotics sold in the area. Methods A cross-sectional field study using the simulated client method was conducted in Surabaya. Five first-line antibiotics were requested with or without prescription (OTC). A certified laboratory analysed the drug content using validated methods. Possible determinants of substandard quality were explored. Results In total, 104 samples from 75 pharmacies, ten drug stores and 39 roadside stalls (kiosks) were obtained. Pharmacy employees filled all OTC requests. Three quarters of kiosks sold antibiotics. Antibiotics were dispensed as single blister strips or repackaged (16%) without label. Ninety five percent of samples carried the label of 14 Indonesian manufacturers. The pharmaceutical quality did not meet BP standards for 18% of samples. Deviations (less active ingredient) were small. There was no association between low content and type of outlet, sold with or without prescription, registration type, price or packaging. Median retail prices of products carrying the same label varied up to 20 fold. Conclusions Antibiotics were available OTC in all visited pharmacies and sold in the streets of an Indonesian city. Most samples contained an active ingredient. We urge to increase enforcement of existing regulations, including legislation that categorizes antibiotics as prescription-only drugs for all types of medicine outlets, to limit further selection of antimicrobial resistance. PMID:20618975

  7. 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. PMID:11820251

  8. Effective over-the-counter acne treatments.

    PubMed

    Bowe, Whitney P; Shalita, Alan R

    2008-09-01

    Acne is the most common disease of the skin, yet only a fraction of acne sufferers are treated with prescription products by physicians. There is, however, a large and expanding market for over-the-counter (OTC) medications, many of which are not only effective but also well tolerated and cosmetically elegant. Given the presence of OTC acne medications on the television, the Internet, and store shelves, patients will be acutely aware of these OTC remedies and will have questions. Patients will expect dermatologists to advise them regarding products to use either as a sole therapy or in combination with prescription drugs. Recently, combinations of OTC acne medications in treatment regimens or "kits" have gained popularity and appear to have increased patient compliance. Quality-of-life outcomes from OTC medication use, in at least one study, have demonstrated good benefit. The most common OTC ingredients include benzoyl peroxide, a potent antibacterial agent, and salicylic acid, a mild comedolytic and antiinflammatory medication. Other, less-common OTC ingredients include sulfur, sodium sulfacetamide, and alpha hydroxy acids. Zinc, vitamin A, tea tree oil, and ayurvedic therapies also are available OTC for acne. Additional and better studies are needed to clarify the benefit of these latter medications. PMID:18786494

  9. 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...

  10. 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

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean... such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  11. 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...

  12. 21 CFR 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  14. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  15. 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

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  16. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS..., petrolatum, phenol, pine tar, rosin, rosin cerate, sassafras oil, sulfur, thymol, triclosan, and zinc oxide... general recognition of the safety and effectiveness of these or any other ingredient for OTC use for...

  17. 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. PMID:25369643

  18. 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

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  19. 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

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  20. 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

    ..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  1. 76 FR 35669 - Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... (ANPR) (43 FR 38206 at 38207, 38223, 38224, 38229, and 38239) as lip protectants, which are allowed to... products (72 FR 49070), several submissions recommended that we include the following dosage forms in the... Food and Drug Administration 21 CFR Part 352 RIN 0910-ZA40 Sunscreen Drug Products for...

  2. Prescription Drug Abuse

    MedlinePlus

    ... what the doctor prescribed, it is called prescription drug abuse. It could be Taking a medicine that ... purpose, such as getting high Abusing some prescription drugs can lead to addiction. These include narcotic painkillers, ...

  3. Prescription Drug Abuse

    MedlinePlus

    ... what the doctor prescribed, it is called prescription drug abuse. It could be Taking a medicine that was ... prescription drugs can lead to addiction. These include narcotic painkillers, sedatives, tranquilizers, and stimulants. Every medicine has ...

  4. Treating Prescription Drug Addiction

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... View all ​Research Reports Opioids: The Prescription Drug & Heroin Overdose Epidemic (HHS website) NIDA Home Site Map ...

  5. Acute generalized exanthematous pustulosis: A rare side effect of a common over-the-counter drug, Acetylsalicylic acid.

    PubMed

    Bahuguna, Amit

    2013-07-01

    Acute generalized exanthematous pustulosis is an uncommon cutaneous reaction characterized by sudden onset of generalized non-follicular aseptic pustules. It is most often secondary to drugs but causes as varied from viral infection to insect bites are reported. A case report of a 48-year-old male who developed pustular eruptions after taking acetylsalicylic acid is reported here. Clinicians need to be aware of this entity when dealing with pustular rash as this rare side effect of a very common drug is both, easy to miss and easy to manage. PMID:23984244

  6. 76 FR 7743 - Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use; Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-11

    ... monograph for OTC laxative drug products published January 15, 1985 (50 FR 2124), FDA proposed labeling for... document March 21, 1975 (40 FR 12902), Recommendations of the Advisory Review advance notice of proposed... preparation of the colon for x-ray and endoscopic examination. (50 FR 12902 at 12940 and 12942) January...

  7. 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

    ... published at 69 FR 53801, September 3, 2004. FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug...OTCRulemakings/ucm072134.htm . In the Federal Register of May 12, 1993 (58 FR 28194), we published a proposed... radiation (58 FR 28194 at 28232 and 28233). The proposed rule referenced published UVA test methods but...

  8. 21 CFR 201.322 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... analgesic/antipyretic active ingredients; required alcohol warning. 201.322 Section 201.322 Food and Drugs... containing internal analgesic/antipyretic active ingredients; required alcohol warning. (a) People who regularly consume large quantities of alcohol (three or more drinks every day) have an increased risk...

  9. Atmospheric identification of active ingredients in over-the-counter pharmaceuticals and drugs of abuse by atmospheric pressure glow discharge mass spectrometry (APGD-MS).

    PubMed

    Brewer, Tim M; Verkouteren, Jennifer R

    2011-09-15

    Atmospheric pressure glow discharge mass spectrometry was used to characterize the active ingredients in pharmaceutical over-the-counter (OTC) drug formulations (Tylenol Allergy, Alka-Seltzer Plus Nighttime, Sudafed, Aleve and Mucinex DM) and drugs of abuse (crack cocaine, methamphetamine, MDMA (ecstasy) and hydrocodone). Material was desorbed and directly ionized under atmospheric conditions by allowing the substance to come in direct contact with the plasma followed by mass spectrometric detection. With this technique, controlled substances and OTC medications were readily distinguished from one another. Characteristic mass spectra were identified for the active ingredients in the OTC and drugs of abuse. Importantly, all drug compounds studied here, both OTC and illicit, demonstrated signals for either molecular ions or protonated molecules as well as fragmentation patterns that are readily identified in the National Institute of Standards and Technology (NIST) electron ionization (EI) mass spectral library. It is believed that this technique holds promise for forensic and law enforcement communities for real-time atmospheric analysis of drugs with database-searchable spectra of controlled substances. PMID:21818799

  10. Gold nanoparticles bridging infra-red spectroscopy and laser desorption/ionization mass spectrometry for direct analysis of over-the-counter drug and botanical medicines.

    PubMed

    Chau, Siu-Leung; Tang, Ho-Wai; Ng, Kwan-Ming

    2016-05-01

    With a coating of gold nanoparticles (AuNPs), over-the-counter (OTC) drugs and Chinese herbal medicine granules in KBr pellets could be analyzed by Fourier Transform Infra-red (FT-IR) spectroscopy and Surface-assisted Laser Desorption/Ionization mass spectrometry (SALDI-MS). FT-IR spectroscopy allows fast detection of major active ingredient (e.g., acetaminophen) in OTC drugs in KBr pellets. Upon coating a thin layer of AuNPs on the KBr pellet, minor active ingredients (e.g., noscapine and loratadine) in OTC drugs, which were not revealed by FT-IR, could be detected unambiguously using AuNPs-assisted LDI-MS. Moreover, phytochemical markers of Coptidis Rhizoma (i.e. berberine, palmatine and coptisine) could be quantified in the concentrated Chinese medicine (CCM) granules by the SALDI-MS using standard addition method. The quantitative results matched with those determined by high-performance liquid chromatography with ultraviolet detection. Being strongly absorbing in UV yet transparent to IR, AuNPs successfully bridged FT-IR and SALDI-MS for direct analysis of active ingredients in the same solid sample. FT-IR allowed the fast analysis of major active ingredient in drugs, while SALDI-MS allowed the detection of minor active ingredient in the presence of excipient, and also quantitation of phytochemicals in herbal granules. PMID:27086100

  11. 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. PMID:26242457

  12. Spatial Access to Syringe Exchange Programs and Pharmacies Selling Over-the-Counter Syringes as Predictors of Drug Injectors' Use of Sterile Syringes

    PubMed Central

    Des Jarlais, Don C.; Ross, Zev; Tempalski, Barbara; Bossak, Brian; Friedman, Samuel R.

    2011-01-01

    Objectives. We examined relationships of spatial access to syringe exchange programs (SEPs) and pharmacies selling over-the-counter (OTC) syringes with New York City drug injectors’ harm reduction practices. Methods. Each year from 1995 to 2006, we measured the percentage of 42 city health districts’ surface area that was within 1 mile of an SEP or OTC pharmacy. We applied hierarchical generalized linear models to investigate relationships between these exposures and the odds that injectors (n = 4003) used a sterile syringe for at least 75% of injections in the past 6 months. Results. A 1-unit increase in the natural log of the percentage of a district's surface area within a mile of an SEP in 1995 was associated with a 26% increase in the odds of injecting with a sterile syringe; a 1-unit increase in this exposure over time increased these odds 23%. A 1-unit increase in the natural log of OTC pharmacy access improved these odds 15%. Conclusions. Greater spatial access to SEPs and OTC pharmacies improved injectors’ capacity to engage in harm reduction practices that reduce HIV and HCV transmission. PMID:21088267

  13. Editorial: Pills over the counter.

    PubMed

    1975-05-17

    A pamphlet published by the Birth Control Trust and followed by a letter in the British Medical Journal has recommended that paramedical personnel be allowed to dispense oral contraceptives if properly supervised. Also, others have recommended that these drugs should be on direct sale to the public. However, because of the multiple risk factors, there is a place for screening before the pills are prescribed. The main objection to freeing the pill from prescription would be the abdication of medical responsibility for supply of potentially dangerous drugs. For an exception to be made for oral contraceptives there should be evidence of a clear benefit to society, which is not believed to be the case. Present contraceptive services would not be improved if the pill went on display on the counters of chemists' shops. PMID:1131602

  14. Asthma medications should be available for over-the-counter use: pro.

    PubMed

    Gerald, Joe K; Wechsler, Michael E; Martinez, Fernando D

    2014-07-01

    Medications that provide quick relief of symptoms and that control airway inflammation are the mainstays of asthma treatment. However, adherence to these medications is suboptimal. The inconvenience and costs associated with obtaining these prescription-only medications are factors that contribute to poor adherence. The Food and Drug Administration recently requested public comment on a new paradigm whereby specific prescription-only medications could be made available over the counter, provided that conditions for their safe use could be established. Many organizations expressed opposition, including the American Thoracic Society and other societies representing patients with respiratory diseases. These organizations cited unsubstantiated benefits and unnecessary risks as reasons to oppose greater over-the-counter availability of current prescription-only medications. This article examines the rationale for, and potential ramifications of, making asthma medications available for nonprescription use. PMID:24964037

  15. Prescription Drugs and Cold Medicines

    MedlinePlus

    ... Abuse » Prescription Drugs & Cold Medicines Prescription Drugs & Cold Medicines Email Facebook Twitter What is Prescription Drug Abuse: ... treatment of addiction. Read more Safe Disposal of Medicines Disposal of Unused Medicines: What You Should Know ( ...

  16. 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…

  17. 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…

  18. 21 CFR 201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. 201.21 Section 201.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions...

  19. 21 CFR 201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. 201.21 Section 201.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions...

  20. 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

    2010-03-01

    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. PMID:20383916

  1. Prescription Drug Abuse

    MedlinePlus

    ... Fitness Diseases & Conditions Infections Q&A School & Jobs Drugs & Alcohol Staying Safe Recipes En Español Making a Change – Your Personal Plan Hot Topics Meningitis Choosing Your Mood Prescription Drug Abuse Healthy School Lunch Planner How Can I ...

  2. 21 CFR 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C). 369.3 Section 369.3 Food and Drugs FOOD AND DRUG... RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

  3. Preventing and Recognizing Prescription Drug Abuse

    MedlinePlus

    ... Abuse » Preventing and recognizing prescription drug abuse Prescription Drug Abuse Email Facebook Twitter Preventing and recognizing prescription drug abuse To ensure proper medical care, patients should discuss ...

  4. Trends in Prescription Drug Abuse

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... View all ​Research Reports Opioids: The Prescription Drug & Heroin Overdose Epidemic (HHS website) NIDA Home Site Map ...

  5. Over-the-counter medicines

    MedlinePlus

    ... anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev . 2013;6:CD006362. PMID: 23733384 www. ... paracetamol) for the common cold in adults. Cochrane Database Syst Rev . 2013;7:CD008800. PMID: 23818046 www. ...

  6. 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 ...

  7. Usage Patterns of Over-the-counter Phenazopyridine (Pyridium)

    PubMed Central

    Shi, Chih-Wen; Asch, Steven M; Fielder, Eve; Gelberg, Lillian; Brook, Robert H; Leake, Barbara; Shapiro, Martin F; Dowling, Patrick; Nichol, Michael B

    2003-01-01

    OBJECTIVES Little is known about how the public uses formerly prescription medications that are available over-the-counter (OTC). This study examines whether consumers inappropriately use and substitute a recently widely distributed OTC urinary analgesic, phenazopyridine, for provider care. DESIGN/SETTING We conducted a cross-sectional survey of a stratified cluster random sample of OTC phenazopyridine purchasers (N = 434) in 31 Los Angeles retail pharmacies over 5 months. Recruited by shelf advertisements, participants were 18 years or older who purchased a phenazopyridine product. Each completed a 25-item self-administered anonymous questionnaire. Inappropriate use was defined as 1) having medical contraindications to phenazopyridine, or 2) not having concurrent antibiotic and/or provider evaluation for the urinary symptoms. RESULTS The survey response rate was 58%. Fifty-one percent of the respondents used OTC phenazopyridine inappropriately, and 38% substituted it for medical care. Multiple logistic regression analyses revealed that inappropriate use was correlated with having little time to see a provider (odds ratio [OR], 1.57; 95% confidence interval [95% CI], 1.26 to 1.96), receiving friend's or family's advice (OR, 1.25; 95% CI, 1.05 to 1.47), having prior urinary tract infections (OR, 0.49; 95% CI, 0.30 to 0.80), having used prescription phenazopyridine, (OR, 0.40; 95% CI, 0.25 to 0.63), and having back pain (OR, 0.34; 95% CI, 0.16 to 0.74). Similar correlates were found in those who substituted OTC phenazopyridine for provider care. Respondents with incorrect knowledge about phenazopyridine's mode of action had 1.9 times greater odds of inappropriate use and 2.2 times greater odds of substitution than those who had correct knowledge about this drug. CONCLUSION Inappropriate use of OTC phenazopyridine appears common. Increasing the public's knowledge about reclassified drugs may help to mitigate this problem. PMID:12709095

  8. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  9. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  10. 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...

  11. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  12. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  13. 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…

  14. 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

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  15. 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

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  16. 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

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  17. 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

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  18. 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

    ... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as... ingredient. The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and scopolamine (l- hyoscine... ingredients as an anticholinergic for cough-cold use. Belladonna alkaloids for inhalation use, as contained...

  19. 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. PMID:25556261

  20. Research Reports: Prescription Drug Abuse

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... since 1999, and by 2007, outnumbered those involving heroin and cocaine. NIDA hopes to change this situation ...

  1. Indices of drug misuse for prescription drugs.

    PubMed

    Davis, H; Baum, C; Graham, D J

    1991-07-01

    Few studies of prescription-drug misuse have taken into account the numbers of prescriptions dispensed for specific drugs. Using data from the Drug Abuse Warning Network (DAWN) and the National Prescription Audit, we calculated indices of drug misuse for specific prescription drugs that are used mainly in outpatient settings and are either benzodiazepines, barbiturates, other sedative-hypnotics, analgesics, or CNS stimulants. In 1983-1985 the drugs associated with the highest numbers of DAWN medical examiner-reported drug-misuse deaths were codeine, diazepam, propoxyphene, phenobarbital, and secobarbital. However, the drugs with the highest indices of DAWN medical examiner-reported drug-misuse deaths/100,000 dispensed prescriptions were methamphetamine, methaqualone, amobarbital, secobarbital, and glutethimide. An index of fatality risk, calculated as 100 x DAWN medical examiner-reported drug-misuse deaths/DAWN emergency room-reported drug-misuse episodes, suggested that the risk of death from a glutethimide-associated drug-misuse episode had increased 92% from 1975-1979 to 1983-1983 and in 1983-1985 was the highest for the drugs studied. These indices might assist public health authorities attempting to design effective strategies to efficiently address the problem of prescription-drug misuse. PMID:1960000

  2. Medicare prescription drug discount cards.

    PubMed

    Bryant, Natasha

    2004-01-01

    With the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003 came the creation of a Part D drug benefit through Medicare. Until that benefit is implemented, Medicare has established a drug discount card program to help your clients save money on their outpatient prescription drug expenses. In this brief, we discuss the Medicare-approved discount cards--who is eligible, how they work, how your clients can best make important decisions about them, and what help is out there for people with low incomes. PMID:15224690

  3. Evaluation of knowledge, attitude, and practice of community pharmacists toward administration of over-the-counter drugs for the treatment of diarrhea in children: A pretest–posttest survey

    PubMed Central

    Foroughinia, Farzaneh; Zarei, Pedram

    2016-01-01

    Objective: In this study, we aimed to assess knowledge, attitude, and practice of community pharmacists toward administration of over-the-counter (OTC) antidiarrheal drugs in our city pharmacies, Shiraz, Iran. Methods: In this descriptive cross-sectional study, 90 pharmacies among 128 pharmacies in our city were randomly chosen. The study was designed into two phases: A standard questionnaire to determine the level of knowledge and attitude of pharmacists and a simulated client method to evaluate practice among them. An educational pamphlet was then given to the pharmacists. One month later, knowledge, attitude, and performance of studied pharmacists were evaluated again using the same method. Findings: Our results showed that an average consultation time by female pharmacists was considerably more than male pharmacists (P < 0.001). Before intervention, only 37.8% of pharmacists performed appropriately by prescribing the proper medicine while this increased to 58.44% after intervention. The average score of pharmacists’ knowledge was statistically increased (P < 0.001) and the pharmacists’ performance was significantly improved (P < 0.001) after the educational intervention. In related to the attitude, pharmacists’ tendency toward prescribing oral rehydration salt solutions (ORS) (P < 0.001) and their belief about the great effect of ORS on the treatment of diarrhea increased significantly after the intervention. Conclusion: It is concluded that training programs such as educational pamphlets and continuing educational seminars may play important roles in increasing pharmacists’ knowledge and therefore improving their performance in prescribing OTC medicines. PMID:27512712

  4. An over-the-counter omission.

    PubMed

    Scheurer, Danielle Bowen

    2006-09-01

    Despite the widespread use of over-the-counter (OTC) medications, their utilization is rarely ascertained at hospital admission. Presented here is an interesting case of acute renal failure and hemolytic anemia attributable to a commonly utilized OTC medication. The chronic use of phenazopyridine accounted for all of these findings. Upon discontinuation, everything normalized within one month. Although the differential diagnosis for renal failure and hemolytic anemia is extensive, scleral icterus, normal bilirubin, and orange-colored urine raised the suspicion of phenazopyridine use. This case report highlights overuse of common OTC medications, as well as a lack of knowledge of potential adverse reactions. With history-taking vigilance and patient education, adverse events from OTC medications can be minimized. PMID:17004539

  5. New 'Superlice' Resist Most Over-The-Counter Remedies

    MedlinePlus

    ... page: https://medlineplus.gov/news/fullstory_160878.html New 'Superlice' Resist Most Over-the-Counter Remedies But ... rather never see in the first place. A new report warns that over-the-counter products have ...

  6. Substance use - prescription drugs

    MedlinePlus

    ... T2, T3, T4, and dors and fours. Codeine syrup mixed with soda can have street namses such ... drugs, they come as powder, pills or capsules, syrup. They can be swallowed, injected, smoked, put into ...

  7. What Are Some Commonly Abused Prescription Drugs?

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... View all ​Research Reports Opioids: The Prescription Drug & Heroin Overdose Epidemic (HHS website) NIDA Home Site Map ...

  8. 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 ...

  9. Oral contraceptives as an over-the-counter medication.

    PubMed

    Halperin, E C

    1994-05-01

    Five physicians debate the pros and cons of changing the prescription requirement for oral contraceptives (OCs) to an over-the-counter (OTC) status. Three of the physicians are in favor of changing the present policy, while the other 2 physicians are in favor of keeping the present policy. Reasons supporting a change to OTC OCs are: the health risks from an unwanted pregnancy are greater than the risks from OC use; the prescription requirement puts an expensive and unnecessary burden on women; and other countries (e.g., India and South Africa) dispense OCs OTC. Reasons for keeping the prescription requirement are: the potential risks of self medication; the possibility of inappropriate use by relatively uninformed patients; and the loss of opportunity for women to obtain a health evaluation, physical examination, and counseling. One family practice physician supports OTC status because this change may reduce the teenage pregnancy rate. She acknowledges, however, that the change will not solve the problem of teenage pregnancy. An advantage of OTC OCs is that women could use them as a postcoital contraceptive. Another physician in favor of OTC status for OCs suggests that the US health department and Planned Parenthood clinics could offer OCs at lower than retail cost to women who undergo an annual health examination. Another physician calls for randomized clinical trials to generate sufficient data to make an informed decision about public and medical policy changes. PMID:8035888

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

    PubMed

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

    2014-08-01

    In recent years, the non-medical use of prescription drugs (without a doctor's prescription) has increased dramatically. Less attention has been paid to the intentional misuse of over-the-counter (OTC) medications. Misuse of OTC medications has negative health consequences similar to those of illicit drugs, including psychosis, tachycardia, seizures and agitation. When mixed with alcohol or other drugs, these medications can also be dangerous: OTC-related emergency room visits increased 70% from 2004 to 2008. This study examined the intentional misuse of OTC medications, the non-medical use of prescription drugs, the use of alcohol and illicit drugs, and psychological factors in two samples of young adults (ages 18-25) from different areas of the United States (Total N = 1,197). Overall, 18.6% of the Colorado sample and 13.0% of the Virginia sample reported lifetime misuse of an OTC medication. Participants who reported misusing OTC medications were also significantly more likely to report using marijuana, ecstasy, cocaine, and non-medical use of prescription analgesics, stimulants, anxiolytics, and sedatives. Participants who reported misusing OTC medications were more than twice as likely to report hazardous alcohol use, relative to individuals who denied misusing OTC medications. Individuals who had misused OTC medications scored significantly higher in sensation seeking and hopelessness and reported more symptoms of depression, anxiety, and somatic distress, relative to those who denied OTC misuse. Results suggest that a considerable minority of young adults are jeopardizing their health with the misuse of OTC medications as part of a pattern of polysubstance use. PMID:24338111

  11. 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…

  12. 21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... for over-the-counter (OTC) use under the OTC drug review. 330.13 Section 330.13 Food and Drugs FOOD...-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.13 Conditions for marketing ingredients recommended for over-the-counter...

  13. 21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for over-the-counter (OTC) use under the OTC drug review. 330.13 Section 330.13 Food and Drugs FOOD...-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.13 Conditions for marketing ingredients recommended for over-the-counter...

  14. 21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... for over-the-counter (OTC) use under the OTC drug review. 330.13 Section 330.13 Food and Drugs FOOD...-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.13 Conditions for marketing ingredients recommended for over-the-counter...

  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. PMID:23245611

  16. 21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review. 330.13 Section 330.13 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE...

  17. Over-the-counter self-medication leading to intracranial hypertension in a young lady.

    PubMed

    Ramana Reddy, A M; Prashanth, L K; Sharat Kumar, G G; Chandana, G; Jadav, Rakesh

    2014-10-01

    Intracranial hypertension (idiopathic-IIH and secondary) is a potentially treatable condition. Although various factors such as female gender and obesity, certain drugs have been implicated as risk factors for IIH, there remains a lack of clarity in the exact causal-effect relationship. In India, self-medication by obtaining drugs over the counter due to lack of adequate drug regulation and ignorance of the public is a very common practice with a potential for severe adverse effects. We present a case of a young lady who has developed intracranial hypertension possibly due to self-medication with steroids and cyproheptadine, obtained over the counter. PMID:25288841

  18. 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... preliminary fee calculation is valid and justifies an adjustment to the preliminary fee calculation....

  19. 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... 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...

  20. Are You Shopping Smart for Prescription Drugs?

    MedlinePlus

    ... struggled for years to keep their prescription drug costs under control. Now, they finally have a resource that provides comparative cost and effectiveness of those drugs. Consumer Reports magazine, ...

  1. 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

  2. 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. PMID:27416314

  3. 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. PMID:24611822

  4. 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

  5. Closing the Prescription Drug Coverage Gap

    MedlinePlus

    ... name drugs when you buy them at a pharmacy or order them through the mail. • Some coverage ... savings if you buy your prescriptions at a pharmacy or order them through the mail. The discount ...

  6. 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

  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 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) * * *...

  8. 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) * * *...

  9. 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)...

  10. 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)...

  11. 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) * * *...

  12. 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)...

  13. 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) * * *...

  14. 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) * * *...

  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. 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. PMID:19838560

  17. Prescription Drug Abuse: A Fast-Growing Problem | NIH MedlinePlus the Magazine

    MedlinePlus

    ... also pose serious health risks related to their abuse. The medications most commonly abused are: Pain relievers - 5.1 ... million Among adolescents, prescription and over-the-counter ... 20 reported abuse of OxyContin. When asked how prescription pain relievers ...

  18. 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. PMID:3228083

  19. 76 FR 68295 - Reducing Prescription Drug Shortages

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ....) THE WHITE HOUSE, October 31, 2011. [FR Doc. 2011-28728 Filed 11-2-11; 11:15 am] Billing code 3295-F2-P ... Documents#0;#0; ] Executive Order 13588 of October 31, 2011 Reducing Prescription Drug Shortages By the... hereby ordered as follows: Section 1. Policy. Shortages of pharmaceutical drugs pose a serious...

  20. Are You Shopping Smart for Prescription Drugs?

    MedlinePlus

    ... program. Photo courtesy of Sara Jorde Photography A new Consumer Reports project compares prescription drugs on effectiveness, safety, ... arthritis, or back pain flare up. While the new Medicare Part D program pays a good portion ... Union, the magazine's publisher, translates the drug findings ...

  1. 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,...

  2. Overdose in infant caused by over-the-counter cough medicine.

    PubMed

    Pugach, Sofya; Pugach, Isaac Z

    2009-04-01

    Each year consumers purchase about 95 million units of over-the-counter medications for pediatric use, an unsafe application that can cause life-threatening effects. Despite a warning from the Food and Drug Administration, many parents or caregivers continue to administer these remedies to children. This report describes the case of a 4-month-old infant presenting to the emergency department with acute life-threatening intoxication including altered mental status, impaired coordination of movements, as well as a positive urine drug test for phencyclidine and an elevated serum ethanol level. Further evaluation uncovered that the actual reason for all clinical symptoms and laboratory test results was over-the-counter cough syrup. PMID:19279531

  3. Recreational Prescription Drug Use among College Students

    ERIC Educational Resources Information Center

    Kolek, Ethan A.

    2009-01-01

    The purpose of this study was to explore recreational prescription drug use among undergraduate students. Although anecdotal accounts on this subject abound, empirical research is extremely limited. Data from a survey of a random sample of 734 students at a large public research university in the Northeast were examined. Results indicate that a…

  4. 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... Specific Drug Products § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

  5. 21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Ipecac syrup; warnings and directions for use for... Specific Drug Products § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

  6. 21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Ipecac syrup; warnings and directions for use for... Specific Drug Products § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

  7. 21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Ipecac syrup; warnings and directions for use for... Specific Drug Products § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Ipecac syrup; warnings and directions for use for... Specific Drug Products § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale... poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for...

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

    PubMed Central

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

    2009-01-01

    Background Acute infective conjunctivitis is a common presentation in general practice. In 2005, three placebo-controlled clinical trials showed that use of topical antibiotics had a small effect on time to clinical resolution. In the same year, chloramphenicol eye drops were made available for sale over the counter. Aim To compare the relative impact of clinical trial evidence and a change to over-the-counter availability on community use of topical chloramphenicol. Design of study Observational study using mainly routinely collected data for England. Setting National prescribing data for England and local data from general practices in Oxfordshire, England. Method Data were collated from three sources: GP prescriptions from the Prescription Pricing Authority, wholesale supply to pharmacists from IMS Health, and an audit of delayed prescribing and non-prescribing from electronic consultation records for acute conjunctivitis, in four general practices. Results The number of general practice prescriptions for topical chloramphenicol fell from 2.3 million in 2004 to 1.9 million in 2007, a reduction of 15.5%. In contrast, over-the-counter sales by pharmacists have increased steadily. The net effect of these changes has been a 47.8% increase in total chloramphenicol use during 2005–2007, with 1.1 million additional packs being used in 2007 compared to 2004. Conclusion Making an antibiotic available over the counter increases its use substantially. This is in conflict with the important public health message that antibiotic use needs to be reduced to combat resistance. These findings support the views of the Chief Medical Officer that no more antibiotics should currently be made available over the counter. PMID:20875257

  10. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Prescription drugs for human use. 201.100 Section 201.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.100 Prescription drugs for human use. A drug subject to...

  11. 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 (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.100 Prescription drugs for human use. A drug subject to...

  12. 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. PMID:24168912

  13. 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…

  14. 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…

  15. Prescription Drug Expenditures and Population Demographics

    PubMed Central

    Morgan, Steven G

    2006-01-01

    Objective To provide detailed demographic profiles of prescription drug utilization and expenditures in order to isolate the impact of demographic change from other factors that affect drug expenditure trends. Data Sources/Study Setting Demographic information and drug utilization data were extracted for virtually the entire British Columbia (BC) population of 1996 and 2002. All residents had public medical and hospital insurance; however their drug coverage resembled the mix of private and public insurance in the United States. Study Design A series of research variables were constructed to illustrate profiles of drug expenditures and drug utilization across 96 age/sex strata. Data Collection/Extraction Methods Drug use and expenditure information was extracted from the BC PharmaNet, a computer network connecting all pharmacies in the province. Principal Findings Per capita drug expenditures increased at an average annual rate of 10.8 percent between 1996 and 2002. Population aging explained 1.0 points of this annual rate of expenditure growth; the balance was attributable to rising age/sex-specific drug expenditures. Conclusions Relatively little of the observed increase in drug expenditures in BC could be attributed to demographic change. Most of the expenditure increase stemmed from the age/sex-specific quantity and type of drugs purchased. The sustainability of drug spending therefore depends not on outside forces but on decisions made by policy makers, prescribers, and patients. PMID:16584456

  16. Enhancing prescription drug innovation and adoption.

    PubMed

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

    2011-06-21

    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 marketplace 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

  17. 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 (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.100 Prescription...

  18. Abuse of over-the-counter dextromethorphan by teenagers.

    PubMed

    Murray, S; Brewerton, T

    1993-10-01

    Dextromethorphan, the d-isomer of the opiate agonist levorphanol, has none of the analgesic or sedative effects associated with the opiates and is approved for over-the-counter use as an antitussive. It is available, in various combinations with other medications, in nonprescription cough suppressant and common cold formulations, and its availability in the United States is not controlled. In this paper we have reported two cases of recreational use of dextromethorphan-containing cough syrup by two unrelated teenage boys. Despite the safety of this medication when used at the recommended dosage, there have been cases of "recreational" use of dextromethorphan as well as death by overdose. Although usually thought to be nonaddictive, dextromethorphan produces a substance dependence syndrome, and physicians should be aware of its abuse potential, particularly by youths. PMID:8211334

  19. Understanding the implications of over the counter statin sales.

    PubMed

    Nuttall, Michaela

    Coronary heart disease (CHD) is the UK's biggest killer. While recommending that all patients can benefit from lifestyle interventions, the current guidelines focus pharmacological management on those at high risk. An over the counter (OTC) statin would enable people with moderate (10-15 per cent) CHD risk to take preventive action. Pharmacists would be able to recommend OTC simvastatin to those at moderate risk by following a simple pharmacy protocol to assess a person's risk. A regime of 10 mg simvastatin daily would have a significant impact on both the low-density lipoprotein cholesterol (LDL-C) level and the CHD risk of those at moderate risk. Cholesterol testing would not be mandatory but would be available in pharmacy to enable people to monitor their progress. PMID:15192918

  20. 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 ...

  1. Constructing a Real-Time Prescription Drug Monitoring System

    PubMed Central

    Lee, Youn Tae; Jo, Emmanuel C.

    2016-01-01

    Objectives The objective of this investigation was to demonstrate the possibility of the construction of a real-time prescription drug monitoring system (PDMOS) using data from the nationwide Drug Utilization Review (DUR) system in Korea. Methods The DUR system collects information on drug prescriptions issued by healthcare practitioners and on drugs dispensed by pharmacies. PDMOS was constructed using this data. The screen of PDMOS is designed to exhibit the number of drug prescriptions, the number of prescriptions dispensed by pharmacies, and the dispensed prescription drug costs on a daily and weekly basis. Data was sourced from the DUR system between June 1, 2016 and July 18, 2016. The TOGA solution developed by the EYEQMC Co. Ltd. of Seoul, Korea was used to produce the screen shots. Results Prescription numbers by medical facilities were more numerous than the number of prescriptions dispensed by pharmacies, as expected. The number of prescriptions per day was between 2 to 3 million. The prescriptions issued by primary care clinics were most numerous, at 75% of the total number of prescriptions. Daily prescription drug costs were found to be approximately US $50 million. The prescription drug costs were highest on Mondays and were reduced towards the end of the week. Prescriptions and dispensed prescriptions numbered approximately 1,200 and 1,000 million, respectively. Conclusions The construction of a real-time PDMOS has been successful to provide daily and weekly information. There was a lag time of only one day at the national level in terms of information extraction, and scarcely any time was required to load the data. Therefore, this study highlights the potential of constructing a PDMOS to monitor the estimate the number of prescriptions and the resulting expenditures from prescriptions. PMID:27525159

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

    PubMed

    Both, Leonard; Botgros, Radu; Cavaleri, Marco

    2015-01-01

    Antimicrobial resistance is recognised as a growing problem that seriously threatens public health and requires prompt action. Concerns have therefore been raised about the potential harmful effects of making antibiotics available without prescription. Because of the very serious concerns regarding further spread of resistance, the over-the-counter (OTC) availability of antibiotics was analysed here. Topical and systemic OTC antibiotics and their indications were determined across 26 European Union (EU) countries and Norway by means of a European survey. We identified a total of 48 OTC products containing 20 different single antibiotics and three antibiotic combinations as active substances, used mainly as topical preparations in short treatment courses. Given the relevance of these medicines and the increasing risk of antimicrobial resistance, it is important to limit the availability of OTC antibiotics and to monitor their use. PMID:26530125

  3. 21 CFR 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Conditions for marketing ingredients recommended... Administrative Procedures § 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC... and will not await publication of a final monograph. Marketing of such a product with a formulation...

  4. Prescription Drug Misuse and Sexual Behavior among Young Adults

    PubMed Central

    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 the alarming increases in prescription drug misuse and the role of demographic characteristics in sexual risk behavior and outcomes, the current study examines 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 (18–29) who misuse 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. PMID:25569204

  5. 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

  6. Prescription drug laws: justified hard paternalism.

    PubMed

    Rainbolt, George W

    1989-01-01

    Prescription drug laws are justified as examples of permissible hard paternalism and not as soft paternalism, which is morally legitimated by the defective cognitive or affective state of the individual on whose behalf the action is performed. Other examples of hard paternalism are considered, along with two strategies for determining the limits of paternalism. It is concluded that instances of permissible hard paternalism exist and that the only acceptable strategy is to balance harm and benefit on a case-by-case basis. PMID:11650113

  7. 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

  8. 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

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

    PubMed Central

    Chan, Zoe Yee Ting; McPherson, Bradley

    2015-01-01

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

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

    PubMed

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

    2008-09-01

    Ideas of participation and partnership in health care consultations have attracted increasing attention in recent years; however the consequences in terms of the necessary shifts in existing relationships are often overlooked. We examine how pharmacists work to maintain their professional expertise against the rise of health-care consumerism. We draw on the following data from a UK study of consultations for over-the-counter (OTC) medicines in two pharmacies: (i) an outline of the pharmacy owners' views of their practice model, (ii) data from observations and tape recorded consultations (iii) interviews with customers and pharmacists and (iv) views expressed in two feedback sessions discussing vignettes developed from observational and interview-based fieldwork. There was no suggestion that attempts to engage customers in discussions about their treatment necessitated a diminution of the importance of pharmaceutical expertise. Indeed, both pharmacists and customers acknowledged the importance of the asymmetry of knowledge between pharmacists and customers. Pharmaceutical expertise was however not always perceived to be necessary and transactions in pharmacies may be treated like those in any other retail environment. Further research using a larger dataset to investigate problems in interactions resulting from tensions between pharmaceutical expertise and consumerism is indicated. PMID:18761511

  11. Prescription Drug Misuse Among Club Drug-Using Young Adults

    PubMed Central

    Kelly, Brian C.; Parsons, Jeffrey T.

    2009-01-01

    Nonmedical prescription (Rx) drug use has recently increased, particularly among young adults. Using time-space sampling to generate a probability-based sample of club-going young adults (18–29), 400 subjects provided data on Rx drug misuse. Club-going young adults misuse Rx drugs at high rates. An overwhelming majority of the sample indicated lifetime use of pain killers, sedatives, and stimulants. A majority indicated recent pain killer use. Variations by gender and sexuality exist in this population. Young lesbian/bisexual women emerged as the group most likely to abuse Rx drugs. Research into the contexts influencing these patterns is imperative. PMID:17994483

  12. 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…

  13. 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...

  14. 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...

  15. Prescription drug abuse. Patient, physician, and cultural responsibilities.

    PubMed

    Wesson, D R; Smith, D E

    1990-05-01

    The abuse of prescription drugs is one facet of America's drug problem that is particularly complex because access to prescription drugs must be maintained for some purposes and contained for others. The American Medical Association has sponsored two national conferences to grapple with the confluence of the medical access to prescription drugs and a national drug abuse control policy. One result has been a classification of misprescribing physicians that blames physicians for prescription drug abuse. The conceptualization and public policy response to prescription drug abuse have been largely shaped by the emotional response to the epidemic of crack cocaine and other nonprescription drug abuse. A new perspective is needed--one that accommodates the evolving role of physicians in society, the life-style choices that physicians enable in their patients, and the respective responsibilities of both physicians and patients in physician-patient transactions. PMID:2349802

  16. Correlates of Prescription Drug Market Involvement among Young Adults

    PubMed Central

    Vuolo, Mike; Kelly, Brian C.; Wells, Brooke E.; Parsons, Jeffrey T.

    2014-01-01

    Background While a significant minority of prescription drug misusers report purchasing prescription drugs, little is known about prescription drug selling. We build upon past research on illicit drug markets, which increasingly recognizes networks and nightlife as influential, by examining prescription drug market involvement. Methods We use data from 404 young adult prescription drug misusers sampled from nightlife scenes. Using logistic regression, we examine recent selling of and being approached to sell prescription drugs, predicted using demographics, misuse, prescription access, and nightlife scene involvement. Results Those from the wealthiest parental class and heterosexuals had higher odds (OR=6.8) of selling. Higher sedative and stimulant misuse (ORs=1.03), having a stimulant prescription (OR=4.14), and having sold other illegal drugs (OR=6.73) increased the odds of selling. College bar scene involvement increased the odds of selling (OR=2.73) and being approached to sell (OR=2.09). Males (OR=1.93), stimulant users (OR=1.03), and sedative prescription holders (OR=2.11) had higher odds of being approached. Discussion College bar scene involvement was the only site associated with selling and being approached; such participation may provide a network for prescription drug markets. There were also differences between actual selling and being approached. Males were more likely to be approached, but not more likely to sell than females, while the opposite held for those in the wealthiest parental class relative to lower socioeconomic statuses. Given that misuse and prescriptions of sedatives and stimulants were associated with prescription drug market involvement, painkiller misusers may be less likely to sell their drugs given the associated physiological dependence. PMID:25175544

  17. Chasing the Bean: Prescription Drug Smoking among Socially Active Youth

    PubMed Central

    Kelly, Brian C.; Vuolo, Mike; Pawson, Mark; Wells, Brooke E.; Parsons, Jeffrey T.

    2015-01-01

    Background Alternative consumption practices of prescription drug misuse have been less well monitored than general prevalence. We describe prescription drug smoking among socially active youth and highlight correlates of this practice. We also examine its association with drug problems, drug dependence, and mental health. Methods We surveyed 404 young adults recruited from nightlife venues in New York via time-space sampling. We use linear and logistic regression models to examine the probability of smoking prescription drugs and its association with drug problems, dependence, and mental health. Qualitative findings supplement the survey data. Results Males have higher odds than females (OR=3.4) and heterosexuals have higher odds than sexual minority youth (OR=2.3) of smoking prescription drugs. Those involved in Electronic Dance Music nightlife have higher odds (OR=2.1) compared to those who do not participate in that scene, while those in college bar scenes have lower odds (OR=0.4) of having smoked prescription drugs. Prescription drug smokers report more drug problems (β=0.322) and greater symptoms of dependence (β=0.298) net of the frequency of misuse and other characteristics. Prescription drug smokers do not report greater mental health problems. Qualitative interview data support these survey findings. Conclusions Prescription drug smoking is a significant drug trend among socially active youth. It is associated with drug problems and symptoms of dependence net of frequency of misuse. Prevention and intervention efforts for youth who misuse prescription drugs should address the issue of prescription drug smoking, and this may be an area for clinicians to address with their adolescent patients. PMID:26003578

  18. 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. PMID:26274819

  19. 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

  20. How Medicare Prescription Drug Plans & Medicare Advantage Plans with Prescription Drug Coverage (MA-PDs) Use Pharmacies,...

    MedlinePlus

    ... drug. Example of step therapy Step 1 —Dr. Smith wants to prescribe a new sleeping pill to ... sleeping pill available. Some of the drugs Dr. Smith considers prescribing are brand-name only prescription drugs. ...

  1. A Drug Interest Survey of Senior High School Students.

    ERIC Educational Resources Information Center

    Sutherland, Mary S.

    The purpose of this study is to determine the drug interests of a senior high school population via a question-writing technique. Specific drug interests in the areas of herbal drugs, illicit drugs, over-the-counter drugs, prescription drugs, and commercial drugs were examined by requesting students to write out what questions they felt their…

  2. 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.…

  3. 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…

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

    MedlinePlus

    ... Bookstore How to Order from the National Technical Information Service NCHS Strategies Used by Adults to Reduce Their Prescription Drug ... conducted over the telephone. The Family component collects information on ... Questions about strategies to reduce prescription drug cost are from the ...

  5. 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. PMID:27265843

  6. 77 FR 46653 - Branded Prescription Drug Fee; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ..., August 18, 2011 (76 FR 51310). The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish... 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...

  7. 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…

  8. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing means the transmission... 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...

  9. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing means the transmission... 42 Public Health 3 2011-10-01 2011-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and...

  10. 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…

  11. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... professional practice. Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing... 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...

  12. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... professional practice. Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing... 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...

  13. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... professional practice. Electronic media has the same meaning given this term in 45 CFR 160.103. E-prescribing... 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...

  14. Over-the-counter sleep aids: widely used but rarely studied.

    PubMed

    Pillitteri, J L; Kozlowski, L T; Person, D C; Spear, M E

    1994-01-01

    Over-the-counter (OTC) sleep aids are used in greater proportions than benzodiazepines for the treatment of sleep problems, yet limited research has focused on these nonprescription drugs. This article reports the results of two studies that examined the use of OTC sleep aids and alcohol for sleep problems by university students. Of those subjects in both studies who reported sleep problems 1 day per month or more, 6.4% of men and 11.4% of women reported using OTC sleep aids, however, a significantly greater percentage of men reported using alcohol to induce sleep (23.4% vs. 10.9%, p < .008). Future studies on OTC sleep aids are recommended to address a broader range of issues such as potential side effects and at-risk populations, tolerance effects, and individual differences in responsiveness and sensitivity to these drugs. PMID:7703708

  15. 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

  16. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

    ... 159779.html FDA OKs Non-Prescription Use of Acne Drug Differin Gel 0.1% is first retinoid ... July 8, 2016 (HealthDay News) -- Good news for acne sufferers: The U.S. Food and Drug Administration has ...

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

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... died from overdoses of any other drug, including heroin and cocaine combined—and many more needed emergency ...

  18. Influences of Motivational Contexts on Prescription Drug Misuse and Related Drug Problems

    PubMed Central

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

    2014-01-01

    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. PMID:25115134

  19. 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. PMID:25115134

  20. 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

  1. 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

  2. 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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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. 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... for human use. A drug subject to the requirements of section 503(b)(1) of the act shall be exempt...

  5. 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. PMID:20469541

  6. Effect of over-the-counter dosages of naproxen sodium and acetaminophen on plasma lithium concentrations in normal volunteers.

    PubMed

    Levin, G M; Grum, C; Eisele, G

    1998-06-01

    Prescription doses of nonsteroidal antiinflammatory agents have been shown to decrease clearance and increase plasma concentrations of lithium. This study was designed to evaluate whether over-the-counter (OTC) doses of naproxen sodium or acetaminophen have the same potential to affect lithium concentration. This was a prospective, crossover, 3-phase study conducted at the Clinical Pharmacology Studies Unit of the Albany Medical Center Hospital during July and August of 1995. The 3-phase study comprised the following: phase 1, lithium carbonate (300 mg every 12 hours) alone for 7 days; phase 2, lithium and either naproxen sodium (220 mg every 8 hours) or acetaminophen (650 mg every 6 hours) for 5 days; and phase 3, a 2-day washout period followed by a crossover to lithium with the alternate drug (acetaminophen or naproxen sodium) for 5 days. Twelve healthy male volunteers were recruited, nine of whom completed the study and were included in the statistical analysis. Mean (+/-SD) plasma lithium concentrations for subjects in treatment group 1 (lithium in phase 1, lithium and naproxen sodium in phase 2, lithium and acetaminophen in phase 3) were 0.38 (+/-0.11), 0.40 (+/-0.07), and 0.36 (+/-0.11) mEq/L, respectively. Mean plasma lithium concentrations for subjects in treatment group 2 (lithium in phase 1, lithium and acetaminophen in phase 2, lithium and naproxen sodium in phase 3) were 0.43 (+/-0.05), 0.48 (+/-0.10), and 0.48 (+/-0.05) mEq/L, respectively. One-way repeated-measures analysis of variance and paired t-test showed no statistically significant differences (p>0.05) in plasma lithium concentrations during any phase of the study. The results of this study demonstrated that OTC doses of naproxen sodium and acetaminophen did not increase plasma lithium concentrations in these volunteers when taken for short periods of time. PMID:9617983

  7. Initiation into Prescription Opioid Misuse among Young Injection Drug Users

    PubMed Central

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

    2011-01-01

    Background Prescription opioids are the most frequently misused class of prescription drugs among young adults. Initiation into prescription opioid misuse is an important public health concern since opioids are increasingly associated with drug dependence and fatal overdose. Descriptive data about initiation into prescription opioid misuse among young injection drug users (IDUs) are scarce. Methods An exploratory qualitative study was undertaken to describe patterns of initiation into prescription opioid misuse among IDUs aged 16 to 25 years. Those young IDUs who had misused a prescription drug at least three times in the past three months were recruited during 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 analysed both quantitatively and qualitatively. Results Initiation into prescription opioid misuse was facilitated by easy access to opioids via participant’s own prescription, family, or friends, and occurred earlier than misuse of other illicit drugs, such as heroin. Nearly all transitioned into sniffing opioids, most injected opioids, and many initiated injection drug use with an opioid. Motives for transitions to sniffing and injecting opioids included obtaining a more potent high and/or substituting for heroin; access to multiple sources of opioids was common among those who progressed to sniffing and injecting opioids. Conclusion Prescription opioid misuse was a key feature of trajectories into injection drug use and/or heroin use among this sample of young IDUs. A new pattern of drug use may be emerging whereby IDUs initiate prescription opioid misuse before using heroin. PMID:21689917

  8. "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

  9. 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

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

    PubMed

    Simonson, William

    2013-01-01

    The article reviews the literature on the role of the pharmacist in patient counseling and discusses how that role may apply to patients with frequent heartburn who are seeking an over-the-counter (OTC) treatment. Searches of the National Library of Medicine PubMed database were conducted using the terms "heartburn," "nonprescription," "therapy," "pharmacist," and "counseling," supplemented by additional searches on counseling for prescription products, and by the author's knowledge of pharmacy practice and the scientific literature. Accurate recognition of the signs of heartburn are an important first step in counseling a patient on the appropriate OTC medication; immediate referral to a health care provider is mandatory if cardiac pain or certain gastrointestinal symptoms are present. When counseling a patient about treatments for heartburn, the pharmacist should practice effective listening in an environment that is conducive to communication by the patient. Proton pump inhibitors are effective for the treatment of heartburn; the histamine2 receptor antagonists and antacids should also be considered for appropriate patients. Adverse events have been noted with proton pump inhibitors; however, overall the benefits significantly outweigh the risks and problems are unlikely to arise during the 2-week duration of OTC treatment of heartburn. Pharmacists can provide valuable services to patients with frequent heartburn, particularly with regard to counseling about the condition and appropriate OTC therapy. The availability of numerous OTC products, including antacids, histamine2 receptor antagonists, and proton pump inhibitors, enables pharmacists to fulfill an important clinical role and improve patient satisfaction. PMID:21642828

  11. Determinants of US Prescription Drug Utilization using County Level Data.

    PubMed

    Nianogo, Thierry; Okunade, Albert; Fofana, Demba; Chen, Weiwei

    2016-05-01

    Prescription drugs are the third largest component of US healthcare expenditures. The 2006 Medicare Part D and the 2010 Affordable Care Act are catalysts for further growths in utilization becuase of insurance expansion effects. This research investigating the determinants of prescription drug utilization is timely, methodologically novel, and policy relevant. Differences in population health status, access to care, socioeconomics, demographics, and variations in per capita number of scripts filled at retail pharmacies across the USA justify fitting separate econometric models to county data of the states partitioned into low, medium, and high prescription drug users. Given the skewed distribution of per capita number of filled prescriptions (response variable), we fit the variance stabilizing Box-Cox power transformation regression models to 2011 county level data for investigating the correlates of prescription drug utilization separately for low, medium, and high utilization states. Maximum likelihood regression parameter estimates, including the optimal Box-Cox λ power transformations, differ across high (λ = 0.214), medium (λ = 0.942), and low (λ = 0.302) prescription drug utilization models. The estimated income elasticities of -0.634, 0.031, and -0.532 in high, medium, and low utilization models suggest that the economic behavior of prescriptions is not invariant across different utilization levels. Copyright © 2015 John Wiley & Sons, Ltd. PMID:25903420

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

    PubMed Central

    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. PMID:3080797

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

    MedlinePlus

    ... Works with a Medicare Advantage Plan or Medicare Cost Plan Medicare offers prescription drug coverage for everyone ... t offer Medicare prescription drug coverage. • A Medicare Cost Plan if it doesn’t offer Medicare prescription ...

  14. [Prescription drug monitoring programs in the United States of America].

    PubMed

    El Burai Félix, Sausan; Mack, Karin

    2014-10-01

    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

  15. 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

  16. 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

  17. Trends in Non-prescription Drug Recalls in Japan.

    PubMed

    Yamamoto, Chikoto; Ishida, Takuya; Osawa, Takashi; Naito, Takafumi; Kawakami, Junichi

    2016-01-01

    Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category. PMID:27592833

  18. Perverse incentives in the Medicare prescription drug benefit.

    PubMed

    McAdams, David; Schwarz, Michael

    2007-01-01

    This paper analyzes some of the perverse incentives that may arise under the current Medicare prescription drug benefit design. In particular, risk adjustment for a stand-alone prescription drug benefit creates perverse incentives for prescription drug plans when making coverage decisions and/or for pharmaceutical companies when setting prices. This problem is new in that it does not arise with risk adjustment for other types of health care coverage. For this and other reasons, Medicare's drug benefit requires especially close regulatory oversight, now and in the future. We also consider a relatively minor change in financing the benefit that could lead to significant changes in how the benefit functions. In particular, if all plans were required to charge the same premium, there would be less diversity in quality, but also less need to regulate formulary composition, less budgetary uncertainty, and less upward pressure on drug prices. PMID:17850042

  19. The drug prescription network: a system-level view of drug co-prescription in community-dwelling elderly people.

    PubMed

    Bazzoni, Gianfranco; Marengoni, Alessandra; Tettamanti, Mauro; Franchi, Carlotta; Pasina, Luca; Djade, Codjo Djignefa; Fortino, Ida; Bortolotti, Angela; Merlino, Luca; Nobili, Alessandro

    2015-04-01

    Networks are well suited to display and analyze complex systems that consist of numerous and interlinked elements. This study aimed at: (1) generating a series of drug prescription networks (DPNs) displaying co-prescription in community-dwelling elderly people; (2) analyzing DPN structure and organization; and (3) comparing various DPNs to unveil possible differences in drug co-prescription patterns across time and space. Data were extracted from the administrative prescription database of the Lombardy Region in northern Italy in 2000 and 2010. DPNs were generated, in which each node represents a drug chemical subclass, whereas each edge linking two nodes represents the co-prescription of the corresponding drugs to the same patient. At a global level, the DPN was a very dense and highly clustered network, whereas at the local level it was organized into anatomically homogeneous modules. In addition, the DPN was assortative by class, because similar nodes (representing drugs with the same anatomic, therapeutic, and pharmacologic annotation) connected to each other more frequently than expected, indicating that similar drugs are often co-prescribed. Finally, temporal changes in the co-prescription of specific drug sub-groups (for instance, proton pump inhibitors) translated into topological changes of the DPN and its modules. In conclusion, complementing more traditional pharmaco-epidemiology methods, the DPN-based method allows appreciatiation (and representation) of general trends in the co-prescription of a specific drug (e.g., its emergence as a heavily co-prescribed hub) in comparison with other drugs. PMID:25531938

  20. 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…

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

    MedlinePlus

    Checklist for Choosing Over-the-Counter (0TC) Medicine for Adults Information I need before going to the store: Problems(s) or symptoms(s) to be treated:_______________________________________________________ ...

  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. PMID:18630234

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

    PubMed

    Urbonas, Gvidas; Kubilienė, Loreta

    2016-04-01

    Background Community pharmacies have an increasing role in self-medication and community health is dependent on the quality of counselling services provided to patients. Some studies show that pharmacists' job satisfaction affects their work quality; other studies found that higher involvement in clinical services increases pharmacists' job satisfaction. Objective To test the relationship between job satisfaction and over-the-counter counselling practice at community pharmacies. Setting Community pharmacies in Lithuania. Method A convenience sample (n = 305) of community pharmacists participated in the cross-sectional survey where they expressed satisfaction with job and reported on their over-the-counter counselling behaviour on self-report scales. The Partial Least Squares Structural Equation Modelling approach was employed for data analysis. Main outcome measure The strength of the relationship between job satisfaction and over-the-counter counselling service. Results A bidirectional relationship between job satisfaction and over-the-counter counselling service was found. In addition, job satisfaction and over-the-counter counselling quality depended on pharmacists' age. Conclusion Organizations were recommended to create a counselling friendly environment that would increase pharmacists' job satisfaction and, in return, counselling quality. Also, additional motivation of the retired pharmacists, as well as development of counselling skills of the younger pharmacy workforce, were seen as a means to improve both organizational climate and counselling quality over the counter. PMID:26666908

  4. Patient knowledge and use of acetaminophen in over-the-counter medications.

    PubMed

    Hurwitz, Jason; Sands, Shannon; Davis, Erica; Nielsen, Joel; Warholak, Terri

    2014-01-01

    OBJECTIVES To evaluate patient knowledge of over-the-counter (OTC) products containing acetaminophen and to determine patients' accuracy in dosing adult, child, and infant formulations. DESIGN Cross-sectional study. SETTING Six community pharmacies in Tucson, AZ, between February and May 2011. PARTICIPANTS 88 adults aged 19 to 89 years. INTERVENTION Investigator-administered, semistructured interviews. MAIN OUTCOME MEASURES Patient knowledge of and ability to safely use OTC products containing acetaminophen, including understanding risks, identifying products, and dosing different formulations. RESULTS Although most (86%) participants heard of acetaminophen, only 68% understood at least one of its uses and only 9% knew the abbreviation APAP. Virtually all knew that consuming too much acetaminophen in 1 day could be harmful, but only 17% and 35% knew that overdoses could result in death or liver damage, respectively. On average, participants correctly identified 80% (range 27-100%) of products with and without acetaminophen from a lineup of 11 OTC products. Although 38% (n = 84) of participants correctly measured both the child and infant doses of acetaminophen, doses ranged from one-half to twice the amount of the labeled child dose and one-third of the labeled infant dose. Findings from the regression analysis suggested that on average, women and those with college degrees had higher overall scores, while participants' age or parent status were nonsignificant predictors. CONCLUSION Many patients remain confused about using acetaminophen safely, signaling the need for greater patient education to prevent unintentional harm. The results further specify common misunderstandings to address during patient contact, which also includes replacing "APAP" with "acetaminophen" on any prescription bottle labels or patient-directed information. PMID:24362497

  5. How Can I End a Prescription Drug Habit Safely?

    MedlinePlus

    ... Fitness Diseases & Conditions Infections Q&A School & Jobs Drugs & Alcohol Staying Safe Recipes En Español Making a Change – Your Personal Plan Hot Topics Meningitis Choosing Your Mood Prescription Drug Abuse Healthy School Lunch Planner How Can I ...

  6. Prescription Drug Abuse & Diversion: Role of the Pain Clinic

    PubMed Central

    Rigg, Khary K.; March, Samantha J.; Inciardi, James A.

    2010-01-01

    The goal of this research is to better understand the role that South Florida pain management clinics may be playing in the abuse and diversion of prescription drugs. This study explores 1) the characteristics and practices of pain clinics that may be facilitating the drug-seeking endeavors of prescription drug abusers and 2) the drug-seeking behaviors of prescription drug abusers who use pain clinics as a primary source for drugs. Thirty in-depth interviews were conducted with prescription drug abusers in South Florida. Interviews were transcribed verbatim and codes were generated based on thematic analyses of the data. Using grounded theory strategies, the analysis revealed six main themes: “pill mills”, on-site pharmacies, liberal prescribing habits, “sponsoring” drug diversion, pain doctor/pharmacy shopping, and faking symptoms/documentation. These findings should provide insights for law enforcement, regulatory agencies, and industry as they attempt to develop appropriate policy initiatives and recommendations for best practices. PMID:21278927

  7. 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? PMID:16459902

  8. Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use. Final order.

    PubMed

    2016-06-29

    The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:27373015

  9. Your Guide to Medicare Prescription Drug Coverage

    MedlinePlus

    ... drug coverage to Original Medicare, some Medicare Private Fee- for- Service ( PFFS) Plans, some Medicare Cost Plans, ... Monthly premium Most drug plans charge a monthly fee that differs from plan to plan. You pay ...

  10. Study on consumers' preferences and habits for over-the-counter analgesics use.

    PubMed

    Lefterova, A; Getov, I

    2004-03-01

    The aim of the present study was to investigate consumers' knowledge, preference habits and use of the over-the-counter (OTC) analgesics. Our survey indicates the preferences of respondents in consultation with medical specialists (medical doctors and pharmacists) and their sources of information about drugs. A questionnaire survey was conducted during the periods March/April and July/August 2002 in 11 community pharmacies situated in Sofia (capital) and two towns in different regions in Eastern Bulgaria. From 250 questionnaires 222 were filled in correctly and analyzed (response rate 89%). Metamizole (dipyrone) is the most popular OTC analgesic--35% of the questioned patients prefer it to relieve the pain. In the second place is paracetamole (acetaminophen), but patients prefer to use it mainly for symptomatic treatment of cold/flu and influenza-like symptoms. More than 50% of patients have indicated that medical doctor recommended them the chosen OTC analgesic and in case of health problems during the therapy they prefer to consult him. They had more confidence in medical doctors' than pharmacists' recommendations and consultation. The main conclusion is that the pharmacists do not have the main say in the choice of OTC analgesics and their rational and correct use. PMID:15068209

  11. Medicaid prescription drug coverage: state efforts to control costs.

    PubMed

    Gencarelli, Dawn M

    2003-05-10

    This paper provides a brief summary of the Medicaid prescription drug benefit. It explains the mechanisms being used by states to control their prescription drug spending within the Medicaid program. The paper also highlights some of the concerns that have been expressed with these mechanisms and the litigation that has been initiated in several states as a result of these efforts. It takes a closer look at three states with cost-containment strategies that have been the focus of increased scrutiny. PMID:12751504

  12. Methods of providing prescription drug benefits in health plans.

    PubMed

    Curtiss, F R

    1986-10-01

    Drug-benefit programs in health plans that offer varying degrees of risk to pharmacy providers are described. Administrators of health plans attempt to control the total cost of a drug benefit by controlling the cost per prescription, number of prescriptions, and administrative expenses. Specific ways to control these factors, such as through discounted product costs, patient copayments, and audits of prescribing practices, are described. Drug-benefit programs generally follow one of three models: fee-for-service contracts, hybrid fee-for-service risk contracts, and full-risk contracts. Examples of plans within each model are described. Full-risk contracts that provide drug benefits on a capitation basis put pharmacy providers at most risk of financial loss since physicians control prescribing. Pharmacists can control their risk by establishing a joint pharmacist and physician prescription fund that includes contract provisions limiting maximum losses, defining exceptions to the drug benefit, and paying close attention to payment schedules and characteristics of the program administrator. Antitrust issues associated with these new types of drug-benefit plans are described. Drug-benefit programs involving risk contracts can aid pharmacy practice by improving cash flow via negotiated prepayments, defining an enrolled patient population, and creating opportunities for generating additional revenue. Drug-benefit programs involving full-risk contracts and hybrid fee-for-service risk contracts will continue to develop, and understanding these models is the first step toward successful risk contracting by pharmacists. PMID:3788994

  13. 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…

  14. 21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .../or FD&C Yellow No. 6 in certain drugs for human use. 201.20 Section 201.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING... in certain drugs for human use. (a) The label for over-the-counter and prescription drug...

  15. 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 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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 or Prescription Status of Specific Drugs...

  17. 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 or Prescription Status of Specific Drugs...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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 or Prescription Status of Specific Drugs...

  19. A political history of medicare and prescription drug coverage.

    PubMed

    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

  20. 76 FR 59897 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ...). SUPPLEMENTARY INFORMATION: Background Need for Correction As published August 18, 2011 (76 FR 51245), the... of FR Doc. 2011-21011, are corrected as follows: 1. On page 51247, column 3, in the preamble, under... Internal Revenue Service 26 CFR Part 51 RIN 1545-BK34 Branded Prescription Drug Fee; Correction...

  1. 76 FR 59898 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... INFORMATION: Need for Correction As published August 18, 2011 (76 FR 51310), the notice of proposed rulemaking... subject of FR Doc. 2011-21012, is corrected as follows: 1. On Page 51311, column 2, under the part heading... Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee; Correction...

  2. 76 FR 59897 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ...). SUPPLEMENTARY INFORMATION: Background Need for Correction As published August 18, 2001 (76 FR 51245), the... Internal Revenue Service 26 CFR Part 51 RIN 1545-BK34 Branded Prescription Drug Fee; Correction AGENCY... 18, 2011. The temporary regulations provide guidance on the annual fee imposed on covered...

  3. 77 FR 48111 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... was published in the Federal Register on Monday, August 6, 2012 (77 FR 46653) relating to the branded...-reference to temporary regulations (REG-112805-10) which was the subject of FR Doc. 2012- 19074, is... Internal Revenue Service 26 CFR Part 51 RIN 1545-BJ39 Branded Prescription Drug Fee; Correction...

  4. 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

  5. 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…

  6. 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…

  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. 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. PMID:18494180

  9. 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 prescription drugs for humans. The Food and...

  10. 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 SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination prescription drugs for humans. The Food and...

  11. 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 as prescription drugs. 250.101 Section 250.101 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...

  12. 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 prescription drugs for humans. The Food and...

  13. 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... concern requiring distribution of FDA-approved patient medication. DATES: Submit either electronic or... information technology. Prescription Drug Product Labeling; Medication Guide Requirements (OMB Control...

  14. Number Of Medicaid Prescriptions Grew, Drug Spending Was Steady In Medicaid Expansion States.

    PubMed

    Wen, Hefei; Borders, Tyrone F; Druss, Benjamin G

    2016-09-01

    Expansions of eligibility for Medicaid under the Affordable Care Act may have increased the number of Medicaid drug prescriptions. However, the expansions did not drive Medicaid spending on prescription drugs overall in 2014. PMID:27605639

  15. Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications

    PubMed Central

    Budnitz, Daniel S.; Lovegrove, Maribeth C.; Rose, Kathleen O.

    2015-01-01

    Objective To reduce dosing errors when administering orally-ingested over-the-counter (OTC) liquid medications, the US Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) released voluntary recommendations for dosing directions and dosing devices. This study assessed recommendation adherence for national brand-name orally-ingested OTC liquid pediatric analgesics/antipyretics and cough, cold, and allergy medications available after the FDA Guidance was finalized in 2011 in order to identify and prioritize specific improvements to dosing directions and dosing devices. Methods Recommendations were categorized as top tier or low tier based on potential to directly address ≥3-fold dosing errors. Labeled dosing directions and accompanying dosing devices were assessed by 2 independent reviewers for adherence to specific recommendations. Results Of 68 products, 91% of dosing directions and 62% of dosing devices adhered to all top tier recommendations; 57% of products adhered to every top tier recommendation and 93% adhered to all or all but one. A dosing was included with all products. No dosing directions used atypical volumetric units (e.g., drams), and no devices used volumetric units that did not appear in dosing directions. Six products used trailing zeros or failed to use leading zeros with decimal doses and 8 did not use small font for fractions. Product adherence to low tier recommendations ranged from 26% to 91%. Conclusion Products adhered to most recommendations in the final FDA Guidance and CHPA Guideline suggesting that these voluntary initiatives promote adherence to recommendations. Improving adherence to recommendations should be prioritized based on potential to reduce harm. PMID:24394683

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

    North, Barbara B.

    2011-01-01

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

  18. Beneficiary price sensitivity in the Medicare prescription drug plan market.

    PubMed

    Frakt, Austin B; Pizer, Steven D

    2010-01-01

    The Medicare stand-alone prescription drug plan (PDP) came into existence in 2006 as part of the Medicare prescription drug benefit. It is the most popular plan type among Medicare drug plans and large numbers of plans are available to all beneficiaries. In this article we present the first analysis of beneficiary price sensitivity in the PDP market. Our estimate of elasticity of enrollment with respect to premium, -1.45, is larger in magnitude than has been found in the Medicare HMO market. This high degree of beneficiary price sensitivity for PDPs is consistent with relatively low product differentiation, low fixed costs of entry in the PDP market, and the fact that, in contrast to changing HMOs, beneficiaries can select a PDP without disrupting doctor-patient relationships. PMID:19191252

  19. 26 CFR 1.1092(c)-3 - Qualifying over-the-counter options.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 11 2010-04-01 2010-04-01 true Qualifying over-the-counter options. 1.1092(c)-3 Section 1.1092(c)-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Wash Sales of Stock Or Securities § 1.1092(c)-3 Qualifying...

  20. 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…

  1. 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…

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

    ERIC Educational Resources Information Center

    Rankin, Jenny Grant

    2013-01-01

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

  3. 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…

  4. 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.…

  5. 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…

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

    PubMed

    Harvin, Andre; Weber, Robert J

    2015-05-01

    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

  7. 42 CFR 410.30 - Prescription drugs used in immunosuppressive therapy.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false Prescription drugs used in immunosuppressive... Other Health Services § 410.30 Prescription drugs used in immunosuppressive therapy. (a) Scope. Payment may be made for prescription drugs used in immunosuppressive therapy that have been approved...

  8. 42 CFR 410.30 - Prescription drugs used in immunosuppressive therapy.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false Prescription drugs used in immunosuppressive... Other Health Services § 410.30 Prescription drugs used in immunosuppressive therapy. (a) Scope. Payment may be made for prescription drugs used in immunosuppressive therapy that have been approved...

  9. 42 CFR 410.30 - Prescription drugs used in immunosuppressive therapy.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 2 2012-10-01 2012-10-01 false Prescription drugs used in immunosuppressive... Other Health Services § 410.30 Prescription drugs used in immunosuppressive therapy. (a) Scope. Payment may be made for prescription drugs used in immunosuppressive therapy that have been approved...

  10. 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

  11. 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. PMID:22899231

  12. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... transaction involving the drug, starting with the manufacturer; and (7) The date of each previous transaction... prescription drugs. 203.50 Section 203.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution §...

  13. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... transaction involving the drug, starting with the manufacturer; and (7) The date of each previous transaction... prescription drugs. 203.50 Section 203.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution §...

  14. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... transaction involving the drug, starting with the manufacturer; and (7) The date of each previous transaction... prescription drugs. 203.50 Section 203.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution §...

  15. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... transaction involving the drug, starting with the manufacturer; and (7) The date of each previous transaction... prescription drugs. 203.50 Section 203.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PRESCRIPTION DRUG MARKETING Wholesale Distribution §...

  16. Direct-to-Consumer Prescription Drug Advertising and the Public

    PubMed Central

    Bell, Robert A; Kravitz, Richard L; Wilkes, Michael S

    1999-01-01

    OBJECTIVE Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. DESIGN Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). SETTING Respondents were interviewed while they were at their residences. PARTICIPANTS Complete data were obtained from 329 adults in Sacramento County, California. MEASUREMENTS AND MAIN RESULTS Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only “completely safe” drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. CONCLUSIONS Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined. PMID:10571712

  17. 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. PMID:10142385

  18. Medical cost offsets from prescription drug utilization among Medicare beneficiaries.

    PubMed

    Roebuck, M Christopher

    2014-10-01

    This brief commentary extends earlier work on the value of adherence to derive medical cost offset estimates from prescription drug utilization. Among seniors with chronic vascular disease, 1% increases in condition-specific medication use were associated with significant (P  less than  0.001) reductions in gross nonpharmacy medical costs in the amounts of 0.63% for dyslipidemia, 0.77% for congestive heart failure, 0.83% for diabetes, and 1.17% for hypertension. PMID:25278321

  19. 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

  20. The Drivers of Overspending on Prescription Drugs in Quebec

    PubMed Central

    Smolina, Kate; Morgan, Steve

    2014-01-01

    According to data from the most recent edition of the Canadian Rx Atlas, Quebec was the province with the highest total spending per capita on prescription drugs. The difference between Quebec and the rest of Canada was 35%, which translates into $1.5 billion dollars of extra spending. This analysis explores the economic cost drivers of the higher level of pharmaceutical spending in Quebec. While much of the additional spending was driven by a higher volume of drugs being prescribed overall, the factors contributing to higher spending differed greatly within particular therapeutic categories. The results and their implications are discussed in the context of pharmaceutical policy environment. PMID:25617512

  1. 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

  2. Over-the-counter enzyme supplements: what a clinician needs to know.

    PubMed

    Edakkanambeth Varayil, Jithinraj; Bauer, Brent A; Hurt, Ryan T

    2014-09-01

    Over-the-counter (OTC) enzyme use is increasing in frequency in the United States. The numerous health benefit claims by manufacturers are leading to a surge in enzyme use for various conditions and symptoms. Clinicians need to help patients navigate this complex realm and make informed decisions about the use of OTC enzymes. This review focuses on key concepts for health care providers to understand the current evidence, risks, and benefits of OTC enzymes. PMID:25103998

  3. 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

  4. The non-destructive identification of solid over-the-counter medications using single particle aerosol mass spectrometry.

    PubMed

    Martin, Audrey N; Farquar, George R; Jones, A Daniel; Frank, Matthias

    2007-01-01

    Single over-the-counter medication tablets were analyzed in real time using Single Particle Aerosol Mass Spectrometry (SPAMS). Dual-polarity time-of-flight mass spectra were obtained for micrometer-sized single particles dislodged from a single tablet without destroying the shape or markings of each tablet. The solid tablet was placed in a modified-top glass vial and shaken to dislodge and introduce micrometer-sized particles into the SPAMS system. Unique spectra from these particles were obtained in less than 1 s for single tablets of aspirin, ibuprofen, pseudoephedrine, phenylephrine, loratadine, or diphenhydramine. The signals obtained allowed the non-destructive identification of an individual tablet in seconds. SPAMS presents an ideal system for high-throughput analysis of solid drugs. PMID:17935106

  5. Hypoglycemia After Antimicrobial Drug Prescription for Older Patients Using Sulfonylureas

    PubMed Central

    Parekh, Trisha M.; Raji, Mukaila; Lin, Yu-Li; Tan, Alai; Kuo, Yong-Fang; Goodwin, James S.

    2016-01-01

    IMPORTANCE Certain antimicrobial drugs interact with sulfonylureas to increase the risk of hypoglycemia. OBJECTIVE To determine the risk of hypoglycemia and associated costs in older patients prescribed glipizide or glyburide who fill a prescription for an antimicrobial drug. DESIGN, SETTING, AND PARTICIPANTS This was a retrospective cohort study of Texas Medicare claims from 2006 to 2009 for patients 66 years or older who were prescribed glipizide or glyburide and who also filled a prescription for 1 of the 16 antimicrobials most commonly prescribed for this population. METHODS We assessed hypoglycemia events and associated Medicare costs in patients prescribed 1 of 7 antimicrobial agents thought to interact with sulfonylureas, using noninteracting antimicrobials as a comparison. We used a repeated measure logistic regression, controlling for age, sex, ethnicity, Medicaid eligibility, comorbidity, prior emergency department visits for hypoglycemia, prior hospitalizations for any cause, nursing home residence, and indication for the antimicrobial. We estimated odds of hypoglycemia, number needed to harm, deaths during hospitalization for hypoglycemia, and Medicare costs for hypoglycemia treatment. MAIN OUTCOMES AND MEASURES Any hospitalization or emergency department visit owing to hypoglycemia within 14 days of antimicrobial exposure. RESULTS In multivariable analyses controlling for patient characteristics and indication for antimicrobial drug use, clarithromycin (odds ratio [OR], 3.96 [95% CI, 2.42–6.49]), levofloxacin (OR, 2.60 [95% CI, 2.18–3.10]), sulfamethoxazole-trimethoprim (OR, 2.56 [95% CI, 2.12–3.10]), metronidazole (OR, 2.11 [95% CI, 1.28–3.47]), and ciprofloxacin (OR, 1.62 [95% CI, 1.33–1.97]) were associated with higher rates of hypoglycemia compared with a panel of noninteracting antimicrobials. The number needed to harm ranged from 71 for clarithromycin to 334 for ciprofloxacin. Patient factors associated with hypoglycemia included older

  6. The federal regulation of prescription drug advertising and promotion.

    PubMed

    Kessler, D A; Pines, W L

    1990-11-14

    Prescription drug advertising has been regulated by the Food and Drug Administration since 1962. In the past decade, pharmaceutical companies have employed new communication mechanisms to reach physicians and, with increasing frequency, consumers. Examples of physician-oriented promotional activities are medical symposia and teleconferences. Consumer-oriented efforts include press conferences, use of celebrity spokespeople, and direct-to-consumer advertising. The Food and Drug Administration has asserted its legal jurisdiction over these nontraditional promotional activities and is regulating them on a case-by-case basis. As nontraditional promotional efforts become more prevalent, the Food and Drug Administration's regulatory framework must be able to meet the challenges of a changing environment. PMID:2231998

  7. 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

  8. 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...

  9. 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…

  10. 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...

  11. 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...

  12. 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...

  13. [The Pharmacist as Gatekeeper of Prescription Drug Abuse: Return to "Community Scientists"].

    PubMed

    Shimane, Takuya

    2016-01-01

      The non-medical use or abuse of prescription drugs, including benzodiazepines, is a growing health problem in Japan. An association between prescription drug overdose and suicide risk has also been reported. The Japanese Ministry of Health, Labour and Welfare has expected pharmacists to act as "gatekeepers", facilitating early identification of individuals at high risk of prescription drug abuse including overdose, supplying medication counseling to patients, and helping to introduce these patients to appropriate medical care. Prescription drugs such as benzodiazepines are widely used in psychiatry. However, these drugs are prescribed not only by psychiatrists but also by other healthcare professionals including primary care physicians. Moreover, in recent years, the dispensing of prescriptions has moved rapidly from inside to outside hospitals, with prescription drugs being dispensed mainly at community pharmacies. Although all healthcare professionals including hospital pharmacists can play a role in preventing prescription drug abuse, the role of the community pharmacist is vital in addressing this problem. Formerly, community pharmacists were recognized as "community scientists", low-threshold accessible healthcare advisors. Now, community pharmacists should return to the role of community scientists to prevent prescription drug abuse. This article begins by reviewing the current situation of prescription drug abuse and dependence in Japan. The role of pharmacists as gatekeepers in preventing prescription drug abuse is then examined. Finally, this article discusses the effect of intervention in the form of gatekeeper training for community pharmacists. PMID:26725672

  14. Computer-aided auditing of prescription drug claims.

    PubMed

    Iyengar, Vijay S; Hermiz, Keith B; Natarajan, Ramesh

    2014-09-01

    We describe a methodology for identifying and ranking candidate audit targets from a database of prescription drug claims. The relevant audit targets may include various entities such as prescribers, patients and pharmacies, who exhibit certain statistical behavior indicative of potential fraud and abuse over the prescription claims during a specified period of interest. Our overall approach is consistent with related work in statistical methods for detection of fraud and abuse, but has a relative emphasis on three specific aspects: first, based on the assessment of domain experts, certain focus areas are selected and data elements pertinent to the audit analysis in each focus area are identified; second, specialized statistical models are developed to characterize the normalized baseline behavior in each focus area; and third, statistical hypothesis testing is used to identify entities that diverge significantly from their expected behavior according to the relevant baseline model. The application of this overall methodology to a prescription claims database from a large health plan is considered in detail. PMID:23821344

  15. Improving Patient Understanding of Prescription Drug Label Instructions

    PubMed Central

    Davis, Terry C.; Federman, Alex D.; Bass, Pat F.; Jackson, Robert H.; Middlebrooks, Mark; Parker, Ruth M.

    2008-01-01

    Background Patient misunderstanding of instructions on prescription drug labels is common and a likely cause of medication error and less effective treatment. Objective To test whether the use of more explicit language to describe dose and frequency of use for prescribed drugs could improve comprehension, especially among patients with limited literacy. Design Cross-sectional study using in-person, structured interviews. Patients Three hundred and fifty-nine adults waiting for an appointment in two hospital-based primary care clinics and one federally qualified health center in Shreveport, Louisiana; Chicago, Illinois; and New York, New York, respectively. Measurement Correct understanding of each of ten label instructions as determined by a blinded panel review of patients’ verbatim responses. Results Patient understanding of prescription label instructions ranged from 53% for the least understood to 89% for the most commonly understood label. Patients were significantly more likely to understand instructions with explicit times periods (i.e., morning) or precise times of day compared to instructions stating times per day (i.e., twice) or hourly intervals (89%, 77%, 61%, and 53%, respectively,  < 0.001). In multivariate analyses, dosage instructions with specific times or time periods were significantly more likely to be understood compared to instructions stating times per day (time periods — adjusted relative risk ratio (ARR) 0.42, 95% Confidence Interval (CI) 0.34–0.52; specific times — ARR 0.60, 95% CI 0.49–0.74). Low and marginal literacy remained statistically significant independent predictors of misinterpreting instructions (low - ARR 2.70, 95% CI 1.81–4.03; marginal -ARR 1.66, 95% CI 1.18–2.32). Conclusions Use of precise wording on prescription drug label instructions can improve patient comprehension. However, patients with limited literacy were more likely to misinterpret instructions despite use of more explicit language. PMID

  16. [Prescription of generic drugs to privately insured persons].

    PubMed

    Wild, Frank

    2012-12-01

    The system-related differences between private health insurance and statutory health insurance in Germany could lead to divergent prescriptions of medication. The study shows that doctors whose privately insured patients have been prescribed the same medication over a long period of time will frequently continue to prescribe the original medication even after its patent protection has expired. By contrast, patients in the statutory health insurance system will usually be switched to generic drugs. However, physicians prescribing medication to a privately insured person for the first time will frequently select generics in the first place. PMID:23236709

  17. Prevalence and Correlates of Prescription Drug Misuse among Socially Active Young Adults

    PubMed Central

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

    2012-01-01

    Background Prescription drug misuse represents an emerging global drug trend. Data indicate that young adults are misusing prescription drugs at high rates. As such, continued surveillance of the patterns of prescription drug misuse among young adults is critical, particularly for those engaged in social scenes known to accommodate drug use. Methods Prevalence and correlates of lifetime and recent prescription drug misuse among urban young adults recruited at nightlife venues using time-space sampling are assessed via prevalence estimates and logistic regression analyses. Results In a diverse sample of 1,207 young adults, 44.1% reported lifetime prescription drug misuse, and 20.3% reported misuse during the past three months. Stimulants were the most common class of drug respondents misused within the past six months (16.7%), followed by pain killers (16.5%) and sedatives (14.5%). While no gender or sexual orientation differences in misuse prevalence existed, Black youth reported the lowest prevalence of misuse. In multivariate analyses, increased age was associated with lower odds of recent misuse, females report lower odds of recent use, and Black, Asian, and Latino individuals had lower odds of recent misuse than Whites. These odds varied by prescription drug type. Negative binomial regression analyses indicate that, among prescription drug misusers, women misuse prescription drugs less frequently. Younger individuals more frequently misuse stimulants and older individuals more frequently misuse sedatives. Racial variation existed with frequency of use across classes. Conclusions This study illustrates the need for health promotion efforts targeting prescription drug misuse among young adults who are highly socially active. Future research should focus on motivations for and factors associated with prescription drug misuse within youth cultures. Further research may provide a fuller sense of how to reduce the impact of prescription drug misuse for nations whose

  18. 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

  19. Over-the-Counter Sale of Emergency Contraception: A Survey of Pharmacists in Delhi

    PubMed Central

    Mishra, Archana; Saxena, Pikee

    2013-01-01

    Introduction Pharmacists play a key role while dispensing over-the-counter emergency contraception (EC) to the client. Aims The study aims to evaluate the knowledge and over-the-counter services provided by the pharmacists in Delhi. Methods A prestructured questionnaire-based survey was conducted in Delhi, the capital city of India. Results Only 60 out of 85 pharmacies approached agreed to participate in the study. Number of packs sold in a month per pharmacy varied from 2 to 500 packs/month. Sixty-two percent of the pharmacists claimed that majority of the clients repeated use during the same month. Only 18% of the clients were referred by doctors while 82% directly approached the pharmacists. Nearly one third of the clients were adolescents. Sixty-seven percent of the pharmacists had adequate knowledge about EC. Only 3.3% asked about the last menstrual period or the time elapsed since the last unprotected intercourse. No pharmacist inquired whether there were one or multiple unprotected acts of intercourse, if any regular contraceptive method was being used, or explored the reason for EC intake. There were 91.7% who explained the dosage schedule to clients. Only half of them explained that the client may experience side effects. None of the pharmacists advised their clients for a sexually transmitted disease screening, and 35% counseled the clients regarding regular contraception. Conclusion Improving the quality of services provided by the pharmacists can clear misconceptions of the clients and promote subsequent regular contraception along with precautions to avoid sexually transmitted diseases. Mishra A and Saxena P. Over-the-counter sale of emergency contraception: A survey of pharmacists in Delhi. Sex Med 2013;1:16–20. PMID:25356282

  20. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  1. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  2. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  3. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  4. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  5. HOW CLINICIANS USE PRESCRIPTION DRUG MONITORING PROGRAMS: A QUALITATIVE INQUIRY

    PubMed Central

    Hildebran, Christi; Cohen, Deborah J.; Irvine, Jessica M.; Foley, Carol; O’Kane, Nicole; Beran, Todd; Deyo, Richard A.

    2014-01-01

    Objectives Prescription drug monitoring programs (PDMP) are now active in most states to assist clinicians in identifying potential controlled drug misuse, diversion or excessive prescribing. Little is still known about the ways in which they are incorporated into workflow and clinical decision making, what barriers continue to exist, and how clinicians are sharing PDMP results with their patients. Design Qualitative data were collected through online focus groups and telephone interviews Setting Clinicians from pain management, emergency and family medicine, psychiatry/behavioral health, rehabilitation medicine, internal medicine and dentistry. Subjects 35 clinicians from 9 states participated. Methods We conducted two online focus groups and seven telephone interviews. A multidisciplinary team then used a grounded theory approach coupled with an immersion-crystallization strategy for identifying key themes in the resulting transcripts. Results Some participants, mainly from pain clinics, reported checking the PDMP with every patient, every time. Others checked only for new patients, for new opioid prescriptions, or for patients for whom they suspected abuse. Participants described varied approaches to sharing PDMP information with patients, including openly discussing potential addiction or safety concerns; avoiding discussion altogether; and approaching discussion confrontationally. Participants described patient anger or denial as a common response and noted the role of patient satisfaction surveys as an influence on prescribing. Conclusion Routines for accessing PDMP data and how clinicians respond to it vary widely. As PDMP use becomes more widespread, it will be important to understand what approaches are most effective for identifying and addressing unsafe medication use. PMID:24833113

  6. [Electronic drug prescription - auto pilot for drug therapy?].

    PubMed

    Schubert, Sten; Neininger, Martina Patrizia; Smers, Stefan; Winter, Alfred; Frontini, Roberto; Bertsche, Astrid; Bertsche, Thilo

    2015-06-01

    In tertiary care, computerized physician order entries may improve performance, cross-linking, and documentation when prescribing drugs. A clinical decision support integrated in these systems is discussed to prevent additional medication errors. For an optimal performance, the implementation into the clinical information systems is required to gain access to patient data (e. g. from laboratory). In routine care, the question rises whether a benefit of the systems can be proven in clinical studies and whether there is a difference between the systems. To achieve optimal results, these systems should also consider specific requirements, i. e. the patient groups and prescribed drugs in the local setting. We performed a systematic literature evaluation searching for published data in the topic electronic prescribing to assess them in a structured analysis considering medical-pharmaceutical aspects. Additionally, we assessed three databases in German language and one in English language taking drug-drug-interactions as an example to compare the identification of drug-related problems. Medication data from our own patients in a paediatric intensive care unit of a university hospital were analysed by the systems. Our results revealed strengths but also limitations of electronic prescribing. PMID:26364374

  7. The Conundrum of Online Prescription Drug Promotion Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    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. 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…

  9. 42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... beneficiary premiums or lower covered Part D drug prices at the point of sale. (ii) Information on negotiated... 42 Public Health 3 2010-10-01 2010-10-01 false Requirements related to qualified prescription drug... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG...

  10. 71 FR 66448 - Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203 Compliance Policy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-11-15

    ... 92N-0297), 1988N-0258 (Formerly 88N- 0258), 2006D-0226] Prescription Drug Marketing Act Pedigree... Marketing Act Pedigree Requirements Questions and Answers; Notice of Availability AGENCY: Food and Drug... ``Prescription Drug Marketing Act--Pedigree Requirements under 21 CFR Part 203'' (PDMA CPG). This CPG...

  11. 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

  12. The impact of 1990 Medicaid drug rebates policy on access to prescriptions.

    PubMed

    Okunade, A A

    2001-01-01

    The U.S. Congress passed a new law (PL 101-508) in 1990 requiring the pharmaceutical manufacturers to grant rebates on prescription drugs sold at retail under the federal Medicaid program. The goals include containing Medicaid program costs and expanding access of the indigent to ethical drug treatments. This paper evaluates the impact of HCFA's mandatory federal upper limit (FUL) prices on the retail sales volume of prescription drugs during 1994. Data of the most frequently dispensed drugs, as measured by the National Prescription Audit of IMS America, are used. Regression model results suggest that the competing drug prices impact sales significantly, and Medicaid drug rebates expand access to drug interventions by stimulating retail transactions. Prescription sales are also own-price insensitive (inelastic) in Medicaid and non-Medicaid market segments. The implications of extending Medicaid prescription drug rebates policy to enrollees in the traditional Medicare program are examined. PMID:11146982

  13. 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..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted From Prescription-Dispensing Requirements § 310.201 Exemption for certain drugs limited by new-drug applications...

  14. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Exemption for certain drugs limited by new-drug..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted From Prescription-Dispensing Requirements § 310.201 Exemption for certain drugs limited by new-drug applications...

  15. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Exemption for certain drugs limited by new-drug..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted From Prescription-Dispensing Requirements § 310.201 Exemption for certain drugs limited by new-drug applications...

  16. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Exemption for certain drugs limited by new-drug..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted From Prescription-Dispensing Requirements § 310.201 Exemption for certain drugs limited by new-drug applications...

  17. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Exemption for certain drugs limited by new-drug..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS New Drugs Exempted From Prescription-Dispensing Requirements § 310.201 Exemption for certain drugs limited by new-drug applications...

  18. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  19. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  20. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  1. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  2. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 310.305 Section 310.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS...

  3. 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

  4. Changing effects of direct-to-consumer broadcast drug advertising information sources on prescription drug requests.

    PubMed

    Lee, Annisa Lai

    2009-06-01

    This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications. PMID:19499430

  5. 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... drugs for humans. The Food and Drug Administration's policy in administering the new-drug,...

  6. Nonmedical Use of Prescription ADHD Stimulants and Preexisting Patterns of Drug Abuse

    PubMed Central

    Sweeney, Christine T.; Sembower, Mark A.; Ertischek, Michelle D.; Shiffman, Saul; Schnoll, Sidney H.

    2013-01-01

    Multidrug use is well documented among nonmedical users of prescription stimulants. We sought to provide insight into the drug use patterns of those reporting nonmedical use of prescription attention-deficit hyperactivity disorder (ADHD) stimulants in an attempt to discern whether such use is a first step in a pattern of drug-abusing behavior or, conversely, is a later development accompanied or preceded by a history of drug abuse. A cross-sectional, population-based survey of the U.S. civilian, non-institutionalized population aged 12 years and older was analyzed for lifetime nonmedical use of prescription ADHD stimulants, lifetime nonmedical use of another prescription drug, illicit drug use, and drug use initiation patterns. This included 443,041 respondents from the 2002–2009 National Survey on Drug Use and Health. Lifetime nonmedical use of prescription ADHD stimulants was reported by 3.4% of those aged 12 years and older. Of these, 95.3% also reported use of an illicit drug (i.e., marijuana, cocaine/crack, heroin, hallucinogens, inhalants) or nonmedical use of another prescription drug (i.e., tranquilizers, pain relievers, or sedatives), and such use preceded nonmedical use of prescription ADHD stimulants in 77.6% of cases. On average, 2.40 drugs were used prior to the first nonmedical use of prescription ADHD stimulants. These data suggest that nonmedical use of prescription ADHD stimulants is not commonly an initiating factor leading to the nonmedical use of other prescription medications or abuse of illicit drugs. Rather, nonmedical use of prescription ADHD stimulants appears to be adopted by individuals already engaged in broader patterns of drug abuse and misuse. PMID:23480243

  7. 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

  8. 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

  9. 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

  10. 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. PMID:15241856

  11. Perceived Drug Use Functions and Risk Reduction Practices Among High-Risk Nonmedical Users of Prescription Drugs

    PubMed Central

    Silva, Karol; Kecojevic, Aleksandar; Lankenau, Stephen E.

    2014-01-01

    Nonmedical use of prescription drugs has become the fastest growing drug problem in the United States, particularly among young adults. This study examines the reasons young polydrug users misuse prescription drugs, and explores how young users employ risk reduction strategies to minimize adverse consequences. The sample was recruited during 2008 and 2009 in Los Angeles and New York, and comprised 45 nonmedical users of prescription drugs, aged 16 to 25. Data from a semistructured interview were analyzed quantitatively and qualitatively. Participants reported nonmedical use of prescription drugs to change mood, to facilitate activity, and to monitor the intake of other substances. Commonly employed risk reduction strategies included calculating pill timing, dosage, and access, and monitoring frequency of use, particularly when combining different substances. Most study participants often planned drug use to occur within socially acceptable parameters, such that prescription drug misuse was a normalized feature of their everyday lives. PMID:25477621

  12. Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

    PubMed Central

    Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

    2012-01-01

    Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

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

    PubMed Central

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

    2016-01-01

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

  14. Use of Drugs Subject to Controlled Prescriptions: a Retrospective Analysis

    PubMed Central

    Demircan, Dilek; Gülmez, Sinem Ezgi; Dönertaş, Başak; Topcu, İbrahim; Yılmaz, Hüseyin; Berkman, Kemal; Akıcı, Ahmet

    2013-01-01

    Objective: Use of drugs that may lead to abuse or dependence are subject to controlled prescriptions (CPs) in many countries, and these are closely monitored by health authorities. According to national regulations in Turkey, CPs may be red coloured (RCPs) or green coloured (GCPs). The aim of this study was to evaluate the use of such drugs in Istanbul. Study Design: Retrospective case-control study. Material and Methods: During the study period (01/01-31/12 2009), 502874 CPs were reported. Among these, 4000 CPs each month were randomly selected and evaluated. Results: The majority of GCPs were issued to women (55.6%), while the majority of RCPs were issued to men (68.4%). GCPs were most frequently prescribed by physicians working in private hospitals (33.6%) while RCPs by physicians working in university hospitals (39.7%). GCPs were mostly prescribed by psychiatrists (37.6%) while for RCPs were child and adolescent psychiatrists (35.9%). Psycholeptics (ATC code N05) were the most prescribed controlled drugs (CDs) (43.8%). Methylphenidate (53.9%) was the mostly prescribed on RCPs and alprazolam (39.6%) was on GCPs. Conclusion: We demonstrate that utilization of CDs shows demographical and institutional differences. These data could be of help to improve surveillance of CDs as well as to train prescribers and patients. PMID:25207068

  15. 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. PMID:25135798

  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. PMID:11727293

  17. Over-the-counter medicine and dietary supplement consumption among academic youth in Poland.

    PubMed

    Bochenek, Tomasz; Godman, Brian; Lipowska, Katarzyna; Mikrut, Karolina; Zuziak, Sandra; Pedzisz, Magdalena; Nowak, Aneta; Pilc, Andrzej

    2016-04-01

    Over-the-counter (OTC) medicines and dietary supplements are increasingly popular in Poland, potentially improving but also potentially posing a threat to public health. The study goal is to characterize and assess behaviors related to use of OTC medicines and dietary supplements among Polish university students. A questionnaire-based survey was performed with students divided into groups (gender, subjects studied, period of studies). The majority of students declared using the products, significantly more females and younger students in their early years. Females tended to be more attentive to product information. Students with a background in biological or medical sciences were also more attentive and less influenced by advertising. The authors present that the differences between the defined groups of students should be utilized in tailored educational activities, aiming to rationalize high consumption of OTC medicines and dietary supplements. Targeting other, especially low-socioeconomic and less-educated, groups should follow. PMID:26886826

  18. Developing a nursing protocol for over-the-counter medications in high school.

    PubMed

    Awbrey, Lucinda Mejdell; Juarez, Sandra M

    2003-02-01

    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 child at school. How do school districts balance the safety of students with the needs of parents wanting their children to have access to OTC medications at school? Following legal guidelines helps to reduce the risk for school nurses. Through the development and utilization of Nursing Standardized Protocols, high school nurses are able to provide nonprescription analgesics for specific common student complaints such as noninjury headaches and dysmenorrhea. On the basis of nursing knowledge and judgment, school nurses provide this service, which results in students returning to class quickly, feeling better, and being ready to learn. PMID:12562220

  19. Over-the-counter topical skincare products: a review of the literature.

    PubMed

    Nolan, Katherine A; Marmur, Ellen S

    2012-02-01

    Topical "anti-aging" products, with their seemingly limitless list of ingredients, make extensive claims to reduce wrinkles, fine lines, and sun damage, among others. Sales in the United States alone for cosmeceutical products are expected to increase by 7.4% per year to $8.2 billion by 2012. However, in this enormous industry, there has been a significant lack of rigorous controlled trials of efficacy. It is difficult for both dermatologists and consumers to make informed decisions in a market that is yet to be clearly defined and regulated. We elucidate the scientific basis for, as well as the literature behind, common active ingredients found in products intended to reverse photoaging, discuss some interesting new activities, and provide a review of several comprehensive studies on over-the-counter (OTC) products. PMID:22270206

  20. 42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Requirements related to qualified prescription drug coverage. 423.104 Section 423.104 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Benefits and...

  1. 42 CFR 410.30 - Prescription drugs used in immunosuppressive therapy.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... therapy. 410.30 Section 410.30 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... Other Health Services § 410.30 Prescription drugs used in immunosuppressive therapy. (a) Scope. Payment may be made for prescription drugs used in immunosuppressive therapy that have been approved...

  2. 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.…

  3. 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…

  4. 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…

  5. 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…

  6. 42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Requirements related to qualified prescription drug coverage. 423.104 Section 423.104 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Benefits and...

  7. 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...-9364. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 2012-8071 of April 12, 2012 (77 FR...

  8. 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... CONTACT: Sabrina Ahmed, (410) 786-7499. SUPPLEMENTARY INFORMATION: I. Background In FR Doc....

  9. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Procedures to determine and document creditable status of prescription drug coverage. 423.56 Section 423.56 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT...

  10. Are Direct to Consumer Advertisements of Prescription Drugs Educational?: Comparing 1992 to 2002

    ERIC Educational Resources Information Center

    Curry, Timothy Jon; Jarosch, Jeff; Pacholok, Shelley

    2005-01-01

    We investigate the educational value of direct-to-consumer (DTC) prescription drug advertisements from 58 popular magazines published in 1992 and 2002. We find that the number of DTC prescription drug ads increased nine-fold from 1992 to 2002, while the advertisements for other health care products increased only slightly. We examine changes in…

  11. 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…

  12. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Coordination of benefits with other providers of prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination...

  13. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Coordination of benefits with other providers of prescription drug coverage. 423.464 Section 423.464 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Coordination...

  14. 71 FR 34249 - Prescription Drug Marketing Act Pedigree Requirements; Effective Date and Compliance Policy Guide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-06-14

    ...), 1988N-0258 (Formerly 88N- 0258), 2006D-0226] Prescription Drug Marketing Act Pedigree Requirements... provisions of the final regulation published in the Federal Register of ] December 3, 1999 (64 FR 67720). The... of a new compliance policy guide (CPG) 160.900 entitled ``Prescription Drug Marketing Act...

  15. Designer steroids - over-the-counter supplements and their androgenic component: review of an increasing problem.

    PubMed

    Rahnema, C D; Crosnoe, L E; Kim, E D

    2015-03-01

    Colloquially referred to by various misleading monikers ('pro-hormones', 'natural steroids', 'testosterone boosters', etc.) designer anabolic steroids have been popular now for over a decade as a way to achieve classic anabolic steroid-like results from products sold in the legal marketplace. Recent evidence suggests that anabolic steroid use may be the most common cause of hypogonadism in men of reproductive age. Despite recent regulatory efforts that have banned specific compounds, many anabolic-androgenic steroids (AAS) remain available in over-the-counter dietary supplements that are legally sold in the United States. Severe side effects including hepatotoxicity, cholestasis, renal failure, hypogonadism, gynecomastia, and infertility have been reported secondary to the use of these products. While some of these side effects may be reversible, more aggressive use may result in more permanent end-organ damage as has been previously described for the case of aggressive AAS users (Rahnema et al., Fertil Steril, 2014). Designer AAS remain easily available for purchase in over-the-counter bodybuilding supplements and these products appear to be increasingly popular, despite the known health risks associated with their use. We conducted a systematic search to identify the designer steroids that are most commonly sold in dietary supplements as of April 2014 and review what is known regarding their potency and toxicity. We propose that the impact of AAS use on the reproductive and hormonal health of men is underestimated in the literature owing to previous studies' failure to account for designer steroid use. Lastly, we make clinical recommendations to help physicians steer patients away from potentially harmful supplements, and summarize key regulatory obstacles that have allowed potent androgens to remain unregulated in the legal marketplace. PMID:25684733

  16. 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…

  17. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  18. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  19. 10 CFR 707.13 - Medical review of results of tests for illegal drug use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Medical review of results of tests for illegal drug use. 707.13 Section 707.13 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES... opportunity to report to the MRO the use of any prescription or over-the-counter medication. If the...

  20. 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. PMID:18826006

  1. Medicare Prescription Drug Plan Enrollees Report Less Positive Experiences Than Their Medicare Advantage Counterparts.

    PubMed

    Elliott, Marc N; Landon, Bruce E; Zaslavsky, Alan M; Edwards, Carol; Orr, Nathan; Beckett, Megan K; Mallett, Joshua; Cleary, Paul D

    2016-03-01

    Since 2006, Medicare beneficiaries have been able to obtain prescription drug coverage through standalone prescription drug plans or their Medicare Advantage (MA) health plan, options exercised in 2015 by 72 percent of beneficiaries. Using data from community-dwelling Medicare beneficiaries older than age sixty-four in 700 plans surveyed from 2007 to 2014, we compared beneficiaries' assessments of Medicare prescription drug coverage when provided by standalone plans or integrated into an MA plan. Beneficiaries in standalone plans consistently reported less positive experiences with prescription drug plans (ease of getting medications, getting coverage information, and getting cost information) than their MA counterparts. Because MA plans are responsible for overall health care costs, they might have more integrated systems and greater incentives than standalone prescription drug plans to provide enrollees medications and information effectively, including, since 2010, quality bonus payments to these MA plans under provisions of the Affordable Care Act. PMID:26953300

  2. Self-management of psychiatric symptoms using over-the-counter (OTC) psychopharmacology: the S-DTM therapeutic model--Self-diagnosis, self-treatment, self-monitoring.

    PubMed

    Charlton, Bruce G

    2005-01-01

    Pharmacological self-management is becoming more widespread in modernizing societies, as part of a general expansion of health care. This may exert a vital corrective balance to the professionalization of health by ensuring that the individual perspective of patients is not neglected. There are many 'good ideas' for new treatments being published which have a plausible scientific rationale for effectiveness and a low likelihood of harm, yet are essentially ignored by mainstream medical research. The most likely avenue for progress is probably the spread of self-management, together with increased sharing of experience via the internet. There is considerable scope for self-management of psychiatric symptoms with psychoactive medication purchased 'over-the-counter' (OTC) and without prescription. A surprisingly wide range of effective psychoactive agents are available with the potential to self-treat many of the common psychiatric problems. These include 'medical' psychopharmacological agents such as analgesics and antihistamines, a plant extract called St. John's Wort (Hypericum), and physical treatments such as early morning bright light therapy. But self-management currently lacks an explicit therapeutic model. A three stage process of S-DTM - self-diagnosis, self-treatment and self-monitoring is proposed and described in relation to psychiatric symptoms. Self-diagnosis describes the skill of introspection to develop awareness of inner bodily states and emotions. A specific sensation is identified and isolated as the 'focal symptom' for subsequent treatment and monitoring. Self-treatment involves choosing a drug (or other therapy) which is intended to alleviate the focal symptom. Self-monitoring entails a continued awareness of the focal system and of general well-being in order to evaluate effect of therapy. Self-monitoring could involve repeated cycles of dose-adjustment, and on-off ('challenge-dechallenge-rechallenge') therapeutic trials. An example of S

  3. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... been made for daytime sedative products: “occasional simple nervous tension,” “nervous irritability,” “nervous tension headache,” “simple nervousness due to common every day overwork and fatigue,” “a...

  4. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... been made for daytime sedative products: “occasional simple nervous tension,” “nervous irritability,” “nervous tension headache,” “simple nervousness due to common every day overwork and fatigue,” “a...

  5. 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

    ...) published in 1978 (43 FR 38206 at 38213 through 38214, August 25, 1978). A panel of sunscreen experts... by an SPF 50 sunscreen product compared to an SPF 30 sunscreen product (64 FR 27666 at 27675). We... inadequate application and infrequent reapplication of sunscreen products (72 FR 49070 at 49086). C....

  6. 49 CFR 219.103 - Prescribed and over-the-counter drugs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... on the basis of the available medical history, that use of the substance by the employee at the... Schedules II through V of the controlled substance list) prescribed or authorized by a medical practitioner, or possession incident to such use, if— (1) The treating medical practitioner or a...

  7. 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. PMID:25862546

  8. 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

  9. 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

  10. Using National Drug Codes and Drug Knowledge Bases to Organize Prescription Records from Multiple Sources

    PubMed Central

    Simonaitis, Linas; McDonald, Clement J

    2009-01-01

    Purpose Pharmacy systems contain electronic prescription information needed for clinical care, decision support, performance measurements and research. The master files of most pharmacy systems include National Drug Codes (NDCs) as well as the local codes they use within their systems to identify the products they dispense. We sought to assess how well one could map the products dispensed by many pharmacies to clinically oriented codes via the mapping tables provided by Drug Knowledge Base (DKB) producers. Methods We obtained a large sample of prescription records from seven different sources. These records either carried a national product code or a local code that could be translated into a national product code via their formulary master. We obtained mapping tables from five DKBs. We measured the degree to which the DKB mapping tables covered the national product codes carried in, or associated with, our sample of prescription records. Results Considering the total prescription volume, DKBs covered 93.0% to 99.8% of the product codes (15 comparisons) from three outpatient, and 77.4% to 97.0% (20 comparisons) from four inpatient, sources. Among the inpatient sources, invented codes explained much – from 36% to 94% (3 of 4 sources) – of the non coverage. Outpatient pharmacy sources invented codes rarely – in 0.11% to 0.21% of their total prescription volume, and inpatient sources, more commonly – in 1.7% to 7.4% of their prescription volume. The distribution of prescribed products is highly skewed: from 1.4% to 4.4% of codes account for 50% of the message volume; from 10.7% to 34.5% of codes account for 90% of the volume. Conclusion DKBs cover the product codes used by outpatient sources sufficiently well to permit automatic mapping. Changes in policies and standards could increase coverage of product codes used by inpatient sources. PMID:19767382

  11. 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. PMID:25120044

  12. 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.…

  13. Prescription drug insurance coverage and patient health outcomes: a systematic review.

    PubMed

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

    2015-02-01

    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

  14. 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...

  15. Windmills and pill mills: can PDMPs tilt the prescription drug epidemic?

    PubMed

    Gugelmann, Hallam; Perrone, Jeanmarie; Nelson, Lewis

    2012-12-01

    Prescription drug monitoring programs (PDMPs) are state-based registries of prescriptions for specific controlled substances. This overview will describe the history and funding of these databases, address those characteristics thought to be of greatest utility for PDMPs and review current literature regarding PDMP effectiveness and their potential limitations. Although more extensive research on PDMP outcomes is needed, these databases are an essential component in ongoing efforts to establish safe and compassionate prescription opioid stewardship. PMID:23180357

  16. NATIONAL SURVEY OF PRESCRIPTION DRUG INFORMATION PROVIDED TO PATIENTS (NSPDIPP)

    EPA Science Inventory

    National telephone surveys were conducted in 1992, 1994, 1996, and 1998 to determine how much prescription medicine information consumers receive and through which sources. Approximately 1,000 U.S. consumers who received a new prescription for themselves or a family member at a r...

  17. 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 reminder labeling to provide price information to consumers. 200.200 Section 200.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing...

  18. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... proprietary name of the drug product, if any; the established (generic) name of the drug product, if any; the... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing § 200.200 Prescription drugs; reminder advertisements and...

  19. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... proprietary name of the drug product, if any; the established (generic) name of the drug product, if any; the... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing § 200.200 Prescription drugs; reminder advertisements and...

  20. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... proprietary name of the drug product, if any; the established (generic) name of the drug product, if any; the... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing § 200.200 Prescription drugs; reminder advertisements and...

  1. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... proprietary name of the drug product, if any; the established (generic) name of the drug product, if any; the... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing § 200.200 Prescription drugs; reminder advertisements and...

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

    PubMed Central

    2013-01-01

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

  3. 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

  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. 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. PMID:25534402

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

    PubMed Central

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

    2014-01-01

    Purpose of the Study: To elicit the thought process or mental model that community pharmacists use when making recommendations on over-the-counter (OTC) medications to older adults and to elicit the current practices of community pharmacists in providing information, advice, and counseling to older adults about potentially inappropriate OTC medications. Design and Methods: Three separate focus groups with pharmacists were conducted with 5 to 8 pharmacists per group. A vignette about an elderly woman seeking an OTC sleep aid was used to elicit information that pharmacists seek to establish when making a recommendation. Focus groups were recorded, transcribed verbatim, and analyzed for themes using the initial and focused coding methods of grounded theory. Results: Community pharmacists’ mental models were characterized by 2 similarities: a similarity in what community pharmacists seek to establish about patients and a similarity in when community pharmacists seek to establish it—the sequence in which they try to learn key details about patients. It was identified that pharmacists gather specific information about the patient’s medication profile, health conditions, characteristics of the problem, and past treatments in order to make a recommendation. Community pharmacists recommended behavioral modifications and seeing their physician prior to recommending an OTC sleep aid, primarily due to medication safety concerns. Implications: Pharmacists can play a key role in assisting older adults to select and use OTC medications. PMID:24197014

  7. Over-The-Counter Nicotine Replacement Therapy: Can its impact on smoking cessation be enhanced?

    PubMed Central

    Amodei, Nancy; Lamb, Rick. J.

    2011-01-01

    Nicotine replacement therapies (NRT) are efficacious smoking cessation aids. However, only minimal increases in smoking cessation followed NRT being made available over-the-counter (OTC) which presumably made these treatments more readily available. To better understand why the U.S. did not experience improvements in smoking cessation following the OTC availability of NRT, it is useful to review factors that determine NRT’s impact on smoking cessation and how these factors played out with the introduction of OTC NRT. We contend that for NRT to have a greater impact on public health, we need to increase the number of individuals making a quit attempt, the proportion using NRT in a quit attempt, and the effectiveness of each quit attempt. Even small increases in the impact of OTC NRT could yield significant benefits in terms of morbidity and mortality. The remainder of this paper provides examples of interventions designed to target each of the above mentioned factors individually as well as examples of interventions that link increased cessation attempts, increased NRT reach, and increased NRT efficacy in order to synergistically increase the impact of OTC NRT. PMID:19071972

  8. 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

  9. Medicare program; e-prescribing and the prescription drug program. Final rule.

    PubMed

    2005-11-01

    This final rule adopts standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). These standards will be the foundation standards or the first set of final uniform standards for an electronic prescription drug program under the MMA, and represent the first step in our incremental approach to adopting final foundation standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care. PMID:16273748

  10. Non-medical use of prescription drugs and sexual risk behavior in young adults.

    PubMed

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

    2011-01-01

    In recent years, the non-medical use of prescription drugs (without a doctor's prescription) has increased dramatically, particularly in young adults. Previous work has noted associations between the non-medical use of prescription drugs and the use of illicit drugs, and associations between the use of illicit drugs and sexual risk behavior. Investigations examining associations between the non-medical use of prescription drugs (NMUPD) and sexual risk behavior are sparse. In the present study, undergraduate students (n=435) ages 18-25 completed an instrument assessing these behaviors. Overall, 35.6% of participants reported NMUPD. Individuals who reported NMUPD were more likely to also report the use of alcohol, marijuana, ecstasy, cocaine, methamphetamine, and poppers. Participants who indicated they had used prescription medications without a doctor's consent had significantly higher rates of sexual risk behavior, including more sexual partners and more instances of unprotected sex in the previous 3 months. Results suggest that a significant minority of young adults are using prescription medication recreationally and are risking negative consequences, including the potential for addiction, dangerous interactions between prescription and recreational drugs, and greater risk for contracting sexually transmitted infections. PMID:20863626

  11. 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…

  12. 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. PMID:25445507

  13. Understanding Nonprescription and Prescription Drug Misuse in Late Adolescence/Young Adulthood

    PubMed Central

    Fleary, Sasha A.; Heffer, Robert W.; McKyer, E. Lisako J.

    2013-01-01

    This study explored the extent to which nonprescription and prescription drugs misuse among adolescents/young adults are related to their perception that it is safer than illicit drugs, ease of access, and lower societal stigma. Adolescents/young adults (N = 465; Mage = 18.57, SD = 0.86) completed an online survey about their nonprescription and prescription drug misuse, other substance use, and correlates of use. Perceived risk, societal stigma, and access to nonprescription and prescription drugs were predictive of misuse. Results support program planners working towards targeting perceived risk and societal stigma in reducing misuse and the need to restrict and monitor access to nonprescription and prescription drugs for adolescents/young adults. PMID:24826368

  14. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... 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 prescription... of each component (amount, frequency, duration) is such that the combination is safe and...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... methamphetamine salts (d-desoxyephedrine, or dl-desoxyephedrine, or their salts), as well as amphetamine inhalers... 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... methamphetamine salts (d-desoxyephedrine, or dl-desoxyephedrine, or their salts), as well as amphetamine inhalers... 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... methamphetamine salts (d-desoxyephedrine, or dl-desoxyephedrine, or their salts), as well as amphetamine inhalers... 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... methamphetamine salts (d-desoxyephedrine, or dl-desoxyephedrine, or their salts), as well as amphetamine inhalers... 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...

  19. 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:...

  20. 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. PMID:26502300

  1. Severe Symptomatic Hypermagnesemia Associated with Over-the-Counter Laxatives in a Patient with Renal Failure and Sigmoid Volvulus

    PubMed Central

    Khairi, Talal; Amer, Syed; Spitalewitz, Samuel; Alasadi, Lutfi

    2014-01-01

    Hypermagnesemia is an uncommon but a potentially serious clinical condition. Over-the-counter magnesium containing products are widely used as antacids or laxatives. Although generally well tolerated in patients with normal renal function, their unsupervised use in the elderly can result in severe symptomatic hypermagnesemia, especially in those patients with concomitant renal failure and bowel disorders. We report a case of severe symptomatic hypermagnesemia associated with over-the-counter laxatives in a 70-year-old male patient with renal failure and sigmoid volvulus, who was successfully treated with hemodialysis. PMID:24563801

  2. 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

  3. 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

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

    PubMed

    Klepser, Michael E

    2014-09-01

    The substantial economic impact of influenza on society results primarily from lost work time and reduced productivity of patients and caregivers and increased use of medical resources. Additionally, since the 1980s, aging of the US population has meant rising influenza-related morbidity and mortality. According to the most current published data on this topic, in 2003 the total economic burden of influenza epidemics in the USA across all age groups was US$87.1 billion. As of February 2013, overall vaccine effectiveness for the 2012/2013 season was estimated to be 56 %. The Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases has concluded that more effective vaccines and vaccination strategies are needed. Moderate efficacy of the influenza vaccine, continued questions regarding the value of treatment with antivirals, and a growing self-care movement have led to increased use of over-the-counter (OTC) medicines, which play a vital role in managing symptoms associated with mild to moderate influenza and provide an estimated US$102 billion in annual savings for the US healthcare system. A primary benefit to society of using OTC medicines to manage influenza is decreased use of the healthcare system, thereby mitigating the socioeconomic burden of influenza. Considering the stresses placed on the US healthcare system and the substantial productivity losses resulting from seasonal influenza as well as the growing self-care movement, OTC medicines will play an important role in the course of future influenza epidemics. PMID:25150045

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... authorized to do so on the beneficiary's behalf. (2) Use of a single card. A card that is issued under § 423... programs providing prescription drug coverage have been made. (2) Reimbursements for excess...

  6. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... on the beneficiary's behalf. (2) Use of a single card. A card that is issued under § 423.120(c) for... prescription drug coverage have been made. (2) Reimbursements for excess cost-sharing and premiums for...

  7. 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 Labels AGENCY: Architectural and Transportation Barriers Compliance Board. ACTION: Notice of meeting...-1111. FOR FURTHER INFORMATION CONTACT: Susan Crawford, Architectural and Transportation...

  8. 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

  9. 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

  10. 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

  11. 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…

  12. 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…

  13. 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. PMID:14983621

  14. Buyer beware? Does the information provided with herbal products available over the counter enable safe use?

    PubMed Central

    2011-01-01

    Background Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information. Methods Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). Results Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages. Conclusions Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due

  15. Prescription drugs in nursing homes: managing costs and quality in a complex environment.

    PubMed

    Mendelson, Dan; Ramchand, Rajeev; Abramson, Richard; Tumlinson, Anne

    2002-11-12

    This brief provides a description of prescription drug use in nursing homes and a summary of current policy issues in this area. The brief first profiles the nursing home pharmaceutical market, outlining the major trends in demographics and drug utilization, the supply chain by which drugs go from manufacturers to pharmacies to nursing home residents, and the alternative arrangements by which prescription drugs in nursing homes are financed. The brief then provides a synopsis of current policy issues, focusing in turn on cost containment and quality improvement initiatives. PMID:12463231

  16. Off-Label Prescription of Psychopharmacological Drugs in Child and Adolescent Psychiatry.

    PubMed

    Braüner, Julie Vestergaard; Johansen, Lily Manzello; Roesbjerg, Troels; Pagsberg, Anne Katrine

    2016-10-01

    This study aimed to describe the frequency of off-label prescriptions of psychopharmacological drugs in a child and adolescent psychiatric setting. A cross-sectional study was conducted on November 1, 2014, including all inpatients and outpatients at the Mental Health Centre for Child and Adolescent Psychiatry, Capital Region of Denmark, aged 0 to 17 years receiving medical treatment with antidepressants, antipsychotic agents, benzodiazepines, melatonin and/or attention deficit hyperactivity disorder (ADHD) medication. We included a total of 5555 prescriptions representing 2932 patients. The main findings were that 32.3% of all prescriptions were off-label, and 41.6% of subjects received at least 1 off-label prescription. The most frequent off-label category was low age, 72.2%, meaning that the drug was not approved for the age group of the patient. The off-label rates for each drug class were as follows: melatonin, 100%; antipsychotic agents, 95.6%; benzodiazepines, 72.5%; antidepressants, 51.1%; and ADHD medication, 2.7%. Prescription of 2 or more psychopharmacological drugs per patient was common (31.5%). The group of subjects with 4 or more prescriptions (n = 36) was characterized by a higher frequency of inpatients, older age, and a different distribution of diagnoses. This study found a frequent use of off-label prescriptions when treating children and adolescents with psychopharmacological drugs other than ADHD medication. In addition, prescription of more than 1 psychotropic drug is common. These findings support the need for extending the evidence base for psychopharmacologic treatment in children and adolescents. PMID:27529772

  17. 77 FR 58848 - Prescription Drug User Fee Act V Patient-Focused Drug Development; Consultation Meetings; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ...The Food and Drug Administration (FDA) is issuing this notice to request that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug......

  18. 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. PMID:7879804

  19. 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…

  20. 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,…