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Sample records for prescription drugs over-the-counter

  1. 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…

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

    PubMed

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

    2005-01-01

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

  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. 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

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

    PubMed

    Jones, Derek

    2011-02-01

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

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

    PubMed

    Jones, Derek

    2011-02-01

    Women have long strived to possess long, thick, and dark eyelashes. Prominent eyes and eyelashes are often considered a sign of beauty and can be associated with increased levels of attractiveness, confidence, and well-being. Numerous options may improve the appearance of eyelashes. Mascara aims to temporarily darken, lengthen, and thicken eyelashes using a combination of waxes, pigments, and resins. Artificial eyelashes can be adhered either to the dermal margin or to individual eyelashes. Individuals may even use eyelash transplantations to improve the appearance of their eyelashes. The unique properties of eyelashes (e.g., relatively long telogen and short anagen phases compared with scalp hairs, slow rate of growth, and a lack of influence by androgens) may allow for specific aesthetic interventions to improve the appearance of natural eyelashes. Some over-the-counter (OTC) products may contain prostaglandin analogs that can affect eyelash growth, but neither the safety nor efficacy of these OTC cosmetics has been fully studied. Originally indicated for the reduction of intraocular pressure, the synthetic prostaglandin analog bimatoprost was recently approved for the treatment of hypotrichosis of the eyelashes. In a double-blinded, randomized, vehicle-controlled trial, bimatoprost safely and effectively grew natural eyelashes, making them longer, thicker, and darker. Bimatoprost was generally safe and well tolerated and appears to provide an additional option for individuals looking to improve the appearance of their eyelashes. PMID:20730536

  8. 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

  9. Over-the-counter drugs and prescribing in general practice.

    PubMed Central

    Baines, D L; Whynes, D K

    1997-01-01

    BACKGROUND: Both the government and the pharmaceutical industry are interested in increasing the use of over-the-counter (OTC) medicines. The reaction on the part of general practitioners is more circumspect. AIM: To investigate whether fundholding or dispensing status and patient exemption from, or prepayment of prescription charges influence the behaviour of general practitioners with respect to prescribing preparations otherwise available OTC. METHOD: Regression analysis of data for all 105 Lincolnshire practices for the fiscal year 1993-94, using the number of items prescribed by the practice that were also available OTC as the outcome variable. Comparison of Audit Commission Thematic Analysis of Prescribing (ACTAP) data for fundholders' and non-fundholders' OTC prescribing in the same year. RESULTS: The prescription of medicines otherwise available OTC is less likely when the practice is fundholding and more likely when the practice has dispensing status. Prescription of such medicines also increases as the proportion of patients exempt from, or having prepaid prescription charges increases. PMID:9196964

  10. 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... or Devices § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives. (a... ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims...

  11. 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

  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 and itches. Some prevent or cure ... the Food and Drug Administration decides whether a medicine is safe enough to sell over-the-counter. ...

  13. 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.

  14. Child-resistant packaging for certain over-the-counter drug products. Final rule.

    PubMed

    2001-08-01

    Pursuant to its 3-0 vote to do so, the Consumer Product Safety Commission (CPSC or Commission) is issuing a rule to require child-resistant (CR) packaging on drugs (OTC switched drugs) approved by the Food and Drug Administration (FDA) for over-the-counter (OTC) sale that contain active ingredients previously available only in prescription drugs. Current Commission regulations require CR packaging for most oral drug products containing prescription-only active ingredients.However, prior to issuance of this rule there was no general requirement to maintain CR packaging of such drug products in forms subsequently approved by the FDA for OTC sale. The Commission is also revoking the current prohibition on granting a petition for an exemption from a CR packaging requirement prior to FDA approval of the drug product in question. The Commission takes these actions under authority of the Poison Prevention Packaging Act of 1970, as amended.

  15. 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

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

    PubMed Central

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

    2014-01-01

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

  17. 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...

  18. 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...

  19. 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)

  20. 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... suitable articles of this type “For the temporary relief of minor sore throats”, provided this...

  1. 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... suitable articles of this type “For the temporary relief of minor sore throats”, provided this...

  2. 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... suitable articles of this type “For the temporary relief of minor sore throats”, provided this...

  3. 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

  4. 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

  5. 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.

  6. 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

  7. Perspectives on switching oral acyclovir from prescription to over-the-counter status: report of a consensus panel.

    PubMed

    Sande, M A; Armstrong, D; Corey, L; Drew, W L; Gilbert, D; Moellering, R C; Smith, L G

    1998-03-01

    The proposed switching of oral acyclovir from prescription to over-the-counter (OTC) status for the 5-day episodic treatment of genital herpes was considered by a consensus panel. It was concluded that self-diagnosis/misdiagnosis, misuse, and adverse drug effects were potential problems with the OTC use of acyclovir. While acyclovir reduces asymptomatic shedding of herpes simplex virus type 2, the reduction in transmission of virus potentially resulting from increased acyclovir use was felt to be of unknown extent but likely to be of benefit overall. The availability of acyclovir would likely be improved. There were differences in opinion as to whether widespread availability of acyclovir (prescription or OTC) may speed the development of viral resistance. However, all panel members felt that granting OTC status may set an undesirable precedent for the switch from prescription to OTC use of other systemically administered antiinfective agents. The effect of this precedent, in terms of accelerating development of multidrug-resistant bacteria, was a major concern of all panel members. The consensus was that the switch of acyclovir to OTC status could not be supported. PMID:9524840

  8. 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…

  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 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... HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.542 Over-the-counter (OTC) drug... safe and effective. (b) Any drug product that is labeled, represented, or promoted for OTC use in...

  12. 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... USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.541 Over-the-counter (OTC) drug... and effective. (b) Any drug product that is labeled, represented, or promoted for OTC use in...

  13. 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

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

    PubMed

    Fernández-Maestre, Roberto; Hill, Herbert H

    2009-08-01

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

  15. Antiperspirant 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) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.

  16. Antiperspirant 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) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention. PMID:12795305

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 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...

  19. 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...

  20. An overview of over the counter drugs in pregnancy and lactation.

    PubMed

    Das, B P; Joshi, M; Pant, C R

    2006-01-01

    Over the counter (OTC) drugs are commonly used by pregnant women. Most OTC drugs are safe in pregnancy but some have unproven safety and may adversely affect the growing foetus. The safety profile of some of the medication may change according to the gestational age of the foetus. Because an estimated 10% or more of the birth defects results from maternal drug exposure, the US Food and Drug Administration (FDA) has assigned a risk category to each drugs. Among the commonly used OTC drugs Acetaminophen, Chlorpheniramine, Kaolin and Pectin preparations and most antacids have a good safety record. The drugs like H2 blockers; Pseudoephedrine and Atropine/Diphenoxylate should be used with caution. The risk and benefit while using OTC drugs in pregnancy has to be assessed.

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

    PubMed

    Douzenis, Athanasios; Michopoulos, Ioannis; Lykouras, Lefteris

    2006-01-01

    A case of a patient with bipolar disorder with a history of hospitalizations and addiction to sulbutiamine is presented. Sulbutiamine is a precursor of thiamine that crosses the blood-brain barrier and is widely available without prescription in most countries or over the internet. Because of this patient's need to consume ever increasing quantities of sulbutiamine, his psychiatric care was severely compromised through him defaulting appointments and frequent changes of psychiatrists. This paper reviews the current scientific knowledge about sulbutiamine, and some of the information and claims available on the web about its use and potential. It is argued that doctors need to be aware of the potential misuse of medication available over the counter or on the internet and its potential harmful influence. PMID:16861144

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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...

  7. 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

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 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. 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

  9. 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

    ... HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.542 Over-the-counter (OTC) drug... treatment of hyperphosphatemia is regarded as a new drug within the meaning of section 201(p) of the Federal... governing use of investigational new drugs set forth in part 312 of this chapter. (d) After November...

  10. 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

    ... USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.541 Over-the-counter (OTC) drug... treatment of hypophosphatemia is regarded as a new drug within the meaning of section 201(p) of the Federal... governing the use of investigational new drugs set forth in part 312 of his chapter. (d) After November...

  11. 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

  12. 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...

  13. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  15. 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...

  16. 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...

  17. 78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash Products; Rescheduling of Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice; rescheduling of public hearing. SUMMARY: The Food and Drug Administration (FDA) is rescheduling a December...

  18. 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.

  19. 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

  20. 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...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to... hypochlorhydria, and because such conditions are asymptomatic, any OTC drug product containing ingredients...

  1. 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

    ... the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the symptoms... and symptoms of this condition. Therefore, self-medication with OTC drug products might unnecessarily... currently available, any OTC drug product containing ingredients offered for use in relieving the...

  2. 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

    ... Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for...), Lactobacillus acidophilus, and Lactobacillus bulgaricus have been present in orally administered OTC drug... currently available, any OTC drug product for oral administration containing ingredients offered for use...

  3. Over the counter drugs (and dietary supplement) exercise: a team-based introduction to biochemistry for health professional students.

    PubMed

    Phadtare, Sangita; Abali, Emine; Brodsky, Barbara

    2013-01-01

    For successful delivery of basic science topics for health-professional students, it is critical to reduce apprehension and illustrate relevance to clinical settings and everyday life. At the beginning of the Biochemistry course for Physician Assistants, a team-based assignment was designed to develop an understanding of the mechanism of action, effectiveness, and toxicity of five common over the counter (OTC) drugs and dietary supplements, and place these familiar medicines in a political and historical context. The objectives of this exercise were to stimulate interest in biochemistry; to provide basic information on enzymes and enzyme inhibitors related to these drugs to be expanded upon later in the course; and to encourage active and interactive learning. Teams of five students were formed, and each student was given an information sheet on aspirin, alpha-galactosidase, orlistat, dextromethorphan, or simvastatin, a low dose statin, which was previously available without prescription at pharmacies in the UK. After each member of the team acquired information on one OTC drug/dietary supplement by reading an assigned information sheet, the team was asked to go through a series of questions, and then submit answers to a quiz as a group. A high rate of success on the quiz, an overwhelmingly positive response on formal course evaluations, and enthusiastic exchanges during class suggested this team-based session accomplished its goals.

  4. 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

  5. 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...

  6. 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

    ... offered over-the-counter (OTC) for use for ingrown toenail relief. 310.538 Section 310.538 Food and Drugs... relief. Based on evidence currently available, any OTC drug product containing ingredients offered for use for ingrown toenail relief cannot be generally recognized as safe and effective. (b) Any OTC...

  7. 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

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

    ERIC Educational Resources Information Center

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

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

  9. 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...

  10. 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... demonstration project under 10 U.S.C. 1092 to allow certain over-the- counter (OTC) medications to be...

  11. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI). 330.12 Section 330.12 Food and Drugs FOOD AND DRUG... Register concerning previously unpublished OTC drugs reviewed by the National Academy of...

  12. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs...) is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act for which an approved new drug application under section 505 of the act and part 314 of...

  13. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Final rule.

    PubMed

    2016-09-01

    The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.

  14. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Final rule.

    PubMed

    2016-09-01

    The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. PMID:27632802

  15. A categorical review on electroanalytical determination of non-narcotic over-the-counter abused antitussive drugs.

    PubMed

    Thapliyal, Neeta; Patel, Harun; Karpoormath, Rajshekhar; Goyal, Rajendra N; Patel, Rajkumar

    2015-09-01

    Dextromethorphan (DXM) and diphenhydramine (DPH) are two commonly used over-the-counter non-narcotic antitussive drugs. Recent reports reveal the widespread abuse of DXM and DPH due to their euphoric and alcohol-like effects. Due to their medicinal importance as well as the apparent increase in their use as abused drugs, it has become critical to determine them in samples of biological, clinical and pharmaceutical interest. The electrochemical techniques for drug analysis have gathered considerable attention due to their pronounced selectivity, sensitivity and simplicity. The given review presents a compilation of published voltammetric and potentiometric methods developed for determination of DXM and DPH. It critically highlights the analytical performances, revealing the recent trends and progress in the specified approach for their analysis. The review forms a basis for further progress in this field and development of improved electrochemical sensors to determine the drug.

  16. The influence of need for cognition and principal display panel factors on over-the-counter drug facts label comprehension.

    PubMed

    Catlin, Jesse R; Pechmann, Cornelia; Brass, Eric P

    2012-01-01

    Nearly all work aimed at optimizing the ability of labeling to communicate over-the-counter (OTC) drug information has focused on back-of-the-package characteristics, such as the Drug Facts label. The effects of front of the package, or principal display panel (PDP) factors, have largely been neglected by researchers. Similarly, heterogeneity in consumers' approach to new information has received scant attention in the context of OTC drugs. This preliminary study tested the hypothesis that display of a drug's brand name on the PDP and individuals' need for cognition influence comprehension of Drug Facts label information. University students (n = 212) that had experienced heartburn but not used the drug class being studied constituted the primary analysis cohort. Students were randomly assigned to review one of two PDPs (brand name or generic), followed by a Drug Facts label and a series of questions related to selection and usage of the drug. Participants with low need for cognition were influenced by the brand name PDP, as those exposed to a PDP featuring a brand (vs. generic) spent less time reading the Drug Facts label and demonstrated lower comprehension of the label information on proper drug selection. These findings suggest that further research is needed to understand the impact of PDP contents and cognitive characteristics of consumers on the communication of OTC drug information. Health care providers should consider communication strategies that account for the challenges patients face in using OTC drugs properly.

  17. 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...) lack of randomization within families, affecting the independence of observations. These...

  18. Simple heuristics in over-the-counter drug choices: a new hint for medical education and practice

    PubMed Central

    Riva, Silvia; Monti, Marco; Antonietti, Alessandro

    2011-01-01

    Introduction Over-the-counter (OTC) drugs are widely available and often purchased by consumers without advice from a health care provider. Many people rely on self-management of medications to treat common medical conditions. Although OTC medications are regulated by the National and the International Health and Drug Administration, many people are unaware of proper dosing, side effects, adverse drug reactions, and possible medication interactions. Purpose This study examined how subjects make their decisions to select an OTC drug, evaluating the role of cognitive heuristics which are simple and adaptive rules that help the decision-making process of people in everyday contexts. Subjects and methods By analyzing 70 subjects’ information-search and decision-making behavior when selecting OTC drugs, we examined the heuristics they applied in order to assess whether simple decision-making processes were also accurate and relevant. Subjects were tested with a sequence of two experimental tests based on a computerized Java system devised to analyze participants’ choices in a virtual environment. Results We found that subjects’ information-search behavior reflected the use of fast and frugal heuristics. In addition, although the heuristics which correctly predicted subjects’ decisions implied significantly fewer cues on average than the subjects did in the information-search task, they were accurate in describing order of information search. A simple combination of a fast and frugal tree and a tallying rule predicted more than 78% of subjects’ decisions. Conclusion The current emphasis in health care is to shift some responsibility onto the consumer through expansion of self medication. To know which cognitive mechanisms are behind the choice of OTC drugs is becoming a relevant purpose of current medical education. These findings have implications both for the validity of simple heuristics describing information searches in the field of OTC drug choices and

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

    PubMed

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

    2012-07-01

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

  1. 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

    ... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold...

  2. 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

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW... over-the-counter (OTC) for the treatment and/or prevention of malaria. (a) Quinine and quinine salts... potentially serious and life-threatening risks associated with the use of quinine at doses employed for...

  3. 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.

  4. Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment.

    PubMed

    2009-03-01

    We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products.

  5. 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...

  6. 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...

  7. 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...

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

    ERIC Educational Resources Information Center

    Jarvis, Dennis J.; And Others

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

  9. 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...

  10. 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...

  11. 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...

  12. 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  14. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  15. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  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

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

  17. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  19. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  20. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  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. Dandruff, seborrheic dermatitis, and psoriasis drug products containing coal tar and menthol for over-the-counter human use; amendment to the monograph. Final rule.

    PubMed

    2007-03-01

    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. PMID:17447341

  5. What information for the patient? Large scale pilot study on experimental package inserts giving information on prescribed and over the counter drugs.

    PubMed Central

    1990-01-01

    OBJECTIVE--To compare the acceptability and the degree of understandability of two drug information leaflets on three over the counter and two prescribed drugs. DESIGN--Prospective observational study. SETTING--Random sample of municipal pharmacies throughout Italy. SUBJECTS--A total of 6992 clients of the pharmacies who requested the study drugs over a period of four months. INTERVENTION--Exposure of patients to two information leaflets, one approved by the Ministry of Health, and the other an experimental sheet prepared by the research working group. MAIN OUTCOME MEASURES--The degree of acceptability of the information was assessed by using a pretested questionnaire. Comments concerning information needs were also encouraged and collected. RESULTS--6992 Clients responded to the questionnaire. Non-metropolitan (urban and rural) areas had the highest rate of participation. The participants strongly preferred the experimental leaflets to the approved leaflets, both with respect to accessibility of the contents (overall preference 78.1% v 17.8%) and ease of understanding the contraindications of drug use (90.2% v 73.7%). Basic attitudes related to the use of written information were similar among clients of different age groups, educational levels (though emerging people with primary school or lower educational levels showed slightly lesser understanding), and geographic areas. Up to 50% of those who took over the counter drugs indicated a disposition to change their drug seeking behaviour on the basis of the information in the experimental leaflet. The comments provided a useful complementary set of data on the information needs expressed by participants. CONCLUSIONS--The results of this pilot study indicate that patients will enter active programmes to investigate the provision of problem oriented drug information. Their information needs seem to concern both prescribed and over the counter drugs. More extensive and systematic work is required to develop an

  6. 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...

  7. 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

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.540 Drug products containing active... regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic...

  8. 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

    ... (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.532 Drug... hypertrophy is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and... governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After August......

  9. 21 CFR 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.536 Drug products... thumbsucking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug... new drug application or abbreviated new drug application, such product is also misbranded...

  10. 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

    ... FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.543 Drug products... new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act... the use of investigational new drugs set forth in part 312 of this chapter. (d) After May 7, 1991,...

  11. 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

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.537... regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act... comply with the requirements and procedures governing the use of investigational new drugs set forth...

  12. 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

    ... NEW DRUGS Requirements for Specific New Drugs or Devices § 310.538 Drug products containing active... product that is labeled, represented, or promoted for ingrown toenail relief is regarded as a new drug... is required for marketing. In the absence of an approved new drug application or abbreviated new...

  13. 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...

  14. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR... requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug... by this section must be sealed using an acceptable tamper-evident technology. (c) Labeling. (1)...

  15. 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

    ... nailbiting or thumbsucking deterrent. Based on evidence currently available, any OTC drug product containing... and effective. (b) Any OTC drug product that is labeled, represented, and promoted as a nailbiting or... investigational new drugs set forth in part 312 of this chapter. (d) After March 2, 1994, any such OTC...

  16. 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

    ... included in an OTC drug monograph. Therefore, the safe and effective use of these enzymes for treating exocrine pancreatic insufficiency cannot be regulated adequately by an OTC drug monograph. Information on... such OTC drug product that contains hemicellulase initially introduced or initially delivered...

  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.

  18. Over-the-counter medications in pregnancy.

    PubMed

    Black, Ronald A; Hill, D Ashley

    2003-06-15

    Pregnant women commonly use over-the-counter medications. Although most over-the-counter drugs have an excellent safety profile, some have unproven safety or are known to adversely affect the fetus. The safety profile of some medications may change according to the gestational age of the fetus. Because an estimated 10 percent or more of birth defects result from maternal drug exposure, the U.S. Food and Drug Administration has assigned a risk category to each drug. Many drugs have not been evaluated in controlled trials and probably will not be because of ethical considerations. Of the commonly used over-the-counter medications, acetaminophen, chlorpheniramine, kaolin and pectin preparations, and most antacids have a good safety record. Other drugs, such as histamine H2-receptor blockers, pseudoephedrine, and atropine/diphenoxylate should be used with caution. If use of smoking cessation products is desired, the intermediate-release preparations minimize the amount of nicotine while maintaining efficacy. With all over-the-counter medications used during pregnancy, the benefit of the drug should outweigh the risk to the fetus.

  19. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  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

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

  1. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  2. 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 ginseng, licorice, mandrake, methyltestosterone, minerals, nux vomica, Pega Palo, sarsaparilla,...

  3. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 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...

  5. 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

    ... June 17, 2011 Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts...; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 310 (Formerly... published at 69 FR 53801, September 3, 2004. FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for...

  6. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national... tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package...

  7. 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...

  8. 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

  9. Demographic, medical, and behavioral characteristics associated with over the counter non-steroidal anti-inflammatory drug use in a population based cohort: results from the Multi-Ethnic Study of Atherosclerosis

    PubMed Central

    Delaney, Joseph A C; Biggs, Mary L.; Kronmal, Richard A; Psaty, Bruce M

    2010-01-01

    Background Three types of non-steroidal anti-inflammatory drugs (NSAIDs) can be obtained both over the counter (OTC) and by prescription in the United States. OTC NSAID use is not recorded in prescription claims databases; this might lead to differential misclassification of NSAID exposure status in studies that use computerized pharmacy databases to study NSAID use. Objective To evaluate characteristics of OTC versus prescription NSAID users Methods This analysis is set within the Multi-Ethnic Study of Atherosclerosis (MESA) study; a prospective cohort study of 6,814 adults from 4 ethnic groups (European descent, Asian, African-American and Hispanic) with a mean age of 62 years. The cohort was restricted to those who initiated NSAID use (aspirin, ibuprofen or naproxen) during follow-up. We compared information about age, sex, ethnicity, body mass index, smoking, diabetes, medication use, education, income, health insurance status and exercisebetween groups. Results OTC NSAID use was prevalent at baseline (25% Aspirin, 9% Ibuprofen, 2% Naproxen). Compared to prescribed NSAID use, OTC NSAID use was lower for users of non-European descent for all classes: aspirin (p<0.0001), ibuprofen (p<0.0001) and naproxen (p=0.0094). For aspirin, differences were seen for male gender (Relative Risk (RR):0.92; 95%(Confidence interval) CI:0.86–0.98), use of lipid lowering drugs (RR:0.88; 95% CI: 0.80–0.96), low income (RR:0.89; 95%CI:0.81–0.97), and participants one standard deviation above average in intentional exercise (RR:1.03; 95%CI:1.01–1.05). Conclusions OTC NSAID use is prevalent in an older multi-ethnic population and OTC users differ from prescription NSAID users. Caution should be exercised when using prescribed NSAIDs as a proxy for NSAID use. PMID:21182156

  10. 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, ...

  11. 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 ...

  12. 77 FR 35986 - Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... certain OTC drugs. FDA is issuing this small entity compliance guide as level 2 guidance consistent with... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved...

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

    PubMed

    Jenkins, A J; Stillwell, M E

    2010-01-01

    Over-the-counter drugs are medications that are available without the requirement of a prescription. They are considered relatively safe and well-tolerated when taken in accordance with the dosing instructions on the package label. However, when taken alone or in combination with other drugs, they possess pharmacological properties that have the potential to facilitate sexual assault. This chapter reviews the chemistry and pharmacology of these drugs. Additionally, a brief overview of analytical methodology is presented. PMID:26242457

  14. [Surveillance study in collaboration with a university-daycare center for elderly people and nursery school for children on the use of over-the-counter drugs and health food in Fukuyama].

    PubMed

    Anraku, Makoto; Inoue, Hirofumi; Sato, Eiji; Hata, Toshiyuki; Tsuchiya, Daiju; Okamura, Nobuyuki; Yoshitomi, Hironori; Kondo, Yuko; Tanaka, Masataka; Tomida, Hisao

    2010-08-01

    To estimate the extent of use of over-the-counter (OTC) drugs and health food, we administered a questionnaire to the parents of children in a nursery school and to elderly people in a daycare center in Fukuyama city. The aim of the questionnaire was to determine the percentage of children and elderly people who use OTC drugs and health food, the purpose of using them, and the types of OTC drugs and health food used. Other questions concerned the person advising them on the use of OTC and health food, the side effects of OTC drugs and health food, and the awareness of children and elderly people regarding possible interactions between prescription drugs and OTC drugs. In children, the most frequently consumed OTC drugs were cold medicines (32.1%), followed by topical creams (22.6%) and eye lotion (14.3%). In elderly people, the most frequently consumed OTC products were eye lotion (18.0%), followed by laxatives (14.8%) and fomentation agents (13.1%). The purchase ratio of health food for children and elderly people were 4.8% and 11.5%, respectively. These results suggest that the need for OTC drugs and health food in children are very different from those in elderly people. In addition, in promoting self-medication, the demand for the opinion of a specialist occupied about 80% or 70% of the total specialist time among children and elderly people, respectively. Therefore, when providing information on health food and OTC drugs, the needs of each generation should be taken into account. The information obtained from the responses received will allow us to provide better pharmaceutical care for both children and elderly people in Fukuyama city.

  15. Over-the-counter suboptimal dispensing of antibiotics in Uganda

    PubMed Central

    Mukonzo, Jackson K; Namuwenge, Proscovia M; Okure, Gildo; Mwesige, Benjamin; Namusisi, Olivia K; Mukanga, David

    2013-01-01

    Background Overuse and misuse of antibiotics is a serious global problem. While resistance to older antibiotics is increasing, development of newer molecules has stalled. Resistance to the existing antibiotics that is largely driven by their high-volume use is a global public health problem. Uganda is one of the countries where prescription-only drugs, including antibiotics, can be obtained over the counter. We determined the rate of antibiotic dispensing and use in Uganda. Methods The study utilized a descriptive cross-sectional study design to determine the number of antibiotic “prescribed” daily doses per 1,000 clients. Data were collected from one health center II, eight general/district hospitals, one national referral hospital, and 62 registered community pharmacies. From each study site, data were collected for five consecutive days over the months of November 2011 to January 2012. Results The overall antibiotic issue rate was 43.2%. Amoxicillin, metronidazole, ciprofloxacin, sulfamethoxazole–trimethoprim, cloxacillin, and ampicillin, belonging to the WHO anatomical therapeutic chemical classifications of penicillin with extended spectra, imidazole derivatives, fluoroquinolones, and sulfonamide–trimethoprim combinations, constituted 70% of the issued antibiotics. About 41% of antibiotics were issued over the counter. At community pharmacies, where 30% of antibiotic dispensing occurred, the number of prescribed daily doses/1,000 antibiotic clients was 4,169 compared to 6,220, 7,350 and 7,500 at general/district hospitals, the national referral hospital, and the health center, respectively. Conclusion In Uganda, at least four in every ten individuals that visit a health-care facility are treated with an antibiotic. Antibiotics are largely given as over-the-counter drugs at community pharmacies. The number of antibiotic prescribed daily doses/1,000 antibiotic clients does not significantly differ between categories of health-care facilities except at

  16. 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.

  17. 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…

  18. Emergency contraception over-the-counter: the medical and legal imperatives.

    PubMed

    Grimes, D A; Raymond, E G; Scott Jones, B

    2001-07-01

    Requiring a physician's prescription for hormonal emergency contraceptive pills makes no sense. Unintended pregnancies remain endemic in the United States, and wider use of emergency contraceptive pills could substantially help. However, the prescription requirement poses an unnecessary barrier to prompt, effective use of this preventive therapy. According to the Durham-Humphrey Amendment of 1951, the default option for all new drugs is, in principle, over-the-counter, unless a drug is addictive or dangerous when self-administered. Clearly, hormonal emergency contraception is neither of these. Emergency contraceptive pills meet all the customary criteria for over-the-counter use: low toxicity, no potential for overdose or addiction, no teratogenicity, no need for medical screening, self-identification of the need, uniform dosage, and no important drug interactions. The Food and Drug Administration is authorized, and, by its own regulations, should be required to switch hormonal emergency contraception to over-the-counter status without delay. The current prescription requirement is not only gratuitous but also harmful to women's health because it impedes access to this important therapy. PMID:11430974

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

    PubMed

    Morice, Alyn H

    2015-12-01

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

  20. 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 ( ...

  1. 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…

  2. [Factors related to purchasing over-the-counter medications online].

    PubMed

    Kishimoto, Keiko; Yoshida, Takeshi; Fukushima, Noriko

    2009-09-01

    We conducted a Web-based survey of approximately 40,000 Internet users on the purchase of over-the-counter (OTC) medications online in March 2009. The valid response rate was 97.8% and the number of responses was 39,208. The number of people who had purchased OTC medications online was 4,653 (11.9%), prescription medicines 792 (2.0%), and medical contact lenses 1,993 (5.1%). As a result of the multiple logistic regression analysis, independent variables with odds ratios (ORs) >1.5 were experience of purchasing prescription-only medicine online (OR=4.997, 95%CI=4.288-5.824), regular supplement use (OR=2.384, 95%CI=2.233-2.548), experience of purchasing colored contact lenses online (OR=2.206, 95%CI=1.632-2.983), no time to visit drugstores (OR=2.092, 95%CI=1.928-2.270), usage of Web sites of uncertain reliability (OR=1.992, 95%CI=1.857-2.137), and experience of purchasing therapeutic contact lenses online (OR=1.796, 95%CI=1.597-2.020). As some people have purchased prescription-only medicine or medical devices and had problems with drug information sources, the development of awareness of medical and pharmaceutical supplies and health and medical information literacy are key priorities to ensure safe OTC medication sales systems.

  3. 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 ...

  4. Medicare Prescription Drug Coverage

    MedlinePlus

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

  5. 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 ...

  6. 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 ...

  7. 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

    ... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.547 Drug products containing quinine offered... a new drug within the meaning of section 201(p) of the act, for which an approved application...

  8. 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 ...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  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

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  14. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  15. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  16. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  17. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  18. 21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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…

  4. 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

  5. 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 ...

  6. 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.

  7. [Drugs prescription for osteoporosis].

    PubMed

    Erviti, J

    2003-01-01

    The aim of this study is to analyse the evolution of the global and relative use of medicines recommended for osteoporosis during the period between 1998 and 2002 in Navarra, and their adaptation to present evidence, making reference to the differences in the prescription profile in primary and specialised care. To this end, information is used from all the prescriptions made within the National Health System where one of these medicines is recommended, issued in pharmacies of Navarra, and billed to the Navarra Health Service-Osasunbidea. The profile of the use of medicines in osteoporosis differs significantly depending on the type of specialist who prescribes them. It would be useful to homogenise the approach to the prevention of bone fractures. In the period under study the use of medicines in Navarra rose by some 85.6% in number of dose/1,000 inhabitants/day. The relative use of hormone replacement therapy fell constantly, the employment of calcitonins remained steady, undergoing a cyclical profile of peaks in winter and valleys in summer, while the relative use of biphosphonates and raloxifen tended to increase. There is a need to evaluate the results on health of the use of these medicines in clinical practice given the discreet efficacy results obtained in clinical trials. Use of calcium should be encouraged because of its potential in the prevention of hip fractures against the rest of the medicinal alternatives. The relative use of raloxifen and calcitonins seems excessive.

  8. Substance use - prescription drugs

    MedlinePlus

    ... substance use; Oxycodone - substance use; Hydrocodone - substance use; Morphine - substance use; Fentanyl - substance use ... fluff, hydros, v-itamin, vic, vike, Watson-387. Morphine. Drugs include Avinza, Duramorph, Kadian, Ormorph, Roxanol. Street ...

  9. 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 ...

  10. 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 ...

  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. 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

  13. Relationships between prescription and non-prescription drug use in an elderly population.

    PubMed

    Poole, C; Jones, D; Veitch, B

    1999-01-01

    This paper explores, at an epidemiological level, the relationship between categories of over-the-counter (OTC) and prescribed (Rx) drugs in a community-resident elderly population. A total of 2818, randomly selected, older adults were interviewed at home about their use of prescribed and non-prescribed medication and other health-related factors. For comparative purposes OTC drugs were classified into 16 therapeutic groups-identical to those used by other researchers; prescribed drugs were classified into 45 British National Formulary (BNF) therapeutic sub-categories. Analyses revealed significant association between certain BNF categories and OTC categories, which may have a clinical explanation. These include a 3-fold increase (P<0.01) of OTC laxative use by those prescribed an antidepressant, and a 4-fold increase (P<0.001) in OTC antacid use among those prescribed oral corticosteroids. Our findings may indicate an attempt by older people to control side effects of prescription medicines with OTC preparations. This study, in part, supports the call by the Royal College of Physicians for further research to determine the effect of interactions (be they pharmacological, behavioural or otherwise) between OTC and prescribed medicines.

  14. 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

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

    PubMed

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

    2013-10-12

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

  16. 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

  17. Revisiting "the origins of compulsory drug prescriptions".

    PubMed Central

    Marks, H M

    1995-01-01

    It has been argued that today's prescription drug market originated in the arbitrary acts of the US Food and Drug Administration (FDA), which in 1938 issued regulations creating a class of drugs that could be sold by prescription only. On the basis of the FDA's administrative records, I argue that the 1938 regulations on prescription drug labeling were initiated by industry and then agreed to by the FDA; that contemporaries understood and accepted the reasons for restricting the use of certain drugs; and that the subsequent evolution of these regulations is best understood as an FDA effort to limit industry abuses of the prescription labeling system. This decade-long war of position ended when drug manufacturers persuaded the US Congress to enshrine their version of prescription labeling in law in a highly politicized struggle over government's role in the economy. Images FIGURE 1 PMID:7832245

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

    PubMed

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

    2014-05-01

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

  19. 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....

  20. 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

  1. 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

  2. Self-reported use of traditional, complementary and over-the-counter medicines by HIV-infected patients on antiretroviral therapy in Pretoria, South Africa.

    PubMed

    Malangu, N

    2007-02-16

    Current management of HIV involves the use of conventional prescription medicines, called 'antiretroviral drugs' (ARV), over-the-counter (OTC), complementary and alternative medicines (CAM), as well as African traditional medicine (ATM). The aim of this study was to determine the prevalence of use of traditional, complementary and over-the-counter medicines. A cross-sectional survey of HIV-infected patients who started ART between July 2004 and August 2005 at Dr George Mukhari Hospital (Pretoria), who consented to be interviewed, was conducted. Using a pre-tested structured questionnaire, data were collected by two trained interviewers on sociodemographic characteristics, and on non-prescribed medicines used of three sources: African traditional medicine (ATM), complementary and alternative medicine (CAM), and over-the-counter (OTC) medicines. The 180 patients who consented to be interviewed had a mean age of 36.7 (+/-8.1) years old; 68.8% were female, 86.7% unemployed, 73.9% with high school level of education, 77.8% single. Some 8.9% of respondents used at least one non-prescribed medicine. In descending order, 4.4% of respondents used ATM, 3.3% CAM, and 1.7% OTC medicines. The ATM products used included unspecified traditional mixtures, and those made of the African potato (Hypoxis hemerocallidea), and coconut (Cocos nucifera); OTC products used were paracetamol and sennosides (Senokot) tablets as well as a soap containing triclosan 1.5%; CAM products used were "sex booster" capsules of unknown composition, mercury-containing soaps (Mekako), and the Zion Church of Christ special tea, a mixture of Rooibos tea (Aspalathus linearis) plus sunflower oil (Helianthus annuus) and prayed for. In conclusion, only 8.9% of HIV-infected patients on ART in this study used a limited range of over-the-counter products as well as those from traditional, complementary and alternative medicine practices.

  3. 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 ...

  4. 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

    ... 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...) use under the OTC drug review. (a) Before the publication in the Federal Register of an...

  5. 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

    ... 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...) use under the OTC drug review. (a) Before the publication in the Federal Register of an...

  6. Sale of prescription drugs over the Internet.

    PubMed

    Armstrong, K; Bloom, B S

    1999-01-01

    Online drugstores represent one of the hottest categories in electronic commerce. The Internet offers great promise in expanding access to prescription drugs for the disabled, the elderly, and people living in rural areas. But with this promise comes the danger of eliminating the safeguards that protect consumers from inappropriate use of medications and adverse drug events. This Issue Brief highlights two studies that investigate the availability of prescription drugs over the Internet, and focuses on the alarming ease with which consumers can obtain drugs without seeing a physician or a pharmacist. PMID:12523341

  7. 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) * * *...

  8. 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)...

  9. 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) * * *...

  10. 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) * * *...

  11. 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) * * *...

  12. 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)...

  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. (a)(1)...

  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. 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

  16. The effect of over-the-counter sales of the nicotine patch and nicotine gum on smoking cessation in California.

    PubMed

    Reed, Mark B; Anderson, Christy M; Vaughn, Jerry W; Burns, David M

    2005-09-01

    The Food and Drug Administration approved over-the-counter (OTC) sale of nicotine gum and nicotine patches in 1996. We used data from the 1996 California Tobacco Survey to compare the rates of nicotine replacement therapy (NRT) use and smoking abstinence in California for each month during a period immediately preceding and immediately following the OTC availability of nicotine gum and patches. For smokers eligible to report a quit attempt, the proportion making a quit attempt using NRT and the proportion remaining abstinent was calculated for each of the 12 months prior to the survey interview. Multiple regression modeling of quit attempts and abstinence included a term for the number of months between the quit attempt and survey interview and dummy variables for the months before and after the OTC availability of NRT. Results showed a significant increase in the fraction of smokers using the patch (P < 0.01) and gum (P < 0.05) immediately following their availability OTC. There was also a significantly higher proportion of smokers reporting abstinence with gum use (P < 0.01) and a significant increase in reported abstinence with patch use (P < 0.01) during the period of time immediately following the availability of these products without a prescription. The results of this study suggest that removing the prescription status of NRT products resulted in an immediate increase in quit attempts and smoking abstinence with the use of nicotine gum or patches.

  17. 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

  18. 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

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

    PubMed

    Huntzinger, Paul Evan

    2004-07-01

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

  20. 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

  1. 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 ...

  2. 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…

  3. 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…

  4. 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

  5. Developing an effective generic prescription drug program.

    PubMed

    Jones, John D

    2003-01-01

    Pharmacy benefit managers (PBMs) use a variety of pricing strategies. When employers have a thorough knowledge of those strategies, they can use them to their advantage to help manage pharmacy benefits. This article discusses PBM strategies in terms of what employers need to know, the questions employers need to ask and goals employers must keep in mind in order to secure the affordable cost and quality prescription drug management programs that they and their employees need and deserve.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 21 CFR 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

  11. 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

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

  12. 21 CFR 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

  13. 21 CFR 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

  14. 21 CFR 369.3 - Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Definitions and Interpretations §...

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

    PubMed

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

    2013-01-01

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

  16. 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

  17. 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…

  18. 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...

  19. 45 CFR 156.122 - Prescription drug benefits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  20. 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

  1. 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

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

    PubMed

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

    2006-01-01

    This investigation was designed to examine prescription drug-related content and learning objectives in Drug Abuse Resistance Education (D.A.R.E.) for upper elementary and middle schools. Specific prescription-drug topics and context associated with content and objectives were coded. The coding system for topics included 126 topics organized within 14 categories. A two-dimensional coding system for context identified Use versus Abuse and Explicit versus Implicit references to prescription drugs. Results indicated that content and objectives found in D.A.R.E. represent a very narrow breadth of prescription drug topics. Moreover, all prescription-drug related content and objectives were presented in an Abuse-Implicit context. Although some educational material in D.A.R.E. modules potentially is related to prescription drugs, none of the content or objectives explicitly identify drugs discussed as prescription drugs. If elementary and middle schools rely on D.A.R.E. modules to teach students about drug abuse, students are likely to be underinformed about prescription drug risks. PMID:16981638

  3. 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.

  4. 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

  5. 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. ...

  6. Adverse reactions to H2-receptor antagonists in Denmark before and after transfer of cimetidine and ranitidine to over-the-counter status.

    PubMed

    Andersen, M; Schou, J S

    1991-10-01

    The H2-receptor antagonists cimetidine and ranitidine were transferred from prescription only to over-the-counter (OTC) status in Denmark on March 27, 1989. Reports to the Danish Committee on Adverse Drug Reactions, a voluntary reporting system, have been evaluated to detect possible changes in frequency and pattern of adverse drug reactions (ADRs) caused by the altered delivery status. From the introduction of cimetidine in 1977 and until March 31, 1990, the Committee received 494 reports of 612 suspected adverse reactions to anti-ulcer drugs. The H2-receptor antagonists (mainly cimetidine and ranitidine) were responsible for 548 (90%) of the ADRs. The study, which presents experience with these drugs from more than a decade and a total consumption corresponding to 65 million treatment days, confirms their excellent safety record. Serious reactions were rare, and when they occurred, reversible. During the first year with cimetidine and ranitidine available OTC no changes were seen in reporting frequency or ADR pattern which could be ascribed to OTC transfer. Only one ADR report concerning OTC cimetidine was received. This may be caused by several factors: the safety of these drugs, the fact that only very little was actually sold OTC, and a relatively low sensitivity of the voluntary reporting system. PMID:1683484

  7. 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.…

  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. "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

  10. 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...

  11. 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 ...

  12. Non-Medical Prescription Drug Use among University Students

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  13. 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…

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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…

  20. 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.

  1. 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

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

    PubMed

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

    2012-07-01

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

  3. 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

  4. 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 ...

  5. 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 ...

  6. 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

  7. 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

  8. The nonmedical use of prescription drugs by adolescents.

    PubMed

    Rogers, Peter D; Copley, LaRae

    2009-04-01

    The abuse of prescription drugs such as opioids, stimulants, tranquilizers, and sleeping pills is the fastest-growing class of drugs being abused by adolescents. Among this class of drugs, prescription opioids are being abused the most, although the abuse of prescription stimulants has been studied the most. There is a paucity of information on the nonmedical use of tranquilizers and sleeping pills. In this article we will discuss the specific prescription drugs that are most commonly abused by adolescents and how physicians need to be cautious when prescribing these drugs. The issue of screening for the abuse of these drugs will be addressed, as will the importance of parents' monitoring the use of these drugs by their own children. PMID:19492687

  9. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... experience adequately documented in medical literature or by other data (to be supplied to the Food and Drug... 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...

  11. A meta-analysis of the efficacy of over-the-counter nicotine replacement

    PubMed Central

    Hughes, J; Shiffman, S; Callas, P; Zhang, J

    2003-01-01

    Objective: To determine whether over-the-counter (OTC) nicotine replacement therapy (NRT) is pharmacologically efficacious, whether it produces abstinence rates similar to those in prescription settings, and to estimate the long term (that is, greater than six month) abstinence rate with OTC NRT. Method: Systematic literature review. Data sources: Medline, Psych Abstracts, bibliographies, requests of scientists. Study selection: Studies comparing OTC NRT versus OTC placebo or studies comparing OTC NRT versus prescription NRT that reported abstinence rates and for which a full study report was available. Data extraction: Two of the authors independently reviewed studies and compared results. Data synthesis: Meta-analysis was performed by first testing for homogeneity across studies, then combining odds ratios (ORs) weighting by inverse variance and proportions weighting by study sample size. Results: One OTC NRT versus OTC placebo nicotine gum study was excluded due to small sample size and different setting. The four remaining studies were randomised trials of nicotine versus placebo patch with ORs of 2.1–3.2. These outcomes were homogenous and when combined resulted in an OR favouring NRT of 2.5 (95% confidence interval (CI) 1.8 to 3.6). Among the two randomised and two non-randomised trials of OTC NRT versus prescription NRT, one small study had an OR of 0.3, two others had ORs of 1.0 and 1.4, and a fourth study had an OR of 3.6. These results were not homogenous; however, when combined via a random effects model the estimated OR was not less than 1.0—that is, OR 1.4 (95% CI 0.6 to 3.3). The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8–11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7% (95% CI 4% to 11%). Conclusions: OTC NRT is pharmacologically efficacious and produces modest quit rates similar to that seen in real world prescription

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

    PubMed

    Worley, Julie

    2014-01-01

    Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing. PMID:25062521

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

    PubMed

    Worley, Julie

    2014-01-01

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

  14. Purchasing Medicare prescription drug benefits: a new proposal.

    PubMed

    Etheredge, L

    1999-01-01

    Medicare policymakers are considering using private-sector firms to offer and manage a prescription drug benefit. In such arrangements Medicare and its potential contractors will need to consider four major areas of risk: selection risk, cost management risk, risks of government as a business partner, and risks that new Medicare benefits will change competitive advantages. This paper considers these risk factors and suggests a model for Medicare prescription drug coverage. By adapting private-sector purchasing practices and using competitive markets, Medicare could offer prescription drug benefits--at affordable premiums for beneficiaries--without resorting to national price controls for pharmaceutical products.

  15. 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

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

    PubMed

    Felicilda-Reynaldo, Faye D

    2014-01-01

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

  17. Patterns of Psychoactive Drug Prescriptions by House Officers for Nonpatients.

    ERIC Educational Resources Information Center

    Clark, Allan W.; And Others

    1988-01-01

    The hypothesis that a source of psychoactive drugs for physician trainees is prescription writing by house officers was tested. A survey determined that, of the number of prescriptions written for nonpatients, the largest number was written for family members and friends, and the second largest for fellow house officers. (Author/MLW)

  18. Medicare program; Medicare prescription drug benefit. Final rule.

    PubMed

    2005-01-28

    This final rule implements the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit. The new voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Although this final rule specifies most of the requirements for implementing the new prescription drug program, readers should note that we are also issuing a closely related rule that concerns Medicare Advantage organizations, which, if they offer coordinated care plans, must offer at least one plan that combines medical coverage under Parts A and B with prescription drug coverage. Readers should also note that separate CMS guidance on many operational details appears or will soon appear on the CMS website, such as materials on formulary review criteria, risk plan and fallback plan solicitations, bid instructions, solvency standards and pricing tools, plan benefit packages. The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Generally, coverage for the prescription drug benefit will be provided under private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare. PDPs must offer a basic prescription drug benefit. MA-PDs must offer either a basic benefit or broader coverage for no additional cost. If this required level of coverage is offered, MA-PDs or PDPs, but not

  19. 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

  20. Senior citizens and the burden of prescription drug outlays: what lessons for the Medicare prescription drug benefit?

    PubMed

    Kanavos, Panos; Gemmill, Marin

    2004-01-01

    This article uses data from a cohort of elderly and retired persons over the 1996-2001 period in the US to (i) determine the extent to which changes in socioeconomic or demographic characteristics, particularly age, income and education, impact the total amount that is spent on prescription drugs and (ii) to analyse the predictors of individual out-of-pocket (OOP) prescription drug outlays among the same cohort and determine whether age, race, sex, income, education, marital status and health status have an influence on these. The analysis considers the implications for elderly individuals who choose to participate in the new Medicare Part D drug benefit, labelled the Medicare Prescription Drug, Improvement, and Modernisation Act of 2003. The results highlight the necessity for the Medicare prescription drug benefit to carefully target the eldest among the elderly, who are most in need and are in danger of becoming trapped in the so-called Medicare 'doughnut hole', i.e. incur high prescription drug outlays, without adequate coverage. The study also finds evidence that women, those who are not married, middle income elderly and those in poor health, who purchase drugs more intensively, are at risk of incurring significant prescription OOP drug outlays.

  1. Association Between Prescription Drug Benefit and Hospital Readmission Rates

    PubMed Central

    Kelso, Christine; Gandhi, Bhumi

    2014-01-01

    Purpose: To determine whether primary care medicine clinic (PCMC) patients with a prescription drug benefit were associated with a lower rate of hospital readmissions. Methods: This study was a retrospective, single-center, cohort study of PCMC patients who had at least 1 hospital readmission in 2011. Eligible patients were divided into 2 groups: patients without prescription drug benefits and patients with prescription drug benefits. Results: Three hundred fifty-two patients met our inclusion criteria. The number of hospital readmissions for patients with a prescription drug benefit was higher than those with no prescription drug benefit (2.453 ± 2.49 vs 1.88 ± 1.91; P = .052). The length of index admission and the length of hospital readmission in days were higher in patients with no prescription drug benefits (index admission, 5.29 ± 6.38 vs 4.59 ± 4.50; P = .428) (readmission, 5.31 ± 5.90 vs 4.48 ± 4.33, P = .166). The number of days to readmission was higher in those with drug benefits (58.12 ± 63.54 vs 53.39 ± 53.47; P = .316). When patient data were separated by CCI scores, it was noted that patients with pharmacy benefits had significantly more hospital readmissions in each CCI score category except for patients with a CCI of 6. Conclusion: Although not statistically significant, patients with prescription drug benefits had more hospital readmissions but shorter hospital lengths of stay. Significant data linking hospital readmissions and prescription insurance benefits, if found in future studies, would provide helpful guidance to health care systems. PMID:24958957

  2. 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 ...

  3. 77 FR 74827 - Working Group on Access to Information on Prescription Drug Container Labels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... a stakeholder working group to develop best practices for making information on prescription drug... working group to develop best practices for making information on prescription drug container labels... to develop best practices for pharmacies on providing independent access to prescription...

  4. 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

  5. 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…

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

    PubMed

    Hellbom, Einar

    2006-01-01

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

  7. 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

  8. Diagnosis-Based Risk Adjustment for Medicare Prescription Drug Plan Payments

    PubMed Central

    Robst, John; Levy, Jesse M.; Ingber, Melvin J.

    2007-01-01

    The 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA) created Medicare Part D, a voluntary prescription drug benefit program. The benefit is a government subsidized prescription drug benefit within Medicare. This article focuses on the development of the prescription drug risk-adjustment model used to adjust payments to reflect the health status of plan enrollees. PMID:17722748

  9. 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

  10. 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

  11. Dynamic aspects of prescription drug use in an elderly population.

    PubMed Central

    Stuart, B; Coulson, N E

    1993-01-01

    OBJECTIVE. This study explores longitudinal patterns in outpatient prescription drug use in an elderly population. DATA SOURCES/STUDY SETTING. Enrollment records and prescription drug claims were obtained for a sample of elderly Pennsylvanians (N = 27,301) who had enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) program at any time between July 1984 and June 1987. Study Design. The study tracks monthly prescription fill rates for sampled PACE beneficiaries from their initial enrollment month through disenrollment, death, or the end of the study (whichever occurred first). We specify two-part multivariate models to assess the effect of calendar time, length of time in the PACE program, and progression to disenrollment or death both on the probability of any prescription use and on the level of use among those who filled at least one prescription claim per month. Control variables include age, gender, race, income, residence, and marital status. DATA COLLECTION/EXTRACTION METHODS. Data were extracted from administrative files maintained by the PACE program, checked for errors, and then formatted as person-month records. PRINCIPAL FINDINGS/CONCLUSIONS. We find a strong positive relationship between drug use and the length of time persons are PACE-enrolled. Persons whose death occurs within a year have much higher prescription utilization rates than do persons whose death is at least a year away, and the differential increases as death nears. Persons who fail to renew PACE coverage use significantly fewer prescription drugs in the year prior to disenrollment. Holding age and other factors constant, we find that average levels of prescription use actually declined over the study period. PMID:8514502

  12. 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.

  13. 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

  14. 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 ...

  15. 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

  16. Availability of over-the-counter emergency contraception in 2 disparate New York City neighborhoods.

    PubMed

    Legare, Katherine; Bakshi, Salina; Keyhani, Salomeh; Howell, Elizabeth A

    2012-11-01

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

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

    PubMed Central

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

    2012-01-01

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

  18. 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 ... medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the...

  19. Are You Shopping Smart for Prescription Drugs?

    MedlinePlus

    ... the new Medicare Part D program pays a good portion of their drug bill, they still face around $260 a month in out-of-pocket expenses. Says Susannah, who is 68, "The Best Buy Drugs site was enormously helpful right away." Consumers Union, the magazine's publisher, translates the drug findings ...

  20. 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

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

    PubMed Central

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

    2014-01-01

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

  2. 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

  3. 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…

  4. 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…

  5. 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.…

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

    PubMed Central

    Johnson, Gina; Helman, Cecil

    2004-01-01

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

  7. 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…

  8. 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…

  9. 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…

  10. 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…

  11. 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…

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

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

    PubMed

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

    2002-01-01

    Using the hospital's drug prescription and distribution system as a guide, benefits and drawbacks of a medical activity management system that is tightly integrated with the supply chain management of a hospital will be discussed from the point of view of various participating healthcare actors. PMID:15058416

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

    PubMed

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

    2014-01-01

    In August 2012, general practitioners of Haute- Garonne received a letter from Health insurance system, informing that prescriptions could be endorsed by "not substituable" after reporting an adverse drug reactions (ADR). Compared to an equivalent period before this letter, we observed an increase of ADRs reports for generics, mainly concerning gastrointestinal ADR and lack of efficacy. PMID:24927508

  19. Justice Implications of a Proposed Medicare Prescription Drug Policy

    ERIC Educational Resources Information Center

    Larkin, Heather

    2004-01-01

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

  20. 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

  1. 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

  2. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  3. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  4. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  5. 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

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

    PubMed Central

    2012-01-01

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

  7. 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

  8. 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

  9. Over-the-counter and out-of-control: legal strategies to protect youths from abusing products for weight control.

    PubMed

    Pomeranz, Jennifer L; Taylor, Lisa M; Austin, S Bryn

    2013-02-01

    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

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

    PubMed

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

    2016-01-01

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

  11. Optic neuropathy associated with the use of over-the-counter sexual enhancement supplements.

    PubMed

    Karli, Sapir Z; Liao, Sophie D; Carey, Andrew R; Lam, Byron L; Wester, Sara T

    2014-01-01

    This case report details an association of the use of over-the-counter sexual enhancement supplements with atypical optic neuropathy. A 42-year-old man presented with right-sided headache and vision loss of the right eye, which deteriorated to a single quadrant of hand motion over 11 days. Serial orbital magnetic resonance imaging scans demonstrated progressive orbital optic nerve enhancement extending into the optic canal despite high-dose steroid treatment. The patient eventually admitted to using several over-the-counter sexual enhancement supplements prior to the onset of symptoms and throughout the course of his steroid treatment, which he subsequently discontinued. His vision improved to 20/200 with an expanded visual field. Anterior ischemic optic neuropathy has been reported in association with phosphodiesterase (PDE)-5 inhibitor use, but visual loss in association with unregulated sexual enhancement supplements has not been studied. While one case cannot establish association, our case is suggestive of potential dangers of over-the-counter sexual enhancement supplements, which may contain PDE-5 inhibitors, "male hormones," and "substances that enhance blood production." The case also underscores the importance of obtaining a careful history of supplements in patients with optic neuropathies. PMID:25378904

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  13. 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...

  14. 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

  15. 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

  16. 21 CFR 203.50 - Requirements for wholesale distribution of prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Requirements for wholesale distribution of 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 §...

  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.

  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. Our prescription drugs kill us in large numbers.

    PubMed

    Gøtzsche, Peter C

    2014-01-01

    Our prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. Around half of those who die have taken their drugs correctly; the other half die because of errors, such as too high a dose or use of a drug despite contraindications. Our drug agencies are not particularly helpful, as they rely on fake fixes, which are a long list of warnings, precautions, and contraindications for each drug, although they know that no doctor can possibly master all of these. Major reasons for the many drug deaths are impotent drug regulation, widespread crime that includes corruption of the scientific evidence about drugs and bribery of doctors, and lies in drug marketing, which is as harmful as tobacco marketing and, therefore, should be banned. We should take far fewer drugs, and patients should carefully study the package inserts of the drugs their doctors prescribe for them and independent information sources about drugs such as Cochrane reviews, which will make it easier for them to say "no thanks". PMID:25355584

  20. Our prescription drugs kill us in large numbers.

    PubMed

    Gøtzsche, Peter C

    2014-01-01

    Our prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. Around half of those who die have taken their drugs correctly; the other half die because of errors, such as too high a dose or use of a drug despite contraindications. Our drug agencies are not particularly helpful, as they rely on fake fixes, which are a long list of warnings, precautions, and contraindications for each drug, although they know that no doctor can possibly master all of these. Major reasons for the many drug deaths are impotent drug regulation, widespread crime that includes corruption of the scientific evidence about drugs and bribery of doctors, and lies in drug marketing, which is as harmful as tobacco marketing and, therefore, should be banned. We should take far fewer drugs, and patients should carefully study the package inserts of the drugs their doctors prescribe for them and independent information sources about drugs such as Cochrane reviews, which will make it easier for them to say "no thanks".

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  2. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  4. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    PubMed Central

    Dzeparoski, Marjan; Trajkovic-Jolevska, Suzana

    2016-01-01

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

  6. Co-Prescription Trends in a Large Cohort of Subjects Predict Substantial Drug-Drug Interactions

    PubMed Central

    Sutherland, Jeffrey J.; Daly, Thomas M.; Liu, Xiong; Goldstein, Keith; Johnston, Joseph A.; Ryan, Timothy P.

    2015-01-01

    Pharmaceutical prescribing and drug-drug interaction data underlie recommendations on drug combinations that should be avoided or closely monitored by prescribers. Because the number of patients taking multiple medications is increasing, a comprehensive view of prescribing patterns in patients is important to better assess real world pharmaceutical response and evaluate the potential for multi-drug interactions. We obtained self-reported prescription data from NHANES surveys between 1999 and 2010, and confirm the previously reported finding of increasing drug use in the elderly. We studied co-prescription drug trends by focusing on the 2009-2010 survey, which contains prescription data on 690 drugs used by 10,537 subjects. We found that medication profiles were unique for individuals aged 65 years or more, with ≥98 unique drug regimens encountered per 100 subjects taking 3 or more medications. When drugs were viewed by therapeutic class, it was found that the most commonly prescribed drugs were not the most commonly co-prescribed drugs for any of the 16 drug classes investigated. We cross-referenced these medication lists with drug interaction data from Drugs.com to evaluate the potential for drug interactions. The number of drug alerts rose proportionally with the number of co-prescribed medications, rising from 3.3 alerts for individuals prescribed 5 medications to 11.7 alerts for individuals prescribed 10 medications. We found 22% of elderly subjects taking both a substrate and inhibitor of a given cytochrome P450 enzyme, and 4% taking multiple inhibitors of the same enzyme simultaneously. By examining drug pairs prescribed in 0.1% of the population or more, we found low agreement between co-prescription rate and co-discussion in the literature. These data show that prescribing trends in treatment could drive a large extent of individual variability in drug response, and that current pairwise approaches to assessing drug-drug interactions may be inadequate for

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

    PubMed

    Karadas, Muhammet; Duymus, Zeynep Yesil

    2015-01-01

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

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

    PubMed

    Karadas, Muhammet; Duymus, Zeynep Yesil

    2015-01-01

    This in vitro study evaluated the whitening effect of four different over-the-counter products compared with a 10% carbamide peroxide (CP) bleaching gel. Specimens obtained from bovine incisors were stained in a tea solution and randomly divided into six groups according to the product used (n=10): CT: conventional toothpaste (negative control); CWT: Crest 3D White toothpaste; CWR: Crest 3D White mouth rinse; CWS: Crest 3D White strips; DW: Dazzling White (paint-on gel); and OP: Opalescence PF 10% CP (at-home bleaching gel, positive control). Over-the-counter products and 10% CP were used according to the manufacturer's recommendations. Color measurements were performed according to the CIELab system using spectrophotometer after staining, and after 4 and 8 weeks of the treatment procedure. The ∆E, ∆L, ∆a, and ∆b values were calculated. The data obtained were analyzed by repeated-measures ANOVA. Tukey's test for multiple comparisons was applied (p<0.05). All groups, except CWT, were effective in tooth whitening in comparison with conventional toothpaste. There was no significant difference in tooth whitening between CWT and CT (p=0.93). CWS, DW and OP groups presented significantly higher color changes than the CWR group. DW and CWS showed similar tooth whitening to OP. PMID:26312975

  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. 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…

  14. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment of standing technical advisory 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...

  15. [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.

  16. 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.

  17. 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

  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. [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

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

    PubMed Central

    2016-01-01

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

  1. 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

    2016-01-01

    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.

  2. 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

  3. 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

  4. 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.

  5. 78 FR 53152 - Prescription Drug User Fee Rates for Fiscal Year 2014; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ...,000''. Dated: August 22, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160-01-P ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Rates for Fiscal Year 2014... Administration is correcting a notice entitled ``Prescription Drug User Fee Rates for Fiscal Year 2014''...

  6. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs containing sulfites; required... Prescription drugs containing sulfites; required warning statements. (a) Sulfites are chemical substances that.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  7. How patients understand the term ‘nonmedical use’ of prescription drugs: insights from cognitive interviews

    PubMed Central

    Halkitis, Perry N.; Horton, Ariana; Khan, Rubina; Gourevitch, Marc N.

    2013-01-01

    Background With rising rates of prescription drug abuse and associated overdose deaths, there is great interest in having accurate and efficient screening tools that identify nonmedical use of prescription drugs in health care settings. We sought to gain a better understanding of how patients interpret questions about misuse of prescription drugs, with the goal of improving the accuracy and acceptability of instruments intended for use in primary care. Methods A total of 27 English speaking adult patients were recruited from an urban safety net primary care clinic to complete a cognitive interview about a four-item screening questionnaire for tobacco, alcohol, illicit drugs, and misuse of prescription drugs. Detailed field notes were analyzed for overall comprehension of the screening items on illicit drug use and prescription drug misuse, the accuracy with which participants classified drugs into these categories, and whether the screening response correctly captured the participant’s substance use behavior. Results Based on initial responses to the screening items, 6 (22%) participants screened positive for past year prescription drug misuse, and 8 (30%) for illicit drug use. The majority (26/27) of participants correctly interpreted the item on illicit drug use, and appropriately classified drugs in this category. Eleven (41%) participants had errors in their understanding of the prescription drug misuse item. The most common error was including use of medications without abuse potential as misuse. All cases of misunderstanding prescription drug misuse occurred among participants who screened negative for illicit drug use. Conclusions Our results suggest that terminology used to describe misuse of prescription medications may be misunderstood by many primary care patients, particularly those who do not use illicit drugs. Failure to improve upon the language used to describe prescription drug misuse in screening questionnaires intended for use in medical

  8. 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

  9. Prescription Data Processing—Its Role in the Control of Drug Abuse

    PubMed Central

    Maronde, Robert F.; Seibert, Stanley; Katzoff, Jack; Silverman, Milton

    1972-01-01

    Prescriptions in an outpatient setting were kept on file for immediate recall by computer terminals. Drugs with abuse potential were found to make up 33.6 percent of all prescriptions, and 12.4 percent of these prescriptions were for excessive quantities. An additional 2.6 percent of these prescriptions represented irrationally large quantities of drugs dispensed by multiple prescriptions. The physician was cooperative and willing to correct this situation when it was brought to his attention by the pharmacist. PMID:5070695

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

    PubMed

    Chung, Ka Fai; Lee, Claire K Y

    2002-01-01

    This study examined the composition of over-the-counter (OTC) sleeping pills in Hong Kong and reviewed the current knowledge about the hypnotic efficacy and safety of their major herbal and dietary supplement constituents. We conducted a cross-sectional survey of OTC sleep aids at drug stores in a residential district of 0.3 million population and literature search using MEDLINE, EMBASE, PsycINFO, China Journal Net, China Biomedical Database and relevant English and Chinese literature. We identified 17 brands of OTC sleeping pill: eleven of them were composed of mixtures of Chinese and Western herbal agents and six brands contained 3 mg of melatonin. The Chinese herbal mixture suanzaorentang, comprising zizyphi spinosi semen, poria cocos, ligusticum wallichii, anemarrhenae rhizoma and glycyrrhizae radix in ratio of 7:5:2:1:1, was the most common OTC sleeping pill available in the survey. Our literature review showed that kava, valerian and melatonin were the better-researched herbs and dietary supplements, however, the data on hypnotic efficacy and safety was inadequate to support their clinical use. More rigorous investigations of the risk-benefit relationship of herbal agents and dietary supplements used for insomnia are needed. PMID:12490346

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

    PubMed

    Chung, Ka Fai; Lee, Claire K Y

    2002-01-01

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

  12. 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

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

    PubMed Central

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

    2015-01-01

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

  14. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  15. 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....

  16. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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 relaxed feeling,” “calming down and relaxing,” “gently soothe away the tension,” “calmative,” “resolving...

  17. 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 relaxed feeling,” “calming down and relaxing,” “gently soothe away the tension,” “calmative,” “resolving...

  18. 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…

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

  4. 78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... prescription drug labeling in 1979 (44 FR 37434, June 26, 1979). However, over the ensuing 25 years, labeling... content and format requirements for labeling to make it easier to access, read, and use (71 FR 3922.... \\2\\ See Sec. 201.56(c). The Agency adopted this approach because research conducted during the...

  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 SERVICES (CONTINUED) DRUGS FOR HUMAN USE GENERAL Combination Drugs § 300.50 Fixed-combination...

  6. 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...

  7. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 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...

  9. 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...

  10. 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

  11. 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...

  12. 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.…

  13. 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…

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

    ERIC Educational Resources Information Center

    Holloway, Katy; Bennett, Trevor

    2012-01-01

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

  15. 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…

  16. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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 VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Eligibility and Enrollment. § 423.56 Procedures to determine and document...

  17. 42 CFR 423.112 - Establishment of prescription drug plan service areas.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... areas. 423.112 Section 423.112 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Benefits and Beneficiary Protections § 423.112 Establishment of prescription drug plan service areas....

  18. 77 FR 19425 - Prescription Drugs Not Administered During Treatment; Update to Administrative Cost for Calendar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

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

  19. 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…

  20. 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…

  1. Medicare program: Medicare Advantage and Prescription Drug Benefit programs: final marketing provisions. Final rule.

    PubMed

    2008-09-18

    This final rule revises the Medicare Advantage (MA) program (Part C) and Medicare Prescription Drug Benefit Program (Part D). The regulation contains new regulatory provisions regarding marketing processes for both programs. The revisions to the Part C and Part D programs are based on lessons we have learned since 2006, the initial year of the prescription drug program and the revised MA program.

  2. 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

  3. 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.

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

    PubMed Central

    Collins, Declan; Oakey, Steve; Ramakrishnan, Venkat

    2011-01-01

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

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

    PubMed

    Jackson Allen, Patricia; Simenson, Steven

    2013-01-01

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

  6. 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

  7. 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.…

  8. 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

  9. Using the theory of planned behavior to predict self-medication with over-the-counter analgesics.

    PubMed

    Pineles, Lisa L; Parente, Rick

    2013-12-01

    Millions of people worldwide use over-the-counter analgesics on a regular basis; yet little is known about how decisions to self-medicate are made. This study used the theory of planned behavior to explore the influence of beliefs about medicines (Beliefs about Medicines Questionnaire) and individual pain experience as predictors of intent to self-medicate. Both emerged as significant predictors of intent to self-medicate. Furthermore, intent to self-medicate significantly predicted reported use of analgesics. These findings indicate that use of over-the-counter pain medication is more likely when the value of the pain relief is greater than concerns about harm.

  10. Characteristics of high-frequency consumers of prescription psychoactive drugs.

    PubMed

    Chambers, C D; White, O Z

    1980-01-01

    Two cohorts of white middle-class housewives who reported themselves as high-frequency consumers of prescription sedatives, tranquilizers, and stimulants have been studied and their characteristics have been reported. One group of these women are residents of a Midwestern state, and the other in a Southern state. These women can best be described as follows: Most reported their primary physician as being a general practitioner (60%), and most reported they had consulted two or more separate physicians during the last year (78%). More than a third (36%) had seen at least three different physicians. Interestingly, while most of these women were consulting general practitioners and/or internists, almost a third were presenting them with general psychological complaints. The self-reported high-frequency users most frequently used the relaxants/minor tranquilizers (64%), followed by sedatives (41%), stimulants (31%), and major tranquilizers (7%). Almost half of all these high-frequency medicine consumers were also regular drinkers (47%), and some 13 to 17% could be considered as heavy drinkers. The majority of the relaxant/minor tranquilizer users had been taking the medications daily or several times a week for at least six months. Less than half of these users, however, felt their "condition" had gotten "better." The majority of the sedative users had also been taking the medications daily or several times a week for at least six months. Less than a third of these users felt the condition that precipitated the prescription had improved during this period of use. Of major importance, only a minority of these long-term high-frequency users of sedatives and relaxants/minor tranquilizers believe these drugs to be habit-forming or to have any potential for physical or psychological harm. Although the stimulant-users were also found to be high-frequency consumers, stimulant-users were found to have been using these drugs for a shorter period of time. There also appears to

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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…

  19. 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…

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-counter through any issuing agent qualified under 31 CFR part 317. To purchase over-the-counter, you must... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May...

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-counter through any issuing agent qualified under 31 CFR part 317. 2 To purchase over-the-counter, you... 31 Money and Finance: Treasury 2 2010-07-01 2010-07-01 false May I purchase definitive Series EE... OFFERING OF UNITED STATES SAVINGS BONDS, SERIES EE Definitive Series EE Savings Bonds § 351.46 May...

  2. 31 CFR 359.34 - May I purchase definitive Series I savings bonds over-the-counter?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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

    PubMed Central

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

    2015-01-01

    Previous reviews have shown that changes in prescription drug insurance benefits can impact 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: (1) they involved collecting empirical data surrounding an expansion or restriction of prescription drug coverage and (2) reported on clinical outcomes. Twenty-three studies demonstrated that broader prescription drug insurance reduces use of other health care services, and positively affects outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the expansions in drug coverage offered by the Affordable Care Act to improve the health of low-income patients receiving state-based health insurance. PMID:25521879

  5. 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

  6. 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...

  7. 21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... labeling for human prescription drug and biological products described in § 201.56(b)(1). 201.57 Section... requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). The requirements in this section apply only to prescription drug products described...

  8. 21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... labeling for human prescription drug and biological products described in § 201.56(b)(1). 201.57 Section... requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). The requirements in this section apply only to prescription drug products described...

  9. 21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... labeling for human prescription drug and biological products described in § 201.56(b)(1). 201.57 Section... requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). The requirements in this section apply only to prescription drug products described...

  10. Emergency department utilization and subsequent prescription drug overdose death

    PubMed Central

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

    2015-01-01

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

  11. A Computational Drug-Target Network for Yuanhu Zhitong Prescription

    PubMed Central

    Lu, Peng; Zhang, Fangbo; Yuan, Yuan; Wang, Songsong

    2013-01-01

    Yuanhu Zhitong prescription (YZP) is a typical and relatively simple traditional Chinese medicine (TCM), widely used in the clinical treatment of headache, gastralgia, and dysmenorrhea. However, the underlying molecular mechanism of action of YZP is not clear. In this study, based on the previous chemical and metabolite analysis, a complex approach including the prediction of the structure of metabolite, high-throughput in silico screening, and network reconstruction and analysis was developed to obtain a computational drug-target network for YZP. This was followed by a functional and pathway analysis by ClueGO to determine some of the pharmacologic activities. Further, two new pharmacologic actions, antidepressant and antianxiety, of YZP were validated by animal experiments using zebrafish and mice models. The forced swimming test and the tail suspension test demonstrated that YZP at the doses of 4 mg/kg and 8 mg/kg had better antidepressive activity when compared with the control group. The anxiolytic activity experiment showed that YZP at the doses of 100 mg/L, 150 mg/L, and 200 mg/L had significant decrease in diving compared to controls. These results not only shed light on the better understanding of the molecular mechanisms of YZP for curing diseases, but also provide some evidence for exploring the classic TCM formulas for new clinical application. PMID:23762151

  12. Symbolic boundaries, subcultural capital and prescription drug misuse across youth cultures.

    PubMed

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

    2015-03-01

    Prescription drug misuse among young adults has surged over the past decade. Yet the contexts surrounding this misuse remain unclear, particularly the subcultural contexts. Many young urban adults participate in youth cultures. This article describes the subcultural contexts of prescription drug misuse in 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 by theorists, 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 in each of these settings. The findings highlight the role of symbolic boundaries and subcultural capital in shaping routine practices of drug use among young adults. These data show that education campaigns about prescription drug misuse should take into account the variability in youth cultural scenes to maximise the efficacy of these messages aimed at young adults.

  13. 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

  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 purchased through the internet: Who are the end users?

    PubMed Central

    Inciardi, James A.; Surratt, Hilary L.; Cicero, Theodore J.; Rosenblum, Andrew; Ahwah, Candice; Bailey, J. Elise; Dart, Richard C.; Burke, John J.

    2012-01-01

    Although prescription drugs are readily available on the Internet, little is known about the prevalence of Internet use for the purchase of medications without a legitimate prescription, and the characteristics of those that obtain non-prescribed drugs through online sources. The scientific literature on this topic is limited to anecdotal reports or studies plagued by small sample sizes. Within this context, the focus of this paper is an examination of five national data sets from the U.S. with the purpose of estimating: (1) how common obtaining prescription medications from the Internet actually is, (2) who are the typical populations of “end users” of these non-prescribed medications, and (3) which drugs are being purchased without a prescription. Three of the data sets are drawn from the RADARS® (Researched Abuse Diversion and Addiction-Related Surveillance) System, a comprehensive series of studies designed to collect timely and geographically specific data on the abuse and diversion of a number of prescription stimulants and opioid analgesics. The remaining data sets include the National Survey on Drug Use and Health (NSDUH) and the Monitoring the Future (MTF) survey. Our analysis yielded uniformly low rates of prescription drug acquisition from online sources across all five data systems we examined. The consistency of this finding across very diverse populations suggests that the Internet is a relatively minor source for illicit purchases of prescription medications by the individual end-users of these drugs. PMID:20227199

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 76 FR 2691 - Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... acetaminophen drugs (final rule, 74 FR 19385, April 29, 2009; and technical amendment, 74 FR 61512, November 25, 2009). \\5\\ Meeting of the Non-Prescription Drug Advisory Committee with members from the Anesthetic and... Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee...

  1. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Amphetamine and methamphetamine inhalers regarded as prescription drugs. 250.101 Section 250.101 Food and Drugs FOOD AND DRUG ADMINISTRATION...-enforcement officials, health officials, individual physicians, parents, and others as well as from Food...

  2. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Amphetamine and methamphetamine inhalers regarded as prescription drugs. 250.101 Section 250.101 Food and Drugs FOOD AND DRUG ADMINISTRATION...-enforcement officials, health officials, individual physicians, parents, and others as well as from Food...

  3. 76 FR 29765 - Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

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

  4. 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:...

  5. Prescription drug abuse & addiction: past, present and future: the paradigm for an epidemic.

    PubMed

    Hall, P Bradley; Hawkinberry, Denzil; Moyers-Scott, Pam

    2010-01-01

    Prescription drug abuse has reached epidemic proportions in the United States and West Virginia is not immune. It is estimated that in 2009, the number of adolescents and adults with a substance abuse and/or dependence problem has reached 23.2 million in the US. There has been an alarming rate of increased sales of methadone, hydrocodone and oxycodone. This article addresses the scope of the problem of prescription drug abuse in West Virginia and the impact by and on the addicted individual. Addiction is a chronic relapsing neuropsychiatric illness manifested by compulsive drug seeking and use. It has created a substantive socioeconomic burden on our state. Prescription drug abuse and addiction increase medical expenses, drug related crime and unemployment. There are misconceptions regarding the etiology and treatment of addiction based on past clinical experience. The view of addiction as volitional misconduct alone has been disproven scientifically. A more current understanding of neurobiological alterations caused by this disease, current treatment strategies and future directions will be presented. This article provides an understanding of prescription drug abuse and addiction's contribution and impact on society's health and social policy. Addressing the problem of prescription drug abuse requires an understanding of the disease of addiction, thus enhancing the effectiveness in diminishing the associated health and social costs. It is the article's intent to illuminate the mutually symbiotic relationship of prescription drug abuse and the disease of addiction and subsequently provide recommendations toward the resolution of this most important issue.

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT... the annual out-of-pocket threshold, and after the annual out-of-pocket threshold. (2) Interaction...

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

    PubMed

    Gönül, F F; Carter, F; Wind, J

    2000-06-01

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

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

    PubMed

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

    2011-03-01

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

  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. Rheologic Profile, Specific Gravity, Surface Tension, and pH of Fifteen Over-the-Counter Preparations.

    PubMed

    Al-Achi, Antoine; Baghat, Tushar; Chukwubeze, Onah; Dembla, Ishwin

    2007-01-01

    Knowledge of the physical characteristics of commercially available over-the-counter preparations can aid the compounding pharmacist in preparing medication. In this study, 15 over-the-counter products were studied with regard to their specific gravity, surface tension, pH, and rheologic profile. The specific gravities of all the products were greater than 1, with the exceptions of Nivea Lotion and rubbing alcohol, which were less than 1. The majority of the products had an acidic pH. With the exception of two products, Citrucel and Chloraseptic, all products demonstrated a surface tension value less than that of water (72.8 dynes/cm). Chloraseptic had the lowest Newtonian viscosity (1.27 cPs), whereas Vicks DayQuil had the highest (098.86 cPs). Citrucel exhibited dilatant-type flow; Suave Shampoo, herbal shampoo, Tangerine Tickle Herbal Shampoo, and Metamucil pseudoplastic flow; the remaining non-Newtonian formulations, plastic flow profiles.

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

    PubMed

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

    2014-02-01

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

  12. Seizure caused by dermal application of over-the-counter eucalyptus oil head lice preparation.

    PubMed

    Waldman, Neil

    2011-10-01

    Natural plant oils such as eucalyptus are common worldwide in non-prescription natural health products. Oral ingestion of eucalyptus oil is well known to produce neurological symptoms and seizures; however, its dermal use is presumed to be safe. We describe a brief, self-limited, tonic-clonic seizure in a healthy 4-year-old girl following dermal exposure to eucalyptus oil as directed for treatment of head lice. Initial symptoms were vomiting, lethargy, and ataxia followed by a grand mal seizure. Recovery occurred rapidly after the skin was washed. Health care providers should be aware that eucalyptus oil toxicity may occur with dermal exposure and should report additional cases.

  13. 75 FR 69093 - Prescription Drug User Fee Act; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Act; Reopening of the Comment... for the notice of public meeting that published in the Federal Register of March 16, 2010 (75 FR 12555...) requires public review of the recommendations for the human drug review program after negotiations with...

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

    PubMed Central

    Brigden, M; Smith, R E

    1997-01-01

    A large number of drugs containing acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter in Canada. The possibility of serious side effects and drug interactions is therefore high. The authors have compiled a comprehensive list of products containing these drugs from information supplied by pharmaceutical databases, independent marketing researchers and Health Canada's Drug Directorate. Physicians should ensure that additional ASA-containing drugs or NSAIDs are not inadvertently taken by patients, especially those receiving oral anticoagulant therapy or those with a qualitative platelet defect. Patients at risk should be cautioned to check with their physician before taking any new medication, even over-the-counter products. PMID:9099173

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

    PubMed

    Morgan, J P

    1977-02-01

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

  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.

  17. 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

  18. 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.

  19. Seizure caused by dermal application of over-the-counter eucalyptus oil head lice preparation.

    PubMed

    Waldman, Neil

    2011-10-01

    Natural plant oils such as eucalyptus are common worldwide in non-prescription natural health products. Oral ingestion of eucalyptus oil is well known to produce neurological symptoms and seizures; however, its dermal use is presumed to be safe. We describe a brief, self-limited, tonic-clonic seizure in a healthy 4-year-old girl following dermal exposure to eucalyptus oil as directed for treatment of head lice. Initial symptoms were vomiting, lethargy, and ataxia followed by a grand mal seizure. Recovery occurred rapidly after the skin was washed. Health care providers should be aware that eucalyptus oil toxicity may occur with dermal exposure and should report additional cases. PMID:21867365

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

    PubMed Central

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

    2010-01-01

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

  1. 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,…

  2. 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…

  3. [Efficiency in the prescription of drugs. Impact of a health policy: automatic change to prescription by active ingredient].

    PubMed

    López de Landache, Isabel Elizondo; Braceras Izaguirre, Leire; Echeto García, Ainara; Gardeazabal Romillo, Maria José; Acevedo Heranz, Paloma

    2013-11-01

    In the Basque Country in June 2010 were changed in the electronic prescription system the treatments prescribed by a brand by active ingredients, all the patients who had prescribed these molecules: atorvastatin, clopidogrel, weekly risedronate and losartan-hydrochlorothiazide. The aim of this study was to evaluate the economic impact of this change automated done in June 2010. Retrospective study of the prescriptions made in the Basque Country of the selected active ingredients. The use of generics of these molecules from May to December 2010 increased from 64 points to 87. Particularly clopidogrel increased from 6.25% in generic prescriptions to 93.76%, losartan + hydrochlorothiazide from 17.94% to 93.83%, 18.92% for atorvastatin acid and 96.03% risedronic 1.76% to 65.97%. If we make the estimation of the amount of active ingredient in generic containers that have been dispensed from June to December 2010. If they had dispensed brand drugs you get this quantity of total savings: 8 104 762.22 euros. This work suggests that a program to promote use of generics increased efficiency in the use of drugs. To promote the use of generic drugs is an efficiency measure implemented in the NHS and in the neighboring countries, in recent figures are reached 40% in securities of U.S.A packaging and around 65% in the Basque Country the consume in early 2010 was much lower than these figures stand at 20% and at the end of the year stood at 27% thanks to the measures taken. PMID:24404717

  4. Management of human resources associated with misuse of prescription drugs: analysis of a national survey.

    PubMed

    Lee, Doohee; Ross, Michael W

    2011-01-01

    Nonmedical use of prescription drugs is increasingly prevalent in the United States, but limited research is available on prescription drugs misuse in the workforce. We investigated whether absenteeism and turnover are associated with having problems linked to prescription drug misuse among employees. We also further explored the moderating effects of employee drug policy and testing on the relation between having problems linked to misuse of prescription pain relievers (PPRs) and absenteeism and turnover. This is a cross-sectional study (n = 2,249) using the 2007 U.S. national survey data ("National Survey on Drug Use and Health"). The multivariate logistic analysis results illustrate, after controlling confounding factors (gender, age, tobacco use, and heroin use), absenteeism and turnover linked to having problems of PPRs misuse. Our findings suggest the moderating effects of employee drug policy on the association between absenteeism and turnover and having problems linked to misuse of PPRs. Also, drug testing was found to moderate the link between having negative outcomes of misuse of PPRs and absenteeism. Having problems associated with misuse of PPRs is linked to absenteeism and turnover. A drug policy program including drug testing may play a significant role in reducing absenteeism and turnover in relation to having problems linked to misuse of PPRs.

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

    PubMed Central

    Schwartz, Lisa M.; Woloshin, Steven

    2013-01-01

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

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

    PubMed

    Schwartz, Lisa M; Woloshin, Steven

    2013-08-20

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

  7. Desisting From Prescription Drug Abuse: An Application of Growth Models to Rx Opioid Users

    PubMed Central

    Gunter, Whitney D.; Kurtz, Steven P.; Bakken, Nicholas W.; O’Connell, Daniel J.

    2012-01-01

    Modern desistance research has examined many facets of desistance, in terms of theoretical predictors of desistance and recidivism, and in terms of differing types of offending. Though predicting desistance from illegal drug use is among these topics, no research to date has examined the predictors of desisting from prescription opioid abuse. This study uses longitudinal data from 318 prescription opioid users to analyze the effects of various predictors of desistance on declining nonmedical prescription opioid use, with an emphasis on gender differences among participants. Results indicate that theoretical and demographic characteristics correspond with differing rates of decline and further vary by gender. PMID:22736809

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

    PubMed Central

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

    2010-01-01

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

  9. Low Literacy Impairs Comprehension of Prescription Drug Warning Labels

    PubMed Central

    Davis, Terry C; Wolf, Michael S; Bass, Pat F; Middlebrooks, Mark; Kennen, Estela; Baker, David W; Bennett, Charles L; Durazo-Arvizu, Ramon; Bocchini, Anna; Savory, Stephanie; Parker, Ruth M

    2006-01-01

    BACKGROUND Adverse events resulting from medication error are a serious concern. Patients' literacy and their ability to understand medication information are increasingly seen as a safety issue. OBJECTIVE To examine whether adult patients receiving primary care services at a public hospital clinic were able to correctly interpret commonly used prescription medication warning labels. DESIGN In-person structured interviews with literacy assessment. SETTING Public hospital, primary care clinic. PARTICIPANTS A total of 251 adult patients waiting for an appointment at the Louisiana State University Health Sciences Center in Shreveport (LSUHSC-S) Primary Care Clinic. MEASUREMENTS Correct interpretation, as determined by expert panel review of patients' verbatim responses, for each of 8 commonly used prescription medication warning labels. RESULTS Approximately one-third of patients (n=74) were reading at or below the 6th-grade level (low literacy). Patient comprehension of warning labels was associated with one's literacy level. Multistep instructions proved difficult for patients across all literacy levels. After controlling for relevant potential confounding variables, patients with low literacy were 3.4 times less likely to interpret prescription medication warning labels correctly (95% confidence interval: 2.3 to 4.9). CONCLUSIONS Patients with low literacy had difficulty understanding prescription medication warning labels. Patients of all literacy levels had better understanding of warning labels that contained single-step versus multiple-step instructions. Warning labels should be developed with consumer participation, especially with lower literate populations, to ensure comprehension of short, concise messages created with familiar words and recognizable icons. PMID:16881945

  10. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  11. 76 FR 77543 - Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  12. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Potassium permanganate preparations as... or Prescription Status of Specific Drugs § 250.108 Potassium permanganate preparations as... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports...

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

    PubMed Central

    2009-01-01

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

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

    PubMed

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

    2008-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  16. Comparing employer-sponsored and federal exchange plans: wide variations in cost sharing for prescription drugs.

    PubMed

    Buttorff, Christine; Andersen, Martin S; Riggs, Kevin R; Alexander, G Caleb

    2015-03-01

    Just under seven million Americans acquired private insurance through the new health insurance exchanges, or Marketplaces, in 2014. The exchange plans are required to cover essential health benefits, including prescription drugs. However, the generosity of prescription drug coverage in the plans has not been well described. Our primary objective was to examine the variability in drug coverage in the exchanges across plan types (health maintenance organization or preferred provider organization) and metal tiers (bronze, silver, gold, and platinum). Our secondary objective was to compare the exchange coverage to employer-sponsored coverage. Analyzing prescription drug benefit design data for the federally facilitated exchanges, we found wide variation in enrollees' out-of-pocket costs for generic, preferred brand-name, nonpreferred brand-name, and specialty drugs, not only across metal tiers but also within those tiers across plan types. Compared to employer-sponsored plans, exchange plans generally had lower premiums but provided less generous drug coverage. However, for low-income enrollees who are eligible for cost-sharing subsidies, the exchange plans may be more comparable to employer-based coverage. Policies and programs to assist consumers in matching their prescription drug needs with a plan's benefit design may improve the financial protection for the newly insured. PMID:25732498

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

    PubMed

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

    2016-01-01

    Direct-to-consumer (DTC) prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding. Participants (4,064 adults) viewed 1 of 15 DTC print ads for fictitious prescription drugs indicated to treat chronic obstructive pulmonary disease, anemia, or lymphoma that varied in disease information presence, type, and format. Participants answered questions that assessed risk and benefit memory, perception, and behavioral intention. Results indicate that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication. PMID:26717304

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

    PubMed Central

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

    2015-01-01

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

  19. FDA approval of comparative claims for prescription drugs--the Moxam case.

    PubMed

    Marcus, D

    1983-01-01

    FDA allowance of comparative claims as part of the approved labeling for new prescription drugs creates special problems. Claims contained in prescription drug labeling are viewed by physicians as embodying not just the normal puffery of the manufacturer, but the considered views of government agency charged with protecting public health. Thus, labeling claims for prescription drugs have an impact and significance that promotional claims for other products do not. In the Moxam case--a dispute between Upjohn and Lilly over the FDA's approval of a comparative claim for a new Lilly antibiotic--the agency recognized this fundamental reality. Faced with the prospect of having to provide a procedure to permit competitors to challenge approval of comparative claims, the FDA has moved toward a policy of not permitting such claims in labeling, while allowing them in advertising.

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

    PubMed

    2014-07-28

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

  1. The Impact of the Medicare Part D Prescription Benefit on Generic Drug Use

    PubMed Central

    Zhang, James X.; Yin, Wesley; Sun, Shawn X.

    2008-01-01

    Background Little information exists regarding the impact of Medicare Part D on generic drug use. Objective To examine changes in the use of generic prescriptions attributable to Part D among a sample of Medicare beneficiaries. Design, participants, and measurements Difference-in-difference analysis of pharmacy claims of Part D enrollees and non-enrollees aged 67–79 years from 2005 to 2006. The final sample represented approximately 2.4 million unique subjects. Analyses were conducted separately for major therapeutic classes, limited to subjects filling at least one prescription within the class during 2005 and 2006, and adjusted for subject characteristics, prescription characteristics, socio-demographic characteristics measured through zipcode-linked Census data, baseline differences between Part D and non-Part D enrollees, and secular trends in generic use. Results Generic drugs accounted for 58% of total prescriptions. Among the entire group of beneficiaries, there was a trend of increased generic drug use in 13 out of 15 drug classes examined. However, after adjusting for potential confounders, the growth rate of generic drug use was lower among Part D enrollees than among non-enrollees; enrollees were slightly less likely to fill prescriptions for generic drugs vs. brand-name drugs in 2006 compared to 2005 (odds ratio 0.95, 95% confidence interval 0.94–0.95). Conclusions Despite secular trends of increased utilization of generic drugs among both Part D enrollees and non-enrollees, the net impact of Part D among these beneficiaries was a modest decrease in the use of generic drugs. This finding, which is consistent with economic theory but contrary to several recent reports, highlights the complexity of assessing the impact of Part D on overall consumer welfare. PMID:18661190

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... which it is possible to determine the complete manufacturing history of the package of the drug. (7) A... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC),...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... which it is possible to determine the complete manufacturing history of the package of the drug. (7) A... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC),...

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

    PubMed

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

    2014-01-01

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

  5. Insurance Coverage of Prescription Drugs and the Rural Elderly

    ERIC Educational Resources Information Center

    Mueller, Curt; Schur, Claudia

    2004-01-01

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

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

    PubMed Central

    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. The qualitative methods we used in this study followed the constant comparison process developed by grounded theory methods and analytical ethnography, which is based on familiarity with the social setting and developing propositions while conducting a research study. We used a triangulation of methods and analysis and included qualitative data, such as participant observation notes and in-depth interviews, as well as quantitative data that we collected in drug history matrices. Five themes emerged from the coding of the interview transcripts: (1) sequential polydrug use; (2) concurrent polydrug use (3) temporary substitution of preferred drug; (4) consequential-based use; and (5) switching from using methamphetamine to using prescription drugs. The trajectory patterns of methamphetamine and prescription drug use complicates treatment significantly. PMID:23285312

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

    PubMed

    Bradford, W David; Lastrapes, William D

    2014-11-01

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

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

    PubMed

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

    2015-01-01

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

  9. Allergy evaluation after emergency treatment: anaphylaxis to the over-the-counter medication clobutinol.

    PubMed

    Seitz, Cornelia S; Bröcker, Eva-B; Trautmann, Axel

    2007-03-01

    Anaphylaxis is traditionally diagnosed and treated as an acute emergency but should be always followed by a search for specific triggers, resulting in avoidance strategies. This case report highlights the relevance of a detailed evaluation after anaphylaxis for diagnosis of a rare but potentially life-threatening allergy. Considering the high frequency of clobutinol application, IgE-mediated allergic hypersensitivity seems extremely rare and has to be distinguished from infection-associated urticaria and angioedema as well as non-specific summation effects. Accidental re-exposure has to be strictly avoided and therefore after identification of clobutinol as the anaphylaxis trigger, the patient received detailed allergy documents including international non-proprietary and trade names of the culprit drug.

  10. Allergy evaluation after emergency treatment: anaphylaxis to the over-the-counter medication clobutinol.

    PubMed

    Seitz, Cornelia S; Bröcker, Eva-B; Trautmann, Axel

    2007-03-01

    Anaphylaxis is traditionally diagnosed and treated as an acute emergency but should be always followed by a search for specific triggers, resulting in avoidance strategies. This case report highlights the relevance of a detailed evaluation after anaphylaxis for diagnosis of a rare but potentially life-threatening allergy. Considering the high frequency of clobutinol application, IgE-mediated allergic hypersensitivity seems extremely rare and has to be distinguished from infection-associated urticaria and angioedema as well as non-specific summation effects. Accidental re-exposure has to be strictly avoided and therefore after identification of clobutinol as the anaphylaxis trigger, the patient received detailed allergy documents including international non-proprietary and trade names of the culprit drug. PMID:17351213

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

    PubMed Central

    Firestone, Michelle; Fischer, Benedikt

    2008-01-01

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

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

    PubMed

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

    2014-01-01

    Non-medical use of prescription drugs (NMUPD) is increasing among the general population, particularly among teenagers and young adults. Although prescription drugs are considered safer than illicit street drugs, NMUPD can lead to detrimental consequences. The aim of the present study was to investigate the relationship between drug use (NMUPD on the one side, illicit street drugs on the other side) with mental health issues and then compare these associations. A representative sample of 5719 young Swiss men aged around 20 years filled in a questionnaire as part of the ongoing baseline Cohort Study on Substance Use Risk Factors (C-SURF). Drug use (16 illicit street drugs and 5 NMUPDs, including sleeping pills, sedatives, pain killers, antidepressants, stimulants) and mental health issues (depression, SF12) were assessed. Simple and multiple linear regressions were employed. In simple regressions, all illicit and prescription drugs were associated with poorer mental health. In multiple regressions, most of the NMUPDs, except for stimulants, were significantly associated with poorer mental health and with depression. On the contrary, the only associations that remained significant between illicit street drugs and mental health involved cannabis. NMUPD is of growing concern not only because of its increasing occurrence, but also because of its association with depression and mental health problems, which is stronger than the association observed between these problems and illicit street drug use, excepted for cannabis. Therefore, NMUPD must be considered in screening for substance use prevention purposes. PMID:24447983

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

    PubMed

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

    2014-01-01

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

  14. Inequity in publicly funded physician care: what is the role of private prescription drug insurance?

    PubMed

    Allin, Sara; Hurley, Jeremiah

    2009-10-01

    This study examines the impact that private financing of prescription drugs in Canada has on equity in the utilization of publicly financed physician services. The complementary nature of prescription drugs and physician service use alongside the reliance on private finance for drugs may induce an income gradient in the use of physicians. We use established econometric methods based on concentration curves to measure equity in physician utilization and its contributors in the province of Ontario. We find that individuals with prescription drug insurance make more physician visits than do those without insurance, and the effect on utilization is stronger for the likelihood of a visit than the conditional number of visits, and stronger for individuals with at least one chronic condition than those with no conditions. Results of the equity analyses reveal that the most important contributors to the pro-rich inequity in physician utilization are income and private prescription drug insurance, while public insurance, which covers older people and those on social assistance, has a pro-poor effect. These findings highlight that inequity in access to and use of publicly funded services may arise from the interaction with privately financed health services that are complements to the use of public services.

  15. Predictability of Prescription Drug Expenditures for Medicare Beneficiaries

    PubMed Central

    Wrobel, Marian V.; Doshi, Jalpa; Stuart, Bruce C.; Briesacher, Becky

    2003-01-01

    MCBS data are used to analyze the predictability of drug expenditures by Medicare beneficiaries. Predictors include demographic characteristics and measures of health status, the majority derived using CMS' diagnosis cost group/hierarchical condition category (DCG/HCC) risk-adjustment methodology. In prospective models, demographic variables explained 5 percent of the variation in drug expenditures. Adding health status measures raised this figure between 10 and 24 percent of the variation depending on the model configuration. Adding lagged drug expenditures more than doubled predictive power to 55 percent. These results are discussed in the context of forecasting, and risk adjustment for the proposed new Medicare drug benefit. PMID:15124376

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

    PubMed

    Southwell, Brian G; Rupert, Douglas J

    2016-03-01

    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

  17. Prescription drug abuse: what is being done to address this new drug epidemic? Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources.

    PubMed

    Manchikanti, Laxmaiah

    2006-10-01

    This comprehensive health policy review of the prescription drug abuse epidemic is based on the written and oral testimony of witnesses at a July 26, 2006 Congressional Hearing, including that of Laxmaiah Manchikanti, MD, the chief executive officer of the American Society of Interventional Pain Physicians and additions from review of the literature. Honorable Mark E. Souder, chairman of the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, introduced the issue as follows: "Prescription drug abuse today is second only to marijuana abuse. In the most recent household survey, initiates to drug abuse started with prescription drugs (especially pain medications) more often than with marijuana. The abuse of prescription drugs is facilitated by easy access (via physicians, the Internet, and the medicine cabinet) and a perception of safety (since the drugs are FDA approved). In addition to the personal toll of drug abuse using prescription drugs, indirect costs associated with prescription drug abuse and diversion include product theft, commission of other crimes to support addiction, law enforcement costs, and encouraging the practice of defensive medicine." The Administration witnesses, Bertha Madras, Nora D. Volkow, MD, Sandra Kweder, MD, and Joe Rannazzisi reviewed the problem of drug abuse and discussed what is being done at the present time as well as future strategies to combat drug abuse, including prescription drug monitoring programs, reducing malprescriptions, public education, eliminating Internet drug pharmacies, and the development of future drugs which are not only tamper-resistant but also non-addictive. The second panel, consisting of consumers and advocates, included Misty Fetco, Linda Surks, and Barbara van Rooyan, all of whom lost their children to drugs, presented their stories and strategies to prevent drug abuse, focusing on education at all levels, development of resistant drugs, and non-opioid treatment of chronic pain. Mathea

  18. Prescription drug abuse: what is being done to address this new drug epidemic? Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources.

    PubMed

    Manchikanti, Laxmaiah

    2006-10-01

    This comprehensive health policy review of the prescription drug abuse epidemic is based on the written and oral testimony of witnesses at a July 26, 2006 Congressional Hearing, including that of Laxmaiah Manchikanti, MD, the chief executive officer of the American Society of Interventional Pain Physicians and additions from review of the literature. Honorable Mark E. Souder, chairman of the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, introduced the issue as follows: "Prescription drug abuse today is second only to marijuana abuse. In the most recent household survey, initiates to drug abuse started with prescription drugs (especially pain medications) more often than with marijuana. The abuse of prescription drugs is facilitated by easy access (via physicians, the Internet, and the medicine cabinet) and a perception of safety (since the drugs are FDA approved). In addition to the personal toll of drug abuse using prescription drugs, indirect costs associated with prescription drug abuse and diversion include product theft, commission of other crimes to support addiction, law enforcement costs, and encouraging the practice of defensive medicine." The Administration witnesses, Bertha Madras, Nora D. Volkow, MD, Sandra Kweder, MD, and Joe Rannazzisi reviewed the problem of drug abuse and discussed what is being done at the present time as well as future strategies to combat drug abuse, including prescription drug monitoring programs, reducing malprescriptions, public education, eliminating Internet drug pharmacies, and the development of future drugs which are not only tamper-resistant but also non-addictive. The second panel, consisting of consumers and advocates, included Misty Fetco, Linda Surks, and Barbara van Rooyan, all of whom lost their children to drugs, presented their stories and strategies to prevent drug abuse, focusing on education at all levels, development of resistant drugs, and non-opioid treatment of chronic pain. Mathea

  19. Direct-to-consumer promotion of prescription drugs. Economic implications for patients, payers and providers.

    PubMed

    Findlay, S D

    2001-01-01

    Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to

  20. Direct-to-consumer promotion of prescription drugs. Economic implications for patients, payers and providers.

    PubMed

    Findlay, S D

    2001-01-01

    Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to

  1. Perception of prescription drug risks: a survey of patients with ankylosing spondylitis.

    PubMed

    O'Brien, B J; Elswood, J; Calin, A

    1990-04-01

    The ways in which patients perceive the risks of prescription drugs are likely to influence treatment preferences and compliance decisions. But very little is known about the perceived frequency of adverse drug reactions (ADR), their perceived causation and attitudes towards the safety regulation of prescription drugs. A sample of 1,034 patients with ankylosing spondylitis (AS) completed a postal questionnaire on the risks of medicines in general and nonsteroidal antiinflammatory drugs (NSAID) in particular. Serious ADR were perceived to be more frequent with NSAID than prescription drugs generally, and those who had experienced a previous ADR (47%) judged ADR to be more frequent (p less than 0.001). When asked to rate the likelihood that each of 7 reasons were causative of ADR, the most likely reason was perceived to be inadequate information to the patient about the drug, and secondly inadequate patient followup by the prescribing doctor. Responses to a hypothetical AS drug risk scenario indicated high safety expectations for antirheumatic agents; 61% thought that the government should take a drug off the market if there is any evidence of fatal ADR. The results of this survey suggest the need for greater patient information and education on the risks and benefits of medicines to modify perceptions and false expectations. PMID:2348431

  2. Drug Safety

    MedlinePlus

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

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

    PubMed Central

    2016-01-01

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

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

    PubMed Central

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Yolles, Stanley F.

    1971-01-01

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

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

    PubMed

    2016-03-01

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

  7. Can Walmart make us healthier? Prescription drug prices and health care utilization.

    PubMed

    Borrescio-Higa, Florencia

    2015-12-01

    This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent.

  8. Time trends of antidepressant drug prescriptions in men versus women in a geographically defined US population

    PubMed Central

    Zhong, Wenjun; Kremers, Hilal Maradit; Yawn, Barbara P.; Bobo, William V.; St Sauver, Jennifer L.; Ebbert, Jon O.; Rutten, Lila J.; Jacobson, Debra J.; Brue, Scott M.; Rocca, Walter A.

    2014-01-01

    Purpose To study time trends of antidepressant drug (AD) prescriptions in a geographically defined US population between 2005 and 2011 for men and women separately. Methods Using the Rochester Epidemiology Project medical records-linkage system, we identified all Olmsted County, MN residents who received AD outpatient prescriptions between 2005 and 2011 (seven years). We calculated the annual age-and sex-specific prevalence over seven years, and used generalized estimating equation models to test for time trends. Results The prevalence of subjects receiving at least one AD prescription was approximately two times higher in women than men consistently across the seven years of the study. The standardized annual prevalence increased from 10.8% in 2005 to 14.4% in 2011 overall, from 7.0% in 2005 to 9.9% in 2011 for men, and from 14.4% in 2005 to 18.6% in 2011 for women. The absolute percent increase was greater in women (4.2% vs. 2.9%; standardized); however, the relative percent increase was greater in men (41.4% vs. 29.2%; standardized). The relative percent increase was greater in the age group 65+ years for both men and women. Conclusions AD prescriptions are increasing over time, especially in the elderly. Women receive more AD prescriptions than men. However, the relative increase in AD prescriptions over time is greater in men than women. PMID:25113318

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

    PubMed Central

    2014-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2004-01-01

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

  12. 76 FR 21431 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ....564, 422.624, and 422.626 published April 4, 2003 at 68 FR 16652 are effective June 6, 2011... (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively). As we have gained experience with... involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors (72...

  13. 42 CFR 423.884 - Requirements for qualified retiree prescription drug plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... written agreement with its health insurance issuer (as defined in 45 CFR 160.103), or group health plan... 42 Public Health 3 2010-10-01 2010-10-01 false Requirements for qualified retiree prescription drug plans. 423.884 Section 423.884 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES,...

  14. 42 CFR 423.884 - Requirements for qualified retiree prescription drug plans.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... have a written agreement with its health insurance issuer (as defined in 45 CFR 160.103), or group... 42 Public Health 3 2012-10-01 2012-10-01 false Requirements for qualified retiree prescription drug plans. 423.884 Section 423.884 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES,...

  15. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... chapter 17 of title 38, U.S.C. (6) Coverage under a Medicare supplemental policy (Medigap policy) as defined at § 403.205 of this chapter. (7) Military coverage under chapter 55 of title 10, U.S.C... status of prescription drug coverage. 423.56 Section 423.56 Public Health CENTERS FOR MEDICARE &...

  16. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... veterans, survivors and dependents under chapter 17 of title 38, U.S.C. (6) Coverage under a Medicare... chapter 55 of title 10, U.S.C., including TRICARE. (8) Individual health insurance coverage (as defined in... status of prescription drug coverage. 423.56 Section 423.56 Public Health CENTERS FOR MEDICARE &...

  17. 75 FR 15376 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... Register of May 6, 1998 (63 FR 24996 at 25002), FTC summarized the factors it takes into account in... these services to avoid the abuse of consumers. In the Federal Register of August 9, 1993 (58 FR 42364... prescription drug television broadcast advertisements (72 FR 47051, August 22, 2007). FDA recognizes...

  18. 75 FR 71189 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... Federal Register on January 28, 2005 (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively... Medicare Part D prescription drug plan sponsors (72 FR 68700). In April 2008, we published a final rule to address policy and technical changes to the Part D program (73 FR 20486). In September 2008 and...

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

  20. 77 FR 4273 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ... information in DTC prescription drug television advertisements (72 FR 47051, August 22, 2007) (Distraction... proposed rule published in the Federal Register of March 29, 2010 (75 FR 15376), to establish standards.... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 29, 2010 (75 FR 15376), FDA...