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Sample records for prescription drugs over-the-counter

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

    MedlinePlus

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

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

    MedlinePlus

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2011-04-01

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

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

    PubMed

    Brass, Eric P

    2004-05-01

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

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

    PubMed

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

    2007-09-01

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

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

    PubMed

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

    2007-01-01

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

  8. 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…

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

    PubMed

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

    2017-08-16

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

  10. 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

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

    PubMed

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

    2006-01-01

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

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

    PubMed

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

    2014-05-01

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

  13. Prescription and Over-the-Counter Medications

    MedlinePlus

    ... use. Prescription Opioid Abuse: A First Step to Heroin Use? Prescription opioid pain medications such as Oxycontin ® and Vicodin ® can have effects similar to heroin when taken in doses or in ways other ...

  14. Drugs involved in drug-facilitated crimes--part II: Drugs of abuse, prescription and over-the-counter medications. A review.

    PubMed

    Shbair, M K S; Eljabour, S; Bassyoni, I; Lhermitte, M

    2010-11-01

    In recent years, there has been a notable increase in the number of reports of drug-facilitated crimes. Usually, individuals report that they were robbed or assaulted while incapacitated by drugs. Most often, these cases have involved drugs that have the ability to produce an effect that leaves the victim in a semiconscious or unconscious state. It is reasonable to assume that the purpose of drug-induced incapacitation is probably largely unchanged with time. This covers the full range of property offences (particularly theft) and crimes against the person (often sexual assault). What have changed are the drugs themselves: the number; type; their accessibility; effects and detection. This review describes the different aspects related to the involvement and use of drugs of abuse, as well as prescription and over-the counter medications in drug-facilitated crimes, which may help people working in this field to expand their knowledge in order to better understand the nature of these crimes or offences.

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

    PubMed

    Lessenger, James E; Feinberg, Steven D

    2008-01-01

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

  16. Association of health-related quality of life with dual use of prescription and over-the-counter nonsteroidal antiinflammatory drugs.

    PubMed

    Kovac, Stacey H; Saag, Kenneth G; Curtis, Jeffrey R; Allison, Jeroan

    2008-02-15

    Inadequate prescription therapy pain management, lack of doctor-patient communication about over-the-counter (OTC) medications, and easy accessibility of OTC medications may contribute to patients using more than 1 medication to manage pain. It is well established that taking multiple nonsteroidal antiinflammatory drugs (NSAIDs) can lead to serious gastrointestinal problems. Little is known about whether use of more than 1 NSAID (i.e., dual use) is related to patient self-reported outcomes, specifically health-related quality of life (HRQOL). We hypothesized that dual use of NSAIDs would be associated with reduced HRQOL. Patients from a managed care organization who filled > or =1 NSAID prescription over a 6-month period were eligible for a telephone interview focusing on NSAID use, which included the Short Form 12 (SF-12) Health Survey. Dual use was defined as taking 2 NSAIDs, either prescription or OTC, at least twice weekly during the past month. A multivariable linear regression model examined the association between dual use and the Physical Component Summary score (PCS-12) from the SF-12. Dual use was associated with lower PCS-12 scores indicating poorer HRQOL, after controlling for clinical and demographic factors. Patients may self-manage their pain to improve their daily activities by taking more than 1 NSAID. However, by attempting to obtain symptom relief, patients may be putting themselves at risk for complications. Providers are likely unaware of patients' risk. Future research should evaluate the causal factors contributing to dual use.

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

    PubMed

    Honig, P K; Gillespie, B K

    1995-11-01

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

  18. Analysis of multiple end points in consumer research in support of switching drugs from prescription to over-the-counter status: the concept of end-point hierarchies.

    PubMed

    Brass, E P; Shay, L E; Leonard-Segal, A

    2009-04-01

    Clinical and regulatory decision making concerning over-the-counter (OTC) drugs requires research designed to understand how consumers will self-manage treatment using the candidate OTC drug. Consumer research for an OTC drug may include studies of label comprehension, self-selection, and actual use. Definition and analysis of end points for these trials have varied in the absence of consensus on optimal approaches. Research programs should prospectively prioritize the importance of label messages based on their roles in the safe and effective use of the drug. The assessment of messages for which failure to heed warnings will expose the consumer to increased risk or clinically relevant treatment failure should receive the highest priority as study end points. Based on the consequences of unheeded warnings, message-specific targets for appropriate response rates can be predefined. This prospective, hierarchical approach to end-point definition, combined with prespecification of targeted correct-response rates, has the potential to increase the scientific rigor and regulatory utility of these important research studies.

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

    PubMed

    Papich, M G

    1990-03-01

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

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

    PubMed

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

    2011-01-01

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

  1. 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

  2. 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.

  3. 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.

  4. 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.

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

    PubMed

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

    2014-12-01

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

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

    PubMed

    Burger, David M

    2014-01-01

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

  7. Analysis of US Food and Drug Administration Warning Letters: False Promotional Claims Relating to Prescription and Over-the-Counter Medications.

    PubMed

    Salas, Maribel; Martin, Michelle; Pisu, Maria; McCall, Erin; Zuluaga, Alvaro; Glasser, Stephen P

    2008-03-01

    Recent studies have suggested that there has been an increase in the number of 'warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached. Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims. There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines. We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for

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

    PubMed

    Moore, Nicholas

    2007-01-01

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

  9. 78 FR 57623 - TRICARE Over-the-Counter Drug Demonstration Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

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

  10. 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.

  11. Usage of antifungal drugs for therapy of genital Candida infections, purchased as over-the-counter products or by prescription: 2. Factors that may have influenced the marked changes in sales volumes during the 1990s.

    PubMed

    Mårdh, Per-Anders; Wågström, Jolanta; Landgren, Maria; Holmén, Jan

    2004-06-01

    The epidemiology of vulvovaginal candidiasis (VVC) and such recurrent infections (RVVC) has been difficult to study as the majority of episodes of these conditions are self-treated by the women affected. In Sweden, all pharmacies are owned by the state and all prescriptions and over-the-counter (OTC) products, such as antifungals, are registered in a database, which offers unique possibilities to study the epidemiology of VVC/RVVC. To analyze all prescriptions and OTC products purchased for therapy of VVC/RVVC and to establish reasons for any observed variation in the sales figures. Sales figures in the Swedish county of Skåne of antifungal drugs for therapy of VVC/RVVC were analyzed by the aid of the 'ACS' database of the National Corporation of Swedish Pharmacies for the years 1990--1999. The size of the female population in the county is approximately half a million. The study showed that 93% of all antifungal drugs for VVC/RVVC were sold as OTC products. An increase in sales of the drugs occurred until mid- 1993/94, followed by a decrease until end of the study period in 1999. Demographic factors (e.g. the number of female inhabitants in the county, pharmacies and health-care units), the pregnancy rate and pharmacy-dependent factors (such as the introduction of shelves for self-selection of antifungal products) did not explain the observed variations in sales. Distinct short-term variations in the number of prescriptions of fluconazole and itraconazole could be explained by drugs company sales campaigns and logistics factors in drug distribution. The sales volumes in the 33 municipalities in the county correlated with the density of the population, which was not the case for the total number of prescriptions made in the county during the 1990s. The variation in antifungal drug sales was similar to that of hormonal intrauterine devices, but this was not the case for oral contraceptives. The total Swedish usage of antibiotics showed a similar variation to that

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

    PubMed

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

    2013-01-01

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

  13. Over-the-Counter Medicines

    MedlinePlus

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

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

    PubMed Central

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

    2014-01-01

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

  15. 21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    PubMed

    Grindlay, Kate; Burns, Bridgit; Grossman, Daniel

    2013-07-01

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

  17. 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

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

    PubMed

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

    2010-09-01

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

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

    PubMed

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

    2015-04-01

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

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

    PubMed

    Tsao, J C

    1997-01-01

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

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

    PubMed

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

    2003-01-01

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

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

    PubMed

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

    2010-11-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    ERIC Educational Resources Information Center

    Tsao, James C.

    1997-01-01

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

  6. 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…

  7. 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…

  8. 77 FR 66182 - TRICARE Over-the-Counter Drug Demonstration Project

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

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

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

    ERIC Educational Resources Information Center

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

    1986-01-01

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

  10. 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 ...

  11. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  12. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  13. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    PubMed

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

    2002-09-01

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

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

    PubMed Central

    Fernández-Maestre, Roberto

    2009-01-01

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

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

    PubMed

    Fernández-Maestre, Roberto; Hill, Herbert H

    2009-08-01

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

  17. 76 FR 56682 - Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

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

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

    PubMed

    2003-06-09

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

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

    PubMed

    Barrenberg, E; Garbe, E

    2015-11-01

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

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

    PubMed

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

    2007-07-01

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

  1. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  2. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  3. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  4. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  5. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the...

  6. 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.

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

    PubMed

    Potts, M; Denny, C

    1995-12-01

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

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

    PubMed

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

    2011-03-01

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

  9. 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

  10. 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.

  11. 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

  12. Absence of 'over-the-counter' medicinal products in on-line prescription records: a risk factor of overlooking interactions in the elderly.

    PubMed

    Olesen, C; Harbig, P; Barat, I; Damsgaard, E M

    2013-02-01

    To assess possible origins of harmful interactions in elderly patients arising from the current absence of information on over-the-counter (OTC) medicines in the Danish 'on-line prescription record'. Information on current use of prescription drugs and OTC medicinal products (non-prescription drugs, herbal medicine, dietary supplements, and others) was collected by home visit interviews. The latter OTC products were not listed in an on-line prescription record that covered the previous two years. Information on interactions between OTC medicines and between OTC products and prescription drugs was obtained from the Danish National Drug Interaction Database. Of the 309 patients recruited (median age 75 years, interquartile range (IQR) 70-81), 229 (74%) used 568 OTC medicines not listed in the Danish 'on-line prescription record', amongst which we identified 166 potential interactions - between OTC treatments or between OTC and prescription drugs. Fifty percent of patients taking OTC medicines were exposed to potential interactions, i.e. one to three instances per patient. Twenty-five percent of patients exposed to interactions experienced interaction listed as 'Can be used with certain precautions'. The absence of information on OTC products in an on-line prescription record entails a risk of overlooking interactions in elderly patients. Such products should be included in on-line medication records to prevent adverse effects from interactions. However, online medication records are not available in all countries and as inclusion of data on OTC drugs seem not to be feasible presently. Still, it is highly recommended that the patient's drug list is reviewed on a regular basis. Copyright © 2012 John Wiley & Sons, Ltd.

  13. The impact of over-the-counter simvastatin on the number of statin prescriptions in the United Kingdom: a view from the General Practice Research Database.

    PubMed

    Filion, Kristian B; Delaney, J A Chris; Brophy, James M; Ernst, Pierre; Suissa, Samy

    2007-01-01

    The United Kingdom (UK) government changed the prescription policy of statins, making low-dose simvastatin (10 mg) available as an over-the-counter (OTC) drug in August 2004. We assessed the impact of this policy change on statin prescribing. We examined all statin prescriptions in the General Practice Research Database (GPRD), a well-validated database of approximately 3.5 million patients, from the first quarter of 2001 to the second quarter of 2005. From 2001, the number of statin prescriptions written for GPRD patients was increasing by approximately 437 prescriptions per 100,000 people per quarter until the time of the policy change. Over the four quarters post-policy implementation, however, this trend changed abruptly (p < 0.0001) with a decrease of 281 prescriptions per 100,000 people per quarter. This decrease was not restricted to prescriptions of 10 mg statins but was also observed for statin prescriptions of >or=20 mg. Several other cardiovascular medications displayed a similar trend as that observed in the number of statin prescriptions. This trend was not observed among non-cardiovascular control medications. Our study suggests that the policy allowing the OTC sale of 10 mg simvastatin has had a significant impact on statin prescriptions by general practitioners. However, this new policy may also be leading to less aggressive statin therapy. An alternative explanation for the observed decrease in statin prescriptions may be related to the unknown factors responsible for the overall decrease observed with other cardiovascular prescription drugs. Copyright (c) 2006 John Wiley & Sons, Ltd.

  14. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011

    PubMed Central

    Qato, Dima M.; Wilder, Jocelyn; Schumm, L. Philip; Gillet, Victoria; Alexander, G. Caleb

    2016-01-01

    IMPORTANCE Prescription and over-the-counter medicines and dietary supplements are commonly used, alone and together, among older adults. However, the effect of recent regulatory and market forces on these patterns is not known. OBJECTIVES To characterize changes in the prevalence of medication use, including concurrent use of prescription and over-the-counter medications and dietary supplements, and to quantify the frequency and types of potential major drug-drug interactions. DESIGN, SETTING, AND PARTICIPANTS Descriptive analyses of a longitudinal, nationally representative sample of community-dwelling older adults 62 to 85 years old. In-home interviews with direct medication inspection were conducted in 2005–2006 and again in 2010–2011. The dates of the analysis were March to November 2015. We defined medication use as the use of at least 1 prescription or over-the-counter medication or dietary supplement at least daily or weekly and defined concurrent use as the regular use of at least 2 medications. We used Micromedex to identify potential major drug-drug interactions. MAIN OUTCOMES AND MEASURES Population estimates of the prevalence of medication use (in aggregate and by therapeutic class), concurrent use, and major drug-drug interactions. RESULTS The study cohort comprised 2351 participants in 2005–2006 and 2206 in 2010–2011. Their mean age was 70.9 years in 2005–2006 and 71.4 years in 2010–2011. Fifty-three percent of participants were female in 2005–2006, and 51.6% were female in 2010–2011. The use of at least 1 prescription medication slightly increased from 84.1% in 2005–2006 to 87.7% in 2010–2011 (P = .003). Concurrent use of at least 5 prescription medications increased from 30.6% to 35.8% (P = .02). While the use of over-the-counter medications declined from 44.4% to 37.9%, the use of dietary supplements increased from 51.8% to 63.7%(P < .001 for both). There were clinically significant increases in the use of statins (33.8% to 46

  15. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011.

    PubMed

    Qato, Dima M; Wilder, Jocelyn; Schumm, L Philip; Gillet, Victoria; Alexander, G Caleb

    2016-04-01

    Prescription and over-the-counter medicines and dietary supplements are commonly used, alone and together, among older adults. However, the effect of recent regulatory and market forces on these patterns is not known. To characterize changes in the prevalence of medication use, including concurrent use of prescription and over-the-counter medications and dietary supplements, and to quantify the frequency and types of potential major drug-drug interactions. Descriptive analyses of a longitudinal, nationally representative sample of community-dwelling older adults 62 to 85 years old. In-home interviews with direct medication inspection were conducted in 2005-2006 and again in 2010-2011. The dates of the analysis were March to November 2015. We defined medication use as the use of at least 1 prescription or over-the-counter medication or dietary supplement at least daily or weekly and defined concurrent use as the regular use of at least 2 medications. We used Micromedex to identify potential major drug-drug interactions. Population estimates of the prevalence of medication use (in aggregate and by therapeutic class), concurrent use, and major drug-drug interactions. The study cohort comprised 2351 participants in 2005-2006 and 2206 in 2010-2011. Their mean age was 70.9 years in 2005-2006 and 71.4 years in 2010-2011. Fifty-three percent of participants were female in 2005-2006, and 51.6% were female in 2010-2011. The use of at least 1 prescription medication slightly increased from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P = .003). Concurrent use of at least 5 prescription medications increased from 30.6% to 35.8% (P = .02). While the use of over-the-counter medications declined from 44.4% to 37.9%, the use of dietary supplements increased from 51.8% to 63.7% (P < .001 for both). There were clinically significant increases in the use of statins (33.8% to 46.2%), antiplatelets (32.8% to 43.0%), and omega-3 fish oils (4.7% to 18.6%) (P < .05 for all

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

    PubMed

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

    2016-06-01

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

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

    PubMed

    Kohli, Erol; Buller, Allison

    2013-02-01

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

  18. 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

  19. 76 FR 35678 - SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

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

  20. Acute generalised exanthematous pustulosis and other severe drug eruptions from over the counter medications: A case report and review of the literature.

    PubMed

    Kline, Amy; Fischer, Gayle

    2016-05-01

    We present a case of acute generalised exanthematous pustulosis in an 11-year-old girl who used Duro-Tuss, an over-the-counter cough mixture containing pholcodine, and present a comprehensive review of the literature on severe drug reactions resulting from using non-prescription medications. This case reinforces the importance of taking a complete medication history. © 2015 The Australasian College of Dermatologists.

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

    PubMed

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

    2016-03-01

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

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

    PubMed

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

    2013-01-01

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

  3. [The over the counter drugs reform in Israel--two years later].

    PubMed

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

    2011-01-01

    In the last two decades there has been a world wide increase in the number of drugs that are being switched from the prescription-only category to non-prescription categories. In Israel, until recently, non-prescription medicines were only permitted to be sold by a pharmacist in pharmacies. In May 2005, following amendments to the law, several non-prescription medicines which were previously sold under a pharmacist's supervision, were reclassified as general-sales-list (GSL) medicines and permitted to be displayed and sold directly off the shelves in pharmacies and in other places such as grocery stores and petrol stations. To study the change in the patterns of consumption of non-prescription drugs in Israel two years after the reform began. A representative sample of the population of Israel was chosen and interviews were conducted at two time points: before the reform commenced and two years after the beginning of the reform. Statistical processing was performed in order to examine the changes in patterns of consumption of non-prescription drugs in Israel between these two time points. In both surveys it was found that: approximately 70% of the Israeli public buys non-prescription medicines; 70% of the people interviewed said that they had been aware of the reform, but of these, about 75% continued buying nonprescription drugs from the pharmacist while 21% bought medicines off the shelves at the pharmacy and 4% purchased medications at grocery stores. The most common reasons for buying medicines off the shelves without a pharmacist were earlier knowLedge about the medication, convenience and availabiLity when the pharmacies were closed. An insignificant difference was observed for the purchase of non-prescription drugs from the different types of pharmacies: the health maintenance organizations (HMO) pharmacies continue to be the leading pharmacies from which the public purchased their non-prescription medicines, white there was a slight increase in the

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. 75 FR 7606 - Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

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

  6. 78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

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

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

    PubMed

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

    2015-11-01

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

  8. 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.

  9. 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...

  10. 77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

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

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

    PubMed

    Nagaraj, Manjushree; Chakraborty, Ananya; Srinivas, B N

    2015-06-01

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

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

    PubMed

    Barrenberg, Eva; Garbe, Edeltraut

    2017-07-01

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

  13. 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

  14. 76 FR 35619 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ...The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the......

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

    ERIC Educational Resources Information Center

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

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

  16. Clinical studies of sweat rate reduction by an over-the-counter soft-solid antiperspirant and comparison with a prescription antiperspirant product in male panelists.

    PubMed

    Swaile, D F; Elstun, L T; Benzing, K W

    2012-03-01

    Individuals with axillary hyperhidrosis have much higher than average sweat rates and are often prescribed anhydrous aluminum chloride (AlCl(3)) solutions. Topical application of these solutions can be irritating to the skin, resulting in poor compliance and lower than desired efficacy. Demonstrate the efficacy of an over the counter "clinical strength" soft-solid antiperspirant using a night time application regimen and compare to a prescription aluminum chloride (6.5%) antiperspirant using male panelists. Gravimetric hot room efficacy testing (100 F and 35% Humidity) was performed comparing an over the counter soft-solid antiperspirant to placebo in a single test. Two separate gravimetric tests were placed comparing a prescription aluminum chloride (6.5%) antiperspirant to the same soft solid product using an intent to treat model. Skin irritation was assessed daily by a trained grader. Placebo testing resulted in 85% of panelists having a reduction in sweating rate greater than 50%. Comparison testing showed the over the counter soft solid reduced sweat rate by an average of 34% better than the prescription product while resulting significantly less skin irritation. Over the counter "clinical strength" soft-solid antiperspirants can be considered as an alternative treatment to aluminum chloride antiperspirants for the treatment of heavy sweating. © 2012 The Author. BJD © 2012 British Association of Dermatologists.

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

    PubMed

    2016-11-23

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

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

    MedlinePlus

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

  19. Over-the-counter and prescription sleep medication and incident stroke: the REasons for Geographic and Racial Differences in Stroke study.

    PubMed

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

    2014-09-01

    Preliminary evidence suggests sleep medications are associated with risk of vascular events; however, the long-term vascular consequences are understudied. This study investigated the relation between sleep medication use and incident stroke. Within the REasons for Geographic And Racial Differences in Stroke study, 21,678 black participants and white participants (≥45 years) with no history of stroke were studied. Participants were recruited from 2003 to 2007. From 2008 to 2010, participants self reported their prescription and over-the-counter sleep medication use over the past month. Suspected stroke events were identified by telephone contact at 6-month intervals and associated medical records were retrieved and physician-adjudicated. Proportional hazards analysis was used to estimate hazard ratios for incident stroke associated with sleep medication use (0, 1-14, and 15+ days per month) controlling for sociodemographics, stroke risk factors, mental health symptoms, and sleep apnea risk. At the sleep assessment, 9.6% of the sample used prescription sleep medication and 11.1% used over-the-counter sleep aids. Over an average follow-up of 3.3 ± 1.0 years, 297 stroke events occurred. Over-the-counter sleep medication use was associated with increased risk of incident stroke in a frequency-response relationship (P = .014), with a 46% increased risk for 1-14 days of use per month (hazards ratio [HR] = 1.46; 95% confidence interval [CI], .99-2.15) and a 65% increased risk for 15+ days (HR = 1.65; 95% CI, .96-2.85). There was no significant association with prescription sleep medications (P = .80). Over-the-counter sleep medication use may independently increase the risk of stroke beyond other risk factors in middle-aged to older individuals with no history of stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  20. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  1. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  4. 21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    PubMed

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

    2004-04-01

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

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

    PubMed

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

    2015-01-01

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

  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

    ...; a prescription drug for hypertension. Acute phosphate nephropathy means a type of nephrocalcinosis... angiotension receptor blocker, a prescription drug for hypertension. Biologic plausibility means a causal... sodium, potassium, calcium, or phosphorous found in the blood and other body fluids. End stage...

  8. Over-the-counter progesterone cream produces significant drug exposure compared to a food and drug administration-approved oral progesterone product.

    PubMed

    Hermann, Anne C; Nafziger, Anne N; Victory, Jennifer; Kulawy, Robert; Rocci, Mario L; Bertino, Joseph S

    2005-06-01

    Progesterone products are available in prescription form as well as over-the-counter (OTC) topical preparations sold for "cosmetic" uses. In a randomized study design, the authors compared the drug exposure from an OTC progesterone cream to a Food and Drug Administration-approved oral preparation at the labeled daily doses recommended for each product. Twelve healthy postmenopausal women received 200-mg oral progesterone capsules once daily for 12 days or progesterone cream 40 mg twice daily for 12 days. At steady state (day 12 of each phase), whole-blood samples were collected over 24 hours (oral progesterone) or 12 hours (topical progesterone) and assayed for total progesterone concentration. No significant differences were found in dose-normalized 24-hour progesterone exposure comparing the cream to oral capsules (median AUC(0-24) 12.5 ng x h/mL vs 10.5 ng x h/mL, respectively; P = .81). In light of the potential risks associated with long-term progesterone use, the authors question whether topical progesterone products should be available OTC.

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

    PubMed

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

    2015-01-01

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

  10. Over-the-counter and Prescription Medications for Acne: A Cross-Sectional Survey in a Sample of University Students in Saudi Arabia

    PubMed Central

    Alshehri, Mohja D.; Almutairi, Abdulsalam T.; Alomran, Asma M.; Alrashed, Batool A.; Kaliyadan, Feroze

    2017-01-01

    Introduction and Background: Acne is a very common dermatological condition found among the adolescent population in Saudi Arabia. Many patients with acne try various forms of self-medication, over the counter medicines (OTC), and prescription medicines for the same. Materials and Methods: This was a cross-sectional study among university students in the Kingdom of Saudi Arabia (KSA). A validated questionnaire was distributed to a convenience sample of university students to evaluate their knowledge and attitudes towards OTC (mainly) as well as prescription medicine for acne. Chi-square and multiple logistic regression tests were used for comparisons between groups. Results: Four hundred and twenty valid, completed questionnaires were obtained. A total of 220 (52.4%) used some type of OTC medications at least once, where as 108 (25.7%) used prescription medicines and 92 (21.9%) used both. The most common OTC medications used were cleansers by 250 participants (41.9%). Among prescription medicines, the most common were topical and oral antibiotics (11.4%). Bivariate and multivariate analysis showed that females are statistically more likely to use OTC medicines compared to males (Odds ratio: 1.7). Conclusion: The use of self-medications and OTC medications is common among university students in KSA. The most common OTC medicine used for acne was cleanser. PMID:28405552

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

    PubMed

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

    2014-02-01

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

  12. Validation of low-dose aspirin prescription data in The Health Improvement Network: how much misclassification due to over-the-counter use?

    PubMed

    Cea Soriano, Lucía; Soriano-Gabarró, Montse; García Rodríguez, Luis A

    2016-04-01

    We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Primary care practitioners (PCPs) were sent questionnaires to provide information on patients' use of OTC low-dose aspirin. One hundred and forty valid questionnaires were received (93.30% [95%CI: 88.16-96.34] response rate). Current use of low-dose aspirin was reported by PCPs in 4.23% (95%CI: 1.45-11.70) (n = 3) of past users (OTC use in one patient) and in 2.9% (95%CI: 0.78-9.70) (n = 2) of never users (OTC use in one patient). In addition, PCPs reported past use of low-dose aspirin in 88.70% (95%CI: 79.31-94.18) (n = 63) of past users (all prescribed; none as OTC) and in 2.82% (95%CI: 0.78-9.70) (n = 2) of never users (as OTC). Among past users, PCPs reported the indication for low-dose aspirin as primary cardiovascular disease (CVD) prevention in 63.16% (95%CI: 50.18-74.48) of patients and secondary CVD prevention in 31.58% (95%CI: 21.00-44.48) of patients. Corresponding percentages based on THIN were 78.95% (95%CI: 66.71-87.53) and 21.1% (95%CI: 12.47-33.29), respectively. Our findings show the small impact of potential misclassification of low-dose aspirin use in THIN due to unrecorded OTC use. The small proportion of false negatives confirms the utility of THIN for utilization and outcome studies of low-dose aspirin. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

  13. Use of, satisfaction with, and willingness to switch prescription and over-the-counter treatments for chronic urticaria: an online survey.

    PubMed

    Stull, Donald E; Gavriel, Sonia

    2009-09-01

    : Chronic urticaria (hives) affects a sizeable number of people worldwide, perhaps as much as 3%. It is often accompanied by angioedema. The negative effects of urticaria and angioedema, and any adverse effects of treatment, can result in significant patient burden. : To explore patients' use of, preferences for, and willingness to switch from prescription to over-the-counter (OTC) treatments for chronic urticaria. In addition, we compared treatment satisfaction with the treatment used most recently for their chronic urticaria. : Data were collected by an online survey using members of international consumer survey panels representative of the general populations in France and Germany. Panelists with urticaria were selected based on answers to screening questions. Respondents were asked, in their native language, questions about their typical course of treatment (prescription vs OTC), satisfaction with treatment, troublesomeness of their typical outbreak, whether their condition had improved or become worse over the past 12 months, and their willingness to try a new treatment if one became available. Descriptive analyses were performed on selected variables. Groups were compared using difference of means tests. Correlations and multiple regressions were performed to assess predictors of satisfaction with treatment and likelihood of switching treatment. : The final study sample consisted of 405 patients. Patients who used prescription treatments were more satisfied and reported greater treatment benefits with their treatment than those using OTC treatments. Patients who felt that their condition had become worse over the past 12 months were more likely to consider switching treatments. Respondents who used Aerius (desloratadine) most recently for treating their symptoms reported greater satisfaction with treatment than did those who used other commonly used prescription treatments most recently. : These results suggest that prescription treatments for chronic

  14. An ecological study of the extent and factors associated with the use of prescription and over-the-counter codeine in Australia.

    PubMed

    Gisev, Natasa; Nielsen, Suzanne; Cama, Elena; Larance, Briony; Bruno, Raimondo; Degenhardt, Louisa

    2016-04-01

    The extent and factors associated with codeine use in the community remain poorly understood despite the widespread global use of codeine. The aim of this study was to examine the use of prescription and over-the-counter (OTC) codeine in Australia and identify the geographic and socio-demographic characteristics associated with prescription and OTC codeine use. National sales data for prescription and OTC codeine (supplied by IMS Health) were used to estimate codeine utilisation (in pack sales and milligrammes) in Australia during 2013, mapped to Australian Bureau of Statistics (ABS) Statistical Local Areas (SLAs) and Remoteness Areas. Socio-demographic characteristics and total population estimates of SLAs were obtained from the ABS. SLA-level data on sex, age distribution, income, occupations involving physical labour and number of pharmacies were included in linear regression analyses to examine their association with total, prescription and OTC codeine use. In total, 27,780,234 packs of codeine were sold in Australia during 2013, equating to 12,376 kg. OTC codeine preparations accounted for 15,490,207 packs (55.8 %) or 4967.30 kg (40.1 %). Nationally, an estimated 1.24 packs (or 554.10 mg) of codeine were sold per person; utilisation was higher in more remote areas. SLAs with a higher percentage of low-income earning households had the highest rates of prescription codeine use (β 0.16, p < 0.001), whereas SLAs with a higher percentage of males had the highest rates of OTC codeine use (β 0.22, p < 0.001). Codeine use is common in Australia, with clear distinctions in the geographic and socio-demographic characteristics associated with prescription and OTC codeine use.

  15. 21 CFR 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  16. 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

  17. 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.

  18. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as...

  19. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as...

  20. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as...

  1. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as...

  2. 21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as...

  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. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2015-09-01

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

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

    PubMed

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

    2010-11-01

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

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

    PubMed Central

    2009-01-01

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

  7. 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…

  8. 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...

  9. 21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  10. 21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. 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...

  12. 21 CFR 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  13. 21 CFR 310.548 - 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  1. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  2. Prescription Drugs

    MedlinePlus

    ... prescription drug misuse? Also known as: Opioids: Hillbilly Heroin, Oxy, OC, Oxycotton, Percs, Happy Pills, Vikes Depressants: ... opioid receptors—the same receptors that respond to heroin . These receptors are found on nerve cells in ...

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

    PubMed

    Brune, Kay; Hinz, Burkhard; Otterness, Ivan

    2009-02-01

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

  4. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Final rule.

    PubMed

    2009-04-29

    The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

  5. 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.

  6. 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

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

    PubMed

    Hadi, Usman; van den Broek, Peterhans; Kolopaking, Erni P; Zairina, Nun; Gardjito, Widjoseno; Gyssens, Inge C

    2010-07-09

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

  8. Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule.

    PubMed

    2002-01-23

    The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the- counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. The criteria and procedures address how OTC drugs initially marketed in the United States after the OTC drug review began in 1972, and OTC drugs without any U.S. marketing experience, can meet the statutory definition of marketing to a "material extent" and "for a material time" and become eligible. If found eligible, the condition would be evaluated for general recognition of safety and effectiveness in accordance with FDA's OTC drug monograph regulations. FDA is also changing the current OTC drug monograph procedures to streamline the process and provide additional information in the review.

  9. Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople.

    PubMed

    Hellier, Elizabeth; Tucker, Mike; Kenny, Natalie; Rowntree, Anna; Edworthy, Judy

    2010-09-01

    This study aimed to examine the utility of using color and shape to differentiate drug strength information on over-the-counter medicine packages. Medication errors are an important threat to patient safety, and confusions between drug strengths are a significant source of medication error. A visual search paradigm required laypeople to search for medicine packages of a particular strength from among distracter packages of different strengths, and measures of reaction time and error were recorded. Using color to differentiate drug strength information conferred an advantage on search times and accuracy. Shape differentiation did not improve search times and had only a weak effect on search accuracy. Using color to differentiate drug strength information improves drug strength identification performance. Color differentiation of drug strength information may be a useful way of reducing medication errors and improving patient safety.

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

    PubMed Central

    2010-01-01

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

  11. 21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

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

    2001-01-01

    OBJECTIVES: This study sought to assess relations of laws prohibiting over-the-counter syringe sales (anti-OTC laws) to population prevalence of injection drug users and HIV prevalence or incidence among 96 US metropolitan areas. METHODS: A cross-sectional analysis was used. RESULTS: Metropolitan areas with anti-OTC laws had a higher mean HIV prevalence (13.8% vs 6.7%) than other metropolitan areas (pseudo-P < .001). In 83 metropolitan areas with HIV prevalence of less than 20%, anti-OTC laws were associated with HIV incidence rates of 1% or greater (pseudo-P < .001). Population proportions of injection drug users did not vary by presence of anti-OTC laws. CONCLUSIONS: Anti-OTC laws are not associated with lower population proportions of injection drug users. Laws restricting syringe access are associated with HIV transmission and should be repealed. PMID:11344889

  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 treating...

  14. 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.

  15. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Amyl nitrite inhalant as a prescription drug for... Prescription Status of Specific Drugs § 250.100 Amyl nitrite inhalant as a prescription drug for human use. (a) Amyl nitrite inhalant has been available over-the-counter for emergency use by the patient in the...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  18. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  20. 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

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

  1. 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

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

  2. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 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

    ..., and delayed urination. There is a lack of adequate data to establish general recognition of the safety... drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic... drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic...

  4. 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

    ..., and delayed urination. There is a lack of adequate data to establish general recognition of the safety... drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic... drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic...

  5. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., and delayed urination. There is a lack of adequate data to establish general recognition of the safety... drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic... drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic...

  6. 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

    ..., and delayed urination. There is a lack of adequate data to establish general recognition of the safety... drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic... drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic...

  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

    ..., and delayed urination. There is a lack of adequate data to establish general recognition of the safety... drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic... drug product labeled, represented, or promoted for OTC use to relieve the symptoms of benign prostatic...

  8. 21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  10. 78 FR 57397 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Announcement of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... Act (21 U.S.C. 353(b)); and (4) the product is an OTC drug and does not bear claims for serious...,'' American Industrial Hygiene Association Journal, vol. 57, pp. 626-633, 1996. Dated: September 12,...

  11. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  12. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  13. Over-the-Counter Access to Oral Contraceptives.

    PubMed

    Grossman, Daniel

    2015-12-01

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

  14. Self-medication of antibacterials without prescription (also called 'over-the-counter' use). A report of a Working Party of the British Society for Antimicrobial Chemotherapy.

    PubMed

    Reeves, D S; Finch, R G; Bax, R P; Davey, P G; Po, A L; Lingam, G; Mann, S G; Pringle, M A

    1999-08-01

    The availability of antimicrobial agents for self-medication may increase and could include antibacterial agents for oral or topical use. Wholesale deregulation of antibacterials would be undesirable and likely to encourage misuse of classes of agents currently important in the management of serious infections. Changed regulation from Prescription-Only Medicine (POM) to Pharmacy (P) medicine of selected agents with indications for short-term use in specific minor infections and illness is likely to have advantages to the user. However, safeguards to their use would need to be included in the Patient Information Leaflet (PIL). Agents and indications for self-medication are discussed. Any alteration in licensed status from POM to P will require careful risk-benefit assessment, including the likely impact on bacterial resistance. Safety issues also include concerns relating to age of the user, pregnancy, underlying disease and the potential for drug interactions. The importance of appropriate information with the PIL is emphasized, as is the role of the pharmacist, while ways of improving adverse event notification and monitoring are discussed. The paucity of good denominator-controlled data on the prevalence of in-vitro resistance is highlighted, and recommendations for improving the situation are made. There are currently no levels of resistance accepted by regulatory bodies on which to base a licensing decision, be it for granting a product licence, renewal of a licence or a change in licensed status from POM to P. Due consideration should be given to: the validation of user-defined indications in comparison with those medically defined; the enhancement of pharmacy advice in the purchase of such agents; improved safety monitoring; the establishment of systematic surveillance of susceptibility data.

  15. [Surveillance study on use of over-the-counter drug and health food by school pharmacist for grade-schooler, junior high school student, and high school students].

    PubMed

    Anraku, Makoto; Tomida, Hisao; Sato, Eiji; Tabuchi, Norihiko; Yoshitomi, Hironori; Okamura, Nobuyuki; Taguchi, Katsuhide; Kondo, Yuko; Murakami, Nobuyuki

    2011-01-01

    In recent years, it is necessary to acquire knowledge not only about medicine but also over-the-counter (OTC) drugs and health food for children, because lowering trend in the age of the health hazard by improper use of health food is reported. Therefore, in order to estimate the extent of use of OTC drugs and health food, the school pharmacists administered a questionnaire to students in grade-school (n=123), junior high school (n=303), and high school (n=115) in Fukuyama city. As a result of the questionnaire survey, surprisingly, the usage ratio of OTC drugs and health food showed the most increase in grade-schooler. The trigger of use of health food is "parents' recommendations" in the lower grades, otherwise the ratio of "use by themselves" was increased in the higher grades. Moreover, a remarkable difference was observed by the kinds of use in students with or without exercise. Interestingly, exercise group expected "physical strength" effects than no exercise group. In addition, the ratio of consultation to the pharmacist at the time of purchase of OTC drugs and health food was low in all grade students. In particular, the ratio of consultation to the pharmacist at the time of purchase of health food was very low in high school students. Therefore, to provide accurate information of medicine and health food for students, the school pharmacist should engage not only in routine work but also in positive guidance about OTC drugs and health food in the future.

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

    PubMed

    Brewer, Tim M; Verkouteren, Jennifer R

    2011-09-15

    Atmospheric pressure glow discharge mass spectrometry was used to characterize the active ingredients in pharmaceutical over-the-counter (OTC) drug formulations (Tylenol Allergy, Alka-Seltzer Plus Nighttime, Sudafed, Aleve and Mucinex DM) and drugs of abuse (crack cocaine, methamphetamine, MDMA (ecstasy) and hydrocodone). Material was desorbed and directly ionized under atmospheric conditions by allowing the substance to come in direct contact with the plasma followed by mass spectrometric detection. With this technique, controlled substances and OTC medications were readily distinguished from one another. Characteristic mass spectra were identified for the active ingredients in the OTC and drugs of abuse. Importantly, all drug compounds studied here, both OTC and illicit, demonstrated signals for either molecular ions or protonated molecules as well as fragmentation patterns that are readily identified in the National Institute of Standards and Technology (NIST) electron ionization (EI) mass spectral library. It is believed that this technique holds promise for forensic and law enforcement communities for real-time atmospheric analysis of drugs with database-searchable spectra of controlled substances. Published in 2011 by John Wiley & Sons, Ltd.

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

    PubMed

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

    2016-05-05

    With a coating of gold nanoparticles (AuNPs), over-the-counter (OTC) drugs and Chinese herbal medicine granules in KBr pellets could be analyzed by Fourier Transform Infra-red (FT-IR) spectroscopy and Surface-assisted Laser Desorption/Ionization mass spectrometry (SALDI-MS). FT-IR spectroscopy allows fast detection of major active ingredient (e.g., acetaminophen) in OTC drugs in KBr pellets. Upon coating a thin layer of AuNPs on the KBr pellet, minor active ingredients (e.g., noscapine and loratadine) in OTC drugs, which were not revealed by FT-IR, could be detected unambiguously using AuNPs-assisted LDI-MS. Moreover, phytochemical markers of Coptidis Rhizoma (i.e. berberine, palmatine and coptisine) could be quantified in the concentrated Chinese medicine (CCM) granules by the SALDI-MS using standard addition method. The quantitative results matched with those determined by high-performance liquid chromatography with ultraviolet detection. Being strongly absorbing in UV yet transparent to IR, AuNPs successfully bridged FT-IR and SALDI-MS for direct analysis of active ingredients in the same solid sample. FT-IR allowed the fast analysis of major active ingredient in drugs, while SALDI-MS allowed the detection of minor active ingredient in the presence of excipient, and also quantitation of phytochemicals in herbal granules. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. A cross-sectional analysis of over-the-counter codeine use among an Australian sample of people who regularly inject drugs.

    PubMed

    Arora, Sheena; Roxburgh, Amanda; Bruno, Raimondo; Nielsen, Suzanne; Burns, Lucy

    2013-11-01

    The study aims to examine the medical and non-medical use of over-the-counter (OTC) codeine combination drugs in a sample of people who inject drugs; and to examine risk factors associated with exceeding the recommended dose of OTC codeine, including the experience of pain. This study analysed annual survey data from a convenience sample of people who inject drugs in Australia who are interviewed for the Illicit Drug Reporting System. People who have injected drugs (n = 902) on at least a monthly basis in the preceding six months across Australia were interviewed. Participants were asked about their use of OTC codeine and their experience of pain. One third (35%) of participants had used OTC codeine in the preceding six months and 52% (95% confidence interval 48.7-55.3) of this group had exceeded the recommended dose on their last occasion of use. This clearly places them at increased risk of harms associated with toxicity from the accompanying analgesic found in combination codeine products. Multivariate analyses demonstrated that those exceeding the recommended codeine dose of OTC codeine were more likely to be experiencing moderate to very severe pain. There is a need to evaluate the approach to pain management in this population. Greater pharmacist involvement, real-time monitoring of sales, the development of screening tools to identify those at risk of harm and further education of primary care practitioners could be beneficial in reducing the risk of harm associated with these medications for all users of OTC codeine, including people who inject drugs. © 2013 Australasian Professional Society on Alcohol and other Drugs.

  19. 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.

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

    PubMed

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

    2002-01-01

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

  1. [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.

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

    PubMed

    Westerlund, Tommy; Barzi, Sahra; Bernsten, Cecilia

    2017-01-01

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

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

    PubMed Central

    2016-01-01

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

  4. Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial

    PubMed Central

    Chen, Q.-J.; Xiang, W.-P.; Zhang, D.-K.; Wang, R.-P.; Luo, Y.-F.; Kang, J.-Z.; Cheng, L.-N.

    2011-01-01

    BACKGROUND An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women. METHODS A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated. RESULTS Of 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously. CONCLUSIONS The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP. PMID:21672924

  5. 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…

  6. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

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

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

    PubMed

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

    2014-04-01

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

  8. 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 opioids, sedatives, ...

  9. 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.

  10. An over-the-counter moisturizer is as clinically effective as, and more cost-effective than, prescription barrier creams in the treatment of children with mild-to-moderate atopic dermatitis: a randomized, controlled trial.

    PubMed

    Miller, Drew W; Koch, Sarah B; Yentzer, Brad A; Clark, Adele R; O'Neill, Jenna R; Fountain, Julie; Weber, Teresa M; Fleischer, Alan B

    2011-05-01

    Atopic dermatitis (AD) is a prevalent skin disorder with significant cost of treatment. Several prescription device moisturizers have been approved by the FDA to treat AD but are significantly more expensive than well-crafted over-the-counter (OTC) moisturizers. No studies have been performed to compare both the clinical efficacy and cost-efficacy of these prescription devices to OTC moisturizers. The purpose of this study is to compare the clinical efficacy and cost-efficacy of a glycyrrhetinic acid-containing barrier repair cream (BRC-Gly, Atopiclair®), a ceramide-dominant barrier repair cream (BRC-Cer, EpiCeram®) and an OTC petroleum-based skin protectant moisturizer (OTC-Pet, Aquaphor Healing Ointment®) as monotherapy for mild-to-moderate AD in children. Thirty-nine patients, age 2-17 years, with mild-to-moderate AD were randomized 1:1:1 to receive one of three treatments-BRC-Gly, BRC-Cer or OTC-Pet-with instructions to apply the treatment three times daily for three weeks. Disease severity and improvement was assessed at baseline and on days 7 and 21. No statistically significant difference for any efficacy assessment was found between the three groups at each time point. The OTC-Pet was found to be at least 47 times more cost-effective than BRC-Gly or BRC-Cer. The relatively small sample size of 39 subjects was not sufficient to establish OTC-Pet as superior treatment in AD. OTC-Pet is as effective in treating mild-to-moderate AD as both BRC-Gly and BRC-Cer and is at least 47 times more cost-effective. II-AF-ATD-Aquaphor, Comparing the Efficacy and Cost-Effectiveness of Aquaphor to Atopiclair and EpiCeram in Children with Mild to Moderate Atopic Dermatitis. REGISTRATION IDENTIFIER: NCT01093469.

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

    PubMed

    2010-03-04

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

  12. Empirical Studies Related to the Effects of Commercial Television Advertising of Over-the-Counter Drugs on Drug Use, Misuse, and Abuse: 1963-1981.

    ERIC Educational Resources Information Center

    Martin, Chorsie E.

    A review of eight major empirical studies relating to the effects of commercial television advertising of proprietary drugs on drug use, misuse, and abuse found in general that no such relationship exists. Among the findings of the studies are the following: (1) no relationship exists between media exposure and marijuana use, (2) drug abusers view…

  13. Substance use -- prescription drugs

    MedlinePlus

    ... high, they cause feelings of well-being, intense happiness, and excitement. As street drugs, depressants come in ... A.D.A.M. Editorial team. Related MedlinePlus Health Topics Prescription Drug Abuse Browse the Encyclopedia A. ...

  14. Over-the-Counter Medicines - Multiple Languages

    MedlinePlus

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

  15. Over-the-counter medicines

    MedlinePlus

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

  16. 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…

  17. Prescription Drug Abuse

    ERIC Educational Resources Information Center

    Hamilton, Gloria J.

    2009-01-01

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

  18. Over-the-counter analgesics.

    PubMed

    Clarence, M

    The increasing availability of analgesic drugs from a variety of outlets may be seen as a welcome development by manufacturers and consumers, but there are poorly acknowledged dangers associated with injudicious usage. Maggie Clarence outlines the properties of the most common products on the market, and emphasises the need for sound patient education from suitably trained personnel.

  19. Prescription drug misuse.

    PubMed

    Monheit, Benny

    2010-08-01

    Recognising and dealing with patients who seek drugs for nonmedical purposes can be a difficult problem in general practice. 'Prescription shoppers' and patients with chronic nonmalignant pain problems are the main people who constitute this small but problematic group. The main drugs they seek are benzodiazepines and opioids. To provide data on current trends in prescription drug abuse and to discuss different strategies on how to deal with this issue in the clinic setting. Misuse of prescription drugs can take the form of injecting oral drugs, selling them on the street, or simply overusing the prescribed amount so that patients run short before the due date and then request extra prescriptions from the doctor. Currently oxycontin and alprazolam are the most abused drugs in Australia. Adequate prescription monitoring mechanisms at the systems level are lacking so we need to rely on our clinical skills and the patient's behaviour pattern over time to detect problematic prescription drug misuse. Management strategies may include saying 'no' to patients, having a treatment plan, and adopting a universal precaution approach toward all patients prescribed drugs of addiction. Among patients with chronic nonmalignant pain, requests for increasing opioid doses need careful assessment to elucidate any nonmedical factors that may be at play.

  20. Prescription Drug Assistance Programs

    MedlinePlus

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

  1. Abuse of prescription drugs.

    PubMed Central

    Wilford, B B

    1990-01-01

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

  2. 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 ...

  3. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  4. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  5. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  6. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  7. 21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  8. Use Over-the-Counter Medicines Wisely

    MedlinePlus

    ... always tell your pharmacist or doctor about the prescription ● Midol ® ● Darvocet ® medicines you are taking before combining them with an OTC medicine. ● Percocet ® ● Zebutal ® Follow Directions The Drug Facts label makes it easier than ever to ...

  9. 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 repellent...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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 ...

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

    PubMed

    Ellis, Walter L

    2012-01-01

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

  16. Changing oral contraceptives from prescription to over-the-counter status: an opinion statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

    PubMed

    McIntosh, Jennifer; Rafie, Sally; Wasik, Mitzi; McBane, Sarah; Lodise, Nicole M; El-Ibiary, Shareen Y; Forinash, Alicia; Kachlic, Marlowe Djuric; Rowe, Emily; Besinque, Kathy

    2011-04-01

    Addressing the issue of unintended pregnancy is a national priority. One proposed strategy to reduce unintended pregnancy is to improve access to oral contraceptives by changing them to over-the-counter (OTC) status. Existing data indicate that oral contraceptives meet safety criteria required of OTC products. Available literature demonstrates that women can self-screen for contraindications to oral contraceptives and can do this as well as clinicians, and experience with OTC emergency contraception suggests that OTC oral contraceptives would not increase sexual risk-taking behavior. Women support OTC access to oral contraceptives, but express an interest in accessing pharmacist counseling. On the basis of these data, the Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports changing oral contraceptives to OTC status under two conditions: that they are sold where a pharmacist is on duty and that there are mechanisms in place to cover OTC contraceptives through Medicaid. Future research should address the issues of out-of-pocket costs to individuals, label-comprehension studies, and models for pharmacist reimbursement for time spent counseling on contraception.

  17. Utilization of self-medication and prescription drugs among 15-year-old children from the German GINIplus birth cohort.

    PubMed

    Italia, Salvatore; Brand, Helmut; Heinrich, Joachim; Berdel, Dietrich; von Berg, Andrea; Wolfenstetter, Silke Britta

    2015-11-01

    The objective was to analyse paediatric drug utilization in relation to self-medication, prescription drugs, and the most reported therapeutic drug categories. Data were collected for 3013 children on their utilization of drugs (4-week prevalence) from a German birth cohort study (GINIplus, 15-year follow-up) using a self-administered questionnaire. The drugs were grouped into over-the-counter drugs and prescription drugs, and were classified according to the anatomical therapeutic chemical classification system. Predictors were analysed using a logistic regression model with four independent variables (gender, study area, maternal education, and parental income). Some 69% of the reported 2489 drugs were over-the-counter drugs, and 31% were prescription drugs. The 4-week prevalence for using any type of drug was 41.0%. Drug categories with high prevalence rates of use were antiinflammatory drugs (10.3%), analgesics (7.1%), and antiallergics (5.0%). Factors associated with higher use of over-the-counter drugs were female gender (OR = 1.56, p < 0.0001) and higher maternal education (OR = 1.60, p = 0.0021; university degree vs. secondary high school). Maternal education was correlated with the use of prescribed or self-medicated antiallergics (positive association) and contraceptives (negative association). The use of antibiotics, methylphenidate, and drugs for thyroid therapy was associated with lower parental income. The use of over-the-counter drugs in 15-year-old children from the GINIplus birth cohort is very common and is predicted by socioeconomic factors such as maternal education. This has to be considered by health care managers when deciding about the exclusion of over-the-counter drugs (normally used for self-medication) from reimbursement or the deregulation of drug sales. Copyright © 2015 John Wiley & Sons, Ltd.

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

    PubMed

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

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

  19. Taking Medicines Safely After Alcohol or Drug Abuse Recovery

    MedlinePlus

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

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

    PubMed

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

    2013-12-01

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

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

    PubMed

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

    2017-02-02

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

  2. 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…

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

    PubMed

    Chambers, Christina

    2015-11-01

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

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

    PubMed

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

    2007-11-01

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

  6. Reading about over-the-counter medications.

    PubMed

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

    2004-01-01

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

  7. The prescription drug abuse epidemic.

    PubMed

    Yu, Hoi-Ying Elsie

    2012-09-01

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

  8. Methadone and prescription drug overdose.

    PubMed

    Hendrikson, Hollie; Hansen, Melissa

    2014-12-01

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

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

    PubMed

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

    2014-08-01

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

  10. Prescription Drugs and Cold Medicines

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... 60 3.00 4.00 Narcotics other than Heroin Past Year - - 4.80 Vicodin Past Year 0. ...

  11. Attitudes toward drug prescription rights: a survey of Ontario chiropractors.

    PubMed

    Emary, Peter Charles; Stuber, Kent Jason

    2015-01-01

    Several published surveys have shown that chiropractors are generally split in their opinions regarding the right to prescribe drugs in chiropractic practice. Many of these studies have been limited by low response rates, leaving the generalizability of their findings open to question. The aim of the current study was to ascertain the general attitudes of chiropractors in Ontario, Canada toward the inclusion of drug prescription rights in their scope of practice. Relationships between these attitudes and the number of years in practice including differences in philosophical orientation were also explored. A 14-item questionnaire was developed and invitations sent via e-mail to all eligible 2,677 chiropractors in active practice registered electronically with the College of Chiropractors of Ontario in February 2015. Data were collected and analyzed using descriptive and inferential statistics. 960 questionnaires were completed for a 36 % response rate. The majority of respondents agreed that chiropractors should be permitted to prescribe musculoskeletal medications such as over-the-counter and prescription-based analgesics, anti-inflammatories, and muscle relaxants. Over two-thirds also felt that with limited prescriptive authority chiropractors could help reduce patients' reliance on these types of drugs. Over three-quarters were opposed however to chiropractors having full prescribing rights. The majority indicated they recommend over-the-counter medications to acute and chronic patients to some extent in clinical practice. Nearly two-thirds perceived their knowledge of musculoskeletal medications as high or very high, while a similar proportion perceived their knowledge of drugs for non-musculoskeletal conditions to be low or very low. A majority of respondents felt that further education in pharmacology would be necessary for those in the profession wishing to prescribe medications. More recent graduates and those who espoused a broad scope of chiropractic

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

    PubMed

    MacFadyen, L; Eadie, D; McGowan, T

    2001-09-01

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

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

    PubMed

    Dameh, Majd; Green, James; Norris, Pauline

    2010-10-01

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

  14. Prescription Drug Abuse

    MedlinePlus

    ... abuse might not lead to physical dependence and withdrawal, the feelings these drugs give people can cause ... especially important for someone who is going through withdrawal from a CNS depressant to speak with a ...

  15. 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

  16. Drugs. Prescription for conflict.

    PubMed

    Moore, Alison

    2006-06-01

    Swindon PCT must review its exceptional circumstances procedures as a result of the Ann Marie Rogers ruling. The PCT lost the case because it had not considered cost in reaching its decision. PCTs are advised not to have blanket policies on drug funding--exceptions should always be allowed for.

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

    MedlinePlus

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

  18. 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 ...

  19. 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.

  20. 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…

  1. 76 FR 51310 - Branded Prescription Drug Fee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

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

  2. 76 FR 51245 - Branded Prescription Drug Fee

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

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

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

    PubMed

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

    2013-10-12

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

  4. 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. Copyright © 2013. Published by Mosby, Inc.

  5. Abuse and Misuse of Prescription and Nonprescription Drugs from Community Pharmacies in Aden City-Yemen.

    PubMed

    Abood, Ebtesam A; Wazaify, Mayyada

    2016-06-06

    The abuse and misuse of prescription and nonprescription or the so-called Over-The-Counter (OTC) drugs is a serious and growing public health problem worldwide. The increased availability of these drugs has contributed to a dramatic rise of inappropriate use. The aim of this study was to investigate abuse/misuse of prescription and non-prescription drugs in community pharmacies in Aden city-Yemen and to gather information about suspected drug abusers in the community. A cross-sectional survey using a structured questionnaire randomly distributed to 200 community pharmacies (June-September 2013). Data were coded and analyzed using SPSS Results: A total of 170 pharmacists completed the questionnaire (85.0% response rate), more than half of which (57.7%) suspected drug abuse/misuse in their pharmacies. The top four suspected medications of abuse were Alprazolam, Ketoprofen, Tramadol, and antibiotics. Most participating pharmacists in this study (83.3%) noticed an increasing pattern of abuse/misuse. The majority of suspects of prescription and non-prescription drug abuse (64.1%) were either chewing Khat or carrying it while buying the drug from the pharmacists. Abuse/misuse of prescription and nonprescription drugs is present in community pharmacies in Aden and it is linked to the recreational use of Khat. Current methods for controlling the problem are ineffective, and better methods should be developed.

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

    PubMed

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

    2005-08-01

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

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

    PubMed

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

    2004-07-01

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

  8. 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.

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

    PubMed Central

    Ravichandran, Abinaya; Basavareddy, Asha

    2016-01-01

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

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

    PubMed

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

    2009-01-01

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

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

    PubMed

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

    2016-01-01

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

  12. 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

  13. Closing the Prescription Drug Coverage Gap

    MedlinePlus

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

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

    PubMed

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

    2014-08-01

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

  15. Management of prescription and nonprescription drug use during pregnancy.

    PubMed

    Morgan, Maria A; Cragan, Janet D; Goldenberg, Robert L; Rasmussen, Sonja A; Schulkin, Jay

    2010-08-01

    To assess screening and treatment patterns of obstetrician-gynecologists regarding medication use during pregnancy. A questionnaire was mailed to 770 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network. The response rate was 58%. Most respondents reported always asking pregnant patients about use of over-the-counter (OTC) (86%) and prescription (98%) drugs; 24% reported not always asking about alternative medications. Far fewer reported always asking nonpregnant patients about use of alcohol (67%), illegal drugs (51%) and OTC medications (52%) than pregnant patients. Two-fifths (41%) reported prescribing a medication during pregnancy for which they had insufficient information about potential effects on the fetus; nearly half (47%) reported that there are medical conditions for which they would like to prescribe medications but do not due to insufficient safety information. Physician responses indicate that they are less likely to refer pregnant than nonpregnant patients to a specialist for treatment of certain conditions. These results indicate that obstetrician-gynecologists sometimes prescribe medications for pregnant patients under less than optimal conditions and emphasize the importance of generating up-to-date information on effects of medications during pregnancy and having it readily available to health care providers.

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

    PubMed

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

    2005-02-01

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

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

    PubMed

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

    2017-10-01

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

  19. 21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. Are You Shopping Smart for Prescription Drugs?

    MedlinePlus

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

  1. Prescription and nonprescription drug use in isfahan, Iran: An observational, cross-sectional study.

    PubMed

    Zargarzadeh, Amir H; Minaeiyan, Mohsen; Torabi, Amir

    2008-02-01

    In Iran, nonprescription (ie, over-the-counter [OTC]) and prescription- only drugs are available at pharmacies. Self-medication and self-prescription practices are widespread. The aim of this study was to assess self-medication and self-prescription practices in Iran, with an emphasis on determining the extent to which prescription-only drugs are obtained without a prescription and dzaracterizing those who engage in this practice. This observational, cross-sectional study was conducted at pharmacies in Isfahan, Iran, between August 2001 and March 2002. The pharmacies were randomly selected from clusters categorized by the number of prescriptions handled or claims submitted to a major insurance company. Drug requesters were categorized accordingly: those who requested drugs with a prescription and those who requested drugs without a prescription. Prescription-only and nonprescription drug items requested at pharmacies were identified and included in the analysis. Cluster sampling was used to determine sample size and also to ensure that the results were reflective of the population studied. In addition, questionnaires were completed by persons who were seeking drugs without a prescription. Observations were also carried out in each pharmacy. To ensure measurement reliability, we conducted a pilot study before the commencement of this study. We determined sample size based on a >90% power to detect change. Fifty pharmacies were selected for inclusion in the study. A total of 33,282 drug items were identified on prescriptions presented at the pharmacies. This number served as sample size for this study. Of this number, 10,101 items were requested without a prescription, of which 9653 items (95.6%) were available and dispensed. Of the items dispensed, 5504 (57.0%) were prescription items. The percentage of prescription-only drugs sold without prescription to total pharmacy sales was 21.9%, 22.8%, 19.5%, and 10.7% in pharmacies with the fewest to the largest (<500, 500

  2. Prescription and nonprescription drug use in isfahan, Iran: An observational, cross-sectional study

    PubMed Central

    Zargarzadeh, Amir H.; Minaeiyan, Mohsen; Torabi, Amir

    2008-01-01

    Background: In Iran, nonprescription (ie, over-the-counter [OTC]) and prescription- only drugs are available at pharmacies. Self-medication and self-prescription practices are widespread. Objective: The aim of this study was to assess self-medication and self-prescription practices in Iran, with an emphasis on determining the extent to which prescription-only drugs are obtained without a prescription and dzaracterizing those who engage in this practice. Methods: This observational, cross-sectional study was conducted at pharmacies in Isfahan, Iran, between August 2001 and March 2002. The pharmacies were randomly selected from clusters categorized by the number of prescriptions handled or claims submitted to a major insurance company. Drug requesters were categorized accordingly: those who requested drugs with a prescription and those who requested drugs without a prescription. Prescription-only and nonprescription drug items requested at pharmacies were identified and included in the analysis. Cluster sampling was used to determine sample size and also to ensure that the results were reflective of the population studied. In addition, questionnaires were completed by persons who were seeking drugs without a prescription. Observations were also carried out in each pharmacy. To ensure measurement reliability, we conducted a pilot study before the commencement of this study. We determined sample size based on a >90% power to detect change. Results: Fifty pharmacies were selected for inclusion in the study. A total of 33,282 drug items were identified on prescriptions presented at the pharmacies. This number served as sample size for this study. Of this number, 10,101 items were requested without a prescription, of which 9653 items (95.6%) were available and dispensed. Of the items dispensed, 5504 (57.0%) were prescription items. The percentage of prescription-only drugs sold without prescription to total pharmacy sales was 21.9%, 22.8%, 19.5%, and 10.7% in pharmacies

  3. Prescription drug abuse: an epidemic dilemma.

    PubMed

    DuPont, Robert L

    2010-06-01

    The nonmedical use of prescribed controlled substances has become a major public health problem. This article reviews the extent of prescription drug abuse reflected in drug overdose deaths, youth drug use and drug-impaired driving. Efforts to reduce illegal, nonmedical use of prescribed controlled drugs must be balanced so as not to interfere with appropriate medical use of these medicines. Future policy options include identifying and expanding leadership in the research and medical communities, creation of a national public education campaign, development of abuse-resistant drug formulas, increasing prescription drug monitoring programs and enforcement efforts, establishing effective drugged driving laws, and improving substance abuse treatment.

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

    PubMed

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

    2009-12-01

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

  5. 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

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

    PubMed

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

    2014-11-24

    Acute cough due to upper respiratory tract infection (URTI) is a common symptom. Non-prescription, over-the-counter (OTC) medicines are frequently recommended as a first-line treatment, but there is little evidence as to whether these drugs are effective. To assess the effects of oral OTC cough preparations for acute cough in children and adults in community settings. We searched CENTRAL (2014, Issue 1), MEDLINE (January 1966 to March week 3 2014), EMBASE (January 1974 to March 2014), CINAHL (January 2010 to March 2014), LILACS (January 2010 to March 2014), Web of Science (January 2010 to March 2014) and the UK Department of Health National Research Register (March 2010). Randomised controlled trials (RCTs) comparing oral OTC cough preparations with placebo in children and adults suffering from acute cough in community settings. We considered all cough outcomes; secondary outcomes of interest were adverse effects. Two review authors independently screened potentially relevant citations, extracted data and assessed study quality. We performed quantitative analysis where appropriate. Due to the small numbers of trials in each category, the limited quantitative data available and the marked differences between trials in terms of participants, interventions and outcome measurement, we felt that pooling of the results was inappropriate.We included 29 trials (19 in adults, 10 in children) involving 4835 people (3799 adults and 1036 children). All studies were placebo-controlled RCTs. However, assessment of the risk of bias of the included studies was limited by poor reporting, particularly for the earlier studies.In the adult studies, six trials compared antitussives with placebo and had variable results. Three trials compared the expectorant guaifenesin with placebo; one indicated significant benefit, whereas the other two did not. One trial found that a mucolytic reduced cough frequency and symptom scores. Two studies examined antihistamine-decongestant combinations

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

    PubMed

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

    2003-11-01

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

  8. Prescription drug abuse in the elderly.

    PubMed

    Martin, Caren McHenry

    2008-12-01

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

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

    PubMed

    Bond, Christine; Hannaford, Philip

    2003-01-01

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

  10. How Can Prescription Drug Addiction Be Treated?

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... same brain targets as other opioids such as heroin, morphine, and opioid pain medications. It has been ...

  11. [Induced drug prescription in oncology patients].

    PubMed

    Mas Arcas, C; Pascual Plá, F; Escrivá Muñz, J J; Boscas Mayans, R

    2004-01-01

    To study drug prescription generated by cancer patients treated at the Emergency Service (ES) of the Instituto Valenciano de Oncología (IVO) in their Primary Health Care Centre (PHCC). A descriptive prospective study has been carried out with patients treated and discharged from the ES of the IVO in November (n=207) and December (n=239) of 2001. 446 patients were treated and discharged; one out of five patients was contacted by telephone 48 hours after discharge to confirm drug prescriptions from the ES. In November, drug prescription was based on brand-name products, while, in December, generic drugs were prescribed. All patients were discharged with a detailed report that included: patient's medical records, consultation reason, physical exploration performed, diagnostic test results, discharge diagnosis and prescribed treatment. When a brand-name drug was prescribed, the majority of patients received the same product at the PHCC (92.5%), while the rest of them received the same active drug with a different brand name. When a generic drug was prescribed, patients received a prescription for the same active substance at the PHCC in 98% of cases (46% generic drug and 54% brand-name). As to length of treatment, 96% were short treatments (less than 2 weeks), while the rest of them were on-going. 80% needed one prescription; 15%, two, and 5% three or more prescriptions. In terms of therapeutic groups, the most commonly prescribed drugs were anti-infectious, analgesics, digestive-metabolism, respiratory, cardiovascular, neurological and miscellaneous. 1. There is a high level of induced drug prescription at PHCC in cancer patients, since primary care physicians usually maintain active substances prescribed by the ES of IVO, with few variations. 2. Promoting a good relationship between Hospital Care and Primary Health Care Centres helps control and reduce pharmaceutical costs. 3. A high correlation can be found between most frequently prescribed drugs in oncological

  12. Prescription drug misuse among antisocial youths.

    PubMed

    Hall, Martin T; Howard, Matthew O; McCabe, Sean Esteban

    2010-11-01

    The aim of this study was to describe the prevalence and correlates of nonmedical prescription drug misuse (PDM) in a state population of youths in residential care for antisocial behavior. Interviews assessing substance use, psychiatric symptoms, antisocial traits/behavior, and traumatic life experiences were conducted with 723 Missouri youths. Participants were predominantly male (87.0%), averaged 15.5 (SD = 1.2) years of age, and constituted 97.7% of the service population sampled. Overall, 314 youths (43.4%) reported lifetime PDM; 33.7%, 32.0%, and 11.2% had misused prescription opioids, tranquilizers, and barbiturates, respectively. Prescription drug misusers were significantly older, and larger proportions were girls, were White, and resided in small towns, compared with non-prescription drug misusers. Prescription drug misusers evidenced significantly more varied, frequent, and problematic psychoactive drug use; evidenced higher levels of distressing psychiatric symptoms; and were nearly twice as likely to have been diagnosed with a psychiatric disorder, compared with non-prescription drug misusers. Traumatic life events, experiences of criminal victimization, and suicidal ideation were significantly more prevalent in the histories of prescription drug misusers, compared with non-prescription drug misusers. In multiple logistic regression models, older age; White racial status; prior inhalant, marijuana, and LSD (lysergic acid diethylamide) use; residence in a small town; and impulsivity were associated with increased risk for PDM. Adolescents in residential care for antisocial behavior have high rates of PDM, as well as comorbid psychiatric and behavioral problems. Youths served in institutional settings should be routinely screened and treated for PDM and co-occurring disorders.

  13. Prescription Drug Misuse Among Antisocial Youths*

    PubMed Central

    Hall, Martin T.; Howard, Matthew O.; Mccabe, Sean Esteban

    2010-01-01

    Objective: The aim of this study was to describe the prevalence and correlates of nonmedical prescription drug misuse (PDM) in a state population of youths in residential care for antisocial behavior. Method: Interviews assessing substance use, psychiatric symptoms, antisocial traits/behavior, and traumatic life experiences were conducted with 723 Missouri youths. Participants were predominantly male (87.0%), averaged 15.5 (SD = 1.2) years of age, and constituted 97.7% of the service population sampled. Results: Overall, 314 youths (43.4%) reported lifetime PDM; 33.7%, 32.0%, and 11.2% had misused prescription opioids, tranquilizers, and barbiturates, respectively. Prescription drug misusers were significantly older, and larger proportions were girls, were White, and resided in small towns, compared with non-prescription drug misusers. Prescription drug misusers evidenced significantly more varied, frequent, and problematic psychoactive drug use; evidenced higher levels of distressing psychiatric symptoms; and were nearly twice as likely to have been diagnosed with a psychiatric disorder, compared with non-prescription drug misusers. Traumatic life events, experiences of criminal victimization, and suicidal ideation were significantly more prevalent in the histories of prescription drug misusers, compared with non-prescription drug misusers. In multiple logistic regression models, older age; White racial status; prior inhalant, marijuana, and LSD (lysergic acid diethylamide) use; residence in a small town; and impulsivity were associated with increased risk for PDM. Conclusions: Adolescents in residential care for antisocial behavior have high rates of PDM, as well as comorbid psychiatric and behavioral problems. Youths served in institutional settings should be routinely screened and treated for PDM and co-occurring disorders. PMID:20946750

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

    PubMed

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

    2012-12-01

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

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

    PubMed

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

    2011-08-01

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

  16. 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.

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

    PubMed

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

    2012-08-15

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

  18. 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.

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

    PubMed

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

    2001-09-01

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

  20. Subtypes of nonmedical prescription drug misuse

    PubMed Central

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

    2010-01-01

    This study used three characteristics (i.e., motive, route of administration, and co-ingestion with alcohol) of nonmedical prescription drug misuse across four separate classes (i.e., pain, sedative/anxiety, sleeping and stimulant medications) to examine subtypes and drug related problems. A Web survey was self-administered by a randomly selected sample of 3,639 undergraduate students attending a large Midwestern 4-year U.S. university. Self-treatment subtypes were characterized by motives consistent with the prescription drug's pharmaceutical main indication, oral only routes of administration, and no co-ingestion with alcohol. Recreational subtypes were characterized by recreational motives, oral or non-oral routes, and co-ingestion. Mixed subtypes consisted of other combinations of motives, routes, and co-ingestion. Among those who reported nonmedical prescription drug misuse, approximately 13% were classified into the recreational subtype, while 39% were in the self-treatment subtype, and 48% were in the mixed subtype. There were significant differences in the subtypes in terms of gender, race and prescription drug class. Approximately 50% of those in subtypes other than self-treatment screened positive for drug abuse. The odds of substance use and abuse were generally lower among self-treatment subtypes than other subtypes. The findings indicate subtypes should be considered when examining nonmedical prescription drug misuse, especially for pain medication. PMID:19278795

  1. 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) * * *...

  2. 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) * * *...

  3. 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) * * *...

  4. 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) The...

  5. 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) The...

  6. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  7. 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 ...

  8. Advancing Best Practices for Prescription Drug Labeling.

    PubMed

    Bailey, Stacy Cooper; Navaratnam, Prakash; Black, Heather; Russell, Allison L; Wolf, Michael S

    2015-11-01

    Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients. English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed. A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data. Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens. Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information. © The Author(s) 2015.

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

    PubMed

    Hansen, Melissa

    2015-03-01

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

  10. Universal prescription drug coverage in Canada

    PubMed Central

    Boothe, Katherine

    2016-01-01

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

  11. 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.

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

    PubMed

    Raharinjatovo, L; Ralandison, S

    2015-01-01

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

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

    PubMed

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

    1996-06-01

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

  14. 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.

  15. A comparison of transdermal over-the-counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back pain and arthritis.

    PubMed

    Castro, Eric; Dent, David

    2017-08-14

    Transdermal lidocaine therapy has become a gold standard as part of a treatment regimen for patients who suffer from localized pain. We compared transdermal patches: over-the-counter (OTC) lidocaine 3.6% combined with menthol 1.25%, prescription lidocaine 5% (Rx) and placebo. In a double-blind, placebo-controlled trial, 87 patients were randomized to: OTC, Rx or placebo. OTC met primary end points of noninferiority compared with Rx for efficacy, side effects and quality of life. Versus placebo, OTC proved superiority for efficacy, general activity and normal work. Side effects were similar. It is theorized that menthol's ability to increase skin permeability facilitated more efficient drug delivery to the site of pain causing higher than expected efficacy. Decreased cost and resource utilization could benefit patients and payers.

  16. 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

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

    PubMed

    Dennis, Amanda; Grossman, Daniel

    2012-06-01

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

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

    PubMed

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

    2008-09-01

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

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

    PubMed

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

    2016-07-01

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

  20. 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

  1. Prescription Drug Monitoring and Dispensing of Prescription Opioids

    PubMed Central

    Brady, Joanne E.; Wunsch, Hannah; DiMaggio, Charles; Lang, Barbara H.; Giglio, James

    2014-01-01

    Objective In the United States, per-capita opioid dispensing has increased concurrently with analgesic-related mortality and morbidity since the 1990s. To deter diversion and abuse of controlled substances, most states have implemented electronic prescription drug monitoring programs (PDMPs). We evaluated the impact of state PDMPs on opioid dispensing. Methods We acquired data on opioids dispensed in a given quarter of the year for each state and the District of Columbia from 1999 to 2008 from the Automation of Reports and Consolidated Orders System and converted them to morphine milligram equivalents (MMEs). We used multivariable linear regression modeling with generalized estimating equations to assess the effect of state PDMPs on per-capita dispensing of MMEs. Results The annual MMEs dispensed per capita increased progressively until 2007 before stabilizing. Adjusting for temporal trends and demographic characteristics, implementation of state PDMPs was associated with a 3% decrease in MMEs dispensed per capita (p=0.68). The impact of PDMPs on MMEs dispensed per capita varied markedly by state, from a 66% decrease in Colorado to a 61% increase in Connecticut. Conclusions Implementation of state PDMPs up to 2008 did not show a significant impact on per-capita opioids dispensed. To control the diversion and abuse of prescription drugs, state PDMPs may need to improve their usability, implement requirements for committee oversight of the PDMP, and increase data sharing with neighboring states. PMID:24587548

  2. Prescription drug monitoring and dispensing of prescription opioids.

    PubMed

    Brady, Joanne E; Wunsch, Hannah; DiMaggio, Charles; Lang, Barbara H; Giglio, James; Li, Guohua

    2014-01-01

    In the United States, per-capita opioid dispensing has increased concurrently with analgesic-related mortality and morbidity since the 1990s. To deter diversion and abuse of controlled substances, most states have implemented electronic prescription drug monitoring programs (PDMPs). We evaluated the impact of state PDMPs on opioid dispensing. We acquired data on opioids dispensed in a given quarter of the year for each state and the District of Columbia from 1999 to 2008 from the Automation of Reports and Consolidated Orders System and converted them to morphine milligram equivalents (MMEs). We used multivariable linear regression modeling with generalized estimating equations to assess the effect of state PDMPs on per-capita dispensing of MMEs. The annual MMEs dispensed per capita increased progressively until 2007 before stabilizing. Adjusting for temporal trends and demographic characteristics, implementation of state PDMPs was associated with a 3% decrease in MMEs dispensed per capita (p=0.68). The impact of PDMPs on MMEs dispensed per capita varied markedly by state, from a 66% decrease in Colorado to a 61% increase in Connecticut. Implementation of state PDMPs up to 2008 did not show a significant impact on per-capita opioids dispensed. To control the diversion and abuse of prescription drugs, state PDMPs may need to improve their usability, implement requirements for committee oversight of the PDMP, and increase data sharing with neighboring states.

  3. [Prescription drug abuse in elderly psychiatric patients].

    PubMed

    Wetterling, Tilman; Schneider, Barbara

    2012-08-01

    Due to demographic changes there will be a fraction of elderly patients with substance use disorders. However, only a few data have been published about elderly abusers of prescription drugs. Since substance abuse is frequently comorbid with psychiatric disorders, treatment in a psychiatric hospital is often needed. In this explorative study elderly people with prescription drug abuse who required psychiatric inpatient treatment should be characterized. This study was part of the gerontopsychiatry study Berlin (Gepsy-B), an investigation of the data of all older inpatients (≥ 65 years) admitted to a psychiatric hospital within a period of 3 years. Among 1266 documented admissions in 110 cases (8.7 %) (mean age: 75.7 ± 7.1 years) prescription drug abuse, mostly of benzodiazepines was diagnosed. Females showed benzodiazepine abuse more often than males. In only a small proportion of the cases the reason for admission was withdrawal of prescribed drugs. 85.5 % suffered from psychiatric comorbidity, mostly depression. As risk factors for abuse depressive symptoms (OR: 3.32) as well as concurrent nicotine (OR: 2.69) or alcohol abuse (OR: 2.14) were calculated. Psychiatric inpatient treatment was primarily not necessary because of prescription drug abuse but because of other psychopathological symptoms. © Georg Thieme Verlag KG Stuttgart · New York.

  4. The street value of prescription drugs

    PubMed Central

    Sajan, A; Corneil, T; Grzybowski, S

    1998-01-01

    BACKGROUND: Although most physicians are aware of the potential for abuse and resale of prescribed medications, little has been done to document it. The purpose of this study was to determine which prescription drugs have street value, what that value is and why these drugs are used. METHODS: A descriptive cross-sectional survey using a semistructured interview technique was carried out on 2 weekdays (Mar. 10 and Apr. 1, 1997) in Vancouver's Downtown Eastside. A total of 58 users and dealers of prescription sedative/hypnotic and narcotic drugs were approached. Information collected included the demographic characteristics of those interviewed, the common street names of the drugs of interest, and their value and method of use. RESULTS: Thirty-two people agreed to participate in the study (participation rate 55%), 7 of whom were dealers. The range in price of sedative/hypnotic drugs was $0.10 to $2. For narcotic drugs the range was much greater, at $0.25 to $75. Descriptive analysis identified the minimum and maximum price and the mode of each preparation. Among the weak narcotic drugs the index drug (highest in demand on the street) was Tylenol No. 3 and among the more potent narcotics, MS Contin 30 mg. INTERPRETATION: A wide variety of prescription sedative/hypnotic and narcotic drugs are available on the street. The mark-up from pharmacy cost can be considerable. Factors influencing pricing include the relative inexperience of the buyer, the availability of illicit narcotics, the current street supply of prescription medications and the time of the month (before or after issue of social assistance cheques). PMID:9700324

  5. Physician perceptions of prescription drug information.

    PubMed

    Evans, K R; Beltramini, R F

    1986-01-01

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

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

    MedlinePlus

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

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

    PubMed

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

    1996-05-01

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

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

    PubMed

    Ren, Jun-guo; Liu, Jian-xun

    2015-09-01

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

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

    PubMed

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

    1996-06-01

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

  10. Women who doctor shop for prescription drugs.

    PubMed

    Worley, Julie; Thomas, Sandra P

    2014-04-01

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

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

    PubMed

    Cheng, C M; McPherson, B

    2000-01-01

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

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

    PubMed

    Bio, L L; Cies, J J

    2017-07-01

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

  13. 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

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

    PubMed

    Levin, Jacquelyn; Miller, Richard

    2011-08-01

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

  15. 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…

  16. 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…

  17. 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…

  18. 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…

  19. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  20. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  1. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  2. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

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

  4. 76 FR 59898 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

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

  5. 76 FR 59897 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Internal Revenue Service 26 CFR Part 51 RIN 1545-BK34 Branded Prescription Drug Fee; Correction AGENCY... engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by..., 2011 and applies to any fee on branded prescription drug sales that is due on or after September 30...

  6. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 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 Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions. For purposes of this...

  7. 75 FR 12555 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... HUMAN SERVICES Food and Drug Administration Prescription Drug User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. SUMMARY: The Food and Drug... FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and...

  8. ENHANCING PRESCRIPTION DRUG INNOVATION AND ADOPTION

    PubMed Central

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

    2014-01-01

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

  9. Controlled prescription drug abuse at epidemic level.

    PubMed

    2006-01-01

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

  10. Quantitative Information on Oncology Prescription Drug Websites.

    PubMed

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

    2016-09-02

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

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

    PubMed

    Bell, Edward A; Tunkel, David E

    2010-05-01

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

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

    PubMed

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

    2004-03-01

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

  13. Combating the prescription painkiller epidemic: a national prescription drug reporting program.

    PubMed

    Shepherd, Joanna

    2014-01-01

    Prescription painkiller abuse is the fastest growing drug problem in the United States. In the past year, approximately one out of twenty Americans reported misuse or abuse of prescription painkillers. Several factors contribute to the prescription painkiller epidemic. Drug abusers use various methods--such as doctor shopping, paying with cash, and filling prescriptions in different states--to avoid detection and obtain prescription painkillers for illegitimate uses. A few rogue physicians and pharmacists, lured by substantial profits, enable drug abusers by illegally prescribing or supplying controlled substances. Even ethical physicians rarely have adequate training to recognize and address prescription drug abuse, and as a result, prescribe painkillers to patients who are not using them for legitimate medical purposes. Similarly, although the majority of pharmacies have taken steps to combat drug abuse and reduce prescription painkiller dispensing, under current reporting systems, pharmacists lack visibility into several important indicators of drug abuse. As a result, even the most vigilant pharmacists find it extremely difficult to identify and detect drug abuse with certainty. While state governments have established prescription drug monitoring programs (PDMPs) to crack down on prescription drug abuse, these programs have proven to be inadequate. The programs currently suffer from inadequate data collection, ineffective utilization of data, insufficient interstate data sharing, and constraints on sharing data with law enforcement and state agencies. By contrast, third-party prescription payment systems run by pharmacy benefit managers (PBMs) or health insurers have been effective in detecting prescription drug abuse. This paper suggests that a national prescription drug reporting program building on existing PBM networks could be significantly more effective than existing state PDMPs in detecting prescription drug abuse.

  14. The impact of information on patient preferences in different delivery patterns: a contingent valuation study of prescription versus OTC drugs.

    PubMed

    Lamiraud, Karine; von Bremen, Konrade; Donaldson, Cam

    2009-12-01

    Our analysis assessed the impact of information on patients' preferences in prescription versus over-the-counter (OTC) delivery systems. A contingent valuation (CV) study was implemented, randomly assigning 534 lay people into the receipt of limited or extended information concerning new influenza drugs. In each information arm, people answered two questions: the first asked about willingness to pay (WTP) for the new prescription drug; the second asked about WTP for the same drug sold OTC. We show that WTP is higher for the OTC scenario and that the level of information plays a significant role in the evaluation of the OTC scenario, with more information being associated with an increase in the WTP. In contrast, the level of information provided has no impact on WTP for prescription medicine. Thus, for the kind of drug considered here (i.e. safe, not requiring medical supervision), a switch to OTC status can be expected to be all the more beneficial, as the patient is provided with more information concerning the capability of the drug. Our results shed light on one of the most challenging issues that health policy makers are currently faced with, namely the threat of a bird flu pandemic. Drug delivery is a critical component of pandemic influenza preparedness. Furthermore, the congruence of our results with the agency and demand theories provides an important test of the validity of using WTP based on CV methods.

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

    ERIC Educational Resources Information Center

    Sutherland, Mary S.

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

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

    ERIC Educational Resources Information Center

    Sutherland, Mary S.

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

  17. Literacy and misunderstanding prescription drug labels.

    PubMed

    Davis, Terry C; Wolf, Michael S; Bass, Pat F; Thompson, Jason A; Tilson, Hugh H; Neuberger, Marolee; Parker, Ruth M

    2006-12-19

    Health literacy has increasingly been viewed as a patient safety issue and may contribute to medication errors. To examine patients' abilities to understand and demonstrate instructions found on container labels of common prescription medications. Cross-sectional study using in-person, structured interviews. 3 primary care clinics serving mostly indigent populations in Shreveport, Louisiana; Jackson, Michigan; and Chicago, Illinois. 395 English-speaking adults waiting to see their providers. Correct understanding of instructions on 5 container labels; demonstration of 1 label's dosage instructions. Correct understanding of the 5 labels ranged from 67.1% to 91.1%. Patients reading at or below the sixth-grade level (low literacy) were less able to understand all 5 label instructions. Although 70.7% of patients with low literacy correctly stated the instructions, "Take two tablets by mouth twice daily," only 34.7% could demonstrate the number of pills to be taken daily. After potential confounding variables were controlled for, low (adjusted relative risk, 2.32 [95% CI, 1.26 to 4.28]) and marginal (adjusted relative risk, 1.94 [CI, 1.14 to 3.27]) literacy were significantly associated with misunderstanding. Taking a greater number of prescription medications was also statistically significantly associated with misunderstanding (adjusted relative risk, 2.98 [CI, 1.40 to 6.34] for > or =5 medications). The study sample was at high risk for poor health literacy and outcomes. Most participants were women, and all spoke English. The authors did not examine the association between misunderstanding and medication error or evaluate patients' actual prescription drug-taking behaviors. Lower literacy and a greater number of prescription medications were independently associated with misunderstanding the instructions on prescription medication labels.

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

    PubMed

    Gebretekle, Gebremedhin Beedemariam; Serbessa, Mirgissa Kaba

    2016-01-01

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

  19. "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

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

    PubMed

    Simonson, William

    2013-01-01

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

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

    PubMed

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

    2002-03-01

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

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

    PubMed Central

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

    2002-01-01

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

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

    PubMed

    West, Constance E; Hunter, David G

    2014-06-01

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

  4. Prescription Drug Abuse in Texas: Mortality and Its Economic Consequences.

    ERIC Educational Resources Information Center

    Harlow, Kirk; Swint, J. Michael

    1981-01-01

    Prescription drug overdose mortality is documented and its economic consequences estimated for Texas in 1978. Drug-related deaths (N=117 out of 397) were due to the use of barbiturates, tranquilizers, and anti-depressants; 85 to mixing drugs. The economic cost of mortality exceeded $43 million, 32 percent of prescription drug overdose. (Author)

  5. Prescription Drug Misuse and Sexual Behavior among Young Adults

    PubMed Central

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

    2015-01-01

    Though research indicates a complex link between substance use and sexual risk behavior, there is limited research on the association between sexual risk behavior and prescription drug misuse. In light of the alarming increases in prescription drug misuse and the role of demographic characteristics in sexual risk behavior and outcomes, the current study examines demographic differences (gender, sexual identity, age, relationship status, parental class background, and race/ethnicity) in sexual risk behavior, sexual behavior under the influence of prescription drugs, and sexual risk behavior under the influence of prescription drugs in a sample of 402 young adults (18–29) who misuse prescription drugs. Nearly half of the sexually active young adult prescription drug misusers in this sample reported recent sex under the influence of prescription drugs, more than three quarters reported recent sex without a condom, and more than one-third reported recent sex without a condom after using prescription drugs. Zero-inflated Poisson regression models indicated that white race, younger age, higher parental class, and being a heterosexual man were all associated with sexual risk behavior, sex under the influence of prescription drugs, and sexual risk under the influence of prescription drugs. Findings have implications for the targeting of prevention and intervention efforts. PMID:25569204

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

    PubMed

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

    2015-01-01

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

  7. Prescription Drug Abuse: From Epidemiology to Public Policy

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2014-01-01

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

  10. Codeine consumption from over-the-counter anti-cough syrup in Taiwan: A useful indicator for opioid abuse.

    PubMed

    Lo, Ming-Yu; Ong, Ming Wei; Lin, Jaung-Geng; Sun, Wei-Zen

    2015-12-01

    Over-the-counter (OTC) anti-cough preparations, many of which contain codeine (an opioid) or dextromethorphan (an opioid-like), are widely available in Taiwan and thus susceptible to overuse or abuse. We aimed to investigate whether opioids in the form of OTC antitussives play a significant role in medication abuse in Taiwan. Data on the consumption of codeine and dextromethorphan in antitussives and expectorants from 2011 through 2014 in Taiwan were provided by IMS Health (Intercontinental Marketing Services). These data were then analyzed for trends and variance according to availability, as prescription or OTC, and according to drug type, as codeine or dextromethorphan, in order to form four primary sectors under opioid-containing anti-cough syrup consumption. From 2011 to 2014, use of opioid-containing cough syrup fluctuated between 6% and 9% from year to year for all cough syrup consumption, with an overall declining trend (11.3% per year relative to 2011). Within the underlying sectors, mean consumption for prescription dextromethorphan (61.4%) outstripped the other three sectors, followed in decreasing order by OTC codeine (20.2%), OTC dextromethorphan (10.5%), and prescription codeine (8.0%). However, movement in consumption corresponded mainly with OTC codeine, whose variance greatly exceeded that of the other sectors, which follow in order of decreasing variance as OTC dextromethorphan, prescription dextromethorphan, and prescription codeine. The fairly low and stable consumption of prescription codeine suggested that physicians in Taiwan were careful in prescribing codeine, and that the medical demand for codeine was stable. The large variance in OTC codeine consumption suggested that a minority of consumers purchased significant quantities of codeine for non-medical purposes. Although opioids in cough syrup were not a large part of overall consumption and thus not widely abused, the data revealed that OTC codeine-containing cough syrup may serve as an

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

    PubMed

    Shimane, Takuya; Matsumoto, Toshihiko; Wada, Kiyoshi

    2012-10-01

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

  12. [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.

  13. Randomized trial of risk information formats in direct-to-consumer prescription drug advertisements.

    PubMed

    Aikin, Kathryn J; O'Donoghue, Amie C; Swasy, John L; Sullivan, Helen W

    2011-01-01

    Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information "in brief summary" about each advertised product's "side effects, contraindications, and effectiveness." Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. . To explore ways in which the brief summary might be improved. . The authors conducted an experimental study that examined 300 consumers' (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (Q&A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). . The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < .01) and reported greater confidence to perform the tasks (P < .01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the Q&A format, the traditional format, and finally the highlights format, P < 0.001. . Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers' understanding of the brief summary.

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

    PubMed Central

    Kelly, Brian C.; Parsons, Jeffrey T.

    2009-01-01

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

  15. 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…

  16. 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...

  17. 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...

  18. 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.

  19. 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

  20. Correlates of prescription drug market involvement among young adults.

    PubMed

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

    2014-10-01

    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. 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. Those from the wealthiest parental class and heterosexuals had higher odds (OR=6.8) of selling. Higher sedative and stimulant misuse (OR=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. 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. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

    MedlinePlus

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

  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.

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

    PubMed

    Montgomery, Emily J; Wasserman, Gary S

    2008-01-01

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

  4. The effect of the Rx-to-OTC switch of loratadine and changes in prescription drug benefits on utilization and cost of therapy.

    PubMed

    Sullivan, Patrick W; Nair, Kavita V; Patel, Bimal V

    2005-06-01

    Numerous prescription products have become available over the counter (OTC) in recent years. Previous simulation models have shown the Rx-to-OTC switch of loratadine to be cost effective. To empirically assess the overall effect of the Rx-to-OTC switch of loratadine and the specific effect of different pharmacy benefit structures on prescription drug utilization and cost among different plan sponsors. Data from a national pharmacy benefit management organization covering lives throughout the United States were used. The analysis included a comparison of the before and after change in prescription utilization and cost for plan sponsors that instituted 1 of 3 second-generation antihistamine (SGA) benefit responses: made no change, moved SGAs to the third tier, or restricted SGA benefits through a requirement for prior authorization. Multivariate regression analysis was used to control for differences across the study groups. There was a substantial decrease in utilization and cost of all prescription drugs and combinations of drug classes. Patients with allergic rhinitis facing restricted prescription benefits for SGAs did not appear to increase utilization of other allergic rhinitis medications or other medications used to treat comorbid conditions such as asthma, sinusitis, and otitis media. Utilization and cost decreased substantially for all types of medications and all pharmacy benefit structures. Future studies need to examine the effect of the Rx-to-OTC switch of loratadine and resultant prescription benefit policies on medical utilization and OTC antihistamine utilization.

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

    PubMed Central

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

    2015-01-01

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

  6. 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.

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

    PubMed

    Urbonas, Gvidas; Kubilienė, Loreta

    2016-04-01

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

  8. Knowledge of drug prescription in dentistry students.

    PubMed

    Guzmán-Álvarez, R; Medeiros, M; Lagunes, Li Reyes; Campos-Sepúlveda, Ae

    2012-01-01

    Students in schools of dentistry attend to patients with illnesses, and often prescribe medication. Because students are still learning, they are influenced by a variety of factors: the different teaching approaches of the professors at the clinics and in the pharmacology course, fellow students, and even the information provided by the pharmaceutical industry. The aim of this pilot study was to assess the prescription knowledge and common mistakes in fourth-year students at the School of Dentistry at the Universidad Nacional Autónoma de México. In March 2010, a survey was conducted among 66 fourth-year students at the School of Dentistry, applying a previously validated questionnaire consisting of six open-ended questions The following factors were assessed: the most frequent illness requiring dental prescription; the most prescribed nonsteroidal anti-inflammatory drugs and antibiotics; the most frequent errors; sources of information used for prescribing drugs; and whether the students knew and followed the World Health Organization Guide to Good Prescribing. The most frequent response for each question was considered the most significant. The most common reason for prescribing medication was infection (n = 37, 56%), followed by pain (n = 24, 38%); the most used painkillers were ibuprofen and acetaminophen at equal levels (n = 25, 37.8%), followed by ketorolac (n = 7, 10.6%), naproxen (n = 6, 9.1%), diclofenac (n = 2, 3%), and aspirin (n = 1, 1.5%); the most widely prescribed antibiotics were amoxicillin (n = 52, 78.9%), ampicillin (n = 7, 10.6%), and penicillin V and clindamycin (n = 3, 4.5%). The most frequent errors reported by students were: lack of knowledge about drug posology (n = 49, 74.2%), improperly filled prescriptions (n = 7, 10.7%), not knowing the brand names and uncertainty about the correct drug indicated for each case (n = 3, 4.54%), not knowing the duration of treatment (n = 2, 3%), not asking the patient about possible allergies, and not

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

    PubMed

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

    2014-03-01

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

  10. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or... outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough... CFR part 341, ``Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products for...

  11. Medicare Beneficiary Knowledge of and Experience with Prescription Drug Cards

    PubMed Central

    Rudolph, Noemi V.; Williams, Sunyna S.

    2007-01-01

    Medicare beneficiaries used prescription drug discount cards, both Medicare and non-Medicare cards, to assist them in paying for the cost of prescription drugs. This article describes the beneficiary's awareness and understanding, sources of information, and experience with drug discount cards a year prior and during the implementation of the Medicare-Approved Prescription Drug Discount Card program. Also, it explores beneficiary characteristics that contribute to card ownership and knowledge about drug discount cards. Understanding these experiences and factors can inform future outreach and education campaigns for the Medicare Drug Coverage program. PMID:18624082

  12. 75 FR 12756 - Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... Collection; Comment Request; Prescription Drug Advertisements AGENCY: Food and Drug Administration, HHS..., contained in FDA's regulations on prescription drug advertisements. DATES: Submit written or electronic... of information technology. Prescription Drug Advertisements--21 CFR 202.1 (OMB Control Number 0910...

  13. Concurrent use of prescription drugs and herbal medicinal products in older adults: a systematic review protocol.

    PubMed

    Agbabiaka, Taofikat; Wider, Barbara; Watson, Leala Kay; Goodman, Claire

    2016-04-21

    There has been a global increase in the use of herbal medicinal products (HMPs). About a quarter of UK adults use HMPs, bought over the counter by self-prescription and often not disclosed to healthcare professionals. Potential herb-drug interaction is a clinical concern, with older people at greater risk because of co-morbidities and slower clearance of pharmacologically active compounds. While there is a good understanding of general herbal medicine use by older people, less is known about the extent and implications of concurrent use with prescription medicines. The aim of this systematic review is to assess the prevalence, patterns, safety issues and other factors associated with concurrent prescription and herbal medicines use among older adults. Systematic electronic searches of MEDLINE, PsychINFO, Excerpta Medica dataBASE (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), Web of Science and Cochrane from inception till present for studies reporting the concurrent use of prescription medicines with HMPs in older adults (≥65 years). Lateral searching via related citation (PubMed) and checking reference lists of identified studies will be performed. Two reviewers will independently screen studies, extract data and appraise methodological quality using the Joanna Briggs Institute checklist for prevalence data and the Critical Appraisal Skills Programme (CASP) checklist. Qualitative and quantitative studies from all settings will be included. Non-empirical papers, in vitro experiments and animal studies will be excluded. Primary outcomes are prevalence and patterns of concurrent use, number and types of prescription and HMPs and adverse reactions reported. Secondary outcomes are disclosure of HMP use to healthcare professionals and cost of HMPs. A narrative synthesis of included studies will be performed to summarise the evidence. This review will synthesise and critically appraise

  14. 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.…

  15. 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

  16. 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…

  17. 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…

  18. 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…

  19. 77 FR 48111 - Branded Prescription Drug Fee; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

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

  20. 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…

  1. 77 FR 46653 - Branded Prescription Drug Fee; Hearing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

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

  2. 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.

  3. 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…

  4. 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

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

    PubMed

    Manski, Ruth; Kottke, Melissa

    2015-09-01

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

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

    PubMed

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

    2008-08-01

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

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

    PubMed

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

    2015-06-01

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

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

    PubMed Central

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

    2014-01-01

    Prescription drug misuse has emerged as a significant problem among young adults. While the effects of motivational contexts have been demonstrated for illicit drugs, the role of motivational contexts in prescription drug misuse remains understudied. Using data from 400 young adults recruited via time-space sampling, we examined the role of motivational contexts in the frequency of misuse of three prescription drug types as well as drug-related problems and symptoms of dependency. Both negative and positive motivations to use drugs are associated with increases in prescription drug misuse frequency. Only negative motivations are associated directly with drug problems and drug dependence, as well as indirectly via prescription pain killer misuse. Addressing positive and negative motivational contexts of prescription drug misuse may not only provide a means to reduce misuse and implement harm reduction measures, but may also inform the content of treatment plans for young adults with prescription drug misuse problems. PMID:25115134

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2016-06-01

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

  11. Adolescent use of prescription drugs to get high in Canada.

    PubMed

    Currie, Cheryl L; Wild, T Cameron

    2012-12-01

    To present epidemiologic information on adolescent use of prescription drugs to get high, and not for medical purposes, in Canada. Data were obtained from 44 344 adolescents in grades 7 to 12 living across Canada's 10 provinces who completed the Youth Smoking Survey in 2008/2009. Nationally, 5.9% of adolescents in grades 7 to 12 reported the use of prescription drugs to get high in the past 12 months in 2008/2009. Females were more likely to report use of pain relievers, sedatives, or tranquilizers to get high, while males were more likely to report the use of prescription stimulants for this purpose. The use of prescription drugs to get high was elevated among older youth, those living in British Columbia, and those who identified as First Nations, Métis, or Inuit. School connectedness was associated with a reduction in this form of prescription drug misuse for all adolescents; however, this protective effect was particularly strong for Aboriginal youth, and may be an important preventative factor for this population. Use of prescription drugs to get high was prevalent among adolescents in Canada in 2008/2009. Findings highlight the need for clinicians to include questions about prescription drugs when screening adolescents for substance abuse in Canada. Findings also highlight the need for evidence-informed strategies to reduce prescription drug misuse among Aboriginal youth living outside First Nations communities in Canada. The results of this study suggest school connectedness may be a particularly important target for these interventions.

  12. 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

  13. Illegal "no prescription" internet access to narrow therapeutic index drugs.

    PubMed

    Liang, Bryan A; Mackey, Tim K; Lovett, Kimberly M

    2013-05-01

    Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online "no prescription" Web sites. We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs). Using the Google search term "buy DRUG no prescription," we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013. For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription. Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

  14. 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

  15. Adverse selection in the Medicare prescription drug program.

    PubMed

    Riley, Gerald F; Levy, Jesse M; Montgomery, Melissa A

    2009-01-01

    The Medicare Part D drug benefit created choices for beneficiaries among many prescription drug plans with varying levels of coverage. As a result, Medicare enrollees with high prescription drug costs have strong incentives to enroll in Part D, especially in plans with more comprehensive coverage. To measure this potential problem of "adverse selection," which could threaten plans' finances, we compared baseline characteristics among groups of beneficiaries with various drug coverage arrangements in 2006. We found some significant differences. For example, enrollees in stand-alone prescription drug plans, especially in plans offering benefits in the coverage gap, or "doughnut hole," had higher baseline drug costs and worse health than enrollees in Medicare Advantage prescription drug plans. Although risk-adjusted payments and other measures have been put in place to account for selection, these patterns could adversely affect future Medicare costs and should be watched carefully.

  16. 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…

  17. 77 FR 52743 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... support new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter... HUMAN SERVICES Food and Drug Administration Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of...

  18. 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...

  19. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    PubMed

    Frosch, Dominick L; Grande, David

    2010-01-01

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

  1. 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.

  2. Medical and nonmedical users of prescription drugs among college students.

    PubMed

    Rozenbroek, Katelyn; Rothstein, William G

    2011-01-01

    To examine medical and nonmedical users of prescription opioids, central nervous system depressants, and stimulants taken individually and in combination. Undergraduates at an urban mid-Atlantic university with 12,000 students. A questionnaire administered in classes provided 413 responses, with a usable response rate of 94%. Nonmedical users obtained prescription drugs from friends and took them with friends. More nonmedical users than medical users took combinations of drugs. Nonmedical users did not show strong preferences for particular drugs. Nonmedical users compared to medical users who took only 1 drug were more likely to take stimulants and less likely to take opioids. The nonmedical use of prescription drugs by college students is a social activity that involves sharing drugs and taking combinations of drugs with friends. Discouraging nonmedical use must focus on the dangers of combining drugs, sharing drugs, and using social gatherings to consume drugs.

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

    PubMed Central

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

    2011-01-01

    Background Prescription opioids are the most frequently misused class of prescription drugs among young adults. Initiation into prescription opioid misuse is an important public health concern since opioids are increasingly associated with drug dependence and fatal overdose. Descriptive data about initiation into prescription opioid misuse among young injection drug users (IDUs) are scarce. Methods An exploratory qualitative study was undertaken to describe patterns of initiation into prescription opioid misuse among IDUs aged 16 to 25 years. Those young IDUs who had misused a prescription drug at least three times in the past three months were recruited during 2008 and 2009 in Los Angeles (n=25) and New York (n=25). Informed by an ethno-epidemiological approach, descriptive data from a semi-structured interview guide were analysed both quantitatively and qualitatively. Results Initiation into prescription opioid misuse was facilitated by easy access to opioids via participant’s own prescription, family, or friends, and occurred earlier than misuse of other illicit drugs, such as heroin. Nearly all transitioned into sniffing opioids, most injected opioids, and many initiated injection drug use with an opioid. Motives for transitions to sniffing and injecting opioids included obtaining a more potent high and/or substituting for heroin; access to multiple sources of opioids was common among those who progressed to sniffing and injecting opioids. Conclusion Prescription opioid misuse was a key feature of trajectories into injection drug use and/or heroin use among this sample of young IDUs. A new pattern of drug use may be emerging whereby IDUs initiate prescription opioid misuse before using heroin. PMID:21689917

  4. Initiation into prescription opioid misuse amongst young injection drug users.

    PubMed

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

    2012-01-01

    Prescription opioids are the most frequently misused class of prescription drugs amongst young adults. Initiation into prescription opioid misuse is an important public health concern since opioids are increasingly associated with drug dependence and fatal overdose. Descriptive data about initiation into prescription opioid misuse amongst young injection drug users (IDUs) are scarce. An exploratory qualitative study was undertaken to describe patterns of initiation into prescription opioid misuse amongst IDUs aged 16-25 years. Those young IDUs who had misused a prescription drug at least three times in the past three months were recruited during 2008 and 2009 in Los Angeles (n=25) and New York (n=25). Informed by an ethno-epidemiological approach, descriptive data from a semi-structured interview guide were analysed both quantitatively and qualitatively. Initiation into prescription opioid misuse was facilitated by easy access to opioids via participant's own prescription, family, or friends, and occurred earlier than misuse of other illicit drugs, such as heroin. Nearly all transitioned into sniffing opioids, most injected opioids, and many initiated injection drug use with an opioid. Motives for transitions to sniffing and injecting opioids included obtaining a more potent high and/or substituting for heroin; access to multiple sources of opioids was common amongst those who progressed to sniffing and injecting opioids. Prescription opioid misuse was a key feature of trajectories into injection drug use and/or heroin use amongst this sample of young IDUs. A new pattern of drug use may be emerging whereby IDUs initiate prescription opioid misuse before using heroin. Copyright © 2011 Elsevier B.V. All rights reserved.

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

    PubMed

    Foster, Lori S; Keele, Rebecca

    2006-04-01

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

  6. Prescription Monitoring Program Trends Among Individuals Arrested in Maine for Trafficking Prescription Drugs in 2014.

    PubMed

    McCall, Kenneth; Nichols, Stephanie D; Holt, Christina; Ochs, Leslie; Cattabriga, Gary; Tu, Chunhao

    2016-06-01

    To evaluate controlled substance prescribing trends available in the Maine Prescription Monitoring Program (PMP) among individuals arrested for prescription drug "trafficking." The demographic characteristics of the individuals who had matching prescription records in the PMP within 90 days of the arrest were identified. A population-based, retrospective cohort study using data from the Maine Diversion Alert Program (DAP) and the Maine PMP. The study population consisted of persons arrested for trafficking prescription drugs in Maine during the 2014 calendar year from January 1 to December 31. There were 594 trafficking arrests reported by the Maine DAP in 2014. The study population consisted of the 235 persons (40%) with arrests involving controlled prescription medications. The mean age of these persons was 33 years (range 18-77 yrs), and 156 (66%) were male. Arrests involved 154 prescription opioids (65%), seven stimulants (3%), seven benzodiazepines (3%), and 77 unspecified controlled prescription drugs (33%). A minority of individuals (n=57, 24%) had a prescription record in the PMP that matched the substance involved in the arrest. Only one person with matching PMP and arrest records utilized ≥ 5 prescribers, while none used ≥ 5 pharmacies within 90 days before the arrest. Payment methods for matching prescriptions were commercial insurance (n=28, 49%), Medicaid (n=19, 33%), Medicare (n=5, 9%), and cash (n=5, 9%). The majority (76%) of persons arrested for prescription drug trafficking did not have PMP records and did not directly obtain the diverted medication from a licensed pharmacy. Traditional red flags, like cash payment and using multiple prescribers or pharmacies, were uncommon. Therefore, arrest records for diversion and PMPs are distinct and complementary tools for identifying individuals at risk for substance misuse. © 2016 Pharmacotherapy Publications, Inc.

  7. 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

  8. 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

  9. [Failure mode and effects analysis on computerized drug prescriptions].

    PubMed

    Paredes-Atenciano, J A; Roldán-Aviña, J P; González-García, Mercedes; Blanco-Sánchez, M C; Pinto-Melero, M A; Pérez-Ramírez, C; Calvo Rubio-Burgos, Miguel; Osuna-Navarro, F J; Jurado-Carmona, A M

    2015-01-01

    To identify and analyze errors in drug prescriptions of patients treated in a "high resolution" hospital by applying a Failure mode and effects analysis (FMEA).Material and methods A multidisciplinary group of medical specialties and nursing analyzed medical records where drug prescriptions were held in free text format. An FMEA was developed in which the risk priority index (RPI) was obtained from a cross-sectional observational study using an audit of the medical records, carried out in 2 phases: 1) Pre-intervention testing, and (2) evaluation of improvement actions after the first analysis. An audit sample size of 679 medical records from a total of 2,096 patients was calculated using stratified sampling and random selection of clinical events. Prescription errors decreased by 22.2% in the second phase. FMEA showed a greater RPI in "unspecified route of administration" and "dosage unspecified", with no significant decreases observed in the second phase, although it did detect, "incorrect dosing time", "contraindication due to drug allergy", "wrong patient" or "duplicate prescription", which resulted in the improvement of prescriptions. Drug prescription errors have been identified and analyzed by FMEA methodology, improving the clinical safety of these prescriptions. This tool allows updates of electronic prescribing to be monitored. To avoid such errors would require the mandatory completion of all sections of a prescription. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  10. 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.

  11. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  12. 76 FR 56201 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

    2012-01-12

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

  17. 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

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

    PubMed

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

    2008-01-01

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

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

    PubMed

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

    2014-04-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2014-04-01

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

  3. 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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  5. 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…

  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. 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…

  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…

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

    ERIC Educational Resources Information Center

    Venditti, Jennifer J.; Surmacz, Cynthia A.

    2012-01-01

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

  10. 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…

  11. 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…

  12. 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…

  13. 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…

  14. 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.…

  15. 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…

  16. 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

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

    PubMed

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

    1986-01-01

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

  18. Which Classes of Prescription Drugs Are Commonly Misused?

    MedlinePlus

    ... Trends and Alerts Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription ... addiction. Chemically, these medications are very similar to heroin, which was originally synthesized from morphine as a ...

  19. Consumer response to dual incentives under multitiered prescription drug formularies.

    PubMed

    Gilman, Boyd H; Kautter, John

    2007-06-01

    To decompose the overall effect of multitiered formularies on drug utilization and spending into the following 2 observed effects on consumer behavior: first, higher copayments on drug equivalents create an incentive to reduce the number of prescriptions, and, second, wider differential copayments between drug equivalents create an incentive to use a greater proportion of generics. We merged drug claims for 352,760 retired Medicare enrollees having employer-sponsored health insurance with benefit information. Our unit of analysis was the enrollee. We used cross-sectional variation in incentive-based formularies to compare the effects of increased copayment amounts for drug equivalents with those of increased copayment differentials between drug equivalents. The study sample may not be representative of the Medicare population. Multivariate regression analysis using the 2002 MarketScan Medicare Supplemental and Coordination of Benefits database and Benefit Plan Design database. A 10% increase in copayments for drug equivalents was associated with a 1.3% reduction in total drug spending, a 16.0% increase in out-of-pocket expenditures, a 2.0% reduction in the number of prescriptions filled, and a 0.7% reduction in proportion of prescriptions filled with generics. A 10% increase in copayment differentials between drug equivalents was associated with a 1.0% reduction in total drug spending, a 4.1% increase in out-of-pocket expenditures, a 1.0% reduction in the number of prescriptions filled, and a 0.7% increase in proportion of prescriptions filled with generics. Increasing copayment differentials between drug equivalents is as effective a strategy for reducing total drug spending as increasing copayment amounts for drug equivalents but better maintains access to prescription medications.

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

    PubMed Central

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

    2013-01-01

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

  1. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... data or reference to published reports, represent that the drug is safer or more effective than another drug, nor may an advertisement contain a quantitative statement of safety or effectiveness (a) unless... favorable data or conclusions from nonclinical studies of a prescription drug, such as studies in laboratory...

  2. Purchasing Prescription Drugs in Canada: Hang Together or Hang Separately

    PubMed Central

    Law, Michael R.; Morgan, Steven G.

    2011-01-01

    Canada's provincial and territorial governments have expressed an interest in bulk purchasing prescription drugs for many years. We propose they start by purchasing selected generic drugs for the entire population and provide them for little or no cost to patients. This politically popular strategy would significantly reduce drug expenditures and improve population health. PMID:22548094

  3. High-Risk Obtainment of Prescription Drugs by Older Adults in New Jersey: The Role of Prescription Opioids.

    PubMed

    Gold, Sarah L; Powell, Kristen Gilmore; Eversman, Michael H; Peterson, N Andrew; Borys, Suzanne; Hallcom, Donald K

    2016-10-01

    To explore the high-risk ways in which older adults obtain prescription opioids and to identify predictors of obtaining prescription opioids from high-risk sources, such as obtaining the same drug from multiple doctors, sharing drugs, and stealing prescription pads. Logistic regression analyses of cross-sectional survey data from the New Jersey Older Adult Survey on Drug Use and Health, a representative random-sample survey. Adults aged 60 and older (N = 725). Items such as obtaining prescriptions for the same drug from more than one doctor and stealing prescription drugs were measured to determine high-risk obtainment of prescription opioids. Almost 15% of the sample used high-risk methods of obtaining prescription opioids. Adults who previously used a prescription opioid recreationally had three times the risk of high-risk obtainment of prescription opioids. These findings illustrate the importance of strengthening prescription drug monitoring programs to reduce high-risk use of prescription drugs in older adults by alerting doctors and pharmacists to potential prescription drug misuse and interactions. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  4. 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

  5. Prescription drug misuse among young adults: looking across youth cultures.

    PubMed

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

    2013-05-01

    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. 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). 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. 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. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  6. 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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2007-01-01

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

  9. 77 FR 12310 - Drugs for Human Use; Drug Efficacy Study Implementation; Prescription Drugs That Contained...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is... applicable to OTC products that comply with an OTC monograph (21 CFR 310.6(f)). Any person who wishes to...

  10. [Comparisons outpatient drug prescriptions: France, Denmark, Norway, Sweden].

    PubMed

    Dezileaux, Barbara; Martinez, Florie

    2016-06-01

    Comparisons outpatient drug prescriptions: France, Denmark, Norway, Sweden. Project compares quantitatively outpatient drug prescriptions in France, Denmark, Norway and Sweden. Data were obtained from national databases; the unit of measurement was defined daily dose per 1000 inhabitants. The five most prescribed drug classes were compared in each country in 2009, then benzodiazepines and antibiotics from 2006 to 2012. A literature review was focused on the context of prescriptions for each country. In 2009, the five most prescribed drug classes in the four countries represented seven classes in total. France was not the biggest prescriber of drugs, but from 2006 to 2012 benzodiazepines and antibiotics were prescribed much more in France than in the other countries. The evolution of prescriptions was different for each country, and very stable in France. In 2009, France was not the biggest drugs consumer of all classes, but was characterized by high prescriptions in some classes. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  11. 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

  12. 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

  13. Telematics integrated system to perform drugs prescription and administration reducing adverse drug events.

    PubMed

    Iadanza, E; Pettenati, M C; Bianchi, L; Turchi, S; Ciofi, L; Pirri, F; Biffi Gentili, G; Giuli, D

    2012-01-01

    In this paper we present PHARMA 2.0 a telematics integrated system aimed at reducing Adverse Drug Events (ADEs) in the phases of drug prescription, transcription, distribution and administration. The proposed system is grounded on three sub-systems: a CPOE (Computerized Prescription Order Entry), an RFID-based drug container and dispenser and a middleware system. The visualization and management of prescription and administration data are handled through a web application designed to comply with international usability regulation.

  14. 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.

  15. Health plans' strategies to control prescription drug spending.

    PubMed

    Wallack, Stanley S; Weinberg, Dana Beth; Thomas, Cindy Parks

    2004-01-01

    A number of recent studies have documented the sizable impact of consumer cost sharing without accounting for the other drug management strategies being adopted simultaneously. This qualitative case study of five of California's largest health plans examines the strategies and methods used to control prescription drug use and spending. Higher cost sharing is being used increasingly. Concurrently, major administrative efforts directed at physicians-including rules, incentives, and education-are being undertaken. These efforts have focused on lowering the cost per prescription by emphasizing generic substitution and therapeutic interchange of less costly drugs.

  16. Prevalence of the Prescription of Potentially Interacting Drugs

    PubMed Central

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

    2013-01-01

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

  17. Prescription Drug Coverage and Spending for Medicare Beneficiaries

    PubMed Central

    Poisal, John A.; Murray, Lauren A.; Chulis, George S.; Cooper, Barbara S.

    1999-01-01

    Outpatient prescription drug coverage is not a Medicare covered benefit. Debate continues in Congress and elsewhere on modernizing the Medicare benefit package, including proposals that would help the Nation's seniors pay for prescription drugs. Very little is known about which persons within the Medicare population have drug coverage from other sources. Using 1995 data from the Medicare Current Beneficiary Survey (MCBS), the authors present information on who has coverage by various sociodemographic categories. The data indicate higher-than-average levels of coverage for minority persons, beneficiaries eligible for Medicare because of disability, and those with higher incomes. PMID:10558017

  18. 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.

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

    PubMed Central

    Taylor, Lisa M.; Austin, S. Bryn

    2013-01-01

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

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

    PubMed

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

    2015-10-01

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

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

    PubMed

    Openshaw, Matthew S

    2005-01-01

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

  2. The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers.

    PubMed

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

    1990-09-01

    In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status by the U.S. Food and Drug Administration to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. This study explores the potential utility of techniques of decision analysis in evaluating the balance of these benefits and risks. Histamine H2 receptor antagonists (H2-blockers), which are currently available only by prescription, are presented as a case study and were examined to determine how OTC availability of these agents would alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders. Currently, about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would: 1) increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%; 2) increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% currently to 43.2%; 3) result in 14 additional cases of serious hematologic disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline; 4) cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care; and 5) decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia. On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the

  3. 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

  4. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... animals or in vitro, that the studies have clinical significance, if clinical significance has not been demonstrated. Data that demonstrate activity or effectiveness for a prescription drug in animal or in vitro... use may be used in advertising except that (a), in the case of anti-infective drugs, in vitro data may...

  5. Reality Television Programs Are Associated With Illegal Drug Use and Prescription Drug Misuse Among College Students.

    PubMed

    Fogel, Joshua; Shlivko, Alexander

    2016-01-02

    Reality television watching and social media use are popular activities. Reality television can include mention of illegal drug use and prescription drug misuse. To determine if reality television and social media use of Twitter are associated with either illegal drug use or prescription drug misuse. Survey of 576 college students in 2011. Independent variables included watching reality television (social cognitive theory), parasocial interaction (parasocial interaction theory), television hours watched (cultivation theory), following a reality television character on Twitter, and demographics. Outcome variables were illegal drug use and prescription drug misuse. Watching reality television and also identifying with reality TV program characters were each associated with greater odds for illegal drug use. Also, following a reality TV character on Twitter had greater odds for illegal drug use and also in one analytical model for prescription drug misuse. No support was seen for cultivation theory. Those born in the United States had greater odds for illegal drug use and prescription drug misuse. Women and Asians had lower odds for illegal drug use. African Americans and Asians had lower odds for prescription drug misuse. Physicians, psychologists, and other healthcare practitioners may find it useful to include questions in their clinical interview about reality television watching and Twitter use. Physician and psychology groups, public health practitioners, and government health agencies should consider discussing with television broadcasting companies the potential negative impact of including content with illegal drugs and prescription drug misuse on reality television programs.

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

    PubMed

    Boukus, Ellyn R; Carrier, Emily R

    2011-12-01

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

  7. The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus.

    PubMed

    Johnson, David A; Katz, Philip O; Armstrong, David; Cohen, Henry; Delaney, Brendan C; Howden, Colin W; Katelaris, Peter; Tutuian, Radu I; Castell, Donald O

    2017-04-01

    The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare

  8. Drug utilization, prescription errors and potential drug-drug interactions: an experience in rural Sri Lanka.

    PubMed

    Rathish, Devarajan; Bahini, Sivaswamy; Sivakumar, Thanikai; Thiranagama, Thilani; Abarajithan, Tharmarajah; Wijerathne, Buddhika; Jayasumana, Channa; Siribaddana, Sisira

    2016-06-25

    Prescription writing is a process which transfers the therapeutic message from the prescriber to the patient through the pharmacist. Prescribing errors, drug duplication and potential drug-drug interactions (pDDI) in prescriptions lead to medication error. Assessment of the above was made in prescriptions dispensed at State Pharmaceutical Corporation (SPC), Anuradhapura, Sri Lanka. A cross sectional study was conducted. Drugs were classified according to the WHO anatomical, therapeutic chemical classification system. A three point Likert scale, a checklist and Medscape online drug interaction checker were used to assess legibility, completeness and pDDIs respectively. Thousand prescriptions were collected. Majority were hand written (99.8 %) and from the private sector (73 %). The most frequently prescribed substance and subgroup were atorvastatin (4 %, n = 3668) and proton pump inhibitors (7 %, n = 3668) respectively. Out of the substances prescribed from the government and private sectors, 59 and 50 % respectively were available in the national list of essential medicines, Sri Lanka. Patients address (5 %), Sri Lanka Medical Council (SLMC) registration number (35 %), route (7 %), generic name (16 %), treatment symbol (48 %), diagnosis (41 %) and refill information (6 %) were seen in less than half of the prescriptions. Most were legible with effort (65 %) and illegibility was seen in 9 %. There was significant difference in omission and/or errors of generic name (P = 0.000), dose (P = 0.000), SLMC registration number (P = 0.000), and in evidence of pDDI (P = 0.009) with regards to the sector of prescribing. The commonest subgroup involved in duplication was non-steroidal anti-inflammatory drugs (NSAIDs) (43 %; 56/130). There were 1376 potential drug interactions (466/887 prescriptions). Most common pair causing pDDI was aspirin with losartan (4 %, n = 1376). Atorvastatin was the most frequently prescribed substance

  9. Utilization of the Arkansas Prescription Monitoring Program to combat prescription drug abuse

    PubMed Central

    Rittenhouse, Rebecca; Wei, Feifei; Robertson, Denise; Ryan, Kevin

    2015-01-01

    Objective The Arkansas Prescription Monitoring Program (AR PMP) was implemented in 2013 to combat prescription drug abuse. All enrollees were invited to participate in a user survey available in February 2014, to identify makeup of users, utilization of the program, and changes made to health care practices after implementation of the program. Methods Of the 3694 individual enrollees invited to participate, 1541 (41.7%) completed the survey. Data collected were analyzed to identify changes in health care practices by program frequency of use and user profession. Results Medical doctors, advanced practice nurses, and pharmacists are the professions who use the program most frequently. Daily AR PMP users are considerably more likely than infrequent users to be prompted to access the program by the involvement of a controlled substance (CS) prescription or by office/facility policy requirements. Increased frequency of use of the AR PMP results in positive impacts on CS prescribing and dispensing practices. Conclusion Compelling more users of the AR PMP to be prompted to access the program by the involvement of a CS prescription or by requirements per office/facility policy may increase frequency of use of the program and thereby changes in health care practices to combat prescription drug abuse. PMID:26191489

  10. [Possibility of interactions between prescription drugs and OTC drugs (2nd report)--interaction between levodopa preparation and OTC Kampo medicines for upset stomach].

    PubMed

    Sunagane, Nobuyoshi; Aikawa, Masaru; Ohta, Takafumi; Uruno, Tsutomu

    2006-11-01

    Our series of studies aimed to examine the possibility of interactions between prescription drugs and over-the-counter (OTC) drugs by monitoring plasma drug concentrations in rats. When a levodopa preparation indicated for patients with Parkinson's disease was administered in combination with Takeda Kampo Ichoyaku K-matsu (A), Taisho Kampo Ichoyaku (B), or Kanebo Kampo Ichoyaku H(C), which are OTC kampo medicines for upset stomach, the plasma levodopa concentration-time curves were shifted downward and the AUC for levodopa was significantly lowered. These results indicate that there may be some interactions between the levodopa preparation and these OTC kampo medicines when ingested together, which leads to a reduction in the bioavailability of levodopa. On the other hand, concomitant administration of the levodopa preparation with Takeda Kampo Ichoyaku A-matsu (D) did not alter any of the pharmacokinetic parameters for levodopa. According to the package inserts for the OTC kampo medicines, A, B and C, but not D, contain metallic additives, such as aluminum silicate and magnesium stearate. In addition, combination with a kampo basis of D (Koshaheiisan-ka-shakuyaku) showed no detectable change in levodopa bioavailability. From these results, it was concluded that metallic additives may play an essential role in generating the drug-interaction between levodopa preparation and OTC kampo medicine for upset stomach.

  11. Promotion of prescription drugs to consumers: case study results.

    PubMed

    Glasgow, Christina; Schommer, Jon C; Gupta, Kiran; Pierson, Krista

    2002-01-01

    Identify key factors related to patients. medication adherence and health outcomes after they received a prescription that they requested based on a prescription drug advertisement. During January 2002, 6 individuals who requested advertised prescription medications and received a prescription from their physician were interviewed. Qualitative analysis was employed to allow for preservation of individual findings and variances in effects for each subject. In all, the 6 patients received 10 prescriptions. For 8 of the 10 requests (80%), the patients were given a prescription for the specific products requested. Of the 10 prescriptions granted to the patients, only one (10%) of the medications was discontinued by the patient due to lack of efficacy. In addition, one patient discontinued one of the products because it was withdrawn from the market. The results showed that individuals (a) may be willing to.just try. new therapies to see if they work better than their existing therapies, (b) appear to make decisions about the usefulness or value of the drug product after a short-term trial, (c) compare the value of the product with the out-of-pocket cost of the product after a short trial, (d) value and seek the advice of their physician about information they see in advertisements, (e) become extremely pleased when they find that the new product actually helps them, and (f) may develop favorable views about advertised prescription drug products, in general, if they had a favorable experience with the first product they requested. Some patients experienced disappointment, side effects, new challenges about how to fit the newly prescribed therapy into their lifestyle and existing drug regimen, the need for follow-up appointments with their physician, and the unwelcome challenge of how to pay for their newly prescribed therapy. Each study subject had unique experiences and outcomes after asking his or her physician for an advertised prescription drug product. Both

  12. Getting to the Root of High Prescription Drug Prices.

    PubMed

    Waxman, Henry; Corr, Bill; Martin, Kristi; Duong, Sophia

    2017-07-01

    ISSUE: Historic increases in prescription drug prices and spending are contributing to unsustainable health care costs in the United States. There is widespread public support for elected officials to address the problem. GOAL: To document the drivers of high U.S. prescription drug prices and offer a broad range of feasible policy actions. METHODS: Interviews with experts and organizations engaged with prescription drug development and utilization, pricing, regulation, and clinical practice. Review of policy documents, proposals, and position statements from a variety of stakeholders. FINDINGS AND CONCLUSIONS: Congress and regulators can undertake a wide range of policy actions to begin to rebalance incentives for innovation and price competition, prioritize patient access and affordability, and maximize the availability of information to patients, providers, and payers.

  13. [Predictive factors of drug prescription: profile of the overprescribing physician].

    PubMed

    Espigares Arroyo, M; Montes Salas, G; Altimiras Roset, J; Iglesias Sánchez, J M; Brioso Jerez, F

    1994-01-01

    Because of increasing pharmaceutical costs, several programs aimed at optimizing physician's prescription have been set up in the last years. However, factors determining prescription volume are not well known yet. The aim of study is to determine which the characteristics of the practitioner (GP) or the working place are related with a higher amount of drug prescription. With data obtained from PE-29, PE-20, and the managing center Human Resources Department databases, concerning the whole GP staff (N = 293), via a multiple regression model, we were able to determine the following factors predicting higher prescription:rural work place, longer distance to reference specialty center, care to children, lack of postgraduate education, short term work contract, and part time staff.

  14. Justice implications of a proposed Medicare prescription drug policy.

    PubMed

    Larkin, Heather

    2004-07-01

    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 historical context of Medicare and reviews the proposals for prescription drug coverage, identifying the concerns raised. Literature critiquing the justice dimensions of health care for the elderly population is reviewed. Justice claims are identified and refined, and social justice theories are used in the analysis of the proposed policies.

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

    PubMed

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

    2010-06-01

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

  16. How Can Prescription Drug Misuse Be Prevented?

    MedlinePlus

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

  17. Epidemiological study of epilepsy by monitoring prescriptions of antiepileptic drugs.

    PubMed

    Banfi, R; Borselli, G; Marinai, C; Borgheresi, A; Cavalieri, A

    1995-07-28

    The aim of this study is to evaluate a simple and effective method of acquiring epidemiological information about epilepsy. Data on antiepileptic drug prescriptions was collected, the utilization pattern being based on defined daily doses (DDDs). Antiepileptic drugs are epidemiological tracers of epilepsy due to their chronic and highly specific usage. Consequently, a prevalence rate for the whole population may be obtained by using DDDs. Data on antiepileptic drug prescriptions for a period of 6 months in 1992 and 6 months in 1993 indicate a utilization of approximately 7 DDDs of antiepileptic drugs per 1,000 inhabitants. The prevalence of epilepsy was estimated by correcting the exposure calculated in DDDs by a factor of 0.68. In our sample, the prevalence of the disease was 5.2 per 1,000 inhabitants in 1992 and 4.9 per 1,000 in 1993. Physician prescriptions were concentrated on four compounds, namely phenobarbital, carbamazepine, valproic acid and phenytoin, which together represented 90% of total antiepileptic drug prescriptions.

  18. Availability of prescription drugs for bipolar disorder at online pharmacies.

    PubMed

    Monteith, Scott; Glenn, Tasha; Bauer, Rita; Conell, Jörn; Bauer, Michael

    2016-03-15

    There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. No evaluation of product quality, packaging or purchasing. Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website

  19. Chronic Health Outcomes and Prescription Drug Copayments in Medicaid.

    PubMed

    Kostova, Deliana; Fox, Jared

    2017-05-01

    Prescription drug copayments and cost-sharing have been linked to reductions in prescription drug use and expenditures. However, little is known about their effect on specific health outcomes. To evaluate the association between prescription drug copayments and uncontrolled hypertension, uncontrolled hypercholesterolemia, and prescription drug utilization among Medicaid beneficiaries with these conditions. Select adults aged 20-64 from NHANES 1999-2012 in 18 states. Uncontrolled hypertension, uncontrolled hypercholesterolemia, and taking medication for each of these conditions. A differencing regression model was used to evaluate health outcomes among Medicaid beneficiaries in 4 states that introduced copayments during the study period, relative to 2 comparison groups-Medicaid beneficiaries in 14 states unaffected by shifts in copayment policy, and a within-state counterfactual group of low-income adults not on Medicaid, while controlling for individual demographic factors and unobserved state-level characteristics. Although uncontrolled hypertension and hypercholesterolemia declined among all low-income persons during the study period, the trend was less pronounced in Medicaid beneficiaries affected by copayments. After netting out concurrent trends in health outcomes of low-income persons unaffected by Medicaid copayment changes, we estimated that introduction of drug copayments in Medicaid was associated with an average rise in uncontrolled hypertension and uncontrolled hypercholesterolemia of 7.7 and 13.2 percentage points, respectively, and with reduced drug utilization for hypercholesterolemia. As Medicaid programs change in the years following the Affordable Care Act, prescription drug copayments may play a role as a lever for controlling hypertension and hypercholesterolemia at the population level.

  20. 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…

  1. 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…

  2. Body pushing, prescription drugs and hospital admission.

    PubMed

    Byard, Roger W; Kenneally, Michaela

    2017-03-15

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

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

    PubMed

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

    2013-07-01

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

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

    PubMed

    Dzeparoski, Marjan; Trajkovic-Jolevska, Suzana

    2016-09-15

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

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

    PubMed

    Wallstrom, Garrick L; Hogan, William R

    2007-12-01

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

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

    PubMed

    Yuan, Bing; Shi, Dong-ping

    2009-01-01

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

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

    PubMed

    Ferber, Reed; Hettinga, Blayne A

    2016-12-01

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

  9. 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…

  10. 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

  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

    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.

  13. 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.

  14. [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.

  15. 76 FR 41434 - Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... the Prescription Drug Marketing Act; Opportunity for Public Comment AGENCY: Food and Drug... remove a section of the Prescription Drug Marketing Act (PDMA) regulations requiring that prior to the... prescription drug marketing and distribution. The primary purpose of the PDMA was to increase safeguards to...

  16. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  17. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  18. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  19. What does the Consumer Price Index for prescription drugs really measure?

    PubMed Central

    Cleeton, David L.; Goepfrich, Valy T.; Weisbrod, Burton A.

    1992-01-01

    This article examines the conceptually desirable attributes of a fully quality-adjusted prescription drug price index. It provides an understanding of how the Consumer Price Index for prescription drugs and medical supplies treats quality changes in prescription drugs and, in particular, quality changes associated with the introduction of new drugs. PMID:10120181

  20. Factors influencing the prescription of drugs of different price levels.

    PubMed

    Semark, Birgitta; Engström, Sven; Brudin, Lars; Tågerud, Sven; Fredlund, Kerstin; Borgquist, Lars; Petersson, Göran

    2013-03-01

    Socioeconomic factors have been suggested to influence the prescribing of newer and more expensive drugs. In the present study, individual and health care provider factors were studied in relation to the prevalence of differently priced drugs. Register data for dispensed drugs were retrieved for 18 486 individuals in a county council in Sweden. The prevalence of dispensed drugs was combined with data for the individual's gender, age, education, income, foreign background, and type of caregiver. For each of the diagnostic groups (chronic obstructive pulmonary disease [COPD], depression, diabetes, and osteoporosis), selected drugs were dichotomized into cost categories, lower and higher price levels. Univariate and multivariate logistic regressions were performed using cost category as the dependent variable and the individual and provider factors as independent variables. In all four diagnostic groups, differences were observed in the prescription of drugs of lower and higher price levels with regard to the different factors studied. Age and gender affected the prescription of drugs of lower and higher price levels more generally, except for gender in the osteoporosis group. Income, education, foreign background, and type of caregiver affected prescribing patterns but in different ways for the different diagnostic groups. Certain individual and provider factors appear to influence the prescribing of drugs of different price levels. Because the average price for the cheaper drugs versus more costly drugs in each diagnostic group was between 19% and 69%, there is a risk that factors other than medical needs are influencing the choice of drug. Copyright © 2013 John Wiley & Sons, Ltd.