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Sample records for prescription drug charges

  1. What impact do prescription drug charges have on efficiency and equity? Evidence from high-income countries

    PubMed Central

    Gemmill, Marin C; Thomson, Sarah; Mossialos, Elias

    2008-01-01

    As pharmaceutical expenditure continues to rise, third-party payers in most high-income countries have increasingly shifted the burden of payment for prescription drugs to patients. A large body of literature has examined the relationship between prescription charges and outcomes such as expenditure, use, and health, but few reviews explicitly link cost sharing for prescription drugs to efficiency and equity. This article reviews 173 studies from 15 high-income countries and discusses their implications for important issues sometimes ignored in the literature; in particular, the extent to which prescription charges contain health care costs and enhance efficiency without lowering equity of access to care. PMID:18454849

  2. Prescription Drug Abuse

    MedlinePlus

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

  3. 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…

  4. 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 ...

  5. 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

  6. 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 ...

  7. Prescription Drugs and Cold Medicines

    MedlinePlus

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

  8. 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…

  9. 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.

  10. 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.

  11. Prescription Drug Abuse

    MedlinePlus

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

  12. 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 ...

  13. 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…

  14. 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...

  15. 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...

  16. 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.

  17. 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 ...

  18. 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 ...

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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) * * *...

  4. 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) * * *...

  5. 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) * * *...

  6. 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)...

  7. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  8. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  9. 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)...

  10. 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)...

  11. 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.

  12. 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

  13. [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.

  14. 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.

  15. 75 FR 12555 - Prescription Drug User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

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

  16. 21 CFR 202.1 - Prescription-drug advertisements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  17. Understanding Medicare Prescription Drug Coverage

    MedlinePlus

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

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

  19. 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.

  20. [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.

  1. 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.

  2. 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…

  3. 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…

  4. 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...

  5. 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)...

  6. 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...

  7. 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)...

  8. 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)...

  9. 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...

  10. 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...

  11. 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

  12. 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.

  13. 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.

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

    MedlinePlus

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

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. [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.

  20. 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...

  1. 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...

  2. 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…

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

    PubMed

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

    2015-01-01

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

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

    PubMed 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

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

    PubMed

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

    2006-01-01

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

  6. 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...

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

    ERIC Educational Resources Information Center

    Office of National Drug Control Policy, 2007

    2007-01-01

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

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

    MedlinePlus

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

  9. 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…

  10. 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…

  11. 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…

  12. 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...

  13. 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...

  14. 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.

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

    PubMed Central

    Southwell, Brian G.; Rupert, Douglas J.

    2016-01-01

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

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 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...

  1. 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...

  2. 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.

  3. 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.

  4. 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

  5. 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...

  6. 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...

  7. 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).

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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.

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

    MedlinePlus

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

  17. 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.

  18. 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?

  19. How Can Prescription Drug Addiction Be Treated?

    MedlinePlus

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

  20. 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 ...

  1. 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.

  2. 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…

  3. 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…

  4. A Political History of Medicare and Prescription Drug Coverage

    PubMed Central

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

    2004-01-01

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

  5. Justice Implications of a Proposed Medicare Prescription Drug Policy

    ERIC Educational Resources Information Center

    Larkin, Heather

    2004-01-01

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

  6. [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.

  7. 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.

  8. [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.

  9. 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…

  10. 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 §...

  11. 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 §...

  12. 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 §...

  13. 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...

  14. 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...

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

    PubMed Central

    2012-01-01

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

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

    PubMed

    Tu, Ha T; Corey, Catherine G

    2008-02-01

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

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

    PubMed

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

    2012-01-01

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

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

    MedlinePlus

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

  19. 77 FR 16973 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

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

  20. 76 FR 68295 - Reducing Prescription Drug Shortages

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

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

  1. 21 CFR 250.100 - Amyl nitrite inhalant as a prescription drug for human use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  3. Medicare prescription drug coverage: Consumer information and preferences

    PubMed Central

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

    2006-01-01

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

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

    PubMed Central

    Harvin, Andre; Weber, Robert J.

    2015-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  7. 76 FR 54599 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

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

  8. 76 FR 63017 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

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

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

    PubMed

    Skipper, Niels

    2013-07-01

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

  10. 76 FR 45831 - Prescription Drug User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

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

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

    ERIC Educational Resources Information Center

    Gutierres, Sara E.; And Others

    1984-01-01

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

  12. Prescription drug misuse/abuse in the elderly.

    PubMed

    Culberson, John W; Ziska, Martin

    2008-09-01

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

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

    PubMed

    Williams, J R; Hensel, P J

    1995-01-01

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

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

    PubMed

    Manchikanti, Laxmaiah

    2007-05-01

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

  15. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  20. 21 CFR 250.101 - Amphetamine and methamphetamine inhalers regarded as prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    PubMed

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

    2011-01-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

    Hallas, Jesper

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Ford, Jason A.

    2009-01-01

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

  16. 78 FR 53152 - Prescription Drug User Fee Rates for Fiscal Year 2014; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

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

  17. 77 FR 1877 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

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

  18. 38 CFR 1.483 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  19. 38 CFR 1.483 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    PubMed Central

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

    2010-01-01

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

  1. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. 21 CFR 300.50 - Fixed-combination prescription drugs for humans.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    PubMed Central

    Rigg, Khary K.; Ibañez, Gladys E.

    2010-01-01

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

  7. New Medicare-approved prescription drug discount card.

    PubMed

    James, John S

    2004-05-28

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

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

    PubMed Central

    McCabe, Sean Esteban

    2008-01-01

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

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

    PubMed

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

    2015-01-01

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

  10. 77 FR 74827 - Working Group on Access to Information on Prescription Drug Container Labels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

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

  11. 77 FR 32407 - Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

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

  12. 75 FR 71064 - Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

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

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

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

    ERIC Educational Resources Information Center

    Holloway, Katy; Bennett, Trevor

    2012-01-01

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

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    ERIC Educational Resources Information Center

    Sambamoorthi, Usha; Shea, Dennis; Crystal, Stephen

    2003-01-01

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

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

    ERIC Educational Resources Information Center

    Lamonica, Aukje K.; Boeri, Miriam

    2012-01-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

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

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

    PubMed

    Miao-Sheng, Chen; Yu-Ti, Shih

    2008-09-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

    Tien, Yu-Yu; Hsia, Renee Y.

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    Alperstein, Neil M

    2014-01-01

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

  9. Diversion of prescription drugs to the black market: what the states are doing to curb the tide.

    PubMed

    Forgione, D A; Neuenschwander, P; Vermeer, T E

    2001-01-01

    The diversion of legitimate controlled substances to the black market is a major cause of medical emergencies, fatalities, and drug-related dependencies. The effects harm not only the illegal user, but also the legitimate patient who may be getting shorted on treatments and innocent medical providers who may be charged with false claim offenses or other professional failures because of diversions that take place during their watch. The dollar magnitude of this crime is estimated to rival the black markets for both crack cocaine and heroine combined. This article addresses the various ways prescription drugs are diverted to the black market, some monitoring programs employed by the states, and guidelines that doctors, pharmacists, and other providers can use to protect themselves against possible liabilities arising from the diversion of prescription drugs. We will also address some of the oppositions to monitoring programs that have been asserted and replies to these oppositions.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  12. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

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

  13. Emergency department utilization and subsequent prescription drug overdose death

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2012-11-01

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

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

    ERIC Educational Resources Information Center

    Moran, John R.; Simon, Kosali Ilayperuma

    2006-01-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

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

    2016-02-01

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

  19. 76 FR 1182 - Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  20. 76 FR 29765 - Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-23

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

  1. 76 FR 58020 - Prescription Drug User Fee Act IV Information Technology Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

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

  2. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

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

  3. 76 FR 41434 - Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

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

    PubMed

    Roy, Sanjoy; Madhavan, S Suresh

    2012-01-01

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

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

    PubMed

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

    1998-01-01

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

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

    PubMed

    Gönül, F F; Carter, F; Wind, J

    2000-06-01

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

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

    PubMed

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

    2003-08-01

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

  8. 76 FR 79194 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    2008-10-09

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

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

    PubMed

    Liu, Shuen-Zen; Romeis, James C

    2004-06-01

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

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

    PubMed

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

    2014-02-01

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

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

    PubMed

    2010-06-01

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

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

    PubMed

    Morgan, J P

    1977-02-03

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

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

    PubMed

    Millstein, Lloyd G

    2003-01-01

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

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

    PubMed

    Lennard, E L; Feinberg, P E

    1994-12-01

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

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

    PubMed

    2010-06-18

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

  19. 76 FR 24901 - Request for Input To Inform a Possible Surgeon General Action on Prescription Drug Abuse in Youth

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

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

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

    ERIC Educational Resources Information Center

    Rozenbroek, Katelyn; Rothstein, William G.

    2011-01-01

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

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

    ERIC Educational Resources Information Center

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

    2006-01-01

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

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

    PubMed

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

    2016-02-01

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

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

    PubMed

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

    2017-02-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

    Bressler, Rubin

    2005-11-01

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

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

    PubMed

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

    2010-01-01

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

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

    PubMed Central

    Schwartz, Lisa M.; Woloshin, Steven

    2013-01-01

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

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

    PubMed

    Schwartz, Lisa M; Woloshin, Steven

    2013-08-20

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

  10. Prescription Pain Medications (Opioids)

    MedlinePlus

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

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

    PubMed Central

    2009-01-01

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

  12. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

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

  13. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  14. 76 FR 77543 - Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  15. 76 FR 2691 - Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

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

  16. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

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

    2015-01-01

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

  18. 78 FR 26374 - An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

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

  19. 78 FR 28860 - Announcement of Requirements and Registration for: “Data Rx: Prescription Drug Abuse Infographic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    Abrahamsson, Tove; Kral, Alex H.

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    2014-07-28

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

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

    PubMed

    DeStefino, Kevin

    2003-01-01

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

  6. Mechanisms of Prescription Drug Diversion Among Impaired Physicians

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Huertas, Melby Karina Zuniga; Campomar, Marcos Cortez

    2008-04-01

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

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

    PubMed

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

    2002-01-01

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

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

    PubMed

    Bradford, W David; Lastrapes, William D

    2014-11-01

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

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

    PubMed

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

    2015-01-01

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

  11. Insurance Coverage of Prescription Drugs and the Rural Elderly

    ERIC Educational Resources Information Center

    Mueller, Curt; Schur, Claudia

    2004-01-01

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

  12. Prescription Drugs Associated with Reports of Violence Towards Others

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    1999-03-01

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

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

    PubMed

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

    2013-12-01

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

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

    PubMed Central

    Firestone, Michelle; Fischer, Benedikt

    2008-01-01

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

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

    PubMed

    Marshall, Carter L

    2004-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

    Southwell, Brian G; Rupert, Douglas J

    2016-01-16

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

    2016-03-01

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

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

    PubMed Central

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Yolles, Stanley F.

    1971-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    PubMed

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

    2016-01-01

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

  5. 78 FR 9589 - Disclosures To Participate in State Prescription Drug Monitoring Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

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

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

  7. 45 CFR 156.295 - Prescription drug distribution and cost reporting.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    PubMed

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

    2013-01-01

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

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

    ERIC Educational Resources Information Center

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

    2004-01-01

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

  10. Medicare program; application of certain appeals provisions to the Medicare prescription drug appeals process. Final rule.

    PubMed

    2009-12-09

    This final rule will implement the procedures that the Department of Health and Human Services will follow at the Administrative Law Judge and Medicare Appeals Council levels in deciding appeals brought by individuals who have enrolled in the Medicare prescription drug benefit program. In addition, it will implement the reopening procedures that will be followed at all levels of appeal.

  11. Sexual Orientation and First-Year College Students' Nonmedical Use of Prescription Drugs

    ERIC Educational Resources Information Center

    Shadick, Richard; Dagirmanjian, Faedra Backus; Trub, Leora; Dawson, Heather

    2016-01-01

    Objective: To examine differences between heterosexual and lesbian, gay, bisexual, and questioning students' nonmedical use of prescription drugs (NMUPD). Participants: First-year university students between October 2009 and October 2013 who self-identified as heterosexual, lesbian, gay, bisexual, or questioning. Methods: Students completed…

  12. 77 FR 4273 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ...-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner; Notice of Availability of Study Data AGENCY: Food and...) television and radio advertisements relating to the side effects and contraindications of an...

  13. Medicare: Prescription Drug Issues. Report to the Chairman, Special Committee on Aging, U.S. Senate.

    ERIC Educational Resources Information Center

    General Accounting Office, Washington, DC. Div. of Human Resources.

    This report was written by the General Accounting Office (GAO) in response to a request by Senator John Melcher that the GAO provide information about prescription drugs as they relate to the needs of the elderly. The information in the report is based on results of an ongoing GAO study of catastrophic illness insurance and is derived from…

  14. Imprecise Frequency Descriptors and the Miscomprehension of Prescription Drug Advertising: Public Policy and Regulatory Implications.

    ERIC Educational Resources Information Center

    Davis, Joel J.

    1999-01-01

    Explores the communicative effectiveness of imprecise frequency descriptors within the context of consumer prescription drug advertising. Conducts two separate studies using a total sample of 147 adults. Finds that consumers are unable to accurately estimate the relative likelihood of side effect occurrence when a list of side effects are preceded…

  15. Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study.

    PubMed

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

    2016-11-01

    We sought to determine whether links from branded prescription drug websites to websites containing disease information mislead participants about drug benefits and whether nonsponsorship disclosures diminish this potential effect. We randomly assigned online panelists with depression (N = 1,071) to view a fictitious prescription drug website that had (a) no link to a disease information website (control), (b) a link with no disclosure, (c) a link with a simple nonsponsorship disclosure, or (d) a link with a detailed nonsponsorship disclosure. If participants in the link conditions did not click the link, they were returned to the drug website and encouraged to click it. All participants then completed an online questionnaire assessing recall, perceptions, and intentions. Few participants (12%) clicked the link without prompting; 67% did so when prompted. Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits. Disclosures did not diminish these effects, and exposure to disease information did not affect other perceptions or intentions. Consumers seem to confuse information on disease websites with information on branded prescription drug websites. Disclosures may not adequately help consumers to distinguish between the 2 types of information.

  16. Prescription and consumption of solid oral drugs dispensed as unitary doses in a third level hospital

    PubMed Central

    Calderón-Guzmán, David; Juárez-Olguín, Hugo; Hernández-García, Ernestina; Medina-Andrade, Alejandro; Juarez Tapia, Belen

    2015-01-01

    Background: The knowledge about the pattern of prescription and consumption of solid oral drugs dispensed as unitary doses (UD) in Mexico is sparing. Purpose: The aim of this study was to describe the pattern of prescription and consumption of solid oral drugs dispensed as unitary doses (UD) in a third level private hospital of Mexico. A retrospective study of a 60-month period (from 2007 to 2011) was carried out to know the pattern of drugs dispensed as UD in a third level hospital. Results: Among the principal drugs consumed were analgesic, antihypertensive, antibiotic, anti-inflammatory, antiepileptic, and diuretics. The dispensation of drugs per year was as follows: 181 drugs with 85,167 UD in 2007; 199 with 90,519 UD in 2008; 193 with 101,479 UD in 2009; 195 with 100,798 UD in 2010; and 198 with 103,913 UD in 2011. Conclusion: The findings confirmed that prescription and consumption of unitary doses in the hospitalization service increased, and revealed the extensive use of analgesics as the principal prescribed drug in this kind of hospital. PMID:27013914

  17. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC),...

  18. 21 CFR 201.100 - Prescription drugs for human use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC),...

  19. Prescription drug coverage: implications for hormonal therapy adherence in women diagnosed with breast cancer.

    PubMed

    Bradley, Cathy J; Dahman, Bassam; Jagsi, Reshma; Katz, Steven; Hawley, Sarah

    2015-11-01

    In spite of its demonstrated benefits, many women do not initiate hormonal therapy, and among those who do, many discontinue it prematurely. We examined whether differences in hormonal therapy adherence may be at least partially explained by the availability of prescription drug coverage. Women aged 20-79 years diagnosed with stage I-III breast cancer between June 2005 and February 2007 were enrolled in the study. Women completed a mailed survey, on average 9 months after diagnosis, and again approximately 4 years later (N = 712). Adjusted logistic regression was used to predict the likelihood of initiating hormonal therapy and hormonal therapy continuation. Women who had prescription drug coverage were more likely to initiate hormonal therapy relative to women without prescription drug coverage (OR 2.91, 95 % CI 1.24-6.84). Women with prescription drug coverage were also more likely to continue hormonal therapy (OR 2.23; 95 % CI 0.99-5.05, p = 0.0543). The lowest income women were also less likely to continue hormonal therapy relative to women with annual household income that exceeded $70,000 (OR 0.55; 95 % CI 0.29-1.04) with a borderline significance of (p = 0.08). This study demonstrates the critical role of prescription drug coverage in hormonal therapy initiation and continuation, independent of health insurance coverage. These findings add to the body of literature that addresses medication adherence. Financial factors must be considered along with behavioral factors that influence adherence, which is becoming increasingly relevant to oncology as treatments are shifted to oral medications, many of which are very expensive.

  20. An assessment of direct-to-consumer advertising of prescription drugs.

    PubMed

    Calfee, J E

    2007-10-01

    Advertising is widely seen by economists and regulators as beneficial to markets and consumers. The prescription drug market offers exceptional opportunities for direct-to-consumer advertising (DTCA) to provide new-product information, improve compliance, alleviate widespread underdiagnosis and undertreatment, and motivate new-product development.5 DTCA can also induce excess or even dangerous prescribing, however, partly because patients are poorly informed and usually pay far less than the full cost of drugs. Empirical research can help resolve these issues.

  1. 76 FR 11794 - Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... Labeled for Prescription Use and Offered for Relief of Symptoms of Cold, Cough, or Allergy; Enforcement..., cough, or allergy and persons who manufacture or cause the manufacture of such products. These drug.... Background A. Cold, Cough, and Allergy Products Covered by This Notice This Federal Register notice...

  2. Consumers responses to coupons in direct-to-consumer advertising of prescription drugs.

    PubMed

    Bhutada, Nilesh S; Cook, Christopher L; Perri, Matthew

    2009-01-01

    A study was conducted to understand the influence of coupons and consumers' level of involvement in direct-to-consumer advertising. Consumers exposed to prescription drug advertising with a coupon had significantly more favorable ad and brand-related attitudes, and intention to inquire about the drug to their doctor. However, there was no significant difference in perceived product risk between consumers exposed to the ad with a coupon and consumers exposed to the ad without a coupon. Highly involved consumers had significantly more favorable ad, brand, and coupon-related attitudes, drug inquiry intention, and perceptions about the risks associated with the drug.

  3. Forces Pushing Prescription Psychotropic Drugs in College Mental Health

    ERIC Educational Resources Information Center

    Whitaker, Leighton C.

    2007-01-01

    A complex of forceful influences is greatly accelerating the use of what are usually referred to as "psychiatric drugs," although most prescribing is not done by psychiatrists. Many other clinicians, including other kinds of physicians, and recently psychologists, prescribe these medications. The influences contributing to this dramatic…

  4. Audit of Psychoactive Drug Prescriptions in Group Homes.

    ERIC Educational Resources Information Center

    Gowdey, Charles W.; And Others

    1987-01-01

    The survey found that of the 1,389 mentally retarded persons living in community supervised residential settings in Southwestern Ontario, 49 percent received some type of psychoactive drug. Specifically, 23 percent received anticonvulsants; 14 percent, neuroleptics; 5 percent, sedative/hypnotics; 3 percent, antidepressants; 3 percent,…

  5. Preferred supplier contracts in post-patent prescription drug markets.

    PubMed

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  6. OxyContin: Prescription Drug Abuse. CSAT Advisory.

    ERIC Educational Resources Information Center

    Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Center for Substance Abuse Treatment.

    Recently, the media have issued numerous reports about the apparent increase in OxyContin abuse and addiction. OxyContin has been heralded as a miracle drug that allows patients with chronic pain to resume a normal life. It has also been called pharmaceutical heroin and is thought to have been responsible for a number of deaths and robberies in…

  7. 77 FR 12310 - Drugs for Human Use; Drug Efficacy Study Implementation; Prescription Drugs That Contained...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

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

  8. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.

    PubMed

    2004-02-23

    The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. Most recently, in the Federal Register of January 31, 2003 (68 FR 4912), FDA delayed the effective date until April 1, 2004. This action further delays the effective date of these requirements until December 1, 2006. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The agency is taking this action to address concerns about the requirements in the final rule raised by affected parties. As explained in the SUPPLEMENTARY INFORMATION section, FDA is working with stakeholders through its counterfeit drug initiative to facilitate widespread, voluntary adoption of track and trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business. If this technology is widely adopted, it is expected to help fulfill the pedigree requirements of the PDMA and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times. Therefore, it is necessary to delay the effective date of Sec

  9. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.

    PubMed

    Plank, Linda S

    2011-01-01

    The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority.

  10. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    PubMed

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

  11. Non-medical use of prescription drugs in a national sample of college women

    PubMed Central

    McCauley, Jenna L.; Amstadter, Ananda B.; Macdonald, Alexandra; Danielson, Carla Kmett; Ruggiero, Kenneth J.; Resnick, Heidi S.; Kilpatrick, Dean G.

    2015-01-01

    Non-medical use of prescription drugs (NMUPD) is one of the fastest growing forms of illicit drug use, with research indicating that college students represent a particularly high risk population. The current study examined demographic characteristics, health/mental health, substance misuse, and rape experiences as potential risk correlates of NMUPD among a national sample of college women (N=2000). Interviews were conducted via telephone using Computer-Assisted Telephone Interviewing technology. NMUPD was assessed by asking if, participants had used a prescription drug non-medically in the past year. NMUPD was endorsed by 7.8% of the sample (n=155). Although incapacitated and drug–alcohol facilitated rape were associated with NMUPD in the initial model, the final multivariable model showed that only lifetime major depression and other forms of substance use/abuse were significantly uniquely associated with an increased likelihood of NMUPD. Implications for primary and secondary prevention and subsequent research are addressed. PMID:21356576

  12. National health spending in 2006: a year of change for prescription drugs.

    PubMed

    Catlin, Aaron; Cowan, Cathy; Hartman, Micah; Heffler, Stephen

    2008-01-01

    In 2006, U.S. health care spending increased 6.7 percent to $2.1 trillion, or $7,026 per person. The health care portion of gross domestic product (GDP) was 16.0 percent, slightly higher than in 2005. Prescription drug spending growth accelerated in 2006 to 8.5 percent, partly as a result of Medicare Part D's impact. Most of the other major health care services and public payers experienced slower growth in 2006 than in prior years. The implementation of Medicare Part D caused a major shift in the distribution of payers for prescription drugs, as Medicare played a larger role in drug purchases than it had before.

  13. Attribute substitution in early enrollment decisions into Medicare prescription drug plans.

    PubMed

    Frakt, Austin B; Pizer, Steven D

    2008-04-01

    Stand-alone outpatient prescription drug plans (PDPs), introduced in January 2006, have become the most popular source for coverage of outpatient prescription drugs under Medicare relative to other available Medicare plan types (e.g. Medicare Advantage drug plans). Using county-level enrollment figures from the Centers for Medicare & Medicaid Services linked to other public sources, we study attribute substitution in beneficiary decision-making with respect to PDP enrollment. To do so, we relate county-level PDP market share to county-level political support for the administration implementing the new benefit (the Bush Administration), controlling for socio-demographic and market characteristics. We find statistically significant evidence that greater support for the Bush administration is associated with increased PDP market share.

  14. Design of a RESTful web information system for drug prescription and administration.

    PubMed

    Bianchi, Lorenzo; Paganelli, Federica; Pettenati, Maria Chiara; Turchi, Stefano; Ciofi, Lucia; Iadanza, Ernesto; Giuli, Dino

    2014-05-01

    Drug prescription and administration processes strongly impact on the occurrence of risks in medical settings for they can be sources of adverse drug events (ADEs). A properly engineered use of information and communication technologies has proven to be a promising approach to reduce these risks. In this study, we propose PHARMA, a web information system which supports healthcare staff in the secure cooperative execution of drug prescription, transcription and registration tasks. PHARMA allows the easy sharing and management of documents containing drug-related information (i.e., drug prescriptions, medical reports, screening), which is often inconsistent and scattered across different information systems and heterogeneous organization domains (e.g., departments, other hospital facilities). PHARMA enables users to access such information in a consistent and secure way, through the adoption of REST and web-oriented design paradigms and protocols. We describe the implementation of the PHARMA prototype, and we discuss the results of the usability evaluation that we carried out with the staff of a hospital in Florence, Italy.

  15. Medicare Part D and Its Effect on the Use of Prescription Drugs and Use of Other Health Care Services of the Elderly

    ERIC Educational Resources Information Center

    Kaestner, Robert; Nasreen Khan,

    2012-01-01

    We examine the effect of gaining prescription drug insurance, as a result of Medicare Part D, on use of prescription drugs and other medical services for a nationally representative sample of Medicare beneficiaries. Given the heightened importance of prescription drugs for those with chronic illness, we provide separate estimates for elderly in…

  16. Quality of Online Pharmacies and Websites Selling Prescription Drugs: A Systematic Review

    PubMed Central

    Merla, Anna; Schulz, Peter J; Gelatti, Umberto

    2011-01-01

    Background Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research. Objective The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits. Methods We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies (World Health Organization, and US and European centers for disease control and drug regulation authorities). We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage. Results We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data (editorials, regulation articles, or the like) including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs

  17. Intravenous methylphenidate abuse. Prototype for prescription drug abuse.

    PubMed

    Parran, T V; Jasinski, D R

    1991-04-01

    Data are presented from a case series of 22 patients who abused methylphenidate hydrochloride (Ritalin-SR). The abuse pattern and symptoms of toxicity were similar to that seen with cocaine hydrochloride and amphetamine sulfate addiction; yet, the morbidity and mortality seen in this case series were greater than usual for a group of patients involved in intravenous drug abuse. We describe the characteristics of the methylphenidate abuse syndrome in terms of the pharmacology of methylphenidate, the constituents of the Ritalin-SR preparation, and the disease of chemical dependence. We propose solutions to the problem of methylphenidate abuse.

  18. Prescription of antimicrobial drugs in Norwegian aquaculture with an emphasis on "new" fish species.

    PubMed

    Grave, Kari; Hansen, Magne Kjerulf; Kruse, Hilde; Bangen, Marit; Kristoffersen, Anja Bråthen

    2008-02-01

    The usage of antimicrobial (AM) drugs in farmed fish in Norwegian aquaculture for the period 2000-2005 was investigated by using prescription data. These data were validated against national sales data of AM drugs sold for use in farmed fish and were found to be highly valid. The defined course dose (DCD) was applied as the unit of measurement to correct for the variations in the dosages between different AM drugs. The DCD(kg) was the amount of an AM drug recommended for the treatment of a 1-kg fish. The calculated number of prescribed DCD(kg)s is an estimate of the biomass of farmed fish that can be treated with a certain amount AM drug. In the present study, the number of prescriptions issued (i.e., numbers of initiated treatments), weight of active substance prescribed and biomass treated were applied to describe the usage. An increase, although modest, in the AM drug usage in Norwegian aquaculture was observed from 2002 to 2005. This increase was accounted for by new-farmed fish species (other than Atlantic salmon and rainbow trout), especially Atlantic cod. The increased usage of AM drugs in cod in the study period was significantly positively correlated to the biomass produced; even so from 2001 to 2005 the number of prescriptions for cod relative to the produced biomass declined. The AM drug usage in Atlantic halibut as well as the production varied during the study period. For other species such as turbot, coalfish and wolffish the usage of AM drugs was found to be negligible. "Mono-therapy" with quinolones may present a selective pressure in regard to development of quinolone resistance.

  19. Prescriptive Oriented Drug Analysis of Multiple Sclerosis Disease by LC-UV in Whole Human Blood.

    PubMed

    Suneetha, A; Rajeswari, Raja K

    2016-02-01

    As a polytherapy treatment, multiple sclerosis disease demands prescriptions with more than one drug. Polytherapy is sometimes rational for drug combinations chosen to minimize adverse effects. Estimation of drugs that are concomitantly administered in polytherapy is acceptable as it shortens the analytical timepoints and also the usage of biological matrices. In clinical phase trials, the withdrawal of biofluids is a critical issue for each analysis. Estimating all the coadminsitered drugs in a single shot will be more effective and economical for pharmaceuticals. A single, simple, rapid and sensitive high-performance liquid chromatography assay method has been developed with UV detection and fully validated for the quantification of 14 drugs (at random combinations) used in the treatment of multiple sclerosis disease. The set of combinations was based on prescriptions to patients. Separations were achieved on an X-Terra MS C18 (100 × 3.9 mm, 5 µm) column. The analytes were extracted from 50 µL aliquots of whole human blood with protein precipitation using acetonitrile. All the drugs were sufficiently stable during storage for 24 h at room temperature and for 23 days at 2-8°C. The percentage recoveries of all drugs were between 90 and 115%, with RSD values <10.6%. This method has been shown to be reproducible and sensitive and can be applied to clinical samples from pharmacokinetic studies and also a useful tool in studying the drug interaction studies.

  20. Researching Prescription Drug Misuse among First Nations in Canada: Starting from a Health Promotion Framework.

    PubMed

    Dell, Colleen Anne; Roberts, Gary; Kilty, Jennifer; Taylor, Kelli; Daschuk, Mitch; Hopkins, Carol; Dell, Debra

    2012-01-01

    The intentional misuse of psychotropic drugs is recognized as a significant public health concern in Canada, although there is a lack of empirical research detailing this. Even less research has been documented on the misuse of prescription drugs among First Nations in Canada. In the past, Western biomedical and individual-based approaches to researching Indigenous health have been applied, whereas First Nations' understandings of health are founded on a holistic view of wellbeing. Recognition of this disjuncture, alongside the protective influence of First Nations traditional culture, is foundational to establishing an empirical understanding of and comprehensive response to prescription drug misuse. We propose health promotion as a framework from which to begin to explore this. Our work with a health promotion framework has conveyed its potential to support the consideration of Western and Indigenous worldviews together in an 'ethical space', with illustrations provided. Health promotion also allots for the consideration of Canada's colonial history of knowledge production in public health and supports First Nations' self-determination. Based on this, we recommend three immediate ways in which a health promotion framework can advance research on prescription drug misuse among First Nations in Canada.

  1. Fighting Prescription Drug Abuse Through State Policy: The Role of Nursing in Successful Implementation.

    PubMed

    Norwood, Connor W; Biviji-Sharma, Rizwana; Knotts, Adam; Omenka, Isaac; Stone, Cynthia; Purviance, Donna

    2015-01-01

    Prescription drug abuse has become a top public health concern in the United States in recent years. Changes in prescribing practices and the way in which health providers manage pain resulted from national quality improvement efforts in the 1990s. Most efforts to reduce morbidity and mortality associated with the prescription drug abuse epidemic occur through policy initiatives at the state level. In 2011, Indiana ranked 17th in the United States and had only implemented a few intervention and prevention strategies. However, through a coordinated effort within the state, Indiana has expanded Good Samaritan laws and adopted rescue drug policies. Furthermore, the nursing workforce in Indiana has played a critical role in the successful implementation of these new policies. Nurses across the state have provided education and training to first responders and lay persons. They have also consulted with law enforcement agencies and other organizations looking to fully leverage the potential of these new state policies. Because of their versatility and clinical expertise, the nursing workforce has and will continue to play a critical role in the successful implementation of state policy initiatives aimed at fighting the prescription drug abuse epidemic.

  2. The role of bioethics in the international prescription drug market: economics and global justice.

    PubMed

    Newland, Shelby E

    2006-01-01

    In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry's behavior is necessary to find ethical solutions towards increasing access. Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/reimportation threaten the saliency of the industry's differential pricing scheme; a case-study of a single "Euro-price" within the European Union illustrates how this will actually create harm to the most needy member states. This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.

  3. Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil

    PubMed Central

    Gonçalves, Marcele Giacomin; Heineck, Isabela

    2016-01-01

    Abstract Objective: To determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil. Methods: Cross-sectional study with retrospective data collection, which analyzed prescriptions issued to 326 patients from August to December/2012 in two basic health units in the city of Viamão, state of Rio Grande do Sul. It included all prescriptions of patients whose medical records or service records were available and complete in relation to the date of presence, weight and date of birth. Off-label prescriptions were those which, in relation to the drug leaflet, showed dose different the recommended range, frequency of prescription and/or different form of administration and younger age than the indicated range. Descriptive statistics with absolute frequencies, means and standard deviations were used. Results: During the study period, a total of 731 drug prescriptions were issued and the frequency of off-label medications prescribed was 31.7%, especially antihistamines and antiasthmatics (32.3% and 31.5%, respectively). The main type of off-label prescription was dose (38.8%), followed by age range (31.5%) and frequency of administration (29.3%). Regarding the dose off-label prescription, overdose was more frequent (93.3%) than the underdose (6.7%). Prescriptions of unapproved drugs were not identified. Conclusions: The study showed that off label prescription is common in both assessed units. The observed percentage of off label prescription was higher than that reported by European studies carried out in primary care. On the other hand, the prescription of drugs not approved for children was not observed. PMID:26530249

  4. Thinking outside the medicine cabinet: a comparative content analysis of direct-to-consumer advertisements for prescription drug treatments.

    PubMed

    McKeever, Robert

    2014-01-01

    This study content analyzed online direct-to-consumer advertisements (DTCA) for prescription drug treatments to explore whether ads for prescription treatments for psychiatric conditions, which are commonly untreated, differ from other drug advertisements. Coded variables included the presence of interactive technological components, use of promotional incentives, and the social contexts portrayed in images shown on each site. Statistical analysis revealed ads for psychiatric medications contained fewer interactive website features, financial incentives, and calls to action than other types of prescription drug advertisements. Implications for health communication researchers are discussed.

  5. The Daniel K. Inouye College of Pharmacy Scripts: Prescription Drug Pricing.

    PubMed

    Sumida, Wesley K; Taniguchi, Ronald; Juarez, Deborah Taira

    2016-01-01

    Prescription drugs have reduced morbidity and mortality and improved the quality of life of millions of Americans. Yet, concerns over drug price increases loom. Drug spending has risen relatively slowly over the past decade because many of the most popular brand-name medicines lost patent protection. In the near future, there will be fewer low-cost generics coming into the market to offset the rising prices of brand-name drugs. Drug expenditures are influenced by both volume and price. This article focuses on how drug prices are set in the United States and current trends. Drug prices are determined through an extremely complicated set of interactions between pharmaceutical manufacturers, wholesalers, retailers, insurers, pharmacy benefit managers (PBMs), managed care organizations, hospitals, chain stores, and consumers. The process differs depending on the type of drug and place of delivery. Rising drug prices have come under increased scrutiny due to increased cost inflation and because many price increases come as a result of mergers and acquisitions of generic drug companies or changes in ownership of brand name drug manufacturers. Other countries have reigned in drug prices by negotiating with or regulating pharmaceutical manufacturers. The best long-term solution to rising drug prices is yet to be determined but the United States will continue to debate this issue and the discussions will get more heated if drug expenditures continue to rise at a rapid rate (ie, increasing 13% in 2014 from the previous year).

  6. Getting a prescription filled

    MedlinePlus

    ... prescription filled; Drugs - how to get prescription filled; Pharmacy - mail order; Pharmacy - internet; Types of pharmacies ... paper prescription that you take to a local pharmacy Calling or e-mailing a pharmacy to order ...

  7. To Dope or Not to Dope: Neuroenhancement with Prescription Drugs and Drugs of Abuse among Swiss University Students

    PubMed Central

    Maier, Larissa J.; Liechti, Matthias E.; Herzig, Fiona; Schaub, Michael P.

    2013-01-01

    Background Neuroenhancement is the use of substances by healthy subjects to enhance mood or cognitive function. The prevalence of neuroenhancement among Swiss university students is unknown. Investigating the prevalence of neuroenhancement among students is important to monitor problematic use and evaluate the necessity of prevention programs. Study aim To describe the prevalence of the use of prescription medications and drugs of abuse for neuroenhancement among Swiss university students. Method In this cross-sectional study, students at the University of Zurich, University of Basel, and Swiss Federal Institute of Technology Zurich were invited via e-mail to participate in an online survey. Results A total of 28,118 students were contacted, and 6,275 students completed the survey. Across all of the institutions, 13.8% of the respondents indicated that they had used prescription drugs (7.6%) or drugs of abuse including alcohol (7.8%) at least once specifically for neuroenhancement. The most frequently used prescription drugs for neuroenhancement were methylphenidate (4.1%), sedatives (2.7%), and beta-blockers (1.2%). Alcohol was used for this purpose by 5.6% of the participants, followed by cannabis (2.5%), amphetamines (0.4%), and cocaine (0.2%). Arguments for neuroenhancement included increased learning (66.2%), relaxation or sleep improvement (51.2%), reduced nervousness (39.1%), coping with performance pressure (34.9%), increased performance (32.2%), and experimentation (20%). Neuroenhancement was significantly more prevalent among more senior students, students who reported higher levels of stress, and students who had previously used illicit drugs. Although “soft enhancers”, including coffee, energy drinks, vitamins, and tonics, were used daily in the month prior to an exam, prescription drugs or drugs of abuse were used much less frequently. Conclusions A significant proportion of Swiss university students across most academic disciplines reported

  8. Media credibility and informativeness of direct-to-consumer prescription drug advertising.

    PubMed

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

    2004-01-01

    In this article, we report the results of a study conducted to determine consumer perceptions of the media credibility and informativeness of direct-to-consumer prescription drug advertising (DTC advertising) and to examine how those perceptions are influenced by consumer predispositions and demographic characteristics, especially consumer age. This study specifically surveyed older consumers, who are the most significant market segment for prescription drugs and particularly susceptible and vulnerable to commercial persuasion. Older consumers' perceptions of DTC advertising were found to be neutral but their evaluation of informativeness was found to be more positive. Attitude toward DTC advertising and DTC advertising familiarity predicted perceived credibility across various media and attitude toward DTC advertising was the most prominent predictor of perceived informativeness. Age and usage of different media were also found to predict credibility and informativeness of DTC advertising in certain types of media. This study's findings provide insight into how older consumers evaluate various DTC advertising media as an information source.

  9. The West Virginia Prescription Drug Abuse Quitline: challenges and lessons learned from running a remote quitline.

    PubMed

    White, Rebecca J; Zullig, Keith J; Lander, Laura; Shockley, Clara; Pack, Robert; Sullivan, Carl

    2012-01-01

    The West Virginia Prescription Drug Abuse Quitline (WVPDAQ) is a resource that offers education and support to individuals and families affected by prescription drug abuse. The WVPDAQ began functioning September 11, 2008, through the use of mobile phone and laptop technology. Although some helplines and quitlines use some aspects of remote technology, most function through traditional call center and landline technology, making the WVPDAQ unique. This article describes the process evaluation of the WVPDAQ and outlines both the positive findings and challenges faced by the WVPDAQ. Lessons learned and future recommendations for remote quitline endeavors are also presented. It is hoped that the experiences and information regarding the WVPDAQ presented can provide best-practice insight for public health practitioners and evaluation personnel who are considering using alternative technologies to deliver quitline services.

  10. 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.

  11. Establishing a Link Between Prescription Drug Abuse and Illicit Online Pharmacies: Analysis of Twitter Data

    PubMed Central

    Cuomo, Raphael

    2015-01-01

    Background Youth and adolescent non-medical use of prescription medications (NUPM) has become a national epidemic. However, little is known about the association between promotion of NUPM behavior and access via the popular social media microblogging site, Twitter, which is currently used by a third of all teens. Objective In order to better assess NUPM behavior online, this study conducts surveillance and analysis of Twitter data to characterize the frequency of NUPM-related tweets and also identifies illegal access to drugs of abuse via online pharmacies. Methods Tweets were collected over a 2-week period from April 1-14, 2015, by applying NUPM keyword filters for both generic/chemical and street names associated with drugs of abuse using the Twitter public streaming application programming interface. Tweets were then analyzed for relevance to NUPM and whether they promoted illegal online access to prescription drugs using a protocol of content coding and supervised machine learning. Results A total of 2,417,662 tweets were collected and analyzed for this study. Tweets filtered for generic drugs names comprised 232,108 tweets, including 22,174 unique associated uniform resource locators (URLs), and 2,185,554 tweets (376,304 unique URLs) filtered for street names. Applying an iterative process of manual content coding and supervised machine learning, 81.72% of the generic and 12.28% of the street NUPM datasets were predicted as having content relevant to NUPM respectively. By examining hyperlinks associated with NUPM relevant content for the generic Twitter dataset, we discovered that 75.72% of the tweets with URLs included a hyperlink to an online marketing affiliate that directly linked to an illicit online pharmacy advertising the sale of Valium without a prescription. Conclusions This study examined the association between Twitter content, NUPM behavior promotion, and online access to drugs using a broad set of prescription drug keywords. Initial results are

  12. Alternative strategies for Medicare payment of outpatient prescription drugs--Part B and beyond.

    PubMed

    Danzon, Patricia M; Wilensky, Gail R; Means, Kathleen E

    2005-03-01

    Reimbursement options for pharmaceuticals reimbursed under Medicare Part B (physician-dispensed drugs) are changing and the new comprehensive Part D Medicare outpatient drug benefit brings further changes. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) replaces traditional policy, of reimbursing Part B drugs at 95% of average wholesale price (AWP, a list price), with a percentage markup over the manufacturer's average selling price; in 2005 an indirect competitive procurement option will be introduced. In our view, although AWP-based reimbursement has been fraught with problems in the past, these could be fixed by constraining growth in AWP and periodically adjusting the discount off AWP. With these revisions, an AWP-based rule would preserve incentives for competitive discounting and deliver savings to Medicare. By contrast, basing Medicare reimbursement on a manufacturer's average selling price undermines incentives for discounting and, like any cost-based reimbursement rule, may result in higher prices to both public and private purchasers. Indirect competitive procurement for drugs alone, using specialty pharmacies, pharmacy benefit managers, or prescription drug plans, is unlikely to constrain costs to acceptable levels unless contractors retain flexibility to use standard benefit management tools. Folding Part B and Part D into comprehensive contracting with health plans for full health services is likely to offer the most efficient approach to managing the drug benefit.

  13. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... provided in paragraph (a) of this section: (1) Prescription drug coverage under a PDP or MA-PD plan. (2... exception of PDPs and MA-PD plans under § 423.56(b)(1) and PACE or cost-based HMO or CMP that provide.... (12) Coverage provided through a State High-Risk Pool as defined under 42 CFR 146.113(a)(1)(vii)....

  14. 42 CFR 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... provided in paragraph (a) of this section: (1) Prescription drug coverage under a PDP or MA-PD plan. (2... exception of PDPs and MA-PD plans under § 423.56(b)(1) and PACE or cost-based HMO or CMP that provide.... (12) Coverage provided through a State High-Risk Pool as defined under 42 CFR 146.113(a)(1)(vii)....

  15. The Use of Prescription Drugs, Recreational Drugs, and “Soft Enhancers” for Cognitive Enhancement among Swiss Secondary School Students

    PubMed Central

    Liakoni, Evangelia; Schaub, Michael P.; Maier, Larissa J.; Glauser, Gaëlle-Vanessa; Liechti, Matthias E.

    2015-01-01

    The use of prescription or recreational drugs for cognitive enhancement (CE) is prevalent among students. However, the prevalence of CE among Swiss school students is unknown. We therefore performed a cross-sectional online survey including ≥ 16-year-old students from bridge-year schools (10th grade), vocational schools, and upper secondary schools (10th-12th grade) in the Canton of Zurich to investigate the prevalence of and motives for the use of prescription drugs, recreational drugs, and/or freely available soft enhancers for CE. A total of 1,139 students were included. Of these, 54.5% reported the use of prescription drugs (9.2%), recreational drugs including alcohol (6.2%), or soft enhancers (51.3%) explicitly for CE at least once in their lives. The last-year and last-month prevalence for CE considering all substances was 45.5% and 39.5%, respectively. Soft enhancers were the substances that were most commonly used (ever, last-year, and last-month, respectively), including energy drinks (33.3%, 28.4%, and 24.6%), coffee (29.8%, 25.1%, and 21.9%), and tobacco (12.6%, 9.3%, and 8.3%). CE with methylphenidate was less prevalent (4.0%, 2.8%, and 2.0%). However, the use of prescription drugs, alcohol, or illegal drugs for CE was reported by 13.3% of the participants. The most common motives for use were to stay awake and improve concentration. CE was more prevalent among students who reported higher levels of stress or performance pressure and students with psychiatric disorders. In conclusion, half of the school students had used a substance at least once in their lives to improve school performance. Soft enhancers were most commonly used. Prevalence rates were similar to those reported by Swiss university students, indicating that the use of prescription or recreational drugs for CE already occurs before starting higher education. Performance pressure, stress, and psychiatric disorders may be associated with CE. PMID:26505633

  16. The Use of Prescription Drugs, Recreational Drugs, and "Soft Enhancers" for Cognitive Enhancement among Swiss Secondary School Students.

    PubMed

    Liakoni, Evangelia; Schaub, Michael P; Maier, Larissa J; Glauser, Gaëlle-Vanessa; Liechti, Matthias E

    2015-01-01

    The use of prescription or recreational drugs for cognitive enhancement (CE) is prevalent among students. However, the prevalence of CE among Swiss school students is unknown. We therefore performed a cross-sectional online survey including ≥ 16-year-old students from bridge-year schools (10th grade), vocational schools, and upper secondary schools (10th-12th grade) in the Canton of Zurich to investigate the prevalence of and motives for the use of prescription drugs, recreational drugs, and/or freely available soft enhancers for CE. A total of 1,139 students were included. Of these, 54.5% reported the use of prescription drugs (9.2%), recreational drugs including alcohol (6.2%), or soft enhancers (51.3%) explicitly for CE at least once in their lives. The last-year and last-month prevalence for CE considering all substances was 45.5% and 39.5%, respectively. Soft enhancers were the substances that were most commonly used (ever, last-year, and last-month, respectively), including energy drinks (33.3%, 28.4%, and 24.6%), coffee (29.8%, 25.1%, and 21.9%), and tobacco (12.6%, 9.3%, and 8.3%). CE with methylphenidate was less prevalent (4.0%, 2.8%, and 2.0%). However, the use of prescription drugs, alcohol, or illegal drugs for CE was reported by 13.3% of the participants. The most common motives for use were to stay awake and improve concentration. CE was more prevalent among students who reported higher levels of stress or performance pressure and students with psychiatric disorders. In conclusion, half of the school students had used a substance at least once in their lives to improve school performance. Soft enhancers were most commonly used. Prevalence rates were similar to those reported by Swiss university students, indicating that the use of prescription or recreational drugs for CE already occurs before starting higher education. Performance pressure, stress, and psychiatric disorders may be associated with CE.

  17. Incidence of Potential Drug-Drug Interactions in a Limited and Stereotyped Prescription Setting - Comparison of Two Free Online Pharmacopoeias

    PubMed Central

    Kannan, Bhaskar; Nagella, Amrutha Bindu; Sathia Prabhu, A; Sasidharan, Gopalakrishnan M; Ramesh, A S

    2016-01-01

    Background: Drug-drug interactions (DDIs) are very common adverse events in health care delivery settings. The use of electronic pharmacopeias can potentially reduce the incidence of DDIs, but they are often thought to be cumbersome to use. This study is aimed at studying the incidence of potential DDIs in a surgical department, where a limited number of drugs are used in stereotyped combinations. We also compared two popular drug compendia in detecting potential DDIs. Methods: The prescriptions of selected patients were entered into Epocrates® and Medscape® for Android smartphones. Potential DDIs were generated and their categories were noted. The warnings generated by Epocrates® were compared with those generated by Medscape® and an agreement index was calculated. Results: Three hundred and thirty-one patients were included for analysis who had received a total of 2,878 drug orders. The incidence of potential DDIs was very high - 89% of all prescriptions. Phenytoin was the drug most commonly implicated, followed by furosemide. Of the DDIs detected, 0.14% were potentially serious and the drug combinations were contraindicated. There was a significant discrepancy between the categories of potential DDIs detected by Epocrates® and Medscape®. No clinically significant DDI was detected in any patient in this cohort. Conclusions: Despite routinely using only a limited number of drugs in stereotyped combinations, prescriptions in surgical departments may not be immune from a significant incidence of DDIs. The use of free apps could reduce the incidence of DDIs, enhance patient safety, and also aid in educating trainees. PMID:28018756

  18. Prescription of Kampo Drugs in the Japanese Health Care Insurance Program

    PubMed Central

    Katayama, Kotoe; Yoshino, Tetsuhiro; Munakata, Kaori; Yamaguchi, Rui; Imoto, Seiya; Miyano, Satoru; Watanabe, Kenji

    2013-01-01

    Kampo medicine or traditional Japanese medicine has been used under Japan's National Health Insurance scheme for 46 years. Recent research has shown that more than 80% of physicians use Kampo in daily practice. However, the use of Kampo from the patient perspective has received scant attention. To assess the current use of Kampo drugs in the National Health Insurance Program, we analysed a total of 67,113,579 health care claim records, which had been collected by Japan's Ministry of Health, Labour and Welfare in 2009. We found that Kampo drugs were prescribed for 1.34% of all patients. Among these, 92.2% simultaneously received biomedical drugs. Shakuyakukanzoto was the most frequently prescribed Kampo drug. The usage of frequently prescribed Kampo drugs differed between the youth and the elderly, males and females, and inpatients and outpatients. Kampo medicine has been employed in a wide variety of conditions, but the prescription rate was highest for disorders associated with pregnancy, childbirth, and the puerperium (4.08%). Although the adoption of Kampo medicine by physicians is large in a variety of diseases, the prescription rate of Kampo drugs is very limited. PMID:24550992

  19. Prescription of kampo drugs in the Japanese health care insurance program.

    PubMed

    Katayama, Kotoe; Yoshino, Tetsuhiro; Munakata, Kaori; Yamaguchi, Rui; Imoto, Seiya; Miyano, Satoru; Watanabe, Kenji

    2013-01-01

    Kampo medicine or traditional Japanese medicine has been used under Japan's National Health Insurance scheme for 46 years. Recent research has shown that more than 80% of physicians use Kampo in daily practice. However, the use of Kampo from the patient perspective has received scant attention. To assess the current use of Kampo drugs in the National Health Insurance Program, we analysed a total of 67,113,579 health care claim records, which had been collected by Japan's Ministry of Health, Labour and Welfare in 2009. We found that Kampo drugs were prescribed for 1.34% of all patients. Among these, 92.2% simultaneously received biomedical drugs. Shakuyakukanzoto was the most frequently prescribed Kampo drug. The usage of frequently prescribed Kampo drugs differed between the youth and the elderly, males and females, and inpatients and outpatients. Kampo medicine has been employed in a wide variety of conditions, but the prescription rate was highest for disorders associated with pregnancy, childbirth, and the puerperium (4.08%). Although the adoption of Kampo medicine by physicians is large in a variety of diseases, the prescription rate of Kampo drugs is very limited.

  20. Marketing drugs, marketing health care relationships: a content analysis of visual cues in direct-to-consumer prescription drug advertising.

    PubMed

    Welch Cline, Rebecca J; Young, Henry N

    2004-01-01

    Proponents and opponents of direct-to-consumer advertising (DTCA) of prescription drugs argue that it promotes greater participation in health care by consumers with significant implications for public health and health care outcomes. This article (a). proposes a social cognitive theoretical framework to explain DTCA's effects, and (b). reports the first in a series of studies on DTCA's observational learning functions that may influence consumer behavior and the physician-patient relationship. This investigation addresses visual features of print DTCA. Results focus on the prevalence and nature of models featured in the ads and how visual cues may offer identity and relational motivators while reinforcing the value of prescription drug treatments. Further, DTCA may market disenfranchising images that increase disparity in health care information and access, despite their argued educational function.

  1. Literacy demands of product information intended to supplement television direct-to-consumer prescription drug advertisements.

    PubMed

    Kaphingst, Kimberly A; Rudd, Rima E; DeJong, William; Daltroy, Lawren H

    2004-11-01

    The US Food and Drug Administration (FDA) allows television direct-to-consumer (DTC) prescription drug advertisements that do not fully disclose drug risks if the ads include "adequate provision" for dissemination of the drug's approved labeling. This requirement can be met in part by referring consumers to multiple text sources of product labeling. This study was designed to assess the materials to which consumers were referred in 23 DTC television advertisements. SMOG assessments showed that the average reading grade levels were in the high school range for the main body sections of the materials and college-level range for the brief summary sections. The Suitability Assessment of Materials (SAM) instrument identified specific difficulties with the materials, including content, graphics, layout, and typography features. Stronger plain language requirements are recommended. Health care providers should be aware that patients who ask about an advertised drug might not have the full information required to make an informed decision.

  2. Pharmaceutical pricing: a review of proposals to improve access and affordability of prescription drugs.

    PubMed

    Tironi, Paula

    2010-01-01

    This article discusses how pharmaceutical innovation achieves remarkable improvements in human health but a significant portion of the U.S. population cannot afford prescription drugs. The author examines ways that patent protection, generics, supply chain complexity, and the cost of innovation and promotion affect access and affordability. The author then looks at the influences of marketing strategies and industry trends such as the patent cliff and pipeline for new drugs, innovations in biotechnology and genomics, comparative effectiveness analysis, and payor and employer strategies on drug prices. An analysis of reform proposals in the context of industry trends suggests that promoting generic drug use and availability through education, prohibiting authorized generics, and restricting the practice of developing follow-on drugs and discontinuing the original formulations upon patent expiration could improve access and affordability most quickly and significantly.

  3. 21 CFR 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary...) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined... section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated...

  4. 21 CFR 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary...) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined... section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated...

  5. 21 CFR 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary...) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined... section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated...

  6. 21 CFR 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary...) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined... section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated...

  7. Multifaceted determinants of online non-prescription drug information seeking and the impact on consumers' use of purchase channels.

    PubMed

    Holtgräfe, Catherine; Zentes, Joachim

    2012-06-01

    The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.

  8. The educational potential of direct-to-consumer prescription drug advertising.

    PubMed

    Kaphingst, Kimberly A; DeJong, William

    2004-01-01

    Food and Drug Administration (FDA) regulations for direct-to-consumer (DTC) prescription drug advertising allow broadcast advertisements with incomplete risk information if the ads refer consumers to physicians, pharmacists, and supplemental information sources. New research reveals several problems with both television advertisements and supplemental text materials that might compromise their ability to meet the FDA's requirement for "fair balance" in the presentation of risks and benefits. In response, we make several recommendations to improve the educational quality of DTC advertising, which can be implemented through either voluntary agreements or revised FDA regulations.

  9. The past, present, and future of direct-to-consumer prescription drug advertising.

    PubMed

    Perri, M; Shinde, S; Banavali, R

    1999-10-01

    Since the first experiences with direct-to-consumer (DTC) prescription drug advertising in the early 1980s, pharmaceutical marketers, government regulators, researchers, health practitioners, and consumers have been both perplexed and intrigued by this practice. As experience with DTC advertising has expanded, so has knowledge and understanding of its risks and rewards. This article discusses important issues in DTC advertising, such as the effects it may have on the patient-practitioner relationship, the diffusion and adoption of new drugs, prices, and competition. It also discusses the future of DTC advertising.

  10. Impact of celebrity pitch in direct-to-consumer advertising of prescription drugs.

    PubMed

    Bhutada, Nilesh S; Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew

    2012-01-01

    Online surveys were conducted to determine the impact of endorser credibility, endorser effectiveness, and consumers' involvement in direct-to-consumer advertising. In a randomized posttest only study, using the elaboration likelihood model, survey participants (U.S. adults) were either exposed to a fictitious prescription drug ad with a celebrity or a noncelebrity endorser. There was no significant difference in credibility and effectiveness between the celebrity and the noncelebrity endorser. High involvement consumers viewed the ad more favorably and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, consumers' involvement did not moderate the effect of celebrity endorser.

  11. Direct-to-consumer advertising of prescription drugs: European Commission persists in putting industry's interests first.

    PubMed

    2013-01-01

    In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.

  12. Knowledge regarding prescription of drugs among dental students: A descriptive study

    PubMed Central

    Jain, Ankita; Gupta, Devanand; Singh, Deepika; Garg, Yogesh; Saxena, Antima; Chaudhary, Himani; Singh, Alpana; Gupta, Rajendra Kumar

    2015-01-01

    Introduction: The act of indicating one or more drugs to be taken by the patient, its dosage, and the interval of the treatment is known as prescribing. It is a dynamic and individualized clinical process. Cultural, social, economic and promotional factors can influence the pattern of prescription. Thus the present study was conducted to evaluate the drug prescription knowledge in third year and final year dental students at Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh, India. Methodology: A questionnaire consisting of 10 open-ended questions was used in a study which was conducted among 170 male and female, third year and final year dental students of Teerthanker Mahaveer Dental College and Research Centre. Tables and graphs were used to represent data. Results: Pain was found to be the most important reason for prescribing medication. Diclofenac was found to be the most commonly prescribed NSAID. While amoxicillin was found to be the most widely prescribed antibiotic. Lack of knowledge about drug posology was the basic reason for error done by students. Maximum number of students gets their information for prescribing drugs from their professors. Maximum number of students was unacquainted about the WHO Guide to Good Prescribing. Conclusion: The knowledge of prescribing drugs is of utmost need for good dental practice and hence, it is essential to expand the knowledge related to pharmacological therapy and to know about the proper therapeutic guidelines. With the help of WHO Guide to Good Prescribing, and some educational programs students will develop better prescribing skills. PMID:26792957

  13. Trends in Exposure to Televised Prescription Drug Advertising, 2003–2011

    PubMed Central

    Kornfield, Rachel; Alexander, G. Caleb; Qato, Dima M.; Kim, Yoonsang; Hirsch, Jan D.; Emery, Sherry L.

    2015-01-01

    Introduction TV accounts for over half of pharmaceutical direct-to-consumer advertising (DTCA) spending in the U.S. The purpose of this study is to quantify average household exposure to branded and non-branded (help-seeking) televised prescription drug advertisements and describe variation over time and according to medication indication and geography. Methods In 2013, Nielsen TV ratings were compiled for prescription pharmaceutical advertising that aired between 2003 and 2011 for the top 75 U.S. media markets. All advertisements were coded as branded or help-seeking. Advertisements were further coded for one of eight prevalent indications (allergies, arthritis, asthma, erectile dysfunction, high cholesterol, smoking cessation, depression, and sleep disorder) or as “other.” Results Televised DTCA exposure increased from 2003 to 2007 and then declined 43% by 2011, to 111 monthly prescription drug advertisements per household. The examined indications were associated with varying amounts and patterns of exposure, with greatest declines among medications for allergies and sleep disorders. Help-seeking advertisements comprised 10% of total exposure, with substantial variation by indication. Conclusions Considerations of DTCA's effects on health care should take into account the shifting concentration of advertising across indications. PMID:25891057

  14. 'He was like a zombie': off-label prescription of antipsychotic drugs in dementia.

    PubMed

    Harding, Rosie; Peel, Elizabeth

    2013-03-01

    This paper explores the legal position of the off-label prescription of antipsychotic medications to people with dementia who experience behavioural and psychological symptoms of dementia (BPSD). Dementia is a challenging illness, and BPSD can be very difficult for carers to manage, with evidence that this contributes to carer strain and can result in the early institutionalisation of people with dementia. As a result, the prescription of antipsychotic and other neuroleptic medications to treat BPSD has become commonplace, in spite of these drugs being untested and unlicensed for use to treat older people with dementia. In recent years, it has become apparent through clinical trials that antipsychotic drugs increase the risk of cerebrovascular accident (stroke) and death in people with dementia. In addition, these types of medication also have other risk factors for people with dementia, including over-sedation and worsening of cognitive function. Drawing on recent questionnaire (n = 185), focus group (n = 15), and interview (n = 11) data with carers of people with dementia, this paper explores the law relating to off-label prescription, and the applicability of medical negligence law to cases where adverse events follow the use of antipsychotic medication. It is argued that the practice of off-label prescribing requires regulatory intervention in order to protect vulnerable patients.

  15. [Evaluation of potential drug interactions in primary health care prescriptions in Vitória da Conquista, Bahia (Brazil)].

    PubMed

    Leão, Danyllo Fábio Lessa; de Moura, Cristiano Soares; de Medeiros, Danielle Souto

    2014-01-01

    Drug interactions are risk factors for the occurrence of adverse drug reactions. The risk for drug interactions includes factors related to prescription that are intrinsic to the patient. This study sought to evaluate the potential drug interactions in primary care prescriptions in Vitória da Conquista in the state of Bahia to fill the knowledge gap on this topic in Brazil. Information about several variables derived from the primary health care prescriptions was collected and drug interactions were evaluated based on information from Medscape and Micromedex(R) databases. Polypharmacy frequency and its association with the occurrence of drug interactions were also evaluated. Results revealed a 48,9% frequency of drug interactions, 74,9% of moderate or greater severity, 8,6% of prescriptions in polypharmacy that in the chi-square test showed a positive association with the occurrence of drug interactions (p < 0,001). Prescriptions from primary care in Vitória da Conquista in the state of Bahia showed a high frequency of drug interactions, however it is necessary to analyze other risk factors for their occurrence at this level of health care.

  16. Prescription Drugs

    MedlinePlus

    ... Percs, Happy Pills, Vikes Depressants: Barbs, Reds, Red Birds, Phennies, Tooies, Yellows, Yellow Jackets; Candy, Downers, Sleeping ... aren’t). It also can cause your body temperature to get dangerously high and make your heart ...

  17. Innocent parties or devious drug users: the views of primary healthcare practitioners with respect to those who misuse prescription drugs

    PubMed Central

    2010-01-01

    Background Many health professionals engage in providing health services for drug users; however, there is evidence of stigmatisation by some health professionals. Prescription drug misusers as a specific group, may also be subject to such judgment. This study aimed to understand issues for primary care health practitioners in relation to prescription drug misuse (PDM), by exploring the attitudes and experiences of healthcare professionals with respect to PDM. Methods Tape-recorded interviews were conducted with a purposive sample of general practitioners (17), community pharmacists (16) and 'key experts' (18) in New Zealand. Interviews were transcribed verbatim and a thematic analysis undertaken. Participants were offered vouchers to the value of NZ$30 for their participation. Results A major theme that was identified was that of two different types of patients involved in PDM, as described by participants - the 'abuser' and the 'overuser'. The 'abuser' was believed to acquire prescription medicines through deception for their own use or for selling on to the illicit market, to use the drugs recreationally, for a 'high' or to stave off withdrawal from illicit drugs. 'Overusers' were characterised as having become 'addicted' through inadvertent overuse and over prescribing, and were generally viewed more sympathetically by practitioners. It also emerged that practitioners' attitudes may have impacted on whether any harm reduction interventions might be offered. Furthermore, whilst practitioners might be more willing to offer help to the 'over-user', it seemed that there is a lack of appropriate services for this group, who may also lack a peer support network. Conclusions A binary view of PDM may not be helpful in understanding the issues surrounding PDM, nor in providing appropriate interventions. There is a need for further exploration of 'over users’ whose needs may not be being met by mainstream drug services, and issues of stigma in relation to

  18. Prescription Opioid Use, Misuse, and Diversion among Street Drug Users in New York City

    PubMed Central

    Rees Davis, W.; Johnson, Bruce D.

    2008-01-01

    Objective The use of heroin, cocaine, and other drugs is well researched in New York City, but prescription opioids (POs) have been overlooked. This study documents patterns of PO use, misuse, and diversion among street drug users, and begins to indicate how drug culture practices interact with the legitimate therapeutic goals of PO prescriptions (e.g. pain management). Methods Staff completed interviews inquiring about the reasons for use of POs and illicit drugs with 586 street drug users. Ethnographers wrote extensive field notes about subjects’ complex patterns of PO use. Results Methadone was used (71.9%) and sold (64.7%) at a higher level than OxyContin, Vicodin, and Percocet, used by between 34% and 38% of the users and sold by between 28% and 41% of the sellers. Recent PO use is associated with the recency of using heroin and cocaine (p<.001). Half of the heroin/cocaine sellers sold POs, and one quarter of the PO sellers only sold POs. Subjects were classified into four groups by whether they diverted POs or used POs to relieve pain or withdrawal rather than for euphoria. This classification was associated with frequency of PO use, whether POs were obtained from doctors/pharmacies or from drug dealers and family members, and those mostly likely to use POs for pain and withdrawal. Conclusions POs are an important component of street drug users’ drug-taking regimes, especially those who are Physically III Chemical Abusers (PICA). Future research is needed to model PO use, misuse, and diversion among this population. PMID:17913395

  19. Physicians' decision process for drug prescription and the impact of pharmaceutical marketing mix instruments.

    PubMed

    Campo, Katia; De Staebel, Odette; Gijsbrechts, Els; van Waterschoot, Walter

    2005-01-01

    This paper provides an in-depth, qualitative analysis of the physicians' decision process for drug prescription. Drugs in the considered therapeutic classes are mainly prescribed by specialists, treating patients with obligatory medical insurance, for a prolonged period of time. The research approach is specifically designed to capture the full complexity and sensitive nature of the physician's choice behavior, which appears to be more hybrid and less rational in nature than is often assumed in quantitative, model-based analyses of prescription behavior. Several interesting findings emerge from the analysis: (i) non-compensatory decision rules seem to dominate the decision process, (ii) consideration sets are typically small and change-resistant, (iii) drug cost is not a major issue for most physicians, (iv) detailing remains one of the most powerful pharmaceutical marketing instruments and is highly appreciated as a valuable and quick source of information, and (v) certain types of non-medical marketing incentives (such as free conference participation) may in some situations also influence drug choices.

  20. Does Reimportation Reduce Price Differences for Prescription Drugs? Lessons from the European Union

    PubMed Central

    Kyle, Margaret K; Allsbrook, Jennifer S; Schulman, Kevin A

    2008-01-01

    Objective To examine the effect of parallel trade on patterns of price dispersion for prescription drugs in the European Union. Data Sources Longitudinal data from an IMS Midas database of prices and units sold for drugs in 36 categories in 30 countries from 1993 through 2004. Study Design The main outcome measures were mean price differentials and other measures of price dispersion within European Union countries compared with within non-European Union countries. Data Collection/Extraction Methods We identified drugs subject to parallel trade using information provided by IMS and by checking membership lists of parallel import trade associations and lists of approved parallel imports. Principal Findings Parallel trade was not associated with substantial reductions in price dispersion in European Union countries. In descriptive and regression analyses, about half of the price differentials exceeded 50 percent in both European Union and non-European Union countries over time, and price distributions among European Union countries did not show a dramatic change concurrent with the adoption of parallel trade. In regression analysis, we found that although price differentials decreased after 1995 in most countries, they decreased less in the European Union than elsewhere. Conclusions Parallel trade for prescription drugs does not automatically reduce international price differences. Future research should explore how other regulatory schemes might lead to different results elsewhere. PMID:18355258

  1. Medicare Part D and the Federal Employees Health Benefits Program: A Comparison of Prescription Drug Coverage

    PubMed Central

    Lovett, Annesha

    2013-01-01

    Background There is much debate currently about how to restructure the Medicare program to achieve better value for the money. Many have cited the Federal Employees Health Benefits Program (FEHBP) as a model for reform. Objective To compare drug coverage and cost-sharing between Medicare Part D and the FEHBP plans. Methods A cross-sectional comparison was conducted of January 2009 data obtained from the Centers for Medicare & Medicaid Services, the Office of Personnel Management, and 3 health plan websites. Regression analysis and t-tests were used to examine drug coverage, copayment, and coinsurance amounts among Medicare Part D and FEHBP plans. The final study sample of Medicare Part D plans consisted of 19 formularies, covering 63% of total Part D enrollment. These 19 formularies represented 232 stand-alone prescription drug plans. In addition, 5 prescription drug plans or formularies in the FEHBP plans were included, which represents 70% of total FEHBP enrollment. Results The results of this study reveal that formulary coverage of the top drugs dispensed and sold in the United States in 2009 ranged from 72% to 94% (average, 84%) in Medicare Part D plans and from 85% to 99% (average, 94%) in the FEHBP plans (P <.01). The mean copayment for generic drugs in Medicare Part D plans was $4.53 compared with a mean of $7.67 (P <.05) in the FEHBP plans. The difference between the 2 programs in mean copayment for brand-name drugs was nonsignificant. For generic drugs, the mean coinsurance rate was 17% for Medicare Part D plans and a mean of 20% for the FEHBP plans (P <.05). Conclusions This analysis shows that there are differences in prescription drug coverage and cost-sharing among plans within Medicare Part D and the FEHBP. To avoid extreme increases in payroll taxes and other revenues or major cutbacks in services, Medicare must explore ways to change the healthcare system to achieve better value for the money. The experience of the FEHBP suggests a possible means of

  2. The effects of involvement and ad type on attitudes toward direct-to-consumer advertising of prescription drugs.

    PubMed

    Limbu, Yam; Torres, Ivonne M

    2009-01-01

    This article examines consumers' attitudes toward Direct-to-Consumer (DTC) advertising of prescription drugs that are influenced by the use different types of DTC ads and product involvement. Our findings suggest that product involvement and the type of DTC ad are significant predictors of consumers' attitudinal responses toward DTC advertising. High involvement consumers have more favorable attitudes toward the drug's price, DTC ad and brand name, and a higher intention to ask a doctor about the advertised drug than low involvement consumers. In contrast to Informational and Reminder DTC ads, Persuasive ads have more favorable effects on consumers' reactions to DTC prescription drug advertising.

  3. Co-Prescription of QT-Interval Prolonging Drugs: An Analysis in a Large Cohort of Geriatric Patients

    PubMed Central

    Schächtele, Simone; Tümena, Thomas; Gaßmann, Karl-Günter; Fromm, Martin F.; Maas, Renke

    2016-01-01

    Background Drug-induced QT-interval prolongation is associated with occurrence of potentially fatal Torsades de Pointes arrhythmias (TdP). So far, data regarding the overall burden of QT-interval prolonging drugs (QT-drugs) in geriatric patients are limited. Objective This study was performed to assess the individual burden of QT-interval prolonging drugs (QT-drugs) in geriatric polymedicated patients and to identify the most frequent and risky combinations of QT-drugs. Methods In the discharge medication of geriatric patients between July 2009 and June 2013 from the Geriatrics in Bavaria–Database (GiB-DAT) (co)-prescriptions of QT-drugs were investigated. QT-drugs were classified according to a publicly available reference site (CredibleMeds®) as ALL-QT-drugs (associated with any QT-risk) or High-risk-QT-drugs (corresponding to QT-drugs with known risk of Torsades de Pointes according to CredibleMeds®) and in addition as SmPC-high-risk-QT-drugs (according to the German prescribing information (SmPC) contraindicated co-prescription with other QT-drugs). Results Of a cohort of 130,434 geriatric patients (mean age 81 years, 67% women), prescribed a median of 8 drugs, 76,594 patients (58.7%) received at least one ALL-QT-drug. Co-prescriptions of two or more ALL-QT-drugs were observed in 28,768 (22.1%) patients. Particularly risky co-prescriptions of High-risk-QT-drugs or SmPC-high-risk-QT-drugs with at least on further QT-drug occurred in 55.9% (N = 12,633) and 54.2% (N = 12,429) of these patients, respectively. Consideration of SmPCs (SmPC-high-risk-QT-drugs) allowed the identification of an additional 15% (N = 3,999) patients taking a risky combination that was not covered by the commonly used CredibleMeds® classification. Only 20 drug-drug combinations accounted for more than 90% of these potentially most dangerous co-prescriptions. Conclusion In a geriatric study population co-prescriptions of two and more QT-drugs were common. A considerable proportion of QT-drugs

  4. How Might the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Affect the Financial Viability of Rural Pharmacies? An Analysis of Preimplementation Prescription Volume and Payment Sources in Rural and Urban Areas

    ERIC Educational Resources Information Center

    Fraher, Erin P.; Slifkin, Rebecca T.; Smith, Laura; Randolph, Randy; Rudolf, Matthew; Holmes, George M.

    2005-01-01

    Passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) has created interest in how the legislation will affect access to prescription drugs among rural beneficiaries. Policy attention has focused to a much lesser degree on the implications of the MMA for the financial viability of rural pharmacies. This article…

  5. Public/Private Partnerships for Prescription Drug Coverage: Policy Formulation and Outcomes in Quebec's Universal Drug Insurance Program, with Comparisons to the Medicare Prescription Drug Program in the United States

    PubMed Central

    Pomey, Marie-Pascale; Forest, Pierre-Gerlier; Palley, Howard A; Martin, Elisabeth

    2007-01-01

    In January 1997, the government of Quebec, Canada, implemented a public/private prescription drug program that covered the entire population of the province. Under this program, the public sector collaborates with private insurers to protect all Quebecers from the high cost of drugs. This article outlines the principal features and history of the Quebec plan and draws parallels between the factors that led to its emergence and those that led to the passage of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) in the United States. It also discusses the challenges and similarities of both programs and analyzes Quebec's ten years of experience to identify adjustments that may help U.S. policymakers optimize the MMA. PMID:17718665

  6. Effectiveness and costs of implementation strategies to reduce acid suppressive drug prescriptions: a systematic review

    PubMed Central

    Smeets, Hugo M; Hoes, Arno W; de Wit, Niek J

    2007-01-01

    Background Evaluation of evidence for the effectiveness of implementation strategies aimed at reducing prescriptions for the use of acid suppressive drugs (ASD). Methods A systematic review of intervention studies with a design according to research quality criteria and outcomes related to the effect of reduction of ASD medication retrieved from Medline, Embase and the Cochrane Library. Outcome measures were the strategy of intervention, quality of methodology and results of treatment to differences of ASD prescriptions and costs. Results The intervention varied from a single passive method to multiple active interactions with GPs. Reports of study quality had shortcomings on subjects of data-analysis. Not all outcomes were calculated but if so rction of prescriptions varied from 8% up to 40% and the cost effectiveness was in some cases negative and in others positive. Few studies demonstrated good effects from the interventions to reduce ASD. Conclusion Poor quality of some studies is limiting the evidence for effective interventions. Also it is difficult to compare cost-effectiveness between studies. However, RCT studies demonstrate that active interventions are required to reduce ASD volume. Larger multi-intervention studies are necessary to evaluate the most successful intervention instruments. PMID:17983477

  7. Study of Drug Utilization Pattern for Skin Diseases in Dermatology OPD of an Indian Tertiary Care Hospital - A Prescription Survey

    PubMed Central

    Pathak, Anuj Kumar; Kumar, Subodh; Kumar, Manish; Dikshit, Harihar

    2016-01-01

    Introduction Skin diseases are the major contributors of disease burden in society. It affects individuals of all ages, neonates to elderly. Owing to its chronic nature, it causes serious impact on quality of life and financial status of the sufferer and his family. The problem gets compounded with the inappropriate and irrational use of medicines. Periodic prescription audit in form of drug utilization study is a way to improve the quality of prescription and curb the menace of irrational prescribing which has become a global phenomenon. Aim This study aims to determine the drug utilization pattern and assess the economic burden of the patient with skin disease. Materials and Methods It was a prospective, cross-sectional study conducted over a period of three months from January to March 2015 in newly diagnosed cases attending outpatient department of Skin and VD, IGIMS, Patna. The prescriptions were analysed with the help of descriptive statistics and results were expressed in percentage. Results Total 752 prescriptions were analysed during the study. Male patients were lesser as compared to female as male to female ratio was 0.88. Over 50% of patients were in adolescent age group i.e. 21-40 years. Acne (17.95%) was most common disease in the study population followed by eczema and Dermatophytosis. Among the drugs, antihistaminics (24.13%) were prescribed most frequently followed by antifungals and antibiotics. Topical agents constituted almost 60% of the total prescription and average number of drugs per prescription was 5.13, irrespective of the dosage forms prescribed. Conclusion This drug utilization study provides an insight to the prescriber regarding various issues related to polypharmacy, cost analysis and prevalent disease pattern in the region. This study also suggests periodic evaluation of prescription pattern to monitor and improve quality of prescription in other departments of the hospital. PMID:27042479

  8. Analysis of clinical records of dental patients attending Jordan University Hospital: Documentation of drug prescriptions and local anesthetic injections

    PubMed Central

    Dar-Odeh, Najla; Ryalat, Soukaina; Shayyab, Mohammad; Abu-Hammad, Osama

    2008-01-01

    Objectives: The aim of this study was to analyze clinical records of dental patients attending the Dental Department at the University of Jordan Hospital: a teaching hospital in Jordan. Analysis aimed at determining whether dental specialists properly documented the drug prescriptions and local anesthetic injections given to their patients. Methods: Dental records of the Dental Department at the Jordan University Hospital were reviewed during the period from April 3rd until April 26th 2007 along with the issued prescriptions during that period. Results: A total of 1000 records were reviewed with a total of 53 prescriptions issued during that period. Thirty records documented the prescription by stating the category of the prescribed drug. Only 13 records stated the generic or the trade names of the prescribed drugs. Of these, 5 records contained the full elements of a prescription. As for local anesthetic injections, the term “LA used” was found in 22 records while the names and quantities of the local anesthetics used were documented in only 13 records. Only 5 records documented the full elements of a local anesthetic injection. Conclusion: The essential data of drug prescriptions and local anesthetic injections were poorly documented by the investigated group of dental specialists. It is recommended that the administration of the hospital and the dental department implement clear and firm guidelines for dental practitioners in particular to do the required documentation procedure. PMID:19209291

  9. Still the Great Debate – "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising

    PubMed Central

    Rollins, Brent L.

    2016-01-01

    The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing? PMID:27239875

  10. Subjective health literacy and older adults' assessment of direct-to-consumer prescription drug ads.

    PubMed

    An, Soontae; Muturi, Nancy

    2011-01-01

    Older adults are increasingly the intended target of direct-to-consumer (DTC) prescription drug ads, but limited evidence exists as to how they assess the educational value of DTC ads and, more importantly, whether their assessment depends on their level of health literacy. In-person interviews of 170 older adults revealed that those with low subjective health literacy evaluated the educational value of DTC ads significantly lower than did those with high subjective health literacy. The results prompt us to pay more scholarly attention to determining how effectively DTC ads convey useful medical information, particularly to those with limited health literacy.

  11. Disseminating findings from a drug class review: using best practices to inform prescription of antiepileptic drugs for bipolar disorder.

    PubMed

    Melvin, Cathy L; Ranney, Leah M; Carey, Timothy S; Evans, W Douglas; AED Dissemination Panel; Kreps, Gary; Linden, Thomas; Oldham, John

    2008-03-01

    Evidence from drug class reviews is often not accessible to practicing clinicians nor is it presented in a way that allows clinicians to use the information to guide treatment and prescribing decisions. Nevertheless, information from such reviews can be very helpful to clinicians as they evaluate the "evidence" provided to them through marketing strategies implemented, primarily, by the pharmaceutical industry and designed to influence their prescribing behavior. Unfortunately, these marketing strategies can be used to promote the off-label use of drugs that may not be efficacious. One example is the pharmaceutical marketing to promote off-label use of gabapentin (Neurontin) for the treatment of bipolar disorder, the legality of which was later addressed in a major lawsuit by the National Association of Attorneys General. We describe an effort to use counter-marketing strategies to compete with those implemented by the pharmaceutical industry and to help clinicians, principally psychiatrists, make use of available evidence to inform their prescription of antiepileptic drugs (AEDs) in the treatment of bipolar disorder. A growing body of literature describes industry marketing practices designed to influence prescriber behavior. This literature suggests that use of competing approaches involving the same underlying strategies to deliver highly credible information from trusted sources can inform prescriber knowledge and prescribing practice. We describe our use of existing evidence to develop accurate and convincing messages and materials to be disseminated nationally to counter industry misinformation and promote evidence-based prescription of AEDs.

  12. Varsity Medical Ethics Debate 2015: should nootropic drugs be available under prescription on the NHS?

    PubMed

    Thorley, Emma; Kang, Isaac; D'Costa, Stephanie; Vlazaki, Myrto; Ayeko, Olaoluwa; Arbe-Barnes, Edward H; Swerner, Casey B

    2016-09-13

    The 2015 Varsity Medical Ethics debate convened upon the motion: "This house believes nootropic drugs should be available under prescription". This annual debate between students from the Universities of Oxford and Cambridge, now in its seventh year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the current usage of nootropic drugs, their safety and whether it would be beneficial to individuals and society as a whole for them to be available under prescription. The Varsity Medical Debate was first held in 2008 with the aim of allowing students to engage in discussion about ethics and policy within healthcare. The event is held annually and it is hoped that this will allow future leaders to voice a perspective on the arguments behind topics that will feature heavily in future healthcare and science policy. This year the Oxford University Medical Society at the Oxford Union hosted the debate.

  13. Has The Era Of Slow Growth For Prescription Drug Spending Ended?

    PubMed Central

    Aitken, Murray; Berndt, Ernst R.; Cutler, David; Kleinrock, Michael; Maini, Luca

    2016-01-01

    In the period 2005–13 the US prescription drug market grew at an average annual pace of only 1.8 percent in real terms on an invoice price basis (that is, in constant dollars and before manufacturers’ rebates and discounts). But the growth rate increased dramatically in 2014, when the market expanded by 11.5 percent—which raised questions about future trends. We determined the impact of manufacturers’ rebates and discounts on prices and identified the underlying factors likely to influence prescription spending over the next decade. These include a strengthening of the innovation pipeline; consolidation among buyers such as wholesalers, pharmacy benefit managers, and health insurers; and reduced incidence of patent expirations, which means that fewer less costly generic drug substitutes will enter the market than in the recent past. While various forecasts indicate that pharmaceutical spending growth will moderate from its 2014 level, the business tension between buyers and sellers could play out in many different ways. This suggests that future spending trends remain highly uncertain. PMID:27605638

  14. Age and the purchase of prescription drug insurance by older adults

    PubMed Central

    Szrek, Helena; Bundorf, M. Kate

    2011-01-01

    The Medicare Part D Prescription Drug Program places an unprecedented degree of choice in the hands of older adults despite concerns over their ability to make effective decisions and desire to have extensive choice in this context. While previous research has compared older adults to younger adults along these dimensions, our study, in contrast, examines how likelihood to delay decision making and preferences for choice differ by age among older age cohorts. Our analysis is based on responses of older adults to a simulation of enrollment in Medicare Part D. We examine how age, numeracy, cognitive reflection, and the interaction between age and performance on these instruments are related to the decision to enroll in a Medicare prescription drug plan and preference for choice in this context. We find that numeracy and cognitive reflection are positively associated with enrollment likelihood and that they are more important determinants of enrollment than age. We also find that greater numeracy is associated with a lower willingness to pay for choice. Hence, our findings raise concern that older adults, and, in particular, those with poorer numerical processing skills, may need extra support in enrolling in the program: they are less likely to enroll than those with stronger numerical processing skills, even though they show greater willingness to pay for choice. PMID:21534689

  15. [Medical prescription and consumption of psychotropic drugs: questions on the differences between men and women].

    PubMed

    Baumann, M; Pommier, J; Deschamps, J P

    1996-01-01

    In health sociology and social epidemiology the gender-related differences in psychotropic drug consumption and prescription have not been throughly investigated. The objective of this review of literature is to analyze women's attitudes and behaviour in psychotropic drug consumption, the cultural influence of the patient's role in the doctor-female patient relation. The family, the society and the cultural aspects related to the role of the patient appear to be factors that strengthen the females' behaviour concerning psychotropic drugs. Results reflect that women consume more psychotropic drugs than men do; when they consult, they obtain them more frequently than men do; and doctors prescribe psychotropic drugs more often to women than to men. However many questions persist about the physicians' role: are the differences in prescriber's attitudes and practices related to their gender or to their patients' gender? Do women doctors prescribe more psychotropic drugs than male doctors? Do the former prescribe more to women than to men? If that is the case, what are the social and cultural reasons that account for this difference? Does a specific socialisation of the two genders account majoritarily for this difference?

  16. Use of Prescription Drug Samples in the USA: A Descriptive Study with Considerations for Pharmacoepidemiology

    PubMed Central

    Hampp, Christian; Greene, Patty; Pinheiro, Simone P.

    2016-01-01

    Introduction Free prescription drug samples provided in physician offices can lead to exposure misclassification in pharmacoepidemiologic studies that rely on pharmacy claims data. Methods We quantified drug-specific sample provision rates based on nationally projected data from a survey of over 3200 US office-based physicians for 1993–2013. Results Between 2009 and 2013, a total of 44.7 % of newly initiated brand-only sitagliptin but only 3.6 % of generically available metformin therapy was provided as samples. We observed similar discrepancies between newly initiated rosuvastatin and simvastatin, dabigatran and warfarin, atomoxetine and methylphenidate, and between oral antibiotic drugs. During continued therapy, sample use was still present though to a lesser extent (sitagliptin 17.0 %, rosuvastatin 23.9 %), and remained high for some oral contraceptives (norethindrone 55.8 %). Oral contraceptives had the longest average days of sample supply (levonorgestrel, continued use 85.1 days). The average days of supply for all other chronically used study drugs ranged from 13.4 (dabigatran, new use) to 25.3 (exenatide, continued use) per sample provided. From 1993 to 2013, we found pronounced drops in sample provisions over time coinciding with more recent generic approval dates. Conclusions We observed markedly differential exposure to medication samples between branded and generic drugs. This can introduce bias in pharmacoepidemiologic studies, especially when adverse events that occur soon after drug initiation are of interest. PMID:26798052

  17. Neuroleptic drug utilization in out-patients--a prescription database study.

    PubMed Central

    Rosholm, J U; Hansen, L J; Hallas, J; Gram, L F

    1993-01-01

    1 A prescription database study was conducted to describe the out-patient utilization of neuroleptics in the Odense area (207,000 inhabitants) during a period of 1 year. 2 Neuroleptic drug use is widespread, the period prevalence being 2.45% of the population. 3 The prevalence increases with increasing age. Fifteen percent of the population aged 90 years or more received neuroleptic drugs in spite of the many warnings against side effects in the elderly. 4 Estimated daily doses of neuroleptics were considerably lower than the Defined Daily Dose, probably as a reflection of many neuroleptics being prescribed to non-psychotic patients, in whom lower doses are used. 5 For perphenazine, a comparison of estimated daily doses from this study with doses from patients whose treatment had been adjusted by plasma concentration monitoring showed that generally much lower doses were used by patients included in this study. PMID:12959276

  18. The economics of direct-to-consumer advertising of prescription-only drugs: prescribed to improve consumer welfare?

    PubMed

    Morgan, Steven; Mintzes, Barbara; Barer, Morris

    2003-10-01

    According to economic theory, one might expect that the informational content of direct-to-consumer advertising of prescription-only drugs would improve consumers' welfare. However, contrasting the models of consumer and market behaviour underlying this theory with the realities of the prescription-only drug market reveals that this market is distinct in ways that render it unlikely that advertising will serve an unbiased and strictly informative function. A review of qualitative evidence regarding the informational content of drug advertising supports this conclusion. Direct-to-consumer prescription drug advertising concentrates on particular products, and features of those products, to the exclusion of others, and the information provided has frequently been found to be biased or misleading in regulatory and academic evaluations. Governments that have so far resisted direct-to-consumer advertising should invest in independent sources of evidence that could help consumers and professionals to better understand the risks and benefits of treating disease with alternative drug and non-drug therapies, rather than permitting direct-to-consumer prescription drug advertising.

  19. Ephemeral profiles of prescription drug and formulation tampering: evolving pseudoscience on the Internet.

    PubMed

    Cone, Edward J

    2006-06-01

    The magnitude of non-therapeutic use, or misuse of prescription pharmaceuticals now rivals that of illicit drug abuse. Drug and formulation tampering enables misusers to administer higher doses by intended and non-intended routes. Perceived motives appear to be a combination of interests in achieving a faster onset and enhancing psychoactive effects. Narcotic analgesics, stimulants, and depressants are widely sought, examined, and tampered with for recreational use. This review examines tampering methods reported on the Internet for selected pharmaceutical products. The Internet provides broad and varied guidance on tampering methods that are specific to drug classes and unique formulations. Instructions are available on crushing, separating, purifying and chemically altering specific formulations to allow changes in dosage, route of administration, and time course of effects. Many pharmaceutical formulations contain features that serve as "barriers" to tampering. The nature and effectiveness of formulation barriers vary widely with many being overcome by adventurous misusers. Examples of successes and failures in tampering attempts are frequently described on Internet sites that support recreational drug use. Successful tampering methods that have widespread appeal evolve into recipes and become archived on multiple websites. Examples of tampering methods include: (1) how to separate narcotic drugs (codeine, hydrocodone, oxycodone) from excipients and non-desirable actives (aspirin, acetaminophen, ibuprofen); (2) overcoming time-release formulations (beads, layers, matrices); (3) removal of active drug from high-dose formulations (patches, pills); (4) alteration of dosage forms for alternate routes of administration. The development of successful formulations that inhibit or prevent drug/formulation tampering with drugs of abuse should take into consideration the scope and practice of tampering methods available to recreational drug users on the Internet.

  20. [Thinking about evaluation of proprietary Chinese medicines containing toxic herbs during switch process of non-prescription drugs].

    PubMed

    Xia, Dongsheng; Cheng, Gang; Li, Xinling; Zhou, Jieming; Xiao, Aili; Zhang, Chengxu; Du, Xiaoxi

    2010-12-01

    To enhance the scientific and fair evaluation about proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs, and to ensure those medicines to be used safely by the public in their self-medication. Combined with current research status of toxic herbs, the experience and knowledge accumulated in the practical work of selection and switch of OTC Chinese medicines for years, thinking about the feasible standards about evaluation and management of proprietary Chinese medicines containing toxic herbs at this stage. Initially established ideas and methods about evaluation of proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs. Basically solved the main problem currently faced by toxic herbs during the OTC switch process of proprietary Chinese medicines, effectively promoted the work on OTC switch, and had the important significance in making consumers use non-prescription drugs conveniently and safely.

  1. Strategic options for brand-name prescription drugs when patents expire.

    PubMed

    Mehta, S C; Mehta, S S

    1997-01-01

    Pharmaceutical companies face a very hostile competitive environment from generic drugs once the patents on their brand name drugs expire. Depending on the country, such patents usually last 10-15 years but no sooner do the patents expire then copies of off-patent brand name drugs, called generics, are introduced, generally by smaller-size and lesser known companies, at significantly lower prices. As health care costs escalate all over the world, efforts to control medication costs have created a major market for generic prescription drugs, particularly in government funded hospitals and in dispensing general practitioner markets of the Asia Pacific and the third world. The world market for generics is estimated at US$20 billion, doubling in only five years and capturing over 30% of the market share. Because of adverse effects on sales and profitability due to the launching of generics, most research based companies that produce original brand-name patented drugs are forced to take counter measures to overcome this problem, particularly when R&D costs for new patents are skyrocketing. This paper develops a brief perspective on this problem and then examines the experiences of many multinational companies in the Singapore market in dealing with the problem. While several different approaches are identified, only one company experience appeared to work successfully and this is discussed in relative detail.

  2. Evidence based educational outreach visits: effects on prescriptions of non-steroidal anti-inflammatory drugs

    PubMed Central

    Bernal-Delgado, E; Galeote-Mayor, M; Pradas-Arnal, F; Peiro-Moreno, S

    2002-01-01

    Design: Randomised controlled simple blind trial, with randomisation into three groups: experimental (evidence based educational outreach visit), placebo (conventional education session), and control (without intervention). Setting: The 24 primary care centres of the National Institute of Healthcare Network in a rural province of Aragon, Spain. Participants: The 24 primary health care teams of the network, with 158 general practitioners (GPs). The teams were randomised into the groups, experimental (8 teams, 48 GPs), placebo (8 teams, 54 GPs), and control (8 teams, 56 GPs). Intervention: Experimental group: one group educational outreach visit, conveying data based on a systematic review of the literature that was reinforced with printed material; placebo group: one non-structured educational session; control group: no intervention. Both educational sessions emphasised that there are no differences in the effectiveness of the NSAIDs reviewed (diclofenac, piroxicam, and tenoxicam); a recommendation was made to prescribe diclofenac over tenoxicam because of price differences. Main outcome measures: Changes in the number of packages prescribed for each of the drugs and changes in the cost per package of NSAIDs prescribed during the six months before, and after the intervention. Results: There were no differences in the basal characteristics of the three groups, except for the number of prescriptions during the six months before the intervention. Prescriptions for NSAIDs decreased homogeneously in the three groups. For tenoxicam, the experimental group reduced prescriptions by 22.5% (95%CI: 34.42 to -10.76), compared with a reduction of 9.78% (95%CI: -17.70 to -1.86) in the placebo group and an increase of 14.44% (95%CI: 5.22 to 23.66) in the control group. The average cost per prescription decreased by 1.91% (95%CI: -0.33% to -3.49%) in the experimental group, 0.16% (95%CI: -0.27% to -2.93%) in the placebo group, and rose by 1.76% (95%CI: 0.35% to 3.17%) in the

  3. Direct-to-consumer marketing of prescription drugs: a current perspective for neurologists and psychiatrists.

    PubMed

    Hollon, Matthew F

    2004-01-01

    In the US and New Zealand, the past decade has seen tremendous growth in the marketing of prescription drugs directly to patients. The pharmaceutical industry has applied pressure in other countries to relax regulations governing such marketing although this has not yet been successful. While we still have much to learn about the potential impact on the public's health of direct-to-consumer (DTC) marketing, some data are available. This article summarises the current literature on the benefits and risks of DTC marketing. This marketing strategy has grown substantially in the US, but only select drugs are advertised. Whether there is net benefit or harm to the public's health as a result of DTC marketing depends critically on which drugs are advertised and the quality of the information provided in promotional material. Critical reviews of this promotional material suggest the information is of poor quality. Notably, 18% of the 50 drugs advertised most intensively in the US were medications used to treat psychiatric and neurological disorders. The impairments in decisional capacity often seen in psychiatric and neurological illness leave patients vunerable to the controlling influence of DTC marketing and, thus, undermine the patient autonomy that is said to be promoted by this marketing strategy. If there is any benefit from DTC marketing it is for significantly undertreated conditions. International restrictions on DTC marketing should remain in place until further evidence of net benefit or harm emerges from the DTC marketing experiment that is taking place in the US and New Zealand.

  4. HIDDEN in PLAIN SIGHT Marketing Prescription Drugs to Consumers in the Twentieth Century

    PubMed Central

    Herzberg, David

    2010-01-01

    Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century. We use trade literature and archival materials to examine the continuity of efforts to promote prescription drugs to consumers and to better grapple with the public health significance of contemporary pharmaceutical marketing practices. PMID:20299640

  5. Hidden in plain sight marketing prescription drugs to consumers in the twentieth century.

    PubMed

    Greene, Jeremy A; Herzberg, David

    2010-05-01

    Although the public health impact of direct-to-consumer (DTC) pharmaceutical advertising remains a subject of great controversy, such promotion is typically understood as a recent phenomenon permitted only by changes in federal regulation of print and broadcast advertising over the past two decades. But today's omnipresent ads are only the most recent chapter in a longer history of DTC pharmaceutical promotion (including the ghostwriting of popular articles, organization of public-relations events, and implicit advertising of products to consumers) stretching back over the twentieth century. We use trade literature and archival materials to examine the continuity of efforts to promote prescription drugs to consumers and to better grapple with the public health significance of contemporary pharmaceutical marketing practices.

  6. Childhood abuse related to nicotine, illicit and prescription drug use by women: pilot study.

    PubMed

    Pederson, Cathy L; Vanhorn, Daniel R; Wilson, Josephine F; Martorano, Lisa M; Venema, Jana M; Kennedy, Sarah M

    2008-10-01

    A sample of 811 women ages 18 to 59 (M=26.0, SD=6.5) responded to an advertisement by telephone. Inquiries were made about childhood abuse status and adult use of alcohol, nicotine, and prescription and illicit drugs. Significant associations were noted for reported sexual, physical, and emotional childhood abuse with use of nicotine, marijuana, and antidepressants in adulthood. Reported childhood physical and emotional abuses were also significantly associated with use of cocaine and anxiolytics, and sexual abuse with antipsychotic use in adulthood. Only childhood emotional abuse was associated with the use of sleeping pills. Number of types of abuse was significantly related with use of nicotine, marijuana, cocaine, antidepressants, antipsychotics, and anxiolytics. Alcohol use was not related to any type of abuse. The long-term effects of childhood emotional abuse may be just as severe as physical or sexual abuse.

  7. Evaluation, use, and usefulness of prescription drug information sources among Anglo and Hispanic Americans.

    PubMed

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

    2010-01-01

    This survey was conducted to determine and compare how Anglo and Hispanic Americans evaluate and use interpersonal, advertising, and mediated sources of prescription drug information. Findings suggest the following: (1) Hispanics rely on doctors, Internet advertising sources, and direct-to-consumer advertising (DTCA), while Anglos frequently use health-related websites and health care professionals; (2) Anglos are more likely to use health-related websites such as WebMD, although Anglos and Hispanics do not appear significantly different in Internet source usefulness evaluation; (3) Hispanics rely on television (TV) and DTC TV advertising more than Anglos, and this tendency is stronger for strong than weak Hispanic identifiers; (4) Hispanics evaluate TV news stories and TV advertising as more useful than Anglos; (5) Hispanics evaluate DTCA more positively and with less skepticism than Anglos; and (6) Hispanic ethnic identification level is positively related to preferences for Spanish-language media and health care professionals.

  8. The unlicensed lives of antidepressants in India: generic drugs, unqualified practitioners, and floating prescriptions.

    PubMed

    Ecks, Stefan; Basu, Soumita

    2009-03-01

    Antidepressant uses have been rising rapidly over the past decades. Two main theories have been advanced to explain this. One claims that socio-economic change causes a global rise of depressive illness. The other holds that European and North American corporations are aggressively marketing antidepressants to expand their global reach. Both theories assume that multinational capitalism drives rising depression rates. Based on ethnographic data from India, this article shows that antidepressants are increasingly used in this country as well, but for reasons than have been little explored yet. Taking fluoxetine (Prozac) as the main example, it is argued that the spread of antidepressants in India is ;unlicensed' by Euro-American corporations in at least three ways: (i) drug marketing is driven by Indian generic producers; (ii) fluoxetine is given by practitioners who have no license to do so; and (iii) knowledge of fluoxetine is spread through unlicensed ;floating' prescriptions that patients take from one prescriber to another.

  9. The Affordable Care Act, health care reform, prescription drug formularies and utilization management tools.

    PubMed

    Ung, Brian L; Mullins, C Daniel

    2015-01-01

    The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability.

  10. A population-based survey of chronic pain and its treatment with prescription drugs.

    PubMed

    Toblin, Robin L; Mack, Karin A; Perveen, Ghazala; Paulozzi, Leonard J

    2011-06-01

    Chronic pain is a common reason for medical visits, but prevalence estimates vary between studies and have rarely included drug treatment data. This study aimed to examine characteristics of chronic pain and its relation to demographic and health factors, and factors associated with treatment of pain with opioid analgesics. A chronic pain module was added to the 2007 Kansas Behavioral Risk Factor Surveillance System (response rate = 61%). Data on prevalence, duration, frequency, and severity of chronic pain, demographics, and health were collected from a representative sample of 4090 adults 18 years and older by telephone. Logistic regression was used to examine the association of both chronic pain and opioid use with demographic and health factors. Chronic pain was reported by 26.0% of the participants and was associated with activity limitations (adjusted odds ratio [AOR] = 3.6, 95% confidence interval [95% CI] 2.8-4.5), arthritis (AOR = 3.3, 95% CI 2.6-4.0), poor mental health (AOR = 2.0, 95% CI 1.4-2.8), poor overall health (AOR = 1.9; 95% CI 1.5-2.5), and obesity (AOR = 1.6; 95% CI 1.2-2.0). Of the 33.4% of people with pain who use prescription pain medication, 45.7% took opioids, including 36.7% of those with mild pain. Chronic pain affects a quarter of adults in Kansas and is associated with poor health. Opioid analgesics are the mainstay of prescribed pharmacotherapy in this group, even among those reporting mild pain. Chronic pain affects 26.0% of adults in the state of Kansas, U.S.A. Overall, 45.7% of people who take prescription drugs for chronic pain reported taking opioid analgesics.

  11. How the US Food and Drug Administration Can Solve the Prescription Drug Shortage Problem

    PubMed Central

    2013-01-01

    Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections’ focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed—the most frequent cause of drug shortages. PMID:23488502

  12. [Appropriate prescription, adherence and safety of non-steroidal anti-inflammatory drugs].

    PubMed

    Sostres, Carlos; Lanas, Ángel

    2016-03-18

    Non-steroidal anti-inflammatory drugs (NSAIDs) are the most numerous category of drugs sharing the same mechanism of action and therapeutic activities (anti-inflammatory, analgesic and anti-pyretic). Despite having similar efficacy for pain relieve, the different available NSAIDs show variability in its safety profile. The risk of gastrointestinal and cardiovascular complications varies depending on the dose of NSAID and also the presence of different risk factors. It is necessary, therefore, an individualized case assessment before establishing the indication of the best NSAID for each patient, taking account of the best gastroprotection strategy. Improved prescription and enhanced treatment adherence are central objectives to reduce NSAID-related complications. A recent consensus of the Spanish Association of Gastroenterology and the Spanish societies of Cardiology and Rheumatology intends to promote the rational use of NSAIDs according to new recent studies. This review provides additional aspects to facilitate the optimal decision-making process in the routine use of these drugs in clinical practice.

  13. Exposure to Prescription Drugs Labeled for Risk of Adverse Effects of Suicidal Behavior or Ideation among 100 Air Force Personnel Who Died by Suicide, 2006-2009

    ERIC Educational Resources Information Center

    Lavigne, Jill E.; McCarthy, Michael; Chapman, Richard; Petrilla, Allison; Knox, Kerry L.

    2012-01-01

    Prescription drugs for many indications are labeled with warnings for potential risk of suicidal ideation or behavior. Exposures to prescription drugs labeled for adverse effects of suicidal behavior or ideation among 100 Air Force personnel who died by suicide between 2006 and 2009 are described. Air Force registry data were linked to…

  14. Trust in online prescription drug information among internet users: the impact on information search behavior after exposure to direct-to-consumer advertising.

    PubMed

    Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew; Zinkhan, George M

    2002-01-01

    The proliferation of both manufacturer-controlled and independent medication-related websites has aroused concern among consumers and policy-makers concerning the trustworthiness of Web-based drug information. The authors examine consumers' trust in on-line prescription drug information and its influence on information search behavior. The study design involves a retrospective analysis of data from a 1998 national survey. The findings reveal that trust in drug information from traditional media sources such as television and newspapers transfers to the domain of the Internet. Furthermore, a greater trust in on-line prescription drug information stimulates utilization of the Internet for information search after exposure to prescription drug advertising.

  15. Exploring the Use of Nonmedical Sources of Prescription Drugs among Immigrant Latinos in the Rural Southeastern USA

    ERIC Educational Resources Information Center

    Vissman, Aaron T.; Bloom, Fred R.; Leichliter, Jami S.; Bachmann, Laura H.; Montano, Jaime; Topmiller, Michael; Rhodes, Scott D.

    2011-01-01

    Background: Little is known about access to medicine among immigrant Latinos in the United States (US). This study explored access to, and use of, prescription drugs obtained from nonmedical sources among recently arrived, Spanish-speaking immigrant Latinos in rural North Carolina (NC). Methods: Our community-based participatory research…

  16. Non-Medical Use of Prescription Drugs among Youth in an Appalachian Population: Prevalence, Predictors, and Implications for Prevention

    ERIC Educational Resources Information Center

    Collins, David; Abadi, Melissa Harris; Johnson, Knowlton; Shamblen, Steve; Thompson, Kirsten

    2011-01-01

    This article examines prevalence of non-medical use of prescription drugs (NMUPD) in a sample of elementary and high school students in an Appalachian Tennessee county. We found that lifetime prevalence of NMUPD (35%) was higher than prevalence of cigarette use (28%) and marijuana use (17%), but lower than lifetime prevalence of alcohol use (46%).…

  17. The Prescription Pattern of Acetaminophen and Non-Steroidal Anti-Inflammatory Drugs in Patients with Liver Cirrhosis.

    PubMed

    Hong, Young Mi; Yoon, Ki Tae; Heo, Jeong; Woo, Hyun Young; Lim, Won; An, Dae Seong; Han, Jun Hee; Cho, Mong

    2016-10-01

    Analgesics, known to be hepatotoxic drugs, are frequently prescribed to patients with liver cirrhosis who are prone to drug-induced liver injury. No guidelines are available regarding the prescription of analgesics in these patients. Therefore, we aimed to evaluate the prescription pattern of most frequently used analgesics in patients with cirrhosis. We assessed the prescription pattern of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with liver cirrhosis registered in Health Insurance Review Assessment Service database between January 1, 2012 and December 31, 2012. A total of 125,505 patients with liver cirrhosis were registered from January 1, 2012 to December 31, 2012. Of that group, 50,798 (40.5%) patients claimed reimbursement for at least one prescription for acetaminophen or NSAIDs during the one year follow-up period. Overall, NSAIDs (82.7%) were more prescribed than acetaminophen (64.5%). NSAIDs were more prescribed than acetaminophen even in decompensated cirrhosis compared with compensated cirrhosis (71.5% vs. 68.8%, P value < 0.001). There was a marked difference in prescription preference between acetaminophen and NSAIDs among physicians. Internists more frequently prescribed acetaminophen than NSAIDs compared to other physicians (50.9% vs. 76.2%, P < 0.001). Gastroenterologists more frequently prescribed acetaminophen over NSAIDs compared to other internists (80.9% vs. 51.2%, P < 0.001). Analgesics were prescribed in 40.5% of patients with cirrhosis. NSAIDs were more frequently prescribed although they should be avoided. The prescription pattern of analgesics were different significantly among physicians in patients with liver cirrhosis. The harmful effects of NSAIDs in patients with cirrhosis should be reminded to all physicians prescribing analgesics.

  18. The Prescription Pattern of Acetaminophen and Non-Steroidal Anti-Inflammatory Drugs in Patients with Liver Cirrhosis

    PubMed Central

    2016-01-01

    Analgesics, known to be hepatotoxic drugs, are frequently prescribed to patients with liver cirrhosis who are prone to drug-induced liver injury. No guidelines are available regarding the prescription of analgesics in these patients. Therefore, we aimed to evaluate the prescription pattern of most frequently used analgesics in patients with cirrhosis. We assessed the prescription pattern of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with liver cirrhosis registered in Health Insurance Review Assessment Service database between January 1, 2012 and December 31, 2012. A total of 125,505 patients with liver cirrhosis were registered from January 1, 2012 to December 31, 2012. Of that group, 50,798 (40.5%) patients claimed reimbursement for at least one prescription for acetaminophen or NSAIDs during the one year follow-up period. Overall, NSAIDs (82.7%) were more prescribed than acetaminophen (64.5%). NSAIDs were more prescribed than acetaminophen even in decompensated cirrhosis compared with compensated cirrhosis (71.5% vs. 68.8%, P value < 0.001). There was a marked difference in prescription preference between acetaminophen and NSAIDs among physicians. Internists more frequently prescribed acetaminophen than NSAIDs compared to other physicians (50.9% vs. 76.2%, P < 0.001). Gastroenterologists more frequently prescribed acetaminophen over NSAIDs compared to other internists (80.9% vs. 51.2%, P < 0.001). Analgesics were prescribed in 40.5% of patients with cirrhosis. NSAIDs were more frequently prescribed although they should be avoided. The prescription pattern of analgesics were different significantly among physicians in patients with liver cirrhosis. The harmful effects of NSAIDs in patients with cirrhosis should be reminded to all physicians prescribing analgesics. PMID:27550489

  19. Drug-Free School Zones: Taking Charge.

    ERIC Educational Resources Information Center

    Thomas, Carol F.

    Information for planning and implementing drug-free school zones within a broader school-community prevention and intervention program is provided in this guidebook. The first section provides background information on drug-free school zone legislation and common elements of drug-free school zones. The risk and protective factors for alcohol and…

  20. The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.

    PubMed

    Kesselheim, Aaron S; Choudhry, Niteesh K

    2008-04-15

    In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and brand-name products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both brand-name and generic drugs, but the prevalence of unauthorized products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.

  1. Multiple Prescription Drug Abuse and Salt Craving in a Psychotic Patient: A Case Report From a Teaching Hospital in Jordan

    PubMed Central

    Jaber, Deema; Al Awwa, Izzat; Wazaify, Mayyada

    2015-01-01

    Introduction: Diuretics and laxative abuse as a means of purging is common in patients with bulimia nervosa and there may be an underestimation of the true prevalence of diuretic abuse, as some are also available without prescription. Case Presentation: A 28-year-old woman presented with tetany due to hypocalcemia, hypokalemia and hypomagnesemia. She had a history of laxative and diuretic abuse, and salt craving. Psychiatric evaluation revealed a disturbed social history with masked depression that necessitated treatment. Conclusions: Multiple prescription drug abuse and salt/salty food addiction usually reflects a personality of addiction, which leads to harmful use and dependence. PMID:26495254

  2. Prescription Drugs: HCFA’s Proposed Drug Utilization Review System Ignores Quality of Care Issues

    DTIC Science & Technology

    1989-07-13

    Page 39 GAO/PEMD-W26ZBR HCFA’s Proposed Drug Utilization Review System Appendix I Major Contributors to This Report Program Evaluation Sushil K... Sharma , Project Manager Bruce Thompson, Project Staff and Methodology Gerald Dillingham, Advisor Division, Washington, Morgan Shulman, Intern D.C. Patrick

  3. Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.

    PubMed

    1982-09-07

    The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.

  4. Nonmedical Use of Prescription Medication Among Adolescents Using Drugs in Quebec

    PubMed Central

    Roy, Élise; Nolin, Marc-Antoine; Traoré, Issouf; Leclerc, Pascale; Vasiliadis, Helen-Maria

    2015-01-01

    Objective: To determine the prevalence and factors associated with nonmedical use of prescription medication (NMUPM) among adolescents who use drugs (ages 12 to 17 years) in Quebec. Method: Secondary data analyses were carried out with data from a 6-month study, namely, the 2010–2011 Quebec Health Survey of High School Students—a large-scale survey that sought to gain a better understanding of the health and well-being of young Quebecers in high school. Bivariate and multivariate logistic regression analyses were conducted to study NMUPM among adolescents who use drugs, according to sociodemographic characteristics, peer characteristics, health indicators (anxiety, depression, or attention-deficit disorder [ADD] with or without hyperactivity), self-competency, family environment, and substance use (alcohol and drug use) factors. Results: Among adolescents who had used drugs in the previous 12 months, 5.4% (95% CI 4.9% to 6.0%) reported NMUPM. Based on multivariate analyses, having an ADD (adjusted odds ratio [AOR] 1.47; 95% CI 1.13 to 1.91), anxiety disorder (AOR 2.14; 95% CI 1.57 to 2.92), low self-esteem (AOR 1.62; 95% CI 1.26 to 2.08), low self-control (AOR 1.95; 95% CI 1.55 to 2.45), low parental supervision (AOR 1.43; 95% CI 1.11 to 1.83), regular alcohol use (AOR 1.72; 95% CI 1.36 to 2.16), and polysubstance use (AOR 4.09; 95% CI 3.06 to 5.48) were associated with increased odds of reporting NMUPM. Conclusions: The observed prevalence of NMUPM was lower than expected. However, the associations noted with certain mental health disorders and regular or heavy use of other psychoactive substances are troubling. Clinical implications are discussed. PMID:26720824

  5. Lifetime history of heroin use is associated with greater drug severity among prescription opioid abusers

    PubMed Central

    Meyer, Andrew C.; Patrick, Mollie E.; Sigmon, Stacey C.

    2014-01-01

    Background While research suggests primary prescription opioid (PO) abusers may exhibit less severe demographic and drug use characteristics than primary heroin abusers, less is known about whether a lifetime history of heroin use confers greater severity among PO abusers. Objective In this secondary analysis, we examined demographic and drug use characteristics as a function of lifetime heroin use among 89 PO-dependent adults screened for a trial evaluating the relative efficacy of buprenorphine taper durations. Exploratory analyses also examined contribution of lifetime heroin use to treatment response among a subset of participants who received a uniform set of study procedures. Methods Baseline characteristics were compared between participants reporting lifetime heroin use ≥5 (H+; n=41) vs. <5 (H−; n=48) times. Treatment response (i.e., illicit opioid abstinence and treatment retention at end of study) was examined in the subset of H+ and H− participants randomized to receive the 4-week taper condition (N=22). Results H+ participants were significantly older and more likely to be male. They reported longer durations of illicit opioid use, greater alcohol-related problems, more past-month cocaine use, greater lifetime IV drug use, and greater lifetime use of cigarettes, amphetamines and hallucinogens. H+ participants also had lower scores on the Positive Symptom Distress and Depression subscales of the Brief Symptom Inventory. Finally, there was a trend toward poorer treatment outcomes among H+ participants. Conclusion A lifetime history of heroin use may be associated with elevated drug severity and unique treatment needs among treatment-seeking PO abusers. PMID:25481453

  6. National Health Spending In 2014: Faster Growth Driven By Coverage Expansion And Prescription Drug Spending.

    PubMed

    Martin, Anne B; Hartman, Micah; Benson, Joseph; Catlin, Aaron

    2016-01-01

    US health care spending increased 5.3 percent to $3.0 trillion in 2014. On a per capita basis, health spending was $9,523 in 2014, an increase of 4.5 percent from 2013. The share of gross domestic product devoted to health care spending was 17.5 percent, up from 17.3 percent in 2013. The faster growth in 2014 that followed five consecutive years of historically low growth was primarily due to the major coverage expansions under the Affordable Care Act, particularly for Medicaid and private health insurance, which contributed to an increase in the insured share of the population. Additionally, the introduction of new hepatitis C drugs contributed to rapid growth in retail prescription drug expenditures, which increased by 12.2 percent in 2014. Spending by the federal government grew at a faster rate in 2014 than spending by other sponsors of health care, leading to a 2-percentage-point increase in its share of total health care spending between 2013 and 2014.

  7. Are antacids necessary as routine prescriptives with non-steroidal anti-inflammatory drugs?

    PubMed

    See, Y; Ng, S C; Tho, K S; Teo, S K

    1998-03-01

    In Singapore, there exists a local habit to routinely prescribe antacids with non-steroidal anti-inflammatory drugs (NSAIDs) perhaps in the belief that gastrointestinal (GI) symptoms and complications are common, and that antacids protect from them. We prospectively studied 140 adults in an orthopaedic clinic who were prescribed a short course of NSAIDs (1 to 4 weeks) without antacids to determine the frequency and severity of GI symptoms. Symptomatic patients were then given antacids to determine their effect on the GI symptoms and followed up by telephone interview. These patients had mild inflammation, soft tissue rheumatism, injury or degenerative disease. All were otherwise well with no known peptic ulcer disease or major illness and were not on ulcerogenic drugs. Only 13 (9.3%) had significant GI symptoms, of which 6 (4.2%) of the total took antacid and 5 (3.5%) had partial or total relief. In this study, GI symptoms were not common with short course NSAIDs in otherwise well patients. Antacids may afford symptomatic relief for GI symptoms. However, because antacids may offer no significant protection against NSAID-induced peptic ulcer, may dangerously mask symptoms of GI irritation, may be troublesome to take and costly on a large scale, we should stop routine prescription of antacids in patients requiring only short-term NSAIDs and not at risk for peptic ulcer disease.

  8. Illicit and prescription drug problems among urban Aboriginal adults in Canada: the role of traditional culture in protection and resilience.

    PubMed

    Currie, Cheryl L; Wild, T Cameron; Schopflocher, Donald P; Laing, Lory; Veugelers, Paul

    2013-07-01

    Illicit and prescription drug use disorders are two to four times more prevalent among Aboriginal peoples in North America than the general population. Research suggests Aboriginal cultural participation may be protective against substance use problems in rural and remote Aboriginal communities. As Aboriginal peoples continue to urbanize rapidly around the globe, the role traditional Aboriginal beliefs and practices may play in reducing or even preventing substance use problems in cities is becoming increasingly relevant, and is the focus of the present study. Mainstream acculturation was also examined. Data were collected via in-person surveys with a community-based sample of Aboriginal adults living in a mid-sized city in western Canada (N = 381) in 2010. Associations were analysed using two sets of bootstrapped linear regression models adjusted for confounders with continuous illicit and prescription drug problem scores as outcomes. Psychological mechanisms that may explain why traditional culture is protective for Aboriginal peoples were examined using the cross-products of coefficients mediation method. The extent to which culture served as a resilience factor was examined via interaction testing. Results indicate Aboriginal enculturation was a protective factor associated with reduced 12-month illicit drug problems and 12-month prescription drug problems among Aboriginal adults in an urban setting. Increased self-esteem partially explained why cultural participation was protective. Cultural participation also promoted resilience by reducing the effects of high school incompletion on drug problems. In contrast, mainstream acculturation was not associated with illicit drug problems and served as a risk factor for prescription drug problems in this urban sample. Findings encourage the growth of programs and services that support Aboriginal peoples who strive to maintain their cultural traditions within cities, and further studies that examine how Aboriginal

  9. Pain, pain catastrophizing, and past legal charges related to drugs.

    PubMed

    Sansone, Randy A; Watts, Daron A; Wiederman, Michael W

    2014-01-01

    Using a self-report survey methodology in a cross-sectional consecutive primary care sample (N = 238), we examined pain at 3 time points (today, past month, past year), pain catastrophizing using the Pain Catastrophizing Scale, and history of legal charges for 5 drug-related crimes as defined by the Federal Bureau of Investigation. Among the subsample of 185 participants with histories of being prescribed analgesics, 33 reported a history of legal charges for drug-related crimes. Analyses of variance among this subsample confirmed statistically significant relationships between the current level of pain and history of legal charges for drug-related crimes, as well as level of pain catastrophizing and history of legal charges for drug-related crimes.

  10. 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.

  11. Medicare program; Medicare Advantage and prescription drug benefit programs: negotiated pricing and remaining revisions. Final rule with comment period.

    PubMed

    2009-01-12

    This rule contains final regulations governing the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D), and interim final regulations governing certain aspects of the Retiree Drug Subsidy (RDS) Program, and reflecting new statutory definitions relating to Special Needs Plans under Part C. The final regulations revising the Part C and Part D regulations include provisions regarding medical savings account (MSA) plans, cost-sharing for dual eligible enrollees in the MA program, the prescription drug payment and novation processes in the Part D program, and the enrollment and appeals processes for both programs. This final rule with comment period also responds to public comments on the May 16, 2008 proposed rule and takes into account statutory revisions contained in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

  12. Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs.

    PubMed

    Chilet-Rosell, Elisa

    2014-01-01

    This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.

  13. Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs

    PubMed Central

    Chilet-Rosell, Elisa

    2014-01-01

    This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes. PMID:25498360

  14. Trends and Determinants of Prescription Drug Use during Pregnancy and Postpartum in British Columbia, 2002–2011: A Population-Based Cohort Study

    PubMed Central

    Smolina, Kate; Hanley, Gillian E.; Mintzes, Barbara; Oberlander, Tim F.; Morgan, Steve

    2015-01-01

    Purpose To describe trends, patterns, and determinants of prescription drug use during pregnancy and postpartum. Methods This is a retrospective, population-based study of all women who gave birth between January 2002 and 31 December 2011 in British Columbia, Canada. Study population consisted of 225,973 women who had 322,219 pregnancies. We examined administrative datasets containing person-specific information on filled prescriptions, hospitalizations, and medical services. Main outcome measures were filled prescriptions during pregnancy and postpartum. We used logistic regressions to examine associations between prescription drug use and maternal characteristics. Results Approximately two thirds of women filled a prescription during pregnancy, increasing from 60% in 2002 to 66% in 2011. The proportion of pregnant women using medicines in all three trimesters of pregnancy increased from 20% in 2002 to 27% in 2011. Use of four or more different types of prescription drug during at least one trimester increased from 8.4% in 2002 to 11.7% in 2011. Higher BMI, smoking during pregnancy, age under 25, carrying multiples, and being diagnosed with a chronic condition all significantly increased the odds of prescription drug use during pregnancy. Conclusions The observed increase in the number of prescriptions and number of different drugs being dispensed suggests a trend in prescribing practices with potentially important implications for mothers, their neonates, and caregivers. Monitoring of prescribing practices and further research into the safety of most commonly prescribed medications is crucial in better understanding risks and benefits to the fetus and the mother. PMID:26011706

  15. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?

    PubMed Central

    Doran, Evan

    2016-01-01

    Hyosun Kim’s report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it PMID:27239884

  16. Opposite Drug Prescription and Cost Trajectories following Integrative and Conventional Care for Pain – A Case-Control Study

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Kohls, Niko; Falkenberg, Torkel

    2014-01-01

    Objectives Pharmacotherapy may have a limited role in long-term pain management. Comparative trajectories of drug prescriptions and costs, two quality-of-care indicators for pain conditions, are largely unknown subsequent to conventional or integrative care (IC) management. The objectives of this study were to compare prescribed defined daily doses (DDD) and cost of first line drugs for pain patients referred to conventional or anthroposophic IC in Stockholm County, Sweden. Methods In this retrospective high quality registry case-control study, IC and conventional care patients were identified through inpatient care registries and matched on pain diagnosis (ICD-10: M79), age, gender and socio-demographics. National drug registry data was used to investigate changes in DDD and costs from 90/180 days before, to 90/180 days after, index visits to IC and conventional care. The primary selected drug category was analgesics, complemented by musculo-skeletal system drugs (e.g. anti-inflammatories, muscle relaxants) and psycholeptics (e.g. hypnotics, sedatives). Results After index care visits, conventional care pain patients (n = 1050) compared to IC patients (n = 213), were prescribed significantly more analgesics. The average (95% CI) group difference was 15.2 (6.0 to 24.3), p = 0.001, DDD/patient after 90 days; and 21.5 (7.4 to 35.6), p = 0.003, DDD/patient after 180 days. The cost of the prescribed and sold analgesics was significantly higher for conventional care after 90 days: euro/patient 10.7 (1.3 to 20.0), p = 0.025. Changes in drug prescription and costs for the other drug categories were not significantly different between groups. Conclusions Drug prescriptions and costs of analgesics increased following conventional care and decreased following IC, indicating potentially fewer adverse drug events and beneficial societal cost savings with IC. PMID:24827981

  17. Study Drugs and Academic Integrity: The Role of Beliefs about an Academic Honor Code in the Prediction of Nonmedical Prescription Drug Use for Academic Enhancement

    ERIC Educational Resources Information Center

    Reisinger, Kelsy B.; Rutledge, Patricia C.; Conklin, Sarah M.

    2016-01-01

    The role of beliefs about academic integrity in college students' decisions to use nonmedical prescription drugs (NMPDs) in academic settings was examined. In Spring 2012 the authors obtained survey data from 645 participants at a small, undergraduate, private liberal arts institution in the Northeastern United States. A broadcast e-mail message…

  18. What Matters Most? Assessing the Influence of Demographic Characteristics, College-Specific Risk Factors, and Poly-Drug Use on Nonmedical Prescription Drug Use

    ERIC Educational Resources Information Center

    Lanier, Christina; Farley, Erin J.

    2011-01-01

    Objective: Although prior recent research has revealed a significant relationship between the nonmedical use of prescription drugs, demographic characteristics, college-specific risk factors, and other substance use among college students, there remains a need to conduct a comparative analysis on the differential impact these factors may have on…

  19. Digital social media, youth, and nonmedical use of prescription drugs: the need for reform.

    PubMed

    Mackey, Tim K; Liang, Bryan A; Strathdee, Steffanie A

    2013-07-26

    The tragic death of 18-year-old Ryan Haight highlighted the ethical, public health, and youth patient safety concerns posed by illicit online nonmedical use of prescription drugs (NUPM) sourcing, leading to a federal law in an effort to address this concern. Yet despite the tragedy and resulting law, the NUPM epidemic in the United States has continued to escalate and represents a dangerous and growing trend among youth and adolescents. A critical point of access associated with youth NUPM is the Internet. Internet use among this vulnerable patient group is ubiquitous and includes new, emerging, and rapidly developing technologies-particularly social media networking (eg, Facebook and Twitter). These unregulated technologies may pose a potential risk for enabling youth NUPM behavior. In order to address limitations of current regulations and promote online safety, we advocate for legislative reform to specifically address NUPM promotion via social media and other new online platforms. Using more comprehensive and modernized federal legislation that anticipates future online developments is critical in substantively addressing youth NUPM behavior occurring through the Internet.

  20. The Moderating Role of Age in Responses to Direct-to-Consumer Prescription Drug Advertising.

    PubMed

    Ball, Jennifer G; Manika, Danae; Stout, Patricia A

    2016-01-01

    Age is an important factor that can influence processing of and response to health messages. Many studies examining evaluations of and responses to direct-to-consumer prescription drug advertising (DTCA) have incorporated age as a predictor variable, moderating variable, or sample criterion. However, findings have been inconsistent. This study attempts to add clarity to this body of research by assessing age differences in the antecedent factors of various DTCA outcomes. A multigroup structural equation modeling analysis revealed several significant differences in variable relationships between older (50+) and younger (<50) adults. Overall, older adults exhibited greater complexity in their consideration of DTCA than younger adults in terms of the sheer number of significant relationships within the model. In particular, trust in mediated health information sources and trust in one's physician appeared to be more relevant predictors for older adults. Trust in DTCA was also distinguished as having an inverse relationship with behavioral intentions among older adults while showing a straightforward positive association with attention among younger adults. Further analysis indicated that health status accounted for some but not all of the age differences. It is suggested that younger adults are more open to seeking additional information following DTCA exposure, whereas older adults remain ambivalent.

  1. Digital Social Media, Youth, and Nonmedical Use of Prescription Drugs: The Need for Reform

    PubMed Central

    Liang, Bryan A; Strathdee, Steffanie A

    2013-01-01

    The tragic death of 18-year-old Ryan Haight highlighted the ethical, public health, and youth patient safety concerns posed by illicit online nonmedical use of prescription drugs (NUPM) sourcing, leading to a federal law in an effort to address this concern. Yet despite the tragedy and resulting law, the NUPM epidemic in the United States has continued to escalate and represents a dangerous and growing trend among youth and adolescents. A critical point of access associated with youth NUPM is the Internet. Internet use among this vulnerable patient group is ubiquitous and includes new, emerging, and rapidly developing technologies—particularly social media networking (eg, Facebook and Twitter). These unregulated technologies may pose a potential risk for enabling youth NUPM behavior. In order to address limitations of current regulations and promote online safety, we advocate for legislative reform to specifically address NUPM promotion via social media and other new online platforms. Using more comprehensive and modernized federal legislation that anticipates future online developments is critical in substantively addressing youth NUPM behavior occurring through the Internet. PMID:23892156

  2. Amendments to regulations regarding eligibility for a Medicare prescription drug subsidy. Final rule.

    PubMed

    2012-01-18

    This final rule adopts, without change, the interim final rule with request for comments we published in the Federal Register on December 29, 2010. The interim final rule incorporated changes to the Medicare prescription drug coverage low-income subsidy (Extra Help) program made by the Patient Protection and Affordable Care Act (Affordable Care Act) enacted in March 2010. Under our interpretation of section 3304 of the Affordable Care Act, if the death of a beneficiary's spouse would decrease or eliminate the subsidy provided by the Extra Help program, we will extend the effective period of eligibility for the most recent determination or redetermination until one year after the month following the month we are notified of the death of the spouse. The effective date of this provision was January 1, 2011. We also revised our regulations to incorporate changes made by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) which affect the way we account for income and resources when determining eligibility for the Extra Help program. The statute provides that we no longer count the value of any life insurance policy as a resource for Extra Help effective on and after January 1, 2010. As of that date, we also no longer count as income the help a beneficiary receives when someone else provides food and shelter, or pays household bills for food, mortgage, rent, electricity, water, property taxes, or heating fuel or gas. These revisions updated our rules to reflect these statutory changes.

  3. Developing Core Competencies for the Prevention and Management of Prescription Drug Misuse: A Medical Education Collaboration in Massachusetts.

    PubMed

    Antman, Karen H; Berman, Harris A; Flotte, Terence R; Flier, Jeffrey; Dimitri, Dennis M; Bharel, Monica

    2016-10-01

    Drug overdose has become the leading cause of injury death in the United States. More than half of those deaths involve prescription drugs, specifically opioids. A key component of addressing this national epidemic is improving prescriber practices.A review of the curricula at the four medical schools in Massachusetts revealed that, although they taught components of addiction medicine, no uniform standard existed to ensure that all students were taught prevention and management strategies for prescription drug misuse. To fill this gap, the governor and the secretary of health and human services invited the deans of the state's four medical schools to convene to develop a common educational strategy for teaching safe and effective opioid-prescribing practices. With leadership from the Department of Public Health and Massachusetts Medical Society, the deans formed the Medical Education Working Group in 2015. This group reviewed the relevant literature and current standards for treating substance use disorders and defined 10 core competencies for the prevention and management of prescription drug misuse.The medical schools have incorporated these competencies into their curricula and have committed to assessing students' competence in these areas. The members of the Medical Education Working Group have agreed to continue to work together on key next steps, including connecting these competencies to those for residents, equipping interprofessional teams to address prescription drug misuse, and developing materials in pain management and opioid misuse for practicing physicians. This first-in-the-nation partnership has yielded cross-institutional competencies that aim to address a public health emergency in real time.

  4. Still the Great Debate - "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    Rollins, Brent L

    2016-02-10

    The above titled paper examined the Food and Drug Administration's (FDA's) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?

  5. Prescription patterns of antihypertensives in a community health centre in Mexico City: a drug utilization study.

    PubMed

    Alba-Leonel, Adela; Carvajal, Alfonso; Fierro, Immaculada; Castillo-Nájera, Fernando; Campos-Ramos, Oscar; Villa-Romero, Antonio; Molina-Guarneros, Juan

    2016-06-01

    Hypertension is highly prevalent; in Mexico, the 2012 National Health and Nutrition Survey reported a prevalence of hypertension of 31.5% in the adult population. Pharmacological treatment is the commonest intervention and has been shown to reduce cardiovascular mortality and morbidity, and total mortality. Accordingly, the type and number of antihypertensives used and the outcome - in terms of blood pressure (BP) control - are important. Therefore, our purpose is to learn the pattern of antihypertensive drug prescription and explore the determinants of BP control in an urban population in Mexico. A retrospective cross-sectional drug utilization study was conducted. Medical records from a community health centre were searched to identify those corresponding to patients diagnosed with hypertension; information upon antihypertensives used and control of the disease was carefully retrieved. A logistic regression model was built to know the main determinants of BP control. A sample of 345 clinical records of interest was identified. Most patients received antihypertensives (86.4%); the leading medications used were angiotensin-converting enzyme inhibitors, 63.8%; beta-blockers (26.5%), diuretics (19.8%), angiotensin-receptor blockers (15.8%) and calcium-channel blockers (6.4%). Only the age (≥55 years) and BMI (>30) of the patients, and the age of the doctors (≥55 years), had an important influence on BP control. Obesity is a particular and important determinant of uncontrolled hypertension; it is worth to act on body weight, on an individual basis. As lack of control has been also tied to elderly doctors, an education programme could be envisaged.

  6. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

    PubMed Central

    Kim, Hyosun

    2015-01-01

    Background: For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. Methods: The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Results: Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion: Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus

  7. Alcohol-Related Problems among Younger Drinkers Who Misuse Prescription Drugs: Results from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC)

    ERIC Educational Resources Information Center

    Hermos, J.; Winter, M.; Heeren, T.; Hingson, R.

    2009-01-01

    The authors determined whether lifetime prescription drug misuse (PDM) associated with increased risks for alcohol-related problems among 18- to 34-year-old, NESARC respondents. Among 8222 "ever-drinkers," 15.4% reported ever "misusing sedatives, tranquilizers, painkillers or stimulants ... as prescriptions or from indirect sources." Outcomes were…

  8. 21 CFR 201.120 - Prescription chemicals and other prescription components.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Prescription chemicals and other prescription... Prescription chemicals and other prescription components. A drug prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions or...

  9. 21 CFR 201.120 - Prescription chemicals and other prescription components.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription chemicals and other prescription... Prescription chemicals and other prescription components. A drug prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions or...

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

    PubMed

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

    2010-11-01

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

  11. [Co-payment on prescription drugs in the Spanish public health system: Certainty, risk and selection of risks].

    PubMed

    Simó Miñana, Juan

    2015-12-01

    The model of co-payment on prescription drugs in the Spanish National Health System (NHS) changed on 1 July 2012. For more than three decades that it was not modified. This article provides a brief historical reminder of the evolution of this model of co-payment. The basic characteristics of this model are compared with the model of copayment on prescription drugs of the Administrative Mutualism (Civil Servants). The document provides detailed information on the percentage of effective copayment, fundraising effects, the economic participation of the patient, among others, in both models. Finally, listed pending improvements not addressed by 2012 changes such as the concentration of the co-payment in the active patient population and risk selection promoted by the differences in the financial contribution between the two models of co-payment (NHS and Mutualist).

  12. Combining user fees exemption with training and supervision helps to maintain the quality of drug prescriptions in Burkina Faso.

    PubMed

    Atchessi, Nicole; Ridde, Valéry; Haddad, Slim

    2013-09-01

    To improve access to health care services, an intervention was implemented in Burkina Faso granting full exemption from user fees. Two further components, staff training and supervision, were added to support the intervention. Our aim in this study was to examine how this tripartite intervention affected the quality of drug prescriptions. Using a mixed methodology, we first conducted an interrupted time series over 24 months. Nine health centres were studied that had previously undergone a process analysis. A total of 14 956 prescriptions for children 0-4 years old were selected by interval sampling from the visit registries from 1 year before to 1 year after the intervention's launch. We then interviewed 14 prescribers. We used three World Health Organization (WHO) indicators to assess drug prescription quality. Analysis was carried out using linear regression and logistic regression. The prescribers' statements underwent content analysis, to understand their perceptions and changes in their practice since the subsidy's introduction. One effect of the intervention was a reduced use of injections (odd ratio (OR) = 0.28 [0.17; 0.46]) in cases of acute lower respiratory tract infections (ALRTI) without comorbidity. Another was a reduction in the inappropriate use of antibiotics in malaria without comorbidity (OR = 0.48 [0.33; 0.70]). The average number of drugs prescribed also decreased (coefficient = -0.14 [-0.20; -0.08]) in cases of ALRTI without comorbidity. The prescribers reported that their practices were either maintained or improved. The user fees exemption programme, combined with health staff training and supervision, did not lead to any deterioration in the quality of drug prescriptions.

  13. Associations Between the Big Five Personality Traits and the Non-Medical Use of Prescription Drugs for Cognitive Enhancement.

    PubMed

    Sattler, Sebastian; Schunck, Reinhard

    2015-01-01

    While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE) behavior are often neglected in research. This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use) as well as a prospective (willingness to use CE drugs) measure of taking prescription drugs with the purpose of augmenting one's cognitive functions (e.g., concentration, memory, or vigilance) without medical necessity. We use data from a large representative survey of German employees (N = 6454, response rate = 29.8%). The Five Factor Model (FFM) of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S), which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (re)use such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future. This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (re)use such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing health

  14. Associations Between the Big Five Personality Traits and the Non-Medical Use of Prescription Drugs for Cognitive Enhancement

    PubMed Central

    Sattler, Sebastian; Schunck, Reinhard

    2016-01-01

    While the number of studies of the non-medical use of prescription drugs to augment cognitive functions is growing steadily, psychological factors that can potentially help explain variance in such pharmaceutical cognitive enhancement (CE) behavior are often neglected in research. This study investigates the association between the Big Five personality traits and a retrospective (prior CE-drug use) as well as a prospective (willingness to use CE drugs) measure of taking prescription drugs with the purpose of augmenting one's cognitive functions (e.g., concentration, memory, or vigilance) without medical necessity. We use data from a large representative survey of German employees (N = 6454, response rate = 29.8%). The Five Factor Model (FFM) of Personality was measured with a short version of the Big Five Personality Traits Inventory (BFI-S), which includes: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. Together with this, demographic variables such as gender, age, education, and income were used as potential confounders in multiple logistic regression models. Our results show a 2.96% lifetime prevalence of CE-drug use and a 10.45% willingness to (re)use such drugs in the future. We found that less conscientious and more neurotic respondents have a higher probability of prior CE-drug use and a greater willingness to use CE drugs in the future. No significant effects were found for openness, extraversion, or agreeableness. Prior CE-drug use was strongly associated with a greater willingness to take such drugs in the future. This study shows that specific personality traits are not only associated with prior enhancement behavior, but also affect the willingness to (re)use such drugs. It helps increase understanding of the risk factors of CE-drug use, which is a health-related behavior that can entail severe side-effects for consumers. The knowledge gathered can thus help improve interventions aimed at minimizing health

  15. Asymmetric responsiveness of physician prescription behavior to drug promotion of competitive brands within an established therapeutic drug class.

    PubMed

    Pedan, Alex; Wu, Hongsheng

    2011-04-01

    This article examines the impact of direct-to-physician, direct-to-consumer, and other marketing activities by pharmaceutical companies on a mature drug category which is in the later stage of its life cycle and in which generics have accrued a significant market share. The main objective of this article is to quantitatively estimate the impact of pharmaceutical promotions on physician prescribing behavior for three different statin brands, after controlling for factors such as patient, physician and physician practice characteristics, generic pressure, et cetera. Using unique panel data of physicians, combined with patient pharmacy prescription records, the authors developed a physician level generalized linear regression model. The generalized estimating equations method was used to account for within physician serial correlations and estimate physician population averaged effects. The findings reveal that even though on average the marketing efforts affect the brand share positively, the magnitude of the effects is very brand specific. Generally, each statin brand has its own trend and because of this, the best choice of predictors for one brand could be suboptimal for another.

  16. The instrumental role of product information: a study of warning labels for non-prescription drugs.

    PubMed

    Discenza, R; Ferguson, J M

    1992-01-01

    The study extends work in informative labeling, fear appeals, and negative information effects. Respondents were given two labels from two packages, one of which contained the experimental treatment. Warning strength was manipulated at three levels: weak, medium, and strong. The data show that, unlike labels on prescription medications, non-prescription warning labels tend to discourage use of the product. Results have implications for information theorists, marketers, and public policy makers.

  17. [Regularity of drugs compatibility of anti-hepatoma traditional Chinese medicine ancient prescriptions and risk evaluation of anti-hepatoma new drug research and development].

    PubMed

    Zhang, Jing; Li, Hong-Fa; Fan, Wei; Liu, Zhen; Man, Shu-Li; Si, Shu-Yong; Gao, Wen-Yuan

    2014-10-01

    Traditional Chinese ancient prescriptions have been used for treatment of liver cancer for a long history and the scientific and rational compatibility is a great wealth for modern research and development (R&D) of new drugs. The research and development of new drugs are often accompanied with a large investment, a long cycle and a high risk, especially for the anti-tumor drugs R&D which are facing more risks and lower successful rate. In this research, the regularity of compatibility of drugs was analyzed from 124 anti-hepatoma ancient prescriptions by computer program. The results can offer help to the R&D of anti-hepatoma new drugs and reduce the risk of drug screening. In addition, we surveyed 22 companies in this field from six provinces such as Beijing, Shanghai, Tianjin and so on and obtained 240 risk assessment questionaires. Then we used qualitative analysis method to interpret the greatest impacts for the risks in the process of R&D, production and sales of anti-hepatoma new drugs. The study provides a basis for anti-liver cancer drugs R&D researchers, who can take effective measures to reduce the R&D risks and improve successful rate.

  18. Design, development, and evaluation of visual aids for communicating prescription drug instructions to nonliterate patients in rural Cameroon.

    PubMed

    Ngoh, L N; Shepherd, M D

    1997-03-01

    In this study, culturally sensitive visual aids designed to help convey drug information to nonliterate female adults who had a prescription for a solid oral dosage form of antibiotic medications were developed and evaluated. The researchers conceptualized the educational messages while a local artist produced the visual aids. Seventy-eight female ambulatory patients were evaluated for comprehension and compliance with antibiotic prescription instructions. The study was conducted in three health centers in Cameroon, West Africa and followed a pre-test, post-test, and follow-up format for three groups: two experimental, and one control. All participants were randomly assigned to either experimental or control groups, 26 patients to each group. Subjects in the experimental groups received visual aids alone or visual aids plus an Advanced Organizer. A comparison of the three groups showed that subjects in the experimental groups scored significantly higher than the control group in both the comprehension and compliance measures.

  19. Examining the Value of Subsidies of Health Plans and Cost-Sharing for Prescription Drugs in the Health Insurance Marketplace

    PubMed Central

    Ngorsuraches, Surachat; Mort, Jane R.

    2016-01-01

    Background The Affordable Care Act (ACA) initiated federally and state-run health insurance exchanges, or marketplaces, with health plans offering subsidies for plan members as well as coverage for essential health benefits, to help individuals, families, and small businesses find health plans that fit their specific needs. A recent study found that the value of these healthcare subsidies varied with the number of health plans in the different geographic rating areas, but that study only examined the premiums and the deductibles of those health plans. Objectives To examine the value of subsidies of health plans, including cost-sharing for prescription drugs in the health insurance marketplace. Methods We have used publicly available health plan data from HealthCare.gov and from county population data obtained from the US Census Bureau in June 2015. The average-weighted premium; medical deductible; medical maximum out-of-pocket spending; and cost-sharing for generic drugs, preferred and nonpreferred brand-name drugs, and specialty drugs were calculated for the second lowest-cost silver plan in each geographic rating area. These were then compared across geographic areas with different numbers of plans to determine the value of the subsidies. We also compared the difference between the cost of the average silver plan and the second lowest-cost silver plan for each area to determine the cost to enrollees if they selected the average silver plan. Results The monetary value of the subsidies provided by health plans was lower in areas with a larger number of plans, because the second lowest-cost silver plans in these areas tended to have lower premiums and higher deductibles. For the most common type of cost-sharing for generic and for preferred brand-name drugs, plan enrollees would likely have a lower or similar copayment if they selected the average-cost silver plan instead of the second lowest-cost silver plan. However, they may end up paying approximately $8 less in

  20. Patterns of prescription drugs use among pregnant women at Sultan Qaboos University Hospital and Sultan Qaboos University Hospital Family and Community Medicine Clinic, Oman

    PubMed Central

    Al-Hamimi, J. Z.; Al Balushi, K. A.

    2016-01-01

    Objective: This study evaluates the patterns of prescription drugs use among women attending antenatal clinic at Sultan Qaboos University Hospital (SQUH) and SQUH Family and Community Medicine clinic (FAMCO), Oman. Methods: The study was a descriptive retrospective cross-sectional study on pregnant women who attended the antenatal clinic at SQUH and FAMCO from February to April 2014 and received a prescription containing at least one drug. Patients’ information was extracted from SQUH electronic records. Results: A total of 105 pregnant women were included in the study. Among the recruited pregnant women, 35 (33.3%) had at least one chronic disease. The average number of drugs prescribed per patient per prescription during the period of pregnancy was 2.33 ± 1.43. Vitamins and minerals were the most frequently prescribed class of drugs (30.60%) followed by analgesics (11.19%) and antidiabetic drugs (10.13%). According to the Food and Drug Administration risk classification, most of the prescribed drugs were from category B (30.0%) and C (27.14%). No drug was prescribed from category X. There was a significant decrease in prescribing category A drugs over the three trimesters (20.7%, 12.7%, and 9.3%, respectively) (P < 0.047). Conclusion: The study gives an overview of the extent of drug prescription during pregnancy and increases the awareness of health-care providers and women about the potential risks of drug use during pregnancy. PMID:28216955

  1. Profile of female patients seeking in-patient treatment for prescription opioid abuse from a tertiary care drug dependence treatment centre from India

    PubMed Central

    Dayal, Prabhoo; Balhara, Yatan Pal Singh

    2016-01-01

    Background & objectives: There has been a limited focus on prescription drug abuse among women in the country. Choice of psychoactive substance, reasons for initiation and co-occurring disorders have been found to be different among men and women. The current study was aimed at studying the profile of female patients seeking in-patient treatment for prescription drug use over a period of five years at a tertiary care drug dependence treatment centre in India. Methods: Case records of all female patients admitted with substance use disorder at a national level drug dependence treatment centre in north India across five years (between January 2008 and December 2012) were reviewed retrospectively to study their socio-demographic and clinical profile. The information was gathered using a semi-structured proforma and detailed case records. Abstinence, relapse and retention rates were calculated. Results: Over the five years, 31 female patients were admitted with prescription drug abuse. Of them, 12 (39%) used prescription opioids and 11 (36%) used prescription opioid along with benzodiazepines. Commonest prescription opioid was pentazocine used by 87 per cent of the women. Twenty two (71%) women were introduced to opioid by medical practitioners and commonest reason for introduction was pain (among 48%). Common co-occurring psychiatric diagnoses were depressive disorder (26%), cluster B traits/disorder (19%) and somatoform disorder (13%). Eight women did not complete treatment and left against medical advice. Thirteen women were advised maintenance treatment, and 70 per cent of them were retained for at least six months. Interpretation & conclusions: Our findings revealed a link between mental illness, pain and non-medical use of prescription opioids among women. Majority of these women received opioids as a legitimate prescription form physician. Therefore, these legitimate prescribers should be trained for pain management to facilitate proper treatment of pain and to

  2. Effect of disease management on prescription drug treatment: what is the right quality measure?

    PubMed

    Mattke, Soeren; Jain, Arvind K; Sloss, Elizabeth M; Hirscher, Randy; Bergamo, Giacomo; O'Leary, June F

    2007-04-01

    Measures of medication adherence have become common parameters with which disease management (DM) programs are being evaluated, leading to the question of how this concept should be measured in the particular context of a DM intervention. We hypothesize that DM improves adherence to prescriptions more than the rate with which prescriptions are being filled. We used health plan claims data to construct 13 common measures of medication adherence for five chronic conditions. The measures were operationalized in three different ways: the Prescription Fill Rate (PFR), which requires only one prescription; the Medication Possession Ratio (MPR), which requires a supply that covers at least 80% of the year; and the Length of Gap (LOG), which requires no gap greater than 30 days between prescriptions. We compared results from a baseline year to results during the first year of a DM program. Changes in adherence were quite small in the first year of the intervention, with no changes greater than six percentage points. In the intervention year, three measures showed a significant increase based on all three operational definitions, but two measures paradoxically decreased based on the PFR. For both, the MPR and the LOG suggested either no change or significant improvement. None of the MPR and LOG measures pointed toward significantly lower compliance in the intervention year. Different ways to operationalize the concept of medication adherence can lead to fundamentally different conclusions. While more complex, MPR- and LOG-based measures could be more appropriate for DM evaluation. Our initial results, however, need to be confirmed by data covering longer term follow-up.

  3. Reducing risk for illicit drug use and prescription drug misuse: High school gay-straight alliances and lesbian, gay, bisexual, and transgender youth.

    PubMed

    Heck, Nicholas C; Livingston, Nicholas A; Flentje, Annesa; Oost, Kathryn; Stewart, Brandon T; Cochran, Bryan N

    2014-04-01

    Previous research suggests that lesbian, gay, bisexual, and transgender (LGBT) youth are at elevated risk for using illicit drugs and misusing prescription drugs relative to heterosexual youth. Previous research also indicates that LGBT youth who attend high schools with a gay-straight alliance (GSA) report having fewer alcohol problems and lower levels of cigarette smoking. The present study investigates whether the absence of a GSA is associated with risk for illicit drug use and prescription drug misuse in a sample of 475 LGBT high school students (M age=16.79) who completed an online survey. After controlling for demographic variables and risk factors associated with illicit drug use, the results of 12 logistic regression analyses revealed that LGBT youth attending a high school without a GSA evidenced increased risk for using cocaine (adjusted odds ratio [adjOR]=3.11; 95% confidence interval [95% CI]=1.23-7.86), hallucinogens (adjOR=2.59; 95% CI=1.18-5.70), and marijuana (adjOR=2.22; 95% CI=1.37-3.59) relative to peers attending a high school with a GSA. Youth without a GSA also evidenced increased risk for the misuse of ADHD medication (adjOR=2.00; 95% CI=1.02-3.92) and prescription pain medication (adjOR=2.00; 95% CI=1.10-3.65). These findings extend the research base related to GSAs and further demonstrate the importance of providing LGBT youth with opportunities for socialization and support within the school setting. Important limitations of the present study are reviewed.

  4. Poor Prescription: The Costs of Imprisoning Drug Offenders in the United States. Policy Report.

    ERIC Educational Resources Information Center

    Schiraldi, Vincent; Holman, Barry; Beatty, Phillip

    Using data from the National Corrections Reporting Program, this study examined trends in imprisoning drug offenders in the United States, focusing on the numbers of incarcerated drug offenders and the relationship between incarceration for drug use and rates of drug use. Overall, the increase in drug admissions to prison from 1986 to 1996 is…

  5. Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.

    PubMed

    2006-11-13

    The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

  6. Prescription drug monitoring program data tracking of opioid addiction treatment outcomes in integrated dual diagnosis care involving injectable naltrexone

    PubMed Central

    Sajid, Ayesha; Whiteman, Aaron; Bell, Richard L.; Greene, Marion S.; Engleman, Eric A.

    2016-01-01

    Background and Objectives Fourfold increases in opioid prescribing and dispensations over 2 decades in the U.S. has paralleled increases in opioid addictions and overdoses, requiring new preventative, diagnostic, and treatment strategies. This study examines Prescription Drug Monitoring Program (PDMP) tracking as a novel measure of opioid addiction treatment outcomes in a university‐affiliated integrated mental health‐addiction treatment clinic. Methods Repeated measure parametrics examined PDMP and urine drug screening (UDS) data before and after first injection for all patients (N = 68) who received at least one long‐acting naltrexone injection (380 mg/IM) according to diagnostic groupings of having either (i) alcohol (control); (ii) opioid; or (iii) combined alcohol and opioid use disorders. Results There were no group differences post‐injection in treatment days, injections delivered, or treatment service encounters. UDS and PDMP measures of opioid exposures were greater in opioid compared to alcohol‐only patients. Post‐first injection, UDS's positive for opioids declined (p < .05) along with PDMP measures of opioid prescriptions (p < .001), doses (p < .01), types (p < .001), numbers of dispensing prescribers (p < .001) and pharmacies (p < .001). Opioid patients without alcohol disorders showed the best outcomes with 50% to 80% reductions in PDMP‐measures of opioids, down to levels of alcohol‐only patients. Conclusions This study shows PDMP utility for measuring opioid addiction treatment outcomes, supporting the routine use of PDMPs in clinical and research settings. Scientific Significance These findings demonstrate that opioid addiction in patients with complex addictions and mental illnesses comorbidities can show effective treatment responses as measured by PDMP tracking of decreases in opioid prescriptions to those patients. (Am J Addict 2016;25:557–564) PMID:27647699

  7. Fair Balance? An Analysis of the Functional Equivalence of Risk and Benefit Information in Prescription Drug Direct-to-Consumer Television Advertising

    ERIC Educational Resources Information Center

    Baird-Harris, Kay

    2009-01-01

    Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…

  8. PTSD, depression, prescription drug use, and health care utilization of Chinese workers affected by the WTC attacks.

    PubMed

    de Bocanegra, Heike Thiel; Moskalenko, Sophia; Kramer, Elizabeth J

    2006-07-01

    This study assessed the impact of the World Trade Center (WTC) attacks on emotional problems, prescription drug usage, and utilization of medical and mental health services within the Chinese community in lower Manhattan. We administered a survey to 148 randomly selected Chinese workers affected by the WTC attacks in March 2003. Although nearly half of the respondents had elevated PTSD and/or elevated depression scores, only a few (4.4%) had talked to a counselor. However, nearly all (86%) reported having visited a physician at least once since September 11, 2001. Individuals with elevated PTSD scores were significantly more likely to have gone to a physician after 9/11. They were also more likely to have received prescription drugs and to indicate an interest in counseling after 9/11 than individuals with low PTSD scores. The findings highlight the role of the primary care physician as gatekeeper for mental health symptoms after a disaster. They further suggest that primary care physicians should use screening tools for depression and posttraumatic stress after a major disaster and that they should be sensitive to potential emotional problems that are associated with somatic complaints.

  9. Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

    PubMed

    Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

    2010-06-01

    This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

  10. An Advance in Prescription Opioid Vaccines: Overdose Mortality Reduction and Extraordinary Alteration of Drug Half-Life.

    PubMed

    Kimishima, Atsushi; Wenthur, Cody J; Zhou, Bin; Janda, Kim D

    2017-01-20

    Prescription opioids (POs) such as oxycodone and hydrocodone are highly effective medications for pain management, yet they also present a substantial risk for abuse and addiction. The consumption of POs has been escalating worldwide, resulting in tens of thousands of deaths due to overdose each year. Pharmacokinetic strategies based upon vaccination present an attractive avenue to suppress PO abuse. Herein, the preparation of two active PO vaccines is described that were found to elicit high-affinity antiopioid antibodies through a structurally congruent drug-hapten design. Administration of these vaccines resulted in a significant blockade of opioid analgesic activity, along with an unprecedented increase in drug serum half-life and protection against lethal overdose.

  11. Nonmedical use of prescription drugs and related negative sexual events: Prevalence estimates and correlates in college students.

    PubMed

    Parks, Kathleen A; Frone, Michael R; Muraven, Mark; Boyd, Carol

    2017-02-01

    The present study of college students investigated (a) the prevalence of nonmedical use of three classes of prescription drugs (stimulants, anxiolytics/sedatives, analgesics), (b) the prevalence of negative sexual events (NSE) associated with any nonmedical use of prescription drugs (NMUPD), and (c) a set of correlates of NSE. The specific NSE were sexual aggression victimization and perpetration, and regretted sex. The correlates of the NSE were sex, race/ethnicity, year in school, psychological symptoms, alcohol use, illegal drug use, and NMUPD. Participants were 509 (254 females, 255 males) randomly-selected college students who reported any NMUPD. The majority (76.2%) of the sample reported ever using stimulants, 38.9% reported ever using anxiolytics/sedatives, and 40.9% reported using analgesics. During NMUPD, 14.3% of the students reported regretted sex, 7.1% of female students reported sexual victimization, and 6.3% of male students reported perpetrating sexual aggression. Multiple logistic regression analyses indicated that anxiolytic/sedative use (Adj. OR=1.99; 95% CI=1.51-2.62) was positively associated with regretted sex, whereas anxiolytic/sedative use (Adj. OR=1.79; 95% CI=1.01-3.16) and psychological symptoms (Adj. OR=1.06; 95% CI=1.02-1.10) were positively associated with sexual victimization. Illegal drug use was positively associated with perpetrating sexual aggression (Adj. OR=4.10; 95% CI=1.21-13.86). These findings suggest that among these college students, NMUPD-associated NSE were not uncommon, and primarily associated with anxiolytic/sedative use. Given the academic, physical, and psychological implications associated with NSE, research needs to further explore the causal nature of these relations.

  12. Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis

    PubMed Central

    2016-01-01

    Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and

  13. Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration.

    PubMed

    Sullivan, Helen W; Campbell, Miriam

    2015-01-01

    Direct-to-consumer prescription drug advertising (DTCA) is a major source of consumer information about prescription drugs. The present study updates 2002 U.S. Food and Drug Administration phone survey questions that found that 44% and 61% of consumers thought that DTCA did not include enough information about benefits and risks, respectively. The present study was administered by mail using a nationally representative sample, and provides a more in-depth understanding of how these beliefs relate to demographic and health characteristics. Data collected from 3,959 respondents to the National Cancer Institute's 2011 Health Information National Trends Survey find results similar to the 2002 survey: 46% and 52% of respondents thought that DCTA did not include enough information about benefits and risks, respectively. Respondents fell into four groups: 23% agreed that DTCA tells enough about drug benefits and risks, 41% disagreed, 18% expressed no opinion, and 18% had discordant beliefs. DTCA attitudes were negatively associated with education, income, and whether respondents purchase prescription drugs; attitudes were positively associated with whether respondents understand prescription drug information. This study confirms that a plurality of Americans believe that DTCA does not include enough information about benefits and risks, suggesting that the educational effect of DTCA could be improved.

  14. 42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... vaccine administration fee for covered Part D drugs that are applicable drugs under the Medicare coverage... MA organizations. Effective January 1, 2006, an MA organization— (i) May not offer an MA...

  15. 42 CFR 423.104 - Requirements related to qualified prescription drug coverage.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... vaccine administration fee for covered Part D drugs that are applicable drugs under the Medicare coverage... MA organizations. Effective January 1, 2006, an MA organization— (i) May not offer an MA...

  16. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  17. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  18. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  19. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  20. 21 CFR 201.22 - Prescription drugs containing sulfites; required warning statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation.... Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite,...

  1. Medications in patients treated with therapeutic plasma exchange: prescription dosage, timing, and drug overdose.

    PubMed

    Ibrahim, Rami B; Balogun, Rasheed A

    2012-01-01

    Therapeutic plasma exchange (TPE) is an extracorporeal process commonly used in clinical medicine for the treatment of a variety of neurological, renal, hematological, dermatological, and other diseases. Inherent to the procedure, patients' plasma removal may lead to the extraction of drugs they are concurrently receiving. This review discusses the published literature assessing TPE's influence on different drug classes' disposition and, when applicable, sets forth management recommendations in cases where the drugs are used at the usual doses and in cases of drug overdose.

  2. Health disparities and direct-to-consumer prescription drug advertising: a content analysis of targeted magazine genres, 1992-2002.

    PubMed

    Mastin, Teresa; Andsager, Julie L; Choi, Jounghwa; Lee, Kyungjin

    2007-01-01

    Health disparities exist in the United States based on race, gender, and socioeconomic status. One way to alleviate some of the disparities regarding certain diseases or conditions is to increase awareness among populations most affected. Physicians have suggested that direct-to-consumer advertising (DTCA) of prescription drugs could play a role in awareness. Social identity theory suggests that individuals are likely to attend messages if they can identify, often based on race or gender, with people portrayed in the messages. This study analyzed DTCA in 11 years of Black, women's, news, and entertainment magazines to determine whether models in the ads targeted specific populations. Black magazines were more likely to contain ads featuring Black models only than were other genres, which had more DTCA picturing White models only. Health conditions the drugs were intended for varied by genre and over time, with STD drugs appearing primarily in Black magazines, and DTCA for heart disease not published in Black magazines, despite cardiovascular diseases being the No. 1 cause of death for Blacks (and Whites). Women's magazines featured DTCA for a wide variety of drugs, reinforcing their roles as caretakers, with proportionally few ads for women's health. Implications for targeted use of magazine genres as a means of providing health information to specific populations are discussed.

  3. Prescriptions and Insurance Plans

    MedlinePlus

    ... the high cost of prescription medicines, most insurance companies and employers are trying to control drug costs. ... is a list of medications that your insurance company will help you pay for. This list is ...

  4. Prescription or proscription? The general failure of attempts to litigate and legislate against PBMS as "fiduciaries," and the role of market forces allowing PBMS to contain private-sector prescription drug prices.

    PubMed

    O'Donnell, Thomas P; Fendler, Mark K

    2007-01-01

    Pharmacy benefit managers (PBMs), which generally administer prescription drug benefits as one component of an employer's or other sponsor's health insurance plan, have come under fire in recent years for turning profits at a time when consumer advocates and employers are struggling to contain the costs of health insurance and prescription drugs. Lawsuits alleging that PBMs are breaching certain fiduciary duties to the health plans they serve, however, have failed for the most part on grounds that PBMs are not "fiduciaries" under the Employee Retirement Income Security Act (ERISA). Moreover, states' attempts to regulate PBMs through legislation imposing fiduciary obligations and other related requirements have also generally failed for many different reasons. This Article examines the PBM industry, recent legal developments concerning PBMs' status as ERISA "fiduciaries", the arguments being made for and against stricter regulation of PBMs' business practices, and why litigation and legislation attempting to impose fiduciary obligations upon PBMs have generally failed. The authors conclude that it is market forces and competition, rather than litigation or legislation, that will effectively motivate PBMs to play a role in the cost containment of prescription drugs in the years ahead.

  5. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better? Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    PubMed

    Doran, Evan

    2016-02-21

    Hyosun Kim's report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it.

  6. Communication Strategies in Direct-to-Consumer Prescription Drug Advertising (DTCA): Application of the Six Segment Message Strategy Wheel.

    PubMed

    Ju, Ilwoo; Park, Jin Seong

    2015-01-01

    This study addresses a void in the literature on direct-to-consumer prescription drug advertising (DTCA) with a theory-based content analysis. The findings indicate that Taylor's communication strategy wheel provides insight into what and how pharmaceutical marketers communicate with consumers by means of DTCA. Major findings are summarized as follows: (a) In most DTC ads, informational and transformational message themes and creative approaches were simultaneously used, indicating a combination strategy; (b) DTCA message themes were associated with creative strategies in alignment with Taylor's framework; and (c) message themes and creative strategies varied across therapeutic categories and DTCA categories with different levels of ad spending. Theoretical and practical implications of the findings are discussed.

  7. Nonmedical prescription drug use among US college students at a Midwest university: a partial test of social learning theory.

    PubMed

    Peralta, Robert L; Steele, Jennifer L

    2010-05-01

    We estimate the prevalence of nonmedical prescription drug (NMPD) use and test social learning theory as an explanation for NMPD use based upon data from a large pilot study. Data were collected from 465 college students at a Midwestern university in the USA using a self-administered questionnaire. The sample was predominantly white (88%), 43% were female and the mean age was 22. Most participants (80%) were not members of social fraternities or sororities. A majority of students did not report NMPD use: 39.4% of respondents reported lifetime NMPD use, 31% reported past-year use, and 14.4% reported past-month use. Multivariate regression results partially supported social learning theory as an explanation for lifetime NMPD use. Limitations and suggestions for future research are suggested.

  8. Development of a Web-Based Clinical Decision Support System for Drug Prescription: Non-Interventional Naturalistic Description of the Antipsychotic Prescription Patterns in 4345 Outpatients and Future Applications

    PubMed Central

    Berrouiguet, Sofian; Barrigón, Maria Luisa; Brandt, Sara A.; Ovejero-García, Santiago; Álvarez-García, Raquel; Carballo, Juan Jose; Lenca, Philippe; Courtet, Philippe; Baca-García, Enrique

    2016-01-01

    Purpose The emergence of electronic prescribing devices with clinical decision support systems (CDSS) is able to significantly improve management pharmacological treatments. We developed a web application available on smartphones in order to help clinicians monitor prescription and further propose CDSS. Method A web application (www.MEmind.net) was developed to assess patients and collect data regarding gender, age, diagnosis and treatment. We analyzed antipsychotic prescriptions in 4345 patients attended in five Psychiatric Community Mental Health Centers from June 2014 to October 2014. The web-application reported average daily dose prescribed for antipsychotics, prescribed daily dose (PDD), and the PDD to defined daily dose (DDD) ratio. Results The MEmind web-application reported that antipsychotics were used in 1116 patients out of the total sample, mostly in 486 (44%) patients with schizophrenia related disorders but also in other diagnoses. Second generation antipsychotics (quetiapine, aripiprazole and long-acting paliperidone) were preferably employed. Low doses were more frequently used than high doses. Long acting paliperidone and ziprasidone however, were the only two antipsychotics used at excessive dosing. Antipsychotic polypharmacy was used in 287 (26%) patients with classic depot drugs, clotiapine, amisulpride and clozapine. Conclusions In this study we describe the first step of the development of a web application that is able to make polypharmacy, high dose usage and off label usage of antipsychotics visible to clinicians. Current development of the MEmind web application may help to improve prescription security via momentary feedback of prescription and clinical decision support system. PMID:27764107

  9. Competition in prescription drug markets: the roles of trademarks, advertising, and generic names.

    PubMed

    Feldman, Roger; Lobo, Félix

    2013-08-01

    We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.

  10. 42 CFR 410.30 - Prescription drugs used in immunosuppressive therapy.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and... carriers may consider factors such as authoritative drug compendia, current medical literature,...

  11. 75 FR 69093 - Prescription Drug User Fee Act; Reopening of the Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ...) requires public review of the recommendations for the human drug review program after negotiations with the... requires that before FDA begins negotiations with the regulated industry on PDUFA reauthorization, we do... drug review program after negotiations with the regulated industry conclude. FDA expects that...

  12. Prescription Drugs: Comparison of DOD, Medicaid, and Medicare Part D Retail Reimbursement Prices

    DTIC Science & Technology

    2014-06-01

    package size and type (e.g., 100 capsules in a bottle ). A drug can have multiple NDCs associated with it. For example, a drug made by one manufacturer, in...Report Fraud, Waste, and Abuse in Federal Programs Congressional Relations Public Affairs Please Print on Recycled Paper.

  13. 75 FR 4973 - Registration Requirements for Importers and Manufacturers of Prescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ...The Drug Enforcement Administration (DEA) is amending its registration regulations to ensure that a registration is obtained for every location where ephedrine, pseudoephedrine, or phenylpropanolamine, or drug products containing one of these chemicals, are imported or manufactured. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the......

  14. 75 FR 52765 - Development and Distribution of Patient Medication Information for Prescription Drugs; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... HUMAN SERVICES Food and Drug Administration Development and Distribution of Patient Medication... patient medication information (PMI) to be provided to patients who are prescribed drug products. Under... determined that the current system is not adequate to ensure that patients receive the essential...

  15. Impact of Animated Spokes-Characters in Print Direct-to-Consumer Prescription Drug Advertising: An Elaboration Likelihood Model Approach.

    PubMed

    Bhutada, Nilesh S; Rollins, Brent L; Perri, Matthew

    2017-04-01

    A randomized, posttest-only online survey study of adult U.S. consumers determined the advertising effectiveness (attitude toward ad, brand, company, spokes-characters, attention paid to the ad, drug inquiry intention, and perceived product risk) of animated spokes-characters in print direct-to-consumer (DTC) advertising of prescription drugs and the moderating effects of consumers' involvement. Consumers' responses (n = 490) were recorded for animated versus nonanimated (human) spokes-characters in a fictitious DTC ad. Guided by the elaboration likelihood model, data were analyzed using a 2 (spokes-character type: animated/human) × 2 (involvement: high/low) factorial multivariate analysis of covariance (MANCOVA). The MANCOVA indicated significant main effects of spokes-character type and involvement on the dependent variables after controlling for covariate effects. Of the several ad effectiveness variables, consumers only differed on their attitude toward the spokes-characters between the two spokes-character types (specifically, more favorable attitudes toward the human spokes-character). Apart from perceived product risk, high-involvement consumers reacted more favorably to the remaining ad effectiveness variables compared to the low-involvement consumers, and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, the moderating effect of consumers' involvement was not observed (nonsignificant interaction effect between spokes-character type and involvement).

  16. Living in the "land of no"? Consumer perceptions of healthy lifestyle portrayals in direct-to-consumer advertisements of prescription drugs.

    PubMed

    Frosch, Dominick L; May, Suepattra G; Tietbohl, Caroline; Pagán, José A

    2011-10-01

    Direct-to-consumer advertising (DTCA) of prescription drugs is the most common form of health communication Americans are exposed to. The effects of DTCA on prescription requests and utilization are well established, but little is known about the effects of advertisements on health behaviors. Many advertisements, especially those promoting drugs to prevent or treat cardiovascular disease, refer to lifestyle change as a way to improve health. However, no studies have examined how consumers interpret these frequently ambiguous messages. We used in-depth interviews with 45 participants, recruited in Los Angeles, USA between April 2007 and July 2008, to explore perceptions of 5 advertisements for drugs that prevent or treat cardiovascular disease (Lipitor(®), Vytorin(®), Zetia(®), Caduet(®), Plavix(®)). We found that participants interpreted advertising messages within their own life context and identified four trajectories for enacting behavior change versus taking prescription drugs: Negotiators, Avoiders, Embracers and Jumpstarters. Underlying these four typologies were beliefs about whether lifestyle change was something an individual could do or was willing to do. Our results also show how an advertisement narrative could potentially shift perceptions of causality by suggesting that high cholesterol is primarily hereditary, thereby obviating the need for lifestyle change. Some participants stated that they would prefer lifestyle change to a particular prescription drug, but felt that others would be more likely to embrace taking a prescription drug. This "Third Person Effect" may be masking participants' intentions by identifying a more socially desirable route to therapeutic change. These findings raise questions about how the typologies are distributed in the population and how advertising may shift consumers' beliefs over time, thereby contributing to new forms of medicalization. Effective regulation of DTCA may require expanding scrutiny beyond the

  17. Charged copolypeptide vesicles with controlled size for intracellular drug delivery

    NASA Astrophysics Data System (ADS)

    Holowka, Eric Peter

    Much focus has been given to the synthesis of polypeptidic based materials due to their unique structural features. These polypeptides commonly are amphiphilic in character that benefit from secondary structural features associated with one of the polymer blocks. These features, such as alpha-helix and beta-sheet conformations, allow for control over nanoscale ordering through self-assembly for use in biological sensors and therapeutic drug delivery. We report the preparation and characterization of charged amphiphilic block copolypeptide vesicle formers using transition metal mediated living ring-opening polymerization of N-carboxyanhydrides (NCAs). The vesicle membranes show fluidic properties suggested by dynamic physical behavior allowing for fine size adjustments using liposomal extrusion methods. This extrusion also allows for a facile mode of encapsulation of biomolecules for drug delivery. Modification of the charged residues has shown vesicle stability under osmotic and thermal stress, in pH buffers, and serum cell media, as well as the ability for lipid interaction and cellular interactions.

  18. Medicare and state health care programs; fraud and abuse: OIG civil money penalties under the Medicare prescription drug discount card program. Interim final rule with comment period.

    PubMed

    2004-05-19

    In accordance with section 1860D-31 of the Social Security Act, this rule sets forth the OIG's new authority for imposing civil money penalties (CMPs) against endorsed sponsors under the Medicare prescription drug discount card program that knowingly engage in false or misleading marketing practices; overcharge program enrollees; or misuse transitional assistance funds.

  19. Medicare and state health care programs; fraud and abuse: OIG civil money penalties under the Medicare prescription drug discount card program. Final rule.

    PubMed

    2004-12-14

    In accordance with section 1860D-31 of the Social Security Act, this rule finalizes OIG's new authority for imposing civil money penalties (CMPs) against endorsed sponsors under the Medicare prescription drug discount card program that knowingly engage in false or misleading marketing practices; overcharge program enrollees; or misuse transitional assistance funds.

  20. 42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region 423.415 Section 423.415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE...

  1. 42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region 423.415 Section 423.415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE...

  2. 42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region 423.415 Section 423.415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE...

  3. 42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region 423.415 Section 423.415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE...

  4. 42 CFR 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region 423.415 Section 423.415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE...

  5. Characterization of Adolescent Prescription Drug Abuse and Misuse Using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R]) System

    ERIC Educational Resources Information Center

    Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick

    2013-01-01

    Objective: To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R])) System. Method: Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all…

  6. Trauma, Emotional Distress, Race and Ethnicity, Gender, Greek Affiliation, and Year-in-School as Predictors of Nonmedical Use of Prescription Drugs among Undergraduate College Students

    ERIC Educational Resources Information Center

    Jeffs, Patrick Thomas

    2013-01-01

    The purpose of this study was to identity how events perceived as traumatic or very difficult to handle, factors of emotional distress, and demographics may predict nonmedical use of prescription drugs (NMPD) among traditional undergraduate college students. This secondary analysis utilized data from the National College Health Assessment II (NCHA…

  7. Effects of comparative claims in prescription drug direct-to-consumer advertising on consumer perceptions and recall.

    PubMed

    O'Donoghue, Amie C; Williams, Pamela A; Sullivan, Helen W; Boudewyns, Vanessa; Squire, Claudia; Willoughby, Jessica Fitts

    2014-11-01

    Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers' perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug's efficacy and risk; therefore, caution should be used when presenting

  8. The rabbit in the hat: dubious argumentation and the persuasive effects of prescription drug advertising (DTCA).

    PubMed

    Rubinelli, Sara; Nakamoto, Kent; Schulz, Peter J

    2008-01-01

    There is an ongoing global debate over the potential benefits and risks of allowing direct-to-consumer advertising of prescription medicines (DTCA). The core of this debate concerns the identification of DTCA either as a beneficial procedure to be promoted or as a damaging procedure to be abolished. Economic data on DTCA suggest that this form of advertising has an impact on consumers. Based on this premise, we explore the use of argumentation theory to inquire into the reasons for this success. In particular, by combining perspectives from argumentation theory and marketing research this paper aims to test the hypothesis of whether DTCA presents information framed in potentially misleading, but persuasive, argumentative structures. We highlight and discuss the results of two studies designed to assess whether readers perceive DTCA as argumentative and, if so, which explicit and implicit elements provide groundings for the inference that consumers draw from the ads. The analysis highlights the presence in DTCA of dubious arguments (fallacies and distracting claims) that may go unnoticed. Also, it illustrates the nature of readers' wrong assumptions that arise independently from the contents of the ads. These factors seem to influence the level of the self-perceived persuasiveness of DTCA.

  9. Can a medical need clause help manage the growing costs of prescription drugs in the EU?

    PubMed

    Brooks, Eleanor; Geyer, Robert

    2016-04-01

    Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

  10. ADVANCED TOOLS FOR ASSESSING SELECTED PRESCRIPTION AND ILLICIT DRUGS IN TREATED SEWAGE EFFLUENTS AND SOURCE WATERS

    EPA Science Inventory

    The purpose of this poster is to present the application and assessment of advanced technologies in a real-world environment - wastewater effluent and source waters - for detecting six drugs (azithromycin, fluoxetine, omeprazole, levothyroxine, methamphetamine, and methylenedioxy...

  11. The cost-effectiveness of direct-to-consumer advertising for prescription drugs.

    PubMed

    Atherly, Adam; Rubin, Paul H

    2009-12-01

    In this paper we use published information to analyze the economic value of Direct to Consumer Advertising (DTCA). The reviewed research finds that DTCA leads to increased demand for the advertised drug and that the effect of the drug tends to be class-wide rather than product specific. There is weak evidence that DTCA may increase compliance and improve clinical outcomes. However, there is little research on the effect of DTCA on inappropriate prescribing or on the characteristics of patients who respond to treatment. On net, if the advertised drugs are cost effective on average and the patients using the drugs in response to the advertisement are similar to other users, DTCA is likely cost effective. Overall, the literature to date is consistent with the idea that DTCA is beneficial, but further research is needed before definitive conclusions can be drawn.

  12. Rational prescription of drugs within similar therapeutic or structural class for gastrointestinal disease treatment: Drug metabolism and its related interactions

    PubMed Central

    Zhou, Quan; Yan, Xiao-Feng; Zhang, Zhong-Miao; Pan, Wen-Sheng; Zeng, Su

    2007-01-01

    AIM: To review and summarize drug metabolism and its related interactions in prescribing drugs within the similar therapeutic or structural class for gastrointestinal disease treatment so as to promote rational use of medicines in clinical practice. METHODS: Relevant literature was identified by performing MEDLINE/Pubmed searches covering the period from 1988 to 2006. RESULTS: Seven classes of drugs were chosen, including gastric proton pump inhibitors, histamine H2-receptor antagonists, benzamide-type gastroprokinetic agents, selective 5-HT3 receptor antagonists, fluoroquinolones, macrolide antibiotics and azole antifungals. They showed significant differences in metabolic profile (i.e., the fraction of drug metabolized by cytochrome P450 (CYP), CYP reaction phenotype, impact of CYP genotype on interindividual pharmacokinetics variability and CYP-mediated drug-drug interaction potential). Many events of severe adverse drug reactions and treatment failures were closely related to the ignorance of the above issues. CONCLUSION: Clinicians should acquaint themselves with what kind of drug has less interpatient variability in clearance and whether to perform CYP genotyping prior to initiation of therapy. The relevant CYP knowledge helps clinicians to enhance the management of patients with gastrointestinal disease who may require treatment with polytherapeutic regimens. PMID:17948937

  13. 21 CFR 310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., and reporting of postmarketing adverse drug experiences to FDA. (b) Definitions. The following... severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral... and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (1) Postmarketing...

  14. Dispelling the myth of "smart drugs": cannabis and alcohol use problems predict nonmedical use of prescription stimulants for studying.

    PubMed

    Arria, Amelia M; Wilcox, Holly C; Caldeira, Kimberly M; Vincent, Kathryn B; Garnier-Dykstra, Laura M; O'Grady, Kevin E

    2013-03-01

    This study tested the hypothesis that college students' substance use problems would predict increases in skipping classes and declining academic performance, and that nonmedical use of prescription stimulants (NPS) for studying would occur in association with this decline. A cohort of 984 students in the College Life Study at a large public university in the US participated in a longitudinal prospective study. Interviewers assessed NPS; Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) cannabis and alcohol use disorders; and frequency of skipping class. Semester grade point average (GPA) was obtained from the university. Control variables were race, sex, family income, high school GPA, and self-reported attention deficit hyperactivity disorder diagnosis. Longitudinal growth curve modeling of four annual data waves estimated the associations among the rates of change of cannabis use disorder, percentage of classes skipped, and semester GPA. The associations between these trajectories and NPS for studying were then evaluated. A second structural model substituted alcohol use disorder for cannabis use disorder. More than one-third (38%) reported NPS for studying at least once by Year 4. Increases in skipping class were associated with both alcohol and cannabis use disorder, which were associated with declining GPA. The hypothesized relationships between these trajectories and NPS for studying were confirmed. These longitudinal findings suggest that escalation of substance use problems during college is related to increases in skipping class and to declining academic performance. NPS for studying is associated with academic difficulties. Although additional research is needed to investigate causal pathways, these results suggest that nonmedical users of prescription stimulants could benefit from a comprehensive drug and alcohol assessment to possibly mitigate future academic declines.

  15. Exercise Prescription.

    ERIC Educational Resources Information Center

    Ribisl, Paul M.

    If exercise programs are to become effective in producing the desired results, then the correct exercise prescription must be applied. Four variables should be controlled in the prescription of exercise: (a) type of activity, (b) intensity, (c) duration, and (d) frequency. The long-term prescription of exercise involves the use of a (a) starter…

  16. Drug-related problems associated with self-medication and medication guided by prescription: A pharmacy-based survey

    PubMed Central

    Panda, Abinash; Pradhan, Supriya; Mohapatra, Gurukrushna; Mohapatra, Jigyansa

    2016-01-01

    Objectives: The objective of this study is to identify and compare the nature of the drug-related problems (DRPs) associated with self-medication and non-self-medication (drug use guided by a prescription). Materials and Methods: The cross-sectional, observational study was conducted on 1100 adult participants at a convenience sample of six retail private pharmacy counters. The data collection form was based on the Pharmaceutical Care Network Europe version 6.2 classification for DRPs. Descriptive statistics was used to represent the prevalence of DRPs. Chi-square test was used to find out the association between the type of medication and DRPs. Odds ratio (OR) with confidence interval (CI) was computed to find the factors determining the occurrence of DRPs. P < 0.05 was considered to be statistically significant. Data were analyzed using SPSS version 16.0. Results: The prevalence of self-medication was 18.72%. The prevalence of DRPs was 17.36%. In the self-medication group, the prevalence of DRPs was high (40.78%) as compared to the non-self-medication group (11.97%). DRP related to inappropriate drug dosing was observed in 44.83% and 40.45% subjects in self-medication and non-self-medication group, respectively (P < 0.001). The subjects in the self-medication group were about 5 times likely to have a DRP (OR: 5.06, CI: 3.59-7.14, P < 0.001). Conclusions: Self-medication is associated with a higher risk of various DRPs. Since retail pharmacy outlet is often the first point of contact between the patient and the health care system in a developing country, interventions like drug information activities at the retail pharmacy is likely to bring down the DRPs associated with self-medication. PMID:27721536

  17. Everyday drug diversions: A qualitative study of the illicit exchange and non-medical use of prescription stimulants on a university campus

    PubMed Central

    Vrecko, Scott

    2015-01-01

    This article investigates everyday experiences and practises that are associated with processes of pharmaceuticalization and with practices of ‘drug diversion’—that is, the illicit exchange and non-medical use of prescription drugs. It reports results from a qualitative study that was designed to examine the everyday dimensions of non-medical prescription stimulant use among students on an American university campus, which involved 38 semi-structured interviews with individuals who used prescription stimulants as a means of improving academic performance. While discussions of drug diversion are often framed in terms of broad, population-level patterns and demographic trends, the present analysis provides a complementary sociocultural perspective that is attuned to the local and everyday phenomena. Results are reported in relation to the acquisition of supplies of medications intended for nonmedical use. An analysis is provided which identifies four different sources of diverted medications (friends; family members; black-market vendors; deceived clinicians), and describes particular sets of understandings, practices and experiences that arise in relation to each different source. Findings suggest that at the level of everyday experience and practice, the phenomenon of prescription stimulant diversion is characterised by a significant degree of complexity and heterogeneity. PMID:25455480

  18. Everyday drug diversions: a qualitative study of the illicit exchange and non-medical use of prescription stimulants on a university campus.

    PubMed

    Vrecko, Scott

    2015-04-01

    This article investigates everyday experiences and practises that are associated with processes of pharmaceuticalization and with practices of 'drug diversion'--that is, the illicit exchange and non-medical use of prescription drugs. It reports results from a qualitative study that was designed to examine the everyday dimensions of non-medical prescription stimulant use among students on an American university campus, which involved 38 semi-structured interviews with individuals who used prescription stimulants as a means of improving academic performance. While discussions of drug diversion are often framed in terms of broad, population-level patterns and demographic trends, the present analysis provides a complementary sociocultural perspective that is attuned to the local and everyday phenomena. Results are reported in relation to the acquisition of supplies of medications intended for nonmedical use. An analysis is provided which identifies four different sources of diverted medications (friends; family members; black-market vendors; deceived clinicians), and describes particular sets of understandings, practices and experiences that arise in relation to each different source. Findings suggest that at the level of everyday experience and practice, the phenomenon of prescription stimulant diversion is characterised by a significant degree of complexity and heterogeneity.

  19. Home-Sweet-Home Health Care [and] Drugs Manufacturing: A Prescription for Jobs.

    ERIC Educational Resources Information Center

    Freeman, Laura; Heffler, Stephen

    1995-01-01

    Lower costs, new technology, and expanded Medicare benefits are some of the reasons for the rapid increase in employment in home health services. Employment in the drugs manufacturing industry has increased despite recessions and structural changes in the economy. (Author/JOW)

  20. ADVANCED TOOLS FOR ASSESSING SELECTED PRESCRIPTION AND ILLICIT DRUGS IN TREATED SEWAGE EFFLUENTS AND SOURCE WATERS

    EPA Science Inventory

    The purpose of this poster is to present the application and assessment of advanced state-of-the-art technologies in a real-world environment - wastewater effluent and source waters - for detecting six drugs [azithromycin, fluoxetine, omeprazole, levothyroxine, methamphetamine, m...

  1. 38 CFR 1.515 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... program, including a program approved by the Secretary of Health and Human Services under section 399O of the Public Health Service Act (42 U.S.C. 280g-3). (c) Participation in PDMPs. VA may disclose to PDMPs.... Examples include the identification of the substance by a national drug code number, quantity...

  2. 38 CFR 1.515 - Disclosure of information to participate in state prescription drug monitoring programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... program, including a program approved by the Secretary of Health and Human Services under section 399O of the Public Health Service Act (42 U.S.C. 280g-3). (c) Participation in PDMPs. VA may disclose to PDMPs.... Examples include the identification of the substance by a national drug code number, quantity...

  3. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from... potassium permanganate is not effective in producing abortion, but that instead the drug produces serious... that the article would be used in an attempt to induce abortion. (4) Any preparation of...

  4. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from... potassium permanganate is not effective in producing abortion, but that instead the drug produces serious... that the article would be used in an attempt to induce abortion. (4) Any preparation of...

  5. 21 CFR 250.108 - Potassium permanganate preparations as prescription drugs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from... potassium permanganate is not effective in producing abortion, but that instead the drug produces serious... that the article would be used in an attempt to induce abortion. (4) Any preparation of...

  6. Pharmacy benefit managers and their obligations during serious prescription drug shortages.

    PubMed

    Teagarden, J R; Epstein, R S

    2013-02-01

    Pharmacy benefit managers are connected to some 215 million Americans and to every prescribing physician and retail pharmacy in the United States. Many of them have their own large and sophisticated dispensing operations. These capabilities could be put to use when drug shortages threaten life. Indeed, these capabilities are such that they confer obligations on pharmacy benefit managers to address such shortages--not only on behalf of their clients but for society in general.

  7. Off-label drugs prescription in neonatology: a physician's duty or a medical hazardous attitude?

    PubMed

    d'Aloja, Ernesto; Paribello, Francesco; Demontis, Roberto; Müller, Mima

    2011-10-01

    The off-label and unlicensed use of drugs in neonatology is a widespread reality in all the NICUs. Several explanations may be given to justify the extension of this phenomenon and, among them, the lack of ad hoc clinical trials in neonatal subpopulation and the freedom to cure worldwide recognized to relatives and physicians. It is well known that adverse effects are more frequent, more serious and more underreported when medicines are used unauthorized or off-label, being physicians in theory responsible for the newborn physical damage. To avoid this responsibility, we believe that a shared legal framework may be helpful where the informative process on risks/benefits ratio for the newborn has a pivotal role. The National and International Scientific Societies should promote a common guidelines also for the informations on drug effects to be supplied to relatives. But at the same time EMA has to implement its strong policy towards the mandatory request on trials, for every new drug, on specific neonatal and pediatric subpopulations.

  8. The Effect of Prescription Opioid Injection on the Risk of Non-Fatal Overdose Among People who Inject Drugs

    PubMed Central

    Lake, Stephanie; Hayashi, Kanna; Buxton, Jane; Milloy, M-J; Dong, Huiru; Wood, Evan; Montaner, Julio; Kerr, Thomas

    2015-01-01

    Objectives Prescription opioid (PO) use by people who inject drugs (PWID) is a growing public health concern. Non-fatal overdose remains a leading source of morbidity among PWID, however, little is known about the relationship between PO injection and non-fatal overdose in this population. In this study we sought to examine the impact of PO injection on non-fatal overdose among PWID from Vancouver, Canada. Methods Data were derived from two open prospective cohorts of PWID for the period of December, 2005 to May, 2014. Multivariable generalized estimating equations were used to examine the odds of overdose among those who injected: POs; heroin; and POs and heroin. Results In total, 1660 PWID (33.7% women) participated in this study. In multivariable analyses, in comparison to those who were injecting non-opioid drugs, exclusive PO injection was not significantly associated with non-fatal overdose (adjusted odds ratio [AOR]: 1.17, 95% confidence interval [CI]: 0.74 – 1.86). The odds of non-fatal overdose were elevated for heroin injection (AOR: 1.72, 95% CI: 1.31 – 2.27), but were greatest for those who injected both heroin and POs (AOR: 2.46, 95% CI: 1.83 – 3.30). Discussion Compared to injecting non-opioids, injecting POs exclusively did not increase risk of non-fatal overdose; however, injecting both POs and heroin doubled the risk. This may reflect consistencies in drug potency and composition when POs are used, as well as unique characteristics of exclusive PO injectors. Our findings call for the continued scale-up of evidence-based overdose prevention interventions for people who inject opioids, including POs. PMID:26454837

  9. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the... relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is... physician. (c) A clear warning statement against use of the drug in the presence of high fever or if...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the... relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is... physician. (c) A clear warning statement against use of the drug in the presence of high fever or if...

  11. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the... relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is... physician. (c) A clear warning statement against use of the drug in the presence of high fever or if...

  12. 21 CFR 310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the... relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is... physician. (c) A clear warning statement against use of the drug in the presence of high fever or if...

  13. Quality of Instructions on Prescription Drug Labels: Effects on Memory and Comprehension in Young and Old Adults.

    ERIC Educational Resources Information Center

    Morrell, Roger W.; And Others

    1989-01-01

    Examined comprehension of and memory for information on prescription labels as function of age, memory load, and study time across three experiments with young and old adults. Older adults consistently manifested poorer recall of prescription information than did younger adults. Both young and old adults had substantial difficulty comprehending…

  14. Amendments to regulations regarding eligibility for a Medicare prescription drug subsidy. Interim final rule with request for comments.

    PubMed

    2010-12-29

    We are revising our regulations to incorporate changes to the Medicare prescription drug coverage low-income subsidy (Extra Help) program made by the Affordable Care Act which was enacted on March 23, 2010. Under our interpretation of section 3304 of the Affordable Care Act and this interim final rule, if the death of a beneficiary's spouse would decrease or eliminate the subsidy provided by the Extra Help program, we will, based on a determination, or redetermination, extend the effective period of eligibility for the most recent determination or redetermination until 1 year after the month following the month we are notified of the death of the spouse. These regulatory changes will allow us to implement this provision of the Affordable Care Act when it goes into effect on January 1, 2011. We are also revising our regulations to incorporate changes made by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), which affect the way we account for income and resources when determining eligibility for the Extra Help program. The statute provides that we no longer count as a resource the value of any life insurance policy for Extra Help applications filed, or redeterminations that are effective, on or after January 1, 2010. In addition, we will no longer count as income the help a beneficiary receives when someone else provides food and shelter, or pays household bills for food, mortgage, rent, electricity, water, property taxes, or heating fuel or gas. These revisions will update our rules to reflect these statutory changes.

  15. A systematic review of reference pricing: implications for US prescription drug spending.

    PubMed

    Lee, Joy Li-Yueh; Fischer, Micahel A; Shrank, William H; Polinski, Jennifer M; Choudhry, Niteesh K

    2012-11-01

    Given rising pharmaceutical expenditures and the widespread use of reference pricing as a costcontainment instrument abroad, we systematically reviewed the evidence evaluating reference pricing policies. We performed a structured electronic search of peer-reviewed journals for studies published before that reported on the effects of reference pricing policies on medication use, payer and patient spending, and resource consumption. Our search yielded 16 studies describing 9 reference-pricing policies from 6 countries. Reference-pricing policies led to decreases in drug prices and increases in utilization of targeted medications, while also reducing payer and patient expenditures. In addition, these policies did not lead to increased use of medical services, such as physician office visits and hospitalization. These results suggest that reference pricing may be an attractive policy strategy for the US healthcare system.

  16. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs.

    PubMed

    Lexchin, Joel; Gagnon, Marc-André

    2014-05-06

    On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by:  Committing Canada to creating a new system of patent term restoration thereby delaying entry of generic medicines by up to two years; Locking in Canada's current term of data protection, and creating barriers for future governments wanting to reverse it;  Implementing a new right of appeal under the patent linkage system that will create further delays for the entry of generics.CETA will only affect intellectual property rights in Canada-not the EU. This analysis estimates that CETA's provisions will increase Canadian drug costs by between 6.2% and 12.9% starting in 2023. The Canadian government committed to compensating provinces for the rise in costs for their public drug plans. Importantly, this means that people paying out-of-pocket for their drugs or receiving them through private insurance, will be charged twice: once through higher drug costs and once more through their federal taxes.As drug costs continue to grow, there are limited options available for provincial/territorial governments: restrict the choice of medicines in public drug plans; transfer costs to patients who typically are either elderly or sick; or take money from other places in the health system, and threaten the viability of Canada's single payer system. CETA will therefore negatively impact the ability of Canada to offer quality health care.

  17. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs

    PubMed Central

    2014-01-01

    On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by: • Committing Canada to creating a new system of patent term restoration thereby delaying entry of generic medicines by up to two years; • Locking in Canada’s current term of data protection, and creating barriers for future governments wanting to reverse it; • Implementing a new right of appeal under the patent linkage system that will create further delays for the entry of generics. CETA will only affect intellectual property rights in Canada—not the EU. This analysis estimates that CETA’s provisions will increase Canadian drug costs by between 6.2% and 12.9% starting in 2023. The Canadian government committed to compensating provinces for the rise in costs for their public drug plans. Importantly, this means that people paying out-of-pocket for their drugs or receiving them through private insurance, will be charged twice: once through higher drug costs and once more through their federal taxes. As drug costs continue to grow, there are limited options available for provincial/territorial governments: restrict the choice of medicines in public drug plans; transfer costs to patients who typically are either elderly or sick; or take money from other places in the health system, and threaten the viability of Canada’s single payer system. CETA will therefore negatively impact the ability of Canada to offer quality health care. PMID:24885309

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

    PubMed Central

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

    2014-01-01

    Aims Most risks of nonsteroidal anti-inflammatory drugs (NSAIDs) are pharmacological, dose and duration dependent. Usage patterns of prescription-only (POM) or ‘over-the-counter (OTC)’ NSAIDs may influence risks, but are not commonly described. Methods The Echantillon Généraliste de Bénéficiaires database, the permanent 1/97 representative sample from the French national healthcare insurance systems, was queried over 2009–2010 to identify usage patterns, concomitant chronic diseases and cardiovascular medication in OTC and POM NSAID users. Results Over 2 years, 229 477 of 526 108 patients had at least one NSAID dispensation; 44 484 patients (19%) were dispensed only OTC NSAIDs (93% ibuprofen) and 121 208 (53%) only POM NSAIDs. The OTC users were younger (39.9 vs. 47.4 years old) and more often female (57 vs. 53%); 69% of OTC users and 49% of POM users had only one dispensation. A mean of 14.6 defined daily doses (DDD) were dispensed over 2 years for OTC vs. 53 for POM; 93% OTC vs. 60% POM patients bought ≤ 30 DDD over 2 years, and 1.5 vs. 12% bought ≥ 90 DDD. Chronic comorbidities were found in 19% of OTC users vs. 28% of POM users; 24 vs. 37% had at least one dispensation of a cardiovascular drug over the 2 years. Conclusions Most of the use of NSAIDs appears to be short term, especially for OTC-type NSAIDs, such as ibuprofen. The validity of risk estimates for NSAIDs extrapolated from clinical trials or from observational studies not including OTC-type usage may need to be revised. PMID:24102791

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

    PubMed Central

    Schmidt, Morten; Hallas, Jesper; Friis, Søren

    2014-01-01

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

  20. 21 CFR 1306.03 - Persons entitled to issue prescriptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Persons entitled to issue prescriptions. 1306.03 Section 1306.03 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE PRESCRIPTIONS General Information § 1306.03 Persons entitled to issue prescriptions. (a) A prescription for a...