The Global Online Sexuality Survey (GOSS): the United States of America in 2011 chapter II: phosphodiesterase inhibitors utilization among English speakers.

INTRODUCTION: Utility of phosphodiesterase inhibitors (PDEi's) for the treatment of erectile dysfunction (ED) has been the focus of experimental and clinical studies. However, public preferences, attitudes, and experiences with PDEi's are rarely addressed from a population/epidemiology viewpoint. The Global Online Sexuality Survey (GOSS) is a worldwide epidemiologic study of sexuality and sexual disorders, first launched in the Middle East in 2010, followed by the United States in 2011. AIM: To describe the utilization rates, trends, and attitudes toward PDEi's in the United States in the year 2011. METHODS: GOSS was randomly deployed to English-speaking male Web surfers in the United States via paid advertising on Facebook®, comprising 146 questions. MAIN OUTCOME MEASURES: Utilization rates and preferences for PDEi's by brand. RESULTS: Six hundred three subjects participated; mean age 53.43 years ± 13.9. Twenty-three point seven percent used PDEi's on more consistent basis, 37.5% of those with ED vs. 15.6% of those without ED (recreational users). Unrealistic safety concerns including habituation were pronounced. Seventy-nine point six percent of utilization was on prescription basis. PDEi's were purchased through pharmacies (5.3% without prescription) and in 16.5% over the Internet (68% without prescription). Nine point six percent nonprescription users suffered coronary heart disease. Prescription use was inclined toward sildenafil, generally, and particularly in severe cases, and shifted toward tadalafil in moderate ED and for recreational use, followed by vardenafil. Nonprescription utilization trends were similar, except in recreational use where sildenafil came first. CONCLUSION: In the United States unrealistic safety concerns over PDEi's utility exist and should be addressed. Preference for particular PDEi's over the others is primarily dictated by health-care providers, despite lack of guidelines that govern physician choice. Online and over-the-counter sales of PDEi's are common, and can expose a subset of users to health risks. Recreational use of PDEi's is common, and could be driven by undiagnosed premature ejaculation.

Classification, location and legitimacy of web-based suppliers of Viagra to the UK.

OBJECTIVES: to categorise online suppliers of Viagra based on their legal status, and to quantify the suppliers within each category. METHODS: Google was used to search for websites offering to sell or supply either proprietary Viagra tablets or generic versions containing sildenafil citrate. Relevant websites were classified as falling into one of three categories, which were further subclassified. Simple descriptive statistics were calculated. KEY FINDINGS: the number of relevant sites found within the first 100 Google hits, following the removal of mirror and affiliate sites, was 44. Only 6.8% of sites identified were legitimate online pharmacies. Some 34.1% of sites offered to sell Viagra to patients in the UK without any form of medical consultation. Whether or not the online consultation offered by 59.1% of sites had to be completed in order to make a purchase could not be confirmed. The location of only three pharmacies could be ascertained; the remainder made various claims as to their location, which could not be verified. CONCLUSIONS: we have been unable to verify that the questionnaires used for online consultations are scrutinised by any healthcare practitioners to determine the appropriateness of the treatment sought. This represents a serious safety concern for UK residents who procure drugs for erectile dysfunction on the internet.

From prescription-only to over-the-counter medicines ('PoM to P'): time for an intermediate category.

BACKGROUND: Increasing numbers of medicines are being made available over the counter in the UK, by purchase in a pharmacy or from other less well-regulated outlets. When this is allowed by the Licensing Authority, it is often subject to certain restrictions. However, some drugs that could usefully be converted from prescription-only medicines (PoM status) to over-the-counter sales in a pharmacy (P status) are not suitable for full over-the-counter status, even with restrictions; and in some cases restrictions vitiate the usefulness of the medicine. AREAS OF AGREEMENT: Drugs that can acceptably be switched from PoM status to P status include those that are used in the treatment of minor ailments or injuries, for health promotion or in palliative care. AREAS OF CONTROVERSY: However, not all drugs that are being switched fall into these categories. Ready availability of antimicrobial drugs over the counter, one of which (azithromycin) has recently been switched, could encourage the emergence of resistant organisms. Drugs that are used for long-term treatment and lifestyle drugs are also controversial, particularly if their adverse effects are of potential concern. On the other hand, the availability of many drugs via the internet removes the ability of regulators to control the supply of such drugs. A POSSIBLE SOLUTION: A new category of purchase, Pharmacist Consultation and Supply, with built-in safeguards, could improve the availability of some medicines under more careful control than is currently available for over-the-counter medicines.

Should sildenafil be available over the counter?

INTRODUCTION: This article considers the process of re-classification of prescription drugs from prescription-only medications to over-the-counter (OTC) prescription drugs. SOURCES OF DATA: The recent change in classification for emergency contraception and simvastatin is explored in detail with similarities and differences being considered for a similar argument to be made for sildenafil. AREAS OF AGREEMENT: The benefits for patients, physicians and other healthcare professionals are considered in detail. AREAS OF CONTROVERSY: We raise concerns about recently developed and existing patient group directions that, although extensive in their assessment, may omit to identify significant contributory factors which would necessitate appropriate medical intervention. GROWING POINTS: While the decision for re-classification to OTC would depend on a number of factors, we argue that, with the proviso of proper assessments being made, sildenafil should be made available as an OTC medication. AREAS TIMELY FOR DEVELOPING RESEARCH: The safety and use of OTC medications for erectile dysfunction at a time when many first line prescription agents are reaching generic status.

Confronting trade-offs in health care: Harvard Pilgrim Health Care's organizational ethics program.

Patients, providers, and policy leaders need a new moral compass to guide them in the turbulent U.S. health care system. Task forces have proposed excellent ethical codes, but these have been seen as too abstract to provide guidance at the front lines. Harvard Pilgrim Health Care's ten-year experience with an organizational ethics program suggests ways in which health care organizations can strengthen transparency, consumer focus, and overall ethical performance and contribute to the national health policy dialogue.

What happened to the prescribing of other COX-2 inhibitors, paracetamol and non-steroidal anti-inflammatory drugs when rofecoxib was withdrawn in Australia?

OBJECTIVES: To analyse how the prescribing of cyclooxygenase-2 (COX-2) inhibitors, non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs) and paracetamol (acetaminophen) changed when rofecoxib was withdrawn in 2004. METHOD: COX-2 inhibitors, paracetamol and ns-NSAID's use was measured using dispensing data for concession beneficiaries subsidized by the Australian Pharmaceutical Benefit Scheme (PBS) for the period of 1997-2005. Data were downloaded from the Medicare Australia website and converted, according to the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) (2005), to DDD/1000 concession beneficiaries/day. RESULTS: In the period 2000-2004, the use of COX-2 inhibitors was progressively increased. Overall NSAID's use changed from approximately 80 to 105 DDD/1000 concession beneficiaries/day while a decrease of ns-NSAIDs from about 70 to 40 DDD/1000 concession beneficiaries/day was observed. Following rofecoxib withdrawal, the overall NSAIDs use declined. In 2005, celecoxib prescription declined (23%) while prescription of meloxicam increased by 62%. Use of paracetamol was steady over the period 1997-2004 (around 40 DDD/1000 concession beneficiaries/day). In April 2005, a slight increase in paracetamol use was observed. CONCLUSION: Our analysis showed that COX-2 inhibitors prescribing markedly influenced the overall NSAIDs prescribing in Australia. When COX-2 inhibitors were introduced their uptake was rapid and extensive. Following rofecoxib withdrawal, the total overall dispensing of NSAIDs returned to a similar value as before COX-2 inhibitors' introduction. The decrease was due both to rofecoxib withdrawal and to a reduction in celecoxib prescribing. However, meloxicam use increased. Paracetamol prescribing was steady, between 1997 and 2005 and was not affected when the COX-2 inhibitors were introduced on to the market and after rofecoxib withdrawal, rather than increasing as might have been anticipated after rofecoxib withdrawal.

Characterizing new users of NSAIDs before and after rofecoxib withdrawal.

AIMS: To characterize patients initiated on nonsteroidal anti-inflammatory drugs (NSAIDs), pre and postrofecoxib withdrawal, by age, gender and concomitant cardiovascular (CV) therapy. METHODS: A national primary care prescription database was used to identify patients who initiated NSAID therapy pre and postrofecoxib withdrawal. Patients receiving CV therapy were identified in the same periods also. Adjusted odds ratios (OR) and 95% confidence intervals are presented. RESULTS: Female patients [OR = 1.15 (1.11, 1.19)], those over 65 years [OR = 2.76 (2.65, 2.86)] and those at CV risk [OR = 1.72 (1.67, 1.79)] were more likely to start on celecoxib (over a nonselective NSAID) than male patients, those under 65 years and those not at CV risk. Similar results were found for rofecoxib and nimesulide. Post-withdrawal analysis showed results comparable to the pre-withdrawal period. CONCLUSION: The results highlight a possible uncertainty experienced by prescribers of treatment alternatives available and a lack of unbiased information at this time for at-risk groups.

The effect of the withdrawal of rofecoxib on prescribing patterns of COX-2 inhibitors in Scotland.

BACKGROUND: Concerns have been raised regarding the cardiovascular safety of the COX-2 inhibitors. In September 2004, rofecoxib was withdrawn from the market as a result of concerns regarding its cardiovascular safety. AIMS & METHODS: We set out to examine the effect of the withdrawal of rofecoxib on the prescription of other COX-2 inhibitors and nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Scotland, using a national prescription database. RESULTS: The withdrawal of rofecoxib led to an initial increase in the prescription of celecoxib as prescribers presumably switched to this alternative agent. However, this rise was short-lived, presumably as a result of concerns that the safety concerning rofecoxib may be a class effect. A parallel increase in the prescription of diclofenac and ibuprofen was also noted, suggesting that prescribers were prescribing these medications as alternatives to COX-2 inhibitors. CONCLUSIONS: While prescribers and their patients may have initially interpreted safety concerns regarding rofecoxib to be drug specific, prescribers appear to have interpreted this effect to be class specific.

Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.

[How to prevent Hansen's disease]. / Como combater hanseníase.

The author indicates as the best measures regarding the prophylaxie of hanseniasis a) The active involvement of the patients as well as those in immediate contact in the struggle against the disease. They should be put on the alert for the discovery of new cases and their indication to a specialist. b) The unrestricted sale of sulfone in order to give to the patients, easer access to that drug. c) The creation of an Institute of Scientific Research for the study of hanseniasis. d) The raising of fundi through government or private (tax deductible), contributions of national and international institutions.