On Over-the-counter Research Articles

Regulatory watch list for 2012: the shifting landscape for hedge funds and other private funds

PurposeThe purpose of this paper is to explain legislative and regulatory changes and related developments that will be of interest to hedge funds and other private funds as they traverse the shifting regulatory landscape in 2012.Design/methodology/approachThe paper provides a general overview of the new regulatory regime that the Dodd‐Frank Act imposes on over‐the‐counter (OTC) derivatives; describes the rescission of a regulatory exclusion from the commodity pool operator (CPO) definition that was previously available to registered investment companies and the repeal of an exemption from CPO registration requirements for operators of funds whose shares are exempt from registration under the Securities Act of 1933; discusses proposed changes to CPO and commodity trading advisor (CTA) compliance requirements; discusses Dodd‐Frank Act changes to existing securities laws and regulations, including with respect to large trader reporting and investment advisers; highlights some of the concerns raised by MF Global, Inc.’s collapse; and describes recent tax law developments.FindingsThe paper reveals that the Dodd‐Frank Act significantly alters the space within which hedge funds and other private funds currently operate.Practical implicationsWhereas the majority of the regulations to implement the Dodd‐Frank Act have yet to become effective, federal regulators are working diligently to implement their mandates and hedge funds and other private funds should begin preparing to comply with the new Dodd‐Frank Act requirements now.Originality/valueThe paper provides expert guidance by experienced securities, derivatives and tax lawyers.

Diclofenac with or without an antiemetic for acute migraine headaches in adults.

Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter (OTC) analgesics. Diclofenac is an established analgesic, and new formulations using the potassium or epolamine salts, which can be dissolved in water, have been developed for rapid absorption, which may be beneficial in acute migraine. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine. To determine the efficacy and tolerability of diclofenac, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 27 September 2011. We included randomised, double-blind, placebo- and/or active-controlled studies using self administered diclofenac to treat a migraine headache episode, with at least 10 participants per treatment arm. Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Five studies (1356 participants) compared oral diclofenac with placebo, and one also compared it with sumatriptan; none combined diclofenac with a self administered antiemetic. Four studies treated attacks with single doses of medication, and two allowed an optional second dose for inadequate response. Only two studies, with three active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for pain-free at two hours, headache relief at two hours, and pain-free responses at 24 hours, respectively.Associated symptoms of nausea, photophobia and phonophobia, and functional disability were reduced within two hours, and similar numbers of participants experienced adverse events, which were mostly mild and transient.There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens; only one study compared oral diclofenac with an active comparator (oral sumatriptan 100 mg). Oral diclofenac potassium 50 mg is an effective treatment for acute migraine, providing relief from pain and associated symptoms, although only a minority of patients experience pain-free responses. Adverse events are mostly mild and transient and occur at the same rate as with placebo.

Public perception on the role of community pharmacists in self-medication and self-care in Hong Kong

BackgroundThe choices for self-medication in Hong Kong are much diversified, including western and Chinese medicines and food supplements. This study was to examine Hong Kong public knowledge, attitudes and behaviours regarding self-medication, self-care and the role of pharmacists in self-care.MethodsA cross-sectional phone survey was conducted, inviting people aged 18 or older to complete a 37-item questionnaire that was developed based on the Thematic Household surveys in Hong Kong, findings of the health prorfessional focus group discussions on pharmacist-led patient self management and literature. Telephone numbers were randomly selected from residential phone directories. Trained interviewers invited eligible persons to participate using the "last birthday method". Associations of demographic characteristics with knowledge, attitudes and beliefs on self-medication, self-care and role of pharmacists, and spending on over-the-counter (OTC) products were analysed statistically.ResultsA total of 1, 560 phone calls were successfully made and 1, 104 respondents completed the survey which indicated a response rate of 70.8%. 63.1% had adequate knowledge on using OTC products. Those who had no formal education/had attended primary education (OR = 3.19, 95%CI 1.78-5.72; p < 0.001), had attended secondary education (OR = 1.50, 95%CI 1.03-2.19; p = 0.035), and aged ≥60 years (OR = 1.82, 95% CI 1.02-3.26; p = 0.042) were more likely to have inadequate knowledge on self-medication. People with chronic disease also tended to spend more than HKD100 on western (OR = 3.58, 95%CI 1.58-8.09; p = 0.002) and Chinese OTC products (OR = 2.94, 95%CI 1.08-7.95; p = 0.034). 94.6% believed that patients with chronic illnesses should self-manage their diseases. 68% agreed that they would consult a pharmacist before using OTC product but only 45% agreed that pharmacists could play a leading role in self-care. Most common reasons against pharmacist consultation on self-medication and self-care were uncertainty over the role of pharmacists and low acceptance level of pharmacists.ConclusionsThe majority of respondents supported patients with chronic illness to self-manage their diseases but less than half agreed to use a pharmacist-led approach in self-care. The government should consider developing doctors-pharmacists partnership programs in the community, enhancing the role of pharmacists in primary care and providing education to patients to improve their awareness on the role of pharmacists in self-medication and self-care.

The Economic Consequences of the U.S. Supreme Court’s Morrison v. National Australia Bank Decision for Foreign Stocks Cross-Listed in U.S. Markets

We show that the U.S. Supreme Court’s ruling in the case of Morrison v. National Australia Bank in June of 2010 was associated with a statistically significant 37 basis point increase on the day in the price deviation between the U.S. cross-listed shares trading in U.S. markets and the underlying home-market shares. The Court unexpectedly ruled that the main fraud-related provisions of U.S. securities laws can apply only to transactions in foreign securities that take place in the U.S. Across our sample of almost 1,000 foreign firms from 42 different countries cross-listed on the major U.S. exchanges as well as those trading on over-the-counter (OTC) markets, the price deviations between the cross-listed and underlying home-market shares widened more dramatically for those companies with a lower presence in the U.S. as measured by the fraction of global trading that takes place in U.S. markets. The market’s revaluation of the cross-listed shares around the decision is consistent with the idea that investors care about the extent to which U.S. securities laws apply, an important driver of the bonding role that U.S. markets play.

Using the SwapClear Client Clearing Service to meet current challenges in the interest rate swaps market

The financial crisis has forced regulators to focus their attention on over-the-counter (OTC) derivatives in order to increase transparency in negotiations and reduce systemic risk. One of the key reforms being proposed is the principle of compulsory centralisation of standardised interest rate swaps (IRS) through clearing houses. The aim of this paper is to explain how a possible answer to the aforementioned development could be given, showing the MPS Capital Services business case. There will be a practical description of the application to the SwapClear Client Clearing Service (offered by the London Clearing House (LCH)) made by MPS Capital Services. After a brief description of the service, the benefits of clearing and the reasons for joining LCH are explained, and some highlights of developed activities and timings are presented, focusing on some of the details of the key operational, legal and contractual aspects. Finally, the determining factors in MPS Capital Services choice of the primary and back-up clearing members will be shown and some of the open issues that the size of the project necessarily involves. As far as future scenarios are concerned, MPS Capital Services believes that the OTC derivatives market will move towards greater segmentation, in which all players in a position to adhere to clearing facilities will do so, thereby gaining access to the professional market, by joining one or more Swap Execution Facilities (SEFs) as a swap dealer.

Developing Consumer-Centered, Nonprescription Drug Labeling: A Study in Acetaminophen

In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers.

Community pharmacists' attitudes to adverse drug reaction reporting

Abstract Objective A “demonstration” scheme for adverse drug reaction (ADR) reporting by United Kingdom community pharmacists began in April, 1997. The objective of this study was to investigate community pharmacists' attitudes to and knowledge of ADR reporting and the “yellow card” scheme. Method Structured face-to-face interview with community pharmacists, using a prepiloted questionnaire. Setting Randomly selected community pharmacies within one demonstration scheme area. Key findings Almost all of the pharmacists (28, 93 per cent) were aware that they were able to report ADRs but only one had done so. Just under half recalled receiving the official information pack and half of these had read it. Reasons given for not submitting reports were lack of information or time, and that most reactions seen were already well-recognised. Although most pharmacists knew that serious reactions to established drugs should be reported, fewer recognised the need to report unusual reactions to established drugs and reactions to herbal medicines. Few participants knew the reporting criteria for “black triangle” drugs. Reporting on over-the-counter (OTC) products was an area specifically identified where it was expected that community pharmacists could “add value” to the previous, yellow card, scheme. It was thus of some concern that 21 pharmacists (70 per cent) agreed that they would be unlikely to report an ADR to a product they had counter-prescribed for a patient. Few respondents had negative attitudes to the scheme. Most agreed that ADR reporting is important, and a professional role in which pharmacists should be involved. Conclusion Community pharmacists are supportive of their involvement in ADR reporting. Their concerns about reporting need to be addressed and further publicity given to the scheme if reporting is to increase. Our findings suggest that more research is needed to identify the factors which encourage and inhibit reporting, and that further efforts may be needed to promote ADR reporting.

Seasonal allergic rhinitis: impact of the disease and considerations for its management

SummaryMany changes to our medical care services are expected to occur in the next several years, and these will substantially affect the treatment of pollinosis. Patients with pollinosis are becoming increasingly dependent on over‐the‐counter (OTC) medicines; today, as many as 25–30% of patients with allergic rhinitis report using these agents. This trend will be further accelerated if switched OTC medicines such as ketotifen and azelastine are sold at general retailers as well as pharmacies and drug stores under new laws. We conducted three surveys on the prescription pattern of drugs against pollinosis during the high pollen count season in 1998, 2003, and 2009. Whereas the use of chemical mediator‐release inhibitors tended to decrease, that of second‐generation antihistamines increased during the period examined. Especially, use of anti‐leukotrienes and prostaglandin D2/chemoattractant receptor‐homologous molecule expressed on Th2 cells antagonists either alone or in combination increased rapidly after their launch in 2000. Despite many successful advances in treatment, however, many patients still remain dissatisfied with their anti‐pollinosis therapy. Therefore, it is essential that physicians keep abreast of what medications are to be switched to OTC status and to maintain patient satisfaction by the appropriate use of good prescription drugs.

Smoking cessation advice provided in 53 Norwegian pharmacies

Abstract Objective To investigate the quality of the smoking cessation advice on over-the-counter (OTC) nicotine replacement treatment (NRT) provided by community and hospital pharmacies in Norway and to assess any change in customer services and pharmaceutical smoking cessation advice after a change in legislation deregulating NRT from pharmacy-only to general sale. Method A mystery shopper made 106 visits to 53 pharmacies in Oslo, Norway. The first visit was when NRT was a pharmacy-only medicine and the second when it had become available from any outlet as a general sales product. The pharmacies were scored on 12 observation parameters regarding customer service and pharmaceutical advice (score 0–4, total possible score was 48). Key findings There was considerable inter- and intra-pharmacy variation in scores. The pharmacies' total score ranged from 3 to 45. On only 14.2% of the visits was the service categorised as ‘Good’. There was no statistically significant difference in total score between the two test periods (P = 0.56), and hence no measurable difference in customer services and pharmaceutical advice as a result of increased competition after the switch to general sale. A scatter plot showed no relationship between the individual pharmacies' total score at the two visits. Conclusions Pharmacies' scores for the quality of their smoking cessation advice were generally low. There was no measurable change in pharmacies' customer service and pharmaceutical advice following the deregulation of NRT. There was little consistency in the total score between the first and the second visit to the same pharmacy. Improvement is needed in the smoking cessation advice provided by Norwegian pharmacies.

News and Notes

News and Notes

Editor’s Letter

We start this issue with a section on over-the-counter (OTC) derivative risks and regulations. Paul Forrester, Joel Telpner, Edmund Parker, Lawrence Hamilton, and Jamila Piracci discuss the numerous legislative bills and Obama Administration proposals for new regulations related to OTC derivatives

Health Beliefs and Over-the-Counter Product Use

Pharmacists are often consulted as medical advisors. Given this case, customers and pharmacists should interact in a trustful way (eg, in terms of responding to customer's needs or recommending a different drug). Consideration of the health beliefs of the customer could improve the interaction between pharmacists and their clients and have a positive impact on medical adherence. To examine the health beliefs of pharmacy customers in Germany, the impact of those beliefs on over-the-counter (OTC) medication use, and associations with sociodemographic variables. By means of literature review and methodical surveys, a standardized questionnaire was designed that contained 68 items concerning health beliefs, habits of OTC product use, decision criteria that customers used when purchasing drugs, and information about the sociodemographic background of the participants. Main outcome measures were reliability (Cronbach's alpha) and correlations. A random sample of 58 pharmacies in Saxony, Germany (10 questionnaires per pharmacy), invited their customers to take part in our study. One hundred twenty-three questionnaires (response rate 53.48%) were completed and returned to us. The outcome suggests that there is a strong association between health beliefs and frequency of use or the type of OTC drug (eg, illness attributions: p < 0.05; preventive lifestyle: p < 0.05). There were no significant associations between sociodemographic variables and chosen drugs. Health beliefs, in terms of the general attitude toward health and illness, illness attribution, prevention, and the attitude toward treatment strategies, influence the kind of remedy (conventional vs complementary medication) that consumers seek. These results may have implications for consultations in pharmacies or for product marketing.

生活者に対するＯＴＣ薬適正使用の啓発講義とその効果

We have found that a lecture on over-the-counter (OTC) medicines including television commercials and case studies that we have been giving to freshmen pharmacy students has been useful in enhancing the professionalism of students as well as their motivation to learn about OTC medicines.In this study,we modified the lecture by adding audience-friendly figures and explanations,and gave it to members of the public to see whether it was effective in enhancing their awareness of the proper use of OTC medicines.It was given to 166 local residents and high-school students who were asked to complete a questionnaire before and after the lecture,and responses were analyzed for 133 people who fully completed the questionnaires.Of the 133 respondents,122 had used OTC medicines previously,and before the lecture,46 of 65 local residents (70.8 %) and 17 of 57 high-school students (29.8%) had considered a pharmacist’s advice in selecting OTC medicines.Further,the number of respondents who desired a pharmacist’s advice in selecting OTC medicines increased to 59 (90.8%) for the local residents and 54 (94.7%) for the high-school students after the lecture.While eight of 65 local residents (12.3%) and 11 of 57 high-school students (19.3%) had not read package inserts before using OTC medicines,after the lecture,all respondents said that package inserts should be read.The results showed that the lecture had increased people’s interest in OTC medicines.These findings suggest that the lecture was useful for increasing the general public’s awareness of the importance of a pharmacist’s advice on the proper use of OTC medicines.

テレビコマーシャルと症例検討を取り入れたＯＴＣ薬に関する薬学１年次早期導入講義の効果

We gave a lecture on over-the-counter (OTC) medicines to freshmen pharmacy students as early as possible to enhance their professional sense and their learning motivation.The impact of the lecture was reinforced through the use of television commercials and a case conference.In addition,questionnaires were given to the 182 students who attended the lecture before and after it,and the responses of the 170 students who fully completed the questionnaires were analyzed.The following results were obtained.For the students who had bought OTC medicines in the past,the package was the most important factor in selecting the medicine.As a result of the lecture,the number of students who wanted help from a pharmacist in selection increased.Of the 166 students who had used OTC medicines in the past,152 had read package inserts.After the lecture,all students said that the package insert should be read before using OTC medicines.Attending the lecture also increased the number of students who considered it important to read the major items of the package insert,such as“Ingredient and amount”and“Drug characteristics”.The lecture also increased students’interest in the pharmacist dealing with OTC medicines about 1.8-fold.In addition,most students were satisfied with the lecture and it stimulated their interest in learning more about OTC medicines.In conclusion,we felt that the lecture had been useful in enhancing professional sense among freshmen pharmacy students as well as their motivation to learn about OTC medicines.

A comparison of community pharmacists' views of over‐the‐counter omeprazole and simvastatin

Simvastatin and omeprazole were re-classified to pharmacy status in Great Britain in summer 2004. The purpose of this study was to compare the views of community pharmacists on over-the-counter (OTC) omeprazole and simvastatin. A pre-piloted questionnaire mailed to 2000 randomly selected community pharmacy premises, with open questions relating to pharmacists' views. Pharmacists' attitudes on aspects of supply were sought using Likert scales. Content analysis was performed on responses to the open question and Wilcoxon signed ranks test (z) used to compare responses to the attitudinal statements. One thousand one hundred and fifty-six questionnaires were returned (57.8%). Themes around omeprazole illustrated positive views compared to concerns relating to simvastatin. Whereas omeprazole was seen as a welcome addition, there were issues around the poor evidence base for simvastatin. Further simvastatin related concerns were in areas of cardiovascular risk assessment, adverse drug reactions and likelihood of patients not committing to therapy. For both agents, excessive cost was an issue. Nearly three-quarters of pharmacists agreed they were entirely confident about selling omeprazole (835, 73%), significantly more than simvastatin (691, 60%); (z = 9.243, p < 0.001). Two re-classified medicines have raised common and product-specific themes. Many themes relate to clinical governance such as evidence-based practice, risk management and continuing professional development (CPD). Views on the availability and circumstances surrounding the OTC supply differ in certain regards, for example, more believe that they should be involved in the sale of simvastatin personally than for sales of omeprazole.

OTC (一般用医薬品) を用いての症候群サーベイランスの試み

We analyzed the possibility of using sales data on over-the-counter (OTC) medicine in syndromic surveillance for early detection and/or prediction of influenza pandemics. Data who collected on daily November 2003-April 2004 sales of common cold medication commercially obtained from 600 pharmacies in Japan enrolled in reporting throughout the 2003/04 influenza season. OTC sales data were compared to daily influenza incidence data to determine correlations and predictability. Data included Sentinel Surveillance of influenza, National Surveillance of Dally Influenza Outpatients (Daily Case Reporting: DCR), and Mailing-List-Based Influenza Epidemic Database (MLflu). The seasonal influenza epidemic peak for 2003-2004 was observed on January 30, February 1, and February 2 for sentinel surveillance, DCR, and MLflu. Sales peaks of OTC medicines occured twice in 2003-2004 season, once at the end of the year and once on January 27. Peak OTC sales for common cold medication per pharmacy were preceded by 18, 21, and 13 days for sentinel surveillance, DCR, and MLflu. OTC sales successfully explained 74-85% in the variation of influenza incidence which is interpretable as sufficient power of explanation. OTC sales proved to be a good indicator of real-time surveillance for influenza epidemics. Further analysis on multiyear data is needed to demonstrate the robustness of results. To confirm the advantage in the system of real-time syndromic surveillance, it is also necessary to check explanatory power of OTC sales on the variation of influenza incidence with prospective datasets.

Nonnarcotic Analgesics and Hypertension

In 2004, individuals in the United States spent >$2.5 billion on over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) and filled >100 million NSAID prescriptions. The most commonly used OTC analgesics include aspirin, acetaminophen, and nonaspirin NSAIDs. Nonnarcotic analgesics are generally considered safe when used as directed but do have the potential to increase blood pressure in patients with hypertension treated with antihypertensives. This is important because hypertension alone has been correlated with an increased risk of cardiovascular disease or stroke. Small increases in blood pressure in patients with hypertension also have been shown to increase cardiovascular morbidity and mortality. Therefore, when nonnarcotic analgesics are taken by patients with hypertension, there may be important implications. This review explores the potential connection among analgesic agents, blood pressure, and hypertension, and discusses possible mechanisms by which analgesics might cause increases in blood pressure. This is followed by a summary of data on the relation between analgesics and blood pressure from both observational and randomized trials.

The Accuracy of Density Forecasts from Foreign Exchange Options

Financial decision makers often consider the information in currency option valuations when making assessments about future exchange rates. The purpose of this article is to systematically assess the quality of option-based volatility and density forecasts. We use a unique dataset consisting of more than 10 years of daily data on over-the-counter (OTC) currency option prices. We find that the OTC implied volatilities provide largely unbiased and fairly accurate forecasts of one-month- and three-month-ahead realized volatility. Furthermore, we find that the one-month option implied density forecasts are well calibrated for the center of the distribution, but we find evidence of misspecification in the tail density forecasts. Copyright 2005, Oxford University Press.

Drug Information Obscured on Over-the-Counter Medication Labels by External Tags

The objective of the study was to determine the quantity and quality of information obscured by anti-theft and price tags on over-the-counter (OTC) medication labels. A cross-sectional field study was conducted by examining OTC medication packages in two cities: Houston, Texas and East Lansing, Michigan. A total of 849 packages of 124 products containing acetaminophen or combinations which included acetaminophen were evaluated for the presence of external tags and the information obscured by them. The results illustrated that more price tags (60.7%) were present than antitheft tags (21.0%). Information concealed by tags was predominantly from the Drug Facts box (50.4%), namely, warnings (23.6%), active ingredients (9.3%), and product use (4.4%). The results revealed that inappropriate tagging practices obscure Food and Drug Administration-mandated information on OTC medication labels. These tags may make it difficult for consumers to make informed decisions regarding product selection and use, thus, strategies for improvement are suggested.

Societal perspectives on over-the-counter (OTC) medicines

Over-the-counter (OTC) medicines are increasingly used for self-medication, but such products can be misused/abused. The aim of this study was to investigate the general public's opinion and perceptions of OTC medicines, including the misuse/abuse of such preparations. Data were collected using a survey administered to 1000 members of the public in 10 study sites in Northern Ireland, using a structured interview technique. The questionnaire was divided into four sections addressing: (a) attitudes towards community pharmacy and patients' contact with pharmacies; (b) attitudes towards the use of OTC medicines; (c) views on OTC medicines in terms of safety, potency and effectiveness; and (d) knowledge and opinion of abuse/misuse of OTC medicines. Data were coded and entered into a custom designed SPSS database for statistical analysis. The majority of participants (74.6%) visited a community pharmacy at least once per month. Almost one-third (32.2%) of participants reported buying OTC drugs at least once per month and the majority (86.4%) would always or often follow the directions on the product. The general public in Northern Ireland were highly aware of the abuse potential of some OTC drugs, with the majority naming painkillers as the products most liable for abuse. Almost one third of the participants reported having personally encountered cases of OTC abuse. This survey revealed that the general public had a high level of awareness of the abuse potential of OTC medicines. These findings indicate that pharmacists could be more proactive in the management of inappropriate OTC drug use.