Over the counter (OTC) artificial tear drops for dry eye syndrome

Science.gov (United States)

Pucker, Andrew D; Ng, Sueko M; Nichols, Jason J

2016-01-01

Background Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears. Objectives To evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches. Selection criteria This review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not

Antihistamines: Understanding Your OTC Options

Science.gov (United States)

... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

Decongestants: OTC Relief for Congestion

Science.gov (United States)

... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

Urticarial vasculitis induced by OTC diet pills: a case report.

Science.gov (United States)

Chérrez Ojeda, Iván; Loayza, Enrique; Greiding, Leonardo; Calderón, Juan Carlos; Cherrez, Annia; Adum, Farid

2015-01-01

Urticarial Vasculitis (UV) is in most of the cases idiopathic; however it has been associated with several conditions and drugs. Over the counter (OTC) diet pills are widely available, even on-line, but they are rarely regulated by pharmaceutical control. We present the case of a 35-year-old female patient suffering of pruriginous and painful wheals more than 1 cm in diameter, with a burning sensation. The eruption lasted more than 24 hours and was accompanied by angioedema, headache and myalgia. No remarkable medical history was found, except for previous intake of OTC diet pills. UV diagnosis was confirmed by the skin biopsy of a lesion. OTC diet pills are widely available worldwide, and due to its widespread use, allergologists and dermatologist should be able to recognize symptoms and lesions of cutaneous vasculitis, which may be under reported.

Cough Medicine: Understanding Your OTC Options

Science.gov (United States)

... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

Where to buy OTC medications? A cross-sectional survey investigating consumers' confidence in over-the-counter (OTC) skills and their attitudes towards the availability of OTC painkillers.

NARCIS (Netherlands)

Brabers, A.E.M.; Dijk, L. van; Bouvy, M.L.; Jong, J.D. de

2013-01-01

Objective: To examine consumers' confidence in their own, and also in other people's, over-the-counter (OTC) skills and to describe their attitude towards the availability of OTC painkillers. Moreover we examined the association between confidence in OTC skills and attitudes. Design:Cross-sectional

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

Science.gov (United States)

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

2014-05-01

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

Getting the Most from Your OTC Medicine

Science.gov (United States)

... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

Illicit drug use and treatment in South Africa: a review.

Science.gov (United States)

Peltzer, Karl; Ramlagan, Shandir; Johnson, Bruce D; Phaswana-Mafuya, Nancy

2010-11-01

This review synthesizes available epidemiological data on current drug use and substance user treatment admissions in South Africa since 1994, and how changes in the political, economic, and social structures within South Africa, both before and after Apartheid, has made the country more vulnerable to drug use. Based on national surveys, current use of cannabis ranged among adolescents from 2% to 9% and among adults it was 2%, cocaine/crack (0.3%), mandrax/sedatives (0.3%), club drugs/amphetamine-type stimulants (0.2%), opiates (0.1%), and hallucinogens (0.1%). The use of primary illicit substance at admission to South African drug user treatment centers was cannabis 16.9%, methamphetamine (tik) 12.8%, crack/cocaine 9.6%, cannabis and mandrax 3.4%, heroin/opiates 9.2%, and prescription and OTC drugs 2.6%. An increase in substance user treatment admissions has increased. While the prevalence of illicit drug use in South Africa is relatively low compared to the United States and Australia, prevention and intervention policies need to be designed to reduce these levels by targeting the more risky subpopulations identified from this review.

Activos Derivados OTC

OpenAIRE

Arroyo Pereiro, Miguel

2015-01-01

El objetivo de este trabajo es proporcionar una visión general de los mercados de derivados financieros OTC, los principales instrumentos, los participantes y algunos aspectos de su regulación. En la actualidad el mercado global de derivados ha alcanzado un gran tamaño, tras crecer exponencialmente desde 1980, convirtiéndose en una parte significativa del mundo de las finanzas globales. Muestra de ello es la contribución destacada que se otorga a los derivados OTC en la crisis financiera inte...

Inter-Dealer OTC E-markets

Directory of Open Access Journals (Sweden)

Iosif ZIMAN

2012-01-01

Full Text Available The global OTC markets have been very active in the past decade as many institutions have chosen to rely on growth in the OTC issuance to facilitate deal-making outside of the exchange regulated avenues. Products included in this category are bonds, converts, volatility and variance swaps, CDS contracts. This paper introduces the financial instruments used in connection with the OTC markets, presents and offers suggestions for setting up generic sell and buys side RFQ and market making systems and introduces the main concepts and compo-nents that need to be taken into account when developing such systems when targeting the growing E-Business focus of the market.

76 FR 6801 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Science.gov (United States)

2011-02-08

.... market after the OTC drug review began and OTC drug products without any marketing experience in the... safety and effectiveness information as explained in Sec. 330.14(f). Safety and effectiveness data... hours to prepare a TEA and 800 hours to prepare and submit safety and effectiveness data to continue to...

Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

Directory of Open Access Journals (Sweden)

Moore N

2015-07-01

Full Text Available Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. Keywords: adverse effects, nonsteroidal anti-inflammatory drugs, gastrointestinal, cardiovascular, renal

Antiemetic Medicines: OTC Relief for Nausea and Vomiting

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... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

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

Science.gov (United States)

Kohli, Erol; Buller, Allison

2013-02-01

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

Pain Relievers: Understanding Your OTC Options

Science.gov (United States)

... Sprays: How to Use Them CorrectlyAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

Association of Risk Perception and Information Provided on the Labels of Over-the-Counter Drugs: Role of Race, Education, Age and Income

Directory of Open Access Journals (Sweden)

Sunil Mathur

2014-01-01

Full Text Available Background: The use of over-the-counter (OTC drugs has increased tremendously, however, information on risk perception regarding the use of OTC drugs and their potential toxicity is scarce. Hence, the purpose of this study was to investigate the perception of OTC drug safety and efficacy based on reading product packaging and the effect of race, education, age and income. Methods: We used the HINTS 2012 data set with total sample size of 2,554. Results: OTC drug users having some high school education had a lower chance of frequently reading information included in the product labeling with the OTC medication. OTC drug users less than 50 years of age were always likely to read drug information on the OTC drug labeling. Also, Non-Hispanic blacks were more likely to read OTC drug labeling than Non-Hispanic whites.  OTC drug users less than 50 years of age consider OTC drugs safer than prescription drugs.  Conversely, OTC drug users with a high school, some college or bachelor’s degree consider OTC drugs less safe than prescription drugs.  Non-Hispanic blacks, non-Hispanic whites, and subjects of lower income were less likely to consider OTC drugs safer than prescription drugs.  OTC drug users with a high school education and some college perceive OTC drugs to be less effective than prescription drugs.Conclusion: To conclude, age, education, race, and income affect risk perception on OTC drugs.  Consumer information programs need to be designed so that meaningful results can be incorporated into public policy. Providing information on the labeling of OTC drugs and likelihood of patients reading this information require further study.

Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use; delay of compliance dates. Final rule; delay of compliance dates; request for comments.

Science.gov (United States)

2012-05-11

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

Consumer judgement and risk perception on availability of over-the-counter-drugs.

OpenAIRE

Brabers, A.E.M.; Dijk, L. van; Bouvy, M.L.; Jong, J.D. de

2011-01-01

Background: Over-the-counter (OTC)-drugs are available without a doctor’s prescription. Whereas this is convenient for consumers, it also makes consumers responsible for appropriate and safe use. European countries differ considerably when it comes to the availability of OTC-drugs. In the Netherlands, the availability of OTC-drugs changed in 2007. A limited number of OTC-drugs can now be sold outside pharmacies and chemistries, mainly in supermarkets. This had led to a discussion on whether c...

Australian OTC Derivatives Markets: Insights from the BIS Semiannual Survey

OpenAIRE

Jason Ahn; Mihovil Matic; Christian Vallence

2012-01-01

The Reserve Bank of Australia recently commenced surveying participants in Australian over-the-counter (OTC) derivatives markets as part of the Bank for International Settlements’ (BIS) semiannual global OTC derivatives survey. Australia’s contribution to the survey complements regulatory efforts to improve the resilience and transparency of Australia’s OTC derivatives markets. It also facilitates a higher frequency comparison of the Australian and foreign OTC derivatives markets. The survey ...

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

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-03-15

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.

Advertising of OTC products in a Nigerian urban setting: content analysis for indications, targets, and advertising appeal.

Science.gov (United States)

Yusuff, Kazeem B; Yusuf, Akeem

2009-01-01

To identify the indications for which treatments were promoted, the segments of population targeted, and the type and extent of advertising appeal used for over-the-counter (OTC) products in a Nigerian urban setting. Using a cross-sectional design, the content of advertisements for OTC products on radio, television, and billboards in a city in southwestern Nigeria were assessed during a 3-month period. Two coders independently assessed 1,492 advertisements for 49 brands of OTC products (interrater reliability [Cohen's kappa] = 0.83 [95% CI 0.80-0.90]). The most frequent indications for OTC products were aches and pain (42.9%), anemia/malnutrition (34.8%), and malaria (22.2%). Of advertisements, 92% were targeted at the primary end user. Use of appeal related to efficacy (100%), psychosocial enhancement (80%), and ease of use (40%) in visual, written, and audio messages was highest in ads on billboards. Efficacy appeal had the highest frequency across the three advertising media (100%); ease-of-use and safety appeal had the lowest frequency (40% and 7.4%, respectively). Nigerian movie stars were used as brand icons in advertisements of OTC products on radio (59.5%), television (52.9%), and billboards (49.6%). The majority of advertisements for OTC products in a Nigerian urban setting used advertising appeal related to efficacy and psychosocial enhancement. Promotional efforts by pharmaceutical manufacturers appear to focus on positive emotional appeal to influence drug purchase and use decisions.

Drug sales data analysis for outbreak detection of infectious diseases: a systematic literature review.

Science.gov (United States)

Pivette, Mathilde; Mueller, Judith E; Crépey, Pascal; Bar-Hen, Avner

2014-11-18

This systematic literature review aimed to summarize evidence for the added value of drug sales data analysis for the surveillance of infectious diseases. A search for relevant publications was conducted in Pubmed, Embase, Scopus, Cochrane Library, African Index Medicus and Lilacs databases. Retrieved studies were evaluated in terms of objectives, diseases studied, data sources, methodologies and performance for real-time surveillance. Most studies compared drug sales data to reference surveillance data using correlation measurements or indicators of outbreak detection performance (sensitivity, specificity, timeliness of the detection). We screened 3266 articles and included 27 in the review. Most studies focused on acute respiratory and gastroenteritis infections. Nineteen studies retrospectively compared drug sales data to reference clinical data, and significant correlations were observed in 17 of them. Four studies found that over-the-counter drug sales preceded clinical data in terms of incidence increase. Five studies developed and evaluated statistical algorithms for selecting drug groups to monitor specific diseases. Another three studies developed models to predict incidence increase from drug sales. Drug sales data analyses appear to be a useful tool for surveillance of gastrointestinal and respiratory disease, and OTC drugs have the potential for early outbreak detection. Their utility remains to be investigated for other diseases, in particular those poorly surveyed.

Ibuprofen: from invention to an OTC therapeutic mainstay.

Science.gov (United States)

Rainsford, K D

2013-01-01

The discovery of ibuprofen's anti-inflammatory activity by Dr (now Professor) Stewart Adams and colleagues (Boots Pure Chemical Company Ltd, Nottingham, UK) 50 years ago represented a milestone in the development of anti-inflammatory analgesics. Subsequent clinical studies were the basis for ibuprofen being widely accepted for treating painful conditions at high anti-rheumatic doses (≤ 2400 mg/d), with lower doses (≤ 1200 mg/d for ≤ 10 days) for mild-moderate acute pain (e.g. dental pain, headache, dysmenorrhoea, respiratory symptoms and acute injury). The early observations have since been verified in studies comparing ibuprofen with newer cyclo-oxygenase-2 selective inhibitors ('coxibs'), paracetamol and other non-steroidal anti-inflammatory drugs (NSAIDs). The use of the low-dose, non-prescription, over-the-counter (OTC) drug was based on marketing approval in 1983 (UK) and 1984 (USA); and it is now available in over 80 countries. The relative safety of OTC ibuprofen has been supported by large-scale controlled studies. It has the same low gastro-intestinal (GI) effects as paracetamol (acetaminophen) and fewer GI effects than aspirin. Ibuprofen is a racemate. Its physicochemical properties and the short plasma-elimination half-life of the R(-) isomer, together with its limited ability to inhibit cyclo-oxygenase-1 (COX-1) and thus prostaglandin (PG) synthesis, compared with that of S(+)-ibuprofen, are responsible for the relatively low GI toxicity. The R(-) isomer is then converted in the body to the S(+) isomer after absorption in the GI tract. Ex vivo inhibition of COX-1 (thromboxane A(2)) and COX-2 (PGE(2)) at the plasma concentrations of S(+)-ibuprofen corresponding to those found in the plasma following ingestion of 400 mg ibuprofen in dental and other inflammatory pain models provides evidence of the anti-inflammatory mechanism at OTC dosages. R(-)-ibuprofen has effects on leucocytes, suggesting that ibuprofen has anti-leucocyte effects, which

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

Science.gov (United States)

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

2016-03-01

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

OTC polyethylene glycol 3350 and pharmacists' role in managing constipation.

Science.gov (United States)

Horn, John R; Mantione, Maria Marzella; Johanson, John F

2012-01-01

To define constipation, assess the pharmacist's role in identifying and treating constipation, and review clinical evidence for the efficacy, safety, and tolerability of polyethylene glycol (PEG) 3350 (MiraLAX-Merck Consumer Care), an osmotic laxative now available over the counter (OTC), across a variety of patient populations routinely encountered in pharmacy settings. Systematic PubMed search of the primary literature for constipation treatment guidelines and clinical trial results for PEG 3350. Pharmacists have a unique role in assisting patients with identifying and managing constipation. Multiple controlled clinical trials have established the efficacy, safety, and tolerability of PEG 3350 at its recommended dose of 17 g once daily. On the basis of this evidence, various professional groups have recommended PEG 3350 for use in improving stool frequency and consistency in patients with constipation. PEG 3350 is approved for short-term use, including treatment of constipation caused by medications. Pharmacists can play an important role in managing constipation with OTC agents. Compared with other available OTC agents, PEG 3350 can be recommended to patients suffering from constipation on the basis of a large body of clinical evidence supporting its efficacy and safety, as well as the high patient acceptance shown for its palatability and once-daily dosing.

One fourth of acutely admitted patients use over-the-counter-drugs 24 hours prior to hospitalisation

DEFF Research Database (Denmark)

Pedersen, Magnus; Brabrand, Mikkel

2014-01-01

INTRODUCTION: Use of over-the-counter (OTC) drugs is increasing and is poorly registered, which can lead to complications. The most commonly used OTC drugs are analgesics, and their usage is highest among elderly patients. Our study investigates the use of OTC drugs 24 hours prior to hospitalisat......INTRODUCTION: Use of over-the-counter (OTC) drugs is increasing and is poorly registered, which can lead to complications. The most commonly used OTC drugs are analgesics, and their usage is highest among elderly patients. Our study investigates the use of OTC drugs 24 hours prior...... to hospitalisation and the effects of this intake. MATERIAL AND METHODS: Junior physicians on call interviewed patients admitted to the medical admission unit at South-West Jutland Hospital in Esbjerg using a modified chart template. Adult patients aged 15 and older admitted during a two-week period in August 2012...

17 CFR 240.3b-12 - Definition of OTC derivatives dealer.

Science.gov (United States)

2010-04-01

... to options, forwards, futures, swap agreements, or collars involving currencies, interest or other... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Definition of OTC derivatives... Securities Exchange Act of 1934 Definitions § 240.3b-12 Definition of OTC derivatives dealer. The term OTC...

Residue depletion of oxytetracycline (OTC) and 4-epi-oxytetracycline (4-epi-OTC) in broiler chicken's claws by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Science.gov (United States)

Cornejo, J; Pokrant, E; Araya, D; Briceño, C; Hidalgo, H; Maddaleno, A; Araya-Jordán, C; San Martin, B

2017-04-01

Antibiotics are widely used in poultry production for the treatment of bacterial diseases. However, residues may remain in products and by-products destined for human consumption or animal feeding. The claws of chickens, which are a by-product of the poultry industry, can directly or indirectly enter the food chain as meals destined to feed other productive animals. Thus, it becomes necessary to determine and quantify antimicrobial residues present in this matrix. The objective of the study was to assess the depletion of oxytetracycline (OTC) and its metabolite 4-epi-OTC in broiler chicken's claws. Claws of 32 broilers treated with a therapeutic dosage of 10% OTC during 7 days were analysed. Samples were taken at days 3, 9, 15 and 19 post-treatment. As for the control group, eight broiler chickens were raised under the same conditions. Extraction was carried out through EDTA-McIlvaine buffer, and clean-up employed a SPE C-18 Sep-Pak®. Instrumental analysis was performed through LC-MS/MS. The concentrations of both analytes were determined in claw samples until day 19 post-treatment. Average concentrations were within the LOD (20 μg kg - 1 ) and LOQ (22 µg kg - 1 ) for OTC and 84 μg kg - 1 for 4-epi-OTC. Withdrawal times (WDTs) of 39 days for OTC and 54 days for 4-epi-OTC were established in claws based on 95% confidence. These findings demonstrate that claws can be a source of antimicrobial residue entry into the food chain, since the results showed that OTC and its metabolite can be found in chicken's claws for long periods, even exceeding the average lifespan of a broiler chicken.

Non-NSAID over-the-counter (OTC) remedies for arthritis: good, bad or indifferent?

Science.gov (United States)

Whitehouse, M W; Butters, D E

1999-01-01

This overview looks at some of the issues involved with the ever-increasing availability of marketed non-prescription products, specifically claiming to treat the pain and inflammation of arthritis and other musculoskeletal problems.The question of whether the buyer is getting (any) value for their money cannot be answered without considering several key issues. These include: (a) reliability of claims; (b) placebo effect (but for how long?); (c) reliability of composition, and reproducibility (especially of natural products); (d) general safety; (e) interactions with other medications; (f) honest labelling (in the absence of stricter guidelines).A particularly difficult problem is to know how to recognise a 'drug of choice', particularly for such a multi-faceted disease as chronic arthritis, when there is so little information about the actual pharmacology/potential toxicity of these OTC products in the standard drug compendia and other readily available reference texts.This grey area can only be illuminated by (i) further introduction (and enforcement) of adequate standards/quality controls for products offered OTC; (ii) earliest prosecution of clinical trials to supercede unverified testimonial claims; (iii) appropriate funding to research/establish basic pharmacology of the active principles.In summary, more research, more regulation, and more realistic investment will be required to dispel present uncertainty about which non-NSAID drugs/nutriceuticals are indeed effective against arthritis/other forms of inflammation, and which are not.

Analysis of the phenomenon of over-the-counter drug abuse and not controlled herbs trade by polish adolescents: Part I

Directory of Open Access Journals (Sweden)

Daria Suchecka

2017-06-01

Full Text Available The phenomenon of stupefying by the use of available over-the-counter drugs (OTC among adolescents is an essential problem in both Poland and throughout the world. Popular analgesics, cold medicine and antihistamines contain psychedelic substances, such as dextromethorphan (DXM, pseudoephedrine/ephedrine, codeine (methylmorphine, dimenhydrinate, paracetamol (acetaminophren and others. Cases of fatal addiction to dextromethorphan, one of the active substances contained in medicines, e.g., the common cold, have been reported. The test results cited by the authors clearly indicate that the use of OTC drugs, whose turnover is not controlled is a domain of females. The extent of use of drugs not prescribed by a doctor has remained for many years at a constant level. The most common poisonings with OTC drugs are caused by those that affect the respiratory system or exert analgesic or antipyretic effects. They are also used in attempted suicides, especially among females. Analyzing poisonings caused by OTC medications their seasonality has been observed. Their number increases during spring–autumn. A territorial differentiation in areas of OTC drug trade in terms of their quantities, with the predominance of southern regions is also noted. Intoxication with psychoactive substances causes the deterioration of relations between young people. In the reviewed studies there is no detailed information on the composition of non-prescription medicines. Moreover, young people have easy access to mushroom fungi, growing in nearby forests and meadows that may have hallucinogenic effects and are available in pharmacies and on the Internet. Med Pr 2017;68(3:413–422

OTC Medicines and Pregnancy

Science.gov (United States)

... need to take medicine regularly because of a health problem, talk with your doctor before you try to get pregnant. There may ... I currently take an OTC medicine for a health problem. Is there another ... Family Physicians, Over-the-Counter Medications in Pregnancy Centers for ...

Use of the over-the-counter drugs by adults and an assessment of the impact of advertisements on consumers

Directory of Open Access Journals (Sweden)

Monika Szpringer

2015-03-01

Full Text Available Introduction: During the last few years there has been a considerable value growth in the demand for the so-called over-the-counter drugs (OTC, available without doctor’s prescription. Using OTC drugs is related to self-treatment, aimed at mitigating first symptoms of a cold, flu, or various types of pain. The omnipresent advertisements for OTC drugs encourage and contribute to the elevated demand. Unfortunately, the marketing techniques used in advertisements fail to provide reliable and objective information to the viewers about specific products. Aim of the research: To determine the respondents’ opinions on using OTC drugs and to assess how advertisements influence the consumers’ needs. Material and methods : The study was conducted by means of a diagnostic survey using a questionnaire. For the purpose of the study, the authors prepared a survey questionnaire, which was used as a research tool. The study included 114 respondents, falling within an age bracket of 18–66 years. Results : The most frequently used OTC drugs were painkillers and medicines for cold and flu symptoms (68.33% of women and 59.09% of men. The drugs were usually bought in pharmacies and grocery/convenience stores. Conclusions: Taking OTC drugs is a widespread phenomenon, both in women and men. The obtained results clearly indicate that advertisements have a considerable impact upon target groups and contribute to increased consumption of OTC drugs.

Preferences and attitudes of older adults of Bialystok, Poland toward the use of over-the-counter drugs

Directory of Open Access Journals (Sweden)

Cybulski M

2018-04-01

Full Text Available Mateusz Cybulski,1 Lukasz Cybulski,2 Elzbieta Krajewska-Kulak,1 Magda Orzechowska,1 Urszula Cwalina3 1Department of Integrated Medical Care, Faculty of Health Sciences, Medical University of Bialystok, Bialystok, Poland; 2National Security Student, Faculty of Social Sciences, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland; 3Department of Statistics and Medical Informatics, Faculty of Health Sciences, Medical University of Bialystok, Bialystok, Poland Purpose: The aim of the study was to assess preferences and attitudes toward the use of over-the-counter (OTC drugs among residents of Bialystok aged 60 or older. Patients and methods: The study included 170 people, inhabitants of Bialystok aged over 60: 85 students of the University of a Healthy Senior and the University of Psychogeriatric Prophylaxis, and 85 students of the University of the Third Age in Bialystok. The study made use of a diagnostic survey conducted via a questionnaire prepared by the authors. Results: The vast majority of respondents bought OTC drugs for own use. About one-third of the respondents from each analyzed group bought OTC drugs less often than once every 3 months. Over half of the respondents bought OTC drugs due to a cold. A majority of the respondents were of the opinion that OTC drugs should be sold only in pharmacies. Over 40% of seniors took 1 OTC drug regularly. Most respondents also took vitamins and supplements. The main sources of information on OTC drugs for the studied seniors were their doctor and pharmacist. Respondents did not always consult the treatment method with a doctor or pharmacist. Over half of the respondents familiarized themselves with the contents of the OTC drug package leaflet. Over three-quarters of the respondents were familiar with drug disposal methods; however, despite declarations of being familiar with these principles, a significant percentage did not bring back medication to a pharmacy or clinic, or threw the drugs

Nonsteroidal Anti-Inflammatory Drugs and Analgesics Use by Kidney Transplant Recipients.

Science.gov (United States)

Mulka-Gierek, Maria; Foroncewicz, Bartosz; Pączek, Leszek; Wawiórko, Elżbieta; Kamińska, Joanna; Kosieradzki, Maciej; Małkowski, Piotr; Małczuk, Bianka; Nazarewski, Sławomir; Mucha, Krzysztof

2018-03-02

BACKGROUND Nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics are the most commonly used drugs and are increasingly available over-the-counter (OTC). In certain groups of patients, including kidney transplant recipients, their use may be complicated by adverse effects or drug interactions. The aim of our study was to assess the causes and frequency of OTC NSAIDs or analgesics use, as well as the awareness of related side effects. MATERIAL AND METHODS We enrolled 94 randomly selected kidney transplant recipients, who represented 5% of all kidney transplant recipients at our center. An anonymous survey consisting of 23 multiple-choice questions was administered voluntarily and anonymously. RESULTS In all, 63% of study patients confirmed taking the OTC painkillers; 22% of these patients took these drugs at least several times a week, and 4% took these drugs daily. For 38% of the study kidney transplant recipients, NSAIDs or analgesics were reported to be the only way to manage their pain. In addition, 30% of study patients were unaware of the risks associated with these drugs, despite the fact that 89% of the study patients consider physicians the best source of information. CONCLUSIONS Our study found that 63% of kidney transplant recipients regularly took OTC painkillers and 30% were unaware of the potential adverse effects. This necessitates continuous, ongoing education of kidney transplant recipients about the risks of OTC NSAIDs or analgesics use.

Consumer judgement and risk perception on availability of over-the-counter-drugs.

NARCIS (Netherlands)

Brabers, A.E.M.; Dijk, L. van; Bouvy, M.L.; Jong, J.D. de

2011-01-01

Background: Over-the-counter (OTC)-drugs are available without a doctor’s prescription. Whereas this is convenient for consumers, it also makes consumers responsible for appropriate and safe use. European countries differ considerably when it comes to the availability of OTC-drugs. In the

Treatment with the cysteine precursor l-2-oxothiazolidine-4-carboxylate (OTC) implicates taurine deficiency in severity of dystropathology in mdx mice.

Science.gov (United States)

Terrill, Jessica R; Boyatzis, Amber; Grounds, Miranda D; Arthur, Peter G

2013-09-01

Oxidative stress has been implicated in the pathology of the lethal skeletal muscle disease Duchenne muscular dystrophy (DMD), and various antioxidants have been investigated as a potential therapy. Recently, treatment of the mdx mouse model for DMD with the antioxidant and cysteine and glutathione (GSH) precursor n-acetylcysteine (NAC) was shown to decrease protein thiol oxidation and improve muscle pathology and ex vivo muscle strength. This study further investigates the mechanism for the benefits of NAC on dystrophic muscle by administering l-2-oxothiazolidine-4-carboxylate (OTC) which also upregulates intracellular cysteine and GSH, but does not directly function as an antioxidant. We observed that OTC, like NAC, decreases protein thiol oxidation, decreases pathology and increases strength, suggesting that the both NAC and OTC function via increasing cysteine and GSH content of dystrophic muscle. We demonstrate that mdx muscle is not deficient in either cysteine or GSH and that these are not increased by OTC treatment. However, we show that dystrophic muscle of 12 week old mdx mice is deficient in taurine, a by-product of disposal of excess cysteine, a deficiency that is ameliorated by OTC treatment. These data suggest that in dystrophic muscles, apart from the strong association of increased oxidative stress and protein thiol oxidation with dystropathology, another major issue is an insufficiency in taurine that can be corrected by increasing the availability of cysteine. This study provides new insight into the molecular mechanism underlying the benefits of NAC in muscular dystrophy and supports the use of OTC as an alternative drug for potential clinical applications to DMD. Copyright © 2013 Elsevier Ltd. All rights reserved.

Hyperammonemic coma in a patient with late-onset OTC deficiency

Directory of Open Access Journals (Sweden)

V. D’Onofrio

2014-06-01

Full Text Available Urea Cycle Disorders ( UCD are among the most common genetic diseases of the metabolism and ornithine transcarbamylase deficiency (OTC, an X-linked defect is the most frequent among them. It is responsible for hyperammonemia that can lead to chronic neurological illness and potentially to death in case of delayed diagnosis and treatment. With regards to the OTC deficiency there is great clinical heterogeneity with early-onset phenotypes with mostly poor prognosis and late-onset phenotypes with a better one. In the article it is reported the case of a 8 years old patient with diagnosis of OTC deficit with late-onset phenotype. The kid was brought to our hospital because of continuous vomiting and gastro- intestinal disorders, associated with irritability and lethargy later resulted into coma. Measurement of plasma ammonia concentration, followed by measurement of plasma amino acid and urine orotic acid levels allowed to diagnose the OTC deficit, lately confirmed by molecular genetic studies. The patient has been promptly treated with Sodium Phenylbutyrate, Arginine and discontinuing the protein intake. Gradually the ammonemia value decreased, and general and neurological conditions improved with resolution of the coma. To conclude, for patients presenting unexplained neurological symptoms, confusion and decreased level of consciousness, up to coma, urea cycle disorders and in particularly OTC deficiency should be considered in the differential diagnosis and an urgent ammonia level determined. In case of hyperammonemia, the treatment should be started immediately , even without a precise ethiologic diagnosis.

Understanding older adults' medication decision making and behavior: A study on over-the-counter (OTC) anticholinergic medications.

Science.gov (United States)

Holden, Richard J; Srinivas, Preethi; Campbell, Noll L; Clark, Daniel O; Bodke, Kunal S; Hong, Youngbok; Boustani, Malaz A; Ferguson, Denisha; Callahan, Christopher M

2018-03-06

Older adults purchase and use over-the-counter (OTC) medications with potentially significant adverse effects. Some OTC medications, such as those with anticholinergic effects, are relatively contraindicated for use by older adults due to evidence of impaired cognition and other adverse effects. To inform the design of future OTC medication safety interventions for older adults, this study investigated consumers' decision making and behavior related to OTC medication purchasing and use, with a focus on OTC anticholinergic medications. The study had a cross-sectional design with multiple methods. A total of 84 adults participated in qualitative research interviews (n = 24), in-store shopper observations (n = 39), and laboratory-based simulated OTC shopping tasks (n = 21). Simulated shopping participants also rank-ordered eight factors on their importance for OTC decision making. Findings revealed that many participants had concerns about medication adverse effects, generally, but were not aware of age-related risk associated with the use of anticholinergic medications. Analyses produced a map of the workflow of OTC-related behavior and decision making as well as related barriers such as difficulty locating medications or comparing them to an alternative. Participants reported effectiveness, adverse effects or health risks, and price as most important to their OTC medication purchase and use decisions. A persona analysis identified two types of consumers: the habit follower, who frequently purchased OTC medications and considered them safe; and the deliberator, who was more likely to weigh their options and consider alternatives to OTC medications. A conceptual model of OTC medication purchase and use is presented. Drawing on study findings and behavioral theories, the model depicts dual processes for OTC medication decision making - habit-based and deliberation-based - as well as the antecedents and consequences of decision making. This model suggests

Some Sleep Drugs Can Impair Driving

Science.gov (United States)

... For Consumers Home For Consumers Consumer Updates Some Sleep Drugs Can Impair Driving Share Tweet Linkedin Pin ... over-the-counter (OTC) drugs. Most Widely Used Sleep Drug Zolpidem—which has been on the market ...

Parent, Teacher, and School Factors Associated with Over-the-Counter Drug Use among Multiracial Youth

Science.gov (United States)

Vidourek, Rebecca A.; King, Keith A.

2013-01-01

Background: Over-the-counter (OTC) drug use is an increasing health issue among adolescents. Purpose: This study investigated OTC drug use among 7th through 12th grade multiracial students in one metropolitan area. Methods: A total of 2134 students completed the PRIDE Questionnaire, which examines alcohol and other drug use. Results: A total of…

77 FR 7946 - Regulatory Agenda

Science.gov (United States)

2012-02-13

... Nutrition and Supplement Facts Labels. 351 Over-the-Counter (OTC) 0910-AF40 Drug Review-Oral Health [email protected] . RIN: 0910-AF22 351. Over-the-Counter (OTC) Drug Review--Oral Health Care Products... approved new drug application, may be legally marketed. The NPRM and final action will address oral health...

17 CFR 240.3b-13 - Definition of eligible OTC derivative instrument.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Definition of eligible OTC derivative instrument. 240.3b-13 Section 240.3b-13 Commodity and Securities Exchanges SECURITIES AND EXCHANGE... Under the Securities Exchange Act of 1934 Definitions § 240.3b-13 Definition of eligible OTC derivative...

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

Science.gov (United States)

Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

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

Prevalence of drug-related problems in self-medication in Danish community pharmacies

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Bente Frøkjær

2012-01-01

Full Text Available Background: Drug-related problems are known to be a major problem associated with pharmacotherapy. A broad range of studies, mainly in the area of prescription-only medicines, supports this fact. Only a few studies have evaluated drug-related problems with over-the-counter medicine and the role of community pharmacies in this. Purpose: To quantify drug-related problems in self-medication (use of over-the-counter medicine identified by community pharmacies in Denmark and to document the interventions by pharmacy staff in relation to the identified drug-related problems. Method: A descriptive study mapping drug-related problems in self-medication registered at the counter at a selected number of Danish community pharmacies. Results: Data for 3,868 consecutive customers with requests for over-the-counter (OTC medicines were registered at 39 community pharmacies. The pharmacies registered a total number of 4,324 OTC medicines requests, illustrating that a customer requested 1.1 OTC medicines on average. Drug-related problems (DRPs were identified for 813 customers, equivalent to DRPs for 21.0 % of all customers, presenting symptoms or requesting OTC medicines, and for 20 % of all over-the-counter medicines requests. 1,239 DRPs were registered, corresponding to an average of 1.5 DRPs per customer requesting OTC medicines. Community pharmacies estimated that they solved or partly solved 76.2 % of the detected DRPs; 73 % were solved without involving a general practitioner. Conclusions: DRPs were identified for 21.0 % of the pharmacy customers presenting a symptom or asking for an OTC medicine. The community pharmacy counselled the customers with DRPs more thoroughly than other customers by giving 2.4 pieces of professional advice, compared to an average of 2.1 to customers in general. It is not possible to determine the magnitude of the safety risk involved. Based on the most frequent categories of DRPs, there were risks of insufficient effect

Prevalence of drug-related problems in self-medication in Danish community pharmacies

Directory of Open Access Journals (Sweden)

Charlotte Rossing

2012-01-01

Full Text Available Background: Drug-related problems are known to be a major problem associated with pharmacotherapy. A broad range of studies, mainly in the area of prescription-only medicines, supports this fact. Only a few studies have evaluated drug-related problems with over-the-counter medicine and the role of community pharmacies in this.Purpose: To quantify drug-related problems in self-medication (use of over-the-counter medicine identified by community pharmacies in Denmark and to document the interventions by pharmacy staff in relation to the identified drug-related problems.Method: A descriptive study mapping drug-related problems in self-medication registered at the counter at a selected number of Danish community pharmacies.Results: Data for 3,868 consecutive customers with requests for over-the-counter (OTC medicines were registered at 39 community pharmacies. The pharmacies registered a total number of 4,324 OTC medicines requests, illustrating that a customer requested 1.1 OTC medicines on average. Drug-related problems (DRPs were identified for 813 customers, equivalent to DRPs for 21.0 % of all customers, presenting symptoms or requesting OTC medicines, and for 20 % of all over-the-counter medicines requests. 1,239 DRPs were registered, corresponding to an average of 1.5 DRPs per customer requesting OTC medicines.Community pharmacies estimated that they solved or partly solved 76.2 % of the detected DRPs; 73 % were solved without involving a general practitioner.Conclusions: DRPs were identified for 21.0 % of the pharmacy customers presenting a symptom or asking for an OTC medicine. The community pharmacy counselled the customers with DRPs more thoroughly than other customers by giving 2.4 pieces of professional advice, compared to an average of 2.1 to customers in general. It is not possible to determine the magnitude of the safety risk involved. Based on the most frequent categories of DRPs, there were risks of insufficient effect, unintended

Over-the-counter medicine abuse ? a review of the literature

OpenAIRE

Cooper, Richard J.

2011-01-01

Background: The sale of over-the-counter (OTC) medicines from pharmacies can help individuals self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognised. This review describes the current knowledge and understanding of OTC medicine abuse. Approach: Comprehensive search of international empirical and review literature between 1990 and 2011. Findings: OTC medicine abuse was identified in many countries and although implicated products...

Talk to Your Kids about Tobacco, Alcohol, and Drugs

Science.gov (United States)

... uses a drug to get high. People might abuse drugs by: Taking too much of a prescription or ... to your kids about the dangers of prescription drug abuse. Share this website about prescription and OTC drug ...

One fourth of acutely admitted patients use over-the-counter-drugs 24 hours prior to hospitalisation

DEFF Research Database (Denmark)

Pedersen, Magnus; Brabrand, Mikkel

2014-01-01

to hospitalisation and the effects of this intake. MATERIAL AND METHODS: Junior physicians on call interviewed patients admitted to the medical admission unit at South-West Jutland Hospital in Esbjerg using a modified chart template. Adult patients aged 15 and older admitted during a two-week period in August 2012...... were included. Patients were asked about consumed OTC drugs, dosage, indication and effect. RESULTS: From a total of 349 admissions, 188 usable chart templates were registered (54%), and information on OTC usage was registered on 165 of these (88%). The patients where elderly (median: 70 years) and 43......, 60% felt an effect of the intake and the majority felt an effect on pain symptoms. CONCLUSION: One in four patients used OTC drugs 24 hours prior to hospitalisation and primarily analgesics were used. Most patients used OTC drugs relevantly and half with a positive effect. The intake is poorly...

Over-the-counter medicine abuse: a review of the\\ud literature

OpenAIRE

Cooper, R. J.

2011-01-01

Background: The sale of over-the-counter (OTC) medicines from pharmacies can help individuals self-manage symptoms. However, some OTC medicines may be abused, with addiction and harms being increasingly recognised. This review describes the current knowledge and understanding of\\ud OTC medicine abuse.\\ud \\ud Approach: Comprehensive search of international empirical and review literature between 1990 and 2011.\\ud \\ud Findings: OTC medicine abuse was identified in many countries and although im...

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

Science.gov (United States)

Westerlund, Tommy; Barzi, Sahra; Bernsten, Cecilia

2017-01-01

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

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

Directory of Open Access Journals (Sweden)

Westerlund T

2017-03-01

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

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

Science.gov (United States)

Riva, Silvia; Monti, Marco; Antonietti, Alessandro

2011-01-01

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

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

Science.gov (United States)

2010-04-01

... may also pertain to prescription drugs): (i) Certain Surgical Sutures (DESI 4725), published in the... filing of objections. (vi) Thorexin Cough Medicine (DESI 11160) for which a notice of opportunity for... following (the referenced document may also pertain to prescription drugs): (i) Certain Sulfonamide...

Evaluation of Community Pharmacists Performance in Management of Cough, Diarrhea and Common Cold using OTC Medication Requests in Hamadan in 2015

Directory of Open Access Journals (Sweden)

A. Rashidi

2016-07-01

Full Text Available Introduction & Objective: Pharmacists usually encounter requests for over the counter drugs. How a pharmacist performs in evaluating patients' signs and symptoms, treating them, and moreover his or her approach in prescribing over the counter (OTC medications were the main goals of this study. Materials & Methods: In this cross- sectional study, the scenarios of cough, diarrhea and com-mon cold were obtained from questionnaires. These scenarios were then designed by deter-mining key questions. From the overall pharmacies in Hamadan, for each of the three scenar-ios, 46 pharmacies were randomly selected and analyzed. Performance of pharmacists, includ-ing their interventions on over the counter counseling, asking key questions, explaining drugs' side effects and interactions, and their approach of prescribing medications, were measured. Moreover, the influence of pharmacists' gender and type of the pharmacy were determined. Results: In 41 out of 179 visits, pharmacists were not present in the pharmacy (22.9%, mostly in suburban pharmacies. The pharmacists' performances in explaining drug interactions were significantly better in urban pharmacies in comparison with suburban ones. Moreover, subur-ban pharmacies and male pharmacists, in comparison with urban pharmacies and female pharmacists, prescribed more drugs. Conclusion: This study shows that despite the pharmacists asking the key questions ,the major-ity of pharmacists made weak recommendations. In order to improve pharmacists perform-ances, modification of educational system for pharmacy students in addition to the continu-ous and effective supervision of authorities on pharmacists' performance in OTC drugs is suggested. (Sci J Hamadan Univ Med Sci 2016; 23 (2:164-171

Thin layer chromatographic analysis of some common over the counter (OTC cough–cold preparations

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Manpreet Kaur Chahal

2016-12-01

Full Text Available In the present study, potential utility of thin layer chromatography to differentiate some common OTC cough–cold preparations was evaluated. Twenty solvent systems were examined from which a solvent systems A comprising methanol:ammonia in the ratio of 100:1.5 (v/v and B comprising chloroform:methanol in the ratio of 90:10 (v/v were found to be most suitable as it showed a high degree of separation of different components of these preparations. It was also found that iodine fuming technique is the best visualizing method for examining the TLC chromatograms of these drug samples prior to subsequent instrumental analysis.

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

Science.gov (United States)

2011-03-03

... comply with an FDA over-the-counter (OTC) drug final monograph, before marketing. DATES: This notice is... the drug products covered by this notice contain active ingredients that were introduced into the... the firm marketing the product has received approval for additional indication(s). In the early 1970s...

17 CFR 240.11a1-6 - Transactions for certain accounts of OTC derivatives dealers.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Transactions for certain accounts of OTC derivatives dealers. 240.11a1-6 Section 240.11a1-6 Commodity and Securities Exchanges... effected by a member of a national securities exchange for the account of an OTC derivatives dealer that is...

A Model of Consumer Response to Over-the-Counter Drug Advertising: Antecedents and Influencing Factors.

Science.gov (United States)

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

2016-01-01

Given the importance of over-the-counter (OTC) drugs in the health care marketplace and lack of systematic research on OTC drug advertising (OTCA) effects, this study tested a theory-based, product category-specific OTCA effects model. Structural equation modeling analysis of data for 1 OTC drug category, analgesics, supported the proposed model, explaining the OTCA effect process from key consumer antecedents to ad involvement, from ad involvement to ad attention, from ad attention to cognitive responses, then to affective/evaluative responses, leading to the final behavioral outcome. Several noteworthy patterns also emerged: (a) Product involvement was directly linked to ad attention, rather than exerting an indirect influence through ad involvement; (b) ad attention was significantly related to both cognitive and affective/evaluative responses to different degrees, with stronger links to cognitive responses; and (c) ad-prompted actions were influenced by both ad trust and ad attitude.

Drug Interactions: What You Should Know

Science.gov (United States)

... all OTC and prescription drugs, dietary supplements, vitamins, botanicals, minerals and herbals you take, as well as ... talk to your doctor before you take any medicine. Also, make sure you know what ingredients are ...

Experience with oral emergency contraception since the OTC switch in Germany.

Science.gov (United States)

Kiechle, Marion; Neuenfeldt, Miriam

2017-03-01

In March 2015, the oral emergency contraceptives levonorgestrel (LNG) and ulipristal acetate (UPA) were released from prescription-only status in Germany. The main research question is to analyse whether the OTC status of oral emergency contraceptives has an influence on the patterns of use. All information is based on searches for public domain sources on emergency contraception. Searches were made for scientific publications, statistics, and surveys. Due to additional active ingredient properties, UPA is superior to LNG in terms of ovulation-inhibiting effect. Since the OTC switch, demand for oral emergency contraceptives has risen by almost 50%, especially at weekends when sexual encounters and thus contraceptive failures are most frequent. However, the age distribution of the users has not changed as a result of the OTC switch. Doctors still play an important role in advising on emergency contraception after the removal of the prescription-only requirement. Pregnancies despite emergency contraception are terminated in more than half of the cases. In federal states with higher rates of use of the morning-after pill, fewer terminations of pregnancy were performed. As a result of the OTC switch, more women and girls use the morning-after pill after unprotected intercourse and the time between unprotected intercourse and taking the oral emergency contraceptive decreases. This is of great advantage in terms of the mechanism of action. UPA is used more frequently than LNG. Only half of all people aged between 16 and 39 years in Germany are aware of the morning-after pill and 94% of women who had a pregnancy terminated in 2015 did not use any emergency contraception after the unprotected intercourse. In the population, there is still a great need for information and education on contraception and emergency contraception.

Ovarian tissue cryopreservation (OTC) in prepubertal girls and young women: an analysis of parents' and patients' decision-making.

Science.gov (United States)

Sullivan-Pyke, Chantae S; Carlson, Claire A; Prewitt, Maureen; Gracia, Clarisa R; Ginsberg, Jill P

2018-04-01

The purpose of this study was to explore the decision-making influences, perceived level of control over decision-making, and mood states of parents and patients who were offered OTC prior to gonadotoxic therapy. Parents and patients, at least 12 years old, who required gonadotoxic therapy and were offered OTC prior to therapy, were asked to complete questionnaires. Two validated instruments were also used: the Decision-Making Control Instrument (DMCI) and the Profile of Mood States (POMS). The factors that influenced decision-making were compared using Student's t test, and the scores of DMCI and POMS were compared using the Mann-Whitney test. Thirty-six parents and 16 patients who elected ovarian tissue cryopreservation (OTC) completed questionnaires. Five parents who declined OTC also completed questionnaires. Accepters thought OTC was a good idea and that, in the future, science would enable cryopreserved ovarian tissue to be used to restore fertility (100% parents, 93.8% patients). Among accepters, the desire for genetically related children and prevention of the stress of infertility drove parents' and patients' decisions (90.9 and 100%, respectively). The desire to prevent the stress of infertility was important to parents, but patients were less likely to report that a desire to prevent the stress of infertility factored into their decision-making (66.7 vs. 50.0%; p decision and displayed low levels of mood disturbance. Though the decision to undergo experimental OTC is difficult and often urgent, this study suggests that families feel in control of their decision-making and report little emotional disturbance.

The Network of Counterparty Risk: Analysing Correlations in OTC Derivatives.

Science.gov (United States)

Nanumyan, Vahan; Garas, Antonios; Schweitzer, Frank

2015-01-01

Counterparty risk denotes the risk that a party defaults in a bilateral contract. This risk not only depends on the two parties involved, but also on the risk from various other contracts each of these parties holds. In rather informal markets, such as the OTC (over-the-counter) derivative market, institutions only report their aggregated quarterly risk exposure, but no details about their counterparties. Hence, little is known about the diversification of counterparty risk. In this paper, we reconstruct the weighted and time-dependent network of counterparty risk in the OTC derivatives market of the United States between 1998 and 2012. To proxy unknown bilateral exposures, we first study the co-occurrence patterns of institutions based on their quarterly activity and ranking in the official report. The network obtained this way is further analysed by a weighted k-core decomposition, to reveal a core-periphery structure. This allows us to compare the activity-based ranking with a topology-based ranking, to identify the most important institutions and their mutual dependencies. We also analyse correlations in these activities, to show strong similarities in the behavior of the core institutions. Our analysis clearly demonstrates the clustering of counterparty risk in a small set of about a dozen US banks. This not only increases the default risk of the central institutions, but also the default risk of peripheral institutions which have contracts with the central ones. Hence, all institutions indirectly have to bear (part of) the counterparty risk of all others, which needs to be better reflected in the price of OTC derivatives.

Functional characterization of the spf/ash splicing variation in OTC deficiency of mice and man.

Directory of Open Access Journals (Sweden)

Ana Rivera-Barahona

Full Text Available The spf/ash mouse model of ornithine transcarbamylase (OTC deficiency, a severe urea cycle disorder, is caused by a mutation (c.386G>A; p.R129H in the last nucleotide of exon 4 of the Otc gene, affecting the 5' splice site and resulting in partial use of a cryptic splice site 48 bp into the adjacent intron. The equivalent nucleotide change and predicted amino acid change is found in OTC deficient patients. Here we have used liver tissue and minigene assays to dissect the transcriptional profile resulting from the "spf/ash" mutation in mice and man. For the mutant mouse, we confirmed liver transcripts corresponding to partial intron 4 retention by the use of the c.386+48 cryptic site and to normally spliced transcripts, with exon 4 always containing the c.386G>A (p.R129H variant. In contrast, the OTC patient exhibited exon 4 skipping or c.386G>A (p.R129H-variant exon 4 retention by using the natural or a cryptic splice site at nucleotide position c.386+4. The corresponding OTC tissue enzyme activities were between 3-6% of normal control in mouse and human liver. The use of the cryptic splice sites was reproduced in minigenes carrying murine or human mutant sequences. Some normally spliced transcripts could be detected in minigenes in both cases. Antisense oligonucleotides designed to block the murine cryptic +48 site were used in minigenes in an attempt to redirect splicing to the natural site. The results highlight the relevance of in depth investigations of the molecular mechanisms of splicing mutations and potential therapeutic approaches. Notably, they emphasize the fact that findings in animal models may not be applicable for human patients due to the different genomic context of the mutations.

Over-the-counter (OTC) bruxism splints available on the Internet

NARCIS (Netherlands)

Wassell, R.W.; Verhees, L.; Lawrence, K.; Davies, S.; Lobbezoo, F.

2014-01-01

Background Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential

[Drug expenditures of pensioners in 1997-2000].

Science.gov (United States)

Swistak, Piotr; Błońska-Fajfrowska, Barbara

2003-01-01

The general purpose of the study, carried out in the group of pensioners was to determine the relation between drug prices, household income and amounts of money spent on drugs in the years 1997-2000. The study was based on representative data gathered from annual household budgets review by Polish Statistical Office and data from pharmaceutical market published in 'Vitamina C++' magazine. The used method combined descriptive, comparative, table-descriptive analysis with graphical analysis. During studied period the real value of expenses on drugs in pensioners' households rose by 39.3% and available income decreased by 5.8%. Increased expenses on drugs caused the rise of the proportion of on spending on drugs in total household expenditure. It rose from 3.9% in 1997 to 5.2% in 2000. Throughout this time period the drug prices increased in real terms: the highest growth (approx. 49%) was noticed in patients' co-payment to reimbursed drugs. Despite rise in spending on drugs, due to the increase in drug retail prices and increasing patients co-payment, pensioners in comparison with 1997, could buy only approx. 93% units of reimbursed drugs in 2000. The possibility of buying drugs within OTC group increased by 18%.

[Drug advertising and promotion: regulations and extent of compliance in five Latin American countries].

Science.gov (United States)

Vacca, Claudia; Vargas, Claudia; Cañás, Martín; Reveiz, Ludovic

2011-02-01

To analyze differing regulations regarding drug promotion, and the extent of compliance as seen in samples of advertising directed to the public in Argentina, Colombia, Ecuador, Nicaragua, and Peru. A total of 683 pieces of promotional material on display in health facilities, pharmacies, and on the street were collected, 132 of which were randomly selected for analysis. The regulations governing pharmaceutical advertising, taken from official websites and interviews with regulatory officials and Ministry of Health staff in the five countries covered, were reviewed, along with their adherence to the ethical criteria of the World Health Organization (WHO). The contents of the materials in the sample were evaluated to determine their degree of compliance with national regulations and WHO recommendations on drug promotion. The countries have regulations incorporating WHO ethical criteria. Over 80% of the material analyzed included the indications for the drug, while over 70% omitted information on adverse effects. Fifty percent of the advertisements for over-the-counter (OTC) drugs on display in pharmacies listed indications not approved by the relevant health authority. In advertising in pharmacies, the risks from inadequate information were not found to differ significantly for OTC or prescription medications. Compared with materials provided in health facilities, the relative risk of the absence of information on dosage in the material distributed in pharmacies was 2.08 (confidence interval 95% 1.32-3.39). Although regulations on drug promotion and advertising in the five countries studied generally incorporate the WHO recommendations, promotional materials often fail to reflect the fact.

HIV infection and OTC supplements: do they really have an impact?

African Journals Online (AJOL)

Repro

treatment of chronic diseases. HIV infection and OTC supplements: do they really have an impact? ... the pathogenesis of HIV-related disease ... venous glycyrrhizin has been used in Japan to ... ulcers) but this would not have much effect on ...

76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

Science.gov (United States)

2011-09-29

... monograph need not obtain FDA approval before marketing if their drug product meets the conditions in part... introduce into the United States an OTC drug product that had been marketed solely in a foreign country...

Final Safety Assessment of Coal Tar as Used in Cosmetics

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-07-01

Coal Tar is a semisolid by-product obtained in the destructive distillation of bituminous coal, which functions in cosmetic products as a cosmetic biocide and denaturant-antidandruff agent is also listed as a function, but this is considered an over-the-counter (OTC) drug use. In 2002, Coal Tar was reported to the Food and Drug Administration (FDA) to be used in four formulations, all of which appear to be OTC drug products. Coal Tar is monographed by the FDA as Category I (safe and effective) OTC drug ingredient for use in the treatment of dandruff, seborrhoea, and psoriasis. Coal Tar is absorbed through the skin of animals and humans and is systemically distributed. Although the Cosmetic Ingredient Review (CIR) Expert Panel believes that Coal Tar use as an antidandruff ingredient in OTC drug preparations is adequately addressed by the FDA regulations, the Panel also believes that the appropriate concentration of use of Coal Tar in cosmetic formulations should be that level that does not have a biological effect in the user. Additional data needed to make a safety assessment include product types in which Coal Tar is used (other than as an OTC drug ingredient), use concentrations, and the maximum concentration that does not induce a biological effect in users.

Removal of oxytetracycline (OTC) in a synthetic pharmaceutical wastewater by a sequential anaerobic multichamber bed reactor (AMCBR)/completely stirred tank reactor (CSTR) system: biodegradation and inhibition kinetics.

Science.gov (United States)

Sponza, Delia Teresa; Çelebi, Hakan

2012-01-01

An anaerobic multichamber bed reactor (AMCBR) was effective in removing both molasses-chemical oxygen demand (COD), and the antibiotic oxytetracycline (OTC). The maximum COD and OTC removals were 99% in sequential AMCBR/completely stirred tank reactor (CSTR) at an OTC concentration of 300 mg L(-1). 51%, 29% and 9% of the total volatile fatty acid (TVFA) was composed of acetic, propionic acid and butyric acids, respectively. The OTC loading rates at between 22.22 and 133.33 g OTC m(-3) d(-1) improved the hydrolysis of molasses-COD (k), the maximum specific utilization of molasses-COD (k(mh)) and the maximum specific utilization rate of TVFA (k(TVFA)). The direct effect of high OTC loadings (155.56 and -177.78 g OTC m(-3) d(-1)) on acidogens and methanogens were evaluated with Haldane inhibition kinetic. A significant decrease of the Haldane inhibition constant was indicative of increases in toxicity at increasing loading rates. Copyright © 2011 Elsevier Ltd. All rights reserved.

Self-medication practice in Ethiopia: a systematic review

Directory of Open Access Journals (Sweden)

Ayalew MB

2017-03-01

Full Text Available Mohammed Biset Ayalew Department of Clinical Pharmacy, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia Background: Self-medication patterns vary among different populations, and are influenced by many factors. No review has been done that comprehensively expresses self-medication practice in Ethiopia. The aim of this study was to provide an overview of the literature on self-medication practice in Ethiopia.Materials and methods: Databases (PubMed, Google Scholar, ResearchGate, and Hinari were searched for published studies on the practice of self-medication in Ethiopia without restriction in the year of publication or methodology. Some studies were also identified through manual Google search. Primary search terms were “self medication”, “Ethiopia”, “self care”, “non-prescription”, “OTC drug use”, “drug utilization”, and “drug hoarding”. Studies that measured knowledge only or attitude only or beliefs only and did not determine the practice of self-medication were excluded.Results: The database search produced a total of 450 papers. After adjustment for duplicates and inclusion and exclusion criteria, 21 articles were found suitable for the review. All studies were cross-sectional in nature. The prevalence of self-medication varied from 12.8% to 77.1%, with an average of 36.8%. Fever/headache, gastrointestinal tract diseases, and respiratory diseases were the commonest illnesses/symptoms for which self-medication was taken. The major reasons for practicing self-medication were previous experience of treating a similar illness and feeling that the illness was mild. Analgesics/antipyretics, antimicrobials, gastrointestinal drugs, and respiratory drugs were the common drug classes used in self-medication. Mainly, these drugs were obtained from drug-retail outlets. The use of self-medication was commonly suggested by pharmacy professionals and friends

THE PROBLEM OF LEGAL REGULATION OF THE OPERATION OF THE OVER-THE-COUNTER (OTC) CURRENCY MARKET (FOREX) IN UKRAINE AND THE EU

OpenAIRE

Eugene Podorozhnyi; Dmytro Sirokha; Pavlo Komirchyi

2017-01-01

The aim of the article is to evaluate the state of legal institutionalization of the OTC foreign exchange market in Ukraine, as well as its comparison with the foreign experience of legal regulation of OTC currency relations in Ukraine and EU countries. The subject of the study is the legal and administrative framework for the functioning of the OTC currency market (Forex) in Ukraine and in the EU countries. The methodology of the study consists of: historical and legal method, which allowed ...

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

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing colloidal silver... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have...

Potentiometric studies on the complexes of tetracycline (TC) and oxytetracycline (OTC) with some metal ions. Potentiometrische Untersuchungen der Komplexe von Tetracyclin (TC) und Oxytetracyclin (OTC) mit einigen Metall-Ionen

Energy Technology Data Exchange (ETDEWEB)

Ghandour, M A; Azab, H A; Hassan, A; Ali, A M [Assiut Univ. (Egypt)

1992-01-01

The interaction of Cr(III), Mn(II), Fe(III), Co(II), Ni(II), Zn(II), Cd(II), Hg(II), Pb(II), Al(III), and UO[sub 2](II) ions with tetracycline (TC) were studied by potentiometric pH titrations. The formation constants of the different binary complexes formed in such systems have been determined at 25[+-]0.1 deg C and [mu]=0.1 moll[sup -1] (NaNO[sub 3]). Potentiometric pH equilibrium measurements have been made under the same conditions for the interaction of oxytetracycline (OTC) and Cu(II), Cd(II), Pb(II), and UO[sub 2](II). The formation of (1:1) binary complexes are inferred from the potentiometric pH titration curves. The protonation constants of TC and OTC were also determined under the same conditions and refined (ESAB2M computer program). The transition metal stability constants are consistent with the Irving-Williams series. (authors).

Summary of: Over-the-counter (OTC) bruxism splints available on the Internet

NARCIS (Netherlands)

Wassell, R.W.; Verhees, L.; Lawrence, K.; Davies, S.; Lobbezoo, F.

2014-01-01

Background Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential

The practice of OTC counseling by community pharmacists in Parana, Brazil

Directory of Open Access Journals (Sweden)

Halila GC

2015-12-01

Full Text Available Background: In order to provide appropriate advice to the patient at the time of dispensing and over-the-counter (OTC medication counseling, community pharmacists need access to current and reliable information about medicines. Brazilian pharmacists have assumed new functions such as prescribing medication, in a dependent model, based in protocols. Objective: To examine the practice of community pharmacists in a Brazilian State, focusing on OTC recommendation. Method: A cross-sectional survey of community pharmacists in a state of Brazil was conducted from October 2013 to January 2014, with data collection through a pre-piloted self-administered anonymous survey via Survey Monkey® platform. Following ethical approval, the online instrument was sent to 8,885 pharmacists registered in Parana State, Brazil, focusing on professionals working in community pharmacies. The questionnaire assessed the community pharmacy setting, the search for information, the knowledge of the evidence-based practice, the important factors to consider when recommending an OTC medicine, and the pharmacist prescribing. Responses were imported into SPSS® (version 22.0 for analysis. Nonparametric tests were used to assess the association between responses and demographic information with a significance level less than 5% (p<0.05. Results: Of the pharmacists, 97.4% dispensed medications and counseled patients for a median of six hours per day. Product's efficacy (97% and adverse effects (62.3% were the most important factors taken into account when counseling a nonprescription medicine. Few pharmacists knew the meaning of terms related to evidence-based health. Most respondents agreed that pharmacists have the necessary training to prescribe. Conclusion: Over-the-counter medication counseling is a daily practice among Brazilian pharmacists. Learning needs exist for community pharmacists in relation to evidence-based practice. Thus, sources of information with good evidence

17 CFR 240.15a-1 - Securities activities of OTC derivatives dealers.

Science.gov (United States)

2010-04-01

... options, forwards, futures, swap agreements, or collars involving currencies, interest or other rates... derivatives dealers. 240.15a-1 Section 240.15a-1 Commodity and Securities Exchanges SECURITIES AND EXCHANGE... Under the Securities Exchange Act of 1934 Exemption of Certain Otc Derivatives Dealers § 240.15a-1...

Now you see it. Now you don't: fair balance and adequate provision in advertisements for drugs before and after the switch from prescription to over-the-counter.

Science.gov (United States)

Faerber, Adrienne E; Kreling, David H

2012-01-01

The objective of this study was to measure differences in fair balance (benefit and risk statements) and adequate provision (toll-free numbers, Internet URLs, print ad references, and medical professional references) in advertising content for drugs that have switched from prescription to over-the-counter (OTC). The Vanderbilt TV News Archive was used to select products to study, to measure the frequency and placement of ads for those products, and to view advertising content for those products. Unique advertisements (n = 108) for loratadine (Claritin), citirizine (Zyrtec), and omeprazole (Prilosec) were analyzed for the presence of adequate provision statements and for the frequency of benefit, risk, and other statements. OTC ads were shorter than prescription ads by 10.6 seconds but contained the same total number of statements. Most prescription ads (n (RX) = 31) contained toll-free numbers (97%), Internet URLs (94%), medical professional references (100%) and print ad references (68%). Few OTC ads (n (OTC) = 77) contained adequate provision statements: 4% contained toll-free numbers and 10% contained Internet URLs. Prescription ads had similar numbers of benefits (1.5) and risks (1.8) per 30 seconds of ad time, and OTC ads had more benefits (6.6) than risks (1.2) per 30 seconds of ad time. Prescription drug ads contained risk statements that listed specific side effects and explicit harms from taking the product, but OTC ads contained nonspecific risk information and statements that implied risk rather than directly identifying risk. Differences in the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulation of advertising affected the balance of risk and benefit information that appeared and the specificity of risk information available.

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

Science.gov (United States)

2011-06-22

.... FDA-2011-D-0404] Guidance for Industry on Topical Acne Drug Products for Over-the- Counter Human Use... entities entitled ``Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and... recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug...

Dos and Don'ts of Giving OTC Cough and Cold Medicines to Your Child

Science.gov (United States)

... workers, extended family members, or babysitters) knows what medicines your child is taking and when he or she should ... ts Don’t give OTC cough and cold medicines to a child younger than 4 years of age unless your ...

Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.

Science.gov (United States)

Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

2014-12-01

The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics.

Radiopharmaceutical drug review process

International Nuclear Information System (INIS)

Frankel, R.

1985-01-01

To ensure proper radioactive drug use (such as quality, diagnostic improvement, and minimal radioactive exposure), the Food and Drug Administration evaluates new drugs with respect to safety, effectiveness, and accuracy and adequacy of the labeling. The IND or NDA process is used for this purpose. A brief description of the process, including the Chemical Classification System and the therapeutic potential classification, is presented as it applies to radiopharmaceuticals. Also, the status of the IND or NDA review of radiopharmaceuticals is given

Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

Science.gov (United States)

Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

2017-08-01

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

INFLUENCE OF ADVERTISING ON THE WAY OF ACTION IN THE ACQUISITION OF OVER-THE-COUNTER DRUGS

Directory of Open Access Journals (Sweden)

Stefan-Dragoş CÎRSTEA

2016-12-01

Full Text Available Advertising of the Over-the-counter drugs is a growing segment. Our research aims to identify the main factors involved in making decisions for the purchase of OTC drugs and to identify what are the ways of informing consumers for this process. To test the hypotheses, a number of statistical tools such as factor analysis, Shapiro-Wilk and Mann-Whitney U tests have been used. The analyzed factors were: (A doctor’s choice , (b former own experience, (c pharmacist’s advice, (d information stated on the prospectus, (e opinion of people who bought that drug, (f opinion of colleagues, friends, relatives, (g price, (h brand, manufacturer, (i information from advertising, (j quality of advertising. For our analysis, we focused on two main populations: students and employed educated people. The main conclusion of this paper is that recent exposure to OTC advertising is likely to change both related behaviors and decision grids.

Drug-targeting methodologies with applications: A review

Science.gov (United States)

Kleinstreuer, Clement; Feng, Yu; Childress, Emily

2014-01-01

Targeted drug delivery to solid tumors is a very active research area, focusing mainly on improved drug formulation and associated best delivery methods/devices. Drug-targeting has the potential to greatly improve drug-delivery efficacy, reduce side effects, and lower the treatment costs. However, the vast majority of drug-targeting studies assume that the drug-particles are already at the target site or at least in its direct vicinity. In this review, drug-delivery methodologies, drug types and drug-delivery devices are discussed with examples in two major application areas: (1) inhaled drug-aerosol delivery into human lung-airways; and (2) intravascular drug-delivery for solid tumor targeting. The major problem addressed is how to deliver efficiently the drug-particles from the entry/infusion point to the target site. So far, most experimental results are based on animal studies. Concerning pulmonary drug delivery, the focus is on the pros and cons of three inhaler types, i.e., pressurized metered dose inhaler, dry powder inhaler and nebulizer, in addition to drug-aerosol formulations. Computational fluid-particle dynamics techniques and the underlying methodology for a smart inhaler system are discussed as well. Concerning intravascular drug-delivery for solid tumor targeting, passive and active targeting are reviewed as well as direct drug-targeting, using optimal delivery of radioactive microspheres to liver tumors as an example. The review concludes with suggestions for future work, considereing both pulmonary drug targeting and direct drug delivery to solid tumors in the vascular system. PMID:25516850

Drug-related problems identified in medication reviews by Australian pharmacists

DEFF Research Database (Denmark)

Stafford, Andrew C; Tenni, Peter C; Peterson, Gregory M

2009-01-01

OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study was to exam......OBJECTIVE: In Australia, accredited pharmacists perform medication reviews for patients to identify and resolve drug-related problems. We analysed the drug-related problems identified in reviews for both home-dwelling and residential care-facility patients. The objective of this study....... These reviews had been self-selected by pharmacists and submitted as part of the reaccreditation process to the primary body responsible for accrediting Australian pharmacists to perform medication reviews. The drug-related problems identified in each review were classified by type and drugs involved. MAIN...... OUTCOME MEASURE: The number and nature of drug-related problems identified in pharmacist-conducted medication reviews. RESULTS: There were 1,038 drug-related problems identified in 234 medication reviews (mean 4.6 (+/-2.2) problems per review). The number of problems was higher (4.9 +/- 2.0 vs. 3.9 +/- 2...

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market

Science.gov (United States)

2011-01-01

Background In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. Results All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market

Directory of Open Access Journals (Sweden)

Merger Eduard

2011-08-01

Full Text Available Abstract Background In recent years, the voluntary over-the-counter (OTC carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. Results All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market.

Science.gov (United States)

Merger, Eduard; Pistorius, Till

2011-08-17

In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a

Pilot Certification, Age of Pilot, and Drug Use in Fatal Civil Aviation Accidents.

Science.gov (United States)

Akparibo, Issaka Y; Stolfi, Adrienne

2017-10-01

This study examined the association between mean age of pilot, pilot license, pilot medical certificate and drug use trends in pilots fatally injured in aircraft accidents. The prevalence of prescription drugs, OTC drugs, controlled drugs and drugs that may be potentially impairing was also examined. This study was a descriptive observational study in which the NTSB Aviation Accident Database was searched from the period beginning January 1, 2012 to December 31, 2014. During the study period a total of 706 accidents involving 711 fatalities were investigated by the NTSB. This study included 633 of these accidents, involving 646 fatalities. Of these pilots, 42.1% had drugs in their biological samples. The prevalence of prescription drugs, controlled drugs, OTC drugs, opioids, and potentially impairing drugs in the fatally injured pilot population over the study period was 28.9%, 15.0%, 20.1%, 5.1%, and 25.5%, respectively. Pilots with any drugs in their samples were significantly older than those without drugs. Medical certificate held was associated with drug use; pilots who held third class certificates had the highest prevalence at 54.1%. Pilot license was not associated with drug use. In 3.8% of the accidents, drugs were a contributing factor in the cause. Despite current FAA medical regulations, potentially impairing drugs are frequently found in biological samples of fatally injured pilots in the U.S. More education of airmen by aviation medical examiners is needed on the safety of drug use.Akparibo IY, Stolfi A. Pilot certification, age of pilot, and drug use in fatal civil aviation accidents. Aerosp Med Hum Perform. 2017; 88(10):931-936.

Multidisciplinary management of ornithine transcarbamylase (OTC) deficiency in pregnancy: essential to prevent hyperammonemic complications

Science.gov (United States)

Lamb, Stephanie; Aye, Christina Yi Ling; Murphy, Elaine; Mackillop, Lucy

2013-01-01

Ornithine transcarbamylase (OTC) deficiency is the most common inborn error in the metabolism of the urea cycle with an incidence of 1 in 14 000 live births. Pregnancy can trigger potentially fatal hyperammonemic crises. We report a successful pregnancy in a 29-year-old primiparous patient with a known diagnosis of OTC deficiency since infancy. Hyperammonemic complications were avoided due to careful multidisciplinary management which included a detailed antenatal, intrapartum and postnatal plan. Management principles include avoidance of triggers, a low-protein diet and medications which promote the removal of nitrogen by alternative pathways. Triggers include metabolic stress such as febrile illness, particularly gastroenteritis, fasting and any protein loading. In our case the patient, in addition to a restricted protein intake, was prescribed sodium benzoate 4 g four times a day, sodium phenylbutyrate 2 g four times a day and arginine 500 mg four times a day to aid excretion of ammonia and reduce flux through the urea cycle. PMID:23283608

Quantitative aspects of recognition of the antibiotic drug oxytetracycline by bovine serum albumin: Calorimetric and spectroscopic studies

Energy Technology Data Exchange (ETDEWEB)

Keswani, Neelam; Choudhary, Sinjan [Department of Chemistry, Indian Institute of Technology Bombay, Powai, Mumbai 400 076 (India); Kishore, Nand [Department of Chemistry, Indian Institute of Technology Bombay, Powai, Mumbai 400 076 (India)

2013-03-15

Highlights: ► Thermodynamics of oxytetracycline (OTC)-bovine serum albumin (BSA) binding addressed. ► ITC and fluorescence spectroscopic analysis provide values of binding constant. ► Binding is mainly ionic, hydrophobic with minor hydrogen bonding contribution. ► Quantitative effects of OTC on BSA stability provided by DSC. ► Preferential complexation of one domain of BSA by OTC at site II is suggested. -- Abstract: A quantitative understanding of the mode of interaction of drugs with target proteins provides a guide for the synthesis of new drug molecules. The binding of the antibiotic drug oxytetracycline with serum albumin has been studied by a combination of isothermal titration calorimetry (ITC), differential scanning calorimetry (DSC), steady-state and time-resolved fluorescence spectroscopy, and circular dichroism spectroscopy. The values of the binding constant (K), enthalpy change (ΔH), entropy (ΔS), and stoichiometry of binding have been determined along with the associated conformational changes in the protein. Oxytetracycline binds to bovine serum albumin with a 1:1 stoichiometry and with a weakly temperature dependent association constant of 1.8 · 10{sup 4} at T = 298.15 K. The effect of ionic strength, tetrabutylammonium bromide, and sucrose on the thermodynamic parameters obtained from ITC and DSC measurements indicate involvement of predominantly ionic and hydrophobic interactions with a minor hydrogen bonding contribution in the drug-protein complexation. The DSC results on the binding of oxytetracycline with bovine serum albumin in the absence and presence of these additives provide quantitative information on the effect of drugs on the stability of bovine serum albumin, and suggest preferential complexation of one of the domains of the protein. The results further indicate that the drug occupies binding site II on bovine serum albumin.

Quantitative aspects of recognition of the antibiotic drug oxytetracycline by bovine serum albumin: Calorimetric and spectroscopic studies

International Nuclear Information System (INIS)

Keswani, Neelam; Choudhary, Sinjan; Kishore, Nand

2013-01-01

Highlights: ► Thermodynamics of oxytetracycline (OTC)-bovine serum albumin (BSA) binding addressed. ► ITC and fluorescence spectroscopic analysis provide values of binding constant. ► Binding is mainly ionic, hydrophobic with minor hydrogen bonding contribution. ► Quantitative effects of OTC on BSA stability provided by DSC. ► Preferential complexation of one domain of BSA by OTC at site II is suggested. -- Abstract: A quantitative understanding of the mode of interaction of drugs with target proteins provides a guide for the synthesis of new drug molecules. The binding of the antibiotic drug oxytetracycline with serum albumin has been studied by a combination of isothermal titration calorimetry (ITC), differential scanning calorimetry (DSC), steady-state and time-resolved fluorescence spectroscopy, and circular dichroism spectroscopy. The values of the binding constant (K), enthalpy change (ΔH), entropy (ΔS), and stoichiometry of binding have been determined along with the associated conformational changes in the protein. Oxytetracycline binds to bovine serum albumin with a 1:1 stoichiometry and with a weakly temperature dependent association constant of 1.8 · 10 4 at T = 298.15 K. The effect of ionic strength, tetrabutylammonium bromide, and sucrose on the thermodynamic parameters obtained from ITC and DSC measurements indicate involvement of predominantly ionic and hydrophobic interactions with a minor hydrogen bonding contribution in the drug-protein complexation. The DSC results on the binding of oxytetracycline with bovine serum albumin in the absence and presence of these additives provide quantitative information on the effect of drugs on the stability of bovine serum albumin, and suggest preferential complexation of one of the domains of the protein. The results further indicate that the drug occupies binding site II on bovine serum albumin

Effect of drug law enforcement on drug market violence: a systematic review.

Science.gov (United States)

Werb, Dan; Rowell, Greg; Guyatt, Gordon; Kerr, Thomas; Montaner, Julio; Wood, Evan

2011-03-01

Violence is amongst the primary concerns of communities around the world and research has demonstrated links between violence and the illicit drug trade, particularly in urban settings. Given the growing emphasis on evidence-based policy-making, and the ongoing severe drug market violence in Mexico and other settings, we conducted a systematic review to examine the impacts of drug law enforcement on drug market violence. We conducted a systematic review using Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. Specifically, we undertook a search of English language electronic databases (Academic Search Complete, PubMed, PsycINFO, EMBASE, Web of Science, Sociological Abstracts, Social Service Abstracts, PAIS International and Lexis-Nexis), the Internet (Google, Google Scholar), and article reference lists, from database inception to January 24, 2011. Overall, 15 studies were identified that evaluated the impact of drug law enforcement on drug market violence, including 11 (73%) longitudinal analyses using linear regression, 2 (13%) mathematical drug market models, and 2 (13%) qualitative studies. Fourteen (93%) studies reported an adverse impact of drug law enforcement on levels of violence. Ten of the 11 (91%) studies employing longitudinal qualitative analyses found a significant association between drug law enforcement and drug market violence. Our findings suggest that increasing drug law enforcement is unlikely to reduce drug market violence. Instead, the existing evidence base suggests that gun violence and high homicide rates may be an inevitable consequence of drug prohibition and that disrupting drug markets can paradoxically increase violence. In this context, and since drug prohibition has not meaningfully reduced drug supply, alternative regulatory models will be required if drug supply and drug market violence are to be meaningfully reduced. Copyright © 2011 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

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

2016-05-05

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

Modeling, analysis and comparison of TSR and OTC methods for MPPT and power smoothing in permanent magnet synchronous generator-based wind turbines

International Nuclear Information System (INIS)

Nasiri, M.; Milimonfared, J.; Fathi, S.H.

2014-01-01

Highlights: • Small signal modeling of PMSG wind turbine with two controllers are introduced. • Poles and zeroes analyzing of OTC and TSR methods is performed. • Generator output power with varying wind speed in PMSG wind turbine is studied. • MPPT capability of OTC and TSR methods to wind speed variations are compared. • Power smoothing capability and reducing mechanical stress of both methods are studied. - Abstract: This paper presents a small signal modeling of a direct-driven permanent magnet synchronous generator (PMSG) based on wind turbine which is connected to the grid via back-to-back converters. The proposed small signal model includes two maximum power point tracking (MPPT) controllers: tip speed ratio (TSR) control and optimal torque control (OTC). These methods are analytically compared to illustrate MPPT and power smoothing capability. Then, to compare the MPPT and power smoothing operation of the mentioned methods, simulations are performed in MATLAB/Simulink software. From the simulation results, OTC is highly efficient in power smoothing enhancement and has clearly good performance to extract maximum power from wind; however, TSR control has definitely fast responses to wind speed variations with the expense of higher fluctuations due to its non-minimum phase characteristic

Effect of herb drug medicine Treatment for Functional Dyspepsia:Controlled Trial

Directory of Open Access Journals (Sweden)

Lee Jae-Jin

2009-06-01

Full Text Available Obejective : Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this research is to examine the equivalent effect of herb drug medicine treatment(H-Dand Over the Counter(OTC for functional dyspepsia. Method : In this controlled study, we compared herb drug medicine(H-D with Over the Counter(OTC of functional dyspepsia. 30 volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index(NDI-K before and after treatments. Result : The results are summarized as follows. 1. In Herb drug medicine and Over the Counter groups, total key symptoms score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. 2. In Herb drug medicine and Over the Counter groups, each symptoms score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. 3. In Herb drug medicine and Over the Counter groups, quality of life score of after treatment were significantly decreased and improve rate of key symptoms was higher than before treatment, but there were no statistical significance between two groups. Conclusion : Herb drug medicine treatment(H-D is effective to improve the symptoms and quality of life in patients with functional dyspepsia.

Interventions to enhance effective communication during over-the-counter consultations in the community pharmacy setting: A systematic review.

Science.gov (United States)

Seubert, Liza J; Whitelaw, Kerry; Hattingh, Laetitia; Watson, Margaret C; Clifford, Rhonda M

2017-12-13

Easy access to effective over-the-counter (OTC) treatments allows self-management of some conditions, however inappropriate or incorrect supply or use of OTC medicines can cause harm. Pharmacy personnel should support consumers in their health-seeking behaviour by utilising effective communication skills underpinned by clinical knowledge. To identify interventions targeted towards improving communication between consumers and pharmacy personnel during OTC consultations in the community pharmacy setting. Systematic review and narrative analysis. Databases searched were MEDLINE, EMBASE, Psycinfo, Cochrane Central Register and Cochrane Database of Systematic Reviews for literature published between 2000 and 30 October 2014, as well as reference lists of included articles. The search was re-run on 18 January 2016 and 25 September 2017 to maximise the currency. Two reviewers independently screened retrieved articles for inclusion, assessed study quality and extracted data. Full publications of intervention studies were included. Participants were community pharmacy personnel and/or consumers involved in OTC consultations. Interventions which aimed to improve communication during OTC consultations in the community pharmacy setting were included if they involved a direct measurable communication outcome. Studies reporting attitudes and measures not quantifiable were excluded. The protocol was published on Prospero Database of Systematic Reviews. Of 4978 records identified, 11 studies met inclusion criteria. Interventions evaluated were: face-to-face training sessions (n = 10); role-plays (n = 9); a software decision making program (n = 1); and simulated patient (SP) visits followed by immediate feedback (n = 1). Outcomes were measured using: SP methodology (n = 10) and a survey (n = 1), with most (n = 10) reporting a level of improvement in some communication behaviours. Empirical evaluation of interventions using active learning techniques

Potentiometric studies on the complexes of tetracycline (TC) and oxytetracycline (OTC) with some metal ions

International Nuclear Information System (INIS)

Ghandour, M.A.; Azab, H.A.; Hassan, A.; Ali, A.M.

1992-01-01

The interaction of Cr(III), Mn(II), Fe(III), Co(II), Ni(II), Zn(II), Cd(II), Hg(II), Pb(II), Al(III), and UO 2 (II) ions with tetracycline (TC) were studied by potentiometric pH titrations. The formation constants of the different binary complexes formed in such systems have been determined at 25±0.1 deg C and μ=0.1 moll -1 (NaNO 3 ). Potentiometric pH equilibrium measurements have been made under the same conditions for the interaction of oxytetracycline (OTC) and Cu(II), Cd(II), Pb(II), and UO 2 (II). The formation of (1:1) binary complexes are inferred from the potentiometric pH titration curves. The protonation constants of TC and OTC were also determined under the same conditions and refined (ESAB2M computer program). The transition metal stability constants are consistent with the Irving-Williams series. (authors)

The use of over-the-counter drugs among surgical and medical patients

DEFF Research Database (Denmark)

Glintborg, Bente; Andersen, Stig Ejdrup; Spang-Hanssen, Eva

2004-01-01

and discharge letters were examined. RESULTS: In totally, 83 surgical and 117 medical patients were included (n=200). Whereas the home inventories of 187 patients comprised 587 OTCs, 13 patients (7%) stored no OTCs. Of the patients, 134 (67%) used OTCs daily and 132 patients (66%) used OTCs on demand; 79...... patients (40%) stored a total of 157 OTCs not currently used. Analgesics were used by 138 patients (78%). Acetaminophen was the OTC used most frequently. Of the 240 OTCs used daily, 238 (99%) had been purchased from pharmacies and 169 (70%) had been prescribed. Of the 430 OTCs used daily or on demand, 348...... daily. Most OTCs are used with the consent of health care professionals and are purchased from pharmacies. Pre-admission OTC use is incompletely recorded in the hospital files. If information was systematically collected from pharmacies and general practitioners, the number of recall biases concerning...

75 FR 30838 - Drometrizole Trisiloxane Eligibility for Potential Inclusion in Sunscreen Monograph; Over-the...

Science.gov (United States)

2010-06-02

... Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety, Effectiveness, and...) sunscreen active ingredients found in the sunscreen monograph. We reviewed a time and extent application... our OTC drug monograph system. We will evaluate the submitted safety and effectiveness data and...

Probing the In Vitro Cytotoxicity of the Veterinary Drug Oxytetracycline

Science.gov (United States)

Chi, Zhenxing; Liu, Rutao; You, Hong; Ma, Shanshan; Cui, Hao; Zhang, Qiang

2014-01-01

The study investigated the effect of oxytetracycline (OTC) on the anti-oxidative defense system, the structure (hemolysis rate and morphology) and function (ATP enzyme activity) of human red blood cells (hRBCs) to investigate the possible toxic mechanism of OTC to hRBCs. The experimental results indicate that OTC can cause a decline in the function of the antioxidant defense system of hRBCs, resulting in oxidative stress. OTC can bring about morphological changes to hRBCs, and further leads to hemolysis, when the concentration of OTC is over 8×10−5 M (about 164 µg/ml). At a low OTC concentration, below 4×10−5 M (82 µg/ml), OTC can enhance the activity of ATP enzyme of hRBCs, known as hormesis. However, at a high concentration, above 4×10−5 M (about 82 µg/ml), the ATP enzymatic activity was inhibited, affecting the function of hRBCs. The estalished mechanism of toxicity of OTC to hRBCs can facilitate a deeper understanding of the toxicity of OTC in vivo. PMID:25019386

Probing the in vitro cytotoxicity of the veterinary drug oxytetracycline.

Directory of Open Access Journals (Sweden)

Zhenxing Chi

Full Text Available The study investigated the effect of oxytetracycline (OTC on the anti-oxidative defense system, the structure (hemolysis rate and morphology and function (ATP enzyme activity of human red blood cells (hRBCs to investigate the possible toxic mechanism of OTC to hRBCs. The experimental results indicate that OTC can cause a decline in the function of the antioxidant defense system of hRBCs, resulting in oxidative stress. OTC can bring about morphological changes to hRBCs, and further leads to hemolysis, when the concentration of OTC is over 8×10(-5 M (about 164 µg/ml. At a low OTC concentration, below 4×10(-5 M (82 µg/ml, OTC can enhance the activity of ATP enzyme of hRBCs, known as hormesis. However, at a high concentration, above 4×10(-5 M (about 82 µg/ml, the ATP enzymatic activity was inhibited, affecting the function of hRBCs. The estalished mechanism of toxicity of OTC to hRBCs can facilitate a deeper understanding of the toxicity of OTC in vivo.

17 CFR 240.36a1-2 - Exemption from SIPA for OTC derivatives dealers.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from SIPA for OTC derivatives dealers. 240.36a1-2 Section 240.36a1-2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934 Rules and Regulations...

Managing price risk in emerging electricity markets : OTC products and applications

International Nuclear Information System (INIS)

Weiss, P.

1998-01-01

The evolution of power markets in the United States from traditional cost based rates to mature markets, characterized by significant specialization, high volume financial market and multiple futures/indices, is described. The meaning and characteristic features of the commodity market in electricity, OTC/futures products for the electricity markets, physical delivery vs. financial settlement, models for producer trading positions and consumer trading positions, long producer position, long spread option position, short consumer position, and long producer time spread position were explained

Method for automatic determination of soybean actual evapotranspiration under open top chambers (OTC) subjected to effects of water stress and air ozone concentration.

Science.gov (United States)

Rana, Gianfranco; Katerji, Nader; Mastrorilli, Marcello

2012-10-01

The present study describes an operational method, based on the Katerji et al. (Eur J Agron 33:218-230, 2010) model, for determining the daily evapotranspiration (ET) for soybean inside open top chambers (OTCs). It includes two functions, calculated day par day, making it possible to separately take into account the effects of concentrations of air ozone and plant water stress. This last function was calibrated in function of the daily values of actual water reserve in the soil. The input variables of the method are (a) the diurnal values of global radiation and temperature, usually measured routinely in a standard weather station; (b) the daily values of the AOT40 index accumulated (accumulated ozone over a threshold of 40 ppb during daylight hours, when global radiation exceeds 50 Wm(-2)) determined inside the OTC; and (c) the actual water reserve in the soil, at the beginning of the trial. The ensemble of these input variables can be automatable; thus, the proposed method could be applied in routine. The ability of the method to take into account contrasting conditions of ozone air concentration and water stress was evaluated over three successive years, for 513 days, in ten crop growth cycles, excluding the days employed to calibrate the method. Tests were carried out in several chambers for each year and take into account the intra- and inter-year variability of ET measured inside the OTCs. On the daily scale, the slope of the linear regression between the ET measured by the soil water balance and that calculated by the proposed method, under different water conditions, are 0.98 and 1.05 for the filtered and unfiltered (or enriched) OTCs with root mean square error (RMSE) equal to 0.77 and 1.07 mm, respectively. On the seasonal scale, the mean difference between measured and calculated ET is equal to +5% and +11% for the filtered and unfiltered OTCs, respectively. The ability of the proposed method to estimate the daily and seasonal ET inside the OTCs is

New aquaculture drugs under FDA review

Science.gov (United States)

Bowker, James D.; Gaikowski, Mark P.

2012-01-01

Only eight active pharmaceutical ingredients available in 18 drug products have been approved by the U.S. Food and Drug Administration for use in aquaculture. The approval process can be lengthy and expensive, but several new drugs and label claims are under review. Progress has been made on approvals for Halamid (chloramine-T), Aquaflor (florfenicol) and 35% PeroxAid (hydrogen peroxide) as therapeutic drugs. Data are also being generated for AQUI-S 20E, a fish sedative.

Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review 1

Science.gov (United States)

Rodrigues, Maria Cristina Soares; de Oliveira, Cesar

2016-01-01

ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. PMID:27598380

Factors associated with the use of dietary supplements and over-the-counter medications in Japanese elderly patients.

Science.gov (United States)

Masumoto, Shoichi; Sato, Mikiya; Maeno, Takami; Ichinohe, Yumiko; Maeno, Tetsuhiro

2018-01-24

The use of dietary supplements and over-the-counter (OTC) drugs is increasing, and there is adequate concern about potential harmful effects. However, there are limited reports on the concurrent use of nonprescription medications with prescription medications in elderly patients. Therefore, this study was conducted to describe the use of dietary supplements and OTC drugs, and to identify predictors for their use in elderly patients using medications prescribed for chronic diseases. This was a cross-sectional study that enrolled 729 patients aged ≥65 years with chronic diseases, between January and March 2016. Data regarding socio-demographic status, medical condition, number of prescriptions, use of nonprescription medications, and psychological status were collected using a self-administered questionnaire and by review of medical records. Data regarding use of dietary supplements and OTC drugs were analyzed using descriptive statistics. Logistic regression analysis was applied to investigate factors associated with the use of dietary supplements and OTC drugs. The regular use of nonprescription drugs was reported by 32.5% of patients. Vitamins were the most commonly used dietary supplements in elderly patients. Female sex, higher educational qualifications, and good economic status were identified as predictors for the use of nonprescription medications. Concurrent use of nonprescription medications with more than 5 prescription medications was detected in 12.2% of participants. The disclosure rate of the use of nonprescription medications by patients to the physician was 30.3%. The use of dietary supplements and OTC drugs was common in elderly patients with chronic diseases, and its use is associated with sex, education, and economic status. General practitioners (GPs) need to recognize the potential use of nonprescription medications, considering that polypharmacy was common and disclosure rate was low in this study.

17 CFR 240.36a1-1 - Exemption from Section 7 for OTC derivatives dealers.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from Section 7 for OTC derivatives dealers. 240.36a1-1 Section 240.36a1-1 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934...

17 CFR 240.15b9-2 - Exemption from SRO membership for OTC derivatives dealers.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Exemption from SRO membership for OTC derivatives dealers. 240.15b9-2 Section 240.15b9-2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934...

THE PROBLEM OF LEGAL REGULATION OF THE OPERATION OF THE OVER-THE-COUNTER (OTC CURRENCY MARKET (FOREX IN UKRAINE AND THE EU

Directory of Open Access Journals (Sweden)

Eugene Podorozhnyi

2017-12-01

Full Text Available The aim of the article is to evaluate the state of legal institutionalization of the OTC foreign exchange market in Ukraine, as well as its comparison with the foreign experience of legal regulation of OTC currency relations in Ukraine and EU countries. The subject of the study is the legal and administrative framework for the functioning of the OTC currency market (Forex in Ukraine and in the EU countries. The methodology of the study consists of: historical and legal method, which allowed determining the preconditions for the emergence of OTC markets in Ukraine and the world and the principles of their functioning; system and structural method, which was used to analyse the world monetary system as an institutional and functional form of organization of international monetary and financial relations; a formal legal method that allowed us to comprehensively investigate a condition of regulation of the functioning of Forex in Ukraine, to identify its shortcomings, gaps, contradictions, and miscalculations, as well as to develop recommendations aimed at their elimination; a comparative and legal method that provided a deeper study of the specifics of the legal regulation of the functioning of Forex in the EU and to define ways of implementing a positive foreign experience in the national legal system. The results of the conducted legal study have shown that in Ukraine, the Forex market operates in legal vacuum conditions that negatively affect either the protection of the rights of forex clients or the amount of tax revenues to the state budget. The most acceptable way to eliminate this shortcoming is to implement the main principles and requirements of the MiFID in the national legislation. Practical impact. The research of experience of EU countries regarding the legal regulation of Forex companies activity and also regarding the creation of legal bases for implementation by the specified companies of self-regulation – it is a necessary

Hyperammonemia: What Urea-lly Need to Know: Case Report of Severe Noncirrhotic Hyperammonemic Encephalopathy and Review of the Literature

Directory of Open Access Journals (Sweden)

Ruby Upadhyay

2016-01-01

Full Text Available Purpose. A 66-year-old man who presented with coma was found to have isolated severe hyperammonemia and diagnosed with a late-onset urea-cycle disorder. He was treated successfully and had full recovery. Methods. We report a novel case of noncirrhotic hyperammonemia and review the literature on this topic. Selected literature for review included English-language articles concerning hyperammonemia using the search terms “hyperammonemic encephalopathy”, “non-cirrhotic encephalopathy”, “hepatic encephalopathy”, “urea-cycle disorders”, “ornithine transcarbamylase (OTC deficiency”, and “fulminant hepatic failure”. Results. A unique case of isolated hyperammonemia diagnosed as late-onset OTC deficiency is presented. Existing evidence about hyperammonemia is organized to address pathophysiology, clinical presentation, diagnosis, and treatment. The case report is discussed in context of the reviewed literature. Conclusion. Late-onset OTC deficiency presenting with severe hyperammonemic encephalopathy and extensive imaging correlate can be fully reversible if recognized promptly and treated aggressively.

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

Science.gov (United States)

Kuribayashi, Ryosuke; Appleton, Scott

2017-09-01

Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

Using over-the-counter medicines safely

Science.gov (United States)

... about OTC drugs. About OTC Medicines You can buy OTC medicines without a prescription in: Drug stores Grocery stores ... Safely You should: Examine the package before you buy it. Make sure it has not been tampered with. Never use medicine you have bought that does not look the ...

77 FR 12059 - Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can...

Science.gov (United States)

2012-02-28

...] Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be... over-the- counter or OTC products) can be purchased by consumers in pharmacies, supermarkets, and other retail establishments without the need for a prescription. Currently, consumers can purchase...

Management of prescription and nonprescription drug use during pregnancy.

Science.gov (United States)

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

2010-08-01

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

17 CFR 240.15c3-4 - Internal risk management control systems for OTC derivatives dealers.

Science.gov (United States)

2010-04-01

...-Counter Markets § 240.15c3-4 Internal risk management control systems for OTC derivatives dealers. (a) An... derivatives dealer's internal risk management control system shall include the following elements: (1) A risk... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Internal risk management...

pH induced polychromatic UV treatment for the removal of a mixture of SMX, OTC and CIP from water

International Nuclear Information System (INIS)

Avisar, D.; Lester, Y.; Mamane, H.

2010-01-01

Water and wastewater effluents contain a vast range of chemicals in mixtures that have different chemical structures and characteristics. This study presents a treatment technology for the removal of mixtures of antibiotic residues (sulfamethoxazole (SMX), oxtetracycline (OTC) and ciprofloxacin (CIP)) from contaminated water. The treatment combines pH modification of the water to an optimal value, followed by a photolytic treatment using direct polychromatic ultraviolet (UV) irradiation by medium pressure UV lamp. The pH adjustment of the treated water leads to structural modifications of the pollutant's molecule thus may enhance direct photolysis by UV light. Results showed that an increase of water pH from 5 to 7 leads to a decrease in degradation rate of SMX and an increase in degradation rate of OTC and CIP, when studied separately and not in a mixture. Thus, the optimal pH values for UV photodegradation in a mixture, involve initial photolysis at pH 5 and then gradually changing the pH from 5 to 7 during the UV exposure. For example, this resulted in 99% degradation of SMX at pH 5 and enhanced degradation of OTC and CIP from 54% and 26% to 91% and 96% respectively when pH was increased from 5 to 7. Thus the pH induced photolytic treatment has a potential in improving treatment of antibiotics in mixtures.

pH induced polychromatic UV treatment for the removal of a mixture of SMX, OTC and CIP from water

Energy Technology Data Exchange (ETDEWEB)

Avisar, D., E-mail: droravi@post.tau.ac.il [Hydro-chemistry Laboratory, Geography and the Environment, Tel Aviv University, Tel Aviv 69978 (Israel); Lester, Y. [Hydro-chemistry Laboratory, Geography and the Environment, Tel Aviv University, Tel Aviv 69978 (Israel); School of Mechanical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv 69978 (Israel); Mamane, H. [School of Mechanical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv 69978 (Israel)

2010-03-15

Water and wastewater effluents contain a vast range of chemicals in mixtures that have different chemical structures and characteristics. This study presents a treatment technology for the removal of mixtures of antibiotic residues (sulfamethoxazole (SMX), oxtetracycline (OTC) and ciprofloxacin (CIP)) from contaminated water. The treatment combines pH modification of the water to an optimal value, followed by a photolytic treatment using direct polychromatic ultraviolet (UV) irradiation by medium pressure UV lamp. The pH adjustment of the treated water leads to structural modifications of the pollutant's molecule thus may enhance direct photolysis by UV light. Results showed that an increase of water pH from 5 to 7 leads to a decrease in degradation rate of SMX and an increase in degradation rate of OTC and CIP, when studied separately and not in a mixture. Thus, the optimal pH values for UV photodegradation in a mixture, involve initial photolysis at pH 5 and then gradually changing the pH from 5 to 7 during the UV exposure. For example, this resulted in 99% degradation of SMX at pH 5 and enhanced degradation of OTC and CIP from 54% and 26% to 91% and 96% respectively when pH was increased from 5 to 7. Thus the pH induced photolytic treatment has a potential in improving treatment of antibiotics in mixtures.

77 FR 29307 - Control of Alcohol and Drug Use: Addition of Post-Accident Toxicological Testing for Non...

Science.gov (United States)

2012-05-17

... and OTC drugs with known risks of adverse side effects, such as pain relievers, anti- depressants, and... between the national government and the States, or on the distribution of power and responsibilities among... relationship between the Federal government and the States, or on the distribution of power and...

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

Science.gov (United States)

2013-11-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1038... information on the formulation, manufacturing, and labeling of currently marketed over- the-counter (OTC... hearing will be held on March 7, 2014, from 9 a.m. to 5 p.m. Submit electronic or written requests to make...

The Influence of Attitudes, Beliefs, and Social Factors on Caregivers' Decisions on the Use of OTC Medications in Preschool Children

National Research Council Canada - National Science Library

Ecklund, Connie

1998-01-01

The purpose of this descriptive correlational study was to determine the extent that social factors, health beliefs, and attitudes influenced caregiver's decisions in home management with over-the-counter (OTC) medications...

Drug promotion practices: A review.

Science.gov (United States)

Jacob, Nilan T

2018-01-18

Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role. The World Health Organization defines drug promotion as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs". With its humble intent of creating awareness among healthcare professionals and updating their knowledge on recent advances in treatment options, drug promotion has been an important tool, but gradually it has evolved to embrace aggressive marketing strategies and sometimes unethical business and scientific practices where the need for profit-making eclipses commitment to patient care and scientific exploration. In this review, we discuss the evolution of drug promotion practices, the various types, its merits and demerits, the influence of drug promotion on physician prescribing behaviour, the role of regulatory bodies, unethical promotional practices and finally summarize with future directions. © 2018 The British Pharmacological Society.

Actual use of and adherence to ibuprofen 400 mg tablet dosing instructions in a simulated OTC environment
.

Science.gov (United States)

Meeves, Suzanne; Leyva, Rina; Richardson, Clark; Wilson, Brenda; Savastano, David M

2017-07-01

Evaluate adherence of US consumers to proposed label directions for a new 400 mg ibuprofen formulation. In this single-arm, open-label, multicenter, 30-day study simulating an over-the-counter (OTC)-like environment, US analgesic consumers reviewed proposed product packaging for a new 400 mg ibuprofen formulation and made a purchase decision. Purchasers used the product as needed and recorded use over 30 days. Outcomes included the percentage of participants who exhibited correct or acceptable product use for the primary endpoint (not exceeding 1,200 mg/day > 2 times during the study) or secondary endpoint (not exceeding 400 mg/dose > 2 times during the study) and adherence to the labeled dosing interval of 6 - 8 hours. Primary endpoint success was met if the lower bound of the 95% confidence interval (CI) was ≥ 85%. Of 685 purchasers providing use data, correct or acceptable use behavior occurred in 95.2% (95% CI: 93.6%, 96.8%) regarding total daily dose and in 84.4% (95% CI: 81.7%, 87.1%) regarding the number of tablets taken per dosing occasion. Most participants (87.3%) never used > 1,200 mg/day or took > 1 tablet/dose (78.1%). Nearly 43% of subjects re-dosed within 6 hours of the previous dose; of these, ~ 82% re-dosed between the 4- and 6-hour time intervals. Adverse events were consistent with prior ibuprofen 200 mg experience. This study provides evidence that a majority of US consumers would be able to use OTC ibuprofen 400 mg tablets in a manner consistent with product labeling. Misuse rates were low and unlikely to generate an excess risk of clinically important adverse events.
.

Advanced drug delivery systems: Nanotechnology of health design A review

Directory of Open Access Journals (Sweden)

Javad Safari

2014-04-01

Full Text Available Nanotechnology has finally and firmly entered the realm of drug delivery. Performances of intelligent drug delivery systems are continuously improved with the purpose to maximize therapeutic activity and to minimize undesirable side-effects. This review describes the advanced drug delivery systems based on micelles, polymeric nanoparticles, and dendrimers. Polymeric carbon nanotubes and many others demonstrate a broad variety of useful properties. This review emphasizes the main requirements for developing new nanotech-nology-based drug delivery systems.

Impacto de la Publicidad Televisiva en la Comercialización de Los Productos otc (de Venta Libre) de la Industria Farmacéutica Privada Ecuatoriana

OpenAIRE

Espol; Viscaino Caiche, Evelyn Esther; Bueno Ortega, Leonela Estefania

2016-01-01

El impacto de la publicidad televisiva en la comercialización de los productos otc (de venta libre) en el sector farmacéutico ecuatoriano usando la metodología de regresión lineal por mínimos cuadrados ordinario (mco). Por lo tanto el objetivo de esta prueba, es dar a conocer a todos los laboratorios con portafolios otc que conforman esta industria, la importancia de invertir en televisión para masificar el conocimiento de su marca por parte del consumidor, entender a qué laboratorios y marc...

Influencers of generic drug utilization: A systematic review.

Science.gov (United States)

Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

2017-08-04

With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

Self-reported responsiveness to direct-to-consumer drug advertising and medication use: results of a national survey

Directory of Open Access Journals (Sweden)

Somes Grant W

2011-09-01

Full Text Available Abstract Background Direct-to-consumer (DTC marketing of pharmaceuticals is controversial, yet effective. Little is known relating patterns of medication use to patient responsiveness to DTC. Methods We conducted a secondary analysis of data collected in national telephone survey on knowledge of and attitudes toward DTC advertisements. The survey of 1081 U.S. adults (response rate = 65% was conducted by the Food and Drug Administration (FDA. Responsiveness to DTC was defined as an affirmative response to the item: "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" Patients reported number of prescription and over-the-counter (OTC medicines taken as well as demographic and personal health information. Results Of 771 respondents who met study criteria, 195 (25% were responsive to DTC. Only 7% respondents taking no prescription were responsive, whereas 45% of respondents taking 5 or more prescription medications were responsive. This trend remained significant (p trend .0009 even when controlling for age, gender, race, educational attainment, income, self-reported health status, and whether respondents "liked" DTC advertising. There was no relationship between the number of OTC medications taken and the propensity to discuss health-related problems in response to DTC advertisements (p = .4. Conclusion There is a strong cross-sectional relationship between the number of prescription, but not OTC, drugs used and responsiveness to DTC advertising. Although this relationship could be explained by physician compliance with patient requests for medications, it is also plausible that DTC advertisements have a particular appeal to patients prone to taking multiple medications. Outpatients motivated to discuss medical conditions based on their exposure to DTC advertising may require a careful medication history to evaluate for

Self-reported responsiveness to direct-to-consumer drug advertising and medication use: results of a national survey.

Science.gov (United States)

Dieringer, Nicholas J; Kukkamma, Lisa; Somes, Grant W; Shorr, Ronald I

2011-09-23

ABSTRACT: BACKGROUND: Direct-to-consumer (DTC) marketing of pharmaceuticals is controversial, yet effective. Little is known relating patterns of medication use to patient responsiveness to DTC. METHODS: We conducted a secondary analysis of data collected in national telephone survey on knowledge of and attitudes toward DTC advertisements. The survey of 1081 U.S. adults (response rate = 65%) was conducted by the Food and Drug Administration (FDA). Responsiveness to DTC was defined as an affirmative response to the item: "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" Patients reported number of prescription and over-the-counter (OTC) medicines taken as well as demographic and personal health information. RESULTS: Of 771 respondents who met study criteria, 195 (25%) were responsive to DTC. Only 7% respondents taking no prescription were responsive, whereas 45% of respondents taking 5 or more prescription medications were responsive. This trend remained significant (p trend .0009) even when controlling for age, gender, race, educational attainment, income, self-reported health status, and whether respondents "liked" DTC advertising. There was no relationship between the number of OTC medications taken and the propensity to discuss health-related problems in response to DTC advertisements (p = .4). CONCLUSION: There is a strong cross-sectional relationship between the number of prescription, but not OTC, drugs used and responsiveness to DTC advertising. Although this relationship could be explained by physician compliance with patient requests for medications, it is also plausible that DTC advertisements have a particular appeal to patients prone to taking multiple medications. Outpatients motivated to discuss medical conditions based on their exposure to DTC advertising may require a careful medication history to evaluate for therapeutic

Assessment of Web-Based Consumer Reviews as a Resource for Drug Performance

Science.gov (United States)

Adusumalli, Swarnaseetha; Lee, HueyTyng; Hoi, Qiangze; Koo, Si-Lin; Tan, Iain Beehuat

2015-01-01

Background Some health websites provide a public forum for consumers to post ratings and reviews on drugs. Drug reviews are easily accessible and comprehensible, unlike clinical trials and published literature. Because the public increasingly uses the Internet as a source of medical information, it is important to know whether such information is reliable. Objective We aim to examine whether Web-based consumer drug ratings and reviews can be used as a resource to compare drug performance. Methods We analyzed 103,411 consumer-generated reviews on 615 drugs used to treat 249 disease conditions from the health website WebMD. Statistical analysis identified 427 drug pairs from 24 conditions for which two drugs treating the same condition had significantly and substantially different satisfaction ratings (with at least a half-point difference between Web-based ratings and Paddictive properties were rated higher than their counterparts in Web-based reviews, and (3) second-line or alternative drugs were rated higher. In addition, Web-based ratings indicated drug delivery problems. If FDA black box warning labels are used to resolve disagreements between publications and online trends, the concordance rate increases to 71% (55/77) (Pmanufacturers to assess the performance of a drug. However, one should be cautious to rely solely on consumer reviews as ratings can be strongly influenced by the consumer experience. PMID:26319108

Formulary Drug Review: Betrixaban.

Science.gov (United States)

Baker, Danial E

2018-02-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Formulary Drug Review: Ocrelizumab.

Science.gov (United States)

Ali, Zaynah K; Baker, Danial E

2017-10-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Formulary Drug Review: Edaravone.

Science.gov (United States)

Ali, Zaynah K; Baker, Danial E

2017-12-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Buccoadhesive drug delivery systems--extensive review on recent patents.

Science.gov (United States)

Pathan, Shadab A; Iqbal, Zeenat; Sahani, Jasjeet K; Talegaonkar, Sushma; Khar, Roop K; Ahmad, Farhan J

2008-01-01

Peroral administration of drugs, although most preferred by both clinicians and patients has several disadvantages such as hepatic first pass metabolism and enzymatic degradation within the GI tract, that prohibit oral administration of certain classes of drugs especially peptides and proteins. Consequently, other absorptive mucosae are considered as potential sites for administration of these drugs. Among the various transmucosal routes studied the buccal mucosa offers several advantages for controlled drug delivery for extended period of time. The mucosa is well supplied with both vascular and lymphatic drainage and first-pass metabolism in the liver and pre-systemic elimination in the gastrointestinal tract is avoided. The area is well suited for a retentive device and appears to be acceptable to the patient. With the right dosage form, design and formulation, the permeability and the local environment of the mucosa can be controlled and manipulated in order to accommodate drug permeation. Buccal drug delivery is thus a promising area for continued research with the aim of systemic and local delivery of orally inefficient drugs as well as feasible and attractive alternative for non-invasive delivery of potent protein and peptide drug molecules. Extensive review pertaining specifically to the patents relating to buccal drug delivery is currently available. However, many patents e.g. US patents 6, 585,997; US20030059376A1 etc. have been mentioned in few articles. It is the objective of this article to extensively review buccal drug delivery by discussing the recent patents available. Buccal dosage forms will also be reviewed with an emphasis on bioadhesive polymeric based delivery systems.

Socio-economic differences in prescription and OTC drug use in Dutch adolescents

NARCIS (Netherlands)

Tobi, H.; Meijer, W.M.; Tuinstra, J.; de Jong-van den Berg, L.T.

2003-01-01

OBJECTIVE: To detect whether there were socio-economic differences in the overall use of prescription and OCT drugs among adolescents. METHODS: This study was a secondary analysis of questionnaire data collected to investigate socio-economic differences in health risk behaviour and decision-making.

A review on proniosomal drug delivery system for targeted drug action.

Science.gov (United States)

Radha, G V; Rani, T Sudha; Sarvani, B

2013-03-01

Proniosomes are dry formulation of water soluble carrier particles that are coated with surfactant. They are rehydrated to form niosomal dispersion immediately before use on agitation in hot aqueous media within minutes. Proniosomes are physically stable during the storage and transport. Drug encapsulated in the vesicular structure of proniosomes prolong the existence of drug in the systematic circulation and enhances the penetration into target tissue and reduce toxicity. From a technical point of view, niosomes are promising drug carriers as they possess greater chemical stability and lack of many disadvantages associated with liposomes, such as high- cost and variable purity problems of phospholipids. The present review emphasizes on overall methods of preparation characterization and applicability of proniosomes in targeted drug action.

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

Science.gov (United States)

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

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

Mechanistic review of drug-induced steatohepatitis

International Nuclear Information System (INIS)

Schumacher, Justin D.; Guo, Grace L.

2015-01-01

Drug-induced steatohepatitis is a rare form of liver injury known to be caused by only a handful of compounds. These compounds stimulate the development of steatohepatitis through their toxicity to hepatocyte mitochondria; inhibition of beta-oxidation, mitochondrial respiration, and/or oxidative phosphorylation. Other mechanisms discussed include the disruption of phospholipid metabolism in lysosomes, prevention of lipid egress from hepatocytes, targeting mitochondrial DNA and topoisomerase, decreasing intestinal barrier function, activation of the adenosine pathway, increasing fatty acid synthesis, and sequestration of coenzyme A. It has been found that the majority of compounds that induce steatohepatitis have cationic amphiphilic structures; a lipophilic ring structure with a side chain containing a cationic secondary or tertiary amine. Within the last decade, the ability of many chemotherapeutics to cause steatohepatitis has become more evident coining the term chemotherapy-associated steatohepatitis (CASH). The mechanisms behind drug-induced steatohepatitis are discussed with a focus on cationic amphiphilic drugs and chemotherapeutic agents. - Highlights: • Reviewed the mechanisms underlying drug-induced steatohepatitis for many compounds • Mitochondrial dysfunction is critical in the development of drug-induced steatohepatitis. • Majority of drugs that induce steatohepatitis are cationic amphiphilic drugs. • Chemotherapeutics that induce CASH are cationic amphiphilic drugs. • Majority of drugs that induce steatohepatitis are carnitine palmitoyltransferase-I inhibitors.

Mechanistic review of drug-induced steatohepatitis

Energy Technology Data Exchange (ETDEWEB)

Schumacher, Justin D., E-mail: Justin.d.schumacher@rutgers.edu; Guo, Grace L.

2015-11-15

Drug-induced steatohepatitis is a rare form of liver injury known to be caused by only a handful of compounds. These compounds stimulate the development of steatohepatitis through their toxicity to hepatocyte mitochondria; inhibition of beta-oxidation, mitochondrial respiration, and/or oxidative phosphorylation. Other mechanisms discussed include the disruption of phospholipid metabolism in lysosomes, prevention of lipid egress from hepatocytes, targeting mitochondrial DNA and topoisomerase, decreasing intestinal barrier function, activation of the adenosine pathway, increasing fatty acid synthesis, and sequestration of coenzyme A. It has been found that the majority of compounds that induce steatohepatitis have cationic amphiphilic structures; a lipophilic ring structure with a side chain containing a cationic secondary or tertiary amine. Within the last decade, the ability of many chemotherapeutics to cause steatohepatitis has become more evident coining the term chemotherapy-associated steatohepatitis (CASH). The mechanisms behind drug-induced steatohepatitis are discussed with a focus on cationic amphiphilic drugs and chemotherapeutic agents. - Highlights: • Reviewed the mechanisms underlying drug-induced steatohepatitis for many compounds • Mitochondrial dysfunction is critical in the development of drug-induced steatohepatitis. • Majority of drugs that induce steatohepatitis are cationic amphiphilic drugs. • Chemotherapeutics that induce CASH are cationic amphiphilic drugs. • Majority of drugs that induce steatohepatitis are carnitine palmitoyltransferase-I inhibitors.

The beginning of a new era - OTC's satellite business services

Science.gov (United States)

Bachmann, Erik

OTC has developed a new range of digital services which will provide business organizations in Australia with high quality private international telecommunications. This range will be known as Satnet and the paper deals with Satnet 2 which is the service offerings using medium-size earth stations (nominally 5- and 7-meter antenna apertures), installed at customers' premises. These services will rely on the Intelsat 6/4 GHz space segment. Operation will be totally digital and will be integrated with no distinction between individual applications such as voice, data, video, etc. Carrier capacities between 64 kb/s and 8.448 Mb/s can be provided and ISDN performance requirements can be supported. The paper describes key service features, systems design and transmission analysis. Consideration is also given to operation, installation and frequency coordination aspects.

[Comparison in dissolution behavior of ethical and over-the counter scopolamine butylbromide].

Science.gov (United States)

Suzuki, Ichie; Miyazaki, Yasunori; Uchino, Tomonobu; Kagawa, Yoshiyuki

2011-01-01

Marketing authorization holders do not disclose any information on the pharmaceutical properties of over-the-counter drugs (OTC). When a drug is switched from a prescription drug to OTC, pharmacists can acquire that information from the corresponding ethical drug (ED) through the package insert, interview form, and so on. However, the pharmaceutical equivalence between ED and OTC is unclear. In this study, we examined the drug dissolution behavior of both ED and OTCs containing scopolamine butylbromide. Dissolution tests were performed by the paddle method using Japanese Pharmacopeia (JP) XV test fluids at pH 1.2, 4.0 and 6.8 and water based on the guidelines for bioequivalence studies of generic products. The dissolution profiles of OTCs differed significantly from ED showing a similarity factor (f2) value ranging from 8.9 to 42.9. Time until 85% dissolution ranged from 23 to 95 min and from 17 to 174 min at pH 1.2 and pH 6.8, respectively. Then JP XV disintegration tests were conducted to investigate differences in the disintegration process. The disintegration time of preparations showing delayed dissolution was prolonged compared to that of others, suggesting that the disintegration of the tablet or capsule is one of the important factors affecting the drug dissolution. These differences in the disintegration and drug dissolution might cause differences in the bioavailability of the drug. For patient safety, more detailed product information of OTCs should be supplied by the manufacturer, and not be assumed from that of corresponding ED.

Biomimetics in drug delivery systems: A critical review.

Science.gov (United States)

Sheikhpour, Mojgan; Barani, Leila; Kasaeian, Alibakhsh

2017-05-10

Today, the advanced drug delivery systems have been focused on targeted drug delivery fields. The novel drug delivery is involved with the improvement of the capacity of drug loading in drug carriers, cellular uptake of drug carriers, and the sustained release of drugs within target cells. In this review, six groups of therapeutic drug carriers including biomimetic hydrogels, biomimetic micelles, biomimetic liposomes, biomimetic dendrimers, biomimetic polymeric carriers and biomimetic nanostructures, are studied. The subject takes advantage of the biomimetic methods of productions or the biomimetic techniques for the surface modifications, similar to what accrues in natural cells. Moreover, the effects of these biomimetic approaches for promoting the drug efficiency in targeted drug delivery are visible. The study demonstrates that the fabrication of biomimetic nanocomposite drug carriers could noticeably promote the efficiency of drugs in targeted drug delivery systems. Copyright © 2017 Elsevier B.V. All rights reserved.

Over-the-Counter Medicines

Science.gov (United States)

Over-the-counter (OTC) medicines are drugs you can buy without a prescription. Some OTC medicines relieve aches, pains and itches. ... medicine is safe enough to sell over-the-counter. Taking OTC medicines still has risks. Some interact ...

Urea Cycle Defects: Early-Onset Disease Associated with A208T Mutation in OTC Gene-Expanding the Clinical Phenotype.

Science.gov (United States)

Sánchez, Ana Isabel; Rincón, Alejandra; García, Mary; Suárez-Obando, Fernando

2017-01-01

Ornithine transcarbamylase deficiency (OMIM: 311250) is the most common disorder of urea cycle disorders, accounting for nearly 50% of all cases. We report a case of a two-month- old male patient, who attends our medical genetics consultation because of low citrulline levels and elevated glutamine to citrulline ratio detected by expanded newborn screening with tandem mass spectrometry. He is an asymptomatic male with a normal physical examination and appropriate neurodevelopmental milestones. The patient has a family history of one older brother who died at 18 months old from severe and sudden hyperammonemia and a maternal aunt who suddenly died at two years old. He had high plasma ammonium concentration and a confirmed OTC mutation (p.A208T). Usually, this mutation causes OTC deficiency of late onset in adult males. However, this report raises awareness about mutations previously described as a late-onset causing disease, which can cause severe hyperammonemia and high risk of dying at an early age.

Urea Cycle Defects: Early-Onset Disease Associated with A208T Mutation in OTC Gene—Expanding the Clinical Phenotype

Directory of Open Access Journals (Sweden)

Ana Isabel Sánchez

2017-01-01

Full Text Available Ornithine transcarbamylase deficiency (OMIM: 311250 is the most common disorder of urea cycle disorders, accounting for nearly 50% of all cases. We report a case of a two-month- old male patient, who attends our medical genetics consultation because of low citrulline levels and elevated glutamine to citrulline ratio detected by expanded newborn screening with tandem mass spectrometry. He is an asymptomatic male with a normal physical examination and appropriate neurodevelopmental milestones. The patient has a family history of one older brother who died at 18 months old from severe and sudden hyperammonemia and a maternal aunt who suddenly died at two years old. He had high plasma ammonium concentration and a confirmed OTC mutation (p.A208T. Usually, this mutation causes OTC deficiency of late onset in adult males. However, this report raises awareness about mutations previously described as a late-onset causing disease, which can cause severe hyperammonemia and high risk of dying at an early age.

A REVIEW ON THE ANALYTICAL TECHNIQUES USED FOR THE DETERMINATION OF PARACETAMOL IN PHARMACEUTICAL FORMULATIONS AND BIOLOGICAL FLUIDS

Directory of Open Access Journals (Sweden)

Aisha Noreen

2016-12-01

Full Text Available Paracetamol (PM is an active metabolite of phenacetin and belongs to p-aminophenol derivatives. It is also termed as acetaminophen. PM is one of the non-steroidal anti-inflammatory drugs (NSAIDs which is used as an analgesic and antipyretic agent. It is an OTC drug and is used as a common household analgesic. It is not used as a substitute of aspirin or any other NSAIDs. It is a weak cyclooxygenase (COX 1 and 2 inhibitor but may inhibit COX-3 in the central nervous system. Many analytical techniques have been used for the assay of PM in pharmaceutical preparations and biological fluids. These techniques include spectrometry, chromatography, spectrofluorimetry, chemiluminescence, electrochemical techniques, flow injection spectrometry and chronoamperometry. In many pharmaceutical preparations PM is also used in combination with other drugs and these techniques have also been used for their simultaneous determination. A detailed review of various analytical techniques used for the assay of PM has been carried out which would be of great help to the chemists and pharmacists involved in the analysis and quality control of drugs.

75 FR 1002 - Submission for OMB Review; Comment Request

Science.gov (United States)

2010-01-07

... derivatives dealers to establish, document, and maintain a system of internal risk management controls. The... establishing, documenting, and reviewing its internal risk management control system, which are designed to... internal risk management control system) + (One new OTC derivatives dealer x 200 hours to maintain an...

Formulary Drug Review: Naldemedine.

Science.gov (United States)

Baker, Danial E

2017-07-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The September 2017 monograph topics are brigatinib, durvalumab, edaravone, midostaurin, and sarilumab. The MUE is on sarilumab.

Clinical Drug-Drug Pharmacokinetic Interaction Potential of Sucralfate with Other Drugs: Review and Perspectives.

Science.gov (United States)

Sulochana, Suresh P; Syed, Muzeeb; Chandrasekar, Devaraj V; Mullangi, Ramesh; Srinivas, Nuggehally R

2016-10-01

Sucralfate, a complex of aluminium hydroxide with sulfated sucrose, forms a strong gastrointestinal tract (GIT) mucosal barrier with excellent anti-ulcer property. Because sucralfate does not undergo any significant oral absorption, sucralfate resides in the GIT for a considerable length of time. The unabsorbed sucralfate may alter the pharmacokinetics of the oral drugs by impeding its absorption and reducing the oral bioavailability. Because of the increased use of sucralfate, it was important to provide a reappraisal of the published clinical drug-drug interaction studies of sucralfate with scores of drugs. This review covers several category of drugs such as non-steroidal anti-inflammatory drugs, fluoroquinolones, histamine H2-receptor blockers, macrolides, anti-fungals, anti-diabetics, salicylic acid derivatives, steroidal anti-inflammatory drugs and provides pharmacokinetic data summary along with study design, objectives and key remarks. While the loss of oral bioavailability was significant for the fluoroquinolone class, it generally varied for other classes of drugs, suggesting that impact of the co-administration of sucralfate is manageable in clinical situations. Given the technology advancement in formulation development, it may be in order feasible to develop appropriate formulation strategies to either avoid or minimize the absorption-related issues when co-administered with sucralfate. It is recommended that consideration of both in vitro and preclinical studies may be in order to gauge the level of interaction of a drug with sucralfate. Such data may aid in the development of appropriate strategies to navigate the co-administration of sucralfate with other drugs in this age of polypharmacy.

Formulary Drug Review: Etelcalcetide.

Science.gov (United States)

Baker, Danial E

2017-11-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433. The November 2017 monograph topics are Ertugliflozin, Glecaprevir / pibrentasvir, Neratinib, Sofosbuvir, velpatasvir, voxilaprevir and SQ C1 esterase inhibitor. The MUE is on glecaprevir, pibrentasvir.

Drugs and bruxism: a critical review.

Science.gov (United States)

Winocur, Ephraim; Gavish, Anat; Voikovitch, Michal; Emodi-Perlman, Alona; Eli, Ilana

2003-01-01

Bruxism associated with drugs can be destructive, resulting in severe consequences to health that include destruction of tooth structure, irreversible harm to the temporomandibular joint, severe myofascial pain, and muscle contraction headache. However, reports concerning a possible association between bruxism and various pharmacologic drugs are scarce and mostly anecdotal. The purpose of this article was to review the existing literature concerning the exacerbating or ameliorating effect of drugs on bruxism in humans. A search of the MEDLINE, EMBASE, and PsicINFO databases from 1982 to 2001 was conducted, and the term bruxism and one of the following terms were used: drugs, medicine(s), pharmaceutical, movement disorders, akathisia, dyskinesia, dystonia, central or autonomic nervous system, dopamine, serotonin, and GABA. Furthermore, a search using the term bruxism was carried out on the weekly journal Reactions, which deals with side effects of drugs. Several chemical terms were searched separately (e.g., caffeine, nicotine). Relevant information was also derived from reference lists of the retrieved publications. The search yielded complex information referring to the association between bruxism and dopamine-related drugs, antidepressant drugs, sedative and anxiolytic drugs, and drugs of abuse. There is insufficient evidence-based data to draw definite conclusions concerning the effects of various drugs on bruxism. Although certain substances related to the dopaminergic, serotonergic, and adrenergic systems suppress or exacerbate bruxist activity in humans and animals, the literature is still controversial, and based mostly on anecdotal case reports. More controlled, evidence-based research on this under-explored subject is needed.

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

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...; (ii) Is prominently placed on the package; and (iii) Is so placed that it will be unaffected if the... product or, if the petition seeks an exemption for a drug class, the name of the drug class, and a list of...

Potential enzyme toxicity of oxytetracycline to catalase

Energy Technology Data Exchange (ETDEWEB)

Zhenxing, Chi; Rutao, Liu; Zhang Hao, E-mail: Trutaoliu@sdu.edu.cn [School of Environmental Science and Engineering, Shandong University, China-America CRC for Environment and Health, Shandong Province, 27 Shanda South Road, Jinan 250100 (China)

2010-10-15

Oxytetracycline (OTC) is a kind of widely used veterinary drugs. The residue of OTC in the environment is potentially harmful. In the present work, the non-covalent toxic interaction of OTC with catalase was investigated by the fluorescence spectroscopy, UV-vis absorption and circular dichroism (CD) spectroscopy at physiological pH 7.4. OTC can interact with catalase to form a complex mainly by van der Waals' interactions and hydrogen bonds with one binding site. The association constants K were determined to be K{sub 293K} = 7.09 x 10{sup 4} L mol{sup -1} and K{sub 311K} = 3.31 x 10{sup 4} L mol{sup -1}. The thermodynamic parameters ({Delta}H{sup o}, {Delta}G{sup o} and {Delta}S{sup o}) of the interaction were calculated. Based on the Foerster theory of non-radiative energy transfer, the distance between bound OTC and the tryptophan residues of catalase was determined to be 6.48 nm. The binding of OTC can result in change of the micro-environment of the tryptophan residues and the secondary structure of catalase. The activity of catalase was also inhibited for the bound OTC. This work establishes a new strategy to probe the enzyme toxicity of veterinary drug residues and is helpful for clarifying the molecular toxic mechanism of OTC in vivo. The established strategy can be used to investigate the potential enzyme toxicity of other small organic pollutants and drugs.

Potential enzyme toxicity of oxytetracycline to catalase

International Nuclear Information System (INIS)

Chi Zhenxing; Liu Rutao; Zhang Hao

2010-01-01

Oxytetracycline (OTC) is a kind of widely used veterinary drugs. The residue of OTC in the environment is potentially harmful. In the present work, the non-covalent toxic interaction of OTC with catalase was investigated by the fluorescence spectroscopy, UV-vis absorption and circular dichroism (CD) spectroscopy at physiological pH 7.4. OTC can interact with catalase to form a complex mainly by van der Waals' interactions and hydrogen bonds with one binding site. The association constants K were determined to be K 293K = 7.09 x 10 4 L mol -1 and K 311K = 3.31 x 10 4 L mol -1 . The thermodynamic parameters (ΔH o , ΔG o and ΔS o ) of the interaction were calculated. Based on the Foerster theory of non-radiative energy transfer, the distance between bound OTC and the tryptophan residues of catalase was determined to be 6.48 nm. The binding of OTC can result in change of the micro-environment of the tryptophan residues and the secondary structure of catalase. The activity of catalase was also inhibited for the bound OTC. This work establishes a new strategy to probe the enzyme toxicity of veterinary drug residues and is helpful for clarifying the molecular toxic mechanism of OTC in vivo. The established strategy can be used to investigate the potential enzyme toxicity of other small organic pollutants and drugs.

Enzyme-triggered nanomedicine: Drug release strategies in cancer therapy (Invited Review)

DEFF Research Database (Denmark)

Andresen, Thomas Lars; Thompson, David H.; Kaasgaard, Thomas

2010-01-01

-based strategies are particularly interesting as they require no prior knowledge of the tumour localization. The basis of this review is an evaluation of the current status of drug delivery strategies focused on triggered drug release by disease-associated enzymes. We limit ourselves to reviewing the liposome...

78 FR 15056 - Submission for OMB Review; Comment Request

Science.gov (United States)

2013-03-08

... establish, document, and maintain a system of internal risk management controls. The Rule sets forth the..., documenting, and reviewing its internal risk management control system, which are designed to, among other... documenting its risk management control system is 2,000 hours and that, on average, a registered OTC...

Formulary Drug Reviews: Glecaprevir/Pibrentasvir.

Science.gov (United States)

Levien, Terri L; Baker, Danial E

2018-04-01

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service , contact Wolters Kluwer customer service at 866-397-3433.

Mesoporous silica formulation strategies for drug dissolution enhancement: a review.

Science.gov (United States)

McCarthy, Carol A; Ahern, Robert J; Dontireddy, Rakesh; Ryan, Katie B; Crean, Abina M

2016-01-01

Silica materials, in particular mesoporous silicas, have demonstrated excellent properties to enhance the oral bioavailability of poorly water-soluble drugs. Current research in this area is focused on investigating the kinetic profile of drug release from these carriers and manufacturing approaches to scale-up production for commercial manufacture. This review provides an overview of different methods utilized to load drugs onto mesoporous silica carriers. The influence of silica properties and silica pore architecture on drug loading and release are discussed. The kinetics of drug release from mesoporous silica systems is examined and the manufacturability and stability of these formulations are reviewed. Finally, the future prospects of mesoporous silica drug delivery systems are considered. Substantial progress has been made in the characterization and development of mesoporous drug delivery systems for drug dissolution enhancement. However, more research is required to fully understand the drug release kinetic profile from mesoporous silica materials. Incomplete drug release from the carrier and the possibility of drug re-adsorption onto the silica surface need to be investigated. Issues to be addressed include the manufacturability and regulation status of formulation approaches employing mesoporous silica to enhance drug dissolution. While more research is needed to support the move of this technology from the bench to a commercial medicinal product, it is a realistic prospect for the near future.

Buccal Mucosa as A Route for Systemic Drug Delivery: A Review

OpenAIRE

Dhaval A. Pate; M. R. Pate; K. R. Pate; N. M. Pate

2012-01-01

Within the oral mucosal cavity, the buccal region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable. It is the objective of this article to review buccal drug delivery by discussing the structure and environment of the oral mucosa and the experimental methods used in assessing buccal drug permeation/absorption. Buccal dosage forms will also be reviewed with an emphasis on bioadhesive polymeric based deliv...

Buccal mucosa as a route for systemic drug delivery: a review.

Science.gov (United States)

Shojaei, A H

1998-01-01

Within the oral mucosal cavity, the buccal region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable. It is the objective of this article to review buccal drug delivery by discussing the structure and environment of the oral mucosa and the experimental methods used in assessing buccal drug permeation/absorption. Buccal dosage forms will also be reviewed with an emphasis on bioadhesive polymeric based delivery systems

A review of drug-drug interactions in older HIV-infected patients.

Science.gov (United States)

Chary, Aarthi; Nguyen, Nancy N; Maiton, Kimberly; Holodniy, Mark

2017-12-01

The number of older HIV-infected people is growing due to increasing life expectancies resulting from the use of antiretroviral therapy (ART). Both HIV and aging increase the risk of other comorbidities, such as cardiovascular disease, osteoporosis, and some malignancies, leading to greater challenges in managing HIV with other conditions. This results in complex medication regimens with the potential for significant drug-drug interactions and increased morbidity and mortality. Area covered: We review the metabolic pathways of ART and other medications used to treat medical co-morbidities, highlight potential areas of concern for drug-drug interactions, and where feasible, suggest alternative approaches for treating these conditions as suggested from national guidelines or articles published in the English language. Expert commentary: There is limited evidence-based data on ART drug interactions, pharmacokinetics and pharmacodynamics in the older HIV-infected population. Choosing and maintaining effective ART regimens for older adults requires consideration of side effect profile, individual comorbidities, interactions with concurrent prescriptions and non-prescription medications and supplements, dietary patterns with respect to dosing, pill burden and ease of dosing, cost and affordability, patient preferences, social situation, and ART resistance history. Practitioners must remain vigilant for potential drug interactions and intervene when there is a potential for harm.

Different contributions of internal reviewers and external experts to labelling decisions on therapeutic indications in new drug reviews in Japan.

Science.gov (United States)

Yokota, M; Kusama, M; Matsuki, N; Ono, S

2013-12-01

External experts play an important role in shaping regulatory decisions in the new drug review process in the United States, Europe and Japan. No rigorous study has been performed addressing how and to what extent external experts, in contrast to internal reviewers in the agency, influence the regulatory decisions during new drug reviews. We examined their contributions in Japanese regulatory reviews in contrast to the internal reviewers, focusing on the labelling decision on therapeutic indications. With the data set of 219 new molecular entities (NMEs) approved in Japan from 2000 to 2009, we observed how proposed indications in labelling were modified in a stepwise manner during the review process and conducted multinomial logistic analysis to examine the possible mechanism behind. We found that interim assessment of indications by the internal reviewers was modified substantially by the influence of the external experts in about 20% of the 219 NMEs. Our analysis suggested that internal reviewers provided their opinion mainly based on strict review discipline, whereas external experts added flexibility and reality to their reviews. Our analysis revealed different evaluations between internal reviewers and external experts during regulatory discussions in new drug reviews and how the external panel contributes to changing internal decisions. This study provides a new and quantitative approach to better label setting by emphasizing the contributions of each stakeholder in new drug reviews, which would improve the efficiency, quality and transparency of new drug reviews to enhance public health. © 2013 John Wiley & Sons Ltd.

Possible drug–drug interaction in dogs and cats resulted from alteration in drug metabolism: A mini review

Directory of Open Access Journals (Sweden)

Kazuaki Sasaki

2015-05-01

Full Text Available Pharmacokinetic drug–drug interactions (in particular at metabolism may result in fatal adverse effects in some cases. This basic information, therefore, is needed for drug therapy even in veterinary medicine, as multidrug therapy is not rare in canines and felines. The aim of this review was focused on possible drug–drug interactions in dogs and cats. The interaction includes enzyme induction by phenobarbital, enzyme inhibition by ketoconazole and fluoroquinolones, and down-regulation of enzymes by dexamethasone. A final conclusion based upon the available literatures and author’s experience is given at the end of the review.

Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway.

Science.gov (United States)

Fog, Amura Francesca; Kvalvaag, Gunnar; Engedal, Knut; Straand, Jørund

2017-12-01

We describe the drug-related problems (DRPs) identified during medication reviews (MRs) and the changes in drug utilization after MRs at nursing homes in Oslo, Norway. We explored predictors for the observed changes. Observational before-after study. Forty-one nursing homes. MRs performed by multidisciplinary teams during November 2011 to February 2014. In all, 2465 long-term care patients. DRPs identified by explicit criteria (STOPP/START and NORGEP) and drug-drug interaction database; interventions to resolve DRPs; drug use changes after MR. A total of 6158 DRPs were identified, an average of 2.6 DRPs/patient, 2.0 for regular and 0.6 for pro re nata (prn) drugs. Of these patients, 17.3% had no DRPs. The remaining 82.7% of the patients had on average 3.0 DRPs/patient. Use of unnecessary drugs (43.5%), excess dosing (12.5%) and lack of monitoring of the drug use (11%) were the most frequent DRPs. Opioids and psychotropic drugs were involved in 34.4% of all DRPs. The mean number of drugs decreased after the MR from 6.8 to 6.3 for regular drugs and from 3.0 to 2.6 for prn drugs. Patients with DRPs experienced a decrease of 1.1 drugs after MR (0.5 for regular and 0.6 for prn drugs). The reduction was most pronounced for the regular use of antipsychotics, antidepressants, hypnotics/sedatives, diuretics, antithrombotic agents, antacid drugs; and for prn use of anxiolytics, opioids, hypnotics/sedatives, metoclopramide and NSAIDs. The medication review resulted in less drug use, especially opioids and psychotropic drugs.

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

Science.gov (United States)

Phadtare, Sangita; Abali, Emine; Brodsky, Barbara

2013-01-01

For successful delivery of basic science topics for health-professional students, it is critical to reduce apprehension and illustrate relevance to clinical settings and everyday life. At the beginning of the Biochemistry course for Physician Assistants, a team-based assignment was designed to develop an understanding of the mechanism of action, effectiveness, and toxicity of five common over the counter (OTC) drugs and dietary supplements, and place these familiar medicines in a political and historical context. The objectives of this exercise were to stimulate interest in biochemistry; to provide basic information on enzymes and enzyme inhibitors related to these drugs to be expanded upon later in the course; and to encourage active and interactive learning. Teams of five students were formed, and each student was given an information sheet on aspirin, alpha-galactosidase, orlistat, dextromethorphan, or simvastatin, a low dose statin, which was previously available without prescription at pharmacies in the UK. After each member of the team acquired information on one OTC drug/dietary supplement by reading an assigned information sheet, the team was asked to go through a series of questions, and then submit answers to a quiz as a group. A high rate of success on the quiz, an overwhelmingly positive response on formal course evaluations, and enthusiastic exchanges during class suggested this team-based session accomplished its goals. Copyright © 2013 Wiley-Liss, Inc.

Systematic review: ursodeoxycholic acid--adverse effects and drug interactions

NARCIS (Netherlands)

Hempfling, W.; Dilger, K.; Beuers, U.

2003-01-01

BACKGROUND: Ursodeoxycholic acid is increasingly being used for the treatment of chronic cholestatic liver diseases. It appears to be generally well tolerated, but a systematic review on drug safety is lacking. AIM: As experimental data suggest a role of bile acids in the regulation of hepatic drug

Striking balance between expedited review and expecting efficacious anticancer drug and biologics: An ongoing challenge

Directory of Open Access Journals (Sweden)

Krishnan Vengadaragava Chary

2017-01-01

Full Text Available Objective: The objective of this study is to assess the postmarketing status: Efficacy and safety drugs and biologics related with cancer approved under expedited review. Methods: This observational, analytical study was carried between January and April 2016 by the Department of Pharmacology and Medical Oncology, Saveetha Medical College. Drugs approved under expedited review, fast-track status and its association with anti-cancer effects, postmarketing efficacy and safety, propensity to induce the second tumor was noted. Drug approval status and average time of review process were obtained from the United States-Food and Drug Administration (FDA, Center for Drugs and Biologics Center (Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Postmarketing adverse events and safety issues were collected FDA adverse effects reporting system. Further, evidence efficacy and safety of drugs were taken from various meta-analysis, reports on BioMed journals, and Cochrane systematic reviews. Results: In the last 5 years, 166 products were approved by expedited review. Out of 166, 48 (28.9% drugs/biologics are anticancer drugs and drugs used in precancerous conditions. The average time of review varies from19 months to 8.2 months. Out of these 48 molecules, 37 (77% molecules received serious adverse event alert. Positive correlation is seen between average time of review and number of adverse events reported. Seven (14.5% drugs were proven to induce second tumor among receivers. Conclusion: Although expedited review facilitates faster approval of drugs; selection and assessment criteria should be stringent to prevent clinical failure, serious adverse effects of such drugs exposed to many individuals. Focus should be given developing chemosensitizing molecule and evaluation of metronomic regimen which is being more optimistic in current cancer therapeutics.

A Review of Economic Behaviour of Drug Consumers

Directory of Open Access Journals (Sweden)

Shahrzad Borumand

2003-11-01

Full Text Available Illicit drug problem is one of the most worrying issues of the presenet century in all countries and anti-drug addiction programs are included in the agenda of all governments and international community. Drug abuse/addiction in Iran has been one of the most important social and economical problems for several years and the number and percentage of drug users/addicts are growing. Campaign against this phenomenon needs in-depth recognition of all aspects (economic, social and political of this problem. So, such programs will be successful in fighting against illicit drugs and drug addiction if they are developed and implemented through a realistic recognition. One can not hope the success of anti-drug programs if they are not planned on the basis of researches. Therefore, reviewing the economical aspect of illicit drugs via usrers’ viewpoints will help to undrestand illicit drug addiction phenomenon. In this article, the behaviour of drug usres is studied on the basis of micro-economic traditional assumptions. The relation between deman and prices of illicit drugs, the relation between tendency to drug consumption and the amount of drug consumption and the relaion between drug consumption and criminal acts are among the discussed issues of this article. Finally, a summary of the situation of illicit drug consumption is presented.

Radiopharmaceuticals drug interactions: a critical review

International Nuclear Information System (INIS)

Santos-Oliveira, Ralph; Smith, Sheila W.; Carneiro-Leao, Ana Maria A.

2008-01-01

Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance) or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here, we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions. (author)

The ethics of HIV research with people who inject drugs in Africa: a desk review.

Science.gov (United States)

Mamotte, Nicole

2012-03-01

Injecting drug use is a growing problem in Africa and a growing risk factor for contracting HIV in the region. It is imperative that HIV research includes injecting drug users so that they too are able to benefit from safe and effective behavioural interventions and biomedical HIV prevention and treatment products. This article relates a critical review of the findings of a desk review of previously published literature. The article examines injecting drug use in relation to HIV-related risk and research in Kenya, Mauritius, Nigeria, South Africa and Tanzania. The ethical challenges of including people who inject drugs in HIV research in Africa are also presented. The review found injecting drug use to be on the increase in all the countries reviewed. HIV-risk behaviour among people who inject drugs, such as needle-sharing and higher-risk sexual behaviour, was also found to be widespread. Furthermore, criminalisation of drug use and strict anti-drug laws are common in the countries reviewed, while harm-reduction programmes for people who inject drugs were found to be limited. The review identified a number of ethical challenges to the involvement of people who inject drugs in HIV research in Africa. This includes the illegal status and stigma surrounding injecting drug use, which may complicate participant recruitment, enrolment and retention. In addition, a lack of funding for supportive programmes to help injecting drug users may hinder the provision of appropriate standards of prevention and care and treatment for those who seroconvert.

Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review

Directory of Open Access Journals (Sweden)

Kanji Salmaan

2012-05-01

Full Text Available Abstract Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s with the drug(s alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Results Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Conclusions Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets and garlic (plus nitrates or warfarin on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

Sentiment Analysis of User-Generated Content on Drug Review Websites

Directory of Open Access Journals (Sweden)

Na, Jin-Cheon

2015-03-01

Full Text Available This study develops an effective method for sentiment analysis of user-generated content on drug review websites, which has not been investigated extensively compared to other general domains, such as product reviews. A clause-level sentiment analysis algorithm is developed since each sentence can contain multiple clauses discussing multiple aspects of a drug. The method adopts a pure linguistic approach of computing the sentiment orientation (positive, negative, or neutral of a clause from the prior sentiment scores assigned to words, taking into consideration the grammatical relations and semantic annotation (such as disorder terms of words in the clause. Experiment results with 2,700 clauses show the effectiveness of the proposed approach, and it performed significantly better than the baseline approaches using a machine learning approach. Various challenging issues were identified and discussed through error analysis. The application of the proposed sentiment analysis approach will be useful not only for patients, but also for drug makers and clinicians to obtain valuable summaries of public opinion. Since sentiment analysis is domain specific, domain knowledge in drug reviews is incorporated into the sentiment analysis algorithm to provide more accurate analysis. In particular, MetaMap is used to map various health and medical terms (such as disease and drug names to semantic types in the Unified Medical Language System (UMLS Semantic Network.

Adverse Cutaneous Reactions to Psychotropic Drugs: A Review

Directory of Open Access Journals (Sweden)

Filipa Novais

2015-11-01

Full Text Available Introduction: Psychotropic drugs are often implicated in cutaneous adverse drug reactions. While most of these reactions have a benign character, it is still important, however, to consider its role in the increasing stigma and treatment adherence. A small number of the cutaneous adverse drug reactions can develop into serious and potentially fatal conditions. Objectives: This article aims to review the most common cutaneous adverse drug reactions in patients taking psychotropic drugs. Methods: In this study, a search was carried out in the MEDLINE database for English language articles published , from 1999 to 2014, using as keywords: psychiatric, psychotropic, cutaneous, adverse reaction, antidepressive agents, antipsychotics, benzodiazepines, mood stabilizers, anticonvulsant, dementia. Information available from the Portuguese regulatory and supervising agency (Infarmed was also included.Results: 121 articles were found with reference to cutaneous adverse drug reactions associated with psychotropic drugs. The drugs most frequently reported as associated with such adverse effects were anticonvulsants used as mood stabilizers, followed by the antipsychotics . The antidementia drugs were rarely associated with serious cutaneous adverse reactions. Discussion and Conclusion: Cutaneous drug adverse reactions are common in psychiatric clinical practice and typically are minor in severity. The most severe reactions are most often associated with the use of mood stabilizing medications. Some of these side effects can be solved with reduction or drug discontinuation. More severe cases should be referred to a specialist in dermatology.

New Approaches to the Methamphetamine Epidemic

OpenAIRE

Zusman, Mara B.

2004-01-01

Methamphetamine abuse has become an epidemic in the United States. As methamphetamine becomes increasingly available, more and more people are trying – and becoming addicted to – this potent drug. But although methamphetamine is made using over-the-counter (OTC) drugs containing pseudoephedrine, shifting OTC drugs containing pseudoephedrine to prescription status is not the solution to the methamphetamine crisis. Rather, society must adopt a comprehensive...

Drug-resistant gram-negative uropathogens: A review.

Science.gov (United States)

Khoshnood, Saeed; Heidary, Mohsen; Mirnejad, Reza; Bahramian, Aghil; Sedighi, Mansour; Mirzaei, Habibollah

2017-10-01

Urinary tract infection(UTI) caused by Gram-negative bacteria is the second most common infectious presentation in community medical practice. Approximately 150 million people are diagnosed with UTI each year worldwide. Drug resistance in Gram-negative uropathogens is a major global concern which can lead to poor clinical outcomes including treatment failure, development of bacteremia, requirement for intravenous therapy, hospitalization, and extended length of hospital stay. The mechanisms of drug resistance in these bacteria are important due to they are often not identified by routine susceptibility tests and have an exceptional potential for outbreaks. Treatment of UTIs depends on the access to effective drugs, which is now threatened by antibiotic resistant Gram-negative uropathogens. Although several effective antibiotics with activity against highly resistant Gram-negatives are available, there is not a unique antibiotic with activity against the high variety of resistance. Therefore, antimicrobial susceptibility tests, correlation between clinicians and laboratories, development of more rapid diagnostic methods, and continuous monitoring of drug resistance are urgent priorities. In this review, we will discuss about the current global status of drug-resistant Gram-negative uropathogens and their mechanisms of drug resistance to provide new insights into their treatment options. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Pharmacogenetics of drug-drug interaction and drug-drug-gene interaction: a systematic review on CYP2C9, CYP2C19 and CYP2D6.

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Bahar, Muh Akbar; Setiawan, Didik; Hak, Eelko; Wilffert, Bob

2017-05-01

Currently, most guidelines on drug-drug interaction (DDI) neither consider the potential effect of genetic polymorphism in the strength of the interaction nor do they account for the complex interaction caused by the combination of DDI and drug-gene interaction (DGI) where there are multiple biotransformation pathways, which is referred to as drug-drug-gene interaction (DDGI). In this systematic review, we report the impact of pharmacogenetics on DDI and DDGI in which three major drug-metabolizing enzymes - CYP2C9, CYP2C19 and CYP2D6 - are central. We observed that several DDI and DDGI are highly gene-dependent, leading to a different magnitude of interaction. Precision drug therapy should take pharmacogenetics into account when drug interactions in clinical practice are expected.

Cancer nanomedicine: a review of recent success in drug delivery.

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Tran, Stephanie; DeGiovanni, Peter-Joseph; Piel, Brandon; Rai, Prakash

2017-12-11

Cancer continues to be one of the most difficult global healthcare problems. Although there is a large library of drugs that can be used in cancer treatment, the problem is selectively killing all the cancer cells while reducing collateral toxicity to healthy cells. There are several biological barriers to effective drug delivery in cancer such as renal, hepatic, or immune clearance. Nanoparticles loaded with drugs can be designed to overcome these biological barriers to improve efficacy while reducing morbidity. Nanomedicine has ushered in a new era for drug delivery by improving the therapeutic indices of the active pharmaceutical ingredients engineered within nanoparticles. First generation nanomedicines have received widespread clinical approval over the past two decades, from Doxil ® (liposomal doxorubicin) in 1995 to Onivyde ® (liposomal irinotecan) in 2015. This review highlights the biological barriers to effective drug delivery in cancer, emphasizing the need for nanoparticles for improving therapeutic outcomes. A summary of different nanoparticles used for drug delivery applications in cancer are presented. The review summarizes recent successes in cancer nanomedicine in the clinic. The clinical trials of Onivyde leading to its approval in 2015 by the Food and Drug Adminstration are highlighted as a case study in the recent clinical success of nanomedicine against cancer. Next generation nanomedicines need to be better targeted to specifically destroy cancerous tissue, but face several obstacles in their clinical development, including identification of appropriate biomarkers to target, scale-up of synthesis, and reproducible characterization. These hurdles need to be overcome through multidisciplinary collaborations across academia, pharmaceutical industry, and regulatory agencies in order to achieve the goal of eradicating cancer. This review discusses the current use of clinically approved nanomedicines, the investigation of nanomedicines in clinical

General anesthesia in cardiac surgery: a review of drugs and practices.

Science.gov (United States)

Alwardt, Cory M; Redford, Daniel; Larson, Douglas F

2005-06-01

General anesthesia is defined as complete anesthesia affecting the entire body with loss of consciousness, analgesia, amnesia, and muscle relaxation. There is a wide spectrum of agents able to partially or completely induce general anesthesia. Presently, there is not a single universally accepted technique for anesthetic management during cardiac surgery. Instead, the drugs and combinations of drugs used are derived from the pathophysiologic state of the patient and individual preference and experience of the anesthesiologist. According to the definition of general anesthesia, current practices consist of four main components: hypnosis, analgesia, amnesia, and muscle relaxation. Although many of the agents highlighted in this review are capable of producing more than one of these effects, it is logical that drugs producing these effects are given in combination to achieve the most beneficial effect. This review features a discussion of currently used anesthetic drugs and clinical practices of general anesthesia during cardiac surgery. The information in this particular review is derived from textbooks, current literature, and personal experience, and is designed as a general overview of anesthesia during cardiac surgery.

Sex differences in drug addiction: a review of animal and human studies.

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Fattore, Liana; Altea, Silvia; Fratta, Walter

2008-01-01

Addiction research has historically neglected research on women, and most studies have been conducted on men only, with the concluding results generalized to the female population. The role of sex differences in vulnerability to drug abuse, their repercussions on prevention and treatment strategies all require detailed studies, as does the progression from recreational drug use to dependence. This review synthesizes evidence of gender differences in drug addiction, with particular emphasis on women's health and implications. We first reviewed behavioral studies showing sex differences in the preference for and self-administration of licit (i.e., alcohol and nicotine) and illicit (i.e., cocaine, amphetamine, heroin and cannabis) substances as revealed by animal models of addiction. Clinical studies demonstrating differences between men and women in craving, drug use, abstinence and relapse will then be examined. For both animal and human studies, the effects of hormones and estrous/menstrual cycle will be reviewed. Finally, neurobiological factors underlying gender differences in vulnerability to drug addiction (i.e., brain morphology and neurotransmission) and need for gender-specific detoxification treatments will be discussed.

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

Science.gov (United States)

2014-01-01

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

Drug Use Normalization: A Systematic and Critical Mixed-Methods Review.

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Sznitman, Sharon R; Taubman, Danielle S

2016-09-01

Drug use normalization, which is a process whereby drug use becomes less stigmatized and more accepted as normative behavior, provides a conceptual framework for understanding contemporary drug issues and changes in drug use trends. Through a mixed-methods systematic review of the normalization literature, this article seeks to (a) critically examine how the normalization framework has been applied in empirical research and (b) make recommendations for future research in this area. Twenty quantitative, 26 qualitative, and 4 mixed-methods studies were identified through five electronic databases and reference lists of published studies. Studies were assessed for relevance, study characteristics, quality, and aspects of normalization examined. None of the studies applied the most rigorous research design (experiments) or examined all of the originally proposed normalization dimensions. The most commonly assessed dimension of drug use normalization was "experimentation." In addition to the original dimensions, the review identified the following new normalization dimensions in the literature: (a) breakdown of demographic boundaries and other risk factors in relation to drug use; (b) de-normalization; (c) drug use as a means to achieve normal goals; and (d) two broad forms of micro-politics associated with managing the stigma of illicit drug use: assimilative and transformational normalization. Further development in normalization theory and methodology promises to provide researchers with a novel framework for improving our understanding of drug use in contemporary society. Specifically, quasi-experimental designs that are currently being made feasible by swift changes in cannabis policy provide researchers with new and improved opportunities to examine normalization processes.

REVIEW: CHITOSAN BASED HYDROGEL POLYMERIC BEADS – AS DRUG DELIVERY SYSTEM

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Manjusha Rani

2010-11-01

Full Text Available Chitosan obtained by alkaline deacetylation of chitin is a non-toxic, biocompatible, and biodegradable natural polymer. Chitosan-based hydrogel polymeric beads have been extensively studied as micro- or nano-particulate carriers in the pharmaceutical and medical fields, where they have shown promise for drug delivery as a result of their controlled and sustained release properties, as well as biocompatibility with tissue and cells. To introduce desired properties and enlarge the scope of the potential applications of chitosan, graft copolymerization with natural or synthetic polymers on it has been carried out, and also, various chitosan derivatives have been utilized to form beads. The desired kinetics, duration, and rate of drug release up to therapeutical level from polymeric beads are limited by specific conditions such as beads material and their composition, bead preparation method, amount of drug loading, drug solubility, and drug polymer interaction. The present review summarizes most of the available reports about compositional and structural effects of chitosan-based hydrogel polymeric beads on swelling, drug loading, and releasing properties. From the studies reviewed it is concluded that chitosan-based hydrogel polymeric beads are promising drug delivery systems.

Drugs related to the etiology of molar incisor hypomineralization: A systematic review.

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Serna, Clara; Vicente, Ascensión; Finke, Christian; Ortiz, Antonio J

2016-02-01

Molar incisor hypomineralization (MIH) is an idiopathic syndrome that has been associated with several etiologic factors. The authors' objective was to systematically review studies in which the investigators had studied how the etiology of MIH was related to medication intake. The search covered a period from January 1, 1965, to September 29, 2014. The search revealed 1,042 articles, to which the authors applied eligibility criteria and selected 20 studies for review. The authors considered 9 of the 20 studies to be high quality. The drugs used in these studies were chemotherapeutic drugs, antibiotics, asthma drugs, antiepileptic drugs, antiviral drugs, antifungal drugs, and antiparasitic drugs. Two reviewers independently performed risk-of-bias assessment and data extraction. The investigators of all of the studies had reported enamel defects, but only 2 sets of investigators had used the term "molar incisor hypomineralization." Owing to the different methodologies used by the investigators of the selected studies, the authors could not perform a meta-analysis of the study results. More well-designed prospective studies are needed to clarify the relationship between MIH and medication. It would be convenient to establish a preventive protocol in patients with a potential risk of developing MIH to avoid the complications that are characteristic of this disease. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

Valuation of Drug Abuse: A Review of Current Methodologies and Implications for Policy Making

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Schori, Maayan

2011-01-01

This article reviews the use of several valuation methods as they relate to drug abuse and places them within the context of U.S. policy. First, cost-of-illness (COI) studies are reviewed and their limitations discussed. Second, three additional economic methods of valuing drug abuse are reviewed, including cost-effectiveness analysis (CEA),…

Physician awareness of drug cost: a systematic review.

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Allan, G Michael; Lexchin, Joel; Wiebe, Natasha

2007-09-01

Pharmaceutical costs are the fastest-growing health-care expense in most developed countries. Higher drug costs have been shown to negatively impact patient outcomes. Studies suggest that doctors have a poor understanding of pharmaceutical costs, but the data are variable and there is no consistent pattern in awareness. We designed this systematic review to investigate doctors' knowledge of the relative and absolute costs of medications and to determine the factors that influence awareness. Our search strategy included The Cochrane Library, EconoLit, EMBASE, and MEDLINE as well as reference lists and contact with authors who had published two or more articles on the topic or who had published within 10 y of the commencement of our review. Studies were included if: either doctors, trainees (interns or residents), or medical students were surveyed; there were more than ten survey respondents; cost of pharmaceuticals was estimated; results were expressed quantitatively; there was a clear description of how authors defined "accurate estimates"; and there was a description of how the true cost was determined. Two authors reviewed each article for eligibility and extracted data independently. Cost accuracy outcomes were summarized, but data were not combined in meta-analysis because of extensive heterogeneity. Qualitative data related to physicians and drug costs were also extracted. The final analysis included 24 articles. Cost accuracy was low; 31% of estimates were within 20% or 25% of the true cost, and fewer than 50% were accurate by any definition of cost accuracy. Methodological weaknesses were common, and studies of low methodological quality showed better cost awareness. The most important factor influencing the pattern and accuracy of estimation was the true cost of therapy. High-cost drugs were estimated more accurately than inexpensive ones (74% versus 31%, Chi-square p price of expensive drugs and overestimate the price of inexpensive ones, demonstrate a

17 CFR 240.15c3-1f - Optional market and credit risk requirements for OTC derivatives dealers (Appendix F to 17 CFR...

Science.gov (United States)

2010-04-01

... charges for market and credit risk pursuant to this Appendix F in lieu of computing securities haircuts...)(2)(vi). Credit Risk (d) The capital charge for credit risk arising from an OTC derivatives dealer's... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Optional market and credit...

Systematic review of drug administration costs and implications for biopharmaceutical manufacturing.

Science.gov (United States)

Tetteh, Ebenezer; Morris, Stephen

2013-10-01

The acquisition costs of biologic drugs are often considered to be relatively high compared with those of nonbiologics. However, the total costs of delivering these drugs also depend on the cost of administration. Ignoring drug administration costs may distort resource allocation decisions because these affect cost effectiveness. The objectives of this systematic review were to develop a framework of drug administration costs that considers both the costs of physical administration and the associated proximal costs; and, as a case example, to use this framework to evaluate administration costs for biologics within the UK National Health Service (NHS). We reviewed literature that reported estimates of administration costs for biologics within the UK NHS to identify how these costs were quantified and to examine how differences in dosage forms and regimens influenced administration costs. The literature reviewed were identified by searching the Centre for Review and Dissemination Databases (DARE, NHS EED and HTA); EMBASE (The Excerpta Medica Database); MEDLINE (using the OVID interface); Econlit (EBSCO); Tufts Medical Center Cost Effectiveness Analysis (CEA) Registry; and Google Scholar. We identified 4,344 potentially relevant studies, of which 43 studies were selected for this systematic review. We extracted estimates of the administration costs of biologics from these studies. We found evidence of variation in the way that administration costs were measured, and that this affected the magnitude of costs reported, which could then influence cost effectiveness. Our findings suggested that manufacturers of biologic medicines should pay attention to formulation issues and their impact on administration costs, because these affect the total costs of healthcare delivery and cost effectiveness.

Subcutaneous drug infusions: a review of problems and solutions.

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Mitten, T

2001-02-01

Subcutaneous drug infusion using a portable syringe driver has had a significant impact on patient comfort in palliative care. It permits the continuous delivery of a range of drug therapies, so bypassing problems of dysphagia, weakness and the inability of many patients in the terminal phase to take oral medication. The devices are not problem-free, however. Mechanical problems, reactions at the infusion site and difficulties with the mixing of drugs in the syringe are all widely recognized. This article reviews some general issues with the operation of portable syringe drivers, and discusses a range of potential problems and their solutions.

21 CFR 330.14 - Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and...

Science.gov (United States)

2010-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR... for each country and explain why there are differences or changes. (v) A description of the country's... marketing, i.e., a large volume of sales with cultural diversity among users of the product. If the...

Designer Drugs: A Review of Literature Abdulsallam Bakdash

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Abdulsallam Bakdash

2015-05-01

Full Text Available A new phenomenon in the drug market has appeared in recent years: there has been an increase in the number and types of designer drugs. A massive influx of these structural and/or functional analogs of controlled substances has resulted in an increase in their marketing and abuse. At present, these drugs are significantly more widely available compared to previous years because they are relatively inexpensive and marketed as being safer than classic drugs of abuse. The most important factor in the spread of designer drugs is that the majority of these substances are undetectable as drugs or illegal drugs in standard drug testing procedures. The biological effects of these substances are largely unknown to both users and medical scientists. However, most known cases of abuse have shown serious and dangerous physical and psychological reactions in users. The manufacturing and marketing of designer drugs presents a major challenge for specialist sectors, especially laboratories that have to test these substances. This highlights the important role of drugcontrol institutions and regulatory and legislative bodies to determine the legal status of these drugs, which are designed and marketed - mostly through the internet - as being legal. All of these factors make it incumbent upon these sectors to form a unified goal and strategy to control these substances and prevent their spread. This review provides fundamental information about designer drugs. This will provide an accurate overview of their status, and will aid future work to develop a regulatory and legislative strategy to combat their manufacture, marketing, and use.

A Review of Adverse Cutaneous Drug Reactions Resulting from the Use of Interferon and Ribavirin

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Nisha Mistry

2009-01-01

Full Text Available Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions.

Application of nanohydrogels in drug delivery systems: recent patents review.

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Dalwadi, Chintan; Patel, Gayatri

2015-01-01

Nanohydrogel combines the advantages of hydrogel and nano particulate systems. Similar to the hydrogel and macrogel, nanohydrogel can protect the drug and control drug release by stimuli responsive conformation or biodegradable bond into the polymer networks. Nanohydrogel has drawn huge interest due to their potential applications, such as carrier in target-specific controlled drug delivery, absorbents, chemical/biological sensors, and bio-mimetic materials. Similar to the nanoparticles, stimuli responsive nanohydrogel can easily be delivered in the liquid form for parenteral drug delivery application. This review highlights the methods to prepare nanohydrogel based on natural and synthetic polymers for diverse applications in drug delivery. It also encompasses the drug loading and drug release mechanism of the nanohydrogel formulation and patents related to the composition and chemical methods for preparation of nanohydrogel formulation with current status in clinical trials.

Determination of Oxytetracycline and 4-Epi-Oxytetracycline Residues in Feathers and Edible Tissues of Broiler Chickens Using Liquid Chromatography Coupled with Tandem Mass Spectrometry.

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Cornejo, Javiera; Pokrant, Ekaterina; Krogh, Magdalena; Briceño, Cristóbal; Hidalgo, Héctor; Maddaleno, Aldo; Araya-Jordán, Carolina; Martín, Betty San

2017-04-01

Antibiotics have been widely used in poultry production for the treatment of bacterial diseases. However, drug residues can remain in products derived from animals after the cessation of the drug therapies. Feathers, in particular, have shown an affinity for antibiotics such as tetracycline, suggesting the persistence of these drugs in nonedible tissue. After the birds are slaughtered, feathers are ground into feather meals, which are used as organic fertilizer or an ingredient in animal diets, thereby entering into the food chain and becoming a potential risk for public health. To evaluate the depletion of oxytetracycline (OTC) and its metabolite 4-epi-oxytetracycline (4-epi-OTC) in the muscles, liver, and feathers, 64 broiler chickens, bred under controlled conditions, were treated orally with a commercial formulation of 10% OTC for 7 days. The analytes were quantified using liquid chromatography-tandem mass spectrometry. OTC and 4-epi-OTC were found in the feathers for 46 days, whereas they were found in the muscle and liver for only 12 and 6 days, respectively. These results prove that the analytes remain in feathers in higher concentrations than they do in edible tissues after treatment with tetracyclines. Thus, feather meals represent a potential source of antimicrobial residue contamination in the food chain.

Systematic review of randomized trials on vasoconstrictor drugs for hepatorenal syndrome

DEFF Research Database (Denmark)

Gluud, Lise L; Christensen, Kurt; Christensen, Erik

2010-01-01

Vasoconstrictor drugs may improve renal function in hepatorenal syndrome (HRS), but the effect on mortality has not been established. We therefore performed a systematic review of randomized trials on vasoconstrictor drugs for type 1 or type 2 HRS. Mortality was the primary outcome measure...

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

Science.gov (United States)

Gammie, Todd; Lu, Christine Y; Babar, Zaheer Ud-Din

2015-01-01

To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

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Todd Gammie

Full Text Available To review existing regulations and policies utilised by countries to enable patient access to orphan drugs.A review of the literature (1998 to 2014 was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35 had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

Review of Drug Quality and Security Act of 2013: The Drug Supply Chain Security Act (DSCSA

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Elona Gjini

2016-10-01

Full Text Available The Drug Supply Chain Security Act (DSCSA signed into law in November 27, 2013 by president Obama creates a uniform national standard for tracing drug products through the supply chain. The goal of DQSA is to enhance FDA’s ability to help protect consumers by detecting and removing potential dangerous products from the pharmaceutics distribution supply chain. A new electronic, interoperable system will identify and trace only prescription drugs in the finished form for human use while distributed in the United States. The purpose of this review was to shed light on a complex and complicated process that it will require cooperation between FDA and drug manufactures, wholesale drug distributors, repackagers and dispensers. The implementation of the DSCSA is based on several law requirements and FDA has developed a schedule with time frames for each of them to be executed over a 10-year period. From this review, FDA recommendations are provided through the FDA Guidance on Identifying Suspect Product document to help trading partners and provide information about the risk of suspect drugs entering the supply chain. Moreover, FDA organized on April 5-6, 2016 in Silver Spring, MD a public workshop to gather valuable feedback from stakeholders who shared their input about the implementation of the new electronic system and its requirements. By the end of 2023, a unified system will provide easier data exchange and less errors, and will increase the safety and security of the pharmaceutical distribution supply chain.   Type: Student Project

Consensus Modeling for Prediction of Estrogenic Activity of Ingredients Commonly Used in Sunscreen Products

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Huixiao Hong

2016-09-01

Full Text Available Sunscreen products are predominantly regulated as over-the-counter (OTC drugs by the US FDA. The “active” ingredients function as ultraviolet filters. Once a sunscreen product is generally recognized as safe and effective (GRASE via an OTC drug review process, new formulations using these ingredients do not require FDA review and approval, however, the majority of ingredients have never been tested to uncover any potential endocrine activity and their ability to interact with the estrogen receptor (ER is unknown, despite the fact that this is a very extensively studied target related to endocrine activity. Consequently, we have developed an in silico model to prioritize single ingredient estrogen receptor activity for use when actual animal data are inadequate, equivocal, or absent. It relies on consensus modeling to qualitatively and quantitatively predict ER binding activity. As proof of concept, the model was applied to ingredients commonly used in sunscreen products worldwide and a few reference chemicals. Of the 32 chemicals with unknown ER binding activity that were evaluated, seven were predicted to be active estrogenic compounds. Five of the seven were confirmed by the published data. Further experimental data is needed to confirm the other two predictions.

Fall-Risk-Increasing Drugs: A Systematic Review and Meta-Analysis: I. Cardiovascular Drugs.

Science.gov (United States)

de Vries, Max; Seppala, Lotta J; Daams, Joost G; van de Glind, Esther M M; Masud, Tahir; van der Velde, Nathalie

2018-04-01

Use of certain medications is recognized as a major and modifiable risk factor for falls. Although the literature on psychotropic drugs is compelling, the literature on cardiovascular drugs as potential fall-risk-increasing drugs is conflicting. The aim of this systematic review and meta-analysis is to provide a comprehensive overview of the associations between cardiovascular medications and fall risk in older adults. Design: A systematic review and meta-analysis. Medline, Embase, and PsycINFO. Key search concepts were "fall," "aged," "causality," and "medication." Studies that investigated cardiovascular medications as risk factors for falls in participants ≥60 years old or participants with a mean age of 70 or older were included. A meta-analysis was performed using the generic inverse variance method, pooling unadjusted and adjusted odds ratios (ORs) separately. In total, 131 studies were included in the qualitative synthesis. Meta-analysis using adjusted ORs showed significant results (pooled OR [95% confidence interval]) for loop diuretics, OR 1.36 (1.17, 1.57), and beta-blocking agents, OR 0.88 (0.80, 0.97). Meta-analysis using unadjusted ORs showed significant results for digitalis, OR 1.60 (1.08, 2.36); digoxin, OR 2.06 (1.56, 2.74); and statins, OR 0.80 (0.65, 0.98). Most of the meta-analyses resulted in substantial heterogeneity that mostly did not disappear after stratification for population and setting. In a descriptive synthesis, consistent associations were not observed. Loop diuretics were significantly associated with increased fall risk, whereas beta-blockers were significantly associated with decreased fall risk. Digitalis and digoxin may increase the risk of falling, and statins may reduce it. For the majority of cardiovascular medication groups, outcomes were inconsistent. Furthermore, recent studies indicate that specific drug properties, such as selectivity of beta-blockers, may affect fall risk, and drug-disease interaction also may play

An Updated Review of the Molecular Mechanisms in Drug Hypersensitivity

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Chun-Bing Chen

2018-01-01

Full Text Available Drug hypersensitivity may manifest ranging from milder skin reactions (e.g., maculopapular exanthema and urticaria to severe systemic reactions, such as anaphylaxis, drug reactions with eosinophilia and systemic symptoms (DRESS/drug-induced hypersensitivity syndrome (DIHS, or Stevens–Johnson syndrome (SJS/toxic epidermal necrolysis (TEN. Current pharmacogenomic studies have made important strides in the prevention of some drug hypersensitivity through the identification of relevant genetic variants, particularly for genes encoding drug-metabolizing enzymes and human leukocyte antigens (HLAs. The associations identified by these studies are usually drug, phenotype, and ethnic specific. The drug presentation models that explain how small drug antigens might interact with HLA and T cell receptor (TCR molecules in drug hypersensitivity include the hapten theory, the p-i concept, the altered peptide repertoire model, and the altered TCR repertoire model. The broad spectrum of clinical manifestations of drug hypersensitivity involving different drugs, as well as the various pathomechanisms involved, makes the diagnosis and management of it more challenging. This review highlights recent advances in our understanding of the predisposing factors, immune mechanisms, pathogenesis, diagnostic tools, and therapeutic approaches for drug hypersensitivity.

An Updated Review of the Molecular Mechanisms in Drug Hypersensitivity

Science.gov (United States)

Abe, Riichiro; Pan, Ren-You; Wang, Chuang-Wei

2018-01-01

Drug hypersensitivity may manifest ranging from milder skin reactions (e.g., maculopapular exanthema and urticaria) to severe systemic reactions, such as anaphylaxis, drug reactions with eosinophilia and systemic symptoms (DRESS)/drug-induced hypersensitivity syndrome (DIHS), or Stevens–Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Current pharmacogenomic studies have made important strides in the prevention of some drug hypersensitivity through the identification of relevant genetic variants, particularly for genes encoding drug-metabolizing enzymes and human leukocyte antigens (HLAs). The associations identified by these studies are usually drug, phenotype, and ethnic specific. The drug presentation models that explain how small drug antigens might interact with HLA and T cell receptor (TCR) molecules in drug hypersensitivity include the hapten theory, the p-i concept, the altered peptide repertoire model, and the altered TCR repertoire model. The broad spectrum of clinical manifestations of drug hypersensitivity involving different drugs, as well as the various pathomechanisms involved, makes the diagnosis and management of it more challenging. This review highlights recent advances in our understanding of the predisposing factors, immune mechanisms, pathogenesis, diagnostic tools, and therapeutic approaches for drug hypersensitivity. PMID:29651444

Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review

Science.gov (United States)

Dubald, Marion; Bourgeois, Sandrine; Andrieu, Véronique; Fessi, Hatem

2018-01-01

The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites. PMID:29342879

Ophthalmic Drug Delivery Systems for Antibiotherapy—A Review

Directory of Open Access Journals (Sweden)

Marion Dubald

2018-01-01

Full Text Available The last fifty years, ophthalmic drug delivery research has made much progress, challenging scientists about the advantages and limitations of this drug delivery approach. Topical eye drops are the most commonly used formulation in ocular drug delivery. Despite the good tolerance for patients, this topical administration is only focus on the anterior ocular diseases and had a high precorneal loss of drugs due to the tears production and ocular barriers. Antibiotics are popularly used in solution or in ointment for the ophthalmic route. However, their local bioavailability needs to be improved in order to decrease the frequency of administrations and the side effects and to increase their therapeutic efficiency. For this purpose, sustained release forms for ophthalmic delivery of antibiotics were developed. This review briefly describes the ocular administration with the ocular barriers and the currently topical forms. It focuses on experimental results to bypass the limitations of ocular antibiotic delivery with new ocular technology as colloidal and in situ gelling systems or with the improvement of existing forms as implants and contact lenses. Nanotechnology is presently a promising drug delivery way to provide protection of antibiotics and improve pathway through ocular barriers and deliver drugs to specific target sites.

Information needs for making clinical recommendations about potential drug-drug interactions: a synthesis of literature review and interviews.

Science.gov (United States)

Romagnoli, Katrina M; Nelson, Scott D; Hines, Lisa; Empey, Philip; Boyce, Richard D; Hochheiser, Harry

2017-02-22

Drug information compendia and drug-drug interaction information databases are critical resources for clinicians and pharmacists working to avoid adverse events due to exposure to potential drug-drug interactions (PDDIs). Our goal is to develop information models, annotated data, and search tools that will facilitate the interpretation of PDDI information. To better understand the information needs and work practices of specialists who search and synthesize PDDI evidence for drug information resources, we conducted an inquiry that combined a thematic analysis of published literature with unstructured interviews. Starting from an initial set of relevant articles, we developed search terms and conducted a literature search. Two reviewers conducted a thematic analysis of included articles. Unstructured interviews with drug information experts were conducted and similarly coded. Information needs, work processes, and indicators of potential strengths and weaknesses of information systems were identified. Review of 92 papers and 10 interviews identified 56 categories of information needs related to the interpretation of PDDI information including drug and interaction information; study design; evidence including clinical details, quality and content of reports, and consequences; and potential recommendations. We also identified strengths/weaknesses of PDDI information systems. We identified the kinds of information that might be most effective for summarizing PDDIs. The drug information experts we interviewed had differing goals, suggesting a need for detailed information models and flexible presentations. Several information needs not discussed in previous work were identified, including temporal overlaps in drug administration, biological plausibility of interactions, and assessment of the quality and content of reports. Richly structured depictions of PDDI information may help drug information experts more effectively interpret data and develop recommendations

The impact of drugs on male fertility: a review.

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Semet, M; Paci, M; Saïas-Magnan, J; Metzler-Guillemain, C; Boissier, R; Lejeune, H; Perrin, J

2017-07-01

Beside cytotoxic drugs, other drugs can impact men's fertility through various mechanisms. Via the modification of the hypothalamic-pituitary-gonadal axis hormones or by non-hormonal mechanisms, drugs may directly and indirectly induce sexual dysfunction and spermatogenesis impairment and alteration of epididymal maturation. This systematic literature review summarizes existing data about the negative impact and associations of pharmacological treatments on male fertility (excluding cytotoxic drugs), with a view to making these data more readily available for medical staff. In most cases, these effects on spermatogenesis/sperm maturation/sexual function are reversible after the discontinuation of the drug. When a reprotoxic treatment cannot be stopped and/or when the impact on semen parameters/sperm DNA is potentially irreversible (Sulfasalazine Azathioprine, Mycophenolate mofetil and Methotrexate), the cryopreservation of spermatozoa before treatment must be proposed. Deleterious impacts on fertility of drugs with very good or good level of evidence (Testosterone, Sulfasalazine, Anabolic steroids, Cyproterone acetate, Opioids, Tramadol, GhRH analogues and Sartan) are developed. © 2017 American Society of Andrology and European Academy of Andrology.

A review on electrospun nanofibers for oral drug delivery

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Abbas Akhgari

2017-10-01

Full Text Available Nowadays, polymer nanofibers have gained attention due to remarkable characteristics such as high porosity and large surface area to volume ratio. Among their fabrication methods, electrospinning technique has been attracted as a simple and reproducible approach. It is a versatile, simple and cost-effective technique for the production of continuous nanofibers with acceptable characteristics such as high porosity, high surface area to volume ratio, high loading capacity and encapsulation efficiency, delivery of multiple drugs, and enhancement of drug solubility. Due to these properties electrospun nanofibers have been extensively used for different biomedical applications including wound dressing, tissue engineering, enzyme immobilization, artificial organs, and drug delivery. Different synthetic and natural polymers have been successfully electrospun into ultrafine fibers. Using electrospun nanofibers as vehicles for oral drug delivery has been investigated in different release manners- fast, biphasic or sustained release. This article presents a review on application of electrospinning technique in oral drug delivery.

A REVIEW ON THE ANALYTICAL TECHNIQUES USED FOR THE DETERMINATION OF PARACETAMOL IN PHARMACEUTICAL FORMULATIONS AND BIOLOGICAL FLUIDS

OpenAIRE

Aisha Noreen; Kiran Qadeer; Zubair Anwar; Iqbal Ahmad

2016-01-01

Paracetamol (PM) is an active metabolite of phenacetin and belongs to p-aminophenol derivatives. It is also termed as acetaminophen. PM is one of the non-steroidal anti-inflammatory drugs (NSAIDs) which is used as an analgesic and antipyretic agent. It is an OTC drug and is used as a common household analgesic. It is not used as a substitute of aspirin or any other NSAIDs. It is a weak cyclooxygenase (COX) 1 and 2 inhibitor but may inhibit COX-3 in the central nervous system. Many analytical ...

Illicit drugs and the environment--a review.

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Pal, Raktim; Megharaj, Mallavarapu; Kirkbride, K Paul; Naidu, Ravi

2013-10-01

Illicit drugs and their metabolites are the latest group of emerging pollutants. Determination of their concentration in environment (such as water bodies, soil, sediment, air) is an indirect tool to estimate the community level consumption of illicit drug and to evaluate potential ecotoxicological impacts from chronic low level exposure. They enter the wastewater network as unaltered drugs and/or their active metabolites by human excretion after illegal consumption or by accidental or deliberate disposal from clandestine drug laboratories. This article critically reviews the occurrence and concentration levels of illicit drugs and their metabolites in different environmental compartments (e.g., wastewater, surface waters, groundwater, drinking water, and ambient air) and their potential impact on the ecosystem. There is limited published information available on the presence of illicit drugs in the environment, reports are available mainly from European countries, UK, USA, and Canada but there is a lack of information from the remainder of the world. Although the environmental concentrations are not very high, they can potentially impact the human health and ecosystem functioning. Cocaine, morphine, amphetamine, and MDMA have potent pharmacological activities and their presence as complex mixtures in water may cause adverse effect on aquatic organisms and human health. However, there is no current regulation demanding the determination of occurrence of these emerging pollutants in treated wastewater, surface water, drinking water, or atmosphere. Thus, critical investigation on distribution pattern of this new group of emerging contaminant and their potential harmful impact on our environment needs immediate attention. Copyright © 2012. Published by Elsevier B.V.

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

Science.gov (United States)

Gammie, Todd

2015-01-01

Objective To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Results Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Conclusions Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases. PMID:26451948

Institutional ethical review and ethnographic research involving injection drug users: a case study.

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Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

Insoluble drug delivery strategies: review of recent advances and business prospects

Science.gov (United States)

Kalepu, Sandeep; Nekkanti, Vijaykumar

2015-01-01

The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects. PMID:26579474

Insoluble drug delivery strategies: review of recent advances and business prospects

Directory of Open Access Journals (Sweden)

Sandeep Kalepu

2015-09-01

Full Text Available The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects.

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

Science.gov (United States)

2012-02-29

...) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice. DATES: Effective Date: This notice is effective February 29, 2012. ADDRESSES: All communications... evidence of effectiveness for various indications for Atarax Tablets (NDA 10-392), Atarax Syrup (NDA 10-485...

A concise review on smart polymers for controlled drug release.

Science.gov (United States)

Aghabegi Moghanjoughi, Arezou; Khoshnevis, Dorna; Zarrabi, Ali

2016-06-01

Design and synthesis of efficient drug delivery systems are of critical importance in health care management. Innovations in materials chemistry especially in polymer field allows introduction of advanced drug delivery systems since polymers could provide controlled release of drugs in predetermined doses over long periods, cyclic and tunable dosages. To this end, researchers have taken advantages of smart polymers since they can undergo large reversible, chemical, or physical fluctuations as responses to small changes in environmental conditions, for instance, in pH, temperature, light, and phase transition. The present review aims to highlight various kinds of smart polymers, which are used in controlled drug delivery systems as well as mechanisms of action and their applications.

Nanocarriers in ocular drug delivery: an update review.

Science.gov (United States)

Wadhwa, Sheetu; Paliwal, Rishi; Paliwal, Shivani Rai; Vyas, S P

2009-01-01

Controlled drug delivery to eye is one of the most challenging fields of pharmaceutical research. Low drug-contact time and poor ocular bioavailability due to drainage of solution, tear turnover and its dilution or lacrimation are the problems associated with conventional systems. In addition, anatomical barriers and physiological conditions of eye are also important parameters which control designing of drug delivery systems. Nanosized carriers like micro/nano-suspensions, liposome, niosome, dendrimer, nanoparticles, ocular inserts, implants, hydrogels and prodrug approaches have been developed for this purpose. These novel systems offer manifold advantages over conventional systems as they increase the efficiency of drug delivery by improving the release profile and also reduce drug toxicity. Conventional delivery systems get diluted with tear, washed away through the lacrimal gland and usually require administering at regular time intervals whereas nanocarriers release drug at constant rate for a prolonged period of time and thus enhance its absorption and site specific delivery. This review presents an overview of the various aspects of the ocular drug delivery, with special emphasis on nanocarrier based strategies, including structure of eye, its barriers, delivery routes and the challenges/limitations associated with development of novel nanocarriers. The recent progresses in therapy of ocular disease like gene therapy have also been included so that future options should also be considered from the delivery point of view. Recent progress in the delivery of proteins and peptides via ocular route has also been incorporated for reader benefit.

Nanoparticle-Mediated Pulmonary Drug Delivery: A Review

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Mukta Paranjpe

2014-04-01

Full Text Available Colloidal drug delivery systems have been extensively investigated as drug carriers for the application of different drugs via different routes of administration. Systems, such as solid lipid nanoparticles, polymeric nanoparticles and liposomes, have been investigated for a long time for the treatment of various lung diseases. The pulmonary route, owing to a noninvasive method of drug administration, for both local and systemic delivery of an active pharmaceutical ingredient (API forms an ideal environment for APIs acting on pulmonary diseases and disorders. Additionally, this route offers many advantages, such as a high surface area with rapid absorption due to high vascularization and circumvention of the first pass effect. Aerosolization or inhalation of colloidal systems is currently being extensively studied and has huge potential for targeted drug delivery in the treatment of various diseases. Furthermore, the surfactant-associated proteins present at the interface enhance the effect of these formulations by decreasing the surface tension and allowing the maximum effect. The most challenging part of developing a colloidal system for nebulization is to maintain the critical physicochemical parameters for successful inhalation. The following review focuses on the current status of different colloidal systems available for the treatment of various lung disorders along with their characterization. Additionally, different in vitro, ex vivo and in vivo cell models developed for the testing of these systems with studies involving cell culture analysis are also discussed.

Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study.

Science.gov (United States)

Roseman, Michelle; Turner, Erick H; Lexchin, Joel; Coyne, James C; Bero, Lisa A; Thombs, Brett D

2012-08-16

To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Cross sectional study. Cochrane Database of Systematic Reviews. Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.

10 CFR 707.13 - Medical review of results of tests for illegal drug use.

Science.gov (United States)

2010-01-01

... another test, performed by the gas chromatography/mass spectrometry method (GC/MS). This procedure is... 10 Energy 4 2010-01-01 2010-01-01 false Medical review of results of tests for illegal drug use... Procedures § 707.13 Medical review of results of tests for illegal drug use. (a) All test results shall be...

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014.

Science.gov (United States)

Hecq, J-D; Godet, M; Jamart, J; Galanti, L

2015-11-01

Microwave freeze-thaw treatment (MFTT) of injectable drugs can support the development of centralized intravenous admixtures services (CIVAS). The aim of the review is to collect information and results about this method. A systematic review of the scientific literature about injectable drug stability studies was performed. The data are presented in a table and describe name of the drug, producer, final concentration, temperature and time of freezing storage, type of microwave oven, thawing power, method of dosage and results after treatment or final long-term storage at 5±3 °C. From 1980 to 2014, 59 drugs were studied by MFTT and the results were presented in 49 publications. Forty papers were presented by 8 teams (2 to 18 by team). The temperatures of freezing storage vary from -70 °C to -10 °C, the time storage from 4 hours to 12 months, the thaw from low to full power. Dosages are mainly made by high performance liquid chromatography. Most of the 59 drugs are stable during and after treatment. Only 3 teams have tested the long-term stability after MFTT, the first for ganciclovir after 7 days, the second for ceftizoxime after 30 days and the third for 19 drugs after 11 to 70 days. This review can help CIVAS to take in charge the productions of ready-to-use injectable drugs. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Use of Over-the-Counter Medication among Pregnant Women in Sharjah, United Arab Emirates

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Abduelmula R. Abduelkarem

2017-01-01

Full Text Available Background. Over-the-counter medications are widely available in pharmacies Their safety profile, however, does not extend to pregnant women. Accordingly, there should be educational programs developed for pregnant women to protect them from the harms of the side effects. Aim. This study was planned and designed with the aim of exploring the awareness and assessing the usage of OTC medications among pregnant women in Sharjah, UAE. Method. A cross-sectional survey using a self-administered questionnaire. Results. More than three-quarters (75.7% reported that they are familiar with the term “over-the-counter drugs.” Interestingly, 40% of the respondents reported that they took OTC drugs during pregnancy, and the majority (94.2% agreed with the survey statement “not all OTC medications are safe to be taken during pregnancy.” Constipation was the most frequent side effect that most of the participants reported during the study period. Folic acid (36%, calcium (28.6%, and iron (35.1% were the most common supplements used by the pregnant women responding. Conclusion. The reported 40% usage of OTC medications among pregnant women in this study is worrisome and calls for the need to educate, counsel, and increase awareness among pregnant women regarding the dangers of OTC drugs usage while pregnant in Sharjah, UAE.

21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

Science.gov (United States)

2010-04-01

..., powdered extract Betaine hydrochloride Bismuth subcarbonate Bismuth subgallate Black radish powder Blessed... Pineapple enzymes Plantago seed Potassium citrate Pyridoxine hydrochloride (vitamin B6) Riboflavin Rice... the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under...

Nonsteroidal Antiinflammatory Drugs for Axial Spondyloarthritis: A Cochrane Review

NARCIS (Netherlands)

Kroon, Féline P. B.; van der Burg, Lennart R. A.; Ramiro, Sofia; Landewé, Robert B. M.; Buchbinder, Rachelle; Falzon, Louise; van der Heijde, Désirée

2016-01-01

To determine the benefits and harms of nonsteroidal antiinflammatory drugs (NSAID) in axial spondyloarthritis (axSpA). Systematic review using Cochrane Collaboration methodology. randomized controlled trials (RCT) and quasi-RCT (to June 2014), investigating NSAID versus any control for axSpA, and

A Methodological Review of US Budget-Impact Models for New Drugs.

Science.gov (United States)

Mauskopf, Josephine; Earnshaw, Stephanie

2016-11-01

A budget-impact analysis is required by many jurisdictions when adding a new drug to the formulary. However, previous reviews have indicated that adherence to methodological guidelines is variable. In this methodological review, we assess the extent to which US budget-impact analyses for new drugs use recommended practices. We describe recommended practice for seven key elements in the design of a budget-impact analysis. Targeted literature searches for US studies reporting estimates of the budget impact of a new drug were performed and we prepared a summary of how each study addressed the seven key elements. The primary finding from this review is that recommended practice is not followed in many budget-impact analyses. For example, we found that growth in the treated population size and/or changes in disease-related costs expected during the model time horizon for more effective treatments was not included in several analyses for chronic conditions. In addition, all drug-related costs were not captured in the majority of the models. Finally, for most studies, one-way sensitivity and scenario analyses were very limited, and the ranges used in one-way sensitivity analyses were frequently arbitrary percentages rather than being data driven. The conclusions from our review are that changes in population size, disease severity mix, and/or disease-related costs should be properly accounted for to avoid over- or underestimating the budget impact. Since each budget holder might have different perspectives and different values for many of the input parameters, it is also critical for published budget-impact analyses to include extensive sensitivity and scenario analyses based on realistic input values.

Solubilization and Interaction Studies of Bile Salts with Surfactants and Drugs: a Review.

Science.gov (United States)

Malik, Nisar Ahmad

2016-05-01

In this review, bile salt, bile salt-surfactant, and bile salt-drug interactions and their solubilization studies are mainly focused. Usefulness of bile salts in digestion, absorption, and excretion of various compounds and their rare properties in ordering the shape and size of the micelles owing to the presence of hydrophobic and hydrophilic faces are taken into consideration while compiling this review. Bile salts as potential bio-surfactants to solubilize drugs of interest are also highlighted. This review will give an insight into the selection of drugs in different applications as their properties get modified by interaction with bile salts, thus influencing their solution behavior which, in turn, modifies the phase-forming behavior, microemulsion, and clouding phenomenon, besides solubilization. Finally, their future perspectives are taken into consideration to assess their possible uses as bio-surfactants without side effects to human beings.

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review

Science.gov (United States)

Manchaiah, Vinaya; Taylor, Brian; Dockens, Ashley L; Tran, Nicole R; Lane, Kayla; Castle, Mariana; Grover, Vibhu

2017-01-01

Background This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids. Method A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review. Results Included studies fell into three domains: 1) electroacoustic characteristics, 2) consumer surveys, and 3) outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level). Low-end (or low-cost) devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis), especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%–19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive outcomes of OTC devices in the elderly population. Of note, OTC outcomes appear better when a hearing health care professional supports these users. Conclusion While some direct-to-consumer hearing devices have the capability to produce adverse effects due to production of dangerously high sound levels and internal noise, the existing literature suggests that there are potential benefits of these devices. Research of direct-to-consumer hearing devices is limited, and current published studies are of weak quality. Much

A peek into the drug development scenario of endometriosis - A systematic review.

Science.gov (United States)

Goenka, Luxitaa; George, Melvin; Sen, Maitrayee

2017-06-01

Endometriosis is a gynaecological disease that is characterised by the presence of endometrium like tissue-epithelium and stroma that develops outside the uterine cavity, which is responsible for pelvic pain and infertility. Even though several medical therapies exist for the treatment of endometriosis, each of the drug class has its own limitations such as cost of treatment, side-effects and its short-term effect on the symptoms of endometriosis. In this review, we have attempted to summarize the current status and challenges of drug development for endometriosis. A systematic review was done and all the RCTs were selected from the identified hits. We included studies that explored the usage of therapeutic drugs on endometriosis patients from inception till November 2016. The search term used was 'Endometriosis' using PubMed and Clinicaltrials.gov. For the final analysis, 60 articles were analyzed and we identified the newly emerging drug therapies for endometriosis treatment and have briefed their current status and challenges in drug development for endometriosis. The quality of the selected studies was assessed based on the degree of bias. The current classes of drugs that have shown promising therapeutic results include Gonadotropin- releasing hormone (GnRH) antagonists, aromatase inhibitors (AI), and selective progesterone and estrogen receptor modulators, dopamine receptor-2-agonists and statins. The drugs that failed midway during development include tanezumab, rosiglitazone, infliximab, pentoxifylline, telapristone acetate, asoprisnil and raloxifene. From the literature review, it appears that the most promising molecules for the treatment of endometriosis in the near future include elagolix, mifepristone, TAK-385, KLH-2109 and ASP1707 and cabergoline. It remains to be seen if these molecules would succeed large phase 3 clinical trials and overcome the regulatory hurdles to become an essential tool in the gynaecologist's armamentarium against endometriosis

National Drug Formulary review of statin therapeutic group using the multiattribute scoring tool

Directory of Open Access Journals (Sweden)

Ramli A

2013-12-01

Full Text Available Azuana Ramli,1,3 Syed Mohamed Aljunid,1,2 Saperi Sulong,2 Faridah Aryani Md Yusof31United Nations University International Institute for Global Health (UNU-IIGH, Kuala Lumpur, Malaysia; 2International Centre for Casemix and Clinical Coding (ITCC, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia; 3Pharmaceutical Services Division, Ministry of Health, Petaling Jaya, MalaysiaPurpose: HMG-CoA reductase inhibitors (statins are extensively used in treating hypercholesterolemia. The statins available in Malaysia include atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, and fluvastatin. Over the years, they have accumulated in the National Drug Formulary; hence, the need for review. Effective selection of the best drugs to remain in the formulary can become complex due to the multiple drug attributes involved, and is made worse by the limited time and resources available. The multiattribute scoring tool (MAST systematizes the evaluation of the drug attributes to facilitate the drug selection process. In this study, a MAST framework was developed to rank the statins based on their utilities or benefits.Methods: Published literature on multicriteria decision analysis (MCDA were studied and five sessions of expert group discussions were conducted to build the MAST framework and to review the evidence. The attributes identified and selected for analysis were efficacy (clinical efficacy, clinical endpoints, safety (drug interactions, serious side effects and documentation, drug applicability (drug strength/formulation, indications, dose frequency, side effects, food–drug interactions, and dose adjustments, and cost. The average weights assigned by the members for efficacy, safety, drug applicability and cost were 32.6%, 26.2%, 24.1%, and 17.1%, respectively. The utility values of the attributes were scored based on the published evidence or/and agreements during the group discussions. The attribute scores were added up

Dutch Wholesale Power Market Review 2002. Executive Summary

International Nuclear Information System (INIS)

Vollebregt, T.; Rusch, H.

2002-01-01

Chapter 1 provides a background to the Dutch power market, covering generation, transmission, distribution, supply, and laws and regulations. Chapter 2 reviews the key market events during 2001 and early 2002, providing analysis and background on an important and tumultuous period in the Dutch market. Chapter 3 explains the structure and timing of the key market mechanisms (Amsterdam Power Exchange, interconnector capacity auctions, TenneT 15-minute balancing market). Chapter 4 briefly reviews fuel price developments and discusses their impact on the costs of generation. Chapter 5 contains a detailed review of the traded Dutch power markets (APX, OTC, interconnection), including the linkages between these markets and an analysis of arbitrage opportunities

Developing artemisinin based drug combinations for the treatment of drug resistant falciparum malaria: A review

Directory of Open Access Journals (Sweden)

Olliaro P

2004-01-01

Full Text Available The emergence and spread of drug resistant malaria represents a considerable challenge to controlling malaria. To date, malaria control has relied heavily on a comparatively small number of chemically related drugs, belonging to either the quinoline or the antifolate groups. Only recently have the artemisinin derivatives been used but mostly in south east Asia. Experience has shown that resistance eventually curtails the life-span of antimalarial drugs. Controlling resistance is key to ensuring that the investment put into developing new antimalarial drugs is not wasted. Current efforts focus on research into new compounds with novel mechanisms of action, and on measures to prevent or delay resistance when drugs are introduced. Drug discovery and development are long, risky and costly ventures. Antimalarial drug development has traditionally been slow but now various private and public institutions are at work to discover and develop new compounds. Today, the antimalarial development pipeline is looking reasonably healthy. Most development relies on the quinoline, antifolate and artemisinin compounds. There is a pressing need to have effective, easy to use, affordable drugs that will last a long time. Drug combinations that have independent modes of action are seen as a way of enhancing efficacy while ensuring mutual protection against resistance. Most research work has focused on the use of artesunate combined with currently used standard drugs, namely, mefloquine, amodiaquine, sulfadoxine/pyrimethamine, and chloroquine. There is clear evidence that combinations improve efficacy without increasing toxicity. However, the absolute cure rates that are achieved by combinations vary widely and depend on the level of resistance of the standard drug. From these studies, further work is underway to produce fixed dose combinations that will be packaged in blister packs. This review will summarise current antimalarial drug developments and outline recent

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Science.gov (United States)

Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

2012-07-01

Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

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Kopp, S W; Bang, H K

2000-01-01

As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

Functional Family Therapy for Young People in Treatment for Nonopioid Drug Use: A Systematic Review

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Filges, Trine; Andersen, Ditte; Jørgensen, Anne-Marie Klint

2018-01-01

Objectives: This review evaluates the evidence on the effects of functional family therapy (FFT) on drug abuse reduction for young people in treatment for nonopioid drug use. Data and Analysis: We followed Campbell Collaboration guidelines to conduct a systematic review of randomized and nonrandomized trials. Results: The search yielded two…

Data sources and methods for ascertaining human exposure to drugs.

Science.gov (United States)

Jones, J K; Kennedy, D L

Estimates of population exposure based on drug use data are critical elements in the post marketing surveillance of drugs and provide a context for assessing the various risks and benefits associated with drug treatment. Such information is important in predicting morbidity and planning public health protection strategies, indepth studies, and regulatory actions. Knowledge that a population of one thousand instead of one million may potentially be exposed to a drug can help determine how a particular regulatory problem will be handled and would obviously be a major determinant in designing a case-control or cohort study. National estimates of drug use give an overview of the most commonly used drug therapies in current practice. They also furnish valuable comparison data for specific studies of drug use limited to one group of drugs, one geographic region, or one medical care setting. The FDA has access to several different national drug use data bases, each measuring a different point in the drug distribution channels. None covers the entire spectrum of drug exposures. The major "holes" in this patchwork of data bases are the inability to measure OTC drug use with any accuracy and the lack of qualitative information on drug use in hospitals. In addition, there is no patient linkage with the data. The data can only show trends in drug use. They impart no sense of the longitudinal use of drugs for individual patients. There is no direct connection between the different data bases, all of which have their own sampling frames and their own projection methodologies. The market research companies have complete control over these methodologies and they are subject to periodic changes, a situation not entirely satisfactory for epidemiologic research. Sometimes it is a struggle to keep up with these changes. Over the past two years, every one of these data bases has undergone some type of sampling or projection methodology change. One important limitation to the use of all

Polymeric Micelles as Novel Carriers for Poorly Soluble Drugs--A Review.

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Reddy, B Pavan Kumar; Yadav, Hemant K S; Nagesha, Dattatri K; Raizaday, Abhay; Karim, Abdul

2015-06-01

Polymeric micelles are used as 'smart drug carriers' for targeting certain areas of the body by making them stimuli-sensitive or by attachment of a specific ligand molecule onto their surface. The main aim of using polymeric micelles is to deliver the poorly water soluble drugs. Now-a-days they are used especially in the areas of cancer therapy also. In this article we have reviewed several aspects of polymeric micelles concerning their mechanism of formation, chemical nature, preparation and characterization techniques, and their applications in the areas of drug delivery.

Laser assisted drug delivery: a review of an evolving technology.

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Sklar, Lindsay R; Burnett, Christopher T; Waibel, Jill S; Moy, Ronald L; Ozog, David M

2014-04-01

Topically applied drugs have a relatively low cutaneous bioavailability. This article reviews the existing applications of laser assisted drug delivery, a means by which the permeation of topically applied agents can be enhanced into the skin. The existing literature suggests that lasers are a safe and effective means of enhancing the delivery of topically applied agents through the skin. The types of lasers most commonly studied in regards to drug delivery are the carbon dioxide (CO2 ) and erbium:yttrium-aluminum-garnet (Er:YAG) lasers. Both conventional ablative and fractional ablative modalities have been utilized and are summarized herein. The majority of the existing studies on laser assisted drug delivery have been performed on animal models and additional human studies are needed. Laser assisted drug delivery is an evolving technology with potentially broad clinical applications. Multiple studies demonstrate that laser pretreatment of the skin can increase the permeability and depth of penetration of topically applied drug molecules for both local cutaneous and systemic applications. © 2014 Wiley Periodicals, Inc.

Patient perceptions of pharmacist roles in guiding self-medication of over-the-counter therapy in Qatar

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Kerry Wilbur

2010-04-01

Full Text Available Kerry Wilbur1, Samah El Salam1, Ebrahim Mohammadi21Qatar University College of Pharmacy, Doha, Qatar; 2Qatar Petroleum Medical Services, Doha, QatarBackground: Self-care, including self-medication with over-the-counter (OTC drugs, facilitates the public’s increased willingness to assume greater responsibility for their own health. Direct consultation with pharmacists provides efficient professional guidance for safe and appropriate OTC use.Objective: The purpose of this study was to characterize patient perceptions of pharmacists and use of nonprescription therapy in an ambulatory care population in Qatar. Methods: Patients having prescriptions filled at one organization’s private medical clinics during two distinct two-week periods were invited to participate in a short verbal questionnaire. Awareness of pharmacist roles in guiding OTC drug selection was assessed, as were patient preferences for OTC indications. Attitudes towards pharmacist and nurse drug knowledge and comfort with direct dispensing were also evaluated.Results: Five hundred seventy patients participated representing 29 countries. Most respondents were men (92.1% with mean age of 38.3 years. Almost 1 in 7 did not know medical complaints could be assessed by a pharmacist (15.3% and 1 in 5 (21.9% were unaware pharmacists could directly supply OTC therapy. The majority (85.3% would be interested in this service. In general, respondents were more comfortable with medication and related advice supplied by pharmacists as opposed to nursing professionals.Conclusion: Patients were familiar with the roles of pharmacists as they pertain to selfmedication with OTC therapy and described the desire to use such a service within this Qatar ambulatory health care setting.Keywords: patient, self-medication, over-the-counter, pharmacist, Qatar

Socio-economics: a propensity of self-medication among OPD patients of a teaching hospital

OpenAIRE

Subha Sankar Chattopadhyay; Angana Datta; Aritra Ghosh; Suvadip Biswas; Krishnendu Mandal; Supreeti Biswas

2016-01-01

Background: Use of over the counter (OTC) drug is very much common in India. Not only medical professionals or educated urban population but also it is common in rural area and low educated person. This study was done to assess the extent of knowledge and practices of OTC drugs among OPD patients of a tertiary care hospital. Methods: A questionnaire based study was conducted among 1680 Medicine OPD (outpatient department) patients. Results: Among the participants, 62% patients taking ...

Systematic review of surveillance by social media platforms for illicit drug use.

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Kazemi, Donna M; Borsari, Brian; Levine, Maureen J; Dooley, Beau

2017-12-01

The use of social media (SM) as a surveillance tool of global illicit drug use is limited. To address this limitation, a systematic review of literature focused on the ability of SM to better recognize illicit drug use trends was addressed. A search was conducted in databases: PubMed, CINAHL via Ebsco, PsychINFO via Ebsco, Medline via Ebsco, ERIC, Cochrane Library, Science Direct, ABI/INFORM Complete and Communication and Mass Media Complete. Included studies were original research published in peer-reviewed journals between January 2005 and June 2015 that primarily focused on collecting data from SM platforms to track trends in illicit drug use. Excluded were studies focused on purchasing prescription drugs from illicit online pharmacies. Selected studies used a range of SM tools/applications, including message boards, Twitter and blog/forums/platform discussions. Limitations included relevance, a lack of standardized surveillance systems and a lack of efficient algorithms to isolate relevant items. Illicit drug use is a worldwide problem, and the rise of global social networking sites has led to the evolution of a readily accessible surveillance tool. Systematic approaches need to be developed to efficiently extract and analyze illicit drug content from social networks to supplement effective prevention programs. © The Author 2017. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Status of drug-resistant tuberculosis in China: A systematic review and meta-analysis.

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Zhang, Jingya; Gou, Haimei; Hu, Xuejiao; Hu, Xin; Shang, Mengqiao; Zhou, Juan; Zhou, Yi; Ye, Yuanxin; Song, Xingbo; Lu, Xiaojun; Chen, Xuerong; Ying, Binwu; Wang, Lanlan

2016-06-01

We conducted a systematic review and meta-analysis on drug-resistant tuberculosis in China to provide useful data for tuberculosis (TB) surveillance and treatment. Several databases, including PubMed, Embase, and the Chinese Biological Medical Database, were systematically searched between January 1, 1999, and August 31, 2015, using strict inclusion and exclusion criteria. The corresponding drug-resistant TB prevalence between the new and previously treated cases was significantly different in almost all of the economic regions. The Eastern coastal region is the most developed economic region with the lowest total drug-resistant TB prevalence (any drug resistance: 28%; 95% confidence interval [CI], 25%-32%; multidrug resistance: 9%; 95% CI, 8%-12%) and the lowest number of new cases (any drug resistance: 21%; 95% CI, 19%-23%; multidrug resistance: 4%; 95% CI, 3%-5%). The Northwest is the least developed area with the lowest drug-resistant TB prevalence for previously treated cases (any drug resistance: 45%; 95% CI, 36%-55%; multidrug resistance: 17%; 95% CI, 11%-26%). The prevalence (multidrug and first-line drug resistance) exhibited a downward trend from 1996-2014. The extensively drug-resistant prevalence in China was 3% (95% CI, 2%-5%) in this review. Overall, the status of drug-resistant tuberculosis in China is notably grim and exhibits regional epidemiologic characteristics. We are in urgent need of several comprehensive and effective control efforts to reverse this situation. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Nanotechnology-Based Drug Delivery Systems for Melanoma Antitumoral Therapy: A Review.

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Rigon, Roberta Balansin; Oyafuso, Márcia Helena; Fujimura, Andressa Terumi; Gonçalez, Maíra Lima; do Prado, Alice Haddad; Gremião, Maria Palmira Daflon; Chorilli, Marlus

2015-01-01

Melanoma (MEL) is a less common type of skin cancer, but it is more aggressive with a high mortality rate. The World Cancer Research Fund International (GLOBOCAN 2012) estimates that there were 230,000 new cases of MEL in the world in 2012. Conventional MEL treatment includes surgery and chemotherapy, but many of the chemotherapeutic agents used present undesirable properties. Drug delivery systems are an alternative strategy by which to carry antineoplastic agents. Encapsulated drugs are advantageous due to such properties as high stability, better bioavailability, controlled drug release, a long blood circulation time, selective organ or tissue distribution, a lower total required dose, and minimal toxic side effects. This review of scientific research supports applying a nanotechnology-based drug delivery system for MEL therapy.

Generic drugs: Review and experiences from South India

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Philip Mathew

2015-01-01

Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

Influences of social reward experience on behavioral responses to drugs of abuse: Review of shared and divergent neural plasticity mechanisms for sexual reward and drugs of abuse.

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Beloate, Lauren N; Coolen, Lique M

2017-12-01

Different factors influence the development of drug addiction in humans, including social reward experiences. In animals, experience with social rewards, such as sexual behavior, pair bonding, social and environmental enrichment, can be protective. However, loss or lack of social rewards can lead to a vulnerability to drug-seeking behavior. The effects of social reward experience on drug-seeking behavior are associated with changes in the neural pathways that control drug-related behavior. This review will provide an introduction and overview of the mesolimbic pathway and the influence of social reward experience on drug-seeking behavior in rodents. Moreover, the research from our laboratory on effects of sexual experience and loss of sex reward on psychostimulant and opiate reward will be reviewed. Finally, we will review current knowledge of the neural mechanisms that underlie these interactions. Investigations of the neural underpinnings by which social and drug rewards interact contribute to improved understanding of the neural basis of vulnerability for drug addiction and reward-related behaviors in general. Copyright © 2017 Elsevier Ltd. All rights reserved.

TRANSDERMAL DRUG DELIVERY SYSTEM: REVIEW

OpenAIRE

Vishvakarama Prabhakar; Agarwal Shivendra; Sharma Ritika; Saurabh Sharma

2012-01-01

Various new technologies have been developed for the transdermal delivery of some important drugs. Today about 74% of drugs are taken orally and are found not to be as effective as desired. To improve such characters transdermal drug delivery system was emerged. Drug delivery through the skin to achieve a systemic effect of a drug is commonly known as transdermal drug delivery and differs from traditional topical drug delivery. Transdermal drug delivery systems (TDDS) are dosage forms involve...

Measurement of Drug Craving in Persian Speaking Subjects; a Review on Current Experiences and Future Perspectives

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Masoomeh Maarefvand

2012-09-01

Full Text Available Background: Drug craving is considered as one of the main cores of drug dependency and addiction. Multidimensionality of drug craving, its cultural-bounded features and its intra individual rapidly changing nature makes it difficult to be measured. Nowadays, regarding different psychometric approaches, there are various instruments available for measurement of different aspects of drug craving but mainly for Latin-based languages in North America and European countries. High prevalence and special conditions, and unique subcultures in substance abuse and addiction in many countries, like Iran, make the design of culturally validated instruments for drug craving assessment priority. Materials and Methods: Comprehensive review on drug craving measurement instruments for Persian speaking subjects have been performed by searching in databases (ELSEVIER, Science Direct and Scientific Information Database (SID and investigating of related documents on regional experiences. Results: In this article seven main categories of drug craving instruments have been reviewed focusing on validated versions in Persian language including: self-reports, reinforcement “proxies”, drug self administration, psycho physiological responding, neurobiological responding, cognitive processing and expressive methods. Conclusion: Reviewing on weak and strength points of each instrument group and national and regional experiences shows that designing and validating a new series of ecologically-validated instruments for multidimensional measurement of drug craving in different addiction subcultures should be prioritized to cover current methodological gaps in substance abuse studies in Iran.

Molecularly imprinted polymers for the detection of illegal drugs and additives: a review.

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Xiao, Deli; Jiang, Yue; Bi, Yanping

2018-04-04

This review (with 154 refs.) describes the current status of using molecularly imprinted polymers in the extraction and quantitation of illicit drugs and additives. The review starts with an introduction into some synthesis methods (lump MIPs, spherical MIPs, surface imprinting) of MIPs using illicit drugs and additives as templates. The next section covers applications, with subsections on the detection of illegal additives in food, of doping in sports, and of illicit addictive drugs. A particular focus is directed towards current limitations and challenges, on the optimization of methods for preparation of MIPs, their applicability to aqueous samples, the leakage of template molecules, and the identification of the best balance between adsorption capacity and selectivity factor. At last, the need for convincing characterization methods, the lack of uniform parameters for defining selectivity, and the merits and demerits of MIPs prepared using nanomaterials are addressed. Strategies are suggested to solve existing problems, and future developments are discussed with respect to a more widespread use in relevant fields. Graphical abstract This review gives a comprehensive overview of the advances made in molecularly imprinting of polymers for use in the extraction and quantitation of illicit drugs and additives. Methods for syntheses, highlighted applications, limitations and current challenges are specifically addressed.

Annual banned-substance review: analytical approaches in human sports drug testing.

Science.gov (United States)

Thevis, Mario; Kuuranne, Tiia; Walpurgis, Katja; Geyer, Hans; Schänzer, Wilhelm

2016-01-01

The aim of improving anti-doping efforts is predicated on several different pillars, including, amongst others, optimized analytical methods. These commonly result from exploiting most recent developments in analytical instrumentation as well as research data on elite athletes' physiology in general, and pharmacology, metabolism, elimination, and downstream effects of prohibited substances and methods of doping, in particular. The need for frequent and adequate adaptations of sports drug testing procedures has been incessant, largely due to the uninterrupted emergence of new chemical entities but also due to the apparent use of established or even obsolete drugs for reasons other than therapeutic means, such as assumed beneficial effects on endurance, strength, and regeneration capacities. Continuing the series of annual banned-substance reviews, literature concerning human sports drug testing published between October 2014 and September 2015 is summarized and reviewed in reference to the content of the 2015 Prohibited List as issued by the World Anti-Doping Agency (WADA), with particular emphasis on analytical approaches and their contribution to enhanced doping controls. Copyright © 2016 John Wiley & Sons, Ltd.

Carbon Nanotubes Hybrid Hydrogels in Drug Delivery: A Perspective Review

Science.gov (United States)

Hampel, Silke; Spizzirri, Umile Gianfranco; Parisi, Ortensia Ilaria; Picci, Nevio; Iemma, Francesca

2014-01-01

The use of biologics, polymers, silicon materials, carbon materials, and metals has been proposed for the preparation of innovative drug delivery devices. One of the most promising materials in this field are the carbon-nanotubes composites and hybrid materials coupling the advantages of polymers (biocompatibility and biodegradability) with those of carbon nanotubes (cellular uptake, stability, electromagnatic, and magnetic behavior). The applicability of polymer-carbon nanotubes composites in drug delivery, with particular attention to the controlled release by composites hydrogel, is being extensively investigated in the present review. PMID:24587993

Reporting of conflicts of interest from drug trials in Cochrane reviews : cross sectional study

NARCIS (Netherlands)

Roseman, Michelle; Turner, Erick H.; Lexchin, Joel; Coyne, James C.; Bero, Lisa A.; Thombs, Brett D.

2012-01-01

Objectives To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Design Cross sectional study. Data sources

Effects of Multidimensional Family Therapy (MDFT) on Nonopioid Drug Abuse: A Systematic Review and Meta-Analysis

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Filges, Trine; Andersen, Ditte; Jørgensen, Anne-Marie Klint

2018-01-01

Purpose: This review evaluates the evidence of the effects of multidimensional family therapy (MDFT) on drug use reduction in young people for the treatment of nonopioid drug use. Method: We followed Campbell Collaboration guidelines to conduct a systematic review of randomized and nonrandomized trials. Meta-analytic methods were used to…

Mixing pleasures: review of the effects of drugs on sex behavior in humans and animal models.

Science.gov (United States)

Frohmader, Karla S; Pitchers, Kyle K; Balfour, Margaret E; Coolen, Lique M

2010-06-01

Drugs of abuse act on the brain circuits mediating motivation and reward associated with natural behaviors. There is ample evidence that drugs of abuse impact male and female sexual behavior. First, the current review discusses the effect of drugs of abuse on sexual motivation and performance in male and female humans. In particular, we discuss the effects of commonly abused drugs including psychostimulants, opiates, marijuana/THC, and alcohol. In general, drug use affects sexual motivation, arousal, and performance and is commonly associated with increased sexual risk behaviors. Second, studies on effects of systemic administration of drugs of abuse on sexual behavior in animals are reviewed. These studies analyze the effects on sexual performance and motivation but do not investigate the effects of drugs on risk-taking behavior, creating a disconnect between human and animal studies. For this reason, we discuss two studies that focus on the effects of alcohol and methamphetamine on inhibition of maladaptive sex-seeking behaviors in rodents. Third, this review discusses potential brain areas where drugs of abuse may be exerting their effect on sexual behavior with a focus on the mesolimbic system as the site of action. Finally, we discuss recent studies that have brought to light that sexual experience in turn can affect drug responsiveness, including a sensitized locomotor response to amphetamine in female and male rodents as well as enhanced drug reward in male rats. Copyright 2009 Elsevier Inc. All rights reserved.

Mechanisms and biomaterials in pH-responsive tumour targeted drug delivery: A review.

Science.gov (United States)

Kanamala, Manju; Wilson, William R; Yang, Mimi; Palmer, Brian D; Wu, Zimei

2016-04-01

As the mainstay in the treatment of various cancers, chemotherapy plays a vital role, but still faces many challenges, such as poor tumour selectivity and multidrug resistance (MDR). Targeted drug delivery using nanotechnology has provided a new strategy for addressing the limitations of the conventional chemotherapy. In the last decade, the volume of research published in this area has increased tremendously, especially with functional nano drug delivery systems (nanocarriers). Coupling a specific stimuli-triggered drug release mechanism with these delivery systems is one of the most prevalent approaches for improving therapeutic outcomes. Among the various stimuli, pH triggered delivery is regarded as the most general strategy, targeting the acidic extracellular microenvironment and intracellular organelles of solid tumours. In this review, we discuss recent advances in the development of pH-sensitive nanocarriers for tumour-targeted drug delivery. The review focuses on the chemical design of pH-sensitive biomaterials, which are used to fabricate nanocarriers for extracellular and/or intracellular tumour site-specific drug release. The pH-responsive biomaterials bring forth conformational changes in these nanocarriers through various mechanisms such as protonation, charge reversal or cleavage of a chemical bond, facilitating tumour specific cell uptake or drug release. A greater understanding of these mechanisms will help to design more efficient drug delivery systems to address the challenges encountered in conventional chemotherapy. Copyright © 2016 Elsevier Ltd. All rights reserved.

The importance the pharmacist for rational use of drugs in children and teenagers

Directory of Open Access Journals (Sweden)

Regiane Cristina dos Santos Moreira Borges

2013-01-01

Full Text Available Medication use without orientation can cause damage, especially among children and teenagers. The World Health Organization (WHO recommends actions to encourage the rational drug use and the Pharmacist is pointed as an important health educator. The goal was to identify the profile of medication use in children and adolescents and discuss the role of pharmacists to promote the rational drug use. A cross-sectional epidemiological study was conducted in three schools in the urban area of Extrema-MG, Brazil. The study included 525 children and adolescents between 0 and 18 years who completed a questionnaire about drug use with their parents or guardians. Children and adolescents who participated in the study, 58.5% reported using drugs in the last 6 months. Most understood the indications of the drugs used. The main causes for the purchase of non-prescription drugs were headache, colds and flu, sore throat and cough. Only a small proportion (7.0% said they do not use "drugs" without prescription. Most have heard about the rational use of medicines (57.5% and seeks the help of the pharmacist for the purchase of OTC drugs ever (57.3% or sometimes (25.1%. The importance of the pharmacist to rational drug use was confirmed by the usage profile observed. Only a minority used only with prescription drugs and most calls for help from the pharmacist to buy non-prescription medicines.

THE IMPORTANCE THE PHARMACIST FOR RATIONAL USE OF DRUGS IN CHILDREN AND TEENAGERS

Directory of Open Access Journals (Sweden)

Regiane Cristina dos Santos Moreira Borges

2013-05-01

Full Text Available Medication use without orientation can cause damage, especially among children and teenagers. The World Health Organization (WHO recommends actions to encourage the rational drug use and the Pharmacist is pointed as an important health educator. The goal was to identify the profile of medication use in children and adolescents and discuss the role of pharmacists to promote the rational drug use. A cross-sectional epidemiological study was conducted in three schools in the urban area of Extrema-MG, Brazil. The study included 525 children and adolescents between 0 and 18 years who completed a questionnaire about drug use with their parents or guardians. Children and adolescents who participated in the study, 58.5% reported using drugs in the last 6 months. Most understood the indications of the drugs used. The main causes for the purchase of non-prescription drugs were headache, colds and flu, sore throat and cough. Only a small proportion (7.0% said they do not use "drugs" without prescription. Most have heard about the rational use of medicines (57.5% and seeks the help of the pharmacist for the purchase of OTC drugs ever (57.3% or sometimes (25.1%. The importance of the pharmacist to rational drug use was confirmed by the usage profile observed. Only a minority used only with prescription drugs and most calls for help from the pharmacist to buy nonprescription medicines.

Methods to assess intended effects of drug treatment in observational studies are reviewed

NARCIS (Netherlands)

Klungel, Olaf H|info:eu-repo/dai/nl/181447649; Martens, Edwin P|info:eu-repo/dai/nl/088859010; Psaty, Bruce M; Grobbee, Diederik E; Sullivan, Sean D; Stricker, Bruno H Ch; Leufkens, Hubert G M|info:eu-repo/dai/nl/075255049; de Boer, A|info:eu-repo/dai/nl/075097346

2004-01-01

BACKGROUND AND OBJECTIVE: To review methods that seek to adjust for confounding in observational studies when assessing intended drug effects. METHODS: We reviewed the statistical, economical and medical literature on the development, comparison and use of methods adjusting for confounding. RESULTS:

Drug Delivery and Cosmeceutical Applications of Poly- Lactic Acid Based Novel Constructs - A Review.

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Ruiz-Ruiz, Federico; Mancera-Andrade, Elena Ivonne; Parra-Saldivar, Roberto; Keshavarz, Tajalli; Iqbal, Hafiz M N

2017-01-01

Poly (lactic acid) (PLA) based novel constructs have been engineered for targeted applications in various biomedical sectors of the modern world. In this context, a special focus has been given to pharmaceutical and cosmeceutical industries. In this review, we extensively reviewed, analyzed and compiled salient information from the authentic bibliographic sources including PubMed, Scopus, Elsevier, Springer, Bentham Science and other scientific databases. A focused review question and inclusion/exclusion criterion were adopted to appraise the quality of retrieved peer-reviewed research literature. Recently, bio-based constructs are being engineered for target applications in different bio- and non-bio sectors of the modern world to address the growing human health-related serious concerns. The utilization of properly designed and structured materials thus allows the creation of a well-defined environment that induces a series of directed measures, and so on. Over the last few years, PLA-based novel constructs have received exceptional attention as potential candidates for various biotechnological and biomedical applications at large and drug delivery in particular. Owing to their unique characteristics including biocompatibility, together with the adjustable thermomechanical and tunable control drug release, PLA has raised interesting applications in many sectors of the medical world. So far, many of such PLA-based bio-constructs have been exploited in drug delivery systems, cosmeceutical products, and therapeutic uses. In recent years, many new applications have been reported for PLA-based materials at the micro- and nano- level, resulting in novel requests for specific drug delivery and cosmeceutical sectors. In summary, this review summarizes recent research on different aspects of PLA and PLA-based novel constructs and their potential biomedical applications. Moreover, with the aid of nanotechnology, PLA has made a positive impact in emerging sectors such as

A Review of Antimicrobial Peptides and Their Therapeutic Potential as Anti-Infective Drugs

Science.gov (United States)

Gordon, Y. Jerold; Romanowski, Eric G.; McDermott, Alison M.

2006-01-01

Purpose. Antimicrobial peptides (AMPs) are an essential part of innate immunity that evolved in most living organisms over 2.6 billion years to combat microbial challenge. These small cationic peptides are multifunctional as effectors of innate immunity on skin and mucosal surfaces and have demonstrated direct antimicrobial activity against various bacteria, viruses, fungi, and parasites. This review summarizes their progress to date as commercial antimicrobial drugs for topical and systemic indications. Methods. Literature review. Results. Despite numerous clinical trials, no modified AMP has obtained Food & Drug Administration approval yet for any topical or systemic medical indications. Conclusions. While AMPs are recognized as essential components of natural host innate immunity against microbial challenge, their usefulness as a new class of antimicrobial drugs still remains to be proven. PMID:16020284

Convergence of anatomy, technology, and therapeutics: a review of laser-assisted drug delivers.

Science.gov (United States)

Brauer, Jeremy A; Krakowski, Andrew C; Bloom, Bradley S; Nguyen, Tuyet A; Geronemus, Roy G

2014-12-01

This is a very exciting time in cutaneous laser surgery with an ever-expanding therapeutic armamentarium and an increased sophistication of available technology. These recent trends have allowed for both a rapid development of interest and exploration of laser-assisted drug delivery and its potential applications. We review the current literature on anatomy, technology, and therapeutics as it relates to laser-assisted drug delivery. The focus of our review is on two areas of interest that have received much attention to date - photodynamic therapy in the treatment of actinic keratoses and nonmelanoma skin cancers as well as the treatment of scarring. We will also discuss potential complications of existing modalities used independently and in laser-assisted drug delivery and conclude with future indications for this burgeoning therapeutic methodology.

Categorization of psychoactive substances into "hard drugs" and "soft drugs": a critical review of terminology used in current scientific literature.

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Janik, Peter; Kosticova, Michaela; Pecenak, Jan; Turcek, Michal

2017-11-01

Precise terminology and definitions are important components of scientific language. Although the terms "hard drugs" and "soft drugs" are used widely by professionals, neither the International Classification of Diseases nor the Diagnostic and Statistical Manual classify psychoactive substances into the categories "hard" and "soft." To analyze the occurrence of the terms "hard drugs" and "soft drugs" in recent scientific literature and to establish the degree of consensus in labeling psychoactive substances as "hard" or "soft." A critical review of scientific papers listed in PubMed and Scopus between 2011 and 2015. Three hundred thirty-four articles were initially identified as potentially relevant for review, 132 of which were included in the final analysis. One hundred twenty-four articles used the term "hard drugs" and 84.7% provided examples of substances considered "hard." Forty-four articles used the term "soft drugs" and 90.9% provided examples of substances considered "soft." Citations of relevant articles supporting categorization as "hard" or "soft" were not given in 90% of the articles. The authors often provided no or only very sparse information on their reasons for considering specific drugs as "hard" or "soft." Although it initially appeared that there is substantial agreement as to which psychoactive substances should be regarded as "hard" and "soft," closer inspection shows that the dividing line is blurred without clear criteria for categorization. At this time, it remains uncertain whether these terms should persist in the scientific literature. We therefore recommend these terms should be avoided or, if used, be clearly and precisely defined.

Comparison of the Benefit Feeling Rate Based on the Sho of OTC Kakkonto, Cold Remedy and Cold Remedy with Kakkonto Combination Product.

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Okita, Mitsuyoshi; Yayoshi, Yuki; Ohara, Kousuke; Negishi, Akio; Akimoto, Hayato; Inoue, Naoko; Numajiri, Sachihiko; Ohshima, Shigeru; Honma, Seiichi; Oshima, Shinji; Kobayashi, Daisuke

2017-10-01

Kakkonto (KK), a traditional Japanese Kampo formulation for cold and flu, is generally sold as an OTC pharmaceuticals used for self-medication. Kampo formulations should be used according to the Sho-symptoms of Kampo medicine. These symptoms refer to the subjective symptoms themselves. Although with OTC pharmaceuticals, this is often not the case. We surveyed the relationship of agreement of Sho with the benefit feeling rate (BFR) of patients who took KK (n=555), cold remedies with KK (CK, n=315), and general cold remedies (GC, n=539) using internet research. BFR of a faster recovery was greater in participants who took the medication early and who had confidence in their physical strength in all treatment groups. BFR was significantly higher in the GC group than in the KK group for patients with headache, runny nose, blocked nose, sneezing, and cough. BFR was also significantly higher in the GC group than in the CK group for headache (males) and cough (females). BFR was the highest in the KK group for stiff shoulders. All cold remedies were more effective when taken early, and the larger the number of Sho that a patient had, the greater the BFR increased. Therefore, a cold remedy is expected to be most effective when there are many cold symptoms and when it is taken at an early stage of the common cold.

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

Science.gov (United States)

2010-04-01

... throat warning:” (G) Warning for drug products containing sodium phosphates set forth in § 201.307(b)(2... (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this... paragraphs (c)(5)(i) through (c)(5)(vii), (c)(5)(ix), and (c)(5)(x) of this section. (ix) The pregnancy...

A systematic review of computerised serious educational games about alcohol and other drugs for adolescents.

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Rodriguez, Daniel M; Teesson, Maree; Newton, Nicola C

2014-03-01

Serious educational games (SEG) have been shown to be effective in educating young people about a range of topics, including languages and maths. This paper identifies the use of computerised SEGs in education about alcohol and other drugs and reviews their impact on the prevention of alcohol and drug use. The Cochrane Library, EMBASE, MEDLINE, ERIC, Scopus, psychINFO, pubMED and DRUG databases were searched in February 2013. Additional publications were obtained from the reference lists of the relevant papers. Studies were included if they described an evaluation of a computerised SEG that targeted alcohol and/or other drugs and had been trialled with adolescents. Eight SEGs were identified targeting tobacco, alcohol, cannabis, methamphetamine, ecstasy, inhalants, cocaine and opioids. Six reported positive outcomes in terms of increased content knowledge and two reported increased negative attitudes towards the targeted drugs. Only one reported a decrease in the frequency of drug use. This is the first review of the efficacy of computerised SEGs for alcohol and other drugs for adolescents. Results suggest that SEGs can increase content knowledge of alcohol and other drugs. Evidence concerning impacts on negative attitudes and alcohol and drug use is limited, with few studies examining these outcomes. © 2013 Australasian Professional Society on Alcohol and other Drugs.

Social costs of illegal drugs, alcohol and tobacco in the European Union: A systematic review.

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Barrio, Pablo; Reynolds, Jillian; García-Altés, Anna; Gual, Antoni; Anderson, Peter

2017-09-01

Drug use accounts for one of the main disease groups in Europe, with relevant consequences to society. There is an increasing need to evaluate the economic consequences of drug use in order to develop appropriate policies. Here, we review the social costs of illegal drugs, alcohol and tobacco in the European Union. A systematic search of relevant databases was conducted. Grey literature and previous systematic reviews were also searched. Studies reporting on social costs of illegal drugs, alcohol and tobacco were included. Methodology, cost components as well as costs were assessed from individual studies. To compare across studies, final costs were transformed to 2014 Euros. Forty-five studies reported in 43 papers met the inclusion criteria (11 for illegal drugs, 26 for alcohol and 8 for tobacco). While there was a constant inclusion of direct costs related to treatment of substance use and comorbidities, there was a high variability for the rest of cost components. Total costs showed also a great variability. Price per capita for the year 2014 ranged from €0.38 to €78 for illegal drugs, from €26 to €1500 for alcohol and from €10.55 to €391 for tobacco. Drug use imposes a heavy economic burden to Europe. However, given the high existing heterogeneity in methodologies, and in order to better assess the burden and thus to develop adequate policies, standardised methodological guidance is needed. [Barrio P, Reynolds J, García-Altés A, Gual A, Anderson P. Social costs of illegal drugs, alcohol and tobacco in the European Union: A systematic review. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

An analysis of redactions in Canada's Common Drug Review Clinical Review Reports and how they relate to the patients' voice.

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Soprovich, Allison; El Kurdi, Sylvia; Eurich, Dean T

2017-09-11

Canada's Common Drug Review (CDR) evaluates drug data from published and unpublished research, as well as input from patient groups, to recommend provincial coverage. Currently, the CDR process gives manufacturers the opportunity to redact information in the final publicly available report. Patients often have strong feelings regarding the efficacy, harms, health-related quality of life (HRQL), and cost associated with the drugs under review and their redacted data. Highlighting Canada's approach will hopefully build on the growing international concern regarding transparency of clinical study data. The purpose was to objectively examine and classify completed, publicly available CDR-Clinical Review Reports (CRR) for redactions, and compare them to the patients' reported interests as patient-centred outcomes. Two independent reviewers searched for and examined publicly available CDR-CRR from November 2013-September 2016 through the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database. Both reviewers separately classified the redactions and patient-reported interests into the following categories: efficacy, harms, HRQL and costs. All discrepancies were rectified by consensus involving a third reviewer. Fifty-two completed CDR-CRR were reviewed. 48 (92%) included patient-reported interests and 40 (77%) had redactions classified in the following categories: efficacy (75%), costs (48%), harms (38%), HRQL (23%). 89% of redactions were outcomes identified as patient-reported interests (69% efficacy, 42% harms, 36% cost, 33% HRQL). When examining drug characteristics, biological agents were statistically associated with increased odds of redactions with respect to either efficacy (OR 3.4, 95% CI 1.0 to 11.6) or harms (OR 3.5, 95% CI 1.02 to 12.4) compared with non-biological agents. Whether data from the CDR-CRR used in the decision-making should be fully disclosed to the public is controversial. Our findings suggest clinical data (efficacy

Nonprescription medications for respiratory symptoms: Facts and marketing fictions.

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Weinberger, Miles; Hendeles, Leslie

2018-05-01

There are many nonprescription (over-the-counter [OTC]) medications available on pharmacy shelves marketed for relief of respiratory symptoms. The number of such medications has been increasing. This review provides an evidence-based examination of OTC products used for respiratory symptoms. Antihistamines, decongestants, mucolytics, antitussives, and intranasal steroids were selected as the most common OTC medications taken by adults and children for various respiratory symptoms. Controlled clinical trials of efficacy were identified by searching a medical literature data base. Those trials and key publications related to the pharmacokinetics and pharmacodynamics of the products were reviewed. Comparisons of the various OTC antihistamines' ability to suppress the effects of histamine were related to their clinical benefit. Intranasal corticosteroids are the preferred agents for maintenance therapy of persistent nasal congestion and are highly effective for symptoms of inhalant allergy other than allergic conjunctivitis. The disconnect between marketing claims and evidence was demonstrated for antihistamines and oral alpha-1 adrenergic agonist decongestants. Data for OTC mucolytics and antitussives were insufficient to justify their use based on the evidence. There was little relationship between marketing claims and evidence regarding OTC medications used for respiratory symptoms. Analysis of data supported cetirizine, levocetirizine, and fexofenadine as the most effective of the OTC antihistamines. There were no data that supported the use of oral phenylephrine as a decongestant. Neither OTC mucolytics or antitussives provided sufficient evidence to justify their use.

Contact lenses as drug controlled release systems: a narrative review

Directory of Open Access Journals (Sweden)

Helena Prior Filipe

2016-06-01

Full Text Available ABSTRACT Topically applied therapy is the most common way to treat ocular diseases, however given the anatomical and physiological constraints of the eye, frequent dosing is required with possible repercussions in terms of patient compliance. Beyond refractive error correction, contact lenses (CLs have, in the last few decades emerged as a potential ophthalmic drug controlled release system (DCRS. Extensive research is underway to understand how to best modify CLs to increase residence time and bioavailability of drugs within therapeutic levels on the ocular surface.These devices may simultaneously correct ametropia and have a role in managing ophthalmic disorders that can hinder CL wear such as dry eye, glaucoma, ocular allergy and cornea infection and injury. In this narrative review the authors explain how the ocular surface structures determine drug diffusion in the eye and summarize the strategies to enhance drug residence time and bioavailability. They synthesize findings and clinical applications of drug soaked CLs as DCRS combined with delivery diffusion barriers, incorporation of functional monomers, ion related controlled release, molecular imprinting, nanoparticles and layering. The authors draw conclusions about the impact of these novel ophthalmic agents delivery systems in improving drug transport in the target tissue and patient compliance, in reducing systemic absorption and undesired side effects, and discuss future perspectives.

Thermosensitive liposomal drug delivery systems: state of the art review

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Kneidl B

2014-09-01

Full Text Available Barbara Kneidl,1,2 Michael Peller,3 Gerhard Winter,2 Lars H Lindner,1 Martin Hossann11Department of Internal Medicine III, University Hospital Munich, 2Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, 3Institute for Clinical Radiology, University Hospital Munich, Ludwig-Maximilians University, Munich, GermanyAbstract: Thermosensitive liposomes are a promising tool for external targeting of drugs to solid tumors when used in combination with local hyperthermia or high intensity focused ultrasound. In vivo results have demonstrated strong evidence that external targeting is superior over passive targeting achieved by highly stable long-circulating drug formulations like PEGylated liposomal doxorubicin. Up to March 2014, the Web of Science listed 371 original papers in this field, with 45 in 2013 alone. Several formulations have been developed since 1978, with lysolipid-containing, low temperature-sensitive liposomes currently under clinical investigation. This review summarizes the historical development and effects of particular phospholipids and surfactants on the biophysical properties and in vivo efficacy of thermosensitive liposome formulations. Further, treatment strategies for solid tumors are discussed. Here we focus on temperature-triggered intravascular and interstitial drug release. Drug delivery guided by magnetic resonance imaging further adds the possibility of performing online monitoring of a heating focus to calculate locally released drug concentrations and to externally control drug release by steering the heating volume and power. The combination of external targeting with thermosensitive liposomes and magnetic resonance-guided drug delivery will be the unique characteristic of this nanotechnology approach in medicine.Keywords: thermosensitive liposomes, phosphatidyloligoglycerol, hyperthermia, high intensity focused ultrasound, drug delivery, drug targeting

The systems containing clays and clay minerals from modified drug release: a review.

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Rodrigues, Luís Alberto de Sousa; Figueiras, Ana; Veiga, Francisco; de Freitas, Rivelilson Mendes; Nunes, Lívio César Cunha; da Silva Filho, Edson Cavalcanti; da Silva Leite, Cleide Maria

2013-03-01

Clays are materials commonly used in the pharmaceutical industry, either as ingredients or as active ingredients. It was observed that when they are administered concurrently, they may interact with drugs reducing their absorption. Therefore, such interactions can be used to achieve technological and biopharmaceutical advantages, regarding the control of release. This review summarizes bibliographic (articles) and technological (patents) information on the use of systems containing clays and clay minerals in modified drug delivery. In this area, formulations such natural clay, commercial clay, synthetic clay, composites clay-polymers, nanocomposites clay-polymers, films and hidrogels composites clay-polymers are used to slow/extend or vectorize the release of drugs and consequently they increase their bioavailability. Finally, this review summarizes the fields of technology and biopharmaceutical applications, where clays are applied. Copyright © 2012 Elsevier B.V. All rights reserved.

A Review of Moxifloxacin for the Treatment of Drug-Susceptible Tuberculosis.

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Naidoo, Anushka; Naidoo, Kogieleum; McIlleron, Helen; Essack, Sabiha; Padayatchi, Nesri

2017-11-01

Moxifloxacin, an 8-methoxy quinolone, is an important drug in the treatment of multidrug-resistant tuberculosis and is being investigated in novel drug regimens with pretomanid, bedaquiline, and pyrazinamide, or rifapentine, for the treatment of drug-susceptible tuberculosis. Early results of these studies are promising. Although current evidence does not support the use of moxifloxacin in treatment-shortening regimens for drug-susceptible tuberculosis, it may be recommended in patients unable to tolerate standard first-line drug regimens or for isoniazid monoresistance. Evidence suggests that the standard 400-mg dose of moxifloxacin used in the treatment of tuberculosis may be suboptimal in some patients, leading to worse tuberculosis treatment outcomes and emergence of drug resistance. Furthermore, a drug interaction with the rifamycins results in up to 31% reduced plasma concentrations of moxifloxacin when these are combined for treatment of drug-susceptible tuberculosis, although the clinical relevance of this interaction is unclear. Moxifloxacin exhibits extensive interindividual pharmacokinetic variability. Higher doses of moxifloxacin may be needed to achieve drug exposures required for improved clinical outcomes. Further study is, however, needed to determine the safety of proposed higher doses and clinically validated targets for drug exposure to moxifloxacin associated with improved tuberculosis treatment outcomes. We discuss in this review the evidence for the use of moxifloxacin in drug-susceptible tuberculosis and explore the role of moxifloxacin pharmacokinetics, pharmacodynamics, and drug interactions with rifamycins, on tuberculosis treatment outcomes when used in first-line tuberculosis drug regimens. © 2017, The American College of Clinical Pharmacology.

Oral controlled release drug delivery system and Characterization of oral tablets; A review

Directory of Open Access Journals (Sweden)

Muhammad Zaman

2016-01-01

Full Text Available Oral route of drug administration is considered as the safest and easiest route of drug administration. Control release drug delivery system is the emerging trend in the pharmaceuticals and the oral route is most suitable for such kind of drug delivery system. Oral route is more convenient for It all age group including both pediatric and geriatrics. There are various systems which are adopted to deliver drug in a controlled manner to different target sites through oral route. It includes diffusion controlled drug delivery systems; dissolution controlled drug delivery systems, osmotically controlled drug delivery systems, ion-exchange controlled drug delivery systems, hydrodynamically balanced systems, multi-Particulate drug delivery systems and microencapsulated drug delivery system. The systems are formulated using different natural, semi-synthetic and synthetic polymers. The purpose of the review is to provide information about the orally controlled drug delivery system, polymers which are used to formulate these systems and characterizations of one of the most convenient dosage form which is the tablets. 

Sex differences in the vulnerability to drug abuse: a review of preclinical studies.

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Roth, Megan E; Cosgrove, Kelly P; Carroll, Marilyn E

2004-10-01

Clinical and preclinical findings indicate that males and females differ on several aspects of drug reinforcement. Females are more vulnerable than males during transition periods of drug use that are characteristic of drug addiction and relapse. Females are also more sensitive than males to the reinforcing effects of stimulants. It has been suggested that ovarian hormones contribute to the mechanisms of action underlying these sex differences. This review examines the preclinical literature on sex differences and ovarian hormonal influences on drug self-administration in animals. It summarizes the findings on the effects of these variables during different phases of drug addiction. Possible differences in the mechanisms of action of drugs of abuse due to interactions with sex differences or ovarian hormonal factors are considered. The animal literature on sex differences in drug abuse treatment effectiveness is also discussed.

Age and impulsive behavior in drug addiction: A review of past research and future directions.

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Argyriou, Evangelia; Um, Miji; Carron, Claire; Cyders, Melissa A

2018-01-01

Impulsive behavior is implicated in the initiation, maintenance, and relapse of drug-seeking behaviors involved in drug addiction. Research shows that changes in impulsive behavior across the lifespan contribute to drug use and addiction. The goal of this review is to examine existing research on the relationship between impulsive behavior and drug use across the lifespan and to recommend directions for future research. Three domains of impulsive behavior are explored in this review: impulsive behavior-related personality traits, delay discounting, and prepotent response inhibition. First, we present previous research on these three domains of impulsive behavior and drug use across developmental stages. Then, we discuss how changes in impulsive behavior across the lifespan are implicated in the progression of drug use and addiction. Finally, we discuss the relatively limited attention given to middle-to-older adults in the current literature, consider the validity of the measures used to assess impulsive behavior in middle-to-older adulthood, and suggest recommendations for future research. Copyright © 2017 Elsevier Inc. All rights reserved.

Family Therapy for Drug Abuse: Review and Updates 2003-2010

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Rowe, Cynthia L.

2012-01-01

Just 15 years ago, Liddle and Dakof ("Journal of Marital and Family Therapy," 1995; 21, 511) concluded, based on the available evidence, that family therapy represented a "promising, but not definitive" approach for the treatment of drug problems among adolescents and adults. Seven years later, Rowe and Liddle (2003) review described considerable…

Injection Drug Use Trajectories Among Migrant Populations: A Narrative Review.

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Melo, Jason S; Mittal, Maria Luisa; Horyniak, Danielle; Strathdee, Steffanie A; Werb, Dan

2018-01-24

Dual epidemics of injection drug use and blood-borne disease, characterized as "syndemics," are present in a range of settings. Behaviors that drive such syndemics are particularly prevalent among mobile drug-using populations, for whom cross-border migration may pose additional risks. This narrative review aims to characterize the risk factors for injection drug use initiation associated with migration, employing a risk environment framework and focusing on the San Diego-Tijuana border region as the most dynamic example of these phenomena. Based on previous literature, we divide migration streams into three classes: intra-urban, internal, and international. We synthesized existing literature on migration and drug use to characterize how mobility and migration drive the initiation of injection drug use, as well as the transmission of hepatitis and HIV, and to delineate how these might be addressed through public health intervention. Population mixing between migrants and receiving communities and the consequent transmission of social norms about injection drug use create risk environments for injection drug use initiation. These risk environments have been characterized as a result of local policy environments, injection drug use norms in receiving communities, migration-related stressors, social dislocation, and infringement on the rights of undocumented migrants. Policies that exacerbate risk environments for migrants may inadvertently contribute to the expansion of epidemics of injection-driven blood-borne disease. Successful interventions that address emerging syndemics in border regions may therefore need to be tailored to migrant populations and distinguish between the vulnerabilities experienced by different migration classes and border settings.

A review of illicit psychoactive drug use in elective surgery patients: Detection, effects, and policy.

Science.gov (United States)

Selvaggi, Gennaro; Spagnolo, Antonio G; Elander, Anna

2017-12-01

Limited information is present in literature regarding detection of illicit drug users visiting physicians when planning elective surgery; also, there is no update manuscript that is illustrating the effects of illicit drugs use that require reconstructive surgery interventions. Aims of this manuscript are: 1) to summarize existing knowledge, and give surgeons information how to detect patients who might possible use illicit drugs; 2) to review the effects of illicit drug use that specifically require reconstructive surgery interventions; 3) to assess on existing policies on asymptomatic illicit drug users when planning elective surgery. Studies were identified by searching systematically in the electronic databases PubMed, Medline, The Cochrane Library and SveMed+. Because of the nature of research questions to be investigated (drug policy and surgery), a "systematic review" was not possible. In spite of some existing policies to detect illicit drug use in specific situations such as workplaces or acute trauma patients, there is a lack of data and lack of information, and subsequently no policy has ever been made, for detection and management of illicit drug use asymptomatic patients requesting or referred for plastic surgery interventions. This manuscript poses questions for further ethical evaluations and future policy. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Parenting Programmes for Preventing Tobacco, Alcohol or Drugs Misuse in Children Less than 18: A Systematic Review

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Petrie, Jane; Bunn, Frances; Byrne, Geraldine

2007-01-01

We conducted a systematic review of controlled studies of parenting programmes to prevent tobacco, alcohol or drug abuse in children less than 18. We searched Cochrane Central Register of Controlled Trials, specialized Register of Cochrane Drugs and Alcohol Group, Pub Med, psych INFO, CINALH and SIGLE. Two reviewers independently screened studies,…

Value-based reimbursement decisions for orphan drugs: a scoping review and decision framework.

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Paulden, Mike; Stafinski, Tania; Menon, Devidas; McCabe, Christopher

2015-03-01

The rate of development of new orphan drugs continues to grow. As a result, reimbursing orphan drugs on an exceptional basis is increasingly difficult to sustain from a health system perspective. An understanding of the value that societies attach to providing orphan drugs at the expense of other health technologies is now recognised as an important input to policy debates. The aim of this work was to scope the social value arguments that have been advanced relating to the reimbursement of orphan drugs, and to locate these within a coherent decision-making framework to aid reimbursement decisions in the presence of limited healthcare resources. A scoping review of the peer reviewed and grey literature was undertaken, consisting of seven phases: (1) identifying the research question; (2) searching for relevant studies; (3) selecting studies; (4) charting, extracting and tabulating data; (5) analyzing data; (6) consulting relevant experts; and (7) presenting results. The points within decision processes where the identified value arguments would be incorporated were then located. This mapping was used to construct a framework characterising the distinct role of each value in informing decision making. The scoping review identified 19 candidate decision factors, most of which can be characterised as either value-bearing or 'opportunity cost'-determining, and also a number of value propositions and pertinent sources of preference information. We were able to synthesize these into a coherent decision-making framework. Our framework may be used to structure policy discussions and to aid transparency about the values underlying reimbursement decisions for orphan drugs. These values ought to be consistently applied to all technologies and populations affected by the decision.

Safety Profile of the Newest Antiepileptic Drugs: A Curated Literature Review.

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Palleria, Caterina; Cozza, Giuseppe; Khengar, Rajeshree; Libri, Vincenzo; De Sarro, Giovambattista

2017-01-01

Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice. However, the main cause of treatment failure is still poor patient compliance due to the occurrence of adverse drug reactions (ADRs) that lead to treatment withdrawal in about 25% of cases before achieving maximal efficacy, and is associated with increasing health care costs. In this Review, we conducted an online database search using Medline, PubMed, Embase, and the Cochrane Online Library to review the available studies highlighting the clinical relevance of side effects, pharmacological interactions, safety and tolerability of the newest AEDs: Brivaracetam (BRV), Cannabidiol (CBD), Eslicarbazepine acetate (ESL), Lacosamide (LCM), and Perampanel (PER). The principal benefit of the newest AEDs, in addition to reduced frequency and seizure severity, is the low number and severity of ADRs reported compared to more historic drugs. Early detection of ADRs could lead to an improvement in patients' quality of life, therefore it is important to monitor ADRs and to adequately perform post marketing surveillance in the clinical practice setting. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A review of integrating electroactive polymers as responsive systems for specialized drug delivery applications.

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Pillay, Viness; Tsai, Tong-Sheng; Choonara, Yahya E; du Toit, Lisa C; Kumar, Pradeep; Modi, Girish; Naidoo, Dinesh; Tomar, Lomas K; Tyagi, Charu; Ndesendo, Valence M K

2014-06-01

Electroactive polymers (EAPs) are promising candidate materials for the design of drug delivery technologies, especially in conditions where an "on-off" drug release mechanism is required. To achieve this, EAPs such as polyaniline, polypyrrole, polythiophene, ethylene vinyl acetate, and polyethylene may be blended into responsive hydrogels in conjunction with the desired drug to obtain a patient-controlled drug release system. The "on-off" drug release mechanism can be achieved through the environmental-responsive nature of the interpenetrating hydrogel-EAP complex via (i) charged ions initiated diffusion of drug molecules; (ii) conformational changes that occur during redox switching of EAPs; or (iii) electroerosion. These release mechanisms are not exhaustive and new release mechanisms are still under investigation. Therefore, this review seeks to provide a concise incursion and critical overview of EAPs and responsive hydrogels as a strategy for advanced drug delivery, for example, controlled release of neurotransmitters, sulfosalicyclic acid from cross-linked hydrogel, and vaccine delivery. The review further discusses techniques such as linear sweep voltammetry, cyclic voltammetry, impedance spectroscopy, and chronoamperometry for the determination of the redox capability of EAPs. The future implications of the hydrogel-EAP composites include, but not limited to, application toward biosensors, DNA hybridizations, microsurgical tools, and miniature bioreactors and may be utilized to their full potential in the form of injectable devices as nanorobots or nanobiosensors. Copyright © 2013 Wiley Periodicals, Inc.

Clinical Drug-Drug Pharmacokinetic Interaction Potential of Sucralfate with Other Drugs

DEFF Research Database (Denmark)

Sulochana, Suresh P; Syed, Muzeeb; Chandrasekar, Devaraj V

2016-01-01

of drugs. This review covers several category of drugs such as non-steroidal anti-inflammatory drugs, fluoroquinolones, histamine H2-receptor blockers, macrolides, anti-fungals, anti-diabetics, salicylic acid derivatives, steroidal anti-inflammatory drugs and provides pharmacokinetic data summary along...

Survey on drug use among high school students: A systematic review

Directory of Open Access Journals (Sweden)

Clamarta Pasuch

2014-08-01

Full Text Available The first experiments with drugs often occur in adolescence, in familiar surroundings, with legal substances such as alcohol and tobacco. Data indicate that adolescence is a phase of exposure and vulnerability to substance use. Objective: To determine the prevalence of drug use among high school students. Method: Systematic review. Results: We found 184 articles, and according to the exclusion criteria, 13 articles were adopted: 3 that address the theme in the South, one in the Northeast, one in the North, and the 8 in the Southeastern Brazilian regions. Discussion: We noticed a growth in drug use among adolescent students in the 13 articles examined. Research reveals significant increase in lifetime use, frequent use and heavy use of various drugs. We found that students have early contact with psychoactive substances, using them in large quantities, whether legal such as alcohol and tobacco, or illicit drugs like marijuana and solvents. The most important variable for this behavior was curiosity. Conclusion: There is an increase in substance use among high school students. Approaching the subject in schools is the best way to prevent drug use.

Drug-Drug and Herb-Drug Interaction-A Comment | Esimone ...

African Journals Online (AJOL)

Clinically relevant drug-drug interactions may be pharmacodynamic or pharmacokinetic. And herbal medicinal products are becoming increasingly popular. Drug interactions can be in vivo or in vitro. Pharmacodynamic outcomes take such forms as Additive, Synergistic, Antagonistic or Indifferent. The paper reviews and ...

A review on recent technologies for the manufacture of pulmonary drugs.

Science.gov (United States)

Hadiwinoto, Gabriela Daisy; Lip Kwok, Philip Chi; Lakerveld, Richard

2018-01-01

This review discusses recent developments in the manufacture of inhalable dry powder formulations. Pulmonary drugs have distinct advantages compared with other drug administration routes. However, requirements of drugs properties complicate the manufacture. Control over crystallization to make particles with the desired properties in a single step is often infeasible, which calls for micronization techniques. Although spray drying produces particles in the desired size range, a stable solid state may not be attainable. Supercritical fluids may be used as a solvent or antisolvent, which significantly reduces solvent waste. Future directions include application areas such as biopharmaceuticals for dry powder inhalers and new processing strategies to improve the control over particle formation such as continuous manufacturing with in-line process analytical technologies.

A review of drug delivery systems based on nanotechnology and green chemistry: green nanomedicine.

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Jahangirian, Hossein; Lemraski, Ensieh Ghasemian; Webster, Thomas J; Rafiee-Moghaddam, Roshanak; Abdollahi, Yadollah

2017-01-01

This review discusses the impact of green and environmentally safe chemistry on the field of nanotechnology-driven drug delivery in a new field termed "green nanomedicine". Studies have shown that among many examples of green nanotechnology-driven drug delivery systems, those receiving the greatest amount of attention include nanometal particles, polymers, and biological materials. Furthermore, green nanodrug delivery systems based on environmentally safe chemical reactions or using natural biomaterials (such as plant extracts and microorganisms) are now producing innovative materials revolutionizing the field. In this review, the use of green chemistry design, synthesis, and application principles and eco-friendly synthesis techniques with low side effects are discussed. The review ends with a description of key future efforts that must ensue for this field to continue to grow.

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

DEFF Research Database (Denmark)

Olesen, Charlotte; Harbig, Philipp; Barat, Ishay

2014-01-01

(herbal medicines, dietary supplements, or non-prescribed drugs) was elicited during home visit interviews. Prescription drug adherence was determined by pill counts. A patient was categorised as non-adherent if the mean adherence rate for all drugs consumed was ... to be adherent than were non-users (odds ratio 0.41; 95 % confidence interval 0.18–0.91). Sensitivity analyses where adherence was defined different show no relationship between adherence and use of OTC medicine. Furthermore, separate analyses of herbal medicines, dietary supplements, or non-prescribed drugs did...... not correlate with adherence to prescriptions. Conclusion Amongst elderly patients on multiple medications a positive relationship was found between the overall use of OTC medicines and adherence to prescription drugs, in contrast to none when adherence were defined different or herbal medicines, dietary...

A global epidemiological perspective on the toxicology of drug-facilitated sexual assault: A systematic review.

Science.gov (United States)

Anderson, Laura Jane; Flynn, Asher; Pilgrim, Jennifer Lucinda

2017-04-01

A systematic review was undertaken to determine the current global prevalence of drug-facilitated sexual assault (DFSA) reported in adults in order to identify trends in the toxicology findings in DFSA around the world over the past 20 years. Databases PubMed, PsycINFO and Scopus were systematically searched using the terms: "drug-facilitated sexual assault", "chemical submission", "date rape", "rape drugs" and "drink-spiking" to identify relevant studies for inclusion in the review. This study focused on adult victims of suspected DFSA aged 16 years and above in which toxicology results were reported. The majority of studies included were published in the United States, followed by the United Kingdom, with only a single study dedicated to this area in both Australia and Europe. Epidemiology, prevalence rates, and toxicology for DFSA appear broadly commensurate across different continents, although there are some differences in how "drug-facilitated sexual assault" is defined, as well as differences in the sensitivity of toxicological analyses. Nonetheless, alcohol is the most commonly detected substance and co-occurrence with other drugs is common. Aside from alcohol there was no other specific drug category associated with DFSA. Cannabinoids and benzodiazepines were frequently detected, but a lack of contextual information made it difficult to establish the extent that these substances contributed to suspected cases of DFSA. This comprehensive review suggests that alcohol intoxication combined with voluntary drug consumption presents the greatest risk factor for DFSA, despite populist perceptions that covert drink-spiking is a common occurrence. There is a need to develop policies that encourage early responders to suspected DFSA (e.g., law enforcement agencies, medical staff, support agencies, etc), to collect detailed information about the individual's licit and illicit drug consumption history, in order to assist in providing appropriate and more thorough

A review of the impact of commercial drug advertising on the ...

African Journals Online (AJOL)

Introduction: Today, the phenomenon of commercial advertising is not a simple information tool to link consumer to producers. The pharmaceutical industry is increasingly influenced by commercial advertising. Self-medication may be one of the major consequences of drug advertising. Methodology: This review article was ...

Post-consumer use efficacies of preservatives in personal care and topical drug products: relationship to preservative category.

Science.gov (United States)

Ravita, Timothy D; Tanner, Ralph S; Ahearn, Donald G; Arms, Erin L; Crockett, Patrick W

2009-01-01

Ninety-six used personal care and topical OTC drug items collected from consumers in the USA were examined for the presence of microbial contaminants. Of the eye and face product type containing global preservative chemistries (i.e., acceptable for use in Japan without major restrictions), 55% yielded numbers of microorganisms in excess of 500 CFU/g (P preservative chemistries, 79% yielded numbers of microorganisms in excess of 500 CFU/g (P preservative chemistries accounted for 88% (n = 14) of the products that had microbial contents above 10(4) CFU/g (P preserved with global preservative chemistries did not maintain as adequate preservation as products with non-global preservatives.

Review of drug treatment of oral submucous fibrosis.

Science.gov (United States)

Chole, Revant H; Gondivkar, Shailesh M; Gadbail, Amol R; Balsaraf, Swati; Chaudhary, Sudesh; Dhore, Snehal V; Ghonmode, Sumeet; Balwani, Satish; Mankar, Mugdha; Tiwari, Manish; Parikh, Rima V

2012-05-01

This study undertook a review of the literature on drug treatment of oral submucous fibrosis. An electronic search was carried out for articles published between January 1960 to November 2011. Studies with high level of evidence were included. The levels of evidence of the articles were classified after the guidelines of the Oxford Centre for Evidence-Based Medicine. The main outcome measures used were improvement in oral ulceration, burning sensation, blanching and trismus. Only 13 publications showed a high level of evidence (3 randomized controlled trials and 10 clinical trials/controlled clinical trials), with a total of 1157 patients. Drugs like steroids, hyaluronidase, human placenta extracts, chymotrypsin and collagenase, pentoxifylline, nylidrin hydrochloride, iron and multivitamin supplements including lycopene, have been used. Only systemic agents were associated with few adverse effects like gastritis, gastric irritation and peripheral flushing with pentoxifylline, and flushingly warm skin with nylidrin hydrochloride; all other side-effects were mild and mainly local. Few studies with high levels of evidence were found. The drug treatment that is currently available for oral submucous fibrosis is clearly inadequate. There is a need for high-quality randomized controlled trials with carefully selected and standardized outcome measures. Copyright © 2011 Elsevier Ltd. All rights reserved.

Drugs reviews

African Journals Online (AJOL)

Angel_D

tests (LFTs) to monitor hepatotoxicity (liver [hepatic] damage) is uncommon in many resource-poor ... cholesterol ester storage disease. ... The problem with many patients is that they are taking several drugs often ... Urine, saliva and other body fluids may be coloured orange-red: this can be very alarming to patients.

Effect of drugs of abuse on social behaviour: a review of animal models.

Science.gov (United States)

Blanco-Gandía, Maria C; Mateos-García, Ana; García-Pardo, Maria P; Montagud-Romero, Sandra; Rodríguez-Arias, Marta; Miñarro, José; Aguilar, María A

2015-09-01

Social behaviour is disturbed in many substance abuse and psychiatric disorders. Given the consensus that social behaviours of lower mammals may help to understand some human emotional reactions, the aim of the present work was to provide an up-to-date review of studies on the changes in social behaviour induced by drugs of abuse. Various animal models have been used to study the relationship between drugs of abuse and social behaviour. Herein, we describe the effects of different substances of abuse on the three most commonly used animal models of social behaviour: the social play test, the social interaction test and the resident-intruder paradigm. The first is the most widely used test to assess adolescent behaviour in rodents, the second is generally used to evaluate a wide repertoire of behaviours in adulthood and the latter is specific to aggressive behaviour. Throughout the review we will explore the most relevant studies carried out to date to evaluate the effects of alcohol, cocaine, opioids, 3,4-methylenedioxymethamphetamine (MDMA), cannabinoids, nicotine and other drugs of abuse on these three paradigms, taking into account the influence of different variables, such as social history, age and type of exposure. Drugs of diverse pharmacological classes induce alterations in social behaviour, although they can be contrasting depending on several factors (drug, individual differences and environmental conditions). Ethanol and nicotine increase social interaction at low doses but reduce it at high doses. Psychostimulants, MDMA and cannabinoids reduce social interaction, whereas opiates increase it. Ethanol and psychostimulants enhance aggression, whereas MDMA, opiates, cannabinoids and nicotine reduce it. Prenatal drug exposure alters social behaviour, whereas drug withdrawal decreases sociability and enhances aggression. As a whole, this evidence has improved our understanding of the social dimension of drug addiction.

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

Science.gov (United States)

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

Quality of online pharmacies and websites selling prescription drugs: a systematic review.

Science.gov (United States)

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

2011-09-30

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. 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. 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. 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, researchers very often found

77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

Science.gov (United States)

2012-07-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

Machine Learning-based Virtual Screening and Its Applications to Alzheimer's Drug Discovery: A Review.

Science.gov (United States)

Carpenter, Kristy A; Huang, Xudong

2018-06-07

Virtual Screening (VS) has emerged as an important tool in the drug development process, as it conducts efficient in silico searches over millions of compounds, ultimately increasing yields of potential drug leads. As a subset of Artificial Intelligence (AI), Machine Learning (ML) is a powerful way of conducting VS for drug leads. ML for VS generally involves assembling a filtered training set of compounds, comprised of known actives and inactives. After training the model, it is validated and, if sufficiently accurate, used on previously unseen databases to screen for novel compounds with desired drug target binding activity. The study aims to review ML-based methods used for VS and applications to Alzheimer's disease (AD) drug discovery. To update the current knowledge on ML for VS, we review thorough backgrounds, explanations, and VS applications of the following ML techniques: Naïve Bayes (NB), k-Nearest Neighbors (kNN), Support Vector Machines (SVM), Random Forests (RF), and Artificial Neural Networks (ANN). All techniques have found success in VS, but the future of VS is likely to lean more heavily toward the use of neural networks - and more specifically, Convolutional Neural Networks (CNN), which are a subset of ANN that utilize convolution. We additionally conceptualize a work flow for conducting ML-based VS for potential therapeutics of for AD, a complex neurodegenerative disease with no known cure and prevention. This both serves as an example of how to apply the concepts introduced earlier in the review and as a potential workflow for future implementation. Different ML techniques are powerful tools for VS, and they have advantages and disadvantages albeit. ML-based VS can be applied to AD drug development. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review.

Science.gov (United States)

Rodrigues, Maria Cristina Soares; Oliveira, Cesar de

2016-09-01

to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. identificar e sintetizar estudos que examinam as interações medicamentosas (IM) e reações adversas a medicamentos (RAM) em idosos polimedicados. revisão integrativa de estudos publicados de janeiro de 2008 a dezembro de 2013, de acordo com critérios de inclusão e exclusão, nas bases de dados eletrônicas MEDLINE e EMBASE. foram analisados 47 estudos de texto completo, incluindo 14,624,492 idosos (≥ 60 anos): 24 (51,1%) sobre RAM, 14 (29,8%) sobre IM e 9 estudos (19,1%) que investigaram tanto IM como RAM. Encontramos uma variedade de desenhos metodológicos. Os estudos revisados reforçaram que a polifarmácia é um processo multifatorial, e os preditores e a prescrição inadequada estão associados a

Recent Advancement and Technological Aspects of Pulsatile Drug Delivery System - A Laconic Review.

Science.gov (United States)

Pandit, Vinay; Kumar, Ajay; Ashawat, Mahendra S; Verma, Chander P; Kumar, Pravin

2017-01-01

Pulsatile drug delivery system (PDDS) shows potential significance in the field of drug delivery to release the maximum amount of drug at a definite site and at specific time. PDDS are mainly time controlled delivery devices having a definite pause period for drug release, which is not affected by acidity, alkalinity, motility and enzymes present in the gastrointestinal tract. Pulsatile medication possess the potential to deliver the drugs in the therapy of diseases where drug dose is essential during sleep, drugs having greater first pass metabolism and absorption at precise location in digestive tract. The review article, discuss the general concepts, marketed formulations and patents or any other recent advancement in pulsatile release technology. It also highlights on diseases requiring therapy by pulsatile release, various researches on herbal pulsatile formulations and quality control aspects of PDDS. Pulsatile medication possess the potential to deliver the drugs in the therapy of diseases where drug dose is essential during sleep, drugs having greater first pass metabolism and absorption at precise location in digestive tract. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Reproductive Health Risks Associated with Occupational Exposures to Antineoplastic Drugs in Health Care Settings: A Review of the Evidence

Science.gov (United States)

Connor, Thomas H.; Lawson, Christina C.; Polovich, Martha; McDiarmid, Melissa A.

2015-01-01

Objectives Antineoplastic drugs are known reproductive and developmental toxicants. Our objective was to review the existing literature of reproductive health risks to workers who handle antineoplastic drugs. Methods A structured literature review of 18 peer-reviewed, English language publications of occupational exposure and reproductive outcomes was performed. Results While effect sizes varied with study size and population, occupational exposure to antineoplastic drugs appears to raise the risk of both congenital malformations and miscarriage. Studies of infertility and time-to-pregnancy also suggested an increased risk for sub-fertility. Conclusions Antineoplastic drugs are highly toxic in patients receiving treatment and adverse reproductive effects have been well documented in these patients. Healthcare workers with chronic, low level occupational exposure to these drugs also appear to have an increased risk of adverse reproductive outcomes. Additional precautions to prevent exposure should be considered. PMID:25153300

Novel investigational drugs for constipation-predominant irritable bowel syndrome: a review.

Science.gov (United States)

Mosińska, Paula; Salaga, Maciej; Fichna, Jakub

2016-01-01

Constipation-predominant irritable bowel syndrome (IBS-C) is a functional gastrointestinal (GI) disorder with an unknown etiology. A number of the drugs tested for IBS-C have also been applied to chronic constipation and chronic idiopathic constipation. Unfortunately, due to severe adverse effects, many drugs envisioned for IBS-C had been withdrawn from the market. Nevertheless, a number of potential new agents for this indication are now under development. The following review describes the most recently developed agents in preclinical as well as Phase 1 and Phase 2 clinical studies. Information was obtained from published literature, abstracts and the latest results found in Clinicaltrial.gov database. The authors put a special interest on glucagon-like peptide 1 analogue, bile acid modulators, serotonergic agents, guanylate cyclase C and cannabinoid antagonists. To enter the market, a newly-developed drug has to meet several criteria, such as good bioavailability or the absence of drug-related adverse events. Taking into account constipation and abdominal pain as the main symptoms in IBS-C, a novel successful drug is usually able to improve both at the same time. Four out of fifteen investigational drugs described in this paper belong to the serotonergic family and have a good prognosis to reach the market; still, more long-term clinical studies are warranted.

Marine Algae as Source of Novel Antileishmanial Drugs: A Review

Directory of Open Access Journals (Sweden)

Lauve Rachel Tchokouaha Yamthe

2017-10-01

Full Text Available Leishmaniasis is a vector-borne neglected tropical disease caused by protozoan parasites of the Leishmania genus and transmitted by the female Phlebotomus and Lutzomyia sand flies. The currently prescribed therapies still rely on pentavalent antimonials, pentamidine, paromomycin, liposomal amphotericin B, and miltefosine. However, their low efficacy, long-course treatment regimen, high toxicity, adverse side effects, induction of parasite resistance and high cost require the need for better drugs given that antileishmanial vaccines may not be available in the near future. Although most drugs are still derived from terrestrial sources, the interest in marine organisms as a potential source of promising novel bioactive natural agents has increased in recent years. About 28,000 compounds of marine origin have been isolated with hundreds of new chemical entities. Recent trends in drug research from natural resources indicated the high interest of aquatic eukaryotic photosynthetic organisms, marine algae in the search for new chemical entities given their broad spectrum and high bioactivities including antileishmanial potential. This current review describes prepared extracts and compounds from marine macroalgae along with their antileishmanial activity and provides prospective insights for antileishmanial drug discovery.

78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

Science.gov (United States)

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

Systematic review of available evidence on 11 high-priced inpatient orphan drugs

NARCIS (Netherlands)

T.A. Kanters (Tim A.); C. de Sonneville (Caroline); W.K. Redekop (Ken); L. van Hakkaart-van Roijen (Leona)

2013-01-01

markdownabstract__Abstract__ __Background__: Attention for Evidence Based Medicine (EBM) is growing, but evidence for orphan drugs is argued to be limited and inferior. This study systematically reviews the available evidence on clinical effectiveness, costeffectiveness and budget impact for

Biodegradation of oxytetracycline by Pleurotus ostreatus mycelium: a mycoremediation technique

International Nuclear Information System (INIS)

Migliore, Luciana; Fiori, Maurizio; Spadoni, Anna; Galli, Emanuela

2012-01-01

Highlights: ► Oxytetracycline uptake and degradation by Pleurotus ostreatus mycelium were measured. ► The role of extracellular laccase in degradation was evaluated. ► The almost complete OTC removal was obtained. ► A possible degradation product was identified in mycelia (ADOTC). ► The system can be considered the first step of an useful mycoremediation technique. - Abstract: Oxytetracycline (OTC) is administered in high doses to livestocks and enters the environmental compartments as a consequence of animal waste disposal. As a first step in setting up a useful mycoremediation technique, an OTC lab degradation test was performed in liquid medium using the ligninolytic fungus Pleurotus ostreatus. OTC disappearance in culture medium was clearly evident as early as the third day of exposure onwards, with an almost complete removal after 14 d. The drug removal was mediated by fungal absorption in the mycelia, where the OTC molecule underwent a degradation step, as demonstrated by mass spectrometry analyses. A putative degradation product, ADOTC (2-acetyl-2-decarboxamido-oxytetracycline) is proposed. Experimental conditions excluded OTC abiotic degradation; the degradation by extracellular laccase was also experimentally discarded.

Biodegradation of oxytetracycline by Pleurotus ostreatus mycelium: a mycoremediation technique

Energy Technology Data Exchange (ETDEWEB)

Migliore, Luciana [Dept. Biology, Tor Vergata University, Via della Ricerca Scientifica, 00133 Rome (Italy); Fiori, Maurizio [Dept. Veterinary Public Health and Food Safety, Istituto Superiore di Sanita, Viale Regina Elena 299, 00161 Rome (Italy); Spadoni, Anna [Dept. Biology, Tor Vergata University, Via della Ricerca Scientifica, 00133 Rome (Italy); Institute of Agro-Environment and Forest Biology, National Research Council, Research Area Rome 1, Via Salaria km 29.300, 00015 Monterotondo Rome (Italy); Galli, Emanuela [Institute of Agro-Environment and Forest Biology, National Research Council, Research Area Rome 1, Via Salaria km 29.300, 00015 Monterotondo Rome (Italy)

2012-05-15

Highlights: Black-Right-Pointing-Pointer Oxytetracycline uptake and degradation by Pleurotus ostreatus mycelium were measured. Black-Right-Pointing-Pointer The role of extracellular laccase in degradation was evaluated. Black-Right-Pointing-Pointer The almost complete OTC removal was obtained. Black-Right-Pointing-Pointer A possible degradation product was identified in mycelia (ADOTC). Black-Right-Pointing-Pointer The system can be considered the first step of an useful mycoremediation technique. - Abstract: Oxytetracycline (OTC) is administered in high doses to livestocks and enters the environmental compartments as a consequence of animal waste disposal. As a first step in setting up a useful mycoremediation technique, an OTC lab degradation test was performed in liquid medium using the ligninolytic fungus Pleurotus ostreatus. OTC disappearance in culture medium was clearly evident as early as the third day of exposure onwards, with an almost complete removal after 14 d. The drug removal was mediated by fungal absorption in the mycelia, where the OTC molecule underwent a degradation step, as demonstrated by mass spectrometry analyses. A putative degradation product, ADOTC (2-acetyl-2-decarboxamido-oxytetracycline) is proposed. Experimental conditions excluded OTC abiotic degradation; the degradation by extracellular laccase was also experimentally discarded.

Dry Eye Treatment Based on Contact Lens Drug Delivery: A Review.

Science.gov (United States)

Guzman-Aranguez, Ana; Fonseca, Begoña; Carracedo, Gonzalo; Martin-Gil, Alba; Martinez-Aguila, Alejandro; Pintor, Jesús

2016-09-01

Dry eye disease affects a substantial segment of the word population with increasing frequency. It is a multifactorial disease of the ocular surface and tear film, which causes ocular discomfort, visual disturbances, and tear instability with potential damage to the cornea and conjunctiva. Because of its multifactorial etiology, the use of different pharmacological treatment for dry eye treatment has been proposed, which include anti-inflammatory molecules, lubricants or comfort agents, and secretagogues. However, in some cases these pharmacological approaches only relieve symptoms temporarily, and consequently, eye care professionals continue to have difficulties managing dry eye. To improve pharmacological therapy that allows a more efficient and long-term action, effective ocular drug delivery of the currently available drugs for dry eye treatment is required. Contact lenses are emerging as alternative ophthalmic drugs delivery systems that provide an increased residence time of the drug at the eye, thus leading to enhanced bioavailability and more convenient and efficacious therapy. In this article, we reviewed the different techniques used to prepare contact lens-based drug delivery systems and focused on articles that describe the delivery of compounds for dry eye treatment through contact lenses.

Review on research of suppression male fertility and male contraceptive drug development by natural products.

Science.gov (United States)

Bajaj, Vijay Kumar; Gupta, Radhey S

2013-08-01

Male contraceptive development in the present scenario is most viable aspect of research due to uncontrolled population growth in the world. In this respect investigators are busy to find out a safe male contraceptive drug. Researchers have started their finding for a suitable drug from natural sources because these are safe and easily acceptable for common man, most of natural sources are plants and their products. In this review 137 plants and their effects on reproduction and reproductive physiology are summarized. Some of them have intense effect on male reproductive system and do not produce any side effects. Reproductive toxicological studies are also important aspects of these kinds of researches, so it is important that drugs are safe and widely acceptable. An ideal male contraceptive can influence semen, testes, hormone level, accessory reproductive organs and general physiology of animals and produced some alterations. Many plants in this review are showing antifertility as well as antispermatogenic effects, so these may be used for further study for contraceptives development but it is important to find out the mechanism of reaction and further laboratory and clinical research on some plants are needed for final male contraceptive drug development. In conclusion this review will help for finding suitable plant products for male contraceptive clinical and laboratory studies.

Lack of gender effect on the pharmacokinetics of oxytetracycline in Fenneropenaeus chinensis after intramuscular administration

Science.gov (United States)

Sun, Ming; Li, Jian; Chang, Zhiqiang; Guo, Wenting; Zhao, Fazhen; Li, Jitao

2015-04-01

Fenneropenaeus chinensis, an economically important shrimp species, currently suffers from epizootic diseases due to high density stocking and bacterial infections. Oxytetracycline (OTC) has been widely used to treat various systemic bacterial infections in shrimp farming. In the present study, the effect of gender on pharmacokinetics of OTC in F. chinensis was investigated. The OTC concentrations in hemolymph of shrimp after single intramuscular administration (75 mg OTC per kg body weight) were analyzed by high performance liquid chromatography and best described with a two-compartment open model which is characterized by a short elimination half-life, low clearance, and a relatively large apparent volume of distribution. The pharmacokinetic equations were C t = 58.54e-0.38 t + 11.67e-0.04 t for females; and C t = 27.94e-0.28 t + 14.87e-0.04 t for males. The distribution and elimination half-lives of OTC were 1.82 and 19.58 h, respectively, in females and 2.50 and 16.11 h, respectively, in males at 22°C. The areas under the drug concentration curve were 480 mg L-1 h-1 in females and 430 mg L-1 h-1 in males. The total body clearance of the drug was 157.11 mL kg-1 h-1 in females and 172.47 mL kg-1 h-1 in males. The apparent volume distribution was 4.44 in females and 4.01 L kg-1 in males. There was no significant difference in pharmacokinetic parameters between female and male shrimps, indicating that there is no need to consider the gender effect in clinical use of OTC in F. chinensis farming.

A comprehensive review of assay methods to determine drugs in breast milk and the safety of breastfeeding when taking drugs.

Science.gov (United States)

Fríguls, Bibiana; Joya, Xavier; García-Algar, Oscar; Pallás, C R; Vall, Oriol; Pichini, Simona

2010-06-01

Most of the licit and illicit drugs consumed by the breastfeeding woman pass into the milk and can modify the production, volume and composition of the milk, as well as hypothetically have short- and long-term harmful effects on the infant. There is much confusion in the scientific community regarding this issue: should a woman breastfeed her baby while continuing to use prescription drugs and/or drugs of abuse? There are many case reports of clinically significant toxicity in breast-fed infants from some substances used by mothers (such as irritability, vomiting, sedation, respiratory depression, shock), but there are too few data on studies conducted in breastfeeding women and their infants to make a realistic risk assessment. The objective measurement of a drug and/or metabolites in maternal milk is the first step when investigating the amount of drug excreted in milk and subsequently calculating the daily dose administered to the breast-fed infant. The present review reports the analytical methods developed to detect different drugs in the breast milk, listing the principal characteristics and validation parameters, advantages and disadvantages. Furthermore, the mechanisms of drug transfer into breast milk are discussed, the correlation between the concentration of the drug in breast milk and potential adverse outcomes on the infant are described for each drug, and suggested harm minimization strategies and approved breastfeeding recommendations are indicated.

Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

Science.gov (United States)

Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

2015-07-10

The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature.

Science.gov (United States)

Tofighi, Babak; Nicholson, Joseph M; McNeely, Jennifer; Muench, Frederick; Lee, Joshua D

2017-07-01

Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;36:477-491]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

The Prevalence of Drug-Resistant Tuberculosis in Mainland China: An Updated Systematic Review and Meta-Analysis.

Science.gov (United States)

Duan, Qionghong; Chen, Zi; Chen, Cong; Zhang, Zhengbin; Lu, Zhouqin; Yang, Yalong; Zhang, Lin

2016-01-01

In recent years, drug resistant tuberculosis (DR-TB) particularly the emergence of multi-drug-resistant tuberculosis (MDR-TB) has become a major public health issue. The most recent study regarding the prevalence of drug-resistant tuberculosis in mainland China was a meta-analysis published in 2011, and the subjects from the included studies were mostly enrolled before 2008, thus making it now obsolete. Current data on the national prevalence of DR-TB is needed. This review aims to provide a comprehensive and up-to-date assessment of the status of DR-TB epidemic in mainland China. A systematic review and meta-analysis of studies regarding the prevalence of drug-resistant tuberculosis in mainland China was performed. Pubmed/MEDLINE, EMBASE, the Cochrane central database, the Chinese Biomedical Literature Database and the China National Knowledge Infrastructure Database were searched for studies relevant to drug-resistant tuberculosis that were published between January 1, 2012 and May 18, 2015. Comprehensive Meta-Analysis (V2.2, Biostat) software was used to analyse the data. A total of fifty-nine articles, published from 2012 to 2015, were included in our review. The result of this meta-analysis demonstrated that among new cases, the rate of resistance to any drug was 20.1% (18.0%-22.3%; n/N = 7203/34314) and among retreatment cases, the rate was 49.8% (46.0%-53.6%; n/N = 4155/8291). Multi-drug resistance among new and retreatment cases was 4.8% (4.0%-5.7%; n/N = 2300/42946) and 26.3% (23.1%-29.7%; n/N = 3125/11589) respectively. The results were significantly heterogeneous (pdrug resistance patterns were found by subgroup analysis according to geographic areas, subject enrolment time, and methods of drug susceptibility test (DST). The prevalence of resistance to any drug evidently dropped for both new and retreatment cases, and multi-drug resistance declined among new cases but became more prevalent among retreatment cases compared to the data before 2008

Nanotechnology-Based Drug Delivery Systems for Treatment of Tuberculosis--A Review.

Science.gov (United States)

da Silva, Patricia Bento; de Freitas, Eduardo Sinésio; Bernegossi, Jessica; Gonçalez, Maíra Lima; Sato, Mariana Rillo; Leite, Clarice Queico Fujimura; Pavan, Fernando Rogério; Chorilli, Marlus

2016-02-01

Tuberculosis (TB) is an infectious and transmissible disease that is caused by Mycobacterium tuberculosis and primarily affects the lungs, although it can affect other organs and systems. The pulmonary presentation of TB, in addition to being more frequent, is also the most relevant to public health because it is primarily responsible for the transmission of the disease. The to their low World Health Organization (WHO) recommends a combined therapeutic regimen of several drugs, such as rifampicin (RIF), isoniazid (INH), pyrazinamide (PZA) and ethambutol (ETB). These drugs have low plasma levels after oral administration, due to their low water solubility, poor permeability and ability to be rapidly metabolized by the liver and at high concentrations. Furthermore, they have short t₁/₂ (only 1-4 hours) indicating a short residence in the plasma and the need for multiple high doses, which can result in neurotoxicity and hepatotoxicity. Nanotechnology drug delivery systems have considerable potential for the treatment of TB. The systems can also be designed to allow for the sustained release of drugs from the matrix and drug delivery to a specific target. These properties of the systems enable the improvement of the bioavailability of drugs, can reduce the dosage and frequency of administration, and may solve the problem of non-adherence to prescribed therapy, which is a major obstacle to the control of TB. The purpose of this study was to systematically review nanotechnology-based drug delivery systems for the treatment of TB.

Chiral Analysis of Methamphetamine in Oral Fluid Samples: A Method to Distinguish Licit from Illicit Drug Use.

Science.gov (United States)

Borg, Damon; Kolb, Elizabeth; Lantigua, Cindy; Stripp, Richard

2018-01-01

Methamphetamine (MAMP) is a popular illicit drug abused for its central nervous system stimulating effects. MAMP is also used therapeutically in the treatment of overeating disorders, narcolepsy, attention deficit disorder, in over-the-counter (OTC) products to ease nasal congestion. MAMP exists in two enantiomeric forms, dextrorotary (d-MAMP) or levorotary (l-MAMP). The compounds are similar in chemical structure, simply differing in the orientation of functional groups around the asymmetric carbon. In part because of the availability of l-MAMP in OTC nasal inhalers, forensic guidelines require a sample to contain greater than 20% d-MAMP to consider illicit drug use when interpreting results. Standard analytical methods readily detect MAMP in biological specimens but cannot resolve the enantiomeric composition of the sample. Specialized analytical techniques based on chiral separation of the enantiomers are required to differentiate d-MAMP from l-MAMP. Our laboratory sought to develop and validate a method for the analysis of oral fluid specimens for d/l-MAMP using a chiral derivatizing agent and traditional reverse phase liquid chromatography tandem mass spectrometry (LC-MS-MS). MAMP was extracted from dilute oral fluid samples using Strata-XC solid phase extraction (SPE) cartridges and derivatized with Marfey's reagent. Chromatographic separation was achieved using Zorbax Eclipse Plus C18 columns. Linearity, accuracy and precision, recovery, matrix effects and specificity of the method were all within acceptable criteria. Intraday accuracy ranged from 93.3 to 103.4% and precision 0.1 to 1.6%. Interday accuracy ranged from 90.0 to 103.4% and precision 3.8 to 11.6%. Finally, having previously tested positive for MAMP using non-chiral analysis, 256 de-identified authentic oral fluid samples were analyzed using this validated method. 98% of all samples tested positive for d-MAMP at greater than 20%.

Ten Tips to Prevent an Accidental Overdose

Science.gov (United States)

... always good practice to first, check the outside packaging for such things as cuts, slices, or tears. ... Ingested OTC Liquid Drug Products (PDF - 595KB) Drug Interactions: What You Should Know Related Consumer Updates Codeine ...

21 CFR 330.2 - Pregnancy-nursing warning.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Pregnancy-nursing warning. 330.2 Section 330.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE...

DRUG MANAGEMENT REVIEWS IN DISTRICT DRUG MANAGEMENT UNIT AND GENERAL HOSPITAL

Directory of Open Access Journals (Sweden)

Max Joseph Herman

2009-12-01

Full Text Available Drug is one of the essential elements in healthcare that should be effectively and efficiently managed. Following thedecentralization in 2001 in Indonesia, drug management has changed in district drug management units and also in District General Hospitals. Certainly this condition influences the sustainability of drug access in primary health care such as in Community Health Center and District General Hospital, especially in drug financing policy. A cross sectional descriptive study to obtain information on drug management in public healthcare in district had been carried out between July and December 2006 in 10 District Public Drug Management Units from 10 district health offices and 9 district general hospitals as samples. Data were collected by interviewing heads of Drug Section in District Health Offices and heads of Hospital Pharmacies using structured questionnaires and observing drug storage in District Drug Management Units, Community Health Centers, and Hospital Pharmacies. Results of the study show that drug planning in District Health Offices and General Hospitals did not meet the basic real need in some districts nor District Hospitals. The minimum health service standards had no been achieved yet. Furthermore, drug procurement, storage and recording as well as reporting was not good enough either, such as shown by the existence of expired drugs. Lead time for drug delivery to community health centers in some districts was longer than the average of lead time in the past 3 years.

Optimization and Simulation in Drug Development - Review and Analysis

DEFF Research Database (Denmark)

Schjødt-Eriksen, Jens; Clausen, Jens

2003-01-01

We give a review of pharmaceutical R&D and mathematical simulation and optimization methods used to support decision making within the pharmaceutical development process. The complex nature of drug development is pointed out through a description of the various phases of the pharmaceutical develo...... development process. A part of the paper is dedicated to the use of simulation techniques to support clinical trials. The paper ends with a section describing portfolio modelling methods in the context of the pharmaceutical industry....

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

Science.gov (United States)

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

2014-04-01

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

Is Project Towards No Drug Abuse (Project TND) an evidence-based drug and violence prevention program? A review and reappraisal of the evaluation studies.

Science.gov (United States)

Gorman, Dennis M

2014-08-01

This paper critically reviews the published evidence pertaining to Project Towards No Drug Abuse (Project TND). Publications from seven evaluation studies of Project TND are reviewed, and the results from these are discussed as related to the following outcomes: main effects on the use of cigarettes, alcohol and marijuana; main effects on the use of "hard drugs," defined in the evaluations as cocaine, hallucinogens, stimulants, inhalants, ecstasy and other drugs (e.g., depressants, PCP, steroids and heroin); subgroup and interaction analyses of drug use; and violence-related behaviors. Very few main effects have been found for cigarette, alcohol and marijuana use in the Project TND evaluations. While studies do report main effects for hard drug use, these findings are subject to numerous threats to validity and may be attributable to the data analyses employed. Similarly, while isolated subgroup and interaction effects were found for alcohol use among baseline nonusers and some violence-related behaviors in the early Project TND evaluations, these findings have not been replicated in more recent studies and may result from multiple comparisons between study conditions. In conclusion, there is little evidence to support the assertion that Project TND is an effective drug or violence prevention program. The broader implications of these findings for prevention science are discussed and suggestions are made as to how the quality of research in the field might be improved.

Glutamatergic transmission in drug reward: implications for drug addiction.

Science.gov (United States)

D'Souza, Manoranjan S

2015-01-01

Individuals addicted to drugs of abuse such as alcohol, nicotine, cocaine, and heroin are a significant burden on healthcare systems all over the world. The positive reinforcing (rewarding) effects of the above mentioned drugs play a major role in the initiation and maintenance of the drug-taking habit. Thus, understanding the neurochemical mechanisms underlying the reinforcing effects of drugs of abuse is critical to reducing the burden of drug addiction in society. Over the last two decades, there has been an increasing focus on the role of the excitatory neurotransmitter glutamate in drug addiction. In this review, pharmacological and genetic evidence supporting the role of glutamate in mediating the rewarding effects of the above described drugs of abuse will be discussed. Further, the review will discuss the role of glutamate transmission in two complex heterogeneous brain regions, namely the nucleus accumbens (NAcc) and the ventral tegmental area (VTA), which mediate the rewarding effects of drugs of abuse. In addition, several medications approved by the Food and Drug Administration that act by blocking glutamate transmission will be discussed in the context of drug reward. Finally, this review will discuss future studies needed to address currently unanswered gaps in knowledge, which will further elucidate the role of glutamate in the rewarding effects of drugs of abuse.

Addressing the challenge of high-priced prescription drugs in the era of precision medicine : A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

NARCIS (Netherlands)

Gronde, T.V. (Toon van der); C.A. Uyl-de Groot (Carin); Pieters, T. (Toine)

2017-01-01

markdownabstractCONTEXT: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. METHOD: A systematic review of Pubmed, the

A review of drug delivery systems based on nanotechnology and green chemistry: green nanomedicine

Directory of Open Access Journals (Sweden)

Jahangirian H

2017-04-01

Full Text Available Hossein Jahangirian,1 Ensieh Ghasemian Lemraski,2 Thomas J Webster,1 Roshanak Rafiee-Moghaddam,3 Yadollah Abdollahi4 1Department of Chemical Engineering, Northeastern University, Boston, MA, USA; 2Department of Chemistry, Faculty of Science, Ilam University, Ilam, Iran; 3School of Chemical Sciences and Food Technology, Faculty of Science and Technology, Universiti Kebangsaan Malaysia, Selangor, 4Department of Electrical Engineering, Faculty of Engineering, University of Malaysia, Kuala Lumpur, Malaysia Abstract: This review discusses the impact of green and environmentally safe chemistry on the field of nanotechnology-driven drug delivery in a new field termed “green nanomedicine”. Studies have shown that among many examples of green nanotechnology-driven drug delivery systems, those receiving the greatest amount of attention include nanometal particles, polymers, and biological materials. Furthermore, green nanodrug delivery systems based on environmentally safe chemical reactions or using natural biomaterials (such as plant extracts and microorganisms are now producing innovative materials revolutionizing the field. In this review, the use of green chemistry design, synthesis, and application principles and eco-friendly synthesis techniques with low side effects are discussed. The review ends with a description of key future efforts that must ensue for this field to continue to grow. Keywords: green chemistry, cancer, drug delivery, nanoparticle

21 CFR 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not...

Science.gov (United States)

2010-04-01

... directions for use and warnings against unsafe use, provides rational concurrent therapy for a significant...) Court appeal. The monograph contained in the final order constitutes final agency action from which appeal lies to the courts. The Food and Drug Administration will request consolidation of all appeals in...

Drug abuse identification and pain management in dental patients: a case study and literature review.

Science.gov (United States)

Hussain, Fahmida; Frare, Robert W; Py Berrios, Karen L

2012-01-01

Properly identifying patients with a history of drug abuse is the first step in providing effective dental care. Dental professionals need to be fully aware of the challenges associated with treating this population. In the current study, the authors analyzed the physical and oral manifestations of illicit drug abuse to aid in the identification of patients who abuse drugs and the pain management strategies needed to treat them. The authors also present a clinical case of a patient with unique skin lesions and discuss the typical clinical findings of drug abuse based on a literature review.

Quality of tuberculosis care by Indian pharmacies: Mystery clients offer new insights

Directory of Open Access Journals (Sweden)

Rosalind Miller

2018-01-01

Full Text Available For many patients in India, pharmacies are their first point of contact, where most drugs, including antibiotics, can be purchased over-the-counter (OTC. Recent standardised (simulated patient studies, covering four Indian cities, provide new insights on how Indian pharmacies manage patients with suspected or known tuberculosis. Correct management of the simulated patients ranged from 13% to 62%, increasing with the certainty of the TB diagnosis. Antibiotics were frequently dispensed OTC to patients, with 16% to 37% receiving such drugs across the cases. On a positive note, these studies showed that no pharmacy dispensed first-line anti-TB drugs. Engagement of pharmacies is important to not only improve TB detection and care, but also limit the abuse of antibiotics.

Addressing the challenge of high-priced prescription drugs in the era of precision medicine : a systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

NARCIS (Netherlands)

van der Gronde, T.; Uyl-de Groot, Carin A; Pieters, A.H.L.M.

2017-01-01

Context. Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method. A systematic review of Pubmed, the Financial Times,

Analysis of over-the-counter medicines use among nursing students

Directory of Open Access Journals (Sweden)

Mlinar Suzana

2015-01-01

Full Text Available Background/Aim. The use of over-the-counter (OTC medication is widespread among the adult and student populations in Slovenia. The aim of the study was to analyse the prevalence of OTC medicines use among nursing students with respect to sociodemographic characteristics. Methods. A total of 241 nursing students in the Faculty of Health Sciences, Ljubljana, were included in the cross-sectional study. A questionnaire was created for the purposes of the study. Statistical analysis was performed with SPSS 20. Descriptive statistics, t-test and the contingency coefficient were calculated. Statistical significance was set at the p-value of < 0.05. Results. The study showed that the use of prescription drugs was significantly higher in women (p = 0.029, students living in rural areas (p = 0.005 and students who described themselves as being of bad health (p = 0.008. At the same time, a third of the respondents had been taking one OTC medicine within the last month; those taking several prescription drugs commonly administered several over-the-counter medicines (p = 0.027. Women used OTC medicines to treat pain and fever (p = 0.001, respiratory issues (p = 0.015, and fungal infections (p < 0.000 more often than men. OTC medicines were also used to treat minor mental health issues by a higher proportion of respondents over 21 years of age (p = 0.005 and women (p < 0.000, while over-the-counter medicines for treating skin conditions were more frequently used in rural areas (p = 0.006. Conclusion. Nursing students tend to use OTC medicines on their own accord, receiving instructions for safe use with their purchase, which points to adequate promotion of safe use of medications in Slovenia. Men's assessment of their personal health tends to be better than that of women, who also use medication more frequently. A connection between poor health and a higher incidence of the use of OTC medicines was established. The use of OTC medicines to treat minor mental

Marine Corps Drug Prevention Review

National Research Council Canada - National Science Library

Stander, Valerie A; Reed, Cheryl; Olson, Cheryl B; Johnson, Judy; Merrill, Lex L; Clapp, John; Elder, John; Lawson, Gary; Mangual, George; Lowe, Nate

2003-01-01

.... Some of the common components were information on the consequences of drug use, decision-making skill training, public pledges not to use drugs, values clarification, goal setting, stress management...

Online drug information platform for the public in Hong Kong-Review of local drug information use and needs.

Science.gov (United States)

Cheng, F W T; So, S W K; Fung, B W T; Hung, W H; Lee, V W Y

2018-06-01

In view of the popularity of Internet usage in Hong Kong, an interactive web-based drug information platform entitled "Ask My Pharmacist - Online University Led drug Enquiry Platform" (AMPOULE) was launched in 2009 to better serve the needs of drug information in Hong Kong. This paper aimed to evaluate the utility of AMPOULE in improving drug-related knowledge among the public and to reassess the needs of the general public in Hong Kong. All enquiries sent via AMPOULE were reviewed. Demographic data, nature of questions and types of drug class covered were analyzed. The workload of pharmacists was examined with respect to the preparation time needed for the enquiry, the lag days to reply and also the timing of enquiry recipient. 2122 enquiries were received from 2009 to 2017. Most enquirers were from Hong Kong (56.6%) and female gender (49.2%). 13% of the concerned subjects were aged over 61-year-old. The most frequent types of questions and medications covered were "Drug Ingredients and Indications" (28.0%) and Adverse Drug Reactions (26.8%) and "Cardiovascular Medication" (21.9%) respectively but these varied in different age groups or enquirer groups. The median time for preparation was 40.0 min (IQR: 25-65 min) while the median time lag was found to be 2.5 days (IQR: 1.0-5.0 days). The number of enquiries received was evenly distributed throughout the day except during 1:00 am to 9:00 am and 7:00 pm to 8:00 pm. AMPOULE has demonstrated that an online platform providing patient-oriented drug information service through the Internet is promising and further promotion is warranted. Current data suggested that the need of different age groups and enquirer groups are different and should therefore be individualized. Copyright © 2018 Elsevier B.V. All rights reserved.

Smart stimuli sensitive nanogels in cancer drug delivery and imaging: a review.

Science.gov (United States)

Maya, S; Sarmento, Bruno; Nair, Amrita; Rejinold, N Sanoj; Nair, Shantikumar V; Jayakumar, R

2013-01-01

Nanogels are nanosized hydrogel particles formed by physical or chemical cross-linked polymer networks. The advantageous properties of nanogels related to the ability of retaining considerable amount of water, the biocompatibility of the polymers used, the ability to encapsulate and protect a large quantity of payload drugs within the nanogel matrix, the high stability in aqueous media, their stimuli responsively behavior potential, and the versatility in release drugs in a controlled manner make them very attractive for use in the area of drug delivery. The materials used for the preparation of nanogels ranged from natural polymers like ovalbumin, pullulan, hyaluronic acid, methacrylated chondroitin sulfate and chitosan, to synthetic polymers like poly (N-isopropylacrylamide), poly (Nisopropylacrylamide- co-acrylic acid) and poly (ethylene glycol)-b-poly (methacrylic acid). The porous nanogels have been finding application as anti-cancer drug and imaging agent reservoirs. Smart nanogels responding to external stimuli such as temperature, pH etc can be designed for diverse therapeutic and diagnostic applications. The nanogels have also been surface functionalized with specific ligands aiding in targeted drug delivery. This review focus on stimuli-sensitive, multi-responsive, magnetic and targeted nanogels providing a brief insight on the application of nanogels in cancer drug delivery and imaging in detail.

Transplantation of frozen-thawed ovarian tissue

DEFF Research Database (Denmark)

Gellert, S E; Pors, S E; Kristensen, Stine Gry

2018-01-01

. CONCLUSION: This study found no indications of sufficient numbers of malignant cells present in the ovarian tissue to cause recurrence of cancer after OTT. Further, it is unlikely that OTC affects the well-being of children born. OTC is now an established method of fertility preservation in Denmark......PURPOSE: The purpose of the study is to review all peer-reviewed published reports of women receiving ovarian tissue transplantation (OTT) with frozen/thawed tissue (OTC) with respect to age, diagnosis, transplantation site, fertility outcome, and potential side effects, including data from all...... women in the Danish program. METHODS: A systematic review of the literature was performed in PubMed combined with results from all patients who had received OTT in Denmark up to December 2017. RESULTS: OTT has been reported from 21 different countries comprising a total of 360 OTT procedures in 318...

Review on potential phytocompounds in drug development for Parkinson disease: A pharmacoinformatic approach

Directory of Open Access Journals (Sweden)

S. Vijayakumar

Full Text Available Parkinson's disease (PD is caused by human physiological function and is ranked as the second most common neurodegenerative disorder. One of the prominent therapies currently available for PD is the use of dopamine agonists which mimic the natural action of dopamine in the brain and stimulate dopamine receptors directly. Currently, available pharmaceutical drugs provide only temporary relief of the disease. Phytocompounds have been identified as promising target of research in the quest for new pharmaceutical compounds as they can produce secondary metabolites with novel chemical structure. In this review the drug development of Parkinson disease has been analyzed using computational tools. Keywords: Parkinson disease, Phytocompounds, Computational methods, Drug development and design

Cyclodextrins improving the physicochemical and pharmacological properties of antidepressant drugs: a patent review.

Science.gov (United States)

Diniz, Tâmara Coimbra; Pinto, Tiago Coimbra Costa; Menezes, Paula Dos Passos; Silva, Juliane Cabral; Teles, Roxana Braga de Andrade; Ximenes, Rosana Christine Cavalcanti; Guimarães, Adriana Gibara; Serafini, Mairim Russo; Araújo, Adriano Antunes de Souza; Quintans Júnior, Lucindo José; Almeida, Jackson Roberto Guedes da Silva

2018-01-01

Depression is a serious mood disorder and is one of the most common mental illnesses. Despite the availability of several classes of antidepressants, a substantial percentage of patients are unresponsive to these drugs, which have a slow onset of action in addition to producing undesirable side effects. Some scientific evidence suggests that cyclodextrins (CDs) can improve the physicochemical and pharmacological profile of antidepressant drugs (ADDs). The purpose of this paper is to disclose current data technology prospects involving antidepressant drugs and cyclodextrins. Areas covered: We conducted a patent review to evaluate the antidepressive activity of the compounds complexed in CDs, and we analyzed whether these complexes improved their physicochemical properties and pharmacological action. The present review used 8 specialized patent databases for patent research, using the term 'cyclodextrin' combined with 'antidepressive agents' and its related terms. We found 608 patents. In the end, considering the inclusion criteria, 27 patents reporting the benefits of complexation of ADDs with CDs were included. Expert opinion: The use of CDs can be considered an important tool for the optimization of physicochemical and pharmacological properties of ADDs, such as stability, solubility and bioavailability.

Glutamatergic transmission in drug reward: Implications for drug addiction

Directory of Open Access Journals (Sweden)

Manoranjan S Dsouza

2015-11-01

Full Text Available Individuals addicted to drugs of abuse such as alcohol, nicotine, cocaine, and heroin are a significant burden on healthcare systems all over the world. The positive reinforcing (rewarding effects of the above mentioned drugs play a major role in the initiation and maintenance of the drug-taking habit. Thus, understanding the neurochemical mechanisms underlying the reinforcing effects of drugs of abuse is critical to reducing the burden of drug addiction in society. Over the last two decades, there has been an increasing focus on the role of the excitatory neurotransmitter glutamate in drug addiction. In this review, pharmacological and genetic evidence supporting the role of glutamate in mediating the rewarding effects of the above described drugs of abuse will be discussed. Further, the review will discuss the role of glutamate transmission in two complex heterogeneous brain regions, namely the nucleus accumbens (NAcc and the ventral tegmental area (VTA, which mediate the rewarding effects of drugs of abuse. In addition, several medications approved by the Food and Drug Administration that act by blocking glutamate transmission will be discussed in the context of drug reward. Finally, this review will discuss future studies needed to address currently unanswered gaps in knowledge, which will further elucidate the role of glutamate in the rewarding effects of drugs of abuse.

[Vegetables as new psychoactive drugs: a narrative review].

Science.gov (United States)

Rodríguez Salgado, Beatriz; Gómez-Arnau Ramírez, Jorge; Sánchez Mateos, Daniel; Dolengevich Segal, Helen

2016-01-21

There is growing interest in plants with psychoactive effects among consumers with different levels of experience. This has generated a need for updated knowledge among medical professionals and other health workers. These plants, which may be used in shamanic healing ceremonies or rituals or just for traditional purposes, have emerged in the Western world as new psychoactive drugs; largely thanks to the ease of purchase, sale, cultivation and exchange of information that the Internet offers. This review summarizes the current knowledge about the most important psychoactive plants, either by their mention in Internet forums or harm-reduction portals or by their allusion in scientific texts.

Media Exposure and Tobacco, Illicit Drugs, and Alcohol Use among Children and Adolescents: A Systematic Review

Science.gov (United States)

Nunez-Smith, Marcella; Wolf, Elizabeth; Huang, Helen Mikiko; Chen, Peggy G.; Lee, Lana; Emanuel, Ezekiel J.; Gross, Cary P.

2010-01-01

The authors systematically reviewed 42 quantitative studies on the relationship between media exposure and tobacco, illicit drug, and alcohol use among children and adolescents. Overall, 83% of studies reported that media was associated with increased risk of smoking initiation, use of illicit drugs, and alcohol consumption. Of 30 studies…

Ultrasonic Vocalizations as a Measure of Affect in Preclinical Models of Drug Abuse: A Review of Current Findings.

Science.gov (United States)

Barker, David J; Simmons, Steven J; West, Mark O

2015-01-01

The present review describes ways in which ultrasonic vocalizations (USVs) have been used in studies of substance abuse. Accordingly, studies are reviewed which demonstrate roles for affective processing in response to the presentation of drug-related cues, experimenter- and self-administered drug, drug withdrawal, and during tests of relapse/reinstatement. The review focuses on data collected from studies using cocaine and amphetamine, where a large body of evidence has been collected. Data suggest that USVs capture animals' initial positive reactions to psychostimulant administration and are capable of identifying individual differences in affective responding. Moreover, USVs have been used to demonstrate that positive affect becomes sensitized to psychostimulants over acute exposure before eventually exhibiting signs of tolerance. In the drug-dependent animal, a mixture of USVs suggesting positive and negative affect is observed, illustrating mixed responses to psychostimulants. This mixture is predominantly characterized by an initial bout of positive affect followed by an opponent negative emotional state, mirroring affective responses observed in human addicts. During drug withdrawal, USVs demonstrate the presence of negative affective withdrawal symptoms. Finally, it has been shown that drug-paired cues produce a learned, positive anticipatory response during training, and that presentation of drug-paired cues following abstinence produces both positive affect and reinstatement behavior. Thus, USVs are a useful tool for obtaining an objective measurement of affective states in animal models of substance abuse and can increase the information extracted from drug administration studies. USVs enable detection of subtle differences in a behavioral response that might otherwise be missed using traditional measures.

Annual banned-substance review: analytical approaches in human sports drug testing.

Science.gov (United States)

Thevis, Mario; Kuuranne, Tiia; Geyer, Hans; Schänzer, Wilhelm

2017-01-01

There has been an immense amount of visibility of doping issues on the international stage over the past 12 months with the complexity of doping controls reiterated on various occasions. Hence, analytical test methods continuously being updated, expanded, and improved to provide specific, sensitive, and comprehensive test results in line with the World Anti-Doping Agency's (WADA) 2016 Prohibited List represent one of several critical cornerstones of doping controls. This enterprise necessitates expediting the (combined) exploitation of newly generated information on novel and/or superior target analytes for sports drug testing assays, drug elimination profiles, alternative test matrices, and recent advances in instrumental developments. This paper is a continuation of the series of annual banned-substance reviews appraising the literature published between October 2015 and September 2016 concerning human sports drug testing in the context of WADA's 2016 Prohibited List. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

Science.gov (United States)

2010-04-01

... agents. Oral wound healing agents have been marketed as aids in the healing of minor oral wounds by means.... (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented...

Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness.

Science.gov (United States)

Fadlallah, Racha; El-Jardali, Fadi; Annan, Farah; Azzam, Hayat; Akl, Elie A

2016-01-01

A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. Several factors are critical to the successful design

Human Drug Discrimination: Elucidating the Neuropharmacology of Commonly Abused Illicit Drugs.

Science.gov (United States)

Bolin, B Levi; Alcorn, Joseph L; Reynolds, Anna R; Lile, Joshua A; Stoops, William W; Rush, Craig R

2016-06-07

Drug-discrimination procedures empirically evaluate the control that internal drug states have over behavior. They provide a highly selective method to investigate the neuropharmacological underpinnings of the interoceptive effects of drugs in vivo. As a result, drug discrimination has been one of the most widely used assays in the field of behavioral pharmacology. Drug-discrimination procedures have been adapted for use with humans and are conceptually similar to preclinical drug-discrimination techniques in that a behavior is differentially reinforced contingent on the presence or absence of a specific interoceptive drug stimulus. This chapter provides a basic overview of human drug-discrimination procedures and reviews the extant literature concerning the use of these procedures to elucidate the underlying neuropharmacological mechanisms of commonly abused illicit drugs (i.e., stimulants, opioids, and cannabis) in humans. This chapter is not intended to review every available study that used drug-discrimination procedures in humans. Instead, when possible, exemplary studies that used a stimulant, opioid, or Δ 9 -tetrahydrocannabinol (the primary psychoactive constituent of cannabis) to assess the discriminative-stimulus effects of drugs in humans are reviewed for illustrative purposes. We conclude by commenting on the current state and future of human drug-discrimination research.

Screening for alcohol and drug use disorders among adults in primary care: a review

Directory of Open Access Journals (Sweden)

Pilowsky DJ

2012-04-01

Full Text Available Daniel J Pilowsky1, Li-Tzy Wu21Departments of Epidemiology and Psychiatry, Columbia University, and the New York State Psychiatric Institute, New York City, NY, 2Department of Psychiatry and Behavioral Sciences, School of Medicine, Duke University Medical Center, Durham, NC, USABackground: The Patient Protection and Affordable Care Act of 2010 supports integration of substance abuse interventions and treatments into the mainstream health care system. Thus, effective screening and intervention for substance use disorders in health care settings is a priority.Objective: This paper reviews the prevalence of alcohol and drug use disorders (abuse or dependence in primary care settings and emergency departments, as well as current screening tools and brief interventions.Methods: MEDLINE was searched using the following keywords: alcohol use, alcohol use disorder, drug use, drug use disorder, screening, primary care, and emergency departments. Using the related-articles link, additional articles were screened for inclusion. This review focuses on alcohol and drug use and related disorders among adults in primary care settings.Conclusion: Screening, brief intervention, and referral for treatment are feasible and effective in primary care settings, provided that funding for screening is available, along with brief interventions and treatment facilities to which patients can be referred and treated promptly.Keywords: brief intervention, emergency departments

Peptide- and saccharide-conjugated dendrimers for targeted drug delivery: a concise review

Science.gov (United States)

Liu, Jie; Gray, Warren D.; Davis, Michael E.; Luo, Ying

2012-01-01

Dendrimers comprise a category of branched materials with diverse functions that can be constructed with defined architectural and chemical structures. When decorated with bioactive ligands made of peptides and saccharides through peripheral chemical groups, dendrimer conjugates are turned into nanomaterials possessing attractive binding properties with the cognate receptors. At the cellular level, bioactive dendrimer conjugates can interact with cells with avidity and selectivity, and this function has particularly stimulated interests in investigating the targeting potential of dendrimer materials for the design of drug delivery systems. In addition, bioactive dendrimer conjugates have so far been studied for their versatile capabilities to enhance stability, solubility and absorption of various types of therapeutics. This review presents a brief discussion on three aspects of the recent studies to use peptide- and saccharide-conjugated dendrimers for drug delivery: (i) synthesis methods, (ii) cell- and tissue-targeting properties and (iii) applications of conjugated dendrimers in drug delivery nanodevices. With more studies to elucidate the structure–function relationship of ligand–dendrimer conjugates in transporting drugs, the conjugated dendrimers hold promise to facilitate targeted delivery and improve drug efficacy for discovery and development of modern pharmaceutics. PMID:23741608

Carbapenems to Treat Multidrug and Extensively Drug-Resistant Tuberculosis: A Systematic Review.

Science.gov (United States)

Sotgiu, Giovanni; D'Ambrosio, Lia; Centis, Rosella; Tiberi, Simon; Esposito, Susanna; Dore, Simone; Spanevello, Antonio; Migliori, Giovanni Battista

2016-03-12

Carbapenems (ertapenem, imipenem, meropenem) are used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB), even if the published evidence is limited, particularly when it is otherwise difficult to identify the recommended four active drugs to be included in the regimen. No systematic review to date has ever evaluated the efficacy, safety, and tolerability of carbapenems. A search of peer-reviewed, scientific evidence was carried out, aimed at evaluating the efficacy/effectiveness, safety, and tolerability of carbapenem-containing regimens in individuals with pulmonary/extra-pulmonary disease which was bacteriologically confirmed as M/XDR-TB. We used PubMed to identify relevant full-text, English manuscripts up to the 20 December 2015, excluding editorials and reviews. Seven out of 160 studies satisfied the inclusion criteria: two on ertapenem, one on imipenem, and four on meropenem, all published between 2005 and 2016. Of seven studies, six were retrospective, four were performed in a single center, two enrolled children, two had a control group, and six reported a proportion of XDR-TB cases higher than 20%. Treatment success was higher than 57% in five studies with culture conversion rates between 60% and 94.8%. The safety and tolerability is very good, with the proportion of adverse events attributable to carbapenems below 15%.

Investigation of β-lactam antibacterial drugs, β-lactamases, and penicillin-binding proteins with fluorescence polarization and anisotropy: a review

Science.gov (United States)

Shapiro, Adam B.

2016-06-01

This review covers the uses of fluorescence polarization and anisotropy for the investigation of bacterial penicillin binding proteins (PBPs), which are the targets of β-lactam antibacterial drugs (penicillins, cephalosporins, carbapenems, and monobactams), and of the β-lactamase enzymes that destroy these drugs and help to render bacterial pathogens resistant to them. Fluorescence polarization and anisotropy-based methods for quantitation of β-lactam drugs are also reviewed. A particular emphasis is on methods for quantitative measurement of the interactions of β-lactams and other inhibitors with PBPs and β-lactamases.

[A review about new approaches using the Internet and computer technology for people with drug use disorder].

Science.gov (United States)

Takano, Ayumi; Miyamoto, Yuki; Matsumoto, Toshihiko

2015-02-01

Over the past two decades, computerized and Internet-based interventions for the treatment of various health problems, including substance abuse, have been developed and used to resolve treatment-related issues. The purpose of this study is to review selected studies that conducted computerized and Internet-based psychosocial interventions for people with drug-use problems. We used a PubMed search to identify relevant studies to our review based on the following inclusion criteria: 1) the study participants were drug users; 2) the Internet or computer technologies were used for the interventions; 3) the study used psychosocial interventions; and 4) meta-analysis and randomized controlled trial (RCT). In total, 12 studies (meta-analysis = 1, RCT = 11) were identified and included in this review. The RCTs extracted in this study were not included in the meta-analysis. The meta-analysis showed that studies targeting people with alcohol and/or drug-use disorders (n = 11) had a small effect size (d = 0.24). However, the effect size was considered heterogeneous. Most of the reviewed RCTs assessed either drug use or abstinence as primary outcome using such methods as self-report and urine test, and showed that intervention groups exhibited greater improvement in the drug use condition than the control groups. The effect sizes (d) ranged from 0.19 to 0.54. One study revealed that a computerized intervention was more cost effective if it was added to treatment as usual. Various interventions were designed to use behavioral therapy approaches, e.g., cognitive behavioral therapy, motivational interviewing, as well as face-to-face interventions. Treatment retention, adverse events, relationship with therapists and engagement in the treatment were assessed as secondary outcomes. These outcomes were equivalent or more effective for the intervention groups compared with the control groups. Computerized and Internet-based psychosocial interventions for drug users have a small to

Title: Studies on drug switchability showed heterogeneity in methodological approaches: a scoping review.

Science.gov (United States)

Belleudi, Valeria; Trotta, Francesco; Vecchi, Simona; Amato, Laura; Addis, Antonio; Davoli, Marina

2018-05-16

Several drugs share the same therapeutic indication, including those undergoing patent expiration. Concerns on the interchangeability are frequent in clinical practice, challenging the evaluation of switchability through observational research. To conduct a scoping review of observational studies on drug switchability to identify methodological strategies adopted to deal with bias and confounding. We searched PubMed, EMBASE, and Web of Science (updated 1/31/2017) to identify studies evaluating switchability in terms of effectiveness/safety outcomes or compliance. Three reviewers independently screened studies extracting all characteristics. Strategies to address confounding, particularly, previous drug use and switching reasons were considered. All findings were summarized in descriptive analyses. Thirty-two studies, published in the last 10 years, met the inclusion criteria. Epilepsy, cardiovascular and rheumatology were the most frequently represented clinical areas. 75% of the studies reported data on effectiveness/safety outcomes. The most frequent study design was cohort (65.6%) followed by case-control (21.9%) and self-controlled (12.5%). Case-control and case-crossover studies showed homogeneous methodological strategies to deal with bias and confounding. Among cohort studies, the confounding associated with previous drug use was addressed introducing variables in multivariate model (47.3%) or selecting only adherent patients (14.3%). Around 30% of cohort studies did not report reasons for switching. In the remaining 70%, clinical parameters or previous occurrence of outcomes were measured to identify switching connected with lack of effectiveness or adverse events. This study represents a starting point for researchers and administrators who are approaching the investigation and assessment of issues related to interchangeability of drugs. Copyright © 2018. Published by Elsevier Inc.

A systematic review of Hepatitis C virus treatment uptake among people who inject drugs in the European Region

DEFF Research Database (Denmark)

Lazarus, Jeffrey V; Sperle, Ida; Maticic, Mojca

2014-01-01

in relation to the number of patients who either: (a) tested HCV antibody-positive; (b) tested positive for HCV-RNA; or (c) tested positive for HCV-RNA and met additional treatment criteria. RESULTS: Twenty-five articles from 12 countries were included in the review. Among groups of drug-using study......BACKGROUND: Fifteen million adults in the World Health Organization European Region are estimated to have active hepatitis C infection. Intravenous drug use is a major hepatitis C transmission route in this region, and people who inject drugs (PWID) constitute a high-risk and high......-prevalence population. A systematic review was conducted to assess levels of hepatitis C treatment uptake among PWID in Europe. METHODS: Searches in MEDLINE and EMBASE were carried out for articles in any language published between 1 January 2000 and 31 December 2012. Articles were included in the review...

21 CFR 328.10 - Alcohol.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Alcohol. 328.10 Section 328.10 Food and Drugs FOOD...-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Ingredients § 328.10 Alcohol. (a) Any over-the-counter (OTC) drug product intended for oral ingestion shall not contain alcohol...

Atomoxetine: A Review of Its Pharmacokinetics and Pharmacogenomics Relative to Drug Disposition.

Science.gov (United States)

Yu, Guo; Li, Guo-Fu; Markowitz, John S

2016-05-01

Atomoxetine is a selective norepinephrine (NE) reuptake inhibitor approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children (≥6 years of age), adolescents, and adults. Its metabolism and disposition are fairly complex, and primarily governed by cytochrome P450 (CYP) 2D6 (CYP2D6), whose protein expression varies substantially from person to person, and by race and ethnicity because of genetic polymorphism. These differences can be substantial, resulting in 8-10-fold differences in atomoxetine exposure between CYP2D6 poor metabolizers and extensive metabolizers. In this review, we have attempted to revisit and analyze all published clinical pharmacokinetic data on atomoxetine inclusive of public access documents from the new drug application submitted to the United States Food and Drug Administration (FDA). The present review focuses on atomoxetine metabolism, disposition, and genetic polymorphisms of CYP2D6 as they specifically relate to atomoxetine, and provides an in-depth discussion of the fundamental pharmacokinetics of the drug including its absorption, distribution, metabolism, and excretion in pediatric and adult populations. Further, a summary of relationships between genetic variants of CYP2D6 and to some degree, CYP2C19, are provided with respect to atomoxetine plasma concentrations, central nervous system (CNS) pharmacokinetics, and associated clinical implications for pharmacotherapy. Lastly, dosage adjustments based on pharmacokinetic principles are discussed.

Strategies for prevention or reduction of drug use for adolescents: systematic literature review

Directory of Open Access Journals (Sweden)

Thamyris Alexandre Salles

2016-06-01

Full Text Available A systematic review was conducted with the objective of identifying scientific evidence of strategies for prevention or reduction of drug use among adolescents. Searches were conducted in databases LILACS, CINAHL, MEDLINE, Scopus and Cochrane Library, with descriptors Ensino, Educação em Saúde, Transtornos relacionados ao uso de substâncias, Adolescentes and Enfermagem Psiquiátrica. Twenty-seven articles were chosen. Results pointed to a variety of software, projects and interventions that are used as strategies for prevention or reduction of drug use among adolescents. Among the studies, 74.1% (n=20 reached satisfactory results and 25.9% (n=7 reached partially satisfactory results. Only Narconon Project and Brief Intervention were widely effective in reducing use of a variety of drugs among adolescents, since the other studies were focused on specific drugs or were limited to use prevention among non-using adolescents.

Evaluation of documented drug interactions and contraindications associated with herbs and dietary supplements: a systematic literature review.

Science.gov (United States)

Tsai, H-H; Lin, H-W; Simon Pickard, A; Tsai, H-Y; Mahady, G B

2012-11-01

The use of herbs and dietary supplements (HDS) alone or concomitantly with medications can potentially increase the risk of adverse events experienced by the patients. This review aims to evaluate the documented HDS-drug interactions and contraindications. A structured literature review was conducted on PubMed, EMBASE, Cochrane Library, tertiary literature and Internet. While 85 primary literatures, six books and two web sites were reviewed for a total of 1,491 unique pairs of HDS-drug interactions, 213 HDS entities and 509 medications were involved. HDS products containing St. John's Wort, magnesium, calcium, iron, ginkgo had the greatest number of documented interactions with medications. Warfarin, insulin, aspirin, digoxin, and ticlopidine had the greatest number of reported interactions with HDS. Medications affecting the central nervous system or cardiovascular system had more documented interactions with HDS. Of the 882 HDS-drug interactions being described its mechanism and severity, 42.3% were due to altered pharmacokinetics and 240 were described as major interactions. Of the 152 identified HDS contraindications, the most frequent involved gastrointestinal (16.4%), neurological (14.5%), and renal/genitourinary diseases (12.5%). Flaxseed, echinacea, and yohimbe had the largest number of documented contraindications. Although HDS-drug interactions and contraindications primarily concerned a relatively small subset of commonly used medications and HDS entities, this review provides the summary to identify patients, HDS products, and medications that are more susceptible to HDS-drug interactions and contraindications. The findings would facilitate the health-care professionals to communicate these documented interactions and contraindications to their patients and/or caregivers thereby preventing serious adverse events and improving desired therapeutic outcomes. © 2012 Blackwell Publishing Ltd.

Nanotechnology-Based Drug Delivery Systems for Photodynamic Therapy of Cancer: A Review.

Science.gov (United States)

Calixto, Giovana Maria Fioramonti; Bernegossi, Jéssica; de Freitas, Laura Marise; Fontana, Carla Raquel; Chorilli, Marlus

2016-03-11

Photodynamic therapy (PDT) is a promising alternative approach for improved cancer treatment. In PDT, a photosensitizer (PS) is administered that can be activated by light of a specific wavelength, which causes selective damage to the tumor and its surrounding vasculature. The success of PDT is limited by the difficulty in administering photosensitizers (PSs) with low water solubility, which compromises the clinical use of several molecules. Incorporation of PSs in nanostructured drug delivery systems, such as polymeric nanoparticles (PNPs), solid lipid nanoparticles (SLNs), nanostructured lipid carriers (NLCs), gold nanoparticles (AuNPs), hydrogels, liposomes, liquid crystals, dendrimers, and cyclodextrin is a potential strategy to overcome this difficulty. Additionally, nanotechnology-based drug delivery systems may improve the transcytosis of a PS across epithelial and endothelial barriers and afford the simultaneous co-delivery of two or more drugs. Based on this, the application of nanotechnology in medicine may offer numerous exciting possibilities in cancer treatment and improve the efficacy of available therapeutics. Therefore, the aim of this paper is to review nanotechnology-based drug delivery systems for photodynamic therapy of cancer.

Nanotechnology-Based Drug Delivery Systems for Photodynamic Therapy of Cancer: A Review

Directory of Open Access Journals (Sweden)

Giovana Maria Fioramonti Calixto

2016-03-01

Full Text Available Photodynamic therapy (PDT is a promising alternative approach for improved cancer treatment. In PDT, a photosensitizer (PS is administered that can be activated by light of a specific wavelength, which causes selective damage to the tumor and its surrounding vasculature. The success of PDT is limited by the difficulty in administering photosensitizers (PSs with low water solubility, which compromises the clinical use of several molecules. Incorporation of PSs in nanostructured drug delivery systems, such as polymeric nanoparticles (PNPs, solid lipid nanoparticles (SLNs, nanostructured lipid carriers (NLCs, gold nanoparticles (AuNPs, hydrogels, liposomes, liquid crystals, dendrimers, and cyclodextrin is a potential strategy to overcome this difficulty. Additionally, nanotechnology-based drug delivery systems may improve the transcytosis of a PS across epithelial and endothelial barriers and afford the simultaneous co-delivery of two or more drugs. Based on this, the application of nanotechnology in medicine may offer numerous exciting possibilities in cancer treatment and improve the efficacy of available therapeutics. Therefore, the aim of this paper is to review nanotechnology-based drug delivery systems for photodynamic therapy of cancer.

Kinetics and mechanism investigation on the destruction of oxytetracycline by UV-254 nm activation of persulfate

Energy Technology Data Exchange (ETDEWEB)

Liu, Yiqing [Faculty of Geosciences and Environmental Engineering, Southwest Jiaotong University, Chengdu 611756 (China); Environmental Engineering and Science Program, University of Cincinnati, Cincinnati, OH 45221-0012 (United States); He, Xuexiang [Environmental Engineering and Science Program, University of Cincinnati, Cincinnati, OH 45221-0012 (United States); Fu, Yongsheng [Faculty of Geosciences and Environmental Engineering, Southwest Jiaotong University, Chengdu 611756 (China); Dionysiou, Dionysios D., E-mail: dionysios.d.dionysiou@uc.edu [Environmental Engineering and Science Program, University of Cincinnati, Cincinnati, OH 45221-0012 (United States)

2016-03-15

Highlights: • The most effective destruction of OTC by UV/PS was achieved at near neutral pH. • Deprotonated HOTC{sup −} had the highest second-order rate constant with SO{sub 4}·{sup −}. • Presence of HCO{sub 3}{sup −} or Cu{sup 2+} enhanced the removal of OTC in UV/PS system. • Total organic carbon was degraded slowly during the mineralization of OTC. • Studies on the degradation mechanism revealed four different reaction pathways. - Abstract: Oxytetracycline (OTC), an important broad-spectrum antibiotic, has been detected extensively in various environmental systems, which may have a detrimental impact on ecosystem and human health through the development of drug resistant bacteria and pathogens. In this study, the degradation of OTC was evaluated by UV-254 nm activated persulfate (PS). The observed UV fluence based pseudo first-order rate constant (k{sub obs}) was found to be the highest at near neutral pH conditions (pH 5.5–8.5). Presence of various natural water constituents had different effects on OTC degradation, with a significant enhancement in the presence of bicarbonate or Cu{sup 2+}. Limited elimination of total organic carbon (TOC) and PS was observed during the mineralization of OTC. Transformation byproducts in the presence and absence of hydroxyl radical scavenging agent tert-butanol (t-BuOH) were identified using ultra-high definition accurate-mass quadrupole time-of-flight liquid chromatography/mass spectrometer (LC-QTOF/MS). Potential OTC degradation mechanism was subsequently proposed revealing four different reaction pathways by SO{sub 4}·{sup −} reaction including hydroxylation (+16 Da), demethylation (−14 Da), decarbonylation (−28 Da) and dehydration (−18 Da). This study suggests that UV-254 nm/PS is a promising treatment technology for the control of water pollution caused by emerging contaminants such as OTC.

Kinetics and mechanism investigation on the destruction of oxytetracycline by UV-254 nm activation of persulfate

International Nuclear Information System (INIS)

Liu, Yiqing; He, Xuexiang; Fu, Yongsheng; Dionysiou, Dionysios D.

2016-01-01

Highlights: • The most effective destruction of OTC by UV/PS was achieved at near neutral pH. • Deprotonated HOTC"− had the highest second-order rate constant with SO_4·"−. • Presence of HCO_3"− or Cu"2"+ enhanced the removal of OTC in UV/PS system. • Total organic carbon was degraded slowly during the mineralization of OTC. • Studies on the degradation mechanism revealed four different reaction pathways. - Abstract: Oxytetracycline (OTC), an important broad-spectrum antibiotic, has been detected extensively in various environmental systems, which may have a detrimental impact on ecosystem and human health through the development of drug resistant bacteria and pathogens. In this study, the degradation of OTC was evaluated by UV-254 nm activated persulfate (PS). The observed UV fluence based pseudo first-order rate constant (k_o_b_s) was found to be the highest at near neutral pH conditions (pH 5.5–8.5). Presence of various natural water constituents had different effects on OTC degradation, with a significant enhancement in the presence of bicarbonate or Cu"2"+. Limited elimination of total organic carbon (TOC) and PS was observed during the mineralization of OTC. Transformation byproducts in the presence and absence of hydroxyl radical scavenging agent tert-butanol (t-BuOH) were identified using ultra-high definition accurate-mass quadrupole time-of-flight liquid chromatography/mass spectrometer (LC-QTOF/MS). Potential OTC degradation mechanism was subsequently proposed revealing four different reaction pathways by SO_4·"− reaction including hydroxylation (+16 Da), demethylation (−14 Da), decarbonylation (−28 Da) and dehydration (−18 Da). This study suggests that UV-254 nm/PS is a promising treatment technology for the control of water pollution caused by emerging contaminants such as OTC.

Drug-induced chest pain and myocardial infarction. Reports to a national centre and review of the literature

NARCIS (Netherlands)

J.P. Ottervanger (Jan Paul); J.H.P. Wilson (Paul); B.H.Ch. Stricker (Bruno)

1997-01-01

textabstractObjectives: To analyse reports of drug-induced myocardial infarction and chest pain sent to a national reporting centre. To review which drugs were suspected of exhibiting these adverse events and what mechanisms were involved. Methods: During the 20-year period 1975 through 1994, a

Evidence-based treatment of frequent heartburn: the benefits and limitations of over-the-counter medications.

Science.gov (United States)

McRorie, Johnson W; Gibb, Roger D; Miner, Philip B

2014-06-01

This review summarizes the pharmacological effects of over-the-counter (OTC) heartburn drugs, and the implications for treating frequent heartburn. PubMed and SCOPUS were searched across all years to identify well-controlled, randomized clinical studies that assessed mechanism of action and efficacy. Antacids can transiently neutralize acid in the esophagus, but do not significantly affect gastric pH or prevent subsequent heartburn episodes. Histamine-2 receptor antagonists (H2 RAs) rapidly develop tolerance with repeat dosing, and exhibit an analgesic effect that may provide heartburn relief while leaving the esophagus exposed to acid. Proton pump inhibitors (PPIs) provide a sustained inhibition of gastric acid production, and are superior to antacids and H2 RAs for control of gastric acid and treatment of frequent heartburn. When recommending therapies for frequent heartburn, it is of particular importance to understand the strengths and weaknesses of available OTC medications. Antacids and H2 RAs are not recommended for treatment of frequent heartburn, while OTC PPIs are both indicated for, and effective for, treatment of frequent heartburn. A PPI dose of 20 mg is optimal for empiric treatment of frequent heartburn, and consistent with the 2013 treatment guidelines established by the American College of Gastroenterology (ACG) for treatment with a minimum effective dose. ©2014 The Author(s) ©2014 American Association of Nurse Practitioners.

21 CFR 349.80 - Professional labeling.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Professional labeling. 349.80 Section 349.80 Food... HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 349.80 Professional labeling. The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but...

21 CFR 330.11 - NDA deviations from applicable monograph.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

Selection of Antiepileptic Drug Polytherapy Based on Mechanisms of Action: The Evidence Reviewed

NARCIS (Netherlands)

Deckers, C.L.P.; Czuczwar, S.J.; Hekster, Y.A.; Keyser, A.J.M.; Kubova, H.; Meinardi, H.; Patsalos, P.N.; Renier, W.O.; Rijn, C.M. van

2000-01-01

Purpose: When monotherapy with antiepileptic drugs (AEDs) fails, combination therapy is tried so as to improve effectiveness, by improving either efficacy, or tolerability, or both. We have reviewed the available studies (both animal and human) on AED polytherapy to determine whether AEDs can be

[Drugs in pregnancy].

Science.gov (United States)

Danchev, N; Astrug, A; Tsankova, V; Nikolova, I

2006-01-01

The use of drugs in pregnancy is being discussed. The influence of different factors, both physiological and drug related (physicochemical characteristics, dose, duration of pharmacotherapy) on the processes of absorption, distribution, protein binding, metabolism and excretion are reviewed. The up-to-date classification of the drugs in relation to their effects on the fetus is presented. Special emphasize is given to drugs (antibiotics, cardio-vascular, psychotropic etc.) used for the treatment of acute and chronic conditions in the course of pregnancy. Drugs used for symptoms like pain, high temperature and constipation are also reviewed. Recommendations for the use of safer drugs in pregnancy are given. Drugs with proven teratogenic effects are presented.

Predictors of over-the-counter medication: A cross-sectional Indian study

OpenAIRE

Abinash Panda; Supriya Pradhan; Gurukrushna Mohapatro; Jaya Singh Kshatri

2017-01-01

Context: The determinants of over-the-counter (OTC) medication need to be understood to design adequate drug information policies. Aim: To determine the prevalence and predictors of OTC medication among the adult population of Berhampur town in Odisha, India. Settings and Design: It was a prospective, cross-sectional, observational study carried out in the private retail pharmacy on a convenience sample of 880 adults over a period of 6 months at Berhampur, Odisha, India. Materials and Methods...

Drug-Target Kinetics in Drug Discovery.

Science.gov (United States)

Tonge, Peter J

2018-01-17

The development of therapies for the treatment of neurological cancer faces a number of major challenges including the synthesis of small molecule agents that can penetrate the blood-brain barrier (BBB). Given the likelihood that in many cases drug exposure will be lower in the CNS than in systemic circulation, it follows that strategies should be employed that can sustain target engagement at low drug concentration. Time dependent target occupancy is a function of both the drug and target concentration as well as the thermodynamic and kinetic parameters that describe the binding reaction coordinate, and sustained target occupancy can be achieved through structural modifications that increase target (re)binding and/or that decrease the rate of drug dissociation. The discovery and deployment of compounds with optimized kinetic effects requires information on the structure-kinetic relationships that modulate the kinetics of binding, and the molecular factors that control the translation of drug-target kinetics to time-dependent drug activity in the disease state. This Review first introduces the potential benefits of drug-target kinetics, such as the ability to delineate both thermodynamic and kinetic selectivity, and then describes factors, such as target vulnerability, that impact the utility of kinetic selectivity. The Review concludes with a description of a mechanistic PK/PD model that integrates drug-target kinetics into predictions of drug activity.

Toxicological Implications and Inflammatory Response in Human Lymphocytes Challenged with Oxytetracycline.

Science.gov (United States)

Di Cerbo, A; Palatucci, A T; Rubino, V; Centenaro, S; Giovazzino, A; Fraccaroli, E; Cortese, L; Ruggiero, G; Guidetti, G; Canello, S; Terrazzano, G

2016-04-01

Antibiotics are widely used in zoo technical and veterinary practices as feed supplementation to ensure wellness of farmed animals and livestock. Several evidences have been suggesting both the toxic role for tetracyclines, particularly for oxytetracycline (OTC). This potential toxicity appears of great relevance for human nutrition and for domestic animals. This study aimed to extend the evaluation of such toxicity. The biologic impact of the drug was assessed by evaluating the proinflammatory effect of OTC and their bone residues on cytokine secretion by in vitro human peripheral blood lymphocytes. Our results showed that both OTC and OTC-bone residues significantly induced the T lymphocyte and non-T cell secretion of interferon (IFN)-γ, as cytokine involved in inflammatory responses in humans as well as in animals. These results may suggest a possible implication for new potential human and animal health risks depending on the entry of tetracyclines in the food-processing chain. © 2015 The Authors Journal of Biochemical and Molecular Toxicology Published Wiley Periodicals, Inc.

A review of mechanisms of circumvention and modulation of chemotherapeutic drug resistance.

Science.gov (United States)

O'Connor, R

2009-05-01

Drug resistance is a serious limitation to the effective treatment of a number of common malignancies. Thirty years of laboratory and clinical research have greatly defined the molecular alterations underlying many drug resistance processes in cancer. Based on this knowledge, strategies to overcome the impact of resistance and increase the efficacy of cancer treatment have been translated from laboratory models to clinical trials. This article reviews laboratory and, in particular, clinical attempts at drug resistance circumvention from early forays in the inhibition of cellular efflux pump-mediated drug resistance through to more selective circumvention agent strategies and into inhibition of the other important mechanisms which can allow cancer cells to survive therapy, such as apoptosis resistance. Despite some promising results to date, resistance inhibition strategies have largely failed due to poor understanding of the pharmacology, dynamics and complexity of the resistance phenotype. With the realisation that new molecularly-targeted agents can also be rendered ineffectual by the actions of resistance mechanisms, a major focus is once again emerging on identifying new strategies/pharmaceuticals which can augment the activity of the arsenal of more conventional cytotoxics and newer targeted anti-cancer drugs. Future tactical directions where old and new resistance strategies may merge to overcome this challenge are discussed.

Removal of cytostatic drugs from aquatic environment: A review

Energy Technology Data Exchange (ETDEWEB)

Zhang, Jiefeng [Division of Environmental and Water Resources, School of Civil and Environmental Engineering, Nanyang Technological University, 50 Nanyang Avenue, Singapore 639798 (Singapore); Chang, Victor W.C., E-mail: wcchang@ntu.edu.sg [Division of Environmental and Water Resources, School of Civil and Environmental Engineering, Nanyang Technological University, 50 Nanyang Avenue, Singapore 639798 (Singapore); Giannis, Apostolos [Residues and Resource Reclamation Centre (R3C), Nanyang Environment and Water Research Institute, Nanyang Technological University, 1 Cleantech Loop, CleanTech One, Singapore 637141 (Singapore); Wang, Jing-Yuan [Division of Environmental and Water Resources, School of Civil and Environmental Engineering, Nanyang Technological University, 50 Nanyang Avenue, Singapore 639798 (Singapore); Residues and Resource Reclamation Centre (R3C), Nanyang Environment and Water Research Institute, Nanyang Technological University, 1 Cleantech Loop, CleanTech One, Singapore 637141 (Singapore)

2013-02-15

Cytostatic drugs have been widely used for chemotherapy for decades. However, many of them have been categorized as carcinogenic, mutagenic and teratogenic compounds, triggering widespread concerns about their occupational exposure and ecotoxicological risks to the environment. This review focuses on trace presence, fate and ecotoxicity of various cytostatic compounds in the environment, with an emphasis on the major sources contributing to their environmental concentrations. Past records have documented findings mainly on hospital effluents though little effort has been directed to household discharges. There is also a lack in physico-chemical data for forecasting the chemodynamics of cytostatics in natural waters along with its human metabolites and environmental transformation products. In this light, obtaining comprehensive ecotoxicity data is becoming pressingly crucial to determine their actual impacts on the ecosystem. Literature review also reveals urinary excretion as a major contributor to various cytostatic residues appeared in the water cycle. As such, engaging urine source-separation as a part of control strategy holds a rosy prospect of addressing the “emerging” contamination issue. State-of-the-art treatment technologies should be incorporated to further remove cytostatic residues from the source-separating urine stream. The benefits, limitations and trends of development in this domain are covered for membrane bio-reactor, reverse/forward osmosis and advanced oxidation processes. Despite the respective seeming advantages of source separation and treatment technology, a combined strategy may cost-effectively prevent the cytostatic residues from seeping into the environment. However, the combination calls for further evaluation on the associated technological, social-economic and administrative issues at hand. Highlights: ► We review the environmental occurrence, fate and ecotoxicity of cytostatic drugs. ► Four major sources contributing to

Neuroimaging Impaired Response Inhibition and Salience Attribution in Human Drug Addiction: A Systematic Review.

Science.gov (United States)

Zilverstand, Anna; Huang, Anna S; Alia-Klein, Nelly; Goldstein, Rita Z

2018-06-06

The impaired response inhibition and salience attribution (iRISA) model proposes that impaired response inhibition and salience attribution underlie drug seeking and taking. To update this model, we systematically reviewed 105 task-related neuroimaging studies (n > 15/group) published since 2010. Results demonstrate specific impairments within six large-scale brain networks (reward, habit, salience, executive, memory, and self-directed networks) during drug cue exposure, decision making, inhibitory control, and social-emotional processing. Addicted individuals demonstrated increased recruitment of these networks during drug-related processing but a blunted response during non-drug-related processing, with the same networks also being implicated during resting state. Associations with real-life drug use, relapse, therapeutic interventions, and the relevance to initiation of drug use during adolescence support the clinical relevance of the results. Whereas the salience and executive networks showed impairments throughout the addiction cycle, the reward network was dysregulated at later stages of abuse. Effects were similar in alcohol, cannabis, and stimulant addiction. Copyright © 2018 Elsevier Inc. All rights reserved.

Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil

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Adriano Max Moreira Reis

2010-03-01

Full Text Available The objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, meta-analyses, and studies on safety were searched on the Medline baseline, the Cochrane Library and SIETES (System of Essential Information in Therapeutics and Health; database in Spanish. Most drugs (62.5% were sold as a fixed-dose combination of two or more drugs. Randomized clinical trials were found for only three drugs: bromhexine, dextromethorphan and guaifenesin. No clinical trials were found for fixed-dose combinations. Systematic reviews on Cochrane did not report any evidence in favor of or against the effectiveness of cough drugs. Efficacy is also unclear, especially regarding fixed-dose combinations. The evidence for the efficacy of OTC cough medications available in Brazil is poor due to the lack of quality studies. Pharmacovigilance of OTC cough medications should be encouraged.O objetivo deste trabalho foi analisar o nível de evidências sobre a eficácia, a efetividade e a segurança dos medicamentos para tosse registrados no Brasil. A base de dados da Agência Nacional de Vigilância Sanitária foi empregada para identificar os medicamentos. Os ensaios clínicos, as revisões sistemáticas, as metanálises e os estudos de segurança foram pesquisados no Medline, the Cochrane Library e SIETES (Sistema de Informações Essenciais em Terapêutica e Saúde, base de dados em espanhol. A maioria dos medicamentos (62,5% eram comercializados como associação em dose fixa com dois ou mais fármacos. Ensaios clínicos randomizados foram encontrados apenas para três fármacos: bromexina, dextrometorfano e guaifenesina; para associações a dose fixa não foram encontrados ensaios clínicos. Revisões sistemáticas publicadas pela Cochrane n

Nanotechnology and Drug Delivery Part 2: Nanostructures for Drug ...

African Journals Online (AJOL)

Some challenges associated with the technology as it relates to drug effectiveness, toxicity, stability, pharmacokinetics and drug regulatory control are discussed in this review. Clearly, nanotechnology is a welcome development that is set to transform drug delivery and drug supply chain management, if optimally developed ...

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review

Directory of Open Access Journals (Sweden)

Manchaiah V

2017-05-01

Full Text Available Vinaya Manchaiah,1–4 Brian Taylor,5 Ashley L Dockens,1 Nicole R Tran,1 Kayla Lane,1 Mariana Castle,1 Vibhu Grover1 1Department of Speech and Hearing Sciences, Lamar University, Beaumont, TX, USA; 2The Swedish Institute for Disability Research, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden; 3Audiology India, Mysore, 4Department of Speech and Hearing, School of Allied Health Sciences, Manipal University, Manipal, India; 5Taylor Audio LLC, Minneapolis, MN, USA Background: This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1 personal sound amplification products (PSAPs, 2 direct-mail hearing aids, and 3 over-the-counter (OTC hearing aids.Method: A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review.Results: Included studies fell into three domains: 1 electroacoustic characteristics, 2 consumer surveys, and 3 outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level. Low-end (or low-cost devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis, especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%–19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive

Drug-botanical interactions: a review of the laboratory, animal, and human data for 8 common botanicals.

Science.gov (United States)

Shord, Stacy S; Shah, Kanan; Lukose, Alvina

2009-09-01

Many Americans use complementary and alternative medicine (CAM) to prevent or alleviate common illnesses, and these medicines are commonly used by individuals with cancer.These medicines or botanicals share the same metabolic and transport proteins, including cytochrome P450 enzymes (CYP), glucuronosyltransferases (UGTs), and P-glycoprotein (Pgp), with over-the-counter and prescription medicines increasing the likelihood of drug-botanical interactions.This review provides a brief description of the different proteins, such as CYPs, UGTs, and Pgp.The potential effects of drug-botanical interactions on the pharmacokinetics and pharmacodynamics of the drug or botanical and a summary of the more common models used to study drug metabolism are described.The remaining portion of this review summarizes the data extracted from several laboratory, animal, and clinical studies that describe the metabolism, transport, and potential interactions of 8 selected botanicals. The 8 botanicals include black cohosh, Echinacea, garlic, Gingko biloba, green tea, kava, milk thistle, and St John's wort; these botanicals are among some of the more common botanicals taken by individuals with cancer.These examples are included to demonstrate how to interpret the different studies and how to use these data to predict the likelihood of a clinically significant drug-botanical interaction.

Radiopharmaceuticals drug interactions: a critical review

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Ralph Santos-Oliveira

2008-12-01

Full Text Available Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here,we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions.Os radiofármacos desempenham função crítica na medicina moderna, primariamente para fins diagnósticos, mas também no monitoramento da progressão de doenças assim como na avaliação de respostas ao tratamento. O uso da tecnologia por imagem tem crescido e conseqüentemente as prescrições de medicamentos (radiofármacos em especial com esse propósito. Este fato, aumenta o risco de interações entre medicamentos e radiofármacos. Interações que podem ter um impacto na

Food and Drug Administration Drug Approval Process: A History and Overview.

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Williams, Christopher Ty

2016-03-01

In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

Enhancing topical analgesic administration: review and prospect for transdermal and transbuccal drug delivery systems.

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Sanz, Roser; Calpena, Ana C; Mallandrich, Mireia; Clares, Beatriz

2015-01-01

Topical administration is an appealing method for drug delivery due to its non-invasiveness, self-controlled application, avoidance of first-pass metabolism in the liver and reduction of systemic side effects compared to other conventional routes such as oral and parenteral. However, topical administration must overcome the permeable barriers that skin and mucosa represent for the drug to achieve its desired therapeutic effect. Penetration of drugs through human skin is mainly impaired by the stratum corneum- the uppermost keratinized skin layer. In contrast, the stratified squamous epithelium (a nonkeratinized tissue) represents the major physical barrier for transbuccal drug administration in humans. Different technologies have been studied to enhance the bioavailability or local effects of drugs administered through skin and buccal mucosa. Those technologies involve the use of physical or chemical enhancers and new dosage forms such as vesicles, cyclodextrins, nanoparticles and other complex systems. Combinations of these technologies may further increase drug delivery in some cases. As analgesia is one of the main therapeutic effects sought through topical administration, this paper focuses on the review of drug delivery systems to improve the topical and transdermal/transbuccal drug delivery of substances with known analgesic action. A discussion of their possibilities and limitations is also included.

A drug's life: the pathway to drug approval.

Science.gov (United States)

Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

2013-10-01

In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

Food-drug interactions

DEFF Research Database (Denmark)

Schmidt, Lars E; Dalhoff, Kim

2002-01-01

Interactions between food and drugs may inadvertently reduce or increase the drug effect. The majority of clinically relevant food-drug interactions are caused by food-induced changes in the bioavailability of the drug. Since the bioavailability and clinical effect of most drugs are correlated......, the bioavailability is an important pharmacokinetic effect parameter. However, in order to evaluate the clinical relevance of a food-drug interaction, the impact of food intake on the clinical effect of the drug has to be quantified as well. As a result of quality review in healthcare systems, healthcare providers...... are increasingly required to develop methods for identifying and preventing adverse food-drug interactions. In this review of original literature, we have tried to provide both pharmacokinetic and clinical effect parameters of clinically relevant food-drug interactions. The most important interactions are those...

Prevalence of drug use among students in mainland China: A systematic review and meta-analysis for 2003-2013.

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Jia, Zhongwei; Jin, Yuanyuan; Zhang, Lingling; Wang, Ziyun; Lu, Zuhong

2018-05-01

In response to calls to reassess and reform international drug policy, we estimated the prevalence of drug use among students in China from 2004 to 2013 through a systematic review and meta-analysis. We systemically identified and reviewed published studies on illicit drug use and abuse of sedative-hypnotics among students in China. We estimated the prevalence of drug use among students using a meta-regression model. The trends in drug use and any geographic differences were assessed using multilevel models, and the association between drug use and sedative-hypnotics abuse was also examined. The pooled prevalence of illicit drug use and sedative-hypnotics abuse in students was 2.10% (95% CI: 1.80-2.50) and 6.10% (95% CI: 5.10-7.20). A significant decrease in the prevalence of illicit drug use was observed in 2009-2013 (OR = 0.28, 95% CI: 0.25-0.32). Students in higher grades showed a higher prevalence of both illicit drug use and sedative-hypnotics abuse than those in lower grades. Provincial differences in illicit drug use (OR = 2.66, 95% CI: 1.24-5.73) and sedative-hypnotics abuse (OR = 1.37, 95% CI: 1.05-1.79) were identified. The geographical area of illicit drug use was observed to be expanding. Prevalence of drug use among students is twice as high as in the general population of adults in China, indicating that drug use is becoming an urgent public health issue among the younger population. Further investigation among school students is needed. Copyright © 2018 Elsevier B.V. All rights reserved.

Kinetics and mechanism investigation on the destruction of oxytetracycline by UV-254nm activation of persulfate.

Science.gov (United States)

Liu, Yiqing; He, Xuexiang; Fu, Yongsheng; Dionysiou, Dionysios D

2016-03-15

Oxytetracycline (OTC), an important broad-spectrum antibiotic, has been detected extensively in various environmental systems, which may have a detrimental impact on ecosystem and human health through the development of drug resistant bacteria and pathogens. In this study, the degradation of OTC was evaluated by UV-254nm activated persulfate (PS). The observed UV fluence based pseudo first-order rate constant (kobs) was found to be the highest at near neutral pH conditions (pH 5.5-8.5). Presence of various natural water constituents had different effects on OTC degradation, with a significant enhancement in the presence of bicarbonate or Cu(2+). Limited elimination of total organic carbon (TOC) and PS was observed during the mineralization of OTC. Transformation byproducts in the presence and absence of hydroxyl radical scavenging agent tert-butanol (t-BuOH) were identified using ultra-high definition accurate-mass quadrupole time-of-flight liquid chromatography/mass spectrometer (LC-QTOF/MS). Potential OTC degradation mechanism was subsequently proposed revealing four different reaction pathways by SO4(-) reaction including hydroxylation (+16Da), demethylation (-14Da), decarbonylation (-28Da) and dehydration (-18Da). This study suggests that UV-254nm/PS is a promising treatment technology for the control of water pollution caused by emerging contaminants such as OTC. Copyright © 2015 Elsevier B.V. All rights reserved.

Oxytetracycline induces DNA damage and epigenetic changes: a possible risk for human and animal health?

Science.gov (United States)

Gallo, Adriana; Landi, Rosaria; Rubino, Valentina; Di Cerbo, Alessandro; Giovazzino, Angela; Palatucci, Anna Teresa; Centenaro, Sara; Guidetti, Gianandrea; Canello, Sergio; Cortese, Laura; Ruggiero, Giuseppina; Alessandrini, Andrea; Terrazzano, Giuseppe

2017-01-01

Oxytetracycline (OTC), which is largely employed in zootechnical and veterinary practices to ensure wellness of farmed animals, is partially absorbed within the gastrointestinal tract depositing in several tissues. Therefore, the potential OTC toxicity is relevant when considering the putative risk derived by the entry and accumulation of such drug in human and pet food chain supply. Despite scientific literature highlights several OTC-dependent toxic effects on human and animal health, the molecular mechanisms of such toxicity are still poorly understood. Here, we evaluated DNA damages and epigenetic alterations by quantitative reverse transcription polymerase chain reaction, quantitative polymerase chain reaction, chromatin immuno-precipitation and Western blot analysis. We observed that human peripheral blood mononuclear cells (PBMCs) expressed DNA damage features (activation of ATM and p53, phosphorylation of H2AX and modifications of histone H3 methylation of lysine K4 in the chromatin) after the in vitro exposure to OTC. These changes are linked to a robust inflammatory response indicated by an increased expression of Interferon (IFN)- γ and type 1 superoxide dismutase (SOD1). Our data reveal an unexpected biological in vitro activity of OTC able to modify DNA and chromatin in cultured human PBMC. In this regard, OTC presence in foods of animal origin could represent a potential risk for both the human and animal health.

A Review for the Analysis of Antidepressant, Antiepileptic and Quinolone Type Drugs in Pharmaceuticals and Environmental Samples.

Science.gov (United States)

Rani, Susheela; Malik, Ashok Kumar; Kaur, Ramandeep; Kaur, Ripneel

2016-09-02

The analysis of drugs in various biological fluids is an important criterion for the determination of the physiological performance of a drug. After sampling of the biological fluid, the next step in the analytical process is sample preparation. Sample preparation is essential for isolation of desired components from complex biological matrices and greatly influences their reliable and accurate determination. The complexity of biological fluids adds to the challenge of direct determination of the drug by chromatographic analysis, therefore demanding a sample preparation step that is often time consuming, tedious and frequently overlooked. However, direct online injection methods offer the advantage of reducing sample preparation steps and enabling effective pre-concentration and clean-up of biological fluids. These procedures can be automated and therefore reduce the requirements for handling potentially infectious biomaterial, improve reproducibility, and minimize sample manipulations and potential contamination. This review is focused on the discovery and development of high-performance liquid chromatography (HPLC) and gas chromatography (GC) with different detectors. The drugs covered in this review are antiepileptics, antidepressant (AD), and quinolones. The application of these methods for determination of these drugs in biological, environmental and pharmaceutical samples has also been discussed.

Critical drug-drug interactions for use in electronic health records systems with computerized physician order entry: review of leading approaches.

Science.gov (United States)

Classen, David C; Phansalkar, Shobha; Bates, David W

2011-06-01

Medications represent the most common intervention in health care, despite their benefits; they also lead to an estimated 1.5 million adverse drug events and tens of thousands of hospital admissions each year. Although some are not preventable given what is known today, many types are, and one key cause which is preventable is drug-drug interactions (DDIs). Most electronic health record systems include programs that can check and prevent these types of interactions as a routine part of medication ordering. Studies suggest that these systems as implemented often do not effectively screen for these DDIs. A major reason for this deficiency is the lack of any national standard for the critical DDIs that should be routinely operationlized in these complex systems. We review the leading critical DDI lists from multiple sources including several leading health systems, a leading commercial content provider, the Leapfrog CPOE Testing Standard, and the new Office of the National Coordinator (ONC) DDI List. Implementation of strong DDI checking is one of the important steps in terms of realizing the benefits of electronic prescribing with respect to safety. Hopefully, the ONC list will make it easier for organizations to ensure they are including the most important interactions, and the Leapfrog List may help these organizations develop an operational DDI list that can be practically implemented. In addition, this review has identified 7 common DDIs that can be the starting point for all organizations in this area of medication safety.

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

Science.gov (United States)

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Umbrella Branding in Pharmaceutical Markets

NARCIS (Netherlands)

Suppliet, Moritz

2017-01-01

Umbrella branding is a marketing practice whereby multi-product firms leverage their reputation across different product categories. This paper investigates how advertising in the market of over-the-counter (OTC) drugs affects the decision to buy prescription drugs from a promoted brand name. I

Systematic Education of Self-Medication at Tokyo University of Pharmacy and Life Sciences.

Science.gov (United States)

Narui, Koji; Samizo, Kazuo; Inoue, Michiko; Watanabe, Kinzo

2016-01-01

The promotion of self-medication by pharmacies, with the aim of encouraging a patient's self-selection of proper OTC drug, is written about in the national action plan "Japan is Back". The subject of self-medication has been improved in the 2013 revised edition of "Model Core Curriculum for Pharmaceutical Education". At Tokyo University of Pharmacy and Life Sciences, the systematic education of self-medication was started from the onset of the six-year course in the third, fourth and fifth grade. We introduce here a new approach in our systematic education of self-medication. In the practice of the fourth grade, groups of around 5-6 students are formed. The pharmacy students assume various roles-of pharmacist, rater, observer, and chairman-and perform role-playing. We prepared a standardized patient (SP) showing various symptoms. The student of the role of pharmacist asks about the SP's symptoms, chooses an OTC drug suitable for the SP, and explains the OTC drug to the SP. After the role-playing, those in the roles of rater, observer, SP, and faculty give feedback to the student who played the role of pharmacist. Because we conduct this role-playing using SPs with a variety of symptoms, we can create a situation similar to a real drugstore.

Computer-based interventions for drug use disorders: A systematic review

Science.gov (United States)

Moore, Brent A.; Fazzino, Tera; Garnet, Brian; Cutter, Christopher J.; Barry, Declan T.

2011-01-01

A range of innovative computer-based interventions for psychiatric disorders have been developed, and are promising for drug use disorders, due to reduced cost and greater availability compared to traditional treatment. Electronic searches were conducted from 1966 to November 19, 2009 using MEDLINE, Psychlit, and EMBASE. 468 non-duplicate records were identified. Two reviewers classified abstracts for study inclusion, resulting in 12 studies of moderate quality. Eleven studies were pilot or full-scale trials compared to a control condition. Interventions showed high acceptability despite substantial variation in type and amount of treatment. Compared to treatment-as-usual, computer-based interventions led to less substance use as well as higher motivation to change, better retention, and greater knowledge of presented information. Computer-based interventions for drug use disorders have the potential to dramatically expand and alter the landscape of treatment. Evaluation of internet and phone-based delivery that allow for treatment-on-demand in patients’ own environment is needed. PMID:21185683

Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials

Directory of Open Access Journals (Sweden)