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Sample records for management drug study

  1. Collaborative drug therapy management: case studies of three community-based models of care.

    PubMed

    Snyder, Margie E; Earl, Tara R; Gilchrist, Siobhan; Greenberg, Michael; Heisler, Holly; Revels, Michelle; Matson-Koffman, Dyann

    2015-01-01

    Collaborative drug therapy management agreements are a strategy for expanding the role of pharmacists in team-based care with other providers. However, these agreements have not been widely implemented. This study describes the features of existing provider-pharmacist collaborative drug therapy management practices and identifies the facilitators and barriers to implementing such services in community settings. We conducted in-depth, qualitative interviews in 2012 in a federally qualified health center, an independent pharmacy, and a retail pharmacy chain. Facilitators included 1) ensuring pharmacists were adequately trained; 2) obtaining stakeholder (eg, physician) buy-in; and 3) leveraging academic partners. Barriers included 1) lack of pharmacist compensation; 2) hesitation among providers to trust pharmacists; 3) lack of time and resources; and 4) existing informal collaborations that resulted in reduced interest in formal agreements. The models described in this study could be used to strengthen clinical-community linkages through team-based care, particularly for chronic disease prevention and management. PMID:25811494

  2. [Drug shortage: determinants, consequences and management].

    PubMed

    Reis, Adriano Max Moreira; Perini, Edson

    2008-04-01

    The present study analyzes drug shortage as a problem reaching beyond the logistic aspect of the health field and discusses its consequences with respect to quality, safety and cost of health care delivery. The pharmaceutical supply chain and the factors that determine the distribution and availability of drugs are discussed. The contribution of the Pharmacy and Therapeutics Committee in preventing and managing drug shortage in health institutions is stressed and measures for drug shortage management are suggested. Finally it is emphasized that drugs should be considered health products rather than consumer goods and as such be given a different treatment by the supply chain. PMID:21936164

  3. Managing spasticity with drugs.

    PubMed

    Simon, O; Yelnik, A P

    2010-09-01

    Spasticity is a common symptom observed after pyramidal system lesion. The treatment of spasticity has considerably changed during last years, notably with the generalization of Botulinum toxin use. However, the treatment of spasticity should consider all therapeutic possibility in accordance with patient status and objective. Drugs are only a part of the treatment and physical therapy must always be used. Others treatments such as surgery, orthosis, occupational therapy must also be discussed individually. Several guidelines are now available for Botulinum toxin treatment but only the French guidelines consider all drug therapies. This review addresses the different drugs commonly used on the basis of an extensive review of literature. Some facts are clearly established by randomized controlled trials but a certain number of questions remains unclear and only clinical experience and consensus can guide injectors. PMID:20927006

  4. Medical Management of Drug-Resistant Tuberculosis

    PubMed Central

    2015-01-01

    Drug-resistant tuberculosis (TB) is still a major threat worldwide. However, recent scientific advances in diagnostic and therapeutic tools have improved the management of drug-resistant TB. The development of rapid molecular testing methods allows for the early detection of drug resistance and prompt initiation of an appropriate treatment. In addition, there has been growing supportive evidence for shorter treatment regimens in multidrug-resistant TB; and for the first time in over 50 years, new anti-TB drugs have been developed. The World Health Organization has recently revised their guidelines, primarily based on evidence from a meta-analysis of individual patient data (n=9,153) derived from 32 observational studies, and outlined the recommended combination and correct use of available anti-TB drugs. This review summarizes the updated guidelines with a focus on the medical management of drug-resistant TB. PMID:26175768

  5. Clinical Management of HIV Drug Resistance

    PubMed Central

    Cortez, Karoll J.; Maldarelli, Frank

    2011-01-01

    Combination antiretroviral therapy for HIV-1 infection has resulted in profound reductions in viremia and is associated with marked improvements in morbidity and mortality. Therapy is not curative, however, and prolonged therapy is complicated by drug toxicity and the emergence of drug resistance. Management of clinical drug resistance requires in depth evaluation, and includes extensive history, physical examination and laboratory studies. Appropriate use of resistance testing provides valuable information useful in constructing regimens for treatment-experienced individuals with viremia during therapy. This review outlines the emergence of drug resistance in vivo, and describes clinical evaluation and therapeutic options of the individual with rebound viremia during therapy. PMID:21994737

  6. A prospective study of tuberculosis drug susceptibility in sabah, malaysia, and an algorithm for management of isoniazid resistance.

    PubMed

    Rashid Ali, Muhammad Redzwan S; Parameswaran, Uma; William, Timothy; Bird, Elspeth; Wilkes, Christopher S; Lee, Wai Khew; Yeo, Tsin Wen; Anstey, Nicholas M; Ralph, Anna P

    2015-01-01

    Introduction. The burden of tuberculosis is high in eastern Malaysia, and rates of Mycobacterium tuberculosis drug resistance are poorly defined. Our objectives were to determine M. tuberculosis susceptibility and document management after receipt of susceptibility results. Methods. Prospective study of adult outpatients with smear-positive pulmonary tuberculosis (PTB) in Sabah, Malaysia. Additionally, hospital clinicians accessed the reference laboratory for clinical purposes during the study. Results. 176 outpatients were enrolled; 173 provided sputum samples. Mycobacterial culture yielded M. tuberculosis in 159 (91.9%) and nontuberculous Mycobacterium (NTM) in three (1.7%). Among outpatients there were no instances of multidrug resistant M. tuberculosis (MDR-TB). Seven people (4.5%) had isoniazid resistance (INH-R); all were switched to an appropriate second-line regimen for varying durations (4.5-9 months). Median delay to commencement of the second-line regimen was 13 weeks. Among 15 inpatients with suspected TB, 2 had multidrug resistant TB (one extensively drug resistant), 2 had INH-R, and 4 had NTM. Conclusions. Current community rates of MDR-TB in Sabah are low. However, INH-resistance poses challenges, and NTM is an important differential diagnosis in this setting, where smear microscopy is the usual diagnostic modality. To address INH-R management issues in our setting, we propose an algorithm for the treatment of isoniazid-resistant PTB. PMID:25838829

  7. Drug-Induced Itch Management.

    PubMed

    Ebata, Toshiya

    2016-01-01

    Drugs may cause itching as a concomitant symptom of drug-induced skin reactions or in the form of pruritus without skin lesions. Drug-induced itch is defined as generalized itching without skin lesions, caused by a drug. Itching associated with drug-induced cholestasis is among the common dermatologic adverse events (dAEs) that induce itching. Some drugs such as opioids, antimalarials, and hydroxyethyl starch are known to induce itching without skin lesions. The clinical features and underlying proposed mechanisms of itching caused by these drugs have been specifically investigated. The recent application of targeted anticancer drugs has increased the survival rate of cancer patients. These new agents cause significant dAEs such as acneiform rashes, dry skin, hand-foot syndrome, paronychia, and itching. Itching is a common side effect of epidermal growth factor receptor inhibitors. Though not life-threatening, these dAEs have a negative impact on a patient's quality of life, leading to dose reduction and possibly less effective cancer therapy. It is important to provide an effective supportive antipruritic treatment without interruption of the administration of these drugs. This chapter concludes by describing basic measures to be taken for diagnosis and treatment of drug-induced itch. The principle of treatment is discontinuation of suspected causative drugs in general except for anticancer medications. In case itching lasts long after drug withdrawal or the causative drug cannot be stopped, vigorous symptomatic antipruritic treatment and specific therapies for different types of drug-induced itch should be undertaken. PMID:27578085

  8. [Prophylactic drug management of migraine].

    PubMed

    Göbel, H; Heinze, A

    2003-10-01

    Migraine prophylaxis with drugs is still an essential part of migraine therapy. This is especially true for those patients with frequent migraines who are in danger of developing drug-induced headaches. Migraine prophylaxis should be taken in consideration in patients who suffer from 7 or more migraine days per month in spite of all non-pharmacological efforts. When choosing a prophylactic drug not only efficacy but tolerability and safety for long-term intake should be considered. Prophylactic drugs used to be classified as drugs of first, second and third choice. According to this step care model treatment was started with a drug of first choice and only in case of lack of efficacy or adverse events a drug of lower choice was selected. Today, in contrast to the traditional step care a stratified care is favored. Treatment is individualized based on an assessment of the patients' medical needs, on comorbidity, the migraine phenotype and most importantly the individual situation of the patient in life. The paper gives an overview of the efficacy and tolerability of drugs used in migraine prophylaxis. PMID:14655662

  9. [Prophylactic drug management of migraine].

    PubMed

    Göbel, H; Heinze, A

    2002-06-01

    Migraine prophylaxis with drugs is still an essential part of migraine therapy. This is especially true for those patients with frequent migraines who are in danger of developing drug-induced headaches. Migraine prophylaxis should be taken in consideration in patients who suffer from 7 or more migraine days per months in spite of all non-pharmacological efforts. When choosing a prophylactic drug not only efficacy but tolerability and safety for long-term intake should be considered. Prophylactic drugs used to be classified as drugs of first, second and third choice. According to this step care model treatment was started with a drug of first choice and only in case of lack of efficacy or adverse events a drug of lower choice was selected. Today, in contrast to the traditional step care a stratified care is favored. Treatment is individualized based on an assessment of the patients' medical needs, on comorbidity, the migraine phenotype and most important the individual situation of the patient in life. The paper gives an overview of the efficacy and tolerability of drugs used in migraine prophylaxis. PMID:12077682

  10. Contemporary management of drug-packers

    PubMed Central

    Kelly, J; Corrigan, M; Cahill, RA; Redmond, HP

    2007-01-01

    Experience with management of drug-packers (mules) is variable among different centres. However, despite a recorded increase in drug trafficking in general, as yet, no unified, clear guidelines exist to guide the medical management of those who only occasionally encounter these individuals. We describe our recent experience with this growing problem and discuss the most salient points concerning the contemporary management of body packers. Our recent experience demonstrates that type IV packages may now be managed conservatively for the most part. PMID:17448234

  11. Iowa Case Management for Rural Drug Abuse

    ERIC Educational Resources Information Center

    Hall, James A.; Vaughan Sarrazin, Mary S.; Huber, Diane L.; Vaughn, Thomas; Block, Robert I.; Reedy, Amanda R.; Jang, MiJin

    2009-01-01

    Objective: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. Method: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual…

  12. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee....

  13. Prospective approach to managing antimicrobial drug shortages.

    PubMed

    Griffith, Milena M; Patel, Jean A; Sutton, Sarah H; Bolon, Maureen K; Esterly, John S; Gross, Alan E; Postelnick, Michael J; Zembower, Teresa R; Scheetz, Marc H

    2012-07-01

    Antimicrobial drug shortages continue to increase, with few new therapeutic options available. Nationally, proposals have been offered to alleviate drug shortages; however, these recommendations are unlikely to effect change in the near future. Thus, antimicrobial stewardship leaders in acute care hospitals must develop a prospective management strategy to lessen the impact of these shortages on patient care. Herein, we describe several resources available to aid professionals in antimicrobial stewardship and healthcare epidemiology to manage drug shortages. An effective approach should include prospectively tracking shortages and maximizing inventory by appropriately managing usage. Several tenets should underpin this management. Alternative agents should be rationally chosen before the inventory of the primary agent has reached zero, ethical considerations should be taken into account, and timely notification and communication with key stakeholders should occur throughout the prescribing and dispensing process. PMID:22669238

  14. A Clinical study of Matra Vasti and an ayurvedic indigenous compound drug in the management of Sandhigatavata (Osteoarthritis).

    PubMed

    Shah, Mayuri R; Mehta, Charmi S; Shukla, V D; Dave, Alankruta R; Bhatt, N N

    2010-04-01

    Sandhigatavata is described under vatavyadhi in all ayurvedic classical texts. Osteoarthritis is the most common articular disorder which begins asymptomatically in the second and third decades and is extremely common by age 70. Here Matra Vasti (therapeutic enema) was given with Bala taila as Vasti is the best treatment for vatavyadhies. It has vatashamaka and rasayana properties. Indigenous compound drug containing Guggulu, Shallaki, Yastimadhu, Pippali, Guduchi, Nirgundi, Kupilu and Godanti was given in one group along with Matra Vasti. In this study, 33 patients of Sandhigatavata completed the treatment. Patients were randomly divided into two groups. Sixteen patients in Group-A (sarvanga Abhyanga-swedana + matravasti) and 17 patients in Group-B (sarvanga Abhyanga-swedana+ matravasti + indigenous compound drug). The results of the study indicate that the patients of both the groups obtained highly significant relief in almost all the signs and symptoms of Sandhigatavata. PMID:22131712

  15. A Clinical study of Matra Vasti and an ayurvedic indigenous compound drug in the management of Sandhigatavata (Osteoarthritis)

    PubMed Central

    Shah, Mayuri R.; Mehta, Charmi S.; Shukla, V. D.; Dave, Alankruta R.; Bhatt, N. N.

    2010-01-01

    Sandhigatavata is described under vatavyadhi in all ayurvedic classical texts. Osteoarthritis is the most common articular disorder which begins asymptomatically in the second and third decades and is extremely common by age 70. Here Matra Vasti (therapeutic enema) was given with Bala taila as Vasti is the best treatment for vatavyadhies. It has vatashamaka and rasayana properties. Indigenous compound drug containing Guggulu, Shallaki, Yastimadhu, Pippali, Guduchi, Nirgundi, Kupilu and Godanti was given in one group along with Matra Vasti. In this study, 33 patients of Sandhigatavata completed the treatment. Patients were randomly divided into two groups. Sixteen patients in Group-A (sarvanga Abhyanga-swedana + matravasti) and 17 patients in Group-B (sarvanga Abhyanga–swedana+ matravasti + indigenous compound drug). The results of the study indicate that the patients of both the groups obtained highly significant relief in almost all the signs and symptoms of Sandhigatavata. PMID:22131712

  16. Case management in a DUI lab: effect on drugs reported.

    PubMed

    Tiscione, Nicholas B; Shan, Xiaoqin; Yeatman, Dustin Tate

    2014-10-01

    An evaluation of an internal laboratory decision to implement a protocol for limiting drug testing based on ethanol concentration in laboratory analysis for driving under the influence (DUI) cases is presented. The described case management strategy is supported by known impairment of ethanol at relatively high concentrations, difficulty assigning a level of contributing impairment from drugs in the presence of high ethanol levels and the likelihood that the drug results may be suppressed at trial. Although the results of this study reinforce the assertion that such protocols lead to the under reporting of drugs in DUI cases, for the majority of cases, 95% in this study, the drug analysis results were not significant and did not warrant the time and resources needed for the additional blood drug testing. Furthermore, the study demonstrated that a high drug positivity rate does not necessarily mean that those drug results are legally or pharmacologically meaningful. Additional research should be conducted with quantitative drug results and casework impact of blood drug screen protocols as previous studies only report drug positivity rates and not whether the drug results would be meaningful to the case. PMID:25217546

  17. A study of the usefulness of a periarticular multimodal drug cocktail injection for pain management after total hip arthroplasty

    PubMed Central

    Nakai, Tsuyoshi; Nakamura, Toshiyuki; Nakai, Takaaki; Onishi, Atsunori; Hashimoto, Kunihiko

    2013-01-01

    Background Measures for pain management after total hip arthroplasty (THA) are important for early improvement in the quality of life after operation and early postoperative rehabilitation. We investigated the analgesic effect of locally injected drugs around the total hip prosthesis. Methods 54 patients undergoing THA were randomized either to receive a periarticular intraoperative injection of a 30-ml mixture containing morphine hydrochloride 10 mg, 0.5% bupivacaine 20 ml, epinephrine 0.3 mg, and saline 8.7 ml or to receive no injection. The perioperative analgesic regimen was standardized. The evaluation items included assessment of pain using a 100-point visual analog scale (VAS) after the patients awoke on the day of the operation and on postoperative day 1, the dose of diclofenac sodium suppository, the number of days for acquiring assisted ambulation with a walking cane, and side effects. Results The VAS score on the day of the operation was significantly low in the injection group. No cardiac or central nervous system toxicity was observed. Conclusions Intraoperative periarticular injection with multimodal drugs can significantly reduce pain on the day of the operation, with no apparent risks, following THA. PMID:24403740

  18. Impact of therapeutic drug monitoring of antiretroviral drugs in routine clinical management of patients infected with human immunodeficiency virus and related health care costs: a real-life study in a large cohort of patients

    PubMed Central

    Perrone, Valentina; Cattaneo, Dario; Radice, Sonia; Sangiorgi, Diego; Federici, Augusto B; Gismondo, Maria Rita; Medaglia, Massimo; Micheli, Valeria; Vimercati, Stefania; Pallone, Enza; Esposti, Luca Degli; Clementi, Emilio

    2014-01-01

    Background Highly active antiretroviral therapy (HAART) has reduced morbidity and mortality in patients infected with human immunodeficiency virus (HIV). Studies have documented high interindividual variability in the pharmacokinetics of antiretroviral drugs, which may impair the success of HAART if not managed properly. Therapeutic drug monitoring (TDM) is a useful diagnostic tool that helps clinicians to optimize drug doses so that drug concentrations associated with the highest therapeutic efficacy are obtained with a reduced risk of concentration-dependent adverse effects. The aim of this study was to assess whether use of TDM improves clinical outcomes and cost of illness. Methods A retrospective cohort study was conducted at L Sacco University Hospital in Milan, Italy, in HIV-infected patients aged ≥18 years with at least one prescription of antiretroviral drugs for which TDM was applied. The inclusion period was from January 2010 to December 2011, with a follow-up period of up to 12 months. Laboratory and administrative databases were analyzed and matched with each other. Results The cohort consisted of 5,347 patients (3,861 males and 1,486 females) of mean age 43.9±12.5 years. We found that TDM had been used in 143 of these patients, among whom adherence with therapy was significantly higher than among those in whom TDM had not been used (94% versus 78%). In TDM-controlled patients, the mean length of HIV-related hospitalization stay and mean cost of hospitalization were significantly reduced with respect to those observed in the group in which TDM had not been used (7.21 days versus 29.47 days and €293 versus €688, respectively). Conclusion Inclusion of TDM as part of routine clinical optimization of drug dosing in HIV-infected patients is associated with higher adherence to therapy, reduced length of hospitalization stay, and reduced cost of illness. PMID:25053888

  19. Management of psychotropic drugs during pregnancy.

    PubMed

    Chisolm, Margaret S; Payne, Jennifer L

    2016-01-01

    Psychiatric conditions (including substance misuse disorders) are serious, potentially life threatening illnesses that can be successfully treated by psychotropic drugs, even during pregnancy. Because few rigorously designed prospective studies have examined the safety of these drugs during pregnancy, the default clinical recommendation has been to discontinue them, especially during the first trimester. However, in the past decade, as more evidence has accumulated, it seems that most psychotropic drugs are relatively safe to use in pregnancy and that not using them when indicated for serious psychiatric illness poses a greater risk to both mother and child, including tragic outcomes like suicide and infanticide. This review presents an up to date and careful examination of the most rigorous scientific studies on the effects of psychotropic drugs in pregnancy. The lack of evidence in several areas means that definite conclusions cannot be made about the risks and benefits of all psychotropic drug use in pregnancy. PMID:26791406

  20. A Pilot Comparative Study of the Clarity and Assessability of the Drug Management Standards of Accreditation Canada and the US Joint Commission

    PubMed Central

    Alemanni, Jordane; Brisseau, Lionel; Lebel, Denis; Vaillancourt, Régis; Rocheleau, Louis; Bussières, Jean-François

    2011-01-01

    Background: There are few data comparing the drug management standards of the US and Canadian agencies that accredit health care institutions. Objective: To evaluate the clarity and assessability of criteria in the drug management standards adopted by Accreditation Canada and the Joint Commission (United States). Methods: A pilot study was conducted to compare the clarity and assessability of the criteria listed in the 2 standards. Criteria that were common to the 2008 versions of the Canadian and US drug management standards were identified. A panel of 12 health care professionals was assembled to independently rate the clarity (i.e., clear or unclear) and the assessability (i.e., assessable or not assessable) of each statement, using a validated comparative grid. Results: In total, there were 143 Canadian standards and 103 US standards. Sixty-two (43%) of the 143 Canadian criteria could be directly paired with a US criterion, whereas 70 (68%) of the 103 US criteria could be paired with one or more Canadian criteria. Six of the US criteria were paired with more than one Canadian criterion, and 12 of the Canadian criteria could be paired with more than one US criterion. Four of the 22 themes in the Canadian standards had no equivalent criteria in the US standards. Panel members from the pharmaceutical practice group evaluated the clarity and assessability of the Canadian criteria more severely than panel members from the nursing practice group: 86% versus 95% of individual ratings were deemed “clear” by these two groups, respectively (p < 0.001) and 64% versus 88% of individual ratings were deemed “assessable” (p < 0.001). There were no criteria that were considered unclear or unassessable by all of the panel members. Conclusions: Few data are available on drug management standards and their impact on health care. A better understanding of these standards, as well as comparisons of Canadian standards with those of other countries, might help in determining

  1. Managing leg ulceration in intravenous drug users.

    PubMed

    Geraghty, Jemell

    2015-09-01

    Chronic venous leg ulceration is a long-term condition commonly associated with lower-limb injecting and chronic venous hypertension caused by collapsed veins, incompetent valves, deep vein thrombosis and reflux. It is not usually a medical emergency, but intravenous (IV) drug users with leg ulcers can attend emergency departments (EDs) with a different primary complaint such as pain or because they cannot access local primary care or voluntary services. Leg ulceration might then be identified during history taking, so it is important that ED nurses know how to assess and manage these wounds. This article explains how to assess and manage chronic venous leg ulcers in patients with a history of IV drug use, and highlights the importance of referral to specialist services when required, and to local primary care or voluntary services, before discharge to prevent admission and re-attendance. PMID:26344539

  2. Studies of food drug interactions.

    PubMed

    Aman, Syed Faisal; Hassan, Fouzia; Naqvi, Baqar S; Hasan, Syed Muhammmad Farid

    2010-07-01

    Medicines can treat and alleviate many diseases provided that they must be taken properly to ensure that they are safe and useful. One issue related with the medicines is that whether to take on empty stomach or with food. The present work gives information regarding food-drug interactions that were studied by collecting seventy five prescriptions from various hospitals. In most of the collected prescriptions, food-drug interactions were detected using the literature available. It was also found that only few studies have been carried out so far on the effect of food on drug disposition in the Asian population. Thus more studies on food-drug interactions particularly in the local population is recommended in order to determine the effect of food and food components on drug disposition and to the kinetics of the drugs which has not yet well highlighted in this part of the world. PMID:20566446

  3. Antecedent Drug Exposure Aetiology and Management Protocols in Steven-Johnson Syndrome and Toxic Epidermal Necrolysis, A Hospital Based Prospective Study

    PubMed Central

    Farhat, Samina; Hassan, Iffat

    2016-01-01

    Aim The study sought to identify the magnitude and characteristic of severe cutaneous adverse reactions (SCAR’s) like Steven–Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Materials and Methods A prospective study was conducted by the Department of Pharmacology in association with Department of Dermatology in SMHS hospital. The study was carried out from June 2013-June 2015 on hospitalized cases of cutaneous adverse drug reaction reporting in hospital. The SCAR’s were reported in a structured questionnaire based on adverse drug reaction (ADR) reporting form provided by the Central Drug Standard Control Organization (CDSCO) Ministry of Health and Family welfare, Government of India. The SCAR’s were analysed for their characteristics, causality, severity and prognosis. Causality assessment was done by using a validated ADR probability scale of Naranjo as well as WHO Uppsala Monitoring Center (WHO-UMC) system for standardized case causality assessment. The management protocol were analysed for their clinical outcome through a proper follow up period. Results A total of 52 hospitalized cases of cutaneous adverse drug reactions were reported during the study period. We identified a total of 15 cases (28%) of SCAR’s involving 9(17%) of SJS and 6 (12%) of TEN. SJS was seen in 2(22%) males and 7(78%) females. TEN was seen in all females (100%) and in no male. Drugs implicated in causing these life threatening reactions were identified as anticonvulsant agents like carbamazepine (CBZ), phenytoin (PHT) and Lamotrigine (LTG), oxicam NSAID, Sulfasalazine and levofloxacin. Despite higher reported mortality rates in SJS and TEN all patients survived with 2 patients surviving TEN suffered from long term opthalmological sequelae of the disease. Conclusion Present study suggest that drug induced cutaneous eruptions are common ranging from common nuisance rashes to rare life threatening diseases like SJS and TEN, SJS/TEN typically occur 1-3 weeks after

  4. [The Importance of Medication History Management by Hospital and Community Pharmacists for Oral Anticancer Drug S-1(Tegafur/Gimeracil/Oteracil Potassium)--A Retrospective Study].

    PubMed

    Maeda, Makoto; Saito, Yoshimasa; Makino, Yoshinori; Iwase, Haruo; Hayashi, Yoshikazu

    2016-01-01

    S-1 (tegafur/gimeracil/oteracil potassium) is an effective oral anticancer drug for treatment of a wide spectrum of cancers. However, it may incur serious adverse effects through factors such as interactions with other drugs, renal dysfunction, or an insufficient washout period. In view of this, pharmacists should play an increasingly significant role in managing the medication history of patients treated with S-1. As there seems to be no standardized management tool for patients receiving S-1, we conducted a retrospective study to evaluate medication history management methods, which are commonly available in community pharmacies as well as hospitals. We identified 128 outpatients who were prescribed S-1 for the first time at the National Cancer Center Hospital from July to December of 2011. These patients were divided into in-hospital (n=48) and out-of-hospital (n=80) groups. The percentage of patients, who dropped out during the first course of S-1 treatment, was 16.7% for the in-hospital group, and 10% for the out-of-hospital group. Examining renal dysfunction, non-elderly patients with low creatinine clearance (Ccr) were found. These results suggest that there is the possibility of side effect occurrence in both the in-hospital and out-of-hospital prescription groups. Community pharmacists should check prescriptions with particular attention to the Ccr. It is necessary to develop mechanisms for cooperation between hospital and community pharmacists, with clear role sharing between them, allowing the community pharmacists to exercise medication history management for patients prescribed S-1 to the same degree as hospital pharmacists based on available information including laboratory test values. PMID:26809530

  5. [Management of antirheumatic drugs in kidney failure].

    PubMed

    Manganelli, Rocco; Manganelli, Serena; Iannaccone, Salvatore; De Simone, Walter

    2015-01-01

    The nephrologist deals with the management of patients with rheumatic disease, both diagnostically and therapeutically. He must determine whether the renal pathology is related to the rheumatologic disease, mostly through the use of the renal biopsy. In the second case, he must know the nephrotoxic potential of the drugs prescribed and adjust their use to the degree of renal impairment. This task is made difficult by the absence of controlled clinical trials regarding their use on patients with renal insufficiency or on chronic dialysis. For this reason, the prescription will have to take into account the pharmacokinetics of the drugs. Kidney failure can affect the metabolism of antirheumatic drugs determining their accumulation, which can lead to increased toxicity, either renal or systemic. On the other hand, dialysis can cause excessive drug removal, leading to sub-therapeutic pharmacological effects and to the need for additional doses. In this brief review, we will consider the nephrotoxic effects of some important drugs used in rheumatology and examined individually, with specific reference to rheumatoid arthritis: methotrexate, leflunamide, hydroxychloroquine, cyclosporine, biological DMARDs. In the past, therapeutic success in rheumatic diseases associated with kidney impairment was severely limited by the well- known nephrotoxicity of drugs such as gold salts, D-penicillamine, NSAIDs, COX-2 inhibitors. Although generally effective, they are contraindicated in case of kidney failure. Biologic therapies have recently opened new therapeutic perspectives. Nevertheless, it is worth stressing how our knowledge of their action is still incomplete and this may result in exposure to immune-mediated renal disease. PMID:26845207

  6. [Terbinafine : Relevant drug interactions and their management].

    PubMed

    Dürrbeck, A; Nenoff, P

    2016-09-01

    The allylamine terbinafine is the probably most frequently prescribed systemic antifungal agent in Germany for the treatment of dermatomycoses and onychomycoses. According to the German drug law, terbinafine is approved for patients who are 18 years and older; however, this antifungal agent is increasingly used off-label for treatment of onychomycoses and tinea capitis in children. Terbinafine is associated with only a few interactions with other drugs, which is why terbinafine can generally be used without problems in older and multimorbid patients. Nevertheless, some potential interactions of terbinafine with certain drug substances are known, including substances of the group of antidepressants/antipsychotics and some cardiovascular drugs. Decisive for the relevance of interactions is-along with the therapeutic index of the substrate and the possible alternative degradation pathways-the genetically determined type of metabolism. When combining terbinafine with tricyclic antidepressants or selective serotonin reuptake inhibitors and serotonin/noradrenalin reuptake inhibitors, the clinical response and potential side effects must be monitored. Problematic is the use of terbinafine with simultaneous treatment with tamoxifen. The administration of potent CYP2D6 inhibitors leads to a diminished efficacy of tamoxifen because one of its most important active metabolites-endoxifen-is not sufficiently available. Therefore, combination of tamoxifen and terbinafine should be avoided. In conclusion, the number of substances which are able to cause clinically relevant interactions in case of simultaneously administration with terbinafine is clear and should be manageable in the dermatological office with adequate monitoring. PMID:27474731

  7. Deliberating Tarceva: A case study of how British NHS managers decide whether to purchase a high-cost drug in the shadow of NICE guidance.

    PubMed

    Hughes, David; Doheny, Shane

    2011-11-01

    This paper examines audio-recorded data from meetings in which NHS managers decide whether to fund high-cost drugs for individual patients. It investigates the work of a Welsh individual patient commissioning (IPC) panel responsible for sanctioning the purchase of 'un-commissioned' treatments for exceptional cases. The case study presented highlights the changing rationales used for approving or denying a cancer drug, Tarceva, during a period when NICE first suggested it was not cost effective, but then changed its position in a final technology appraisal recommending use when the cost did not exceed that of an alternative product. Our data show how decisions taken in the shadow of NICE guidance remain complex and subject to local discretion. Guidance that takes time to prepare, is released in stages, and relates to particular disease stages, must be interpreted in the context of particular cases. The case-based IPC panel discourse stands in tension with the standardised population-based recommendations in guidance. Panel members, who based their decisions on the central notions of 'efficacy' and 'exceptionality', often struggled to apply NICE information on cost-effectiveness to their deliberations on efficacy (clinical effectiveness). The case study suggests that the complex nature of decision making makes standardization of outcomes very difficult to achieve, so that local professional judgement is likely to remain central to health care rationing at this level. PMID:22000765

  8. Ocular Drug Delivery for Glaucoma Management

    PubMed Central

    Gooch, Nathan; Molokhia, Sarah A.; Condie, Russell; Burr, Randon Michael; Archer, Bonnie; Ambati, Balamurali K.; Wirostko, Barbara

    2012-01-01

    Current glaucoma management modalities are hindered by low patient compliance and adherence. This can be due to highly complex treatment strategies or poor patient understanding. Treatments focus on the management or reduction of intraocular pressure. This is most commonly done through the use of daily topical eye drops. Unfortunately, despite effective therapies, glaucoma continues to progress, possibly due to patients not adhering to their treatments. In order to mitigate these patient compliance issues, many sustained release treatments are being researched and are entering the clinic. Conjunctival, subconjunctival, and intravitreal inserts, punctal plugs, and drug depots are currently in clinical development. Each delivery system has hurdles, yet shows promise and could potentially mitigate the current problems associated with poor patient compliance. PMID:24300188

  9. Drug management of pain in cancer patients.

    PubMed Central

    Tuttle, C B

    1985-01-01

    Chronic severe cancer pain is often not well controlled because both patient and physician have a poor understanding of the nature of the pain and of the actions of various potent analgesics. Physicians often fail to tailor analgesic dosages to the needs of the individual and unnecessarily limit the dosage because they have an ill founded fear that the patient will become addicted. The basis of rational management of cancer pain with drugs is an appropriate analgesic given regularly in doses adequate to suppress pain continuously. This review compares the potent analgesics and identifies and discusses those that have a role in treating chronic cancer pain. It emphasizes the value of morphine sulfate and gives information on starting and individualizing dosages and managing side effects. PMID:2856896

  10. Experimental study and evaluation of radioprotective drugs

    NASA Technical Reports Server (NTRS)

    Smith, D. E.; Thomson, J. F.

    1968-01-01

    Experimental study evaluates radioprotective drugs administered before exposure either orally or intravenously. Specifically studied are the sources of radiation, choice of radiation dose, choice of animals, administration of drugs, the toxicity of protective agents and types of protective drug.

  11. Increased Access to Care and Appropriateness of Treatment at Private Sector Drug Shops with Integrated Management of Malaria, Pneumonia and Diarrhoea: A Quasi-Experimental Study in Uganda

    PubMed Central

    Awor, Phyllis; Wamani, Henry; Tylleskar, Thorkild; Jagoe, George; Peterson, Stefan

    2014-01-01

    Introduction Drug shops are a major source of care for children in low income countries but they provide sub-standard care. We assessed the feasibility and effect on quality of care of introducing diagnostics and pre-packaged paediatric-dosage drugs for malaria, pneumonia and diarrhoea at drug shops in Uganda. Methods We adopted and implemented the integrated community case management (iCCM) intervention within registered drug shops. Attendants were trained to perform malaria rapid diagnostic tests (RDTs) in each fever case and count respiratory rate in each case of cough with fast/difficult breathing, before dispensing recommended treatment. Using a quasi-experimental design in one intervention and one non-intervention district, we conducted before and after exit interviews for drug seller practices and household surveys for treatment-seeking practices in May–June 2011 and May–June 2012. Survey adjusted generalized linear models and difference-in-difference analysis was used. Results 3759 (1604 before/2155 after) household interviews and 943 (163 before/780 after) exit interviews were conducted with caretakers of children under-5. At baseline, no child at a drug shop received any diagnostic testing before treatment in both districts. After the intervention, while no child in the non-intervention district received a diagnostic test, 87.7% (95% CI 79.0–96.4) of children with fever at the intervention district drug shops had a parasitological diagnosis of malaria, prior to treatment. The prevalence ratios of the effect of the intervention on treatment of cough and fast breathing with amoxicillin and diarrhoea with ORS/zinc at the drug shop were 2.8 (2.0–3.9), and 12.8 (4.2–38.6) respectively. From the household survey, the prevalence ratio of the intervention effect on use of RDTs was 3.2 (1.9–5.4); Artemisinin Combination Therapy for malaria was 0.74 (0.65–0.84), and ORS/zinc for diarrhoea was 2.3 (1.2–4.7). Conclusion iCCM can be utilized to improve

  12. Collaborative drug therapy management and comprehensive medication management-2015.

    PubMed

    McBane, Sarah E; Dopp, Anna L; Abe, Andrew; Benavides, Sandra; Chester, Elizabeth A; Dixon, Dave L; Dunn, Michaelia; Johnson, Melissa D; Nigro, Sarah J; Rothrock-Christian, Tracie; Schwartz, Amy H; Thrasher, Kim; Walker, Scot

    2015-04-01

    The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication-related outcomes in collaborative practice environments. New models of care delivery emphasize patient-centered, team-based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team-based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication-related outcomes. PMID:25884536

  13. Management of type 2 diabetes and its prescription drug cost before and during the economic crisis in Greece: an observational study

    PubMed Central

    2014-01-01

    Background The aim of the present study is to examine the clinical indices related to cardiovascular risk management of Greek patients with type 2 diabetes, before and after the major economic crisis that emerged in the country. Methods In this retrospective database study, the medical records of patients with type 2 diabetes treated at three diabetes outpatient centers of the national health system during 2006 and 2012 were examined. Only patients with at least six months of follow-up prior to the recorded examination were included. The prescription cost was calculated in Euros per patient-year (€PY). Results A total of 1953 medical records (938 from 2006 and 1015 from 2012) were included. There were no significant differences in adjusted HbA1c, systolic blood pressure and HDL-C, while significant reductions were observed in LDL-C and triglycerides. In 2012, a higher proportion of patients were prescribed glucose-lowering, lipid-lowering and antihypertensive medications. Almost 4 out of 10 patients were prescribed the new incretin-based medications, while the use of older drugs, except for metformin, decreased. A significant increase in the adjusted glucose-lowering prescription cost (612.4 [586.5-638.2] €PY vs 390.7 [363.5-418.0]; p < 0.001) and total prescription cost (1306.7 [1264.6-1348.7] €PY vs 1122.3[1078.1-1166.5]; p < 0.001) was observed. The cost of antihypertensive prescriptions declined, while no difference was observed for lipid-lowering and antiplatelet agents. Conclusions During the economic crisis, the cardiovascular risk indices of Greek patients with type 2 diabetes being followed in public outpatient diabetes clinics did not deteriorate and in the case of lipid profile improved. However, the total prescription cost increased, mainly due to the higher cost of glucose-lowering prescriptions. PMID:24593679

  14. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... to reduce medication errors and adverse drug interactions and improve medication use that include...

  15. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... to reduce medication errors and adverse drug interactions and improve medication use that include...

  16. [Quality management systems in drugs regulatory authorities: social impact].

    PubMed

    Frías-Ferreiro, G; Ysa-Sánchez, A M; García-Gutiérrez, B; García-García, V

    2010-01-01

    The aim of this paper is to illustrate the social impact of drugs regulatory authorities' procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described. PMID:19857983

  17. Designer drugs 2015: assessment and management.

    PubMed

    Weaver, Michael F; Hopper, John A; Gunderson, Erik W

    2015-01-01

    Recent designer drugs, also known as "legal highs," include substituted cathinones (e.g., mephedrone, methylone, and methylenedioxypyrovalerone, often referred to as "bath salts"); synthetic cannabinoids (SCs; e.g., Spice); and synthetic hallucinogens (25I-NBOMe, or N-bomb). Compound availability has evolved rapidly to evade legal regulation and detection by routine drug testing. Young adults are the primary users, but trends are changing rapidly; use has become popular among members of the military. Acute toxicity is common and often manifests with a constellation of psychiatric and medical effects, which may be severe (e.g., anxiety, agitation, psychosis, and tachycardia), and multiple deaths have been reported with each of these types of designer drugs. Clinicians should keep designer drugs in mind when evaluating substance use in young adults or in anyone presenting with acute neuropsychiatric complaints. Treatment of acute intoxication involves supportive care targeting manifesting signs and symptoms. Long-term treatment of designer drug use disorder can be challenging and is complicated by a lack of evidence to guide treatment. PMID:25928069

  18. Systematic review on quality control for drug management programs: Is quality reported in the literature?

    PubMed Central

    Holtorf, Anke-Peggy; McAdam-Marx, Carrie; Schaaf, David; Eng, Benjamin; Oderda, Gary

    2009-01-01

    Background Maintaining quality of care while managing limited healthcare resources is an ongoing challenge in healthcare. The objective of this study was to evaluate how the impact of drug management programs is reported in the literature and to identify potentially existing quality standards. Methods This analysis relates to the published research on the impact of drug management on economic, clinical, or humanistic outcomes in managed care, indemnity insurance, VA, or Medicaid in the USA published between 1996 and 2007. Included articles were systematically analyzed for study objective, study endpoints, and drug management type. They were further categorized by drug management tool, primary objective, and study endpoints. Results None of the 76 included publications assessed the overall quality of drug management tools. The impact of 9 different drug management tools used alone or in combination was studied in pharmacy claims, medical claims, electronic medical records or survey data from either patient, plan or provider perspective using an average of 2.1 of 11 possible endpoints. A total of 68% of the studies reported the impact on plan focused endpoints, while the clinical, the patient or the provider perspective were studied to a much lower degree (45%, 42% and 12% of the studies). Health outcomes were only accounted for in 9.2% of the studies. Conclusion Comprehensive assessment of quality considering plan, patient and clinical outcomes is not yet applied. There is no defined quality standard. Benchmarks including health outcomes should be determined and used to improve the overall clinical and economic effectiveness of drug management programs. PMID:19243591

  19. Patent term extension systems differentiate Japanese and US drug lifecycle management.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-01-01

    Drug lifecycle management (LCM) contributes to maximizing drug discovery investment returns. After initial drug approval, additional approvals can be sought for novel indications and formulations to extend product marketability. Patents provide additional barriers to entry and patent term extension systems facilitate extension of these. Several aspects of the US and Japanese patent term extension systems differ. Therefore, we compared both systems using a drug LCM case study to highlight the differences. Our findings indicate that the extension of multiple drug patents on multiple occasions in Japan produces a more complicated range of extended patent protections, compared with the US system. PMID:26360052

  20. Collaborative drug therapy management and its application to pharmaceutical compounding.

    PubMed

    Anderson, Derick

    2007-01-01

    Patient care within the US healthcare system is changing constantly, as are the roles of healthcare practitioners, including pharmacists. For over 30 years, pharmacists have promoted the concept of clinical pharmacy, which places pharmacists in a central role in patient medication management. The goal is to allow the pharmacist to become a vital part of treatment planning by individualizing patients' therapeutic regimens. The Collaborative Drug Therapy Management agreement is a step toward that goal. The combination of drug therapy management and compounding pharmacy can be powerful in meeting patients' specific needs. PMID:23974486

  1. Microfluidics for Drug Discovery and Development: From Target Selection to Product Lifecycle Management

    PubMed Central

    Kang, Lifeng; Chung, Bong Geun; Langer, Robert; Khademhosseini, Ali

    2009-01-01

    Microfluidic technologies’ ability to miniaturize assays and increase experimental throughput have generated significant interest in the drug discovery and development domain. These characteristics make microfluidic systems a potentially valuable tool for many drug discovery and development applications. Here, we review the recent advances of microfluidic devices for drug discovery and development and highlight their applications in different stages of the process, including target selection, lead identification, preclinical tests, clinical trials, chemical synthesis, formulations studies, and product management. PMID:18190858

  2. Microfluidics for drug discovery and development: from target selection to product lifecycle management.

    PubMed

    Kang, Lifeng; Chung, Bong Geun; Langer, Robert; Khademhosseini, Ali

    2008-01-01

    Microfluidic technologies' ability to miniaturize assays and increase experimental throughput have generated significant interest in the drug discovery and development domain. These characteristics make microfluidic systems a potentially valuable tool for many drug discovery and development applications. Here, we review the recent advances of microfluidic devices for drug discovery and development and highlight their applications in different stages of the process, including target selection, lead identification, preclinical tests, clinical trials, chemical synthesis, formulations studies and product management. PMID:18190858

  3. Anticonvulsant drugs for management of pain: a systematic review.

    PubMed Central

    McQuay, H.; Carroll, D.; Jadad, A. R.; Wiffen, P.; Moore, A.

    1995-01-01

    OBJECTIVE--To determine effectiveness and adverse effects of anticonvulsant drugs in management of pain. DESIGN--Systematic review of randomised controlled trials of anticonvulsants for acute, chronic, or cancer pain identified by using Medline, by hand searching, by searching reference lists, and by contacting investigators. SUBJECTS--Between 1966 and February 1994, 37 reports were found; 20 reports, of four anticonvulsants, were eligible. MAIN OUTCOME MEASURES--Numbers needed to treat were calculated for effectiveness, adverse effects, and drug related withdrawal from study. RESULTS--The only placebo controlled study in acute pain found no analgesic effect of sodium valproate. For treating trigeminal neuralgia, carbamazepine had a combined number needed to treat of 2.6 for effectiveness, 3.4 for adverse effects, and 24 for severe effects (withdrawal from study). For treating diabetic neuropathy, anticonvulsants had a combined number needed to treat of 2.5 for effectiveness, 3.1 for adverse effects, and 20 for severe effects. For migraine prophylaxis, anticonvulsants had a combined number needed to treat of 1.6 for effectiveness, 2.4 for adverse effects, and 39 for severe effects. Phenytoin had no effect on the irritable bowel syndrome, and carbamazepine had little effect on pain after stroke. Clonazepam was effective in one study for temporomandibular joint dysfunction. No study compared one anticonvulsant with another. CONCLUSIONS--Anticonvulsants were effective for trigeminal neuralgia and diabetic neuropathy and for migraine prophylaxis. Minor adverse effects occurred as often as benefit. PMID:7580659

  4. Prevalence of illicit drug use in patients without controlled substance abuse in interventional pain management.

    PubMed

    Manchikanti, Laxmaiah; Pampati, Vidyasagar; Damron, Kim S; Beyer, Carla D; Barnhill, Renee C

    2003-04-01

    Drug abuse with illicit drugs and licit drugs has been increasing steadily over the past decade. A recent National Household Survey on Drug Abuse found statistically significant increases between 2000 and 2001 in the use of multiple drugs, including marijuana, cocaine, and non-medical use of pain relievers and tranquilizers. Prescription controlled substance abuse is a major issue in chronic pain management. Various means suggested to avoid or monitor abuse in patients in treatment include urine/serum drug screening whenever requested, along with other precautions including one prescribing physician and one designated pharmacy, etc. Based on the present evidence, physicians assume that patients adhering to controlled substance agreements and without obvious dependency behavior do not abuse either illicit or licit drugs. Thus, it is accepted that there is no necessity to perform routine urine/drug testing in this specific group of the patient population. One hundred patients undergoing interventional pain management and receiving controlled substances were randomly selected for evaluation of illicit drug abuse by urine drug testing. They were selected from a total of 250 patients who were identified as non-abusers of prescription drugs. Results showed that illicit drug abuse in patients without history of controlled substance abuse was seen in 16 patients. Thirteen of the 16 patients tested positive for marijuana and 3 patients tested positive for cocaine. Only one patient tested positive for a combined use of both marijuana and cocaine. This study showed that, in an interventional pain management setting, there is significant use of illicit drugs (16%) with 13% use of marijuana and 3% use of cocaine in patients who are considered as non-abusers of prescription controlled substances and those who are adherent to controlled substance agreements. However, if cocaine is considered as a hardcore drug in contrast to marijuana, abuse of hardcore illicit drugs is only 3

  5. Social Studies. Health: Drugs, Society and You.

    ERIC Educational Resources Information Center

    Faulkner, Brenda F.

    The major intent of this interdisciplinary quinmester course for grades seven through twelve is to examine the need, problems, consequences, and social aspects of drug abuse. By studying the history and medicine of drug use, students learn background information that helps them define and categorize legitimate and illegitimate drug use, and…

  6. [MANAGEMENT OF PSYCHOTROPIC DRUGS IN HIV-INFECTED PATIENTS].

    PubMed

    Zirulnik, Jorge L

    2015-01-01

    Here we make a revision about the rational use of psychopharmacological drugs in HIV/AIDS patients. We revised the clinical use of psychotropic drugs in this setting. In the clinical spectrum, the most frequent clinical pictures are the depression, anxiety disorders, psychosis, delirium, and the cognitive and behavioral neuropsychiatric symptoms associated with the HIV/AIDS dementia and the substance abuse-dependence. Also, we analyzed the most important pharmacological interactions between psychotropic drugs and antiretrovirals. The medical education and the interdisciplinary work are the basic topics to an adequate clinical management of this kind of patients. PMID:26650559

  7. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... and systems to reduce medication errors and adverse drug interactions and improve medication use...

  8. Atopic Dermatitis: Drug Delivery Approaches in Disease Management.

    PubMed

    Lalan, Manisha; Baweja, Jitendra; Misra, Ambikanandan

    2015-01-01

    In this review, we describe the very basic of atopic dermatitis (AD), the established management strategies, and the advances in drug delivery approaches for successful therapeutic outcomes. The multifactorial pathophysiology of AD has given rise to the clinician's paradigm of topical and systemic therapy and potential combinations. However, incomplete remission of skin disorders like AD is a major challenge to be overcome. Recurrence is thought to be due to genetic and immunological etiologies and shortcomings in drug delivery. This difficulty has sparked research in nanocarrier-based delivery approaches as well as molecular biology-inspired stratagems to deal with the immunological imbalance and to address insufficiencies of delivery propositions. In this review, we assess various novel drug delivery strategies in terms of their success and utility. We present a brief compilation and assessment of management modalities to sensitize the readers to therapeutic scenario in AD. PMID:26080926

  9. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management...

  10. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm....

  11. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice..., 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management Advisory...

  12. An Oral Contraceptive Drug Interaction Study

    ERIC Educational Resources Information Center

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  13. [Pain management with herbal antirheumatic drugs].

    PubMed

    Chrubasik, Sigrun; Pollak, S

    2002-01-01

    Herbal antirheumatics are indicated in painful inflammatory and degenerative rheumatic diseases. Their mechanism of action is broader than that of synthetic antirheumatics. Particular preparations from Devils's Claw with 50 to 100 mg of harpagoside in the daily dosage as well as a particular willow bark extract with 120 to 240 mg salicin in the daily dosage proved efficacy in a number of clinical studies including confirmatory ones. Exploratory studies indicate that these herbal antirheumatics were not inferior to the selective COX-2 inhibitor rofecoxib when treating acute exacerbations of chronic low back pain. For the proprietary nettle root extract IDS23 promising in vitro/in vivo results indicate an anti-inflammatory effect, however there are only 2 open uncontrolled clinical studies available and the proof of efficacy is still missing. Safety data in order to recommend use during pregnancy and lactation are only available for the herbal combination product Phytodolor prepared from aspen, ash and goldenrod. In principle, blackcurrent leaf with not less than 1.5% flavonoids may be an appropriate antirheumatic. Likewise, the seed oils of blackcurrent, evening primrose and borage offering at least 1 to 3 g gammalinolenic acid/day are recommendable. In case superiority versus placebo has been established, proprietary herbal antirheumatics should be administered before the conventional analgesics due to the lower incidence of adverse events. PMID:12017748

  14. Drug sample management in University of Montreal family medicine teaching units

    PubMed Central

    Lussier, Marie-Thérèse; Vanier, Marie-Claude; Authier, Marie; Diallo, Fatoumata Binta; Gagnon, Justin

    2015-01-01

    Abstract Objective To describe the management and distribution of drug samples in family medicine teaching units (FMUs). Design Cross-sectional descriptive study. Setting All 16 FMUs affiliated with the Department of Family Medicine and Emergency Medicine at the University of Montreal in Quebec. Participants Health care professionals (physicians, residents, pharmacists, and nurses) who manage (n = 22) and dispense (n = 294) drug samples in the FMUs. Methods Data were collected between February and March 2013 using 2 self-administered questionnaires completed by health care professionals who manage or dispense drug samples. The data were subjected to descriptive and bivariate analyses. Results The participation rate was 100.0% for staff who manage drug samples and 72.5% for those who dispense them. Of the 16 participating FMUs, 12 have drug sample cabinets. Eight of the FMUs have a written institutional policy governing the management of drug samples. Of the 76.2% of respondents who said they distributed samples, more than half did not know whether their institution had a policy. In 7 of 12 FMUs with drug sample cabinets, access to samples is not restricted to those authorized to prescribe medications. Cabinets are most often managed by nurses (9 of 12 FMUs). Only 4 of 12 FMUs take regular inventory of cabinet contents. The main reasons cited for dispensing samples were to help a patient financially and to test for tolerance and efficacy when initiating or modifying a treatment for a patient. Three-quarters (78.2%) of dispensers reported that sometimes they were unable to find the drug they wanted in the cabinet; half of those consequently gave patients drugs that were not their first choice. More than half the dispensers reported they never or only occasionally referred patients to their community pharmacists. Conclusion A portrait of drug sample management and dispensation in the academic FMUs emerged from this study. This study provides insight into current

  15. Skin conditions: new drugs for managing skin disorders.

    PubMed

    Nguyen, Tam; Zuniga, Ramiro

    2013-04-01

    New drugs are available for managing several common skin disorders. For psoriasis, topical corticosteroids remain the first-line therapy, but topical vitamin D3 analogs, such as calcipotriene, now have a role. They are as effective as medium-potency topical steroids but without steroid side effects, though they can induce hypercalcemia if the dose exceeds 100 g/week. For more severe cases, methotrexate has been widely used, but other drugs now also are prescribed. They include calcineurin inhibitors, such as cyclosporine, and more recently, biologic agents, such as tumor necrosis factor inhibitors. For children and pregnant women, in whom the previously discussed drugs are not appropriate, narrowband UV-B light often is the first-line treatment. For eczema, patients requiring steroid-sparing topical drugs can be treated with calcineurin inhibitors (ie, pimecrolimus or tacrolimus); between the 2, tacrolimus is the first choice for adults and children older than 2 years. When systemic management is needed, oral calcineurin inhibitors (eg, cyclosporine) are appropriate, though oral steroids often are needed for severe cases. The need for systemic management can sometimes be delayed with use of diluted bleach baths. For acne vulgaris, standard treatments with topical benzoyl peroxide and topical or systemic antibiotics are used widely, as are oral contraceptives, but oral isotretinoin is the most effective treatment. PMID:23600334

  16. HIV Drug-Resistant Patient Information Management, Analysis, and Interpretation

    PubMed Central

    Mars, Maurice

    2012-01-01

    Introduction The science of information systems, management, and interpretation plays an important part in the continuity of care of patients. This is becoming more evident in the treatment of human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS), the leading cause of death in sub-Saharan Africa. The high replication rates, selective pressure, and initial infection by resistant strains of HIV infer that drug resistance will inevitably become an important health care concern. This paper describes proposed research with the aim of developing a physician-administered, artificial intelligence-based decision support system tool to facilitate the management of patients on antiretroviral therapy. Methods This tool will consist of (1) an artificial intelligence computer program that will determine HIV drug resistance information from genomic analysis; (2) a machine-learning algorithm that can predict future CD4 count information given a genomic sequence; and (3) the integration of these tools into an electronic medical record for storage and management. Conclusion The aim of the project is to create an electronic tool that assists clinicians in managing and interpreting patient information in order to determine the optimal therapy for drug-resistant HIV patients. PMID:23611761

  17. Drug-drug interaction studies on first-line anti-tuberculosis drugs.

    PubMed

    Bhutani, Hemant; Singh, Saranjit; Jindal, K C

    2005-01-01

    The purpose of this study was to carry out drug-drug compatibility studies on pure first line anti-tuberculosis drugs, viz., rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol hydrochloride (E). Various possible binary, ternary, and quaternary combinations of the four drugs were subjected to accelerated stability test conditions of 40 degrees C and 75% relative humidity (RH) for 3 months. For comparison, parallel studies were also conducted on single drugs. Changes were looked for in the samples drawn after 15, 30, 60, and 90 days of storage. Analyses for R, H, and Z were carried out using a validated HPLC method. The E was analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS), as it does not absorb in ultraviolet (UV). All single pure drugs were relatively stable and showed only 3%-5% degradation under accelerated conditions for 3 months. However, significant interactions were observed in case of the drug mixtures. In particular, ternary and quaternary drug combinations containing R and H along with Z and/or E were very unstable, showing 90%-95% and 70%-75% loss of R and H, respectively. In all these cases, isonicotinyl hydrazone (HYD) of 3-formylrifamycin and H was found to be the major degradation product. In case of RE and RZE mixtures, where H was absent, 3-formylrifamycin was instead the key degradation product. Another unidentified peak was observed in the mixture containing RZE. Apart from these chemical changes, considerable physical changes were also observed in pure E and the mixtures containing E, viz., RE, ZE, RHE, RZE, and RHZE. In addition, significant physical changes associated with noteworthy loss of H and E were also observed in mixtures containing HE and HZE. The present study thus amply shows that the four primary anti-tuberculosis drugs, when present together, interact with each other in a multiple and complex manner. PMID:16370181

  18. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION...

  19. The VACS Index Accurately Predicts Mortality and Treatment Response among Multi-Drug Resistant HIV Infected Patients Participating in the Options in Management with Antiretrovirals (OPTIMA) Study

    PubMed Central

    Brown, Sheldon T.; Tate, Janet P.; Kyriakides, Tassos C.; Kirkwood, Katherine A.; Holodniy, Mark; Goulet, Joseph L.; Angus, Brian J.; Cameron, D. William; Justice, Amy C.

    2014-01-01

    Objectives The VACS Index is highly predictive of all-cause mortality among HIV infected individuals within the first few years of combination antiretroviral therapy (cART). However, its accuracy among highly treatment experienced individuals and its responsiveness to treatment interventions have yet to be evaluated. We compared the accuracy and responsiveness of the VACS Index with a Restricted Index of age and traditional HIV biomarkers among patients enrolled in the OPTIMA study. Methods Using data from 324/339 (96%) patients in OPTIMA, we evaluated associations between indices and mortality using Kaplan-Meier estimates, proportional hazards models, Harrel’s C-statistic and net reclassification improvement (NRI). We also determined the association between study interventions and risk scores over time, and change in score and mortality. Results Both the Restricted Index (c = 0.70) and VACS Index (c = 0.74) predicted mortality from baseline, but discrimination was improved with the VACS Index (NRI = 23%). Change in score from baseline to 48 weeks was more strongly associated with survival for the VACS Index than the Restricted Index with respective hazard ratios of 0.26 (95% CI 0.14–0.49) and 0.39(95% CI 0.22–0.70) among the 25% most improved scores, and 2.08 (95% CI 1.27–3.38) and 1.51 (95%CI 0.90–2.53) for the 25% least improved scores. Conclusions The VACS Index predicts all-cause mortality more accurately among multi-drug resistant, treatment experienced individuals and is more responsive to changes in risk associated with treatment intervention than an index restricted to age and HIV biomarkers. The VACS Index holds promise as an intermediate outcome for intervention research. PMID:24667813

  20. Thermodynamic Studies for Drug Design and Screening

    PubMed Central

    Garbett, Nichola C.; Chaires, Jonathan B.

    2012-01-01

    Introduction A key part of drug design and development is the optimization of molecular interactions between an engineered drug candidate and its binding target. Thermodynamic characterization provides information about the balance of energetic forces driving binding interactions and is essential for understanding and optimizing molecular interactions. Areas covered This review discusses the information that can be obtained from thermodynamic measurements and how this can be applied to the drug development process. Current approaches for the measurement and optimization of thermodynamic parameters are presented, specifically higher throughput and calorimetric methods. Relevant literature for this review was identified in part by bibliographic searches for the period 2004 – 2011 using the Science Citation Index and PUBMED and the keywords listed below. Expert opinion The most effective drug design and development platform comes from an integrated process utilizing all available information from structural, thermodynamic and biological studies. Continuing evolution in our understanding of the energetic basis of molecular interactions and advances in thermodynamic methods for widespread application are essential to realize the goal of thermodynamically-driven drug design. Comprehensive thermodynamic evaluation is vital early in the drug development process to speed drug development towards an optimal energetic interaction profile while retaining good pharmacological properties. Practical thermodynamic approaches, such as enthalpic optimization, thermodynamic optimization plots and the enthalpic efficiency index, have now matured to provide proven utility in design process. Improved throughput in calorimetric methods remains essential for even greater integration of thermodynamics into drug design. PMID:22458502

  1. Contingency management: utility in the treatment of drug abuse disorders.

    PubMed

    Stitzer, M L; Vandrey, R

    2008-04-01

    Contingency management (CM) is a strategy that uses positive reinforcement to improve the clinical outcomes of substance abusers in treatment, especially sustained abstinence from drugs of abuse. Further, CM has been adopted to improve methodology and interpretation of outcomes in clinical trials testing new pharmacotherapies and to improve adherence to efficacious medications in substance abuse patients. Thus, CM has proven to be widely useful as a direct therapeutic intervention and as a tool in treatment development. PMID:18305456

  2. Clinical Management of Nonsteroidal Anti-inflammatory Drug Hypersensitivity

    PubMed Central

    2008-01-01

    Hypersensitivity diseases caused by nonsteroidal anti-inflammatory agents are relatively common in the population. This article summarizes the present understanding on the various allergic and nonallergic clinical pictures produced through hypersensitivity to these drugs using the pathogenic classification of hypersensitivity reactions recently proposed by the Nomenclature Committee of the World Allergy Organization to guide clinicians in the diagnosis and management of patients with these conditions. PMID:23283307

  3. A theoretical examination of the relative importance of evolution management and drug development for managing resistance

    PubMed Central

    McClure, Nathan S.; Day, Troy

    2014-01-01

    Drug resistance is a serious public health problem that threatens to thwart our ability to treat many infectious diseases. Repeatedly, the introduction of new drugs has been followed by the evolution of resistance. In principle, there are two complementary ways to address this problem: (i) enhancing drug development and (ii) slowing the evolution of drug resistance through evolutionary management. Although these two strategies are not mutually exclusive, it is nevertheless worthwhile considering whether one might be inherently more effective than the other. We present a simple mathematical model that explores how interventions aimed at these two approaches affect the availability of effective drugs. Our results identify an interesting feature of evolution management that, all else equal, tends to make it more effective than enhancing drug development. Thus, although enhancing drug development will necessarily be a central part of addressing the problem of resistance, our results lend support to the idea that evolution management is probably a very significant component of the solution as well. PMID:25377456

  4. Use of analgesic drugs for pain management in sheep.

    PubMed

    Lizarraga, I; Chambers, J P

    2012-03-01

    Awareness of pain and its effects is increasing within the veterinary profession, but pain management in food animals has been neglected. Sheep seldom receive analgesics despite various conditions, husbandry practice and experimental procedures being known to be painful, e.g. footrot, mastitis, vaginal prolapse, castration, vasectomy, penis deviation, and laparoscopy. The evidence supporting use of analgesic drugs in this species is reviewed here. Opioid agonists are of dubious efficacy and are short acting. α₂-agonists such as xylazine are good, short-lived analgesics, but induce hypoxaemia. Non-steroidal anti-inflammatory drugs (NSAID) such as ketoprofen provide long-lasting analgesia, but not as marked as that from α₂-agonists; they should be more widely used for inflammatory pain. Local anaesthetics reliably block pain signals, but may also induce motor blockade. Balanced analgesia using more than one class of drug, such as an α₂ agonist (e.g. medetomidine) and N-methyl-D-aspartate antagonist (e.g. ketamine), with the combination selected for the circumstances, probably provides the best analgesia for severe pain. It should be noted that there are no approved analgesic drugs for use in sheep and therefore the use of such drugs in this species has to be off-label. This information may be useful to veterinary practitioners, biomedical researchers, and regulators in animal welfare to develop rational analgesic regimens which ultimately may improve the health and welfare of sheep in both farming and experimental conditions. PMID:22352925

  5. Vaccine and Drug Ontology Studies (VDOS 2014).

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2016-01-01

    The "Vaccine and Drug Ontology Studies" (VDOS) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, developing new models such as the Vaccine Ontology (VO) and Ontology of Adverse Events (OAE), vernacular medical terminologies such as the Consumer Health Vocabulary (CHV). The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The five full-length papers included in this 2014 thematic issue focus on two main themes: (i) General vaccine/drug-related ontology development and exploration, and (ii) Interaction and network-related ontology studies. PMID:26918107

  6. Pharmacokinetic drug-drug interaction and their implication in clinical management

    PubMed Central

    Palleria, Caterina; Di Paolo, Antonello; Giofrè, Chiara; Caglioti, Chiara; Leuzzi, Giacomo; Siniscalchi, Antonio; De Sarro, Giovambattista; Gallelli, Luca

    2013-01-01

    Drug-drug interactions (DDIs) are one of the commonest causes of medication error in developed countries, particularly in the elderly due to poly-therapy, with a prevalence of 20-40%. In particular, poly-therapy increases the complexity of therapeutic management and thereby the risk of clinically important DDIs, which can both induce the development of adverse drug reactions or reduce the clinical efficacy. DDIs can be classify into two main groups: pharmacokinetic and pharmacodynamic. In this review, using Medline, PubMed, Embase, Cochrane library and Reference lists we searched articles published until June 30 2012, and we described the mechanism of pharmacokinetic DDIs focusing the interest on their clinical implications. PMID:24516494

  7. New analytical strategies in studying drug metabolism.

    PubMed

    Staack, Roland F; Hopfgartner, Gérard

    2007-08-01

    Identification and elucidation of the structures of metabolites play major roles in drug discovery and in the development of pharmaceutical compounds. These studies are also important in toxicology or doping control with either pharmaceuticals or illicit drugs. This review focuses on: new analytical strategies used to identify potential metabolites in biological matrices with and without radiolabeled drugs; use of software for metabolite profiling; interpretation of product spectra; profiling of reactive metabolites; development of new approaches for generation of metabolites; and detection of metabolites with increased sensitivity and simplicity. Most of the new strategies involve mass spectrometry (MS) combined with liquid chromatography (LC). PMID:17583803

  8. Fee structure for investigational drug studies.

    PubMed

    Anandan, J V; Isopi, M J; Warren, A J

    1993-11-01

    The development and implementation of a fee structure for a pharmacy-coordinated investigational drug service is described. A pilot task and time study established specific time and cost elements for investigational drug services provided by the pharmacy department. To fully assess the costs in dispensing investigational drugs, each research study that used the investigational drug service was broken down into five phases of service. Each phase was further categorized by specific tasks or activities, and a time element to perform each activity or task was determined. Since some studies could require more elaborate randomization of patients, more extensive review of protocols, or more individualized dispensing procedures than others, a range of charges was derived: $2800 for standard protocols to $5700 for more complicated studies. An institutional drug therapy newsletter describing the services and costs was distributed to all medical staff members and principal investigators. The development of a fee structure for an investigational drug service coordinated by the pharmacy department has ensured that pharmacy services are adequately reimbursed and has allowed the department to allocate appropriate personnel to provide the services. PMID:8266958

  9. Management of drug interactions with beta-blockers: continuing education has a short-term impact

    PubMed Central

    Driesen, Annelies; Simoens, Steven; Laekeman, Gert

    There is a lack of clear guidelines regarding the management of drug-drug interactions. Objective To assess the impact of an educational intervention on the management of drug interactions with beta-blockers. Methods The study had a controlled before-and-after design. The intervention group (n=10 pharmacies) received a continuing education course and guidelines on the management of drug interactions with beta-blockers. The control group (n=10 pharmacies) received no intervention. Pharmacy students and staff of internship pharmacies participated in this study. Before and after the intervention, students registered interactions with beta-blockers during two weeks. Information was obtained on drug information of the beta-blocker and the interacting drug, patient’s demographics, and the mode of transaction. Results A total number of 288 interactions were detected during both study periods. Most beta-blockers causing an interaction were prescribed for hypertension, and interacted with hypoglycemic agents, NSAIDs, or beta2-agonists. Pharmacists’ intervention rate was low (14% in the pre-test compared to 39% in the post-test), but increased significantly in the post-test in the intervention group. Reasons for overriding the interaction included limited clinical relevance, refill prescriptions, not being aware of the interaction, and communication problems with the prescriber. Conclusion An interactive continuing education course, during which practice-oriented guidelines were offered, affected pharmacists’ short-term behavior at the counter in dealing with interactions of beta-blockers. Continuing education plays a role in raising pharmacists’ awareness and responsibility towards the detection and management of drug interactions in the pharmacy. PMID:25214902

  10. An Effectiveness Trial of Contingency Management in a Felony Preadjudication Drug Court

    ERIC Educational Resources Information Center

    Marlowe, Douglas B.; Festinger, David S.; Dugosh, Karen L.; Arabia, Patricia L.; Kirby, Kimberly C.

    2008-01-01

    This study evaluated a contingency management (CM) program in a drug court. Gift certificates for compliance were delivered at 4- to 6-week intervals (total value = $390.00). Participants in one condition earned gift certificates that escalated by $5.00 increments. Participants in a second condition began earning higher magnitude gift…

  11. Addressing drug adherence using an operations management model.

    PubMed

    Nunlee, Martin; Bones, Michelle

    2014-01-01

    OBJECTIVE To provide a model that enables health systems and pharmacy benefit managers to provide medications reliably and test for reliability and validity in the analysis of adherence to drug therapy of chronic disease. SUMMARY The quantifiable model described here can be used in conjunction with behavioral designs of drug adherence assessments. The model identifies variables that can be reproduced and expanded across the management of chronic diseases with drug therapy. By creating a reorder point system for reordering medications, the model uses a methodology commonly seen in operations research. The design includes a safety stock of medication and current supply of medication, which increases the likelihood that patients will have a continuous supply of medications, thereby positively affecting adherence by removing barriers. CONCLUSION This method identifies an adherence model that quantifies variables related to recommendations from health care providers; it can assist health care and service delivery systems in making decisions that influence adherence based on the expected order cycle days and the expected daily quantity of medication administered. This model addresses the possession of medication as a barrier to adherence. PMID:24407742

  12. Adverse drug interactions with nonsteroidal anti-inflammatory drugs (NSAIDs). Recognition, management and avoidance.

    PubMed

    Johnson, A G; Seideman, P; Day, R O

    1993-02-01

    The prevalence and incidence of adverse drug interactions involving nonsteroidal anti-inflammatory drugs (NSAIDs) remains unknown. To identify those proposed drug interactions of greatest clinical significance, it is appropriate to focus on interactions between commonly used and/or commonly coprescribed drugs, interactions for which there are numerous well documented case reports in reputable journals, interactions validated by well designed in vivo human studies and those affecting high-risk drugs and/or high-risk patients. While most interactions between NSAIDs and other drugs are pharmacokinetic, NSAID-related pharmacodynamic interactions may be considerably more important in the clinical context, and prescriber ignorance is likely to be a major determinant of many adverse drug interactions. Prescribing NSAIDs is relatively contraindicated for patients on oral anticoagulants due to the risk of haemorrhage, and for patients taking high-dose methotrexate due to the dangers of bone marrow toxicity, renal failure and hepatic dysfunction. Combination NSAID therapy cannot be justified as toxicity may be increased without any improvement in efficacy. Where lithium or anti-hypertensives are coprescribed with NSAIDs, close monitoring is mandatory for lithium toxicity and hypertension, respectively, and aspirin (acetylsalicylic acid) or sulindac are preferred. Phenytoin or oral hypoglycaemic agents may be administered with NSAIDs other than pyrazoles and salicylates provided that patients are monitored carefully at the initiation and cessation of NSAID treatment. Digoxin, aminoglycosides and probenecid may be coprescribed with NSAIDs, but close monitoring is required, particularly for high-risk patients such as the elderly. Indomethacin and triamterene should be avoided due to the risk of renal failure. High dose aspirin should be replaced by naproxen in patients on valproic acid (sodium valproate) and care is required when corticosteroids are administered to patients

  13. Critical Assessment of Implantable Drug Delivery Devices in Glaucoma Management

    PubMed Central

    Manickavasagam, Dharani; Oyewumi, Moses O.

    2013-01-01

    Glaucoma is a group of heterogeneous disorders involving progressive optic neuropathy that can culminate into visual impairment and irreversible blindness. Effective therapeutic interventions must address underlying vulnerability of retinal ganglion cells (RGCs) to degeneration in conjunction with correcting other associated risk factors (such as elevated intraocular pressure). However, realization of therapeutic outcomes is heavily dependent on suitable delivery system that can overcome myriads of anatomical and physiological barriers to intraocular drug delivery. Development of clinically viable sustained release systems in glaucoma is a widely recognized unmet need. In this regard, implantable delivery systems may relieve the burden of chronic drug administration while potentially ensuring high intraocular drug bioavailability. Presently there are no FDA-approved implantable drug delivery devices for glaucoma even though there are several ongoing clinical studies. The paper critically assessed the prospects of polymeric implantable delivery systems in glaucoma while identifying factors that can dictate (a) patient tolerability and acceptance, (b) drug stability and drug release profiles, (c) therapeutic efficacy, and (d) toxicity and biocompatibility. The information gathered could be useful in future research and development efforts on implantable delivery systems in glaucoma. PMID:24066234

  14. Salivary Secretory Disorders, Inducing Drugs, and Clinical Management

    PubMed Central

    Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Lahor-Soler, Eduard; Farré, Magí

    2015-01-01

    Background: Salivary secretory disorders can be the result of a wide range of factors. Their prevalence and negative effects on the patient's quality of life oblige the clinician to confront the issue. Aim: To review the salivary secretory disorders, inducing drugs and their clinical management. Methods: In this article, a literature search of these dysfunctions was conducted with the assistance of a research librarian in the MEDLINE/PubMed Database. Results: Xerostomia, or dry mouth syndrome, can be caused by medication, systemic diseases such as Sjögren's Syndrome, glandular pathologies, and radiotherapy of the head and neck. Treatment of dry mouth is aimed at both minimizing its symptoms and preventing oral complications with the employment of sialogogues and topical acting substances. Sialorrhea and drooling, are mainly due to medication or neurological systemic disease. There are various therapeutic, pharmacologic, and surgical alternatives for its management. The pharmacology of most of the substances employed for the treatment of salivary disorders is well-known. Nevertheless, in some cases a significant improvement in salivary function has not been observed after their administration. Conclusion: At present, there are numerous frequently prescribed drugs whose unwanted effects include some kind of salivary disorder. In addition, the differing pathologic mechanisms, and the great variety of existing treatments hinder the clinical management of these patients. The authors have designed an algorithm to facilitate the decision making process when physicians, oral surgeons, or dentists face these salivary dysfunctions. PMID:26516310

  15. The role of the clinical pharmacologist in the management of adverse drug reactions.

    PubMed

    Moore, N

    2001-01-01

    The classical definition of clinical pharmacology is the study or the knowledge of the effects of drugs in humans. The activities of a clinical pharmacologist can vary from country to country, usually ranging from involvement in clinical trials, especially fundamental pharmacodynamic studies, to studies of pharmacokinetics and drug metabolism, to pharmacogenetics. Most clinical pharmacologists outside industry are in hospitals or university hospitals and research centres. In addition to research, this implies teaching of clinical pharmacology, and interacting with other medical staff: in the field of research, giving advice on clinical trials methodology and often managing a therapeutic drug monitoring centre. Some clinical pharmacologists have clinical departments with beds or consulting offices. Can there be another role for the clinical pharmacologist that would increase his or her usefulness for the medical community? Adverse drug reactions (ADRs) are remarkably complex events, related to drug effects, patient characteristics (background diseases, genetics), and drug/disease interactions. Evaluation of ADRs requires understanding of drug mechanisms and interactions, and of disease diagnostics, especially in the discussion of alternative diagnoses. This implies expertise as a pharmacologist and a clinician. In addition, because not all adverse reactions or interactions are in the Summary of Product Characteristics, and because problems arise long before they report in the literature, it is necessary for the clinical pharmacologist to have knowledge of ongoing regulatory processes, in addition to having access to the published literature. Helping clinicians cope with individual patient problems will also improve the clinical pharmacologist's integration into the healthcare process. PMID:11219484

  16. Youth and Drugs. Internships in Drug Education: A Feasibility Study.

    ERIC Educational Resources Information Center

    Cheaney, Lee

    New statistics indicate that drug use is prevalent among today's youth for reasons of alienation, affluency, a philosophy of experimentation, peer pressure of social acceptance, availability of drugs, and changing values. The solution lies not in punitive measures but in education as a practical approach. Although much is being done toward drug…

  17. ALCOHOL AND DRUG SERVICE STUDY (ADSS)

    EPA Science Inventory

    The Alcohol and Drug Services Study (ADSS) is a nationally representative survey of substance abuse treatment facilities and clients. The data were collected to estimate the client length of stay and the costs of treatment as well as to describe the post-treatment status of clien...

  18. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee....

  19. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... published an Advisory Bulletin (75 FR 2926) implementing the annual collection of contractor MIS drug and...; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information.... Operators are reminded that drug and alcohol testing information must be submitted for...

  20. A Time Management Study.

    ERIC Educational Resources Information Center

    Gothberg, Helen M.; And Others

    In order to evaluate time management practices among managers of large academic libraries, questionnaires were mailed to 189 library directors. A total of 158 surveys were returned for a response rate of 82%. Items used to collect data in the questionnaire were based on time management literature and were grouped into five categories: (1) a…

  1. Diacerein: A potential therapeutic drug for the management of experimental periodontitis in rats

    PubMed Central

    Zaki, Basma Mostafa; Mahmoud, Enji Ahmed; Aly, Azza Ahmed

    2015-01-01

    Introduction: Knowledge about the pathogenic process in the progression of periodontal disease indicates that the central cause of periodontal disease is the loss of a healthy balance between microbial virulence factors and the host’s inflammatory response. The aim of this study was to evaluate the potential effectiveness of diacerein as an anti-inflammatory drug in the management of experimental periodontitis in rats. Methods: The study included 60 albino rats that were divided into two groups. Periodontitis was induced in both groups. The drug group received systemic administration of diacerein, and the control group received a placebo. IL-1ß was measured two weeks after the induction of periodontitis and before the administration of the drug (baseline measurement), and it was measured again at the end of two and end of four weeks after scaling and root planning and diacerein administration. Results: The results indicated that there was a significant decrease in IL-1ß level in both groups. For the control group, there were significant decreases of the IL-1ß values from the baseline to two weeks and also from the baseline to four weeks, with p-values of 0.0001 for both comparisons. The same results were obtained for the drug group. Conclusion: It was concluded that it is likely that diacerein may play a therapeutic role as a potent anti-inflammatory drug in the management of periodontitis. PMID:26435830

  2. Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children

    PubMed Central

    Chhim, Rebecca F.; Shelton, Chasity M.; Christensen, Michael L.

    2013-01-01

    The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children. PMID:23616733

  3. Performance of online drug information databases as clinical decision support tools in infectious disease medication management.

    PubMed

    Polen, Hyla H; Zapantis, Antonia; Clauson, Kevin A; Clauson, Kevin Alan; Jebrock, Jennifer; Paris, Mark

    2008-01-01

    Infectious disease (ID) medication management is complex and clinical decision support tools (CDSTs) can provide valuable assistance. This study evaluated scope and completeness of ID drug information found in online databases by evaluating their ability to answer 147 question/answer pairs. Scope scores produced highest rankings (%) for: Micromedex (82.3), Lexi-Comp/American Hospital Formulary Service (81.0), and Medscape Drug Reference (81.0); lowest includes: Epocrates Online Premium (47.0), Johns Hopkins ABX Guide (45.6), and PEPID PDC (40.8). PMID:18999059

  4. Antiretroviral Drug Interactions: Overview of Interactions Involving New and Investigational Agents and the Role of Therapeutic Drug Monitoring for Management

    PubMed Central

    Rathbun, R. Chris; Liedtke, Michelle D.

    2011-01-01

    Antiretrovirals are prone to drug-drug and drug-food interactions that can result in subtherapeutic or supratherapeutic concentrations. Interactions between antiretrovirals and medications for other diseases are common due to shared metabolism through cytochrome P450 (CYP450) and uridine diphosphate glucuronosyltransferase (UGT) enzymes and transport by membrane proteins (e.g., p-glycoprotein, organic anion-transporting polypeptide). The clinical significance of antiretroviral drug interactions is reviewed, with a focus on new and investigational agents. An overview of the mechanistic basis for drug interactions and the effect of individual antiretrovirals on CYP450 and UGT isoforms are provided. Interactions between antiretrovirals and medications for other co-morbidities are summarized. The role of therapeutic drug monitoring in the detection and management of antiretroviral drug interactions is also briefly discussed. PMID:24309307

  5. Baseline Antihypertensive Drug Count and Patient Response to Hypertension Medication Management.

    PubMed

    Crowley, Matthew J; Olsen, Maren K; Woolson, Sandra L; King, Heather A; Oddone, Eugene Z; Bosworth, Hayden B

    2016-04-01

    Telemedicine-based medication management improves hypertension control, but has been evaluated primarily in patients with low antihypertensive drug counts. Its impact on patients taking three or more antihypertensive agents is not well-established. To address this evidence gap, the authors conducted an exploratory analysis of an 18-month, 591-patient trial of telemedicine-based hypertension medication management. Using general linear models, the effect of medication management on blood pressure for patients taking two or fewer antihypertensive agents at study baseline vs those taking three or more was compared. While patients taking two or fewer antihypertensive agents had a significant reduction in systolic blood pressure with medication management, those taking three or more had no such response. The between-subgroup effect difference was statistically significant at 6 months (-6.4 mm Hg [95% confidence interval, -12.2 to -0.6]) and near significant at 18 months (-6.0 mm Hg [95% confidence interval, -12.2 to 0.2]). These findings suggest that baseline antihypertensive drug count may impact how patients respond to hypertension medication management and emphasize the need to study management strategies specifically in patients taking three or more antihypertensive medications. PMID:26370918

  6. Indicators of Club Management Practices and Biological Measurements of Patrons’ Drug and Alcohol Use

    PubMed Central

    Byrnes, Hilary F.; Miller, Brenda A.; Johnson, Mark B.; Voas, Robert B.

    2015-01-01

    Background Electronic Music Dance Events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. Objectives The relationship between club management practices and biological measures of patrons’ alcohol/drug use is examined. Methods Observational data from 25 events across 6 urban clubs were integrated with survey data (N=738 patrons, 42.8% female) from patrons exiting these events, 2010–2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Results Analyses revealed that serving intoxicated patrons and safety signs were related to less substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. Conclusions/Importance Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed. PMID:24832721

  7. Use of intramuscular methadone in managing intravenous drug abuse.

    PubMed

    Bezant, Edward Michael

    2014-01-01

    A 30-year-old woman was referred to the Acute Pain Team for their advice on how to manage her current pain, in light of her unique pre-admission medications. On questioning it was discovered that the patient was receiving 50 mg of intramuscular methadone daily, in the community. She was a former intravenous drug user who had been enrolled into a methadone substitution programme for 10 years and had been receiving her methadone intramuscularly for the past 6 years. It had been discovered that her addiction was not solely to opioids but, moreover, to the process of injecting as well. She was diagnosed with obsessive compulsive disorder, with a needle fixation, and started on the intramuscular methadone regimen on which she has maintained abstinence from heroin for 6 years. PMID:25414219

  8. Emerging Trends in the Use of Drugs to Manage the Challenging Behaviour of People with Intellectual Disability

    ERIC Educational Resources Information Center

    McGillivray, Jane A.; McCabe, Marita P.

    2006-01-01

    Background: Concerns about the pharmacological management of the behaviour of individuals with intellectual disability have resulted in the development of legislative and procedural controls. Method: This Australian study provided a comparison of 873 reported cases where drugs were administered to manage behaviour in March 2000, with 762 cases…

  9. In vitro drug release mechanism and drug loading studies of cubic phase gels.

    PubMed

    Lara, Marilisa G; Bentley, M Vitória L B; Collett, John H

    2005-04-11

    Glyceryl monooleate/water cubic phase systems were investigated as drug delivery systems, using salicylic acid as a model drug. The liquid crystalline phases formed by the glyceryl monooleate (GMO)/water systems were characterized by polarizing microscopy. In vitro drug release studies were performed and the influences of initial water content, swelling and drug loading on the drug release properties were evaluated. Water uptake followed second-order swelling kinetics. In vitro release profiles showed Fickian diffusion control and were independent on the initial water content and drug loading, suggesting GMO cubic phase gels suitability for use as drug delivery system. PMID:15778062

  10. Therapeutic Management of Familial Hypercholesterolemia: Current and Emerging Drug Therapies.

    PubMed

    Patel, Roshni S; Scopelliti, Emily M; Savelloni, Julie

    2015-12-01

    Familial hypercholesterolemia (FH) is a genetic disorder characterized by significantly elevated low-density lipoprotein cholesterol (LDL-C) concentrations that result from mutations of the LDL receptor, apolipoprotein B (apo B-100), and proprotein convertase subtilisin/kexin type 9 (PCSK9). Early and aggressive treatment can prevent premature atherosclerotic cardiovascular disease in these high-risk patients. Given that the cardiovascular consequences of FH are similar to typical hypercholesterolemia, traditional therapies are utilized to decrease LDL-C levels. Patients with FH should receive statins as first-line treatment; high-potency statins at high doses are often required. Despite the use of statins, additional treatments are often necessary to achieve appropriate LDL-C lowering in this patient population. Novel drug therapies that target the pathophysiologic defects of the condition are continuously emerging. Contemporary therapies including mipomersen (Kynamro, Genzyme), an oligonucleotide inhibitor of apo B-100 synthesis; lomitapide (Juxtapid, Aegerion), a microsomal triglyceride transfer protein inhibitor; and alirocumab (Praluent, Sanofi-Aventis/Regeneron) and evolocumab (Repatha, Amgen), PCSK9 inhibitors, are currently approved by the U.S. Food and Drug Administration for use in FH. This review highlights traditional as well as emerging contemporary therapies with supporting clinical data to evaluate current recommendations and discuss the future direction of FH management. PMID:26684558

  11. PET IMAGING STUDIES IN DRUG ABUSE RESEARCH.

    SciTech Connect

    Fowler, J.S.; Volkow, N.D.; Ding, Y.S.; Logan, J.; Wang, G.J.

    2001-01-29

    . This will be followed by highlights of PET studies of the acute effects of the psychostimulant drugs cocaine and methylphenidate (ritalin) and studies of the chronic effects of cocaine and of tobacco smoke on the human brain. This chapter concludes with the description of a study which uses brain imaging coupled with a specific pharmacological challenge to address the age-old question of why some people who experiment with drugs become addicted while others do not.

  12. Doctoral Women: Managing Emotions, Managing Doctoral Studies

    ERIC Educational Resources Information Center

    Aitchison, Claire; Mowbray, Susan

    2013-01-01

    This paper explores the experiences of women doctoral students and the role of emotion during doctoral candidature. The paper draws on the concept of emotional labour to examine the two sites of emotional investment students experienced and managed during their studies: writing and family relationships. Emotion is perceived by many dominant…

  13. Nonclinical Evaluations of Small-Molecule Oncology Drugs: Integration into Clinical Dose Optimization and Toxicity Management.

    PubMed

    Dambach, Donna M; Simpson, Natalie E; Jones, Thomas W; Brennan, Richard J; Pazdur, Richard; Palmby, Todd R

    2016-06-01

    Multidisciplinary approaches that incorporate nonclinical pharmacologic and toxicologic characterization of small-molecule oncology drugs into clinical development programs may facilitate improved benefit-risk profiles and clinical toxicity management in patients. The performance of the current nonclinical safety-testing scheme was discussed, highlighting current strengths and areas for improvement. While current nonclinical testing appears to predict the clinical outcome where the prevalence of specific adverse effects are high, nonclinical testing becomes less reliable for predicting clinical adverse effects that occur infrequently, as with some kinase inhibitors. Although adverse effects associated with kinase inhibitors can often be predicted on the basis of target biology, drugs can be promiscuous and inhibit targets with poorly defined function and associated risks. Improvements in adverse effect databases and better characterization of the biologic activities of drug targets may enable better use of computational modeling approaches in predicting adverse effects with kinase inhibitors. Assessing safety of a lead candidate in parallel with other drug properties enables incorporation of a molecule's best features during chemical design, eliminates the worst molecules early, and permits timely investigation/characterization of toxicity mechanisms for identified liabilities. A safety lead optimization and candidate identification strategy that reduces intrinsic toxicity and metabolic risk and enhances selectivity can deliver selective kinase inhibitors that demonstrate on-target adverse effects identified nonclinically. Integrating clinical and nonclinical data during drug development can facilitate better identification and management of oncology drugs. Follow-up nonclinical studies may be used to better understand the risks in a given patient population and minimize or manage these risks more appropriately. Clin Cancer Res; 22(11); 2618-22. ©2016 AACR SEE ALL

  14. [Evaluation of the complementary drug Factor AF2 as a supportive agent in management of advanced urothelial carcinoma. Prospective randomized multicenter study].

    PubMed

    Krege, S; Hinke, A; Otto, T; Rübben, H

    2002-03-01

    This is a prospective randomized multicenter trial for evaluation of the biological response modifier Factor AF2 in advanced urothelial cancer treated with chemotherapy. Main aim of the study was the analysis of supportive effects. Additionally patients were examined with regard to tumor response, time to progression and survival. 106 patients with advanced urothelial cancer received chemotherapy with cisplatin and methotrexate. They were randomized for additional Factor AF2 (500 mg i.v., given at days 0-3, 7-10 and 11-14). Myelotoxicity was more common and severe in the group without Factor AF2 reaching statistical significance. Gastrointestinal side effects occurred in both groups, though grade III to IV toxicity was more common without Factor AF2. Overall remission rate was 38%, median survival 33 weeks, mean time to progression 20 weeks. There was no significant difference between the two groups with or without Factor AF2. PMID:11993095

  15. Data base management study

    NASA Technical Reports Server (NTRS)

    1976-01-01

    Data base management techniques and applicable equipment are described. Recommendations which will assist potential NASA data users in selecting and using appropriate data base management tools and techniques are presented. Classes of currently available data processing equipment ranging from basic terminals to large minicomputer systems were surveyed as they apply to the needs of potential SEASAT data users. Cost and capabilities projections for this equipment through 1985 were presented. A test of a typical data base management system was described, as well as the results of this test and recommendations to assist potential users in determining when such a system is appropriate for their needs. The representative system tested was UNIVAC's DMS 1100.

  16. Drug use among inner-city African American women: the process of managing loss.

    PubMed

    Roberts, C A

    1999-09-01

    The grounded theory study described in this article investigated illicit drug use in the lives of 32 drug-using women living in two inner-city neighborhoods of a large metropolitan U.S. city. The underlying purpose was to describe the process of how life situations and events influenced the onset of drug use and changes in drug-using behaviors. Analysis of in-depth interviews revealed several themes. The basic social process, managing loss, was identified. Painful feelings of loss resulted from the separation of someone or something from the lives of participants and included death or desertion of a significant other, loss of child custody, and rejection by a significant other. Emotional, physical, and sexual abuse resulted in a loss of ability to give and receive love and trust in oneself or others. Losses resulted in an escalation of drug use. Findings have implications for interventions to assist women in dealing with drug use, violence in their lives, self-care, and parenting. PMID:10558371

  17. Can drug-drug interactions be predicted from in vitro studies?

    PubMed

    Kremers, Pierre

    2002-03-19

    Potential drug-drug interactions as well as drug-xenobiotic interactions are a major source of clinical problems, sometimes with dramatic consequences. Investigation of drug-drug interactions during drug development is a major concern for the drug companies while developing new drugs. Our knowledge of the drug-metabolising enzymes, their mechanism of action, and their regulation has made considerable progress during the last decades. Various efficient in vitro approaches have been developed during recent years and powerful computer-based data handling is becoming widely available. All these tools allow us to initiate, early in the development of new chemical entities, large-scale studies on the interactions of drugs with selective cytochrome P-450 (CYP) isozymes, drug receptors, and other cellular entities. Standardisation and validation of these methodological approaches significantly improve the quality of the data generated and the reliability of their interpretation. The simplicity and the low costs associated with the use of in vitro techniques have made them a method of choice to investigate drug-drug interactions. Promising successes have been achieved in the extrapolation of in vitro data to the in vivo situation and in the prediction of drug-drug interaction. Nevertheless, linking in vitro and in vivo studies still remains fraught with difficulties and should be made with great caution. PMID:12806001

  18. The Challenges in Managing HIV in People Who Use Drugs

    PubMed Central

    Kamarulzaman, Adeeba; Altice, Frederick L.

    2015-01-01

    Purpose of review HIV management in PWUD is typically complex and challenging due to the presence of multiple medical and psychiatric comorbidities as well as social, physical, economic and legal factors that often disrupt the HIV continuum of care. In this review we describe the individual, health systems and societal barriers to HIV treatment access and care retention for people who use drugs. Additionally the clinical management of HIV infected PWUD is often complicated by the presence of multiple infectious and non-infectious comorbidities. Recent findings Improved ART adherence can be achieved through the provision of opiate substitution therapy (OST), directly administered antiretroviral therapy (DAART) and integration of ART with OST services. Recent advances with direct-acting antivirals (DAA) for HCV have shown superior outcomes compared to interferon based regimes in HIV-HCV co-infected patients. Newer diagnostic technologies for tuberculosis hold promise for earlier diagnosis for PWUD co-infected with TB Summary HIV-infected PWUDs are a key population who frequently experience suboptimal outcomes along the HIV continuum of care. A comprehensive strategy that encompasses evidence-based prevention and treatment interventions that target the individual, family, healthcare system, legal and societal structure is required to ensure greater participation and success in HIV treatment and care. PMID:25490106

  19. Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

    PubMed Central

    Mackey, Tim K

    2012-01-01

    Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

  20. Progress in the study of drug nanocrystals.

    PubMed

    Shi, Jing; Guo, Fei; Zheng, Aiping; Zhang, Xiaoyan; Sun, Jianxu

    2015-12-01

    The poor water solubility of many candidate drugs remains a major obstacle to their development and clinical use, especially for oral drug delivery. Nanocrystal technology can improve the solubility and dissolution rates of many poorly water-soluble drugs very effectively, significantly improving their oral bioavailability and decreasing the food effect. For this reason, this technology is becoming a key area of drug delivery research. This review presents much of the recent progress in nanocrystal drug pharmaceuticals, including the characteristics, composition, preparation technology, and clinical applications of these drugs. Finally, the effect of nanocrystal technology on insoluble drugs is quantified and described. PMID:26817271

  1. Hepatotoxicity Related to Anti-tuberculosis Drugs: Mechanisms and Management.

    PubMed

    Ramappa, Vidyasagar; Aithal, Guruprasad P

    2013-03-01

    Development of idiosyncratic hepatotoxicity is an intricate process involving both concurrent as well as sequential events determining the direction of the pathways, degree of liver injury and its outcome. Decades of clinical observation have identified a number of drug and host related factors that are associated with an increased risk of antituberculous drug-induced hepatotoxicity, although majority of the studies are retrospective with varied case definitions and sample sizes. Investigations on genetic susceptibility to hepatotoxicity have so far focused on formation and accumulation reactive metabolite as well as factors that contribute to cellular antioxidant defense mechanisms and the environment which can modulate the threshold for hepatocyte death secondary to oxidative stress. Recent advances in pharmacogenetics have promised the development of refined algorithms including drug, host and environmental risk factors that allow better tailoring of medications based on accurate estimates of risk-benefit ratio. Future investigations exploring the pathogenesis of hepatotoxicity should be performed using human tissue and samples whenever possible, so that the novel findings can be translated readily into clinical applications. PMID:25755470

  2. Drug Court Effectiveness: A Matched Cohort Study in the Dane County Drug Treatment Court

    ERIC Educational Resources Information Center

    Brown, Randall

    2011-01-01

    Drug treatment courts (DTCs) are widely viewed as effective diversion programs for drug-involved offenders; however, previous studies frequently used flawed comparison groups. In the current study, the author compared rates of recidivism for drug court participants to rates for a traditionally adjudicated comparison group matched on potentially…

  3. Are we using drugs rationally? A survey study from Turkey

    PubMed Central

    Ozdinc, Serife; Sensoy, Nazli; Kurt, Rumeysa; Altas, Sevda; Altun, Ramazan

    2015-01-01

    Objectives: To investigate the rational use of drugs from patient’s perspective. Methods: This study was conducted at the Afyon Kocatepe University Training and Research Hospital between February and March 2013. Data were collected with a questionnaire. Descriptive statistics and Chi-Square test were used. Results: About 54% (n=419) of participants reported that they used drugs without the advice of a physician. The 19-24 age group, secondary and high school graduates, and students used drugs more often without consulting a physician (P < 0.05). Participants that used drugs after consulting a physician did not fully use the drugs as recommended by the physician, and physicians did not give patients adequate information about prescribed drug(s). 72% of participants stored drug(s) at home. Conclusions: Rational use of drugs is not completely achieved. Certain patient groups and even physicians are closer to being a part of the irrational use of drugs. PMID:26649005

  4. Comprehensive stormwater management study

    SciTech Connect

    Morrison, T. ); Alter, M. ); Wassum, R.H. )

    1994-02-01

    This article examines Tucson, Arizona's approach to stormwater management. The topics of the article include the quantity and quality of stormwater, developing the stormwater master plan, meeting environmental and regulatory constraints. Tucson's comprehensive, watershed by watershed approach to public works planning and stormwater program development is described.

  5. Modelling Simple Experimental Platform for In Vitro Study of Drug Elution from Drug Eluting Stents (DES)

    NASA Astrophysics Data System (ADS)

    Kalachev, L. V.

    2016-06-01

    We present a simple model of experimental setup for in vitro study of drug release from drug eluting stents and drug propagation in artificial tissue samples representing blood vessels. The model is further reduced using the assumption on vastly different characteristic diffusion times in the stent coating and in the artificial tissue. The model is used to derive a relationship between the times at which the measurements have to be taken for two experimental platforms, with corresponding artificial tissue samples made of different materials with different drug diffusion coefficients, to properly compare the drug release characteristics of drug eluting stents.

  6. [The importance of clinical data management in improvement of drug evaluation].

    PubMed

    Huang, Qin; Wang, Jun

    2015-11-01

    Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment. PMID:26911033

  7. Drug utilisation study in a tertiary care center: recommendations for improving hospital drug dispensing policies.

    PubMed

    Mittal, Niti; Mittal, R; Singh, I; Shafiq, Nusrat; Malhotra, S

    2014-07-01

    Drug therapy accounts for a major portion of health expenditure. A useful strategy for achieving cost efficient healthcare is drug utilisation research as it forms the basis for making amendments in drug policies and helps in rational drug use. The present observational study was conducted to generate data on drug utilization in inpatients of our tertiary care hospital to identify potential targets for improving drug prescribing patterns. Data was collected retrospectively from randomly selected 231 medical records of patients admitted in various wards of the hospital. WHO Anatomical Therapeutic Chemical/Defined Daily Dose methodology was used to assess drug utilisation data and drug prescriptions were analysed by WHO core drug indicators. Antibiotics were prescribed most frequently and also accounted for majority of drug costs. The prescribed daily dose for most of the antibiotics corresponded to defined daily dose reflecting adherence to international recommendations. Brand name prescribing and polypharmacy was very common.78% of the total drugs prescribed were from the National List of Essential Medicines 2003. Restricting the use of newer and costlier antibiotics, branded drugs and number of drugs per prescription could be considered as targets to cut down the cost of drug therapysignificantly. PMID:25284928

  8. Practical considerations and patient selection for intrathecal drug delivery in the management of chronic pain

    PubMed Central

    Saulino, Michael; Kim, Philip S; Shaw, Erik

    2014-01-01

    Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of “last resort”, intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a “critical mass” intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients’ needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents – morphine and ziconotide – are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations

  9. The Development and Evaluation of an Integrated Electronic Prescribing and Drug Management System for Primary Care

    PubMed Central

    Tamblyn, Robyn; Huang, Allen; Kawasumi, Yuko; Bartlett, Gillian; Grad, Roland; Jacques, André; Dawes, Martin; Abrahamowicz, Michal; Perreault, Robert; Taylor, Laurel; Winslade, Nancy; Poissant, Lise; Pinsonneault, Alain

    2006-01-01

    Objective: To develop and evaluate the acceptability and use of an integrated electronic prescribing and drug management system (MOXXI) for primary care physicians. Design: A 20-month follow-up study of MOXXI (Medical Office of the XXIst Century) implementation in 28 primary care physicians and 13,515 consenting patients. Measurement: MOXXI was developed to enhance patient safety by integrating patient demographics, retrieving active drugs from pharmacy systems, generating an automated problem list, and providing electronic prescription, stop order, automated prescribing problem alerts, and compliance monitoring functions. Evaluation of technical performance, acceptability, and use was conducted using audit trails, questionnaires, standardized tasks, and information from comprehensive health insurance databases. Results: Perceived improvements in continuity of care and professional autonomy were associated with physicians' expected use of MOXXI. Physician speed in using MOXXI improved substantially in the first three months; however, only the represcribing function was faster using MOXXI than by handwritten prescription. Physicians wrote electronic prescriptions in 36.9 per 100 visits and reviewed the patient's drug profile in 12.6 per 100 visits. Physicians rated printed prescriptions, the current drug list, and the represcribing function as the most beneficial aspects of the system. Physicians were more likely to use the drug profile for patients who used more medication, made more emergency department visits, had more prescribing physicians, and lower continuity of care. Conclusion: Primary care physicians believed an integrated electronic prescribing and drug management system would improve continuity of care, and they were more likely to use the system for patients with more complex, fragmented care. PMID:16357357

  10. Practical considerations and patient selection for intrathecal drug delivery in the management of chronic pain.

    PubMed

    Saulino, Michael; Kim, Philip S; Shaw, Erik

    2014-01-01

    Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of "last resort", intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a "critical mass" intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients' needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents - morphine and ziconotide - are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations for intrathecal

  11. Drug Monitoring Programs Do Curb Overdose Deaths: Study

    MedlinePlus

    ... 159528.html Drug Monitoring Programs Do Curb Overdose Deaths: Study Opioid epidemic demands such measures, researcher says ... News) -- Drug monitoring programs appear to help reduce deaths from prescription painkillers called opioids, a new study ...

  12. Management systems research study

    NASA Technical Reports Server (NTRS)

    Bruno, A. V.

    1975-01-01

    The development of a Monte Carlo simulation of procurement activities at the NASA Ames Research Center is described. Data cover: simulation of the procurement cycle, construction of a performance evaluation model, examination of employee development, procedures and review of evaluation criteria for divisional and individual performance evaluation. Determination of the influences and apparent impact of contract type and structure and development of a management control system for planning and controlling manpower requirements.

  13. Present concepts in management of atrial fibrillation: From drug therapy to ablation

    PubMed Central

    Forleo, Giovanni B; Santini, Luca; Romeo, Francesco

    2009-01-01

    Atrial fibrillation (AF) management requires knowledge of its pattern of presentation, underlying conditions, and decisions about restoration and maintenance of sinus rhythm, control of the ventricular rate, and anti-thrombotic therapy. Maintenance of sinus rhythm is a desirable goal in AF patients because the prevention of recurrence may improve cardiac function, relieve symptoms and reduce the likelihood of adverse events. Anti-arrhythmic drug therapy is the first-line treatment for patients with paroxysmal and persistent AF based on current guidelines. However, currently used drugs have limited efficacy and cause cardiac and extracardiac toxicity. Thus, there is a continued need to develop new drugs, device and ablative approaches to rhythm management. Additionally, simpler and safer stroke prevention regimens are needed for AF patients on life-long anticoagulation, including occlusion of the left atrial appendage. The results of the Randomized Evaluation of Long-Term Anticoagulant Therapy study are encouraging in these settings. Knowledge on the pathophysiology of AF is rapidly expanding and identification of focally localized triggers has led to the development of new treatment options for this arrhythmia. Conversely, the clinical decision whether to restore and maintain sinus rhythm or simply control the ventricular rate has remained a matter of intense debate. In the minority of patients in whom AF cannot be adequately managed by pharmacological therapy, the most appropriate type of non-pharmacological therapy must be selected on an individualized basis. Curative treatment of AF with catheter ablation is now a legitimate option for a large number of patients. The evolution of hybrid therapy, in which two or more different strategies are employed in the same patient, may be an effective approach to management of AF. In any case, planning a treatment regimen for AF should include evaluation of the risks inherent in the use of various drugs as well as more

  14. Drug-induced lupus erythematosus: incidence, management and prevention.

    PubMed

    Chang, Christopher; Gershwin, M Eric

    2011-05-01

    The generation of autoantibodies and autoimmune diseases such as systemic lupus erythematosus has been associated with the use of certain drugs in humans. Early reports suggested that procainamide and hydralazine were associated with the highest risk of developing lupus, quinidine with a moderate risk and all other drugs were considered low or very low risk. More recently, drug-induced lupus has been associated with the use of the newer biological modulators such as tumour necrosis factor (TNF)-α inhibitors and interferons. The clinical features and laboratory findings of TNFα inhibitor-induced lupus are different from that of traditional drug-induced lupus or idiopathic lupus, and standardized criteria for the diagnosis of drug-induced lupus have not been established. The mechanism(s) responsible for the development of drug-induced lupus may vary depending on the drug or even on the patient. Besides lupus, other autoimmune diseases have been associated with drugs or toxins. Diagnosis of drug-induced lupus requires identification of a temporal relationship between drug administration and symptom development, and in traditional drug-induced lupus there must be no pre-existing lupus. Resolution of symptoms generally occurs after cessation of the drug. In this review, we will discuss those drugs that are more commonly associated with drug-induced lupus, with an emphasis on the new biologicals and the difficulty of making the diagnosis of drug-induced lupus against a backdrop of the autoimmune diseases that these drugs are used to treat. Stimulation of the immune system by these drugs to cause autoimmunity may in fact be associated with an increased effectiveness in treating the pathology for which they are prescribed, leading to the dilemma of deciding which is worse, the original disease or the adverse effect of the drug. Optimistically, one must hope that ongoing research in drug development and in pharmacogenetics will help to treat patients with the maximum

  15. Drug-induced QT interval prolongation: mechanisms and clinical management

    PubMed Central

    Nachimuthu, Senthil; Assar, Manish D.

    2012-01-01

    The prolonged QT interval is both widely seen and associated with the potentially deadly rhythm, Torsades de Pointes (TdP). While it can occur spontaneously in the congenital form, there is a wide array of drugs that have been implicated in the prolongation of the QT interval. Some of these drugs have either been restricted or withdrawn from the market due to the increased incidence of fatal polymorphic ventricular tachycardia. The list of drugs that cause QT prolongation continues to grow, and an updated list of specific drugs that prolong the QT interval can be found at www.qtdrugs.org. This review focuses on the mechanism of drug-induced QT prolongation, risk factors for TdP, culprit drugs, prevention and monitoring of prolonged drug-induced QT prolongation and treatment strategies. PMID:25083239

  16. Records management modernization study

    SciTech Connect

    Kadec, S.; Hill, L.G.; Riemer, C.A.

    1989-12-01

    The Department of Veterans Affairs (VA) has a single purpose or mission: to provide benefits to the veterans of the nation. Most of these benefits are provided through its medical and health facilities located around the country: the hospitals, nursing homes, and clinics that give medical examinations and provide long-term care or hospitalization. A second sizeable program managed by the Veterans Benefit Administration (VBA) gives pensions, benefits for disability and education, insurance, and home loans to those veterans eligible under law and specific service conditions. In support of the benefits programs, VA staff in the regional offices (ROs) receive and create a large amount of documentation. This documentation supports the award or disallowance of benefits by providing the information necessary to determine eligibility and the amount of the award. This paperwork, which is necessary to document actions and support the appeals process, creates a huge record-keeping problem for the ROs. 6 tabs.

  17. Combo Drug for Childhood Asthma Appears Safe in Study

    MedlinePlus

    ... news/fullstory_160721.html Combo Drug for Childhood Asthma Appears Safe in Study FDA to review findings, ... 2016 (HealthDay News) -- Lingering safety concerns regarding an asthma drug for children may be put to rest ...

  18. Risk Assessment of Drug Management Process in Women Surgery Department of Qaem Educational Hospital (QEH) Using HFMEA Method (2013)

    PubMed Central

    khani-Jazani, Reza; Molavi-Taleghani, Yasamin; Seyedin, Hesam; Vafaee-Najar, Ali; Ebrahimipour, Hossein; Pourtaleb, Arefeh

    2015-01-01

    Evaluation and improvement of drug management process are essential for patient safety. The present study was performed whit the aim of assessing risk of drug management process in Women Surgery Department of QEH using HFMEA method in 2013. A mixed method was used to analyze failure modes and their effects with HFMEA. To classify failure modes; nursing errors in clinical management model, for classifying factors affecting error; approved model by the UK National Health System, and for determining solutions for improvement; Theory of Inventive Problem Solving, were used. 48 failure modes were identified for 14 sub-process of five steps drug management process. The frequency of failure modes were as follow :35.3% in supplying step, 20.75% in prescription step, 10.4% in preparing step, 22.9% in distribution step and 10.35% in follow up and monitoring step. Seventeen failure modes (35.14%) were considered as non-acceptable risk (hazard score≥ 8) and were transferred to decision tree. Among 51 Influencing factors, the most common reasons for error were related to environmental factors (21.5%), and the less common reasons for error were related to patient factors (4.3%). HFMEA is a useful tool to evaluating, prioritization and analyzing failure modes in drug management process. Revision drug management process based focus-PDCA, assessing adverse drug reactions (ADR), USE patient identification bracelet, holding periodical pharmaceutical conferences to improve personnel knowledge, patient contribution in drug therapy; are performance solutions which were placed in work order. PMID:25901157

  19. Risk Assessment of Drug Management Process in Women Surgery Department of Qaem Educational Hospital (QEH) Using HFMEA Method (2013).

    PubMed

    Khani-Jazani, Reza; Molavi-Taleghani, Yasamin; Seyedin, Hesam; Vafaee-Najar, Ali; Ebrahimipour, Hossein; Pourtaleb, Arefeh

    2015-01-01

    Evaluation and improvement of drug management process are essential for patient safety. The present study was performed whit the aim of assessing risk of drug management process in Women Surgery Department of QEH using HFMEA method in 2013. A mixed method was used to analyze failure modes and their effects with HFMEA. To classify failure modes; nursing errors in clinical management model, for classifying factors affecting error; approved model by the UK National Health System, and for determining solutions for improvement; Theory of Inventive Problem Solving, were used. 48 failure modes were identified for 14 sub-process of five steps drug management process. The frequency of failure modes were as follow :35.3% in supplying step, 20.75% in prescription step, 10.4% in preparing step, 22.9% in distribution step and 10.35% in follow up and monitoring step. Seventeen failure modes (35.14%) were considered as non-acceptable risk (hazard score≥ 8) and were transferred to decision tree. Among 51 Influencing factors, the most common reasons for error were related to environmental factors (21.5%), and the less common reasons for error were related to patient factors (4.3%). HFMEA is a useful tool to evaluating, prioritization and analyzing failure modes in drug management process. Revision drug management process based focus-PDCA, assessing adverse drug reactions (ADR), USE patient identification bracelet, holding periodical pharmaceutical conferences to improve personnel knowledge, patient contribution in drug therapy; are performance solutions which were placed in work order. PMID:25901157

  20. Researching Lived Experience of Drugs and Crime: A Phenomenological Study of Drug-Dependent Inmates.

    PubMed

    Facchin, Federica; Margola, Davide

    2016-10-01

    This study identified the main components of the drugs and crime experience of a sample of 25 drug-dependent inmates interviewed in prison. Text analyses were conducted using a phenomenological method. The sample was characterized by a disruptive childhood in multi-problematic families and deviant social contexts where drug use and crime were considered normal since early adolescence. Drug initiation involved recreational use of dance drugs and/or cocaine, and the pleasure experienced was identified as the cause of subsequent persistent use. Three pathways that led to dependence were identified: The narcissistic pathway was defined as involving uncontrolled cocaine and amphetamines to feel powerful and limitless. The posttraumatic pathway was defined as involving post-trauma self-destructive drug use, while the pain relief pathway was defined as involving multiple substances to relieve pain. The second and third pathways were more directly associated with crime aimed at sustaining drug use. PMID:26631683

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

    ERIC Educational Resources Information Center

    Yolles, Stanley F.

    1971-01-01

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

  2. Automated method for study of drug metabolism

    NASA Technical Reports Server (NTRS)

    Furner, R. L.; Feller, D. D.

    1973-01-01

    Commercially available equipment can be modified to provide automated system for assaying drug metabolism by continuous flow-through. System includes steps and devices for mixing drug with enzyme and cofactor in the presence of pure oxygen, dialyzing resulting metabolite against buffer, and determining amount of metabolite by colorimetric method.

  3. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    NASA Astrophysics Data System (ADS)

    Hamlekhan, Azhang; Sinha-Ray, Suman; Takoudis, Christos; Mathew, Mathew T.; Sukotjo, Cortino; Yarin, Alexander L.; Shokuhfar, Tolou

    2015-06-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT.

  4. Alcohol and Drug Use among "Street" Adolescents: An Exploratory Study.

    ERIC Educational Resources Information Center

    McKirnan, David J.; Johnson, Tina

    Although adolescent alcohol and drug use is decreasing, many teenagers continue to use alcohol and drugs. Studies of adolescent alcohol use typically sample intact high school populations, excluding dropouts and adolescents alienated from straight high school populations. Alcohol and drug use and alcohol related attitudes were measured in 62…

  5. Parent Drug Education: A Participatory Action Research Study into Effective Communication about Drugs between Parents and Unrelated Young People

    ERIC Educational Resources Information Center

    Mallick, Jane

    2007-01-01

    Parent drug education is considered a key aspect of drug prevention. Effective communication acts as protective factor for drug misuse in young people. This study is a Participatory Action Research study of "Drugsbridge", a drug education programme that has an emphasis on facilitating intergenerational communication about drugs between parents and…

  6. Drug abuse in Costa Rica: a review of several studies.

    PubMed

    Alfaro Murillo, E

    1990-01-01

    This article provides a review of drug use surveys conducted by Costa Rica's Institute on Alcoholism and Drug Dependence during the years 1983-1987. These studies dealt with a wide range of subjects--residents of marginal neighborhoods, juvenile male and adult female detainees, and high school students--as well as with the general population. Overall, the studies indicated that the most commonly used illicit drug was marijuana, that the bulk of the drug users (excluding alcohol and tobacco users) were young males, that relevant levels of cocaine use were starting to occur, and that the country's general drug abuse picture poses a problem in need of immediate attention. PMID:2331555

  7. A randomized pilot study of the Engaging Moms Program for family drug court.

    PubMed

    Dakof, Gayle A; Cohen, Jeri B; Henderson, Craig E; Duarte, Eliette; Boustani, Maya; Blackburn, Audra; Venzer, Ellen; Hawes, Sam

    2010-04-01

    In response to the need for effective drug court interventions, the effectiveness of the Engaging Moms Program (EMP) versus Intensive Case Management Services (ICMS) on multiple outcomes for mothers enrolled in family drug court was investigated. In this intent-to-treat study, mothers (N = 62) were randomly assigned to either usual drug court care or the Engaging Moms drug court program. Mothers were assessed at intake and 3, 6, 12, and 18 months following intake. Results indicated that at 18 months post drug court enrollment, 77% of mothers assigned to EMP versus 55% of mothers assigned to ICMS had positive child welfare dispositions. There were statistically significant time effects for both intervention groups on multiple outcomes including substance use, mental health, parenting practices, and family functioning. EMP showed equal or better improvement than ICMS on all outcomes. The results suggest that EMP in family drug court is a viable and promising intervention approach to reduce maternal addiction and child maltreatment. PMID:20116961

  8. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study

    PubMed Central

    Mirošević Skvrce, Nikica; Macolić Šarinić, Viola; Mucalo, Iva; Krnić, Darko; Božina, Nada; Tomić, Siniša

    2011-01-01

    Aim To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. Methods In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. Results HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P < 0.001) than among the remaining reports (580 out of 1982; n = 2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. Conclusion The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education. PMID:21990078

  9. [Therapeutic Drug Management for Transplanted Women with a Planned Pregnancy: About Two Cases of Lung and Heart-lung Transplantation].

    PubMed

    Zecchini, Céline; Chanoine, Sébastien; Chapuis, Claire; Claustre, Johanna; Schir, Edith; Allenet, Benoît; Saint Raymond, Christel; Bedouch, Pierrick

    2015-01-01

    Advances in lung transplantation allow the women of childbearing age to consider becoming mothers. When planning to become pregnant, a therapeutic drug management of immunosuppressive drugs and associated therapies is required. It must take into account teratogenic and fetotoxic drugs, as well as pharmacokinetic changes encountered during pregnancy. Increasingly data are currently available on the management of immunosuppressive drugs and associated therapies during pregnancy. We report the case management of drug therapy before and during pregnancy in two patients after a lung or heart-lung transplantation. To prevent the emergence of complications for mother and child, a literature review has been necessary to manage drug therapies of each patient. PMID:26223163

  10. Pain management discussion forum: serious interaction among frequently used drugs for chronic pain.

    PubMed

    Breivik, Harald

    2014-06-01

    A query and response regarding a patient who was taking high-dose tramadol and duloxetine is presented. The patient developed serotonin syndrome. Risks for this clinically important drug interaction and management of the syndrome are discussed. PMID:24801976

  11. [Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case].

    PubMed

    Tang, Jian-yuan; Huang, Fang-hua; Zhu, Fei-peng

    2009-11-01

    FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation. PMID:20329620

  12. Drug Abuse in Paediatric Dentistry: A Cross-Sectional Study

    PubMed Central

    Sharma, Meenakshi; Tandon, Sandeep; Chugh, Tina; Sharma, Sanjay; PS, Parmod; Aggarwal, Vishal; Kashyap, Nilotpal

    2014-01-01

    Compared to adult medicine, drug use in children is not extensively researched. Objective: The objective of present study is to find out drug prescribing pattern in the Department of Pedodontics and Preventive Dentistry and Orthodontics in teaching hospitals in Rajasthan, India. Methods: A prospective study was conducted in June 2011. A total of 619 prescriptions were collected randomly. Prescribing pattern was analyzed using WHO basic drug indicator. Results: The average number of drugs and antimicrobial agent prescribed per prescription were 2.24 and 0.81 respectively. Antimicrobial agent contained 81.74% of all prescriptions. Most common groups of drugs prescribed by pedodontist were NSAIDS & Antipyretics (37.7%), Antimicrobial (36.4%) and Vitamins (12.3%). Prophylactic use of antimicrobial agents was 5.5 ± 0.5 days. Fixed dose combination (45.6%) frequently used by brand name. twelve percent generic drugs were used. Most of the drugs were from Essential Drug List especially a only one drug was prescribed. Conclusion: There is a need of mass awareness amongst dentists about good prescribing habit. Every institution must have Drugs and Therapeutic Committees. The five steps of WHO Program on Rational Use of Drugs (RUD) should be followed for rational prescribing of drugs. PMID:24783138

  13. [Management of TB suspected cases of drug resistant tuberculosis requiring a second treatment].

    PubMed

    Caminero, José A

    2004-06-01

    The management of patients with resistance to anti tuberculous drugs is complex and therefore must be managed by physician specialists. The most difficult patients are the cases in retreatment, where some very different possibilities are possible, as abandonment, failures and relapses. Patients with multi-drug resistant (MDR) tuberculosis are the most difficult to treat; MDR appears in all the failures or non-adherences to the treatment regime. To elaborate a scheme of retreatment for these patients, two guidelines must be followed: (1) do not rely on outcomes of drug susceptibility tests and (2) a detailed history of drug treatment must be considered of paramount importance. With this information, a retreatment scheme can be formulated that involves the use of at least three drugs not previously taken by the patient. For a successful control of tuberculosis, the national tuberculosis programs in Latin American countries must assure careful management of newly diagnosed patients. Secondly, if resources are available, a bank of second-line drugs must be ready for managing retreatment situations (e.g., 3 Z-Kn-Eth-Of/15 Z-Eth-Of) if first line drug treatments fail. Using individualized retreatment with second line drugs is recommended only in industrialized countries, and for a few middle income countries as a last resort. PMID:15495588

  14. Legal and ethical dilemmas in drug management for team physicians and athletic trainers.

    PubMed

    St Mary, E W

    1998-05-01

    Increasing violations of prescription drug regulations should alert physicians, trainers, and physiotherapists at collegiate and professional levels. Failure to adhere to state and federal requirements can have severe consequences for both physician and nonphysician practitioners. Training manuals that include a chapter on drug management will not allow disciplinary powers in themselves, but will put the problems in proper perspective for athletic trainers. PMID:9598847

  15. Non-drug Non-invasive Treatment in the Management of Low Back Pain

    PubMed Central

    Sahu, RL

    2014-01-01

    Background: Low back pain (LBP) is a major medical problem. World-wide, from 60% to 80% of people will have it during their lifetime and 2-5% will have it at any given time. The disease impacts upon activities of daily living ultimately leading to a loss of functional independence and quality of life. Aim: The main purpose of this study was to assess the results of non-drug non-invasive treatment in the management of LBP. Subjects and Methods: This was prospective study conducted in the Department of Orthopedics in M. M. Medical College, Mullana, Ambala, Haryana, India from June 2005 to June 2010. A total of 251 out-patients of LBP with a mean age of 45 years were studied. They were managed with non-invasive treatment and were followed for 24 months. Results: Objective Lumbar Spine Assessments up to the age of 40 years at 2 years were excellent. At 40-60 years of age, it was good to excellent. Over the age of 60 years, it was good. The back pain functional scale were found very good up to the age of 40 years at 2-year follow-up, good to very good between 40 and 60 years and over the age of 60 years it was good. Conclusions: Non-drug non-invasive interventions can reduce pain and improve function in LBP. PMID:25328793

  16. [Research on our hospital inventory management status quo of traditional Chinese medicine drugs and treatment method].

    PubMed

    Zhang, Ying-Nan; Xu, Wen

    2014-03-01

    Under the background of the new medical reform, a large variety of traditional Chinese medicine from complicated sources, Chinese traditional medicine of actor of true and false of the quality directly affect the drug safety and clinical efficacy, but also relate to the social and economic benefits of hospital. Along with the development of the modern management of medical institutions and drug circulation circulation system reform in our country, the hospital drug inventory, supply and management work is an important topic for the pharmaceutical trading. However, there is always contradiction, dispensary need to supple pharmacy, in order to satisfy the demands of hospital patients with normal diagnosis and treatment work. However, if the drug inventory is too much, not only increases the drug monitoring problem, at the same time, but also causes storage costs rise. Therefore, completing scientific and reasonable storage and management becomes urgent problems at present. Wherefore, our country administration of traditional Chinese medicine in 2007 promulgated the "Chinese traditional medicine yinpian management norms in hospital", aims to standardize management of Chinese traditional medicine quality and improve the safety of drugs. The author through looking up information and visiting survey, to understand the currently existing problems, and summarizes the literature inland and abroad in recent years Chinese medicine drug inventory management work experience, in view of status quo of Chinese medicine inventory management in China, put forward the solution. To guarantee TCM pharmacy management more standardized, more standard, to adapt to the new reform of Chinese traditional medicine industry, improve the management level of hospital, defend the hospital's reputation and the patient's interests. PMID:24956868

  17. Use of Serotonergic Drugs in Canada for Gastrointestinal Motility Disorders: Results of a Retrospective Cohort Study

    PubMed Central

    Manji, Farouq; Lam, Jennifer; Taylor, Brian M.

    2016-01-01

    Background. Surgery for GI dysmotility is limited to those with severe refractory disease. Though effective, use of serotonergic promotility drugs has been restricted in Canada due to adverse events. We aimed to investigate utilization of promotility serotonergic drugs in patients under consideration for surgical management. Methods. A retrospective cohort study was conducted using prospectively collected data. The study population included consecutive patients referred to a motility clinic for consideration of bowel resection at a Canadian tertiary hospital (1996–2011). Univariable tests and multivariable logistic regression analyses were used to assess predictors of serotonergic drug use. Results. Of 128 patients, the majority (n = 98, 76.6%) had constipation-dominant symptoms. Only 25% (n = 32) had tried serotonergic promotility drugs. There was no association between use of these drugs and severity of constipation nor was there an association between serotonergic drug use and presence of diffuse dysmotility (all p > 0.05). The majority of patients (n = 97, 75.8%) underwent some type of surgical resection, which was associated with considerable morbidity (n = 13, 13.4%). Conclusions. Surgical management of GI dysmotility results in serious morbidity. Serotonergic promotility drugs may allow patients to avoid surgery but disease severity does not predict use of these drugs. PMID:27313955

  18. A study on drug safety monitoring program in India.

    PubMed

    Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

    2014-09-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  19. A Study on Drug Safety Monitoring Program in India

    PubMed Central

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  20. Pharmacogenomic study using bio- and nanobioelectrochemistry: Drug-DNA interaction.

    PubMed

    Hasanzadeh, Mohammad; Shadjou, Nasrin

    2016-04-01

    Small molecules that bind genomic DNA have proven that they can be effective anticancer, antibiotic and antiviral therapeutic agents that affect the well-being of millions of people worldwide. Drug-DNA interaction affects DNA replication and division; causes strand breaks, and mutations. Therefore, the investigation of drug-DNA interaction is needed to understand the mechanism of drug action as well as in designing DNA-targeted drugs. On the other hand, the interaction between DNA and drugs can cause chemical and conformational modifications and, thus, variation of the electrochemical properties of nucleobases. For this purpose, electrochemical methods/biosensors can be used toward detection of drug-DNA interactions. The present paper reviews the drug-DNA interactions, their types and applications of electrochemical techniques used to study interactions between DNA and drugs or small ligand molecules that are potentially of pharmaceutical interest. The results are used to determine drug binding sites and sequence preference, as well as conformational changes due to drug-DNA interactions. Also, the intention of this review is to give an overview of the present state of the drug-DNA interaction cognition. The applications of electrochemical techniques for investigation of drug-DNA interaction were reviewed and we have discussed the type of qualitative or quantitative information that can be obtained from the use of each technique. PMID:26838928

  1. An Exploratory Study Examining the Spatial Dynamics of Illicit Drug Availability and Rates of Drug Use

    ERIC Educational Resources Information Center

    Freisthler, Bridget; Gruenewald, Paul J.; Johnson, Fred W.; Treno, Andrew J.; Lascala, Elizabeth A.

    2005-01-01

    This study examines the spatial relationship between drug availability and rates of drug use in neighborhood areas. Responses from 16,083 individuals were analyzed at the zip code level (n = 158) and analyses were conducted separately for youth and adults using spatial regression techniques. The dependent variable is the percentage of respondents…

  2. Managing la malilla: Exploring drug treatment experiences among injection drug users in Tijuana, Mexico, and their implications for drug law reform

    PubMed Central

    Syvertsen, Jennifer; Pollini, Robin A.; Lozada, Remedios; Vera, Alicia; Rangel, Gudelia; Strathdee, Steffanie A.

    2012-01-01

    Background In August 2009, Mexico reformed its drug laws and decriminalized small quantities of drugs for personal use; offenders caught three times will be mandated to enter drug treatment. However, little is known about the quality or effectiveness of drug treatment programs in Mexico. We examined injection drug users’ (IDUs) experiences in drug treatment in Tijuana, Mexico, with the goal of informing program planning and policy. Methods We examined qualitative and quantitative data from Proyecto El Cuete, a multi-phased research study on HIV risk among IDUs in Tijuana. Phase I consisted of 20 in-depth interviews and Phase II employed respondent-driven sampling to recruit 222 IDUs for a quantitative survey. We also reviewed national drug policy documents, surveillance data, and media reports to situate drug users’ experiences within the broader sociopolitical context. Results Participants in the qualitative study were 50% male with a mean age of 32; most injected heroin (85.0%) and methamphetamine (60.0%). The quantitative sample was 91.4% male with a mean age of 35; 98.2% injected heroin and 83.7% injected heroin and methamphetamine together. The majority of participants reported receiving treatment: residential treatment was most common, followed by methadone; other types of services were infrequently reported. Participants’ perceptions of program acceptability and effectiveness were mixed. Mistreatment emerged as a theme in the qualitative interviews and was reported by 21.6% of Phase II participants, primarily physical (72.0%) and verbal (52.0%) abuse. Conclusions Our results point to the need for political, economic, and social investment in the drug treatment system before offenders are sentenced to treatment under the revised national drug law. Resources are needed to strengthen program quality and ensure accountability. The public health impact of the new legislation that attempts to bring drug treatment to the forefront of national drug policy

  3. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... . SUPPLEMENTARY INFORMATION: I. Background In a notice published in the Federal Register of January 7, 2011 (76 FR..., 1982 (47 FR 22610), FDA revoked the temporary exemption that permitted these drug products, and those... (49 FR 32681) that the Agency was withdrawing approval of NDAs 8-306, 8-604, and 11-265 pertaining...

  4. 76 FR 1174 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... and other parties in response to various DESI notices covering relevant products. \\3\\ 38 FR 34481 (December 14, 1973). \\4\\ 38 FR 4006 (February 9, 1973) and 37 FR 15022 (July 27, 1972). All drugs covered by... Federal Register on May 25, 1982 (47 FR 22606), FDA revoked the temporary exemption that permitted...

  5. Laboratory Management of Drug-Facilitated Sexual Assault Cases.

    PubMed

    LeBeau, M A

    2010-01-01

    Over the past two decades, cases of drug-facilitated sexual assaults (DFSA) have increased in forensic laboratories in many parts of the world. Investigators of DFSA allegations know of the many challenges associated with these cases, but forensic toxicologists find that delays in the reporting of such crimes to law enforcement and subsequent lags in specimen collection are particularly important concerns. These delays are usually a result of the traumatic experience of sexual assaults, as well as the amnesic effect of the drugs typically used to commit DFSA. Unfortunately, such a delay in specimen collection may be the difference between detecting traces of a drug (or metabolite) and reporting a negative result. Therefore, it is imperative for toxicology laboratories to properly prepare for DFSA cases by developing forms, policies, and procedures to ensure that truly meaningful analyses are performed. This article provides guidance in the steps laboratories may take to best prepare themselves to analyze evidentiary specimens from DFSA investigations. PMID:26242459

  6. Management studies in medical education.

    PubMed

    Noor Ghani, S; Saimy, I

    2005-08-01

    In 1977, the World Health Assembly (WHA) set the social target--the "Health For All" goal and in 1995, urged member states to "re-orientate medical education and medical practice for "Health For All" (resolution WHA 48.8). This led to World Health Organisation to enunciate the "5-star doctor" needing skills in healthcare management, quality assurance and health economics. The Faculty of Medicine, University of Malaya introduced the New Integrated Curriculum (NIC) in 1995. The objective was aimed at producing a competent doctor with a holistic approach to the practice of medicine. This was to be achieved by having 3 strands of studies i.e. The Scientific Basis of Medicine (SBM), the Doctor, Patient, Health and Society (DPHS), and Personal and Professional Development (PPD) over the 5-year programme, split into 3 phases. Elements of the "5-star doctor" were introduced in strand 2--DPHS and strand 3--PPD. Management studies were introduced in the Personal and Professional Development (PPD) strand. This led to an instructional module--"Principles of Management in Health Care Services (PMGT)" comprising of the Management of Self, Resources and People and incorporating a three week field programme. Evaluation is undertaken at the end of the phase IIIA of the studies. This NIC approach will be able to produce a "5-star doctor", a team player, leader, communicator and an effective manager. PMID:16315627

  7. Solid state drug-polymer miscibility studies using the model drug ABT-102.

    PubMed

    Jog, Rajan; Gokhale, Rajeev; Burgess, Diane J

    2016-07-25

    Amorphous solid dispersions typically suffer storage stability issues due to: their amorphous nature, high drug loading, uneven drug:stabilizer ratio and plasticization effects as a result of hygroscopic excipients. An extensive solid state miscibility study was conducted to aid in understanding the mechanisms involved in drug/stabilizer interactions. ABT-102 (model drug) and nine different polymers with different molecular weights and viscosities were selected to investigate drug/polymer miscibility. Three different polymer:drug ratios (1:3, 1:1 and 3:1, w/w) were analyzed using: DSC, FTIR and PXRD. Three different techniques were used to prepare the amorphous solid dispersions: serial dilution, solvent evaporation and spray drying. Spray drying was the best method to obtain amorphous solid dispersions. However, under certain conditions amorphous formulations could be obtained using solvent evaporation. Melting point depression was used to calculate interaction parameters and free energy of mixing for the various drug polymer mixtures. The spray dried solid dispersions yielded a negative free energy of mixing which indicated strong drug-polymer miscibility compared to the solvent evaporation and serial dilution method. Soluplus was the best stabilizer compared to PVP and HPMC, which is probably a consequence of strong hydrogen bonding between the two CO moieties of soluplus and the drug NH moieities. PMID:27265312

  8. Drug data coding and analysis in epidemiologic studies.

    PubMed

    Pahor, M; Chrischilles, E A; Guralnik, J M; Brown, S L; Wallace, R B; Carbonin, P

    1994-08-01

    In epidemiologic studies that collect comprehensive information on medication use, the complexity of dealing with a large number of trade and generic names may limit the utilization of these data bases. This paper shows the specific advantage of using two coding systems, one to maximize efficiency of data entry, and the other to facilitate analysis by organizing the drug ingredients into hierarchical categories. The approach used by two large surveys, one in the USA and one in Italy, is described: the Established Populations for Epidemiologic Studies of the Elderly (EPESE) and the 'Gruppo Italiano di Farmacovigilanza nell' Anziano' (GIFA). To enter the medications into a computerized database, codes matching the drug product names are needed. In the EPESE the prescription and over the counter drug products are coded with the Drug Products Information Coding System (DPICS) and the Iowa Nonprescription Drug Products Information Coding System (INDPICS), respectively. The GIFA study uses the coding system of the Italian Ministry of Health (MINSAN), with a unique numeric code for each drug product available in Italy. To simplify the analytical process the drug entry codes are converted into hierarchical coding systems with unique codes for specific drug ingredients, chemical and therapeutic categories. The EPESE and GIFA drug data are coded with the Iowa Drug Information System (IDIS) ingredient codes, and the Anatomical Therapeutic and chemical (ATC) codes, respectively. Examples are provided that show coding of diuretics in these two studies and demonstrate the analytic advantages of these systems. PMID:7843344

  9. Reasons for illicit drug use in people with schizophrenia: Qualitative study

    PubMed Central

    2010-01-01

    Background Drug misuse is an important clinical problem associated with a poorer outcome in patients who have a diagnosis of schizophrenia. Qualitative studies have rarely been used to elicit reasons for drug use in psychosis, but not in schizophrenia. Methods Seventeen people with a diagnosis of schizophrenia and who had used street drugs were interviewed and asked to describe, in narrative form, their street drug use from their early experiences to the present day. Grounded theory was used to analyse the transcripts. Results We identified five reasons for continuing street drug use. The reasons were: as an 'identity defining vocation', 'to belong to a peer group', due to 'hopelessness', because of 'beliefs about symptoms and how street drugs influence them' and viewing drugs as 'equivalent to taking psychotropic medication'. Street drugs were often used to reduce anxiety aroused by voice hearing. Some participants reported street drugs to focus their attention more on persecutory voices in the hope of outwitting their perceived persecutors. Conclusions It would be clinically useful to examine for the presence of the five factors in patients who have a diagnosis of schizophrenia and use street drugs, as this is likely to help the clinician to tailor management of substance misuse to the individual patient's beliefs. PMID:21092168

  10. Drugs for Pain Management in Shock Wave Lithotripsy

    PubMed Central

    Bach, Christian; Zaman, Faruquz; Kachrilas, Stefanos; Kumar, Priyadarshi; Buchholz, Noor; Masood, Junaid

    2011-01-01

    Objective. With this review, we provide a comprehensive overview of the main aspects and currently used drugs for analgesia in shockwave lithotripsy. Evidence Acquisition. We reviewed current literature, concentrating on newer articles and high-quality reviews in international journals. Results. No standardized protocols for pain control in SWL exist, although it is crucial for treatment outcome. General and spinal anaesthesia show excellent pain control but are only recommended for selected cases. The newer opioids and nonsteroidal anti-inflammatory drugs are able to deliver good analgesia. Interest in inhalation anaesthesia with nitrous oxide, local anaesthesia with deep infiltration of the tissue, and dermal anaesthesia with EMLA or DMSO has recently rekindled, showing good results in terms of pain control and a favourable side effect profile. Tamsulosin and paracetamol are further well-known drugs being currently investigated. Conclusion. Apart from classically used drugs like opioids and NSARs, medicaments like nitrous oxide, paracetamol, DMSA, or refined administration techniques for infiltration anaesthesia show a good effectiveness in pain control for SWL. PMID:22135735

  11. Misuse of "study drugs:" prevalence, consequences, and implications for policy

    PubMed Central

    Sussman, Steve; Pentz, Mary Ann; Spruijt-Metz, Donna; Miller, Toby

    2006-01-01

    Background Non-medical/illegal use of prescription stimulants popularly have been referred to as "study drugs". This paper discusses the current prevalence and consequences of misuse of these drugs and implications of this information for drug policy. Results Study drugs are being misused annually by approximately 4% of older teens and emerging adults. Yet, there are numerous consequences of misuse of prescription stimulants including addiction, negative reactions to high dosages, and medical complications. Policy implications include continuing to limit access to study drugs, finding more safe prescription drug alternatives, interdiction, and public education. Conclusion Much more work is needed on prescription stimulant misuse assessment, identifying the extent of the social and economic costs of misuse, monitoring and reducing access, and developing prevention and cessation education efforts. PMID:16764722

  12. Case Studies in Broadcast Management.

    ERIC Educational Resources Information Center

    Coleman, Howard W.

    This collection of case studies, based on factual situations which have challenged broadcast managers in recent years, is designed to stimulate thinking about and solving of "real world" problems in commercial radio and television operations. Topics of a serious, long-run nature include enlarging the radio audience; station revenue and economy;…

  13. Drug Dependence in Pregnancy: Clinical Management of Mother and Child. Services Research Reports and Monograph Series.

    ERIC Educational Resources Information Center

    Finnegan, Loretta P., Ed.

    This resouce manual compiles research findings concerning treatment of pregnant addicts. Major topics covered are: (1) prevalence and classification of psychotropic drug use; (2) pharmacologic effects on mother and infant; (3) clinical management during pregnancy; (4) management of labor, delivery, and the immediate post-partum period; (5)…

  14. Environmental Management: A Comprehensive Strategy for Reducing Alcohol and Other Drug Use on College Campuses.

    ERIC Educational Resources Information Center

    DeJong, William; Vince-Whitman, Cheryl; Colthurst, Tom; Cretella, Maggie; Gilbreath, Michael; Rosati, Michael; Zweig, Karen

    This guide presents a comprehensive strategy, called "environmental management," for alcohol and other drug (AOD) prevention in institutions of higher education. The environmental management approach utilizes, in addition to educational programs, changes in the physical, social, economic, and legal environment accomplished through a combination of…

  15. Best practice for the pharmacological management of hyperthyroid cats with antithyroid drugs.

    PubMed

    Daminet, S; Kooistra, H S; Fracassi, F; Graham, P A; Hibbert, A; Lloret, A; Mooney, C T; Neiger, R; Rosenberg, D; Syme, H M; Villard, I; Williams, G

    2014-01-01

    Pharmacological management of feline hyperthyroidism offers a practical treatment option for many hyperthyroid cats. Two drugs have been licensed for cats in the last decade: methimazole and its pro-drug carbimazole. On the basis of current evidence and available tablet sizes, starting doses of 2·5 mg methimazole twice a day and 10 to 15 mg once a day for the sustained release formulation of carbimazole are recommended. These doses should then be titrated to effect in order to obtain circulating total thyroxine (TT4) concentrations in the lower half of the reference interval. Treated cases should be monitored for side-effects, especially during the first months of treatment. Some side-effects may require discontinuation of treatment. At each monitoring visit, clinical condition and quality of life should also be evaluated, with special attention to possible development of azotaemia, hypertension and iatrogenic hypothyroidism. When euthyroidism has been achieved, monitoring visits are recommended after 1 month, 3 months and biannually thereafter. Cats with pre-existing azotaemia have shorter survival times. However, development of mild azotaemia during the initial course of treatment, unless associated with hypothyroidism, does not appear to decrease survival time. The long-term effects of chronic medical management require further study. PMID:24372075

  16. Antipsychotic Drug-Induced Somnolence: Incidence, Mechanisms, and Management.

    PubMed

    Fang, Fang; Sun, Hongwei; Wang, Zuowei; Ren, Ming; Calabrese, Joseph R; Gao, Keming

    2016-09-01

    Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition. According to the ARI in acute schizophrenia, bipolar mania, and bipolar depression, antipsychotics can be classified as high somnolence (clozapine), moderate somnolence (olanzapine, perphenazine, quetiapine, risperidone, ziprasidone), and low somnolence (aripiprazole, asenapine, haloperidol, lurasidone, paliperidone, cariprazine). The risk of somnolence with blonanserin, brexpiprazole, chlorpromazine, iloperidone, sertindole, and zotepine needs further investigation. The rates of somnolence were positively correlated to dose and duration for some antipsychotics, but not for others. Many factors, including antipsychotic per se, the method used to measure somnolence, patient population, study design, and dosing schedule, might affect the incidence of antipsychotic-induced somnolence. The mechanisms of antipsychotic-induced somnolence are likely multifactorial, although the blockade of histamine 1 receptors and α1 receptors may play a major role. The management of antipsychotic-induced somnolence should include sleep hygiene education, choosing an antipsychotic with a lower risk for somnolence, starting at a lower dose with a slower titration based on psychiatric diagnoses, adjusting doses when necessary, and minimizing concurrent somnolence-prone agents. Since most cases of somnolence were mild to moderate, allowing tolerance to

  17. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study

    PubMed Central

    Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-01-01

    labeling of annotated PDDIs across a broader range of drug product labels. Preannotation of drug mentions may ease the annotation task. However, preannotation of PDDIs, as operationalized in this study, presented the participants with difficulties. Future work should test if these issues can be addressed by the use of better performing NLP and a different approach to presenting the PDDI preannotations to users during the annotation workflow. PMID:27066806

  18. Managing Mental Health Problems in Everyday Life: Drug Treatment Client's Self-Care Strategies

    ERIC Educational Resources Information Center

    Holt, Martin; Treloar, Carla

    2008-01-01

    Little is understood about the self-care activities undertaken by drug treatment clients. Using data from a qualitative study of drug treatment and mental health we identify the self-care practices of drug treatment clients diagnosed with anxiety and depression. Seventy-seven participants were interviewed in four sites across Australia.…

  19. Outage management: A case study

    SciTech Connect

    Haber, S.B.; Barriere, M.T. ); Roberts, K.H. . Walter A. Haas School of Business)

    1992-01-01

    Outage management issues identified from a field study conducted at a two-unit commercial pressurized water reactor (PWR), when one unit was in a refueling outage and the other unit was at full power operation, are the focus of this paper. The study was conduced as part of the US Nuclear Regulatory Commission's (NRC) organizational factors research program, and therefore the issues to be addressed are from an organizational perspective. Topics discussed refer to areas identified by the NRC as critical for safety during shutdown operations, including outage planning and control, personnel stress, and improvements in training and procedures. Specifically, issues in communication, management attention, involvement and oversight, administrative processes, organizational culture, and human resources relevant to each of the areas are highlighted by example from field data collection. Insights regarding future guidance in these areas are presented based upon additional data collection subsequent to the original study.

  20. Outage management: A case study

    SciTech Connect

    Haber, S.B.; Barriere, M.T.; Roberts, K.H.

    1992-09-01

    Outage management issues identified from a field study conducted at a two-unit commercial pressurized water reactor (PWR), when one unit was in a refueling outage and the other unit was at full power operation, are the focus of this paper. The study was conduced as part of the US Nuclear Regulatory Commission`s (NRC) organizational factors research program, and therefore the issues to be addressed are from an organizational perspective. Topics discussed refer to areas identified by the NRC as critical for safety during shutdown operations, including outage planning and control, personnel stress, and improvements in training and procedures. Specifically, issues in communication, management attention, involvement and oversight, administrative processes, organizational culture, and human resources relevant to each of the areas are highlighted by example from field data collection. Insights regarding future guidance in these areas are presented based upon additional data collection subsequent to the original study.

  1. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  2. Southern African Treatment Resistance Network (SATuRN) RegaDB HIV drug resistance and clinical management database: supporting patient management, surveillance and research in southern Africa.

    PubMed

    Manasa, Justen; Lessells, Richard; Rossouw, Theresa; Naidu, Kevindra; Van Vuuren, Cloete; Goedhals, Dominique; van Zyl, Gert; Bester, Armand; Skingsley, Andrew; Stott, Katharine; Danaviah, Siva; Chetty, Terusha; Singh, Lavanya; Moodley, Pravi; Iwuji, Collins; McGrath, Nuala; Seebregts, Christopher J; de Oliveira, Tulio

    2014-01-01

    Substantial amounts of data have been generated from patient management and academic exercises designed to better understand the human immunodeficiency virus (HIV) epidemic and design interventions to control it. A number of specialized databases have been designed to manage huge data sets from HIV cohort, vaccine, host genomic and drug resistance studies. Besides databases from cohort studies, most of the online databases contain limited curated data and are thus sequence repositories. HIV drug resistance has been shown to have a great potential to derail the progress made thus far through antiretroviral therapy. Thus, a lot of resources have been invested in generating drug resistance data for patient management and surveillance purposes. Unfortunately, most of the data currently available relate to subtype B even though >60% of the epidemic is caused by HIV-1 subtype C. A consortium of clinicians, scientists, public health experts and policy markers working in southern Africa came together and formed a network, the Southern African Treatment and Resistance Network (SATuRN), with the aim of increasing curated HIV-1 subtype C and tuberculosis drug resistance data. This article describes the HIV-1 data curation process using the SATuRN Rega database. The data curation is a manual and time-consuming process done by clinical, laboratory and data curation specialists. Access to the highly curated data sets is through applications that are reviewed by the SATuRN executive committee. Examples of research outputs from the analysis of the curated data include trends in the level of transmitted drug resistance in South Africa, analysis of the levels of acquired resistance among patients failing therapy and factors associated with the absence of genotypic evidence of drug resistance among patients failing therapy. All these studies have been important for informing first- and second-line therapy. This database is a free password-protected open source database available on

  3. EMPADE Study: Evaluation of Medical Prescriptions and Adverse Drug Events in COPD Patients Admitted to Intensive Care Unit

    PubMed Central

    Khan, M. Amer; Khan, M. Nematullah; Sultan, Ihtisham; Khan, M. Aamer; Ali, S. Amir; Farooqui, Afroze

    2015-01-01

    Introduction Inappropriate drug usage may preclude ideal benefit due to increased medical cost, antimicrobial resistance, adverse effects and mortality. Therefore drug utilization studies have become a plausible means in evaluating the healthcare systems. COPD management usually involves more than one drug which may escalate the risk of ADEs (adverse drug events). Aim The present study was aimed at assessing the current drug practice and ADEs in COPD management in ICU. Materials and Methods A total of 1,044 patients admitted for the treatment of COPD were included in the study. Their prescriptions were recorded for evaluation of drug utilization and patients were counseled for assessing ADEs. Results were evaluated by Chi-square test and percentages. Result All-embracing 15,360 drugs were prescribed at an average of 14.71 drugs per patient, wherein β2-agonists were extensively prescribed agents followed by inhaled-corticosteroids and anti-cholinergics. 372 ADEs were reported in 252 patients, wherein restlessness was the most frequent ADE and theophylline was found to be associated with highest cases of ADEs. Conclusion Practitioners should prescribe least number of drugs to mitigate the likelihood of adverse outcomes in patients due to numerous drugs usage, which may be achieved by following GOLD guidelines. The present work may help in improving the current management of COPD by rectifying the flaws delineated in this article. PMID:26675667

  4. Difficulties in Treatment and Management of Epilepsy and Challenges in New Drug Development

    PubMed Central

    Wahab, Abdul

    2010-01-01

    Epilepsy is a serious neurological disorder that affects around 50 million people worldwide. Almost 30% of epileptic patients suffer from pharmacoresistance, which is associated with social isolation, dependent behaviour, low marriage rates, unemployment, psychological issues and reduced quality of life. Currently available antiepileptic drugs have a limited efficacy, and their negative properties limit their use and cause difficulties in patient management. Antiepileptic drugs can provide only symptomatic relief as these drugs suppress seizures but do not have ability to cure epileptogenesis. The long term use of antiepileptic drugs is limited due to their adverse effects, withdrawal symptoms, deleterious interactions with other drugs and economic burden, especially in developing countries. Furthermore, some of the available antiepileptic drugs may even potentiate certain type of seizures. Several in vivo and in vitro animal models have been proposed and many new antiepileptic drugs have been marketed recently, but large numbers of patients are still pharmacoresistant. This review will highlight the difficulties in treatment and management of epilepsy and the limitations of available antiepileptic drugs and animal seizure models.

  5. Common Heartburn Drugs Linked to Kidney Disease in Study

    MedlinePlus

    ... fullstory_158313.html Common Heartburn Drugs Linked to Kidney Disease in Study But finding can't show whether ... heartburn may be at increased risk of developing kidney disease, a new study suggests. The research is the ...

  6. Impotence Drugs Won't Raise Melanoma Risk, Study Suggests

    MedlinePlus

    ... fullstory_159365.html Impotence Drugs Won't Raise Melanoma Risk, Study Suggests Researchers say skin cancer in ... aren't likely to boost the risk of melanoma skin cancer, a new study reports. Why the ...

  7. Management of Psychotropic Drug-Induced DRESS Syndrome: A Systematic Review.

    PubMed

    Bommersbach, Tanner J; Lapid, Maria I; Leung, Jonathan G; Cunningham, Julie L; Rummans, Teresa A; Kung, Simon

    2016-06-01

    Drug rash with eosinophilia and systemic symptoms (DRESS) is a severe cutaneous eruption that has been linked to several common drugs and drug categories, including antiepileptics, allopurinol, sulfonamides, and various antibiotics; however, because of a number of recent case reports linking psychotropic medications to this condition, DRESS is increasingly recognized among psychiatrists. We systematically reviewed all psychotropic drugs linked to DRESS syndrome, and this article summarizes the clinical management relevant to psychiatric professionals. A comprehensive search was performed using Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Web of Science, Scopus, and Litt's Drug Eruption and Reaction Database for articles published in English during the past 20 years (1996-2015) using the search terms (1) psychotropic drugs OR serotonin uptake inhibitors AND DRESS or (2) psychotropic drugs AND drug reaction (or rash) eosinophilia systemic syndrome, and all article abstracts were screened for inclusion and exclusion criteria by 3 reviewers. Two independent reviewers examined the full text of 163 articles, of which 96 (25 original articles, 12 review articles, 55 case reports, and 4 letters to the editor) were included in the systematic review. We identified 1072 cases of psychotropic drug-induced DRESS, with carbamazepine, lamotrigine, phenytoin, valproate, and phenobarbital being the most implicated drugs. Based on our review of the literature, we outline management principles that include prompt withdrawal of the causative drug, hospitalization, corticosteroid therapy, and novel treatments, including intravenous immunoglobulin, cyclophosphamide, and cyclosporine, for corticosteroid-resistant DRESS. Finally, we outline strategies for treating comorbid psychiatric illness after a DRESS reaction to the psychotropic medication. PMID:27126302

  8. Case Studies: Profiles of Women Recovering from Drug Addiction.

    ERIC Educational Resources Information Center

    Miller, Suzanne M.

    1995-01-01

    Profiles two women over an eight-month study who abused alcohol and other drugs while pregnant and describes their recovery from the addiction. Examines, from an ecological framework, the women's experiences with drug addiction, treatment, and recovery, and recounts their situation through each. (JPS)

  9. Heat Management Strategy Trade Study

    SciTech Connect

    Nick Soelberg; Steve Priebe; Dirk Gombert; Ted Bauer

    2009-09-01

    This Heat Management Trade Study was performed in 2008-2009 to expand on prior studies in continued efforts to analyze and evaluate options for cost-effectively managing SNF reprocessing wastes. The primary objective was to develop a simplified cost/benefit evaluation for spent nuclear fuel (SNF) reprocessing that combines the characteristics of the waste generated through reprocessing with the impacts of the waste on heating the repository. Under consideration were age of the SNF prior to reprocessing, plutonium and minor actinide (MA) separation from the spent fuel for recycle, fuel value of the recycled Pu and MA, age of the remaining spent fuel waste prior to emplacement in the repository, length of time that active ventilation is employed in the repository, and elemental concentration and heat limits for acceptable glass waste form durability. A secondary objective was to identify and qualitatively analyze remaining issues such as (a) impacts of aging SNF prior to reprocessing on the fuel value of the recovered fissile materials, and (b) impact of reprocessing on the dose risk as developed in the Yucca Mountain Total System Performance Assessment (TSPA). Results of this study can be used to evaluate different options for managing decay heat in waste streams from spent nuclear fuel.

  10. Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.

    PubMed

    Jadhav, Pravin R; Neal, Lauren; Florian, Jeff; Chen, Ying; Naeger, Lisa; Robertson, Sarah; Soon, Guoxing; Birnkrant, Debra

    2010-09-01

    This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques. PMID:20881217

  11. A screening study of drug-drug interactions in cerivastatin users: an adverse effect of clopidogrel.

    PubMed

    Floyd, J S; Kaspera, R; Marciante, K D; Weiss, N S; Heckbert, S R; Lumley, T; Wiggins, K L; Tamraz, B; Kwok, P-Y; Totah, R A; Psaty, B M

    2012-05-01

    An analysis of a case-control study of rhabdomyolysis was conducted to screen for previously unrecognized cytochrome P450 enzyme (CYP) 2C8 inhibitors that may cause other clinically important drug-drug interactions. Medication use in cases of rhabdomyolysis using cerivastatin (n = 72) was compared with that in controls using atorvastatin (n = 287) for the period 1998-2001. The use of clopidogrel was strongly associated with rhabdomyolysis (odds ratio (OR) 29.6; 95% confidence interval (CI), 6.1-143). In a replication effort that used the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS), it was found that clopidogrel was used more commonly in patients with rhabdomyolysis receiving cerivastatin (17%) than in those receiving atorvastatin (0%, OR infinity; 95% CI = 5.2-infinity). Several medications were tested in vitro for their potential to cause drug-drug interactions. Clopidogrel, rosiglitazone, and montelukast were the most potent inhibitors of cerivastatin metabolism. Clopidogrel and its metabolites also inhibited cerivastatin metabolism in human hepatocytes. These epidemiological and in vitro findings suggest that clopidogrel may cause clinically important, dose-dependent drug-drug interactions with other medications metabolized by CYP2C8. PMID:22419147

  12. Pharmacokinetic/pharmacodynamic studies in drug product development.

    PubMed

    Meibohm, Bernd; Derendorf, Hartmut

    2002-01-01

    In the quest of ways for rationalizing and accelerating drug product development, integrated pharmacokinetic/pharmacodynamic (PK/PD) concepts provide a highly promising tool. PK/PD modeling concepts can be applied in all stages of preclinical and clinical drug development, and their benefits are multifold. At the preclinical stage, potential applications might comprise the evaluation of in vivo potency and intrinsic activity, the identification of bio-/surrogate markers, as well as dosage form and regimen selection and optimization. At the clinical stage, analytical PK/PD applications include characterization of the dose-concentration-effect/toxicity relationship, evaluation of food, age and gender effects, drug/drug and drug/disease interactions, tolerance development, and inter- and intraindividual variability in response. Predictive PK/PD applications can also involve extrapolation from preclinical data, simulation of drug responses, as well as clinical trial forecasting. Rigorous implementation of the PK/PD concepts in drug product development provides a rationale, scientifically based framework for efficient decision making regarding the selection of potential drug candidates, for maximum information gain from the performed experiments and studies, and for conducting fewer, more focused clinical trials with improved efficiency and cost effectiveness. Thus, PK/PD concepts are believed to play a pivotal role in streamlining the drug development process of the future. PMID:11782894

  13. Tuberculosis treatment and management--an update on treatment regimens, trials, new drugs, and adjunct therapies.

    PubMed

    Zumla, Alimuddin; Chakaya, Jeremiah; Centis, Rosella; D'Ambrosio, Lia; Mwaba, Peter; Bates, Matthew; Kapata, Nathan; Nyirenda, Thomas; Chanda, Duncan; Mfinanga, Sayoki; Hoelscher, Michael; Maeurer, Markus; Migliori, Giovanni Battista

    2015-03-01

    WHO estimates that 9 million people developed active tuberculosis in 2013 and 1·5 million people died from it. Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis continue to spread worldwide with an estimated 480,000 new cases in 2013. Treatment success rates of MDR and XDR tuberculosis are still low and development of new, more effective tuberculosis drugs and adjunct therapies to improve treatment outcomes are urgently needed. Although standard therapy for drug-sensitive tuberculosis is highly effective, shorter, more effective treatment regimens are needed to reduce the burden of infectious cases. We review the latest WHO guidelines and global recommendations for treatment and management of drug-sensitive and drug-resistant tuberculosis, and provide an update on new drug development, results of several phase 2 and phase 3 tuberculosis treatment trials, and other emerging adjunct therapeutic options for MDR and XDR tuberculosis. The use of fluoroquinolone-containing (moxifloxacin and gatifloxacin) regimens have failed to shorten duration of therapy, and the new tuberculosis drug pipeline is sparse. Scale-up of existing interventions with increased investments into tuberculosis health services, development of new antituberculosis drugs, adjunct therapies and vaccines, coupled with visionary political leadership, are still our best chance to change the unacceptable status quo of the tuberculosis situation worldwide and the growing problem of drug-resistant tuberculosis. PMID:25773212

  14. Synthetic cannabinoids to avoid urine drug screens: Implications for contingency management and other treatments for drug dependence.

    PubMed

    Ninnemann, Andrew L; Lechner, William V; Borges, Allison; Lejuez, C W

    2016-12-01

    Contingency management (CM) is an effective treatment for substance use dependence. Within CM, rewards or vouchers promote continued abstinence by acting as alternative reinforcers to substance use. However, CM relies on the use of accurate biochemical verification methods, such as urinalysis, to verify abstinence. Synthetic cannabinoids (SCs) pose a risk for CM treatment because they are not easily detected by common urinalysis techniques. Although SCs pose a risk, there is limited information regarding current rates of SC use within substance dependent populations as well as rates of substance use and psychiatric disorders among those who use SCs in treatment. We discuss emerging research on these topics and potential implications for CM treatments. Findings suggest CM researchers should test for and query SC use among those being treated for cannabis and cocaine use problems as well as among younger populations of substance users. Implications of other novel psychoactive substances for drug treatment and drug urinalysis are also discussed. PMID:27424166

  15. Supporting parents in managing drugs for children with cystic fibrosis.

    PubMed

    Slatter, Amanda; Francis, Sally-Anne; Smith, Felicity; Bush, Andrew

    A semi-structured interview guide was used to interview 17 parents of children with cystic fibrosis identified through a shared care patient database at a London hospital to examine parents' medication-related roles and problems. Parents described their responsibilities in the home and the problems experienced, including adherence to regiments, involvement in decision-making, and relationships with the hospital teams and other healthcare professionals. The findings confirmed medication management as an integral part of the informal caring role. Many practical problems of ensuring the availability and administration of medication on a regular basis were described. Information gaps and problems with medication adherence increased the stress of providing effective care. The involvement of healthcare professionals across primary, secondary and tertiary care sectors in supporting parents in all aspects of medication management, including the development of strategies for transferring the responsibility for medication to their children, must be improved. PMID:15573006

  16. In vitro microscale systems for systematic drug toxicity study.

    PubMed

    Sung, Jong Hwan; Shuler, Michael L

    2010-01-01

    After administration, drugs go through a complex, dynamic process of absorption, distribution, metabolism and excretion. The resulting time-dependent concentration, termed pharmacokinetics (PK), is critical to the pharmacological response from patients. An in vitro system that can test the dynamics of drug effects in a more systematic way would save time and costs in drug development. Integration of microfabrication and cell culture techniques has resulted in 'cells-on-a-chip' technology, which is showing promise for high-throughput drug screening in physiologically relevant manner. In this review, we summarize current research efforts which ultimately lead to in vitro systems for testing drug's effect in PK-based manner. In particular, we highlight the contribution of microscale systems towards this goal. We envision that the 'cells-on-a-chip' technology will serve as a valuable link between in vitro and in vivo studies, reducing the demand for animal studies, and making clinical trials more effective. PMID:19701779

  17. Multi-Drug-Loaded Microcapsules with Controlled Release for Management of Parkinson's Disease.

    PubMed

    Baek, Jong-Suep; Choo, Chee Chong; Qian, Cheng; Tan, Nguan Soon; Shen, Zexiang; Loo, Say Chye Joachim

    2016-07-01

    Parkinson's disease (PD) is a progressive disease of the nervous system, and is currently managed through commercial tablets that do not sufficiently enable controlled, sustained release capabilities. It is hypothesized that a drug delivery system that provides controlled and sustained release of PD drugs would afford better management of PD. Hollow microcapsules composed of poly-l-lactide (PLLA) and poly (caprolactone) (PCL) are prepared through a modified double-emulsion technique. They are loaded with three PD drugs, i.e., levodopa (LD), carbidopa (CD), and entacapone (ENT), at a ratio of 4:1:8, similar to commercial PD tablets. LD and CD are localized in both the hollow cavity and PLLA/PCL shell, while ENT is localized in the PLLA/PCL shell. Release kinetics of hydrophobic ENT is observed to be relatively slow as compared to the other hydrophilic drugs. It is further hypothesized that encapsulating ENT into PCL as a surface coating onto these microcapsules can aid in accelerating its release. Now, these spray-coated hollow microcapsules exhibit similar release kinetics, according to Higuchi's rate, for all three drugs. The results suggest that multiple drug encapsulation of LD, CD, and ENT in gastric floating microcapsules could be further developed for in vivo evaluation for the management of PD. PMID:27253884

  18. The role of local drug delivery in the management of periodontal diseases: a comprehensive review.

    PubMed

    Greenstein, G; Polson, A

    1998-05-01

    This review article evaluates the role of local drug delivery systems in the management of periodontal diseases. The efficacy of several local delivery devices (i.e., tetracycline fibers, metronidazole and minocycline gels, chlorhexidine chips, and doxycycline polymer) which are either commercially available in the United States or abroad, or are currently under consideration for Food and Drug Administration (FDA) approval are discussed. The drug delivery systems are assessed with regard to their functional characteristics, effectiveness as a monotherapy, as compared to scaling and root planing, and ability to enhance conventional therapy. Furthermore, controversies associated with local delivery are addressed (e.g., induction of bacterial resistant strains, the efficacy of systemic versus local drug delivery, and whether local drug delivery should function as an alternative or as an adjunct to conventional treatment). PMID:9623893

  19. "Addicted to Euphoria": The History, Clinical Presentation, and Management of Party Drug Misuse.

    PubMed

    Bearn, Jenny; O'Brien, Matthew

    2015-01-01

    Eating, drinking, sexual activity, and parenting invoke pleasure, an emotion that promotes repetition of these behaviors, are essential for survival. Euphoria, a feeling or state of intense excitement and happiness, is an amplification of pleasure, aspired to one's essential biological needs that are satisfied. People use party drugs as a shortcut to euphoria. Ecstasy (3,4-methylenedioxymethamphetamine), γ-hydroxybutyric acid, and ketamine fall under the umbrella of the term "party drugs," each with differing neuropharmacological and physiological actions. This chapter seeks to survey the history and epidemiology of party drug use; we will then discuss the pharmacological characteristics of each drug to provide a platform for understanding the difficulties that party drug users encounter through intoxication, harmful use, dependence, and withdrawal and how these should be clinically managed. PMID:26070759

  20. Drugs foresight 2020: a Delphi expert panel study

    PubMed Central

    2014-01-01

    Background Historically substance misuse has been relatively common in western countries, but comparatively few Finns report drug use. The Drugs 2020 study aimed at foreseeing changes in the drug situation in Finland by the year 2020. Methods The Delphi method was used, utilizing drug experts of the EU national network in Finland. Results Marked growth was foreseen in drug use, especially in synthetic designer drugs and misuse of medicinal drugs. Significant increase was also expected in growing cannabis at home. However, the control of drug market was expected to shift more into the hands of organized crime. No consensus was reached on how drug prices will develop in the time period. Drug use is likely to remain punishable although the use and possession of cannabis may be treated less severely. It seems likely that health and social services resources will be directed towards medicinal treatment. Conclusions Foresight can be utilized in preparing for the future; desirable developments can be fostered, and measures can be taken to curb probable but undesirable lines of development. Based on the results of this study, the experts’ view is that it is highly likely that the Finnish society will have to prepare for an increase in the demand for drug-related care, both in terms of content of the care and financing the services. Also, the forecasted increase in the role of legal prescription medicine used as intoxicants will call for efforts not only in changing prescription practices but in border and police control measures, as well. Parallel developments have been foreseen in the UK and Sweden, and it is likely that similar trends will actualize also in other western countries. PMID:24885142

  1. Impact of Participatory Design for Drug-Drug Interaction Alerts. A Comparison Study Between Two Interfaces.

    PubMed

    Luna, Daniel; Otero, Carlos; Risk, Marcelo; Stanziola, Enrique; González Bernaldo de Quirós, Fernán

    2016-01-01

    Decision support systems for alert drug-drug interactions have been shown as valid strategy to reduce medical error. Even so the use of these systems has not been as expected, probably due to the lack of a suitable design. This study compares two interfaces, one of them developed using participatory design techniques (based on user centered design processes). This work showed that the use of these techniques improves satisfaction, effectiveness and efficiency in an alert system for drug-drug interactions, a fact that was evident in specific situations such as the decrease of errors to meet the specified task, the time, the workload optimization and users overall satisfaction with the system. PMID:27577343

  2. Architecture for a Federated Drug Reference in a managed care environment.

    PubMed Central

    Ketchell, D. S.; Ibrahim, K. N.; Murri, N. A.; Wareham, P. S.; Bell, D. M.; Jankowski, T. A.

    1996-01-01

    We describe a model of drug information query management that supports the integration of various types of pharmaceutical information and the delivery of that information through a common interface. Our prototype drug reference system makes use of the World Wide Web client/server architecture as a front-end to federate this data. Although originally intended as an electronic Hospital Formulary, the system has been redefined as a result of input from physicians to include formularies of multiple managed care plans. The underlying database is designed for integration with an electronic medical record as well as education and research resources for faculty and students in an academic medical center environment. PMID:8947699

  3. Drug abuse in Nepal: a rapid assessment study.

    PubMed

    Chatterjee, A; Uprety, L; Chapagain, M; Kafle, K

    1996-01-01

    A rapid assessment of drug abuse in Nepal was conducted at different sites, including eight municipalities in the five development regions of the country. To interview various groups of key informants, such methods as semi-structured interviews, in-depth interviews and focus group discussions were used. A snowball sampling strategy for respondents who were drug abusers and a judgemental sampling strategy for the non-drug-using key informants were applied. About one fifth of the sample was recruited from the treatment centres and the rest from the community. Drug abusers in prison were interviewed, and secondary data from treatment centres and prisons analysed. The study revealed that the sample of drug abusers had a mean age of 23.8 years and was overwhelmingly male. Most respondents lived with their families and were either unemployed or students. About 30 per cent of the sample was married. A large majority of the sample had a family member or a close relative outside the immediate family who smoked or drank alcohol and a friend who smoked, drank or used illicit drugs. Apart from tobacco and alcohol, the major drugs of abuse were cannabis, codeine-containing cough syrup, nitrazepam tablets, buprenor-phine injections and heroin (usually smoked, rarely injected). The commonest sources of drugs were other drug-using friends, cross-border supplies from India or medicine shops. The commonest source of drug money was the family. There has been a clear trend towards the injection of buprenorphine by abusers who smoke heroin or drink codeine cough syrup. The reasons cited for switching to injections were the unavailability and rising cost of non-injectable drugs and the easy availability and relative cheapness of injectables. About a half of the injecting drug users (IDUs) commonly reported sharing injecting equipment inadequately cleaned with water. Over a half of IDUs reported visiting needle-exchange programmes at two of the study sites where such programmes were

  4. Adjunct therapy of Ayurvedic medicine with anti tubercular drugs on the therapeutic management of pulmonary tuberculosis

    PubMed Central

    Debnath, P. K.; Chattopadhyay, Jaydeb; Mitra, Achintya; Adhikari, Anjan; Alam, Mirza Samsur; Bandopadhyay, S. K.; Hazra, Jayram

    2012-01-01

    Background: Pulmonary tuberculosis (PTB) is an age old disease described in Vedic Medicine as ‘Yakshma’. Later on, in Ayurveda it earned a prefix and found way into mythology as ‘Rajayakshma’. After the discovery of streptomycin, the therapeutic management of PTB received a major breakthrough. The treatment module changed remarkably with the formulation of newer anti-tubercular drugs (ATD) with appreciable success. Recent resurgence of PTB in developed countries like United States posed a threat to the medical community due to resistant strains. Consequently, WHO looked toward traditional medicine. Literature reveals that Ayurvedic treatment of PTB was in vogue in India before the introduction of ATD with limited success. Records show that 2766 patients of PTB were treated with Ayurvedic drugs in a tertiary care hospital in Kolkata in the year 1933-1947. Objectives: To evaluate the toxicity reduction and early restoration by adjunct therapy of Ayurvedic drugs by increasing the bio-availability of ATDs. Materials and Methods: In the present study, treatment response of 99 patients treated with ATD as an adjunct with Aswagandha (Withania somnifera) and a multi-herbal formulation described in Chikitsa-sthana of Charaka samhita i.e. Chyawanprash were investigated. Hematological profile, sputum bacterial load count, immunoglobulin IgA and IgM, blood sugar, liver function test, serum creatinine were the assessed parameters besides blood isoniazid and pyrazinamide, repeated after 28 days of treatment. Results: The symptoms abated, body weight showed improvement, ESR values were normal, there was appreciable change in IgA and IgM patterns and significantly increased bioavailability of isoniazid and pyrazinamide were recorded. Conclusion: This innovative clinical study coupled with empowered research may turn out to be promising in finding a solution for the treatment of PTB. PMID:23125511

  5. A 2013 workshop: vaccine and drug ontology studies (VDOS 2013).

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2014-01-01

    The 2013 "Vaccine and Drug Ontology Studies" (VDOS 2013) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have contributed to dramatic improvements in public health worldwide. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, as well as developing new models such as Vaccine Ontology. The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The six full-length papers included in this thematic issue focuses on three main areas: (i) ontology development and representation, (ii) ontology mapping, maintaining and auditing, and (iii) ontology applications. PMID:24650607

  6. Drug taking beliefs of Australian adolescents: a pilot study.

    PubMed

    Skrzypiec, Grace; Owens, Laurence

    2013-01-01

    In this study adolescents offered their insights and perspectives of factors associated with adolescent illicit drug taking intentions. The factors explored were identified using a cross-disciplinary approach involving the Theory of Planned Behavior (TPB) and criminological theories, and these formed the framework for data analysis. Interviews with 24 students aged 15-17 found that adolescents' beliefs to drug taking attitudes, subjective norms, perceived behavioral control, moral norms, negative affect, and reputation enhancement involved a number a sub-themes that provided an in-depth understanding of the association of these components to intended drug use. The incorporation of these elements in drug education programs could be an effective approach in prevention interventions for adolescent drug use. PMID:24855880

  7. [Study on the regulation of autophagy against anticancer drugs' toxicity].

    PubMed

    Lou, Xiao-e; Zhu, Yi; He, Qiao-jun

    2016-01-01

    Autophagy is a crucial biological process in eukaryotes, which is involved in cell growth, survival and energy metabolism. It has been confirmed that autophagy mediates toxicity of anticancer drugs, especially in heart, liver and neuron. It is important to understand the function and mechanism of autophagy in anticancer drugs-induced toxicity. Given that autophagy is a double-edged sword in the maintenance of the function of heart, liver and neuron, the autophagy-mediated toxicity are very complicated in the body. We provide a review on the concept of autophagy and current status about autophagy-mediated toxicity of anticancer drugs. The knowledge is crucial in the basic study of anticancer drugs-induced toxicity, and provides some strategies for the development of alleviating the toxicity of anticancer drugs. PMID:27405158

  8. Management of the metabolic effects of HIV and HIV drugs.

    PubMed

    Brown, Todd T; Glesby, Marshall J

    2012-01-01

    Morphologic and metabolic abnormalities, including subcutaneous adipose tissue wasting, central adipose tissue accumulation, dyslipidemia and disorders of glucose metabolism are common among HIV-infected patients receiving highly active antiretroviral therapy (HAART) and contribute to the risk of cardiovascular disease in this population. The pathogenesis of these disorders is due to complicated interactions between effects of chronic HIV infection, HAART medications and patient factors, including genetic susceptibility. HAART has transformed HIV into a chronic condition for many patients and as a result the majority of HIV-infected patients in many areas of the developed world will soon be aged ≥50 years. Given that metabolic and cardiovascular diseases increase with aging, knowledge of the optimal management of these conditions is essential for practitioners caring for HIV-infected patients, including endocrine subspecialists. This Review highlights the clinical management of these disorders, focusing on the latest evidence regarding the efficacy of treatment strategies, newly available medications and potential interactions between HAART medications and medications used to treat metabolic disorders. PMID:21931374

  9. A Study of the Credibility Factor in Drug Education Programs

    ERIC Educational Resources Information Center

    Pascale, Pietro J.; Streit, Fred

    1972-01-01

    This empirical study has examined by chi-square procedures the relationship between educational level of students and the degree to which they will endorse various sources of information concerning drug problems. (Author)

  10. Arthritis Possible Side Effect of Certain Cancer Drugs: Study

    MedlinePlus

    ... gov/news/fullstory_159602.html Arthritis Possible Side Effect of Certain Cancer Drugs: Study Doctors should weigh ... research is needed to confirm a cause-and-effect relationship, the researchers said. Still, "I don't ...

  11. Management of HIV/AIDS in older patients–drug/drug interactions and adherence to antiretroviral therapy

    PubMed Central

    Burgess, Mary J; Zeuli, John D; Kasten, Mary J

    2015-01-01

    Patients with human immunodeficiency virus (HIV) are living longer with their disease, as HIV has become a chronic illness managed with combination antiretroviral therapy (cART). This has led to an increasing number of patients greater than 50 years old living successfully with HIV. As the number of older adults with HIV has increased, there are special considerations for the management of HIV. Older adults with HIV must be monitored for drug side effects and toxicities. Their other non-HIV comorbidities should also be considered when choosing a cART regimen. Older adults with HIV have unique issues related to medication compliance. They are more likely than the younger HIV patients to have vision loss, cognitive impairment, and polypharmacy. They may have lower expectations of their overall health status. Depression and financial concerns, especially if they are on a fixed income, may also contribute to noncompliance in the aging HIV population. PMID:26604826

  12. Drug use in children: cohort study in three European countries

    PubMed Central

    Verhamme, Katia M C; Nicolosi, Alfredo; Murray, Macey L; Neubert, Antje; Caudri, Daan; Picelli, Gino; Sen, Elif Fatma; Giaquinto, Carlo; Cantarutti, Luigi; Baiardi, Paola; Felisi, Maria-Grazia; Ceci, Adriana; Wong, Ian C K

    2008-01-01

    Objective To provide an overview of drug use in children in three European countries. Design Retrospective cohort study, 2000-5. Setting Primary care research databases in the Netherlands (IPCI), United Kingdom (IMS-DA), and Italy (Pedianet). Participants 675 868 children aged up to 14 (Italy) or 18 (UK and Netherlands). Main outcome measure Prevalence of use per year calculated by drug class (anatomical and therapeutic). Prevalence of “recurrent/chronic” use (three or more prescriptions a year) and “non-recurrent” or “acute” use (less than three prescriptions a year) within each therapeutic class. Descriptions of the top five most commonly used drugs evaluated for off label status within each anatomical class. Results Three levels of drug use could be distinguished in the study population: high (>10/100 children per year), moderate (1-10/100 children per year), and low (<1/100 children per year). For all age categories, anti-infective, dermatological, and respiratory drugs were in the high use group, whereas cardiovascular and antineoplastic drugs were always in the low use group. Emollients, topical steroids, and asthma drugs had the highest prevalence of recurrent use, but relative use of low prevalence drugs was more often recurrent than acute. In the top five highest prevalence drugs topical inhaled and systemic steroids, oral contraceptives, and topical or systemic antifungal drugs were most commonly used off label. Conclusion This overview of outpatient paediatric prescription patterns in a large European population could provide information to prioritise paediatric therapeutic research needs. PMID:19029175

  13. Managing risks in drug discovery: reproducibility of published findings.

    PubMed

    Kannt, Aimo; Wieland, Thomas

    2016-04-01

    In spite of tremendous advances in biopharmaceutical science and technology, the productivity of pharmaceutical research and development has been steadily declining over the last decades. The reasons for this decline are manifold and range from improved standard of care that is more and more difficult to top to inappropriate management of technical and translational risks along the R&D value chain. In this short review, major types of risks in biopharmaceutical R&D and means to address them will be described. A special focus will be on a risk, i.e., the lack of reproducibility of published information, that has so far not been fully appreciated and systematically analyzed. Measures to improve reproducibility and trust in published information will be discussed. PMID:26883784

  14. Drug Management of Visceral Pain: Concepts from Basic Research

    PubMed Central

    Davis, Mellar P.

    2012-01-01

    Visceral pain is experienced by 40% of the population, and 28% of cancer patients suffer from pain arising from intra- abdominal metastasis or from treatment. Neuroanatomy of visceral nociception and neurotransmitters, receptors, and ion channels that modulate visceral pain are qualitatively or quantitatively different from those that modulate somatic and neuropathic pain. Visceral pain should be recognized as distinct pain phenotype. TRPV1, Na 1.8, and ASIC3 ion channels and peripheral kappa opioid receptors are important mediators of visceral pain. Mu agonists, gabapentinoids, and GABAB agonists reduce pain by binding to central receptors and channels. Combinations of analgesics and adjuvants in animal models have supra-additive antinociception and should be considered in clinical trials. This paper will discuss the neuroanatomy, receptors, ion channels, and neurotransmitters important to visceral pain and provide a basic science rationale for analgesic trials and management. PMID:22619712

  15. Regional solid waste management study

    SciTech Connect

    Not Available

    1992-09-01

    In 1990, the Lower Savannah Council of Governments (LSCOG) began dialogue with the United States Department of Energy (DOE) regarding possibilities for cooperation and coordination of solid waste management practices among the local governments and the Savannah River Site. The Department of Energy eventually awarded a grant to the Lower Savannah Council of Governments for the development of a study, which was initiated on March 5, 1992. After careful analysis of the region`s solid waste needs, this study indicates a network approach to solid waste management to be the most viable. The network involves the following major components: (1) Rural Collection Centers, designed to provide convenience to rural citizens, while allowing some degree of participation in recycling; (2) Rural Drop-Off Centers, designed to give a greater level of education and recycling activity; (3) Inert landfills and composting centers, designed to reduce volumes going into municipal (Subtitle D) landfills and produce useable products from yard waste; (4) Transfer Stations, ultimate landfill disposal; (5) Materials Recovery Facilities, designed to separate recyclables into useable and sellable units, and (6) Subtitle D landfill for burial of all solid waste not treated through previous means.

  16. An exploratory study of drug use in bar environments

    PubMed Central

    Trocki, Karen; Michalak, Laurence; McDaniel, Patricia

    2010-01-01

    The purpose of this paper is to explore the characteristics of bars where drug use was observed compared to those where no drug use was observed. The study was done through a combination of qualitative and quantitative techniques gleaned through observations and interviews. Among the most important of indicators were the type of activity (particularly dancing) and the level of rowdiness evident in the bars. In addition drug use bars had higher levels of other types of rule-breaking. Patron characteristics (more men) and behavioral patterns (more sexual risk-taking) also distinguished these bars. PMID:25221431

  17. General Practitioners' Management of Psychostimulant Drug Misuse: Implications for Education and Training

    ERIC Educational Resources Information Center

    Alkhamis, Ahmed; Matheson, Catriona; Bond, Christine

    2009-01-01

    Aims: To provide baseline data regarding GPs' knowledge, experience, and attitudes toward the management of PsychoStimulant Drug Misuse (PSDM) patients to inform future education and training initiatives. Methods: A structured cross-sectional postal questionnaire was developed following initial content setting interviews, piloted then sent to a…

  18. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    ERIC Educational Resources Information Center

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha A.; Davis, Thomas B.; Marsh, Cheryl

    2011-01-01

    This article reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to PCM (n = 92) or standard probation (n = 91) and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support, and service utilization.…

  19. Evaluating Environmental Management Approaches to Alcohol and Other Drug Abuse Prevention. Prevention Updates

    ERIC Educational Resources Information Center

    DeJong, William; Langford, Linda M.

    2006-01-01

    Recent years have seen an upsurge in prevention work focused on changing the campus and community environments in which college students make decisions about alcohol and other drug (AOD) use. This approach, called "environmental management," is based on three fundamental premises: (1) Substance use problems are aggravated by a physical, social,…

  20. Thermoresponsive polymeric gel as an on-demand transdermal drug delivery system for pain management.

    PubMed

    Indulekha, S; Arunkumar, P; Bahadur, D; Srivastava, R

    2016-05-01

    The main aim of this work is to design a heat triggered transdermal drug delivery system (TDDS) using a thermoresponsive polymer, poly (N-vinyl caprolactam) [PNVCL] based gel, where in patients can themselves administer a pulse of drug on mere application of heat pad over the TDDS, whenever pain is experienced. The phase transition temperature of PNVCL was tuned to 35 °C by grafting it onto a pH sensitive biopolymer, Chitosan, to synthesize Chitosan-g-PNVCL (CP) co-polymer which render the gel both thermo- and pH-responsive property. The application of triggered delivery was explored by loading acetamidophenol (a model hydrophilic drug) and etoricoxib (a model hydrophobic drug). In vitro drug release experiments were performed at three different temperatures (25, 32 and 39 °C) at two different pH (5.5 and 7) to study its drug release with response to temperature and pH. Drug release profiles obtained were found to have enhanced release for both the drugs respectively at 39 °C (above LCST) and pH5.5 when compared to other release conditions. In vitro skin permeation of both the drugs performed in rat abdominal skin using Franz diffusion cell showed enhanced drug release when the skin was subjected to higher temperature (39 °C). Moreover, it was also found that skin permeation for hydrophobic drug was better than that of hydrophilic drug. The in vivo biocompatibility studies of the CP gel in rat skin proved that the gel is biocompatible. The results obtained demonstrated the potential use of the thermoresponsive CP gel as an on-demand localized drug delivery system. PMID:26952404

  1. Prescription Drug Abuse: Epidemiology, Regulatory Issues, Chronic Pain Management with Narcotic Analgesics

    PubMed Central

    Manubay, Jeanne M.; Muchow, Carrie; Sullivan, Maria A.

    2012-01-01

    Synopsis The epidemic of prescription drug abuse has reached a critical level, which has received national attention. Physicians must learn strategies to effectively treat chronic pain, and help reduce the rates of prescription drug abuse. This chapter will provide insight into the epidemiology of prescription drug abuse, explain regulatory issues, and provide guidelines for the assessment and management of pain, particularly with chronic opioid therapy. The use of informed consent forms, treatment agreements, risk documentation tools, and regular monitoring of the 4 “A's” helps to educate patients, as well as guide management based on treatment goals. By using universal precautions, and being aware of aberrant behaviors, physicians may feel more confident in identifying and addressing problematic behaviors. PMID:21356422

  2. Knowledge Management Analysis: A Case Study

    ERIC Educational Resources Information Center

    Mecha, Ezi I.; Desai, Mayur S.; Richards, Thomas C.

    2009-01-01

    It is imperative for businesses to manage knowledge and stay competitive in the marketplace. Knowledge management is critical and is a key to prevent organizations from duplicating their efforts with a subsequent improvement in their efficiency. This study focuses on overview of knowledge management, analyzes the current knowledge management in…

  3. CNODES: the Canadian Network for Observational Drug Effect Studies.

    PubMed

    Suissa, Samy; Henry, David; Caetano, Patricia; Dormuth, Colin R; Ernst, Pierre; Hemmelgarn, Brenda; Lelorier, Jacques; Levy, Adrian; Martens, Patricia J; Paterson, J Michael; Platt, Robert W; Sketris, Ingrid; Teare, Gary

    2012-01-01

    Although administrative health care databases have long been used to evaluate adverse drug effects, responses to drug safety signals have been slow and uncoordinated. We describe the establishment of the Canadian Network for Observational Drug Effect Studies (CNODES), a collaborating centre of the Drug Safety and Effectiveness Network (DSEN). CNODES is a distributed network of investigators and linked databases in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia. Principles of operation are as follows: (1) research questions are prioritized by the coordinating office of DSEN; (2) the linked data stay within the provinces; (3) for each question, a study team formulates a detailed protocol enabling consistent analyses in each province; (4) analyses are "blind" to results obtained elsewhere; (5) protocol deviations are permitted for technical reasons only; (6) analyses using multivariable methods are lodged centrally with a methods team, which is responsible for combining the results to provide a summary estimate of effect. These procedures are designed to achieve high internal validity of risk estimates and to eliminate the possibility of selective reporting of analyses or outcomes. The value of a coordinated multi-provincial approach is illustrated by projects studying acute renal injury with high-potency statins, community-acquired pneumonia with proton pump inhibitors, and hyperglycemic emergencies with antipsychotic drugs. CNODES is an academically based distributed network of Canadian researchers and data centres with a commitment to rapid and sophisticated analysis of emerging drug safety signals in study populations totalling over 40 million. PMID:23687528

  4. 21 CFR 310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved. 310.303 Section 310.303 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Records and Reports...

  5. Drug Targets for Cardiovascular-Safe Anti-Inflammatory: In Silico Rational Drug Studies.

    PubMed

    Shahbazi, Sajad; Sahrawat, Tammanna R; Ray, Monalisa; Dash, Swagatika; Kar, Dattatreya; Singh, Shikha

    2016-01-01

    Cyclooxygenase-2 (COX-2) plays an important role in memory consolidation and synaptic activity, the most fundamental functions of the brain. It converts arachidonic acid to prostaglandin endoperoxide H2. In contrast, if over-expressed, it causes inflammation in response to cytokine, pro-inflammatory molecule, and growth factor. Anti-inflammatory agents, by allosteric or competitive inhibition of COX-2, alleviate the symptoms of inflammation. Coxib family drugs, particularly celecoxib, are the most famous anti-inflammatory agents available in the market showing significant inhibitory effect on COX-2 activity. Due to high cardiovascular risk of this drug group, recent researches are focused on the investigation of new safer drugs for anti-inflammatory diseases. Natural compounds, particularly, phytochemicals are found to be good candidates for drug designing and discovery. In the present study, we performed in silico studies to quantitatively scrutinize the molecular interaction of curcumin and its structural analogs with COX-2, COX-1, FXa and integrin αIIbβIII to investigate their therapeutic potential as a cardiovascular-safe anti-inflammatory medicine (CVSAIM). The results of both ADMET and docking study indicated that out of all the 39 compounds studied, caffeic acid had remarkable interaction with proteins involved in inflammatory response. It was also found to inhibit the proteins that are involved in thrombosis, thereby, having the potential to be developed as therapeutic agent. PMID:27258084

  6. Drug Targets for Cardiovascular-Safe Anti-Inflammatory: In Silico Rational Drug Studies

    PubMed Central

    Shahbazi, Sajad; Sahrawat, Tammanna R.; Ray, Monalisa; Dash, Swagatika; Kar, Dattatreya; Singh, Shikha

    2016-01-01

    Cyclooxygenase-2 (COX-2) plays an important role in memory consolidation and synaptic activity, the most fundamental functions of the brain. It converts arachidonic acid to prostaglandin endoperoxide H2. In contrast, if over-expressed, it causes inflammation in response to cytokine, pro-inflammatory molecule, and growth factor. Anti-inflammatory agents, by allosteric or competitive inhibition of COX-2, alleviate the symptoms of inflammation. Coxib family drugs, particularly celecoxib, are the most famous anti-inflammatory agents available in the market showing significant inhibitory effect on COX-2 activity. Due to high cardiovascular risk of this drug group, recent researches are focused on the investigation of new safer drugs for anti-inflammatory diseases. Natural compounds, particularly, phytochemicals are found to be good candidates for drug designing and discovery. In the present study, we performed in silico studies to quantitatively scrutinize the molecular interaction of curcumin and its structural analogs with COX-2, COX-1, FXa and integrin αIIbβIII to investigate their therapeutic potential as a cardiovascular-safe anti-inflammatory medicine (CVSAIM). The results of both ADMET and docking study indicated that out of all the 39 compounds studied, caffeic acid had remarkable interaction with proteins involved in inflammatory response. It was also found to inhibit the proteins that are involved in thrombosis, thereby, having the potential to be developed as therapeutic agent. PMID:27258084

  7. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS)...

  8. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS)...

  9. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS)...

  10. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS)...

  11. [Risk Management of Teratogenic Drugs ~The Current States of Practice in Europe, US and Japan~].

    PubMed

    Takagi, Tatsuya; van Bennekom, Carla; Amann, Steffen; Hattori, Chizuko; Shirakuni, Yuko; Sato, Tsugumichi; Nasu, Masao

    2015-01-01

    Thalidomide was approved for the treatment of multiple myeloma in Japan under a risk management program, named TERMS, in 2008. Since then, we have been conducting a survey of the stakeholders to assess the effectiveness of TERMS. These surveys showed patients had enough knowledge of the risks of thalidomide. In the USA, legislation in 2007 granted its U.S. Food and Drug Administration (FDA) the authority to require Risk Evaluation and Mitigation Strategies (REMS) when necessary to ensure that a drug's benefits outweigh its risks. As of 2015, more than 70 drugs, including thalidomide, have REMS programs. In Germany, in the early 1960s, over 5000 children were born with deformities. Therefore, the safety regulations in Germany go far beyond the European Medicines Agency (EMA) safety regulations at the time of thalidomide re-approval; thalidomide can be prescribed by a special prescribing form, including both proof of the patients' awareness of information about the risks, and participation in a pregnancy prevention program. While Japan has taken similar safety measures, a portion of thalidomide is still privately imported there. By March 2013, 594 patients have been registered to Japan's Safety Management System for Unapproved Drugs (SMUD), which was introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2009. The number of females of child bearing potential (FCBPs) was 33 and the fraction (33/594=5.6%) was higher than that (48/7370=0.7%) in the case of TERMS. Risk management of thalidomide is described in this review. PMID:26234426

  12. Availability of drugs and medical supplies for emergency obstetric care: experience of health facility managers in a rural District of Tanzania

    PubMed Central

    2014-01-01

    Background Provision of quality emergency obstetric care relies upon the presence of skilled health attendants working in an environment where drugs and medical supplies are available when needed and in adequate quantity and of assured quality. This study aimed to describe the experience of rural health facility managers in ensuring the timely availability of drugs and medical supplies for emergency obstetric care (EmOC). Methods In-depth interviews were conducted with a total of 17 health facility managers: 14 from dispensaries and three from health centers. Two members of the Council Health Management Team and one member of the Council Health Service Board were also interviewed. A survey of health facilities was conducted to supplement the data. All the materials were analysed using a qualitative thematic analysis approach. Results Participants reported on the unreliability of obtaining drugs and medical supplies for EmOC; this was supported by the absence of essential items observed during the facility survey. The unreliability of obtaining drugs and medical supplies was reported to result in the provision of untimely and suboptimal EmOC services. An insufficient budget for drugs from central government, lack of accountability within the supply system and a bureaucratic process of accessing the locally mobilized drug fund were reported to contribute to the current situation. Conclusion The unreliability of obtaining drugs and medical supplies compromises the timely provision of quality EmOC. Multiple approaches should be used to address challenges within the health system that prevent access to essential drugs and supplies for maternal health. There should be a special focus on improving the governance of the drug delivery system so that it promotes the accountability of key players, transparency in the handling of information and drug funds, and the participation of key stakeholders in decision making over the allocation of locally collected drug funds. PMID

  13. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  14. A Proposal of Operational Risk Management Method Using FMEA for Drug Manufacturing Computerized System

    NASA Astrophysics Data System (ADS)

    Takahashi, Masakazu; Nanba, Reiji; Fukue, Yoshinori

    This paper proposes operational Risk Management (RM) method using Failure Mode and Effects Analysis (FMEA) for drug manufacturing computerlized system (DMCS). The quality of drug must not be influenced by failures and operational mistakes of DMCS. To avoid such situation, DMCS has to be conducted enough risk assessment and taken precautions. We propose operational RM method using FMEA for DMCS. To propose the method, we gathered and compared the FMEA results of DMCS, and develop a list that contains failure modes, failures and countermeasures. To apply this list, we can conduct RM in design phase, find failures, and conduct countermeasures efficiently. Additionally, we can find some failures that have not been found yet.

  15. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury.

    PubMed

    Chalasani, Naga P; Hayashi, Paul H; Bonkovsky, Herbert L; Navarro, Victor J; Lee, William M; Fontana, Robert J

    2014-07-01

    Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug reaction and it can lead to jaundice, liver failure, or even death. Antimicrobials and herbal and dietary supplements are among the most common therapeutic classes to cause DILI in the Western world. DILI is a diagnosis of exclusion and thus careful history taking and thorough work-up for competing etiologies are essential for its timely diagnosis. In this ACG Clinical Guideline, the authors present an evidence-based approach to diagnosis and management of DILI with special emphasis on DILI due to herbal and dietary supplements and DILI occurring in individuals with underlying liver disease. PMID:24935270

  16. Software for Managing Parametric Studies

    NASA Technical Reports Server (NTRS)

    Yarrow, Maurice; McCann, Karen M.; DeVivo, Adrian

    2003-01-01

    The Information Power Grid Virtual Laboratory (ILab) is a Practical Extraction and Reporting Language (PERL) graphical-user-interface computer program that generates shell scripts to facilitate parametric studies performed on the Grid. (The Grid denotes a worldwide network of supercomputers used for scientific and engineering computations involving data sets too large to fit on desktop computers.) Heretofore, parametric studies on the Grid have been impeded by the need to create control language scripts and edit input data files painstaking tasks that are necessary for managing multiple jobs on multiple computers. ILab reflects an object-oriented approach to automation of these tasks: All data and operations are organized into packages in order to accelerate development and debugging. A container or document object in ILab, called an experiment, contains all the information (data and file paths) necessary to define a complex series of repeated, sequenced, and/or branching processes. For convenience and to enable reuse, this object is serialized to and from disk storage. At run time, the current ILab experiment is used to generate required input files and shell scripts, create directories, copy data files, and then both initiate and monitor the execution of all computational processes.

  17. Managing potential drug-drug interactions between gastric acid-reducing agents and antiretroviral therapy: experience from a large HIV-positive cohort.

    PubMed

    Lewis, J M; Stott, K E; Monnery, D; Seden, K; Beeching, N J; Chaponda, M; Khoo, S; Beadsworth, M B J

    2016-02-01

    Drug-drug interactions between antiretroviral therapy and other drugs are well described. Gastric acid-reducing agents are one such class. However, few data exist regarding the frequency of and indications for prescription, nor risk assessment in the setting of an HIV cohort receiving antiretroviral therapy. To assess prevalence of prescription of gastric acid-reducing agents and drug-drug interaction within a UK HIV cohort, we reviewed patient records for the whole cohort, assessing demographic data, frequency and reason for prescription of gastric acid-reducing therapy. Furthermore, we noted potential drug-drug interaction and whether risk had been documented and mitigated. Of 701 patients on antiretroviral therapy, 67 (9.6%) were prescribed gastric acid-reducing therapy. Of these, the majority (59/67 [88.1%]) were prescribed proton pump inhibitors. We identified four potential drug-drug interactions, which were appropriately managed by temporally separating the administration of gastric acid-reducing agent and antiretroviral therapy, and all four of these patients remained virally suppressed. Gastric acid-reducing therapy, in particular proton pump inhibitor therapy, appears common in patients prescribed antiretroviral therapy. Whilst there remains a paucity of published data, our findings are comparable to those in other European cohorts. Pharmacovigilance of drug-drug interactions in HIV-positive patients is vital. Education of patients and staff, and accurate data-gathering tools, will enhance patient safety. PMID:25721922

  18. Preparing for safety issues following drug approval: pre-approval risk management considerations

    PubMed Central

    Sharrar, Robert G.

    2013-01-01

    Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are conducted in the postapproval arena, the design of the plans and studies as well as the development of effective postapproval tools and mitigation strategies should be carried out pre-approval. The pre-approval period also provides the opportunity to fully understand the treatment population that is included in the clinical trial program and to determine how the target population for the drug after approval may differ from the clinical trial patient population. When regulators or sponsors have expressed concerns about safety issues identified during clinical development, the result may be a postapproval commitment in the form of a registry or an observational safety study or, in the US, a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval. Specific examples are given for risk mitigation activities that can be conducted pre-approval. PMID:25114783

  19. Nitazoxanide: Nematicidal Mode of Action and Drug Combination Studies

    PubMed Central

    Somvanshi, Vishal S.; Ellis, Brian L.; Hu, Yan; Aroian, Raffi V.

    2014-01-01

    Intestinal nematodes or roundworms (aka soil-transmitted helminths or STHs) cause great disease. They infect upwards of two billion people, leading to high morbidity and a range of health problems, especially in infected children and pregnant women. Development of resistance to the two main classes of drugs used to treat intestinal nematode infections of humans has been reported. To fight STH infections, we need new and more effective drugs and ways to improve the efficacy of the old drugs. One promising alternative drug is nitazoxanide (NTZ). NTZ, approved for treating human protozoan infections, was serendipitously shown to have therapeutic activity against STHs. However, its mechanism of action against nematodes is not known. Using the laboratory nematode Caenorhabditis elegans, we show that NTZ acts on the nematodes through avr-14, an alpha-type subunit of a glutamate-gated chloride ion channel known for its role in ivermectin susceptibility. In addition, a forward genetic screen to select C. elegans mutants resistant to NTZ resulted in isolation of two NTZ resistant mutants that are not in avr-14, suggesting that additional mechanisms are involved in resistance to NTZ. We found that NTZ combines synergistically with other classes of anthelmintic drugs, i.e. albendazole and pyrantel, making it a good candidate for further studies on its use in drug combination therapy of STH infections. Given NTZ acts against a wide range of nematode parasites, our findings also validate avr-14 as an excellent target for pan-STH therapy. PMID:24412397

  20. Towards a Clinical Decision Support System for Drug Allergy Management: Are Existing Drug Reference Terminologies Sufficient for Identifying Substitutes and Cross-Reactants?

    PubMed

    Ogallo, William; Kanter, Andrew S

    2015-01-01

    Drug allergy cross-reactivity checking is an important component of electronic health record systems. Currently, a single, open-source medication dictionary that can provide this function does not exist. In this study, we assessed the feasibility of using RxNorm and NDF-RT (National Drug File--Reference Terminology) for allergy management decision support. We evaluated the performance of using the Pharmacological Class, Mechanism of Action and Chemical Structure NDF-RT classifications in discriminating between safe and cross-reactive alternatives to a sample of common drug allergens. The positive predictive values for the three approaches were 96.3%, 99.3% and 96.2% respectively. The negative predictive values were 94.7%, 56.8% and 92.6%. Our findings suggest that in the absence of an established medication allergy classification system, using the Pharmacologic Class and Chemical Structure classifications in NDF-RT may still be effective for discriminating between safe and cross-reactive alternatives to potential allergens. PMID:26262387

  1. Rooting out institutional corruption to manage inappropriate off-label drug use.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. PMID:24088156

  2. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... Federal Register of September 12, 2006 (71 FR 53696), FDA announced the availability of a draft guidance... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  3. Drug Craving Terminology among Opiate Dependents; A Mixed Method Study

    PubMed Central

    Maarefvand, Masoomeh; Ghiasvand, Hamid Reza

    2013-01-01

    Objective Drug craving is defined as an urge to continue substance abuse. Drug dependents use different terms to express their subjective feeling of craving. This study was an attempt to generate an understanding of craving terminology among different groups of Persian speaking Iranian opiate dependents. Method Terms used for the meaning of drug craving were listed by 36 ex-opiate dependents in focus group discussion meetings in the first phase of the study. These terms were composed from Craving Terms Questionnaire. In the second phase, 120 subjects in 3 groups of opiate dependents and a group of Current Opiate Abusers rated usage frequency of each term in the questionnaire under a Twelve-Step Program, Methadone Maintenance, and Other Abstinence-based Programs. Results Eighty nine terms were categorized in stimulation and triggering, attention bias and obsession, decision making difficulty, information processing impairment, withdrawal induction, drug euphoric experience, mental urge, motor control problem, negative valancing and stigmatizing. Terms for the three categories of mental urge, attention bias and obsession and motor control problem were used more than others. Patients in Methadone Maintenance Treatment (MMT) group used different categories of craving terms in comparison to other groups. Abstinent cases reported higher total score for craving terms in comparison to other groups in Twelve-Step Program and other abstinence-based programs. Conclusion Each craving-related term is associated with some aspects of the multidimensional concept of craving. A drug-craving thesaurus could provide a better understanding of craving nature from a drug dependent point of view. There are differences among abstinence vs. maintenance based treated opiate dependents in using craving terms. Addiction therapists will benefit from accessing drug dependents’ lexicon to assess and create therapeutic alliance with their clients. PMID:24130609

  4. Nanobiological studies on drug design using molecular mechanic method

    PubMed Central

    Ghaheh, Hooria Seyedhosseini; Mousavi, Maryam; Araghi, Mahmood; Rasoolzadeh, Reza; Hosseini, Zahra

    2015-01-01

    Background: Influenza H1N1 is very important worldwide and point mutations that occur in the virus gene are a threat for the World Health Organization (WHO) and druggists, since they could make this virus resistant to the existing antibiotics. Influenza epidemics cause severe respiratory illness in 30 to 50 million people and kill 250,000 to 500,000 people worldwide every year. Nowadays, drug design is not done through trial and error because of its cost and waste of time; therefore bioinformatics studies is essential for designing drugs. Materials and Methods: This paper, infolds a study on binding site of Neuraminidase (NA) enzyme, (that is very important in drug design) in 310K temperature and different dielectrics, for the best drug design. Information of NA enzyme was extracted from Protein Data Bank (PDB) and National Center for Biotechnology Information (NCBI) websites. The new sequences of N1 were downloaded from the NCBI influenza virus sequence database. Drug binding sites were assimilated and homologized modeling using Argus lab 4.0, HyperChem 6.0 and Chem. D3 softwares. Their stability was assessed in different dielectrics and temperatures. Result: Measurements of potential energy (Kcal/mol) of binding sites of NA in different dielectrics and 310K temperature revealed that at time step size = 0 pSec drug binding sites have maximum energy level and at time step size = 100 pSec have maximum stability and minimum energy. Conclusions: Drug binding sites are more dependent on dielectric constants rather than on temperature and the optimum dielectric constant is 39/78. PMID:26605248

  5. Using improved serial blood sampling method of mice to study pharmacokinetics and drug-drug interaction.

    PubMed

    Watanabe, Ayahisa; Watari, Ryosuke; Ogawa, Keiko; Shimizu, Ryosuke; Tanaka, Yukari; Takai, Nozomi; Nezasa, Ken-ichi; Yamaguchi, Yoshitaka

    2015-03-01

    In pharmacokinetic evaluation of mice, using serial sampling methods rather than a terminal blood sampling method could reduce the number of animals needed and lead to more reliable data by excluding individual differences. In addition, using serial sampling methods can be valuable for evaluation of the drug-drug interaction (DDI) potential of drug candidates. In this study, we established an improved method for serially sampling the blood from one mouse by only one incision of the lateral tail vein, and investigated whether our method could be adapted to pharmacokinetic and DDI studies. After intravenous and oral administration of ibuprofen and fexofenadine (BCS class II and III), the plasma concentration and pharmacokinetic parameters were evaluated by our method and a terminal blood sampling method, with the result that both methods gave comparable results (ibuprofen: 63.8 ± 4.0% and 64.4%, fexofenadine: 6.5 ± 0.7% and 7.9%, respectively, in bioavailability). In addition, our method could be adapted to DDI study for cytochrome P450 and organic anion transporting polypeptide inhibition. These results demonstrate that our method can be useful for pharmacokinetic evaluation from the perspective of reliable data acquisition as well as easy handling and low stress to mice and improve the quality of pharmacokinetic and DDI studies. PMID:25452230

  6. AC biosusceptometry in the study of drug delivery.

    PubMed

    Corá, L A; Romeiro, F G; Stelzer, M; Américo, M F; Oliveira, R B; Baffa, O; Miranda, J R A

    2005-06-15

    Conventionally, pharmaceutical substances are administered orally because the gastrointestinal tract possesses the appropriate features for drug absorption. Nevertheless, the gastrointestinal tract physiology is complex and influenced by many factors. These factors must be completely understood for the optimization of oral drug delivery systems. Although in vitro tests provide information about release and drug absorption profiles, in vivo studies are essential, due to the biological variability. Several techniques have been employed in an attempt to conveniently characterize the behavior of solid dosage forms in vivo. The noninvasive biomagnetic technique of alternate current biosusceptometry (ACB) has been used in studies focusing on gastrointestinal motility and, more recently, to evaluate the performance of magnetic dosage forms. This article will discuss the main characteristics of AC biosusceptometry and its applicability for determination of the relationship between the human gastrointestinal tract and orally administered pharmaceutical dosage forms. PMID:15935871

  7. The Art and Science of Diagnosing and Managing Drug-induced Liver Injury in 2015 and Beyond.

    PubMed

    Lewis, James H

    2015-11-01

    Drug-induced liver injury (DILI) remains a leading reason why new compounds are dropped from further study or are the subject of product warnings and regulatory actions. Hy's Law of drug-induced hepatocellular jaundice causing a case-fatality rate or need for transplant of 10% or higher has been validated in several large national registries, including the ongoing, prospective U.S. Drug-Induced Liver Injury Network. It serves as the basis for stopping rules in clinical trials and in clinical practice. Because DILI can mimic all known causes of acute and chronic liver disease, establishing causality can be difficult. Histopathologic findings are often nonspecific and rarely, if ever, considered pathognomonic. A daily drug dose >50-100 mg is more likely to be hepatotoxic than does <10 mg, especially if the compound is highly lipophilic or undergoes extensive hepatic metabolism. The quest for a predictive biomarker to replace alanine aminotransferase is ongoing. Markers of necrosis and apoptosis such as microRNA-122 and keratin 18 may prove useful in identifying patients at risk for severe injury when they initially present with a suspected acetaminophen overdose. Although a number of drugs causing idiosyncratic DILI have HLA associations that may allow for pre-prescription testing to prevent hepatotoxicity, the cost and relatively low frequency of injury among affected patients limit the current usefulness of such genome-wide association studies. Alanine aminotransferase monitoring is often recommended but has rarely been shown to be an effective method to prevent serious DILI. Guidelines on the diagnosis and management of DILI have recently been published, although specific therapies remain limited. The LiverTox Web site has been introduced as an interactive online virtual textbook that makes the latest information on more than 650 agents available to clinicians, regulators, and drug developers alike. PMID:26116527

  8. DigiSpenser--a GSM-based drug management and compliance monitoring system.

    PubMed

    Schukat, M; Rudroju, B

    2011-01-01

    Approximately one-third of all independently living elderly people are not compliant with their drug therapy. This lack of medication management results either in undermedication or overmedication, causing unnecessary and often serious health risks. This problem will worsen in the future with the change of demographics and cost constraints in the health sector. Therefore there is a need for (cost-) effective reliable approaches to compliance monitoring. To date numerous care schemes, retrospective assessment procedures and compliance supports tools have been introduced, but none of them has fully solved the problem of medication non-compliance yet. This paper will address some of the factors that need to be considered when designing such systems and will showcase DigiSpenser, a recently developed compliance monitoring and drug management system. PMID:22255537

  9. Drug Taking Beliefs of Australian Adolescents: A Pilot Study

    ERIC Educational Resources Information Center

    Skrzypiec, Grace; Owens, Laurence

    2013-01-01

    In this study adolescents offered their insights and perspectives of factors associated with adolescent illicit drug taking intentions. The factors explored were identified using a cross-disciplinary approach involving the Theory of Planned Behavior (TPB) and criminological theories, and these formed the framework for data analysis. Interviews…

  10. Studies on pharmacokinetic drug interaction potential of vinpocetine

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background: Vinpocetine, a semi-synthetic derivative of vincamine, is a popular dietary supplement used for the treatment of several central nervous system related disorders. Despite its wide use, no pharmacokinetic drug interaction studies are reported in literature. Due to increasing use of dietar...

  11. Theoretical and experimental studies of the stability of drug-drug interact.

    PubMed

    Soares, Monica F R; Alves, Lariza D S; Nadvorny, Daniela; Soares-Sobrinho, José L; Rolim-Neto, Pedro J

    2016-11-01

    Several factors can intervene in the molecular properties and consequently in the stability of drugs. The molecular complexes formation often occur due to favor the formation of hydrogen bonds, leading the system to configuration more energy stable. This work we aim to investigate through theoretical and experimental methods the relation between stability and properties of molecular complexes the molecular complex formed between the drugs, efavirenz (EFV), lamivudine (3TC) and zidovudine (AZT). With this study was possible determining the most stable complex formed between the compounds evaluated. In addition the energy and structural properties of the complex formed in relation to its individual components allowed us to evaluate the stability of the same. PMID:27267283

  12. Medical emergencies and drugs: an online study guide.

    PubMed

    2008-05-01

    The Editorial Board of the Journal of Endodontics has developed a literature-based study guide of topical areas related to endodontics. This study guide is intended to give the reader a focused review of the essential endodontic literature and does not cite all possible articles related to each topic. Although citing all articles would be comprehensive, it would defeat the idea of a study guide. This section will cover medical emergencies and drugs. PMID:18457703

  13. Challenges in Acute Heart Failure Clinical Management: Optimizing Care Despite Incomplete Evidence and Imperfect Drugs

    PubMed Central

    Maisel, Alan S.; Storrow, Alan B.

    2015-01-01

    Acute heart failure is a common condition associated with considerable morbidity, mortality, and cost. However, evidence-based data on treating heart failure in the acute setting are limited, and current individual treatment options have variable efficacy. The healthcare team must often individualize patient care in ways that may extend beyond available clinical guidelines. In this review, we address the question, “How do you do the best you can clinically with incomplete evidence and imperfect drugs?” Expert opinion is provided to supplement guideline-based recommendations and help address the typical challenges that are involved in the management of patients with acute heart failure. Specifically, we discuss 4 key areas that are important in the continuum of patient care: differential diagnosis and risk stratification; choice and implementation of initial therapy; assessment of the adequacy of therapy during hospitalization or observation; and considerations for discharge/transition of care. A case study is presented to highlight the decision-making process throughout each of these areas. Evidence is accumulating that should help guide patients and healthcare providers on a path to better quality of care. PMID:25679083

  14. Pharmacognostical studies of the plant drug Mimosae tenuiflorae cortex.

    PubMed

    Rivera-Arce, E; Gattuso, M; Alvarado, R; Zárate, E; Agüero, J; Feria, I; Lozoya, X

    2007-09-25

    The bark of the Mimosa tenuiflora (Willd.) Poiret (Leguminoseae) tree, known as tepescohuite in Mexico, is commonly used in this country and in Central America to elaborate different products for the treatment of skin burns and lesions. The cicatrizing properties of extracts obtained from this bark have been scientifically studied, attributing the main biological activity to its tannin and saponin content. Studies include clinical trials of phytodrugs based on Mimosae tenuiflora bark extracts for treatment of venous leg ulcerations. Recent commercialization of the plant drug Mimosae tenuiflorae cortex requires pharmacognostical information to develop quality-control methods for raw materials and extracts produced with this plant drug. The present paper reports a group of ethnobotanical, morphological, chemical, and molecular studies performed with Mimosae tenuiflora materials obtained by collection in the southeastern Mexican state of Chiapas. Macro- and micro-morphological parameters were established to authenticate the genuine drug that allowed detection of adulterants usually found in commercial samples of this plant material. These morphological characteristics can be used for rapid identification of the drug and are particularly useful in the case of powdered materials. The chemical studies performed demonstrated that tannins represent the major component group in the bark. Its content in genuine tepescohuite is 16% and is mainly composed of proanthocyanidins, a condition permitting a tannin-based chemical-control method for fingerprinting the plant drug. Contrariwise, the saponin concentration in Mimosae tenuiflora bark is extremely low, and its isolation and content evaluation represent a complex procedure that is unsuitable for routine control purposes. Finally, random amplified DNA (RAPD) analysis results a useful tool for obtaining DNA specific markers of Mimosae tenuiflora species which should be useful in future studies involving raw material

  15. Severe idiosyncratic drug reactions with epidermal necrolysis: A 5-year study

    PubMed Central

    Fadeyibi, I. O.; Ademiluyi, S. A.; Ajose, F. O.; Jewo, P. I.; Akinola, O. I.

    2011-01-01

    Introduction: Idiosyncratic drug reactions (IDRs) are unexpected responses to a drug. The spectrums of severe cutaneous reactions include Stevens–Johnson Syndrome (SJS), SJS/Lyell Syndrome and Toxic Epidermal Necrolysis (TEN). The conditions are associated with high mortality. This study was designed to determine the causal agents, patterns of presentations, review the management and make recommendations to reduce the incidence and mortality of this class of drug reactions. Materials and Methods: A retrospective study was made of patients seen with IDR in the Lagos State University Teaching Hospital, LASUTH, between January, 2004 and December, 2008. They were cases admitted with bullous skin eruptions with associated systemic symptoms. Results: Sixty-seven patients were seen, with 45 (67.2%) satisfying the inclusion criteria. Fifteen males and 30 females were involved, giving a male to female (M:F) ratio of 1:2. Their ages ranged from 7 to 79 years (mean, 40.02 ± 17.89 years). Peak incidences occurred among the 20–24 and 30–34 year age groups. The causal agents were antibiotics (48.89%), sulphonamides (24.44%), herbal preparations (17.78%) and artemisinin drugs (8.89%). Conclusions: The age groups with the peak incidence are the most likely to indulge more in drug abuse in environments with poor drug control. Diagnosis of SJS, SJS/TEN and TEN were missed in many patients at first contact due to the progressive nature of the conditions. Patients needed reviews at regular intervals when IDR was suspected. Health education to prevent drug abuse is important and herbal preparations should be scientifically studied to determine the efficacy and side-effects. PMID:22279281

  16. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  17. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  18. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  19. Elderly self-management: a qualitative study

    PubMed Central

    Ravanipour, Maryam; Salehi, Shayesteh; Taleghani, Fariba; Abedi, Heidar Ali

    2010-01-01

    BACKGROUND: The population of elderly in Iran and in the world is increasing. It is predicted that the population of elderly reaches to 10 millions in Iran by the year 2019. Elders more than other age groups are at risk of chronic diseases and health problems; and elderly affects their self-management and makes them feel disabled. Since the knowledge of self-management for Iranian elderly is not well developed, this paper aimed to determine the concept of self-management for Iranian elders. METHODS: This was a qualitative study with grounded theory approach on Iranian elderly self-management. Data were collected through deep interviews with 26 participants in a period of one year and were analyzed using a Strauss Corbin analysis method. RESULTS: Self-management in the context of power means using different managing methods in dealing with daily life needs, especially in interactions with others in a way that accelerates affairs with efficiency and satisfaction. The main categories emerged from this qualitative study included: managing plans, managing life goals and policies, persuading the desired goals, managing self-care, directing others, coordinating and consulting with others. CONCLUSIONS: The findings of this study provided a deep understanding of elderly perceptions of self-management in their lives. These findings can be a baseline for future researches on developing effective health interventions such as developing a nursing model for increasing the elderly self-management abilities in Iran. Such a model can provide a strong basis for nursing care. PMID:21589781

  20. Manpower Management Studies: Selected Abstracts.

    ERIC Educational Resources Information Center

    Ryerson, William R., Comp.

    This bibliography contains 58 selected abstracts of research reports dating back to 1964 on the general subject of manpower management. It was prepared from a search of the National Technical Information Service data base of more than 300,000 documents submitted by agencies of the Federal Government and also by private organizations or individuals…

  1. Biomembrane models and drug-biomembrane interaction studies: Involvement in drug design and development

    PubMed Central

    Pignatello, R.; Musumeci, T.; Basile, L.; Carbone, C.; Puglisi, G.

    2011-01-01

    Contact with many different biological membranes goes along the destiny of a drug after its systemic administration. From the circulating macrophage cells to the vessel endothelium, to more complex absorption barriers, the interaction of a biomolecule with these membranes largely affects its rate and time of biodistribution in the body and at the target sites. Therefore, investigating the phenomena occurring on the cell membranes, as well as their different interaction with drugs in the physiological or pathological conditions, is important to exploit the molecular basis of many diseases and to identify new potential therapeutic strategies. Of course, the complexity of the structure and functions of biological and cell membranes, has pushed researchers toward the proposition and validation of simpler two- and three-dimensional membrane models, whose utility and drawbacks will be discussed. This review also describes the analytical methods used to look at the interactions among bioactive compounds with biological membrane models, with a particular accent on the calorimetric techniques. These studies can be considered as a powerful tool for medicinal chemistry and pharmaceutical technology, in the steps of designing new drugs and optimizing the activity and safety profile of compounds already used in the therapy. PMID:21430952

  2. Carer involvement with drug services: a qualitative study

    PubMed Central

    Orr, Linda C; Barbour, Rosaline S; Elliott, Lawrie

    2013-01-01

    BackgroundEmpirical research suggests that involving carers brings benefits to families and services. Consequently, drug-related policy and guidance has increasingly encouraged drug services to involve carers at all levels of service provision. ObjectiveTo explore the purpose and scope of carer involvement with adult drug services in North-east Scotland. Design, Setting and ParticipantsA total of 82 participants (20 informal carers, 43 service providers and 19 policy makers) were purposively selected to take part in a qualitative study. Eight focus groups and 32 interviews were conducted between 2007 and 2008. FindingsThree themes were identified through thematic coding: ‘Current levels of involvement’, ‘Use of the term carer’ and ‘Opportunities for change?’ Carer involvement was described as limited, unplanned and unstructured, and consisted largely of information and advice, practical and emotional support, and signposting of services. Although use of the term ‘carer’ was contested within and across the groups, caring in a drug context was considered the ‘same but different’ from caring in other contexts. Carers remained sceptical that services actually wanted to involve them in supporting their relative or to offer carers support in their own right. Many service providers and policy makers regarded carer involvement as an aspiration. ConclusionEncouraging carers, service providers and policy makers to reach a shared understanding of caring in a drug context may help translation of policy into practice. However, there is also a fundamental need for drug services to widen the level and type of involvement activities on offer to carers. PMID:23216899

  3. Drug silica nanocomposite: preparation, characterization and skin permeation studies.

    PubMed

    Pilloni, Martina; Ennas, Guido; Casu, Mariano; Fadda, Anna Maria; Frongia, Francesca; Marongiu, Francesca; Sanna, Roberta; Scano, Alessandra; Valenti, Donatella; Sinico, Chiara

    2013-01-01

    The aim of this work was to evaluate silica nanocomposites as topical drug delivery systems for the model drug, caffeine. Preparation, characterization, and skin permeation properties of caffeine-silica nanocomposites are described. Caffeine was loaded into the nanocomposites by grinding the drug with mesoporous silica in a ball mill up to 10 h and the efficiency of the process was studied by XRPD. Formulations were characterized by several methods that include FTIR, XRPD, SEM and TEM. The successful loading of caffeine was demonstrated by XRPD and FTIR. Morphology was studied by SEM that showed particle size reduction while TEM demonstrated formation of both core-shell and multilayered caffeine-silica structures. Solid-state NMR spectra excluded chemical interactions between caffeine and silica matrix, thus confirming that no solid state reactions occurred during the grinding process. Influence of drug inclusion in silica nanocomposite on the in vitro caffeine diffusion into and through the skin was investigated in comparison with a caffeine gel formulation (reference), using newborn pig skin and vertical Franz diffusion cells. Results from the in vitro skin permeation experiments showed that inclusion into the nanocomposite reduced and delayed caffeine permeation from the silica nanocomposite in comparison with the reference, independently from the amount of the tested formulation. PMID:22324371

  4. Integration of Biosensors and Drug Delivery Technologies for Early Detection and Chronic Management of Illness

    PubMed Central

    Ngoepe, Mpho; Choonara, Yahya E.; Tyagi, Charu; Tomar, Lomas Kumar; du Toit, Lisa C.; Kumar, Pradeep; Ndesendo, Valence M. K.; Pillay, Viness

    2013-01-01

    Recent advances in biosensor design and sensing efficacy need to be amalgamated with research in responsive drug delivery systems for building superior health or illness regimes and ensuring good patient compliance. A variety of illnesses require continuous monitoring in order to have efficient illness intervention. Physicochemical changes in the body can signify the occurrence of an illness before it manifests. Even with the usage of sensors that allow diagnosis and prognosis of the illness, medical intervention still has its downfalls. Late detection of illness can reduce the efficacy of therapeutics. Furthermore, the conventional modes of treatment can cause side-effects such as tissue damage (chemotherapy and rhabdomyolysis) and induce other forms of illness (hepatotoxicity). The use of drug delivery systems enables the lowering of side-effects with subsequent improvement in patient compliance. Chronic illnesses require continuous monitoring and medical intervention for efficient treatment to be achieved. Therefore, designing a responsive system that will reciprocate to the physicochemical changes may offer superior therapeutic activity. In this respect, integration of biosensors and drug delivery is a proficient approach and requires designing an implantable system that has a closed loop system. This offers regulation of the changes by means of releasing a therapeutic agent whenever illness biomarkers prevail. Proper selection of biomarkers is vital as this is key for diagnosis and a stimulation factor for responsive drug delivery. By detecting an illness before it manifests by means of biomarkers levels, therapeutic dosing would relate to the severity of such changes. In this review various biosensors and drug delivery systems are discussed in order to assess the challenges and future perspectives of integrating biosensors and drug delivery systems for detection and management of chronic illness. PMID:23771157

  5. Integration of biosensors and drug delivery technologies for early detection and chronic management of illness.

    PubMed

    Ngoepe, Mpho; Choonara, Yahya E; Tyagi, Charu; Tomar, Lomas Kumar; du Toit, Lisa C; Kumar, Pradeep; Ndesendo, Valence M K; Pillay, Viness

    2013-01-01

    Recent advances in biosensor design and sensing efficacy need to be amalgamated with research in responsive drug delivery systems for building superior health or illness regimes and ensuring good patient compliance. A variety of illnesses require continuous monitoring in order to have efficient illness intervention. Physicochemical changes in the body can signify the occurrence of an illness before it manifests. Even with the usage of sensors that allow diagnosis and prognosis of the illness, medical intervention still has its downfalls. Late detection of illness can reduce the efficacy of therapeutics. Furthermore, the conventional modes of treatment can cause side-effects such as tissue damage (chemotherapy and rhabdomyolysis) and induce other forms of illness (hepatotoxicity). The use of drug delivery systems enables the lowering of side-effects with subsequent improvement in patient compliance. Chronic illnesses require continuous monitoring and medical intervention for efficient treatment to be achieved. Therefore, designing a responsive system that will reciprocate to the physicochemical changes may offer superior therapeutic activity. In this respect, integration of biosensors and drug delivery is a proficient approach and requires designing an implantable system that has a closed loop system. This offers regulation of the changes by means of releasing a therapeutic agent whenever illness biomarkers prevail. Proper selection of biomarkers is vital as this is key for diagnosis and a stimulation factor for responsive drug delivery. By detecting an illness before it manifests by means of biomarkers levels, therapeutic dosing would relate to the severity of such changes. In this review various biosensors and drug delivery systems are discussed in order to assess the challenges and future perspectives of integrating biosensors and drug delivery systems for detection and management of chronic illness. PMID:23771157

  6. Bioprostethic mitral valve thrombosis due to oral contraceptive drug use and management with ultra-slow thrombolytic therapy.

    PubMed

    Yesin, Mahmut; Kalçik, Macit; Gündüz, Sabahattin; Astarcioğlu, Mehmet Ali; Gürsoy, Mustafa Ozan; Karakoyun, Süleyman; Özkan, Mehmet

    2016-03-01

    Prosthetic valve thrombosis is a severe complication, which usually occurs in inadequately anticoagulated patients. Mechanical valve thrombosis is more common than bioprosthetic valve thrombosis (BVT). Oral contraceptive drugs are associated with increased risk of thromboembolism in women. The possible association between oral contraceptive drug use and BVT has never been reported before. We present a case of obstructive BVT occurring after the use of an oral contraceptive drug and successful management with ultra-slow thrombolytic therapy. PMID:26378817

  7. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    PubMed Central

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha; Davis, Thomas; Marsh, Cheryl

    2008-01-01

    This paper reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to either PCM (n=92) or standard probation (n=91), and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support and service utilization. Arrest data were collected from administrative datasets. The sample (N=183) included mostly African American (57%) and White (20%) women, with a mean age of 34.7 (SD = 9.2) and mean education of 11.6 years (SD = 2.1). Cocaine and heroin were the most frequently reported drugs of abuse, 86% reported prior history of incarceration, and 74% had children. Women assigned to both PCM and standard probation showed change over time in the direction of clinical improvement on 7 of 10 outcomes measured. However, changes observed for the PCM group were no different than those observed for the standard probation group. Higher levels of case management, drug abuse treatment, and probationary supervision may be required to achieve improved outcomes in this population. PMID:21464888

  8. "Let's Talk about Drugs": Pilot Study of a Community-Level Drug Prevention Intervention Based on Motivational Interviewing Principles

    ERIC Educational Resources Information Center

    Newbery, Natasha; McCambridge, Jim; Strang, John

    2007-01-01

    Purpose: The feasibility of a community-level drug prevention intervention based upon the principles of motivational interviewing within a further education college was investigated in a pilot study. Design/methodology/approach: The implementation over the course of a single term of "Let's Talk about Drugs" was studied with both action research…

  9. Drugs of abuse in urban groundwater. A case study: Barcelona.

    NASA Astrophysics Data System (ADS)

    Jurado, A.; Mastroianni, N.; Vazquez-Suñe, E.; Carrera, J.; Tubau, I.; Pujades, E.; Postigo, C.; Lopez de Alda, M.; Barceló, D.

    2012-04-01

    This study is concerned with drugs of abuse (DAs) and their metabolites in urban groundwater at field scale in relation to (1) the spatial distribution of the groundwater samples, (2) the depth of the groundwater sample, (3) the presence of DAs in recharge sources, and (4) the identification of processes affecting the fate of DAs in groundwater. To this end, urban groundwater samples were collected in the city of Barcelona and a total of 21 drugs were analyzed including cocainics, amphetamine-like compounds, opioids, lysergics and cannabinoids and the prescribed drugs benzodiazepines. Overall, the highest groundwater concentrations and the largest number of detected DAs were found in zones basically recharged by a river that receives large amounts of effluents from waste water treatment plants (WWTPs). In contrast, the urbanized areas yielded not only lower concentrations but also a much smaller number of drugs, which suggests a local origin. In fact, cocaine and its metabolite were dominant in more prosperous neighbourhoods, whereas the cheaper (MDMA) was the dominant DA in poorer districts. Concentrations of DAs estimated mainly from the waste water fraction in groundwater samples were consistently higher than the measured ones, suggesting that DAs undergo removal processes in both reducing and oxidizing conditions.

  10. Studying illicit drug trafficking on Darknet markets: Structure and organisation from a Canadian perspective.

    PubMed

    Broséus, J; Rhumorbarbe, D; Mireault, C; Ouellette, V; Crispino, F; Décary-Hétu, D

    2016-07-01

    Cryptomarkets are online marketplaces that are part of the Dark Web and mainly devoted to the sale of illicit drugs. They combine tools to ensure anonymity of participants with the delivery of products by mail to enable the development of illicit drug trafficking. Using data collected on eight cryptomarkets, this study provides an overview of the Canadian illicit drug market. It seeks to inform about the most prevalent illicit drugs vendors offer for sale and preferred destination countries. Moreover, the research gives an insight into the structure and organisation of distribution networks existing online. In particular, we provide information about how vendors are diversifying and replicating across marketplaces. We inform on the number of listings each vendor manages, the number of cryptomarkets they are active on and the products they offer. This research demonstrates the importance of online marketplaces in the context of illicit drug trafficking. It shows how the analysis of data available online may elicit knowledge on criminal activities. Such knowledge is mandatory to design efficient policy for monitoring or repressive purposes against anonymous marketplaces. Nevertheless, trafficking on Dark Net markets is difficult to analyse based only on digital data. A more holistic approach for investigating this crime problem should be developed. This should rely on a combined use and interpretation of digital and physical data within a single collaborative intelligence model. PMID:26978791

  11. Indigenous Studies Speaks to Environmental Management

    NASA Astrophysics Data System (ADS)

    Richmond, Laurie; Middleton, Beth Rose; Gilmer, Robert; Grossman, Zoltán; Janis, Terry; Lucero, Stephanie; Morgan, Tukoroirangi; Watson, Annette

    2013-11-01

    This article describes the increasing connections between the fields of Indigenous studies and environmental management and examines some of the ways that an Indigenous studies perspective can guide thinking about environmental management. Indigenous groups have been involved in the management of environmental and natural resources on their lands since time immemorial. Indigenous groups have also become increasingly involved in Western practices of environmental management with the advent of co-management institutions, subsistence boards, traditional ecological knowledge forums, and environmental issues affecting Indigenous resources. Thus, it is an important time for scholarship that explores how Indigenous groups are both shaping and being affected by processes of environmental management. This article summarizes key findings and themes from eight papers situated at the intersection of these two fields of study and identify means by which environmental managers can better accommodate Indigenous rights and perspectives. It is the authors’ hope that increased dialog between Indigenous studies and environmental management can contribute to the building of sustainable and socially just environmental management practices.

  12. [Quantum-pharmacological aspects of cardiovascular drugs studying].

    PubMed

    Zahorodnyĭ, M I; Nebesna, T Iu; Kazakova, O O; Horchakova, N O; Svintsits'kyĭ, A S; Chekman, I S

    2013-01-01

    Quantum pharmacology allows to study the mechanisms of action of cardiovascular drugs, to predict pharmacological activity and identify the most pronounced pharmacodynamic efficacy and therapeutic activity of new compounds. Calculation of quantum-pharmacological parameters for molecules of beta-blockers (propranolol, atenolol, metoprolol, carvedilol) in aqueous media, research its hydrophobic interaction with receptors allow to form a theoretical basis for the development of new generations of more effective and safe medicines for hypertension treatment. Increased hydrophobicity leads to poor solubility of carvedilol in water and high--in the lipids. The clinical pharmacology of the drug is shown by such indicators as the therapeutic dose, half-life and degree of metabolism in the liver. Due to enhanced interaction with adrenergic receptor effective dose of carvedilol is an order of magnitude lower than other beta-blockers, even with the relatively low bioavailability. Reduced bioavailability of carvedilol versus atenolol, metoprolol and propranolol is caused by elevated metabolism during the first pass through the liver, which is also due to the hydrophobicity of the drug. High solubility in lipids appears to extend the half-life of carvedilol. QSAR studies make an important contribution to the study of the properties of chemical compounds and their pharmacological activity. Software, used for computation of studied properties, has a significant role. A large number of descriptors allows a qualitative and quantitative assessment of the molecules of chemical compounds and prediction of their influence on cardiovascular system. PMID:23951907

  13. A prospective study of adverse drug reactions in hospitalized children

    PubMed Central

    Martínez-Mir, Inocencia; García-López, Mercedes; Palop, Vicente; Ferrer, José M; Rubio, Elena; Morales-Olivas, Francisco J

    1999-01-01

    Aims There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. Methods An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. Results A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR = 1.66, 95% CI 1.03–2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. Conclusions Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients. PMID:10383547

  14. Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study

    PubMed Central

    2014-01-01

    Background Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. Methods In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. Results After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. Conclusion In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most

  15. Use of immobilized enzymes in drug metabolism studies.

    PubMed

    Dulik, D M; Fenselau, C

    1988-04-01

    The immobilization of drug-metabolizing enzymes onto polymeric supports offers several advantages over use of conventional microsomal or soluble enzyme preparations. These include increased storage stability, facilitated separation of products from the incubation mixture, the ability to recover and reuse the enzyme catalyst, and in many cases, stabilization of the tertiary structure of membrane-bound enzymes. Attachment of the protein to the solid support may be accomplished by adsorption, covalent bonding, or entrapment techniques. This methodology has been successfully utilized for studies with such enzymes as cytochrome P-450, UDP-glucuronyltransferases, glutathione S-transferases, S-methyltransferases, and N-acetyltransferases. Although often employed for the synthesis of xenobiotic metabolites, immobilized enzymes have been used for mechanistic and relative reactivity studies, limited kinetic studies, and extracorporeal detoxification. Co-immobilization of multiple drug-metabolizing enzyme systems has made possible the sequential formation of metabolites arising from oxidation followed by conjugation. Immobilized enzymes may also be used in the prediction of species-dependent metabolic pathways. The potential for large-scale synthesis of drug metabolites using this methodology has been explored. PMID:3127263

  16. Drug related problems in type 2 diabetes patients with hypertension: a cross-sectional retrospective study

    PubMed Central

    2013-01-01

    Background Type 2 diabetes (T2DM) patients with hypertension are at increased risk for experiencing drug-related problems (DRPs) since they often receive multiple medications and have multiple comorbidities. To date, there is a lack of studies conducted in T2DM patients with hypertension. This study aims to analyze the DRPs and identify factors affecting the DRPs in this patient population. Method This retrospective study involved T2DM patients with hypertension and was conducted at a tertiary hospital in Malaysia from January 2009 to December 2011. The assessment of DRPs was based on the Pharmaceutical Network Care Europe (PCNE) tool version 5.01. Results Two hundred patients with a total of 387 DRPs were identified. Among these patients, 90.5% had at least one DRP, averaging 1.9 ± 1.2 problems per patient. The most common DRPs encountered were insufficient awareness of health and diseases (26%), drug choice problems (23%), dosing problems (16%) and drug interactions (16%). The most implicated drugs were aspirin, clopidogrel, simvastatin, amlodipine and metformin. The six domains of DRPs found to have statistically significant associations were renal impairment, polypharmacy, cardiovascular disease, elderly status, and duration of hospital stay. Conclusions Early identification of the types and patterns of DRPs and the factors associated to them may enhance the prevention and management of DRPs in T2DM patients with hypertension. PMID:23289895

  17. Quantitative ToF-SIMS studies of protein drug release from biodegradable polymer drug delivery membranes

    NASA Astrophysics Data System (ADS)

    Burns, Sarah A.; Gardella, Joseph A.

    2008-12-01

    Biodegradable polymers are of interest in developing strategies to control protein drug delivery. The protein that was used in this study is Keratinocyte Growth Factor (KGF) which is a protein involved in the re-epithelialization process. The protein is stabilized in the biodegradable polymer matrix during formulation and over the course of polymer degradation with the use of an ionic surfactant Aerosol-OT (AOT) which will encapsulate the protein in an aqueous environment. The release kinetics of the protein from the surface of these materials requires precise timing which is a crucial factor in the efficacy of this drug delivery system. Time-of-flight secondary ion mass spectrometry (ToF-SIMS) was used in the same capacity to identify the molecular ion peak of the surfactant and polymer and use this to determine surface concentration. In the polymer matrix, the surfactant molecular ion peak was observed in the positive and negative mode at m/ z 467 and 421, respectively. These peaks were determined to be [AOT + Na +] and [AOT - Na +]. These methods are used to identify the surfactant and protein from the polymer matrix and are used to measure the rate of surface accumulation. The second step was to compare this accumulation rate with the release rate of the protein into an aqueous solution during the degradation of the biodegradable film. This rate is compared to that from fluorescence spectroscopy measurements using the protein autofluorescence from that released into aqueous solution [C.M. Mahoney, J. Yu, A. Fahey, J.A.J. Gardella, SIMS depth profiling of polymer blends with protein based drugs, Appl. Surf. Sci. 252 (2006), 6609-6614.].

  18. Managing Chronic Pain in Special Populations with Emphasis on Pediatric, Geriatric, and Drug Abuser Populations.

    PubMed

    Baumbauer, Kyle M; Young, Erin E; Starkweather, Angela R; Guite, Jessica W; Russell, Beth S; Manworren, Renee C B

    2016-01-01

    In the adult population chronic pain can lead to loss of productivity and earning potential, and decreased quality of life. There are distinct groups with increased vulnerability for the emergence of chronic pain. These groups may be defined by developmental status and/or life circumstances. Within the pediatric, geriatric, and drug abuser populations, chronic pain represents a significant health issue. This article focuses on known anatomic, physiologic, and genetic mechanisms underlying chronic pain in these populations, and highlights the need for a multimodal approach from multiple health care professionals for management of chronic pain in those with the most risk. PMID:26614727

  19. Case Studies for Management Development in Bangladesh.

    ERIC Educational Resources Information Center

    McLean, Gary N.

    Eight case studies appropriate for use in a course in management development were prepared and are provided in this document. The typical case describes a real business situation in which a real manager had to reach a decision. The case gives quantitative and qualitative information that is, or may be, relevant to that decision. Questions for…

  20. Study on Case Teaching of Financial Management

    ERIC Educational Resources Information Center

    Che, Zhenghong; Che, Zhengmei

    2011-01-01

    Case teaching is an efficient teaching method of management. It plays an important role to enhance the students' ability to practice the theory. However, case teaching of financial management has not achieved the expected results. The paper aims to study the importance, characteristics and corresponding methods of case teaching method of financial…

  1. Case Studies in Managing Psychological Depth.

    ERIC Educational Resources Information Center

    Ringer, Martin; Gillis, H. L.

    This paper outlines a model for assessing and managing psychological depth in outdoor and experiential group work, and presents two case studies of the complexity of such management in real life. The model contains eight levels of emotional risk and presents four criteria for assessing the level to which a particular event or discussion may lead…

  2. Self-Managed Studying in College Courses.

    ERIC Educational Resources Information Center

    Edwards, K. Anthony

    In an introductory psychology course, students were taught some principles of "adjustment" using self-management techniques and were required to conduct a self-management project. The four student projects reported herein were specifically designed to improve study skills through use of Premack's principle and stimulus control. Course materials…

  3. Natural Resources Management: Course of Study.

    ERIC Educational Resources Information Center

    Ingvalson, Brian

    The document presents a course outline for the study of natural resources management by junior and senior year high school students. Basic information and practical experiences are offered to the student in the classroom and through several field trips in order to acquire more knowledge in various areas of natural resources and their management.…

  4. Validation of the Drug Abuse Screening Test (DAST-10): A study on illicit drug use among Chinese pregnant women

    PubMed Central

    Lam, Lap Po; Leung, Wing Cheong; Ip, Patrick; Chow, Chun Bong; Chan, Mei Fung; Ng, Judy Wai Ying; Sing, Chu; Lam, Ying Hoo; Mak, Wing Lai Tony; Chow, Kam Ming; Chin, Robert Kien Howe

    2015-01-01

    We assessed the Chinese version of the Drug Abuse Screening Test (DAST-10) for identifying illicit drug use during pregnancy among Chinese population. Chinese pregnant women attending their first antenatal visit or their first unbooked visit to the maternity ward were recruited during a 4-month study period in 2011. The participants completed self-administered questionnaires on demographic information, a single question on illicit drug use during pregnancy and the DAST-10. Urine samples screened positive by the urine Point-of-Care Test were confirmed by gas chromatography-mass spectrometry. DAST-10 performance was compared with three different gold standards: urinalysis, self-reported drug use, and evidence of drug use by urinalysis or self-report. 1214 Chinese pregnant women participated in the study and 1085 complete DAST-10 forms were collected. Women who had used illicit drugs had significantly different DAST-10 scores than those who had not. The sensitivity of DAST-10 for identify illicit drug use in pregnant women ranged from 79.2% to 33.3% and specificity ranged from 67.7% to 99.7% using cut-off scores from ≥1 to ≥3. The ~80% sensitivity of DAST-10 using a cut-off score of ≥1 should be sufficient for screening of illicit drug use in Chinese pregnant women, but validation tests for drug use are needed. PMID:26091290

  5. Prediction of in vivo drug performance using in vitro dissolution coupled with STELLA: a study with selected drug products.

    PubMed

    Chakraborty, Sumon; Yadav, Lokesh; Aggarwal, Deepika

    2015-01-01

    Prediction of the in vivo performance of the drug product from the in vitro studies is the major challenging job for the pharmaceutical industries. From the current regulatory perspective, biorelevant dissolution media should now be considered as quality control media in order to avoid the risk associated. Physiological based pharmacokinetic models (PBPK) coupled with biorelevant dissolution medium is widely used in simulation and prediction of the plasma drug concentration and in vivo drug performance. The present investigation deals with the evaluation of biorelevant dissolution media as well as in vivo drug performance by PBPK modelling using STELLA® simulation software. The PBPK model was developed using STELLA® using dissolution kinetics, solubility, standard gastrointestinal parameters and post-absorptive disposition parameters. The drug product selected for the present study includes Linezolid film-coated immediate-release tablets (Zyvox), Tacrolimus prolonged-release capsules (Advagraf), Valganciclovir tablets (Valcyte) and Mesalamine controlled-release capsules (Pentasa) each belonging to different biopharmaceutics classification system (BCS). The simulated plasma drug concentration was analyzed and pharmacokinetic parameters were calculated and compared with the reported values. The result from the present investigation indicates that STELLA® when coupled with biorelevant dissolution media can predict the in vivo performance of the drug product with prediction error less than 20% irrespective of the dosage form (immediate release versus modified release) and BCS Classification. Thus, STELLA® can be used for in vivo drug prediction which will be helpful in generic drug development. PMID:25494535

  6. Validation of the Drug Abuse Screening Test (DAST-10): A study on illicit drug use among Chinese pregnant women.

    PubMed

    Lam, Lap Po; Leung, Wing Cheong; Ip, Patrick; Chow, Chun Bong; Chan, Mei Fung; Ng, Judy Wai Ying; Sing, Chu; Lam, Ying Hoo; Mak, Wing Lai Tony; Chow, Kam Ming; Chin, Robert Kien Howe

    2015-01-01

    We assessed the Chinese version of the Drug Abuse Screening Test (DAST-10) for identifying illicit drug use during pregnancy among Chinese population. Chinese pregnant women attending their first antenatal visit or their first unbooked visit to the maternity ward were recruited during a 4-month study period in 2011. The participants completed self-administered questionnaires on demographic information, a single question on illicit drug use during pregnancy and the DAST-10. Urine samples screened positive by the urine Point-of-Care Test were confirmed by gas chromatography-mass spectrometry. DAST-10 performance was compared with three different gold standards: urinalysis, self-reported drug use, and evidence of drug use by urinalysis or self-report. 1214 Chinese pregnant women participated in the study and 1085 complete DAST-10 forms were collected. Women who had used illicit drugs had significantly different DAST-10 scores than those who had not. The sensitivity of DAST-10 for identify illicit drug use in pregnant women ranged from 79.2% to 33.3% and specificity ranged from 67.7% to 99.7% using cut-off scores from ≥ 1 to ≥ 3. The ~ 80% sensitivity of DAST-10 using a cut-off score of ≥ 1 should be sufficient for screening of illicit drug use in Chinese pregnant women, but validation tests for drug use are needed. PMID:26091290

  7. Usual care and management of fall risk increasing drugs in older dizzy patients in Dutch general practice

    PubMed Central

    Stam, Hanneke; Harting, Thomas; van der Sluijs, Marjolijn; van Marum, Rob; van der Horst, Henriëtte; van der Wouden, Johannes C.; Maarsingh, Otto R.

    2016-01-01

    Objective For general practitioners (GPs) dizziness is a challenging condition to deal with. Data on the management of dizziness in older patients are mostly lacking. Furthermore, it is unknown whether GPs attempt to decrease Fall Risk Increasing Drugs (FRIDs) use in the management of dizziness in older patients. The aim of this study is to gain more insight into GP’s management of dizziness in older patients, including FRID evaluation and adjustment. Design Data were derived from electronic medical records, obtained over a 12-month period in 2013. Setting Forty-six Dutch general practices. Patients The study sample comprised of 2812 older dizzy patients of 65 years and over. Patients were identified using International Classification of Primary Care codes and free text. Main outcome measures Usual care was categorized into wait-and-see strategy (no treatment initiated); education and advice; additional testing; medication adjustment; and referral. Results Frequently applied treatments included a wait-and-see strategy (28.4%) and education and advice (28.0%). Additional testing was performed in 26.8%; 19.0% of the patients were referred. Of the patients 87.2% had at least one FRID prescription. During the observation period, GPs adjusted the use of one or more FRIDs for 11.7% of the patients. Conclusion This study revealed a wide variety in management strategies for dizziness in older adults. The referral rate for dizziness was high compared to prior research. Although many older dizzy patients use at least one FRID, FRID evaluation and adjustment is scarce. We expect that more FRID adjustments may reduce dizziness and dizziness-related impairment. Key PointsIt is important to know how general practitioners manage dizziness in older patients in order to assess potential cues for improvement.This study revealed a wide variety in management strategies for dizziness in older patients.There was a scarcity in Fall Risk Increasing Drug (FRID) evaluation and adjustment

  8. Non interventional drug studies in oncology: Why we need them?

    PubMed

    Mishra, Divya; Vora, Jesal

    2010-10-01

    Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs). While the randomized nature of the RCT ensures its high internal validity by removing bias, their 'controlled' nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct. PMID:21350727

  9. [Gaviscon in reflux symptoms. Results of a drug monitoring study].

    PubMed

    Hutt, H J; Tauber, O; Flach, D

    1990-10-30

    335 general practitioners participated in an observational study of the alginic acid-containing antacid preparation Gaviscon over a period of eight months. In this period, 2927 patients with reflux disease were treated. Some 62.3% of the patients were treated for six to eight days. Both the tablet and suspension forms of the drug were considered to be effective by both physician and patient in more than 94% of the cases. Drug toleration was also considered good in more than 95% of the cases. The taste of Gaviscon was described as good by 54.7% of the patients, and acceptable by 33.5%. Pregnant women with reflux symptoms were observed in a separate group (n = 52). PMID:2258131

  10. Progress of drug-loaded polymeric micelles into clinical studies.

    PubMed

    Cabral, Horacio; Kataoka, Kazunori

    2014-09-28

    Targeting tumors with long-circulating nano-scaled carriers is a promising strategy for systemic cancer treatment. Compared with free small therapeutic agents, nanocarriers can selectively accumulate in solid tumors through the enhanced permeability and retention (EPR) effect, which is characterized by leaky blood vessels and impaired lymphatic drainage in tumor tissues, and achieve superior therapeutic efficacy, while reducing side effects. In this way, drug-loaded polymeric micelles, i.e. self-assemblies of amphiphilic block copolymers consisting of a hydrophobic core as a drug reservoir and a poly(ethylene glycol) (PEG) hydrophilic shell, have demonstrated outstanding features as tumor-targeted nanocarriers with high translational potential, and several micelle formulations are currently under clinical evaluation. This review summarizes recent efforts in the development of these polymeric micelles and their performance in human studies, as well as our recent progress in polymeric micelles for the delivery of nucleic acids and imaging. PMID:24993430

  11. 21 CFR 310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Records and Reports § 310.303 Continuation of long-term studies, records, and... application. Some drugs, because of the nature of the condition for which they are intended, must be used...

  12. Preliminary Favorable Outcome for Medically and Surgically Managed Extensively Drug-Resistant Tuberculosis, France, 2009–2014

    PubMed Central

    Henry, Benoît; Revest, Matthieu; Dournon, Nathalie; Epelboin, Loïc; Mellon, Guillaume; Bellaud, Guillaume; Mordant, Pierre; Le Dû, Damien; Véziris, Nicolas; Bernard, Christine; Morel, Sébastien; Jauréguiberry, Stéphane; Michelet, Christian; Bricaire, François; Caumes, Éric

    2016-01-01

    We report 20 cases of extensively drug-resistant tuberculosis managed in France. Treatment was individualized and included bedaquiline and linezolid for most patients and surgery in 8 patients. At last follow-up (22 months), 19 patients had achieved conversion from positive to negative on culture testing. These promising results of comprehensive management obtained in a small series deserve confirmation. PMID:26891089

  13. Preliminary Favorable Outcome for Medically and Surgically Managed Extensively Drug-Resistant Tuberculosis, France, 2009-2014.

    PubMed

    2016-03-01

    We report 20 cases of extensively drug-resistant tuberculosis managed in France. Treatment was individualized and included bedaquiline and linezolid for most patients and surgery in 8 patients. At last follow-up (22 months), 19 patients had achieved conversion from positive to negative on culture testing. These promising results of comprehensive management obtained in a small series deserve confirmation. PMID:26891089

  14. Drug Use during Acute Illness in Tigray Region, Northern Ethiopia: A Household Study

    PubMed Central

    Wondimu, Abrham; Molla, Fantahun; Abrha, Solomon; Mohammed, Jemal; Demeke, Birhanu; Eticha, Tadele; Assen, Admassu; Melkam, Wondim; Gebre-Samuel, Naod; Berhe, Derbew Fikadu; Tadese, Ebisa; Endris, Kedir

    2015-01-01

    Background Drug use study in the community enables health authorities to understand pattern of drug utilization and its related aspects. This, in turn, can help to develop rational drug policies to be harmonized in accordance to the need of the community. Objective The aim of this study was to assess drug use during acute illness by the general population in Tigray region, Northern Ethiopia. Method A community based cross-sectional study was undertaken in April 2013 in Tigray Region, Ethiopia. A total of 1034 households were interviewed in the study. A multi-stage sampling technique was used to select households. Data were collected using a pre-tested structured questionnaire. Data were analyzed using descriptive statistics and bivariate and multivariate logistic regression model. Results Out of 1000 households, 210(21%) reported an episode of acute illness. The prevalence of acute illnesses in rural areas 126(25%) (AOR = 1.83, 95% CI: 1.21–2.76) was significantly higher than that of urban areas 84(17%). Cough, runny nose, sore throat, earache, fever and headache added up to 155(52%) of all reported symptoms of acute illnesses. The majority of the patients 162 (77%) took modern medications for the managements of their diseases. Half 105(50%) of the consumed medications were antibiotics. The large proportions 173(83%) of medicines for acute illness were taken orally. The greater proportions 150(93%) of medications were prescribed by health professionals. Thirty-four households (21%) reported treatment discontinuation. Conclusion The prevalence of acute illnesses in this study was found to be 21%. Acute illnesses were more common in rural areas than urban areas. Antibiotics were the most frequently used drugs for acute illnesses. PMID:26658645

  15. Power module Data Management System (DMS) study

    NASA Technical Reports Server (NTRS)

    1978-01-01

    Computer trades and analyses of selected Power Module Data Management Subsystem issues to support concurrent inhouse MSFC Power Study are provided. The charts which summarize and describe the results are presented. Software requirements and definitions are included.

  16. Interval Management Display Design Study

    NASA Technical Reports Server (NTRS)

    Baxley, Brian T.; Beyer, Timothy M.; Cooke, Stuart D.; Grant, Karlus A.

    2014-01-01

    In 2012, the Federal Aviation Administration (FAA) estimated that U.S. commercial air carriers moved 736.7 million passengers over 822.3 billion revenue-passenger miles. The FAA also forecasts, in that same report, an average annual increase in passenger traffic of 2.2 percent per year for the next 20 years, which approximates to one-and-a-half times the number of today's aircraft operations and passengers by the year 2033. If airspace capacity and throughput remain unchanged, then flight delays will increase, particularly at those airports already operating near or at capacity. Therefore it is critical to create new and improved technologies, communications, and procedures to be used by air traffic controllers and pilots. National Aeronautics and Space Administration (NASA), the FAA, and the aviation industry are working together to improve the efficiency of the National Airspace System and the cost to operate in it in several ways, one of which is through the creation of the Next Generation Air Transportation System (NextGen). NextGen is intended to provide airspace users with more precise information about traffic, routing, and weather, as well as improve the control mechanisms within the air traffic system. NASA's Air Traffic Management Technology Demonstration-1 (ATD-1) Project is designed to contribute to the goals of NextGen, and accomplishes this by integrating three NASA technologies to enable fuel-efficient arrival operations into high-density airports. The three NASA technologies and procedures combined in the ATD-1 concept are advanced arrival scheduling, controller decision support tools, and aircraft avionics to enable multiple time deconflicted and fuel efficient arrival streams in high-density terminal airspace.

  17. Effective management tools for participants at Codex Committee on Residues of Veterinary Drugs meetings.

    PubMed

    Kay, Jack F

    2016-05-01

    The Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) fulfils a number of functions revolving around standard setting. The core activities of the CCRVDF include agreeing priorities for assessing veterinary drug residues, recommending maximum residue limits for veterinary drugs in foods of animal origin, considering methods of sampling and analyses, and developing codes of practice. Draft standards are developed and progress through an agreed series of steps common to all Codex Alimentarius Commission Committees. Meetings of the CCRVDF are held at approximately 18-month intervals. To ensure effective progress is made with meetings at this frequency, the CCRVDF makes use of a number of management tools. These include circular letters to interested parties, physical and electronic drafting groups between plenary sessions, meetings of interested parties immediately prior to sessions, as well as break out groups within sessions and detailed discussions within the CCRVDF plenary sessions. A range of these approaches is required to assist advances within the standards setting process and can be applied to other Codex areas and international standard setting more generally. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27443198

  18. A stewardship intervention program for safe medication management and use of antidiabetic drugs

    PubMed Central

    Zhao, Rui-yi; He, Xiao-wen; Shan, Yan-min; Zhu, Ling-ling; Zhou, Quan

    2015-01-01

    Background Diabetes patients are complex due to considerations of polypharmacy, multimorbidities, medication adherence, dietary habits, health literacy, socioeconomic status, and cultural factors. Meanwhile, insulin and oral hypoglycemic agents are high-alert medications. Therefore it is necessary to require a multidisciplinary team’s integrated endeavors to enhance safe medication management and use of antidiabetic drugs. Methods A 5-year stewardship intervention program, including organizational measures and quality improvement activities in storage, prescription, dispensing, administration, and monitoring, was performed in the Second Affiliated Hospital of Zhejiang University, People’s Republic of China, a 3,200-bed hospital with 3.5 million outpatient visits annually. Results The Second Affiliated Hospital of Zhejiang University has obtained a 100% implementation rate of standard storage of antidiabetic drugs in the Pharmacy and wards since August 2012. A zero occurrence of dispensing errors related to highly “look-alike” and “sound-alike” NovoMix 30® (biphasic insulin aspart) and NovoRapid® (insulin aspart) has been achieved since October 2011. Insulin injection accuracy among ward nurses significantly increased from 82% (first quarter 2011) to 96% (fourth quarter 2011) (P<0.05). The number of medication administration errors related to insulin continuously decreased from 20 (2011) to six (2014). The occurrence rate of hypoglycemia in non–endocrinology ward diabetes inpatients during 2011–2013 was significantly less than that in 2010 (5.03%–5.53% versus 8.27%) (P<0.01). Percentage of correct management of hypoglycemia by nurses increased from 41.5% (April 2014) to 67.2% (August 2014) (P<0.01). The percentage of outpatient diabetes patients receiving standard insulin injection education increased from 80% (April 2012) to 95.2% (October 2012) (P<0.05). Insulin injection techniques among diabetes outpatients who started to receive insulin were

  19. Experimental and theoretical studies of implant assisted magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Aviles, Misael O.

    One way to achieve drug targeting in the body is to incorporate magnetic nanoparticles into drug carriers and then retain them at the site using an externally applied magnetic field. This process is referred to as magnetic drug targeting (MDT). However, the main limitation of MDT is that an externally applied magnetic field alone may not be able to retain a sufficient number of magnetic drug carrier particles (MDCPs) to justify its use. Such a limitation might not exist when high gradient magnetic separation (HGMS) principles are applied to assist MDT by means of ferromagnetic implants. It was hypothesized that an Implant Assisted -- MDT (IA-MDT) system would increase the retention of the MDCPs at a target site where an implant had been previously located, since the magnetic forces are produced internally. With this in mind, the overall objective of this work was to demonstrate the feasibility of an IA-MDT system through mathematical modeling and in vitro experimentation. The mathematical models were developed and used to demonstrate the behavior and limitations of IA-MDT, and the in vitro experiments were designed and used to validate the models and to further elucidate the important parameters that affect the performance of the system. IA-MDT was studied with three plausible implants, ferromagnetic stents, seed particles, and wires. All implants were studied theoretically and experimentally using flow through systems with polymer particles containing magnetite nanoparticles as MDCPs. In the stent studies, a wire coil or mesh was simply placed in a flow field and the capture of the MDCPs was studied. In the other cases, a porous polymer matrix was used as a surrogate capillary tissue scaffold to study the capture of the MDCPs using wires or particle seeds as the implant, with the seeds either fixed within the polymer matrix or captured prior to capturing the MDCPs. An in vitro heart tissue perfusion model was also used to study the use of stents. In general, all

  20. Implementation of a drug-use and disease-state management program.

    PubMed

    Skledar, S J; Hess, M M

    2000-12-15

    A drug-use and disease-state management (DUDSM) program was instituted in 1996 at a teaching hospital associated with a large nonprofit health care system. The program's goals are to optimize pharmacotherapeutic regimens, evaluate health outcomes of identified disease states, and evaluate the economic impact of pharmacotherapeutic options for given disease states by developing practice guidelines. Through a re-engineering process, resources within the pharmacy department were identified that could be devoted to the DUDSM program, including the use of clinical pharmacy specialists, promotion of staff pharmacists into the DUDSM program, a pharmacy technician, and information systems support. A strength of the program is its systematic approach for developing and implementing new initiatives, as well as monitoring compliance with all initiatives on an ongoing basis. The initiative-design process incorporates continuous quality improvement principles, outcome design and evaluation, competency assessment for all pharmacists, multidisciplinary collaboration, and sophisticated information systems. Seventy-five initiatives have been implemented, ranging from simple dose-optimization strategies for specific drugs to complicated practice guidelines for managing specific disease states. Improved patient outcomes have been documented, including reduced length of stay, postsurgical wound infection, adverse drug reactions, and medication errors. Documented cost savings exceeded $4 million annually for fiscal years 1996-97 through 1999-2000. Overall compliance with DUDSM initiatives exceeds 80%, and physician service profiling has been initiated to monitor variant prescribing. The DUDSM program has successfully integrated practice guidelines into therapeutic decision-making, resulting in improved patient-care outcomes and cost savings. PMID:11148941

  1. Nanostructured Delivery Systems: Augmenting the Delivery of Antiretroviral Drugs for Better Management of HIV/AIDS.

    PubMed

    Singh, Gurinder; Pai, Roopa S; Mustafa, Sanaul

    2015-01-01

    In the last two decades, HIV-1, the retrovirus associated with acquired immunodeficiency syndrome (AIDS), is globally one of the primary causes of morbidity and mortality. Unfortunately, existing approaches for interventions are not able to suppress the progression of infection due to this virus. Of the many obstacles, viral entry into the mono-nuclear phagocyte system encompassing monocytes/macrophages and dendritic cells is a major concern. Viral infection is also responsible for the subsequent distribution of the virus into various tissues throughout the organism. Tremendous progress has been made during the past few years to diagnose and treat patients with HIV/AIDS infection, yet much remains to be done. Recommended treatment involves long-term and multiple drug therapy that causes severe side effects. With almost 12% of the world population suffering from HIV/AIDS, better management of this global threat is highly desired. Nanostructured delivery systems hold promise for improving the situation. Such systems can facilitate the uptake of antiretroviral drugs, causing a considerable improvement in HIV/AIDS therapy. Nanoscale systems have intriguing potential to drastically improve existing HIV/AIDS diagnosis and treatment platforms. Nanosystems constitute a wide range of systems varying from polymeric nanoparticles, to solid-lipid nanoparticles, liposomes, micro- and nanoemulsions, dendrimers, and self-nanoemulsifying systems. Improved bioavailability, solubility, stability, and biocompatibility make them an ideal choice for delivery of antiretroviral drugs. The present review initially describes an updated bird's-eye view account of the literature. Then, we provide a relatively sententious overview on updated patents of recent nanostructured delivery systems for antiretroviral drugs. Finally, we discuss low-cost therapy (such as antioxidants and immune modulators) for the treatment and prevention of HIV/AIDS. PMID:26559551

  2. Adverse event management in mass drug administration for neglected tropical diseases.

    PubMed

    Caplan, Arthur; Zink, Amanda

    2014-03-01

    The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of

  3. Pharmacokinetic drug interactions with clopidogrel: updated review and risk management in combination therapy

    PubMed Central

    Wang, Zhi-Yu; Chen, Meng; Zhu, Ling-Ling; Yu, Lu-Shan; Zeng, Su; Xiang, Mei-Xiang; Zhou, Quan

    2015-01-01

    Background Coprescribing of clopidogrel and other drugs is common. Available reviews have addressed the drug–drug interactions (DDIs) when clopidogrel is as an object drug, or focused on combination use of clopidogrel and a special class of drugs. Clinicians may still be ignorant of those DDIs when clopidogrel is a precipitant drug, the factors determining the degree of DDIs, and corresponding risk management. Methods A literature search was performed using PubMed, MEDLINE, Web of Science, and the Cochrane Library to analyze the pharmacokinetic DDIs of clopidogrel and new P2Y12 receptor inhibitors. Results Clopidogrel affects the pharmacokinetics of cerivastatin, repaglinide, ferulic acid, sibutramine, efavirenz, and omeprazole. Low efficacy of clopidogrel is anticipated in the presence of omeprazole, esomeprazole, morphine, grapefruit juice, scutellarin, fluoxetine, azole antifungals, calcium channel blockers, sulfonylureas, and ritonavir. Augmented antiplatelet effects are anticipated when clopidogrel is coprescribed with aspirin, curcumin, cyclosporin, St John’s wort, rifampicin, and angiotensin-converting enzyme inhibitors. The factors determining the degree of DDIs with clopidogrel include genetic status (eg, cytochrome P540 [CYP]2B6*6, CYP2C19 polymorphism, CYP3A5*3, CYP3A4*1G, and CYP1A2-163C.A), species differences, and dose strength. The DDI risk does not exhibit a class effect, eg, the effects of clopidogrel on cerivastatin versus other statins, the effects of proton pump inhibitors on clopidogrel (omeprazole, esomeprazole versus pantoprazole, rabeprazole), the effects of rifampicin on clopidogrel versus ticagrelor and prasugrel, and the effects of calcium channel blockers on clopidogrel (amlodipine versus P-glycoprotein-inhibiting calcium channel blockers). The mechanism of the DDIs with clopidogrel involves modulating CYP enzymes (eg, CYP2B6, CYP2C8, CYP2C19, and CYP3A4), paraoxonase-1, hepatic carboxylesterase 1, P-glycoprotein, and organic anion

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

    PubMed Central

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

    2014-01-01

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

  5. A long and winding road; evolution of antimicrobial drug development - crisis management.

    PubMed

    Echols, Roger M

    2012-11-01

    The development of antimicrobial drugs has evolved from observational case reports to complex randomized prospective clinical trials in specific treatment indications. Beginning around the year 2000, the US FDA has evolved its approach on study design and other study characteristics, which has made the conduct of these studies more difficult and the outcomes for sponsors more risky. This has contributed to the decline in the discovery and development of new antimicrobials, which are needed to address the increasing problem of bacterial resistance to existing marketed products. This study reviews the historical basis for the current regulatory climate including the various crises that have led to considerable political pressures on the agency. Recent efforts to resolve development uncertainties and to provide economic incentives for future antimicrobial drug development are presented. PMID:23241188

  6. Component architecture in HIS: a drug order entry case study.

    PubMed

    Schlesinger, J M; Blumenfeld, B; Broverman, C

    1997-01-01

    Historically, many healthcare information systems (HIS) have been designed around monolithic architectures that rely upon a single organization to provide most, if not all, of the system's business logic. Recent advances in distributed systems technology and healthcare standards make a component-based architecture feasible in building today's HIS. The First DataBank Drug Toolkit is used as a case study for the role of components in the design of a HIS. Several technical challenges associated with building truly plug and play components are discussed. PMID:10175372

  7. Understanding and managing the impact of HPMC variability on drug release from controlled release formulations.

    PubMed

    Zhou, Deliang; Law, Devalina; Reynolds, Judie; Davis, Lynn; Smith, Clifford; Torres, Jose L; Dave, Viraj; Gopinathan, Nishanth; Hernandez, Daniel T; Springman, Mary Kay; Zhou, Casey Chun

    2014-06-01

    The purpose of this study is to identify critical physicochemical properties of hydroxypxropyl methylcellulose (HPMC) that impact the dissolution of a controlled release tablet and develop a strategy to mitigate the HPMC lot-to-lot and vendor-to-vendor variability. A screening experiment was performed to evaluate the impacts of methoxy/hydroxypropyl substitutions, and viscosity on drug release. The chemical diversity of HPMC was explored by nuclear magnetic resonance (NMR), and the erosion rate of HPMC was investigated using various dissolution apparatuses. Statistical evaluation suggested that the hydroxypropyl content was the primary factor impacting the drug release. However, the statistical model prediction was not robust. NMR experiments suggested the existence of structural diversity of HPMC between lots and more significantly between vendors. Review of drug release from hydrophilic matrices indicated that erosion is a key aspect for both poorly soluble and soluble drugs. An erosion rate method was then developed, which enabled the establishment of a robust model and a meaningful HPMC specification. The study revealed that the overall substitution level is not the unique parameter that dictates its release-controlling properties. Fundamental principles of polymer chemistry and dissolution mechanisms are important in the development and manufacturing of hydrophilic matrices with consistent dissolution performance. PMID:24652662

  8. Practical Guide to the Management of Acute and Chronic Pain in the Presence of Drug Tolerance for the Healthcare Practitioner

    PubMed Central

    Vadivelu, Nalini; Singh-Gill, Harman; Kodumudi, Gopal; Kaye, Aaron Joshua; Urman, Richard D.; Kaye, Alan David

    2014-01-01

    Background Drug tolerance has been on the rise in recent years worldwide, and consequently, pain management in our population has become challenging. Methods Discussed in this review are commonly abused drugs and considerations for treating acute and chronic pain states in patients with substance disorders. Results After marijuana, alcohol, and tobacco, the most widely abused substances are oxycodone (Oxycontin), diazepam (Valium), and methylphenidate (Ritalin). Urine testing can detect metabolites of drugs used by patients and is useful for assessing drug abuse, medication diversion, and drug interactions. The comprehensive treatment of pain in a patient with addictive disorder or tolerance must address 3 issues: the patient's addiction, any associated psychiatric conditions, and the patient's pain. Eliciting a detailed history of drug abuse—illicit drugs as well as prescription drugs—and ascertaining if the patient is currently enrolled in a methadone maintenance program for the treatment of drug addiction is vital. Conclusion Medical observation, supportive care, multidisciplinary pain management, and timely interventions as necessary are the keys to safe outcomes in these patients. PMID:25249810

  9. Cranberry juice ingestion and clinical drug-drug interaction potentials; review of case studies and perspectives.

    PubMed

    Srinivas, Nuggehally R

    2013-01-01

    Cranberry juice is a popular beverage with many health benefits. It has anthocyanins to supplement dietary needs. Based on in vitro evidence cranberry juice is an inhibitor of CYP enzymes and at higher amounts as potent as ketoconazole (CYP3A) and fluconazole (CYP2C9). There is, however, a discrepancy between in vitro and in vivo observations with respect to a number of substrates (cyclosporine, warfarin, flurbiprofen, tizanidine, diclofenac, amoxicillin, ceflacor); with the exception of a single report on midazolam, where there was a moderate increase in the AUC of midazolam in subjects pre-treated with cranberry juice. However, another study questions the clinical relevancy of in vivo pharmacokinetic interaction between cranberry juice and midazolam. The controversy may be due to a) under in vitro conditions all anthocyanin principles may be available to have a concerted effort in CYP inhibition; however, limited anthocyanin principles may be bioavailable with varying low levels in the in vivo studies; b) a faster clearance of the active anthocyanin principles under in vivo conditions may occur, leading to low threshold levels for CYP inhibition; c) efficient protein binding and/or rapid tissue uptake of the substrate may have precluded the drug availability to the enzymes in the in vivo studies. With respect to pharmacodynamic aspects, while the debate continues on the issue of an interaction between warfarin and cranberry juice, the summation of the pharmacodynamics data obtained in patients and healthy subjects from different prospectively designed and controlled clinical trials does not provide overwhelming support for the existence of a pharmacodynamic drug interaction for normal cranberry juice ingestion. However, it is apparent that consumption of large quantities of cranberry juice (about 1-2 L per day) or cranberry juice concentrates in supplements for an extended time period (>3-4 weeks) may temporally alter the effect of warfarin. Therefore, the total

  10. Study Sees No Link Between Common Epilepsy Drug, Certain Birth Defects

    MedlinePlus

    ... 158169.html Study Sees No Link Between Common Epilepsy Drug, Certain Birth Defects Large review found no ... Despite initial concern from early studies, taking the epilepsy drug lamotrigine (Lamictal) during pregnancy may not raise ...

  11. Teaching older adults to self-manage medications: preventing adverse drug reactions.

    PubMed

    Curry, Linda Cox; Walker, Charles; Hogstel, Mildred O; Burns, Paulette

    2005-04-01

    Older adults use more prescription and OTC medications than any other age group. Because their medication regimens often are complicated by many medications and different doses, times, and administration methods, older adults are at high risk for medication mismanagement. The most common errors associated with medication mismanagement include mixing OTC and prescription medications, discontinuing prescriptions, taking wrong dosages, using incorrect techniques, and consuming inappropriate foods with specific medications. Both human and environmental factors contribute to medication mismanagement among older adults. Human factors include faulty communication between the health care provider and the patient; the patient's lack of knowledge; ADRs; alcohol-drug interactions; use of OTC medications and herbal products; cognitive, sensory, and motor impairments; and polypharmacy. Environmental factors include high cost of prescribed medications, improper medication storage, and absence of clearly marked expiration dates. Nurses need to take advantage of both formal and informal teaching opportunities in all settings to prepare a patient for medication self-management. Teaching should be individualized and based on a thorough assessment of the patient's abilities to administer medication safely and the specific medication regimen. By involving older adults as active partners in their health care, many errors and medication-related health problems can be prevented. New technologies and devices have the potential for improving the patient's self-management of medications. The role of nurses in educating older adults and their families about proper medication management is vital. PMID:15839523

  12. Drug Education Based on a Knowledge, Attitude, and Experience Study

    ERIC Educational Resources Information Center

    Grant, John A.

    1971-01-01

    Results of a questionnaire concerning factual knowledge of attitudes toward, and experience with a variety of drugs are reported. It was concluded that marihuana and other drugs are readily available to secondary school students, and widespread experimentation exists; however, a strict dichotomy exists between marihuana and other drugs. (Author/BY)

  13. Evaluating drug delivery with salt formation: Drug disproportionation studied in situ by ATR-FTIR imaging and Raman mapping.

    PubMed

    Ewing, Andrew V; Wray, Patrick S; Clarke, Graham S; Kazarian, Sergei G

    2015-01-01

    Two different vibrational spectroscopic approaches, ATR-FTIR spectroscopic imaging and Raman mapping, were used to investigate the components within a tablet containing an ionised drug during dissolution experiments. Delivering certain drugs in their salt form is a method that can be used to improve the bioavailability and dissolution of the poorly aqueous soluble materials. However, these ionised species have a propensity to covert back to their thermodynamically favourable free acid or base forms. Dissolution experiments of the ionised drug in different aqueous media resulted in conversion to the more poorly soluble free acid form, which is detrimental for controlled drug release. This study investigates the chemical changes occurring to formulations containing a development ionised drug (37% by weight), in different aqueous pH environments. Firstly, dissolution in a neutral medium was studied, showing that there was clear release of ionised monosodium form of the drug from the tablet as it swelled in the aqueous medium. There was no presence of any drug in the monohydrate free acid form detected in these experiments. Dissolution in an acidic (0.1M HCl) solution showed disproportionation forming the free acid form. Disproportionation occurred rapidly upon contact with the acidic solution, initially resulting in a shell of the monohydrate free acid form around the tablet edges. This slowed ingress of the solution into the tablet before full conversion of the ionised form to the free acid form was characterised in the spectroscopic data. PMID:25910459

  14. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study.

    PubMed

    Hon, Chun-Yip; Chua, Prescillia Ps; Danyluk, Quinn; Astrakianakis, George

    2014-06-01

    Occupational exposure to antineoplastic drugs has been documented to result in various adverse health effects. Despite the implementation of control measures to minimize exposure, detectable levels of drug residual are still found on hospital work surfaces. Cleaning these surfaces is considered as one means to minimize the exposure potential. However, there are no consistent guiding principles related to cleaning of contaminated surfaces resulting in hospitals to adopt varying practices. As such, this pilot study sought to evaluate current cleaning protocols and identify those factors that were most effective in reducing contamination on drug preparation surfaces. Three cleaning variables were examined: (1) type of cleaning agent (CaviCide®, Phenokil II™, bleach and chlorhexidine), (2) application method of cleaning agent (directly onto surface or indirectly onto a wipe) and (3) use of isopropyl alcohol after cleaning agent application. Known concentrations of antineoplastic drugs (either methotrexate or cyclophosphamide) were placed on a stainless steel swatch and then, systematically, each of the three cleaning variables was tested. Surface wipes were collected and quantified using high-performance liquid chromatography-tandem mass spectrometry to determine the percent residual of drug remaining (with 100% being complete elimination of the drug). No one single cleaning agent proved to be effective in completely eliminating all drug contamination. The method of application had minimal effect on the amount of drug residual. In general, application of isopropyl alcohol after the use of cleaning agent further reduced the level of drug contamination although measureable levels of drug were still found in some cases. PMID:23929731

  15. From Abstinence to Relapse: A Preliminary Qualitative Study of Drug Users in a Compulsory Drug Rehabilitation Center in Changsha, China

    PubMed Central

    Yang, Mei; Mamy, Jules; Gao, Pengcheng; Xiao, Shuiyuan

    2015-01-01

    Background Relapse among abstinent drug users is normal. Several factors are related to relapse, but it remains unclear what individuals’ actual life circumstances are during periods of abstinence, and how these circumstances facilitate or prevent relapse. Objective To illuminate drug users’ experiences during abstinence periods and explore the real-life catalysts and inhibitors contributing to drug use relapse. Method Qualitative in-depth interviews were conducted with 20 drug users recruited from a compulsory isolated drug rehabilitation center in Changsha. The interviews were guided by open-ended questions on individuals’ experiences in drug use initiation, getting addicted, treatment history, social environment, abstinence, and relapse. Participants were also encouraged to share their own stories. Interviews were digitally recorded and fully transcribed. The data of 18 participants who reported abstinence experiences before admission were included in the analyses. The data were analyzed using a thematic analysis with inductive hand coding to derive themes. Results Most drug users were able to successfully abstain from drugs. During abstinence, their lives were congested with challenges, such as adverse socioeconomic conditions, poor family/social support, interpersonal conflicts, and stigma and discrimination, all of which kept them excluded from mainstream society. Furthermore, the police’s system of ID card registration, which identifies individuals as drug users, worsened already grave situations. Relapse triggers reported by the participants focused mainly on negative feelings, interpersonal conflicts, and stressful events. Craving was experienced but not perceived as a relapse trigger by most participants. Conclusions This study of in-depth interview with drug users found evidence of situations and environments they live during abstinence appear rather disadvantaged, making it extremely difficult for them to remain abstinent. Comprehensive programs

  16. [Role of the community pharmacist in the management of drug related problems in home care patients].

    PubMed

    Van de Putte, M; Appels, S; Boone, T; Collienne, S; Daems, T; De Lepeleire, J; Foulon, V

    2012-09-01

    Medication management in home care is an error prone process. In a small pilot project in Flanders, community pharmacists collaborated with physicians and home care nurses through a shared electronic care plan, to optimize the medication management of their home care patients. The pilot project shows that GPs and nurses are positive about the possible contribution of the pharmacist in medication management of home care patients. A larger follow up study is necessary to further identify possible roles of pharmacists in home care and to show related health benefits. PMID:23697093

  17. Directional reflectance analysis for identifying counterfeit drugs: Preliminary study.

    PubMed

    Wilczyński, Sławomir; Koprowski, Robert; Błońska-Fajfrowska, Barbara

    2016-05-30

    The WHO estimates that up to 10% of drugs on the market may be counterfeit. In order to prevent intensification of the phenomenon of drug counterfeiting, the methods for distinguishing genuine medicines from fake ones need to be developed. The aim of this study was to try to develop simple, reproducible and inexpensive method for distinguishing between original and counterfeit medicines based on the measurement of directional reflectance. The directional reflectance of 6 original Viagra(®) tablets (Pfizer) and 24 (4 different batches) counterfeit tablets (imitating Viagra(®)) was examined in six spectral bands: from 0.9 to 1.1 μm, from 1.9 to 2.6 μm, from 3.0 to 4.0 μm, from 3.0 to 5.0 μm, from 4.0 to 5.0 μm, from 8.0 to 12.0 μm, and for two angles of incidence, 20° and 60°. Directional hemispherical reflectometer was applied to measure directional reflectance. Significant statistical differences between the directional reflectance of the original Viagra(®) and counterfeit tablets were registered. Any difference in the value of directional reflectance for any spectral band or angle of incidence identifies the drug as a fake one. The proposed method of directional reflectance analysis enables to differentiate between the real Viagra(®) and fake tablets. Directional reflectance analysis is a fast (measurement time under 5s), cheap and reproducible method which does not require expensive equipment or specialized laboratory staff. It also seems to be an effective method, however, the effectiveness will be assessed after the extension of research. PMID:26977587

  18. Acetylated starch nanocrystals: Preparation and antitumor drug delivery study.

    PubMed

    Xiao, Huaxi; Yang, Tao; Lin, Qinlu; Liu, Gao-Qiang; Zhang, Lin; Yu, Fengxiang; Chen, Yuejiao

    2016-08-01

    In this study, we developed a new nanoparticulate system for acetylated starch nanocrystals (ASN) using broken rice. ASN with different degrees of substitution (DS) of 0.04, 0.08 and 0.14 were prepared using acetic anhydride as acetylating agent through reaction with starch nanocrystals (SN). The resulting ASN were investigated for the capability to load and release doxorubicin hydrochloride (DOX), and the antitumor activities of DOX-loaded SN and DOX-loaded ASN were evaluated as potential drug delivery systems for cancer therapy. Cellular uptake and cytotoxicity of nanocrystals and the DOX-loaded nanocrystals were investigated using fluorescence microscopy and a 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) (MTT) assay. Compared with acetylated starches (AS) and native starches (NS), ASN with DS 0.14 loaded up to 6.07% of DOX with a higher loading efficiency of 91.1% and had steadier drug-release rates. Toxicity analysis using the rat hepatocytes model suggested that ASN was biocompatible and could be used for drug delivery. Furthermore, ASN were taken up by cancer cells in vitro and significantly enhanced the cytotoxicity of DOX against HeLa human cervical carcinoma cells. The IC50 value of DOX-loaded ASN-DS 0.14 was 3.8μg/mL for 24h of treatment, which was significantly lower than that of free DOX (21μg/mL). These results indicate that the prepared ASN using broken rice is a promising vehicle for the controlled delivery of DOX for cancer therapy. PMID:27156696

  19. Open Source Drug Discovery in Practice: A Case Study

    PubMed Central

    Årdal, Christine; Røttingen, John-Arne

    2012-01-01

    Background Open source drug discovery offers potential for developing new and inexpensive drugs to combat diseases that disproportionally affect the poor. The concept borrows two principle aspects from open source computing (i.e., collaboration and open access) and applies them to pharmaceutical innovation. By opening a project to external contributors, its research capacity may increase significantly. To date there are only a handful of open source R&D projects focusing on neglected diseases. We wanted to learn from these first movers, their successes and failures, in order to generate a better understanding of how a much-discussed theoretical concept works in practice and may be implemented. Methodology/Principal Findings A descriptive case study was performed, evaluating two specific R&D projects focused on neglected diseases. CSIR Team India Consortium's Open Source Drug Discovery project (CSIR OSDD) and The Synaptic Leap's Schistosomiasis project (TSLS). Data were gathered from four sources: interviews of participating members (n = 14), a survey of potential members (n = 61), an analysis of the websites and a literature review. Both cases have made significant achievements; however, they have done so in very different ways. CSIR OSDD encourages international collaboration, but its process facilitates contributions from mostly Indian researchers and students. Its processes are formal with each task being reviewed by a mentor (almost always offline) before a result is made public. TSLS, on the other hand, has attracted contributors internationally, albeit significantly fewer than CSIR OSDD. Both have obtained funding used to pay for access to facilities, physical resources and, at times, labor costs. TSLS releases its results into the public domain, whereas CSIR OSDD asserts ownership over its results. Conclusions/Significance Technically TSLS is an open source project, whereas CSIR OSDD is a crowdsourced project. However, both have enabled high quality

  20. Socio-demographic correlates of injection drug use among male drug users: a cross sectional study in Nepal.

    PubMed

    Neupane, Sanjeev Raj; Mishra, Shiva Raj; Adhikari, Samaj; Poudyal, Amod Kumar

    2014-12-01

    Drug abuse is one of the major public health problems in Nepal. The objective of this study is to explore the factors responsible for the injecting drug use in Nepal. A cross sectional study was conducted among drug users in Pokhara sub metropolitan city in Nepal. Taking prevalence of 20% at 95% confidence interval and 20% non-response rate, 448 samples were calculated for face to face interviews. Most of the study participants were >24 year's age. Sixty-one percentage of the participants were unemployed. The largest percentage belonged to Gurung/Rai/Pun (37%) ethnic groups, and had completed secondary level of education (47.5%). In the logistic regression analysis occupation, motivating factors for drug use, ever been to custody, age at first drug use, age at first sex, money spent on drugs, ever been rehabilitated and age of the respondents showed a statistically significant association with injecting drug use status. The respondents having business [Adjusted Odds ratio (aOR) 4.506, 95% CI (1.677-12.104)], service [aOR 2.698, 95% CI (a1.146-6.355], having tragedy/turmoil [aOR 3.867, 95% CI (1.596-9.367)], family problem [aOR 2.010, 95% CI (2.010-53.496)], had sex at >19 years [aOR 1.683, 95% CI (1.017-2.785)], rehabilitated >2 times [aOR 4.699, 95% CI (1.401-15.763)], >24 years age group [aOR 1.741, 95% CI (1.025-2.957)] had higher odds of having injecting habits. Having money spent on drugs >3,000 NRs (300 USD) [aOR 0.489, 95%CI (0.274-0.870), not been to custody (aOR 0.330, 95%CI (0.203-0.537)] and having curiosity for drug use [aOR 0.147, 95% CI (0.029-0.737)] were found to be protective for injecting drug use. This study recommends the harm reduction program specifically focused on drug users of occupational groups like business, service and the youths through public health actions to stop transiting them to injecting drug use. PMID:24705679

  1. Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

    PubMed Central

    Bojnanska, Erika; Kalina, Michal; Bartonickova, Eva; Opravil, Tomas; Vesely, Michal; Pekar, Miloslav

    2014-01-01

    The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation. PMID:25317424

  2. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.

    PubMed

    Choi, Stephanie H; Lionberger, Robert A

    2016-07-01

    For ophthalmic drug products, the determination of bioequivalence can be challenging, as drug concentrations at the site of action cannot always be measured. The FDA has recommended a variety of studies that can be used to demonstrate bioequivalence for different ophthalmic drug products. Product-specific bioequivalence recommendations for 28 ophthalmic products have been posted on FDA's website as of May 2016, outlining the specific tests which should be performed to demonstrate bioequivalence. The type of study that can be used to demonstrate bioequivalence depends on the drug product's active pharmaceutical ingredient(s), dosage form, indication, site of action, mechanism of action, and scientific understanding of drug release/drug availability and drug product characteristics. This article outlines the FDA's current guidance on studies to demonstrate bioequivalence through clinical endpoint studies, pharmacokinetic studies, and in vitro studies for generic ophthalmic drug products. PMID:27184578

  3. “Pressured to prescribe” The impact of economic and regulatory factors on South-Eastern ED physicians when managing the drug seeking patient

    PubMed Central

    Kelly, Sharon; Johnson, Giffe T.; Harbison, Raymond D.

    2016-01-01

    Objective: The purpose of this study was to elicit the opinions of Emergency Department (ED) physicians, currently practicing in the United States, regarding the impact of economic and regulatory factors on their management of patients exhibiting “drug seeking” behavior. Methods: A descriptive, cross-sectional study, utilizing a convenience sample of ED physicians located in Florida and Georgia was conducted for a period of 2 months. The inclusion criteria specified that any ED physician, currently practicing within the United States, could participate. Results: Of the ED physicians surveyed (n = 141), 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism and 98% related patient satisfaction scores as being too highly emphasized by reimbursement entities as a means of evaluating their patient management. Rising patient volumes and changes in the healthcare climate were cited by ED physicians as impacting their management of patients exhibiting “drug seeking” behavior. Conclusions: The ED physician faces unique challenges in changing healthcare and economic climates. Requirements to address pain as the “fifth vital sign,” patient satisfaction based reimbursement metrics and an economically driven rise in ED patient volume, may have inadvertently created an environment conducive to exploitation by prescription opioid abusers. There is an identified need for the development of continuing medical education and standardized regulatory and legislative protocols to assist ED physicians in the appropriate management of patients exhibiting “drug seeking” behavior. PMID:27162437

  4. Prospective Observational Study of Adverse Drug Reactions of Anticancer Drugs Used in Cancer Treatment in a Tertiary Care Hospital

    PubMed Central

    Saini, V. K.; Sewal, R. K.; Ahmad, Yusra; Medhi, B.

    2015-01-01

    Adverse drug reactions associated with the use of anticancer drugs are a worldwide problem and cannot be ignored. Adverse drug reactions can range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to observe the suspected adverse drug reactions of cancer chemotherapy in patients aged >18 years having cancer attending Postgraduate Institute of Medical Education and Research, Chandigarh. During the study period, 101 patients of breast cancer and 73 patients of lung cancer were screened for occurrence of adverse drug reactions during their treatment with chemotherapy. About 87.36% patients experienced adverse drug reactions, 90.09% and 83.56% of breast and lung cancer patients experienced at least one adverse drug reaction respectively. In breast cancer patients, 41.58% patients were prescribed fluorouracil+doxorubicin+cyclophosphamide while paclitaxel was prescribed to 22.77% patients. Alopecia (54.94%), nail discolouration (43.96%), dysgeusia (38.46%), anorexia (30.77%), nausea (29.67%), and neuropathy (29.67%) were found to be very common in breast cancer patients treated with single/combined regimen. In lung cancer group of patients, cisplatin with docetaxel, cisplatin with pemetrexed and cisplatin with irinotecan were prescribed to 30.14, 24.65 and 17.81% patients, respectively. Dysgeusia (40.98%), diarrhoea (39.34%), anorexia (32.77%) and constipation (31.15%) and alopecia (31.15%) were commonly observed adverse drug reactions having lung cancer patients. Causality assessments using World Health Organization causality assessment scale showed that observed adverse drug reactions were of probable (64.67%) and possible (35.33%) categories. Alopecia, dysgeusia, anorexia, constipation diarrhoea, nausea, nail discoloration were more prevalent amongst the cancer patients undergoing chemotherapy. PMID:26997696

  5. Prospective Observational Study of Adverse Drug Reactions of Anticancer Drugs Used in Cancer Treatment in a Tertiary Care Hospital.

    PubMed

    Saini, V K; Sewal, R K; Ahmad, Yusra; Medhi, B

    2015-01-01

    Adverse drug reactions associated with the use of anticancer drugs are a worldwide problem and cannot be ignored. Adverse drug reactions can range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to observe the suspected adverse drug reactions of cancer chemotherapy in patients aged >18 years having cancer attending Postgraduate Institute of Medical Education and Research, Chandigarh. During the study period, 101 patients of breast cancer and 73 patients of lung cancer were screened for occurrence of adverse drug reactions during their treatment with chemotherapy. About 87.36% patients experienced adverse drug reactions, 90.09% and 83.56% of breast and lung cancer patients experienced at least one adverse drug reaction respectively. In breast cancer patients, 41.58% patients were prescribed fluorouracil+doxorubicin+cyclophosphamide while paclitaxel was prescribed to 22.77% patients. Alopecia (54.94%), nail discolouration (43.96%), dysgeusia (38.46%), anorexia (30.77%), nausea (29.67%), and neuropathy (29.67%) were found to be very common in breast cancer patients treated with single/combined regimen. In lung cancer group of patients, cisplatin with docetaxel, cisplatin with pemetrexed and cisplatin with irinotecan were prescribed to 30.14, 24.65 and 17.81% patients, respectively. Dysgeusia (40.98%), diarrhoea (39.34%), anorexia (32.77%) and constipation (31.15%) and alopecia (31.15%) were commonly observed adverse drug reactions having lung cancer patients. Causality assessments using World Health Organization causality assessment scale showed that observed adverse drug reactions were of probable (64.67%) and possible (35.33%) categories. Alopecia, dysgeusia, anorexia, constipation diarrhoea, nausea, nail discoloration were more prevalent amongst the cancer patients undergoing chemotherapy. PMID:26997696

  6. The patterns of toxicity and management of acute nonsteroidal anti-inflammatory drug (NSAID) overdose

    PubMed Central

    Hunter, Laura J; Wood, David M; Dargan, Paul I

    2011-01-01

    The nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for their analgesic, anti-inflammatory and antipyretic actions. They are commonly taken in overdose in many areas of the world. The majority of patients with acute NSAID overdose will remain asymptomatic or develop minor self-limiting gastrointestinal symptoms. However, serious clinical sequelae have been reported in patients with acute NSAID overdose and these include convulsions, metabolic acidosis, coma and acute renal failure. There appear to be some differences between the NSAIDs in terms of the relative risk of these complications; in particular mefenamic acid is most commonly associated with convulsions. The management of these serious clinical features is largely supportive and there are no specific antidotes for acute NSAID toxicity. PMID:27147851

  7. Effects of meals on hemodynamics: implications for antihypertensive drug studies.

    PubMed

    Fagan, T C; Conrad, K A; Mar, J H; Nelson, L

    1986-03-01

    The ingestion of food is known to affect blood pressure and heart rate, but food is often allowed in patients under observation for antihypertensive drug effects. Seventy-seven patients with essential hypertension were observed for 8 hours after a 16-hour fast. Thirty-six continued to fast, 20 ate a high-carbohydrate meal, and 21 ate a meal of their own choice. Blood pressure and heart rate did not change during fasting, but both meals lowered mean supine and standing diastolic blood pressures during the subsequent 4 hours by 3 to 7 mm Hg (P less than 0.001). The high-carbohydrate meal reduced supine systolic blood pressure by 6 mm Hg (P less than 0.0001). Both meals increased supine and standing heart rates by 5 to 8 bpm (P less than 0.001). After the self-selected meal, standing systolic blood pressure increased in younger patients but decreased in older patients. Food ingestion during antihypertensive drug studies may interfere with the interpretation of results and should be avoided whenever possible. PMID:3948465

  8. Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study.

    PubMed

    Habermann, Frank; Fritzsche, Juliane; Fuhlbrück, Frederike; Wacker, Evelin; Allignol, Arthur; Weber-Schoendorfer, Corinna; Meister, Reinhard; Schaefer, Christof

    2013-08-01

    Women of childbearing age are often affected with psychotic disorders, requiring the use of antipsychotic medication during pregnancy. In the present study, we prospectively followed the pregnancies of 561 women exposed to second-generation antipsychotic agents (SGAs; study cohort) and compared these to 284 pregnant women exposed to first-generation antipsychotic agents (FGAs; comparison cohort I) and to 1122 pregnant women using drugs known as not harmful to the unborn (comparison cohort II). Subjects were enrolled through the Institute's consultation service. Major malformation rates of SGA exposed were higher compared to comparison cohort II (adjusted odds ratio, 2.17; 95% confidence interval, 1.20-3.91), possibly reflecting a detection bias concerning atrial and ventricular septal defects. Postnatal disorders occurred significantly more often in infants prenatally exposed to SGAs (15.6%) and FGAs (21.6%) compared to 4.2% of comparison cohort II. Cumulative incidences of elective terminations of pregnancy were significantly higher in both the study cohort (17%) and comparison cohort I (21%) compared to comparison cohort II (3%), whereas the rates of spontaneous abortions did not differ. The numbers of stillbirths and neonatal deaths were within the reference range. Preterm birth and low birth weight were more common in infants exposed to FGAs. To conclude, our findings did not reveal a major teratogenic risk for SGAs, making the better studied drugs of this group a treatment option during pregnancy. Because neonates exposed to SGAs or FGAs in the last gestational week are at higher risk of postnatal disorders, delivery should be planned in clinics with neonatal intensive care units. PMID:23764684

  9. Programmatic Management of Drug-Resistant Tuberculosis: An Updated Research Agenda

    PubMed Central

    Mitnick, Carole D.; Hatton, Marita L.; Brigden, Grania; Cobelens, Frank; Grobusch, Martin P.; Horsburgh, Robert; Lange, Christoph; Lienhardt, Christian; Oren, Eyal; Podewils, Laura J.; Seaworth, Barbara; van den Hof, Susan; Daley, Charles L.; Gebhard, Agnes C.; Wares, Fraser

    2016-01-01

    Introduction There are numerous challenges in delivering appropriate treatment for multidrug-resistant tuberculosis (MDR-TB) and the evidence base to guide those practices remains limited. We present the third updated Research Agenda for the programmatic management of drug-resistant TB (PMDT), assembled through a literature review and survey. Methods Publications citing the 2008 research agenda and normative documents were reviewed for evidence gaps. Gaps were formulated into questions and grouped as in the 2008 research agenda: Laboratory Support, Treatment Strategy, Programmatically Relevant Research, Epidemiology, and Management of Contacts. A survey was distributed through snowball sampling to identify research priorities. Respondent priority rankings were scored and summarized by mean. Sensitivity analyses explored weighting and handling of missing rankings. Results Thirty normative documents and publications were reviewed for stated research needs; these were collapsed into 56 research questions across 5 categories. Of more than 500 survey recipients, 133 ranked priorities within at least one category. Priorities within categories included new diagnostics and their effect on improving treatment outcomes, improved diagnosis of paucibacillary and extra pulmonary TB, and development of shorter, effective regimens. Interruption of nosocomial transmission and treatment for latent TB infection in contacts of known MDR−TB patients were also top priorities in their respective categories. Results were internally consistent and robust. Discussion Priorities retained from the 2008 research agenda include shorter MDR-TB regimens and averting transmission. Limitations of recent advances were implied in the continued quest for: shorter regimens containing new drugs, rapid diagnostics that improve treatment outcomes, and improved methods of estimating burden without representative data. Conclusion There is continuity around the priorities for research in PMDT. Coordinated

  10. Predicting Heavy Drug Use. Results of a Longitudinal Study, Youth Characteristics Describing and Predicting Heavy Drug Use by Adults

    ERIC Educational Resources Information Center

    Schildhaus, Sam; Shaw-Taylor, Yoku; Pedlow, Steven; Pergamit, Michael R.

    2004-01-01

    The primary aim of this study was to describe the movement of adolescents and young adults into and out of drug use and to predict heavy drug use. The data source is the Department of Labor's National Longitudinal Survey of Youth, which began in 1979 with a sample of 12,686 adolescents aged 14-21. After 17 rounds and 19 years, the response rate in…

  11. Pain management in trauma: A review study

    PubMed Central

    Ahmadi, Alireza; Bazargan-Hejazi, Shahrzad; Heidari Zadie, Zahra; Euasobhon, Pramote; Ketumarn, Penkae; Karbasfrushan, Ali; Amini-Saman, Javad; Mohammadi, Reza

    2016-01-01

    Abstract: Background: Pain in trauma has a role similar to the double-edged sword. On the one hand, pain is a good indicator to determine the severity and type of injury. On the other hand, pain can induce sever complications and it may lead to further deterioration of the patient. Therefore, knowing how to manage pain in trauma patients is an important part of systemic approach in trauma. The aim of this manuscript is to provide information about pain management in trauma in the Emergency Room settings. Methods: In this review we searched among electronic and manual documents covering a 15-yr period between 2000 and 2016. Our electronic search included Pub Med, Google scholar, Web of Science, and Cochrane databases. We looked for articles in English and in peer-reviewed journals using the following keywords: acute pain management, trauma, emergency room and injury. Results: More than 3200 documents were identified. After screening based on the study inclusion criteria, 560 studies that had direct linkage to the study aim were considered for evaluation based World Health Organization (WHO) pain ladder chart. Conclusions: To provide adequate pain management in trauma patients require: adequate assessment of age-specific pharmacologic pain management; identification of adequate analgesic to relieve moderate to severe pain; cognizance of serious adverse effects of pain medications and weighting medications against their benefits, and regularly reassessing patients and reevaluating their pain management regimen. Patient-centered trauma care will also require having knowledge of barriers to pain management and discussing them with the patient and his/her family to identify solutions. PMID:27414816

  12. Management of Biomedical Waste: An Exploratory Study

    PubMed Central

    Abhishek, K N; Suryavanshi, Harshal N; Sam, George; Chaithanya, K H; Punde, Prashant; Singh, S Swetha

    2015-01-01

    Background: Dental operatories pose a threat due to the high chances of infection transmission both to the clinician and the patients. Hence, management of dental waste becomes utmost importance not only for the health benefit of the dentist himself, but also people who can come into contact with these wastes directly or indirectly. The present study was conducted to find out the management of biomedical waste in private dental practice among 3 districts of Karnataka. Materials and Methods: The study population included 186 private practitioners in 3 districts of Karnataka (Coorg, Mysore, Hassan), South India. A pre-tested self-administered questionnaire was distributed to assess the knowledge and practices regarding dental waste management. Descriptive statistics was used to summarize the results. Results: Out of 186 study subjects, 71 (38%) were females and 115 (62%) were males. The maximum number of participants belonged to the age group of 28-33 years (29%). Undergraduate qualification was more (70%). 90 (48%) participants had an experience of 0-5 years. Chi-square analysis showed a highly significant association between participant who attended continuing dental education (CDE) program and their practice of dental waste management. Conclusion: Education with regards to waste management will help in enhancing practices regarding the same. In order to fill this vacuum CDE programs have to be conducted in pursuance to maintain health of the community. PMID:26435621

  13. No Link Between Anti-Smoking Drugs, Mental Health Issues: Study

    MedlinePlus

    ... news/fullstory_158456.html No Link Between Anti-Smoking Drugs, Mental Health Issues: Study Meds like Chantix ... FRIDAY, April 22, 2016 (HealthDay News) -- The anti-smoking drugs Chantix (varenicline) and Wellbutrin (bupropion) don't ...

  14. Meta-Analysis of Day Treatment and Contingency-Management Dismantling Research: Birmingham Homeless Cocaine Studies (1990-2006)

    ERIC Educational Resources Information Center

    Schumacher, Joseph E.; Milby, Jesse B.; Wallace, Dennis; Meehan, Dawna-Cricket; Kertesz, Stefan; Vuchinich, Rudy; Dunning, Jonathan; Usdan, Stuart

    2007-01-01

    Four successive randomized clinical trials studying contingency management (CM), involving various treatment arms of drug-abstinent housing and work therapy and day treatment (DT) with a behavioral component, were compared on common drug abstinence outcomes at 2 treatment completion points (2 and 6 months). The clinical trials were conducted from…

  15. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Applicability of ânew drugâ or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products. 310.6 Section 310.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  16. Ranolazine: Drug overview and possible role in primary microvascular angina management.

    PubMed

    Cattaneo, Mattia; Porretta, Alessandra Pia; Gallino, Augusto

    2015-02-15

    Ranolazine is a novel well-tolerated anti-ischemic drug, which selectively inhibits late sodium current and exerts metabolic properties without any hemodynamic effect. Ranolazine has been approved as a second-line medical treatment for symptomatic stable coronary artery disease. Primary microvascular angina (MVA) is suspected when angina symptoms occur in patients with demonstrated myocardial ischemia, absence of myocardial disease and normal coronary artery angiography. Recent clinical data suggest that MVA represents a complex entity, which has been increasingly recognized as a significant cause of morbidity. High variability and low response to traditional anti-anginal treatment characterize primary MVA. Despite the fact that clinical and preclinical evidence provides information regarding ranolazine usefulness in primary MVA management, only three recent small randomized trials have investigated this issue. By selecting peer-reviewed literature in Pubmed and Cochrane Library, this review provides an overview on ranolazine pharmacology and efficacy, focusing on recent evidence suggesting its usefulness in management of primary MVA. PMID:25555283

  17. Bedaquiline versus placebo for management of multiple drug-resistant tuberculosis: A systematic review

    PubMed Central

    Charan, Jaykaran; Reljic, Tea; Kumar, Ambuj

    2016-01-01

    Background: Multidrug-resistant tuberculosis (MDR-TB) is associated with significant morbidity and mortality. Bedaquiline is the first drug approved for treating MDR-TB. Objectives: We performed a systematic review and meta-analysis to summarize the totality of all available evidence on the efficacy of bedaquiline for the management of MDR-TB. Materials and Methods: We searched the following PubMed and Cochrane Registry of Clinical Trials. Randomized controlled trials (RCTs) with a parallel design comparing bedaquiline versus any treatment for the management of MDR-TB in adults were eligible for inclusion. Data were pooled under a random effects model. Results: Two trials published as three manuscripts with a total of 207 patients were included. As per the Cochrane risk of bias tool, majority of parameter were labeled as high or unclear risk of bias. Bedaquiline compared with placebo was associated with a statistically significant decrease in time to conversion of positive sputum culture to negative at 8 and 24 weeks with a significant increase in mortality on long-term follow-up. There was no difference in completion rates between bedaquiline and placebo. Conclusion: Bedaquiline is an effective treatment modality for MDR-TB but needs to be balanced against significant mortality. Future Phase 3 RCTs are needed to make a conclusive recommendation. PMID:27127322

  18. Detection and management of drug-resistant tuberculosis in HIV-infected patients from lower income countries

    PubMed Central

    Ballif, Marie; Nhandu, Venerandah; Wood, Robin; Dusingize, Jean Claude; Carter, E. Jane; Cortes, Claudia P.; McGowan, Catherine C.; Diero, Lameck; Graber, Claire; Renner, Lorna; Hawerlander, Denise; Kiertiburanakul, Sasisopin; Du, Quy Tuan; Sterling, Timothy R.; Egger, Matthias; Fenner, Lukas

    2015-01-01

    Setting Drug resistance threatens tuberculosis (TB) control, particularly among HIV-infected persons. Objective We surveyed antiretroviral therapy (ART) programs from lower-income countries on prevention and management of drug-resistant TB. Design We used online questionnaires to collect program-level data in 47 ART programs in Southern Africa (14), East Africa (8), West Africa (7), Central Africa (5), Latin America (7) and Asia-Pacific (6 programs) in 2012. Patient-level data were collected on 1,002 adult TB patients seen at 40 of the participating ART programs. Results Phenotypic drug susceptibility testing was available at 36 (77%) ART programs, but only used for 22% of all TB patients. Molecular drug resistance testing was available at 33 (70%) programs and used for 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the whole treatment, 16 (34%) during intensive phase only and 11 (23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line TB regimens; 18 (38%) reported TB drug shortages. Conclusions Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower income countries. DOT was not always implemented and drug supply was regularly interrupted, which may contribute to the global emergence of drug resistance. PMID:25299866

  19. Challenges in Individualizing Drug Dosage for Intensive Care Unit Patients: Is Augmented Renal Clearance What We Really Want to Know? Some Suggested Management Approaches and Clinical Software Tools.

    PubMed

    Jelliffe, Roger

    2016-08-01

    Acutely ill intensive care unit (ICU) patients often have large apparent volumes of distribution of drugs and, because of this, their drug clearance (CL) is usually also increased. 'Augmented renal Cl' is a current issue in the management of drug therapy for acutely ill and unstable ICU patients; however, Cl, the product of volume and the rate constant for excretion, describes only a theoretical volume of drug cleared per unit of time. Information of the actual rate of movement of the drug itself is obscured. It is suggested that the most useful clinical information is given by describing drug volume and elimination rate constant separately. This also permits better understanding of the patient's separate issues of fluid balance and drug elimination, especially when dialysis, renal replacement therapy, or extracorporeal membrane oxygenation (ECMO) may be used, and facilitates management of these two important separate clinical issues. Optimal management of drug therapy also requires optimal methods embodied in clinical software to describe drug behavior in these highly unstable patients, and considerably more data than for ordinary patients. The interacting multiple model (IMM) clinical software facilitates management of both fluid balance and drug therapy in these unstable patients. Illustrative cases are discussed, and new monitoring and management strategies are suggested. Like other ICU skills, physicians need to learn optimal tools for managing drug therapy in the ICU. Further work should help evaluate these new approaches. PMID:26914772

  20. Critical appraisal of the guidelines for the management of ankylosing spondylitis: disease-modifying antirheumatic drugs.

    PubMed

    Soriano, Enrique R; Clegg, Daniel O; Lisse, Jeffrey R

    2012-05-01

    Surprisingly, little data are available for the use of disease-modifying antirheumatic drugs in ankylosing spondylitis. Sulfasalazine has been the best studied. Efficacy data for individual agents (including pamidronate) and combinations of agents are detailed in this review. Intriguingly, these agents continue to be used with some frequency, even in the absence of efficacy data. To answer these questions, additional systematic studies of these agents in ankylosing spondylitis are needed and will likely need to be done by interested collaborative groups such as SPARTAN. PMID:22543537

  1. Management System for EMR Work Study Program.

    ERIC Educational Resources Information Center

    Columbia County Board of Public Instruction, Lake City, FL. Exceptional Child Education Dept.

    A computerized information management system involving the specification of objectives, the coding of teacher evaluations of students, and a variety of possible outputs has been used in a work study program for educable mentally retarded adolescents. Instructional objectives are specified and coded by number and category. Evaluation is by means of…

  2. From addiction to infection: managing drug abuse in the context of HIV/AIDS in Africa.

    PubMed

    Akindipe, Taiwo; Abiodun, Lolade; Adebajo, Sylvia; Lawal, Rahman; Rataemane, Solomon

    2014-09-01

    People who use drugs are at higher risk of HIV: directly through the sharing of injecting equipment, indirectly through associated risk behavior, and physiologically through the substances' impact on the immune system. Drug users, especially people who inject drugs (PWID) are a bridge to the general population. The treatment of drug addiction and provision of harm reduction interventions have impact on HIV transmission and incidence. Addiction treatment reduces the frequency of drug-related risky behaviors and enhances access and adherence to HIV treatment, resulting in fewer new infections. However, the drug policies of many African countries are punitive and hostile to harm reduction programs. These fuel criminalization of drug use and discrimination against the drug user thereby preventing individuals with drug addiction from accessing treatment programs. There is need to formulate policies aimed at protecting the rights of people with drug addiction and address the ethical aspects of treatment. PMID:26050376

  3. Epidemiological study of fixed drug eruption in Pointe-Noire.

    PubMed

    Ognongo-Ibiaho, A N; Atanda, H L

    2012-11-01

    A prospective study was conducted over a 27 month period in order to determine the epidemiological profile of fixed drug eruption (FDE) observed during a dermatological consultation at Pointe-Noire. During the study period 54 out of 9,070 persons consulting (0.6%) suffered from clinically diagnosed FDE. The variables studied were: age, sex, medicine and point of sale. The average age of onset was 30 years. The frequency of onset was higher in males (38 patients) than in females (16 patients). The incriminated medicines were: the sulfamides (48 patients) including Cotrimoxazole (45 patients ) and Sulfadoxine and Pyremethamine (3 patients) Coartem(®) + Doliprane(®) (1 patient), Chloramphenicol(®) (1 patient), Amidol(®) (1 patient), Duocotexin(®) + Paracetamol(®) (1 patient), Surquina(®) (1 patient), Amodiaquine(®) (1 patient). The point of sale was illicit (peddlers, markets) for 44 patients; for 10 patients it was a lawful outlet (pharmacies). This study shows that cotrimoxazole bought at illicit points of sale is the main etiology of FDE in the department, confirming that these medicines are counterfeit. The involvement of dermatologists in the fight against the illicit sale of medicines should be made a priority. PMID:23210952

  4. Vehicle Systems and Excipients Used in Minipig Drug Development Studies.

    PubMed

    Weaver, Margaret L; Grossi, Anette Blak; Schützsack, Jorgen; Parish, Joanna; Løgsted, Jeanet; Bøgh, Ingrid Brück; Cameron, David; Harvey, Warren; Festag, Matthias; Downes, Noel; Venturella, Silvana; Schlichtiger, Julia; Mhedhbi, Sofiene; Ross, Vanessa; Kissner, Thomas; Stark, Claudia; Milano, Stephane; Heining, Peter; Sanchez-Felix, Manual

    2016-04-01

    Minipigs have been used for dermal drug development studies for decades, and they are currently more frequently considered as the second nonrodent species for pivotal nonclinical studies, in lieu of the dog or nonhuman primate, for compounds delivered via standard systemic routes of administration. Little is known about the tolerability of different excipients in minipigs; sharing knowledge of excipient tolerability and compositions previously used in nonclinical studies may avoid testing of inadequate formulations, thereby contributing to reduced animal usage. This article reviews vehicles employed in the Göttingen(®)minipig based on the combined experience from a number of pharmaceutical companies and contract research organizations. The review includes vehicles tolerated for single or multiple dosing by the Göttingen minipig, some of which are not appropriate for administration to other common nonrodent species (e.g., dogs). By presenting these data for dermal, oral, subcutaneous, and intravenous routes of administration, studies to qualify these vehicles in minipigs can be minimized or avoided. Additionally, investigators may more frequently consider using the minipig in place of higher species if the tolerability of a vehicle in the minipig is known. PMID:26674803

  5. Spacelab data management subsystem phase B study

    NASA Technical Reports Server (NTRS)

    1974-01-01

    The Spacelab data management system is described. The data management subsystem (DMS) integrates the avionics equipment into an operational system by providing the computations, logic, signal flow, and interfaces needed to effectively command, control, monitor, and check out the experiment and subsystem hardware. Also, the DMS collects/retrieves experiment data and other information by recording and by command of the data relay link to ground. The major elements of the DMS are the computer subsystem, data acquisition and distribution subsystem, controls and display subsystem, onboard checkout subsystem, and software. The results of the DMS portion of the Spacelab Phase B Concept Definition Study are analyzed.

  6. Systematic review of drug utilization studies & the use of the drug classification system in the WHO-SEARO Region

    PubMed Central

    Bachhav, Sagar S.; Kshirsagar, Nilima A.

    2015-01-01

    Background & objectives: Information available on drug consumption is inadequate in most low and middle income countries. This systematic review was conducted to analyse published work on drug utilization research/studies (DUR) in the SEARO region of WHO for study objectives, methodology, results and recommendations and to identify the need for improving DUR and the use of the ATC/DDD system. Methods: A literature search for DUR was carried out in biomedical databases (PubMed, Scirus, Scopus and Google Scholar) up to May 2012. Publications were selected if those were in the English language, describing DUR or prescription practices, and study conducted in the WHO-SEARO countries. Results: A total of 318 publications were included in the review. Of these, 67 per cent were from India and 13 per cent were from Thailand. Majority of the publications were hospital based; only 16 per cent were community based. The ATC/DDD system was used in only 20 per cent of the publications, of which 73 per cent publications used DDD indicators. Several publications focused on antibiotics (31%). Publications that recommended the need for a policy or intervention to improve prescription practices/rational drug use amounted to 35 per cent. Interpretation & conclusions: Drug utilization studies using ATC/DDD system need to be promoted and carried out on an ongoing basis. DUR is important for rational use of drugs. Its relevance to policy making and resource allocation needs to be emphasized. PMID:26354209

  7. Drug-drug interaction and doping, part 1: an in vitro study on the effect of non-prohibited drugs on the phase I metabolic profile of toremifene.

    PubMed

    Mazzarino, Monica; de la Torre, Xavier; Fiacco, Ilaria; Palermo, Amelia; Botrè, Francesco

    2014-05-01

    The present study was designed to provide preliminary information on the potential impact of metabolic drug-drug interaction on the effectiveness of doping control strategies currently followed by the anti-doping laboratories to detect the intake of banned agents. In vitro assays based on the use of human liver microsomes and recombinant CYP isoforms were designed and performed to characterize the phase I metabolic profile of the prohibited agent toremifene, selected as a prototype drug of the class of selective oestrogen receptor modulators, both in the absence and in the presence of medicaments (fluconazole, ketoconazole, itraconazole, miconazole, cimetidine, ranitidine, fluoxetine, paroxetine, nefazodone) not included in the World Anti-Doping Agency list of prohibited substances and methods and frequently administered to athletes. The results show that the in vitro model developed in this study was adequate to simulate the in vivo metabolism of toremifene, confirming the results obtained in previous studies. Furthermore, our data also show that ketoconazole, itraconazole, miconazole and nefazodone cause a marked modification in the production of the metabolic products (i.e. hydroxylated and carboxylated metabolites) normally selected by the anti-doping laboratories as target analytes to detect toremifene intake; moderate variations were registered in the presence of fluconazole, paroxetine and fluoxetine; while no significant modifications were measured in the presence of ranitidine and cimetidine. This evidence imposes that the potential effect of drug-drug interactions is duly taken into account in anti-doping analysis, also for a broader significance of the analytical results. PMID:24431005

  8. Which bioequivalence study for a racemic drug? Application to milnacipran.

    PubMed

    Deprez, D; Chassard, D; Baille, P; Mignot, A; Ung, H L; Puozzo, C

    1998-01-01

    Milnacipran, a new non tricyclic antidepressant drug, is a racemic mixture (F2207) composed of two enantiomers: F2695 and F2696, both demonstrated to be active. A randomized open label, single-dose latin square study was undertaken in 24 healthy volunteers to compare, based on racemate data, the relative bioavailability of two new formulations to that of a reference formulation. Later on, as suggested by actual regulatory trend, analysis was carried out on enantiomer data, although in a supportive way. Bioequivalence was assessed on calculation of 90% confidence intervals for log-transformed Cmax and AUC(0-infinity) and on Wilcoxon test for Tmax with a 5% level of significance. Based on racemate data, both test formulations were demonstrated to be equivalent to the reference capsule in terms of Cmax and AUC-(0-infinity). Differences in Tmax reached statistical significance, although their mean magnitude was small, and probably not relevant when related to antidepressant long-term therapy. When considering the test capsule - reference capsule comparison, the equivalence demonstrated for the racemate reflect that of each enantiomer. On the contrary, equivalence between the test tablet and the reference capsule demonstrated for the racemate, is not supported by both enantiomers as Cmax of F2696 fails to reach bioequivalence criteria, making more uncertain the conclusion of bioequivalence. From this experience, it seems than when equivalence is demonstrated close to the limits for the racemate, it is difficult, especially for a low variability drug such as milnacipran, to comply with equivalence criteria for both enantiomers. PMID:9725476

  9. Pharmacokinetic Drug Interactions of Antimicrobial Drugs: A Systematic Review on Oxazolidinones, Rifamycines, Macrolides, Fluoroquinolones, and Beta-Lactams

    PubMed Central

    Bolhuis, Mathieu S.; Panday, Prashant N.; Pranger, Arianna D.; Kosterink, Jos G. W.; Alffenaar, Jan-Willem C.

    2011-01-01

    Like any other drug, antimicrobial drugs are prone to pharmacokinetic drug interactions. These drug interactions are a major concern in clinical practice as they may have an effect on efficacy and toxicity. This article provides an overview of all published pharmacokinetic studies on drug interactions of the commonly prescribed antimicrobial drugs oxazolidinones, rifamycines, macrolides, fluoroquinolones, and beta-lactams, focusing on systematic research. We describe drug-food and drug-drug interaction studies in humans, affecting antimicrobial drugs as well as concomitantly administered drugs. Since knowledge about mechanisms is of paramount importance for adequate management of drug interactions, the most plausible underlying mechanism of the drug interaction is provided when available. This overview can be used in daily practice to support the management of pharmacokinetic drug interactions of antimicrobial drugs. PMID:24309312

  10. Drugs: A Pilot Study of Minneapolis Secondary School Students.

    ERIC Educational Resources Information Center

    Faunce, R. W.; Johnson, Larry

    The results of a survey of over 1800 junior high and senior high school students are presented. Purposes of the survey were: (1) to obtain information about the extent of drug use and experimentation; (2) to obtain suggestions for improving Minneapolis Public Schools' health education curriculum; and (3) to pretest the drug education questionnaire…

  11. A study of pipeline drugs in neuroendocrine tumors

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Inhibition of neovessel development can stabilize tumor growth. A rapid in vitro method that can evaluate the effectiveness of anti-angiogenic drugs would aid in drug development. We tested a series of investigational agents to determine their ability to inhibit angiogenesis in our in vitro human a...

  12. Preemptive antiretroviral therapy modifications for the management of potential clinically significant drug interactions with direct acting hepatitis C therapies.

    PubMed

    Stambough, Megan; Roman, Martha; Blair, Donald C; Sidman, Eric F; Miller, Christopher D

    2016-03-01

    We report a case series of HIV/HCV co-infected patients who underwent preemptive antiretroviral therapy modifications to manage clinically significant drug interactions with HCV therapy. Among the 15 patients reviewed, all changed to a raltegravir-based regimen and none experienced a loss of virologic suppression or increase in HIV-RNA. PMID:25824150

  13. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form The following form is the MIS Data Collection form required for use beginning in 2011...

  14. Bridging the gap: the role of pharmacists in managing the drug supply cycle within non-governmental organizations.

    PubMed

    Villacorta-Linaza, Rocio

    2009-10-01

    Access to essential medicines remains one of the biggest problems that developing countries are facing in health care systems. Non-governmental organizations (NGOs) are implementing health programmes on the ground in areas affected by natural disasters or conflict. A vital component of these health programmes is the drug supply system. Based on a field research conducted in Pakistan 2007 and a field work experience in Afghanistan within an international NGO-Merlin-this paper analysed the four functions of the Drug Supply Cycle (Selection, Procurement, Distribution and Use) focusing attention on the importance in management support systems once the emergency phase is over. It shows the core role that the pharmacist plays within NGOs as a member of the health staff with the ability to improve the management of the Drug Supply Cycle. PMID:19957305

  15. Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.

    PubMed

    Lee, Caroline A; O'Connor, Meeghan A; Ritchie, Tasha K; Galetin, Aleksandra; Cook, Jack A; Ragueneau-Majlessi, Isabelle; Ellens, Harma; Feng, Bo; Taub, Mitchell E; Paine, Mary F; Polli, Joseph W; Ware, Joseph A; Zamek-Gliszczynski, Maciej J

    2015-04-01

    Breast cancer resistance protein (BCRP; ABCG2) limits intestinal absorption of low-permeability substrate drugs and mediates biliary excretion of drugs and metabolites. Based on clinical evidence of BCRP-mediated drug-drug interactions (DDIs) and the c.421C>A functional polymorphism affecting drug efficacy and safety, both the US Food and Drug Administration and European Medicines Agency recommend preclinical evaluation and, when appropriate, clinical assessment of BCRP-mediated DDIs. Although many BCRP substrates and inhibitors have been identified in vitro, clinical translation has been confounded by overlap with other transporters and metabolic enzymes. Regulatory recommendations for BCRP-mediated clinical DDI studies are challenging, as consensus is lacking on the choice of the most robust and specific human BCRP substrates and inhibitors and optimal study design. This review proposes a path forward based on a comprehensive analysis of available data. Oral sulfasalazine (1000 mg, immediate-release tablet) is the best available clinical substrate for intestinal BCRP, oral rosuvastatin (20 mg) for both intestinal and hepatic BCRP, and intravenous rosuvastatin (4 mg) for hepatic BCRP. Oral curcumin (2000 mg) and lapatinib (250 mg) are the best available clinical BCRP inhibitors. To interrogate the worst-case clinical BCRP DDI scenario, study subjects harboring the BCRP c.421C/C reference genotype are recommended. In addition, if sulfasalazine is selected as the substrate, subjects having the rapid acetylator phenotype are recommended. In the case of rosuvastatin, subjects with the organic anion-transporting polypeptide 1B1 c.521T/T genotype are recommended, together with monitoring of rosuvastatin's cholesterol-lowering effect at baseline and DDI phase. A proof-of-concept clinical study is being planned by a collaborative consortium to evaluate the proposed BCRP DDI study design. PMID:25587128

  16. Drug-DNA Interaction Studies of Acridone-Based Derivatives.

    PubMed

    Thimmaiah, Kuntebomanahalli; Ugarkar, Apoorva G; Martis, Elvis F; Shaikh, Mushtaque S; Coutinho, Evans C; Yergeri, Mayur C

    2015-01-01

    N10-alkylated 2-bromoacridones are a novel series of potent antitumor compounds. DNA binding studies of these compounds were carried out using spectrophotometric titrations, Circular dichroism (CD) measurements using Calf Thymus DNA (CT DNA). The binding constants were identified at a range of K=0.3 to 3.9×10(5) M(-1) and the percentage of hypochromism from the spectral titrations at 28-54%. This study has identified a compound 9 with the good binding affinity of K=0.39768×10(5) M(-1) with CT DNA. Molecular dynamics (MD) simulations have investigated the changes in structural and dynamic features of native DNA on binding to the active compound 9. All the synthesized compounds have increased the uptake of Vinblastine in MDR KBChR-8-5 cells to an extent of 1.25- to1.9-fold than standard modulator Verapamil of similar concentration. These findings allowed us to draw preliminary conclusions about the structural features of 2-bromoacridones and further chemical enhancement will improve the binding affinity of the acridone derivatives to CT-DNA for better drug-DNA interaction. The molecular modeling studies have shown mechanism of action and the binding modes of the acridones to DNA. PMID:25874941

  17. Multidrug Resistant and Extensively Drug Resistant Bacteria: A Study

    PubMed Central

    Basak, Silpi; Singh, Priyanka; Rajurkar, Monali

    2016-01-01

    Background and Objective. Antimicrobial resistance is now a major challenge to clinicians for treating patients. Hence, this short term study was undertaken to detect the incidence of multidrug-resistant (MDR), extensively drug-resistant (XDR), and pandrug-resistant (PDR) bacterial isolates in a tertiary care hospital. Material and Methods. The clinical samples were cultured and bacterial strains were identified in the department of microbiology. The antibiotic susceptibility profile of different bacterial isolates was studied to detect MDR, XDR, and PDR bacteria. Results. The antibiotic susceptibility profile of 1060 bacterial strains was studied. 393 (37.1%) bacterial strains were MDR, 146 (13.8%) strains were XDR, and no PDR was isolated. All (100%) Gram negative bacterial strains were sensitive to colistin whereas all (100%) Gram positive bacterial strains were sensitive to vancomycin. Conclusion. Close monitoring of MDR, XDR, or even PDR must be done by all clinical microbiology laboratories to implement effective measures to reduce the menace of antimicrobial resistance. PMID:26942013

  18. Case studies in the family treatment of drug abuse.

    PubMed

    Noone, R J; Reddig, R L

    1976-09-01

    This article, with case illustrations, attempts to demonstrate that drug-abuse behavior can be understood more clearly in the light of family loyalties and unresolved family crises than from the perspective that drug abusers are social deviates.1 Drug abuse is viewed as symptomatic, as a signal that both drug abuser and his or her family are having difficulty in getting past a particular stage in the natural unfolding life cycle of a family. Treatment of drug abuse is seen primarily as helping the family to become "unstuck," thereby freeing the individual's and family's energy for the task of self-development and growth rather than expending it to maintain rigid patterns of interaction in an attempt to prevent change. PMID:1026451

  19. Declining Drug Use in Relation to Increased Drug Education: A Trend Study 1979-1991.

    ERIC Educational Resources Information Center

    Smart, Reginald G.; And Others

    1993-01-01

    Examined data from repeated cross-sectional probability surveys of alcohol/drug use conducted biennially since 1979 in Ontario schools to determine relationships between classroom alcohol, tobacco, and cannabis education and student use of these substances. Found strong inverse association between increases in exposure to alcohol and drug…

  20. Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug

    PubMed Central

    Mubyazi, Godfrey M; Gonzalez-Block, Miguel A

    2005-01-01

    Introduction Research is an essential tool in facing the challenges of scaling up interventions and improving access to services. As in many other countries, the translation of research evidence into drug policy action in Tanzania is often constrained by poor communication between researchers and policy decision-makers, individual perceptions or attitudes towards the drug and hesitation by some policy decision-makers to approve change when they anticipate possible undesirable repercussions should the policy change as proposed. Internationally, literature on the role of researchers on national antimalarial drug policy change is limited. Objectives To describe the (a) role of researchers in producing evidence that influenced the Tanzanian government replace chloroquine (CQ) with sulfadoxine-pyrimethamine (SP) as the first-line drug and the challenges faced in convincing policy-makers, general practitioners, pharmaceutical industry and the general public on the need for change (b) challenges ahead before a new drug combination treatment policy is introduced in Tanzania. Methods In-depth interviews were held with national-level policy-makers, malaria control programme managers, pharmaceutical officers, general medical practitioners, medical research library and publications officers, university academicians, heads of medical research institutions and district and regional medical officers. Additional data were obtained through a review of malaria drug policy documents and participant observations were also done. Results In year 2001, the Tanzanian Government officially changed its malaria treatment policy guidelines whereby CQ – the first-line drug for a long time was replaced with SP. This policy decision was supported by research evidence indicating parasite resistance to CQ and clinical CQ treatment failure rates to have reached intolerable levels as compared to SP and amodiaquine (AQ). Research also indicated that since SP was also facing rising resistance trend

  1. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    PubMed

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

  2. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance......

  3. 78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... HUMAN SERVICES Food and Drug Administration Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug Evaluation and Research Data Standards Program Documents AGENCY: Food and...) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data...

  4. Methodological Issues in Controlled Studies on Effects of Prenatal Exposure to Drug Abuse. Research Monograph 114.

    ERIC Educational Resources Information Center

    Kilbey, M. Marlyne, Ed.; Asghar, Khursheed, Ed.

    This monograph presents the proceedings of the first National Institute on Drug Abuse technical review related to the conduct of controlled studies on prenatal exposure to drugs of abuse. Papers in the monograph are categorized by session. The first session (two papers) focused on the detection and quantification of prenatal drug exposure in…

  5. Emerging Trends and Innovations in the Identification and Management of Drug Use among Adolescents and Young Adults

    PubMed Central

    Lord, Sarah; Marsch, Lisa

    2014-01-01

    One in four youths aged 12 to 17 years and more than half of young adults aged 18 to 25 years in the United States have used an illicit drug in their lifetime. A significant number progress to problematic use, and only 1 in 10 young people who meet criteria for dependence or abuse receive some form of treatment. Despite advances in the field, effectively intervening along the continuum of drug use involvement remains a challenge. In this article, we review the current epidemiology of illicit drug use by young people; describe recent advances in assessment, intervention and treatment; and highlight how technology can help overcome barriers to effective management of drug use among young people. PMID:22423469

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

    PubMed

    Ung, Brian L; Mullins, C Daniel

    2015-01-01

    The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability. PMID:25217142

  7. Management of nonsteroidal anti-inflammatory drug-related peptic ulcer bleeding.

    PubMed

    Sung, J J

    2001-01-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) have superseded Helicobacter pylori infection as the most important cause of peptic ulcer bleeding. Eradication of H. pylori in NSAID users will not affect ulcer healing. In high-risk patients with a history of ulcer bleeding, curing H. pylori infection alone without acid suppression has substantially reduced the risk of rebleeding caused by low-dose aspirin but not nonaspirin NSAIDs. In a study comparing the safety profile of misoprostol in combination with NSAID against nabumetone in high-risk patients with a history of ulcer bleeding, both strategies were unable to confer significant protection against the risk of rebleeding. PMID:11165993

  8. Diagnosis and Management of Drug-Induced Liver Injury (DILI) in Patients with Pre-Existing Liver Disease.

    PubMed

    Teschke, Rolf; Danan, Gaby

    2016-08-01

    The relationship between drugs and pre-existing liver disease is complex, particularly when increased liver tests (LTs) or new symptoms emerge in patients with pre-existing liver disease during drug therapy. This requires two strategies to assess whether these changes are due to drug-induced liver injury (DILI) as a new event or due to flares of the underlying liver disease. Lacking a valid diagnostic biomarker, DILI is a diagnosis of exclusion and requires causality assessment by RUCAM, the Roussel Uclaf Causality Assessment Method, to establish an individual causality grading of the suspected drug(s). Flares of pre-existing liver disease can reliably be assessed in some hepatotropic virus infections by polymerase chain reaction (PCR) and antibody titers at the beginning and in the clinical course to ascertain flares during the natural course of the disease. Unfortunately, flares cannot be verified in many other liver diseases such as alcoholic liver disease, since specific tests are unavailable. However, such a diagnostic approach using RUCAM applied to suspected DILI cases includes clinical and biological markers of pre-existing liver diseases and would determine whether drugs or underlying liver diseases caused the LT abnormalities or the new symptoms. More importantly, a clear diagnosis is essential to ensure effective disease management by drug cessation or specific treatment of the flare up due to the underlying disease. PMID:27091053

  9. Anthelmintic drugs and nematicides: studies in Caenorhabditis elegans.

    PubMed

    Holden-Dye, Lindy; Walker, Robert J

    2014-01-01

    Parasitic nematodes infect many species of animals throughout the phyla, including humans. Moreover, nematodes that parasitise plants are a global problem for agriculture. As such, these nematodes place a major burden on human health, on livestock production, on the welfare of companion animals and on crop production. In the 21st century there are two major challenges posed by the wide-spread prevalence of parasitic nematodes. First, many anthelmintic drugs are losing their effectiveness because nematode strains with resistance are emerging. Second, serious concerns regarding the environmental impact of the nematicides used for crop protection have prompted legislation to remove them from use, leaving agriculture at increased risk from nematode pests. There is clearly a need for a concerted effort to address these challenges. Over the last few decades the free-living nematode Caenorhabditis elegans has provided the opportunity to use molecular genetic techniques for mode of action studies for anthelmintics and nematicides. These approaches continue to be of considerable value. Less fruitful so far, but nonetheless potentially very useful, has been the direct use of C. elegans for anthelmintic and nematicide discovery programmes. Here we provide an introduction to the use of C. elegans as a 'model' parasitic nematode, briefly review the study of nematode control using C. elegans and highlight approaches that have been of particular value with a view to facilitating wider-use of C. elegans as a platform for anthelmintic and nematicide discovery and development. PMID:25517625

  10. Biokinetics in repeated-dosing in vitro drug toxicity studies.

    PubMed

    Kramer, Nynke I; Di Consiglio, Emma; Blaauboer, Bas J; Testai, Emanuela

    2015-12-25

    The aim of the EU FP7 Predict-IV project was to improve the predictivity of in vitro assays for unwanted effects of drugs after repeated dosing. The project assessed the added benefit of integrating long-lived in vitro organotypic cell systems with 'omics' technologies and in silico modelling, including systems biology and pharmacokinetic assessments. RPTEC/TERT1 kidney cells, primary rat and human hepatocytes, HepaRG liver cells and 2D and 3D primary brain cultures were dosed daily or every other day for 14 days to a selection of drugs varying in their mechanism of pharmacological action. Since concentration-effect relationships not only depend on the activity of the drug or the sensitivity of the target, but also on the distribution of compounds in the in vitro system, the concentration of a selection of drugs in cells, microtitre plate plastic and medium was measured over time. Results, reviewed in this paper, indicate that lipophilic drugs bind significantly to plastic labware. A few drugs, including less lipophilic drugs, bind to cell-attachment matrices. Chemicals that reach high concentrations in cells, including cyclosporin A and amiodarone, significantly accumulate over time after repeated dosing, partly explaining their increased toxicity after repeated dosing, compared to a single dose. PMID:26362508

  11. Human hepatoma cell lines on gas foaming templated alginate scaffolds for in vitro drug-drug interaction and metabolism studies.

    PubMed

    Stampella, A; Rizzitelli, G; Donati, F; Mazzarino, M; de la Torre, X; Botrè, F; Giardi, M F; Dentini, M; Barbetta, A; Massimi, M

    2015-12-25

    Liver in vitro systems that allow reliable prediction of major human in vivo metabolic pathways have a significant impact in drug screening and drug metabolism research. In the present study, a novel porous scaffold composed of alginate was prepared by employing a gas-in-liquid foaming approach. Galactose residues were introduced on scaffold surfaces to promote cell adhesion and to enhance liver specific functions of the entrapped HepG2/C3A cells. Hepatoma cells in the gal-alginate scaffold showed higher levels of liver specific products (albumin and urea) and were more responsive to specific inducers (e.g. dexamethasone) and inhibitors (e.g. ketoconazole) of the CYP3A4 system than in conventional monolayer culture. HepG2/C3A cells were also more efficient in terms of rapid elimination of testosterone, used as a model substance, at rates comparable to those of in vivo excretion. In addition, an improvement in metabolism of testosterone, in terms of phase II metabolite formation, was also observed when the more differentiated HepaRG cells were used. Together the data suggest that hepatocyte/gas templated alginate-systems provide an innovative high throughput platform for in vitro drug metabolism and drug-drug interaction studies, with broad fields of application, and might provide a valid tool for minimizing animal use in preclinical testing of human relevance. PMID:26456671

  12. The 3-metros study of drugs and crime in South Africa: findings and policy implications.

    PubMed

    Parry, Charles D; Plüddemann, Andreas; Louw, Antoinette; Leggett, Ted

    2004-01-01

    This study examined the drug-crime nexus by investigating the prevalence of recent drug use among persons arrested by the police. Data were gathered during August/September 2000 from 1050 adult arrestees in eight police stations in Cape Town, Durban, and Johannesburg (South Africa). Measures included urinalysis results for cannabis, methaqualone (Mandrax), opiates, cocaine, amphetamines, and benzodizepines, and a questionnaire designed to assess socioeconomic and demographic backgrounds of arrestees, history of prior arrests and imprisonment, current arrest information, profile of substance use, etc. Results of the study show high levels of drug use among arrestees, with 45% testing positive for at least one drug (mainly cannabis and Mandrax). A greater proportion of arrestees in Cape Town tested positive for drugs than in the other sites. Data were also analyzed in terms of gender, age, race, location (site and police station), and offense category. Persons arrested on charges of housebreaking or for drugs/alcohol offenses were particularly likely to test positive for drugs. Drug positive arrestees were more likely to have had a prior arrest. Among the conclusions of the study are that 1) strategies to reduce drug use and drug related crime must be area specific, 2) particular attention needs to focus on young offenders, 3) police need to be trained to recognize particular symptoms and to establish protocols on handling arrestees under the influence of drugs, and 4) diversion to treatment of drug using offenders deserves more consideration. PMID:15083560

  13. Drugs under preclinical and clinical study for treatment of acute and chronic lymphoblastic leukemia

    PubMed Central

    Jacob, Joe Antony; Salmani, Jumah Masoud Mohammad; Chen, Baoan

    2016-01-01

    Targeted therapy has modernized the treatment of both chronic and acute lymphoblastic leukemia. The introduction of monoclonal antibodies and combinational drugs has increased the survival rate of patients. Preclinical studies with various agents have resulted in positive outputs with Phase III trial drugs and monoclonal antibodies entering clinical trials. Most of the monoclonal antibodies target the CD20 and CD22 receptors. This has led to the approval of a few of these drugs by the US Food and Drug Administration. This review focuses on the drugs under preclinical and clinical study in the ongoing efforts for treatment of acute and chronic lymphoblastic leukemia. PMID:27382259

  14. Pharmacokinetic drug–drug interactions between 1,4-dihydropyridine calcium channel blockers and statins: factors determining interaction strength and relevant clinical risk management

    PubMed Central

    Zhou, Yi-Ting; Yu, Lu-Shan; Zeng, Su; Huang, Yu-Wen; Xu, Hui-Min; Zhou, Quan

    2014-01-01

    Background Coadministration of 1,4-dihydropyridine calcium channel blockers (DHP-CCBs) with statins (or 3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase inhibitors) is common for patients with hypercholesterolemia and hypertension. To reduce the risk of myopathy, in 2011, the US Food and Drug Administration (FDA) Drug Safety Communication set a new dose limitation for simvastatin, for patients taking simvastatin concomitantly with amlodipine. However, there is no such dose limitation for atorvastatin for patients receiving amlodipine. The combination pill formulation of amlodipine/atorvastatin is available on the market. There been no systematic review of the pharmacokinetic drug–drug interaction (DDI) profile of DHP-CCBs with statins, the underlying mechanisms for DDIs of different degree, or the corresponding management of clinical risk. Methods The relevant literature was identified by performing a PubMed search, covering the period from January 1987 to September 2013. Studies in the field of drug metabolism and pharmacokinetics that described DDIs between DHP-CCB and statin or that directly compared the degree of DDIs associated with cytochrome P450 (CYP)3A4-metabolized statins or DHP-CCBs were included. The full text of each article was critically reviewed, and data interpretation was performed. Results There were three circumstances related to pharmacokinetic DDIs in the combined use of DHP-CCB and statin: 1) statin is comedicated as the precipitant drug (pravastatin–nimodipine and lovastatin–nicardipine); 2) statin is comedicated as the object drug (isradipine–lovastatin, lacidipine–simvastatin, amlodipine–simvastatin, benidipine-simvastatin, azelnidipine– simvastatin, lercanidipine–simvastatin, and amlodipine–atorvastatin); and 3) mutual interactions (lercanidipine–fluvastatin). Simvastatin has an extensive first-pass effect in the intestinal wall, whereas atorvastatin has a smaller intestinal first-pass effect. The interaction

  15. Evaluation of Drug Utilization Patterns during Initial Treatment in the Emergency Room: A Retroprospective Pharmacoepidemiological Study

    PubMed Central

    Cheekavolu, Chakrapani; Pathapati, Rama Mohan; Babasaheb Laxmansingh, Kudagi; Saginela, Satish Kumar; Makineedi, Veera Prasad; Siddalingappa; Kumar, Amitabh

    2011-01-01

    Background. We assessed the prescribing trends, average number of drugs per prescription, and cost per prescription during the initial contact of the patient with the physician in emergency room. Methods. This retro-prospective study was conducted over a period of six months. Medical records of two hundred patients were reviewed for prescribing patterns. Results. 52 different types of drugs (996 drugs) were prescribed in total 200 prescriptions during the mean time spent in emergency room of 2.8 ± 1.4 hours. The average number of drugs per prescription was 4.2 ± 1.2. 95% of drugs were prescribed by trade name. Average drugs cost per prescription was 784 ± 134 rupees (17USD). Conclusion. Polypharmacy remains the main form of irrational prescribing. Prescribing patterns of drugs were knowledge based rather than WHO criteria for rational use of drugs. PMID:22242208

  16. Economic Sanctions Against Iran, and Drug Use in Tehran, Iran: A 2013 Pilot Study.

    PubMed

    Deilamizade, Abbas; Esmizade, Sara

    2015-01-01

    This qualitative study was conducted in 2013 among male drug user patients referred to Drop-In Centers (n = 23) and Residential Treatment Centers (n = 25) in Tehran. The results show that when the price of drugs increases, some drug users tend to use cheaper drugs, which are more harmful, use more harmful routes of administration, such as injecting drugs, sharing needles, and make money illegally. Economic sanctions have threatened Iranian people's economic status since 2006 and have become more intense in 2010 and 2011. As an important consequence of these economic sanctions, the price of drugs, as well as other goods and services, have increased in Iran in recent years. Given these "big economic events," big changes in the patterns of drug use, and an increase in drug use-related harms, can be expected to occur in the near future. PMID:25723313

  17. A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India

    PubMed Central

    Hire, Rohan; Kale, A. S.; Dakhale, G. N.; Gaikwad, Nilesh

    2014-01-01

    Objective 1) To assess the adverse drug reactions (ADRs) of second-line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR-TB) in central India on the basis of causality, severity and avoidability scales. 2) To investigate the relationship of MDR-TB (primary or secondary) and the presence of diabetes mellitus (DM) with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug-resistant tuberculosis patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January 2012 to December 2012 with a follow-up of nine months. Encountered ADRs were noted along with the time of sputum conversion. Results Total 64 ADRs were reported in 55 patients out of total 110 patients (n=110). As per the Naranjo causality assessment of ADRs, seven patients had definite, 45 had probable, and 3 had possible causal relation with drugs of DOTS-Plus regimen. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being definitely avoidable, 26 possibly avoidable, 23 not avoidable and three not evaluable. Mean sputum smear conversion time was significantly higher in patients with a secondary type than that of primary type of MDR TB and in patients with DM than those without DM. Conclusion ADRs were common in patients of MDR-TB on DOTs-Plus drug regimen. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regimen compared to DOTS regimen in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and clinical parameters and instituting appropriate measures. PMID:25237474

  18. Drug utilization in pediatric neurology outpatient department: A prospective study at a tertiary care teaching hospital

    PubMed Central

    Bhatt, Krutika M.; Malhotra, Supriya D.; Patel, Kamlesh P.; Patel, Varsha J.

    2014-01-01

    Background: Neurological disorders are a significant cause of morbidity, mortality and adversely affect quality of life among pediatric patients. In India, more than 30% population is under 20 years of age, many of whom present late during the course of illness. Several drugs prescribed to pediatric population suffering from neurological disorders may be off label or unlicensed. Aims and Objectives: To study drug use pattern, identify off-label/unlicensed drug use and to check potential for drug-drug interactions in patients attending outpatient department of pediatric neurology at a tertiary care teaching hospital. Methodology: Prescriptions of patients attending pediatric neurology outpatient department were collected prospectively for 8 weeks. They were analyzed for prescribing pattern, WHO core prescribing indicators, off-label/unlicensed drug use and potential for drug-drug interactions. Result: A total of 140 prescriptions were collected, male female ratio being 2:1. Epilepsy was the most common diagnosis (73.57%) followed by breath holding spells, migraine and developmental disorders. Partial seizure was the most common type of epilepsy (52.42%). Average number of drugs prescribed per patient was 1.56. Most commonly prescribed drug was sodium valproate (25.11%) followed by phenytoin (11.41%). About 16% of the prescriptions contained newer antiepileptic drugs. More than 60% of the drugs were prescribed from WHO essential drug list. In 8.57% of cases drugs were prescribed in off-label/unlicensed manner. Twenty-six percent prescriptions showed potential for drug interactions. Conclusion: Epilepsy is the most common neurological disease among children and adolescents. Sodium valproate is the most commonly prescribed drug. A few prescriptions contained off-label/unlicensed drugs. PMID:25278669

  19. Drug Induced Hearing Loss: Researchers Study Strategies to Preserve Hearing

    MedlinePlus

    ... dying due to ototoxic drugs. Please describe the benefits of your findings. Our results advance our understanding ... hearing is critical to their developing speech and language skills. Our goal is to improve the lives ...

  20. Study Compares Drugs for Common Diabetic Eye Disease

    MedlinePlus

    ... other meds for more severe cases of macular edema, research shows To use the sharing features on ... loss of vision from a condition called macular edema. Three drugs for the disease -- Avastin, Eylea and ...

  1. Prescribing Patterns of Drugs in Acute Respiratory Distress Syndrome (ARDS): An Observational Study

    PubMed Central

    Rao, Shobitha; Chogtu, Bharti

    2015-01-01

    Introduction: Acute respiratory distress syndrome (ARDS) is characterized by acute respiratory failure and is associated with wide range of clinical disorders. Controversy prevails over the pharmacological intervention in this disease. The aim of the study was to observe the prescribing pattern of drugs in patients with ARDS managed at a tertiary care hospital. Materials and Methods: This observational study was conducted at tertiary care hospital in India. Data of patients admitted from January 2010 to December 2012 was collected. Patients aged more than 18 years admitted in ICU, who were diagnosed to have ARDS during the study period, were included. A total of 150 patients of ARDS were selected. Data was collected as per the pre designed proforma and it included patients’ age, gender, clinical disorders precipitating ARDS, prescribing pattern of drugs and outcome. The data of the subjects was collected till discharge from hospital or death. Results: Infection was the cause of ARDS in 81.3% (n=122) of subjects. Antibiotics were prescribed in all the subjects and beta-lactams were prescribed in 97.3% (n=146). 41.3% (n=62) were prescribed corticosteroids, 39.3% (n=59) diuretics and 89.3% (n=134) intravenous fluids. Conclusion: The outcome of patients on different pharmacological treatment did not show any statistically significant difference. PMID:25859465

  2. Environmental Management: An Approach to Alcohol and Other Drug Prevention. Prevention Updates

    ERIC Educational Resources Information Center

    Higher Education Center for Alcohol and Other Drug Abuse and Violence Prevention, 2002

    2002-01-01

    Most campus alcohol and other drug (AOD) programs include prevention, intervention, and treatment services designed to address individual students' knowledge of the consequences of alcohol and other drug use, to improve their skills in resisting such behavior, or to address existing problematic use of or addiction to alcohol or other drugs.…

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

    PubMed Central

    Chakraborty, Ananya; Srinivas, B.N

    2015-01-01

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

  4. Driving Under the Influence of Non-Alcohol Drugs--An Update Part I: Epidemiological Studies.

    PubMed

    Gjerde, H; Strand, M C; Mørland, J

    2015-07-01

    Epidemiological studies of the association between drug use and involvement in road traffic crashes (RTCs) published from January 1998 to February 2015 have been reviewed. Cohort andpopulation studies compared RTC involvement among drug users and non-drug users, case-control studies compared drug use among RTC-involved and non-RTC-involved drivers, and responsibility studies and case-crossover studies were performed for RTC-involved drivers. Difficulties associated with the types of studies are discussed with a special focus on case-control studies. Statistically significant associations between drug use and RTC involvement were found for benzodiazepines and z-hypnotics in 25 out of 28 studies, for cannabis in 23 out of 36 studies, for opioids in 17 out of 25 studies, for amphetamines in 8 out of 10 studies, for cocaine in 5 out of 9 studies, and for antidepressants in 9 out of 13 studies. It was a general trend among studies that did not report significant associations between the use of these drugs and increased RTC risk that they often had either poor statistical power or poor study design compared to studies that found an association. Simultaneous use of two or more psychoactive drugs was associated with higher RTC risk. Studies on the combination of alcohol and drugs have not been reviewed in this article even though this combination is known to be associated with the highest RTC risk. PMID:26227253

  5. An international multicenter study on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing.

    PubMed

    Simen, Birgitte B; Braverman, Michael S; Abbate, Isabella; Aerssens, Jeroen; Bidet, Yannick; Bouchez, Olivier; Gabriel, Christian; Izopet, Jacques; Kessler, Harald H; Stelzl, Evelyn; Di Giallonardo, Francesca; Schlapbach, Ralph; Radonic, Aleksander; Paredes, Roger; Recordon-Pinson, Patricia; Sakwa, James; St John, Elizabeth P; Schmitz-Agheguian, Gudrun G; Metzner, Karin J; Däumer, Martin P

    2014-08-01

    The detection of mutant spectra within the viral quasispecies is critical for therapeutic management of HIV-1 infections. Routine clinical application of ultrasensitive genotyping requires reproducibility and concordance within and between laboratories. The goal of the study was to evaluate a new protocol on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing (454-UDS) in an international multicenter study. Sixteen blinded HIV-1 subtype B samples were provided for 454-UDS as both RNA and cDNA with viral titers of 88,600-573,000 HIV-1 RNA copies/ml. Eight overlapping amplicons spanning protease (PR) codons 10-99 and reverse transcriptase (RT) codons 1-251 were generated using molecular barcoded primers. 454-UDS was performed using the 454 Life Sciences/Roche GS FLX platform. PR and RT sequences were analyzed using 454 Life Sciences Amplicon Variant Analyzer (AVA) software. Quantified variation data were analyzed for intra-laboratory reproducibility and inter-laboratory concordance. Routine population sequencing was performed using the ViroSeq HIV-1 genotyping system. Eleven laboratories and the reference laboratory 454 Life Sciences sequenced the HIV-1 sample set. Data presented are derived from seven laboratories and the reference laboratory since severe study protocol execution errors occurred in four laboratories leading to exclusion. The median sequencing depth across all sites was 1364 reads per position (IQR=809-2065). 100% of the ViroSeq-reported mutations were also detected by 454-UDS. Minority HIV-1 drug resistance mutations, defined as HIV-1 drug resistance mutations identified at frequencies of 1-25%, were only detected by 454-UDS. Analysis of 10 preselected majority and minority mutations were consistently found across sites. The analysis of drug-resistance mutations detected between 1 and 10% demonstrated high intra- and inter-laboratory consistency in frequency estimates for both RNA and prepared cDNA samples, indicating robustness of the

  6. Identifying and assessing highly hazardous drugs within quality risk management programs.

    PubMed

    Sussman, Robert G; Schatz, Anthony R; Kimmel, Tracy A; Ader, Allan; Naumann, Bruce D; Weideman, Patricia A

    2016-08-01

    Historically, pharmaceutical industry regulatory guidelines have assigned certain active pharmaceutical ingredients (APIs) to various categories of concern, such as "cytotoxic", "hormones", and "steroids". These categories have been used to identify APIs requiring segregation or dedication in order to prevent cross-contamination and protect the quality and safety of drug products. Since these terms were never defined by regulatory authorities, and many novel pharmacological mechanisms challenge these categories, there is a recognized need to modify the historical use of these terms. The application of a risk-based approach using a health-based limit, such as an acceptable daily exposure (ADE), is more appropriate for the development of a Quality Risk Management Program (QRMP) than the use of categories of concern. The toxicological and pharmacological characteristics of these categories are discussed to help identify and prioritize compounds requiring special attention. Controlling airborne concentrations and the contamination of product contact surfaces in accordance with values derived from quantitative risk assessments can prevent adverse effects in workers and patients, regardless of specific categorical designations to which these APIs have been assigned. The authors acknowledge the movement away from placing compounds into categories and, while not yet universal, the importance of basing QRMPs on compound-specific ADEs and risk assessments. Based on the results of a risk assessment, segregation and dedication may also be required for some compounds to prevent cross contamination during manufacture of APIs. PMID:27267171

  7. Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients

    PubMed Central

    Argoff, Charles E; Gloth, F Michael

    2011-01-01

    Osteoarthritis is common in patients ≥65 years of age. Although nonsteroidal anti-inflammatory drugs (NSAIDs) are often prescribed for osteoarthritis pain, they pose age-related cardiovascular, renal, and gastrointestinal risks. Two topical NSAIDs, diclofenac sodium 1% gel (DSG) and diclofenac sodium 1.5% in 45.5% dimethylsulfoxide solution (D-DMSO), are approved in the US for the treatment of osteoarthritis pain. Topical NSAIDs have shown efficacy and safety in knee (DSG, D-DMSO) and hand (DSG) osteoarthritis. Analyses of data from randomized controlled trials of DSG in hand and knee osteoarthritis demonstrate significant improvement of pain and function in both younger patients (<65 years) and older patients (≥65 years) and suggest good safety and tolerability. However, long-term safety data in older patients are limited. Topical NSAIDs can ease medication administration and help address barriers to pain management in older patients, such as taking multiple medications and inability to swallow, and are a valuable option for long-term care providers. PMID:22076115

  8. Antiresorptive drugs beyond bisphosphonates and selective oestrogen receptor modulators for the management of postmenopausal osteoporosis.

    PubMed

    Reginster, J Y; Neuprez, A; Beaudart, C; Lecart, M P; Sarlet, N; Bernard, D; Disteche, S; Bruyere, O

    2014-06-01

    Osteoporotic fractures are a major cause of morbidity in the elderly population. Since postmenopausal osteoporosis is related to an increase in osteoclastic activity at the time of menopause, inhibitors of bone resorption have genuinely been considered an adequate strategy for prevention and treatment of osteoporosis. Bisphosphonates and selective oestrogen receptor modulators are widely prescribed to treat osteoporosis. However, other antiresorptive drugs have been developed for the management of osteoporosis, with the objective of providing a substantial reduction in osteoporotic fractures at all skeletal sites, combined with an acceptable long-term skeletal and systemic safety profile. Denosumab, a human monoclonal antibody to receptor activator for nuclear factor kappa B ligand, has shown efficacy against vertebral, nonvertebral and hip fractures. Its administration every 6 months as a subcutaneous formulation might significantly influence compliance and persistence to therapy. Additional results regarding long-term skeletal safety (i.e. osteonecrosis of the jaw and atypical diaphyseal femoral fracture) are needed. Odanacatib, a selective cathepsin K inhibitor, is a promising new approach to the inhibition of osteoclastic resorption, with the potential to uncouple bone formation from bone resorption. Results regarding its anti-fracture efficacy are expected in the coming months. PMID:24797286

  9. Toxicology screening in urban trauma patients: drug prevalence and its relationship to trauma severity and management.

    PubMed

    Sloan, E P; Zalenski, R J; Smith, R F; Sheaff, C M; Chen, E H; Keys, N I; Crescenzo, M; Barrett, J A; Berman, E

    1989-12-01

    Although toxicology screening is often used when treating trauma patients, its utility and significance remain controversial. Data from 623 toxicology screens performed in urban trauma center patients with mental status alterations are reported. The study patients were predominantly black and male, with a mean age of 32 (+/- 22) years. Overall, 86% of screens were positive. Substances of abuse, including ethanol, were noted in 525 (84%) of urine toxicology screens. Ethanol, cannabinoids, and cocaine were the drugs most commonly found in urine, with positivity noted in 53%, 37%, and 34% of screens. Serum analysis was 44% positive, with ethanol noted in 41% of patients. In blacks, the odds ratio of illicit drug use before trauma ranged from 1.9 to 4.2 (p less than 0.005), and in those aged 17 to 40 years, the odds ratio for illicit urine drugs ranged from 4.7 to 16.8 (p less than 0.001). In patients older than 40 years, the odds of a positive serum ethanol level were 1.7 times greater than in younger patients, and a level above 300 mg% was 3.8 times more likely in this age group (p less than 0.001). When serum ethanol was detected, the odds ratio of a head injury was 1.4 relative to patients without serum ethanol (p less than 0.06), and the odds ratio for abdominal injury was 1.6 for patients with serum ethanol (p less than 0.03). The odds of a TS less than 12 were 1.8 (p less than 0.05), and the odds of a GCS less than 12 were 3.3 (p less than 0.001) with ethanol levels greater than 100 mg%.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2593195

  10. Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine-A Study with Felodipine as a Model Drug.

    PubMed

    Lindfors, Lennart; Jonsson, Malin; Weibull, Emelie; Brasseur, James G; Abrahamsson, Bertil

    2015-09-01

    The aim of this study was to understand and predict the influence of hydrodynamic effects in the small intestine on dissolution of primary and aggregated drug particles. Dissolution tests of suspensions with a low-solubility drug, felodipine, were performed in a Couette cell under hydrodynamic test conditions corresponding to the fed small intestine. Dissolution was also performed in the USP II apparatus at two paddle speeds of 25 and 200 rpm and at different surfactant concentrations below critical micelle concentration. The experimental dissolution rates were compared with theoretical calculations. The different levels of shear stress in the in vitro tests did not influence the dissolution of primary or aggregated particles and experimental dissolution rates corresponded very well to calculations. The dissolution rate for the aggregated drug particles increased after addition of surfactant because of deaggregation, but there were still no effect of hydrodynamics. In conclusion, hydrodynamics do not influence dissolution and deaggregation of micronized drug particles in the small intestine of this model drug. Surface tension has a strong effect on the deaggregation and subsequent dissolution. Addition of surfactants at in vivo relevant surface tension levels is thus critical for in vivo predictive in vitro dissolution testing. PMID:25980801

  11. The Honeywell Studies: How Managers Learn to Manage.

    ERIC Educational Resources Information Center

    Zemke, Ron

    1985-01-01

    Describes how a group of Honeywell Corporation human resources specialists determined how the organization's management development process could be improved to support the needs of the business. Discusses corporate management development strategy, curriculum, conference center, on-the-job experiences, and how experience, relationships, and…

  12. Factorial design studies of antiretroviral drug-loaded stealth liposomal injectable: PEGylation, lyophilization and pharmacokinetic studies

    NASA Astrophysics Data System (ADS)

    Sudhakar, Beeravelli; Krishna, Mylangam Chaitanya; Murthy, Kolapalli Venkata Ramana

    2016-01-01

    The aim of the present study was to formulate and evaluate the ritonavir-loaded stealth liposomes by using 32 factorial design and intended to delivered by parenteral delivery. Liposomes were prepared by ethanol injection method using 32 factorial designs and characterized for various physicochemical parameters such as drug content, size, zeta potential, entrapment efficiency and in vitro drug release. The optimization process was carried out using desirability and overlay plots. The selected formulation was subjected to PEGylation using 10 % PEG-10000 solution. Stealth liposomes were characterized for the above-mentioned parameters along with surface morphology, Fourier transform infrared spectrophotometer, differential scanning calorimeter, stability and in vivo pharmacokinetic studies in rats. Stealth liposomes showed better result compared to conventional liposomes due to effect of PEG-10000. The in vivo studies revealed that stealth liposomes showed better residence time compared to conventional liposomes and pure drug solution. The conventional liposomes and pure drug showed dose-dependent pharmacokinetics, whereas stealth liposomes showed long circulation half-life compared to conventional liposomes and pure ritonavir solution. The results of statistical analysis showed significance difference as the p value is (<0.05) by one-way ANOVA. The result of the present study revealed that stealth liposomes are promising tool in antiretroviral therapy.

  13. Managerial activities and skills of nurse managers: an exploratory study.

    PubMed

    Lin, Li-Min; Wu, Jen-Her; White, Louis P

    2005-01-01

    In this study, the authors used the activity competency model (Wu, Chen, and Lin 2004) to investigate the perceived importance of managerial activities and skills required of three levels of nurse managers. They identify the portfolio of the management activities and the needed skills at each management level. The results of this study provide guidelines for management development programs, training, and career planning for nurse managers, and can also serve as guidelines for recruiting and selecting effective nurse managers. PMID:16190515

  14. Temporal differences in gamma-hydroxybutyrate overdoses involving injecting drug users versus recreational drug users in Helsinki: a retrospective study

    PubMed Central

    2012-01-01

    Background Gamma-hydroxybutyrate (GHB) and gamma-butyrolactone (GBL) have been profiled as 'party drugs' used mainly at dance parties and in nightclubs on weekend nights. The purpose of this study was to examine the frequency of injecting drug use among GHB/GBL overdose patients and whether there are temporal differences in the occurrence of GHB/GBL overdoses of injecting drug and recreational drug users. Methods In this retrospective study, the ambulance and hospital records of suspected GHB- and GBL overdose patients treated by the Helsinki Emergency Medical Service from January 1st 2006 to December 31st 2007 were reviewed. According to the temporal occurrence of the overdose, patients were divided in two groups. In group A, the overdose occurred on a Friday-Saturday or Saturday-Sunday night between 11 pm-6 am. Group B consisted of overdoses occurring on outside this time frame. Results Group A consisted of 39 patient contacts and the remaining 61 patient contacts were in group B. There were statistically significant differences between the two groups in (group A vs. B, respectively): history of injecting drug abuse (33% vs. 59%, p = 0.012), reported polydrug and ethanol use (80% vs. 62%, p = 0.028), the location where the patients were encountered (private or public indoors or outdoors, 10%, 41%, 41% vs. 25%, 18%, 53%, p = 0.019) and how the knowledge of GHB/GBL use was obtained (reported by patient/bystanders or clinical suspicion, 72%, 28% vs. 85%, 10%, p = 0.023). Practically all (99%) patients were transported to emergency department after prehospital care. Conclusion There appears to be at least two distinct groups of GHB/GBL users. Injecting drug users represent the majority of GHB/GBL overdose patients outside weekend nights. PMID:22296777

  15. Update on administration of anesthetics and psychoactive drugs for pain management in China.

    PubMed

    Gu, Weiping

    2015-06-01

    Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people's health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued 'the regulations on the administration of anesthetic drugs and psychotropic drugs' in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse. PMID:26068438

  16. A Study on Polypharmacy and Potential Drug-Drug Interactions among Elderly Patients Admitted in Department of Medicine of a Tertiary Care Hospital in Puducherry

    PubMed Central

    Kalyansundaram, Dharani; Bahurupi, Yogesh

    2016-01-01

    Introduction The proportion of elderly population has been constantly increasing over last few years. Polypharmacy is unavoidable in the elderly as they often suffer from multiple co-morbidities. Potential drug-drug interaction due to polypharmacy and potential inappropriate medication among the elderly must be carefully assessed. Aim To find out polypharmacy and potential drug-drug interactions among elderly patients admitted and discharged in Department of Medicine. Materials and Methods This study was carried out on 100 patients above 65 years of age both males and females. Data was collected through review of case sheets. Polypharmacy was observed based on admission and discharge prescriptions. Frequently occurring drug-drug interactions were assessed using online checks. Results Mean number of drugs prescribed to patients on admission (7.61 ± 3.37) was more than that on discharge (5.48±2.46). More than half of these patients received 5 to 9 number of drugs. On admission 52.69% potential drug-drug interactions were observed and on discharge 52.91%. Most common drug interactions observed in both the groups were of moderate grade. Conclusion From the present study we can conclude that polypharmacy leads to more potential drug-drug interactions. To improve drug safety in this high-risk population, appropriate prescribing is very important. PMID:27042480

  17. The Science Manager's Guide to Case Studies

    SciTech Connect

    Branch, Kristi M.; Peffers, Melissa S.; Ruegg, Rosalie T.; Vallario, Robert W.

    2001-09-24

    This guide takes the science manager through the steps of planning, implementing, validating, communicating, and using case studies. It outlines the major methods of analysis, describing their relative merits and applicability while providing relevant examples and sources of additional information. Well-designed case studies can provide a combination of rich qualitative and quantitative information, offering valuable insights into the nature, outputs, and longer-term impacts of the research. An objective, systematic, and credible approach to the evaluation of U.S. Department of Energy Office of Science programs adds value to the research process and is the subject of this guide.

  18. Automation impact study of Army Training Management

    SciTech Connect

    Sanquist, T.F.; Schuller, C.R.; McCallum, M.C.; Underwood, J.A.; Bettin, P.J.; King, J.L.; Melber, B.D.; Hostick, C.J.; Seaver, D.A.

    1988-01-01

    The main objectives of this impact study were to identify the potential cost savings associated with automated Army Training Management (TM), and to perform a cost-benefit analysis for an Army-wide automated TM system. A subsidiary goal was to establish baseline data for an independent evaluation of a prototype Integrated Training Management System (ITMS), to be tested in the fall of 1988. A structured analysis of TM doctrine was performed for comparison with empirical data gathered in a job analysis survey of selected units of the 9ID (MTZ) at Ft. Lewis, Washington. These observations will be extended to other units in subsequent surveys. The survey data concerning staffing levels and amount of labor expended on eight distinct TM tasks were analyzed in a cost effectiveness model. The main results of the surveys and cost effectiveness modelling are summarized. 18 figs., 47 tabs.

  19. Drug Utilization Study in Medical Emergency Unit of a Tertiary Care Hospital in North India

    PubMed Central

    Kaur, Sharonjeet; Rajagopalan, Sujit; Bhalla, Ashish; Pandhi, Promila; Malhotra, Samir

    2014-01-01

    Objective. To generate data on the drug utilization pattern and cost of drug treatment and to determine the rationality of prescriptions. Methods. A retrospective cross-sectional drug utilization study was conducted in the medical emergency unit of our hospital. Patient case records were reviewed to extract data on the pattern of drug use. Cost of drug treatment for the emergency visit was calculated by referring to the cost mentioned in Monthly Index of Medical Specialties and the rationality of prescriptions was evaluated using WHO core indicators of drug utilization. Results. 1100 case records were reviewed. Majority of patients received proton pump inhibitors followed by multivitamins. The median cost per prescription was 119.23$ (7.32$–7663.46$). Majority (49.9%) of drug cost was driven by antibiotics alone. An average of 4.9 drugs was prescribed per prescription. There were 14.89% encounters with antibiotics. 75.17% of the drugs were given as injectables and only 29.27% of the drugs were prescribed as generics. Conclusion. There is need to rationalize the drug therapy in terms of increasing prescribing of drugs by generic name and to avoid overuse of PPIs and multivitamins in emergency unit. Also the hospital pharmacy should be encouraged to procure more cost effective alternative antibiotics in future. PMID:24883208

  20. Overdose of drugs for attention-deficit hyperactivity disorder: clinical presentation, mechanisms of toxicity, and management.

    PubMed

    Spiller, Henry A; Hays, Hannah L; Aleguas, Alfred

    2013-07-01

    The prevalence of attention-deficit hyperactivity disorder (ADHD) in the USA is estimated at approximately 4-9% in children and 4% in adults. It is estimated that prescriptions for ADHD medications are written for more than 2.7 million children per year. In 2010, US poison centers reported 17,000 human exposures to ADHD medications, with 80% occurring in children <19 years old and 20% in adults. The drugs used for the treatment of ADHD are diverse but can be roughly separated into two groups: the stimulants such as amphetamine, methylphenidate, and modafinil; and the non-stimulants such as atomoxetine, guanfacine, and clonidine. This review focuses on mechanisms of toxicity after overdose with ADHD medications, clinical effects from overdose, and management. Amphetamine, dextroamphetamine, and methylphenidate act as substrates for the cellular monoamine transporter, especially the dopamine transporter (DAT) and less so the norepinephrine (NET) and serotonin transporter. The mechanism of toxicity is primarily related to excessive extracellular dopamine, norepinephrine, and serotonin. The primary clinical syndrome involves prominent neurological and cardiovascular effects, but secondary complications can involve renal, muscle, pulmonary, and gastrointestinal (GI) effects. In overdose, the patient may present with mydriasis, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and seizures. The management of amphetamine, dextroamphetamine, and methylphenidate overdose is largely supportive, with a focus on interruption of the sympathomimetic syndrome with judicious use of benzodiazepines. In cases where agitation, delirium, and movement disorders are unresponsive to benzodiazepines, second-line therapies include antipsychotics such as ziprasidone or haloperidol, central alpha-adrenoreceptor agonists such as dexmedetomidine, or propofol. Modafinil is not US FDA approved for treatment of ADHD

  1. Drug-drug interaction and doping, part 2: an in vitro study on the effect of non-prohibited drugs on the phase I metabolic profile of stanozolol.

    PubMed

    Mazzarino, Monica; de la Torre, Xavier; Fiacco, Ilaria; Botrè, Francesco

    2014-10-01

    The present study was designed to provide preliminary information on the potential impact of metabolic drug-drug interaction on the effectiveness of doping control strategies currently followed by the anti-doping laboratories to detect the intake of prohibited agents. In vitro assays based on the use of human liver microsomes and recombinant cytochrome P450 isoforms were developed and applied to characterize the phase I metabolic profile of the prohibited agent stanozolol, both in the absence and in the presence of substances (ketoconazole, itraconazole, miconazole, cimetidine, ranitidine, and nefazodone) not included in the World Anti-Doping Agency (WADA) list of prohibited substances and methods and frequently administered to athletes. The results show that the in vitro model utilized in this study is adequate to simulate the in vivo metabolism of stanozolol. Furthermore, our data showed that ketoconazole, itraconazole, miconazole, and nefazodone caused a marked modification in the production of the metabolic products (3'-hydroxy-stanozolol, 4β-hydroxy-stanozolol and 16β-hydroxy-stanozolol) normally selected by the anti-doping laboratories as target analytes to detect stanozolol intake. On the contrary, moderate variations were registered in the presence of cimetidine and no significant modifications were measured in the presence of ranitidine. This evidence confirms that the potential effect of drug-drug interactions is duly taken into account also in anti-doping analysis. PMID:24535830

  2. A 2013 workshop: vaccine and drug ontology studies (VDOS 2013)

    PubMed Central

    2014-01-01

    The 2013 “Vaccine and Drug Ontology Studies” (VDOS 2013) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have contributed to dramatic improvements in public health worldwide. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs – extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, as well as developing new models such as Vaccine Ontology. The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The six full-length papers included in this thematic issue focuses on three main areas: (i) ontology development and representation, (ii) ontology mapping, maintaining and auditing, and (iii) ontology applications. PMID:24650607

  3. A Guide for the Management of Speical Education Programs. 4.0 Drug Information for Educators, Parents, and Students. Newday Operations Guide for Drug Dependent Minor Programs.

    ERIC Educational Resources Information Center

    Santa Cruz County Superintendent of Schools, CA.

    Presented is the fourth component of a special day class program for drug dependent minors, Drug Information for Educators, Parents, and Students. The first section, intended for educators, includes a drug abuse chart, information on the drug subculture, information on patterns of drug abuse and misconceptions about drugs, and suggested activities…

  4. Decellularized skeletal muscle as an in vitro model for studying drug-extracellular matrix interactions.

    PubMed

    Wassenaar, Jean W; Boss, Gerry R; Christman, Karen L

    2015-09-01

    Several factors can affect drug absorption after intramuscular (IM) injection: drug solubility, drug transport across cell membranes, and drug metabolism at the injection site. We found that potential interactions between the drug and the extracellular matrix (ECM) at the injection site can also affect the rate of absorption post-injection. Using decellularized skeletal muscle, we developed a simple method to model drug absorption after IM injection, and showed that the nature of the drug-ECM interaction could be investigated by adding compounds that alter binding. We validated the model using the vitamin B12 analog cobinamide with different bound ligands. Cobinamide is being developed as an IM injectable treatment for cyanide poisoning, and we found that the in vitro binding data correlated with previously published in vivo drug absorption in animals. Commercially available ECM products, such as collagen and GelTrex, did not recapitulate drug binding behavior. While decellularized ECM has been widely studied in fields such as tissue engineering, this work establishes a novel use of skeletal muscle ECM as a potential in vitro model to study drug-ECM interactions during drug development. PMID:26125502

  5. Study on microvisualizing assay of delivered drug infiltration using 2-color optical coherence dosigraphy

    NASA Astrophysics Data System (ADS)

    Nakamichi, Yu; Saeki, Souichi; Saito, Takashi; Hiro, Takafumi; Matsuzaki, Masunori

    2009-02-01

    Recently, clinical treatments applying drug delivery system (DDS) have been being developed. However, it is quite difficult to in vivo diagnose spatiotemporal distribution of drug infiltration, so the validation study should be too insufficient to progress the DDS development. In this study, we propose a visualizing assay of DDS, namely 2-Color Optical Coherence Dosigraphy (2C-OCD). 2C-OCD is based on optical coherence tomography using two waveband "2-Color" light sources having different optical absorbance of drug. This can simultaneously provide microscale tomographic images of scatterer density and drug concentration. In order to evaluate the efficacy of this technique, this was applied to drug-diffusion phenomena in microchannel and lipidrich plaques of rabbit with drug administration, respectively. As a result of diffusion experiment, it was confirmed that 2C-OCD can visualize a cross-sectional map of drug concentration, with spatial resolution 5 micro m × 10 μm and accuracy plus-minus 13.0 μM. In ex vivo animal experiment, the enhancement of absorptivity could be observed inside lipidrich plaques, in which DDS drug could be therein uptaken by drug administration. The absorption maps corresponding to drug concentration were calculated, comparing with their histological images. Consequently, they had good coincidence with histological examinations, therefore, it was concluded that 2C-OCD could visualize drug infiltration in biological tissue with almost the same spatial resolution as OCT system.

  6. Antibiotic-loaded chitosan-Laponite films for local drug delivery by titanium implants: cell proliferation and drug release studies.

    PubMed

    Ordikhani, Farideh; Dehghani, Mehdi; Simchi, Arash

    2015-12-01

    In this study, chitosan-Laponite nanocomposite coatings with bone regenerative potential and controlled drug-release capacity are prepared by electrophoretic deposition technique. The controlled release of a glycopeptide drug, i.e. vancomycin, is attained by the intercalation of the polymer and drug macromolecules into silicate galleries. Fourier-transform infrared spectrometry reveals electrostatic interactions between the charged structure of clay and the amine and hydroxyl groups of chitosan and vancomycin, leading to a complex positively-charged system with high electrophoretic mobility. By applying electric field the charged particles are deposited on the surface of titanium foils and uniform chitosan films containing 25-55 wt% Laponite and 937-1655 µg/cm(2) vancomycin are obtained. Nanocomposite films exhibit improved cell attachment with higher cell viability. Alkaline phosphatase assay reveals enhanced cell proliferation due the gradual dissolution of Laponite particles into the culture medium. In-vitro drug-release studies show lower release rate through a longer period for the nanocomposite compared to pristine chitosan. PMID:26507202

  7. Two cholesterol derivative-based PEGylated liposomes as drug delivery system, study on pharmacokinetics and drug delivery to retina

    NASA Astrophysics Data System (ADS)

    Geng, Shengyong; Yang, Bin; Wang, Guowu; Qin, Geng; Wada, Satoshi; Wang, Jin-Ye

    2014-07-01

    In this study, two cholesterol derivatives, (4-cholesterocarbonyl-4‧-(N,N,N-triethylamine butyloxyl bromide) azobenzene (CAB) and 4-cholesterocarbonyl-4‧-(N,N-diethylamine butyloxyl) azobenzene (ACB), one of which is positively charged while the other is neutral, were synthesized and incorporated with phospholipids and cholesterol to form doxorubicin (DOX)-loaded liposomes. PEGylation was achieved by including 1,2-distearoyl-sn-glycero-3-phosphatiylethanol-amine-N-[methoxy-(polyethylene glycol)-2000 (DSPE-PEG2000). Our results showed that PEGylated liposomes displayed significantly improved stability and the drug leakage was decreased compared to the non-PEGylated ones in vitro. The in vivo study with rats also revealed that the pharmacokinetics and circulation half-life of DOX were significantly improved when liposomes were PEGylated (p < 0.05). In particular, the neutral cholesterol derivative ACB played some role in improving liposomes’ stability in systemic circulation compared to the conventional PC liposome and the positively charged CAB liposome, with or without PEGylation. In addition, in the case of local drug delivery, the positively charged PEG-liposome not only delivered much more of the drug into the rats’ retinas (p < 0.001), but also maintained much longer drug retention time compared to the neutral PEGylated liposomes.

  8. Surface Modifications of Titanium Implants by Multilayer Bioactive Coatings with Drug Delivery Potential: Antimicrobial, Biological, and Drug Release Studies

    NASA Astrophysics Data System (ADS)

    Ordikhani, Farideh; Zustiak, Silviya Petrova; Simchi, Abdolreza

    2016-04-01

    Recent strategies to locally deliver antimicrobial agents to combat implant-associated infections—one of the most common complications in orthopedic surgery—are gaining interest. However, achieving a controlled release profile over a desired time frame remains a challenge. In this study, we present an innovative multifactorial approach to combat infections which comprises a multilayer chitosan/bioactive glass/vancomycin nanocomposite coating with an osteoblastic potential and a drug delivery capacity. The bioactive drug-eluting coating was prepared on the surface of titanium foils by a multistep electrophoretic deposition technique. The adopted deposition strategy allowed for a high antibiotic loading of 1038.4 ± 40.2 µg/cm2. The nanocomposite coating exhibited a suppressed burst release with a prolonged sustained vancomycin release for up to 6 weeks. Importantly, the drug release profile was linear with respect to time, indicating a zero-order release kinetics. An in vitro bactericidal assay against Staphylococcus aureus confirmed that releasing the drug reduced the risk of bacterial infection. Excellent biocompatibility of the developed coating was also demonstrated by in vitro cell studies with a model MG-63 osteoblast cell line.

  9. Use of non-formulary drugs in children at a Brazilian teaching hospital: a descriptive study

    PubMed Central

    Tramontina, Mariana Y.; Heineck, Isabela; Dos Santos, Luciana

    Objective To characterise the prescription of non-formulary drugs to children and neonates at a Brazilian teaching hospital and identify adverse drug reactions (ADRs), drug interactions, and prescription of potentially hazardous medicines. Methods A prospective exploratory study was carried out between January and May 2011 at the general paediatric wards and paediatric oncology, paediatric intensive care, and neonatal care units of the study hospital. Non-formulary drugs were categorised as approved, off-label, or not approved for use in children according to Brazilian compendia. Electronic health records were actively searched for ADRs and the possibility of moderate to severe interactions between non-formulary drugs and other medicines was determined with the Micromedex® database. Results Overall, 109 children or neonates received non-formulary drugs. Of these drugs, 54% were approved for use in children, 12.2% were used off-label, and 33.8% were not approved for use in children. Non-formulary drugs accounted for 13.4% of total prescriptions; 5.3% of drugs had a potential for interactions and five were possibly associated with ADRs. Conclusions Prescription of non-formulary drugs not approved for use in children was common at the study hospital. Studies such as this provide information on the use of medicines for special indications and permit assessment of the relevance of hospital formularies for the paediatric population. PMID:24155845

  10. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    PubMed

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2016-01-01

    Despite ongoing progress towards treating mental illness, there remain significant difficulties in selecting probable candidate drugs from the existing database. We describe an ontology - oriented approach aims to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. Along with this approach, we report a case study in which we attempted to explore the candidate drugs that effective for both bipolar disorder and epilepsy. We constructed an ontology that incorporates the knowledge between the two diseases and performed semantic reasoning task on the ontology. The reasoning results suggested 48 candidate drugs that hold promise for a further breakthrough. The evaluation was performed and demonstrated the validity of the proposed ontology. The overarching goal of this research is to build a framework of ontology - based data integration underpinning psychiatric drug repurposing. This approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders. PMID:27570661

  11. Oral drug self-administration: an overview of laboratory animal studies.

    PubMed

    Meisch, R A

    2001-06-01

    Many abused drugs can be established as orally delivered reinforcers for rhesus monkeys and other animals. Benzodiazepines, barbiturates, opioids, psychomotor stimulants, dissociative anesthetics, and ethanol can come to serve as reinforcers when taken by mouth. The principal problems in establishing drugs as reinforcers by the oral route of administration are (1) aversive taste, (2) delay in onset of central nervous system effects, and (3) consumption of low volumes of drug solution. Strategies have been devised to successfully overcome these problems, and orally delivered drugs can be established as effective reinforcers. Reinforcing actions are demonstrated by consumption of greater volumes of drug solution than volumes of the water vehicle, and supporting evidence for reinforcing effects consists of the maintenance of behavior under intermittent schedules of reinforcement and the generation of orderly dose-response functions. This article presents an overview of studies of behavior reinforced by oral drug reinforcement. Factors that control oral drug intake include dose, schedule of reinforcement, food restriction, and alternative reinforcers. Many drugs, administered by the experimenter, can alter oral drug reinforcement. Relative reinforcing effects can be assessed by choice procedures and by persistence of behavior across increases in schedule size. In general, reinforcing effects increase directly with dose. Rhesus monkeys prefer combinations of reinforcing drugs to the component drugs. The taste of drug solutions may act as a conditioned reinforcer and a discriminative stimulus. Consequences of drug intake include tolerance and physiological dependence. Findings with orally self-administered drugs are similar to many findings with other positive reinforcers, including intravenously self-administered drugs. PMID:11522433

  12. EPR studies of intermolecular interactions and competitive binding of drugs in a drug-BSA binding model.

    PubMed

    Akdogan, Y; Emrullahoglu, M; Tatlidil, D; Ucuncu, M; Cakan-Akdogan, G

    2016-08-10

    Understanding intermolecular interactions between drugs and proteins is very important in drug delivery studies. Here, we studied different binding interactions between salicylic acid and bovine serum albumin (BSA) using electron paramagnetic resonance (EPR) spectroscopy. Salicylic acid was labeled with a stable radical (spin label) in order to monitor its mobilized (free) or immobilized (bound to BSA) states. In addition to spin labeled salicylic acid (SL-salicylic acid), its derivatives including SL-benzoic acid, SL-phenol, SL-benzene, SL-cyclohexane and SL-hexane were synthesized to reveal the effects of various drug binding interactions. EPR results of these SL-molecules showed that hydrophobic interaction is the main driving force. Whereas each of the two functional groups (-COOH and -OH) on the benzene ring has a minute but detectable effect on the drug-protein complex formation. In order to investigate the effect of electrostatic interaction on drug binding, cationic BSA (cBSA) was synthesized, altering the negative net charge of BSA to positive. The salicylic acid loading capacity of cBSA is significantly higher compared to that of BSA, indicating the importance of electrostatic interaction in drug binding. Moreover, the competitive binding properties of salicylic acid, ibuprofen and aspirin to BSA were studied. The combined EPR results of SL-salicylic acid/ibuprofen and SL-ibuprofen/salicylic acid showed that ibuprofen is able to replace up to ∼83% of bound SL-salicylic acid, and salicylic acid can replace only ∼14% of the bound SL-ibuprofen. This indicates that ∼97% of all salicylic acid and ibuprofen binding sites are shared. On the other hand, aspirin replaces only ∼23% of bound SL-salicylic acid, and salicylic acid replaces ∼50% of bound SL-aspirin, indicating that ∼73% of all salicylic acid and aspirin binding sites are shared. These results show that EPR spectroscopy in combination with the spin labeling technique is a very powerful

  13. A Review of Compression, Ventilation, Defibrillation, Drug Treatment, and Targeted Temperature Management in Cardiopulmonary Resuscitation

    PubMed Central

    Pan, Jian; Zhu, Jian-Yong; Kee, Ho Sen; Zhang, Qing; Lu, Yuan-Qiang

    2015-01-01

    Objective: Important studies of cardiopulmonary resuscitation (CPR) techniques influence the development of new guidelines. We systematically reviewed the efficacy of some important studies of CPR. Data Sources: The data analyzed in this review are mainly from articles included in PubMed and EMBASE, published from 1964 to 2014. Study Selection: Original articles and critical reviews about CPR techniques were selected for review. Results: The survival rate after out-of-hospital cardiac arrest (OHCA) is improving. This improvement is associated with the performance of uninterrupted chest compressions and simple airway management procedures during bystander CPR. Real-time feedback devices can be used to improve the quality of CPR. The recommended dose, timing, and indications for adrenaline (epinephrine) use may change. The appropriate target temperature for targeted temperature management is still unclear. Conclusions: New studies over the past 5 years have evaluated various aspects of CPR in OHCA. Some of these studies were high-quality randomized controlled trials, which may help to improve the scientific understanding of resuscitation techniques and result in changes to CPR guidelines. PMID:25673462

  14. Approach to the Diagnosis and Management of Drug-Induced Immune Thrombocytopenia

    PubMed Central

    Arnold, Donald M.; Nazi, Ishac; Warkentin, Theodore E.; Smith, James W.; Toltl, Lisa J.; George, James N.; Kelton, John G.

    2013-01-01

    Drug-induced immune thrombocytopenia (DITP) is a challenging clinical problem that is under-recognized, difficult to diagnose and associated with severe bleeding complications. DITP may be caused by classic drug-dependent platelet antibodies (eg, quinine); haptens (eg, penicillin); fiban-dependent antibodies (eg, tirofiban); monoclonal antibodies (eg, abciximab); autoantibody formation (eg, gold); and immune complex formation (eg, heparin). A thorough clinical history is essential in establishing the diagnosis of DITP and should include exposures to prescription medications, herbal preparations and even certain foods and beverages. Clinical and laboratory criteria have been established to determine the likelihood of a drug being the cause of thrombocytopenia, but these criteria can only be applied retrospectively. The most commonly implicated drugs include quinine, quinidine, trimethoprim/sulfamethoxazole and vancomycin. We propose a practical approach to the diagnosis of the patient with suspected DITP. Key features are: the presence of severe thrombocytopenia (platelet nadir <20 × 109/L); bleeding complications; onset 5 to 10 days after first drug exposure, or within hours of subsequent exposures or after first exposure to fibans or abciximab; and exposure to drugs that have been previously implicated in DITP reactions. Treatment involves stopping the drug(s), administering platelet transfusions or other therapies if bleeding is present and counselling on future drug avoidance. The diagnosis can be confirmed by a positive drug re-challenge, which is often impractical, or by demonstrating drug-dependent platelet reactive antibodies in vitro. Current test methods, which are mostly flow cytometry-based, must show drug-dependence, immunoglobulin binding, platelet specificity and ideally should be reproducible across laboratories. Improved standardization and accessibility of laboratory testing should be a focus of future research. PMID:23845922

  15. Drug utilization study in ophthalmology outpatients at a tertiary care teaching hospital.

    PubMed

    Jadhav, Pradeep R; Moghe, Vijay V; Deshmukh, Yeshwant A

    2013-12-22

    In view of the advancement in drug development and availability of new ocular therapeutics in the discipline of ophthalmology, we attempted to study the drug utilization and describe the prescribing practices of ophthalmologists in a tertiary care teaching hospital. Method. A prospective, cross-sectional, observational study was conducted on patients attending Outpatient Department of Ophthalmology for curative complaints. Prescriptions of 600 patients treated were analyzed by the WHO prescribing indicators and additional indices. Results. Analysis showed that the average number of drugs per prescription was 1.49. Percentage of drugs prescribed by generic name was 2.35%. Percentage of encounters with antibiotics was 44.83%. Percentage of drugs prescribed from National Essential drug list (NEDL)/National Formulary of India (NFI) was 19.48%. Patient's knowledge of correct dosage was 93.83%. Antimicrobial agents were the most commonly prescribed drugs followed by antiallergy drugs and ocular lubricants. Fluoroquinolones accounted for 60% of the total antimicrobial drugs, of which gatifloxacin was the most frequently prescribed fluoroquinolone. Conclusion. The study indicated an awareness of polypharmacy, but showed ample scope for improvement in encouraging the ophthalmologists to prescribe by generic name and selection of essential drugs from NEDL/NFI. PMID:24455298

  16. Availability of antidotes and key emergency drugs in tertiary care hospitals of Punjab and assessment of the knowledge of health care professionals in the management of poisoning cases.

    PubMed

    Arslan, Naheed; Khiljee, Sonia; Bakhsh, Allah; Ashraf, Muhammad; Maqsood, Iram

    2016-03-01

    This study was conducted to evaluate the availability of antidotes/key emergency drugs in tertiary care hospitals of the Punjab province, and to assess the knowledge of health care professionals in the stocking and administration of antidotes in the proper management of poisoning cases. Seventeen (n=17) tertiary care hospitals of Punjab Pakistan were selected. Two performas (A and B) were designed for 26 antidotes/key emergency drugs and given to the hospital pharmacists and physicians respectively. It was observed that Activated Charcoal, being the universal antidote was found only in 6 hospitals (41%). Digoxin Immune Fab, Edentate Calcium disodium and Glucagon were not available in emergency department of any hospital and even not included in the formulary of any hospital. About 80% pharmacists were aware of the method of preparation of Activated Charcoal and 85% physicians were familiar with its route of administration. Data showed that tertiary care hospitals of Punjab do not stock antidotes according to national drug policy. Moreover the study strongly suggests the development of health care centers and professional by organizing antidote awareness programs, continuous education and record keeping of poisonous cases and availability of emergency drugs around the clock. PMID:27087082

  17. Current progress in the management of rare diseases and orphan drugs in China

    PubMed Central

    Gong, Shiwei; Jin, Si

    2012-01-01

    Summary Currently, the issues of how to treat rare diseases and to improve accessibility to orphan drugs are arousing more and more concerns in China. Here we describe the push and pull incentive policies for rare diseases and orphan drugs and analyze the coverage and reimbursement level of rare diseases in the current Chinese medical insurance system. Three key obstacle factors that hinder Chinese patients' accessibility to timely drug treatment are summarized. Based on a comprehensive analysis, the measures of orphan drugs legislation, incentive mechanism, supply mechanism, and reimbursement mechanism are urgently expected to be established with the purpose of improving healthcare for patients with rare diseases in China. PMID:25343073

  18. Prescription drugs in nursing homes: managing costs and quality in a complex environment.

    PubMed

    Mendelson, Dan; Ramchand, Rajeev; Abramson, Richard; Tumlinson, Anne

    2002-11-12

    This brief provides a description of prescription drug use in nursing homes and a summary of current policy issues in this area. The brief first profiles the nursing home pharmaceutical market, outlining the major trends in demographics and drug utilization, the supply chain by which drugs go from manufacturers to pharmacies to nursing home residents, and the alternative arrangements by which prescription drugs in nursing homes are financed. The brief then provides a synopsis of current policy issues, focusing in turn on cost containment and quality improvement initiatives. PMID:12463231

  19. How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001–2012

    PubMed Central

    Ward, Derek J; Slade, Angharad; Genus, Tracey; Martino, Orsolina I; Stevens, Andrew J

    2014-01-01

    Objectives Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value. Design and setting Retrospective observational study of new drug entries in the British National Formulary (BNF). Primary and secondary outcome measures Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation. Results Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively). Conclusions Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences. PMID

  20. Behavioral endophenotypes of drug addiction: Etiological insights from neuroimaging studies.

    PubMed

    Jupp, Bianca; Dalley, Jeffrey W

    2014-01-01

    This article reviews recent advances in the elucidation of neurobehavioral endophenotypes associated with drug addiction made possible by the translational neuroimaging techniques magnetic resonance imaging (MRI) and positron emission tomography (PET). Increasingly, these non-invasive imaging approaches have been the catalyst for advancing our understanding of the etiology of drug addiction as a brain disorder involving complex interactions between pre-disposing behavioral traits, environmental influences and neural perturbations arising from the chronic abuse of licit and illicit drugs. In this article we discuss the causal role of trait markers associated with impulsivity and novelty-/sensation-seeking in speeding the development of compulsive drug administration and in facilitating relapse. We also discuss the striking convergence of imaging findings from these behavioural traits and addiction in rats, monkeys and humans with a focus on biomarkers of dopamine neurotransmission, and highlight areas where further research is needed to disambiguate underlying causal mechanisms. This article is part of a Special Issue entitled 'NIDA 40th Anniversary Issue'. PMID:23756169

  1. Values and beliefs of psychedelic drug users: a cross-cultural study.

    PubMed

    Lerner, Michael; Lyvers, Michael

    2006-06-01

    Psychedelic drugs such as LSD and psilocybin are often claimed to be capable of inducing life-changing experiences described as mystical or transcendental, especially if high doses are taken. The present study examined possible enduring effects of such experiences by comparing users of psychedelic drugs (n = 88), users of nonpsychedelic illegal drugs (e.g., marijuana, amphetamines) (n = 29) and non illicit drug-using social drinkers (n = 66) on questionnaire measures of values, beliefs and emotional empathy. Samples were obtained from Israel (n = 110) and Australia (n = 73) in a cross-cultural comparison to see if values associated with psychedelic drug use transcended culture of origin. Psychedelic users scored significantly higher on mystical beliefs (e.g., oneness with God and the universe) and life values of spirituality and concern for others than the other groups, and lower on the value of financial prosperity, irrespective of culture of origin. Users of nonpsychedelic illegal drugs scored significantly lower on a measure of coping ability than both psychedelic users and non illicit drug users. Both groups of illegal drug users scored significantly higher on empathy than non illicit drug users. Results are discussed in the context of earlier findings from Pahnke (1966) and Doblin (1991) of the transformative effect of psychedelic experiences, although the possibility remains that present findings reflect predrug characteristics of those who chose to take psychedelic drugs rather than effects of the drugs themselves. PMID:16903453

  2. Implicit and Explicit Drug-Related Cognitions during Detoxification Treatment Are Associated with Drug Relapse: An Ecological Momentary Assessment Study

    ERIC Educational Resources Information Center

    Marhe, Reshmi; Waters, Andrew J.; van de Wetering, Ben J. M.; Franken, Ingmar H. A.

    2013-01-01

    Objective: Relapse is a major problem in drug addiction treatment. Both drug craving and drug-related cognitions (e.g., attentional bias and implicit attitudes to drugs) may contribute to relapse. Using ecological momentary assessments, we examined whether craving and cognitions assessed during drug detoxification treatment were associated with…

  3. Drug interactions between antihypertensive drugs and non-steroidal anti-inflammatory agents: a descriptive study using the French Pharmacovigilance database.

    PubMed

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-04-01

    Drug-drug interactions (DDIs) between antihypertensive drugs and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to adverse drug reactions (ADRs). Guidelines are available to help prescribers deal with these drug associations, but their implementation is not well evaluated. The aims of this study were to assess the prevalence of NSAIDs exposure in patients treated with antihypertensive drugs, using the French Pharmacovigilance database, and explore the ADRs related to DDIs between antihypertensive drugs and NSAIDs. Over the 11, 442 notifications of ADRs recorded in this database in patients treated with oral antihypertensive drugs between 2008 and 2010, 517 (4.5 and 95% CI: 4.1-4.9) also included exposure to NSAIDs. These subjects were more frequently women, took more drugs in general, and were younger and less frequently treated with antiplatelet drugs. In 24.2% of them (125 patients), a DDI between NSAIDs and antihypertensive drugs was potentially the cause of the reported ADR. Acute renal failure caused by DDIs between NSAIDs and angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or diuretics was the most frequently reported ADR (20.7%). Finally, in the French Pharmacovigilance database, around one-fourth of associations NSAIDs  +  antihypertensive drugs are associated with a 'serious' ADR (mainly acute renal failure), suggesting that this well-known DDI is not enough taken into account by prescribers. PMID:23190210

  4. Dilemma of managing asymptomatic children referred with “culture-confirmed” drug-resistant tuberculosis

    PubMed Central

    Loveday, Marian; Sunkari, Babu; Marais, Ben J; Master, Iqbal; Brust, James CM

    2016-01-01

    Background The diagnosis of drug-resistant tuberculosis (DR-TB) in children is challenging and treatment is associated with many adverse effects. Objective We aimed to assess if careful observation, without initiation of second-line treatment, is safe in asymptomatic children referred with “culture-confirmed” DR-TB. Setting KwaZulu-Natal, South Africa - an area with high burdens of HIV, TB and DR-TB. Design, Intervention, Main outcome measures We performed an outcome review of children with “culture-confirmed” DR-TB who were not initiated on second-line TB treatment, as they were asymptomatic with normal chest radiographs on examination at our specialist referral hospital. Children were followed up every other month for the first year, with a final outcome assessment at the end of the study. Results In total, 43 asymptomatic children with normal chest radiographs were reviewed. The median length of follow-up until final evaluation was 549 days (IQR 259-722 days); most (34; 83%) children were HIV-uninfected. Resistance patterns included 9 (21%) mono-resistant and 34 (79%) multidrug-resistant (MDR) strains. Fifteen children (35%) had been treated with first-line TB treatment, prior to presentation at our referral hospital. At the final evaluation 34 (80%) children were well, 7 (16%) were lost to follow up, 1 (2%) received MDR-TB treatment and 1 (2%) died of unknown causes. The child who received MDR-TB treatment developed new symptoms at the 12 month review and responded well to second-line treatment. Conclusion Bacteriological evaluation should not be performed in the absence of any clinical indication. If drug-resistant M. tuberculosis is detected in an asymptomatic child with a normal chest radiograph close observation may be an appropriate strategy, especially in settings where potential laboratory error and poor record keeping are constant challenges. PMID:27044259

  5. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... specific protocols. This guidance finalizes the draft guidance issued on September 19, 2011 (76 FR 58018... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to...

  6. Evaluating Drugs and Food Additives for Public Use: A Case Studies Approach.

    ERIC Educational Resources Information Center

    Merritt, Sheridan V.

    1980-01-01

    Described is a case study used in an introductory college biology course that provides a basis for generating debate on an issue concerning the regulation of controversial food additives and prescription drugs. The case study contained within this article deals with drug screening, specifically with information related to thalidomide. (CS)

  7. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... the draft guidance published in the Federal Register of May 1, 2009 (74 FR 20322). This guidance is... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for... entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance...

  8. Unlocking the spiritual with club drugs: a case study of two youth cultures.

    PubMed

    Joe-Laidler, Karen; Hunt, Geoffrey

    2013-09-01

    Researchers have become increasingly interested in the link between spirituality and the use and misuse of drugs as well as intervention. First, studies have pointed to spirituality and religious involvement as a protective factor against substance use. Second, the quest for spirituality can play a role in drug use. This article has two aims. First, it seeks to examine the features of spirituality connected with both recovery from drug misuse and psychoactive drug use. Second, it seeks to understand the latter in the context of contemporary youth culture. We draw from our comparative study on club drug use among young people in two cultural locales-San Francisco and Hong Kong, where two different drugs, ecstasy and ketamine, have become associated in different dance party settings with a spiritual awakening of self-awareness and liberation. PMID:24041171

  9. Development, implementation and management of a drug testing program in the workplace

    SciTech Connect

    Burtis, C.A.

    1990-01-01

    To combat the rising use of drugs in the workplace many American companies have implemented drug testing programs and are testing employees and job applicants for use of illegal drugs. In addition, on September 15, 1986, Executive Order No.12564 was issued by President Reagan, which requires all federal agencies to develop programs and policies, one of the goals of which is to achieve a drug-free federal workplace. Included in this Executive Order is the requirement that federal agencies implement drug testing has become a prevalent practice as a means to detect and deter drug use in the workplace. Before a drug testing program is implemented, it is imperative that policies and procedures are developed that (1) ensure the accuracy of test results, (2) protect the validity and integrity of the specimen, (3) guarantee due process, and (4) maintain confidentiality. To make certain that these prerequisites were met in the government drug testing programs, the US Department of Health and Human Services (HHS) was directed to develop technical and scientific guidelines for conducting such programs. 15 refs., 1 fig., 2 tabs.

  10. Remaining Off Alcohol and Drugs: A Self-Management Skills Program for Abstinence.

    ERIC Educational Resources Information Center

    Dunphy, Peter Hughes

    The Remaining Off Alcohol and Drugs Program (ROAD) was developed to teach newly abstinent chemical misusing clients how to remain alcohol and drug free. It provides its participants with a repertoire of knowledge, skills and behaviors that they can use in dealing with the most common problems caused by discontinuing chemical use and which can be…

  11. Design Project on Controlled-Release Drug Delivery Devices: Implementation, Management, and Learning Experiences

    ERIC Educational Resources Information Center

    Xu, Qingxing; Liang, Youyun; Tong, Yen Wah; Wang, Chi-Hwa

    2010-01-01

    A design project that focuses on the subject of controlled-release drug delivery devices is presented for use in an undergraduate course on mass transfer. The purpose of the project is to introduce students to the various technologies used in the fabrication of drug delivery systems and provide a practical design exercise for understanding the…

  12. Drug salt formation via mechanochemistry: the case study of vincamine.

    PubMed

    Hasa, Dritan; Perissutti, Beatrice; Cepek, Cinzia; Bhardwaj, Sunil; Carlino, Elvio; Grassi, Mario; Invernizzi, Sergio; Voinovich, Dario

    2013-01-01

    assisted mechanochemical salification (SEAMS) in comparison with the vincamine citrate obtained by classical synthetic route. The samples were characterized by, besides XPS, high resolution transmission electron microscopy (HRTEM), X-ray powder diffraction (XRPD), in vitro solubilization kinetics and in vivo oral pilot study in rats. Finally, in order to monitor over time possible disproportionation phenomena, stability studies have been performed by repeating XPS analysis after 8 months. As expected, the the SEAMS-vincamine salt consisted of particles both crystalline and amorphous. The solubilization kinetics was superior to the corresponding salt probably thanks to the favorable presence of the hydrophilic excipient although the two salts were bioequivalent in rats after oral administration. Furthermore, no evidence of disporportionation phenomena in the SEAMS-vincamine salt was found after storage. In conclusion, in the case of forming salts of poorly soluble drugs, the SEAMS process may be an interesting alternative to both classical synthetic routes, eliminating the need for solvent removal, and simple neat mechanochemical salification, overcoming the problem of limited process yield. PMID:23186380

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

    PubMed

    Huertas, Melby Karina Zuniga; Campomar, Marcos Cortez

    2008-04-01

    The Direct-to-Consumer (DTC) advertising of medicines encourages people to ask doctors for certain medicines and treatments that require medical prescription. In order to enhance their persuasive power, advertising models recommend matching the appeals (rational and/or emotional) to the consumer's attitude (cognitive and/ or affective) towards the product. This recommendation leads to controversies in the context of DTC advertising. Emotional appeals, although frequently used, would always be inadequate in that kind of advertising. In absence of empiric evidence of the consumer's perspective, a descriptive research was undertaken with the objective of evaluating: i) the components of the attitude toward medicines; ii) attitude and behavioral intentions in response to DTC ads (one appealing to reason and the other appealing to emotion). A prescription weight loss drug was chosen for this purpose. The results revealed a predominantly cognitive attitude toward the product and an attitude and behavioral intention more favorable to the rational ad. Negative cognition about the product played an outstanding role canceling the persuasive power of emotional appeals. PMID:21936169

  14. Traumeel – an emerging option to nonsteroidal anti-inflammatory drugs in the management of acute musculoskeletal injuries

    PubMed Central

    Schneider, Christian

    2011-01-01

    Musculoskeletal injuries are on the rise. First-line management of such injuries usually employs the RICE (rest, ice, compression, and elevation) approach to limit excessive inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are also commonly used to limit inflammation and to control pain. Traumeel®, a preparation with bioregulatory effects is also used to treat the symptoms associated with acute musculoskeletal injuries, including pain and swelling. Traumeel is a fixed combination of biological and mineral extracts, which aims to apply stimuli to multiple targets to restore normal functioning of regulatory mechanisms. This paper presents the accumulating evidence of Traumeel’s action on the inflammatory process, and of its efficacy and tolerability in randomized trials, as well as observational and surveillance studies for the treatment of musculoskeletal injuries. Traumeel has shown comparable effectiveness to NSAIDs in terms of reducing symptoms of inflammation, accelerating recovery, and improving mobility, with a favorable safety profile. While continued research and development is ongoing to broaden the clinical evidence of Traumeel in acute musculoskeletal injury and to further establish its benefits, current information suggests that Traumeel may be considered as an anti-inflammatory agent that is at least as effective and appears to be better tolerated than NSAIDs. PMID:21556350

  15. Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.

    PubMed

    Liu, Lichuan; Bello, Akintunde; Dresser, Mark J; Heald, Donald; Komjathy, Steven Ferenc; O'Mara, Edward; Rogge, Mark; Stoch, S Aubrey; Robertson, Sarah M

    2016-02-01

    Ketoconazole has been widely used as a strong cytochrome P450 (CYP) 3A (CYP3A) inhibitor in drug-drug interaction (DDI) studies. However, the US Food and Drug Administration has recommended limiting the use of ketoconazole to cases in which no alternative therapies exist, and the European Medicines Agency has recommended the suspension of its marketing authorizations because of the potential for serious safety concerns. In this review, the Innovation and Quality in Pharmaceutical Development's Clinical Pharmacology Leadership Group (CPLG) provides a compelling rationale for the use of itraconazole as a replacement for ketoconazole in clinical DDI studies and provides recommendations on the best practices for the use of itraconazole in such studies. Various factors considered in the recommendations include the choice of itraconazole dosage form, administration in the fasted or fed state, the dose and duration of itraconazole administration, the timing of substrate and itraconazole coadministration, and measurement of itraconazole and metabolite plasma concentrations, among others. The CPLG's recommendations are based on careful review of available literature and internal industry experiences. PMID:26044116

  16. Religious treatments for drug addiction: an exploratory study in Brazil.

    PubMed

    van der Meer Sanchez, Zila; Nappo, Solange A

    2008-08-01

    The main objective of the present work is to understand the processes used in emerging Catholic and Protestant religious interventions for recovery from drug dependence, from the vantage point of individuals subjected to them. A qualitative method and an intentional sample selected by criteria were adopted for this investigation, which was conducted in São Paulo, Brazil. An in-depth semi-structured interview was conducted with 57 predominantly male former drug users who fit the criteria: they had been submitted to non-medical religious treatments to treat dependence and were abstinent for at least 6 months. Crisis was found to be the main reason leading interviewees to seek treatment; this includes, losing family, losing employment, and experiencing severe humiliation. Evangelicals most used religious resources exclusively as treatment, showing strong aversion to the role of doctors and to any type of pharmacological treatment. A common feature of Catholic and Protestant groups is the importance ascribed to praying and talking to God, described by subjects as strongly anxiolytic, and a means to control drug craving. Confession and forgiveness, through faith conversion or penitences, respectively, appeal strongly to the restructuring of life and increase of self-esteem. Religious interventions were considered effective by the individuals who underwent them and were seen as attractive for the humane, respectful treatment they delivered. The key aspects of this type of treatment are social support provided by the receiving group, equal treatment, and instant, judgment-free acceptance. The success of these actions, then, is not only due to some "supernatural" aspect, as might be assumed, but also more to the unconditional dedication of human beings to their peers. Given the difficulty in treating drug dependence, religious interventions could be used as a complementary treatment for conventional therapies. PMID:18501491

  17. [Experimental study of radiation protective efficacy of Vinca alkaloid drugs].

    PubMed

    Krasil'nikov, I I; Zhakovko, E B; Chigareva, N G

    1994-01-01

    In experiments with rats and dogs exposed to whole-body nonlethal and lethal gamma-radiation (2; 2,9 or 7.5 Gy) the radioprotective efficacy Vinca alkaloids drugs was investigated. It has been shown that enterally administered Vincanor (10 mg/kg over a three-day period) increased the radioresistance of animals. The prolonged radioprotective effect of Vincanor are discussed with regard to the phenomenon of sequential partial DNA synthesis inhibition in radiosensitive tissues. PMID:8069381

  18. Microprinting of liver micro-organ for drug metabolism study.

    PubMed

    Chang, Robert C; Emami, Kamal; Jeevarajan, Antony; Wu, Honglu; Sun, Wei

    2011-01-01

    In their normal in vivo matrix milieu, tissues assume complex well-organized 3D architectures. Therefore, a primary aim in the tissue engineering design process is to fabricate an optimal analog of the in vivo scenario, in which the precise configuration and composition of cells and bioactive matrix components can establish the well-defined biomimetic microenvironments that promote cell-cell and cell-matrix interactions. With the advent and refinements in microfabricated systems which can present physical and chemical cues to cells in a controllable and reproducible fashion unrealizable with conventional tissue culture, high-fidelity, high-throughput in vitro models are achieved. The convergence of solid freeform fabrication (SFF) technologies, namely microprinting, along with microfabrication techniques, a 3D microprinted micro-organ, can serve as an in vitro platform for cell culture, drug screening, or to elicit further biological insights. This chapter firstly details the principles, methods, and applications that undergird the fabrication process development and adaptation of microfluidic devices for the creation of a drug screening model. This model involves the combinatorial setup of an automated syringe-based, layered direct cell writing microprinting process with soft lithographic micropatterning techniques to fabricate a microscale in vitro device housing a chamber of microprinted 3D micro-organ that biomimics the cell's natural microenvironment for enhanced performance and functionality. In order to assess the structural formability and biological feasibility of such a micro-organ, 3D cell-encapsulated hydrogel-based tissue constructs are microprinted reproducibly in defined design patterns and biologically characterized for both viability and cell-specific function. Another key facet of the in vivo microenvironment that is recapitulated with the in vitro system is the necessary dynamic perfusion of the 3D microscale liver analog with cells probed for

  19. Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study

    PubMed Central

    Gulati, Sasha; Solheim, Ole; Carlsen, Sven M.; Øie, Lise R.; Jensberg, Heidi; Gulati, Agnete M.; Giannadakis, Charalampis; Jakola, Asgeir S.; Salvesen, Øyvind

    2015-01-01

    Background A wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014.   Methods and design The aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1 st, 2008, to December 31 st, 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database.   Trial registration number Clinicaltrials.gov (NCT02481011) PMID:26918124

  20. Polymeric nanoparticles containing diazepam: preparation, optimization, characterization, in-vitro drug release and release kinetic study

    NASA Astrophysics Data System (ADS)

    Bohrey, Sarvesh; Chourasiya, Vibha; Pandey, Archna

    2016-03-01

    Nanoparticles formulated from biodegradable polymers like poly(lactic-co-glycolic acid) (PLGA) are being extensively investigated as drug delivery systems due to their two important properties such as biocompatibility and controlled drug release characteristics. The aim of this work to formulated diazepam loaded PLGA nanoparticles by using emulsion solvent evaporation technique. Polyvinyl alcohol (PVA) is used as stabilizing agent. Diazepam is a benzodiazepine derivative drug, and widely used as an anticonvulsant in the treatment of various types of epilepsy, insomnia and anxiety. This work investigates the effects of some preparation variables on the size and shape of nanoparticles prepared by emulsion solvent evaporation method. These nanoparticles were characterized by photon correlation spectroscopy (PCS), transmission electron microscopy (TEM). Zeta potential study was also performed to understand the surface charge of nanoparticles. The drug release from drug loaded nanoparticles was studied by dialysis bag method and the in vitro drug release data was also studied by various kinetic models. The results show that sonication time, polymer content, surfactant concentration, ratio of organic to aqueous phase volume, and the amount of drug have an important effect on the size of nanoparticles. Hopefully we produced spherical shape Diazepam loaded PLGA nanoparticles with a size range under 250 nm with zeta potential -23.3 mV. The in vitro drug release analysis shows sustained release of drug from nanoparticles and follow Korsmeyer-Peppas model.

  1. Knowledge, perceptions and use of generic drugs: a cross sectional study

    PubMed Central

    de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

    2014-01-01

    Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

  2. Changing patterns of "drug abuse" in the United States: connecting findings from macro- and microepidemiologic studies.

    PubMed

    Sloboda, Zili

    2002-01-01

    Trend analyses of the U.S. monitoring data systems (the National Household Survey on Drug Abuse and the Monitoring the Future Study) and of the country's surveillance program, the Community Epidemiology Work Group (CEWG), indicate that several new "drug abuse" patterns have emerged over the past several years. For adolescents, drug use rates are converging for females and males, the mean age at which youngsters initiate drug use has declined, and more young adolescents are reporting using drugs. Furthermore, emergent new drug use patterns are being observed by the CEWG. The use of drugs such as Rohypnol, the injecting of crack-cocaine, and the spread of methamphetamines by new traffickers challenge our existing knowledge and understanding of drug use and its prevention. The National Institute on Drug Abuse has funded several large longitudinal studies that follow selected children and adolescents into their twenties, and some into their thirties. This research has been a rich source of information on the determinants of initiating and continuing drug abuse. Yet the findings from the surveys have not been well explored by the longitudinal studies, nor have the findings from the longitudinal studies been used in the surveys to better understand the observed changing trends in drug use patterns. This paper addresses six issues that have been observed from the findings from analyses of data from the surveys or macroepidemiologic studies. Information from the sub-population or micro-epidemiologic studies are reviewed for possible hypotheses to explain each issue. Suggestions for further research and implications for prevention also are presented. PMID:12180563

  3. Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century

    PubMed Central

    2013-01-01

    Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner. PMID:23822656

  4. 21 CFR 20.106 - Studies and reports prepared by or with funds provided by the Food and Drug Administration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Studies and reports prepared by or with funds provided by the Food and Drug Administration. 20.106 Section 20.106 Food and Drugs FOOD AND DRUG... Categories of Records § 20.106 Studies and reports prepared by or with funds provided by the Food and...

  5. Driving under the influence of non-alcohol drugs--An update. Part II: Experimental studies.

    PubMed

    Strand, M C; Gjerde, H; Mørland, J

    2016-07-01

    Experimental studies on the impairing effects of drugs of relevance to driving-related performance published between 1998 and 2015 were reviewed. Studies with on-the-road driving, driving simulators, and performance tests were included for benzodiazepines and related drugs, cannabis, opioids, stimulants, GHB, ketamine, antihistamines, and antidepressants. The findings in these experimental studies were briefly discussed in relation to a review of epidemiological studies published recently. The studies mainly concluded that there may be a significant psychomotor impairment after using benzodiazepines or related drugs, cannabis, opioids, GHB, or ketamine. Low doses of central stimulants did not seem to cause impairment of driving behavior. PMID:27257716

  6. A Comparative Study of the Attitudes of College Students and Drug Treatment Center Residents Toward Drugs, Other Drug Users and Themselves.

    ERIC Educational Resources Information Center

    Page, Richard C.; Mitchell, Sam

    1986-01-01

    Assessed the attitudes of college students and drug treatment center residents with histories of using marijuana and amphetamines. The drug treatment center residents tended to devalue themselves, drugs, and peers in the drug culture to a greater extent than the students. (Author/BL)

  7. Co-Prescribing of Potentially Interacting Drugs during Warfarin Therapy - A Population-Based Register Study.

    PubMed

    Rikala, Maria; Hauta-Aho, Milka; Helin-Salmivaara, Arja; Lassila, Riitta; Korhonen, Maarit Jaana; Huupponen, Risto

    2015-08-01

    We analysed the occurrence of co-prescribing of potentially interacting drugs during warfarin therapy in the community-dwelling population of Finland. We identified drugs having interaction potential with warfarin using the Swedish Finnish INteraction X-referencing drug-drug interaction database (SFINX) and obtained data on drug purchases from the nationwide Prescription Register. We defined warfarin users as persons purchasing warfarin in 2010 (n = 148,536) and followed them from their first prescription in 2010 until the end of the calendar year. Co-prescribing was defined as at least 1-day overlap between warfarin and interacting drug episodes. In addition, we identified persons who initiated warfarin therapy between 1 January 2007 and 30 September 2010 (n = 110,299) and followed these incident users for a 3-month period since warfarin initiation. Overall, 74.4% of warfarin users were co-prescribed interacting drugs. Co-prescribing covered 46.4% of the total person-years of warfarin exposure. Interacting drugs that should be avoided with warfarin were co-prescribed for 13.4% of warfarin users. The majority of the co-prescriptions were for drugs that are not contraindicated during warfarin therapy but require special consideration. Among incident users, 57.1% purchased potentially interacting drugs during the 3-month period after initiation, while 9.0% purchased interacting drugs that should be avoided with warfarin. To conclude, the occurrence of co-prescribing of potentially interacting drugs was high during warfarin therapy. Our findings highlight the importance of close monitoring of warfarin therapy and the need for further studies on the clinical consequences of co-prescribing of interacting drugs with warfarin. PMID:25537751

  8. Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: retrospective cohort study

    PubMed Central

    Pearce, Hannah Louise; Croft, Peter; Singh, Swaran; Crome, Ilana; Bashford, James; Frisher, Martin

    2014-01-01

    Objective To test the hypothesis that people taking anxiolytic and hypnotic drugs are at increased risk of premature mortality, using primary care prescription records and after adjusting for a wide range of potential confounders. Design Retrospective cohort study. Setting 273 UK primary care practices contributing data to the General Practice Research Database. Participants 34 727 patients aged 16 years and older first prescribed anxiolytic or hypnotic drugs, or both, between 1998 and 2001, and 69 418 patients with no prescriptions for such drugs (controls) matched by age, sex, and practice. Patients were followed-up for a mean of 7.6 years (range 0.1-13.4 years). Main outcome All cause mortality ascertained from practice records. Results Physical and psychiatric comorbidities and prescribing of non-study drugs were significantly more prevalent among those prescribed study drugs than among controls. The age adjusted hazard ratio for mortality during the whole follow-up period for use of any study drug in the first year after recruitment was 3.46 (95% confidence interval 3.34 to 3.59) and 3.32 (3.19 to 3.45) after adjusting for other potential confounders. Dose-response associations were found for all three classes of study drugs (benzodiazepines, Z drugs (zaleplon, zolpidem, and zopiclone), and other drugs). After excluding deaths in the first year, there were approximately four excess deaths linked to drug use per 100 people followed for an average of 7.6 years after their first prescription. Conclusions In this large cohort of patients attending UK primary care, anxiolytic and hypnotic drugs were associated with significantly increased risk of mortality over a seven year period, after adjusting for a range of potential confounders. As with all observational findings, however, these results are prone to bias arising from unmeasured and residual confounding. PMID:24647164

  9. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    PubMed

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2015-01-01

    There remain significant difficulties selecting probable candidate drugs from existing databases. We describe an ontology-oriented approach to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. We also report a case study in which we attempted to explore candidate drugs effective for bipolar disorder and epilepsy. We constructed an ontology incorporating knowledge between the two diseases and performed semantic reasoning tasks with the ontology. The results suggested 48 candidate drugs that hold promise for further breakthrough. The evaluation demonstrated the validity our approach. Our approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders. PMID:26262350

  10. The elimination of selected drug products from the Michigan Medicaid formulary: a case study.

    PubMed

    Smith, D M; McKercher, P L

    1984-05-01

    The purpose of this study was to evaluate the prescribing behavior, recipient response, and economic impact of the removal of selected prescription drug products from the Michigan Medicaid formulary. The frequency with which alternate legend drugs were prescribed and the frequency of continuous therapy via out-of-pocket cash were determined. From 17 independent Michigan pharmacies, a total of 137 patients with prescriptions for at least one eliminated drug product was identified. Of the Medicaid recipients on continuous therapy, 46% discontinued therapy. Over 23% had an alternate legend drug prescribed still covered under the Medicaid drug benefit. The alternate drug resulted in significantly higher acquisition costs. Over 30% of the recipients continued therapy at their own expense, representing a cost savings to the Medicaid program. PMID:10299510

  11. Incorporation of tramadol drug into Li-fluorohectorite clay: A preliminary study of a medical nanofluid

    NASA Astrophysics Data System (ADS)

    Valdés, L.; Hernández, D.; de Ménorval, L. Ch.; Pérez, I.; Altshuler, E.; Fossum, J. O.; Rivera, A.

    2016-07-01

    During the last years, clays have been increasingly explored as hosts for drugs. In the present paper, we have been able to host the non-steroidal anti-inflammatory drug, Tramadol, into the clay Li-fluorohectorite (Li-Fh). We preliminary evaluate its incorporation by means of UV spectroscopy and X ray diffraction. Our results indicate that the clay hosts the drug molecule in its interlayer space. We suggest a set of parameters to guarantee an efficient incorporation process. Future studies will concentrate on the release of the drug from the clay nanofluid.

  12. Feasibility of providing interventions for injection drug users in pharmacy settings: a case study among San Francisco pharmacists.

    PubMed

    Rose, Valerie J; Lutnick, Alexandra; Kral, Alex H

    2014-01-01

    In addition to syringe exchange programs, pharmacies are important venues where injection drug users (IDUs) can access non-prescription syringes and other prevention interventions. This study assessed the feasibility of providing a range of interventions for IDUs in pharmacy settings. Semi-structured qualitative interviews were conducted with 23 participants (policy makers, owner/managers, dispensing pharmacists, and pharmacy staff) from independent and chain/retail pharmacies in San Francisco, California, USA. The highest level of support was for a coupon syringe program and educational materials. Several overarching themes illustrate challenges to implementing pharmacy-based preventive interventions: time, space, sufficient staff, pharmacist training, legal considerations, pharmacist attitudes toward IDUs, and cost and reimbursement issues. This study provides concrete examples of the types of preventive services that pharmacists support and consider feasible, and illustrates that pharmacists welcome the opportunity to broaden their role as critical partners in public health matters related to injection drug use. PMID:25052881

  13. Feasibility of Providing Interventions for Injection Drug Users in Pharmacy Settings: A Case Study Among San Francisco Pharmacists

    PubMed Central

    Rose, Valerie J.; Lutnick, Alexandra; Kral, Alex H.

    2014-01-01

    In addition to syringe exchange programs, pharmacies are important venues where injection drug users (IDUs) can access non-prescription syringes and other prevention interventions. This study assessed the feasibility of providing a range of interventions for IDUs in pharmacy settings. Semi-structured qualitative interviews were conducted with 23 participants (policy makers, owner/managers, dispensing pharmacists, and pharmacy staff) from independent and chain/retail pharmacies in San Francisco, California, USA. The highest level of support was for a coupon syringe program and educational materials. Several overarching themes illustrate challenges to implementing pharmacy-based preventive interventions: time, space, sufficient staff, pharmacist training, legal considerations, pharmacist attitudes toward IDUs, and cost and reimbursement issues. This study provides concrete examples of the types of preventive services that pharmacists support and consider feasible, and illustrates that pharmacists welcome the opportunity to broaden their role as critical partners in public health matters related to injection drug use. PMID:25052881

  14. Pain, Epilepsy Drug Lyrica May Increase Birth Defects Risk, Study Suggests

    MedlinePlus

    ... nih.gov/medlineplus/news/fullstory_158906.html Pain, Epilepsy Drug Lyrica May Increase Birth Defects Risk, Study ... prescribed for a range of health problems, including epilepsy, fibromyalgia and anxiety. The new study findings should ...

  15. Pain, Epilepsy Drug Lyrica May Increase Birth Defects Risk, Study Suggests

    MedlinePlus

    ... 158906.html Pain, Epilepsy Drug Lyrica May Increase Birth Defects Risk, Study Suggests Expectant mothers should probably ... pregabalin (Lyrica) may slightly increase the risk for birth defects, a new study suggests. In a small ...

  16. Large Variation in Brain Exposure of Reference CNS Drugs: a PET Study in Nonhuman Primates

    PubMed Central

    Varnäs, Katarina; Lundquist, Stefan; Nakao, Ryuji; Amini, Nahid; Takano, Akihiro; Finnema, Sjoerd J.; Halldin, Christer; Farde, Lars

    2015-01-01

    Background: Positron emission tomography microdosing of radiolabeled drugs allows for noninvasive studies of organ exposure in vivo. The aim of the present study was to examine and compare the brain exposure of 12 commercially available CNS drugs and one non-CNS drug. Methods: The drugs were radiolabeled with 11C (t 1/2 = 20.4 minutes) and examined using a high resolution research tomograph. In cynomolgus monkeys, each drug was examined twice. In rhesus monkeys, a first positron emission tomography microdosing measurement was repeated after preadministration with unlabeled drug to examine potential dose-dependent effects on brain exposure. Partition coefficients between brain and plasma (K P) were calculated by dividing the AUC0-90 min for brain with that for plasma or by a compartmental analysis (V T). Unbound K P (K P u,u) was obtained by correction for the free fraction in brain and plasma. Results: After intravenous injection, the maximum radioactivity concentration (C max, %ID) in brain ranged from 0.01% to 6.2%. For 10 of the 12 CNS drugs, C max, %ID was >2%, indicating a preferential distribution to brain. A lower C max, %ID was observed for morphine, sulpiride, and verapamil. K P ranged from 0.002 (sulpiride) to 68 (sertraline) and 7 of 13 drugs had K P u,u close to unity. For morphine, sulpiride, and verapamil, K P u,u was <0.3, indicating impaired diffusion and/or active efflux. Brain exposure at microdosing agreed with pharmacological dosing conditions for the investigated drugs. Conclusions: This study represents the largest positron emission tomography study on brain exposure of commercially available CNS drugs in nonhuman primates and may guide interpretation of positron emission tomography microdosing data for novel drug candidates. PMID:25813017

  17. Can a medical need clause help manage the growing costs of prescription drugs in the EU?

    PubMed

    Brooks, Eleanor; Geyer, Robert

    2016-04-01

    Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems? PMID:26333920

  18. [Integration of drug treatment in the management concept of prostate cancer].

    PubMed

    Cathomas, R

    2013-10-01

    The drug treatment of prostate cancer was for many years based on androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analogues.This treatment still represents the standard first line treatment for advanced prostate cancer. In cases of progression to metastatic castration-resistant prostate cancer (mCRPC) further treatment options used to be limited. Only the chemotherapy drug docetaxel could demonstrate a significant overall survival benefit. Within the last few years, however, five new treatments for patients with mCRCP have achieved significant results in large phase III trials. Interestingly they have different mechanisms of action: abiraterone is a testosterone synthesis inhibitor, enzalutamide is a novel antiandrogen, cabazitaxel is a cytotoxic drug, radium-223 is a radionuclide and sipuleucel-T an immunotherapy. Further new drugs are under investigation. The integration of these new treatment options as well as an optimal sequence and combination is the main focus of current research. PMID:23896735

  19. Cannabis: a self-medication drug for weight management? The never ending story.

    PubMed

    Bersani, Francesco Saverio; Santacroce, Rita; Coviello, Marialuce; Imperatori, Claudio; Francesconi, Marta; Vicinanza, Roberto; Minichino, Amedeo; Corazza, Ornella

    2016-02-01

    In a society highly focused on physical appearance, people are increasingly using the so-called performance and image-enhancing drugs (PIEDs) or life-style drugs as an easy way to control weight. Preliminary data from online sources (e.g. websites, drug forums, e-newsletters) suggest an increased use of cannabis amongst the general population as a PIED due to its putative weight-loss properties. The use of cannabis and/or cannabis-related products to lose weight may represent a new substance-use trend that should be carefully monitored and adequately investigated, especially in light of the well-known adverse psychiatric and somatic effects of cannabis, its possible interaction with other medications/drugs and the unknown and potentially dangerous composition of synthetic cannabimimetics preparations. PMID:26456495

  20. Using Healthcare IC Cards to manage the drug doses of chronic disease patients.

    PubMed

    Lai, Jiun-Tze; Hou, Ting-Wei; Yeh, Chiun-Lin; Chao, Chien-Min

    2007-02-01

    In Taiwan's medical system, the Healthcare IC Card is used as form of secure data storage. This research applies the Healthcare IC Card to record the chronic disease patient's recent drug doses, diagnoses and prescriptions. With the Hospital Information System, this research combines the diagnosis records stored in the Healthcare IC Card to establish a platform which could simulate the procedures of a doctor in examining a patient and checking the circumstances of the patient's repetitive drug doses and drugs interactions. The experiment is based on a data log of about 22,000 items of drug prescribed to 43 diabetes patients and about 88,200 items to 192 high blood pressure patients. The results show that the proposed approach would have reduced the waste of medical resources, strengthened Taiwan's medical system and increased the public's health. PMID:16494858

  1. Demand for a Medicare prescription drug benefit: exploring consumer preferences under a managed competition framework.

    PubMed

    Cline, Richard R; Mott, David A

    2003-01-01

    Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit. PMID:13677564

  2. Niacin as a drug repositioning candidate for hyperphosphatemia management in dialysis patients

    PubMed Central

    Shin, Sooyoung; Lee, Sukhyang

    2014-01-01

    Nearly all patients with end-stage renal disease develop hyperphosphatemia. These patients typically require oral phosphate binders for life-long phosphorus management, in addition to dietary restrictions and maintenance dialysis. Recently, niacin, a traditional antilipemic agent, drew attention as an experimental treatment for hyperphosphatemia. The purpose of this article was to report on new findings regarding niacin’s novel effects and to review the possibility of repurposing niacin for hyperphosphatemia treatment in dialysis patients by elucidating its safety and efficacy profiles along with its synergistic clinical benefits. Following approval from the Institutional Review Board, we tracked the yearly trends of order frequency of niacin in comparison with statins and sevelamer in a tertiary care hospital. Also, a Cochrane Library and PubMed literature search was performed to capture prospective clinical trials on niacin’s hypophosphatemic effects in dialysis patients. Niacin use in clinical settings has been on the wane, and the major contribution to that originates from the wide use of statins. Niacin use rates have further plummeted following a trial failure which prompted the suspension of the niacin-laropiprant (a flushing blocker) combination product in the global market. Our literature search identified ten relevant articles. Overall, all studies demonstrated that niacin or nicotinamide (the metabolite form) reduced serum phosphorus levels as well as Ca-P products significantly. Additive beneficial effects on lipid parameters were also observed. Sevelamer appeared superior to niacin in a comparative study, but the study design had several limitations. The intervention dosage for niacin ranged from 375 to 1,500 mg/day, with the average daily dose of approximately 1,000–1,500 mg. Niacin can be a patient-convenient and inexpensive alternative or adjunctive therapy for phosphorus management in dialysis patients. Further well-designed, large

  3. Use of drug therapy to manage acute cutaneous necrosis of the skin.

    PubMed

    Wallace, Jill S; Hall, John C

    2010-04-01

    Acute cutaneous necrosis is defined as a sudden onset of gangrenous skin changes in the skin, associated with significant morbidity and mortality. The following diseases are included in this discussion: coumadin necrosis, heparin necrosis, brown recluse spider bite, necrotizing fasciitis, vasculitis, pyoderma gangrenosum, calciphylaxis, clotting abnormalities and embolic phenomena. The importance of early diagnosis, early distinction and early drug therapy or drug withdrawal must match the diagnosis for maximal preservation of the skin and underlying tissue. PMID:20514791

  4. Drug usage review sample studies in long-term care facilities.

    PubMed

    Stewart, J E; Kabat, H F; Wertheimer, A I

    1976-02-01

    The usage of 10 drugs in five long-term care facilities was reviewed to evaluate the effectiveness of a five-step systematic method of drug usage review. Medical care evaluation sample studies are required under the Medicare and Medicaid programs, and drug usage review sample studies may satisfy this requirement. The five-step method involved selection of the health problem to be studied; development of criteria of care; measurement of specific performance data and comparison with the criteria; establishment of the audit committee evaluation process; and design and implementation of educational activities. In each facility, data were collected on abstract sheets designed to indicate when a patient's drug usage did not conform to criteria established by a committee of health professionals. Incidents of nonconformance were then examined. The largest number of exceptions to the criteria related to monitoring the effectiveness of drug therapy. Data by drug revealed higher nonconformance rates for digoxin, hydrochlorothiazide, methyldopa and thioridazine. A small number of exceptions was found in drug administration, indicating that the patients were receiving medications as ordered and that few errors were made in transcribing. This systematic approach to identifying drug usage patterns can be used by pharmacists to coordinate sample studies and to fulfill their consultant role in long-term facilities required by federal regulations. PMID:816197

  5. An Exploratory Study of Drug-Exposed Infants: Case Substantiation and Subsequent Child Maltreatment

    ERIC Educational Resources Information Center

    Sun, An-Pyng; Freese, Margaret P.; Fitzgerald, Mark

    2007-01-01

    This study explores factors related to drug-exposed infants' case substantiation and subsequent child maltreatment. Child protective services computerized administrative data (from January 1998 to October 2001) were obtained from an urban Nevada county. The data included 457 drug-exposed infant cases. Chi-square, t-test, one-way ANOVA, and…

  6. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... as other than “effective” by a panel of the National Academy of Sciences—National Research...

  7. Longitudinal HIV Risk Behavior among the Drug Abuse Treatment Outcome Studies (DATOS) Adult Sample

    ERIC Educational Resources Information Center

    Murphy, Debra A.; Brecht, Mary-Lynn; Herbeck, Diane; Evans, Elizabeth; Huang, David; Hser, Yih-Ing

    2008-01-01

    Longitudinal trajectories for HIV risk were examined over 5 years following treatment among 1,393 patients who participated in the nationwide Drug Abuse Treatment Outcome Studies. Both injection drug use and sexual risk behavior declined over time, with most of the decline occurring between intake and the first-year follow-up. However, results of…

  8. Impact of Opioid and Nonopioid Drugs on Postsurgical Pain Management in the Rat.

    PubMed

    Wilson, Natalie M; Ripsch, Matthew S; White, Fletcher A

    2016-01-01

    Aim. Nonsteroidal anti-inflammatory drugs or opioids are commonly used to control surgical pain following veterinary and clinical procedures. This study evaluated the efficacy of postoperative ketorolac or buprenorphine following abdominal surgery. Main Methods. Mean arterial pressure (MAP), heart rate, animal activity, corticosterone levels, and a nociceptive sensitivity assay were used to evaluate 18 adult male Sprague-Dawley rats which underwent aortic artery occlusion for implantation of a radiotelemetry device. The animals were treated postoperatively with intraperitoneal injections of vehicle, ketorolac (10 mg/kg), or buprenorphine (0.06 mg/kg) every 8 hours for 3 days. Key Findings. There were no consistent significant changes in any of the telemetry parameters after treatment with ketorolac compared with no saline treatment with the exception of increased MAP in the buprenorphine group during the first 48 hours when compared with other treatment groups. There was a sustained increase in fecal corticosterone levels from baseline on days 2-7 with buprenorphine compared with vehicle- or ketorolac-treated animals. All treatment conditions displayed reduced paw withdrawal thresholds (PWTs) from day 1 to day 21 following surgery. Compared with the vehicle treatment group, buprenorphine-treated animals exhibited significantly lower PWT levels from day 4 to 14 days. Significance. Given the prolonged increase in fecal corticosterone levels and pronounced changes in tactile hyperalgesia behavior in rodents subjected to buprenorphine treatment, these data suggest that ketorolac may be superior to buprenorphine for the treatment of postprocedure pain behavior in rodents. PMID:27069684

  9. Impact of Opioid and Nonopioid Drugs on Postsurgical Pain Management in the Rat

    PubMed Central

    Wilson, Natalie M.; Ripsch, Matthew S.; White, Fletcher A.

    2016-01-01

    Aim. Nonsteroidal anti-inflammatory drugs or opioids are commonly used to control surgical pain following veterinary and clinical procedures. This study evaluated the efficacy of postoperative ketorolac or buprenorphine following abdominal surgery. Main Methods. Mean arterial pressure (MAP), heart rate, animal activity, corticosterone levels, and a nociceptive sensitivity assay were used to evaluate 18 adult male Sprague-Dawley rats which underwent aortic artery occlusion for implantation of a radiotelemetry device. The animals were treated postoperatively with intraperitoneal injections of vehicle, ketorolac (10 mg/kg), or buprenorphine (0.06 mg/kg) every 8 hours for 3 days. Key Findings. There were no consistent significant changes in any of the telemetry parameters after treatment with ketorolac compared with no saline treatment with the exception of increased MAP in the buprenorphine group during the first 48 hours when compared with other treatment groups. There was a sustained increase in fecal corticosterone levels from baseline on days 2–7 with buprenorphine compared with vehicle- or ketorolac-treated animals. All treatment conditions displayed reduced paw withdrawal thresholds (PWTs) from day 1 to day 21 following surgery. Compared with the vehicle treatment group, buprenorphine-treated animals exhibited significantly lower PWT levels from day 4 to 14 days. Significance. Given the prolonged increase in fecal corticosterone levels and pronounced changes in tactile hyperalgesia behavior in rodents subjected to buprenorphine treatment, these data suggest that ketorolac may be superior to buprenorphine for the treatment of postprocedure pain behavior in rodents. PMID:27069684

  10. Added value of whole-genome sequencing for management of highly drug-resistant TB

    PubMed Central

    Outhred, Alexander C.; Jelfs, Peter; Suliman, Basel; Hill-Cawthorne, Grant A.; Crawford, Archibald B. H.; Marais, Ben J.; Sintchenko, Vitali

    2015-01-01

    Objectives Phenotypic drug susceptibility testing (DST) for Mycobacterium tuberculosis takes several weeks to complete and second-line DST is often poorly reproducible, potentially leading to compromised clinical decisions. Following a fatal case of XDR TB, we investigated the potential benefit of using whole-genome sequencing to generate an in silico drug susceptibility profile. Methods The clinical course of the patient was reviewed, assessing the times at which phenotypic DST data became available and changes made to the therapeutic regimen. Whole-genome sequencing was performed on the earliest available isolate and variants associated with drug resistance were identified. Results The final DST report, including second-line drugs, was issued 10 weeks after patient presentation and 8 weeks after initial growth of M. tuberculosis. In the interim, the patient may have received a compromised regimen that had the potential to select for further drug resistance. The in silico susceptibility profile, extrapolated from evolving evidence in the literature, provided comparable or superior data to the DST results for second-line drugs and could be generated in a much shorter timeframe. Conclusions We propose routine whole-genome sequencing of all MDR M. tuberculosis isolates in adequately resourced settings. This will improve individual patient care, monitor for transmission events and advance our understanding of resistance-associated mutations. PMID:25492392

  11. Participants’ Perceptions of a Multidisciplinary Training Program for Graduate and Postgraduate Students in Drug Use Management and Policy

    PubMed Central

    Conrad, Patricia; Langille-Ingram, Ethel

    2013-01-01

    Objective. To determine graduate and postgraduate students’ perceptions of a drug use management and policy program that applied wide-ranging policy research skills to inform pharmaceutical decision-making. Design. Nine cohorts of graduate and postgraduate students from diverse academic and professional backgrounds were paired with health-system preceptors for 4 months, and supported by faculty advisors and administrators, to complete research projects that generated evidence to inform policy decisions. Assessment. A self-administered survey instrument was sent to all alumni of the program over the previous 10 years. The majority of respondents indicated: their prior academic coursework could be applied to everyday life; service-learning projects complemented university programs; participation led to greater awareness of decision-makers’ needs and appreciation of their tacit knowledge; and communication abilities were enhanced with decision-makers, and academics. Many also reported personal desire to fulfill healthcare-system research needs; personal belief in their ability to make a difference; and increased postgraduation marketability. Conclusion. A drug use management and policy program allowed graduate students from various disciplines to develop new skills and collaborate with experts to produce research evidence that was relevant to drug policy that addressed real-world problems. PMID:23788813

  12. Food, Drugs, and TV: The Social Study of Corporate Science

    ERIC Educational Resources Information Center

    Schleifer, David; Penders, Bart

    2011-01-01

    This article describes the contributions in this special issue, which brings together contributions that explore the varied ways in which science is practiced, managed, contested, and abandoned in corporate settings. From these empirical contributions, the authors aim to provoke reflection on the usefulness of the demarcations between for-profit…

  13. Influence of an e-mail with a drug information attachment on sales of prescribed drugs: a randomized controlled study

    PubMed Central

    Edward, Christina; Himmelmann, Anders; Wallerstedt, Susanna M

    2007-01-01

    Background To provide doctors with producer-independent information to facilitate choice of treatment is an important task. The objective of the present study was to evaluate if an e-mail with a drug information attachment has effects on sales of prescribed drugs and if the design of the attachment is of importance. Methods The Swedish pharmaceutical benefit board found rizatriptan (Maxalt®) 10 mg to be the most cost-effective triptan. All 119 heads of primary care units in western Sweden were randomized to receive information concerning this conclusion via (i) e-mail with attachment I, (ii) e-mail with attachment II or (iii) no information (control). Attachment I was a short one (heading plus three lines text), whereas attachment II was a long one (heading plus one page text and one page with tables). The change in percentage rizatriptan of total triptans sold before and after the intervention (May – July 2004 and May – July 2005, respectively) was compared between the groups. Results Totally 48,229 (2004) and 50,674 (2005) defined daily doses of triptans were prescribed and sold during May – July in primary care units in the western part of Sweden. The absolute change in percentage rizatriptan was greater in the intervention groups compared with the control group 2 (25th – 75th percentile: -3 – 7) vs 0 (-7 - 5), P = 0.031). The absolute change in percentage rizatriptan did not differ between the two attachment groups (P = 0.93). Conclusion An e-mail with a drug information attachment may influence sales of prescribed drugs. No difference between different designs of the attachment could be detected. PMID:17942000

  14. Evaluation of utility of pharmacokinetic studies in phase I trials of two oncology drugs

    PubMed Central

    Wu, Kehua; House, Larry; Ramírez, Jacqueline; Seminerio, Michael J.; Ratain, Mark J.

    2013-01-01

    Purpose There are many phase I trials of oncology drug combinations, very few of which report clinically significant pharmacokinetic interactions. We hypothesized that the utility of such pharmacokinetic drug-drug interaction (DDI) studies is low in the absence of a mechanistic hypothesis. Experimental Design We retrospectively reviewed 152 phase I (2 drug) combination studies published in 2007–2011. Results Only 28 (18%) studies had an implicit or explicit rationale, either inhibition/induction of a drug metabolizing enzyme or transporter, co-substrates for the same enzyme or transporter, potential for end-organ toxicity, or protein binding. Only 12 (8%) studies demonstrated a statistically significant DDI, based on change in clearance (or area under the curve) of parent drug and/or active metabolite. There was a strong association between a rationale and a demonstrable drug interaction, as only 2% of studies without a rationale demonstrated a DDI, compared to 32% of studies with a rationale (Fisher’s exact test, p<10−6). Conclusion DDI studies should not be routinely performed as part of phase I trials of oncology combinations. PMID:24056785

  15. Evaluation of the Feasibility and Utility of a Pharmacist-Centered Collaborative Drug Therapy Management Program for Oncology-Based Symptom Management.

    PubMed

    Hansen, Elizabeth A; Pietkiewicz, John M; Blum, Bonnie L

    2016-06-01

    Collaborative drug therapy management (CDTM) is a practice agreement between a pharmacist and a physician, which allows the pharmacist to assume responsibility of drug therapy management. There has been limited documentation of CDTM practices in the oncology setting. Therefore, a CDTM program in the gynecology oncology clinic at Roswell Park Cancer Institute (RPCI) was initiated to establish the feasibility and utility of CDTM and its effects on patient care and physician satisfaction. Primarily, 3 symptoms were managed by the CDTM pharmacists, namely chemotherapy-induced nausea and vomiting (CINV), chemotherapy-induced peripheral neuropathy (CIPN), and women's health. The CDTM program showed favorable results after a short 4-month period. The CDTM pharmacists were referred a total of 12 consultations for CDTM purposes; 8 patients enrolled in the CIPN CDTM protocol, 3 in the CINV protocol, and 1 in the women's health protocol. The CDTM pharmacists were able to perform a total of 54 consultations, with a mean time of 16.9 minutes spent with each patient per consultation. Additionally, the CDTM pharmacists made 70 interventions and identified 6 medication-related adverse effects. The patient and physician satisfaction survey demonstrated the value of the CDTM pharmacists, and respondents were supportive of the program. PMID:25510586

  16. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    PubMed

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy. PMID:25750163

  17. Application of intracerebral microdialysis to study regional distribution kinetics of drugs in rat brain.

    PubMed

    de Lange, E C; Bouw, M R; Mandema, J W; Danhof, M; de Boer, A G; Breimer, D D

    1995-11-01

    1. The purpose of the present study was to determine whether intracerebral microdialysis can be used for the assessment of local differences in drug concentrations within the brain. 2. Two transversal microdialysis probes were implanted in parallel into the frontal cortex of male Wistar rats, and used as a local infusion and detection device respectively. Within one rat, three different concentrations of atenolol or acetaminophen were infused in randomized order. By means of the detection probe, concentration-time profiles of the drug in the brain were measured at interprobe distances between 1 and 2 mm. 3. Drug concentrations were found to be dependent on the drug as well as on the interprobe distance. It was found that the outflow concentration from the detection probe decreased with increasing lateral spacing between the probes and this decay was much steeper for acetaminophen than for atenolol. A model was developed which allows estimation of kbp/Deff (transfer coefficient from brain to blood/effective diffusion coefficient in brain extracellular fluid), which was considerably larger for the more lipohilic drug, acetaminophen. In addition, in vivo recovery values for both drugs were determined. 4. The results show that intracerebral microdialysis is able to detect local differences in drug concentrations following infusion into the brain. Furthermore, the potential use of intracerebral microdialysis to obtain pharmacokinetic parameters of drug distribution in brain by means of monitoring local concentrations of drugs in time is demonstrated. PMID:8581296

  18. Rheological characterization and drug release studies of gum exudates of Terminalia catappa Linn.

    PubMed

    Kumar, Sadhis V; Sasmal, Dinakar; Pal, Subodh C

    2008-01-01

    The present study was undertaken to evaluate the gum exudates of Terminalia catappa Linn. (TC gum) as a release retarding excipient in oral controlled drug delivery system. The rheological properties of TC gum were studied and different formulation techniques were used to evaluate the comparative drug release characteristics. The viscosity was found to be dependent on concentration and pH. Temperature up to 60 degrees C did not show significant effect on viscosity. The rheological kinetics evaluated by power law, revealed the shear thinning behavior of the TC gum dispersion in water. Matrix tablets of TC gum were prepared with the model drug dextromethorphan hydrobromide (DH) by direct compression, wet granulation and solid dispersion techniques. The dissolution profiles of the matrix tablets were compared with the pure drug containing capsules using the USP Basket apparatus with 500 ml phosphate buffer of pH 6.8 as a dissolution medium. The drug release from the compressed tablets containing TC gum was comparatively sustained than pure drug containing capsules. Even though all the formulation techniques showed reduction of dissolution rate, aqueous wet granulation showed the maximum sustained release of more than 8 h. The release kinetics estimated by the power law revealed that the drug release mechanism involved in the dextromethorphan matrix is anomalous transport as indicated by the release exponent n values. Thus the study confirmed that the TC gum might be used in the controlled drug delivery system as a release-retarding polymer. PMID:18661243

  19. [Exploration and demonstration study on drug combination from clinical real world].

    PubMed

    Xie, Yan-ming; Wang, Lian-xin; Wang, Yong-yan

    2014-09-01

    Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM. PMID:25532371

  20. Guidelines for Managing and Writing a Self Study for Accreditation.

    ERIC Educational Resources Information Center

    Garner, S. J.; Vice, Janna

    2000-01-01

    Proposes guidelines for managing and writing self-study documents prepared by school district business officials seeking accreditation by the International Association for Management Education. Includes description of the writing team and an organized data-collection method. (PKP)

  1. Minimally Invasive Swine Experimental Model for the In Vivo Study of Liver Metabolism of Drugs

    PubMed Central

    Piazza, O; Romano, R; Scarpati, G; Esposito, C; Cavaglià, E; Corona, M

    2012-01-01

    Purpose To develop a clinically relevant porcine model for the study of hepatic metabolism of drugs by means of hepatic vein catheterization. Materials and Methods: review of literature and elaboration of a hypothesis, design of an experimental method. Results: recent clinical studies were conducted by withdrawing cirrhotic patients’ blood from right hepatic vein during hepatic vein pressure gradient measurements. Basing on our personal clinical experience and evaluation of research needs, an experimental model is proposed. Conclusions: contemporary measurement of peripheral and hepatic concentration of drugs by peripheral vein and hepatic vein catheterization can be used to create a reliable and reproducible porcine model to study liver metabolism of drugs in vivo. PMID:23905064

  2. The role of radiology in diagnosis and management of drug mules: an update with new challenges and new diagnostic tools.

    PubMed

    Bulakci, Mesut; Cengel, Ferhat

    2016-01-01

    Emergency physicians and radiologists have been increasingly encountering internal concealment of illegal drugs. The packages commonly contain powdered solid drugs such as cocaine, heroin, methamphetamine and hashish, but they may also contain cocaine in the liquid form. The second type of package has recently been more commonly encountered, and poses a greater diagnostic challenge. As clinical evaluation and laboratory tests frequently fail to make the correct diagnosis, imaging examination is typically required. Imaging methods assume a vital role in the diagnosis, follow-up and management. Abdominal X-ray, ultrasonography, CT and MRI are used for the imaging purposes. Among the aforementioned methods, low-dose CT is state-of-the-art in these cases. It is of paramount importance that radiologists have a full knowledge of the imaging characteristics of these packages and accurately guide physicians and security officials. PMID:26867003

  3. A 2012 Workshop: Vaccine and Drug Ontology in the Study of Mechanism and Effect (VDOSME 2012).

    PubMed

    He, Yongqun; Toldo, Luca; Burns, Gully; Tao, Cui; Abernethy, Darrell R

    2012-01-01

    Vaccines and drugs have contributed to dramatic improvements in public health worldwide. Over the last decade, there have been efforts in developing biomedical ontologies that represent various areas associated with vaccines and drugs. These ontologies combined with existing health and clinical terminology systems (e.g., SNOMED, RxNorm, NDF-RT, MedDRA, VO, OAE, and AERO) could play significant roles on clinical and translational research. The first "Vaccine and Drug Ontology in the Study of Mechanism and Effect" workshop (VDOSME 2012) provided a platform for discussing problems and solutions in the development and application of biomedical ontologies in representing and analyzing vaccines/drugs, vaccine/drug administrations, vaccine/drug-induced immune responses (including positive host responses and adverse events), and similar topics. The workshop covered two main areas: (i) ontologies of vaccines, of drugs, and of studies thereof; and (ii) analysis of administration, mechanism and effect in terms of representations based on such ontologies. Six full-length papers included in this thematic issue focus on ontology representation and time analysis of vaccine/drug administration and host responses (including positive immune responses and adverse events), vaccine and drug adverse event text mining, and ontology-based Semantic Web applications. The workshop, together with the follow-up activities and personal meetings, provided a wonderful platform for the researchers and scientists in the vaccine and drug communities to demonstrate research progresses, share ideas, address questions, and promote collaborations for better representation and analysis of vaccine and drug-related terminologies and clinical and research data. PMID:23249650

  4. Health Canada's use of its priority review process for new drugs: a cohort study

    PubMed Central

    Lexchin, Joel

    2015-01-01

    Objectives Priority reviews of new drug applications are resource intensive and drugs approved through this process have a greater likelihood of acquiring a serious safety warning compared to drugs approved through the standard process. Therefore, when Health Canada uses priority reviews, it is important that it accurately identifies products that represent a significant therapeutic advance. The purpose of this study is to compare Health Canada's use of priority reviews to therapeutic ratings from two independent organisations, the Patented Medicine Prices Review Board (PMPRB) and the French drug bulletin Prescrire International, over the period 1 January 1997–31 December 2012. Design Cohort study. Data sources Annual reports of the Therapeutic Products Directorate, and the Biologics and Genetic Therapies Directorate; evaluations of therapeutic innovation from PMPRB and Prescrire International; WHO Collaborating Centre for Drug Statistics Methodology. Interventions Assessments by PMPRB and Prescrire International treated as a gold standard for postmarket therapeutic value. Primary and secondary outcome measures Drug-by-drug comparison between the review status from Health Canada and the therapeutic status from PMPRB/Prescrire using κ values, and positive and negative predictive values. Analysis of the per cent of all new drug applications put into the priority review category over the 16-year period. Results Health Canada approved 426 new drugs, and 345 were evaluated by PMPRB and/or Prescrire. 91 had a priority review and 52 were assessed as innovative (p=0.0003). Agreement between Health Canada and PMPRB/Prescrire was only fair (κ=0.330). The positive predictive value for Health Canada's review assignments was 36.3% and the negative predictive value was 92.5%. Conclusions Health Canada's assignment of a priority approval to a new drug submission is only a fair predictor of the drug's therapeutic value once it is marketed. Health Canada should review its

  5. Management of patients with multidrug-resistant/extensively drug-resistant tuberculosis in Europe: a TBNET consensus statement

    PubMed Central

    Lange, Christoph; Abubakar, Ibrahim; Alffenaar, Jan-Willem C.; Bothamley, Graham; Caminero, Jose A.; Carvalho, Anna Cristina C.; Chang, Kwok-Chiu; Codecasa, Luigi; Correia, Ana; Crudu, Valeriu; Davies, Peter; Dedicoat, Martin; Drobniewski, Francis; Duarte, Raquel; Ehlers, Cordula; Erkens, Connie; Goletti, Delia; Günther, Gunar; Ibraim, Elmira; Kampmann, Beate; Kuksa, Liga; de Lange, Wiel; van Leth, Frank; van Lunzen, Jan; Matteelli, Alberto; Menzies, Dick; Monedero, Ignacio; Richter, Elvira; Rüsch-Gerdes, Sabine; Sandgren, Andreas; Scardigli, Anna; Skrahina, Alena; Tortoli, Enrico; Volchenkov, Grigory; Wagner, Dirk; van der Werf, Marieke J.; Williams, Bhanu; Yew, Wing-Wai; Zellweger, Jean-Pierre; Cirillo, Daniela Maria

    2014-01-01

    The emergence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) substantially challenges TB control, especially in the European Region of the World Health Organization, where the highest prevalence of MDR/XDR cases is reported. The current management of patients with MDR/XDR-TB is extremely complex for medical, social and public health systems. The treatment with currently available anti-TB therapies to achieve relapse-free cure is long and undermined by a high frequency of adverse drug events, suboptimal treatment adherence, high costs and low treatment success rates. Availability of optimal management for patients with MDR/XDR-TB is limited even in the European Region. In the absence of a preventive vaccine, more effective diagnostic tools and novel therapeutic interventions the control of MDR/XDR-TB will be extremely difficult. Despite recent scientific advances in MDR/XDR-TB care, decisions for the management of patients with MDR/XDR-TB and their contacts often rely on expert opinions, rather than on clinical evidence. This document summarises the current knowledge on the prevention, diagnosis and treatment of adults and children with MDR/XDR-TB and their contacts, and provides expert consensus recommendations on questions where scientific evidence is still lacking. PMID:24659544

  6. Drug Use and Sex Work Among At-risk Women: A Qualitative Study of Initial Factors

    PubMed Central

    Roshanfekr, Payam; Noori, Roya; Dejman, Masoumeh; Fathi Geshnigani, Zahra; Rafiey, Hassan

    2015-01-01

    Background: In recent years, there has been an increasing interest in performing research on drug use and sex work among at-risk women. Although there is a well-documented literature of the initial reasons associated with drug use and sex work among women, there is, however, a paucity of information in this area in Iran. Objectives: This study aimed to explore the initial reasons associated with drug use and sex work in a group of female treatment seekers, who presented health-related risk behaviors, in Tehran, Iran. Patients and Methods: This qualitative study enrolled a total of 65 at-risk women, from five women-specific drug clinics, who participated in the study in 2011. Individual in-depth interviews were conducted. Focus group interviews were conducted with 10 key informants. All interviews were audio-taped and thematically written. The recorded data were analyzed using ATLASti qualitative research software version 10. Results: The median age of the sample was 34 years. In addition, 44.6% of subjects were opiate users, and 55.4% were users of opiates and methamphetamine. Sex work was the main source of income for almost half of the sample. The most frequently reported reasons, associated with initial drug use, were extrinsic motivations, including the drug-using family, friends or social networks. Intrinsic motivations, including curiosity and individual willingness to use drugs, were other initial reasons. The most frequently reported reasons, associated with initial sex work, included the need to purchase drugs and financial problems. Conclusions: The study findings demonstrated a number of reasons associated with initial drug use and sex work. The role of sex work in providing drugs necessitates education and prevention. Special treatment programs should be implemented to prevent sex work among at-risk women in Iran. PMID:26288649

  7. Pharmacokinetic drug-drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus.

    PubMed

    Zack, Julia; Berg, Jolene; Juan, Axel; Pannacciulli, Nicola; Allard, Martine; Gottwald, Mildred; Zhang, Heather; Shao, Yongwu; Ben-Yehuda, Ori; Jochelson, Phil

    2015-03-01

    Ranolazine and metformin may be frequently co-administered in subjects with chronic angina and co-morbid type 2 diabetes mellitus (T2DM). The potential for a drug-drug interaction was explored in two phase 1 clinical studies in subjects with T2DM to evaluate the pharmacokinetics and safety of metformin 1000 mg BID when administered with ranolazine 1000 mg BID (Study 1, N = 28) or ranolazine 500 mg BID (Study 2, N = 25) as compared to metformin alone. Co-administration of ranolazine 1000 mg BID with metformin 1000 mg BID resulted in 1.53- and 1.79-fold increases in steady-state metformin Cmax and AUCtau , respectively; co-administration of ranolazine 500 mg BID with metformin 1000 mg BID resulted in 1.22- and 1.37-fold increases in steady-state metformin Cmax and AUCtau , respectively. Co-administration of ranolazine and metformin was well tolerated in these T2DM subjects, with no serious adverse events or drug-related adverse events leading to discontinuation. The most common adverse events were nausea, diarrhea, and dizziness. These findings are consistent with a dose-related interaction between ranolazine and metformin, and suggest that a dose adjustment of metformin may not be required with ranolazine 500 mg BID; whereas, the metformin dose should not exceed 1700 mg of total daily dose when using ranolazine 1000 mg BID. PMID:27128216

  8. Cavity wounds management: a multicentre pilot study.

    PubMed

    Meaume, Sylvie; Facy, Olivier; Munoz-Bongrand, Nicolas; Ribemont, Annie-Claude; Sigal, Michele-Lea; Couffinhal, Jean-Claude; Trial, Chloe; Tacca, Olivier; Bohbot, Serge

    The objective of this study was to assess acceptability (based on pain at removal), efficacy and tolerance of an absorbent and cohesive rope(UrgoClean Rope, Laboratoires Urgo) in the local management of deep cavity wounds. This study was a prospective, multicentre (13), non comparative clinical study. Patients presenting with an acute or chronic non-infected cavity wound were followed up for four weeks and assessed weekly with a physical examination, in addition to volumetric,planimetric and photographic evaluations. Pain at removal was the primary criterion, assessed on a Visual Analogic Scale. The percentage of the wound surface area reduction and volumetric reduction were considered as secondary efficacy criteria. Forty three patients were included in this study. After one week of treatment dressing removal was painless and continued to be so throughout the period of the trial(four weeks). Median surface area at baseline was 7.74 cm2 and was reduced by 54.5% at week 4 (relative area reduction). Median wound volumetric value was noted 12 ml at baseline and was reduced by 72.7% by the end of treatment. The cohesiveness of the new rope was considered very good by health professionals. No residue was observed on the wound bed during the dressing change with the new rope. There were no adverse events related to the tested rope, during this trial.Pain-free removal associated with good efficacy and tolerance were observed with this new cohesive rope in the healing process of deep cavity wounds and could represent a therapeutic alternative to the usual ropes used in such indications. PMID:24180023

  9. Characterization and in vitro drug release studies of a natural polysaccharide Terminalia catappa gum (Badam gum).

    PubMed

    Meka, Venkata Srikanth; Nali, Sreenivasa Rao; Songa, Ambedkar Sunil; Kolapalli, Venkata Ramana Murthy

    2012-12-01

    The main objective of the present study is the physicochemical characterization of naturally available Terminalia catappa gum (Badam gum [BG]) as a novel pharmaceutical excipient and its suitability in the development of gastroretentive floating drug delivery systems (GRFDDS) to retard the drug for 12 h when the dosage form is exposed to gastrointestinal fluids in the gastric environment. As BG was being explored for the first time for its pharmaceutical application, physicochemical, microbiological, rheological, and stability studies were carried out on this gum. In the present investigation, the physicochemical properties, such as micromeritic, rheological, melting point, moisture content, pH, swelling index, water absorption, and volatile acidity, were evaluated. The gum was characterized by scanning electron microscopy, differential scanning calorimetry (DSC), powder X-ray diffraction studies (PXRD), and Fourier transform infrared spectroscopy (FTIR). Gastroretentive floating tablets of BG were prepared with the model drug propranolol HCl by direct compression methods. The prepared tablets were evaluated for all their physicochemical properties, in vitro buoyancy, in vitro drug release, and rate order kinetics. PBG 04 was selected as an optimized formulation based on its 12-h drug release and good buoyancy characteristics. The optimized formulation was characterized with FTIR, DSC, and PXRD studies, and no interaction between the drug and BG was found. Thus, the study confirmed that BG might be used in the gastroretentive drug delivery system as a release-retarding polymer. PMID:23090110

  10. Public Management of Science Case Studies.

    ERIC Educational Resources Information Center

    American Univ., Washington, DC. Coll. of Public Affairs.

    Presented are six papers pertaining to the management of science, research, and development by federal agencies. The papers were prepared by students in a management of science course offered at the American University, Washington, D.C. Federal agencies reviewed include: National Aeronautics and Space Administration (NASA); Department of…

  11. Interdependency Management in Universities: A Case Study

    ERIC Educational Resources Information Center

    Braun, Dietmar; Benninghoff, Martin; Ramuz, Raphaël; Gorga, Adriana

    2015-01-01

    There remains uncertainty in scientific discussions regarding the governance of universities in new public management regimes in terms of who actually "rules" in the university. Apparently, a strengthened management leadership is confronted with continuing elements of academic self-regulation and professional autonomy in knowledge…

  12. Full quantum mechanical study of binding of HIV-1 protease drugs

    NASA Astrophysics Data System (ADS)

    Zhang, Da W.; Zhang, John Z. H.

    Fully quantum mechanical studies of detailed binding interactions between HIV-1 protease and six FDA (Food and Drug Administration)-approved drugs (saquinavir, indinavir, ritonavir, nelfinavir, amprenavir, and lopinavir) are carried out using a recently developed MFCC (molecular fractionation with conjugate caps) method. The MFCC calculation produces a quantum mechanical interaction spectrum for any protease drug binding complex. Detailed quantitative analysis on binding of lopinavir to specific residues of the protease is given from the current study. The present calculation shows that the dominant binding of lopinavir to the protease is through the formation of a strong hydrogen bond between the central hydroxyl group of the drug to the aspartate oxygen of Asp25 in one of the two chains of the protease (A chain). This is closely followed by hydrogen binding of the drug to Asp29 in the B chain and somewhat weak hydrogen bonding to Asp30, Gly27, Gly48, and Ile50 in both chains. By partitioning all six drugs into four building blocks besides the central component containing the hydroxyl group, MFCC calculation finds that block III has essentially no binding interaction with the protease and the major binding interactions of these drugs are from blocks II and IV, in addition to the dominant central hydroxyl group. This detailed quantitative information on drug binding to the protease is very useful in rational design of new and improved inhibitors of HIV-1 protease and its mutants.

  13. Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications. Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation. This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. Methods/design The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo. Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The

  14. Could Education Contribute to Reduce Prevalence of HIV among Injecting Drug Users? A Case Study of IDUs from the Rehabilitation Center for Drugs Users

    ERIC Educational Resources Information Center

    Rajbhandari, Mani Man Singh

    2008-01-01

    This study primarily focuses on Injecting Drug Users (IDUs) from the Narconon Nepal for drugs rehabilitation and prevention center. The study attempt to explore the changing behavior of IDUs from the education received from the rehabilitation center which contributes to reduce the prevalence of HIV among IDUs. The data were collected through semi…

  15. Top management and management science: An exploratory study in 15 Federal civilian agencies

    NASA Technical Reports Server (NTRS)

    White, M. J.

    1971-01-01

    A study of the relation between top managers in Federal agencies and the operations research and management science (OR/MS) group is reported. Sixteen managers were questioned about the following characteristics: closeness of top managers to OR/MS groups; top managers' attitudes toward the OR/MS activities; relation between closeness and these attitudes; and top managers' use of OR/MS groups. It is concluded that OR/MS is relevant to many top managers and that OR/MS has begun to play a role in decisions. Top management attitudes and actions are not related in obvious ways. The consequences to top management's use of and closeness to an OR/MS group need not be the success of the group as a professional, innovative, research-oriented unit.

  16. Drug discovery management, small is still beautiful: Why a number of companies get it wrong.

    PubMed

    Knutsen, Lars J S

    2011-06-01

    This review provides an account of why more companies involved in drug discovery fail than succeed at releasing the creative energy of gifted scientists, whose invention of new drugs they rely upon to remain at the forefront of the biopharma industry. Initiatives aimed at improving output of new chemical entities often have the opposite effect from that intended and scientists become demotivated. Those with drive, vision and enthusiasm may move to smaller companies to rediscover the spirit of discovery. Some executives fail to understand the psyche of researchers; an applied understanding of the intrinsic motivation of scientists would improve research performance. Entities that focus on smaller autonomous units and sound ethical values will discover the most innovative and successful new drugs. PMID:21504798

  17. Strategies for obtaining unpublished drug trial data: a qualitative interview study

    PubMed Central

    2013-01-01

    Background Authors of systematic reviews have difficulty obtaining unpublished data for their reviews. This project aimed to provide an in-depth description of the experiences of authors in searching for and gaining access to unpublished data for their systematic reviews, and to give guidance on best practices for identifying, obtaining and using unpublished data. Methods This is a qualitative study analyzing in-depth interviews with authors of systematic reviews who have published Cochrane reviews or published systematic reviews outside of The Cochrane Library. We included participants who 1) were the first or senior author of a published systematic review of a drug intervention, 2) had expertise in conducting systematic reviews, searching for data, and assessing methodological biases, and 3) were able to participate in an interview in English. We used non-random sampling techniques to identify potential participants. Eighteen Cochrane authors were contacted and 16 agreed to be interviewed (89% response rate). Twenty-four non-Cochrane authors were contacted and 16 were interviewed (67% response rate). Results Respondents had different understandings of what was meant by unpublished data, including specific outcomes and methodological details. Contacting study authors was the most common method used to obtain unpublished data and the value of regulatory agencies as a data source was underappreciated. Using the data obtained was time consuming and labor intensive. Respondents described the collaboration with other colleagues and/or students required to organize, manage and use the data in their reviews, generally developing and using templates, spreadsheets and computer programs for data extraction and analysis. Respondents had a shared belief that data should be accessible but some had concerns about sharing their own data. Respondents believed that obtaining unpublished data for reviews has important public health implications. There was widespread support for

  18. Knowledge and Adherence to the National Guidelines for Malaria Case Management in Pregnancy among Healthcare Providers and Drug Outlet Dispensers in Rural, Western Kenya

    PubMed Central

    Riley, Christina; Dellicour, Stephanie; Ouma, Peter; Kioko, Urbanus; ter Kuile, Feiko O.; Omar, Ahmeddin; Kariuki, Simon; Buff, Ann M.; Desai, Meghna; Gutman, Julie

    2016-01-01

    Background Although prompt, effective treatment is a cornerstone of malaria control, information on provider adherence to malaria in pregnancy (MIP) treatment guidelines is limited. Incorrect or sub-optimal treatment can adversely affect the mother and fetus. This study assessed provider knowledge of and adherence to national case management guidelines for uncomplicated MIP. Methods We conducted a cross-sectional study from September to November 2013, in 51 health facilities (HF) and a randomly-selected sample of 39 drug outlets (DO) in the KEMRI/CDC Health and Demographic Surveillance System area in western Kenya. Provider knowledge of national treatment guidelines was assessed with standardized questionnaires. Correct practice required adequate diagnosis, pregnancy assessment, and treatment with correct drug and dosage. In HF, we conducted exit interviews in all women of childbearing age assessed for fever. In DO, simulated clients posing as first trimester pregnant women or as relatives of third trimester pregnant women collected standardized information. Results Correct MIP case management knowledge and practice were observed in 45% and 31% of HF and 0% and 3% of DO encounters, respectively. The correct drug and dosage for pregnancy trimester was prescribed in 62% of HF and 42% of DO encounters; correct prescription occurred less often in first than in second/ third trimesters (HF: 24% vs. 65%, p<0.01; DO: 0% vs. 40%, p<0.01). Sulfadoxine-pyrimethamine, which is not recommended for malaria treatment, was prescribed in 3% of HF and 18% of DO encounters. Exposure to artemether-lumefantrine in first trimester, which is contraindicated, occurred in 29% and 49% of HF and DO encounters, respectively. Conclusion This study highlights knowledge inadequacies and incorrect prescribing practices in the treatment of MIP. Particularly concerning is the prescription of contraindicated medications in the first trimester. These issues should be addressed through comprehensive

  19. Exploiting the potential of intranet for managing drug spectrum a web base publication in a Tertiary Care Hospital in Mumbai

    PubMed Central

    Shetty, Yashashri Chandrakant; Patel, Tejal Chetan; Parmar, Urwashi Indrakumar

    2015-01-01

    Objective: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. Materials and Methods: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. Results: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66%) respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%). 67 (49.62%) respondents have accessed. 67 (49.62%) did not have the time to visit intranet site whereas 67 (49.62%) have not accessed intranet. 89 (65.92%) respondents were not aware of the drug spectrum. 101 (74.81%) respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33%) knew about the intranet periodical drug spectrum, but most of the respondents (33.33%) explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. Conclusion: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but the

  20. Drug-eluting stents in the management of peripheral arterial disease

    PubMed Central

    Bosiers, Marc; Cagiannos, Catherine; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2008-01-01

    Since major meta-analyses of randomized controlled trials in interventional cardiology showed the potential of drug-eluting stents in decreasing restenosis and reintervention rates after coronary artery stenting, one of the next steps in the treatment of arterial occlusive disease is the transfer of the active coating technology towards peripheral arterial interventions. In this manuscript, we aim to provide a literature overview on available peripheral (lower limb, renal, and supra-aortic) drug-eluting stent applications, debate the cost implications, and give recommendations for future treatment strategies. PMID:18827906

  1. Cryogenic Propellant Management Device: Conceptual Design Study

    NASA Technical Reports Server (NTRS)

    Wollen, Mark; Merino, Fred; Schuster, John; Newton, Christopher

    2010-01-01

    Concepts of Propellant Management Devices (PMDs) were designed for lunar descent stage reaction control system (RCS) and lunar ascent stage (main and RCS propulsion) missions using liquid oxygen (LO2) and liquid methane (LCH4). Study ground rules set a maximum of 19 days from launch to lunar touchdown, and an additional 210 days on the lunar surface before liftoff. Two PMDs were conceptually designed for each of the descent stage RCS propellant tanks, and two designs for each of the ascent stage main propellant tanks. One of the two PMD types is a traditional partial four-screen channel device. The other type is a novel, expanding volume device which uses a stretched, flexing screen. It was found that several unique design features simplified the PMD designs. These features are (1) high propellant tank operating pressures, (2) aluminum tanks for propellant storage, and (3) stringent insulation requirements. Consequently, it was possible to treat LO2 and LCH4 as if they were equivalent to Earth-storable propellants because they would remain substantially subcooled during the lunar mission. In fact, prelaunch procedures are simplified with cryogens, because any trapped vapor will condense once the propellant tanks are pressurized in space.

  2. Unemployment and illegal drug use: concordant evidence from a prospective study and national trends.

    PubMed Central

    Peck, D F; Plant, M A

    1986-01-01

    Data from a previous study of 1036 young people in the Lothian region that indicated an association between unemployment and illegal drug use were examined in more depth to investigate the inter-relation between duration of unemployment and the use of illegal drugs, alcohol, and tobacco. After factors such as social class background and educational qualifications had been taken into account a weak but significant association was found between duration of unemployment and illegal drug use. No such association was found for alcohol or tobacco. Similar results were obtained from an analysis of national statistics related to unemployment and illegal drug use. Both sets of data thus indicate that illegal drug use is moderately associated with unemployment. PMID:3094720

  3. No Link Between Anti-Smoking Drugs, Mental Health Issues: Study

    MedlinePlus

    ... html No Link Between Anti-Smoking Drugs, Mental Health Issues: Study Meds like Chantix and Wellbutrin may ... Disorders Quitting Smoking Recent Health News Related MedlinePlus Health Topics Medicines Mental Disorders Quitting Smoking About MedlinePlus ...

  4. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... provide recommendations to industry on the design of self- selection studies for nonprescription drug... guidance discusses general concepts to be considered in the design and conduct of a self-selection...

  5. Azilsartan as a Potent Antihypertensive Drug with Possible Pleiotropic Cardiometabolic Effects: A Review Study

    PubMed Central

    Georgiopoulos, Georgios; Katsi, Vasiliki; Oikonomou, Dimitrios; Vamvakou, Georgia; Koutli, Evangelia; Laina, Aggeliki; Tsioufis, Constantinos; Nihoyannopoulos, Petros; Tousoulis, Dimitrios

    2016-01-01

    Background: Hypertension related cardiovascular (CV) complications could be amplified by the presence of metabolic co-morbidities. Azilsartan medoxomil (AZL-M) is the eighth approved member of angiotensin II receptor blockers (ARBs), a drug class of high priority in the management of hypertensive subjects with diabetes mellitus type II (DMII). Methods: Under this prism, we performed a systematic review of the literature for all relevant articles in order to evaluate the efficacy, safety, and possible clinical role of AZL-M in hypertensive diabetic patients. Results: AZL-M was found to be more effective in terms of reducing indices of blood pressure over alternative ARBs or angiotensin-converting enzyme (ACE) inhibitors with minimal side effects. Preclinical studies have established pleiotropic effects for AZL-M beyond its primary antihypertensive role through differential gene expression, up-regulation of membrane receptors and favorable effect on selective intracellular biochemical and pro-atherosclerotic pathways. Conclusion: Indirect but accumulating evidence from recent literature supports the efficacy and safety of AZL-M among diabetic patients. However, no clinical data exist to date that evince a beneficial role of AZL-M in patients with metabolic disorders on top of its antihypertensive effect. Further clinical studies are warranted to assess the pleiotropic cardiometabolic benefits of AZL-M that are derived from preclinical research. PMID:27536242

  6. Understanding public drug procurement in India: a comparative qualitative study of five Indian states

    PubMed Central

    Singh, Prabal Vikram; Tatambhotla, Anand; Kalvakuntla, Rohini; Chokshi, Maulik

    2013-01-01

    Objective To perform an initial qualitative comparison of the different procurement models in India to frame questions for future research in this area; to capture the finer differences between the state models through 53 process and price parameters to determine their functional efficiencies. Design Qualitative analysis is performed for the study. Five states: Tamil Nadu, Kerala, Odisha, Punjab and Maharashtra were chosen to ensure heterogeneity in a number of factors such as procurement type (centralised, decentralised or mixed); autonomy of the procurement organisation; state of public health infrastructure; geography and availability of data through Right to Information Act (RTI). Data on procurement processes were collected through key informant analysis by way of semistructured interviews with leadership teams of procuring organisations. These process data were validated through interviews with field staff (stakeholders of district hospitals, taluk hospitals, community health centres and primary health centres) in each state. A total of 30 actors were interviewed in all five states. The data collected are analysed against 52 process and price parameters to determine the functional efficiency of the model. Results The analysis indicated that autonomous procurement organisations were more efficient in relation to payments to suppliers, had relatively lower drug procurement prices and managed their inventory more scientifically. Conclusions The authors highlight critical success factors that significantly influence the outcome of any procurement model. In a way, this study raises more questions and seeks the need for further research in this arena to aid policy makers. PMID:23388196

  7. A procedure for studying the within-session onset of human drug discrimination.

    PubMed Central

    Silverman, K; Mumford, G K; Griffiths, R R

    1994-01-01

    The purpose of the present study was to develop a procedure for measuring the within-session onset of human drug discrimination. During daily sessions, under double-blind conditions, caffeine-abstinent adults ingested a letter-coded capsule containing 178 mg caffeine or placebo. Trials were presented at 30-s intervals, beginning immediately after drug ingestion and continuing for 60 min. On each trial, subjects could guess which of their two letter-coded drugs they had received by pressing a left button (for one drug) or right button (for the other drug); subjects could also press a center "no guess" button instead of guessing. Each trial ended after one button press. After each session, subjects were told which drug they had received. Subjects earned one point (worth $0.10 per point) for each correct guess. Subjects lost either 0, 1, or 10 points for each incorrect guess; the point-loss contingencies were varied in random order across sessions. Discrimination earnings accumulated across all sessions. The point-loss contingencies decreased random responding and delayed the discrimination time course. Overall, this procedure provided an orderly and relatively continuous measure of the within-session onset of drug discrimination and should have a range of applications in understanding the human behavioral pharmacology of drugs. PMID:8169567

  8. Drug use and fatal motor vehicle crashes: a case-control study.

    PubMed

    Li, Guohua; Brady, Joanne E; Chen, Qixuan

    2013-11-01

    Drugged driving is a serious safety concern, but its role in motor vehicle crashes has not been adequately studied. Using a case-control design, the authors assessed the association between drug use and fatal crash risk. Cases (n=737) were drivers who were involved in fatal motor vehicle crashes in the continental United States during specific time periods in 2007, and controls (n=7719) were participants of the 2007 National Roadside Survey of Alcohol and Drug Use by Drivers. Overall, 31.9% of the cases and 13.7% of the controls tested positive for at least one non-alcohol drug. The estimated odds ratios of fatal crash involvement associated with specific drug categories were 1.83 [95% confidence interval (CI): 1.39, 2.39] for marijuana, 3.03 (95% CI: 2.00, 4.48) for narcotics, 3.57 (95% CI: 2.63, 4.76) for stimulants, and 4.83 (95% CI: 3.18, 7.21) for depressants. Drivers who tested positive for both alcohol and drugs were at substantially heightened risk relative to those using neither alcohol nor drugs (Odds Ratio=23.24; 95% CI: 17.79, 30.28). These results indicate that drug use is associated with a significantly increased risk of fatal crash involvement, particularly when used in combination with alcohol. PMID:24076302

  9. Application of Caco-2 Cell Line in Herb-Drug Interaction Studies: Current Approaches and Challenges

    PubMed Central

    Awortwe, C.; Fasinu, P.S.; Rosenkranz, B.

    2015-01-01

    The Caco-2 model is employed in pre-clinical investigations to predict the likely gastrointestinal permeability of drugs because it expresses cytochrome P450 enzymes, transporters, microvilli and enterocytes of identical characteristics to the human small intestine. The FDA recommends this model as integral component of the Biopharmaceutics Classification System (BCS). Most dedicated laboratories use the Caco-2 cell line to screen new chemical entities through prediction of its solubility, bioavailability and the possibility of drug-drug or herb-drug interactions in the gut lumen. However, challenges in the inherent characteristics of Caco-2 cell and inter-laboratory protocol variations have resulted to generation of irreproducible data. These limitations affect the extrapolation of data from pre-clinical research to clinical studies involving drug-drug and herb-drug interactions. This review addresses some of these caveats and enumerates the plausible current and future approaches to reduce the anomalies associated with Caco-2 cell line investigations focusing on its application in herb-drug interactions. PMID:24735758

  10. The role of nurses in comprehensive care management of pregnant women with drug addiction.

    PubMed

    McKeever, Amy E; Spaeth-Brayton, Sylvia; Sheerin, Sarah

    2014-01-01

    Drug addiction during pregnancy is a complex health and social issue that requires an interdisciplinary health care team providing nonjudgmental, comprehensive care. Critical challenges include onset of and attendance at prenatal care, potential obstetric complications, transition to extrauterine life and potential neonatal abstinence syndrome for the neonate, newborn feeding issues, postpartum depression and risk of relapse for women. PMID:25145717

  11. Using Social Media Data to Identify Potential Candidates for Drug Repurposing: A Feasibility Study

    PubMed Central

    Liu, Hongfang; Nambisan, Priya

    2016-01-01

    Background Drug repurposing (defined as discovering new indications for existing drugs) could play a significant role in drug development, especially considering the declining success rates of developing novel drugs. Typically, new indications for existing medications are identified by accident. However, new technologies and a large number of available resources enable the development of systematic approaches to identify and validate drug-repurposing candidates. Patients today report their experiences with medications on social media and reveal side effects as well as beneficial effects of those medications. Objective Our aim was to assess the feasibility of using patient reviews from social media to identify potential candidates for drug repurposing. Methods We retrieved patient reviews of 180 medications from an online forum, WebMD. Using dictionary-based and machine learning approaches, we identified disease names in the reviews. Several publicly available resources were used to exclude comments containing known indications and adverse drug effects. After manually reviewing some of the remaining comments, we implemented a rule-based system to identify beneficial effects. Results The dictionary-based system and machine learning system identified 2178 and 6171 disease names respectively in 64,616 patient comments. We provided a list of 10 common patterns that patients used to report any beneficial effects or uses of medication. After manually reviewing the comments tagged by our rule-based system, we identified five potential drug repurposing candidates. Conclusions To our knowledge, this is the first study to consider using social media data to identify drug-repurposing candidates. We found that even a rule-based system, with a limited number of rules, could identify beneficial effect mentions in patient comments. Our preliminary study shows that social media has the potential to be used in drug repurposing. PMID:27311964

  12. Rapid assessment response (RAR) study: drug use and health risk - Pretoria, South Africa

    PubMed Central

    2011-01-01

    Background Within a ten year period South Africa has developed a substantial illicit drug market. Data on HIV risk among drug using populations clearly indicate high levels of HIV risk behaviour due to the sharing of injecting equipment and/or drug-related unprotected sex. While there is international evidence on and experience with adequate responses, limited responses addressing drug use and drug-use-related HIV and other health risks are witnessed in South Africa. This study aimed to explore the emerging problem of drug-related HIV transmission and to stimulate the development of adequate health services for the drug users, by linking international expertise and local research. Methods A Rapid Assessment and Response (RAR) methodology was adopted for the study. For individual and focus group interviews a semi-structured questionnaire was utilised that addressed key issues. Interviews were conducted with a total of 84 key informant (KI) participants, 63 drug user KI participants (49 males, 14 females) and 21 KI service providers (8 male, 13 female). Results and Discussion Adverse living conditions and poor education levels were cited as making access to treatment harder, especially for those living in disadvantaged areas. Heroin was found to be the substance most available and used in a problematic way within the Pretoria area. Participants were not fully aware of the concrete health risks involved in drug use, and the vague ideas held appear not to allow for concrete measures to protect themselves. Knowledge with regards to substance related HIV/AIDS transmission is not yet widespread, with some information sources disseminating incorrect or unspecific information. Conclusions The implementation of pragmatic harm-reduction and other evidence-based public health care policies that are designed to reduce the harmful consequences associated with substance use and HIV/AIDS should be considered. HIV testing and treatment services also need to be made available in

  13. Management of EGFR-inhibitor associated rash: a retrospective study in 49 patients

    PubMed Central

    2012-01-01

    Background In recent years inhibitors directed against the epidermal growth factor receptor (EGFR) have evolved as effective targeting cancer drugs. Characteristic papulopustular exanthemas, often described as acneiform rashes, are the most frequent adverse effect associated with this class of novel cancer drugs and develop in > 90% of patients. Notably, the rash may significantly compromise the patients' quality of life, thereby potentially leading to incompliance as well as dose reduction or even termination of the anti-EGFR therapy. Yet, an effective dermatologic management of cutaneous adverse effects can be achieved. Whereas various case reports, case series or expert opinions on the management of EGFR-inhibitor (EGFRI) induced rashes have been published, data on systematic management studies are sparse. Methods Here, we present a retrospective, uncontrolled, comparative study in 49 patients on three established regimens for the management of EGFRI-associated rashes. Results Strikingly, patients' rash severity improved significantly over three weeks of treatment with topical mometason furoate cream, topical prednicarbate cream plus nadifloxacin cream, as well as topical prednicarbate cream plus nadifloxacin cream plus systemic isotretinoin. Conclusions In summary our results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions. Whereas mild to moderate rashes should be treated with basic measures in combination with topical glucocorticosteroids or combined regiments using glucocorticosteroids and antiseptics/antibiotics, more severe or therapy-resistant rashes are likely to respond with the addition of systemic retinoids. PMID:22472354

  14. Projecting future drug expenditures--1996.

    PubMed

    Santell, J P

    1996-01-15

    The use of information on inflation, pharmacoeconomics, generic competition, new drug entities, site-specific drug-use patterns, legislation, and the changing health care environment in the projection of drug expenditures is discussed. Drug price inflation has declined from 6.9% in 1991 to 2.1% for part of 1995. Much of the decline is attributable to deep discounts given by manufacturers to managed care institutions. Some marketing specialists are predicting that drug manufacturers will begin to scale back discounts. Pharmaceutical industry analysts project that overall price increase for pharmaceuticals in the next 12-24 months will average 2.8% (range, 0-6%). Pharmacists need to be able to understand and critically evaluate pharmacoeconomic research, particularly studies conducted by the pharmaceutical industry. Savings due to increases in generic product selection may be offset to some degree by extensions of patent expiration dates under the General Agreement on Tariffs and Trade (GATT). Drug budget projections should include a complete review of new drugs and biotechnology agents pending FDA approval, drugs pending approval for new indications, and common unlabeled uses of expensive existing agents. Various methods are available for tracking drug-use patterns in specific practice settings. When resources are limited, pharmacy managers may elect to target only high-cost drugs; a proactive approach, such as projecting costs and developing guidelines for costly agents before their market release and before consideration by the pharmacy and therapeutics committee, is advantageous. Relevant legislative activities in 1995 included reform proposals for Medicare, Medicaid, and FDA; the Federal Acquisition Streamlining Act; and GATT. Disease management and other approaches to pharmacy benefits have increased opportunities for cooperative arrangements between drug companies and health care providers that may have major effects on drug marketing and pricing. Combining

  15. The rise of injecting drug use in east Africa: a case study from Kenya

    PubMed Central

    Beckerleg, Susan; Telfer, Maggie; Hundt, Gillian Lewando

    2005-01-01

    Studies on injecting drug use in East Africa are reviewed. The existingstudies document the spread of heroin injection in Kenya and Tanzania, both countries where HIV rates are high. No data from Uganda on injecting drug use was found by the authors. A case study of the growth of heroin injection in a Kenyan coastal town is presented. The need for needle-exchange programmes and other prevention services is discussed. PMID:16122382

  16. Energy management study for lunar oxygen production

    NASA Technical Reports Server (NTRS)

    Fazzolare, R. A.; Wong-Swanson, B. G.

    1989-01-01

    Energy management opportunities in the process of hydrogen reduction of ilmenite for lunar oxygen production are being investigated. An optimal energy system to supply the power requirements for the process will be determined.

  17. Verification of a Quality Management Theory: Using a Delphi Study

    PubMed Central

    Mosadeghrad, Ali Mohammad

    2013-01-01

    Background: A model of quality management called Strategic Collaborative Quality Management (SCQM) model was developed based on the quality management literature review, the findings of a survey on quality management assessment in healthcare organisations, semi-structured interviews with healthcare stakeholders, and a Delphi study on healthcare quality management experts. The purpose of this study was to verify the SCQM model. Methods: The proposed model was further developed using feedback from thirty quality management experts using a Delphi method. Further, a guidebook for its implementation was prepared including a road map and performance measurement. Results: The research led to the development of a context-specific model of quality management for healthcare organisations and a series of guidelines for its implementation. Conclusion: A proper model of quality management should be developed and implemented properly in healthcare organisations to achieve business excellence. PMID:24596883

  18. Multispectroscopic studies of the interaction of calf thymus DNA with the anti-viral drug, valacyclovir

    NASA Astrophysics Data System (ADS)

    Shahabadi, Nahid; Fatahi, Navid; Mahdavi, Maryam; Nejad, Zahra Kiani; Pourfoulad, Mehdi

    2011-12-01

    The present study investigated the binding interaction between an antiviral drug, valacyclovir and calf thymus DNA (CT-DNA) using emission, absorption, circular dichroism, viscosity and DNA melting studies. In fluorimetric studies, thermodynamic enhancement constant ( KD) and bimolecular enhancement constant ( KB) were calculated at different temperatures and demonstrated that fluorescence enhancement is not initiated by a dynamic process, but instead by a static process that involves complex DNA formation in the ground state. Further, the enthalpy and entropy of the reaction between the drug and CT-DNA showed that the reaction is exothermic and enthalpy-favored. In addition, detectable changes in the circular dichroism spectrum of CT-DNA in the presence of valacyclovir indicated conformational changes in the DNA double helix following interaction with the drug. All these results prove that this antiviral drug interacts with CT-DNA via an intercalative mode of binding.

  19. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    PubMed

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications. PMID:25564333

  20. Drug administration in animal studies of cardiac arrest does not reflect human clinical experience

    PubMed Central

    Reynolds, Joshua C.; Rittenberger, Jon C.; Menegazzi, James J.

    2007-01-01

    Introduction To date, there is no evidence showing a benefit from any advanced cardiac life support (ACLS) medication in out-of-hospital cardiac arrest (OOHCA), despite animal data to the contrary. One explanation may be a difference in the time to first drug administration. Our previous work has shown the mean time to first drug administration in clinical trials is 19.4 minutes. We hypothesized that the average time to drug administration in large animal experiments occurs earlier than in OOHCA clinical trials. Methods We conducted a literature review between 1990 and 2006 in MEDLINE using the following MeSH headings: swine, dogs, resuscitation, heart arrest, EMS, EMT, ambulance, ventricular fibrillation, drug therapy, epinephrine, vasopressin, amiodarone, lidocaine, magnesium, and sodium bicarbonate. We reviewed the abstracts of 331 studies and 197 full manuscripts. Exclusion criteria included: non-peer reviewed, all without primary animal data, and traumatic models. From these, we identified 119 papers that contained unique information on time to medication administration. The data are reported as mean, ranges, and 95% confidence intervals. Mean time to first drug administration in animal laboratory studies and clinical trials was compared with a t-test. Regression analysis was performed to determine if time to drug predicted ROSC. Results Mean time to first drug administration in 2378 animals was 9.5 minutes (range 3.0–28.0; 95% CI around mean 2.78, 16.22). This is less than the time reported in clinical trials (19.4 min, p<0.001). Time to drug predicted ROSC (Odds Ratio 0.844; 95% CI 0.738, 0.966). Conclusion Shorter drug delivery time in animal models of cardiac arrest may be one reason for the failure of animal studies to translate successfully into the clinical arena. PMID:17360097