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Sample records for management drug study

  1. Drug use in business bathrooms: An exploratory study of manager encounters in New York City

    PubMed Central

    Wolfson-Stofko, Brett; Bennett, Alex S.; Elliott, Luther; Curtis, Ric

    2017-01-01

    Background Though public bathroom drug injection has been documented from the perspective of people who inject drugs, no research has explored the experiences of the business managers who oversee their business bathrooms and respond to drug use. These managers, by default, are first-responders in the event of a drug overdose and thus of intrinsic interest during the current epidemic of opioid-related overdoses in the United States. This exploratory study assists in elucidating the experiences that New York City business managers have with people who inject drugs, their paraphernalia, and their overdoses. Methods A survey instrument was designed to collect data on manager encounters with drug use occurring in their business bathrooms. Recruitment was guided by convenience and purposive approaches. Results More than half of managers interviewed (58%, n = 50/86) encountered drug use in their business bathrooms, more than a third (34%) of these managers also found syringes, and the vast majority (90%) of managers had received no overdose recognition or naloxone training. Seven managers encountered unresponsive individuals who required emergency assistance. Conclusion The results from this study underscore the need for additional research on the experiences that community stakeholders have with public injection as well as educational outreach efforts among business managers. This research also suggests that there is need for a national dialogue about potential interventions, including expanded overdose recognition and naloxone training and supervised injection facilities (SIF)/drug consumption rooms (DCR), that could reduce public injection and its associated health risks. PMID:27768996

  2. Drug use in business bathrooms: An exploratory study of manager encounters in New York City.

    PubMed

    Wolfson-Stofko, Brett; Bennett, Alex S; Elliott, Luther; Curtis, Ric

    2017-01-01

    Though public bathroom drug injection has been documented from the perspective of people who inject drugs, no research has explored the experiences of the business managers who oversee their business bathrooms and respond to drug use. These managers, by default, are first-responders in the event of a drug overdose and thus of intrinsic interest during the current epidemic of opioid-related overdoses in the United States. This exploratory study assists in elucidating the experiences that New York City business managers have with people who inject drugs, their paraphernalia, and their overdoses. A survey instrument was designed to collect data on manager encounters with drug use occurring in their business bathrooms. Recruitment was guided by convenience and purposive approaches. More than half of managers interviewed (58%, n=50/86) encountered drug use in their business bathrooms, more than a third (34%) of these managers also found syringes, and the vast majority (90%) of managers had received no overdose recognition or naloxone training. Seven managers encountered unresponsive individuals who required emergency assistance. The results from this study underscore the need for additional research on the experiences that community stakeholders have with public injection as well as educational outreach efforts among business managers. This research also suggests that there is need for a national dialogue about potential interventions, including expanded overdose recognition and naloxone training and supervised injection facilities (SIF)/drug consumption rooms (DCR), that could reduce public injection and its associated health risks. Copyright © 2016 Elsevier B.V. All rights reserved.

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

    PubMed

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

    2012-01-01

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

  4. 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

    2015-03-26

    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.

  5. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    ERIC Educational Resources Information Center

    Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

    2008-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

  6. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    PubMed Central

    FRIEDMANN, PETER D.; KATZ, ELIZABETH C.; RHODES, ANNE G.; TAXMAN, FAYE S.; O'CONNELL, DANIEL J.; FRISMAN, LINDA K.; BURDON, WILLIAM M.; FLETCHER, BENNETT W.; LITT, MARK D.; CLARKE, JENNIFER; MARTIN, STEVEN S.

    2009-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment counselors to provide role induction counseling, contract for pro-social behavior, and deliver contingent reinforcement of behaviors consistent with treatment objectives. The Step'n Out study will randomize 450 drug-involved parolees to collaborative behavioral management or usual parole. Follow-up at 3-and 9-months will assess primary outcomes of rearrest, crime and drug use. If collaborative behavioral management is effective, its wider adoption could improve the outcomes of community reentry of drug-involved ex-offenders. PMID:19809591

  7. Collaborative Drug Therapy Management: Case Studies of Three Community-Based Models of Care

    PubMed Central

    Snyder, Margie E.; Earl, Tara R.; 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

  8. Learning to manage vasoactive drugs-A qualitative interview study with critical care nurses.

    PubMed

    Häggström, Marie; Bergsman, Ann-Christin; Månsson, Ulrika; Holmström, Malin Rising

    2017-04-01

    Being a nurse in an intensive care unit entails caring for seriously ill patients. Vasoactive drugs are one of the tools that are used to restore adequate circulation. Critical care nurses often manage and administer these potent drugs after medical advice from physicians. To describe the experiences of critical care nurses learning to manage vasoactive drugs, and to highlight the competence required to manage vasoactive drugs. Twelve critical care nurses from three hospitals in Sweden were interviewed. Qualitative content analysis was applied. The theme "becoming proficient requires accuracy, practice and precaution" illustrated how critical care nurses learn to manage vasoactive drugs. Learning included developing cognitive, psychomotor, and effective skills. Sources for knowledge refers to specialist education combined with practical exercises, collegial support, and accessible routine documents. The competence required to manage vasoactive drugs encompassed well-developed safety thinking that included being careful, in control, and communicating failures. Specific skills were required such as titrating doses, being able to analyse and evaluate the technological assessments, adapting to the situation, and staying calm. Learning to manage vasoactive drugs requires a supportive introduction for novices, collegial support, lifelong learning, and a culture of safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Laboratory tests in the clinical risk management of potential drug-drug interactions: a cross-sectional study using drug-dispensing data from 100 Dutch community pharmacies.

    PubMed

    Geerts, Arjen F J; De Koning, Fred H P; De Smet, Peter A G M; Van Solinge, Wouter W; Egberts, Toine C G

    2009-01-01

    Patient safety and the life cycle of a drug are negatively influenced by the still increasing occurrence of potential drug-drug interactions (DDIs). Clinical risk management of potential DDIs is required in patients using drugs to influence the benefit-risk profile positively. Information about laboratory test results, in particular, may be useful in the assessment of potential DDIs for the individual patient. The objective of this study was to examine the frequency and nature of laboratory tests required for the assessment of the clinical relevance of potential DDIs in Dutch community pharmacies. In addition, the nature and clinical relevance of these potential DDIs is analysed. All patients from 100 Dutch community pharmacies using, according to dispensing information, two or more drugs concomitantly on a specified date (Wednesday, 4 April 2007), were included (n = 223,019). The anonymous dispensing data of the included patients were analysed against a list of DDIs requiring laboratory tests for the assessment of their clinical relevance. The number of patients at risk for these potential DDIs with severe adverse reactions was calculated. The frequency of potential DDIs requiring laboratory tests were stratified by age, sex and degree of polypharmacy. Of the included patients, 24.4% had one or more potential DDIs (n = 54,427). In 9.0% of the included patients, one or more laboratory tests for the assessment of clinical relevance of the potential DDI were required (n = 19,968). The frequency of DDIs requiring laboratory tests increased with increasing age and number of drugs, but was not related to sex. The most commonly required laboratory tests were for renal function (42.2%), electrolytes (20.1%) and coagulation (13.1%). The percentage of patients at risk for potential DDIs requiring laboratory tests with adverse reaction category F (serious, irrecoverable disablement or death) was 2.5%; category E (increased risk of failure of life-saving therapy) was 0

  10. Management of postoperative pain in abdominal surgery in Spain. A multicentre drug utilization study

    PubMed Central

    Vallano, Antonio; Aguilera, Cristina; Arnau, Josep Maria; Baños, Josep-Eladi; Laporte, Joan-Ramon

    1999-01-01

    Participating centres: Hospital Universitario San Juan, Alicante: Maria Jesús Olaso, Javier Agulló, Clara Faura. Hospital Torrecárdenas, Almería: Carmen Fernández Sánchez, Miguel Lorenzo Campos, Juan Manuel Rodríguez Alonso. Hospital Quirúrgic Adriano, Barcelona: Carmen Alerany Pardo, Paquita Alvarez González, Teresa Martín Benito. Hospital Universitari del Mar-IMIM, Barcelona: Magí Farré, Maite Terán. Corporació Sanitària Parc Taulí, Sabadell: Montserrat Cañellas, Sergio Zavala, Josep Planell. Hospital Universitari de la Santa Creu i Sant Pau: Gonzalo Calvo, Rosa Morros, Silvia Mateo. Hospital General Vall d’Hebron, Barcelona: Carmen Bosch, María José Martínez. Hospital Universitario Virgen de la Victoria, Málaga: Maribel Lucena, José Antonio González, Gabriel Carranque. Hospital Clínico Universitario San Carlos, Madrid: Emilio Vargas, Amparo Gil López-Oliva, Míriam García Mateos. Hospital Universitario Marqués de Valdecilla, Santander: Mario González, Antonio Cuadrado. Hospital Universitario Virgen de la Macarena, Sevilla: Juan Antonio Durán, Pilar Máyquez, María Isabel Serrano. Hospital Universitario Virgen del Rocío, Sevilla: Jaume Torelló, Juan Ramón Castillo, María de las Nieves Merino. Aims Postoperative pain is common in hospital-admitted patients. Its management is determined by different therapeutic traditions and by the attitudes of health professionals in each hospital. The aim of this study was to describe the patterns of prescription and administration of analgesic drugs used for postoperative pain after abdominal surgery in Spanish hospitals, to know the prevalence and the severity of postoperative pain, and to determine the extent of variability in the management of postoperative pain among the participating centres. Methods The study was a multicentre descriptive cross-sectional drug utilization study in 12 Spanish hospitals. The subjects were an unselected sample of consecutive patients undergoing abdominal

  11. Study Drugs

    MedlinePlus

    ... think clearly, and be alert. Doctors recommend that teens get about 9 hours of sleep per night. Exercise . Get blood pumping the natural ... Date reviewed: July 2015 previous 1 • 2 For Teens For Kids For Parents MORE ON THIS TOPIC Homework Help How Much Sleep Do I Need? Prescription Drug Abuse How to ...

  12. Disease management ... drug data debate.

    PubMed

    Muir, L

    1997-06-05

    Desperately seeking a new way to generate profits, pharmacy benefit managers are trying to sell employers and HMOs on the notion of using their mountains of drug-claim information to manage chronic diseases. But skeptics point out that prescription data tell only part of the treatment story.

  13. Medical Management of Drug-Resistant Tuberculosis.

    PubMed

    Jeon, Doosoo

    2015-07-01

    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.

  14. 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

  15. Factors to Improve the Management of Hepatitis C in Drug Users: An Observational Study in an Addiction Centre

    PubMed Central

    Moussalli, Joseph; Delaquaize, Helene; Boubilley, Dominique; Lhomme, Jean Pierre; Merleau Ponty, Jules; Sabot, David; Kerever, Anne; Valleur, Marc; Poynard, Thierry

    2010-01-01

    Barriers to management of HCV in injection drug users are related to patients, health providers, and facilities. In a primary care drug user's addiction centre we studied access to HCV standard of care before and after using an onsite total care concept provided by a multidisciplinary team and noninvasive liver fibrosis evaluation. A total of 586 patients were seen between 2002 and 2004. The majority, 417 patients, were HCV positive and of these patients 337 were tested positive for HCV RNA. In 2002, patients were sent to the hospital. with the Starting of 2003, patients were offered standard of care HCV management in the center by a team of general practitioners, a consultant hepatologist, psychiatrists, nurses, and a health counsellor. Liver fibrosis was assessed by a non invasive method. In 2002, 6 patients had liver fibrosis assessment at hospital facilities, 4 patients were assessed with liver biopsy and 2 patients with Fibrotest-Actitest. 2 patients were treated for HCV at hospital. In 2003 and 2004, 224 patients were assessed with Fibrotest-Actitest on site. Of these, 85 were treated for HCV. SVR was achieved in 43%. We conclude that the combination of an onsite multidisciplinary team with the use of a noninvasive assessment method led to improved management of HCV infection in drug users' primary care facility. PMID:20811482

  16. Factors to improve the management of hepatitis C in drug users: an observational study in an addiction centre.

    PubMed

    Moussalli, Joseph; Delaquaize, Helene; Boubilley, Dominique; Lhomme, Jean Pierre; Merleau Ponty, Jules; Sabot, David; Kerever, Anne; Valleur, Marc; Poynard, Thierry

    2010-01-01

    Barriers to management of HCV in injection drug users are related to patients, health providers, and facilities. In a primary care drug user's addiction centre we studied access to HCV standard of care before and after using an onsite total care concept provided by a multidisciplinary team and noninvasive liver fibrosis evaluation. A total of 586 patients were seen between 2002 and 2004. The majority, 417 patients, were HCV positive and of these patients 337 were tested positive for HCV RNA. In 2002, patients were sent to the hospital. with the Starting of 2003, patients were offered standard of care HCV management in the center by a team of general practitioners, a consultant hepatologist, psychiatrists, nurses, and a health counsellor. Liver fibrosis was assessed by a non invasive method. In 2002, 6 patients had liver fibrosis assessment at hospital facilities, 4 patients were assessed with liver biopsy and 2 patients with Fibrotest-Actitest. 2 patients were treated for HCV at hospital. In 2003 and 2004, 224 patients were assessed with Fibrotest-Actitest on site. Of these, 85 were treated for HCV. SVR was achieved in 43%. We conclude that the combination of an onsite multidisciplinary team with the use of a noninvasive assessment method led to improved management of HCV infection in drug users' primary care facility.

  17. Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe.

    PubMed

    Vermeer, N S; Duijnhoven, R G; Straus, S M J M; Mantel-Teeuwisse, A K; Arlett, P R; Egberts, A C G; Leufkens, H G M; De Bruin, M L

    2014-12-01

    Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

  18. 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.

  19. The impact of pharmacovigilance on drug portfolio management.

    PubMed

    Bucurescu, S

    2014-01-01

    This review examines the influence of pharmacovigilance on drug portfolio. As a result of pharmacovigilance studies, actions are taken by national drug administrations and/or the World Health Organization (WHO) that have a strong impact on drug portfolio management: drug withdrawal from medical practice, discovery of new therapeutic indications, discovery of drug interactions, preference for specific pharmaceutical formulations, discovery of contraindications and change of drug prescription status.

  20. Age- and Sex-related Prevalence and Drug Utilization Pattern in the Management of Type 2 Diabetes Mellitus and its Comorbidity with Cardiovascular Diseases: A Comparative Study.

    PubMed

    Das, S; Haroled Peter, P L; Bhavani, M Lakshmi; Naresh, P; Ramana, M V

    2015-01-01

    A cross-sectional study of 250 cases of type 2 diabetes management was conducted in a governmental tertiary care hospital of urban south India to determine the comparative prevalence of type 2 diabetes and its comorbidity with cardiovascular diseases in diabetic population, core drug use indicators and drug utilization pattern in the management of diabetics entirely and with cardiovascular diseases. Highest prevalent age group for type 2 diabetes/cardiovascular diseases (greater incidence in female than male) was 51-60 years. The 62.8% prevalence of cardiovascular diseases in the diabetic population ascertained in the study could provide an evidence-based rationale for the World Health Organization guidelines for the management of hypertension in type 2 diabetics. Incidence of polypharmacy (6.06, the mean number of total drug products prescribed); 59.26% of encounters prescribed antibiotics; 17.6 and 18.5 min of average consultation and dispensing time, respectively; 100% of drugs actually dispensed and adequately labeled; 81.26% of patients having knowledge of correct dosage and average drug cost of Indian Rupees 145.54 per prescription were the core drug use indicators found mainly. Moreover, drugs prescribed from the Essential Drug List were more than 90% and thereby indicated the drug use in this set-up quite rational. Around 71.09% of cardiovascular agents prescribed by generic name revealed the cost effective medical care. Among the agents in type 2 diabetes management, Actrapid(®) (35.43%) was the highest. Among the cardiovascular agents prescribed, lasix (19.37%) was the highest. Cardiovascular agents prescribed orally by 76.48% signified the good prescription habit indicating the improved patients' adherence to the treatment. The present study emphasizes the need of early detection of hypertension as a preliminary diagnostic parameter of cardiovascular diseases in diabetics and appropriate management through concomitant therapy of cardiovascular drugs to

  1. Thoracoscopic sympathectomy is a valuable addition in the management of recreational intra-arterial drug injection. Pilot study.

    PubMed

    El Samadoni, Ayman; Nada, Ahmad; Mostafa, Hisham

    2010-01-01

    Intra-arterial Injection (IAI) of illicit substances by drug abusers may result in acute ischemia, limb loss or permanent functional deficit. No prospective human studies have shown that any specific treatment is superior to another. Thoracoscopic sympathectomy (TS) has proven efficacy in upper limb ischemia due to organic blockade. This is a pilot study to evaluate the effect of thoracoscopic sympathectomy addition to the management protocol of recreational intra-arterial drug injection. A total of 11 victims of upper limb IAI of recreational drug were recruited (10 males) with age range from 18 to 43 years old (average 30+/-8.3 years). Tissue Ischemia Score (TIS) was used for pretreatment assessment of the degree of ischemic injury and severity of pain was evaluated pre- and post-operatively using visual analog score (VAS) and compared using Student's t test. Pre-operative VAS score was 6.9+/-1.8. All enrolled patients were treated according to the following protocol; anticoagulation, calcium channel blocker, opiates for pain, and TS. Patients received the stated protocol for minimum of 72h (range 3-8 days; mean 5; average 4.7+/-1.5 days). Freedom of amputation and improvement of pain scores were the study endpoints. No mortality, yet one case had bleeding secondary to anticoagulant and one case of post-operative pneumothorax that required chest tube drainage for 24h. No patients had wet gangrene or spreading infection. Freedom of amputation was achieved in nine patients, 81% (7 patients had normal outcome and other two had permanent neurological deficit). Two patients (18%) had tissue necrosis with dry gangrene and mummification of the affected digits with eventual amputation. Postoperative VAS pain score was 2.09+/-1.37 (p<0.05). Pain medications were suspended in 6 patients (54.5%), reduced in 4 (36%) and unchanged in 1 (9%). All patients with TIS score 2 or less had a normal outcome while those with scores 3 and 4 had a variable outcome. Using regression

  2. Managing drug withdrawal in the newborn infant.

    PubMed

    Kuschel, Carl

    2007-04-01

    The management of the infant exposed to drugs in utero poses significant challenges. Symptoms and signs of neonatal abstinence syndrome (NAS) are non-specific but most commonly associated with withdrawal from maternal opioids. A high index of suspicion is required when presented with an infant who could be manifesting symptoms of NAS. In the absence of a reliable history of maternal drug exposure, analysis of neonatal meconium or urine may be indicated. Approximately 90% of infants exposed to opioids will exhibit signs of NAS, although a smaller proportion will require pharmacological treatment. Although few studies have evaluated the advantages of different therapeutic agents and strategies, opioid withdrawal is best treated initially with opioid medication. Supportive care of the infant should include assessment of the adequacy of feeding, evaluation of social circumstances (particularly child protection issues) and surveillance for transmission of viral infection.

  3. Drug-induced photosensitivity: culprit drugs, management and prevention.

    PubMed

    Drucker, Aaron M; Rosen, Cheryl F

    2011-10-01

    Photo-induced drug eruptions are cutaneous adverse events due to exposure to a drug and either ultraviolet or visible radiation. Based on their pathogenesis, they can be classified as phototoxic or photoallergic drug eruptions, although in many cases it is not possible to determine whether a particular eruption is due to a phototoxic or photoallergic mechanism. In this review, the diagnosis, prevention and management of drug-induced photosensitivity are discussed. Diagnosis is based primarily on the history of drug intake and the clinical appearance of the eruption, primarily affecting sun-exposed areas of the skin. Phototesting and photopatch testing can be useful adjuncts in making a diagnosis. The mainstay of management is prevention, including informing patients of the possibility of increased sun sensitivity and the use of sun protective measures. However, once the eruption has occurred, it may be necessary to discontinue the culprit medication and treat the eruption with a potent topical corticosteroid. Drugs that have been implicated in causing photosensitive eruptions are reviewed. Tetracycline, doxycycline, nalidixic acid, voriconazole, amiodarone, hydrochlorothiazide, naproxen, piroxicam, chlorpromazine and thioridazine are among the most commonly implicated medications. We review the medical literature regarding evidence for the culpability of each drug, including the results of phototesting, photopatch testing and rechallenge testing.

  4. 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…

  5. 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…

  6. FibroScan used in street-based outreach for drug users is useful for hepatitis C virus screening and management: a prospective study.

    PubMed

    Foucher, J; Reiller, B; Jullien, V; Léal, F; di Cesare, E S; Merrouche, W; Delile, J-M; de Lédinghen, V

    2009-02-01

    Although hepatitis C virus (HCV) infection prevalence is high among drug users, they do not commonly receive regular care in academic centres. The aim of this prospective study was to assess the influence of FibroScan use on HCV screening and management in street-based outreach. From January 2006 to January 2007, all consecutive drug users were offered noninvasive evaluation of liver fibrosis with FibroScan. After FibroScan, parameters were recorded with a structured, face-to-face questionnaire by outreach workers. All 298 subjects accepted FibroScan evaluation drug use was--ever injected heroin (69%), ever snorted or injected cocaine (89%), current chronic alcohol abuse (44%). The median FibroScan score was 5.3 kPa. Before blood sampling, 34% of subjects reported HCV positivity. HCV positivity was found in 83 cases. All these subjects had positive HCV-RNA. Forty-five subjects agreed to meet a hepatologist. By multivariate analysis, never snorted cocaine, consumed alcohol < 21 drinks per week, duration of injected heroin > 7 years, and FibroScan > 7.1 kPa were significantly associated with HCV positivity. Thus in a street-based outreach service for drug users, the acceptance of FibroScan is excellent. FibroScan with a hospital-based physician may facilitate screening and management of drug users for HCV infection.

  7. Strategies to manage antifungal drug resistance.

    PubMed

    Tseng, Hsiang-Kuang; Perfect, John R

    2011-02-01

    Invasive fungal infections continue to cause significant morbidity and mortality in immunocompromised hosts. From more than half a million deaths from cryptococcosis in sub-Saharan Africa to an unchanging death rate from invasive candidiasis, despite three antifungal classes of drugs, insights into better strategies to reduce therapeutic failures or resistance are needed. This review examines the issues around antifungal drug resistance from both a basic description of the failures and how they are detected to the variety of issues that need to be addressed to help prevent failures for successful management. The reader will gain an understanding of the clinical complexities in this patient population for management of invasive fungal infections. Throughout the review, principles of management are given along with some specific clinical examples to illustrate the issues and frame the knowledge base. From this discussion it is hoped that the clinician can use the insights provided to manage individual patients and find links to the evidence-based material that support its conclusions. Also, this review specifically identifies the limitations of present management and directs clinicians to gather additional information and provide even better treatment strategies. Invasive fungal infections are life-threatening complications of serious underlying diseases. Their management can be complicated by both direct and clinical drug resistance and by understanding these possibilities and correcting them; most patients can be successfully managed with present antifungal drugs if the underlying diseases can be controlled.

  8. Deprivation, clubs and drugs: results of a UK regional population-based cross-sectional study of weight management strategies

    PubMed Central

    2014-01-01

    Background Despite rising levels of obesity in England, little is known about slimming club and weight loss drug (medication) use or users. In order to inform future commissioning, we report the prevalence of various weight management strategies and examine the associations between slimming club and medication use and age, gender, deprivation and body mass index. Methods A population based cross-sectional survey of 26,113 adults was conducted in South Yorkshire using a self-completed health questionnaire. Participants were asked whether they had ever used the following interventions to manage their weight: increasing exercise, healthy eating, controlling portion size, slimming club, over the counter weight loss medication, or meal replacements. Factors associated with slimming club and weight-loss medication use were explored using logistic regression. Results Over half of the sample was either overweight (36.6%) or obese (19.6%). Obesity was more common in the most deprived areas compared to the least deprived (26.3% vs. 12.0%). Healthy eating (49.0%), controlling portion size (43.4%), and increasing exercise (43.0%) were the most commonly reported weight management strategies. Less common strategies were attending a slimming club (17.2%), meal replacements (3.4%) and weight-loss medication (3.2%). Adjusting for BMI, age, deprivation and long standing health conditions, women were significantly more likely to report ever using a slimming club (adjusted OR = 18.63, 95% CI = 16.52–21.00) and more likely to report ever using over the counter weight-loss medications (AOR = 3.73, 95% CI = 3.10-4.48), while respondents from the most deprived areas were less likely to report using slimming clubs (AOR = 0.60, 95% CI = 0.53-0.68), and more likely to reporting using weight loss medications (AOR =1.38, 95% CI = 1.05-1.82). Conclusion A large proportion of individuals report having used weight management strategies. Slimming clubs and over-the-counter weight loss medication

  9. 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

  10. 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.

  11. Drugs for pain management in dentistry.

    PubMed

    Hargreaves, K; Abbott, P V

    2005-12-01

    Pain is one of the most common reasons patients seek dental treatment. It may be due to many different diseases/conditions or it may occur after treatment. Dentists must be able to diagnose the source of pain and have strategies for its management. The '3-D's' principle--diagnosis, dental treatment and drugs--should be used to manage pain. The first, and most important, step is to diagnose the condition causing the pain and identify what caused that condition. Appropriate dental treatment should then be undertaken to remove the cause of the condition as this usually provides rapid resolution of the symptoms. Drugs should only be used as an adjunct to the dental treatment. Most painful problems that require analgesics will be due to inflammation. Pain management drugs include non-narcotic analgesics (e.g., non-steroidal anti-inflammatory drugs, paracetamol, etc) or opioids (i.e., narcotics). Non-steroidal anti-inflammatory drugs (NSAIDs) provide excellent pain relief due to their anti-inflammatory and analgesic action. The most common NSAIDs are aspirin and ibuprofen. Paracetamol gives very effective analgesia but has little anti-inflammatory action. The opioids are powerful analgesics but have significant side effects and therefore they should be reserved for severe pain only. The most commonly-used opioid is codeine, usually in combination with paracetamol. Corticosteroids can also be used for managing inflammation but their use in dentistry is limited to a few very specific situations.

  12. Management of nonimmediate hypersensitivity reactions to drugs.

    PubMed

    Roujeau, Jean-Claude; Haddad, Cynthia; Paulmann, Maren; Mockenhaupt, Maja

    2014-08-01

    Nonimmediate hypersensitivity to drugs has a huge diversity of clinical presentations affecting exclusively or predominantly a single organ (most often the skin) or multiple organs. The latter is the rule with drug reaction with eosinophilia and systemic symptoms, and with drug-induced vasculitis. The management includes a dozen successive steps. Finally, the patient should be provided clear information on the suspected cause of the reaction, recommendations for follow-up after severe reactions associated with a risk of sequelae, and clear recommendations for future use of medications. Pharmacovigilance networks should be informed.

  13. [Comparative study of drug efficacy and drug additives between generic drugs and original drugs].

    PubMed

    Katoh, Hiromi; Yoshii, Michiko; Ozawa, Koichiro

    2007-12-01

    In the present study, we tested three kinds of sleeping drugs, consisting mainly of triazolam, brotizolam, and flunitrazepam, to compare the drug efficacy of generic drugs with that of original drugs. After these drugs were administered orally to mice, drug efficacy was evaluated in terms of ambulation, onset time of sleep, and duration of sleep in the open field test. For all kinds of sleep-inducing drugs, the drug efficacy of most generic drugs is not necessarily equal to that of the original drug. The main reason for the difference appears to be due to differences in the rate of absorption of the main drug. Any other differences between an original drug and a generic drug are caused by drug additives, the crystal form of the main drug, the formulation, and so on. In this study, the formulation was not the reason for the differences because all of the drugs were pulverized in a mortar and had no special coating. The drug additives for all the drugs are listed and the drug efficacy compared. Unfortunately, the information was not sufficient to shed any light on the differences in drug efficacy. For effective drug therapy, more information on drug additives should be provided.

  14. [Drug addiction and anaesthesia: most popular recreational drugs in Germany and anaesthesiological management of drug addicts].

    PubMed

    Rundshagen, Ingrid

    2010-05-01

    Drug addicts need special anesthesiological care due to their co-morbidities, their modified need for analgesics and anesthetics and/or their specific substitution therapies. In spite of the high incidence of addiction worldwide controlled studies and evidence based recommendations for the anaesthesiological management of the patients are missing. The perioperative care is not the treatment of addiction, on the contrary the specific aspects of a chronic disease have to be accepted. Equally important perioperative treatment strategies for the management of drug addicts include: 1. stabilisation of the physical dependence by substitution therapies. 2. avoidance of distress or craving. 3. perioperative stress relief. 4. strict avoidance of inadequate analgesic treatment. 5. postoperative optimization with regional or systemic analgesia with non-opioids, opiods and co-analgesics. 6. consideration of specific physical or psychological comorbidities. Inadequate analgesic treatment is known to be responsible for relapses into addiction and has strictly to be avoided. This holds true even for people with long term drug abstinence. Georg Thieme Verlag Stuttgart * New York.

  15. Management of psychotropic drugs during pregnancy.

    PubMed

    Chisolm, Margaret S; Payne, Jennifer L

    2016-01-20

    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.

  16. Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.

    PubMed

    de Jong, Loek; Härmark, Linda; van Puijenbroek, Eugène

    2016-05-01

    The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. A prospective, observational cohort study was performed. A total of 2490 first-time metformin users were recruited through pharmacies in the Netherlands between February 1, 2008, and April 1, 2012. Patients were invited to complete six web-based questionnaires at 2-week, 6-week, 3-month, 6-month, 9-month and 12-month intervals after starting treatment with metformin. Information was gathered about patient characteristics, ADRs and drug use. The occurrence of at least one possible ADR related to the use of metformin was reported by 34.5 % of the patients. A higher proportion of females reported the occurrence of an ADR (39.6 %) compared to the proportion in males (30.9 %). Some patients (11.4 %) stopped using metformin within 1 year after start. More than half of the patients (50.8 %) undertook no action regarding metformin after the occurrence of ADRs. A high number of patients (77.7 %) recovered or were still recovering from ADRs despite continuation of metformin. Most ADRs occurred shortly after the beginning of the treatment, with a median latency time of 1-6 days. The study revealed some ADR-specific differences in occurrence rate, latency time, management and outcome. This study successfully obtained information about frequency, latency time, outcome and management of frequently occurring ADRs related to the use of metformin in daily practise.

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

    PubMed

    Farhat, Samina; Banday, Muddasir; Hassan, Iffat

    2016-01-01

    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). 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. 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. 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 initiation of therapy. Aromatic AED's, LTG, oxicam NSAID

  18. 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

  19. [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.

  20. [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.

  1. 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

  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.

  3. 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.

  4. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  5. 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... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  6. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  7. Safety and efficacy of a novel drug elores (ceftriaxone+sulbactam+disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study.

    PubMed

    Chaudhary, Manu; Mir, Mohd Amin; Ayub, Shiekh Gazalla

    In India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  8. Management of multiple drug-resistant tuberculosis.

    PubMed

    Hutchison, D C S; Drobniewski, F A; Milburn, H J

    2003-01-01

    There has been a worldwide increase in multiple drug-resistant tuberculosis (MDR-TB) which has in the past been associated with a poor prognosis. In the U.K., about half of the cases live in the London area and we have set out to obtain further information on their treatment and outcome. We examined the risk factors, drug resistance, drug treatment, sputum conversion, and outcome in patients with MDR-TB at three hospitals in South London and diagnosed during the period June 1995-January 1999. Human Immunodeficiency Virus (HIV)-positive patients were excluded. There were 760 patients resident in Lambeth, Southwark and Lewisham Health Authority (LSLHA) who were notified as tuberculosis (TB) during the time period and who were of negative or unknown HIV status. (The population of LSLHA is approx.750,000.) There was a total of 13 patients with MDR-TB, known or presumed to be HlV negative. Their median age was 28 years (range 15-53); nine (69%) were born outside the U.K. and 11 had pulmonary disease; they had organisms resistant to a median of two first-line drugs (range 2-4) and to a median of four of all drugs tested (range 2-10). They received treatment with a median of six drugs (range 3-9). Eight were followed up for at least 3 years (range 3-6) after the completion of treatment; at their last assessment none had features of active TB and all were sputum negative (smear and culture). Two returned to their countries of origin during treatment; they were sputum negative at that time. Two patients are well and continue on treatment in the U.K. One patient (known HIV negative) died following treatment failure. In conclusion, we obtained disease-free survival in eight cases of MDR-TB, known or presumed to be HIV negative and followed up for 3 years or more. The prognosis for patients treated at specialised centres is good (and better than is generally believed). We describe a new protocol for the detection and management of MDR-TB.

  9. Research in the field of drug therapy safety management

    PubMed Central

    Möller, Horst; Aly, Amin-Farid

    2013-01-01

    In August 2011, the Coordination Group for the implementation and continuation of the agenda for improving medication safety in Germany published a memorandum on the development of research in the field of drug therapy safety management (Memorandum on Drug Therapy Safety Management Research). The memorandum highlights the need for research into this field for the German health care system. It describes current research objectives, thematic priorities and the characteristics of the methodology of drug therapy safety management research. After presenting the current state of research into drug therapy safety management, suggestions are made regarding further necessary activities. PMID:24007447

  10. Pediatric status epilepticus: improved management with new drug therapies?

    PubMed

    Verrotti, Alberto; Ambrosi, Michela; Pavone, Piero; Striano, Pasquale

    2017-06-01

    Status Epilepticus (SE) is the most common neurological emergency of childhood. It requires prompt administration of appropriately selected anti-seizure medications. Areas covered: Following a distinction between estabilished and emergent drugs, we present pharmacological treatment options and their clinical utility in children, with a short mention on alternatives to drug treatment. We also propose an algorithm for the management of pediatric SE. For this review a Pubmed, Medline and Embase search was performed. Expert opinion: In early SE in children, in the prehospital setting, rectal diazepam or buccal midazolam are efficacious drugs; whereas in the hospital setting, intravenous lorazepam or diazepam are indicated. As regard estabilished stage of SE, in addition to the 'classic' compounds, such as phenytoin and phenobarbital, other drugs such as valproic acid, levetiracetam and lacosamide have been demonstrated efficacious. Treatment recommendations of refractory SE depend on retrospective case series and uncontrolled studies. We reported experiences about the use of midazolam, propofol, ketamine and lidocaine. They could be a valid option, but further prospective studies are necessary. Over the last few decades, important advances in basic mechanisms underlying refractory SE have been achieved, but few data are available regarding management of these stages.

  11. Management of drug-interaction alerts in community pharmacies.

    PubMed

    Indermitte, J; Beutler, M; Bruppacher, R; Meier, C R; Hersberger, K E

    2007-04-01

    Drug-interaction alert systems are commonly used in community pharmacies to identify potential drug-drug interactions. However, depending on the software default setting, pharmacists may override alerts because they are too numerous. We explored the handling of drug-interaction alerts by community pharmacies in Switzerland. Data were collected by 15 trained pharmacy students in 15 Swiss community pharmacies. The medication history and the drug-interaction alerts of 600 patients who had >or=2 drugs on prescription were assessed, and the pharmacists in charge were interviewed about their management of drug-interaction alerts. In the 15 pharmacies studied, the computer systems were programmed to flag only 'severe' drug interactions in four, 'severe or moderate' in six or 'severe, moderate or minor' in five pharmacies. The median frequency of drug-interaction alerts increased with decreasing default severity level from 0.5 to 40, respectively, to 76 per 40 patient visits and pharmacy. Because of these default settings, 277 (35 x 2%) of 787 potential drug-interaction alerts on new or repeated prescriptions were overridden by the computer systems. Only 256 (32 x 5%) of 787 potential drug interactions emerged from new prescriptions. The alert systems produced 656 alerts of which 146 were irrelevant because of multiple alerting of the same interaction or of drug combinations currently no longer taken. Of the 510 remaining relevant drug-interaction alerts, 289 (56 x 7%) were overridden by community pharmacists without any action taken. If the pharmacist took care of a patient's prescription him- or herself (as opposed to just controlling a prescription after a technician took care of the patient), fewer drug-interaction alerts were overridden by the pharmacist [Odds ratio (OR) 0 x 6, 95% confidence interval (CI) 0 x 42-0 x 98; P=0 x 042). Technical overrides (by default settings) and pharmacists' overrides together accounted for 71 x 9% (566 of 787 potential drug

  12. 'Designer drugs'. Recognizing and managing their toxic effects.

    PubMed

    Sternbach, G L; Varon, J

    1992-06-01

    "Adam," "Eve," "ecstasy," "China white." Illicit street drugs such as these are called designer drugs because they are designed to elicit certain effects and to bypass legal classification. Unfortunately, use and abuse of such substances can lead to serious medical problems and even death. Drs Sternbach and Varon describe the best-known compounds and discuss clinical characteristics and management of designer drug intoxication.

  13. 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.

  14. Prospective study of the efficacy of antibiotics versus antitussive drugs for the management of URTI-related acute cough in children.

    PubMed

    Zanasi, Alessandro; Lanata, Luigi; Saibene, Federico; Fontana, Giovanni; Dicpinigaitis, Peter V; Venier, Valentina; De Blasio, Francesco

    2016-01-01

    Acute cough is one of the most frequent symptoms prompting a visit to a health care provider, usually following a viral upper respiratory tract infection (URTI). The disproportionate use of antibiotics in children with URTIs, recently highlighted in the medical literature, could lead to associated side effects, without any beneficial effect. Although an early, albeit inappropriate, antibiotic prescription increases parental satisfaction, URTIs are predominantly viral infections and are generally self-limiting. Therefore the aim of this study was to analyze the effectiveness of antibiotics compared to symptomatic drugs (central and peripheral antitussives) on URTI-related cough in a pediatric population. This is a prospective observational study of 330 children who required pediatric consultation for acute cough. Severity, frequency and type of cough were assessed at baseline and after 6 days of treatment (antitussives n = 123, antibiotics n = 89 or combination of them n = 38) or no treatment (n = 80). The outcome of cough management after 6 days was analyzed in terms of resolution, improvement, no change or worsening of symptoms. Study assessments were performed using a standardized questionnaire administered to parents. Between children treated with antitussives or antibiotics, there was a statistically significant difference in the resolution of cough. Moreover, if considering peripheral antitussives, the resolution of cough was significantly higher with antitussives than with antibiotics (p < 0.01). There was no difference in cough resolution between children treated with antitussives and those receiving a combination of antibiotics and antitussives, either central and peripheral antitussives. Antibiotics are generally not useful nor appropriate in treating acute cough due to the common cold. Furthermore, inappropriate antibiotic use introduces the possibility of adverse side effects as well as promotion of antibiotic resistance. The

  15. Indicators of drug-seeking aberrant behaviours: the feasibility of use in observational post-marketing cohort studies for risk management.

    PubMed

    Layton, Deborah; Osborne, Vicki; Al-Shukri, Mohammad; Shakir, Saad A W

    2014-08-01

    Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufacturer, with an additional pharmacovigilance activity requested by the regulatory authority, to investigate the risks of misuse, abuse, criminal use, off-label use and accidental exposure to FEBT after the product became commercially available. A Modified Prescription-Event Monitoring (M-PEM), observational, post-authorisation safety surveillance (PASS) study was conducted, with an overall aim to examine the use of FEBT in relation to their safety as prescribed in primary care in England. One of the exploratory objectives included estimating the prevalence of aberrant behaviours during FEBT treatment. To determine the feasibility of estimating the prevalence of risk factors associated with dependence on starting treatment and aberrant behaviours in patients during treatment with a prototypical abuse liable substance (fentanyl), as based on the application of an existing index (the Chabal criteria). Data were collected as part of the M-PEM PASS study; exposure and outcome data (including risk factors for dependence and aberrant behaviours based on behavioural not clinical manifestations) were derived from questionnaires sent to primary care physicians in England during April 2008 to June 2011. For the exploratory objective of interest, descriptive statistics and simple (non-weighted) risk scores were constructed on aggregate counts (score ≥3 considered 'high-risk'). Supplementary analyses explored the relationship between the two indices and the characteristics of patients with aberrant behaviours and those without (crude odds ratios plus 95% confidence interval (CI) were calculated). In a cohort of 551 patients, the prevalence of at least one pre-existing risk

  16. 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.

  17. New concepts in the management of adverse drug reactions.

    PubMed

    Bahna, Sami L; Khalili, Barzin

    2007-01-01

    Our understanding of drug reactions and their management has changed markedly in recent years with the development of several new concepts. Epidermal cell death seen in Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) may result from Fas-Fas ligand-mediated apoptosis. Intravenous immunoglobulin (IVIG) contains anti-Fas antibodies that can abrogate apoptosis. Most studies on IVIG in SJS and TEN reported improvement in arresting disease progression and reduction in time to healing. Furthermore, several studies have dispelled the myth of sulfonamide cross-reactivity. Immune-mediated reactions against antibacterial sulfonamides are directed against two unique side chains that non-antibacterial sulfonamides do not contain. Certain patients seem to have a genetic predisposition for "multiple drug sensitivities." Hence, they may react to several drugs that are not necessarily cross-reacting. Also, multiple studies have shown that IgE-mediated nonsteroidal anti-inflammatory drugs (NSAIDs) cross-reactivity is uncommon. Rather, it is cyclooxygenase (COX) 1 inhibition that results in pseudoallergic reactions to multiple NSAIDs. Several studies have indicated that selective COX-2 inhibitors can be safely administered in patients with aspirin-exacerbated respiratory disease and NSAID-induced cutaneous reactions, although their use has been curtailed by their cardiovascular side effects. Biological agents, such as infliximab, are being increasingly used for a variety of diseases and have caused adverse reactions in some patients. Studies differ as to whether concomitant immunosuppressive use with infliximab affects the development of drug-specific antibodies and infusion reactions. Successful desensitization protocols have been developed for reactions to some of these agents.

  18. Fixed drug eruptions: presentation, diagnosis, and management.

    PubMed

    Flowers, Hal; Brodell, Robert; Brents, Melissa; Wyatt, Julie Porter

    2014-11-01

    Fixed drug eruption (FDE) is a well-defined, circular, hyperpigmenting plaque that recurs as one or a few lesions always in fixed locations upon ingestion of a drug. FDE commonly occurs on the genitals, lips, trunk, and hands. Although the lesions are distinctive, the diagnosis of FDE often is missed because it shares none of the characteristics of more common morbilliform drug rashes. The diagnosis can be confirmed by histopathologic examination of a small punch biopsy specimen. Drug avoidance is the mainstay of treatment, and antihistamines can reduce associated pruritus. Raising awareness of this condition will increase the likelihood of prompt diagnosis leading to resolution within days to weeks after the offending drug is discontinued.

  19. Prevalence of Renal Insufficiency in cancer patients and implications for anticancer drug management: the renal insufficiency and anticancer medications (IRMA) study.

    PubMed

    Launay-Vacher, Vincent; Oudard, Stéphane; Janus, Nicolas; Gligorov, Joseph; Pourrat, Xavier; Rixe, Olivier; Morere, Jean-François; Beuzeboc, Philippe; Deray, Gilbert

    2007-09-15

    The Renal Insufficiency and Cancer Medications (IRMA) study is a French national observational study. The results from this study of nearly 5,000 patients demonstrated the high prevalence of renal impairment in a population of patients with solid tumors. Every cancer patient who presented at oncology departments that participated in the study over at least 1 of 2 predefined periods during 2004 were included. Renal function was calculated using Cockcroft-Gault and abbreviated Modification of Diet in Renal Disease (aMDRD) formulae to estimate the prevalence of renal insufficiency (RI) according to the Kidney Disease Outcomes Quality Initiative-Kidney Disease Improving Global Outcomes definition and stratification. Anticancer drugs were studied with regard to their potential renal toxicity and dosage adjustment. Of the 4,684 patients from the 15 centers, 7.2% had serum creatinine levels >110 micromol/L. However, when they were assessed using Cockcroft-Gault and aMDRD formulae, 57.4% and 52.9% of patients had abnormal renal function or RI, respectively. Of the 7,181 anticancer drug prescriptions, 53.4% required dose adjustments for RI. Of the patients treated, 79.9% received at least 1 such drug. And 80.1% received potentially nephrotoxic drugs. RI was common in patients with cancer, and drug dosage adjustments often were necessary. Renal function should be evaluated in all cancer patients using either the Cockcroft-Gault formula or the aMDRD formula, including patients with normal serum creatinine levels. In patients who are at high risk for drug toxicity, the dosage should be adapted to renal function, and the use of nephrotoxic therapies should be avoided whenever possible. (c) 2007 American Cancer Society.

  20. Living with Fibromyalgia, Drugs Approved to Manage Pain

    MedlinePlus

    ... Consumers Home For Consumers Consumer Updates Living with Fibromyalgia, Drugs Approved to Manage Pain Share Tweet Linkedin ... syndrome, and depression. back to top What Causes Fibromyalgia? Scientists believe that the condition may be due ...

  1. Managing Drug Resistance in Cancer: Role of Cancer Informatics.

    PubMed

    Gautam, Ankur; Chaudhary, Kumardeep; Kumar, Rahul; Gupta, Sudheer; Singh, Harinder; Raghava, Gajendra P S

    2016-01-01

    Understanding and managing cancer drug resistance is the main goal of the modern oncology programs worldwide. One of the major factors contributing to drug resistance in cancer cells is the acquired mutations in drug targets. Advances in sequencing technologies and high-throughput screening assays have generated huge information related to pharmaco-profiling of anticancer drugs and revealed the mutational spectrum of different cancers. Systematic meta-analysis of this complex data is very essential to make useful conclusions in order to manage cancer drug resistance. Bioinformatics can play a significant role to interpret this complex data into useful conclusions. In this chapter, the use of bioinformatics platforms, particularly CancerDR, in understanding the cancer drug resistance is described.

  2. Clinical risk management of herb–drug interactions

    PubMed Central

    De Smet, Peter A G M

    2007-01-01

    The concomitant use of conventional and herbal medicines can lead to clinically relevant herb–drug interactions. Clinical risk management offers a systematic approach to minimize the untoward consequences of these interactions by paying attention to: (i) risk identification and assessment; (ii) development and execution of risk reduction strategies; and (iii) evaluation of risk reduction strategies. This paper reviews which steps should be explored or taken in these domains to improve the clinical risk management of adverse herb–drug interactions. PMID:17116126

  3. Improved management of drugs, hormones and pesticides in Africa.

    PubMed

    Mitema, E S

    2009-03-01

    Drugs, hormones and pesticides are chemical compounds used for alleviation of various diseases in animals. There are many classes of drugs which have been used and in the case of natural steroid hormones these have been used to increase mass gain by stimulating protein anabolism. Pesticides have been used for many years in the control of ectoparasites which transmit important human and livestock diseases. The purpose of the present article is to review procedures for management of veterinary products to facilitate national and international trade. These compounds and/or their metabolites have the potential to cause undesirable health effects to either target animals or consumers. Most African countries do not have competent authorities to conduct risk analysis for veterinary drug and pesticide residues in edible tissues. Because of the possible undesirable health effects from residues of veterinary compounds, the FAO/WHO established expert groups to establish acceptable daily intake and maximum residue levels (MRLs) for each drug or pesticide. In the case of natural steroids like oestradiol, progesterone and testosterone implants, no withdrawal period is required since there is no risk to the consumer. Bulls can have levels of testosterone ranging from 535-10,950 pg/g, heifers 92-250 and treated steers 100 pg/g, respectively. Data to enable approval of drugs and pesticides is to a large extent similar and include toxicity studies, reproductive studies, stability studies, safety, efficacy, tissue residue depletion studies and environmental impact. Good practice in the use of acaricides as indicated on the label is inevitable so that residue levels of these compounds remain below the specified MRL. Enactment and enforcement of legislations by various countries for the control of registration, sale, distribution and usage of ethical products should be enforced including use of prescriptions by veterinarians. Good practice in the use of veterinary drugs is the

  4. Designer drugs 2015: assessment and management.

    PubMed

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

    2015-03-25

    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.

  5. An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

    PubMed

    Chua, S S; Tea, M H; Rahman, M H A

    2009-04-01

    Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

  6. Management of the newborn infant affected by maternal opiates and other drugs of dependency.

    PubMed

    Oei, Julee; Lui, Kei

    2007-01-01

    Illicit drug use during pregnancy is common and probably underestimated in the majority of published studies. The infant exposed to opiates or other drugs of dependency during intrauterine development is at risk for post-natal withdrawal as well as to long-term problems that are associated with drug-effects and often, adverse social circumstances. This article examines the early management of the infant and mother for detection and monitoring of drug-exposure, pharmacological intervention for withdrawal and the management of associated, particularly infective and psychosocial, problems. Practical concerns surrounding these issues are discussed and further research on psychosocial intervention to improve long-term outcome are much needed.

  7. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ...; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information... Operators to Report Contractor Management Information System (MIS) Data; and New Method for Operators to... ``user name'' and ``password'' for the Drug and Alcohol Management Information System (DAMIS)...

  8. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  9. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  10. Merging lab, drug data boosts disease management.

    PubMed

    2000-02-01

    Merging lab and pharmacy data can benefit disease management. Integrating lab data with other data sets gave Blue Cross Blue Shield of Southeast Michigan a way to focus its diabetes disease management program, assess the effectiveness of therapy, and profile physicians. Learn how the plan's experience in data integration can apply to hospital systems and why pursuing a partner in such a project might be a wise move.

  11. A Cooperative Model to Improve Hospital Equipments and Drugs Management

    NASA Astrophysics Data System (ADS)

    Baffo, Ilaria; Confessore, Giuseppe; Liotta, Giacomo; Stecca, Giuseppe

    The cost of services provided by public and private healthcare systems is nowadays becoming critical. This work tackles the criticalities of hospital equipments and drugs management by emphasizing its implications on the whole healthcare system efficiency. The work presents a multi-agent based model for decisional cooperation in order to address the problem of integration of departments, wards and personnel for improving equipments, and drugs management. The proposed model faces the challenge of (i) gaining the benefits deriving from successful collaborative models already used in industrial systems and (ii) transferring the most appropriate industrial management practices to healthcare systems.

  12. Managing the unmanageable: the nature and impact of drug risk in physician groups.

    PubMed

    Lipton, Helene Levens; Agnew, Jonathan D; Stebbins, Marilyn R; Kuo, Angela; Dudley, R Adams

    2005-08-01

    As drug costs rose in the 1990s, health maintenance organizations (HMOs) began transferring risk for prescription drug expenditures to physician groups. With principal-agent theory as a framework for understanding drug-risk transfer, we used a multiple case-study design to examine the relationship between the level of drug risk that a physician group accepts and the physician group's adoption of drug-use management strategies. The data demonstrated that adoption of drug-use management innovations was not related to level of risk for pharmacy costs and that factors other than drug-risk level (e.g., contracting and data issues, financial and market factors, and physician group assessments of the fairness and incentives of risk contracts) can influence the principal-agent relationship. The data also revealed a novel form of information asymmetry between physicians and HMOs and unexpected failures of HMOs to fully enable their physician-agents. We believe these observations reflect the complexity of relationships in the health care system and have implications for the use of incentives. Based on principal-agent theory and our findings, we offer an alternative approach to drug-risk contracting that reduces physicians responsibility for aspects of drug use that are beyond their control while maintaining the incentives to manage drug costs and use that were the original intent of drug-risk contracting.

  13. 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. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Preventing and managing antiretroviral drug resistance.

    PubMed

    Kuritzkes, Daniel R

    2004-05-01

    Development of resistance to antiretroviral drugs (ARVs) is a major impediment to optimum treatment of HIV-1 infection. Although resistance testing can help to select subsequent regimens when virologic failure occurs, cross-resistance, which affects all classes of ARVs, may make it more difficult to achieve optimum control of HIV. We have known for some time that our first choice of antiretroviral therapy offers the best chance to control HIV replication and that initial therapy should be selected with an eye on future options. Potency is the first line of defense against the development of resistance. Other factors that affect resistance development include: tolerability, potential for optimum adherence, and genetic and pharmacologic barriers to development of resistance. If resistance emerges, only a single drug may be affected initially, and a rapid change in ARVs may preserve the efficacy of other components. One cautionary note is that we can no longer assume that a patient's HIV is fully susceptible to all ARVs even in the initial regimen. Transmission of drug-resistant HIV means that the genetic composition may be that of an "experienced" virus with reduced susceptibility to ARVs. Resistance testing at the time of transmission is most likely to reveal this resistance, but over time the dominant genetic pattern may revert to wild-type, and be missed by resistance testing. Because "archived" resistant HIV may emerge quickly once treatment is initiated, we need to keep this in mind when selecting initial therapy.

  15. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

    PubMed

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darsø, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Løvland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen

    2017-01-01

    Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. none. not relevant. .

  16. Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.

    PubMed

    Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan

    2010-01-01

    To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.

  17. 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.

  18. 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

  19. 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%.

  20. Health concerns and management of select veterinary drug residues.

    PubMed

    Baynes, Ronald E; Dedonder, Keith; Kissell, Lindsey; Mzyk, Danielle; Marmulak, Tara; Smith, Geof; Tell, Lisa; Gehring, Ronette; Davis, Jennifer; Riviere, Jim E

    2016-02-01

    The aim of this manuscript is to review the potential adverse health effects in humans if exposed to residues of selected veterinary drugs used in food-producing animals. Our other objectives are to briefly inform the reader of why many of these drugs are or were approved for use in livestock production and how drug residues can be mitigated for these drugs. The selected drugs include several antimicrobials, beta agonists, and phenylbutazone. The antimicrobials continue to be of regulatory concern not only because of their acute adverse effects but also because their use as growth promoters have been linked to antimicrobial resistance. Furthermore, nitroimidazoles and arsenicals are no longer approved for use in food animals in most jurisdictions. In recent years, the risk assessment and risk management of beta agonists, have been the focus of national and international agencies and this manuscript attempts to review the pharmacology of these drugs and regulatory challenges. Several of the drugs selected for this review can cause noncancer effects (e.g., penicillins) and others are potential carcinogens (e.g., nitroimidazoles). This review also focuses on how regulatory and independent organizations manage the risk of these veterinary drugs based on data from human health risk assessments.

  1. Dual Drug Delivery Using Lactic Acid Conjugated SLN for Effective Management of Neurocysticercosis.

    PubMed

    Devi, Rekha; Jain, Ankit; Hurkat, Pooja; Jain, Sanjay K

    2015-10-01

    The debut study was aimed to develop Lactic acid (LA)-conjugated solid lipid nanoparticles (SLN-LA) bearing albendazole (ALB) and prednisolone (PRD) for effective management of neurocysticercosis (NCC). LA was coupled to SLN by post-insertion technique. SLNs were characterized for particle size and size distribution, shape, and percent drug entrapment efficiency. In vitro drug release kinetics, fluorescence study and in vitro transendothelial transport, hematological studies and pharmacokinetic studies were carried out to predict the fullest drug delivery potential. Spherical SLNs (~100 nm) with good drug entrapments (~64 and ~78% for ALB and PRD, respectively) showed in vitro initial fast release (i.e., 20-40% drugs release in 4 h) followed by sustained release for more than 48 h. Fluorescence study and in vitro transendothelial transport depicted selective brain uptake of SLN-LA compared to SLN attributed to carrier mediated transport via monocarboxylic acid transporters (MCT - 1/2/3). Pharmacokinetic parameters such as AUC0-t and AUMC0-t and Cllast showed good drugs withholding capacity of SLNs. Organ distribution studies reflected high accumulation of drugs (ALB, 7.6 ± 0.31%; PRD, 5.21 ± 0.24%) in the brain after 24 h in case of SLN-LA as compared to plain drugs solution. SLN-LA in hematological studies revealed insignificant toxicity to blood cells. The overall study paved the potential advances in brain targeting with synergistic acting drugs for effective management of NCC.

  2. Management of drug and food interactions with azole antifungal agents in transplant recipients.

    PubMed

    Dodds-Ashley, Elizabeth

    2010-08-01

    Azole antifungal agents are frequently used in hematopoietic stem cell and solid organ transplant recipients for prevention or treatment of invasive fungal infections. However, because of metabolism by or substrate activity for various isoenzymes of the cytochrome P450 system and/or P-glycoprotein, azole antifungals have the potential to interact with many of the drugs commonly used in these patient populations. Thus, to identify drug interactions that may result between azole antifungals and other drugs, we conducted a literature search of the MEDLINE database (1966-December 2009) for English-language articles on drug interaction studies involving the azole antifungal agents fluconazole, itraconazole, voriconazole, and posaconazole. Another literature search between each of the azoles and the immunosuppressants cyclosporine, tacrolimus, and sirolimus, as well as the corticosteroids methylprednisolone, dexamethasone, prednisolone, and prednisone, was also conducted. Concomitant administration of azoles and immunosuppressive agents may cause clinically significant drug interactions resulting in extreme immunosuppression or toxicity. The magnitude and duration of an interaction between azoles and immunosuppressants are not class effects of the azoles, but differ between drug combinations and are subject to interpatient variability. Drug interactions in the transplant recipient receiving azole therapy may also occur with antibiotics, chemotherapeutic agents, and acid-suppressive therapies, among other drugs. Initiation of an azole antifungal in transplant recipients nearly ensures a drug-drug interaction, but often these drugs are required. Management of these interactions first involves knowledge of the potential drug interaction, appropriate dosage adjustments when necessary, and therapeutic or clinical monitoring at an appropriate point in therapy to assess the drug-drug interaction (e.g., immunosuppressive drug concentrations, signs and symptoms of toxicity

  3. Burns from illegal drug manufacture: case series and management.

    PubMed

    Porter, C J W; Armstrong, J R

    2004-01-01

    This case series presents our experience with burns sustained while manufacturing illegal drugs. All adult burn admissions in an 18-month period were retrospectively reviewed. All patients suspected of sustaining burns from illegal drug manufacture were contacted. Information regarding the burn mechanism was sought. Nine of the 64 adult burn admissions were caused by explosions during the manufacture of cannabis oil. Young males with hand and face burns were heavily represented. First-aid treatment was often ignored in favor of hiding incriminating evidence. Only two patients gave honest admission histories. Illegal drug manufacture is becoming more common as synthetic drugs become more consumer desirable. Burns sustained may be thermal and/or chemical. Dishonest patient histories negatively influence burn management. A high level of suspicion is required for diagnosing and treating burns from illegal drug manufacture. Public education is unlikely to be effective as the financial rewards outweigh the perceived risks.

  4. Methods for Managing Variation in Clinical Drug Names

    PubMed Central

    Peters, Lee; Kapusnik-Uner, Joan E.; Bodenreider, Olivier

    2010-01-01

    Objectives: To develop normalization methods for managing the variation in clinical drug names. Methods: Manual examination of drug names from RxNorm and local variants collected from formularies led to the identification of three types of drug-specific normalization rules: expansion of abbreviations (e.g., tab to tablet);reformatting of specific elements (e.g., space between number and unit); and removal of salt variants (e.g., succinate from metoprolol succinate). Results: After drug-specific normalization, recall of 3397 previously non-matching names from formularies reaches 45% overall (70% of some subsets), compared to 10–20% after generic normalization. Ambiguity has not increased significantly in the RxNorm dataset. Conclusions: A limited number of drug-specific normalization operations provide significant improvement over general language normalization. PMID:21347056

  5. [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.

  6. Toxicologic Studies for Investigational New Drugs.

    DTIC Science & Technology

    This annual report presents the results of three toxicological studies on an investigational new drug completed from 15 September 1981 through 30...Investigational New Drug Applications for Phase I and early Phase II clinical studies. One drug (WR 6026-2HCl) has been tested for Walter Reed Army

  7. 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

    ... Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or... outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough... CFR part 341, ``Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products for...

  8. The implications of urine drug testing in pain management.

    PubMed

    Vadivelu, Nalini; Chen, Isabel L; Kodumudi, Vijay; Ortigosa, Esperanza; Gudin, Maria Teresa

    2010-07-02

    In the treatment of pain management, physicians employ a variety of drugs, ranging from low-impact to highly potent, and to maximize patient health, urine toxicology analyses can significantly improve the delivery of pain treatment. Drugs such as opioids that are used for pain management are peculiar in that they provide effective pain relief and have a high risk of addiction. The use of illicit drugs in the general population has been on the rise; however, self-reporting and close monitoring of patient behavior are insufficient means to detect drug abuse and confirm compliance. Therefore, in order to create more effective drug treatment plans, physicians must understand and account for the implications of patient drug use history. Urine toxicology analysis is an important tool for pain physicians because it is more sensitive than most alternative blood tests, more efficient and cost-effective. Urine testing in addition to improving patient pain management also has forensic and legal implications. There are however limitations to urine toxicology methods as they can produce false-positive and false-negative results and are prone to human error and sample contamination There is also a need for more specific and rapid urine drug testing. Healthcare professionals should therefore be familiar with the limitations of various urine drug testing methods, and possess skills necessary to properly interpret these results. This review suggests that the overall benefits incurred by both the patient's short-term and long-term health support the routine integration of urine toxicology analysis in routine clinical care. In addition to improving health care and patient health, it has a strong potential to improve patient-physician relationships and protects the interest of involved healthcare practitioners.

  9. Identification and management of prescription drug abuse in pregnancy.

    PubMed

    Worley, Julie

    2014-01-01

    Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing.

  10. [Non-drug-based management of Alzheimer's disease].

    PubMed

    de Sant'Anna, Martha; Morat, Brune

    2013-01-01

    Alzheimer's disease requires specific patient management. This can involve non-drug-based treatments such as a cognitive stimulation programme to reinforce the patient's skills. By offering a combination of information and training to the family and caregivers, the patient's quality of life can be improved.

  11. Bureau of Land Management density management study.

    Treesearch

    John Cissel; Paul Anderson; Shanti Berryman; Sam Chan; Deanna Olson; Klaus. Puettman

    2004-01-01

    The Bureau of Land Management (BLM), Pacific Northwest Research Station (PNW), U.S. Geological Survey (USGS), and Oregon State University (OSU) established the Density Management Study (DMS) in 1994 to develop and test options for young stand management to meet Northwest Forest Plan objectives in western Oregon. The DMS demonstrates and evaluates alternative approaches...

  12. 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.

  13. 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 Committee...

  14. 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...

  15. Drug discrimination studies with ibogaine.

    PubMed

    Helsley, S; Rabin, R A; Winter, J C

    2001-01-01

    The results of the studies described here support the hypothesis that ibogaine produces its effects via selective interactions with multiple receptors. It appears that 5-HT2A, 5-HT2C, and sigma 2 receptors are involved in mediating the stimulus effects of ibogaine. In addition, opiate receptors may also be involved. In contrast, sigma 1, PCP/MK-801, 5-HT3, and 5-HT1A receptors do not appear to play a major role. Ibogaine's hallucinogenic effects may be explained by its interactions with 5-HT2A and 5-HT2C receptors, while its putative antiaddictive properties may result from its interactions with sigma 2 and opiate receptors. Alternatively, the possibility that ibogaine's hallucinogenic properties underlie its antiaddictive effects, as previously suggested (34), would support a role for 5-HT2 receptors in mediating the reported therapeutic effects of ibogaine. Certainly many questions remain regarding ibogaine's mechanism of action. Although drug discrimination will be useful for answering some of those questions, the true potential of this technique is realized whin it is combined with other techniques. The next few years promise to be fruitful with respect to our understanding of this agent. Reasons supporting this belief include advances in the study of sigma receptors, interest in ibogaine's effects on second messenger systems, and the development of ibogaine congeners such as 18-methoxycoronaridine (35). In conclusion, the aforementioned studies should serve to guide further endeavors. Pertinent questions have been generated: What is the role of sigma receptors in the effects of ibogaine, especially with regard to addiction? How does ibogaine affect opiate neurotransmission? What effects, if any, do the Harmala alkaloids have on addiction phenomena? What is the mechanism of action of harmaline? Can 10-hydroxyibogamine serve as a discriminative stimulus and, if so, what receptor interactions mediate its stimulus effects? Does the ibogaine-trained stimulus

  16. Extensively drug-resistant tuberculosis: epidemiology and management.

    PubMed

    Matteelli, Alberto; Roggi, Alberto; Carvalho, Anna Cc

    2014-01-01

    The advent of antibiotics for the treatment of tuberculosis (TB) represented a major breakthrough in the fight against the disease. However, since its first use, antibiotic therapy has been associated with the emergence of resistance to drugs. The incorrect use of anti-TB drugs, either due to prescription errors, low patient compliance, or poor quality of drugs, led to the widespread emergence of Mycobacterium tuberculosis strains with an expanding spectrum of resistance. The spread of multidrug-resistant (MDR) strains (ie, strains resistant to both isoniazid and rifampicin) has represented a major threat to TB control since the 1990s. In 2006, the first cases of MDR strains with further resistance to fluoroquinolone and injectable drugs were described and named extensively drug-resistant TB (XDR-TB). The emergence of XDR-TB strains is a result of mismanagement of MDR cases, and treatment relies on drugs that are less potent and more toxic than those used to treat drug-susceptible or MDR strains. Furthermore, treatment success is lower and mortality higher than achieved in MDR-TB cases, and the number of drugs necessary in the intensive phase of treatment may be higher than the four drugs recommended for MDR-TB. Linezolid may represent a valuable drug to treat cases of XDR-TB. Delamanid, bedaquiline, and PA-824 are new anti-TB agents in the development pipeline that have the potential to enhance the cure rate of XDR-TB. The best measures to prevent new cases of XDR-TB are the correct management of MDR-TB patients, early detection, and proper treatment of existing patients with XDR-TB.

  17. Drug-induced hyperhidrosis and hypohidrosis: incidence, prevention and management.

    PubMed

    Cheshire, William P; Fealey, Robert D

    2008-01-01

    The human sweating response is subject to the influence of diverse classes of drugs. Some act centrally at the hypothalamus or at spinal thermoregulatory centres, while others act at sympathetic ganglia or at the eccrine-neuroeffector junction. Pharmacological disturbances of sweating have broad clinical implications. Drugs that induce hyperhidrosis, or sweating in excess of that needed to maintain thermoregulation, can cause patient discomfort and embarrassment, and include cholinesterase inhibitors, selective serotonin reuptake inhibitors, opioids and tricyclic antidepressants. Drugs that induce hypohidrosis, or deficient sweating, can increase the risk of heat exhaustion or heat stroke and include antimuscarinic anticholinergic agents, carbonic anhydrase inhibitors and tricyclic antidepressants. As acetylcholine is the principal neuroeccrine mediator, anhidrosis is one of the clinical hallmarks by which acute anticholinergic toxicity may be recognized. The symptom of dry mouth often accompanies the less apparent symptom of hypohidrosis because the muscarinic M(3) acetylcholine receptor type predominates at both sweat and salivary glands. Management options include dose reduction, drug substitution or discontinuation. When compelling medical indications require continuation of a drug causing hyperhidrosis, the addition of a pharmacological agent to suppress sweating can help to reduce symptoms. When hypohidrotic drugs must be continued, deficient sweating can be managed by avoiding situations of heat stress and cooling the skin with externally applied water. The availability of clinical tests for the assessment of sudomotor dysfunction in neurological disease has enhanced recognition of the complex effects of drugs on sweating. Advances in the understanding of drug-induced anhidrosis have also enlarged the therapeutic repertoire of effective treatments for hyperhidrosis.

  18. Drug seller adherence to clinical protocols with integrated management of malaria, pneumonia and diarrhoea at drug shops in Uganda.

    PubMed

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

    2015-07-16

    Drug shops are usually the first source of care for febrile children in Uganda although the quality of care they provide is known to be poor. Within a larger quasi-experimental study introducing the WHO/UNICEF recommended integrated community case management (iCCM) of malaria, pneumonia and diarrhoea intervention for community health workers in registered drug shops, the level of adherence to clinical protocols by drug sellers was determined. All drug shops (N = 44) in the intervention area were included and all child visits (N = 7,667) from October 2011-June 2012 to the participating drug shops were analysed. Drug shops maintained a standard iCCM register where they recorded the children seen, their symptoms, diagnostic test performed, treatments given and actions taken. The proportion of children correctly assessed and treated was determined from the registers. Malaria management: 6,140 of 7,667 (80.1%) total visits to drug shops were of children with fever. 5986 (97.5%) children with fever received a malaria rapid diagnostic test (RDT) and the RDT positivity rate was 78% (95% CI 77-79). 4,961/5,307 (93.4%) children with a positive RDT received artemisinin combination therapy. Pneumonia management: after respiratory rate assessment of children with cough and fast/difficult breathing, 3,437 (44.8%) were categorized as "pneumonia", 3,126 (91.0%) of whom received the recommended drug-amoxicillin. Diarrhoea management: 2,335 (30.5%) child visits were for diarrhoea with 2,068 (88.6%) correctly treated with oral rehydration salts and zinc sulphate. Dual/Triple classification: 2,387 (31.1%) children had both malaria and pneumonia and 664 (8.7%) were classified as having three illnesses. Over 90% of the children with dual or triple classification were treated appropriately. Meanwhile, 381 children were categorized as severely sick (with a danger sign) with 309 (81.1%) of them referred for appropriate management. With the introduction of the iCCM intervention at drug

  19. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Arthritis Drugs Advisory Committee and...: Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General...

  20. Default Drug Doses in Anesthesia Information Management Systems.

    PubMed

    Rodriquez, Luis I; Smaka, Todd J; Mahla, Michael; Epstein, Richard H

    2017-07-01

    In the United States, anesthesia information management systems (AIMS) are well established, especially within academic practices. Many hospitals are replacing their stand-alone AIMS during migration to an enterprise-wide electronic health record. This presents an opportunity to review choices made during the original implementation, based on actual usage. One area amenable to this informatics approach is the configuration in the AIMS of quick buttons for typical drug doses. The use of such short cuts, as opposed to manual typing of doses, simplifies and may improve the accuracy of drug documentation within the AIMS. We analyzed administration data from 3 different institutions, 2 of which had empirically configured default doses, and one in which defaults had not been set up. Our first hypothesis was that most (ie, >50%) of drugs would need at least one change to the existing defaults. Our second hypothesis was that for most (>50%) drugs, the 4 most common doses at the site lacking defaults would be included among the most common doses at the 2 sites with defaults. If true, this would suggest that having default doses did not affect the typical administration behavior of providers. The frequency distribution of doses for all drugs was determined, and the 4 most common doses representing at least 5% of total administrations for each drug were identified. The appropriateness of the current defaults was determined by the number of changes (0-4) required to match actual usage at the 2 hospitals with defaults. At the institution without defaults, the most frequent doses for the 20 most commonly administered drugs were compared with the default doses at the other institutions. At the 2 institutions with defaults, 84.7% and 77.5% of drugs required at least 1 change in the default drug doses (P < 10 for both compared with 50%), confirming our first hypothesis. At the institution lacking the default drug doses, 100% of the 20 most commonly administered doses (representing

  1. 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

  2. Drug utilisation study in patients receiving antiepileptic drugs in Colombia.

    PubMed

    Machado-Alba, J E; Calvo-Torres, L F; García-Betancur, S; Aguirre-Novoa, A; Bañol-Giraldo, A M

    2016-03-01

    This study examines the indications according to which antiepileptic drugs are prescribed and used in a population of patients enrolled in the Colombian national health system (SGSSS). Retrospective cross-sectional study. From the pool of individuals in 34 Colombian cities who used antiepileptic drugs between 18 July, 2013 and 31 August, 2014 during a period of no less than 12 months, we obtained a random sample stratified by city. Socio-demographic, pharmacological and comorbidity variables were analysed. Continuous and categorical variables were compared, and logistic regression models were used. Our patient total was 373 patients, with 197 women (52.1%) and a mean age of 41.9 ± 21.7 years; 65.4% of the patients were treated with monotherapy. The most frequently used drugs were valproic acid (53.1%) and carbamazepine (33.2%). Epilepsy was the most frequent indication (n=178; 47.7%); however, 52.3% of the patients were prescribed antiepileptics for different indications, especially neuropathic pain (26.8%), affective disorders (14.2%) and migraine prophylaxis (12.3%). A total of 81 patients with epilepsy (46.6%) displayed good seizure control while another 25 (14.4%) had drug-resistant epilepsy. In the multivariate analysis, medication adherence was associated with a lower risk of treatment failure in patients with epilepsy (OR: 0.27; 95%CI, 0.11-0.67). In Colombia, antiepileptic drugs are being used for indications other than those originally intended. Monotherapy is the most commonly used treatment approach, together with the use of classic antiepileptic drugs. Copyright © 2015 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  3. Management for improving patients’ knowledge and understanding about drug allergy

    PubMed Central

    Jarernsiripornkul, Narumol; Chaipichit, Nataporn; Chumworathayi, Pansu; Krska, Janet

    2014-01-01

    Background: Drug allergy a serious adverse drug reaction commonly concerned in healthcare practice. Inadequate documentation and communication between health providers, and limited health literacy and knowledge in patients could contribute to the re-occurrence of allergic reactions. Objective: To evaluate the effectiveness of initiatives aiming to improve patients’ knowledge, understanding and behavior in preventing recurrent drug allergy. Methods: A before-and-after study was conducted at an 800-bed university teaching hospital, involving patients with a history of drug allergy. Questionnaires, completed at baseline and one month after receiving information were used to compare knowledge and understanding of drug allergy and behaviors in relation to drug allergy cards. Patients in Group 1 received a brochure only, but patients in Group 2 also received a pharmacist counseling intervention in addition to the brochure. Outcomes were evaluated within intervention group and between intervention groups. Results: The study included 299 (30.4%) and 100 patients (100.0%) in Groups 1 and 2 respectively who completed the baseline questionnaire, of whom 179 (59.8%) and 96 (96.0%) completed the follow-up questionnaire. At baseline, higher educational levels and possession of a drug allergy card were significantly associated with better knowledge about drug allergy. After intervention, Group 2 had significantly greater increases in mean overall knowledge scores than Group 1 (p<0.01) and also greater increases in the proportions self-reporting carrying and presenting drug allergy cards (p<0.05 and p<0.01). Conclusions: Pharmacist counseling plus brochure may be more effective than brochure alone in promoting patients’ knowledge of drug allergy and drug allergy card importance. PMID:25883688

  4. How drug life-cycle management patent strategies may impact formulary management.

    PubMed

    Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

    2016-10-01

    Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

  5. Why hospital pharmacists have failed to manage antimalarial drugs stock-outs in pakistan? A qualitative insight.

    PubMed

    Malik, Madeeha; Hassali, Mohamed Azmi Ahmad; Shafie, Asrul Akmal; Hussain, Azhar

    2013-01-01

    Purpose. This study aimed to explore the perceptions of hospital pharmacists towards drug management and reasons underlying stock-outs of antimalarial drugs in Pakistan. Methods. A qualitative study was designed to explore the perceptions of hospital pharmacists regarding drug management and irrational use of antimalarial drugs in two major cities of Pakistan, namely, Islamabad (national capital) and Rawalpindi (twin city). Semistructured interviews were conducted with 16 hospital pharmacists using indepth interview guides at a place and time convenient for the respondents. Interviews, which were audiotaped and transcribed verbatim, were evaluated by thematic content analysis and by other authors' analysis. Results. Most of the respondents were of the view that financial constraints, inappropriate drug management, and inadequate funding were the factors contributing toward the problem of antimalarial drug stock-outs in healthcare facilities of Pakistan. The pharmacists anticipated that prescribing by nonproprietary names, training of health professionals, accepted role of hospital pharmacist in drug management, implementation of essential drug list and standard treatment guidelines for malaria in the healthcare system can minimize the problem of drug stock outs in healthcare system of Pakistan. Conclusion. The current study showed that all the respondents in the two cities agreed that hospital pharmacist has failed to play an effective role in efficient management of anti-malarial drugs stock-outs.

  6. Why Hospital Pharmacists Have Failed to Manage Antimalarial Drugs Stock-Outs in Pakistan? A Qualitative Insight

    PubMed Central

    Hassali, Mohamed Azmi Ahmad; Shafie, Asrul Akmal; Hussain, Azhar

    2013-01-01

    Purpose. This study aimed to explore the perceptions of hospital pharmacists towards drug management and reasons underlying stock-outs of antimalarial drugs in Pakistan. Methods. A qualitative study was designed to explore the perceptions of hospital pharmacists regarding drug management and irrational use of antimalarial drugs in two major cities of Pakistan, namely, Islamabad (national capital) and Rawalpindi (twin city). Semistructured interviews were conducted with 16 hospital pharmacists using indepth interview guides at a place and time convenient for the respondents. Interviews, which were audiotaped and transcribed verbatim, were evaluated by thematic content analysis and by other authors' analysis. Results. Most of the respondents were of the view that financial constraints, inappropriate drug management, and inadequate funding were the factors contributing toward the problem of antimalarial drug stock-outs in healthcare facilities of Pakistan. The pharmacists anticipated that prescribing by nonproprietary names, training of health professionals, accepted role of hospital pharmacist in drug management, implementation of essential drug list and standard treatment guidelines for malaria in the healthcare system can minimize the problem of drug stock outs in healthcare system of Pakistan. Conclusion. The current study showed that all the respondents in the two cities agreed that hospital pharmacist has failed to play an effective role in efficient management of anti-malarial drugs stock-outs. PMID:24223321

  7. A purchaser experience of managing new expensive drugs: interferon beta.

    PubMed Central

    Rous, E.; Coppel, A.; Haworth, J.; Noyce, S.

    1996-01-01

    Interferon beta is a new and expensive drug for treating multiple sclerosis. One published trial has shown that it reduces the exacerbation rate in patients who have relapsing-remitting disease without important disability. This paper describes the development of a strategy for purchasing the drug in one region of England before its licensing. Purchasers felt unable to decline funding for this marginally effective drug and thereby undertake explicit rationing. To ensure prescribing was within the guidelines, a vast communication network had to be sustained with managers, general practitioners, neurologists, the Multiple Sclerosis Society, and professional advisers in all the purchasing authorities. The workload involved was considerable. The dilemma of rationing in a public service with a high political profile is demonstrated. PMID:8916757

  8. Utilization of pharmacogenomics and therapeutic drug monitoring for opioid pain management.

    PubMed

    Jannetto, Paul J; Bratanow, Nancy C

    2009-07-01

    The use of medication in pain management currently involves empirical adjustment based on observed clinical outcome and the presence of adverse drug reactions. In this study, pharmacogenomics and therapeutic drug monitoring were used to evaluate the clinical effectiveness of genotyping chronic pain patients on analgesic therapy. It was hypothesized that patients who have inherited polymorphisms in CYP2D6 that make them poor or intermediate metabolizers of opioid medications would have higher steady-state concentrations of those opioids and may be more likely to experience adverse drug reactions. In an attempt to investigate the relationship between the polymorphic enzymes, steady-state drug concentrations, therapeutic effects and side effects, 61 patients were clinically evaluated and genotyped, and drug concentrations were measured and outcomes analyzed. Samples were collected and DNA extracted from whole blood using a Puregene DNA isolation kit. CYP2D6 genotyping (*3, *4, *5, *6, *7, *8 and gene duplication) were carried out using Pyrosequencing. Steady-state plasma concentrations of methadone, oxycodone, hydrocodone and tramadol were determined by HPLC tandem mass spectrometry. The results demonstrated the prevalence of CYP2D6 polymorphisms in the population undergoing pain management was not statistically different from the general population. The majority of the pain patients (54%) were extensive metabolizers; 41% were intermediate metabolizers and 5% poor metabolizers. Poor metabolizers in general tended to have the highest steady-state drug concentrations compared with extensive metabolizers (poor metabolizers > intermediate metabolizers > extensive metabolizers) although this wasn't statistically significant. Also, a relationship between oxycodone steady-state drug concentrations and pain relief was found. A total of 80% of patients reporting adverse drug reactions also had impaired CYP2D6 metabolism. The remaining 20% with adverse drug reactions had other

  9. 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.

  10. Future applications of high-resolution MS to meet the demands for pain management drug testing.

    PubMed

    Crews, Bridgit O

    2014-01-01

    Urine specimens submitted for pain management drug testing often contain multiple psychotherapeutic drugs, in addition to opioids. Immunoassay-based screen-and-confirm approaches typically used for clinical drug testing have limited sensitivity to detect therapeutic concentrations of many drugs prescribed in pain management and do not differentiate between drugs in the same class. In addition, screening for all the various illicit and prescription drugs that may be present in the pain management population requires as many as 10-20 individual immunoassays. High-resolution MS approaches have the potential to transform the way clinical drug testing is performed for pain management.

  11. 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

  12. 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

    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

    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. 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. 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. 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.

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

    PubMed

    McClure, Nathan S; Day, Troy

    2014-12-22

    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.

  14. 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

  15. Managing the challenge of chemically reactive metabolites in drug development.

    PubMed

    Park, B Kevin; Boobis, Alan; Clarke, Stephen; Goldring, Chris E P; Jones, David; Kenna, J Gerry; Lambert, Craig; Laverty, Hugh G; Naisbitt, Dean J; Nelson, Sidney; Nicoll-Griffith, Deborah A; Obach, R Scott; Routledge, Philip; Smith, Dennis A; Tweedie, Donald J; Vermeulen, Nico; Williams, Dominic P; Wilson, Ian D; Baillie, Thomas A

    2011-04-01

    The normal metabolism of drugs can generate metabolites that have intrinsic chemical reactivity towards cellular molecules, and therefore have the potential to alter biological function and initiate serious adverse drug reactions. Here, we present an assessment of the current approaches used for the evaluation of chemically reactive metabolites. We also describe how these approaches are being used within the pharmaceutical industry to assess and minimize the potential of drug candidates to cause toxicity. At early stages of drug discovery, iteration between medicinal chemistry and drug metabolism can eliminate perceived reactive metabolite-mediated chemical liabilities without compromising pharmacological activity or the need for extensive safety evaluation beyond standard practices. In the future, reactive metabolite evaluation may also be useful during clinical development for improving clinical risk assessment and risk management. Currently, there remains a huge gap in our understanding of the basic mechanisms that underlie chemical stress-mediated adverse reactions in humans. This review summarizes our views on this complex topic, and includes insights into practices considered by the pharmaceutical industry.

  16. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... 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... risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products...

  17. Predicting and managing adverse reactions of psychotropic drugs.

    PubMed

    Ilyina, Rosa Yu; Pasynkova, Olga O; Ziganshina, Lilia E

    2013-01-01

    Neuroleptic induced extrapyramidal disorders are often presented in a form of orofacial hyperkinesias and dystonia. Rational use of neuroleptic drugs requires individualised approach to a patient, however simple criteria for determining individual, "personalised" dosage regimen have not been fully developed for routine practice in resource-limited hospital settings. To study the tonus of tongue muscles as a measure of orofacial dystonia and the total hepatic oxidative capacity as a potential predictor of excessive vulnerability to neuroleptic-induced dystonia in psychiatric patients. We measured the maximal force of the tongue manoeuvre (F, g/cm2), the total (integral) hepatic oxidative capacity by the antipyrine-test and used chlorpromazine equivalent to calculate the total daily neuroleptic load in 283 psychiatric patients and 30 healthy volunteers. The tonus of tongue muscles depends on the total daily neuroleptic dose and the length of antipsychotic treatment. The higher the total daily neuroleptic dose and the longer the treatment history, the greater the tongue muscles' tonus is. The tongue muscles' tonus was greater in patients with low rate of oxidative antipyrine metabolism. Antidepressants contributed to the increased tonus of the tongue muscles in "slow metabolisers" of antipyrine. The simple and cheap measurements of total hepatic oxidative capacity and of muscle tonus of the tongue could be used to predict and manage neuroleptic-induced adverse reactions.

  18. 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

  19. 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…

  20. 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…

  1. Drug resistance in influenza A virus: the epidemiology and management

    PubMed Central

    Hussain, Mazhar; Galvin, Henry D; Haw, Tatt Y; Nutsford, Ashley N; Husain, Matloob

    2017-01-01

    Influenza A virus (IAV) is the sole cause of the unpredictable influenza pandemics and deadly zoonotic outbreaks and constitutes at least half of the cause of regular annual influenza epidemics in humans. Two classes of anti-IAV drugs, adamantanes and neuraminidase (NA) inhibitors (NAIs) targeting the viral components M2 ion channel and NA, respectively, have been approved to treat IAV infections. However, IAV rapidly acquired resistance against both classes of drugs by mutating these viral components. The adamantane-resistant IAV has established itself in nature, and a majority of the IAV subtypes, especially the most common H1N1 and H3N2, circulating globally are resistant to adamantanes. Consequently, adamantanes have become practically obsolete as anti-IAV drugs. Similarly, up to 100% of the globally circulating IAV H1N1 subtypes were resistant to oseltamivir, the most commonly used NAI, until 2009. However, the 2009 pandemic IAV H1N1 subtype, which was sensitive to NAIs and has now become one of the dominant seasonal influenza virus strains, has replaced the pre-2009 oseltamivir-resistant H1N1 variants. This review traces the epidemiology of both adamantane- and NAI-resistant IAV subtypes since the approval of these drugs and highlights the susceptibility status of currently circulating IAV subtypes to NAIs. Further, it provides an overview of currently and soon to be available control measures to manage current and emerging drug-resistant IAV. Finally, this review outlines the research directions that should be undertaken to manage the circulation of IAV in intermediate hosts and develop effective and alternative anti-IAV therapies. PMID:28458567

  2. Optimizing hepatitis C virus treatment through pharmacist interventions: Identification and management of drug-drug interactions

    PubMed Central

    Langness, Jacob A; Nguyen, Matthew; Wieland, Amanda; Everson, Gregory T; Kiser, Jennifer J

    2017-01-01

    AIM To quantify drug-drug-interactions (DDIs) encountered in patients prescribed hepatitis C virus (HCV) treatment, the interventions made, and the time spent in this process. METHODS As standard of care, a clinical pharmacist screened for DDIs in patients prescribed direct acting antiviral (DAA) HCV treatment between November 2013 and July 2015 at the University of Colorado Hepatology Clinic. HCV regimens prescribed included ledipasvir/sofosbuvir (LDV/SOF), paritaprevir/ritonavir/ombitasvir/dasabuvir (OBV/PTV/r + DSV), simeprevir/sofosbuvir (SIM/SOF), and sofosbuvir/ribavirin (SOF/RBV). This retrospective analysis reviewed the work completed by the clinical pharmacist in order to measure the aims identified for the study. The number and type of DDIs identified were summarized with descriptive statistics. RESULTS Six hundred and sixty four patients (83.4% Caucasian, 57% male, average 56.7 years old) were identified; 369 for LDV/SOF, 48 for OBV/PTV/r + DSV, 114 for SIM/SOF, and 133 for SOF/RBV. Fifty-one point five per cent of patients were cirrhotic. Overall, 5217 medications were reviewed (7.86 medications per patient) and 781 interactions identified (1.18 interactions per patient). The number of interactions were fewest for SOF/RBV (0.17 interactions per patient) and highest for OBV/PTV/r + DSV (2.48 interactions per patient). LDV/SOF and SIM/SOF had similar number of interactions (1.28 and 1.48 interactions per patient, respectively). Gastric acid modifiers and vitamin/herbal supplements commonly caused interactions with LDV/SOF. Hypertensive agents, analgesics, and psychiatric medications frequently caused interactions with OBV/PTV/r + DSV and SIM/SOF. To manage these interactions, the pharmacists most often recommended discontinuing the medication (28.9%), increasing monitoring for toxicities (24.1%), or separating administration times (18.2%). The pharmacist chart review for each patient usually took approximately 30 min, with additional time for more complex

  3. Accuracy of manual entry of drug administration data into an anesthesia information management system.

    PubMed

    Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

    2014-11-01

    Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

  4. Drug nanocarrier, the future of atopic diseases: Advanced drug delivery systems and smart management of disease.

    PubMed

    Shao, Mei; Hussain, Zahid; Thu, Hnin Ei; Khan, Shahzeb; Katas, Haliza; Ahmed, Tarek A; Tripathy, Minaketan; Leng, Jing; Qin, Hua-Li; Bukhari, Syed Nasir Abbas

    2016-11-01

    Atopic dermatitis (AD) is a chronically relapsing skin inflammatory disorder characterized by perivascular infiltration of immunoglobulin-E (IgE), T-lymphocytes and mast cells. The key pathophysiological factors causing this disease are immunological disorders and the compromised epidermal barrier integrity. Pruritus, intense itching, psychological stress, deprived physical and mental performance and sleep disturbance are the hallmark features of this dermatological complication. Preventive interventions which include educational programs, avoidance of allergens, exclusive care towards skin, and the rational selection of therapeutic regimen play key roles in the treatment of dermatosis. In last two decades, it is evident from a plethora of studies that scientific focus is being driven from conventional therapies to the advanced nanocarrier-based regimen for an effective management of AD. These nanocarriers which include polymeric nanoparticles (NPs), hydrogel NPs, liposomes, ethosomes, solid lipid nanoparticles (SLNs) and nanoemulsion, provide efficient roles for the target specific delivery of the therapeutic payload. The success of these targeted therapies is due to their pharmaceutical versatility, longer retention time at the target site, avoiding off-target effects and preventing premature degradation of the incorporated drugs. The present review was therefore aimed to summarise convincing evidence for the therapeutic superiority of advanced nanocarrier-mediated strategies over the conventional therapies used in the treatment of AD.

  5. 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…

  6. 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

  7. GPs' views on patient drug use and the pharmacist's role in DRP management.

    PubMed

    Westerlund, Tommy; Brånstad, Jan-Olof

    2010-10-01

    The aim of this study was to examine general practitioners' (GPs') views on (1) patients' drug-related problems (DRPs) and noncompliance and (2) the role of pharmacy practitioners in DRP management. A brief questionnaire was designed and distributed to 224 GPs in Sweden. Totally 152 GPs responded (68%). Most felt that pharmacy practitioners could improve patients' drug use by identifying DRPs. A majority of the GPs also found presentations and analyses of their local pharmacies' DRP documentation valuable. According to the GPs' experiences, adverse drug effects and therapy failure were the most salient problems in patients' drug use. Half of the doctors believed that 50-75% of their patients were compliant with their prescribed drug treatments. A majority of the GPs found a 75-95% degree of compliance acceptable. The surveyed GPs demonstrated very positive attitudes towards the role of pharmacy practitioners in improving patients' drug use and managing DRPs. The GPs realised that many patients were not compliant with their prescribed drug treatments and accepted an imperfect compliance.

  8. Management of noninfectious posterior uveitis with intravitreal drug therapy

    PubMed Central

    Tan, Hui Yi; Agarwal, Aniruddha; Lee, Cecilia S; Chhablani, Jay; Gupta, Vishali; Khatri, Manoj; Nirmal, Jayabalan; Pavesio, Carlos; Agrawal, Rupesh

    2016-01-01

    Uveitis is an important cause of vision loss worldwide due to its sight-threatening complications, especially cystoid macular edema, as well as choroidal neovascularization, macular ischemia, cataract, and glaucoma. Systemic corticosteroids are the mainstay of therapy for noninfectious posterior uveitis; however, various systemic side effects can occur. Intravitreal medication achieves a therapeutic level in the vitreous while minimizing systemic complications and is thus used as an exciting alternative. Corticosteroids, antivascular endothelial growth factors, immunomodulators such as methotrexate and sirolimus, and nonsteroidal anti-inflammatory drugs are currently available for intravitreal therapy. This article reviews the existing literature for efficacy and safety of these various options for intravitreal drug therapy for the management of noninfectious uveitis (mainly intermediate, posterior, and panuveitis). PMID:27789936

  9. New antiplatelet and anticoagulant drugs. Considerations for dental patient management.

    PubMed

    Cohen, Harold V; Quek, Samuel Y P; Subramanian, Gayathri; Abbas, Ali

    2013-01-01

    A recent occurrence in dental practice is the noting of new "blood thinners" when the clinician is reviewing a patient's medical history and medications. "Doc, I take Pradaxa or Effient or Xarelto" etc. After many years of the widespread use of aspirin and Coumadin there has appeared a new generation of medications focused on reducing thromboembolic events in patients at risk. This trend has been driven by a need for drugs providing better drug efficacy based on patient biologic processing of the medications and the frequency and cost factors associated with the monitoring the degree of anticoagulation. Guidelines for assessing bleeding risk and managing patients on these new medications in dental practice are not yet defined and are empirically based on medical practitioner experience. This paper will review these new medications and will discuss current considerations for dental patient care. (Note that not all new antiplatelet and anticoagulant medications will be reviewed in this paper.)

  10. Strategic balance of drug lifecycle management options differs between domestic and foreign companies in Japan.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-01-01

    Drug approvals and patent protections are critical in drug lifecycle management (LCM) in order to maximize drug discovery investment returns. We analyzed drug LCM activities implemented by 10 top companies in Japan, focusing on drug approvals and patent term extensions. Foreign companies acquired numerous drug approvals primarily for new molecular entities (NMEs), while Japanese companies mainly obtained approvals for improved drugs including new indications, and intensively extended patent terms. Furthermore, we discovered three factors likely responsible for differences in drug LCM strategies of Japanese and foreign companies: research and development capacities for drugs, drug lags of foreign-origin NMEs, and cooperation between Research and Development Departments and Intellectual Property Departments.

  11. Prophylactic drug management for febrile seizures in children.

    PubMed

    Offringa, Martin; Newton, Richard; Cozijnsen, Martinus A; Nevitt, Sarah J

    2017-02-22

    Febrile seizures occurring in a child older than one month during an episode of fever affect 2% to 4% of children in Great Britain and the United States and recur in 30%. Rapid-acting antiepileptics and antipyretics given during subsequent fever episodes have been used to avoid the adverse effects of continuous antiepileptic drugs. To evaluate primarily the effectiveness and safety of antiepileptic and antipyretic drugs used prophylactically to treat children with febrile seizures; but also to evaluate any other drug intervention where there was a sound biological rationale for its use. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2016, Issue 7); MEDLINE (1966 to July 2016); Embase (1966 to July 2016); Database of Abstracts of Reviews of Effectiveness (DARE) (July 2016). We imposed no language restrictions. We also contacted researchers in the field to identify continuing or unpublished studies. Trials using randomised or quasi-randomised participant allocation that compared the use of antiepileptic, antipyretic or other plausible agents with each other, placebo or no treatment. Two review authors (RN and MO) independently applied predefined criteria to select trials for inclusion and extracted the predefined relevant data, recording methods for randomisation, blinding and exclusions. For the 2016 update a third author (MC) checked all original inclusions, data analyses, and updated the search. Outcomes assessed were seizure recurrence at 6, 12, 18, 24, 36, and 48 months and at age 5 to 6 years in the intervention and non-intervention groups, and adverse medication effects. We assessed the presence of publication bias using funnel plots. We included 40 articles describing 30 randomised trials with 4256 randomised participants. We analysed 13 interventions of continuous or intermittent prophylaxis and their control treatments. Methodological quality was moderate to poor in most studies. We found no significant

  12. 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

  13. Risk Management Plans: are they a tool for improving drug safety?

    PubMed

    Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

    2010-08-01

    In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

  14. Ayurvedic management of adverse drug reactions with Shvitrahara Varti

    PubMed Central

    Jadav, Hasmukh R.; Ghetiya, Hitesh; Prashanth, B.; Galib; Patgiri, B. J.; Prajapati, P. K.

    2013-01-01

    Adverse drug reactions (ADR) are an expression that describes harm associated with the use of medications at therapeutic dose. Traditional medicines also can develop ADRs due to their improper use. Shvitrahara Varti, one of such medicines holds Bakuchi as a component and is to be used judiciously. Furanocoumarins like psoralen present in Bakuchi makes skin hypersensitive and causes phytophotodermatitis in few cases. Hence, one should be careful while using medicines that contain Bakuchi. One such case is observed, where extensive reactions with application of Shvitrahara Varti were noticed and managed with Ayurvedic treatment. PMID:24250129

  15. 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.

  16. Drug-induced cutaneous photosensitivity: incidence, mechanism, prevention and management.

    PubMed

    Moore, Douglas E

    2002-01-01

    lipids and proteins. NSAIDs without the 2-arylpropionic acid group are also photoactive, but with differing mechanisms leading to a less severe biological outcome. In the antibacterial drug class, the tetracyclines, fluoroquinolones and sulfonamides are the most photoactive. Photocontact dermatitis due to topically applied agents interacting with sunlight has been reported for some sunscreen and cosmetic ingredients, as well as local anaesthetic and anti-acne agents. Prevention of photosensitivity involves adequate protection from the sun with clothing and sunscreens. In concert with the preponderance of free radical mechanisms involving the photosensitising drugs, some recent studies suggest that diet supplementation with antioxidants may be beneficial in increasing the minimum erythemal UV radiation dose.

  17. 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.

  18. Safe procedure development to manage hazardous drugs in the workplace.

    PubMed

    Gaspar Carreño, Marisa; Achau Muñoz, Rubén; Torrico Martín, Fátima; Agún Gonzalez, Juan José; Sanchez Santos, Jose Cristobal; Cercos Lletí, Ana Cristina; Ramos Orozco, Pedro

    2017-03-01

    To develop a safety working procedure for the employees in the Intermutual Hospital de Levante (HIL) in those areas of activity that deal with the handling of hazardous drugs (MP). The procedure was developed in six phases: 1) hazard definition; 2) definition and identification of processes and development of general correct work practices about hazardous drugs' selection and special handling; 3) detection, selection and set of specific recommendations to handle with hazardous drugs during the processes of preparation and administration included in the hospital GFT; 4) categorization of risk during the preparation/administration and development of an identification system; 5) information and training of professionals; 6) implementation of the identification measures and prevention guidelines. Six processes were detected handling HD. During those processes, thirty HD were identified included in the hospital GFT and a safer alternative was found for 6 of them. The HD were classified into 4 risk categories based on those measures to be taken during the preparation and administration of each of them. The development and implementation of specific safety-work processes dealing with medication handling, allows hospital managers to accomplish effectively with their legal obligations about the area of prevention and provides healthcare professional staff with the adequate techniques and safety equipment to avoid possible dangers and risks of some drugs. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  19. [Designing a software for drug management in special situations at a hospital's drug administration service].

    PubMed

    Sánchez Cuervo, Marina; Muñoz García, María; Gómez de Salazar López de Silanes, María Esther; Bermejo Vicedo, Teresa

    2015-03-01

    to describe the features of a computer program for management of drugs in special situations (off-label and compassionate use) in a Department of Hospital Pharmacy (PD). To describe the methodology followed for its implementation in the Medical Services. To evaluate their use after 2 years of practice. the design was carried out by pharmacists of the PD. The stages of the process were: selection of a software development company, establishment of a working group, selection of a development platform, design of an interactive Viewer, definition of functionality and data processing, creation of databases, connection, installation and configuration, application testing and improvements development. A directed sequential strategy was used for implementation in the Medical Services. The program's utility and experience of use were evaluated after 2 years. a multidisciplinary working group was formed and developed Pk_Usos®. The program works in web environment with a common viewer for all users enabling real time checking of the request files' status and that adapts to the management of medications in special situations procedure. Pk_Usos® was introduced first in the Oncology Department, with 15 oncologists as users of the program. 343 patients had 384 treatment requests managed, of which 363 are authorized throughout two years. PK_Usos® is the first software designed for the management of drugs in special situations in the PD. It is a dynamic and efficient tool for all professionals involved in the process by optimization of times. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  20. 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.

  1. A pilot study on the impact of known drug-drug interactions in cancer patients.

    PubMed

    Ussai, Silvia; Petelin, Riccardo; Giordano, Antonio; Malinconico, Mario; Cirillo, Donatella; Pentimalli, Francesca

    2015-08-25

    When a patient concomitantly uses two or more drugs, a drug-drug interaction (DDI) can possibly occur, potentially leading to an increased or decreased clinical effect of a given treatment. Cancer patients are at high risk of such interactions because they commonly receive multiple medications. Moreover, most cancer patients are elderly and require additional medications for comorbidities. Aim of this preliminary observational study was to evaluate the incidence of well known and established DDIs in a cohort of cancer outpatients undergoing multiple treatments. Anamnestic and clinical data were collected for 64 adult patients in the ambulatory setting with malignant solid tumors who were receiving systemic anticancer treatment. Patients also declared all drugs prescribed by other specialists or self-taken in the previous 2 weeks. DDIs were divided into two different groups: 'neoplastic DDIs' (NDDIs), involving antitumoral drugs, and 'not neoplastic DDIs' (nDDIs), involving all other classes of drugs. The severity of DDIs was classified as major, moderate and minor, according to the 'Institute for Pharmacological Research Mario Negri' definition. About 34 % of cancer outpatients within our cohort were prescribed/assumed interacting drug combinations. The most frequent major NDDIs involved the anticoagulant warfarin (33 % of total NDDIs) that, in association with tamoxifen, or capecitabine and paclitaxel, increased the risk of haemorrhage. About 60 % of nDDIs involved acetylsalicylic acid. Overall, 16 % of DDIs were related to an A-level strength of recommendation to be avoided. The lack of effective communication among specialists and patients might have a role in determining therapeutic errors. Our pilot study, although limited by a small cohort size, highlights the urgent need of implementing the clinical management of cancer outpatients with new strategies to prevent or minimize potential harmful DDIs.

  2. Mapping lifecycle management activities for blockbuster drugs in Japan based on drug approvals and patent term extensions.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-02-01

    Drug lifecycle management (LCM), which entails acquiring drug approvals and patent protections, contributes to maximizing drug discovery investment returns. In a previous survey, a comparative analysis between Japan and the USA indicated that a unique patent term extension system has an important role in Japanese drug LCM. Therefore, in this survey, we focused on drug approvals and patent term extensions, and found that the LCM for blockbuster drugs in Japan can be categorized into three types (drug approval-oriented LCM, patent term extension-oriented LCM, and inactive-type LCM), of which the first two have been implemented recently. Here, we suggest a strategy for selecting a suitable LCM approach among these three types based on the prospects for drug improvements.

  3. Extensively drug-resistant tuberculosis: epidemiology and management challenges.

    PubMed

    Dheda, Keertan; Warren, Robin M; Zumla, Alimuddin; Grobusch, Martin P

    2010-09-01

    Widespread global use of rifampin for 2 decades preceded the emergence of clinically significant multidrug-resistant tuberculosis (MDR-TB) in the early 1990s. The prevalence of MDR-TB has gradually increased such that it accounts for approximately 5% of the global case burden of disease (approximately half a million cases in 2007). Eclipsing this worrying trend is the widespread emergence of extensively drug-resistant TB (XDR-TB). This article reviews the insights provided by clinical and molecular epidemiology regarding global trends and transmission dynamics of XDR-TB, and the challenges clinicians have to face in diagnosing and managing cases of XDR-TB. The ethical and management dilemmas posed by recurrent defaulters, XDR-TB treatment failures, and isolation of incurable patients are also discussed. Given the past global trends in MDR-TB, if aggressive preventive and management strategies are not implemented, XDR-TB has the potential to severely cripple global control efforts of TB.

  4. "Selling smarter, not harder": Life course effects on drug sellers' risk perceptions and management.

    PubMed

    Fader, Jamie J

    2016-10-01

    Policies undergirding the American War on Drugs assume that drug offenders respond rationally to adjustments in sanction certainty and severity. Previous studies find that instead of absolute deterrence, or the termination of criminal activity, drug offenders employ restrictive deterrence, or a variety of risk management strategies. Extant research and current drug policy both fail to examine the interaction of risk perception, management techniques, and life course events or circumstances. This dynamic examination of apprehension avoidance strategies relies on in-depth interviews mapping out the careers of 20 drug sellers in Philadelphia, Pennsylvania. It examines their risk perceptions and risk management strategies and techniques, exploring rationales for shifts in offending behavior. Respondents were highly risk-averse but used a narrow definition of sanctions relevant to shaping future offending behavior, typically making small adjustments in sales techniques. Rationales for these shifts included sanctions, personal preference, and life course events or circumstances. Only one attributed lasting desistance from offending to a sanction, although life course events such as parenthood and employment were associated with short-term and planned desistance. The limited relevance of sanctions to offenders' thinking about risk avoidance contextualizes the widespread failure of policies designed to deter drug sales. Findings support a growing conclusion that severity of punishment is a less powerful deterrent than certainty and that adjustments in certainty after arrest are offense-specific. The relationship of life course events - especially employment - to desistance and resumed offending suggest that social policies may be more effective than criminal justice sanctions in reducing drug offending. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. 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.

  6. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    PubMed

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management.

  7. 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.

  8. 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

    2008-11-06

    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).

  9. 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…

  10. [Integrated management of patients with schizophrenia: beyond psychotropic drugs].

    PubMed

    Taborda Zapata, Eliana; Montoya Gonzalez, Laura Elisa; Gómez Sierra, Natalia María; Arteaga Morales, Laura María; Correa Rico, Oscar Andrés

    2016-01-01

    Schizophrenia is a complex disease with severe functional repercussions; therefore it merits treatment which goes beyond drugs. It requires an approach that considers a diathesis-stress process that includes rehabilitation, psychotherapeutic strategies for persistent cognitive, negative and psychotic symptoms, psychoeducation of patient and communities, community adaptation strategies, such as the introduction to the work force, and the community model, such as a change in the asylum paradigm. It is necessary to establish private and public initiatives for the integrated care of schizophrenia in the country, advocating the well-being of those with the disease. The integrated management of schizophrenic patients requires a global view of the patient and his/her disease, and its development is essential. Copyright © 2015 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  11. Managing drug-resistant epilepsy: challenges and solutions

    PubMed Central

    Dalic, Linda; Cook, Mark J

    2016-01-01

    Despite the development of new antiepileptic drugs (AEDs), ~20%–30% of people with epilepsy remain refractory to treatment and are said to have drug-resistant epilepsy (DRE). This multifaceted condition comprises intractable seizures, neurobiochemical changes, cognitive decline, and psychosocial dysfunction. An ongoing challenge to both researchers and clinicians alike, DRE management is complicated by the heterogeneity among this patient group. The underlying mechanism of DRE is not completely understood. Many hypotheses exist, and relate to both the intrinsic characteristics of the particular epilepsy (associated syndrome/lesion, initial response to AED, and the number and type of seizures prior to diagnosis) and other pharmacological mechanisms of resistance. The four current hypotheses behind pharmacological resistance are the “transporter”, “target”, “network”, and “intrinsic severity” hypotheses, and these are reviewed in this paper. Of equal challenge is managing patients with DRE, and this requires a multidisciplinary approach, involving physicians, surgeons, psychiatrists, neuropsychologists, pharmacists, dietitians, and specialist nurses. Attention to comorbid psychiatric and other diseases is paramount, given the higher prevalence in this cohort and associated poorer health outcomes. Treatment options need to consider the economic burden to the patient and the likelihood of AED compliance and tolerability. Most importantly, higher mortality rates, due to comorbidities, suicide, and sudden death, emphasize the importance of seizure control in reducing this risk. Overall, resective surgery offers the best rates of seizure control. It is not an option for all patients, and there is often a significant delay in referring to epilepsy surgery centers. Optimization of AEDs, identification and treatment of comorbidities, patient education to promote adherence to treatment, and avoidance of triggers should be periodically performed until further

  12. 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…

  13. 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…

  14. 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

  15. Management of multi- and extensively drug-resistant tuberculosis in Ukraine: how well are we doing?

    PubMed Central

    Cherenko, S.; Feschenko, Y.; Pogrebna, M.; Senko, Y.; Barbova, A.; Manzi, M.; Denisiuk, O.; Ramsay, A.; Zachariah, R.

    2014-01-01

    Setting: A tertiary care facility in Ukraine, a high multi- and extensively drug-resistant tuberculosis (MDR/XDR-TB) burden country. Objectives: To assess the management and treatment outcomes of MDR, pre-XDR-TB and XDR-TB. Design: Cohort study using programme data, 2006–2011. Results: Of 484 individuals with drug-resistant TB, 217 (45%) had MDR-, 153 (32%) pre-XDR- and 114 (24%) XDR-TB. Of all resistant types completing the intensive phase of treatment, 322 (67%) were alive and had culture converted. This included 157 (72%) with MDR- and 61 (54%) with XDR-TB. At the end of the continuation phase of treatment, 106 (22%) had treatment success and 378 (78%) had unfavourable outcomes, including 110 (23%) failures, 21 (4%) deaths, 71 (15%) losses to follow-up and 176 (36%) with an unknown outcome. This was associated with more than one lung cavity being affected, a history of treatment with second-line anti-tuberculosis drugs, poor adherence and XDR-TB. A total of 226 (47%) patients reported at least one adverse drug reaction, the most common being gastrointestinal and vestibular toxicity. Conclusion: Outcomes of MDR- and XDR-TB were satisfactory in the intensive phase; however, this was not sustained during the ambulatory period. If we are to do better, urgent measures are needed to improve ambulatory management, including making safer, shorter and more effective drug regimens available. PMID:26393102

  16. 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

  17. Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol

    PubMed Central

    Westbrook, J I; Li, L; Raban, M Z; Baysari, M T; Prgomet, M; Georgiou, A; Kim, T; Lake, R; McCullagh, C; Dalla-Pozza, L; Karnon, J; O'Brien, T A; Ambler, G; Day, R; Cowell, C T; Gazarian, M; Worthington, R; Lehmann, C U; White, L; Barbaric, D; Gardo, A; Kelly, M; Kennedy, P

    2016-01-01

    Introduction Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS). The study will also investigate system impact on clinical work processes. Methods and analysis A stepped-wedge cluster randomised controlled trial (SWCRCT) will measure changes pre-eMM and post-eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system 1 week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT design will be repeated (stage 2). Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospitals Network and Macquarie University. Results will be reported through academic journals and

  18. Advances in drug discovery and biochemical studies.

    PubMed

    Kita, Kiyoshi; Shiomi, Kazuro; Omura, Satoshi

    2007-05-01

    Japanese researchers continue to discover new means to combat parasites and make important contributions toward developing tools for global control of parasitic diseases. Streptomyces avermectinius, the source of ivermectin, was discovered in Japan in the early 1970s and renewed and vigorous screening of microbial metabolites in recent years has led to the discovery of new antiprotozoals and anthelminthics, including antimalarial drugs. Intensive studies of parasite energy metabolism, such as NADH-fumarate reductase systems and the synthetic pathways of nucleic acids and amino acids, also contribute to the identification of novel and unique drug targets.

  19. 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

  20. Challenges in managing HIV in people who use drugs.

    PubMed

    Kamarulzaman, Adeeba; Altice, Frederick L

    2015-02-01

    HIV management in people who use drugs (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 PWUD. In addition, the clinical management of HIV-infected PWUD is often complicated by the presence of multiple infectious and noninfectious comorbidities. Improved HIV treatment outcomes can be enhanced through improved testing and linkage strategies along with better treatment retention and antiretroviral (ART) adherence. Improved ART adherence can be achieved through the provision of opioid substitution therapy (OST), directly administered ART (DAART) and integration of ART with OST services. Recent advances with direct-acting antivirals (DAAs) for hepatitis C virus (HCV) have shown superior outcomes than interferon-based regimes in HIV-HCV coinfected patients. Newer diagnostic technologies for tuberculosis (TB) hold promise for earlier diagnosis for PWUD coinfected with TB, and TB treatment outcomes are improved through combination with OST. 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.

  1. Introduction to hepatic drug metabolizing enzyme induction in drug safety evaluation studies.

    PubMed

    Botts, Suzanne; Ennulat, Daniela; Francke-Carroll, Sabine; Graham, Mark; Maronpot, Robert R; Mohutsky, Michael

    2010-08-01

    The following three articles represent the output of a combined effort initiated by the Scientific Regulatory Policy Committee of the Society of Toxicologic Pathology to provide a unified review of current scientific practices and relevant literature and provide suggestions regarding the recognition, interpretation, and risk assessment of hepatic drug metabolizing enzyme (DME) induction studies. The core objective was to provide a review that the scientific community including pathologists, regulatory scientists, toxicologists, investigative scientists, and others would find valuable for managing, designing, and interpreting toxicity studies supporting regulatory filings. Three working groups composed of scientists from industry, academia, and regulatory agencies were convened to review the available literature on important aspects of the interpretation and risk assessment of hepatic microsomal DME enzyme induction in three publications. The three reviews are as follows: "Effects of Hepatic Drug Metabolizing Enzyme Induction on Clinical Pathology Parameters in Animals and Man," Toxicol Pathol "Hepatic Drug Metabolizing Enzyme Induction: Microscopic and Ultrastructural Appearance," Toxicol Pathol "Hepatic Drug Metabolizing Enzyme Induction and Implications for Preclinical and Clinical Risk Assessment," Toxicol Pathol The purpose of this introduction is not to summarize the articles but rather to frame the series and to provide a common mechanistic introduction.

  2. School District Drug and Alcohol Study.

    ERIC Educational Resources Information Center

    Crabtree, Michael

    Marijuana and alcohol use by high school students has continued to increase through the latter part of the 1970's. To gain information on the extent of this problem in their area, a school district in rural western Pennsylvania approved a study of drug and alcohol usage by the school district's 2,200 students. For reasons of confidentiality, all…

  3. Analytical and Characterization Studies of Organic Chemicals, Drugs, and Drug Formulation

    DTIC Science & Technology

    2011-11-21

    of the bulk drugs, drug products, to determine their stability under defined conditions, to prepare formulations of bulk drugs for biological...testing, and to coordinate ongoing stability studies on an artesunate dosage form with a subcontractor. 15. SUBJECT TERMS Anti-Parasitic Drugs, Chemical...Defense Agents, Chemical Analyses, Stability Studies, Formulation Development 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18

  4. 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

  5. Drugs and pharmaceuticals: management of intoxication and antidotes.

    PubMed

    Smith, Silas W

    2010-01-01

    The treatment of patients poisoned with drugs and pharmaceuticals can be quite challenging. Diverse exposure circumstances, varied clinical presentations, unique patient-specific factors, and inconsistent diagnostic and therapeutic infrastructure support, coupled with relatively few definitive antidotes, may complicate evaluation and management. The historical approach to poisoned patients (patient arousal, toxin elimination, and toxin identification) has given way to rigorous attention to the fundamental aspects of basic life support--airway management, oxygenation and ventilation, circulatory competence, thermoregulation, and substrate availability. Selected patients may benefit from methods to alter toxin pharmacokinetics to minimize systemic, target organ, or tissue compartment exposure (either by decreasing absorption or increasing elimination). These may include syrup of ipecac, orogastric lavage, activated single- or multi-dose charcoal, whole bowel irrigation, endoscopy and surgery, urinary alkalinization, saline diuresis, or extracorporeal methods (hemodialysis, charcoal hemoperfusion, continuous venovenous hemofiltration, and exchange transfusion). Pharmaceutical adjuncts and antidotes may be useful in toxicant-induced hyperthermias. In the context of analgesic, anti-inflammatory, anticholinergic, anticonvulsant, antihyperglycemic, antimicrobial, antineoplastic, cardiovascular, opioid, or sedative-hypnotic agents overdose, N-acetylcysteine, physostigmine, L-carnitine, dextrose, octreotide, pyridoxine, dexrazoxane, leucovorin, glucarpidase, atropine, calcium, digoxin-specific antibody fragments, glucagon, high-dose insulin euglycemia therapy, lipid emulsion, magnesium, sodium bicarbonate, naloxone, and flumazenil are specifically reviewed. In summary, patients generally benefit from aggressive support of vital functions, careful history and physical examination, specific laboratory analyses, a thoughtful consideration of the risks and benefits of

  6. Therapeutic drug management of linezolid: a missed opportunity for clinicians?

    PubMed

    Cattaneo, Dario; Gervasoni, Cristina; Cozzi, Valeria; Castoldi, Simone; Baldelli, Sara; Clementi, Emilio

    2016-12-01

    Some studies have shown that adjustments to the linezolid dose guided by therapeutic drug monitoring (TDM) can reduce interindividual variability in drug exposure and improve linezolid tolerability. In this study, 6 years of linezolid TDM, a diagnostic service for our hospital and others in the Milan (Italy) area, is described. Samples were collected immediately before the morning dose intake (trough concentrations) in steady-state conditions. Linezolid concentrations were quantified by a validated high-performance liquid chromatography (HPLC) method. Four hundred linezolid trough concentrations from 220 patients were collected. A 20-fold variability in linezolid levels was observed. Positive and significant correlations between linezolid trough concentrations and patient age (r = 0.325, P <0.01) or serum creatinine (r = 0.511, P <0.01) were found. A progressive increase in linezolid concentrations with time was observed in a subgroup of patients with more than one TDM assessment. Elderly patients, especially those aged >80 years and with impaired renal function, are at a higher risk of overexposure to linezolid. Despite the observed progressive increase in linezolid concentrations over time, most physicians did not change the drug dose according to the TDM results, even in the presence of frank overexposure to linezolid.

  7. The Long-term Outcomes of Sibutramine Effectiveness on Weight (LOSE Weight) study: evaluating the role of drug therapy within a weight management program in a group-model health maintenance organization.

    PubMed

    Porter, Julie A; Raebel, Marsha A; Conner, Douglas A; Lanty, Frances A; Vogel, Erin A; Gay, Elizabeth C; Merenich, John A

    2004-06-01

    To assess the benefit of sibutramine hydrochloride monohydrate within a weight management program. Prospective randomized controlled trial in a health maintenance organization. Obese patients (n = 588) starting a weight management program were enrolled. Patients were randomly assigned to participate in the program alone or to participate in the program and receive sibutramine for 12 months. Outcome measures were change in weight, body mass index (BMI), percentage body fat, serum lipids, serum glucose, and blood pressure. At baseline, there was a younger age and higher weight, BMI, and waist circumference in the drug group. There was more degenerative joint disease in the nondrug group. The mean weight loss at 6 months was 6.8 kg (95% confidence interval [CI], -7.4 to -6.1 kg) in the drug group vs 3.1 kg (95% CI, -3.8 to -2.4 kg) (P < .001) in the nondrug group. Weight loss was maintained at 12 months. Significant reductions in BMI, body fat, and waist circumference occurred in the drug group. There were no significant changes in laboratory values or blood pressure. Patients taking sibutramine experienced a significant increase in heart rate (1.7 beats/min [95% CI, 0.5-2.9 beats/min] vs -0.4 beats/min [95% CI, -1.5 to 0.8 beats/min]; P <.004). In this managed care setting, the effectiveness and safety of sibutramine were similar to those observed in randomized, double-blind clinical efficacy trials.

  8. Ocular Toxoplasmosis: Therapy-Related Adverse Drug Reactions and Their Management.

    PubMed

    Helfenstein, M; Zweifel, S; Barthelmes, D; Meier, F; Fehr, J; Böni, C

    2017-03-22

    Background There are different treatment options for ocular toxoplasmosis (OT). "Classic" therapy consists of pyrimethamine, sulfadiazine and folinic acid combined with systemic steroids and is still widely used. However, potentially severe side effects of this therapy have been reported. The aim of this retrospective study was to evaluate the incidence and types of adverse drug reactions in patients treated for OT. Clinical management of each adverse drug reaction was assessed. Patients and Methods In this retrospective analysis, we reviewed data of patients with OT, who were consecutively examined between December 2011 and December 2015 at the Department of Ophthalmology, University Hospital Zurich. Results In total, 49 patients had at least one episode of active OT. In 54 (83.0 %) of 65 treated episodes, the classic regimen was used. Of the 37 patients who received classic treatment, 9 (24.3 %) developed at least one adverse drug reaction which led to drug discontinuation, including elevated creatinine (5.4 %), elevated liver enzymes (5.4 %), vomiting (5.4 %), rash (5.4 %) and facial swelling (2.7 %). In 5 patients, treatment was switched to another drug, while in the other 4 patients, therapy was stopped. In these 9 patients, inflammation was well controlled 8 weeks after onset of therapy. No patient suffered from severe side effects, such as potentially life-threatening allergic reactions or pancytopenia. Conclusions In OT patients who were treated with classic therapy, adverse drug reactions are common. Therefore, clinical and laboratory monitoring is mandatory. Adverse drug reactions may require interdisciplinary management.

  9. 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.

  10. 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.

  11. Models for placental transfer studies of drugs.

    PubMed

    Bourget, P; Roulot, C; Fernandez, H

    1995-02-01

    Pregnancy is a specific dynamic state, and the potential usefulness of caring for a disorder in the fetus or the mother is now well established. Previously, pregnant women have been excluded from clinical trials, therefore only a few studies concerning evaluation of the pregestational metabolism or transplacental transfer (TPT) of drugs exist. Questions regarding the TPT of drugs are extensive and complex. For example, does TPT occur at a given gestational age, in the context of a particular type of pathology or when a drug is administered by a certain dosage regimen? If this is the case, what is the rapidity of penetration of the products of conception by the drug (bearing in mind its physicochemical characteristics)? Need harmful adverse effects on the child be feared? Is such penetration desirable, of no consequence, or dangerous? Does the possibility exist of accumulation in the placenta, fetal tissue or amniotic fluid? Should such findings modify the therapeutic regimens of drugs given to expectant mothers? Exchange mechanisms are complicated and models developed in vitro only partially reflect the actual equilibria that exist between mother and fetus. These include: (i) the perfused cotyledon model, which while simple, elegant and inexpensive, offers only a localised, restricted and fixed view of pregnancy; (ii) isolated anatomical fractions that are informative, but which straddle the border between physiology and pharmacology; and (iii) the necessary study, using microsomes, of placental metabolic capacity (enzyme cartography). In vivo study of TPT is based upon various multicompartmental pharmacokinetic models, some of which have been relatively validated in animals. The simplest indicator for the in vivo evaluation of TPT of a drug in the human species is determination of a feto-maternal blood concentration ratio (usually performed at the time of placental separation). However, the usefulness and limitations of this parameter are controversial, and it

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

    PubMed Central

    Ramappa, Vidyasagar; Aithal, Guruprasad P.

    2012-01-01

    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

  13. Does urine drug abuse screening help for managing patients? A systematic review.

    PubMed

    Dupouy, Julie; Mémier, Vincent; Catala, Hélène; Lavit, Michel; Oustric, Stéphane; Lapeyre-Mestre, Maryse

    2014-03-01

    In the field of addiction, assessment of psychoactive substance use is a key element. Nevertheless, self-reports and clinical examination underestimate the use of psychoactive substances. The implementation of urine drug screening tests (UDS) should improve this assessment. While the diagnostic value of UDS is well demonstrated, the consequences of carrying out UDS on medical management have not been established. Our aim was to summarize the evidence pertaining to the efficacy of UDS for medical management. A systematic review of clinical trials, quasi-randomized and observational studies was performed using PubMed, Cochrane database of systematic review, Cochrane central register of controlled trials, PsycINFO, National Institute on Drug Abuse, ISI Web of Science. The methodological quality was assessed with the score developed by Starrels et al.; the report quality using the CONSORT and the STROBE checklists. The main outcome was medical management or consequences of management for patients in terms of psychoactive substance consumption and its complications, be they medical, social or professional. Eight studies met the inclusion criteria: one randomized clinical trial, two quasi-randomized studies, one cohort, and four cross-sectional studies. The methodological quality was judged to be poor, with the exception of the randomized clinical trial (fair quality). The value of UDS in managing patients was not clearly indicated in these studies. Few studies, with poor quality, have assessed the value of UDS in managing patients using psychoactive substances; though with insufficiency to demonstrate the interest of carrying out UDS. Therefore, pragmatic intervention studies are necessary. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  14. Drug-induced seizures in the elderly. Causative agents and optimal management.

    PubMed

    Franson, K L; Hay, D P; Neppe, V; Dahdal, W Y; Mirza, W U; Grossberg, G T; Chatel, D M; Szwabo, P A; Kotegal, S

    1995-07-01

    We conducted a review of drugs that were most commonly associated with inducing seizures in the elderly population. The method for determining the risk of these agents includes evaluating the utilisation and the percentage of adverse events in previous studies and case reports. Classes of medications, such as anti-psychotics and antidepressants, are extensively reviewed to provide the clinician with treatment options in high risk patients. The risk of seizures secondary to the withdrawal of alcohol (ethanol) and benzodiazepines, and methods employed to minimise the risk are discussed. In addition, the management of patients with drug-induced seizures is delineated. Drug-induced seizures are a potentially serious adverse effect. It is important that clinicians are aware of which classes of medications and individual medications are associated with reducing seizure threshold.

  15. An effectiveness trial of contingency management in a felony preadjudication drug court.

    PubMed

    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 certificates, and the density of reinforcement was gradually decreased. No main effects of CM were detected, which appears to be attributable to a ceiling effect from the intensive contingencies already delivered in the drug court and the low density of reinforcement. Preplanned interaction analyses suggested that participants with more serious criminal backgrounds might have performed better in the CM conditions. This suggests that CM programs may be best suited for more incorrigible drug offenders.

  16. Evaluation of Probation Case Management (PCM) for Drug-Involved Women Offenders

    ERIC Educational Resources Information Center

    Chan, Monica; Guydish, Joseph; Prem, Rosemary; Jessup, Martha A.; Cervantes, Armando; Bostrom, Alan

    2005-01-01

    Based on availability of case management services, drug-involved women offenders entered either a probation case management (PCM) intervention(n = 65) or standard probation(n = 44). Participants were placed in the case management condition until all slots were filled, then placed in standard probation until case management slots opened.…

  17. 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

  18. Program management model study

    NASA Technical Reports Server (NTRS)

    Connelly, J. J.; Russell, J. E.; Seline, J. R.; Sumner, N. R., Jr.

    1972-01-01

    Two models, a system performance model and a program assessment model, have been developed to assist NASA management in the evaluation of development alternatives for the Earth Observations Program. Two computer models were developed and demonstrated on the Goddard Space Flight Center Computer Facility. Procedures have been outlined to guide the user of the models through specific evaluation processes, and the preparation of inputs describing earth observation needs and earth observation technology. These models are intended to assist NASA in increasing the effectiveness of the overall Earth Observation Program by providing a broader view of system and program development alternatives.

  19. Dimensions and Characteristics of Personnel Manager Perceptions of Effective Drug-Testing Programs.

    ERIC Educational Resources Information Center

    Gomez-Mejia, Luis R.; Balkin, David B.

    1987-01-01

    Examined characteristics of drug-testing programs that were associated with personnel managers' judgments of the programs' effectiveness using data gathered from human resource managers (N=190). Results showed drug-testing programs considered to be effective were supported by ancillary activities (such as employee assistance programs), targeted…

  20. [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.

  1. 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.

  2. Safety Management Status among Nurses Handling Anticancer Drugs: Nurse Awareness and Performance Following Safety Regulations.

    PubMed

    Jeong, Kyeong Weon; Lee, Bo-Young; Kwon, Myung Soon; Jang, Ji-Hye

    2015-01-01

    This study identified the actual conditions for safe anticancer drug management among nurses and the relationship between level of awareness and performance of anticancer drug safety regulations in terms of preparation, administration, and disposal. The respondents were 236 nurses working with chemotherapy in wards and outpatient clinics in five hospitals in and near Seoul. Safety regulations provided for the anticancer drug the Occupational Safety Health Administration (OSHA, 1999), as modified for an earlier study, were used. The results showed that the level of awareness and performance on the anticancer drug safety regulations indicate their preparation (3.38±0.55, 2.38±0.98), administration (3.52±0.46, 3.17±0.70), general handling and disposal (3.33±0.54, 2.42±0.90) on a scale 0 to 5. Also, there were significant differences in job positions, work experience, type of preparation, and continuing education and a positive relationship between the level of awareness and nursing performance. Thus, nurses should receive continuing education on the handling of anticancer drugs to improve the level of performance following safety regulations.

  3. Diuretics: still essential drugs for the management of hypertension.

    PubMed

    Fuchs, Flávio Danni

    2009-06-01

    According to most current international guidelines for hypertension, diuretics are indicated for elderly and black patients, unless they have any of a long list of other preferential indications. These recommendations are mostly based on the results of corporate-sponsored and biased trials, which have unsuccessfully tried to demonstrate the existence of pleiotropic effects of newer agents. Metaregression analyses have shown that the benefits of treatments are directly proportional to the difference in blood pressure between trial arms. New analyses of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) trial demonstrated the superiority of chlorthalidone over other agents in the prevention of end-stage renal disease in diabetics and of cardiovascular events in newer cases of diabetes. Despite this evidence, patients continue to withdraw from effective therapies in recent trials. The use of diuretics has also been challenged by the results of the Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial, which employed hydrochlorothiazide, a diuretic with lower potency and duration of action than chlorthalidone. Diuretics are still essential drugs for hypertension management, but diuretics with higher potency and duration of action, such as chlorthalidone, should be preferred.

  4. 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.

  5. Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

    PubMed

    Liang, Bryan A; Mackey, Tim K

    2012-02-09

    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. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. 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. 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. 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.

  6. A study on comparative efficacyof hypolipidemic drugs.

    PubMed

    Sher, A; Ullah, A; Mateen, A

    1995-01-01

    A study was carried out on the comparative efficacy of Lopid, Mevacor, Bezalip and Lasona in sixteen hyperlipidemic subjects. All the subjects were on Lopid at least for the last 15 days. Lopid therapy was discontinued after determining blood lipid profile of the subjects on day zero (day of 1st contact). The subjects were divided into three groups and after a washout period of 15 days, they were given three different drugs for the next 15 days. Subjects in group a (6), b (5) and c (5) received Mevacor, Bezalip and lasona respectively. In the present study mevacor was found to be the most potent hypolipidemic drug in lowering blood cholesterol and Low density lipoprotein (LDL) while lopid was most effective in keeping blood Triglycerides (TG) and High density lipoproteins (HDL) level within the desired limits. Bezalip and Lasona were also sufficiently effective in changing blood lipid profile, but lasona showed a negligible effect on HDL rise as compared with Bezalip or any other drug used in this study.

  7. 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

  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. German drug monitoring studies with nabumetone.

    PubMed

    Stroehmann, I; Fedder, M; Zeidler, H

    1990-01-01

    Although randomised controlled comparative trials concerning the efficacy of the drug tested can produce reliable results in a limited number of selected patient groups, drug monitoring studies involving 10,000 patients or more are the methods of choice to detect rare adverse events. The aim of this drug monitoring study was to evaluate the efficacy and safety of dispersible nabumetone tablets. 8865 patients (46.2% male, 53.5% female, mean age 55 years, range 14.95) were involved in the investigation carried out by 1172 general practitioners. The disease indications comprised osteoarthritis (69.8%), soft-tissue rheumatism (11.3%), rheumatoid arthritis (9.9%) and soft tissue injuries (7.7%). Most of the patients (67.3%) received a daily dose of nabumetone 1 g for up to 6 weeks. Efficacy was evaluated at baseline, and after 1 week, 3 weeks and 6 weeks of treatment. With regard to global efficacy, overall improvement (symptoms resolved or markedly improved) was assessed in 82% of the patients. Elimination or at least significant improvement of pain on movement occurred in 95%, pain on pressure in 90% and pain at rest in 89% of the patients with symptoms. In relation to swelling, morning stiffness and joint mobility, elimination or at least significant improvement occurred in 79%, 80% and 82% of patients, respectively. 1846 patients (20.8%) had frequent periods of NSAID-related symptoms before treatment with nabumetone. A total of 1174 adverse events occurred in 850 patients (9.6%), most comprising minor gastrointestinal complaints. Considering that at least 25,000 patients have been documented in 2 German drug monitoring studies, it is therefore unlikely that any unexpected side effects will occur in the future. Consequently, nabumetone can be classified as an effective and safe NSAID.

  10. How unlicensed drug vendors in rural Uganda perceive their role in the management of childhood malaria.

    PubMed

    Liow, Eric; Kassam, Rosemin; Sekiwunga, Richard

    2016-12-01

    A large number of caregivers in Uganda rely on the private drug delivery sector to manage childhood illnesses such as malaria. In rural settings where the formal private sector is scarce, unlicensed retail drug outlets are an important initial source of care for households. Despite their abundance, little is known about them. This study explores unlicensed retail drug outlet vendors' perceptions of their practice and social environment in one rural district of Uganda. A qualitative design using semi-structured interviews was conducted with vendors from unlicensed retail drug outlets across all 10 sub-counties of Butaleja District. The study was conducted over a six-week period in 2011. Open-ended questions were used to gain insight into participants' perspectives, and data were analyzed using acceptable qualitative research protocols. Interviews were carried out with 75 vendors by trained local research assistants. Most vendors operated out of drug shops, just over half were both owners and shop attendants, and only 14% had qualifications to apply for operating a licensed drug shop. Vendors' experiences with managing malaria in children aged five and under in their community revealed five major themes, their perceptions of: 1) their role in the community, 2) their ability to manage uncomplicated malaria in young children, 3) the challenges of day-to-day operations, 4) the effect of regulatory policies on their ability to serve their communities, and 5) the prospect of future training programs. While the literature has raised concerns regarding the quality of care provided at such unlicensed outlets, most vendors in this study had a limited awareness of their deficiencies. There was a general sentiment among vendors that the public health system within Butaleja was failing the community and their presence was filling an important vacuum. Given the dominance of unlicensed retail drug outlets over their formal (licensed) counterparts in many rural settings, further

  11. Drug treatment patterns for the management of men with lower urinary tract symptoms associated with benign prostatic hyperplasia who have both storage and voiding symptoms: a study using the health improvement network UK primary care data.

    PubMed

    Hakimi, Zalmai; Johnson, Michelle; Nazir, Jameel; Blak, Betina; Odeyemi, Isaac A O

    2015-01-01

    Real-world data on the pharmacological management of men who have lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are limited. To characterize men with LUTS/BPH who had both storage and voiding symptoms and to evaluate treatment patterns in UK primary care. This was an observational study of men aged ≥45 years with a diagnosis, symptoms or therapies indicative of LUTS/BPH with both storage and voiding components. These men were identified from the large Health Improvement Network (THIN) database between 1 January 2004 and 30 September 2011. Drug prescriptions and switching/discontinuation patterns for α₁-blockers and antimuscarinics. We identified 8694 men with a median age of 66.0 (interquartile range [IQR], 59.0-74.0) years. Most (7850; 90.3%) received an α₁-blocker, and 2167 (24.9%) received antimuscarinic therapy over a median of 2.1 years. The most commonly prescribed α₁-blocker was tamsulosin (81.8%); most frequent antimuscarinics were tolterodine (41.0%), oxybutynin (37.2%) and solifenacin (35.7%). Concomitant prescription of α1-blocker and antimuscarinic therapy (within 30 days of each other) was received by 1160 men (14.8% of α₁-blocker-treated men). Of α₁-blocker recipients, 3024 (38.5%) discontinued during follow-up, while 1149 (53.0%) discontinued antimuscarinic therapy. Of 2167 men who received an antimuscarinic, 476 (22.0%) switched to another antimuscarinic. Of the three most commonly prescribed antimuscarinics, solifenacin had the lowest proportions of discontinuations (43.0%) and switches (15.3%), and the longest median duration of therapy (90 days, IQR 30-300). General practice consultations accounted for most resource use (5307.9 per 1000 patient-years). This study presents real-world management of men with LUTS/BPH who have both storage and voiding symptoms. The low proportion of men who received concomitant α₁-blocker and antimuscarinic therapy suggests that some patients are sub

  12. 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

  13. [Preventive measures for drug addiction in the middle scale hospital--our challenge for ideal drug management system in the operating rooms].

    PubMed

    Nakasuji, Masato; Tanaka, Masuji; Imanaka, Norie; Kawashima, Hiroko; Asada, Akira

    2007-09-01

    Drug addiction of doctors has become social problems recently due to inappropriate drug management system in the operating theater. It goes without saying that we must behave ourselves as doctors. In addition, current drug management system should be improved and all drugs stocked in the operating theater should be counted by pharmacists after surgery. Kansai Denryoku Hospital with four hundred beds started new drug management system in December 2005. Drug sets for each surgical patient in the cart are delivered from the pharmacy every morning. A drug set is carried to the each operating room by an anesthesiologist or a nurse and they write down administered drugs in the document after surgery. Pharmacists collect the drug cart the following morning and check each drug set and document in the pharmacy. All drugs can not be carried out from the operating theater without permission, and anesthesiologists and nurses do not have to spend too much time on drug management. Extra one hour is needed for pharmacists to check the drug set in the pharmacy. We consider that our new drug management system can substitute a satellite pharmacy, which is recognized currently as ideal drug management system in the operating theater, in the middle scale hospitals without enough pharmacists assigned exclusively to the operating theater.

  14. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    PubMed

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  15. 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

  16. Seniors' uncertainty management of direct-to-consumer prescription drug advertising usefulness.

    PubMed

    DeLorme, Denise E; Huh, Jisu

    2009-09-01

    This study provides insight into seniors' perceptions of and responses to direct-to-consumer prescription drug advertising (DTCA) usefulness, examines support for DTCA regulation as a type of uncertainty management, and extends and gives empirical voice to previous survey results through methodological triangulation. In-depth interview findings revealed that, for most informants, DTCA usefulness was uncertain and this uncertainty stemmed from 4 sources. The majority had negative responses to DTCA uncertainty and relied on 2 uncertainty-management strategies: information seeking from physicians, and inferences of and support for some government regulation of DTCA. Overall, the findings demonstrate the viability of uncertainty management theory (Brashers, 2001, 2007) for mass-mediated health communication, specifically DTCA. The article concludes with practical implications and research recommendations.

  17. The use of oral fluid for therapeutic drug management: clinical and forensic toxicology.

    PubMed

    Langman, Loralie J

    2007-03-01

    One of the underlying tenets of clinical pharmacology is that only free drugs are pharmacologically active. It is thought that only free drugs can cross biological membranes to interact with a given receptor to alter its function, and that drug responses, both efficacious and toxic, are a function of unbound concentrations. The rationale for measuring drugs in oral fluid is that the free fraction of a drug in plasma reaches equilibrium with the drug in saliva. Although reports concerning the appearance of organic solutes in saliva have been in the literature for over 70 years, it has only been in the past 30 years that there has been emphasis on the appearance of drugs. Although many assumptions for drug level monitoring in saliva are made, the primary requisite for salivary monitoring to be useful is a constant or predictable relationship between the drug concentration in saliva and the drug concentration in plasma. Measurement of oral fluid drug levels for the purpose of managing patients and making dosage adjustments may be useful for select drugs or drug classes. However, it does not appear to be useful for the majority of drugs therapeutically monitored. Some work with antipsychotic medications has indicated that although the measurement of drug concentrations themselves may not be useful for dosage adjustment, the ratio of parent drug to metabolite may reflect altered metabolic status due to either pharmacogenetic variation or other clinical conditions. Furthermore, analysis of saliva may provide a cost-effective approach for the screening of large populations.

  18. 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…

  19. 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…

  20. Advanced Practice Internship: Experiential Learning in a Drug Use and Disease State Management Program

    PubMed Central

    Skledar, Susan J.; McKaveney, Teresa P.; Ward, Charles O.; Culley, Colleen M.; Ervin, Kelly C.; Weber, Robert J.

    2006-01-01

    Objective Establish a 3-year hospital internship within a drug use and disease state management program that would provide doctor of pharmacy students with experiential learning while still completing their classroom studies. Design As paid interns, students engaged in group and individual activities that assessed clinical practice guidelines. Patient monitoring and clinical intervention techniques were learned through prospective evaluation of drug therapy. Students designed evidence-based treatment guidelines and participated in all phases of development, including multidisciplinary approval, implementation, and evaluation stages. Assessment Student competency was continually monitored through direct observation by a preceptor and written examinations. Patient case studies, group discussions, and poster presentations allowed assessment of student growth in knowledge and communication skills. Conclusion The comprehensive structure of this internship provides a broad perspective for understanding the role of the hospital pharmacist in providing pharmaceutical care. Close supervision maximizes student learning potential and fosters a mentoring relationship for both personal and professional growth. PMID:17136188

  1. 77 FR 43337 - Drugs for Human Use; Drug Efficacy Study Implementation; Certain Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... enacted in 1938, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) required that ``new drugs'' (see... commerce. To this end, the FD&C Act made it the sponsor's responsibility, before marketing a new drug, to... to be marketed without independent approval. In 1962, Congress amended the FD&C Act to require...

  2. 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

  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. 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.

  5. Theoretical studies of anticancer drugs, lexitropsins

    SciTech Connect

    Kabir, S.

    1992-01-01

    The purpose of this research study was to gather information about the structure and activity of some anticancer drugs, leading eventually to better drug designs. The following studies were undertaken: (1) The investigation via geometry optimization of the structure of one small lexitropsin, amidinomycin, which is an oligopeptide that binds to the minor groove of B-DNA. (2) Proton affinities of some hydrogen acceptor rings that are present in some lexitropsin were studied in order to estimate their capacities to bind to GC sequences of DNA. (3) Binding power of one of the DNA bases, thymine, to either guanidinium ion as present in netropsin or aminopyrrolidinium ion moiety as is present in anthelvencin was compared in order to determine how much these two groups contributed to the overall binding of netropsin and anthelvencin to the base sequences of DNA. It was found that ab initio calculations on amidinomycin agree well with the experimental results and the proton affinities of imidazole is much higher than the one of oxazole which in turn is much higher than the one of thiazole and a methyl group substitutent increases the proton of imidazole, while a peptidic group decreases it. Also, it was found that the binding of guanidinium and aminopyrrolidinium ions to uracil as a model for thymine is very similar.

  6. The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

    PubMed

    Chawla, Anita; Carls, Ginger; Deng, Edmund; Tuttle, Edward

    2015-07-01

    Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

  7. A management study template for learning about postwildfire management.

    Treesearch

    B.T. Bormann; J.A. Laurence; K. Shimamoto; J. Thrailkill; J. Lehmkuhl; G. Reeves; A. Markus; D.W. Peterson; E. Forsman

    2008-01-01

    The concept of management studies--implemented by managers as normal business to meet priority learning needs--is applied to a priority regional question: how to manage after a large wildfire to better meet preexisting or new societal needs. Because of a lack of knowledge and studies, deciding how to manage after wildfire is fraught with uncertainty. We have developed...

  8. 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)

  9. Drug reactions affecting the nail unit: diagnosis and management.

    PubMed

    Piraccini, Bianca Maria; Iorizzo, Matilde

    2007-04-01

    Several drugs may be responsible for the development of nail abnormalities, but only a few classes are consistently associated with nail symptoms. Drug-induced nail abnormalities result from toxicity to the matrix, the nail bed, the periungual tissues, or the digit blood vessels. Pharmacologic agents that most frequently produce nail abnormalities include retinoids, indinavir, and cancer chemotherapeutic agents.

  10. 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)

  11. Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study.

    PubMed

    Pernod, Gilles; Wu, Haifeng; de Maistre, Emmanuel; Lazarchick, John; Kassis, Jeannine; Aguilar, Carlos; Vera, Pascual M; Palareti, Gualtiero; D'Angelo, Armando

    2016-11-29

    Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard of care setting. D-dimer assay was performed in consecutive, ambulatory outpatients suspected of pulmonary embolism, with low/moderate PTP, and without medical conditions or in clinical settings known to alter default D-dimer values regardless of the presence of thrombosis using a threshold of 0.5 μg/ml (fibrinogen equivalent units) for venous thromboembolism exclusion. Results were used to determine test performance. Of 1141 patients who underwent D-dimer testing, 1060 had valid results and completed study as planned. STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance requirements, with a sensitivity of 97.6% (95% confidence interval: 91.7-99.7%) and a negative predictive value of 99.7% (95% confidence interval: 99.0-100%). STA-Liatest D-Di assay has an excellent performance when used in combination with a PTP score in relevant patients and has the potential to minimize the economic healthcare burden avoiding unnecessary and expensive imaging tests.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The

  12. Drug Induced Hearing Loss: Researchers Study Strategies to Preserve Hearing

    MedlinePlus

    ... JavaScript on. Feature: Drug-Induced Hearing Loss Researchers Study Strategies to Preserve Hearing Past Issues / Spring 2016 Table ... Read More "Drug Induced Hearing Loss" Articles Researchers Study Strategies to Preserve Hearing / What Is Ototoxicity? Spring 2016 ...

  13. Drugs of abuse: management of intoxication and antidotes.

    PubMed

    Montoya, Ivan D; McCann, David J

    2010-01-01

    Illicit drug intoxications are an increasing public health problem for which, in most cases, no antidotes are clinically available. The diagnosis and treatment of these intoxications requires a trained clinician with experience in recognizing the specific signs and symptoms of intoxications to individual drugs as well as polydrug intoxications, which are more the rule than the exception. To make the diagnosis, the clinical observation and a urine toxicology test are often enough. Evaluating the blood levels of drugs is frequently not practical because the tests can be expensive and results may be delayed and unavailable to guide the establishment of a treatment plan. Other laboratory tests may be useful depending on the drug or drugs ingested and the presence of other medical complications. The treatment should be provided in a quiet, safe and reassuring environment. Vital signs should be closely monitored. Changes in blood pressure, respiratory frequency and temperature should be promptly treated, particularly respiratory depression (in cases of opiate intoxication) or hyperthermia (in cases of cocaine or amphetamine intoxication). Intravenous fluids should be administered as soon as possible. Other psychiatric and medical complication should receive appropriate symptomatic treatment. Research on immunotherapies, including vaccines, monoclonal and catalytic antibodies, seems to be a promising approach that may yield specific antidotes for drugs of abuse, helping to ameliorate the morbidity and mortality associated with illicit drug intoxications.

  14. Emerging role of drug interaction studies in drug development: the good, the bad, and the unknown.

    PubMed

    Alfaro, C L

    2001-01-01

    Significant scientific advancements in the last decade have armed researchers with tools to assess drug metabolism and the effects of drugs on metabolic pathways; however, most of this research has focused on cytochrome P450 isozymes. Early delineation of this information aids in the prediction of potential drug-drug interactions, which may ultimately determine whether a compound is pursued in the drug development process. The recent withdrawals of medications such as terfenadine, astemizole, cisapride, and mibefradil from the market demonstrate the relevance of this a priori approach--the risk of drug interactions was largely unrecognized prior to their approval by the Food and Drug Administration (FDA). Drug interaction studies for new drug applications (NDAs) field between 1987 and 1991 were largely in vivo studies with potential coadministered drugs, whereas for NDAs field between 1992 and 1997, the majority of studies involved metabolic mechanisms and in vitro methodology. Despite current limitations in the extrapolation of in vitro drug metabolism data to the in vivo environment, in vitro studies remain the mainstay of initial evaluations in this area primarily because of the high throughput nature of these investigations and the reduced cost compared with in vivo studies. The FDA has published several guidance documents in the area of drug metabolism and drug interaction studies in drug development with suggestions for in vitro as well as in vivo approaches to these investigations. Current and future research will likely focus on in vitro models for cytochrome P450 induction, Phase II metabolism, and drug transporters, and include validation and extrapolation of these approaches in vivo.

  15. Development of a multiple-drug delivery implant for intraocular management of proliferative vitreoretinopathy.

    PubMed

    Zhou, T; Lewis, H; Foster, R E; Schwendeman, S P

    1998-11-13

    A prototype multiple-drug delivery implant has been developed for the intraocular management of proliferative vitreoretinopathy (PVR). Because of the recurrent nature of the disease, PVR causes blindness in approximately 7% of patients who have undergone retinal re-attachment surgery. The poly(dl-lactide-co-glycolide) 50/50 (PLGA) implant consists of three cylindrical segments, each of which contains one of the following drugs: 5-fluorouridine (5FUrd, an antimetabolite), triamcinolone (Triam, a corticosteroid), and human recombinant tissue plasminogen activator (t-PA, a thrombolytic agent). The device can be inserted through a 20-gauge syringe needle into the vitreous body of the eye. The implant also possesses a PLGA coating over the t-PA-containing terminal segment, which creates a lag-time to deliver t-PA when most needed and to decrease the risk of postoperative bleeding. Two methods of cylinder fabrication were investigated: heat and solvent extrusion. The release behavior of several drugs was examined as a function of the processing variables including: extrusion method, drug loading, polymer molecular weight, and drug particle size. The presence of either the organic solvent (acetone) during processing or a highly water-soluble drug (5FUrd) in the formulation increased the polymer porosity, which in turn, increased the drug release-rate. Drug loading effects were consistent with percolation concepts, and a low-molecular-weight PLGA (e.g., Mw=42000 for inherent viscosity=0.58 dl/g) was desirable to produce controlled release close to one month. Based on pharmacological and pharmacokinetic data of these compounds and our clinical experience with this disease, several design criteria for a combined implant were devised. Optimal cylindrical segments from the formulation studies were selected and combined in series to form a contiguous implant. After successful combination and coating procedures were developed, prototype implants were prepared. From the 3-drug

  16. High-content screening data management for drug discovery in a small- to medium-size laboratory: results of a collaborative pilot study focused on user expectations as indicators of effectiveness.

    PubMed

    Berlinicke, Cynthia A; Ackermann, Christopher F; Chen, Steve H; Schulze, Christoph; Shafranovich, Yakov; Myneni, Sahiti; Patel, Vimla L; Wang, Jian; Zack, Donald J; Lindvall, Mikael; Bova, G Steven

    2012-08-01

    High-content screening (HCS) technology provides a powerful vantage point to approach biological problems; it allows analysis of cell parameters, including changes in cell or protein movement, shape, or texture. As part of a collaborative pilot research project to improve bioscience research data integration, we identified HCS data management as an area ripe for advancement. A primary goal was to develop an integrated data management and analysis system suitable for small- to medium-size HCS programs that would improve research productivity and increase work satisfaction. A system was developed that uses Labmatrix, a Web-based research data management platform, to integrate and query data derived from a Cellomics STORE database. Focusing on user expectations, several barriers to HCS productivity were identified and reduced or eliminated. The impact of the project on HCS research productivity was tested through a series of 18 lab-requested integrated data queries, 7 of which were fully enabled, 7 partially enabled, and 4 enabled through data export to standalone data analysis tools. The results are limited to one laboratory, but this pilot suggests that through an "implementation research" approach, a network of small- to medium-size laboratories involved in HCS projects could achieve greater productivity and satisfaction in drug discovery research.

  17. 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.

  18. Drug hypersensitivity in human immunodeficiency virus-infected patient: challenging diagnosis and management

    PubMed Central

    Widhani, Alvina; Karjadi, Teguh Harjono

    2014-01-01

    Human immunodeficiency virus (HIV)-infected patients present complex immunological alterations. Multiple drugs that usually prescribed for prevention or treatment of opportunistic infections and antiretroviral pose these patients a higher risk of developing drug hypersensitivity. All antiretroviral agents and drugs to treat opportunistic infections have been reported to cause drug hypersensitivity reactions. Allergic reactions with antiretroviral are not restricted to older agents, although newer drugs usually more tolerated. Cutaneous adverse drug reactions are the most common manifestation of drug hypersensitivity in HIV, typically manifesting as maculopapular rash with or without systemic symptoms in the presence or absence of internal organ involvement. The onset of an allergic reaction is usually delayed. Severe drug hypersensitity reactions as erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis develop more often in HIV-infected patients compared to other populations. Mild to moderate rash without systemic symptom or organ involvement usually do not need drug discontinuation. Appropriate diagnosis and management of drug hypersensitivity reactions are essential, especially in patients with very low CD4+ T-cell count and multiple opportunistic infections. Clinicians should aware of different half-life of each drug when decided to stop the drug. Knowledge of the metabolism, recognition of the risk factors, and the ability to suggest the probability of particular drug as causative are also important points. A step wise rechallenge test or desensitization with the offending drug might be a preferable action and more commonly used in managing drug hypersensitivity in HIV-infected patients. Desensitization protocols have been successfully done for several antiretroviral and opportunistic infection drugs. PMID:24527412

  19. Description of drug therapy problem resolution in a statewide care management program.

    PubMed

    Renfro, Chelsea Phillips; Ferreri, Stefanie P; Williams, Neil; Clark, Cole; Pfeiffenberger, Trista

    To describe drug therapy problem (DTP) resolution as part of a statewide, team-based care management program. This was a retrospective, observational study of DTPs documented between March 1 and August 31, 2015. Data were retrieved from a Web-based platform 5 months after the observation period. DTPs were placed into groups based on the credentials of the person who documented the DTP. Next, they were identified as being documented in a transitional or nontransitional care setting. DTPs were further classified into 1 of 3 categories: medication adherence, discrepancy, or optimization. Lastly, DTP resolution was assessed. Results were analyzed using descriptive statistics. During the 6-month study period, 135,100 DTPs were documented, with 99% (n = 133,847) being documented by social work care managers, nurse care managers, and pharmacy staff personnel. Pharmacy staff personnel documented the majority of DTPs (51.5%), and the majority of DTPs (55%) were identified in the transitional care setting. Nurse care managers resolved more discrepancy DTPs (59.3%), whereas pharmacy staff personnel resolved more optimization DTPs (47.2%). Social work care managers resolved more medication adherence DTPs (68.6%). Pharmacy staff personnel primarily identified and resolved opportunities to optimize medication use, whereas nurse care managers primarily identified and resolved medication discrepancies. Social work care managers primarily identified and resolved problems related to medication adherence. When each member of the interdisciplinary care team functioned at the top of their license, all types of DTPs were effectively identified and resolved. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  20. Perioperative Management of a Patient With an Intrathecal Drug Delivery Device Infusing Ziconotide: A Case Report.

    PubMed

    Patel, Sephalie; Hafez, Osama; Sexton, Wade J; Edwards, David A

    2017-02-15

    Intrathecal ziconotide is used for the treatment of chronic pain and is delivered by an implanted drug delivery device. Anesthesiologists should be familiar with the perioperative management of the pump as well as the potential adverse events related to continued ziconotide infusion during general anesthesia. A case is presented demonstrating the perioperative management of an intrathecal drug delivery device infusing ziconotide in a patient presenting for radical cystectomy with pelvic lymphadenectomy and ileal conduit diversion.

  1. Perioperative Management of a Patient With an Intrathecal Drug Delivery Device Infusing Ziconotide.

    PubMed

    Patel, Sephalie; Hafez, Osama; Sexton, Wade J; Edwards, David A

    2016-12-09

    Intrathecal ziconotide is used for the treatment of chronic pain and is delivered by an implanted drug delivery device. Anesthesiologists should be familiar with the perioperative management of the pump as well as the potential adverse events related to continued ziconotide infusion during general anesthesia. A case is presented demonstrating the perioperative management of an intrathecal drug delivery device infusing ziconotide in a patient presenting for radical cystectomy with pelvic lymphadenectomy and ileal conduit diversion.

  2. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  3. [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.

  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

    ... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-1981-N-0361 (formerly 81N-0391), FDA-1981-N... Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Opportunity To Affirm Outstanding Hearing Requests; Final Resolution of Dockets ACTION: Notice. SUMMARY: The Food and Drug...

  5. [National study of drug habits in Uruguay].

    PubMed

    Míguez, H; Magri, R

    1995-03-01

    The results of a prevalence study of alcohol abuse and drugs use in the general population of the República Oriental del Uruguay are showed here. A national household sample was drawn from the most important urban areas and 2500 persons, aged between 15 and 65 years, were selected and interviewed. Illicit substances use (include use of any of the following: marihuana, cocaine, inhalants, hallucinogens) reached 4.5% for the lifetime prevalence period, 1.1% in the last twelve months and 0.7% for the last thirty day. Twenty percent of the sample classified for tobacco dependence, and alcohol abuse, in the last 30 days, was 19.5%. Significant associations, by sex and age, were found.

  6. [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.

  7. 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

  8. 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;…

  9. [Oxazaphosphorinane drugs. New analogues, metabolic studies, and therapeutic approaches].

    PubMed

    Misiura, Konrad

    2004-01-01

    Recent studies on oxazaphosphorinane drugs, with the main focus on those carried out in Poland, are briefly reviewed. Research leading to the introduction of the new antitumor drug (S)-(-)-bromofosfamide are presented. The utility of phosphorus nuclear magnetic resonance in studies of ifosfamide metabolism and an application of analogues of the final, active metabolite of this drug in gene therapy are shown.

  10. Many Doctors Get Payments from Drug Companies, Study Shows

    MedlinePlus

    ... 164203.html Many Doctors Get Payments From Drug Companies, Study Shows But few patients know about financial ... News) -- Many American doctors receive payments from drug companies, but few patients know about those financial ties, ...

  11. Malaria Drug Protected Mouse Fetus from Zika: Study

    MedlinePlus

    ... 167128.html Malaria Drug Protected Mouse Fetus From Zika: Study More research is needed on effects in ... A malaria drug protected mice fetuses from the Zika virus, researchers report. In humans, Zika infection during ...

  12. The importance of drug metabolites synthesis: the case-study of cardiotoxic anticancer drugs.

    PubMed

    Hrynchak, Ivanna; Sousa, Emília; Pinto, Madalena; Costa, Vera Marisa

    2017-05-01

    Anticancer drugs are presently guarantying more survivors as a result of more powerful drugs or combinations of drugs used in therapy. Thus, it has become more crucial to study and overcome the side effects of these therapies. Cardiotoxicity is one of the most relevant side effects on the long-term cancer survivors, because of its high social and economic impact. Drug metabolism can result in active metabolites or toxic metabolites that can lead to important side effects. The metabolites of anticancer drugs are possible culprits of cardiotoxicity; however, the cardiotoxicity of many of the metabolites in several drug classes was not yet suitably studied so far. On the other hand, the use of prodrugs that are bioactivated through metabolism can be a good alternative to obtain more cardio safe drugs. In this review, the methods to obtain and study metabolites are summarized and their application to the study of a group of anticancer drugs with acknowledged cardiotoxicity is highlighted. In this group of drugs, doxorubicin (DOX, 1), mitoxantrone (MTX, 2), cyclophosphamide (CTX, 3) and 5-fluorouracil (5-FU, 4) are included, as well as the tyrosine kinase inhibitors, such as imatinib (5), sunitinib (6) and sorafenib (7). Only with the synthesis and purification of considerable amounts of the metabolites can reliable studies be performed, either in vitro or in vivo that allow accurate conclusions regarding the cardiotoxicity of anticancer drug metabolites and then pharmacological prevention or treatment of the cardiac side effects can be done.

  13. The role of specialty pharmacy drugs in the management of inflammatory diseases.

    PubMed

    Mullican, Kelly A; Francart, Suzanne J

    2016-06-01

    Specialty drugs used in patients with inflammatory disease states are reviewed, with a focus on the pharmacist's roles in facilitating medication procurement and in the clinical management of affected patients. Pharmacists in the ambulatory care and community settings are strategically placed to be actively involved in specialty drug procurement and clinical management of patients with inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, inflammatory bowel disease, and ankylosing spondylitis. Specialty medications used in the treatment of these diseases include anti-tumor necrosis factor (TNF) disease-modifying antirheumatic drugs (DMARDs), non-TNF DMARDs, and interleukin inhibitors. Pharmacist involvement in drug procurement in this area includes navigating insurance barriers and helping patients address high out-of-pocket costs; clinical management activities can include ensuring appropriate baseline screening and vaccine administration, providing drug-specific patient education, and performing routine follow-up and assessment. Patient education is the single biggest area where pharmacists can have a direct impact on overall clinical management of patients receiving specialty drugs for the treatment of inflammatory diseases. These patients need to be educated about dosing, administration, storage and disposal, common and rare adverse effects, adverse-effect management strategies, expectations of drug effect, and considerations for unique circumstances such as illness and planned surgery. Specialty drugs represent one of the fastest-growing sectors of pharmacy spending, with inflammatory disease therapies at the forefront. As pharmacists are accessible healthcare practitioners, their responsibilities should include financial and clinical management of patients with inflammatory diseases who are receiving specialty drugs. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  14. Time spent by Belgian hospital pharmacists on supply disruptions and drug shortages: An exploratory study

    PubMed Central

    De Weerdt, Elfi; De Rijdt, Thomas; Simoens, Steven; Casteels, Minne; Huys, Isabelle

    2017-01-01

    Introduction Supply problems of drugs are an increasing and worldwide problem, also in Belgium. Hospital pharmacists try to manage drug supply problems to minimize the impact on patient care. This study aims to quantify in a detailed manner how much time employees of 17 Belgian hospital pharmacies spend on drug supply problems. Methods During six months, employees of Belgian hospital pharmacies filled in the daily time spent on drug supply problems using a template containing all steps which can be executed to manage drug supply problems. Additionally, Belgian hospital pharmacists were asked to report the drugs which experienced drug supply problems together with the solution for this problem. Results Hospital pharmacists spent a median of 109 minutes a week on drug supply problems, with a minimum of 40 minutes per week and a maximum of 216 minutes per week. Fifty-nine percent of the total time spent on drug supply problems was executed by hospital pharmacists, 27% by pharmacy technicians; the rest was performed by logistic or administrative personnel. About one third of the total time spent was invested in gathering information on the supply problem. About two third of the supply disruptions caused drug shortages, meaning there was a need to switch to another (generic) therapeutic alternative. For most drug shortages, a Belgian generic medicine could be found. However in some cases, the alternative had to be ordered abroad or for some drug shortages, no alternative was available. Conclusion These exploratory results on time spent by hospital pharmacists on drug supply problems in Belgium highlight the economic impact of drug supply problems for hospital pharmacies. A fully reliable, daily updated list on the federal agencies websites would be a major help to hospital pharmacists. PMID:28350827

  15. Managing delegation in the FDA: reducing delay in new-drug review.

    PubMed

    Olson, Mary K

    2004-06-01

    This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95 percent confidence interval, 11 to 51 percent, p = .01). The results suggest that increased agency resources alone cannot explain the reductions in drug-review times. Evidence suggests that other reform-specific factors facilitated the change. Such factors may include the agency's desire to obtain program renewal and secure future fee revenues as well as heightened industry monitoring. Additional results show that there were significant increases in the speed of review for novel drugs in the reform era and for drugs in certain classes that have historically experienced longer delays. The results suggest that the user fee reform has helped politicians manage delegation and reduce delay in new-drug review.

  16. Molecular dynamics study on DNA nanotubes as drug delivery vehicle for anticancer drugs.

    PubMed

    Liang, Lijun; Shen, Jia-Wei; Wang, Qi

    2017-05-01

    In recent years, self-assembled DNA nanotubes have emerged as a type of nano-biomaterials with great potential for biomedical applications. To develop universal nanocarriers for smart and targeted drug delivery from DNA nanotubes, the understanding of interaction mechanism between DNA nanotubes and drugs is essential. In this study, the interactions between anti-cancer drugs and DNA nanotubes were investigated via molecular dynamics simulation. Our simulation results demonstrated that the DNA nanotubes could serve as a good drug delivery material by absorption of anti-cancer drugs with π-π interactions. At high concentration of anti-cancer drugs, most of the drugs could be absorbed by DNA nanotubes. Therefore, it could greatly decrease the aggregation of anti-cancer drugs in aqueous solution. In addition, the stability of DNA nanotubes could be improved with the absorption of anti-cancer drugs. These findings greatly enhance the understanding of the interaction mechanism of DNA nanotubes and anti-cancer drugs. Our study suggests that DNA nanotubes are promising delivery vehicles by strong absorption of anti-cancer drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. 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.

  18. 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.

  19. Novel pharmacotherapeutic targets for the management of drug addiction.

    PubMed

    Heidbreder, Christian

    2005-12-05

    Despite individual variation in the liability to the abuse of psychoactive substances, there is substantial commonality shared by drugs of abuse. The knowledge of these common mechanisms together with the continued elucidation of the neurobiological underpinnings of withdrawal symptoms, drug intake, craving, relapse, and co-morbid psychiatric associations are critically important for the development of new therapeutic strategies. The present review will focus on recent advances in the development of innovative pharmacotherapeutic agents, which should promote higher efficacy (abstinence, prevention of relapse, long-term recovery) and patient compliance, as well as improved safety profiles.

  20. Medical management and antiepileptic drugs in hypothalamic hamartoma.

    PubMed

    Helen Cross, J; Spoudeas, Helen

    2017-06-01

    Hypothalamic hamartoma may present with epilepsy, specifically gelastic or dacrystic seizures, or endocrine dysfunction, commonly precocious puberty. The epilepsy in many patients is drug resistant, and has a high association with progressive cognitive, learning and behavioral difficulty. Medical treatment of seizures remains problematic, with many resistant to drug treatment. Surgical resection, or disconnection of the hamartoma provides the optimal chance of seizure control but with a relatively high risk of endocrine dysfunction, the result of interference with the hypothalamic-pituitary axis in many. Careful assessment and monitoring by specialist centers with discussion of optimal intervention is required for individual cases. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  1. Oral adverse effects of gastrointestinal drugs and considerations for dental management in patients with gastrointestinal disorders

    PubMed Central

    Karthik, Ramya; Karthik, K. S.; David, Chaya; Ameerunnisa; Keerthi, G.

    2012-01-01

    Gastrointestinal disease is associated with alterations in the mouth or influence the course of the dental diseases, and the dental health care workers are expected to recognize, diagnose, and treat oral conditions associated with gastrointestinal diseases and also provide safe and appropriate dental care for afflicted individuals. Drugs used in the management of these diseases result in oral adverse effects and also are known to interact with those prescribed during dental care. Hence, this article has reviewed the drug considerations and guidelines for drug use during dental management of patients with gastrointestinal diseases. PMID:23066260

  2. Therapeutic drug monitoring in the management of HIV-infected patients.

    PubMed

    Ivanovic, Jelena; Jelena, Ivanovic; Nicastri, Emanuele; Emanuele, Nicastri; Ascenzi, Paolo; Paolo, Ascenzi; Bellagamba, Rita; Rita, Bellagamba; De Marinis, Elisabetta; Elisabetta, De Marinis; Notari, Stefania; Stefania, Notari; Pucillo, Leopoldo Paolo; Paolo, Pucillo Leopoldo; Tozzi, Valerio; Valerio, Tozzi; Ippolito, Giuseppe; Giuseppe, Ippolito; Narciso, Pasquale; Pasquale, Narciso

    2008-01-01

    The rate of HIV-positive patients that fails to reach or to maintain a durable virological suppression under anti-retroviral (ARV) therapy might be as high as 50%, therefore new tools to improve ARV drug efficacy are urgently needed. Among others, therapeutic drug monitoring (TDM) is a strategy by which the dosing regimen for a patient is guided by measurement of plasma drug levels, enabling physicians to optimize ARV drug efficacy and to avoid drug-related toxicity. The most used analytical methods to determine plasma levels of ARV drugs are HPLC-UV and HPLC-MS(/MS), recently MALDI-based methods and enzyme immunoassay (EIA) technologies have been also employed. The wide inter-patient variability in ARV drug pharmacokinetic supports the application of TDM to the clinical management of HIV-infected patients. Drug-drug and drug-food interactions, drug binding to plasma proteins, drug sequestering by erythrocytes, hepatic impairment, sex, age, pregnancy, and host genetic factors are sources of inter-patient variability affecting ARV drug pharmacokinetics. Combining the information of TDM and resistance tests in genotypic inhibitory quotient (GIQ) is likely to be of great clinical utility. Indeed, only two clinical trials on GIQ, both conducted using ARV drugs not more commonly in use, have shown clinical benefits. The design of new trials with long follow-up and sample size representative of the current HIV prevalence is urgently needed to give indications for GIQ as an early predictor of virological response. Here, the basic principles and the available methods for TDM in the management of HIV-infected patients are reviewed.

  3. Active controlled studies in antibiotic drug development.

    PubMed

    Dane, Aaron

    2011-01-01

    The increasing concern of antibacterial resistance has been well documented, as has the relative lack of antibiotic development. This paradox is in part due to challenges with clinical development of antibiotics. Because of their rapid progression, untreated bacterial infections are associated with significant morbidity and mortality. As a consequence, placebo-controlled studies of new agents are unethical. Rather, pivotal development studies are mostly conducted using non-inferiority designs versus an active comparator. Further, infections because of comparator-resistant isolates must usually be excluded from the trial programme. Unfortunately, the placebo-controlled data classically used in support of non-inferiority designs are largely unavailable for antibiotics. The only available data are from the 1930s and 1940s and their use is associated with significant concerns regarding constancy and assay sensitivity. Extended public debate on this challenge has led to proposed solutions by some in which these concerns are addressed by using very conservative approaches to trial design, endpoints and non-inferiority margins, in some cases leading to potentially impractical studies. To compound this challenge, different Regulatory Authorities seem to be taking different approaches to these key issues. If harmonisation does not occur, antibiotic development will become increasingly challenging, with the risk of further decreases in the amount of antibiotic drug development. However with clarity on Regulatory requirements and an ability to feasibly conduct global development programmes, it should be possible to bring much needed additional antibiotics to patients. Copyright © 2011 John Wiley & Sons, Ltd.

  4. Computerized clinical decision support systems for drug prescribing and management: a decision-maker-researcher partnership systematic review.

    PubMed

    Hemens, Brian J; Holbrook, Anne; Tonkin, Marita; Mackay, Jean A; Weise-Kelly, Lorraine; Navarro, Tamara; Wilczynski, Nancy L; Haynes, R Brian

    2011-08-03

    Computerized clinical decision support systems (CCDSSs) for drug therapy management are designed to promote safe and effective medication use. Evidence documenting the effectiveness of CCDSSs for improving drug therapy is necessary for informed adoption decisions. The objective of this review was to systematically review randomized controlled trials assessing the effects of CCDSSs for drug therapy management on process of care and patient outcomes. We also sought to identify system and study characteristics that predicted benefit. We conducted a decision-maker-researcher partnership systematic review. We updated our earlier reviews (1998, 2005) by searching MEDLINE, EMBASE, EBM Reviews, Inspec, and other databases, and consulting reference lists through January 2010. Authors of 82% of included studies confirmed or supplemented extracted data. We included only randomized controlled trials that evaluated the effect on process of care or patient outcomes of a CCDSS for drug therapy management compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive. Sixty-five studies met our inclusion criteria, including 41 new studies since our previous review. Methodological quality was generally high and unchanged with time. CCDSSs improved process of care performance in 37 of the 59 studies assessing this type of outcome (64%, 57% of all studies). Twenty-nine trials assessed patient outcomes, of which six trials (21%, 9% of all trials) reported improvements. CCDSSs inconsistently improved process of care measures and seldomly improved patient outcomes. Lack of clear patient benefit and lack of data on harms and costs preclude a recommendation to adopt CCDSSs for drug therapy management.

  5. Should eligibility for medication therapy management be based on drug adherence?

    PubMed

    Stuart, Bruce; Loh, Ellen; Miller, Laura; Roberto, Pamela

    2014-01-01

    Medicare Part D prescription drug plans must offer medication therapy management (MTM) services to qualified enrollees. Eligibility criteria used by plan sponsors are restrictive, and fewer than 10% of Part D enrollees receive MTM services. The extent to which plan criteria identify beneficiaries most at risk for suboptimal medication use is unknown. To (a) evaluate potential underuse of and poor adherence to evidence-based medications used in the treatment of Medicare beneficiaries with diabetes, heart failure, and chronic obstructive pulmonary disease (COPD) over 3 years; (b) determine whether MTM eligibility criteria used by the modal Part D plan in 2011 (drug spending ≥ $3,000, ≥ 3 chronic conditions, ≥ 8 Part D medications) identified Part D enrollees at greatest risk for underuse of and poor adherence to these drugs; and (c) demonstrate how sensitive MTM eligibility is to variations in criteria levels. Study subjects were selected from a 5% random sample of Part D enrollees with 1 or more of these diseases in 2006 and followed through 2008 or death. Longitudinal patterns of exposure and adherence to angiotensin-converting-enzyme inhibitor/angiotensin receptor blockers, beta-blockers, and COPD controller drugs were tracked comparing patterns for enrollees meeting/not meeting the modal 2011 MTM eligibility criteria. Use of evidence-based medication was consistently suboptimal for every disease cohort studied. Higher rates of exposure and adherence were observed among those with high drug spending taking multiple Part D drugs. Current MTM criteria were found to target beneficiaries with above average utilization of evidence-based medication and to exclude those with more problematic utilization patterns. We estimate that lowering the maximum required drug count from 8 to 2 would increase the percentage of beneficiaries eligible for MTM by two thirds. Our findings suggest that MTM eligibility criteria are not optimally targeted to capture underuse of and

  6. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    PubMed

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    duration in the 2 years before and after voluntary approval or UDI action increased from 31 days (IQR = 0-339) to 217 days (IQR = 0-406; P = 0.053). The UDI was associated with higher drug prices and more frequent drug shortages when compared with the period before UDI action, while the approval process for these drugs did not necessarily require new clinical evidence to establish safety or efficacy. This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the

  7. 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)…

  8. 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…

  9. [A new joint approach to drug management: clinical pharmacy services and risk management unit].

    PubMed

    Schwartz, Vardit; Kravitz, Martine Szyper

    2015-04-01

    According to the "To Err is Human" report, medication-related errors are common in medicine and may have several and different effects. Clinical Pharmacy is a leading worldwide established pharmacy service which has been improving the quality of care for the last 30 years. The accumulated experience shows improved quality of care, improved patient safety and economic benefit. These understandings led to the definition and expansion of the Clinical Pharmacist Intervention Program and a joint project with the Risk Management Unit was created. A characterization process was conducted, parameters were defined for monitoring and surveillance and interventions were devised. The relevant data requiring pharmacist intervention was defined (e.g., dose adjustments, contraindications, side-effects); a report was devised, based on the patient's electronic medical record; daily follow-up included analysis, stratification, quantification and understanding of the different types of pharmacist interventions. The pharmacist interventions were summed up and assessed for performance and quality control. Between March 2013 and February 2014 the medical records of 14,499 patients were examined in our hospital Only in 16% of the records an active pharmacist intervention was performed, according to the parameters defined. Interventions for potentially high risk events such as therapeutic duplication, drug administration in spite of contraindication and in spite of documented allergy were very rare, less than 2% of all the pharmacist interventions. This joint venture, which is based on an existing platform, reflects an up-to-date view of an important facet of the clinical work performed at the hospital, helps identify trends, potential failures and vulnerabilities with regard to medication treatment and allows the formulation of intervention programs to improve the quality and safety of drug therapy.

  10. The pregnant patient: considerations for dental management and drug use.

    PubMed

    Cengiz, Servi Burcak

    2007-03-01

    The pregnant woman who presents for dental care requires special consideration. This article reviews physiologic changes associated with pregnancy and current considerations for the dental treatment of pregnant dental patients, as well as for pregnant dental professionals. The limitations and safety of commonly used drugs and anesthetics are discussed. Recommendations for prenatal oral counseling are presented.

  11. 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

  12. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    PubMed

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  13. 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.

  14. 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…

  15. 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

  16. Clopidogrel-Paclitaxel Drug-Drug Interaction: A Pharmacoepidemiologic Study.

    PubMed

    Agergaard, K; Mau-Sørensen, M; Stage, T B; Jørgensen, T L; Hassel, R E; Steffensen, K D; Pedersen, J W; Milo, Mlh; Poulsen, S H; Pottegård, A; Hallas, J; Brøsen, K; Bergmann, T K

    2017-09-01

    Paclitaxel is mainly eliminated by CYP2C8 in the liver. CYP2C8 is strongly inhibited by the clopidogrel metabolite acyl-β-D-glucuronide. To determine if this interaction has clinical relevance, we identified 48 patients treated with clopidogrel and paclitaxel using databases and a prescription register. Peripheral sensory neuropathy was retrospectively evaluated from medical charts and compared to that of 88 age- and sex-matched controls treated with paclitaxel and low-dose aspirin. By a cumulative dose of 1,500 mg paclitaxel, 35% of the patients had developed severe neuropathy. The overall hazard ratio between clopidogrel use and severe paclitaxel neuropathy was 1.7 (95% confidence interval, 0.9-3.0). Among those receiving a high-dose paclitaxel regimen, the hazard ratio was 2.3 (95% confidence interval, 1.1-4.5). Our study indicates that clopidogrel is associated with a clinically relevant increased risk of neuropathy in patients treated with high-dose paclitaxel. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  17. A Randomized Pilot Study of the Engaging Moms Program for Family Drug Court

    PubMed Central

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

    2010-01-01

    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

  18. 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

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

    PubMed

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

    2010-11-01

    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. 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. 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. 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 should be systematically evaluated. Copyright

  20. Longitudinal studies of drug abuse in a fifteen-year-old population. 3. Hidden drug abuse.

    PubMed

    Holmberg, M B

    1985-02-01

    The hidden drug abuse in a stratified sample of a year cohort born in 1953 was studied by measuring the difference between drug abuse stated in interviews and registered in public health and social welfare files in 1968, 1973 and 1976. Among men who had stated high-frequency drug use in a school questionnaire in 1968 hidden drug abuse comprised two thirds of the total abuse, among women from the same group one half. In groups with lower degrees of abuse hidden drug abuse was 70-90% of the total abuse. Intravenous abuse was mostly known to public health and social welfare authorities. When trying to estimate the total number of drug abusers in an area there is reason to at least double the figures presented in case-finding studies.

  1. Integration of heterogeneous clinical decision support systems and their knowledge sets: feasibility study with Drug-Drug Interaction alerts.

    PubMed

    Kam, Hye Jin; Kim, Jeong Ah; Cho, InSook; Kim, Yoon; Park, Rae Woong

    2011-01-01

    There exist limitations in both commercial and in-house clinical decision support systems (CDSSs) and issues related to the integration of different knowledge sources and CDSSs. We chose Standard-based Shareable Active Guideline Environment (SAGE) as a new architecture with knowledge integration and a centralized knowledge base which includes authoring/management functions and independent CDSS, and applied it to Drug-Drug Interaction (DDI) CDSS. The aim of this study was to evaluate the feasibility of the newly integrated DDI alerting CDSS into a real world hospital information system involving construction of an integrated CDSS derived from two heterogeneous systems and their knowledge sets. The proposed CDSS was successfully implemented and compensated for the weaknesses of the old CDSS from knowledge integration and management, and its applicability in actual situations was verified. Although the DDI CDSS was constructed as an example case, the new CDS architecture might prove applicable to areas of CDSSs.

  2. 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.

  3. 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…

  4. 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…

  5. 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.

  6. Risk Management of Hospitalized Psychiatric Patients Taking Multiple QTc-Prolonging Drugs.

    PubMed

    Vandael, Eline; Vandenberk, Bert; Willems, Rik; Reyntens, Johan; Vandenberghe, Joris; Foulon, Veerle

    2017-10-01

    Drug-related QTc prolongation has been linked with Torsade de Pointes and sudden cardiac death. The objective of this study was to investigate the impact of starting an additional QTc-prolonging drug on the QTc interval of psychiatric inpatients. An observational study was performed between May 2011 and December 2014 in 6 Belgian psychiatric hospitals. Inpatients who were already taking 1 QTc-prolonging drug or more could be included in the study when an additional QTc-prolonging drug was started. Electrocardiograms were performed at baseline and follow-up. Demographic, medical, medication, and laboratory data were collected. A risk score was used to estimate the risk of QTc prolongation based on patient-specific risk factors. A cutoff value of 8 points was set as high risk for QTc prolongation. One hundred fifty-two patients (44.7% women; mean age, 44 [SD, 17] years) were included who received a prescription for an additional QTc-prolonging drug. There was a small but significant difference (P = 0.032) in mean QTc interval between baseline (409.1 [SD, 21.8] milliseconds) and follow-up (411.8 [SD, 21.7] milliseconds). Three patients developed a prolonged QTc interval in the follow-up electrocardiogram (QTc, ≥450 [men]/470 [women] milliseconds); 8 patients had a delta QTc of 30 milliseconds or longer. No cases of torsade de pointes or sudden cardiac death were identified. Fifty-eight patients (38.2%) had a risk score of 8 or higher; these patients had a significantly longer QTc interval at follow-up than did patients with a risk score of lower than 8 (P < 0.001). Only a limited number of patients developed a prolonged QTc interval after the start of an additional QTc-prolonging drug. Nevertheless, it is still important to screen for high-risk patients at baseline. A risk score can help to select high-risk patients and to stimulate an appropriate and feasible risk management of QTc prolongation in psychiatry.

  7. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective.

    PubMed

    Gilron, Ian

    2006-06-01

    Anticonvulsant drugs are effective in the treatment of chronic neuropathic pain but were not, until recently, thought to be useful in more acute conditions such as postoperative pain. However, similar to nerve injury, surgical tissue injury is known to produce neuroplastic changes leading to spinal sensitization and the expression of stimulus-evoked hyperalgesia and allodynia. Pharmacological effects of anticonvulsant drugs which may be important in the modulation of these postoperative neural changes include suppression of sodium channel, calcium channel and glutamate receptor activity at peripheral, spinal and supraspinal sites. The purpose of this article is to review preclinical evidence and clinical trial data describing the efficacy and safety of anticonvulsant drugs in the setting of postoperative pain management. A Medline search was performed to retrieve available literature on the basic and clinical pharmacology of anticonvulsant drugs as they pertain to postoperative pain management. Numerous laboratory studies have described analgesic effects of different anticonvulsant drugs in experimental pain models. Furthermore, several recent clinical trials have shown that anticonvulsants may reduce spontaneous and movement-evoked pain, as well as decrease opioid requirements postoperatively. Some early findings suggest further that anticonvulsant drugs may alleviate postoperative anxiety, accelerate postoperative functional recovery and reduce chronic postsurgical pain. Given the incomplete efficacy of currently available non-opioid analgesics, and the identified benefits of opioid sparing, anticonvulsant medications may be useful adjuncts for postoperative analgesia. Further research in this field is warranted.

  8. Management of Drooling in Cerebral Palsy: Three Single Case Studies.

    ERIC Educational Resources Information Center

    Owen, S. E.; Stern, L. M.

    1992-01-01

    This study examined use of benztropine drug therapy to control drooling in 3 children (ages 5, 9, and 12) with moderately severe cerebral palsy. Significant improvement in all three cases suggested a role for medication in the management of drooling in prepubescent children who fail to respond to physical therapy or behavioral programs. (DB)

  9. Genome-Wide Association Studies of Drug-Resistance Determinants.

    PubMed

    Volkman, Sarah K; Herman, Jonathan; Lukens, Amanda K; Hartl, Daniel L

    2017-03-01

    Population genetic strategies that leverage association, selection, and linkage have identified drug-resistant loci. However, challenges and limitations persist in identifying drug-resistance loci in malaria. In this review we discuss the genetic basis of drug resistance and the use of genome-wide association studies, complemented by selection and linkage studies, to identify and understand mechanisms of drug resistance and response. We also discuss the implications of nongenetic mechanisms of drug resistance recently reported in the literature, and present models of the interplay between nongenetic and genetic processes that contribute to the emergence of drug resistance. Throughout, we examine artemisinin resistance as an example to emphasize challenges in identifying phenotypes suitable for population genetic studies as well as complications due to multiple-factor drug resistance. Copyright © 2016. Published by Elsevier Ltd.

  10. 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

  11. 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

  12. Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study

    PubMed Central

    Yang, Caijun; Wu, Lina; Cai, Wenfang; Zhu, Wenwen; Shen, Qian; Li, Zongjie; Fang, Yu

    2016-01-01

    Objective Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. Methods A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities. Results Thirty participants took part in the study. Eight traditional Chinese medicines and 87 types of biologicals and chemicals were reported to be in short supply. Most were essential medicines. Five main determinants of drug shortages were detected: too low prices, too low market demands, Good Manufacturing Practice (GMP) issues, materials issues, and approval issues for imported drugs. Five different solutions were proposed by the participants: 1) let the market decide the drug price; 2) establish an information platform; 3) establish a reserve system; 4) enhance the communication among the three parties in the supply chain; and 5) improve hospital inventory management. Conclusions Western China was currently experiencing a serious drug shortage. Numerous reasons for the shortage were identified. Most drug shortages in China were currently because of “too low prices.” To solve this problem, all of the stakeholders, especially the government, needed to participate in managing the drug shortages. PMID:27780218

  13. Extensively Drug-Resistant Tuberculosis: Principles of Resistance, Diagnosis, and Management.

    PubMed

    Wilson, John W; Tsukayama, Dean T

    2016-04-01

    Extensively drug-resistant (XDR) tuberculosis (TB) is an unfortunate by-product of mankind's medical and pharmaceutical ingenuity during the past 60 years. Although new drug developments have enabled TB to be more readily curable, inappropriate TB management has led to the emergence of drug-resistant disease. Extensively drug-resistant TB describes Mycobacterium tuberculosis that is collectively resistant to isoniazid, rifampin, a fluoroquinolone, and an injectable agent. It proliferates when established case management and infection control procedures are not followed. Optimized treatment outcomes necessitate time-sensitive diagnoses, along with expanded combinations and prolonged durations of antimicrobial drug therapy. The challenges to public health institutions are immense and most noteworthy in underresourced communities and in patients coinfected with human immunodeficiency virus. A comprehensive and multidisciplinary case management approach is required to optimize outcomes. We review the principles of TB drug resistance and the risk factors, diagnosis, and managerial approaches for extensively drug-resistant TB. Treatment outcomes, cost, and unresolved medical issues are also discussed. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  14. 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.

  15. Antihypertensive drugs for elderly patients: a cross- sectional study

    PubMed Central

    Lim, Ka Keat; Sivasampu, Sheamini; Khoo, Ee Ming

    2015-01-01

    INTRODUCTION As the population ages, the prevalence of hypertension also increases. Although primary care is usually the patient’s first point of contact for healthcare, little is known about the management of hypertension among elderly patients at the primary care level. This study aimed to determine the antihypertensive prescription trend for elderly patients, the predictors of antihypertensive use and any inappropriate prescribing practices in both public and private primary care settings. METHODS Data on patient demographics, diagnosis, prescription pattern, payment mode and follow-up was extracted from a cross-sectional study involving 122 public primary care clinics and 652 private primary care clinics in Malaysia. Encounters with hypertensive patients aged ≥ 60 years were included. RESULTS A total of 1,017 antihypertensive medications were prescribed – calcium channel blockers (27.1%), beta blockers (25.5%), diuretics (23.3%), angiotensin-converting enzyme inhibitors (14.9%) and angiotensin receptor blockers (6.3%). Out of the 614 patient encounters, 53.1% of the patients were prescribed monotherapy, 31.6% were prescribed dual therapy, 12.2% triple therapy, 2.8% quadruple therapy and 0.3% quintuple therapy. Type of primary care clinic and payment mode were significant predictors for the prescription of combination therapy and fixed-dose combination therapy, respectively. Four types of inappropriate prescriptions were identified. CONCLUSION Calcium channel blockers were the most common antihypertensive drug prescribed and more than half of the elderly patients were on monotherapy. Antihypertensive drug prescription was found to be associated with the type of primary care clinic and the payment mode, suggesting that prescription is influenced by the cost of the drug. PMID:25597751

  16. Current Drug Managements of Wilson's Disease: From West to East.

    PubMed

    Li, Wen-Jie; Chen, Chen; You, Zhi-Fei; Yang, Ren-Min; Wang, Xiao-Ping

    2016-01-01

    Wilson's disease (WD), also called hepatolenticular degeneration, is an autosomal recessive inheritance disorder of copper metabolism characterized by the multiple mutations in the ATP-ase 7B gene of chromosome 13q. About half of the WD patients have neurological or psychiatric symptoms. As WD is a kind of medicable or nearly curable neurodegenerative disease in the field of medicine, early consideration/examination and without delay/ life-long treatment usually lead to better prognoses. The drugs, also named as anticopper agents, are commonly used in clinics including D-penicillamine, trientine, sodium dimercaptosuccinate, dimercaptosuccinic acid, zinc and tetrathiomolybdate. This provides detailed reviews about these medicines.

  17. Current Drug Managements of Wilson's Disease: From West to East

    PubMed Central

    Li, Wen-Jie; Chen, Chen; You, Zhi-Fei; Yang, Ren-Min; Wang, Xiao-Ping

    2016-01-01

    Wilson's disease (WD), also called hepatolenticular degeneration, is an autosomal recessive inheritance disorder of copper metabolism characterized by the multiple mutations in the ATP-ase 7B gene of chromosome 13q. About half of the WD patients have neurological or psychiatric symptoms. As WD is a kind of medicable or nearly curable neurodegenerative disease in the field of medicine, early consideration/examination and without delay/ life-long treatment usually lead to better prognoses. The drugs, also named as anticopper agents, are commonly used in clinics including D-penicillamine, trientine, sodium dimercaptosuccinate, dimercaptosuccinic acid, zinc and tetrathiomolybdate. This provides detailed reviews about these medicines. PMID:26639459

  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.

  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. Pharmaceutical cost management and access to psychotropic drugs: The U.S. context

    PubMed Central

    Huskamp, Haiden A.

    2006-01-01

    In recent years, prescription drug expenditures in the United States have increased rapidly. In 2003, spending on prescription medications totaled $179.2 billion dollars, or approximately 11% of national health expenditures [Smith, C., Cowan, C., Sensenig, A., Catlin, A., & the Health Accounts Team. (2005). Health spending growth slows in 2003. Health Affairs, 24 (1) 185–194]. In response to rapid increases in prescription drug expenditures, both public and private payers of health care services have adopted strategies to try to contain drug costs, including drug formularies, prior authorization programs, cost sharing and utilization management. In this paper, I provide a background on prescription drug spending trends, financing, and access to medications; describe some of the tools used most commonly to manage prescription drug utilization; present results from the literature on the impact of these tools; and discuss some implications of this information for the new Medicare prescription drug benefit to be implemented in 2006 as well as for future prescription drug innovation. PMID:16150490

  1. 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. PMID:27713344

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

    PubMed

    Wahab, Abdul

    2010-07-05

    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.

  3. Families as Case Managers: A Longitudinal Study.

    ERIC Educational Resources Information Center

    Seltzer, Marsha Mailick; And Others

    1989-01-01

    Performed follow-up study measuring effects of case management training on management activities of families of elderly persons. Interviewed 78 subjects from original study and found case management to be normative activity for families of elderly. Noted differences reported between male and female case managers and in types of obstacles…

  4. 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. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. 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…

  6. 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.…

  7. 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.…

  8. Management of prescription and nonprescription drug use during pregnancy.

    PubMed

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

    2010-08-01

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

  9. Gastroretentive drug delivery systems for therapeutic management of peptic ulcer.

    PubMed

    Garg, Tarun; Kumar, Animesh; Rath, Goutam; Goyal, Amit K

    2014-01-01

    A peptic ulcer, stomach ulcer, or gastric ulcer, also known as peptic ulcer disease (PUD), is a very common chronic disorder of the stomach which is mainly caused by damage or impairment of the stomach lining. Various factors such as pepsin, gastric acid, H. pylori, NSAIDs, prostaglandins, mucus, bicarbonate, and blood flow to mucosa play an important role in causing peptic ulcers. In this review article, our main focus is on some important gastroretentive drug delivery systems (GRDDS) (floating, bioadhesive, high density, swellable, raft forming, superporous hydrogel, and magnetic systems) which will be helpful in gastroretention of different dosage forms for treatment of peptic ulcer. GRDDS provides a mean for controlled release of compounds that are absorbed by active transport in the upper intestine. It also enables controlled delivery for paracellularly absorbed drugs without a decrease in bioavailability. The above approaches are specific for targeting and leading to a marked improvement in the quality of life for a large number of patients. In the future, it is expected that they will become of growing significance, finally leading to improved efficiencies of various types of pharmacotherapies.

  10. 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

  11. Psychotropic drugs for the management of cancer-related fatigue: a systematic review and meta-analysis.

    PubMed

    Qu, D; Zhang, Z; Yu, X; Zhao, J; Qiu, F; Huang, J

    2016-11-01

    Cancer-related fatigue (CRF) is a common symptom affecting 60-90% of cancer survivors, and effective management for CRF is not yet available. Recently, an increasing number of trials examining the use of psychotropic drugs for the treatment of CRF have been performed, but these trials have yielded inconsistent results. Therefore, we conducted a meta-analysis aimed at assessing the effect and safety of psychotropic drugs for the management of CRF. Ten eligible trials of the psychotropic drugs methylphenidate and modafinil in a total of 1582 participants treated for CRF were subjected to statistical analyses. A meta-analysis of seven of these studies indicated that methylphenidate was superior to placebo for the treatment of CRF. Another meta-analysis of three studies evaluating modafinil found that this drug was no better than placebo. Adverse events were similar between both methylphenidate and modafinil and the placebo groups. Our meta-analysis indicated that the treatment of CRF with methylphenidate appears to be effective, whereas modafinil provides no benefit. These results of this analysis warrant further trials to confirm the efficacy and safety of psychotropic drugs for the treatment of CRF. © 2015 John Wiley & Sons Ltd.

  12. 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.

  13. 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. Copyright © 2016. Published by Elsevier B.V.

  14. 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. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  15. Cytotoxic Drug Dispersal, Cytotoxic Safety, and Cytotoxic Waste Management: Practices and Proposed India-specific Guidelines.

    PubMed

    Capoor, Malini R; Bhowmik, Kumar Tapas

    2017-01-01

    This article deals with practices related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management and attempts at India-specific guidelines for their dispersal and disposal. The articles related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management were reviewed from PubMed and their applicability in Indian health-care facilities (HCFs) was also reviewed. All HCFs dealing with cytotoxic drugs should consider cytotoxic policy, patient safety and health-care worker safety, and environmental monitoring program as per the available international guidelines customized as per Indian conditions. Utmost care in handling cytotoxic waste is quintessential. The formation of India-specific cytotoxic guidelines requires the inputs from all stakeholders. Cytotoxic waste, cytotoxic safety, and cytotoxic waste management should be the subject of a national strategy with an infrastructure, cradle-to-grave legislation, competent regulatory authority, and trained personnel.

  16. Cytotoxic Drug Dispersal, Cytotoxic Safety, and Cytotoxic Waste Management: Practices and Proposed India-specific Guidelines

    PubMed Central

    Capoor, Malini R; Bhowmik, Kumar Tapas

    2017-01-01

    This article deals with practices related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management and attempts at India-specific guidelines for their dispersal and disposal. The articles related to cytotoxic drug dispersal, cytotoxic safety, and cytotoxic waste management were reviewed from PubMed and their applicability in Indian health-care facilities (HCFs) was also reviewed. All HCFs dealing with cytotoxic drugs should consider cytotoxic policy, patient safety and health-care worker safety, and environmental monitoring program as per the available international guidelines customized as per Indian conditions. Utmost care in handling cytotoxic waste is quintessential. The formation of India-specific cytotoxic guidelines requires the inputs from all stakeholders. Cytotoxic waste, cytotoxic safety, and cytotoxic waste management should be the subject of a national strategy with an infrastructure, cradle-to-grave legislation, competent regulatory authority, and trained personnel. PMID:28900329

  17. Recent progress in solid-state NMR studies of drugs confined within drug delivery systems.

    PubMed

    Skorupska, Ewa; Jeziorna, Agata; Kazmierski, Slawomir; Potrzebowski, Marek J

    2014-01-01

    Recent progress in the application of solid-state NMR (SS NMR) spectroscopy in structural studies of active pharmaceutical ingredients (APIs) embedded in different drug carriers is detailed. This article is divided into sections. The first part reports short characterization of the nanoparticles and microparticles that can be used as drug delivery systems (DDSs). The second part shows the applicability of SS NMR to study non-steroidal anti-inflammatory drugs (NSAIDs). In this section, problems related to API-DDS interactions, morphology, local molecular dynamics, nature of inter- or intramolecular connections, and pore filling are reviewed for different drug carriers (e.g. mesoporous silica nanoparticles (MSNs), cyclodextrins, polymeric matrices and others). The third and fourth sections detail the recent applications of SS NMR for searching for antibiotics and anticancer drugs confined in zeolites, MSNs, amorphous calcium phosphate and other carriers.

  18. Pediatric off-label drug use in China: risk factors and management strategies.

    PubMed

    Zhang, Lingli; Li, Youping; Liu, Yi; Zeng, Linan; Hu, Die; Huang, Liang; Chen, Min; Lv, Juan; Yang, Chunsong

    2013-02-01

    To analyze the risk factors of pediatric off-label drug use, and propose management strategies for policy making of the pediatric off-label drug use in China. (i) We applied stratified random sampling to select recipes of children aged 0 to 18 years in pediatric clinics and wards of the West China Second University Hospital in 2010. (ii) All included prescriptions were categorized as off-label use or on-label use, according to the latest package insert licensed by the State Food and Drug Administration. (iii) Risk factors and the weights were calculated using logistic regression. (iv) The correlation between risk factors and the different kinds of off-label prescriptions was presented using adjusted odds ratio, and the impact of the risk factors was measured using standardized partial regression coefficient. (v) SPSS 16.0 was used for statistic analysis. (vi) From the perspective of the medical institutions, pharmaceutical enterprises, professional institutions, and the public, we combined the results of the Evidence-based research on the policy of the off-label drug use in 15 countries and the results of risk factor analysis, in order to propose management strategies for the policy making of pediatric off-label drug use in China. (i) Using the method of sampling, we received 2640 recipes from outpatients and 14,374 prescriptions from 749 inpatients. (ii) The neonates (0 to 27 days) had higher risk in off-label drug use than the other three children age groups. (iii) The dermatological medicines (D), nervous system medicines (N), traditional Chinese medicines, and respiratory drugs (R) were high-risk off-label medicines whose labels should be updated more frequently. (iv) The great factors of off-label drug use are those influence health status and relate to health services (ICD-10:Z00-Z99) (mainly in the clinic of child care and growth development, and in the ward of chemotherapy). (v) Off-label drug use in the ward was 4.4 times than that in clinic service (P < 0

  19. Study of drug diffusion rate by laser beam deflection technique.

    PubMed

    Swapna, Mohanachandran Nair S; Anitha, Madhu J; Sankararaman, Sankaranarayana Iyer

    2017-06-01

    Drug administration is an unavoidable part of treatment. When a drug is administered orally or intravenously, it gets absorbed into the blood stream. The rate and efficiency of absorption depend on the route of administration. When a drug is administered through the oral route, it penetrates the epithelial cells of the intestinal mucosa. The diffusion of the drug into the blood stream depends on various parameters, such as concentration, temperature, and the nature of the mucous membrane. The passive diffusion of drugs is found to obey Fick’s law. Water soluble drugs penetrate the cell membrane through aqueous channel or pores. Hence, the study of diffusion of drugs into the water and finally into the blood stream is important. An attempt has been made to study the diffusion of the drug in water as 60% to 80% of human body is water. For the study of drug diffusion in water, a commonly used cough syrup of specific gravity 1.263 is used. It is found that the diffusion rate increases with the concentration of the drug.

  20. Study of drug diffusion rate by laser beam deflection technique

    NASA Astrophysics Data System (ADS)

    Swapna, Mohanachandran Nair. S.; Anitha, Madhu J.; Sankararaman, Sankaranarayana Iyer

    2017-06-01

    Drug administration is an unavoidable part of treatment. When a drug is administered orally or intravenously, it gets absorbed into the blood stream. The rate and efficiency of absorption depend on the route of administration. When a drug is administered through the oral route, it penetrates the epithelial cells of the intestinal mucosa. The diffusion of the drug into the blood stream depends on various parameters, such as concentration, temperature, and the nature of the mucous membrane. The passive diffusion of drugs is found to obey Fick's law. Water soluble drugs penetrate the cell membrane through aqueous channel or pores. Hence, the study of diffusion of drugs into the water and finally into the blood stream is important. An attempt has been made to study the diffusion of the drug in water as 60% to 80% of human body is water. For the study of drug diffusion in water, a commonly used cough syrup of specific gravity 1.263 is used. It is found that the diffusion rate increases with the concentration of the drug.

  1. 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

  2. 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.

  3. The Efficacy of Two Intravenous Sedative Drugs in Management of Uncooperative Children for Dental Treatments

    PubMed Central

    Kaviani, Nasser; Ashrafi, Sanaz; Jabbarifar, Seyed Ebrahim; Ghaffari, Elham

    2015-01-01

    Statement of the Problem Some children do not show an appropriate cooperation with their dentist. A number of them cannot be managed by local anesthesia and the usual techniques used to control behaviors, so further steps are required to control their pain and anxiety. Pharmaceutical control is recommended through sedation or general anesthesia. Purpose This study was aimed to evaluate two groups of drugs in intravenous sedation method. Materials and Method In this clinical trial intervention study, patients were randomly divided into two groups of 18 and 20 and each group received either intravenous midazolam-ketamine or midazolam-fentanyl. During the procedure, 0.25mg midazolam was administered to both groups if needed. The scores of intraoperative sedation and operation conditions were evaluated and recorded by dental sedation teacher groups (DSTG) system in the 10th, 20th, 30th and 40th minutes of the operation. The results were analyzed by SPSS (version 16) using independent T-test, Wilcoxon, Mann-Whitney and Pearson Chi-Square tests as appropriated. Results There was no significant difference between the two groups in sedation period (p= 0.55), recovery time (p= 0.18), Frankl score (p= 0.83(, score of intraoperative sedation and operating conditions (p> 0.05), and sedation complications (p= 0.612). In addition, no complication occurred in recovery. Conclusion There was no significant difference between the two drug groups; both were appropriate in controlling children’s behavior. PMID:26106632

  4. Management of patients with psoriasis treated with biological drugs needing a surgical treatment.

    PubMed

    Fabiano, Antonella; De Simone, Clara; Gisondi, Paolo; Piaserico, Stefano; Lasagni, Claudia; Pellacani, Giovanni; Conti, Andrea

    2014-11-01

    Tumor necrosis factor alpha (TNF-α) is a cytokine that plays a critical role in inflammatory and immune processes and in the control of infections and sepsis. Data on the perioperative management of patients treated with biologic drugs are limited and mainly in patients with rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). This retrospective study assesses variations in the incidence of side effects between psoriatic patients who temporarily discontinue or continue biological therapy before surgical treatment. Despite the immunosuppressive risk, our results suggest that postoperative complications are not influenced by the suspension of biologic therapies. As TNF-α plays a role in promoting collagen synthesis and wound healing, we suggest that anti-TNFs should be discontinued before major surgery, whereas for minor surgery, the lower rates of infections favor anti-TNF-α continuation, particularly since suspending anti-TNF therapy is known to induce psoriasis relapse.

  5. 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…

  6. 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…

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

    PubMed Central

    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 are ≥50 years. Since 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 most recent 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

  8. 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

  9. Lymphocyte transformation studies in drug hypersensitivity

    PubMed Central

    Warrington, R.J.; Tse, K.S.

    1979-01-01

    In a group of patients with clinically diagnosed drug hypersensitivity the in vitro lymphocyte response to the suspected drug was assessed by the lymphocyte transformation test. The test gave positive results in all 15 patients with penicillin-induced immediate or accelerated allergic reactions and positive immediate skin-test reactivity to the major or the minor antigenic determinant of penicillin, or both, but in only 3 of the 12 patients with delayed-onset maculopapular rashes induced by penicillin, despite positive immediate reactivity to the skin-test reagents. Lymphocyte stimulation greater than five times the control level was demonstrated for five patients with penicillin-induced erythroderma, Stevens-Johnson syndrome or a serum-sickness-like illness, or with methicillin-induced interstitial nephritis, all of whom had negative reactions to the appropriate skin-test reagents. A low level of stimulation was seen in eight other skin-test-negative patients with possible allergic reactions induced by penicillins. However, in all subjects tested the stimulation was significantly greater than the mean for control subjects. For 9 of 11 patients with isoniazid-induced hepatitis or maculopapular rashes, but for only 8 of 31 patients with eruptions induced by a variety of drugs other than penicillins and isoniazid, significant stimulation occurred in the lymphocyte transformation test. It is concluded that the lymphocyte transformation test is useful in the detection of hypersensitivity to the penicillins (although in IgE-mediated reactions skin testing is clearly preferable) and isoniazid but is of limited value in the demonstration of hypersensitivity to other drugs. PMID:445303

  10. Lymphocyte transformation studies in drug hypersensitivity.

    PubMed

    Warrington, R J; Tse, K S

    1979-05-05

    In a group of patients with clinically diagnosed drug hypersensitivity the in vitro lymphocyte response to the suspected drug was assessed by the lymphocyte transformation test. The test gave positive results in all 15 patients with penicillin-induced immediate or accelerated allergic reactions and positive immediate skin-test reactivity to the major or the minor antigenic determinant of penicillin, or both, but in only 3 of the 12 patients with delayed-onset maculopapular rashes induced by penicillin, despite positive immediate reactivity to the skin-test reagents.Lymphocyte stimulation greater than five times the control level was demonstrated for five patients with penicillin-induced erythroderma, Stevens-Johnson syndrome or a serum-sickness-like illness, or with methicillin-induced interstitial nephritis, all of whom had negative reactions to the appropriate skin-test reagents. A low level of stimulation was seen in eight other skin-test-negative patients with possible allergic reactions induced by penicillins. However, in all subjects tested the stimulation was significantly greater than the mean for control subjects.For 9 of 11 patients with isoniazid-induced hepatitis or maculopapular rashes, but for only 8 of 31 patients with eruptions induced by a variety of drugs other than penicillins and isoniazid, significant stimulation occurred in the lymphocyte transformation test.It is concluded that the lymphocyte transformation test is useful in the detection of hypersensitivity to the penicillins (although in IgE-mediated reactions skin testing is clearly preferable) and isoniazid but is of limited value in the demonstration of hypersensitivity to other drugs.

  11. 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

  12. [Drug information management through the intranet of a hospital center].

    PubMed

    Juárez Giménez, J C; Mendarte Barrenechea, L; Gil Luján, G; Sala Piñol, F; Lalueza Broto, P; Girona Brumós, L; Monterde Junyent, J

    2006-01-01

    This paper describes the methodology used for the implementation and validation of a network resource incorporated to the intranet of the Hospital, in order to retain and disseminate information from the Drug Information Center (DIC) of a pharmacy service in a hospital center. A working group designed the structure, contents, memory needs, priority of access for users and a quality assessment questionnaire. The resource developed by the working group had a capacity of 70 Gb and its structure was based on HTML documents, including files with different format and 12 theme areas. Two levels of priority of access were established depending on the user and two persons were in charge of the resource. The questionnaire was delivered after three months of use. Sixty nine per cent of the users regarded the resource as very useful and 31%, as useful. The final structure, according to the results of the survey, had 11 theme areas. The use of the hospital Intranet in order to include and organize DIC information can be very simple and economic. Furthermore, the involvement of all the users in its design and structure can facilitate the practical use of this tool and improve its quality.

  13. 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

  14. Pharmacy benefit managers and their obligations during serious prescription drug shortages.

    PubMed

    Teagarden, J R; Epstein, R S

    2013-02-01

    Pharmacy benefit managers are connected to some 215 million Americans and to every prescribing physician and retail pharmacy in the United States. Many of them have their own large and sophisticated dispensing operations. These capabilities could be put to use when drug shortages threaten life. Indeed, these capabilities are such that they confer obligations on pharmacy benefit managers to address such shortages--not only on behalf of their clients but for society in general.

  15. 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

  16. Prescribing psychotropic drugs in general practice: three year study.

    PubMed Central

    Jones, L; Simpson, D; Brown, A C; Bainton, D; McDonald, H

    1984-01-01

    A three year longitudinal study of psychotropic drug prescribing in one inner city general practice showed that there was a greater use of such drugs among women and elderly men and women. Repeat prescriptions without consultation accounted for 44% of prescriptions written. We think that any attempt to reduce the volume of prescriptions for psychotropic drugs should take into account the prescribing habits and attitudes of doctors as well as the problems and needs of patients. PMID:6435768

  17. Membrane–drug interactions studied using model membrane systems

    PubMed Central

    Knobloch, Jacqueline; Suhendro, Daniel K.; Zieleniecki, Julius L.; Shapter, Joseph G.; Köper, Ingo

    2015-01-01

    The direct interaction of drugs with the cell membrane is often neglected when drug effects are studied. Systematic investigations are hindered by the complexity of the natural membrane and model membrane systems can offer a useful alternative. Here some examples are reviewed of how model membrane architectures including vesicles, Langmuir monolayers and solid supported membranes can be used to investigate the effects of drug molecules on the membrane structure, and how these interactions can translate into effects on embedded membrane proteins. PMID:26586998

  18. Contingent reinforcement sustains post-detoxification abstinence from multiple drugs: a preliminary study with methadone patients.

    PubMed

    Chutuape, M A; Silverman, K; Stitzer, M

    1999-03-01

    This study examined the efficacy of a urinalysis-based contingency management program for preventing relapse to abused drugs following a brief residential detoxification. Fourteen methadone maintenance patients who were chronic benzodiazepine users were enrolled in a 7-day inpatient benzodiazepine detoxification and randomly assigned to receive Contingency Management (N = 7) or Standard Care (N = 7) therapy upon return to outpatient methadone treatment. In the Contingency Management condition, a methadone take-home dose or a US $25 voucher (patient's choice) could be earned for each urine sample submitted on a Monday, Wednesday or Friday that was free of opiates, cocaine and benzodiazepines. Data analysis and interpretation focused on within-group post-hoc differences due to group differences on employment and legal status, potentially confounding baseline variables. Repeated measures analysis of variance showed that Contingency Management patients submitted significantly more drug-free urine samples during the intervention compared to pre-detoxification (p < 0.01), whereas no significance changes were observed from pre- to post-detoxification in the Standard Care patients. Employment and legal status of patients may have facilitated response to contingency management procedures, but did not prevent relapse when contingency management procedures were withdrawn. Overall, these preliminary results suggest that abstinence-based contingency management is a promising strategy for preventing relapse to multiple drugs of abuse in a subset of methadone maintenance patients when abstinence has been initiated through brief inpatient treatment.

  19. Sampling of illicit drugs for quantitative analysis. Part I: heterogeneity study of illicit drugs in Europe.

    PubMed

    Dujourdy, L; Csesztregi, T; Bovens, M; Franc, A; Nagy, J

    2013-09-10

    Sampling of illicit drugs for qualitative and quantitative analysis would normally be considered as routine and comparable tasks in forensic drugs laboratories and previously similar statistical sampling approaches have been applied. However, we believe that two different sampling approaches, based on two different theoretical and statistical backgrounds are more appropriate. Furthermore the application of the qualitative sampling approach can be impractical for quantitative sampling as it could generate many analytical samples from a single seizure. In some countries the purity of the illicit drug in a seizure may affect the criminal sentence and therefore, reliable results for quantitative analysis are crucial. It was decided to investigate a new approach, which although incorporating some statistics also took account of our background knowledge about the composition of the drugs we were analysing. The ultimate goal was to produce recommendations for a practical sampling plan for quantitative analysis. It was found that the two key factors which had a significant effect on obtaining a representative analytical sample from a bulk seizure were the heterogeneity of the drug powder and the particle sizes of its components. This article concentrates on drug heterogeneity. Particle size effects will be addressed in part II of this study. A sampling plan was devised for a range of drug seizure types and asked ENFSI member laboratories to use it when analysing real drug seizures to provide heterogeneity data for the most common illicit drugs (heroin, cocaine, amphetamine, MDMA and cannabis (herbal and resin)). It was found that for routine quantitative drugs analysis, the sampling problems caused by heterogeneity can be solved by using an incremental sampling protocol. Furthermore, the number of increments that need to be taken for a particular drug is dependent on the relative standard deviation (RSD) required by an individual laboratory and the analytical method that

  20. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: observational study

    PubMed Central

    Howard, R; Avery, A; Howard, P; Partridge, M

    2003-01-01

    Objective: To describe the drugs and types of medicine management problems most frequently associated with preventable drug related admissions to an acute medical admissions unit. Design: Observation study. Setting: Medical admissions unit in a teaching hospital in Nottingham, UK. Participants: 4093 patients seen by pharmacists on the medical admissions unit between 1 January and 30 June 2001. Main outcome measures: Proportion of admissions that were drug related and preventable, classification of the underlying causes of preventable drug related admissions, and identification of drugs most commonly associated with preventable drug related admissions. Results: Of the admissions seen by pharmacists, 265 (6.5%) were judged to be drug related and 178 (67%) of these were judged to be preventable. Preventable admissions were mainly due to problems with prescribing (63 cases (35%)), monitoring (46 cases (26%)), and adherence to medication (53 cases (30%)). The drugs most commonly implicated were NSAIDs, antiplatelets, antiepileptics, hypoglycaemics, diuretics, inhaled corticosteroids, cardiac glycosides, and beta-blockers. Conclusions: Potentially preventable drug related morbidity was associated with 4.3% of admissions to a medical admissions unit. In 91% of cases these admissions were related to problems with either prescribing, monitoring, or adherence. PMID:12897361

  1. Management of clandestine drug laboratories: need for evidence-based environmental health policies.

    PubMed

    Al-Obaidi, Tamara A; Fletcher, Stephanie M

    2014-01-01

    Clandestine drug laboratories (CDLs) have been emerging and increasing as a public health problem in Australia, with methamphetamine being the dominant illegally manufactured drug. However, management and remediation of contaminated properties are still limited in terms of regulation and direction, especially in relation to public and environmental health practice. Therefore, this review provides an update on the hazards and health effects associated with CDLs, with a specific look at the management of these labs from an Australian perspective. Particularly, the paper attempts to describe the policy landscape for management of CDLs, and identifies current gaps and how further research may be utilised to advance understanding and management of CDLs and inform public health policies. The paper highlights a significant lack of evidence-based policies and guidelines to guide regulatory authority including environmental health officers in Australia. Only recently, the national Clandestine Drug Laboratory Guidelines were developed to assist relevant authority and specialists manage and carry out investigations and remediation of contaminated sites. However, only three states have developed state-based guidelines, some of which are inadequate to meet environmental health requirements. The review recommends well-needed inter-sectoral collaborations and further research to provide an evidence base for the development of robust policies and standard operating procedures for safe and effective environmental health management and remediation of CDLs.

  2. Management of drug-resistant cyathostominosis on a breeding farm in central North Carolina.

    PubMed

    Little, D; Flowers, J R; Hammerberg, B H; Gardner, S Y

    2003-05-01

    Possible anthelmintic resistance on a breeding farm where a rapid rotation anthelmintic programme had been implemented for 9 years was investigated. Cyathostomins resistant to fenbendazole and pyrantel were documented by faecal worm egg count reduction test (FWECRT). To 1) manage small strongyle transmission in a herd of horses in which resistance to both pyrantel pamoate and fenbendazole was identified and thereby reduce the risk of clinical disease in the individual animal, 2) monitor the change in resistance patterns over time and 3) monitor the efficacy of ivermectin over the study period. Targeted ivermectin treatment of horses on the farm was instituted for mature horses with faecal worm egg counts (FWEC) > 200 eggs/g (epg) and for horses < age 2 years with FWEC > 100 epg. Over a 30 month period, targeted ivermectin treatment achieved acceptable control in mares, as judged by FWEC, and improved control of patent cyathostome infection in consecutive foal crops. Egg reappearance time (ERT) after treatment with ivermectin was < 8 weeks in mares and foals more frequently in the second year of the study than in the first year. Numbers of anthelmintic treatments were reduced by 77.6 and 533% in the mare and foal group, respectively. Targeted ivermectin treatment may be an economically viable method of managing multiple drug resistant cyathostominosis. Use of ivermectin should be monitored closely for development of resistance.

  3. [Interstitial lung disease associated with chemotherapy and molecularly-targeted drug: diagnosis and management].

    PubMed

    Saito, Yoshinobu; Gemma, Akihiko

    2011-12-01

    A number of anticancer drugs, especially molecularly-targeted drugs, have been developed every year. Drug-induced interstitial lung disease(DILD)is a common adverse event associated with molecularly-targeted drugs, and it is therefore important to obtain information about the DILD risks of each drug. Recently, all-case surveillance of new drugs have been carried out frequently as post-marketing surveillance. This allows one to understand the accurate status of DILD, such as its incidence rate and prognosis. The diagnosis of DILD is often difficult because there is no specific diagnostic approach. It is necessary to distinguish DILD from various other diseases including infectious disease, cancer progression, congestive heart failure, etc. Among those, respiratory infection is an important disease in the differential diagnosis of DILD, because patients receiving anticancer drugs are likely to be susceptible to infection. As for the treatment of DILD, the general rule is the discontinuation of the offending drug, and if necessary, the administration of corticosteroid is indicated. However, an exceptional treatment is required for DILD caused by mTOR inhibitor, for which we must take account of the adequate management.

  4. A pilot study of loss aversion for drug and non-drug commodities in cocaine users.

    PubMed

    Strickland, Justin C; Beckmann, Joshua S; Rush, Craig R; Stoops, William W

    2017-09-12

    Numerous studies in behavioral economics have demonstrated that individuals are more sensitive to the prospect of a loss than a gain (i.e., loss aversion). Although loss aversion has been well described in "healthy" populations, little research exists in individuals with substance use disorders. This gap is notable considering the prominent role that choice and decision-making play in drug use. The purpose of this pilot study was to evaluate loss aversion in active cocaine users. Current cocaine users (N=38; 42% female) participated in this within-subjects laboratory pilot study. Subjects completed a battery of tasks designed to assess loss aversion for drug and non-drug commodities under varying risk conditions. Standardized loss aversion coefficients (λ) were compared to theoretically and empirically relevant normative values (i.e., λ=2). Compared to normative loss aversion coefficient values, a precise and consistent decrease in loss aversion was observed in cocaine users (sample λ≈1). These values were observed across drug and non-drug commodities as well as under certain and risky conditions. These data represent the first systematic study of loss aversion in cocaine-using populations and provide evidence for equal sensitivity to losses and gains or loss equivalence. Futures studies should evaluate the specificity of these effects to a history of cocaine use as well as the impact of manipulations of loss aversion on drug use to determine how this phenomenon may contribute to intervention development efforts. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    PubMed

    Marshall, Carter L

    2004-01-01

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

  6. Drug-based pain management in people with dementia after hip or pelvic fractures: a systematic review protocol.

    PubMed

    Kuske, S; Moschinski, K; Andrich, S; Stephan, A; Gnass, I; Sirsch, E; Icks, A

    2016-07-13

    Studies show that people with dementia do not receive the same amount of analgesia after a hip or pelvic fracture compared to those without cognitive impairment. However, there is no systematic review that shows to what extent and how drug-based pain management is performed for people with dementia following a hip or pelvic fracture. The aim of this systematic review is to identify studies addressing drug-based pain management for people with dementia who have had a hip or pelvic fracture for which they had either an operation or conservative treatment. We will analyse to what extent and how the drug-based pain treatment for people with dementia is performed across all settings and how it is assessed in the studies. The development of this systematic review protocol was guided by the PRISMA-P requirements, which will be taken into consideration during the review procedure. MEDLINE, EMBASE, CINAHL, Web of Knowledge and ScienceDirect will be searched, using keywords such as "analgesia", "dementia", "cognitive impairment", "pain treatment", "hip fracture" or "pelvic fracture". Publications published up to January 2016 will be included. The data extraction and a content analysis will be carried out systematically, followed by a critical appraisal. This review will provide a valuable overview on the current evidence on drug-based pain management for PwD in all settings who were conservatively treated after a hip or pelvic fracture. The review may expose a need to enhance pain management for PwD. It may also provide motivation for healthcare providers and policymakers to give this topic their attention and to facilitate further research by considering aspects of care transitions in all settings. PROSPERO CRD42016037309.

  7. 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.…

  8. Antiplatelet and anticoagulant drugs management before gastrointestinal endoscopy: do clinicians adhere to current guidelines?

    PubMed

    Bruno, Mauro; Marengo, Andrea; Elia, Chiara; Caronna, Stefania; Debernardi-Venon, Wilma; Manfrè, Selene Francesca; Musso, Alessandro; Puglisi, Flavia; Sguazzini, Carlo; Rizzetto, Mario; De Angelis, Claudio

    2015-01-01

    Managing antiplatelet and anticoagulant drugs before endoscopy may be challenging. To assess whether the pre-endoscopic management of antiplatelet/anticoagulant drugs is adherent to current guidelines and the influence of patients' characteristics, referring physician's specialty, type of endoscopic procedure and therapeutic regimen on adherence. Two hundred and twenty patients taking aspirin, thienopyridines or warfarin and scheduled for upper endoscopy (± biopsies), variceal band ligation, colonoscopy (± biopsies or polypectomy), were prospectively analyzed. In 109 patients (49.5%) the management of antiplatelet/anticoagulant drugs was thoroughly compliant with guidelines. Neither demographic characteristics, nor in/outpatient status, nor type of endoscopic procedure, nor physician's specialty influenced the adherence but the therapeutic regimen had a significant impact (p < 0.0001) as compliance was less likely in patients on warfarin. Unwarranted drugs withholding was more frequent before colonoscopy than upper endoscopy (p = 0.0001). Warfarin was stopped longer than recommended more frequently than aspirin (p = 0.009). The International Normalized Ratio was properly checked before endoscopy in 47.7% of patients. Among the 55 patients who withheld warfarin, the decision about bridging to low molecular weight heparin was appropriate in 21 (38.2%). Compliance with guidelines is low especially in the management of warfarin, both among gastroenterologists and other physicians. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  9. 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…

  10. 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,…

  11. 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.…

  12. 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…

  13. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.

  14. 'Designer drugs': update on the management of novel psychoactive substance misuse in the acute care setting.

    PubMed

    Smith, Christopher D; Robert, Stefanie

    2014-08-01

    The use of novel psychoactive substances ('legal highs' or 'designer drugs') is increasing worldwide. Patients misusing such substances have been reported to experience severe or prolonged side effects requiring admission to acute or critical care wards. These complications can be life threatening if misdiagnosed or mismanaged. As physicians have traditionally had less involvement with the management of such patients compared with their colleagues in emergency departments an update in the management of such patients is indicated. Here we present a summary of the management of those novel substances with the potential for serious complications based on a review of current literature.

  15. A Study of Pharmacy Students' Attitudes Toward Drug Abuse

    ERIC Educational Resources Information Center

    Miederhoff, Patrick; And Others

    1978-01-01

    Pharmacy students' attitudes toward drug abuse was compared with those of students with different majors. Scores were compared with professional practitioners in other studies using the Measurement of Attitudes Toward Drugs scale. Changes in attitudes as students proceed through their pharmacy curricula were also investigated. (SW)

  16. 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)

  17. 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)

  18. Analytical and Characterization Studies of Organic Chemicals, Drugs, and Drug Formulation

    DTIC Science & Technology

    2010-11-01

    release the drug product, and to conduct stability studies under cGMP shelf-life and accelerated conditions. Afton Scientific Corporation is to... Afton also served in this capacity in 2004 for the first batch of artesunic acid IV drug product, SRI batch # 14462-16. A second emphasis of our...support during the report period is as follows: Dalton Pharma Services Afton Scientific Corporation Steris Isomedix Services USAMRMC

  19. The effect of a case management intervention on drug treatment entry among treatment-seeking injection drug users with and without comorbid antisocial personality disorder.

    PubMed

    Havens, Jennifer R; Cornelius, Llewellyn J; Ricketts, Erin P; Latkin, Carl A; Bishai, David; Lloyd, Jacqueline J; Huettner, Steven; Strathdee, Steffanie A

    2007-03-01

    We examined the effect of a case management intervention on drug treatment entry among injection drug users (IDUs) with and without comorbid antisocial personality disorder (ASPD). Injection drug users attending the Baltimore Needle Exchange Program who sought and were granted referrals to opioid agonist treatment were randomized to receive a strengths-based case management intervention or passive referral. Of 162 IDUs, 22.8% met the DSM-IV criteria for ASPD. Compared to those without ASPD, IDUs with comorbid ASPD who spent 25 or more minutes with their case manager prior to their treatment entry date were 3.51 times more likely to enter treatment than those receiving less than 5 min, adjusting for intervention status, race, and treatment site (95% confidence interval 1.04-11.89). Providing case management services to IDUs with comorbid ASPD may facilitate treatment entry and reduce the negative consequences of drug abuse.

  20. Financial risk relationships and adoption of management strategies in physician groups for self-administered injectable drugs.

    PubMed

    Agnew, Jonathan D; Stebbins, Marilyn R; Hickman, David E; Lipton, Helene Levins

    2003-01-01

    To consider the extent, nature, and range of risk arrangements between physician groups and health maintenance organizations (HMOs) for self-administered injectable (SAI) drugs; to examine types and frequencies of SAI drug-use management strategies adopted by physician groups; and to explore the relationship between locus and level of financial risk for SAIs and physician group strategy adoption. We used a multiple case-study design to select physician groups and their health maintenance organization (HMO) contractual partners in 4 markets in the United States (Northwest, Northeast, Midwest, Southwest). Physician groups in these markets were chosen based on size (e50 physicians) and experience with drug risk (e1 year). Physician groups were asked to identify their 3 major HMO contractual partners in each market. Telephone interviews were conducted from January 2000 to June 2001, with the resulting purposive sample of 37 individuals representing 20 physician groups. We found that the level and locus of SAI financial risk were related to the adoption of management strategies. Physician groups with higher financial risk for SAIs adopted more strategies than lower-risk groups. Groups with SAI financial risk in the medical services capitation (MSC) adopted 9.2 strategies per group. In contrast, groups with SAI financial risk in the pharmacy-risk budget (PRB) averaged 1.5 strategies per group. Groups with SAI financial risk in both the MSC and PRB fell in-between, averaging 4.5 strategies per group. The most frequently adopted strategy was designing evidenced-based therapeutic guidelines, i.e., protocols based on evidence from the peer-reviewed literature used to guide physicians in the treatment of typically chronic conditions (9 groups, 45% of sample). The second most common strategy involved adapting the existing utilization management system to process SAIs (7 groups, 35%) and the establishment of office procedures for internal authorization (5 groups, 25%). The

  1. The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management

    PubMed Central

    Patel, Teresa; Fisher, Stanley P.

    2016-01-01

    Objective This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. Methods The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. Results Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest‐ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. Conclusions The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success. PMID:27477689

  2. Mining severe drug-drug interaction adverse events using Semantic Web technologies: a case study.

    PubMed

    Jiang, Guoqian; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2015-01-01

    Drug-drug interactions (DDIs) are a major contributing factor for unexpected adverse drug events (ADEs). However, few of knowledge resources cover the severity information of ADEs that is critical for prioritizing the medical need. The objective of the study is to develop and evaluate a Semantic Web-based approach for mining severe DDI-induced ADEs. We utilized a normalized FDA Adverse Event Report System (AERS) dataset and performed a case study of three frequently prescribed cardiovascular drugs: Warfarin, Clopidogrel and Simvastatin. We extracted putative DDI-ADE pairs and their associated outcome codes. We developed a pipeline to filter the associations using ADE datasets from SIDER and PharmGKB. We also performed a signal enrichment using electronic medical records (EMR) data. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the DDI-induced ADEs into the CTCAE in the Web Ontology Language (OWL). We identified 601 DDI-ADE pairs for the three drugs using the filtering pipeline, of which 61 pairs are in Grade 5, 56 pairs in Grade 4 and 484 pairs in Grade 3. Among 601 pairs, the signals of 59 DDI-ADE pairs were identified from the EMR data. The approach developed could be generalized to detect the signals of putative severe ADEs induced by DDIs in other drug domains and would be useful for supporting translational and pharmacovigilance study of severe ADEs.

  3. Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

    PubMed

    Weaver, Joyce; Grenade, Lois La; Kwon, Hyon; Avigan, Mark

    2009-01-01

    Marketed pharmaceuticals are evaluated for safety by the US Food and Drug Administration (FDA) throughout the life cycle of the products. The FDA uses data from controlled clinical trials, from postmarketing case reports reported to the FDA's Adverse Event Reporting System, from epidemiological studies, and from registries to evaluate the safety of approved products. For some products, including some products used in dermatologic medicine, risks become apparent during the postmarketing period that require additional measures beyond product labeling and routine pharmacovigilance. The FDA continues to seek additional tools to assess risk, including pharmacogenomic biomarkers for adverse drug reactions and the use of large medical record and epidemiological databases for the systematic detection and characterization of drug-associated safety outcomes.

  4. Drug-induced liver injury: Advances in mechanistic understanding that will inform risk management.

    PubMed

    Mosedale, M; Watkins, P B

    2016-11-09

    Drug-induced liver injury (DILI) is a major public health problem. Intrinsic (dose-dependent) DILI associated with acetaminophen overdose is the number one cause of acute liver failure in the US. However, the most problematic type of DILI impacting drug development is idiosyncratic, occurring only very rarely among treated patients and often only after several weeks or months of treatment with the offending drug. Recent advances in our understanding of the pathogenesis of DILI suggest that three mechanisms may underlie most hepatocyte effects in response to both intrinsic and idiosyncratic DILI drugs: mitochondrial dysfunction, oxidative stress, and alterations in bile acid homeostasis. However, in some cases hepatocyte stress promotes an immune response that results in clinically important idiosyncratic DILI. This review discusses recent advances in our understanding of the pathogenesis of both intrinsic and idiosyncratic DILI as well as emerging tools and techniques that will likely improve DILI risk identification and management.

  5. Interaction of Antipsychotic Drugs with Sucrase, Kinetics and Structural Study.

    PubMed

    Jafari, Narges; Dehganpour, Helia; Ghavanini, Nava; Mollasalehi, Hamidreza; Minai-Tehrani, Dariush

    2017-01-01

    In patients with the Congenital Sucrase-Isomaltase Deficiency (CSID), who lack intestinal sucrase-isomaltase enzyme, a suspension of yeast sucrase is applied as a drug to compensate the enzyme deficiency. While antipsychotic drugs are used for the treatment of schizophrenia, administering multiple drugs at the same time may counteract each other. In this study, the interaction between trifluoperazine and haloperidol as antipsychotic drugs on oral drug yeast sucrase was investigated. In this regard, the kinetic parameters of enzyme were determined in the presence or absence of the drugs. The kinetic parameters of the drugs such as Ki and IC50 were also calculated. Lineweaver - Burk plot was used to reveal the type of inhibition. The results showed that both drugs could reduce sucrase activity and decrease the Vmax of the enzyme by non-competitive inhibition. The IC50 and Ki values of the drugs were determined to be 0.7 and 0.068 mM and 0.45 and 0.063 mM for haloperidol and trifluoperazine, respectively. The results suggested that trifluoperazine binds to the enzyme with higher affinity than haloperidol. Fluorescence measurement was used for conformational investigations of the drugs and sucrase interaction. It was shown that the drugs bind to free enzyme and enzyme-substrate complex which are accompanied with hyperchromicity. This suggests that tryptophan residues of the enzyme transferred to hydrophobic medium after binding of the drugs to the enzyme. The finding of this research revealed that both trifluoperazine and haloperidol could inhibit sucrase in non-competitive manner. The kinetic parameters and conformational changes due to binding of trifluoperazine to the enzyme were different from that of haloperidol. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  6. Immortal time bias in drug safety cohort studies: spontaneous abortion following nonsteroidal antiinflammatory drug exposure.

    PubMed

    Daniel, Sharon; Koren, Gideon; Lunenfeld, Eitan; Levy, Amalia

    2015-03-01

    Experimental research of drug safety in pregnancy is generally not feasible because of ethical issues. Therefore, most of the information about drug safety in general and teratogenicity in particular is obtained through observational studies, which require careful methodologic design to obtain unbiased results. Immortal time bias occurs when some cases do not "survive" sufficient time in the study, and as such, they have reduced chances of being defined as "exposed" simply because the durations of their follow-ups were shorter. For example, studies that examine the risk for spontaneous abortions in women exposed to a drug during pregnancy are susceptible to immortal time bias because the chance of drug exposure increases the longer a pregnancy lasts. Therefore, the drug tested may falsely be found protective against the outcome tested. The objective of the current study was to illustrate the extent of immortal time bias using a cohort study of pregnancies assessing the risk for spontaneous abortions following nonsteroidal antiinflammatory drug exposure. We assembled 3 databases containing data on spontaneous abortions, births and drug dispensions to create the present study's cohort. The risk for spontaneous abortion was assessed using 2 statistical analysis methods that were compared for 2 definitions of exposure (dichotomous, exposed vs unexposed, regular Cox regression vs Cox regression with time-varying exposure). Significant differences were found in the risk for spontaneous abortions between the 2 statistical methods, both for groups and for most specific nonsteroidal antiinflammatory drugs (nonselective Cox inhibitors - hazard ratio, 0.70; 95% confidence interval, 0.61-0.94 vs hazard ratio, 1.10; 95% confidence interval, 0.99-1.22 for dichotomous vs time-varying exposure analyses, respectively). Furthermore, a significant correlation was found between the median misclassified immortal time for each drug and the extent of the bias. Immortal time bias can

  7. Drug-based pain management for people with dementia after hip or pelvic fractures: a systematic review.

    PubMed

    Moschinski, Kai; Kuske, Silke; Andrich, Silke; Stephan, Astrid; Gnass, Irmela; Sirsch, Erika; Icks, Andrea

    2017-02-14

    Studies indicate that people with dementia do not receive the same amount of analgesia after a hip or pelvic fracture compared to those without cognitive impairment. However, there is no systematic review that shows to what extent drug-based pain management is performed for people with dementia following a hip or pelvic fracture. The aim of this systematic review was to identify and analyse studies that investigate drug-based pain management for people with dementia with a hip or pelvic fracture in all settings. Treatment could be surgical or conservative. We also analysed study designs, methods and variables, as well as which assessments were applied to measure pain management and mental status. The development of this systematic review protocol was guided by the PRISMA-P requirements, which were taken into consideration during the review procedures. MEDLINE, EMBASE, CINAHL, Web of Knowledge and ScienceDirect were searched. Studies published up to January 2016 were included. The data extraction, content and quantitative descriptive analysis were carried out systematically, followed by a critical appraisal. Eight of the 13 included studies focusing on patient data showed that people with dementia received less drug-based pain management than people without cognitive impairment. Four studies based on surveys of healthcare professionals stated that cognitive impairment is a major barrier for effective pain management. There was heterogeneity regarding the assessment of the mental status and the pain assessment of the patients. The assessment of the drugs administered in all of the studies working with patient data was achieved through chart reviews. People with dementia do not seem to receive the same amount of opioid analgesics after hip fracture as people without cognitive impairment. There is need to enhance pain assessment and management for these patients. Future research should pay more attention to the use of the appropriate items for assessing cognitive

  8. Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

    PubMed

    Kales, A; Scharf, M B; Soldatos, C R; Bixler, E O

    1979-07-01

    The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

  9. Severe Cutaneous Adverse Drug Reactions: A Clinicoepidemiological Study

    PubMed Central

    Sasidharanpillai, Sarita; Riyaz, Najeeba; Khader, Anza; Rajan, Uma; Binitha, Manikoth P; Sureshan, Deepthi N

    2015-01-01

    Background: Drug eruptions range from transient erythema to the life threatening severe cutaneous adverse reactions (SCAR) that encompass Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms complex (DRESS). Aims and Objectives: To study the clinical and epidemiological aspects of cutaneous adverse drug reactions (CADR). Materials and Methods: Ethical clearance was obtained from the institutional ethics committee. All patients admitted in the Dermatology ward of our tertiary care hospital with CADR (those who fit in the category of probable or possible drug reaction as per WHO casuality assessment) from first September 2011 to 31st August 2012 were included in this cross sectional study after obtaining written informed consent. The drug reaction patterns observed in the study population were determined and the common offending drugs were identified. Results: In the study, population of males outnumbered females and the majority were between 46 and 60 years of age. The commonest reaction pattern observed was SJS- TEN spectrum of illness and aromatic anticonvulsants were the common offending drugs. Prompt withdrawal of the culprit drug and administration of systemic steroids with or without I/V Ig reverted the adverse reaction in all except one. Conclusion: Severe drug reactions predominated as the study population was comprised of inpatients of a tertiary referral centre. Though; previous authors had reported a mortality rate of up to 20% in DRESS, all our patients with this reaction pattern, responded well to treatment. The mortality rate among TEN cases was much lower than the previous reports. Early diagnosis, prompt withdrawal of the suspected drug, careful monitoring for development of complications and immediate intervention can improve the prognosis of CADR. PMID:25657416

  10. 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.

  11. 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

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 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...

  12. 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

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 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...

  13. 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

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 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...

  14. 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

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 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...

  15. 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

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the...

  16. A Longitudinal Study of Multiple Drug Use and Overdose Among Young People Who Inject Drugs.

    PubMed

    Riley, Elise D; Evans, Jennifer L; Hahn, Judith A; Briceno, Alya; Davidson, Peter J; Lum, Paula J; Page, Kimberly

    2016-05-01

    To determine the association between multiple drug use and nonfatal overdose among young people (younger than 30 years) who inject drugs. We completed a longitudinal study of 173 injection drug users younger than 30 years living in San Francisco, California, between April 2012 and February 2014. The odds of nonfatal overdose increased significantly as heroin and benzodiazepine pill-taking days increased and when alcohol consumption exceeded 10 drinks per day compared with 0 drinks per day. Heroin, benzodiazepine, and alcohol use were independently associated with nonfatal overdose over time among young people who inject drugs. Efforts to address multiple central nervous system depressant use remain an important component of a comprehensive approach to overdose, particularly among young people.

  17. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Arthritis Advisory Committee and the... to the notice of a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk... meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee...

  18. 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

  19. In vitro drug release study of methacrylate polymer blend system: effect of polymer blend composition, drug loading and solubilizing surfactants on drug release.

    PubMed

    Li, Jun; Barrow, David; Howell, Holly; Kalachandra, Sid

    2010-02-01

    The application of polymers as the drug delivery systems for treating oral infections is a relatively new area of research. The present study was to test the release of the antibacterial drug chlorhexidine diacetate (CHDA), the antifungal drug Nystatin (NYS) and the antiviral drug acyclovir (ACY) from polymer blends of poly(ethyl methacrylate) and poly(n-hexyl methacrylate) of different compositions. The effects of polymer blend composition, drug loading and solubilizing surfactants on the release of the drugs have been studied. Measurements of the in vitro rate of drug release showed a sustained release of drug over extended periods of time. Drug release rates decreased with increasing PEMA content in polymer blends. CHDA release rates increased steadily with increasing drug load. The drug release rates increased with the addition of surfactants. This study demonstrates that the three therapeutic agents show a sustained rate of drug release from polymer blends of PEMA and PHMA over extended periods of time. By varying polymer blend compositions as well as the drug concentration (loading), it is possible to control the drug release rates to a desired value. The drug release rate is enhanced by addition of surfactants that solubilize drugs in the polymer blends.

  20. Monitoring and management of antituberculosis drug induced hepatotoxicity.

    PubMed

    Agal, Subhash; Baijal, Rajiv; Pramanik, Snehanshu; Patel, Nikhil; Gupte, Parijat; Kamani, Praful; Amarapurkar, Deepak

    2005-11-01

    Hepatotoxicity to antituberculosis therapy (ATT) poses a major challenge. This often results in inadequate therapy. The risk of fulminant hepatic failure and mortality is high once icteric hepatitis develops. There is no consensus on monitoring protocols and for the reintroduction of ATT. All patients (from the Department of Internal Medicine and Gastroenterology, Jagjivanram Hospital and the Department of Gastroenterology, Bombay Hospital, Mumbai, India) with a diagnosis of tuberculosis, who were to receive ATT during the study period, were included in the present study for prospective periodic laboratory monitoring for the development of hepatotoxicity. Those patients who developed hepatotoxicity formed Group A (n = 21), whereas those who did not develop hepatotoxicity were included in Group C (n = 179). For the purpose of comparison with Group A, all the patients who presented directly with ATT induced hepatotoxicity during the study period were categorized as Group B (n = 24). Group A and B were further studied after normalization of liver functions for sequential reintroduction with therapeutic doses at a weekly interval. In Group A, 66.6% (14 patients) of the patients were diagnosed in the asymptomatic period. Seven patients had symptomatic hepatitis, but none had icteric illness. There were no mortalities in Group A. In contrast, all the patients in Group B had symptomatic hepatitis (75% icteric hepatitis). There was a mortality rate of 16.6% (four patients). Of the 41 patients from Groups A and B who survived, reintroduction was successful in 38/39 (97.4%). In the remaining two patients who were in Group B, reintroduction was not attempted because of decompensated liver disease. Periodic laboratory monitoring is important in detecting hepatotoxicity at an early stage, thereby preventing mortality. Sequential reintroduction is often successful.

  1. Updates on Managing Type 2 Diabetes Mellitus with Natural Products: Towards Antidiabetic Drug Development.

    PubMed

    Alam, Fahmida; Islam, Md Asiful; Kamal, M A; Gan, Siew Hua

    2016-08-13

    Over the years, natural products have shown success as antidiabetics in vitro, in vivo and in clinical trials. Because natural product-derived drugs are more affordable and effective with fewer side-effects compared to conventional therapies, pharmaceutical research is increasingly leaning towards the discovery of new antidiabetic drugs from natural products targeting pathways or components associated with type 2 diabetes mellitus (T2DM) pathophysiology. However, the drug discovery process is very lengthy and costly with significant challenges. Therefore, various techniques are currently being developed for the preclinical research phase of drug discovery with the aim of drug development with less time and efforts from natural products. In this review, we have provided an update on natural products including fruits, vegetables, spices, nuts, beverages and mushrooms with potential antidiabetic activities from in vivo, in vitro and clinical studies. Synergistic interactions between natural products and antidiabetic drugs; and potential antidiabetic active compounds from natural products are also documented to pave the way for combination treatment and new drug discovery, respectively. Additionally, a brief idea of the drug discovery process along with the challenges that arise during drug development from natural products and the methods to conquer those challenges are discussed to create a more convenient future drug discovery process.

  2. 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

  3. [Recommendations of the Spanish Society for Pediatric Infectious Diseases (SEIP) on the management of drug-resistant tuberculosis].

    PubMed

    Mellado Peña, M J; Baquero-Artigao, F; Moreno-Perez, D

    2009-11-01

    Drug resistant tuberculosis (TB-R), and in particular, multidrug resistant tuberculosis (MDR-TB) is a global public health problem, as well as a problem in our country. Cases of TB-R and MDR-TB have increased mainly in HIV, immigrant and socially disadvantaged populations, but a notable increase in the general population has also been observed. This aspect reinforces the need for a systematic study of sensitivity of all the isolates in a reference laboratory to optimally guide the treatment. Children are especially vulnerable to this severe disease due to the limited knowledge of second line anti-tuberculous drugs, in terms of their pharmacokinetic data, optimal doses, or their long term toxicity, all this eventually resulting in the compassionate use of drugs. Another aspect which further complicates the management of R-TB in children is the limited yield of cultures, which frequently leads to clinician designing drug combinations according to the sensitivity of the initial strain. The epidemiological pattern in our country has currently changed. There is a reported increase in isoniazid-resistant strains; therefore, a four drugs regime is mandatory for the initial period in children, until reliable sensitivity results are available. Treatment should be directly observed or at least supervised by paediatricians. The management of latent infections or exposure to a resistant TB case also requires an accurate, strict and prolonged supervision by expert paediatricians. Authorities and health care professionals who deal with TB should be prepared to face this new phenomenon with appropriate measures. The knowledge of second line drugs for children, as well as mechanisms to ensure the therapeutic adherence and long term control of disease, are essential.

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

    PubMed

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

    2016-06-01

    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. Data were derived from electronic medical records, obtained over a 12-month period in 2013. Forty-six Dutch general practices. 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. Usual care was categorized into wait-and-see strategy (no treatment initiated); education and advice; additional testing; medication adjustment; and referral. 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. 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 Points It 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. The referral rate for dizziness was high compared with previous research.

  5. Denosumab: an investigational drug for the management of postmenopausal osteoporosis

    PubMed Central

    Lewiecki, E Michael

    2008-01-01

    Denosumab (AMG 162) is an investigational fully human monoclonal antibody with a high affinity and specificity for receptor activator of nuclear factor-κB ligand (RANKL), a cytokine member of the tumor necrosis factor family. RANKL, the principal mediator of osteoclastic bone resorption, plays a major role in the pathogenesis of postmenopausal osteoporosis and other skeletal disorders associated with bone loss. Denosumab inhibits the action of RANKL, thereby reducing the differentiation, activity, and survival of osteoclasts, and lowering the rate of bone resorption. Clinical trials have shown that denosumab increases bone mineral density (BMD) and reduces bone turnover in postmenopausal women with low BMD. Studies to evaluate the fracture risk benefit and long-term safety of denosumab in women with postmenopausal osteoporosis (PMO) are ongoing. Denosumab is a potential treatment for PMO and other skeletal disorders. PMID:19707445

  6. A STUDY ON CRISIS MANAGEMENT,

    DTIC Science & Technology

    THREAT EVALUATION, DECISION MAKING), (*STRATEGIC WARFARE, THREAT EVALUATION), (*FOREIGN POLICY, DECISION MAKING), OPERATIONS RESEARCH, MANAGEMENT ...PLANNING AND CONTROL, AERIAL WARFARE, USSR, PERCEPTION, GAME THEORY, WEAPON SYSTEMS , WARFARE, EGYPT, ISRAEL, JORDAN, LEBANON, CUBA, CYPRUS, THEORY, COMMUNISTS, CHINA, SOUTH KOREA, NORTH KOREA.

  7. A mechanistic model for drug release from PLGA-based drug eluting stent: A computational study.

    PubMed

    Naghipoor, Jahed; Rabczuk, Timon

    2017-09-08

    Atherosclerosis in the coronary artery is one of the leading causes of death in the world. The stenting as a minimally invasive technique was considered as an effective tool to reduce the severity of atherosclerotic stenosis. In-stent restenosis is the main drawback of the stenting in the coronary artery. Understanding the mechanism of drug release from drug-eluting stents and drug uptake in the arterial wall and obtaining more information about their functionality using mathematical modeling and numerical simulation, could be considered as a predictive tool to investigate in-stent restenosis growth which is experimentally expensive to study. In this work, the local delivery of a therapeutic agent from a PLGA-based bioabsorbable stent implanted in a coronary artery to predict the drug release as well as spatio-temporal drug distribution in a coronary artery with a vulnerable plaque is mathematically modeled and numerically simulated. The effect of copolymer ratio on drug release has been also investigated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. 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.

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

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2014-03-20

    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.

  10. Army Ecosystem Management Policy Study

    DTIC Science & Technology

    1997-03-01

    principles to manage biological and physical systems in a manner that safeguards the long-term ecological sustainability, natural diversity, and...focus on ecosystem management (e.g., biodiversity conservation; restoration of native ecological systems). In all fairness, such a judgment would be...decisions. Regardless of which view one adheres to, a region can be defined along multiple dimensions—biological, physical , socio -cultural and economic. The

  11. Biochemical Studies on the Mechanism of Drug Action.

    DTIC Science & Technology

    The primary objectives of this research project were to study the mechanism of action of three common drugs, theophylline, acetylsalicylic acid and diphenylthiohydantoin (DPTH), in normal and thiamin deficient rats.

  12. 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.

  13. Bibliometric Analysis of Medication Errors and Adverse Drug Events Studies.

    PubMed

    Huang, Hung-Chi; Wang, Cheng-Hua; Chen, Pi-Ching; Lee, Yen-Der

    2015-07-31

    Medication errors and adverse drug events are a key concern of the health-care industry. The objectives of this study were to map the intellectual structure of the studies of medication errors and adverse drug events and to investigate the developing path of this literature and interrelationships among the main topics. The Web of Science database was searched for documentation of medication errors and adverse drug events from 1961 to 2013. The most cited articles and references were profiled and analyzed using HistCite software to draw a historiograph and Ucinet software to draw a sociogram. The database search revealed 3343 medication errors and 3342 adverse drug event documents. The most cited articles on medication errors focused on 3 key themes from 1961 to 2013, namely, medication errors in adult inpatients, computerized physician order entry in medication error studies, and medication errors in pediatric inpatients. The developing path for the most cited articles about adverse drug events from 1987 to 2013 was as follows: detection, analysis, effect, and prevention from adult inpatient to pediatric inpatient settings and from hospitalized care to ambulatory care. In addition, social network analysis based on the most cited references revealed a close relationship between medication errors and adverse drug events. The mapping results provide a valuable tool for researchers to access the literature in this field and can be used to help identify the direction of medication errors and adverse drug events research.

  14. Evaluation of gliadins nanoparticles as drug delivery systems: a study of three different drugs.

    PubMed

    Duclairoir, C; Orecchioni, A-M; Depraetere, P; Osterstock, F; Nakache, E

    2003-03-06

    In this paper, biopolymer nanoparticles are studied, which unlike many synthetic carriers used for controlled release, are biocompatible and biodegradable systems. Gliadins nanoparticles are obtained by a desolvatation method, also known as drawning-out precipitation. These particles have been shown to be interesting as drug release systems for all-trans-retinoic acid. The aim of this paper was to study the influence of the polarity of different drugs on nanoparticle characteristics such as size and drug loading efficiency. Three drugs of three different polarities were studied: the hydrophobic Vitamin E (VE), the slightly polar mixture of linalool and of linalyl acetate (LLA) and the cationic amphiphilic benzalkonium chloride (BZC). This comparative work shows that the amount of the entrapped VE and LLA is higher than that of the cationic BZC, confirming a strong interaction between gliadins and apolar compounds, due to the apolarity of the proteins. This interaction results in a low diffusion coefficient and a partition coefficient in favour of gliadins, resulting in a low permeability coefficient. The drug release kinetics of two substances, LLA and BZC, are observed, in showing a burst effect, then a diffusion process, which can be modelled assuming that the particles are homogeneous spheres.

  15. Sodium glucose co-transporter 2 inhibitor luseogliflozin in the management of type 2 diabetes: a drug safety evaluation.

    PubMed

    Yabe, Daisuke; Hamamoto, Yoshiyuki; Seino, Yusuke; Kuwata, Hitoshi; Kurose, Takeshi; Seino, Yutaka

    2017-10-01

    Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co., Ltd. and was approved as an oral anti-diabetic drug for T2D in Japan Areas covered: The overall safety and efficacy of SGLT2 inhibitor luseogliflozin are summarized on the basis of a literature review, with a focus on reported adverse drug reactions in preapproval clinical trials and a post-marketing surveillance. Expert opinion: SGLT2 inhibitor luseogliflozin is well tolerated, significantly improves hyperglycemia in preapproval clinical trials, and has a favorable safety profile in both preapproval clinical trials and post-marketing surveillance in elderly patients. While long-term safety and efficacy remain to be seen, luseogliflozin can benefit T2D patients worldwide. However, healthcare professionals must perform appropriate patient education that includes temporary withdrawal of luseogliflozin during patient a 'sick day' and avoidance of strict carbohydrate restriction during luseogliflozin treatment.

  16. 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

  17. Bioequivalence studies of drugs prescribed mainly for women.

    PubMed

    McGilveray, Iain J

    2011-01-01

    The basic components of pharmacokinetics are absorption, distribution, metabolism, and excretion. During pregnancy there may be changes in one or many of these components. Early drug studies did not include a representative proportion of women, however, researchers as well as regulators agree that studies on the sex differences in the disposition of drugs are important, but at what stage in the clinical trial process? Except for drugs used only in women, such as those for estrogen-dependent breast cancer, caution prevails and the differences are usually studied at phase 3. Studies in pregnant women are much rarer but some do get done, e.g., with antivirals and antimalarials, where the positive risk-benefit of these agents is the likelihood that fetal transfer of these drugs might help protect the fetus. Women are being included in pharmacokinetic studies for new drug applications in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), U.S. Food and Drug Administration (FDA), and Health Canada (HC) guidances. A new look at bioequivalence studies, to compare results in men and women, would help determine if interactions of formulation and gender are a problem.

  18. Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management.

    PubMed

    Knepper, Todd C; Saller, James; Walko, Christine M

    2017-02-15

    The nonradiologic medical management of solid tumors has evolved from the use of traditional cytotoxic agents to modern targeted therapies, monoclonal antibodies, and immunotherapies. Advances in the understanding of cancer biology and therapeutic strategies have resulted in increasing numbers of new drug applications and approvals. Consequently, practicing oncologists need to learn how the newly available agents function and what toxicities to watch for, as well as ways to optimize the use of both new drugs and previously approved drugs with new indications. In 2016, the US Food and Drug Administration approved three novel drugs for the treatment of solid malignancies-olaratumab in selected patients with soft-tissue sarcoma, atezolizumab for the treatment of bladder cancer, and rucaparib for the treatment of ovarian cancer; also in 2016, the use of previously approved anticancer agents (including atezolizumab) was expanded into 11 new patient populations. The diversity of options for patients is evident in the broad range of the 2016 approvals, which include immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and traditional cytotoxic agents. This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning.

  19. 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

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

    PubMed

    Mkoka, Dickson Ally; Goicolea, Isabel; Kiwara, Angwara; Mwangu, Mughwira; Hurtig, Anna-Karin

    2014-03-19

    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). 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. 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. 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.

  1. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  2. 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

  3. 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.

  4. Disability and Study: Layers of Management

    ERIC Educational Resources Information Center

    Werth, Shalene; Hammer, Sara; d'Abadie, Danielle

    2014-01-01

    The findings of this paper are based on a 3-year study of students registered with disability services at an Australian, regional university between 2008 and 2010. The concept of self-management, in its various dimensions, was a key theme emerging from the study. We argue that participants in our study employ "layers of self-management"…

  5. CYANOS: A Data Management System for Natural Product Drug Discovery Efforts Using Cultured Microorganisms

    PubMed Central

    Chlipala, George E.; Krunic, Aleksej; Mo, Shunyan; Sturdy, Megan; Orjala, Jimmy

    2010-01-01

    A software package, termed “CYANOS”, has been developed to facilitate the data management and data mining for natural product drug discovery efforts. This system allows for the management of data associated with field collections, culture conditions, harvests, extractions, chemical separations, and biological evaluation. This software utilizes a MySQL database for data storage, which allows for reporting and data mining via third party tools. In addition, a web-based interface was constructed to allow for multi-user access from a variety of desktop platforms. The code for this system is freely available and has been released under the Illinois Open Source license. PMID:21162567

  6. The patient taking antiplatelet drugs: a review with dental management considerations.

    PubMed

    Aubertin, Mary A

    2008-01-01

    Antiplatelet drugs are used in clinical practice to prevent the adverse sequelae of thromboses in atherosclerotic arteries of the heart, brain, and limbs and in the veins and heart chambers. They have diverse mechanisms of action, half-lives, and pharmacodynamic effects. A major concern among dental health care providers is the potential for excessive bleeding after invasive dental procedures. This article reviews the current antiplatelet agents used for managing cardiovascular and cerebrovascular diseases and suggests how patients taking these agents may be managed when invasive dental procedures are planned.

  7. Contingency management reduces drug-related human immunodeficiency virus risk behaviors in cocaine-abusing methadone patients.

    PubMed

    Hanson, Tressa; Alessi, Sheila M; Petry, Nancy M

    2008-07-01

    Contingency management (CM) is efficacious in reducing drug use. This study examined whether CM also reduces human immunodeficiency virus (HIV) risk behaviors and if these effects are mediated by longest duration of abstinence achieved during treatment. Data were analyzed from a subset of participants in a combined data set of three published randomized controlled trials of CM treatments. A community-based methadone maintenance clinic. One-hundred and sixty-five cocaine-abusing methadone maintenance patients. Participants received either standard methadone treatment or standard methadone treatment with CM for 3 months. The HIV Risk Behavior Scale (HRBS) was administered prior to randomization to a study condition and 3 months after the study treatments ended. The primary objective indicator of drug use was longest duration of cocaine and opioid abstinence achieved during treatment. Relative to those assigned to standard care, participants receiving CM significantly decreased overall HIV risk behaviors and injection drug use risk behaviors. CM participants also achieved longer durations of consecutive cocaine and opioid abstinence during treatment. Duration of abstinence achieved mediated the relationship between treatment condition and HRBS difference scores. These results suggest that CM treatment reduces HIV drug use risk behaviors in cocaine-abusing methadone maintenance patients.

  8. Drug users' sexual relationships and the social organisation of risk: the sexual relationship as a site of risk management.

    PubMed

    Rhodes, T; Quirk, A

    1998-01-01

    Research on "risk behaviour" in the time of AIDS has emphasised how social relationships influence individuals' responses to risk. Yet the social relationship remains an under-utilised unit of analysis in risk behaviour research. Drawing on qualitative research with illicit drug users in London, this paper illustrates how drug users' sexual relationships act as key sites of risk management in individuals' drug use and everyday lifestyles. First, while recent research has almost exclusively focused on the dangers of disease transmission, our findings show that drug users perceived their sexual relationships as influencing a variety of risks associated with heroin and other opioid drugs. Here, two types of relationships--"gear" and "straight" relationships--were perceived to be particularly important. Second, while research has tended to focus on drug and health risks as an outcome of relationships, drug users' accounts emphasise that managing risks to their relationships is an important facet of everyday risk management made complicated by drug use. It is argued that risk is a product of social interactions, and that the sexual relationship is an important site of risk management in this process. Future interventions should target drug users' sexual relationships as agents of risk management and behaviour change.

  9. Decision analysis and drug development portfolio management: uncovering the real options value of your projects.

    PubMed

    Rosati, Nicoletta

    2002-04-01

    Project selection and portfolio management are particularly challenging in the pharmaceutical industry due to the high risk - high stake nature of the drug development process. In the recent years, scholars and industry experts have agreed that traditional Net-Present-Value evaluation of the projects fails to capture the value of managerial flexibility, and encouraged adopting a real options approach to recover the missed value. In this paper, we take a closer look at the drug development process and at the indices currently used to rank projects. We discuss the economic value of information and of real options arising in drug development and present decision analysis as an ideal framework for the implementation of real options valuation.

  10. Oral targeted therapies: managing drug interactions, enhancing adherence and optimizing medication safety in lymphoma patients.

    PubMed

    Liewer, Susanne; Huddleston, Ashley N

    2015-04-01

    The advent of newer, targeted oral chemotherapy medications such as small molecule kinase inhibitors, ibrutinib and idelalisib, has created additional options for the treatment of lymphoma. The targeted nature of these agents offers many patient-identified advantages over older, intravenously administered chemotherapy regimens such as ease of self-administration and an increased sense of independence. However, newer oral agents also present unique challenges not previously experienced with older therapies that may affect safety, efficacy and patient adherence. In this article, we review oral agents for the treatment of lymphoma, how to evaluate and manage drug-drug and drug-food interactions with concomitant oral medications, and issues with patient adherence as well as methods to determine adherence for oral chemotherapy.

  11. Toxicological screening in heroin users: implications for management of drug misuse

    PubMed Central

    Skidmore, Carol A.; Robertson, J. Roy; Simpson, D.; Jarvie, D.R.

    1987-01-01

    The toxicological screening of 200 urine samples from 55 known heroin users claiming to be abstinent revealed that in 18% of samples (24% of users tested) opiates were unexpectedly detected. Other substances, many of which were psychoactive drugs, were identified in 35% of samples. Cocaine was not detected in any samples. In addition, nicotine was found in 91% of users and caffeine in 44%. The data showed the presence of polydrug abuse in 29% of subjects and suggested there is an illegal supply of drugs originating from doctors' prescriptions. The requirement for more general use of toxicological screening and the implications of the results for management of drug takers in general practices are discussed. PMID:3450865

  12. Enrollment Management Study: Five Scenarios.

    ERIC Educational Resources Information Center

    Albers, James R.; Burns, James A.

    The effect of enrollment level changes on the long-range future of Western Washington University are investigated. Due to the high rate of Washington state in-migration, declining enrollments are not projected for Western Washington University. The impact of managed enrollment goals was examined to help the university determine the most…

  13. [Drug interactions and their management in patients with human immunodeficiency virus infection].

    PubMed

    Cabarcos Ortíz de Barrón, A; Martínez Vázquez, J M; Lorenzo Zúñiga, V; Barrio Gómez, E

    1998-03-01

    In fact patients with human immune deficiency virus infection are in treatment with multidrugs regimen, also in antiretrovirical therapy as profilaxis and treatment opportunist infections and other problems, in other fact the high tase of intravenous drugs users in meta-done programming (one of the principal transmission cause). Consequently is necessary an rational approximation to this problem also in the deepth knowledgment of his mechanisms and his management in the daily clinical practice.

  14. Drug resistant tuberculosis in prisons in Azerbaijan: case study.

    PubMed

    Coninx, R; Pfyffer, G E; Mathieu, C; Savina, D; Debacker, M; Jafarov, F; Jabrailov, I; Ismailov, A; Mirzoev, F; de Haller, R; Portaels, F

    1998-05-09

    To document the existence of drug resistance in a tuberculosis treatment programme that adheres strictly to the DOTS principles (directly observed treatment, short course) and to determine the extent of drug resistance in a prison setting in one of the republics of the former Soviet Union. Case study. Central Penitentiary Hospital in Baku, the referral centre for tuberculosis patients from all prisons in Azerbaijan. Prisoners with tuberculosis: 28 selected patients not responding clinically or bacteriologically to the standard treatment (group 1) and 38 consecutive patients at admission to the programme (group 2). Drug resistance of Mycobacterium tuberculosis strains grown from sputum. All the non-responding patients (group 1) had strains resistant to at least one drug. 25 (89%) of the non-responding patients and nine (24%) of the consecutive patients had M tuberculosis strains resistant to both rifampicin and isoniazid. A further 17 patients in group 2 had strains resistant to one or more first line drugs. Drug resistant M tuberculosis strains are common in prisons in Azerbaijan. Tuberculosis problems tend to be worse in prisons, but prisoners and former prisoners may have an important role in the transmission of tuberculosis, particularly of drug resistant forms, in the community. National programmes to control tuberculosis will have to take into account and address the problems in prisons to ensure their success.

  15. Drug dispensing systems in Gaza hospitals: a comparative study.

    PubMed

    Al Adham, M; Abu Hamad, B

    2011-10-01

    Implementing an appropriate drug dispensing system in hospitals is essential to ensure the safe and rational use of drugs. This study aimed to assess the unit-dose drug dispensing system (DDS) and the ward-stock DDS utilized in Gaza hospitals to ascertain which system is more beneficial. The quantitative, comparative cross-sectional design utilized structured interviews with pharmacists and head nurses, missing drug registration sheets and drug administration observation checklists. The number of missing units per drug item dispensed (mean 3.4 and 1.8 respectively) and medication administration errors per patient (mean 1.8 and 0.9 respectively) were statistically significantly lower in the hospital using the unit-dose DDS than the ward-stock DDS. The unit-dose DDS appeared to be safer, with fewer missing drugs, was more positively perceived by staff and was more supportive of good clinical pharmacy practice. Its use in other hospitals in the Gaza Strip is recommended.

  16. What is the Cost of Diagnosis and Management of Drug Resistant Tuberculosis in South Africa?

    PubMed Central

    Pooran, Anil; Pieterson, Elize; Davids, Malika; Theron, Grant; Dheda, Keertan

    2013-01-01

    Background Drug-resistant tuberculosis (DR-TB) is undermining TB control in South Africa. However, there are hardly any data about the cost of treating DR-TB in high burden settings despite such information being quintessential for the rational planning and allocation of resources by policy-makers, and to inform future cost-effectiveness analyses. Methodology We analysed the comparative 2011 United States dollar ($) cost of diagnosis and treatment of drug sensitive TB (DS-TB), MDR-TB and XDR-TB, based on National South African TB guidelines, from the perspective of the National TB Program using published clinical outcome data. Principal Findings Assuming adherence to national DR-TB management guidelines, the per patient cost of XDR-TB was $26,392, four times greater than MDR-TB ($6772), and 103 times greater than drug-sensitive TB ($257). Despite DR-TB comprising only 2.2% of the case burden, it consumed ∼32% of the total estimated 2011 national TB budget of US $218 million. 45% and 25% of the DR-TB costs were attributed to anti-TB drugs and hospitalization, respectively. XDR-TB consumed 28% of the total DR-TB diagnosis and treatment costs. Laboratory testing and anti-TB drugs comprised the majority (71%) of MDR-TB costs while hospitalization and anti-TB drug costs comprised the majority (92%) of XDR-TB costs. A decentralized XDR-TB treatment programme could potentially reduce costs by $6930 (26%) per case and reduce the total amount spent on DR-TB by ∼7%. Conclusion/Significance Although DR-TB forms a very small proportion of the total case burden it consumes a disproportionate and substantial amount of South Africa’s total annual TB budget. These data inform rational resource allocation and selection of management strategies for DR-TB in high burden settings. PMID:23349933

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

    NASA Astrophysics Data System (ADS)

    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.

  18. [Studies on market of drug delivery system product and drug delivery system of compound Chinese medicine].

    PubMed

    Feng, Yi; Xu, De-Sheng; Hong, Yan-Long; Zhang, Ning; Ma, Yue-Ming

    2006-10-01

    Based on the progress in the world market of drug delivery system (DDS) product and the research profile of DDS of compound Chinese Medicine, The article puts forward a new method of studies on DDS of compound Chinese Medicine. It is expected that the theory of compatibility of compound Chinese Medicine can be shown and its role can be exerted to the largest extent with the application of pharmaceutics technology to change the mode of drug delivery of activated components of compound Chinese Medicine.

  19. 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

  20. Identification and initial management of intoxication by alcohol and other drugs in the pediatric emergency room.

    PubMed

    Pianca, Thiago Gatti; Sordi, Anne Orgle; Hartmann, Thiago Casarin; von Diemen, Lisia

    2017-09-05

    To review the screening, diagnosis, evaluation, and treatment of intoxication by alcohol and other drugs in children and adolescents in the emergency scenario. This was a narrative literature review. The detection of this problem in the emergency room can be a challenge, especially when its assessment is not standardized. The intentional and episodic use of large amounts of psychoactive substances by adolescents is a usual occurrence, and unintentional intoxication is more common in children younger than 12 years. The clinical picture in adolescents and children differs from that in adults and some particularities are important in the emergency scenario. After management of the acute condition, interventions targeting the adolescent at risk may be effective. The diagnosis and treatment of intoxication by alcohol and other drugs in adolescents and children in the emergency scenario requires a systematic evaluation of the use of these drugs. There are few specific treatments for intoxication, and the management comprehends support measures and management of related clinical complications. Copyright © 2017. Published by Elsevier Editora Ltda.

  1. Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices.

    PubMed

    Stearns, Lisa; Boortz-Marx, Richard; Du Pen, Stuart; Friehs, Gerhard; Gordon, Michael; Halyard, Michelle; Herbst, Laurel; Kiser, Jennifer

    2005-01-01

    A substantial number of patients with cancer suffer considerable pain at some point during their disease, and approximately 25% of cancer patients die in pain. Providing effective pain management for patients with severe pain that impacts quality of life can present the oncologist or palliative care specialist with complex clinical challenges that often require multifaceted therapeutic measures. This paper presents multidisciplinary consensus-based recommendations for the treatment of intractable cancer pain using intrathecal drug delivery systems, which offer rapid and effective pain relief with less toxicity relative to oral or parenteral administration. Intrathecal drug delivery systems can be highly effective in a variety of patient settings, including cases of refractory pain, diminished performance status, poor tolerability of oral medications, polyanalgesia for complex pain, and inadequate dosing due to addiction concerns. The use of implantable or external systems is discussed, as well as implantation procedures, drug titration recommendations, and management of potential side effects. The authors offer a newly developed algorithm for delivering intraspinal analgesia in patients with cancer. The intent is that increased understanding of available options for truly effective pain management in the oncology and palliative care arena and the benefits of multidisciplinary cooperation will translate into genuine improvements in patient quality of life and a measurable decrease in the number of patients who suffer needlessly in their final days.

  2. An intensive drug monitoring study suggesting possible clinical irrelevance of impaired drug disposition in liver disease.

    PubMed Central

    Naranjo, C A; Busto, U; Janecek, E; Ruiz, I; Roach, C A; Kaplan, K

    1983-01-01

    1 Liver disease can alter the disposition and clinical effects of drugs. However, even though altered drug disposition occurs, there is no clinical evidence relating it to an increased susceptibility to adverse drug reactions (ADRs). 2 An intensive prospective drug monitoring study of 2,582 hospitalized patients was conducted. The adverse drug reactions probability scale (APS) was used to assess ADRs. Only non-mild, definite or probable ADRs (APS greater than or equal to 5) were included. Severity of liver dysfunction was assessed by a composite clinical and laboratory index (CCLI). 3 The frequency of ADRs was higher in 402 patients with cirrhosis (27.4%) than in 661 with renal dysfunction (22.8%) and in 249 with other parenchymatous liver diseases (13.7%) or in 1,270 patients with neither liver diseases nor renal dysfunction (10.9%) (chi 2 3 = 85.53, P less than 0.001). The frequency of ADRs in cirrhotics was highly correlated with the severity of the liver dysfunction measured by CCLI (r = 0.82, P less than 0.001). 4 Drugs predominantly eliminated by liver metabolism were not among those most commonly inducing ADRs or those causing severe reactions in cirrhotics. Thus, frusemide caused the most common and the most severe ADRs, whereas reactions induced by sedatives were uncommon. Drug-induced hepatic encephalopathy was more common in cirrhotics receiving diuretics (13.3%) than in those receiving sedatives (1.8%) (chi 2 y.c. = 5.29, P less than 0.025). Patients with alcoholic liver disease had more drug-induced hepatic encephalopathy (7.7%) than those with non-alcoholic liver disease (1.2%) (chi 2 y.c. = 11.86, P less than 0.001). 5 These results indicate that susceptibility to ADRs is increased only in severe cirrhosis and that the most common and severe ADRs seem more likely related to enhanced pharmacodynamic action than to impaired drug disposition. PMID:6849781

  3. Bioanalysis for plasma protein binding studies in drug discovery and drug development: views and recommendations of the European Bioanalysis Forum.

    PubMed

    Buscher, Brigitte; Laakso, Sirpa; Mascher, Hermann; Pusecker, Klaus; Doig, Mira; Dillen, Lieve; Wagner-Redeker, Winfried; Pfeifer, Thomas; Delrat, Pascal; Timmerman, Philip

    2014-03-01

    Plasma protein binding (PPB) is an important parameter for a drug's efficacy and safety that needs to be investigated during each drug-development program. Even though regulatory guidance exists to study the extent of PPB before initiating clinical studies, there are no detailed instructions on how to perform and validate such studies. To explore how PPB studies involving bioanalysis are currently executed in the industry, the European Bioanalysis Forum (EBF) has conducted three surveys among their member companies: PPB studies in drug discovery (Part I); in vitro PPB studies in drug development (Part II); and in vivo PPB studies in drug development. This paper reflects the outcome of the three surveys, which, together with the team discussions, formed the basis of the EBF recommendation. The EBF recommends a tiered approach to the design of PPB studies and the bioanalysis of PPB samples: 'PPB screening' experiments in (early) drug discovery versus qualified/validated procedures in drug development.

  4. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    PubMed

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  5. Data management system evolution study

    NASA Technical Reports Server (NTRS)

    Douglas, Katherine

    1990-01-01

    Hardware and software products and technologies that are available for implementation in the early space station data management system (DMS) design are expected to have limited capabilities in such areas as system performance, capacity, and throughput. With the anticipated growth in operations and payload user requirements during the space station's operational phase, a knowledge base of technological advancements and their possible incorporation into the DMS design will be maintained. System growth and technologies insertion issues for DMS design and development are addressed.

  6. Lake Erie Wastewater Management Study.

    DTIC Science & Technology

    1982-09-01

    uptake (Ref 6). A detailed discussion of the methods used to calculate nutrient loadings to Lake Erie is contained in a separate technical report of...successfully adopting these practices. Besides changing tillage practices, several practices (e.g. the method of fertilizer application, pesticide usage...Management Alternatives for Erosion Control and Phosphorus Reduction. Emphaais has been placed on conservation tillage as a cost effective method of

  7. Data management system evolution study

    NASA Technical Reports Server (NTRS)

    Douglas, Katherine

    1990-01-01

    Hardware and software products and technologies that are available for implementation in the early space station data management system (DMS) design are expected to have limited capabilities in such areas as system performance, capacity, and throughput. With the anticipated growth in operations and payload user requirements during the space station's operational phase, a knowledge base of technological advancements and their possible incorporation into the DMS design will be maintained. System growth and technologies insertion issues for DMS design and development are addressed.

  8. Case Studies in Middle Management Supervision

    ERIC Educational Resources Information Center

    White, Lori S.

    2011-01-01

    This chapter presents a series of supervision-related case studies of situations that midlevel managers might face. Individuals enrolled in a midlevel management professional development course recommended the topics selected for this chapter. Drawing upon her experience teaching the course, the author selected four case studies that individuals…

  9. Do advertisements for antihypertensive drugs in Australia promote quality prescribing? A cross-sectional study.

    PubMed

    Montgomery, Brett D; Mansfield, Peter R; Spurling, Geoffrey K; Ward, Alison M

    2008-05-20

    Antihypertensive medications are widely prescribed by doctors and heavily promoted by the pharmaceutical industry. Despite strong evidence of the effectiveness and cost-effectiveness of thiazide diuretics, trends in both promotion and prescription of antihypertensive drugs favour newer, less cost-effective agents. Observational evidence shows correlations between exposure to pharmaceutical promotion and less ideal prescribing. Our study therefore aimed to determine whether print advertisements for antihypertensive medications promote quality prescribing in hypertension. We performed a cross-sectional study of 113 advertisements for antihypertensive drugs from 4 general practice-oriented Australian medical publications in 2004. Advertisements were evaluated using a quality checklist based on a review of hypertension management guidelines. Main outcome measures included: frequency with which antihypertensive classes were advertised, promotion of thiazide class drugs as first line agents, use of statistical claims in advertisements, mention of harms and prices in the advertisements, promotion of assessment and treatment of cardiovascular risk, promotion of lifestyle modification, and targeting of particular patient subgroups. Thiazides were the most frequently advertised drug class (48.7% of advertisements), but were largely promoted in combination preparations. The only thiazide advertised as a single agent was the most expensive, indapamide. No advertisement specifically promoted any thiazide as a better first-line drug. Statistics in the advertisements tended to be expressed in relative rather than absolute terms. Drug costs were often reported, but without cost comparisons between drugs. Adverse effects were usually reported but largely confined to the advertisements' small print. Other than mentioning drug interactions with alcohol and salt, no advertisements promoted lifestyle modification. Few advertisements (2.7%) promoted the assessment of cardiovascular risk

  10. Do advertisements for antihypertensive drugs in Australia promote quality prescribing? A cross-sectional study

    PubMed Central

    Montgomery, Brett D; Mansfield, Peter R; Spurling, Geoffrey K; Ward, Alison M

    2008-01-01

    Background Antihypertensive medications are widely prescribed by doctors and heavily promoted by the pharmaceutical industry. Despite strong evidence of the effectiveness and cost-effectiveness of thiazide diuretics, trends in both promotion and prescription of antihypertensive drugs favour newer, less cost-effective agents. Observational evidence shows correlations between exposure to pharmaceutical promotion and less ideal prescribing. Our study therefore aimed to determine whether print advertisements for antihypertensive medications promote quality prescribing in hypertension. Methods We performed a cross-sectional study of 113 advertisements for antihypertensive drugs from 4 general practice-oriented Australian medical publications in 2004. Advertisements were evaluated using a quality checklist based on a review of hypertension management guidelines. Main outcome measures included: frequency with which antihypertensive classes were advertised, promotion of thiazide class drugs as first line agents, use of statistical claims in advertisements, mention of harms and prices in the advertisements, promotion of assessment and treatment of cardiovascular risk, promotion of lifestyle modification, and targeting of particular patient subgroups. Results Thiazides were the most frequently advertised drug class (48.7% of advertisements), but were largely promoted in combination preparations. The only thiazide advertised as a single agent was the most expensive, indapamide. No advertisement specifically promoted any thiazide as a better first-line drug. Statistics in the advertisements tended to be expressed in relative rather than absolute terms. Drug costs were often reported, but without cost comparisons between drugs. Adverse effects were usually reported but largely confined to the advertisements' small print. Other than mentioning drug interactions with alcohol and salt, no advertisements promoted lifestyle modification. Few advertisements (2.7%) promoted the

  11. Drug-drug interactions with sodium-glucose cotransporters type 2 (SGLT2) inhibitors, new oral glucose-lowering agents for the management of type 2 diabetes mellitus.

    PubMed

    Scheen, André J

    2014-04-01

    Inhibitors of sodium-glucose cotransporters type 2 (SGLT2) reduce hyperglycaemia by decreasing renal glucose threshold and thereby increasing urinary glucose excretion. They are proposed as a novel approach for the management of type 2 diabetes mellitus. They have proven their efficacy in reducing glycated haemoglobin, without inducing hypoglycaemia, as monotherapy or in combination with various other glucose-lowering agents, with the add-on value of promoting some weight loss and lowering arterial blood pressure. As they may be used concomitantly with many other drugs, we review the potential drug-drug interactions (DDIs) regarding the three leaders in the class (dapagliglozin, canagliflozin and empagliflozin). Most of the available studies were performed in healthy volunteers and have assessed the pharmacokinetic interferences with a single administration of the SGLT2 inhibitor. The exposure [assessed by peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC)] to each SGLT2 inhibitor tested was not significantly influenced by the concomitant administration of other glucose-lowering agents or cardiovascular agents commonly used in patients with type 2 diabetes. Reciprocally, these medications did not influence the pharmacokinetic parameters of dapagliflozin, canagliflozin or empagliflozin. Some modest changes were not considered as clinically relevant. However, drugs that could specifically interfere with the metabolic pathways of SGLT2 inhibitors [rifampicin, inhibitors or inducers of uridine diphosphate-glucuronosyltransferase (UGT)] may result in significant changes in the exposure of SGLT2 inhibitors, as shown for dapagliflozin and canagliflozin. Potential DDIs in patients with type 2 diabetes receiving chronic treatment with an SGLT2 inhibitor deserve further attention, especially in individuals treated with several medications or in more fragile patients with hepatic and/or renal impairment.

  12. Newsmaking on drugs: a qualitative study with journalism professionals.

    PubMed

    Mastroianni, Fabio C; Noto, Ana Regina

    2008-09-01

    Drugs are a frequent subject in the news media. Despite the existence of an important dynamic interplay between the print media, public opinion, and public policies, studies on these relationships are still scarce regarding the drug issue. The objective of this study is to understand the newsmaking process regarding drugs from the vantage point of Brazilian journalism professionals. Using qualitative research, semistructured interviews were conducted among an intentional sample of 22 professionals who write news stories and articles about drugs in nationwide news media. Interviewees mentioned illegality and crime as the main factors leading to the production of stories and articles. They claimed that by instilling fear among readers, newspapers and magazines tend to increase their audiences and/or sales. Most interviewees considered the coverage of drugs in Brazil as weak. Main problems reported include lack of knowledge on the subject, and not enough time to prepare the stories. It was concluded that the newsmaking process regarding drugs undergoes a series of interferences that compromise the content of the stories, therefore social strategies are needed in order to improve the quality of the material published in Brazil.

  13. A comparative study of orphan drug prices in Europe

    PubMed Central

    Young, Katherine Eve; Soussi, Imen; Hemels, Michiel; Toumi, Mondher

    2017-01-01

    ABSTRACT Background and Objective: This study assessed price differences by comparing annual treatment costs of similarly available orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Annual treatment costs per drug were calculated using ex-factory prices from IHS POLI and country price databases. The treatment cost in the comparator country was compared to the UK and ratios were analysed. Subanalyses were done on disease areas and UK cost quartiles. Results: 120 orphan drugs were included. Compared to the UK, the average costs were more expensive in France (1.13), Germany (1.11), Italy (1.08), Spain (1.07), and were cheaper in Sweden (0.99) and Norway (0.88). The average ratios offered a restrictive view as ratios were greatly heterogeneous (0.26 to 1.92) which was also seen in the different disease areas. The averaged ratios varied minimally among the cost quartiles which shows that cost differences were similar for the most expensive and least expensive orphan drugs in the UK. Conclusions: Individual orphan drug prices can vary widely across European countries, although on average these differences are relatively minor. This study suggests that in Europe, we may not be able predict which country may have higher or lower prices for orphan drugs. PMID:28473887

  14. 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

  15. Infection control in hospitals managing drug-resistant tuberculosis in Pakistan: how are we doing?

    PubMed Central

    Khan, M. A.; Fatima, R.; Yaqoob, A.; Mirza, A.; Qadeer, E.; Shakeel, M.; Heldal, E.; Kumar, A. M. V.

    2017-01-01

    Setting: Ten hospitals managing drug-resistant tuberculosis (TB) in Pakistan. Objective: To assess the implementation of TB infection control (IC) practices and reasons for non-adherence to guidelines. Design: This was a descriptive study conducted between April and October 2016 with three components: 1) non-participant observation of service delivery areas (SDAs) (n = 82) in hospitals (n = 10) using structured checklists; 2) exit interviews with 100 patients (10 per hospital); and 3) interviews with 100 health-care workers (HCWs, 10/hospital). Results: Of the 82 SDAs, posters were displayed in 34 (41%), mechanical ventilation was implemented in 79% and functional ultraviolet germicidal irradiation (UVGI) was available in only 26%. Patient interviews showed 50–65% adherence to triage and use of personal protective measures. Key reasons for non-adherence were lack of adequate supplies, discomfort using N-95 masks, a lack of knowledge or training, perceived non-cooperation by patients, poor maintenance of mechanical ventilators and UVGI due to unstable electricity supply, a lack of clarity in roles (no-one designated in charge) and staff shortages and subsequent workloads. Adherence to natural ventilation usage was poor for reasons related to climate and privacy. Conclusion: Implementation of TBIC measures in hospitals was suboptimal. Urgent measures need to be put in place, including retraining of HCWs, addressing weaknesses in mask and poster supplies and constant supervision and monitoring. PMID:28775940

  16. Challenges in acute heart failure clinical management: optimizing care despite incomplete evidence and imperfect drugs.

    PubMed

    Teichman, Sam L; Maisel, Alan S; Storrow, Alan B

    2015-03-01

    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.

  17. Pharmacists' advancing roles in drug and disease management: a review of states' legislation.

    PubMed

    McKnight, Alicia G; Thomason, Angela R

    2009-01-01

    To determine which states in the United States have provisions in place for pharmacist participation in drug and disease management programs and/or collaborative practice agreements and to provide comparison and discussion regarding such provisions. A secondary endpoint was the requirements of certification, credentialing, and registration with the specific state's rules and regulations. Information was gathered from states' statutes, rules, and regulations. Acquisition of each state's laws was achieved through various forms of electronic media. Data were accessed from January to March 2008. 19 states (38%) had specific provisions for disease management, 33 (66%) had provisions for drug therapy management, and 37 (74%) had provisions for collaborative practice. A total of 11 states (22%) specified that pharmacists receive specialized training to participate in such endeavors. Board approval or notification for collaborative practice agreements was required in 16 states (32%). With varying degrees of autonomy and restriction, pharmacists in certain states have the ability to develop disease management and/or collaborative practice programs. For pharmacists to take advantage of these new direct patient care opportunities, knowing the rules and requirements of their state's legislation is essential.

  18. 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.

  19. Drug management of prostate cancer: prevalence and consequences of renal insufficiency.

    PubMed

    Launay-Vacher, Vincent; Ayllon, Jorge; Janus, Nicolas; Spano, Jean-Philippe; Ray-Coquard, Isabelle; Gligorov, Joseph; Pourrat, Xavier; Morere, Jean-François; Beuzeboc, Philippe; Deray, Gilbert; Oudard, Stéphane

    2009-10-01

    The Renal Insufficiency and Anticancer Medications (IRMA) study reported a renal insufficiency (RI) prevalence of 50%-60% in a population of almost 5000 patients with solid tumors, 80% of whom were being treated with anticancer drugs that either necessitated dosage adjustment or were potentially nephrotoxic drugs. A national multicenter study from 15 cancer centers in France analyzed IRMA data on patients with prostate cancer. Data on patients with prostate cancer from the IRMA study were analyzed. Renal function was calculated using Cockcroft-Gault and abbreviated Modification of Diet in Renal Disease (aMDRD) formulas to estimate the prevalence of RI. Anticancer drugs' potential renal toxicity and need for dosage adjustment were detailed. Of the 222 IRMA patients with prostate cancer, 14.9% had a serum creatinine (SCr) level of > 110 micromol/L. When using Cockcroft-Gault and aMDRD formulas, 62.6% and 55.9%, respectively, of the patients had RI. Of the 228 anticancer drug prescriptions, 82.9% required dose adjustments for RI or were drugs with no available data on their administration in patients with RI. Of the patients treated, 86.9% received >or= 1 such drug, but only 29.1% received nephrotoxic drugs. The prevalence of RI in patients with prostate cancer was very high in spite of a normal SCr level in most cases. Some anticancer drugs, particularly some bisphosphonates and platinum salts, might be nephrotoxic and/or need dosage adjustment. However, other important drugs in prostate cancer, such as docetaxel, neither require dose reduction nor present with potential nephrotoxicity. Both issues were significantly more important in the patients with bone metastases compared with those with nonmetastatic disease.

  20. Concomitant use of anti-dementia drugs with psychotropic drugs in Norway--a population-based study.

    PubMed

    Langballe, Ellen Melbye; Engdahl, Bo; Selbaek, Geir; Nordeng, Hedvig

    2011-12-01

    Concomitant use of anti-dementia drugs with psychotropic drugs is potentially problematic in patients with dementia. The aim of this study was to investigate how frequently patients in Norway use anti-dementia drugs concomitantly with psychotropic drugs. Analyses are based on data from the Norwegian Prescription Database. All patients who had an anti-dementia drug (ATC-code N06D) dispensed from a Norwegian pharmacy between January 2004 and July 2009 were included. A total of 33,816 individuals received anti-dementia drugs at some time during this period. The total concomitant use of anti-dementia drugs with psychotropic drugs was 57.4% in men and 65.8% in women. Compared with men, a significantly higher percentage of women used antidepressants (35.8% versus 27.2%), mild hypnotics (28.8% versus 23.6%), benzodiazepines (25.4% versus 20.8%) and opioids (22.8% versus 17.4%) concomitantly with anti-dementia drugs. Concomitant use of antipsychotics with anti-dementia drugs was about 16% for both male and female patients. Of the total sample, 11.9% of the women and 11.7% of the men used acetylcholinesterase inhibitor (AChEI) anti-dementia drugs concomitantly with an interacting psychotropic drug. The concomitant use of psychotropic drugs with anti-dementia drugs was extensive, especially among women. Co-medication with potentially interacting drugs occurred at a rate of one in 10. The concomitant use of anti-dementia drugs with psychotropic drugs identified in this study may inform the ongoing clinical debate about drug use in this patient group. Copyright © 2011 John Wiley & Sons, Ltd.

  1. Effect of Hypothermia and Targeted Temperature Management on Drug Disposition and Response Following Cardiac Arrest: A Comprehensive Review of Preclinical and Clinical Investigations.

    PubMed

    Anderson, Kacey B; Poloyac, Samuel M; Kochanek, Patrick M; Empey, Philip E

    2016-12-01

    Targeted temperature management (TTM) has been shown to reduce mortality and improve neurological outcomes in out-of-hospital cardiac arrest (CA) patients and in neonates with hypoxic-ischemic encephalopathy (HIE). TTM has also been associated with adverse drug events in the critically ill patient due to its effect on drug pharmacokinetics (PKs) and pharmacodynamics (PDs). We aim to evaluate the current literature on the effect of TTM on drug PKs and PDs following CA. MEDLINE/PubMed databases were searched for publications, which include the MeSH terms hypothermia, drug metabolism, drug transport, P450, critical care, cardiac arrest, hypoxic-ischemic encephalopathy, pharmacokinetics, and pharmacodynamics between July 2006 and October 2015. Twenty-three studies were included in this review. The studies demonstrate that hypothermia impacts PK parameters and increases concentrations of cytochrome-P450-metabolized drugs in the cooling and rewarming phase. Furthermore, the current data demonstrate a combined effect of CA and hypothermia on drug PK. Importantly, these effects can last greater than 4-5 days post-treatment. Limited evidence suggests hypothermia-mediated changes in the Phase II metabolism and the Phase III transport of drugs. Hypothermia also has been shown to potentially decrease the effect of specific drugs at the receptor level. Therapeutic hypothermia, as commonly deployed/applied during TTM, alters PK, and elevates concentrations of several commonly used medications. Hypothermia-mediated effects are an important factor when dosing and monitoring patients undergoing TTM treatment.

  2. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.

    PubMed

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.

  3. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India

    PubMed Central

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    Objectives: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Materials and Methods: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. Results: A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. Conclusions: This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society. PMID:27721535

  4. 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

  5. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases.

    PubMed

    Vande Casteele, Niels; Herfarth, Hans; Katz, Jeffry; Falck-Ytter, Yngve; Singh, Siddharth

    2017-09-01

    Therapeutic drug monitoring (TDM), which involves measurement of drug or active metabolite levels and anti-drug antibodies, is a promising strategy that can be used to optimize inflammatory bowel disease therapeutics. It is based on the premise that there is a relationship between drug exposure and outcomes, and that considerable inter-individual variability exists in how patients metabolize the drug (pharmacokinetics) and the magnitude and duration of response to therapy (pharmacodynamics). Therefore, the American Gastroenterological Association has prioritized clinical guidelines on the role of TDM in the management of inflammatory bowel disease. To inform these clinical guidelines, this technical review was developed in accordance with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework for interventional and prognostic studies, and focused on the application of TDM for biologic therapy, specifically anti-tumor necrosis factor-α agents, and for thiopurines. Focused questions address the benefits and risks of a strategy of reactive TDM (in patients with active inflammatory bowel disease) to guide treatment changes compared with empiric treatment changes, and the benefits and risks of a strategy of routine proactive TDM (during routine clinical care in patients with quiescent disease) compared with no routine TDM. Additionally, the review addresses the benefits and risks of routine measurement of thiopurine methyltransferase enzyme activity or genotype before starting thiopurine therapy compared with empiric weight-based dosing and explores the performance of different trough drug concentrations for anti-tumor necrosis factor agents and thiopurines to inform clinical decision making when applying TDM in a reactive setting. Due to a paucity of data, this review does not address the role of TDM for more recently approved biologic agents, such as vedolizumab or ustekinumab. Copyright © 2017 AGA Institute. Published by Elsevier

  6. Procurement and Supply Management System for MDR-TB in Nigeria: Are the Early Warning Targets for Drug Stock Outs and Over Stock of Drugs Being Achieved?

    PubMed Central

    Jatau, Bolajoko; Avong, Yohanna; Ogundahunsi, Olumide; Shah, Safieh; Tayler Smith, Katherine; Van den Bergh, Rafael; Zachariah, Rony; van Griensven, Johan; Ekong, Ernest; Dakum, Patrick

    2015-01-01

    Background The World Health Organisation (WHO) introduced the twelve early warning indicators for monitoring and evaluating drug Procurement and Supply management (PSM) systems, intended to prevent drug stock-outs and overstocking. Nigeria- one of the high Multi Drug Resistant Tuberculosis (MDR-TB) burden countries, scaled-up treatment in 2012 with the concurrent implementation of a PSM system. Method We evaluated how well this system functioned using the WHO indicators, including all seven MDR-TB treatment centres in the country that were functional throughout 2013. Results The quantity of MDR-TB drugs ordered for 2013 matched the annual forecast and all central orders placed during the year were delivered in full and on time. Drug consumption was 81%–106% of the quantity allocated for routine consumption. Timely submission of complete inventory reports ranged from 86–100%, late submissions being 5–15 days late. Forty to 71% of treatment centres placed a drug order when stock was below the minimum level of three months. The proportion of drug orders received at the treatment centres in full and on time ranged from 29–80%, late orders being 1–19 days late. Conclusion The PSM was found to be performing well in terms of forecasting and procurement of MDR-TB drugs, but there were shortcomings in drug distribution, reporting at treatment centre level and in drug order placements. Despite these gaps, there were no stock outs. These findings indicate that where it matters most, namely ensuring that no drug stock outs affect patient management, the PSM system is effective. Addressing the observed shortcomings will help to strengthen the existing PSM system in anticipation of a growing MDR-TB case burden in the country. PMID:26098673

  7. Procurement and Supply Management System for MDR-TB in Nigeria: Are the Early Warning Targets for Drug Stock Outs and Over Stock of Drugs Being Achieved?

    PubMed

    Jatau, Bolajoko; Avong, Yohanna; Ogundahunsi, Olumide; Shah, Safieh; Tayler Smith, Katherine; Van den Bergh, Rafael; Zachariah, Rony; van Griensven, Johan; Ekong, Ernest; Dakum, Patrick

    2015-01-01

    The World Health Organisation (WHO) introduced the twelve early warning indicators for monitoring and evaluating drug Procurement and Supply management (PSM) systems, intended to prevent drug stock-outs and overstocking. Nigeria--one of the high Multi Drug Resistant Tuberculosis (MDR-TB) burden countries, scaled-up treatment in 2012 with the concurrent implementation of a PSM system. We evaluated how well this system functioned using the WHO indicators, including all seven MDR-TB treatment centres in the country that were functional throughout 2013. The quantity of MDR-TB drugs ordered for 2013 matched the annual forecast and all central orders placed during the year were delivered in full and on time. Drug consumption was 81%-106% of the quantity allocated for routine consumption. Timely submission of complete inventory reports ranged from 86-100%, late submissions being 5-15 days late. Forty to 71% of treatment centres placed a drug order when stock was below the minimum level of three months. The proportion of drug orders received at the treatment centres in full and on time ranged from 29-80%, late orders being 1-19 days late. The PSM was found to be performing well in terms of forecasting and procurement of MDR-TB drugs, but there were shortcomings in drug distribution, reporting at treatment centre level and in drug order placements. Despite these gaps, there were no stock outs. These findings indicate that where it matters most, namely ensuring that no drug stock outs affect patient management, the PSM system is effective. Addressing the observed shortcomings will help to strengthen the existing PSM system in anticipation of a growing MDR-TB case burden in the country.

  8. Carer involvement with drug services: a qualitative study.

    PubMed

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

    2013-09-01

    Empirical 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. To explore the purpose and scope of carer involvement with adult drug services in North-east Scotland. A 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. Three 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. Encouraging 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. © 2012 John Wiley & Sons Ltd.

  9. 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

  10. Optimizing urine drug testing for monitoring medication compliance in pain management.

    PubMed

    Melanson, Stacy E F; Ptolemy, Adam S; Wasan, Ajay D

    2013-12-01

    It can be challenging to successfully monitor medication compliance in pain management. Clinicians and laboratorians need to collaborate to optimize patient care and maximize operational efficiency. The test menu, assay cutoffs, and testing algorithms utilized in the urine drug testing panels should be periodically reviewed and tailored to the patient population to effectively assess compliance and avoid unnecessary testing and cost to the patient. Pain management and pathology collaborated on an important quality improvement initiative to optimize urine drug testing for monitoring medication compliance in pain management. We retrospectively reviewed 18 months of data from our pain management center. We gathered data on test volumes, positivity rates, and the frequency of false positive results. We also reviewed the clinical utility of our testing algorithms, assay cutoffs, and adulterant panel. In addition, the cost of each component was calculated. The positivity rate for ethanol and 3,4-methylenedioxymethamphetamine were <1% so we eliminated this testing from our panel. We also lowered the screening cutoff for cocaine to meet the clinical needs of the pain management center. In addition, we changed our testing algorithm for 6-acetylmorphine, benzodiazepines, and methadone. For example, due the high rate of false negative results using our immunoassay-based benzodiazepine screen, we removed the screening portion of the algorithm and now perform benzodiazepine confirmation up front in all specimens by liquid chromatography-tandem mass spectrometry. Conducting an interdisciplinary quality improvement project allowed us to optimize our testing panel for monitoring medication compliance in pain management and reduce cost. Wiley Periodicals, Inc.

  11. Drug utilization pattern of anti-epileptic drugs: a pharmacoepidemiologic study in Oman.

    PubMed

    Hanssens, Y; Deleu, D; Al Balushi, K; Al Hashar, A; Al-Zakwani, I

    2002-10-01

    To get an insight into the type and aetiology of epileptic seizures; to describe the drug utilization pattern of anti-epileptic drugs (AEDs) for the treatment of various forms of epileptic seizures in this tertiary referral centre in Oman; and to compare our drug utilization pattern with that from other countries. In addition, the tolerability of AEDs and the use of therapeutic drug monitoring (TDM) were evaluated. In a 6-month study, all epileptic patients aged 14 and above who were prescribed an AED were considered for analysis. Demographic data, type and aetiology of epileptic seizures, AED data, tests performed and adverse drug reaction (ADR) data were collected. A total of 1039 prescriptions originated from 488 epileptic patients. The age ranged from 14 to 77 years (median, 24 years). Generalized tonic-clonic seizures (51%) of idiopathic/cryptogenic origin (83%) were the most common type and aetiology of epileptic seizures, respectively. An average of 1.34 AEDs per patient was prescribed with 78% of patients being on monotherapy. Sodium valproate (49%) was the most frequently prescribed AED, followed by carbamazepine (44%), phenytoin (12%) and lamotrigine (11%). Ten patients suffered an ADR and phenobarbital followed by carbamazepine were most commonly the subject of TDM. Unlike the results in most other studies, generalized seizures represented the majority of epileptic seizures. The selection of the AEDs corresponded well with their known efficacy profiles for specific epileptic seizure types. Monotherapy was the type of therapy most frequently used, and sodium valproate and carbamazepine were the most commonly used AEDs.

  12. [Implementation of ontology-based clinical decision support system for management of interactions between antihypertensive drugs and diet].

    PubMed

    Park, Jeong Eun; Kim, Hwa Sun; Chang, Min Jung; Hong, Hae Sook

    2014-06-01

    The influence of dietary composition on blood pressure is an important subject in healthcare. Interactions between antihypertensive drugs and diet (IBADD) is the most important factor in the management of hypertension. It is therefore essential to support healthcare providers' decision making role in active and continuous interaction control in hypertension management. The aim of this study was to implement an ontology-based clinical decision support system (CDSS) for IBADD management (IBADDM). We considered the concepts of antihypertensive drugs and foods, and focused on the interchangeability between the database and the CDSS when providing tailored information. An ontology-based CDSS for IBADDM was implemented in eight phases: (1) determining the domain and scope of ontology, (2) reviewing existing ontology, (3) extracting and defining the concepts, (4) assigning relationships between concepts, (5) creating a conceptual map with CmapTools, (6) selecting upper ontology, (7) formally representing the ontology with Protégé (ver.4.3), (8) implementing an ontology-based CDSS as a JAVA prototype application. We extracted 5,926 concepts, 15 properties, and formally represented them using Protégé. An ontology-based CDSS for IBADDM was implemented and the evaluation score was 4.60 out of 5. We endeavored to map functions of a CDSS and implement an ontology-based CDSS for IBADDM.

  13. The effect size, study design, and development experience in commercially sponsored studies for new drug applications in approved drugs.

    PubMed

    Fukunaga, Satoshi; Kusama, Makiko; Ono, Shunsuke

    2014-01-01

    Pharmaceutical companies incorporate different features into the trials for new drug applications (NDAs) to render them efficient, making use of their experience. The objective of this analysis was to examine the associations between outcome and features related to study design and clinical development experience in commercially sponsored clinical trials. We collected data of phase 2 and phase 3 trials of all the drugs that obtained approval for depression, schizophrenia, asthma, hypertension, and diabetes in Japan from 1970 to 2011. In total, 145 trials from 90 test drugs were eligible for our study. We calculated the effect size, the standard mean of differences between test drug and comparator therapeutic effects, as the objective variable for use in our analysis. A linear mixed effect model with nested and crossed random effects was used in the analysis including variety of therapeutic area, test drugs and clinical trials. The analysis showed that trial features including sample size, subjective endpoints and active comparator of the same mode of action were negatively associated with effect size. In addition, sponsors' domestic clinical development experience with similar drugs seemed to have a positive association, but prior development experience in foreign countries did not. The accumulation of skills and knowledge within sponsors, and accumulated experience in domestic professionals who implement clinical trials under study contracts with sponsors would be of great importance for yielding clear outcomes. This study provides additional evidence with respect to possible sizes and directions of the influence of study design features that must be considered when planning and implementing trials for new drug applications, and when retrospectively comparing outcomes from trials with different designs and environments.

  14. Top Management Education, An Evaluation Study.

    ERIC Educational Resources Information Center

    Jerkedal, Ake

    A study of top management education was carried out in a practical training situation to determine attitude change and relationships between training objectives and training evaluation, initial standing and change, and initial standing and background factors. Subjects were 140 people completing one of five management courses. A questionnaire and…

  15. 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.…

  16. 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…

  17. 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…

  18. 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…

  19. Nanobiological studies on drug design using molecular mechanic method.

    PubMed

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

    2015-01-01

    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. 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. 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. Drug binding sites are more dependent on dielectric constants rather than on temperature and the optimum dielectric constant is 39/78.

  20. 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

  1. Adoption study demonstrating two genetic pathways to drug abuse.

    PubMed

    Cadoret, R J; Yates, W R; Troughton, E; Woodworth, G; Stewart, M A

    1995-01-01

    Studies of adoptees have demonstrated that there are two genetic factors leading to alcohol abuse and/or dependence (abuse/dependence). In addition, environmental factors found in the adoptive family also predict alcohol abuse/dependency independently. One study has found evidence that a similar model of two genetic factors and independent adoptive family factors were involved in drug abuse. Our study was designed to test the hypothesis that genetic factors defined by alcohol abuse/dependency and anti-social personality disorder in biologic parents were etiologic in drug abuse/dependency and that psychiatric problems in adoptive parents were an additional factor associated with drug abuse/dependence. A sample of 95 male adoptees, separated at birth from their biologic parents, were followed up as adults to determine their psychiatric diagnosis and their substance use/abuse in a structured interview administered blind to biologic parent diagnoses. A high-risk, case-control design was used wherein half of the adoptees came from biologic parents known to be alcohol abuser/dependent and/or have antisocial personalities (diagnoses from hospital or prison records). These adoptees were matched for age, sex, and adoption agency to a control group of adoptees whose biologic parents were not found in the hospital and prison record search. Adoptive home environment was assessed by structured interviews, including psychiatric assessment of both adoptive parents. Data were analyzed by log-linear modeling, which showed evidence of two genetic pathways to drug abuse/dependency. One pathway went directly from a biologic parent's alcoholism to drug abuse/dependency. The second pathway was more circuitous, and started with anti-social personality disorder in the biologic parent and proceeded through intervening variables of adoptee aggressivity, conduct disorder, antisocial personality disorder, and, eventually, ended in drug abuse/dependency. Environmental factors defined by

  2. Implementing a new drug record system: a qualitative study of difficulties perceived by physicians and nurses

    PubMed Central

    Andersen, S

    2002-01-01

    Objectives: To identify organisational difficulties faced by physicians and nurses when using drug prescribing sheets for recording both drug prescriptions and drug administration. Design: Qualitative interview study. Setting: Two general internal medicine wards. Participants: Seven physicians and eight nurses. Main outcome measures: Difficulties explicitly identified by the participants during the interviews. Results: The implementation of procedures conflicted with existing structure, culture, and routines. Insufficient competence within the system to use the drug prescribing sheets created resistance and made people down the line create their own interpretations and solutions to the problems they faced. A total of nine problems were identified: (1) insufficient knowledge and uncertainty about procedures, (2) ignorance of sources of error, (3) unclear responsibilities, (4) low community spirit, (5) insufficient communication, (6) clinician autonomy and low acceptance of change, (7) strong professional identity, (8) low priority task, and (9) logistical problems. Conclusions: Unawareness of procedures, insufficient dissemination of knowledge, and insufficient cooperation and scepticism among those who put drug handling into practice is likely to have an impact on the quality of health care. The identification of these obstacles may help managers to improve the quality of the drug handling process on internal medicine wards and make it possible to select a framework for changing the clinical behaviour of doctors and nurses. PMID:12078363

  3. Implementing a new drug record system: a qualitative study of difficulties perceived by physicians and nurses.

    PubMed

    Andersen, S E

    2002-03-01

    To identify organisational difficulties faced by physicians and nurses when using drug prescribing sheets for recording both drug prescriptions and drug administration. Qualitative interview study. Two general internal medicine wards. Seven physicians and eight nurses. Difficulties explicitly identified by the participants during the interviews. The implementation of procedures conflicted with existing structure, culture, and routines. Insufficient competence within the system to use the drug prescribing sheets created resistance and made people down the line create their own interpretations and solutions to the problems they faced. A total of nine problems were identified: (1) insufficient knowledge and uncertainty about procedures, (2) ignorance of sources of error, (3) unclear responsibilities, (4) low community spirit, (5) insufficient communication, (6) clinician autonomy and low acceptance of change, (7) strong professional identity, (8) low priority task, and (9) logistical problems. Unawareness of procedures, insufficient dissemination of knowledge, and insufficient cooperation and skepticism among those who put drug handling into practice is likely to have an impact on the quality of health care. The identification of these obstacles may help managers to improve the quality of the drug handling process on internal medicine wards and make it possible to select a framework for changing the clinical behaviour of doctors and nurses.

  4. Pharmacokinetic drug interaction profile of omeprazole with adverse consequences and clinical risk management

    PubMed Central

    Li, Wei; Zeng, Su; Yu, Lu-Shan; Zhou, Quan

    2013-01-01

    Background Omeprazole, a proton pump inhibitor (PPI), is widely used for the treatment of dyspepsia, peptic ulcer, gastroesophageal reflux disease, and functional dyspepsia. Polypharmacy is common in patients receiving omeprazole. Drug toxicity and treatment failure resulting from inappropriate combination therapy with omeprazole have been reported sporadically. Systematic review has not been available to address the pharmacokinetic drug-drug interaction (DDI) profile of omeprazole with adverse consequences, the factors determining the degree of DDI between omeprazole and comedication, and the corresponding clinical risk management. Methods Literature was identified by performing a PubMed search covering the period from January 1988 to March 2013. The full text of each article was critically reviewed, and data interpretation was performed. Results Omeprazole has actual adverse influences on the pharmacokinetics of medications such as diazepam, carbamazepine, clozapine, indinavir, nelfinavir, atazanavir, rilpivirine, methotrexate, tacrolimus, mycophenolate mofetil, clopidogrel, digoxin, itraconazole, posaconazole, and oral iron supplementation. Meanwhile, low efficacy of omeprazole treatment would be anticipated, as omeprazole elimination could be significantly induced by comedicated efavirenz and herb medicines such as St John’s wort, Ginkgo biloba, and yin zhi huang. The mechanism for DDI involves induction or inhibition of cytochrome P450, inhibition of P-glycoprotein or breast cancer resistance protein-mediated drug transport, and inhibition of oral absorption by gastric acid suppression. Sometimes, DDIs of omeprazole do not exhibit a PPI class effect. Other suitable PPIs or histamine 2 antagonists may be therapeutic alternatives that can be used to avoid adverse consequences. The degree of DDIs associated with omeprazole and clinical outcomes depend on factors such as genotype status of CYP2C19 and CYP1A2, ethnicity, dose and treatment course of precipitant

  5. 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.

  6. The management of cytotoxic drug wastes in Shiraz, Iran: an overview of all government and private chemotherapy settings, and comparison with national and international guidelines.

    PubMed

    Askarian, Mehrdad; Momeni, Mohsen; Danaei, Mina

    2013-06-01

    Excessive use of cytotoxic drugs owing to a dramatic increase in malignancy incidence leads to the production of high amounts of cytotoxic wastes. In Iran, management of hazardous wastes has been neglected in recent decades. The aim of this study was to determine the amount of intravenous cytotoxic drug wastes, their collection and disposal status in chemotherapy wards, and to compare the current status with standard guidelines in Shiraz, Iran. This cross-sectional study was performed using data collected during 2 consecutive months, from 22 June to 22 August 2011, in all 13 chemotherapy wards in Shiraz. The amount of prescribed drugs, drugs waste, collection and disposal status of cytotoxic drugs were recorded. We then compared the current status of waste collection and disposal in our samples with our national guideline. The prescription of cytotoxic drugs and the amount of total drugs waste reached approximately 6 and 0.2 kilograms respectively. Total vials volume was calculated to be approximately 1000 l in order to estimate the volume of containers required for the encapsulation method. The results demonstrated that the current status of cytotoxic waste collection and disposal is inappropriate, and none of the facilities under study followed our guidelines perfectly. The adherence to all recommendations and guidelines was poorer in private wards than in government-run ones. The management of cytotoxic wastes is inappropriate and our existing national guidelines are lacking. Suggestions for the best management of cytotoxic waste are revising the existing guidelines, allocating a sufficient budget, training healthcare workers, providing multiple administration options of cytotoxic drugs and accomplishing a surveillance system.

  7. Practical guidelines for diagnosis and early management of drug-induced liver injury

    PubMed Central

    Tajiri, Kazuto; Shimizu, Yukihiro

    2008-01-01

    The spectrum of drug-induced liver injury (DILI) is both diverse and complex. The first step in diagnosis is a suspicion of DILI based on careful consideration of recent comprehensive reports on the disease. There are some situations in which the suspicion of DILI is particularly strong. Exclusion of other possible etiologies according to the pattern of liver injury is essential for the diagnosis. In patients with suspected DILI, diagnostic scales, such as the Councils for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) scale, may be helpful for the final diagnosis. Early management of DILI involves prompt withdrawal of the drug suspected of being responsible, according to serum levels of alanine aminotransferase (ALT), alkaline phosphatase (ALP), and total bilirubin (T-Bil). However, as DILI patients may show resolution of liver injury without discontinuation of the drug, it should be carefully evaluated whether the suspected drug should be discontinued immediately with adequate consideration of the importance of the medication. PMID:19058303

  8. Effect of quality chronic disease management for alcohol and drug dependence on addiction outcomes.

    PubMed

    Kim, Theresa W; Saitz, Richard; Cheng, Debbie M; Winter, Michael R; Witas, Julie; Samet, Jeffrey H

    2012-12-01

    We examined the effect of the quality of primary care-based chronic disease management (CDM) for alcohol and/or other drug (AOD) dependence on addiction outcomes. We assessed quality using (1) a visit frequency based measure and (2) a self-reported assessment measuring alignment with the chronic care model. The visit frequency based measure had no significant association with addiction outcomes. The self-reported measure of care-when care was at a CDM clinic-was associated with lower drug addiction severity. The self-reported assessment of care from any healthcare source (CDM clinic or elsewhere) was associated with lower alcohol addiction severity and abstinence. These findings suggest that high quality CDM for AOD dependence may improve addiction outcomes. Quality measures based upon alignment with the chronic care model may better capture features of effective CDM care than a visit frequency measure. Copyright © 2012 Elsevier Inc. All rights reserved.

  9. Next-Generation Human Immunodeficiency Virus Sequencing for Patient Management and Drug Resistance Surveillance.

    PubMed

    Noguera-Julian, Marc; Edgil, Dianna; Harrigan, P Richard; Sandstrom, Paul; Godfrey, Catherine; Paredes, Roger

    2017-09-15

    High-quality, simplified, and low-cost human immunodeficiency virus (HIV) drug resistance tests that are able to provide timely actionable HIV resistance data at individual, population, and programmatic levels are needed to confront the emerging drug-resistant HIV epidemic. Next-generation sequencing technologies embedded in automated cloud-computing analysis environments are ideally suited for such endeavor. Whereas NGS can reduce costs over Sanger sequencing, automated analysis pipelines make NGS accessible to molecular laboratories regardless of the available bioinformatic skills. They can also produce highly structured, high-quality data that could be examined by healthcare officials and program managers on a real-time basis to allow timely public health action. Here we discuss the opportunities and challenges of such an approach. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  10. EFFECT OF QUALITY CHRONIC DISEASE MANAGEMENT FOR ALCOHOL AND DRUG DEPENDENCE ON ADDICTION OUTCOMES

    PubMed Central

    Kim, Theresa W.; Saitz, Richard; Cheng, Debbie M.; Winter, Michael R; Witas, Julie; Samet, Jeffrey H.

    2012-01-01

    We examinedthe effect ofthe quality of primary care-basedchronic disease management (CDM)for alcohol and/or other drug (AOD) dependenceonaddiction outcomes.We assessed qualityusing 1)avisit frequencybased measure and 2) a self-reported assessment measuring alignment with the chronic care model. The visit frequency based measure had no significant association with addiction outcomes. Theself-reported measure of care - when care was at a CDM clinic - was associated with lower drug addiction severity.The self-reported assessment of care from any healthcare source (CDM clinic or elsewhere)was associated with lower alcoholaddiction severity and abstinence.These findings suggest that high quality CDM for AOD dependence may improve addiction outcomes.Quality measuresbased upon alignment with the chronic care model may better capture features of effective CDM care than a visitfrequency measure. PMID:22840687

  11. Drug-related problems vary with medication category and treatment duration in Taiwanese heart failure outpatients receiving case management.

    PubMed

    Hsu, Wan-Tseng; Shen, Li-Jiuan; Lee, Chii-Ming

    2016-05-01

    Heart failure (HF) patients are at high risk of having drug-related problems (DRPs). We aim to describe the frequency, types, and temporal occurrence of DRPs in Taiwanese HF outpatients receiving case management. In this study, we included 141 patients from HF clinics in three hospitals in Taiwan from October 2008 to December 2010. Nurse case managers at each of the participating sites registered case report forms (CRFs) for patients during clinic visits. DRPs were classified using the Pharmaceutical Care Network Europe Foundation (PCNE) classification system and documented by pharmacists after reviewing CRFs and participating in multidisciplinary team discussions. For 141 clinic participants, the average duration of medication use was 17 months, and 796 DRPs were reported. The DRPs most frequently recorded were the need for laboratory tests (32.7% of total DRPs), followed by potential interaction (29.6%), nonallergic side effects (13.3%), and insufficient awareness of health and disease (9.5%). The drugs most frequently causing a DRP were angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, diuretics, warfarin, spironolactone, and β-blockers. The incidence rates of total DRPs was maximal during the initial 3 months of medication treatment, whereas the incidence rates of each category of DRPs showed multiform changes over time among various drug classes. In Taiwan where the clinical pharmacist system is not well organized, HF outpatients still had a high prevalence of DRPs despite intensive monitoring by nurse case managers. Clinical pharmacists play critical roles in detecting potential DRPs during long-term medication treatment for this population. Copyright © 2015. Published by Elsevier B.V.

  12. Blonanserin - A Novel Antianxiety and Antidepressant Drug? An Experimental Study.

    PubMed

    Limaye, Ramchandra Prabhakar; Patil, Aditi Nitin

    2016-09-01

    Many psychiatric disorders show signs and symptoms of anxiety and depression. A drug with both, effects and lesser adverse effects is always desired. Blonanserin is a novel drug with postulated effect on anxiety and depression. The study was aimed to evaluate the effect of Blonanserin on anxiety and depression in animal models. By using elevated plus maze test and forced swimming test, the antianxiety and antidepressant effects were evaluated. Animal ethics protocols were followed strictly. Total 50 rats (10 rats per group) were used for each test. As a control drug diazepam and imipramine were used in elevated plus maze and forced swimming test respectively. Blonanserin was tested for 3 doses 0.075, 0.2 and 0.8mg. These doses were selected from previous references as well as by extrapolating human doses. This study showed an antianxiety effect of Blonanserin comparable to diazepam, which was statistically significant. Optimal effect was observed with 0.075mg, followed by 0.2 and 0.8mg. It also showed an antidepressant effect which was statistically significant. Optimal effect was observed at 0.2mg dose. The results showed that at a dose range of 0.075 and 0.2mg Blonanserin has potential to exert an adjuvant antianxiety and antidepressant activity in animal models. In order to extrapolate this in patient, longer clinical studies with comparable doses should be planned. The present study underlines potential of Blonanserin as a novel drug for such studies.

  13. Quality of drug treatment of childhood persistent asthma in Maryland medicaid recipients in transition from managed fee for service to managed capitation.

    PubMed

    Singhal, Puneet K; Zuckerman, Ilene; Stuart, Bruce; Magder, Laurence; Rubin, Haya

    2007-05-01

    From December 1991 to June 1997, approximately 80% of Maryland's Medicaid recipients were served through a fee-for-service (FFS) managed care delivery system in which assigned primary care providers served as gatekeepers for hospital and specialty services. The remaining 20% of recipients were voluntarily enrolled in 1 of 5 available health maintenance organizations (HMOs). Beginning in June 1997, Maryland required most Medicaid recipients to enroll in capitated managed care organizations (MCOs), also referred to as managed Medicaid plans. Although research has been conducted on the quality of asthma care among MCOs and in MCOs for Medicaid versus non-Medicaid members, the quality of asthma care has been less well studied for MCO patients than for FFS patients. To determine whether quality of drug use among Medicaid children with persistent asthma was different after the transition from the managed care FFS system to a capitated managed Medicaid system. This 4-year retrospective cohort study (from June 1, 1996, to December 31, 2000) followed children aged 5 to 18 years with persistent asthma (defined by the existence of at least 1 medical claim with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code of 493.x and receipt of 2 or more pharmacy claims for beta2-agonists in a 6-month period) enrolled in Maryland Medicaid as they transitioned from the managed FFS system to 1 of 4 large capitated MCOs. Children were selected from a review of Medicaid enrollment records and medical and pharmacy FFS claims filed between June 1, 1996, and December 31, 1997. Children with a diagnosis of cystic fibrosis were excluded. The asthma quality indicator was defined as the proportion of children with persistent asthma (who had 2 or more claims for any short-acting beta2-agonists [SABAs], including metered-dose inhalers, nebulizers, or oral forms, which we defined as rescue medication, within a 6-month period), who also had at least 1

  14. Socioeconomic factors, morbidity and drug utilization--an ecological study.

    PubMed

    Henricson, K; Stenberg, P; Rametsteiner, G; Ranstam, J; Hanson, B S; Melander, A

    1998-07-01

    The aim of the present study was to elucidate the relations between demographic and socioeconomic factors, morbidity and the utilization of major drug groups in an urban Swedish population. The study was performed as an ecological analysis during November 1991 in the 17 different districts of Malmö, the third largest Swedish city (235,000 inhabitants). The material comprised 86,228 ACT-coded drug items which corresponded to 76% of all prescriptions dispensed during the study month. Of these, 43,032, dispensed to patients aged 15-64 years, were analysed in the present work. Age standardized drug utilization was expressed as the number of dispensed Defined Daily Doses per 1000 inhabitants per day. Morbidity was measured in terms of reimbursed days on sick leave. The sociodemographic parameters used were socioeconomic status (SES), employment rate, median income per family, households on social allowance, and ethnicity. For four of the five major pharmacological groups (ATC-groups A, C, J, N and R, i.e. alimentation, circulation, infectious diseases, nervous system and respiration), most pronouncedly group N and least so group R, utilization correlated positively with not only the extent of morbidity but also with an unfavourable socioeconomic situation, high proportion of immigrants, and households on social allowance or with low income and/or with a low employment rate. The utilization of antibiotics (group J), however, instead correlated negatively with these parameters. For all five drug groups, these trends were similar among men and women, albeit with varying strength. In conclusion, socioeconomic factors may have a profound influence on the utilization of several major drug groups. At least in the case of antibiotics, the consequence of this influence is irrational drug use.

  15. Epidemiological study of epilepsy by monitoring prescriptions of antiepileptic drugs.

    PubMed

    Banfi, R; Borselli, G; Marinai, C; Borgheresi, A; Cavalieri, A

    1995-07-28

    The aim of this study is to evaluate a simple and effective method of acquiring epidemiological information about epilepsy. Data on antiepileptic drug prescriptions was collected, the utilization pattern being based on defined daily doses (DDDs). Antiepileptic drugs are epidemiological tracers of epilepsy due to their chronic and highly specific usage. Consequently, a prevalence rate for the whole population may be obtained by using DDDs. Data on antiepileptic drug prescriptions for a period of 6 months in 1992 and 6 months in 1993 indicate a utilization of approximately 7 DDDs of antiepileptic drugs per 1,000 inhabitants. The prevalence of epilepsy was estimated by correcting the exposure calculated in DDDs by a factor of 0.68. In our sample, the prevalence of the disease was 5.2 per 1,000 inhabitants in 1992 and 4.9 per 1,000 in 1993. Physician prescriptions were concentrated on four compounds, namely phenobarbital, carbamazepine, valproic acid and phenytoin, which together represented 90% of total antiepileptic drug prescriptions.

  16. 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.

  17. 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.

  18. 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…

  19. Studies on pharmacokinetic drug interaction potential of vinpocetine

    USDA-ARS?s Scientific Manuscript database

    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...

  20. 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…

  1. Management of a Complicated Ruptured Infected Pseudoaneurysm of the Femoral Artery in a Drug Addict

    PubMed Central

    Psathas, Emmanouil; Lioudaki, Stella; Karantonis, Fotios-Filippos; Charalampoudis, Petros; Papadopoulos, Othon; Klonaris, Chris

    2012-01-01

    Infected pseudoaneurysm of the femoral artery represents a devastating complication of intravenous drug abuse, especially in the event of rupture. Operative strategy depends upon the extent of arterial injury and the coexistence of infection or sepsis. Options range from simple common femoral artery (CFA) ligation to complex arterial reconstruction with autologous grafts (arterial, venous, or homografts). We report herein the management of a 29-year-old male patient who was urgently admitted with a ruptured pseudoaneurysm of the right CFA, extending well above the inguinal ligament. Multidisciplinary approach with multiple arterial reconstructions and subsequent coverage of the tissue defect with a rectus abdominis musculocutaneous flap transposition was performed. PMID:23227421

  2. 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.

  3. Study of process induced polymorphic transformations in fluconazole drug.

    PubMed

    Desai, Satish R; Dharwadkar, Sanjiv R

    2009-01-01

    The polymorphic form-I of the fluconazole drug commonly crystallized from the solution phase could be obtained by the solid state transformation of form-II employing different process parameters. As received fluconazole-II drug melted at 138.4 degrees C. The molten drug undercooled almost to ambient temperature of 30 degrees C and solidified to a glassy mass which, on ageing for 48 h transformed to a white powder which could be identified as fluconazole-I. The same glassy mass on heating at 5 degrees C/min, without ageing, also underwent polymorphic transformation to fluconazole-I above 81 degrees C. The application of uniaxial pressure of 200 kg/cm2 on as received fluconazole-II sample also yielded form-I of the drug. This phase transformation was enhanced by the application of pressure (200 kg/cm2) on the as received sample aged for 36 months. The phase transformation was concluded from the difference in differential scanning calorimetric (DSC) curves of the original sample (form-II) and the products obtained by adopting the different processing routes. The DSC patterns of fluconozole-I obtained by different methods were found to be identical. The phase transformation in the as received drug (form-II) induced by different process parameters, concluded from the DSC data was corroborated by X- ray diffraction (XRD) studies and scanning electron microscope (SEM) photographs of the two polymorphic forms. The intrinsic dissolution rates of polymorphic form-I and -II and the influence of crystal habit on the drug dissolution process have also been studied.

  4. 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

  5. Role of the post-marketing authorisation studies in drug risk surveillance: specifications and methodologies.

    PubMed

    Tubach, Florence; Lamarque-Garnier, Véronique; Castot, Anne

    2011-01-01

    Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part of the community revision. These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact ... can complete available safety data.The Giens Round Table examined PASS from the risk management plans of a sample of marketing authorisation holders (participants to the Round Table) and identified the main characteristics of proposed actions. Concerning the specifications and the choice of methodology, only a general outline has been sketched in view of the complexity and diversity of drug risks situations.

  6. 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

  7. Tablet splitting of psychotropic drugs for patients with dementia: a pharmacoepidemiologic study in a Brazilian sample.

    PubMed

    Mascarenhas Starling, Flávio; Medeiros-Souza, Patrícia; Francisco de Camargos, Einstein; Ferreira, Felipe; Rodrigues Silva, Alessandra; Homem-de-Mello, Maurício

    2015-10-01

    The objective of this study was to assess the frequency of tablet splitting of psychotropic drugs in a population of older adults with a diagnosis of dementia. This retrospective, cross-sectional study examined a sample of geriatric outpatients seen at a public center specializing in the care of elderly patients, a referral center for management of dementias in general, especially Alzheimer dementia to identify the frequency of tablet splitting of psychotropic drugs and the factors that may be involved in this practice. Comparison of the presence or absence of tablet splitting in relation to several parameters was assessed by means of P values; between-group differences with an α < 5% (P < 0.05) were deemed significant. The presence of dementia was significantly associated with prescriptions implying to split tablets, which was found in 88 patients with dementia (34.9%) versus 90 patients without dementia (23.7%) (P = 0.002). Among the 88 patients with dementia who split tablets, 64 (72.7%) split tablets of psychotropic drugs. These results indicate the importance of identifying the practice of tablet splitting, particularly when it involves psychotropic drugs, because it entails several factors that can reduce the efficacy of the drug therapy. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  8. Sphingolipids Are Dual Specific Drug Targets for the Management of Pulmonary Infections: Perspective

    PubMed Central

    Sharma, Lalita; Prakash, Hridayesh

    2017-01-01

    Sphingolipids are the major constituent of the mucus secreted by the cells of epithelial linings of lungs where they maintain the barrier functions and prevent microbial invasion. Sphingolipids are interconvertible, and their primary and secondary metabolites have both structural and functional roles. Out of several sphingolipid metabolites, sphingosine-1 phosphate (S1P) and ceramide are central molecules and decisive for sphingolipid signaling. These are produced by enzymatic activity of sphingosine kinase-1 (SK-1) upon the challenge with either biological or physiological stresses. S1P and ceramide rheostat are important for the progression of various pathologies, which are manifested by inflammatory cascade. S1P is a well-established secondary messenger and associated with various neuronal, metabolic, and inflammatory diseases other than respiratory infections such as Chlamydia pneumoniae, Streptococcus pneumoniae, and Mycobacterium tuberculosis. These pathogens are known to exploit sphingolipid metabolism for their opportunistic survival. Decreased sphingosine kinase activity/S1P content in the lung and peripheral blood of tuberculosis patients clearly indicated a dysregulation of sphingolipid metabolism during infection and suggest that sphingolipid metabolism is important for management of infection by the host. Our previous study has demonstrated that gain of SK-1 activity is important for the maturation of phagolysosomal compartment, innate activation of macrophages, and subsequent control of mycobacterial replication/growth in macrophages. Furthermore, S1P-mediated amelioration of lung pathology and disease severity in TB patients is believed to be mediated by the selective activation or rearrangement of various S1P receptors (S1PR) particularly S1PR2, which has been effective in controlling respiratory fungal pathogens. Therefore, such specificity of S1P–S1PR would be paramount for triggering inflammatory events, subsequent activation, and fostering

  9. Survey Evaluating the Practice of Children's Hospitals Having Pharmacist Collaborative Drug Therapy Management Protocols

    PubMed Central

    Welsh, Chelsea; Miah, Rukshana

    2016-01-01

    OBJECTIVES: The purpose of this study is to determine how frequently children's hospitals in the United States are using pharmacist-physician collaborative drug therapy management (CDTM), and to characterize their use in this population. METHODS: A phone survey was created to collect data regarding the use of pharmacist-physician CDTM at children's hospitals. Children's hospitals were called between February 2014 and April 2014. Data were collected from either a clinical pharmacist or pharmacy director. Pharmacists were asked to answer questions regarding hospital demographics as well as to what extent and for which medications they use CDTM. Differences between types of hospitals were evaluated using Fisher exact test. RESULTS: A total of 171 children's hospitals were identified; 51.5% hospitals (n = 88) completed the survey. Of the 88 hospitals that completed the survey, 32 (31.7%) had some level of CDTM in place. Of the 28 children's hospitals with CDTM in place that completed the survey, all allowed pharmacists to modify doses and monitor therapy, and 75% provided pharmacists with the ability to initiate the first dose. The specific medications that were included in the CDTM protocols in children's hospitals included vancomycin (n = 23), aminoglycosides (n = 22), anticoagulation medications (n = 7), and total parenteral nutrition (n = 3). Training was required for pharmacists to participate in CDTM protocols at most hospitals (n = 26). Lack of support from medical staff was the most common perceived barrier. No differences were identified between types of children's hospitals. CONCLUSION: CDTM protocols are practiced in about one third of the children's hospitals. Pharmacists commonly initiate, monitor, and modify therapies as part of these protocols. The most frequently included medications were vancomycin and aminoglycosides. PMID:28018151

  10. Review article: new drug formulations, chemical entities and therapeutic approaches for the management of ulcerative colitis.

    PubMed

    Ng, S C; Kamm, M A

    2008-10-01

    Treatment options for ulcerative colitis (UC) are expanding with the development of novel drug formulations and dosing regimens and new chemical entities. Although the goals of medical therapy for UC remain unchanged, that is to induce and to maintain remission, focus has also centred on improving patient compliance, modifying the natural course of disease and healing the mucosa. To examine novel formulations, new chemical entities and novel therapeutic approaches to the management of UC. Searches for all studies related to UC treatment in Medline and abstracts from major national and international meetings published in the last 10 years. 5-Aminosalicylic acids (5-ASA) remain the standard first-line treatment for patients with mild to moderately active UC. New formulations with altered delivery, and new dosing regimens have demonstrated possible improvements in efficacy compared with historically available preparations and dosing patterns. Once-daily dosing, micropellet formulations,and high-dose tablets offer enhanced efficacy and improved compliance. 5-ASA is now recognized as a ligand for peroxisome proliferator activated receptor-gamma (PPAR-gamma) and it has a role as a chemo-preventive agent in long-standing UC. New colonic release corticosteroid formulations help to limit systemic toxicity; turmeric, tacrolimus and infliximab have shown promising results. New anti-inflammatory targeted therapies include an anti-CD3 antibody, selective integrin blockers, anti-IL-2 antibody and PPAR-gamma agonists. The evolution of novel oral 5-ASA formulations and dosage regimens,and recent development of new molecules have expanded the therapeutic armamentarium of UC.

  11. Avoiding the quality assurance boondoggle in drug treatment programs through total quality management.

    PubMed

    Fountain, D L

    1992-01-01

    This paper considers limitations to three often-used approaches for improving treatment quality in a drug abuse treatment program: supervisory review, internal program evaluations, and standard quality assurance. Total Quality Management (TQM) is then presented as a technique that maximizes the effectiveness of quality-improvement strategies and builds on them by establishing a more comprehensive approach to improving treatment quality. This paper recommends issues for treatment providers to consider in designing an efficacious TQM approach. Specific organizational characteristics are discussed that can either enhance or defeat TQM. The program should be goal oriented and have the broad commitment of staff and management to quality improvement. It should also have a well-defined and tailored system for monitoring, feedback, and change. Moreover, the program should delegate authority and responsibility to staff for improvements, possess organizational readiness, and contain an evaluative component that can determine whether TQM is meeting the program's needs.

  12. Drug promotional practices in Mumbai: a qualitative study.

    PubMed

    Roy, Nobhojit; Madhiwalla, Neha; Pai, Sanjay A

    2007-01-01

    We conducted a qualitative study to determine the range of promotional practices influencing drug usage in Mumbai. Open-ended interviews were conducted with 15 senior executives in drug companies, 25 chemists and 25 doctors; focus group discussions were held with 36 medical representatives. The study provided a picture of what might be described as an unholy alliance: manufacturers, chemists and doctors conspire to make profits at the expense of consumers and the public's health, even as they negotiate with each other on their respective shares of these profits. Misleading information, incentives and unethical trade practices were identified as methods to increase the prescription and sale of drugs. Medical representatives provide incomplete medical information to influence prescribing practices; they also offer incentives including conference sponsorship. Doctors may also demand incentives, as when doctors' associations threaten to boycott companies that do not comply with their demands for sponsorship. Manufacturers, chemists and medical representatives use various unethical trade practices. Of particular interest was the finding that chemists are major players in this system, providing drug information directly to patients. The study also reinforced our impression that medical representatives are the least powerful of the four groups.

  13. Potential drug interactions with statins: Estonian register-based study

    PubMed Central

    Volmer, Daisy; Hartikainen, Sirpa; Zharkovsky, Alexander

    2015-01-01

    In Estonia, HMG-CoA reductase inhibitors are widely used to modify lipid levels but there are no current data on additional medicines prescribed alongside the statins. The aim of this study was to identify the frequency of potential clinically relevant interactions at a national level among an outpatient population treated with statins between January and June 2008, based on the prescription database of the Estonian Health Insurance Fund. This retrospective prevalence study included 203,646 outpatients aged 50 years or older, of whom 29,367 received statin therapy. The study analysed individuals who had used at least one prescription medicine for a minimum of 7 days concomitantly with statins. Potential drug interactions were analysed using Epocrates online, Stockley’s Drug Interactions, and the drug interaction database developed in Estonia. Statins metabolised by the CYP3A4 isoenzyme were prescribed to 64% of all statin users. Medicines known to have potentially clinically significant interactions with statins were prescribed to 4.6% of patients. The drugs prescribed concomitantly most often with simvastatin were warfarin (5.7%) and amiodarone (3.9%), whereas digoxin (1.2%) and ethinylestradiol (2%) were prescribed with atorvastatin. Potential interactions were not detected in the treatment regimens of rosuvastatin, pravastatin, and fluvastatin users. PMID:28352703

  14. Study urges prisons to consider condoms, drug needles.

    PubMed

    1996-10-04

    A study of sexual activity and intravenous drug use in U.S. correctional facilities reveals that condoms, dental dams, and sterile needles should be made available to inmates. The rate of AIDS is 7 times higher among prisoners than among the general population. The study revealed that sexual activity and drug use occurs frequently and usually without the use of measures that would protect inmates from HIV transmission. Focus group participants disclosed that prisoners often exchange sex for drugs, and protection. Drug use is common and inmates reportedly use dirty syringes and use makeshift syringes from unsafe material. An editorial accompanying the study indicates that current measures to prevent HIV transmission in prisons are ineffective and do not recognize the diverse nature of inmates' needs and behavior. It is also noted that making condoms available to male prisoners might be challenging since most male inmates will not acknowledge that they have sex with other men. Female prisoners, however, freely admit to having consensual sex with other female inmates.

  15. 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

  16. Drug utilization studies: a tool for determining the effectiveness of drug use.

    PubMed Central

    Laporte, J R; Porta, M; Capella, D

    1983-01-01

    To evaluate the quality of the consumption of medicines in Spain, its potential efficacy, and its evolution during the last years, an assessment of the 'intrinsic value' of the most sold pharmaceutical specialities (amounting to more than 50% of total pharmaceutical market) was carried out. A panel of five clinical pharmacologist classified medicines, according to their intrinsic value, in four groups: (i) 'high value' (41% of analyzed medicines in 1980); (ii) 'relative value' (12% in 1980); (iii) 'doubtful value' (3%); (iv) 'no value' (23%), and (v) 'unacceptable value' (21%). Drugs were also classified according to their expected potential of use; and three groups were formed: (i) 'high' (32%); (ii) 'relatively high' (14%), and (iii) 'reduced' (10%). A fourth group of 'not applicable' (44%) in this classification was formed with pharmaceuticals considered unvaluable or unacceptable in the first classification. The results of this study suggest that this kind of analysis may be a useful tool to evaluate the efficacy of drugs in the community, and to identify priorities and guidelines in the selection of drugs in each country. PMID:6626422

  17. Cubic phases for studies of drug partition into lipid bilayers.

    PubMed

    Engström, S; Nordén, T P; Nyquist, H

    1999-08-01

    Drug partition into lipid bilayers in a cubic liquid-crystalline phase was investigated. Glyceryl monooleate was used to form the lipid bilayer in a reversed bicontinuous cubic liquid-crystalline phase. The reason for using the cubic phase is that it may coexist with an external aqueous phase, and that the phase boundary (cubic phase/aqueous bulk) is well-defined due to the stiffness of the cubic phase. This makes the cubic phase a potential candidate for high throughput screening (HTS) of the lipophilicity and the dissociation constant (if any) of drug compounds. Clomethiazole (CMZ), lidocaine, prilocaine and 4-phenylbutylamine (4-PBA) were chosen as model drug compounds. It was shown that it is possible to determine a pH-dependent apparent partition coefficient, Kbl/w, of a drug compound using a lipid bilayer expressed as a cubic liquid-crystalline structure. Good agreement was found when the resulting Kbl/w vs. pH curves for CMZ, lidocaine and prilocaine were fitted to a mathematical expression. This included the bilayer/water partition coefficient for the unionised and ionised drug respectively and the pKa of the drug. The effect of different experimental conditions; such as amount of cubic phase, temperature, agitation, sample preparation and interfacial area between the cubic phase and the aqueous bulk on the partition kinetics were investigated as well. The studies reveal that the time needed to reach partition equilibrium was, as expected, substantially reduced (from days to hours) by decreasing the amount of cubic phase, increasing the interfacial area between the cubic phase and the aqueous phase, and increasing the temperature and the agitation of the sample. It was also shown that the bilayer affinity of 4-PBA was increased when a zwitterionic lipid (i.e. dioleoyl phosphatidylcholine, DOPC) was incorporated in the bilayer.

  18. [Psychotropic drugs induced weight gain: a review of the literature concerning epidemiological data, mechanisms and management].

    PubMed

    Ruetsch, O; Viala, A; Bardou, H; Martin, P; Vacheron, M N

    2005-01-01

    , antipsychotic drugs) and weight gain despite reduced appetite which can be explained by an altered resting metabolic rate (TCA, SSRI, Monoaminoxidase Inhibitors MAO I). According to current concepts, appetite and feeding are regulated by a complex of neurotransmitters, neuromodulators, cytokines and hormones interacting with the hypothalamus, including the leptin and the tumor necrosis factor system. The pharmacologic mechanisms underlying weight gain are presently poorly understood: maybe the different activities at some receptor systems may induce it, but also genetic predisposition. Understanding of the metabolic consequences of psychotropic drugs (weight gain, diabetes, dyslipidemia) is essential: the insulin-like effect of lithium is known; treatment with antipsychotic medications increases the risk of impaired glucose tolerance and diabetes mellitus. Several management options of weight gain are available from choosing or switching to another drug, dietary advices, increasing physical activities, behavioural treatment, but the best approach seems to attempt to prevent the weight gain : patients beginning maintenance therapy should be informed of that risk, and nutritional assessment and counselling should be a routine part of treatment management, associated with monitoring of weight, BMI, blood pressure, biological parameters (baseline and three months monitoring of fasting glucose level, fasting cholesterol and triglyceride levels, glycosylated haemoglobin). Psychiatrics must pay attention to concomitant medications and individual factors underlying overweight and obesity. Weight gain has been described since the discovery and the use of the firstpsychotropic drugs, but seems to intensify with especially some of the second generation antipsychotic medications ; understanding of the side effects of psychotropic drugs, including their metabolic consequences (weight gain, diabetes, dyslipidemia) is essential for the psychiatrics to avoid on the one hand a risk of lack of

  19. Multiple comparisons in drug efficacy studies: scientific or marketing principles?

    PubMed

    Leo, Jonathan

    2004-01-01

    When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.

  20. Nonsteroidal antiinflammatory drugs (NSAIDs) and physiotherapy management of musculoskeletal conditions: a professional minefield?

    PubMed Central

    Kumar, Saravana; Grimmer, Karen

    2005-01-01

    In Australia, physiotherapy is a primary contact profession when practiced in private ambulatory settings. Primary contact means that physiotherapists take responsibility for diagnosis, decisions on interventions, appropriate ongoing management, and costs related to benefits. For most physiotherapists, the most common clinical presentations relate to symptoms from musculoskeletal conditions. There is considerable research evidence for many “physiotherapy” techniques in the management of musculoskeletal symptoms. As part of these management strategies, some physiotherapists may use nonsteroidal antiinflammatory drugs (NSAIDs) as an adjunct to treatment. Physiotherapists do not have the training or the legislative powers to prescribe NSAIDs. However, they can recommend that patients seek advice about appropriate adjunct NSAIDs from pharmacists and/or medical practitioners. The roles and responsibilities of key health providers in this area appear to be well defined in terms of minimizing medication misadventure and optimizing patient health outcomes. A recent survey of physiotherapist behaviors and practices, however, identified a number of “gray” areas that could confront unwary physiotherapists, or pose dilemmas for those without the support of medical/pharmacist colleagues. These gray areas relate to the adjunct use of topical NSAIDs in physiotherapy management and making recommendations for the use of oral NSAIDs. This paper reports on qualitative data that highlights the dilemmas confronting physiotherapists. PMID:18360546

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  2. Drugs and Youth. Teaching Social Studies in an Age of Crisis, No. 1.

    ERIC Educational Resources Information Center

    Wolk, Donald J., Ed.

    This pamphlet was written for social studies teachers to inform and stimulate the creative programing of drug education. Chapters written by the editor were: 1) Why drugs?; 2) The Drugs of Concern; 3) Excessive Drug Use: Signs, Symptoms, and Family-Related Factors; and, 4) Four Rules for Teaching about Drugs. Other authors and chapter titles are:…

  3. Analytical lessons learned from selected therapeutic protein drug comparability studies.

    PubMed

    Federici, Marcia; Lubiniecki, Anthony; Manikwar, Prakash; Volkin, David B

    2013-05-01

    The successful implementation of process and product changes for a therapeutic protein drug, both during clinical development and after commercialization, requires a detailed evaluation of their impact on the protein's structure and biological functionality. This analysis is called a comparability exercise and includes a data driven assessment of biochemical equivalence and biological characterization using a cadre of analytical methodologies. This review focuses on describing analytical results and lessons learned from selected published therapeutic protein comparability case studies both for bulk drug substance and final drug product. An overview of the currently available analytical methodologies typically used is presented as well as a discussion of new emerging analytical techniques. The potential utility of several novel analytical approaches to comparability studies is discussed including distribution and stability of protein drugs in vivo, and enhanced evaluation of higher-order protein structure in actual formulations using hydrogen/deuterium exchange mass spectrometry, two-dimensional nuclear magnetic resonance fingerprinting or empirical phase diagrams. In addition, new methods for detecting and characterizing protein aggregates and particles are presented as these degradants are of current industry-wide concern. The critical role that analytical methodologies play in elucidating the structure-function relationships for therapeutic protein products during the overall assessment of comparability is discussed.

  4. 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.