In-home drug storage and utilization habits: a Sudanese study.

PubMed

Yousif, M A

2002-01-01

Community drug-use habits were studied in 469 household units in different areas of Sudan. About 97.7% of the investigated families had at least one drug product stored at home. The study revealed a high rate of self-medication (46.9%), repeated use of unfinished stored drugs (55.0%), a high rate of drug exchange among families (59.3%) and poor compliance (71.2%). In Sudan there is still a great need to educate and to motivate the general public regarding the principles of rational drug use in order to safeguard health and avoid economic losses.

Prescription Drug Utilization and Reimbursement Increased Following State Medicaid Expansion in 2014.

PubMed

Mahendraratnam, Nirosha; Dusetzina, Stacie B; Farley, Joel F

2017-03-01

The Affordable Care Act (ACA) expanded health care and medication insurance coverage through Medicaid expansion in select states. Expansion has the potential to increase the availability of health services to patients, including prescription medications. However, limited studies have examined how expansion affected prescription drug utilization and reimbursement. To compare prescription drug utilization (number of prescriptions filled) and reimbursement trends between states that did and did not expand Medicaid coverage in 2014, while accounting for known effects of expansion on Medicaid enrollment. We conducted a comparative interrupted time series using retrospective Medicaid state drug utilization data from 2011 to 2014. After inclusion/exclusion criteria, 8 states that expanded Medicaid in 2014 and 10 states that did not expand Medicaid were studied. Primary outcomes were changes in quarterly prescription drug utilization and quarterly total prescription drug reimbursement before and after expansion. To account for increases in enrollment in expansion states, secondary outcomes were per-member-per-quarter (PMPQ) utilization and reimbursement before and after expansion. Expansion states experienced a 1.4 million prescriptions per quarter and $163 million per quarter increase in utilization and reimbursement above the change in rates observed in nonexpansion states after expansion (P < 0.001). Specifically, 1 year after ACA implementation, expansion states used 17.0% more prescriptions and spent 36.1% more in reimbursement than the quarter preceding expansion. Expansion and nonexpansion states experienced significant drops in PMPQ prescriptions immediately after expansion (P < 0.001), but PMPQ prescriptions and reimbursement trends increased by the end of the postexpansion period in expansion states (P < 0.029 and P < 0.001, respectively). Study results suggest that Medicaid expansion offers vulnerable patients who were previously uninsured increased access to

Comparison of Drug Utilization Patterns in Observational Data: Antiepileptic Drugs in Pediatric Patients.

PubMed

Bourgeois, Florence T; Olson, Karen L; Poduri, Annapurna; Mandl, Kenneth D

2015-10-01

Physicians require information on the comparative benefits and harms of medications for optimal treatment decisions. However, this type of data is limited, especially for pediatric patients. Our aim was to use observational data to measure and compare medication utilization patterns in a pediatric patient population. Using pharmacy claims data from a large, national-scale insurance program in the USA, we identified all patients with a diagnosis of epilepsy treated with a first-generation antiepileptic drug (carbamazepine, ethosuximide, phenobarbital, phenytoin, or valproate) or a second-generation antiepileptic drug [carbamazepine extended release (XR), gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproate XR, or zonisamide]. Treatment periods were defined on the basis of prescription fill dates and medication days supplied. Medication use was measured for individual antiepileptic drugs and for first-generation and second-generation drugs as groups. There were 2527 patients (54 %) who initiated therapy with first-generation antiepileptics and 2139 patients (46 %) who initiated therapy with second-generation antiepileptics. First- and second-generation drugs had the same 1-year retention rates [26 % (95 % confidence interval (CI) 24-28) and 26 % (95 % CI 25-28), respectively], and 26 % of patients (95 % CI 25-28) and 29 % of patients (95 % CI 27-31) who started on a first- or second-generation antiepileptic medication, respectively, resumed treatment with the initial drug after discontinuation. Overall, 73 % of patients (95 % CI 71-74) were treated with only one antiepileptic drug, with similar rates for patients started on first- and second-generation drugs [71 % (95 % CI 69-73) versus 74 % (95 % CI 72-76)]. Comparing drug utilization patterns in a pediatric population using observational data, we found similar rates of retention and therapeutic changes. These findings are consistent with the available comparative data and

Utility of Cardiac Troponin to Predict Drug Overdose Mortality

PubMed Central

Stimmel, Barry; Hoffman, Robert S.; Vlahov, David

2016-01-01

Drug overdose is now the leading cause of injury-related mortality in the USA, but the prognostic utility of cardiac biomarkers is unknown. We investigated whether serum cardiac troponin I (cTnI) was associated with overdose mortality. This prospective observational cohort studied adults with suspected acute drug overdose at two university hospital emergency departments (ED) over 3 years. The endpoint was in-hospital mortality, which was used to determine test characteristics of initial/peak cTnI. There were 437 overdoses analyzed, of whom there were 20 (4.6 %) deaths. Mean initial cTnI was significantly associated with mortality (1.2 vs. 0.06 ng/mL, p <0.001), and the ROC curve revealed excellent cTnI prediction of mortality (AUC 0.87, CI 0.76–0.98). Test characteristics for initial cTnI (90 % specificity, 99 % negative predictive value) were better than peak cTnI (88.2 % specificity, 99.2 % negative predictive value), and initial cTnI was normal in only one death out of the entire cohort (1/437, CI 0.1–1.4 %). Initial cTnI results were highly associated with drug overdose mortality. Future research should focus on high-risk overdose features to optimize strategies for utilization of cTnI as part of the routine ED evaluation for acute drug overdose. PMID:26541348

Comparison of drug utilization patterns in observational data: antiepileptic drugs in pediatric patients

PubMed Central

Bourgeois, Florence T; Olson, Karen L; Poduri, Annapurna; Mandl, Kenneth D

2015-01-01

Purpose Physicians require information on the comparative benefits and harms of medications for optimal treatment decisions. However, this type of data is limited, especially for pediatric patients. Objective Our aim was to use observational data to measure and compare medication utilization patterns in a pediatric patient population. Methods Using pharmacy claims data from a large, national-scale insurance program in the US, we identified all patients with a diagnosis of epilepsy treated with a first-generation (carabamazepine, ethosuximide, phenobarbital, phenytoin, valproate) or second-generation (carbamazepine XR, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproate XR, zonisamide) antiepileptic drug. Treatment periods were defined based on prescription fill dates and medication days supplied. Medication use was measured for individual antiepileptic drugs and for first-generation and second-generation drugs as groups. Results There were 2527 (54%) patients who initiated therapy with first-generation and 2139 (46%) with second-generation antiepileptics. First- and second-generation drugs had the same one-year retention rates (26% [95%CI 24–28] and 26% [95%CI 25–28], respectively). A total of 26% (95%CI 25–28) and 29% (95%CI 27–31) of patients who started on a first- or second-generation antiepileptic medication, respectively, resumed treatment with the initial drug after discontinuation. Overall, 73% (95%CI 71–74) of patients were treated with only one antiepileptic drug, with similar rates for patients started on first- and second-generation drugs (71% [95%CI 69–73] vs 74% [95%CI 72–76]). Conclusions Comparing drug utilization patterns in a pediatric population using observational data, we found similar rates of retention and therapeutic changes. These findings are consistent with available comparative data and demonstrate an approach that could be extended to other drug classes and conditions in pediatric

Drug utilization pattern during pregnancy in North India.

PubMed

Sharma, Rashmi; Kapoor, Bhuvneshvar; Verma, Ujala

2006-07-01

Pregnancy is a special physiological condition, where drug treatment presents a special concern. To evaluate the drug utilization pattern during pregnancy and to evaluate the effect of the educational and economic status on it.. The retrospective cross-sectional study. The postgraduate Department of Pharmacology and Therapeutics of a medical college. and the antenatal clinic of the institution. Medical students filled 405 questionnaires after interviewing pregnant women (243 primigravida and 152 multigravida). All the collected questionnaires were analysed for various study parameters. Inter-group comparison was done using chi-square test. P value < 0.05 was considered statistically significant. A total of 700, 1086 and 686 drugs, with an average of 1.73, 2.89 and 2.49 drugs per pregnant women, were used during first, second and third trimester of pregnancy, respectively. A majority of the drugs used, were from category-A, followed by category-B and category-D. However, category C and X drugs constituted 2.90 (20) and 5.71% (40) of drugs used during the third trimester and first trimester, respectively. Herbal/homeopathic drugs constituted 6.42 (45), 3.68 (40) and 1.46% (10) of the drugs used in the first, second and third trimester of pregnancy, respectively (P=649). 33.33% (135) women believed that drug use during pregnancy is dangerous to both mother and child and 37.03% (150) believed that drugs are dangerous throughout pregnancy. 55.55% (225) females advocated the use of iron/folic acid during pregnancy. 24.69% (100) of women had knowledge about barrier contraceptives. Self-medication and homeopathic/ herbal drugs use was found more in graduates than in undergraduates; as well as, it was more in the higher socioeconomic group than the lower socioeconomic group. There is a need to educate and counsel women of child-bearing age, regarding the advantages and disadvantages of drug use during pregnancies, with special reference to alternative therapies and self-medication.

Drug utilization research in primary health care as exemplified by physicians' quality assessment groups.

PubMed

von Ferber, L; Luciano, A; Köster, I; Krappweis, J

1992-11-01

Drugs in primary health care are often prescribed for nonrational reasons. Drug utilization research investigates the prescription of drugs with an eye to medical, social and economic causes and consequences of the prescribed drug's utilization. The results of this research show distinct differences in drug utilization in different age groups and between men and women. Indication and dosage appear irrational from a textbook point of view. This indicates nonpharmacological causes of drug utilization. To advice successfully changes for the better quality assessment groups of primary health care physicians get information about their established behavior by analysis of their prescriptions. The discussion and the comparisons in the group allow them to recognize their irrational prescribing and the social, psychological and economic reasons behind it. Guidelines for treatment are worked out which take into account the primary health care physician's situation. After a year with 6 meetings of the quality assessment groups the education process is evaluated by another drug utilization analysis on the basis of the physicians prescription. The evaluation shows a remarkable improvement of quality and cost effectiveness of the drug therapy of the participating physicians.

Out-of-pocket drug costs and drug utilization patterns of postmenopausal Medicare beneficiaries with osteoporosis.

PubMed

Conwell, Leslie Jackson; Esposito, Dominick; Garavaglia, Susan; Meadows, Eric S; Colby, Margaret; Herrera, Vivian; Goldfarb, Seth; Ball, Daniel; Marciniak, Martin

2011-08-01

The Medicare Part D coverage gap has been associated with lower adherence and drug utilization and higher discontinuation. Because osteoporosis has a relatively high prevalence among Medicare-eligible postmenopausal women, we examined changes in utilization of osteoporosis medications during this coverage gap. The purpose of this study was to investigate changes in out-of-pocket (OOP) drug costs and utilization associated with the Medicare Part D coverage gap among postmenopausal beneficiaries with osteoporosis. This retrospective analysis of 2007 pharmacy claims focuses on postmenopausal female Medicare beneficiaries enrolled in full-, partial-, or no-gap exposure standard or Medicare Advantage prescription drug plans (PDPs), retiree drug subsidy (RDS) plans, or the low-income subsidy program. We compared beneficiaries with osteoporosis who were taking teriparatide (Eli Lilly and Company, Indianapolis, Indiana) (n = 5657) with matched samples of beneficiaries who were taking nonteriparatide osteoporosis medications (NTO; n = 16,971) or who had other chronic conditions (OCC; n = 16,971). We measured average monthly prescription drug fills and OOP costs, medication discontinuation, and skipping. More than half the sample reached the coverage gap; OOP costs then rose for teriparatide users enrolled in partial- or full-gap exposure plans (increase of 121% and 186%; $300 and $349) but fell for those in no-gap exposure PDPs or RDS plans (decrease of 49% and 30%; $131 and $40). OOP costs for beneficiaries in partial- or full-gap exposure PDPs increased >120% (increase of $144 and $176) in the NTO group and nearly doubled for the OCC group (increase of $124 and $151); these OOP costs were substantially lower than those for teriparatide users. Both teriparatide users and NTO group members discontinued or skipped medications more often than persons in the OCC group, regardless of plan or benefit design. Medication discontinuation and OOP costs among beneficiaries with

Internalized HIV and Drug Stigmas: Interacting Forces Threatening Health Status and Health Service Utilization Among People with HIV Who Inject Drugs in St. Petersburg, Russia

PubMed Central

Burke, Sara E.; Dovidio, John F.; Levina, Olga S.; Uusküla, Anneli; Niccolai, Linda M.; Heimer, Robert

2016-01-01

Marked overlap between the HIV and injection drug use epidemics in St. Petersburg, Russia, puts many people in need of health services at risk for stigmatization based on both characteristics simultaneously. The current study examined the independent and interactive effects of internalized HIV and drug stigmas on health status and health service utilization among 383 people with HIV who inject drugs in St. Petersburg. Participants self-reported internalized HIV stigma, internalized drug stigma, health status (subjective rating and symptom count), health service utilization (HIV care and drug treatment), sociodemographic characteristics, and health/behavioral history. For both forms of internalized stigma, greater stigma was correlated with poorer health and lower likelihood of service utilization. HIV and drug stigmas interacted to predict symptom count, HIV care, and drug treatment such that individuals internalizing high levels of both stigmas were at elevated risk for experiencing poor health and less likely to access health services. PMID:26050155

An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system.

PubMed

Zuppa, Athena; Vijayakumar, Sundararajan; Jayaraman, Bhuvana; Patel, Dimple; Narayan, Mahesh; Vijayakumar, Kalpana; Mondick, John T; Barrett, Jeffrey S

2007-09-01

Drug utilization in the inpatient setting can provide a mechanism to assess drug prescribing trends, efficiency, and cost-effectiveness of hospital formularies and examine subpopulations for which prescribing habits may be different. Such data can be used to correlate trends with time-dependent or seasonal changes in clinical event rates or the introduction of new pharmaceuticals. It is now possible to provide a robust, dynamic analysis of drug utilization in a large pediatric inpatient setting through the creation of a Web-based hospital drug utilization system that retrieves source data from our accounting database. The production implementation provides a dynamic and historical account of drug utilization at the authors' institution. The existing application can easily be extended to accommodate a multi-institution environment. The creation of a national or even global drug utilization network would facilitate the examination of geographical and/or socioeconomic influences in drug utilization and prescribing practices in general.

Impact of cost sharing on specialty drug utilization and outcomes: a review of the evidence and future directions.

PubMed

Doshi, Jalpa A; Li, Pengxiang; Ladage, Vrushabh P; Pettit, Amy R; Taylor, Erin A

2016-03-01

Specialty drugs often represent major medical advances for patients with few other effective options available, but high costs have attracted the attention of both payers and policy makers. We reviewed the evidence regarding the impact of cost sharing on utilization of specialty drugs indicated for rheumatoid arthritis (RA), multiple sclerosis (MS), and cancer, and on the use of nondrug medical services, health outcomes, and spending. Systematic review of Medline-indexed studies identified via an OVID search for articles published in English from 1995 to 2014, using combinations of terms for cost sharing and specialty drugs, and/or our 3 conditions of interest. We identified additional studies from reference lists. We identified 19 articles focusing on specialty drugs indicated for MS (n = 9), cancer (n = 8), and RA (n = 8). Studies examined prescription abandonment (n = 3), initiation or any utilization (n = 8), adherence (n = 9), persistence/discontinuation (n = 7), number of claims (n = 1), and drug spending (n = 1). Findings varied by disease, but generally indicated stronger effects for noninitiation or abandonment of a prescription at the pharmacy and somewhat smaller effects for refill behavior and drug spending once patients initiated therapy. Studies have not examined specialty tier cost sharing seen under Medicare Part D or health insurance exchanges, nor effects on medical utilization, spending, or health outcomes. Evidence to date generally indicates reductions in specialty drug utilization associated with higher cost sharing; effects have varied by type of disease and specialty drug use outcome. We draw upon our findings and the gaps in evidence to summarize future directions for research and policy.

Teaching exercise of drug utilization by medical students.

PubMed

Das, B P; Sethi, A; Nutan, K; Gunjan

2005-01-01

The prescription is a vital written document communicating between the physician, the patient and the pharmacist. The audit of prescribing pattern is a component of medical audit, which seeks monitoring, evaluation and necessary modifications in the prescribing practices of prescribers to achieve rational and cost effective medical care for the patients, The present drug utilization study was conducted by fourth year MBBs students during their research posting in the department of Pharmacology at B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan. The prescriptions were randomly collected from BPKIHS pharmacy over a period of 3 weeks. The auditing was done in the form of a semi structured performa containing the patients particulars with regard to age, sex, and residence, the details of the illness and prescribed drug information. The data was analyzed at the end of the study. The study points out that the maximum (27.5%) prescriptions were from General Outpatient Department (GOPD) followed by ENT (16.5%), Internal medicine (15.5%) and General surgery (10%). This indicates the distribution of patient load in hospital and the dominant areas to be targeted for intervention. Further, the proportion of antimicrobial agents (AMAs) i.e. 26.03% use was low and was prescribed empirically in most of the cases. There was use of expensive AMAs and irrational prescribing of combinations of AMAs in some prescriptions. Other prevailing drugs which were prescribed were analgesics. The usage of nimesulide and rofecoxib. withdrawn by FDA were used recurrently in this setup. There was greater use of dubious drugs of unproven benefit like vitamins, calcium etc. The diagnosis of the disease were not mentioned in 32.5% of prescriptions, The dose, frequency and duration of drugs were unascertained in majority of prescriptions that might lead to health hazards. This exercise might change the behavior of existing prescribers and also of the future doctors.

Are prescription drug insurance choices consistent with expected utility theory?

PubMed

Bundorf, M Kate; Mata, Rui; Schoenbaum, Michael; Bhattacharya, Jay

2013-09-01

To determine the extent to which people make choices inconsistent with expected utility theory when choosing among prescription drug insurance plans and whether tabular or graphical presentation format influences the consistency of their choices. Members of an Internet-enabled panel chose between two Medicare prescription drug plans. The "low variance" plan required higher out-of-pocket payments for the drugs respondents usually took but lower out-of-pocket payments for the drugs they might need if they developed a new health condition than the "high variance" plan. The probability of a change in health varied within subjects and the presentation format (text vs. graphical) and the affective salience of the clinical condition (abstract vs. risk related to specific clinical condition) varied between subjects. Respondents were classified based on whether they consistently chose either the low or high variance plan. Logistic regression models were estimated to examine the relationship between decision outcomes and task characteristics. The majority of respondents consistently chose either the low or high variance plan, consistent with expected utility theory. Half of respondents consistently chose the low variance plan. Respondents were less likely to make discrepant choices when information was presented in graphical format. Many people, although not all, make choices consistent with expected utility theory when they have information on differences among plans in the variance of out-of-pocket spending. Medicare beneficiaries would benefit from information on the extent to which prescription drug plans provide risk protection. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Impact of pharmacy benefit design on prescription drug utilization: a fixed effects analysis of plan sponsor data.

PubMed

Roebuck, M Christopher; Liberman, Joshua N

2009-06-01

To study the impact of various elements of pharmacy benefit design on both the absolute and relative utilization of generics, brands, retail pharmacy, and mail service. Panel data on 1,074 plan sponsors covering 21.6 million individuals over 12 calendar quarters (2005-2007). A retrospective analysis of pharmacy claims. To control for potential endogeneity, linear fixed effects models were estimated for each of six dependent variables: the generic utilization rate, the brand utilization rate, the generic dispensing rate (GDR), the retail pharmacy utilization rate, the mail service utilization rate, and the mail distribution rate. Most member cost-share variables were nonlinearly associated with changes in prescription drug utilization. Marginal effects were generally greater in magnitude for brand out-of-pocket costs than for generic out-of-pocket costs. Time dummies, as well as other pharmacy benefit design elements, also yielded significant results. Prior estimates of the effect of member cost sharing on prescription drug utilization may be biased if complex benefit designs, mail service fulfillment, and unmeasured factors such as pharmaceutical pipelines are not accounted for. Commonly cited relative utilization metrics, such as GDR, may be misleading if not examined alongside absolute prescription drug utilization.

The Association Between Stimulant, Opioid, and Multiple Drug Use on Behavioral Health Care Utilization in a Safety-Net Health System.

PubMed

Calcaterra, Susan L; Keniston, Angela; Blum, Joshua; Crume, Tessa; Binswanger, Ingrid A

2015-01-01

Prior studies show an association between drug use and health care utilization. The relationship between specific drug type and emergent/urgent, inpatient, outpatient, and behavioral health care utilization has not been examined. We aimed to determine if multiple drug use was associated with increased utilization of behavioral health care. To assess health care utilization, we conducted a retrospective cohort study of patients who accessed health care at a safety-net medical center and affiliated clinics. Using electronic health records, we categorized patients who used stimulants, opioids, or multiple drugs based on urine toxicology screening tests and/or International Classification of Diseases, 9th Revision (ICD-9). Remaining patients were categorized as patients without identified drug use. Health care utilization by drug use group and visit type was determined using a negative binomial regression model. Associations were reported as incidence rate ratios. Utilization was described by rates of health care-related visits for inpatient, emergent/urgent, outpatient, and behavioral health care among patients who used drugs, categorized by drug types, compared with patients without identified drug use. Of 95,198 index visits, 4.6% (n=4340) were by patients who used drugs. Opioid and multiple drug users had significantly higher rates of behavioral health care visits than patients without identified drug use (opioid incidence rate ratio [IRR]=7.2; 95% confidence interval [CI]: 3.8-13.8; multiple drug use IRR=5.6, 95% CI: 3.3-9.7). Patients who used stimulants were less likely to use behavioral health services (IRR=1.3, 95% CI: 0.9-2.0) when compared with opioid and multiple drug users, but were more likely to use inpatient (IRR=1.6, 95% CI: 1.4-1.8) and emergent/urgent care (IRR=1.4, 95% CI: 1.3-1.5) services as compared with patients without identified drug use. Integrated medical and mental health care and drug treatment may reduce utilization of costly health care

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

Code of Federal Regulations, 2010 CFR

2010-10-01

... PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.153 Drug utilization... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). 423.153 Section 423.153 Public Health CENTERS FOR MEDICARE...

Gastroprotection during the administration of non-steroidal anti-inflammatory drugs. A drug-utilization study.

PubMed

Carvajal, Alfonso; Arias, Luis H Martín; Vega, Eva; Sánchez, José Antonio García; Rodríguez, Igor Martín; Ortega, Pilar García; del Pozo, Javier García

2004-08-01

There has been an increase of anti-ulcer drug consumption in Spain. A high proportion of this consumption may be due to the use of those drugs as gastroprotective agents when co-prescribed with non-steroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to learn how these treatments are being used: the prevalence of use, the type of drug and the main features of patients. A sample of patients going to pharmacies with a NSAID prescription, with or without a gastroprotective agent, was obtained. A survey questionnaire was distributed to learn clinical and demographic data of the patients. Of the 942 patients interviewed, 41.6% were co-treated with a gastroprotective agent in addition to the NSAID. Most of these patients received proton-pump inhibitors and, to a lesser extent, histamine-2-receptor antagonists, antacids and prostaglandin analogues. The use of gastroprotective agents increased with age, treatment duration and illness chronicity; specialists prescribed a higher proportion of those co-treatments than did general practitioners. There was a high prescription rate of gastroprotective agents; in general, these were used according to recommendations. However, the type of gastroprotective agents being used does not seem to be justified by the current guidelines: histamine-2-receptor antagonists and antacid drugs have not proved their efficacy in this indication. The fact that one in four treatments with gastroprotective drugs was issued to patients without associated risk factors identifies a possible problem where an intervention could be appropriate.

Forecasting drug utilization and expenditure in a metropolitan health region.

PubMed

Wettermark, Björn; Persson, Marie E; Wilking, Nils; Kalin, Mats; Korkmaz, Seher; Hjemdahl, Paul; Godman, Brian; Petzold, Max; Gustafsson, Lars L

2010-05-17

New pharmacological therapies are challenging the healthcare systems, and there is an increasing need to assess their therapeutic value in relation to existing alternatives as well as their potential budget impact. Consequently, new models to introduce drugs in healthcare are urgently needed. In the metropolitan health region of Stockholm, Sweden, a model has been developed including early warning (horizon scanning), forecasting of drug utilization and expenditure, critical drug evaluation as well as structured programs for the introduction and follow-up of new drugs. The aim of this paper is to present the forecasting model and the predicted growth in all therapeutic areas in 2010 and 2011. Linear regression analysis was applied to aggregate sales data on hospital sales and dispensed drugs in ambulatory care, including both reimbursed expenditure and patient co-payment. The linear regression was applied on each pharmacological group based on four observations 2006-2009, and the crude predictions estimated for the coming two years 2010-2011. The crude predictions were then adjusted for factors likely to increase or decrease future utilization and expenditure, such as patent expiries, new drugs to be launched or new guidelines from national bodies or the regional Drug and Therapeutics Committee. The assessment included a close collaboration with clinical, clinical pharmacological and pharmaceutical experts from the regional Drug and Therapeutics Committee. The annual increase in total expenditure for prescription and hospital drugs was predicted to be 2.0% in 2010 and 4.0% in 2011. Expenditures will increase in most therapeutic areas, but most predominantly for antineoplastic and immune modulating agents as well as drugs for the nervous system, infectious diseases, and blood and blood-forming organs. The utilisation and expenditure of drugs is difficult to forecast due to uncertainties about the rate of adoption of new medicines and various ongoing healthcare

What is known about the cost-effectiveness of orphan drugs? Evidence from cost-utility analyses.

PubMed

Picavet, E; Cassiman, D; Simoens, S

2015-06-01

In times of financial and economic hardship, governments are looking to contain pharmaceutical expenditure by focusing on cost-effective drugs. Because of their high prices and difficulties in demonstrating effectiveness in small patient populations, orphan drugs are often perceived as not able to meet traditional reimbursement threshold value for money. The aim of this study was to provide an overview of the available evidence on the cost-effectiveness of orphan drugs. All orphan drugs listed as authorized on the website of the European Medicines Agency on 21 November 2013 were included in the analysis. Cost-utility analyses (CUAs) were identified by searching the Tufts Medical Center Cost-Effectiveness Analysis Registry and Embase. For each CUA, a number of variables were collected. The search identified 23 articles on the Tufts registry and 167 articles on Embase. The final analysis included 45 CUAs and 61 incremental cost-utility ratios (ICURs) for 19 orphan drugs. Of all ICURS, 16·3% were related to dominant drugs (i.e. more effective and less expensive than the comparator), 70·5% were related to drugs that are more effective, but at a higher cost, and 13·1% were related to dominated drugs (i.e. less effective and more expensive than the comparator). The median overall ICUR was €40 242 per quality-adjusted life year (QALY) with a minimum ICUR of €6311/QALY and a maximum ICUR of €974,917/QALY. This study demonstrates that orphan drugs can meet traditional reimbursement thresholds. Considering a threshold of £30,000/QALY, in this study, ten (52·6%) of a total of 19 orphan drugs for which data were available meet the threshold. As much as fifteen orphan drugs (78·9%) are eligible for reimbursement if a threshold of €80,000/QALY is considered. © 2015 John Wiley & Sons Ltd.

Forecasting drug utilization and expenditure in a metropolitan health region

PubMed Central

2010-01-01

Background New pharmacological therapies are challenging the healthcare systems, and there is an increasing need to assess their therapeutic value in relation to existing alternatives as well as their potential budget impact. Consequently, new models to introduce drugs in healthcare are urgently needed. In the metropolitan health region of Stockholm, Sweden, a model has been developed including early warning (horizon scanning), forecasting of drug utilization and expenditure, critical drug evaluation as well as structured programs for the introduction and follow-up of new drugs. The aim of this paper is to present the forecasting model and the predicted growth in all therapeutic areas in 2010 and 2011. Methods Linear regression analysis was applied to aggregate sales data on hospital sales and dispensed drugs in ambulatory care, including both reimbursed expenditure and patient co-payment. The linear regression was applied on each pharmacological group based on four observations 2006-2009, and the crude predictions estimated for the coming two years 2010-2011. The crude predictions were then adjusted for factors likely to increase or decrease future utilization and expenditure, such as patent expiries, new drugs to be launched or new guidelines from national bodies or the regional Drug and Therapeutics Committee. The assessment included a close collaboration with clinical, clinical pharmacological and pharmaceutical experts from the regional Drug and Therapeutics Committee. Results The annual increase in total expenditure for prescription and hospital drugs was predicted to be 2.0% in 2010 and 4.0% in 2011. Expenditures will increase in most therapeutic areas, but most predominantly for antineoplastic and immune modulating agents as well as drugs for the nervous system, infectious diseases, and blood and blood-forming organs. Conclusions The utilisation and expenditure of drugs is difficult to forecast due to uncertainties about the rate of adoption of new

Trends in the Outpatient Utilization of Antipsychotic Drugs in the City of Zagreb in the Ten-Year Period as a Tool to Assess Drug Prescribing Rationality.

PubMed

Polić-Vižintin, Marina; Tripković, Ingrid; Štimac, Danijela; Šostar, Zvonimir; Orban, Mirjana

2016-12-01

The aim was to determine distribution and trends in the outpatient utilization of antipsychotics to evaluate the rationality of antipsychotic drug prescribing during the ten year period. The epidemiological method of descriptive and analytical observation was used. Data on drug utilization from Zagreb Municipal Pharmacy were used to calculate the number of defined daily doses (DDD) and DDD per 1000 inhabitants per day (DDD/TID) using the World Health Organization Anatomical-Therapeutic-Chemical methodology. The ratio of typical versus atypical antipsychotics served as an indicator on assessing the rationality of the utilization. Data on the use of anticholinergics in the treatment of neuroleptic side effects were also included. Outpatient utilization of antipsychotics showed a declining pattern from 14.17 in 2001 to 8.42 DDD/TID in 2010. The utilization of atypical antipsychotics increased by 60% (from 3.68 to 5.89 DDD/TID), while the utilization of typical antipsychotics decreased by 76% (from 10.49 to 2.53 DDD/TID). The drugs showing the largest increase were olanzapine (from 1.21 to 2.78 DDD/TID) and quetiapine (from 0 to 0.68 DDD/TID). The typical/atypical antipsychotic ratio changed from 1:0.4 in 2001 to 1:2.3 in 2010. A 2.3-fold decrease was recorded in the utilization of anticholinergics (from 2.05 to 0.91 DDD/TID). Total consumption of neuroleptics significantly decreased. A decrease was also recorded in the utilization of anticholinergics. Study results pointed to two favorable features, i.e. low use of typical antipsychotics and the ratio of typical and atypical antipsychotics. Implementation of the new clinical guidelines for nervous system disorders and updating of the list of reimbursable drugs with the addition of new ones contributed to the observed improvement in the prescribing patterns during the study period. Using the WHO ATC/DDD methodology and rationality indicators in the assessment of trends in the outpatient utilization of

Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

PubMed

Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

2006-01-01

To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

The clinical utility index as a practical multiattribute approach to drug development decisions.

PubMed

Poland, B; Hodge, F L; Khan, A; Clemen, R T; Wagner, J A; Dykstra, K; Krishna, R

2009-07-01

We identify some innovative approaches to predicting overall patient benefit from investigational drugs to support development decisions. We then illustrate calculation of a probabilistic clinical utility index (CUI), an implementation of multiattribute utility that focuses on clinical attributes. We recommend use of the CUI for the support of early drug development decisions because of its practicality, reasonable accuracy, and transparency to decision makers, at stages in which financial factors that may dominate later-phase decisions are less critical.

Drug therapy problems and medication discrepancies during care transitions in super-utilizers.

PubMed

Surbhi, Satya; Munshi, Kiraat D; Bell, Paula C; Bailey, James E

First, to investigate the prevalence and types of drug therapy problems and medication discrepancies among super-utilizers, and associated patient characteristics. Second, to examine the outcomes of pharmacist recommendations and estimated cost avoidance through care transitions support focused on medication management. Retrospective analysis of the pharmacist-led interventions as part of the SafeMed Program. A large nonprofit health care system serving the major medically underserved areas in Memphis, Tennessee. Three hundred seventy-four super-utilizing SafeMed participants with multiple chronic conditions and polypharmacy. Comprehensive medication review, medication therapy management, enhanced discharge planning, home visits, telephone follow-up, postdischarge medication reconciliation, and care coordination with physicians. Types of drug therapy problems, outcomes of pharmacist recommendations, estimated cost avoided, medication discrepancies, and self-reported medication adherence. Prevalence of drug therapy problems and postdischarge medication discrepancies was 80.7% and 75.4%, respectively. The most frequently occurring drug therapy problems were enrollee not receiving needed medications (33.4%), underuse of medications (16.9%), and insufficient dose or duration (11.2%). Overall 50.8% of the pharmacist recommendations were accepted by physicians and patients, resulting in an estimated cost avoidance of $293.30 per drug therapy problem identified. Multivariate analysis indicated that participants with a higher number of comorbidities were more likely to have medication discrepancies (odds ratio 1.23 [95% CI 1.05-1.44]). Additional contributors to postdischarge medication discrepancies were difficulty picking up and paying for medications and not being given necessary prescriptions before discharge. Drug therapy problems and medication discrepancies are common in super-utilizers with multiple chronic conditions and polypharmacy during transitions of care

Generic antiepileptic drugs and associated medical resource utilization in the United States.

PubMed

Labiner, D M; Paradis, P E; Manjunath, R; Duh, M S; Lafeuille, M-H; Latrémouille-Viau, D; Lefebvre, P; Helmers, S L

2010-05-18

To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States. Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (< or = 2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints. A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.13-1.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.19-1.30]; outpatient visits: IRR [95% CI] = 1.14 [1.13-1.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.27-1.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs. Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International

Patterns and predictors of analgesic use in pregnancy: a longitudinal drug utilization study with special focus on women with migraine.

PubMed

Harris, Gerd-Marie Eskerud; Wood, Mollie; Eberhard-Gran, Malin; Lundqvist, Christofer; Nordeng, Hedvig

2017-07-14

Few studies have investigated the drug utilization patterns and factors predicting drug use in pregnant women with migraine. This longitudinal drug utilization study aimed to describe patterns of analgesic use in a sample of Norwegian pregnant women according to their migraine history, and to identify predictors for analgesic use among these women. Pregnant women giving birth at Akershus University Hospital between 2008 and 2010 were recruited at ultrasound examination in gestational week 17. Data were collected by questionnaires in gestational weeks 17 and 32, and at 8 weeks postpartum, and linked to birth records. Women were grouped into four categories according to migraine history: no migraine history, previous migraine history, recent migraine history (within 1 year prior to pregnancy) and migraine in pregnancy. Patterns of use of analgesics were analyzed descriptively. Multivariable logistic regression was used to identify factors predicting analgesic use. Out of 1981 women, 5.0% reported having migraine in pregnancy, 13.2% had a recent history of migraine, 11.5% had a previous history of migraine, and 68.8% reported no history of migraine. Analgesic use declined during pregnancy. Many women switched from triptans and non-steroidal anti-inflammatory drugs to paracetamol, which constituted most of the analgesic use. Factors associated with analgesic use included recent migraine history (OR 1.6, 95% CI 1.2-2.2), more severe headache intensity (OR 1.3, 95% CI 1.3-1.4), smoking (OR 1.9, 95% CI 1.1-3.3) and multiparity (OR 1.4, 95% CI 1.1-1.7). Women with migraine stop or switch medications during pregnancy. Analgesic use in pregnancy is affected by migraine characteristics and intensity, and also by socio-demographic factors. Clinicians should bear this in mind when giving advice on adequate management of migraine in pregnancy and safe analgesic use.

Employment services utilization and outcomes among substance abusing offenders participating in California's proposition 36 drug treatment initiative.

PubMed

Evans, Elizabeth; Hser, Yih-Ing; Huang, David

2010-10-01

California drug treatment programs may use funds to address barriers to work faced by Proposition 36 offenders, most of whom are not working at treatment entry, but employment services utilization and related behavioral outcomes have never been studied. This study examined primary data collected on 1,453 offenders by 30 programs during 2004 to explore the characteristics, employment services utilization, and outcomes of those who did and did not receive employment services while in drug treatment. One-year outcomes were mostly similar across groups, however, increases in the proportion of offenders employed, receiving income from employment and family or friends, and being paid for work were significantly greater among the received-employment-services group, and a greater proportion of this group also completed drug treatment. Employment services utilization was less likely for persons recruited from outpatient settings and more likely with greater severity of family/social problems and desire for services. Odds of employment one-year post-treatment entry were higher for those of Hispanic race/ethnicity (vs. White) and for those with treatment completion/longer retention but lower for those who were older, lived in specific counties, had greater employment problem severity at intake, and received other income-related services. Strategies for improving employment services utilization and outcomes among Proposition 36 offenders are discussed.

[Pharmacoeconomic indicators of cardiovascular drug utilization in the Republic of Croatia and city of Zagreb in 2008].

PubMed

Stimac, Danijela; Stambuk, Ivanka

2010-12-01

In comparison with original drugs, generic drugs have the same efficacy but considerably lower price and should therefore be preferred to original drugs on prescribing. The aim of the present study was to assess outpatient utilization and rationality of cardiovascular drug prescribing in the City of Zagreb and Republic of Croatia based on the generic to original drug prescribing ratio. Data on the financial indicators and number of cardiovascular drug packages issued in 2008 were obtained from the Croatian Institute of Health Insurance. These data were used to calculate the number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day). The index of generic/original drug utilization was determined for Zagreb and Croatia as a measure for assessment of prescribing rationality; the significance of difference was determined by X2-test. The rate of prescribing original cardiovascular drugs was significantly higher in Zagreb as compared with Croatia as a whole. The index of prescribing generic versus original drugs was 1.20 (249/208 DDD/1000/day) in Zagreb and 1.65 (249/151 DDD/1000/day) in Croatia. Difference in the utilization of generic drugs between Zagreb and Croatia as determined by X2-test (the level of statistical significance was set at P<0.05) was statistically significant (P=0.021). The highest differences were recorded in the most widely prescribed drug groups, i.e. ACE inhibitors with the generic/original drug index of 1.38 in Zagreb and 2.02 in Croatia; and hypolipemics with the generic/original drug index of 0.96 in Zagreb and 1.34 in Croatia. According to financial indicators, the generic/original drug index was 1.44 in Croatia and only 0.96 in Zagreb. The significantly greater influence of pharmaceutical industry marketing in Zagreb entailed the significantly higher rate of original drug prescribing, which is associated with considerably greater drug expenses. Measures to stimulate prescribing generic drugs should be

Drug Treatment Service Utilization and Outcomes for Hispanic and White Methamphetamine Abusers

PubMed Central

Niv, Noosha; Hser, Yih-Ing

2006-01-01

Objective To examine differences in drug treatment service needs, utilization, satisfaction, and outcomes between Hispanic and white methamphetamine (meth) abusers. Data Sources Intake assessments and follow-up interviews of 128 Hispanic and 371 non-Hispanic white meth abusers admitted during 2000–2001 to 43 drug treatment programs in 13 counties across California. Study Design A prospective longitudinal study comparing ethnic differences in problem severity during pre- and posttreatment periods, as well as in services received during treatment. Data Collection/Extraction Methods The Addiction Severity Index (ASI) was administered at both intake and the 9-month follow-up to assess clients' problem severity in a number of domains. Service utilization and satisfaction were assessed 3 months following treatment admission. Principal Findings Hispanics were less educated and reported more employment difficulties than whites. Whites were more likely to be treated in residential programs than Hispanics despite similar severity in drug and alcohol use, legal, medical and family/social problems, and psychiatric status. Significantly more whites than Hispanics received psychiatric services, likely because more of them were treated in residential programs. Whites also reported receiving greater numbers of total services and services addressing alcohol and psychiatric problems. While no ethnic differences were found in treatment satisfaction and several other outcomes, Hispanics demonstrated better family and social outcomes than whites. Conclusions Both Hispanic and white meth abusers improved after treatment, although benefits from treatment can be further enhanced if services underscore different facets of their psychosocial problems. PMID:16899005

Drug utilization according to reason for prescribing: a pharmacoepidemiologic method based on an indication hierarchy.

PubMed

Wallach Kildemoes, Helle; Hendriksen, Carsten; Andersen, Morten

2012-10-01

To develop a pharmacoepidemiologic method for drug utilization analysis according to indication, gender, and age by means of register-based information. Statin utilization in 2005 was applied as an example. Following the recommendations for statin therapy, we constructed an indication hierarchy with eight mutually exclusive levels of register markers of cardiovascular disease and diabetes. Danish residents, as of January 1, 1996, were followed at the individual level in nationwide registers with respect to dispensed prescriptions of cardiovascular drugs and antidiabetics (1996-2005) along with discharge diagnoses and surgical procedures (1977-2005). The highest current possible indication level was assigned to all cohort members. Stratified by indication, gender, and age, statin treatment prevalence and incidence were calculated. Statin treatment prevalence was highest among individuals with myocardial infarction and tended to be higher among men with indications in the upper part of the hierarchy, but it was higher among women (especially the elderly) in the lower part of the hierarchy. Treatment incidence rates followed roughly the same pattern. Women with no register marker or primary hypertension accounted for almost 50% of all incident female users; among men, the figure was 35%. The proportion of incident users with ischemic heart disease or myocardial infarction increased with age. The proposed indication hierarchy provided new insight into prescription patterns of statins. The method can be implemented for other drug categories and could be useful for studying trends in drug utilization, differential drug adherence, and cross-national comparisons. Copyright © 2011 John Wiley & Sons, Ltd.

Health plan utilization and costs of specialty drugs within 4 chronic conditions.

PubMed

Gleason, Patrick P; Alexander, G Caleb; Starner, Catherine I; Ritter, Stephen T; Van Houten, Holly K; Gunderson, Brent W; Shah, Nilay D

2013-09-01

Drugs are most typically defined as specialty because they are expensive; however, other criteria used to define a drug as specialty include biologic drugs, the need to inject or infuse the drug, the requirement for special handling, or drug availability only via a limited distribution network. Specialty drugs play an increasingly important role in the treatment of chronic conditions such as multiple sclerosis (MS), rheumatoid arthritis (RA), psoriasis, and inflammatory bowel disease (IBD), yet little is known regarding the comprehensive medical and pharmacy benefit utilization and cost trends for these conditions. To describe MS, RA, psoriasis, and IBD trends for condition prevalence, treatment with specialty drugs, specialty costs, nonspecialty costs, and total direct costs of care within the medical and pharmacy benefits. This was a descriptive analysis of a commercially insured population made up of 1 million members, using integrated medical and pharmacy administrative claims data from 2008 to 2010. Analyses were limited to continuously enrolled commercially insured individuals less than 65 years of age. Condition-specific cohorts for MS, RA, psoriasis, and IBD were defined using standardized criteria. Trends in condition prevalence, specialty drug use for the conditions, and direct total cost of care were analyzed. The direct costs were subcategorized into the following: medical benefit specialty drug costs, medical benefit all other costs, pharmacy benefit specialty drug costs, and pharmacy benefit all other costs. Trends and compound annual growth rates were calculated for the total cost of care and subcategory costs from 2008 through 2010. Condition prevalence ranged from a low of 1,720 per million members for MS to a high of 4,489 per million members for RA. Psoriasis and MS condition prevalence rates were unchanged over the 3 years; however, IBD prevalence increased 7.0%, and RA prevalence increased 9.7%. The rate of specialty drug use was lowest for IBD

ChEMBL web services: streamlining access to drug discovery data and utilities

PubMed Central

Davies, Mark; Nowotka, Michał; Papadatos, George; Dedman, Nathan; Gaulton, Anna; Atkinson, Francis; Bellis, Louisa; Overington, John P.

2015-01-01

ChEMBL is now a well-established resource in the fields of drug discovery and medicinal chemistry research. The ChEMBL database curates and stores standardized bioactivity, molecule, target and drug data extracted from multiple sources, including the primary medicinal chemistry literature. Programmatic access to ChEMBL data has been improved by a recent update to the ChEMBL web services (version 2.0.x, https://www.ebi.ac.uk/chembl/api/data/docs), which exposes significantly more data from the underlying database and introduces new functionality. To complement the data-focused services, a utility service (version 1.0.x, https://www.ebi.ac.uk/chembl/api/utils/docs), which provides RESTful access to commonly used cheminformatics methods, has also been concurrently developed. The ChEMBL web services can be used together or independently to build applications and data processing workflows relevant to drug discovery and chemical biology. PMID:25883136

Utilizing the protein corona around silica nanoparticles for dual drug loading and release

NASA Astrophysics Data System (ADS)

Shahabi, Shakiba; Treccani, Laura; Dringen, Ralf; Rezwan, Kurosch

2015-10-01

A protein corona forms spontaneously around silica nanoparticles (SNPs) in serum-containing media. To test whether this protein corona can be utilized for the loading and release of anticancer drugs we incorporated the hydrophilic doxorubicin, the hydrophobic meloxicam as well as their combination in the corona around SNPs. The application of corona-covered SNPs to osteosarcoma cells revealed that drug-free particles did not affect the cell viability. In contrast, SNPs carrying a protein corona with doxorubicin or meloxicam lowered the cell proliferation in a concentration-dependent manner. In addition, these particles had an even greater antiproliferative potential than the respective concentrations of free drugs. The best antiproliferative effects were observed for SNPs containing both doxorubicin and meloxicam in their corona. Co-localization studies revealed the presence of doxorubicin fluorescence in the nucleus and lysosomes of cells exposed to doxorubicin-containing coated SNPs, suggesting that endocytotic uptake of the SNPs facilitates the cellular accumulation of the drug. Our data demonstrate that the protein corona, which spontaneously forms around nanoparticles, can be efficiently exploited for loading the particles with multiple drugs for therapeutic purposes. As drugs are efficiently released from such particles they may have a great potential for nanomedical applications.A protein corona forms spontaneously around silica nanoparticles (SNPs) in serum-containing media. To test whether this protein corona can be utilized for the loading and release of anticancer drugs we incorporated the hydrophilic doxorubicin, the hydrophobic meloxicam as well as their combination in the corona around SNPs. The application of corona-covered SNPs to osteosarcoma cells revealed that drug-free particles did not affect the cell viability. In contrast, SNPs carrying a protein corona with doxorubicin or meloxicam lowered the cell proliferation in a concentration

Microemulsion utility in pharmaceuticals: Implications for multi-drug delivery.

PubMed

Callender, Shannon P; Mathews, Jessica A; Kobernyk, Katherine; Wettig, Shawn D

2017-06-30

Emulsion technology has been utilized extensively in the pharmaceutical industry. This article presents a comprehensive review of the literature on an important subcategory of emulsions, microemulsions. Microemulsions are optically transparent, thermodynamically stable colloidal systems, 10-100nm diameter, that form spontaneously upon mixing of oil, water and emulsifier. This review is the first to address advantages and disadvantages, as well as considerations and challenges in multi-drug delivery. For the period 1 January 2011-30 April 2016, 431 publications related to microemulsion drug delivery were identified and screened according to microemulsion, drug classification, and surfactant types. Results indicate the use of microemulsions predominantly in lipophilic drug delivery (79.4%) via oil-in-water microemulsions and non-ionic surfactants (90%) for oral or topical administration. Cancer is the disease state most targeted followed by inflammatory diseases, microbial infections and cardiovascular disease. Key generalizations from this analysis include: 1) microemulsion formulation is largely based on trial-and-error despite over 1200 publications related to microemulsion drug delivery since their discovery in 1943; 2) characterization using methods including interfacial tension, droplet size, electrical conductivity, turbidity and viscosity may provide additional information for greater predictability; 3) microemulsion drug delivery publications arise primarily from China (27%) and India (21%) suggesting additional research opportunities elsewhere. Copyright © 2017 Elsevier B.V. All rights reserved.

ChEMBL web services: streamlining access to drug discovery data and utilities.

PubMed

Davies, Mark; Nowotka, Michał; Papadatos, George; Dedman, Nathan; Gaulton, Anna; Atkinson, Francis; Bellis, Louisa; Overington, John P

2015-07-01

ChEMBL is now a well-established resource in the fields of drug discovery and medicinal chemistry research. The ChEMBL database curates and stores standardized bioactivity, molecule, target and drug data extracted from multiple sources, including the primary medicinal chemistry literature. Programmatic access to ChEMBL data has been improved by a recent update to the ChEMBL web services (version 2.0.x, https://www.ebi.ac.uk/chembl/api/data/docs), which exposes significantly more data from the underlying database and introduces new functionality. To complement the data-focused services, a utility service (version 1.0.x, https://www.ebi.ac.uk/chembl/api/utils/docs), which provides RESTful access to commonly used cheminformatics methods, has also been concurrently developed. The ChEMBL web services can be used together or independently to build applications and data processing workflows relevant to drug discovery and chemical biology. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

Utilization of self-medication and prescription drugs among 15-year-old children from the German GINIplus birth cohort.

PubMed

Italia, Salvatore; Brand, Helmut; Heinrich, Joachim; Berdel, Dietrich; von Berg, Andrea; Wolfenstetter, Silke Britta

2015-11-01

The objective was to analyse paediatric drug utilization in relation to self-medication, prescription drugs, and the most reported therapeutic drug categories. Data were collected for 3013 children on their utilization of drugs (4-week prevalence) from a German birth cohort study (GINIplus, 15-year follow-up) using a self-administered questionnaire. The drugs were grouped into over-the-counter drugs and prescription drugs, and were classified according to the anatomical therapeutic chemical classification system. Predictors were analysed using a logistic regression model with four independent variables (gender, study area, maternal education, and parental income). Some 69% of the reported 2489 drugs were over-the-counter drugs, and 31% were prescription drugs. The 4-week prevalence for using any type of drug was 41.0%. Drug categories with high prevalence rates of use were antiinflammatory drugs (10.3%), analgesics (7.1%), and antiallergics (5.0%). Factors associated with higher use of over-the-counter drugs were female gender (OR = 1.56, p < 0.0001) and higher maternal education (OR = 1.60, p = 0.0021; university degree vs. secondary high school). Maternal education was correlated with the use of prescribed or self-medicated antiallergics (positive association) and contraceptives (negative association). The use of antibiotics, methylphenidate, and drugs for thyroid therapy was associated with lower parental income. The use of over-the-counter drugs in 15-year-old children from the GINIplus birth cohort is very common and is predicted by socioeconomic factors such as maternal education. This has to be considered by health care managers when deciding about the exclusion of over-the-counter drugs (normally used for self-medication) from reimbursement or the deregulation of drug sales. Copyright © 2015 John Wiley & Sons, Ltd.

Posaconazole exposure-response relationship: evaluating the utility of therapeutic drug monitoring.

PubMed

Dolton, Michael J; Ray, John E; Marriott, Deborah; McLachlan, Andrew J

2012-06-01

Posaconazole has become an important part of the antifungal armamentarium in the prophylaxis and salvage treatment of invasive fungal infections (IFIs). Structurally related to itraconazole, posaconazole displays low oral bioavailability due to poor solubility, with significant drug interactions and gastrointestinal disease also contributing to the generally low posaconazole plasma concentrations observed in patients. While therapeutic drug monitoring (TDM) of plasma concentrations is widely accepted for other triazole antifungal agents such as voriconazole, the utility of TDM for posaconazole is controversial due to debate over the relationship between posaconazole exposure in plasma and clinical response to therapy. This review examines the available evidence for a relationship between plasma concentration and clinical efficacy for posaconazole, as well as evaluating the utility of TDM and providing provisional target concentrations for posaconazole therapy. Increasing evidence supports an exposure-response relationship for plasma posaconazole concentrations for prophylaxis and treatment of IFIs; a clear relationship has not been identified between posaconazole concentration and toxicity. Intracellular and intrapulmonary concentrations have been studied for posaconazole but have not been correlated to clinical outcomes. In view of the high mortality and cost associated with the treatment of IFIs, increasing evidence of an exposure-response relationship for posaconazole efficacy in the prevention and treatment of IFIs, and the common finding of low posaconazole concentrations in patients, TDM for posaconazole is likely to be of significant clinical utility. In patients with subtherapeutic posaconazole concentrations, increased dose frequency, administration with high-fat meals, and withdrawal of interacting medications from therapy are useful strategies to improve systemic absorption.

A Proposal for Better Drug Utilization and Education in Tompkins County (New York)

ERIC Educational Resources Information Center

Rivkin, Lawrence S.

1976-01-01

This proposal contains a mechanism to provide the population with useful drug information at the time of purchase. This mechanism may also provide the system with useful information concerning drug utilization by the consuming public. Such information is vital to health planners and others interested in health care delivery. (Author)

Temporal Changes in Prescription of Neuropharmacologic Drugs and Utilization of Resources Related to Neurologic Morbidity in Mechanically Ventilated Children With Bronchiolitis.

PubMed

Shein, Steven L; Slain, Katherine; Wilson-Costello, Deanne; McKee, Bryan; Rotta, Alexandre T

2017-12-01

Critically ill children with bronchiolitis may require neuropharmacologic medications and support for neuro-functional sequelae, but current practices are not well described. We aimed to describe recent trends in neuropharmacology and utilization of neuro-rehabilitation resources in mechanically ventilated children with bronchiolitis. Analysis of the multicenter Pediatric Health Information System database. Forty-seven U.S. children's hospitals. PICU patients less than 2 years old with bronchiolitis undergoing mechanical ventilation between 2006 and 2015. None. Annual rates of utilization of neuropharmacologic medications (sedatives, analgesics, etc) and of neuro-rehabilitation services (physical therapy, neurologic consultation, etc) over the 10-year study period were compared. Neuropharmacologic medications prescribed on greater than or equal to 2 days were extracted. Utilization of MRI of the brain, neurologic consultation, swallow evaluation, occupational therapy, and physical therapy was also extracted. Among 12,508 subjects, the median age was 2.8 months, ~50% had comorbid conditions, and the median duration of mechanical ventilation was 7 days. The percentage of children prescribed greater than or equal to five drugs/drug classes increased over the study period from 36.5% to 55.8% (p < 0.001). There were significant increases over time in utilization of 10 of the 15 individual drugs/drug classes analyzed. More than half of subjects (6,294 [50.3%]) received at least one service that evaluates/treats neurologic morbidity. There were significant increases in the use of greater than or equal to one service (36.3% in 2006 to 59.6% in 2015; p < 0.001) and in the use of greater than or equal to two services (20.8% to 34.8%; p < 0.001). Utilization of each of the five individual resources increased significantly during the study period, but use of vasoactive medications and mortality did not. Prescription of neuropharmacologic agents increased over time using

Determinants of NSAID choice in rheumatoid arthritis--a drug utilization study.

PubMed

Inotai, András; Mészáros, Agnes

2012-01-01

Long term nonsteroidal anti-inflammatory drug (NSAID) medication is associated with gastrointestinal (GI) adverse events. This paper aimed to depict main determinants of NSAID drug choice (GI safe/traditional NSAIDs) in a rheumatoid arthritis (RA) patient sample (n=143). According to our logistic regression model, current/prior GI adverse events in the anamnesis was the only significant determinant of GI safer NSAID use (OR 3.1, p = 0.01). There was significant difference regarding most NSAIDs between the RA study sample and the total Hungarian population, suggesting that chronic administration could also influence the NSAID choice. GI safe NSAIDs were much preferred in the RA study sample than in the total population. In conclusion, the NSAID medication of the observed 143 patients was considered to be reasonable regarding both cardiovascular and GI safety.

Association between switching antiepileptic drug products and healthcare utilization: A systematic review.

PubMed

Kwan, Patrick; Palmini, André

2017-08-01

There is ongoing concern whether switching between different antiepileptic drug (AED) products may compromise patient care. We systematically reviewed changes in healthcare utilization following AED switch. We searched MEDLINE and EMBASE databases (1980-October 2016) for studies that assessed the effect of AED switching in patients with epilepsy on outpatient visits, emergency room visits, hospitalization and hospital stay duration. A total of 14 articles met the inclusion criteria. All were retrospective studies. Four provided findings for specific AEDs only (lamotrigine, topiramate, phenytoin and divalproex), 9 presented pooled findings from multiple AEDs, and 1 study provided both specific (lamotrigine, topiramate, oxcarbazepine, and levetiracetam) and pooled findings. Three studies found an association between a switch of topiramate and an increase in healthcare utilization. Another three studies found that a brand-to-generic lamotrigine switch was not associated with an increased risk of emergently treated events (ambulance use, ER visits or hospitalization). The outcomes of the pooled AED switch studies were inconsistent; 5 studies reported an increased healthcare utilization while 5 studies did not. Studies that have examined the association between an AED switch and a change in healthcare utilization report conflicting findings. Factors that may explain these inconsistent outcomes include inter-study differences in the type of analysis undertaken (pooled vs individual AED data), the covariates used for data adjustment, and the type of switch examined. Future medical claim database studies employing a prospective design are encouraged to address these and other factors in order to enhance inter-study comparability and extrapolation of findings. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Drugs foresight 2020: a Delphi expert panel study.

PubMed

Lintonen, Tomi; Konu, Anne; Rönkä, Sanna; Kotovirta, Elina

2014-05-03

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. The Delphi method was used, utilizing drug experts of the EU national network in Finland. 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. 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.

Clinical utility of genetic testing in pediatric drug-resistant epilepsy: a pilot study.

PubMed

Ream, Margie A; Mikati, Mohamad A

2014-08-01

The utility of genetic testing in pediatric drug-resistant epilepsy (PDRE), its yield in "real life" clinical practice, and the practical implications of such testing are yet to be determined. To start to address the above gaps in our knowledge as they apply to a patient population seen in a tertiary care center. We retrospectively reviewed our experience with the use of clinically available genetic tests in the diagnosis and management of PDRE in one clinic over one year. Genetic testing included, depending on clinical judgment, one or more of the following: karyotype, chromosomal microarray, single gene sequencing, gene sequencing panels, and/or whole exome sequencing (WES). We were more likely to perform genetic testing in patients with developmental delay, epileptic encephalopathy, and generalized epilepsy. In our unique population, the yield of specific genetic diagnosis was relatively high: karyotype 14.3%, microarray 16.7%, targeted single gene sequencing 15.4%, gene panels 46.2%, and WES 16.7%. Overall yield of diagnosis from at least one of the above tests was 34.5%. Disease-causing mutations that were not clinically suspected based on the patients' phenotypes and representing novel phenotypes were found in 6.9% (2/29), with an additional 17.2% (5/29) demonstrating pharmacologic variants. Three patients were incidentally found to be carriers of recessive neurologic diseases (10.3%). Variants of unknown significance (VUSs) were identified in 34.5% (10/29). We conclude that genetic testing had at least some utility in our patient population of PDRE, that future similar larger studies in various populations are warranted, and that clinics offering such tests must be prepared to address the complicated questions raised by the results of such testing. Copyright © 2014. Published by Elsevier Inc.

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

PubMed

Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

2013-01-01

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

Impact of decentralization on health services in Uganda: a look at facility utilization, prescribing and availability of essential drugs.

PubMed

Anokbonggo, W W; Ogwal-Okeng, J W; Obua, C; Aupont, O; Ross-Degnan, D

2004-02-01

Uganda began implementation of a structural adjustment programme (SAP) in July 1994 in order to improve social services. The decentralization of health services administration to district level was intended to improve the quality of health services and pharmaceutical supplies in the hospitals, with resultant increase in the level of utilization of health facilities. This study evaluated the impact of the decentralization policy on health facility utilization; availability of essential drugs, and prescribing patterns for acute respiratory infections (ARI), diarrhoea, and malaria in two district hospitals in Uganda. Mixed method evaluation design, involving both quantitative and qualitative methods. Time series analyses of data from utilization, pharmacy stock, and prescription records before and after the policy change. Key informant interviews and focus group discussions to obtain information on perceptions and attitude of stakeholders on the process of the policy implementation. STUDY SETTING AND POPULATION: The study was conducted in two district hospitals in northern Uganda. A total of seven years of utilization and pharmacy stock data including 5040 patient records from the hospitals were analysed retrospectively. In-depth interviews were conducted among 11 politicians from each district; 100 open-ended questionnaires were administered to patients in each hospital; 86 health care workers were interviewed using semi-structured questionnaires; and focus group discussions were conducted with 23 health care providers. Facility utilization was evaluated by average monthly attendance in the outpatient department and paediatric ward admissions. Availability was assessed as average number of drugs per month. Prescribing indicator outcomes included: for malaria, percent chloroquine tablets and percent chloroquine injection; for ARI, percent receiving antibiotics or injections; for diarrhoea, use of oral rehydration salts (ORS), antidiarrhoeal mixtures, and antibiotics

Utility of Phenotypic and Genotypic Testing in the Study of Mycobacterium tuberculosis Resistance to First-Line Anti-Tuberculosis drugs.

PubMed

Alba Álvarez, Luz María; García García, José María; Pérez Hernández, M Dolores; Martínez González, Susana; Palacios Gutiérrez, Juan José

2017-04-01

To determine the utility of molecular techniques in the diagnosis of resistance and the extent of resistance to first-line drugs in our region. From 2004 to 2013, 1,889 strains of Mycobacterium tuberculosis complex isolated in Asturias, Spain, were studied using phenotypic (Clinical and Laboratory Standards Institute guidelines) and molecular (INNOLiPA RIF-TB © ; GenotypeMDRplus © ; GenotypeMDRsl © ) sensitivity tests. 1,759 strains (94.52%) were sensitive to all first-line drugs, and 102 strains (5.48%) showed some resistance: 81 strains (4.35%) were resistant to 1 single drug, 14 (0.75%) were polyresistant, and 7 (0.37%) were multiresistant (resistant to rifampicin and isoniazid). In total, 137 resistances were identified: 60 to isoniazid (3.22%), 7 to rifampicin (0.37%), 9 to pyrazinamide (0.48%), 11 to ethambutol (0.59%), and 50 to streptomycin (2.68%). Of the mutations detected, 75.9% (63/83) correlated with resistance, while 24.09% of mutations detected (20/83) were not associated with resistance; 16 of these involved a silent mutation at codon 514 of the rpoB gene. Between 0 and 90% of strains, depending on the drug under consideration, were resistant even when no gene mutations were detected using marketed systems. Molecular techniques are very useful, particularly for obtaining rapid results, but these must be confirmed with standard phenotypic sensitivity testing. The rate of resistance in our region is low and multi-drug resistantcases (0.37%) are sporadic. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Strategies for Utilizing Neuroimaging Biomarkers in CNS Drug Discovery and Development: CINP/JSNP Working Group Report.

PubMed

Suhara, Tetsuya; Chaki, Shigeyuki; Kimura, Haruhide; Furusawa, Makoto; Matsumoto, Mitsuyuki; Ogura, Hiroo; Negishi, Takaaki; Saijo, Takeaki; Higuchi, Makoto; Omura, Tomohiro; Watanabe, Rira; Miyoshi, Sosuke; Nakatani, Noriaki; Yamamoto, Noboru; Liou, Shyh-Yuh; Takado, Yuhei; Maeda, Jun; Okamoto, Yasumasa; Okubo, Yoshiaki; Yamada, Makiko; Ito, Hiroshi; Walton, Noah M; Yamawaki, Shigeto

2017-04-01

Despite large unmet medical needs in the field for several decades, CNS drug discovery and development has been largely unsuccessful. Biomarkers, particularly those utilizing neuroimaging, have played important roles in aiding CNS drug development, including dosing determination of investigational new drugs (INDs). A recent working group was organized jointly by CINP and Japanese Society of Neuropsychopharmacology (JSNP) to discuss the utility of biomarkers as tools to overcome issues of CNS drug development.The consensus statement from the working group aimed at creating more nuanced criteria for employing biomarkers as tools to overcome issues surrounding CNS drug development. To accomplish this, a reverse engineering approach was adopted, in which criteria for the utilization of biomarkers were created in response to current challenges in the processes of drug discovery and development for CNS disorders. Based on this analysis, we propose a new paradigm containing 5 distinct tiers to further clarify the use of biomarkers and establish new strategies for decision-making in the context of CNS drug development. Specifically, we discuss more rational ways to incorporate biomarker data to determine optimal dosing for INDs with novel mechanisms and targets, and propose additional categorization criteria to further the use of biomarkers in patient stratification and clinical efficacy prediction. Finally, we propose validation and development of new neuroimaging biomarkers through public-private partnerships to further facilitate drug discovery and development for CNS disorders. © The Author 2016. Published by Oxford University Press on behalf of CINP.

Awareness of Mothers and Doctors about Drug Utilization Pattern for Illnesses Encountered during Pregnancy.

PubMed

Kureshee, Nargis Ibrahim; Dhande, Priti Pravin

2013-11-01

Careful consideration of the benefit to the mother and risk to the foetus, is required, while prescribing drugs during pregnancy. To assess the pattern of drug utilization during pregnancy and to explore the knowledge, attitude and awareness on drug use by the antenatal mother in a tertiary care hospital setup in western India. Observational, cross-sectional study involved holding interviews on 501 pregnant women, in OPD and IPD of Obstetrics-Gynaecology Department using a pilot-based questionnaire, was done. Data from prescriptions and case-files were also collected. Drugs were classified pharmacologically and according to teratogenic potential using U.S.FDA classification. Study population was classified according to the trimester of pregnancy and educational and socioeconomic status. Intergroup comparison was done using Chi-square test. Majority of the drugs were from Category A(71.2%) and Category B (16.5%), followed by those from Categories C(9.09%), D(1.12%) and X(0.7%). Category A drugs were significantly used more in first trimester, while Category C and D drugs were used in the last two trimesters (p<0.0001) for pregnancy associated complications. Only 24.55% of the women believed that drug use in pregnancy could be harmful to both mother and baby, while 35.52% believed that drug use could be dangerous throughout pregnancy. Patients' educational and socio-economic statuses influenced their compliance for nutritional supplements prescribed during pregnancy and their awareness on common contraceptive methods. Higher education and socioeconomic class provided information on safety of barrier contraception during pregnancy. Study revealed careful prescribing behaviour of physicians. Lack of awareness on safety of drugs in pregnancy and contraceptive use advocates a need for educating and counselling women of child bearing ages.

Emergency department utilization and subsequent prescription drug overdose death

PubMed Central

Brady, Joanne E.; DiMaggio, Charles J.; Keyes, Katherine M.; Doyle, John J.; Richardson, Lynne D.; Li, Guohua

2015-01-01

Purpose Prescription drug overdose (PDO) deaths are a critical public health problem in the United States. This study aims to assess the association between emergency department (ED) utilization patterns in a cohort of ED patients and the risk of subsequent unintentional PDO mortality. Methods Using data from the New York Statewide Planning and Research Cooperative System for 2006–2010, a nested case-control design was used to examine the relationship between ED utilization patterns in New York State residents of age 18–64 years and subsequent PDO death. Results The study sample consisted of 2732 case patients who died of PDO and 2732 control ED patients who were selected through incidence density sampling. With adjustment for demographic characteristics, and diagnoses of pain, substance abuse, and psychiatric disorders, the estimated odds ratios of PDO death relative to one ED visit or less in the previous year were 4.90 (95% confidence interval [CI]: 4.50–5.34) for those with two ED visits, 16.61 (95% CI: 14.72–18.75) for those with three ED visits, and 48.24 (95% CI: 43.23–53.83) for those with four ED visits or more. Conclusions Frequency of ED visits is strongly associated with the risk of subsequent PDO death. Intervention programs targeting frequent ED users are warranted to reduce PDO mortality. PMID:25935710

The effect of incentive-based formularies on prescription-drug utilization and spending.

PubMed

Huskamp, Haiden A; Deverka, Patricia A; Epstein, Arnold M; Epstein, Robert S; McGuigan, Kimberly A; Frank, Richard G

2003-12-04

Many employers and health plans have adopted incentive-based formularies in an attempt to control prescription-drug costs. We used claims data to compare the utilization of and spending on drugs in two employer-sponsored health plans that implemented changes in formulary administration with those in comparison groups of enrollees covered by the same insurers. One plan simultaneously switched from a one-tier to a three-tier formulary and increased all enrollee copayments for medications. The second switched from a two-tier to a three-tier formulary, changing only the copayments for tier-3 drugs. We examined the utilization of angiotensin-converting-enzyme (ACE) inhibitors, proton-pump inhibitors, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins). Enrollees covered by the employer that implemented more dramatic changes experienced slower growth than the comparison group in the probability of the use of a drug and a major shift in spending from the plan to the enrollee. Among the enrollees who were initially taking tier-3 statins, more enrollees in the intervention group than in the comparison group switched to tier-1 or tier-2 medications (49 percent vs. 17 percent, P<0.001) or stopped taking statins entirely (21 percent vs. 11 percent, P=0.04). Patterns were similar for ACE inhibitors and proton-pump inhibitors. The enrollees covered by the employer that implemented more moderate changes were more likely than the comparison enrollees to switch to tier-1 or tier-2 medications but not to stop taking a given class of medications altogether. Different changes in formulary administration may have dramatically different effects on utilization and spending and may in some instances lead enrollees to discontinue therapy. The associated changes in copayments can substantially alter out-of-pocket spending by enrollees, the continuation of the use of medications, and possibly the quality of care. Copyright 2003 Massachusetts Medical Society

Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radford, L.R.; Rankin, W.L.; Barnes, V.

This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclearmore » utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.« less

Variability in utilization of drug eluting stents in United States: Insights from nationwide inpatient sample.

PubMed

Panaich, Sidakpal S; Badheka, Apurva O; Arora, Shilpkumar; Patel, Nileshkumar J; Thakkar, Badal; Patel, Nilay; Singh, Vikas; Chothani, Ankit; Deshmukh, Abhishek; Agnihotri, Kanishk; Jhamnani, Sunny; Lahewala, Sopan; Manvar, Sohilkumar; Panchal, Vinaykumar; Patel, Achint; Patel, Neil; Bhatt, Parth; Savani, Chirag; Patel, Jay; Savani, Ghanshyambhai T; Solanki, Shantanu; Patel, Samir; Kaki, Amir; Mohamad, Tamam; Elder, Mahir; Kondur, Ashok; Cleman, Michael; Forrest, John K; Schreiber, Theodore; Grines, Cindy

2016-01-01

We studied the trends and predictors of drug eluting stent (DES) utilization from 2006 to 2011 to further expound the inter-hospital variability in their utilization. We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2006 and 2011 using ICD-9-CM procedure code, 36.06 (bare metal stent) or 36.07 (drug eluting stents) for Percutaneous Coronary Intervention (PCI). Annual hospital volume was calculated using unique identification numbers and divided into quartiles for analysis. We built a hierarchical two level model adjusted for multiple confounding factors, with hospital ID incorporated as random effects in the model. About 665,804 procedures (weighted n = 3,277,884) were analyzed. Safety concerns arising in 2006 reduced utilization DES from 90% of all PCIs performed in 2006 to a nadir of 69% in 2008 followed by increase (76% of all stents in 2009) and plateau (75% in 2011). Significant between-hospital variation was noted in DES utilization irrespective of patient or hospital characteristics. Independent patient level predictors of DES were (OR, 95% CI, P-value) age (0.99, 0.98-0.99, <0.001), female(1.12, 1.09-1.15, <0.001), acute myocardial infarction(0.75, 0.71-0.79, <0.001), shock (0.53, 0.49-0.58, <0.001), Charlson Co-morbidity index (0.81,0.77-0.86, <0.001), private insurance/HMO (1.27, 1.20-1.34, <0.001), and elective admission (1.16, 1.05-1.29, <0.001). Highest quartile hospital (1.64, 1.25-2.16, <0.001) volume was associated with higher DES placement. There is significant between-hospital variation in DES utilization and a higher annual hospital volume is associated with higher utilization rate of DES. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Utility of coloured hair for the detection of drugs and alcohol.

PubMed

Agius, Ronald

2014-06-01

The aim of this paper is to assess the utility of coloured hair for the detection of drugs and alcohol in a large statistically significant population. The positivity rate, the 1st, 5th, 50th, 95th, and 99th percentiles of five amphetamines, cannabinoids, cocaine, four opiates, methadone, buprenorphine, seven benzodiazepines, and ethyl glucuronide (EtG) in 9488 non-treated and 1026 cosmetically treated (dyed or bleached) authentic hair samples was compared. Analytical methods used were accredited for forensic purposes at the cut-offs defined by the German driving licence re-granting medical and psychological assessment (MPA) guidelines. Considering only the drug classes for which at least 10 positive samples were detected, the positivity rate in non-treated hair was highest for alcohol (4.50%; measured using EtG at concentrations ≥ 7 pg/mg hair), followed by THC (2.00%), cocaine (1.75%), and amphetamine (0.59%). While the 1st to 99th percentile range was significantly lower for drugs in treated, compared to non-treated hair, no significant change was observed for EtG. Additionally, no significant difference in the positivity rate was observed between treated hair and non-treated hair for both drugs and EtG. This study is the first attempt to evaluate the influence of cosmetic treatment, mainly dying, on the positivity rate for both drugs and EtG in hair samples submitted routinely for abstinence testing and the first to indicate that dyed and eventually bleached hair is not necessarily useless in detecting drugs and/or alcohol consumption, thus making coloured hair analysis still useful, often being the only possibility to prove such misuse. Copyright © 2014 John Wiley & Sons, Ltd.

[High utilization of health insurance services by the elderly--analysis of hospital and drug utilization data].

PubMed

Nordheim, Johanna; Maaz, Asja; Winter, Maik H J; Kuhlmey, Adelheid; Hofmann, Werner

2006-01-01

The present contribution discusses the utilization of the healthcare system by elderly patients in Germany. First, the paper focuses on the detailed characterization of a group of people aged 60 years or more (N = 73,454). Second, the objective is to analyze the data for high utilization of healthcare services by older men and women. The analysis is based on data regularly recorded by a German health insurance agency for the year 2000. High utilization is operationalized by a 10% cutoff for users with the highest number of treatments, highest costs and/or other criteria depending on the respective health service sector. The insured group investigated received approximately 1.4 million prescriptions, producing costs of 42 million E. High utilizers account for 32% of all prescriptions and 44% of the costs, respectively. At the same time, the age groups with the highest prescription rates do not cause the highest costs: So the relationship between age and prescription drug expenses as well as between age and prescription rates does not display an arithmetically increasing pattern. Within the timeframe investigated 26,000 hospital treatments were accounted for by 21.75% of the elderly under research. In total, they caused expenses of 88 million E. High utilization in the hospital sector was operationalized by four criteria. Sex- and age-specific analysis of high utilization of hospital treatment revealed that the four different criteria apply to different insured groups. In summary, the high utilization of healthcare services appears to be a multidimensional phenomenon.

Mental Health Service and Drug Treatment Utilization: Adolescents with Substance Use/Mental Disorders and Dual Diagnosis

ERIC Educational Resources Information Center

Cheng, Tyrone C.; Lo, Celia C.

2010-01-01

This research is a secondary data analysis of the impact of adolescents' mental/substance-use disorders and dual diagnosis on their utilization of drug treatment and mental health services. By analyzing the same teenagers who participated in the NIMH Methods for the Epidemiology of Child and Adolescent Mental Disorders (MECA) study, logistic…

Experimental design and statistical analysis for three-drug combination studies.

PubMed

Fang, Hong-Bin; Chen, Xuerong; Pei, Xin-Yan; Grant, Steven; Tan, Ming

2017-06-01

Drug combination is a critically important therapeutic approach for complex diseases such as cancer and HIV due to its potential for efficacy at lower, less toxic doses and the need to move new therapies rapidly into clinical trials. One of the key issues is to identify which combinations are additive, synergistic, or antagonistic. While the value of multidrug combinations has been well recognized in the cancer research community, to our best knowledge, all existing experimental studies rely on fixing the dose of one drug to reduce the dimensionality, e.g. looking at pairwise two-drug combinations, a suboptimal design. Hence, there is an urgent need to develop experimental design and analysis methods for studying multidrug combinations directly. Because the complexity of the problem increases exponentially with the number of constituent drugs, there has been little progress in the development of methods for the design and analysis of high-dimensional drug combinations. In fact, contrary to common mathematical reasoning, the case of three-drug combinations is fundamentally more difficult than two-drug combinations. Apparently, finding doses of the combination, number of combinations, and replicates needed to detect departures from additivity depends on dose-response shapes of individual constituent drugs. Thus, different classes of drugs of different dose-response shapes need to be treated as a separate case. Our application and case studies develop dose finding and sample size method for detecting departures from additivity with several common (linear and log-linear) classes of single dose-response curves. Furthermore, utilizing the geometric features of the interaction index, we propose a nonparametric model to estimate the interaction index surface by B-spine approximation and derive its asymptotic properties. Utilizing the method, we designed and analyzed a combination study of three anticancer drugs, PD184, HA14-1, and CEP3891 inhibiting myeloma H929 cell line

Clinical Utility of LC3 and p62 Immunohistochemistry in Diagnosis of Drug-Induced Autophagic Vacuolar Myopathies: A Case-Control Study

PubMed Central

Lee, Han S.; Daniels, Brianne H.; Salas, Eduardo; Bollen, Andrew W.; Debnath, Jayanta; Margeta, Marta

2012-01-01

Background Some patients treated with chloroquine, hydroxychloroquine, or colchicine develop autophagic vacuolar myopathy, the diagnosis of which currently requires electron microscopy. The goal of the current study was to develop an immunohistochemical diagnostic marker for this pathologic entity. Methodology Microtubule-associated protein light chain 3 (LC3) has emerged as a robust marker of autophagosomes. LC3 binds p62/SQSTM1, an adapter protein that is selectively degraded via autophagy. In this study, we evaluated the utility of immunohistochemical stains for LC3 and p62 as diagnostic markers of drug-induced autophagic vacuolar myopathy. The staining was performed on archival muscle biopsy material, with subject assignment to normal control, drug-treated control, and autophagic myopathy groups based on history of drug use and morphologic criteria. Principal Findings In all drug-treated subjects, but not in normal controls, LC3 and p62 showed punctate staining characteristic of autophagosome buildup. In the autophagic myopathy subjects, puncta were coarser and tended to coalesce into linear structures aligned with the longitudinal axis of the fiber, often in the vicinity of vacuoles. The percentage of LC3- and p62-positive fibers was significantly higher in the autophagic myopathy group compared to either the normal control (p<0.001) or the drug-treated control group (p<0.05). With the diagnostic threshold set between 8% and 15% positive fibers (depending on the desired level of sensitivity and specificity), immunohistochemical staining for either LC3 or p62 could be used to identify subjects with autophagic vacuolar myopathy within the drug-treated subject group (p≤0.001). Significance Immunohistochemistry for LC3 and p62 can facilitate tissue-based diagnosis of drug-induced autophagic vacuolar myopathies. By limiting the need for electron microscopy (a time consuming and costly technique with high specificity, but low sensitivity), clinical use of these

Clinical utility of LC3 and p62 immunohistochemistry in diagnosis of drug-induced autophagic vacuolar myopathies: a case-control study.

PubMed

Lee, Han S; Daniels, Brianne H; Salas, Eduardo; Bollen, Andrew W; Debnath, Jayanta; Margeta, Marta

2012-01-01

Some patients treated with chloroquine, hydroxychloroquine, or colchicine develop autophagic vacuolar myopathy, the diagnosis of which currently requires electron microscopy. The goal of the current study was to develop an immunohistochemical diagnostic marker for this pathologic entity. Microtubule-associated protein light chain 3 (LC3) has emerged as a robust marker of autophagosomes. LC3 binds p62/SQSTM1, an adapter protein that is selectively degraded via autophagy. In this study, we evaluated the utility of immunohistochemical stains for LC3 and p62 as diagnostic markers of drug-induced autophagic vacuolar myopathy. The staining was performed on archival muscle biopsy material, with subject assignment to normal control, drug-treated control, and autophagic myopathy groups based on history of drug use and morphologic criteria. In all drug-treated subjects, but not in normal controls, LC3 and p62 showed punctate staining characteristic of autophagosome buildup. In the autophagic myopathy subjects, puncta were coarser and tended to coalesce into linear structures aligned with the longitudinal axis of the fiber, often in the vicinity of vacuoles. The percentage of LC3- and p62-positive fibers was significantly higher in the autophagic myopathy group compared to either the normal control (p<0.001) or the drug-treated control group (p<0.05). With the diagnostic threshold set between 8% and 15% positive fibers (depending on the desired level of sensitivity and specificity), immunohistochemical staining for either LC3 or p62 could be used to identify subjects with autophagic vacuolar myopathy within the drug-treated subject group (p ≤ 0.001). Immunohistochemistry for LC3 and p62 can facilitate tissue-based diagnosis of drug-induced autophagic vacuolar myopathies. By limiting the need for electron microscopy (a time consuming and costly technique with high specificity, but low sensitivity), clinical use of these markers will improve the speed and accuracy of

Use of Pregabalin - A Nationwide Pharmacoepidemiological Drug Utilization Study with Focus on Abuse Potential.

PubMed

Schjerning, O; Pottegård, A; Damkier, P; Rosenzweig, M; Nielsen, J

2016-07-01

Pregabalin is currently approved for the treatment of epilepsy, generalized anxiety disorder and neuropathic pain with a licensed dosage range of 150 mg to 600 mg/day. Growing concern about the abuse potential of pregabalin is partly based on reports of pregabalin being used in dosages that exceed the approved therapeutic range. To identify predictors of pregabalin use above recommended dosage, we conducted a pharmacoepidemological drug utilization study using the Danish nationwide registers. We deployed 4 measures of abuse: high use (≥600 mg/day) or very high use (≥1 200 mg/day) over a 6- or 12-month period, respectively. Multiple logistic regression was used to identify patient and treatment characteristics that were associated with either abuse marker. Out of 42 520 pregabalin users 4 090 (9.6%) were treated with more than 600 mg/day for 6 months and 2 765 (6.5%) for more than 12 months. Male gender and prescription of antipsychotics and benzodiazepines were associated with increased risk of use of above the recommended dosage. Use of pregabalin above recommended dosages was rare but abuse may occur in susceptible patients. © Georg Thieme Verlag KG Stuttgart · New York.

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

PubMed

Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

2015-09-23

To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs

The effect of new and continuing prescription drug use on cost: a longitudinal analysis of chronic and seasonal utilization.

PubMed

Fairman, K A

2000-05-01

To provide basic information about 2 factors contributing to rising prescription drug costs--utilization trends and product selection. Prescription drug costs have risen sharply in recent years, and continued growth is expected. There is little consensus about appropriate cost-management strategies, in part because quantitative data on the causes and implications of increased drug costs are lacking. This study followed 463,820 continuously enrolled adult (> or = 18 years of age on January 1, 1996) utilizers of 15 chronic or seasonal therapeutic classes for 2.5 years (January 1996 through June 1998) using a pharmacy benefit manager's multiple-payer claims database. Outcome measures included (1) change in utilization rate, (2) relationship between new use and utilization growth, (3) stability of the treated population (ie, mostly long-term use vs high rates of turnover), and (4) product mix changes (ie, cost per dispensed day for 1996 vs 1997 and for new vs continuing users, controlling for inflation). Of the 463,820 utilizers, 97% were commercially insured and 3% enrolled in Medicare risk plans; 40% were enrolled in managed care and the remainder covered by indemnity insurance. Rates of growth and turnover varied substantially by class. The highest 2-year utilization rate change was 66.7% for antihyperlipidemic agents; change was < 10% in only 3 classes. Across classes, an average of 38.7% of 1997 users were new (ie, no use in 1996) and an average of 34.0% of 1996 users were dropouts (ie, no use in 1997). Utilization growth depended heavily on treatment continuation; classes with high dropout rates (eg, antirheumatic, antiasthmatic) did not have high growth rates, even with high rates of new use. In most classes, costs were not higher for new than for continuing users. In some classes, however (eg, antipsychotic, antidiabetic), both new and continuing users increased their use of newer, more expensive products. Because factors underlying rising prescription drug

Impact of China's Public Hospital Reform on Healthcare Expenditures and Utilization: A Case Study in ZJ Province

PubMed Central

Zhang, Hao; Hu, Huimei; Wu, Christina; Yu, Hai; Dong, Hengjin

2015-01-01

Background High drug costs due to supplier-induced demand (SID) obstruct healthcare accessibility in China. Drug prescriptions can generate markup-related profits, and the low prices of other medical services can lead to labor-force underestimations; therefore, physicians are keen to prescribe drugs rather than services. Thus, in China, a public hospital reform has been instituted to cancel markups and increase service prices. Methods A retrospective pre/post-reform study was conducted in ZJ province to assess the impact of the reform on healthcare expenditures and utilization, ultimately to inform policy development and decision-making. The main indicators are healthcare expenditures and utilization. Results Post-reform, drug expenditures per visit decreased by 8.2% and 15.36% in outpatient and inpatient care, respectively; service expenditures per visit increased by 23.03% and 27.69% in outpatient and inpatient care, respectively. Drug utilization per visit increased by 5.58% in outpatient care and underwent no significant change in inpatient care. Both were lower than the theoretical drug-utilization level, which may move along the demand curve because of patient-initiated demand (PID); this indicates that SID-promoted drug utilization may decrease. Finally, service utilization per visit increased by 6% in outpatient care and by 13.10% in inpatient care; both were higher than the theoretical level moving along the demand curve, and this indicates that SID-promoted service utilization may increase. Conclusion The reform reduces drug-prescription profits by eliminating drug markups; additionally, it compensates for service costs by increasing service prices. Post-reform, the SID of drug prescriptions decreased, which may reduce drug-resource waste. The SID of services increased, with potentially positive and negative effects: accessibility to services may be promoted when physicians provide more services, but the risk of resource waste may also increase. This

Impact of China's Public Hospital Reform on Healthcare Expenditures and Utilization: A Case Study in ZJ Province.

PubMed

Zhang, Hao; Hu, Huimei; Wu, Christina; Yu, Hai; Dong, Hengjin

2015-01-01

High drug costs due to supplier-induced demand (SID) obstruct healthcare accessibility in China. Drug prescriptions can generate markup-related profits, and the low prices of other medical services can lead to labor-force underestimations; therefore, physicians are keen to prescribe drugs rather than services. Thus, in China, a public hospital reform has been instituted to cancel markups and increase service prices. A retrospective pre/post-reform study was conducted in ZJ province to assess the impact of the reform on healthcare expenditures and utilization, ultimately to inform policy development and decision-making. The main indicators are healthcare expenditures and utilization. Post-reform, drug expenditures per visit decreased by 8.2% and 15.36% in outpatient and inpatient care, respectively; service expenditures per visit increased by 23.03% and 27.69% in outpatient and inpatient care, respectively. Drug utilization per visit increased by 5.58% in outpatient care and underwent no significant change in inpatient care. Both were lower than the theoretical drug-utilization level, which may move along the demand curve because of patient-initiated demand (PID); this indicates that SID-promoted drug utilization may decrease. Finally, service utilization per visit increased by 6% in outpatient care and by 13.10% in inpatient care; both were higher than the theoretical level moving along the demand curve, and this indicates that SID-promoted service utilization may increase. The reform reduces drug-prescription profits by eliminating drug markups; additionally, it compensates for service costs by increasing service prices. Post-reform, the SID of drug prescriptions decreased, which may reduce drug-resource waste. The SID of services increased, with potentially positive and negative effects: accessibility to services may be promoted when physicians provide more services, but the risk of resource waste may also increase. This warrants further research. It is

Clinical utility of therapeutic drug monitoring in biological disease modifying anti-rheumatic drug treatment of rheumatic disorders: a systematic narrative review.

PubMed

Van Herwaarden, Noortje; Van Den Bemt, Bart J F; Wientjes, Maike H M; Kramers, Cornelis; Den Broeder, Alfons A

2017-08-01

Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have improved the treatment outcomes of inflammatory rheumatic diseases including Rheumatoid Arthritis and spondyloarthropathies. Inter-individual variation exists in (maintenance of) response to bDMARDs. Therapeutic Drug Monitoring (TDM) of bDMARDs could potentially help in optimizing treatment for the individual patient. Areas covered: Evidence of clinical utility of TDM in bDMARD treatment is reviewed. Different clinical scenarios will be discussed, including: prediction of response after start of treatment, prediction of response to a next bDMARD in case of treatment failure of the first, prediction of successful dose reduction or discontinuation in case of low disease activity, prediction of response to dose-escalation in case of active disease and prediction of response to bDMARD in case of flare in disease activity. Expert opinion: The limited available evidence does often not report important outcomes for diagnostic studies, such as sensitivity and specificity. In most clinical relevant scenarios, predictive value of serum (anti-) drug levels is absent, therefore the use of TDM of bDMARDs cannot be advocated. Well-designed prospective studies should be done to further investigate the promising scenarios to determine the place of TDM in clinical practice.

Patterns of prescription antihypertensive drug utilization and adherence to treatment guidelines in the city of Novi Sad.

PubMed

Tomas, Ana; Tomić, Zdenko; Milijasević, Boris; Ban, Milica; Horvat, Olga; Vukmirović, Sasa; Sabo, Ana

2016-06-01

Hypertension is one of the leading causes of cardiovascular morbidity and mortality and more than a half of all health insurance expenditures for reimbursed medicines are allocated to antihypertensive drugs in Serbia. The aim of this study was to identify the antihypertensive drug utilization patterns among hypertensive outpatients in the city of Novi Sad, Serbia, determine the adherence to clinical guidelines and address the economic aspects of current prescribing practices. This retrospective observational study was conducted in Novi Sad over a period of six months. The data on the number of packages, size their, and retail price of antihypertensives issued on prescription in outpatients with the diagnosis of essential arterial hypertension was collected from all state-owned pharmacies in Novi Sad. Drug consumption was analyzed using the Anatomical Therapeutic Chemical (ATC)/ defined daily dose (DDD) methodology. Total consumption of antihypertensives issued on prescription over a 6-month period in the city of Novi sad, Serbia was 283.48 DDD per 1,000 inhabitans per day (DID). Angiotensin converting enzyme inhibitors (ACEi) were most commonly prescribed drugs, and were used 3 times more often than calcium channel blockers and 5 times more than beta-blockers. The consumption of diuretics and angiotensin receptor antagonists was low within all the groups of outpatients. Both national and international guidelines state superiority and effectiveness of diuretics in treatment of hypertension in the elderly, but their consumption was unreasonable low despite the fact that over 70% of all antihypertensive drugs in the city of Novi Sad were dispensed in people aged > 60. The use of more expensive ACEi was observed despite the guidelines deeming all the drugs of this class equally effective in treatment of hypertension. Large differences in utilization of different groups of antihypertensive agents were noted in this study. Underutilization of valuable, efficacious, and

The utilization of Arabic online drug information among adults in Saudi Arabia.

PubMed

Abanmy, Norah O; Al-Quait, Nouf A; Alami, Amani H; Al-Juhani, Meshaal H; Al-Aqeel, Sinaa

2012-10-01

In Saudi Arabia, the utilization of the world wide web has become increasingly popular. However, the exact figure of such use is unknown. This study aimed to determine the percentage of, and experience with, online Arabic drug information by Arabic-speaking adults in Saudi Arabia. A web based questionnaire was used. The questionnaire language was Arabic. Public were invited to participate in the survey through e-mails, Twitter, WhatsApp and Facebook in March 2012. The survey included 17 items examining the types of accessed Arabic drug information, the respondent's demographics, their ability to easily find and understand Arabic drug-related information, and their trustfulness and dependency on such information websites. Of the 422 Arabic speaking adults who answered the questionnaire, 88% stated that they used Arabic websites to answer drug-related questions. Of the respondents, 50% had a bachelor's degree, 44% were young adults, over half were female (60%), and 72% of them have a chronic disease. The ease of retrieving online information was the most common reason (69%) for consulting such websites. Google as a search engine was the most frequently (86%) accessible website. Although respondents reported different drug-related topics in their online searching, the search for adverse effects was the most common (68%). Respondents claimed that they could easily find (65%) and understand (49%) the drug-related information. Although a good number of respondents qualified this type of information as good, double-checking of information on other websites was highly recommended. Trustfulness was one of the important parameters to measure and 205 respondents (55%) claimed that they only trusted half of the information cited. Moreover, around 48% of respondents considered that finding the same information on more than one website increased its trustfulness. Surprisingly, 54% of respondents did not depend on Arabic information websites when making decisions on drug use

A cost-utility analysis of drug treatments in patients with HBeAg-positive chronic hepatitis B in Thailand

PubMed Central

2014-01-01

Background Only lamivudine has been included for patients with chronic hepatitis B (CHB) in the National List of Essential Drugs (NLED), a pharmaceutical reimbursement list in Thailand. There have also been no economic evaluation studies of CHB drug treatments conducted in Thailand yet. In order to fill this gap in policy research, the objective of this study was to compare the cost-utility of each drug therapy (Figure 1) with palliative care in patients with HBeAg-positive CHB. Methods A cost-utility analysis using an economic evaluation model was performed to compare each drug treatment for HBeAg-positive CHB patients. A Markov model was used to estimate the relevant costs and health outcomes during a lifetime horizon based on a societal perspective. Direct medical costs, direct non-medical costs, and indirect costs were included, and health outcomes were denoted in life years (LYs) and quality-adjusted life years (QALYs). The results were presented as an incremental cost effectiveness ratio (ICER) in Thai baht (THB) per LY or QALY gained. One-way sensitivity and probabilistic sensitivity analyses were applied to investigate the effects of model parameter uncertainties. Results The ICER values of providing generic lamivudine with the addition of tenofovir when drug resistance occurred, generic lamivudine with the addition of tenofovir based on the road map guideline, and tenofovir monotherapy were -14,000 (USD -467), -8,000 (USD -267) , and -5,000 (USD -167) THB per QALY gained, respectively. However, when taking into account all parameter uncertainties in the model, providing generic lamivudine with the addition of tenofovir when drug resistance occurred (78% and 75%) and tenofovir monotherapy (18% and 24%) would yield higher probabilities of being cost-effective at the societal willingness to pay thresholds of 100,000 (USD 3,333) and 300,000 (USD 10,000) THB per QALY gained in Thailand, respectively. Conclusions Based on the policy recommendations from this

An investigation of the representativity of neuropsychiatrists and their patients in a drug utilization observation study on fluoxetine.

PubMed

Schaaf, B; Linden, M; Weber, H J

1997-01-01

This study presents a methodological approach to an expost facto investigation of sample bias in drug utilization observation (DUO) studies using the example of a DUO with the nontricyclic antidepressant fluoxetine. A total of 479 psychiatrists and neurologists and 2,401 patients were investigated. The purpose of the study was to judge the representativeness of our DUO sample for two populations: first, for all psychiatrics and neurologists prescribing fluoxetine or all patients being treated with fluoxetine in Germany and, second, for all psychiatrists and neurologists prescribing antidepressants or all patients being treated with antidepressants in Germany. Criteria for the representativeness test were physician variables (gender, size of community where practicing, federal state, age, volume of prescriptions) and patient variables (gender, age, prescription-related diagnosis, concurrent illnesses, concomitant medications). The study shows that the DUO sample can rightfully claim representativeness in the majority of parameters for the psychiatrists and neurologists prescribing fluoxetine and for the patients being treated with fluoxetine. There are more noticeable discrepancies with regard to the psychiatrists and neurologists in general and to the patients being treated with antidepressants in general. The methodological problems of pharmacoepidemiological investigation of representativeness are discussed.

Race/ethnic disparities in the utilization of treatment for drug dependent inmates in U.S. state correctional facilities.

PubMed

Nowotny, Kathryn M

2015-01-01

Research has documented racial and ethnic disparities in utilization, access, continuity, and quality of care for psychiatric disorders including treatment for substance use disorders among those with similar need in the general community. Currently, the extent of racial and ethnic disparities in treatment within U.S. correctional facilities is unknown. This study examines race/ethnic disparities in treatment for drug dependent inmates using the 2004 Survey of Inmates in State Correctional Facilities. Fixed effects logistic regression is used to analyze treatment outcomes for 5180 inmates housed within 286 prisons. The analysis accounts for differences in background characteristics (i.e., age, gender, marital status, foreign born status, veteran status), socioeconomic characteristics (i.e., education, employment prior to incarceration), mental health (i.e., diagnosis with a serious mental illness), and incarceration experiences (i.e., current conviction, previous incarceration episodes, time served, additional sentencing requirements, external social support, disciplinary violations). The findings identify a remarkable unmet need among drug dependent inmates in that less than one-half of drug dependent inmates had received any type of treatment in prison at the time of the interview with the most common treatment type being self-help groups. Compared to whites, drug dependent Latino inmates have significantly lower odds of utilizing treatment, yet there are no significant black--white disparities found. The current study suggests that treatment for drug dependent inmates needs to be expanded to include clinically or medically based treatment since the failure to address addictions in the criminal legal system has been identified as the single most significant reason for rearrest and recidivism once released. Copyright © 2014 Elsevier Ltd. All rights reserved.

Patterns of finasteride use in the male populations of four Nordic countries: A cross-national drug utilization study.

PubMed

Kjærulff, T M; Ersbøll, A K; Green, A; Emneus, M; Pukkala, E; Bolin, K; Stavem, K; Iversen, P; Brasso, K; Hallas, J; Thygesen, L C

2016-06-01

Objective Finasteride 5 mg is a drug used to treat prostate hyperplasia. Little is known about its pattern of usage. This cross-national analysis of individual-level data from Denmark, Finland, Norway and Sweden was undertaken to appraise its usage and describe cross-national differences. Materials and methods Individual-level data from nationwide prescription registers in Denmark (1995-2009), Finland (1997-2010), Norway (2004-2009) and Sweden (July 2005-2011) were used to examine cross-national finasteride utilization patterns in the adult male population (≥15 years). The study presents period prevalences, incidence rates, waiting time distributions and Lorenz curves. Results During the study period, 295,620 men had at least one prescription redemption of finasteride 5 mg, and there were approximately 3 million dispensing events of finasteride prescriptions in the four Nordic countries. Different patterns of finasteride use were observed among the four Nordic countries. The period prevalence was markedly higher in Finland and Sweden than in Denmark and Norway. In 2009, period prevalences were 18.2/1000 males in Finland and 12.0/1000 males in Sweden compared to 6.7/1000 males in Norway and 4.9/1000 males in Denmark. Incidence rates of finasteride use for Finland, Norway and Sweden were about three times that for Denmark in 2008-2009. Long-term use of finasteride was found in all four Nordic countries with a high ratio between prevalent and incident users. Conclusion Despite resemblances regarding political systems and healthcare services in the Nordic countries, differences in finasteride utilization were found across Denmark, Finland, Norway and Sweden.

Systemic fluoroquinolone prescriptions for hospitalized children in Belgium, results of a multicenter retrospective drug utilization study.

PubMed

Meesters, Kevin; Mauel, Reiner; Dhont, Evelyn; Walle, Johan Vande; De Bruyne, Pauline

2018-02-23

Fluoroquinolones (FQ) are increasingly prescribed for children, despite being labeled for only a limited number of labeled pediatric indications. In this multicenter retrospective drug utilization study, we analyzed indications for systemic FQ prescriptions in hospitalized children and the appropriateness of the prescribed dose. Using data obtained from electronic medical files, the study included all children who received a systemic FQ prescription in two Belgian university children's hospitals between 2010 and 2013. Two authors reviewed prescribed daily doses. Univariate and multivariate logistic regression models were used to analyze risk factors for inadequately dosing. Results262 FQ prescriptions for individual patients were included for analysis. 16.8% of these prescriptions were for labeled indications, and 35.1% were guided by bacteriological findings. Prescribed daily dose was considered to be inappropriate in 79 prescriptions (30.2%). Other FQ than ciprofloxacin accounted for 9 prescriptions (3.4%), of which 8 were correctly dosed. Underdosing represented 45 (56.9%) dosing errors. Infants and preschool children were at particular risk for dosing errors, with associated adjusted OR of 0.263 (0.097-0.701) and 0.254 (0.106-0.588) respectively. FQ were often prescribed off-label and not guided by bacteriological findings in our study population. Dosing errors were common, particularly in infants and preschool children. FQ prescriptions for children should be improved by specific pediatric antimicrobial stewardship teams. Furthermore, pharmacokinetic studies should optimise dosing recommendations for children.

Prescription patterns of antihypertensives in a community health centre in Mexico City: a drug utilization study.

PubMed

Alba-Leonel, Adela; Carvajal, Alfonso; Fierro, Immaculada; Castillo-Nájera, Fernando; Campos-Ramos, Oscar; Villa-Romero, Antonio; Molina-Guarneros, Juan

2016-06-01

Hypertension is highly prevalent; in Mexico, the 2012 National Health and Nutrition Survey reported a prevalence of hypertension of 31.5% in the adult population. Pharmacological treatment is the commonest intervention and has been shown to reduce cardiovascular mortality and morbidity, and total mortality. Accordingly, the type and number of antihypertensives used and the outcome - in terms of blood pressure (BP) control - are important. Therefore, our purpose is to learn the pattern of antihypertensive drug prescription and explore the determinants of BP control in an urban population in Mexico. A retrospective cross-sectional drug utilization study was conducted. Medical records from a community health centre were searched to identify those corresponding to patients diagnosed with hypertension; information upon antihypertensives used and control of the disease was carefully retrieved. A logistic regression model was built to know the main determinants of BP control. A sample of 345 clinical records of interest was identified. Most patients received antihypertensives (86.4%); the leading medications used were angiotensin-converting enzyme inhibitors, 63.8%; beta-blockers (26.5%), diuretics (19.8%), angiotensin-receptor blockers (15.8%) and calcium-channel blockers (6.4%). Only the age (≥55 years) and BMI (>30) of the patients, and the age of the doctors (≥55 years), had an important influence on BP control. Obesity is a particular and important determinant of uncontrolled hypertension; it is worth to act on body weight, on an individual basis. As lack of control has been also tied to elderly doctors, an education programme could be envisaged. © 2016 The Authors Fundamental & Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of Société Française de Pharmacologie et de Thérapeutique.

Psychosocial Correlates of Clinicians' Prescription Drug Monitoring Program Utilization.

PubMed

Pugliese, John A; Wintemute, Garen J; Henry, Stephen G

2018-05-01

The purpose of this study is to extend prior research on barriers to use of a prescription drug monitoring program by examining psychosocial correlates of intended use among physicians and pharmacists. Overall, 1,904 California physicians and pharmacists responded to a statewide survey (24.1% response rate) from August 2016 to January 2017. Participants completed an online survey examining attitudes toward prescription drug misuse and abuse, prescribing practices, prescription drug monitoring program design and ease of use, professional obligations, and normative beliefs regarding prescription drug monitoring program use. Data were analyzed in 2017. Perceived prescription drug monitoring program usefulness and normative beliefs fully mediated the relationship between concern about prescription drug abuse and intentions to use the prescription drug monitoring program. Clinicians' sense of professional and moral obligation to use the prescription drug monitoring program was unrelated to intention to use the prescription drug monitoring program despite a positive relationship with concern about misuse and abuse. Compared with physicians, pharmacists reported greater concern about prescription drug misuse, greater professional and moral obligation to use prescription drug monitoring program, and greater rating of prescription drug monitoring program usefulness. Interventions that target normative beliefs surrounding prescription drug monitoring program use and how to use prescription drug monitoring programs effectively are likely to be more effective than those that target professional obligations or moralize to the medical community. Published by Elsevier Inc.

Treatment Utilization Among Adolescent Substance Users: Findings from the 2002 to 2013 National Survey on Drug Use and Health.

PubMed

Haughwout, Sarah P; Harford, Thomas C; Castle, I-Jen P; Grant, Bridget F

2016-08-01

Adolescent substance users face serious health and social consequences and benefit from early diagnosis and treatment. The objectives of this study were to observe trends in treatment utilization; examine correlates of treatment utilization and treatment types/settings among adolescent substance users with and without substance use disorder (SUD); and assess gender differences. National Survey on Drug Use and Health data were pooled across 2002 to 2013, with a combined sample of 79,885 past-year substance users ages 12 to 17 (17,510 with SUD and 62,375 without SUD). Treatment was defined as receiving treatment or counseling for use of alcohol or any drug, not counting cigarettes. Trends were assessed by joinpoint linear regression, and multivariable logistic regression assessed odds ratios of treatment utilization. Percentages of past-year treatment use did not change in 2002 to 2013. Treatment utilization was more prevalent among adolescents with SUD than without (11.4% vs. 1.4%) and among males than females. Among adolescents with and without SUD, criminal justice involvement and perceiving a need for treatment increased adolescent treatment utilization, while SUDs other than alcohol abuse, older age, and talking to parents increased treatment use among adolescents with SUD, and polysubstance use and male gender increased treatment among those without SUD. Treatment gaps persisted among non-Hispanic Blacks for both groups with and without SUD, male Hispanics with SUD, female non-Hispanic Asians without SUD, and private insurance coverages. Gender differences were observed in SUD, race/ethnicity, and insurance coverage. Most adolescents received treatment for both alcohol and drug use, and self-help group and outpatient rehabilitation facility were the most used treatment settings. Treatment utilization among adolescents with past-year substance use remained low and unimproved in 2002 to 2013. Treatment gaps among minority populations, insurance coverage, and in

Theoretical Studies for Dendrimer-Based Drug Delivery.

PubMed

Bello, Martiniano; Fragoso-Vázquez, Jonathan; Correa-Basurto, José

2017-01-01

Numerous theoretical studies have been performed to iteratively optimize the physicochemical properties such as dendrimer size and surface constituents in solution, as well as their molecular recognition properties for drugs, lipid membranes, nucleic acids and proteins, etc. Molecular modeling approaches such as docking and molecular dynamic (MD) simulations have supported experimental efforts by providing important insights into the structural properties of dendrimers in solution and possible binding properties of drugs at the atomic level. We review the utilization of molecular modelling tools to obtain insight into the study and design of dendrimers, with particular importance placed on the improvement of binding properties of dendrimers for their use as drug nanocarriers and to increase the water solubility properties and drug delivery. The modeling studies discussed in this review have provided substantial insight into the physicochemical properties of dendrimers in solution, including solvent pH and counterion distribution, at the atomic level, as well as the elucidation of some of the key interactions in solution of unmodified and modified dendrimers with some drugs of pharmaceutics interest and biological systems such as nucleic acids, proteins and lipid membranes. the described studies illustrate that whether simulations will be run at the all-atom or coarse-grained level, physicochemical conditions such as the type of force field, the treatment of electrostatics effects, counterion distribution, protonation state of dendrimers, and dendrimer concentrations which have been probed to play a crucial role in the structural behavior and binding properties must be prudently incorporated in the simulations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Experimental Design for Multi-drug Combination Studies Using Signaling Networks

PubMed Central

Huang, Hengzhen; Fang, Hong-Bin; Tan, Ming T.

2017-01-01

Summary Combinations of multiple drugs are an important approach to maximize the chance for therapeutic success by inhibiting multiple pathways/targets. Analytic methods for studying drug combinations have received increasing attention because major advances in biomedical research have made available large number of potential agents for testing. The preclinical experiment on multi-drug combinations plays a key role in (especially cancer) drug development because of the complex nature of the disease, the need to reduce development time and costs. Despite recent progresses in statistical methods for assessing drug interaction, there is an acute lack of methods for designing experiments on multi-drug combinations. The number of combinations grows exponentially with the number of drugs and dose-levels and it quickly precludes laboratory testing. Utilizing experimental dose-response data of single drugs and a few combinations along with pathway/network information to obtain an estimate of the functional structure of the dose-response relationship in silico, we propose an optimal design that allows exploration of the dose-effect surface with the smallest possible sample size in this paper. The simulation studies show our proposed methods perform well. PMID:28960231

Study Drugs

MedlinePlus

... to quit, they may have withdrawal symptoms like depression, thoughts of suicide, intense drug cravings, sleep problems, and fatigue. The health risks aren't the only downside to study drugs. Students caught with illegal prescription drugs may get suspended ...

The impact of China's retail drug price control policy on hospital expenditures: a case study in two Shandong hospitals.

PubMed

Meng, Qingyue; Cheng, Gang; Silver, Lynn; Sun, Xiaojie; Rehnberg, Clas; Tomson, Göran

2005-05-01

In China, 44.4% of total health expenditures in 2001 were for pharmaceuticals. Containment of pharmaceutical expenditures is a top priority for policy intervention. Control of drug retail prices was adopted by the Chinese government for this purpose. This study aims to examine the impact of this policy on the containment of hospital drug expenditures, and to analyze contributing factors. This is a retrospective pre/post-reform case study in two public hospitals. Financial records were reviewed to analyze changes in drug expenditures for all patients. A tracer condition, cerebral infarction, was selected for in-depth examination of changes in prices, utilization, expenditures and rationality of drugs. In the two hospitals, a total of 104 and 109 cerebral infarction cases, hospitalized respectively before and after the reform, were selected. Prescribed daily dose (PDD) was used for measuring drug utilization, and the contribution of price and utilization to changes in drug expenditures were decomposed. Rationality of drug use post-reform was reviewed based on published literature. Drug expenditures for all patients still increased rapidly in the two hospitals after implementation of the pricing policy. In the provincial hospital, drug expenditures per patient for cerebral infarction cases declined, but not significantly. This was mainly attributable to reduced utilization. In the municipal hospital, drug expenditure per patient increased by 50.1% after the reform, mainly due to greater drug utilization. Three to five fold higher drug expenditure per inpatient day in the provincial hospital was due to use of more expensive drugs. Of the top 15 drugs for treating cerebral infarction cases after the reform, 19.5% and 46.5% of the expenditures, in the provincial and municipal hospitals, respectively, were spent on drugs with prices set by the government. A large proportion of expenditures for the top 15 drugs, at least 65% and 41% in the provincial and municipal

Effect of Prescription Drug Coupons on Statin Utilization and Expenditures: A Retrospective Cohort Study.

PubMed

Daubresse, Matthew; Andersen, Martin; Riggs, Kevin R; Alexander, G Caleb

2017-01-01

Drug coupons are widely used, but their effects are not well understood. To quantify the effect of coupons on statin use and expenditures. Retrospective cohort analysis of IMS Health LRx LifeLink database. U.S. retail pharmacy transactions. Incident statin users who initiated branded atorvastatin or rosuvastatin between June 2006 and February 2013. Monthly statin utilization (pill-days of therapy), switching (filling a different statin), termination (failure to refill statin for 6 mo), and out-of-pocket and total costs. Of 1.1 million incident atorvastatin and rosuvastatin users, 2% used a coupon for at least one statin fill. At 1 year, compared with noncoupon users, those who used a statin coupon on their first fill were dispensed an equal number of monthly pill-days (23.7 vs 23.8), were less likely to switch statins (14.4% vs 16.3%), and were less likely to have terminated statin therapy (31.3% vs 39.2%). At 4 years, coupon users were more likely to have switched (45.5% vs 40.8%) and less likely to have terminated statin therapy (50.6% vs 61.1%) compared with noncoupon users. Those who used greater numbers of coupons were substantially less likely to switch and terminate statin therapies. Monthly out-of-pocket costs were lower among coupon than noncoupon users at 1 year ($9.7 vs $15.1), but total monthly costs were qualitatively similar ($115.5 vs $116.9). At 4 years, monthly out-of-pocket costs among coupon users remained lower ($14.3 vs $16.6) compared with noncoupon users. Sensitivity analyses supported the main results. Coupons for branded statins are associated with higher utilization and lower rates of discontinuation and short-term switching to other statin products. © 2016 Pharmacotherapy Publications, Inc.

Can Untargeted Metabolomics Be Utilized in Drug Discovery/Development?

PubMed

Caldwell, Gary W; Leo, Gregory C

2017-01-01

Untargeted metabolomics is a promising approach for reducing the significant attrition rate for discovering and developing drugs in the pharmaceutical industry. This review aims to highlight the practical decision-making value of untargeted metabolomics for the advancement of drug candidates in drug discovery/development including potentially identifying and validating novel therapeutic targets, creating alternative screening paradigms, facilitating the selection of specific and translational metabolite biomarkers, identifying metabolite signatures for the drug efficacy mechanism of action, and understanding potential drug-induced toxicity. The review provides an overview of the pharmaceutical process workflow to discover and develop new small molecule drugs followed by the metabolomics process workflow that is involved in conducting metabolomics studies. The pros and cons of the major components of the pharmaceutical and metabolomics workflows are reviewed and discussed. Finally, selected untargeted metabolomics literature examples, from primarily 2010 to 2016, are used to illustrate why, how, and where untargeted metabolomics can be integrated into the drug discovery/preclinical drug development process. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris.

PubMed

Tan, Xi; Al-Dabagh, Amir; Davis, Scott A; Lin, Hsien-Chang; Balkrishnan, Rajesh; Chang, Jongwha; Feldman, Steven R

2013-06-01

Acne vulgaris is a common chronic disease that may require long-term treatment. Medication adherence is critical to acne management; non-adherence is a common reason for treatment failure and can lead to poor quality of life. The aim of the study was to examine medication adherence, healthcare costs, and utilization associated with acne drugs among acne patients in the USA. This was a retrospective cohort study from January 2004 to December 2007 using the Marketscan Medicaid Database, a national healthcare claims database. The study followed acne patients aged 0-64 years for 90 days after the first acne drug prescription to measure acne medication adherence, acne-related outpatient visits, and total acne-related healthcare costs. Adherence was measured among different acne drug classes using medication possession ratio (MPR). Multivariate regression analyses were conducted to assess the outcomes. The study included 24,438 eligible patients, of whom 89.39 % were under 18 years old. The average adherence rate to acne drugs (MPR) was 0.34, and only 11.74 % of the patients were adherent (MPR ≥0.80). Patients with drug refills had a higher adherence rate (MPR = 0.74) than who those without refills (MPR = 0.27). Factors significantly associated with adherence were age, comorbidity, gender, number of drug refills and number of drug classes used. Patients were more adherent to oral retinoids than any other acne drug classes (MPR = 0.78, 57 % adherent). Patients were less adherent to oral antibiotics (MPR = 0.21) and topical retinoids (MPR = 0.31). After controlling for medication use behavior, the use of oral antibiotics decreased the number of acne-related outpatient visits by 50.9 % (p < 0.001) and lowered acne-related total costs by 51.7 % (p < 0.001). Medication non-adherence is generally prevalent among young acne patients enrolled in Medicaid. The combination of a topical retinoid and an antibiotic agent may be a good choice given their associated healthcare

Race/Ethnic Disparities in the Utilization of Treatment for Drug Dependent Inmates in U.S. State Correctional Facilities

PubMed Central

Nowotny, Kathryn M.

2014-01-01

This study examines race/ethnic disparities in treatment for drug dependent inmates in state correctional facilities. The data come from the 2004 Survey of Inmates in State Correctional Facilities. Fixed effects logistic regression is used to analyze treatment outcomes for 5,180 inmates housed within 286 prisons. The analysis accounts for differences in background characteristics (i.e., age, gender, marital status, foreign born status, veteran status), socioeconomic characteristics (i.e., education, employment prior to incarceration), mental health (i.e., diagnosis with a serious mental illness), and incarceration experiences (i.e., current conviction, previous incarceration episodes, time served, additional sentencing requirements, external social support, disciplinary violations). The findings identify a remarkable unmet need among drug dependent inmates in that less than one-half of drug dependent inmates had received any type of treatment in prison at the time of the interview with the most common treatment type being self-help groups. Compared to whites, drug dependent Latino inmates have significantly lower odds of utilizing treatment, yet there are no significant black-white disparities found. Implications for drug treatment within prisons are discussed. PMID:25270722

Comparing the Medicaid Retrospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies.

PubMed

Prada, Sergio I

2017-12-01

The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR and involves ongoing and periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug-drug interaction, or medically unnecessary care, implementing corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure prescription drug cost-savings generated from its DUR programs on an annual basis, but it provides no guidance or unified methodology for doing so. To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid retrospective DUR program in federal fiscal years 2014 and 2015. For each state, the cost-savings methodologies included in the Medicaid DUR 2014 and 2015 reports were downloaded from Medicaid's website. The reports were then reviewed and synthesized. Methods described by the states were classified according to research designs often described in evaluation textbooks. In 2014, the most often used prescription drugs cost-savings estimation methodology for the Medicaid retrospective DUR program was a simple pre-post intervention method, without a comparison group (ie, 12 states). In 2015, the most common methodology used was a pre-post intervention method, with a comparison group (ie, 14 states). Comparisons of savings attributed to the program among states are still unreliable, because of a lack of a common methodology available for measuring cost-savings. There is great variation among states in the methods used to measure prescription drug utilization cost-savings. This analysis suggests that there is still room for improvement in terms of

Drug utilization, prescription errors and potential drug-drug interactions: an experience in rural Sri Lanka.

PubMed

Rathish, Devarajan; Bahini, Sivaswamy; Sivakumar, Thanikai; Thiranagama, Thilani; Abarajithan, Tharmarajah; Wijerathne, Buddhika; Jayasumana, Channa; Siribaddana, Sisira

2016-06-25

Prescription writing is a process which transfers the therapeutic message from the prescriber to the patient through the pharmacist. Prescribing errors, drug duplication and potential drug-drug interactions (pDDI) in prescriptions lead to medication error. Assessment of the above was made in prescriptions dispensed at State Pharmaceutical Corporation (SPC), Anuradhapura, Sri Lanka. A cross sectional study was conducted. Drugs were classified according to the WHO anatomical, therapeutic chemical classification system. A three point Likert scale, a checklist and Medscape online drug interaction checker were used to assess legibility, completeness and pDDIs respectively. Thousand prescriptions were collected. Majority were hand written (99.8 %) and from the private sector (73 %). The most frequently prescribed substance and subgroup were atorvastatin (4 %, n = 3668) and proton pump inhibitors (7 %, n = 3668) respectively. Out of the substances prescribed from the government and private sectors, 59 and 50 % respectively were available in the national list of essential medicines, Sri Lanka. Patients address (5 %), Sri Lanka Medical Council (SLMC) registration number (35 %), route (7 %), generic name (16 %), treatment symbol (48 %), diagnosis (41 %) and refill information (6 %) were seen in less than half of the prescriptions. Most were legible with effort (65 %) and illegibility was seen in 9 %. There was significant difference in omission and/or errors of generic name (P = 0.000), dose (P = 0.000), SLMC registration number (P = 0.000), and in evidence of pDDI (P = 0.009) with regards to the sector of prescribing. The commonest subgroup involved in duplication was non-steroidal anti-inflammatory drugs (NSAIDs) (43 %; 56/130). There were 1376 potential drug interactions (466/887 prescriptions). Most common pair causing pDDI was aspirin with losartan (4 %, n = 1376). Atorvastatin was the most frequently prescribed substance

Comparative Resuscitation Measures for Drug Toxicities Utilizing Lipid Emulsions

DTIC Science & Technology

2015-01-13

experimental, mixed research design Methods: For each drug studied, seven swine were assigned to eight ACLS or BLS protocol resuscitation groups ...studied drug overdose. For example, with bupivacaine, seventy- one percent of the epinephrine/lipid group survived compared to 19% of all the groups ...surviving. The Epinephrine only group yielded three survivors and the Lipid emulsion only group yielded one survivor. No swine in the CPR only or

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

Comparing the Medicaid Retrospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies

PubMed Central

Prada, Sergio I.

2017-01-01

Background The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR and involves ongoing and periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug–drug interaction, or medically unnecessary care, implementing corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure prescription drug cost-savings generated from its DUR programs on an annual basis, but it provides no guidance or unified methodology for doing so. Objectives To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid retrospective DUR program in federal fiscal years 2014 and 2015. Method For each state, the cost-savings methodologies included in the Medicaid DUR 2014 and 2015 reports were downloaded from Medicaid's website. The reports were then reviewed and synthesized. Methods described by the states were classified according to research designs often described in evaluation textbooks. Discussion In 2014, the most often used prescription drugs cost-savings estimation methodology for the Medicaid retrospective DUR program was a simple pre-post intervention method, without a comparison group (ie, 12 states). In 2015, the most common methodology used was a pre-post intervention method, with a comparison group (ie, 14 states). Comparisons of savings attributed to the program among states are still unreliable, because of a lack of a common methodology available for measuring cost-savings. Conclusion There is great variation among states in the methods used to measure prescription drug utilization cost-savings. This analysis suggests that

An overview of herbal supplement utilization with particular emphasis on possible interactions with dental drugs and oral manifestations.

PubMed

Abebe, Worku

2003-01-01

Herbal medication in the United States is a popular form of therapy. This paper provides an overview of the utilization of herbal supplements with particular emphasis on possible interactions with oral health drugs and oral manifestations. Herbal supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA), which limits their regulation by the U.S Food and Drug Administration (FDA). A number of studies indicate that there is a progressive increase in the utilization of herbal supplements. The majority of consumers of these products are white, middle-aged women who have some college education. Many of the consumers use pharmaceutical drugs concurrently, but most do not inform their health-care providers about their use of herbal supplements. Various herbal supplements have been reported or are suspected to interact with certain oral health drugs, the most important one being 1) bromelain, cayenne, chamomile, feverfew, dong quai, eleuthro/Seberian ginseng, garlic, ginkgo, ginger, ginseng and licorice interacting with aspirin; 2) aloe latex, ephedra, ginseng, rhubarb, cascara sagrada, licorice, and senna interacting with corticosteriods; 3) kava, St. John's wort, chamomile, and valerian interacting with central nervous system (CNS) depressant drugs; and 4) herbs acting on the gastrointestinal system, altering the absorption of several orally administered drugs. Further, the use of some herbal supplements has been reported to be associated with oral manifestations, including aphthous ulcers, lip and tongue irritation, and swelling with feverfew; gingival bleeding with feverfew and ginkgo; tongue numbness with echinacea; xerostomia with St. John's wort; oral and lingual dyskinesia with kava; and salivation with yohimbe. These potential effects of herbal supplements in conjunction with factors related to regulation restrictions suggest that the use of these products may be associated with various adverse reactions that can affect oral health and

Adverse drug effects in hospitalized elderly: Data from the Healthcare Cost and Utilization Project

PubMed Central

Shamliyan, Tatyana

2010-01-01

We aimed to analyze trends in hospital admissions due to adverse drug effects between the years 2000 to 2007 among the elderly using the National Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project. We identified the discharges with the principal and all listed diagnoses related to adverse drug effects and associated hospital charges using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes. Between 2000 and 2007, 321,057 patients over 65 years were discharged with a principal diagnosis related to an adverse drug effect. Hospital charges were $5,329,276,300 or $666,159,537 annual cost. The number of discharges and total hospital charges did not change over the examined years, while mean charge per discharge increased on average by $1064 ± 384 per year. Total hospital charges for drug-induced gastritis with hemorrhage increased the most by $11,206,555 per year among those 66–84 years old and by $8,646,456 per year among those older than 85 years. During 2007, 791,931 elderly had adverse treatment effects among all listed diagnoses with hospital charges of $937,795,690. Effective drug management interventions are needed to improve safety of treatments in the elderly. PMID:22291486

Variation in Antiosteoporotic Drug Prescribing and Spending Across Spain. A Population-Based Ecological Cross-Sectional Study.

PubMed

Sanfélix-Gimeno, Gabriel; Librero-López, Julián; Modroño-Riaño, Gracia; Peiró, Salvador; Rodríguez-Bernal, Clara L

2018-01-01

Introduction: Evidence has shown that utilization of antiosteoporotic medications does not correspond with risk, and studies on other therapies have shown that adequacy of pharmaceutical prescribing might vary between regions. Nevertheless, very few studies have addressed the variability in osteoporotic drug consumption. We aimed to describe variations in pharmaceutical utilization and spending on osteoporotic drugs between Health Areas (HA) in Spain. Methods: Population-based cross-sectional ecological study of expenditure and utilization of the five therapeutic groups marketed for osteoporosis treatment in Spain in 2009. Small area variation analysis (SAVA) methods were used. The units of analysis were the 168 HA of 13 Spanish regions, including 7.2 million women aged 50 years and older. The main outcomes were the defined daily dose (DDD) per 1000 inhabitants and day (DDD/1000/Day) dispensed according to the pharmaceutical claims reimbursed, and the expenditure on antiosteoporotics at retail price per woman ≥50 years old and per year. Results: The average osteoporosis drug consumption was 116.8 DDD/1000W/Day, ranging from 78.5 to 158.7 DDD/1000W/Day between the HAs in the 5th and 95th percentiles. Seventy-five percent of the antiosteoporotics consumed was bisphosphonates, followed by raloxifene, strontium ranelate, calcitonins, and parathyroid hormones including teriparatide. Regarding variability by therapeutic groups, biphosphonates showed the lowest variation, while calcitonins and parathyroid hormones showed the highest variation. The annual expenditure on antiosteoporotics was €426.5 million, translating into an expenditure of €59.2 for each woman ≥50 years old and varying between €38.1 and €83.3 between HAs in the 5th and 95th percentiles. Biphosphonates, despite accounting for 79% of utilization, only represented 63% of total expenditure, while parathyroid hormones with only 1.6% of utilization accounted for 15% of the pharmaceutical spending

Pediatric Asthma Mortality and Hospitalization Trends Across Asia Pacific Relationship With Asthma Drug Utilization Patterns

PubMed Central

2009-01-01

Background The wide variability in prevalence of childhood asthma across Asia Pacific is well documented, but less is known about its trends in mortality and hospitalization. Objectives To examine pediatric asthma mortality and hospitalization trends of selected countries across Asia Pacific, and also patterns of asthma drug utilization. Materials and Methods Mortality and population data were sourced from the World Health Organization's mortality database. Data on hospitalization were obtained by direct inquiry and from government and scientific publications. Drug use for asthma was expressed as a controller-to-reliever (C:R) ratio (ie, units of inhaled corticosteroids/units of short-acting β-agonists, sold in each country). Time-series regression analyses were used to examine temporal patterns and study association between deaths, hospitalizations, and drug use. Results Japan showed a decreasing trend in pediatric asthma mortality whereas an increase was observed in Thailand. Hospitalizations decreased in Australia and Singapore but increased in Taiwan, Republic of China. C:R ratios increased significantly across the countries. Conclusions Mixed trends in pediatric asthma mortality and hospitalization rates were observed, which coincided with a uniform increase in C:R ratios. This may reflect importance of other aspects of asthma management besides pharmacotherapy. PMID:23283014

Drug utilization review of cephalosporins in a secondary care hospital in United Arab Emirates.

PubMed

Abou-Shaaban, Mohammad; Ali, Areeg Anwer; Rao, Padma G M; Majid, Asif

2016-12-01

Background Cephalosporins are one of the most commonly used antibiotics in United Arab Emirates (UAE). Few studies have been carried out to evaluate the antibiotic utilization pattern in UAE in spite of the obvious increase in cephalosporins resistance during the past decade. Objective To assess the prescriptions pattern of cephalosporins among physicians at a secondary care hospital in Ras Al Khaimah, UAE. Method This observational prospective study was carried out during October 2013 to April 2014. The data of in patients were documented in the predesigned patient profile form and was analyzed for patient's, drug's and drug's therapy related parameters. Results The 3rd generation cephalosporins constituted 83.6 % of the prescriptions, with ceftriaxone being the most commonly used one (81.1 %). They were mainly prescribed for the treatment of the lower respiratory tract infections (60.2 %). Seven (3.5 %) different ADRs linked to cephalosporin use were observed ranging from oral thrush to clostridium difficile infection. A total of 1039 antimicrobial and nonantimicrobial medications were prescribed concomitantly with cephalosporins. Conclusion The 3rd generation cephalosporins were commonly prescribed by parenteral route. Thus, there is a strong need for rationalizing their use to preserve their efficacy and prevent the development of resistance in the region.

Plasmonic nanocarrier grid-enhanced Raman sensor for studies of anticancer drug delivery.

PubMed

Kurzątkowska, Katarzyna; Santiago, Ty; Hepel, Maria

2017-05-15

Targeted drug delivery systems using nanoparticle nanocarriers offer remarkable promise for cancer therapy by discriminating against devastating cytotoxicity of chemotherapeutic drugs to healthy cells. To aid in the development of new drug nanocarriers, we propose a novel plasmonic nanocarrier grid-enhanced Raman sensor which can be applied for studies and testing of drug loading onto the nanocarriers, attachment of targeting ligands, dynamics of drug release, assessment of nanocarrier stability in biological environment, and general capabilities of the nanocarrier. The plasmonic nanogrid sensor offers strong Raman enhancement due to the overlapping plasmonic fields emanating from the nearest-neighbor gold nanoparticle nanocarriers and creating the enhancement "hot spots". The sensor has been tested for immobilization of an anticancer drug gemcitabine (2',2'-difluoro-2'-deoxycytidine, GEM) which is used in treatment of pancreatic tumors. The drawbacks of currently applied treatment include high systemic toxicity, rapid drug decay, and low efficacy (ca. 20%). Therefore, the development of a targeted GEM delivery system is highly desired. We have demonstrated that the proposed nanocarrier SERS sensor can be utilized to investigate attachment of targeting ligands to nanocarriers (attachment of folic acid ligand recognized by folate receptors of cancer cells is described). Further testing of the nanocarrier SERS sensor involved drug release induced by lowering pH and increasing GSH levels, both occurring in cancer cells. The proposed sensor can be utilized for a variety of drugs and targeting ligands, including those which are Raman inactive, since the linkers can act as the Raman markers, as illustrated with mercaptobenzoic acid and para-aminothiophenol. Copyright © 2017 Elsevier B.V. All rights reserved.

Use of gastroprotective agents in recommended doses in hospitalized patients receiving NSAIDs: a drug utilization study.

PubMed

Erdeljic, Viktorija; Francetic, Igor; Macolic Sarinic, Viola; Bilusic, Marinko; Makar Ausperger, Ksenija; Huic, Mirjana; Mercep, Iveta

2006-10-01

In recent years, studies investigated to what extend recommendations for co-prescribing gastroprotective agents in prevention of NSAID-induced gastrointestinal complications are followed in clinical practice. However, only a few studies have also taken into consideration the recommended dose of gastroprotectives prescribed in NSAID-induced ulcer prophylaxis. The aim of our study was to evaluate the prevalence of concomitant use of gastroprotectives with NSAIDs in hospitalized patients, with emphasis on the recommended dose of gastroprotectives for ulcer prophylaxis. This observational, cross-sectional, drug utilization study included all adult patients receiving NSAIDs hospitalized in the Clinical Hospital Center Zagreb on the day of the study. Data on age, sex, comorbidities, indications for NSAID use, type/dose of NSAIDs and gastroprotectives, history of gastrointestinal events, active gastrointestinal symptoms and risk factors were evaluated. Study outcomes were: (1) prevalence of prescription of gastroprotectives among NSAID-users at risk; (2) prevalence of prescription of gastroprotective in recommended dose; (3) association between risk factors and prescription of GPAs. The rates of gastroprotectives prescription were significantly higher in NSAID-users with concomitant risk factors as compared to patients without risk factors [47/70 (67.1%) and 8/22 (36.4%), respectively; p=0.01072]. However, gastroprotection in recommended ulcer-preventive dose was low in both groups [8/70 (11.4%) and 9/92 (9.8%), respectively]. The number of concomitant risk factors did not increase the odds of receiving anti-ulcer therapy (odds ratio 0.7279). Thirty-three percent of patients with concomitant risk factors were not prescribed gastroprotectives. Ibuprofen, NSAID with the lowest risk of inducing gastrointestinal complications, was prescribed in only two patients. The results indicate high awareness among hospital physicians about possible NSAID-induced gastrointestinal

Trends in prescription drug utilization and spending for the Department of Defense, 2002-2007.

PubMed

Devine, Joshua W; Trice, Shana; Spridgen, Stacia L; Bacon, Thomas A

2009-09-01

Examine trends in U.S. Department of Defense (DoD) outpatient drug spending and utilization between 2002 and 2007. We analyzed pharmacy claims data from the U.S. Military Health System (MHS), using a cross-sectional analysis at the prescription and patient-year level and measuring utilization in 30-day equivalent prescriptions and expenditures in dollars. Pharmaceutical spending more than doubled in DoD, from $3 billion in FY02 to $6.5 billion in FY07. The largest increase occurred in the DoD community pharmacy network, where utilization grew from 6 million 30-day equivalent prescriptions in the first quarter of FY02 to more than 16 million in the last quarter of FY07. The smallest increase in annual spending occurred in FY07 (5.5%), down from a high of 27.5% in FY03. The MHS has experienced rapid growth in pharmaceutical spending since FY02. However, there are signs that growth in pharmaceutical spending may be slowing.

Effect of a therapeutic maximum allowable cost (MAC) program on the cost and utilization of proton pump inhibitors in an employer-sponsored drug plan in Canada.

PubMed

Mabasa, Vincent H; Ma, Johnny

2006-06-01

Therapeutic maximum allowable cost (MAC) is a managed care intervention that uses reference pricing in a therapeutic class or category of drugs or an indication (e.g., heartburn). Therapeutic MAC has not been studied in Canada or the United States. The proton pump inhibitor (PPI) rabeprazole was used as the reference drug in this therapeutic MAC program based on prices for PPIs in the province of Ontario. No PPI is available over the counter in Canada. To evaluate the utilization and anticipated drug cost savings for PPIs in an employer-sponsored drug plan in Canada that implemented a therapeutic MAC program for PPIs. An employer group with an average of 6,300 covered members, which adopted the MAC program for PPIs in June 2003, was compared with a comparison group comprising the book of business throughout Canada (approximately 5 million lives) without a PPI MAC program (non-MAC group). Pharmacy claims for PPIs were identified using the first 6 characters of the generic product identifier (GPI 492700) for a 36-month period from June 1, 2002, through May 31, 2005. The primary comparison was the year prior to the intervention (from June 1, 2002, through May 31, 2003) and the first full year following the intervention (June 1, 2004, through May 31, 2005). Drug utilization was evaluated by comparing the market share of each of the PPIs for the 2 time periods and by the days of PPI therapy per patient per year (PPPY) and days of therapy per prescription (Rx). Drug cost was defined as the cost of the drug (ingredient cost), including allowable provincial pharmacy markup but excluding pharmacy dispense fee. Cost savings were calculated from the allowed drug cost per claim, allowed cost per day, and allowed cost PPPY. (All amounts are in Canadian dollars.) The MAC intervention group experienced an 11.7% reduction in the average cost per day of PPI drug therapy, from 2.14 US dollars in the preperiod to 1.89 US dollars in the postperiod, compared with a 3.7% reduction in

Effects of electronic prescribing on formulary compliance and generic drug utilization in the ambulatory care setting: a retrospective analysis of administrative claims data.

PubMed

Ross, S Michael; Papshev, Diana; Murphy, Erin L; Sternberg, David J; Taylor, Jeffrey; Barg, Ronald

2005-06-01

Electronic prescribing (e-prescribing) provides formulary information at the point of care. The objective of this study was to assess the effects of e-prescribing on formulary compliance and generic utilization. This was a retrospective analysis of pharmacy claims data from a large national managed care organization. A sample of 95 providers using predominantly e-prescribing was randomly selected (e-prescriber group). A matched sample of 95 traditional prescribers was selected (traditional prescriber group), matched to the e-prescriber group by zip code and medical specialty. A total of 110,975 paid pharmacy claims, for the 12 months from August 1, 2001, through July 31, 2002, were analyzed to assess the effect of e-prescribing on formulary compliance and generic utilization. All paid pharmacy claims were examined for each group; for the e-prescriber group, this included all claims, not just those prescribed using an e-prescribing device. A written qualitative survey was distributed to physicians and office managers to assess e-prescribing usage, sources of formulary information, and effects of e-prescribing on office resources. Both predominantly e-prescribers and traditional prescribers demonstrated high levels of formulary compliance, 83.2% versus 82.8%, respectively (P=0.32). Formulary compliance for these groups did not differ from the overall prescriber population (82.0%). There was not a difference in generic drug utilization rates between e-prescribers and traditional prescribers (absolute rates 37.3% versus 36.9%, P=0.18). Qualitative survey responses supported previously reported research indicating reductions in calls both to and from pharmacies for prescription orders. An examination of paid pharmacy claims from a large, national managed care organization demonstrated no differences between predominantly e-prescribers and traditional prescribers in measures of formulary compliance or generic drug utilization. Future studies should examine keystroke data

A study on utilization of oral contraceptives in the City of Zagreb (2008-2010).

PubMed

Zelić-Kerep, Ana; Stimac, Danijela; Ozić, Sanja; Zivković, Kresimir; Zivković, Nikica

2014-06-01

Main aim of this study is to quantify and analyze the utilization and utilization trends of oral hormonal contraceptives in the City of Zagreb, 2008-2010, and to propose potential interventions, if necessary. Data gathered from Zagreb pharmacies were assessed by Anatomical Therapeutic Chemical Classification of drugs and Daily Defined Dose methodology. An alarming decrease in total utilization of hormonal contraceptives by 76% from 2008-2009 was found as the main result of this study. A major decrease by 95.5% in utilization of G03AB04 subgroup, sequential combined oral contraceptives, was noted in the year 2009. The subgroup G03AC0, progesterone-only pill group, showed a stable trend, and it became the most utilized subgroup in 2010, due to the decrease in utilization of both fixed and sequential combined oral contraceptives. Utilization of oral contraceptives in Croatia is not regulated adequately, since such dynamics in utilization can occur unnoticed. Measures need to take place in order to improve this situation. Proposed measures include organized farmacovigilance, prescription based on guidelines, and strict screening for risk factors in women seeking oral contraception. More research is required in Croatia to understand the pattern of utilization of hormonal contraceptives and to find the true cause of decrease in utilization of oral contraceptives.

A Study of Outpatient Pharmacy Utilization at Naval Hospital, Camp Lejeune

DTIC Science & Technology

2002-07-01

5,468.87 LAMOTRIGINE 19 $4,907.53 ROSIGLITAZONE MALEATE 43 $4,849.93 ATORVASTATIN CALCIUM 47 $4,761.28 Table 10. Pharmacy Utilization 45 The Top 20 NHCL... ATORVASTATIN CALCIUM 246 $19,647.89 OXYCODONE HCL 132 $17,217.78 LANSOPRAZOLE 118 $16,499.98 PIOGLITAZONE HCL 83 $11,250.99 LORATADINE 150 $10,138.27...2,564.48 ATORVASTATIN CALCIUM 17 $2,276.93 LANSOPRAZOLE 13 $2,268.28 Table 13. Pharmacy Utilization 48 The Top 20 Drugs Utilized by NHCL Non-Prime

Do drug formulary policies reflect evidence of value?

PubMed

Neumann, Peter J; Lin, Pei-Jung; Greenberg, Dan; Berger, Marc; Teutsch, Steven; Mansley, Edward; Weinstein, Milton C; Rosen, Allison B

2006-01-01

To investigate the extent to which preferred drug lists and tiered formularies reflect evidence of value, as measured in published cost-utility analyses (CUAs). Using 1998-2001 data from a large registry of cost-effectiveness analyses, we examined the 2004 Florida Medicaid preferred drug list and the 2004 Harvard Pilgrim Pharmacy Program 3-tier formulary, and compared cost-utility ratios (standardized to 2002 US dollars) of drugs with preferred and nonpreferred status. Few drugs on the formularies had any cost-utility data available. Of those that did, median cost-utility ratios were somewhat higher (less favorable) for Florida's preferred drugs compared with the nonpreferred drugs (25,465 dollars vs 13,085 dollars; P = .09). Ratios did not differ for drugs on tiers 1 and 2 of the Harvard Pilgrim formulary, although they were higher for tier 3 and for excluded drugs (18,309 dollars, 18,846 dollars, 52,119 dollars, and 22,580 dollars, respectively; P = .01). Among therapies reported to be cost-saving or to have cost-utility ratios below 50,000 dollars, 77% had favored status in Florida Medicaid and 73% in Harvard Pilgrim. Among dominated drug interventions (reported to be more costly and less effective than alternatives), 95% had favored status in Florida Medicaid and 56% in Harvard Pilgrim. This study underscores the paucity of published cost-utility data available to formulary committees. Some discrepancies prevail between the value of drugs, as reflected in published cost-utility ratios, and the formulary placement policies of 2 large health plans.

Reservoir-Based Drug Delivery Systems Utilizing Microtechnology

PubMed Central

Stevenson, Cynthia L.; Santini, John T.; Langer, Robert

2012-01-01

This review covers reservoir-based drug delivery systems that incorporate microtechnology, with an emphasis on oral, dermal, and implantable systems. Key features of each technology are highlighted such as working principles, fabrication methods, dimensional constraints, and performance criteria. Reservoir-based systems include a subset of microfabricated drug delivery systems and provide unique advantages. Reservoirs, whether external to the body or implanted, provide a well-controlled environment for a drug formulation, allowing increased drug stability and prolonged delivery times. Reservoir systems have the flexibility to accommodate various delivery schemes, including zero order, pulsatile, and on demand dosing, as opposed to a standard sustained release profile. Furthermore, the development of reservoir-based systems for targeted delivery for difficult to treat applications (e.g., ocular) has resulted in potential platforms for patient therapy. PMID:22465783

Indolealkylamines: biotransformations and potential drug-drug interactions.

PubMed

Yu, Ai-Ming

2008-06-01

Indolealkylamine (IAA) drugs are 5-hydroxytryptamine (5-HT or serotonin) analogs that mainly act on the serotonin system. Some IAAs are clinically utilized for antimigraine therapy, whereas other substances are notable as drugs of abuse. In the clinical evaluation of antimigraine triptan drugs, studies on their biotransformations and pharmacokinetics would facilitate the understanding and prevention of unwanted drug-drug interactions (DDIs). A stable, principal metabolite of an IAA drug of abuse could serve as a useful biomarker in assessing intoxication of the IAA substance. Studies on the metabolism of IAA drugs of abuse including lysergic acid amides, tryptamine derivatives and beta-carbolines are therefore emerging. An important role for polymorphic cytochrome P450 2D6 (CYP2D6) in the metabolism of IAA drugs of abuse has been revealed by recent studies, suggesting that variations in IAA metabolism, pharmaco- or toxicokinetics and dynamics can arise from distinct CYP2D6 status, and CYP2D6 polymorphism may represent an additional risk factor in the use of these IAA drugs. Furthermore, DDIs with IAA agents could occur additively at the pharmaco/toxicokinetic and dynamic levels, leading to severe or even fatal serotonin toxicity. In this review, the metabolism and potential DDIs of these therapeutic and abused IAA drugs are described.

Healthcare resource utilization following switch or discontinuation in multiple sclerosis patients on disease modifying drugs.

PubMed

Reynolds, Matthew W; Stephen, Reejis; Seaman, Chris; Rajagopalan, Kitty

2010-03-01

The objective of this study was to explore the cost and utilization in the period following discontinuations or switches of disease modifying drugs (DMDs) for patients with multiple sclerosis (MS). Secondary objectives included an assessment of the time to switch or discontinuation from index DMD treatment. Cases were defined as a billed MS diagnosis in continuously enrolled patients initiated with interferon-beta1a IM, interferon-beta1b SC, glatiramer acetate, and interferon-beta1a SC found in the PharMetrics Patient-Centric Database. Information on patient demographics, diagnoses, procedures, pharmacy-dispensed drugs, and costs was extracted; reasons for discontinuation and expenses outside of the healthcare system were not available. Treatment discontinuations and switches between study drugs were defined using pharmacy prescription patterns and analyzed by descriptive and regression methods. The non-pharmacy medical costs in the 18 months following switching or discontinuation were compared to the costs in a randomly selected similar period for those patients who did not switch or discontinue these agents. A total of 5,772 MS patients were continuously enrolled and were treated with one or more of the four drugs of interest, and about half of these patients switched drugs or discontinued treatment for at least 90 days. Patients initiated with interferon-beta1b SC were more likely to discontinue treatment compared to interferon-beta1a IM users. Non-pharmaceutical medical costs were highest for those switching treatments followed by those discontinuing DMDs in the 18 months following a switch or discontinuation, compared to persistent users of these drugs. Interferon beta1b SC initiators had higher costs following changes or discontinuations, while glatiramer acetate and interferon-beta1a SC users had lower subsequent costs compared to interferon-beta1a IM users. Unfortunately, the reasons for stopping the initial treatment cannot be determined from analysis of

Outpatient utilization of psychopharmaceuticals in the City of Zagreb 2001-2006.

PubMed

Stimac, Danijela; Culig, Josip

2009-03-01

A comprehensive insight into drug utilization as an economic and primarily a public health issue can only be acquired in the context of overall health state of the respective population. The objectives of the study were: 1) to determine the real outpatient utilization of psychopharmaceuticals in Zagreb, 2) to determine the psychopharmaceutical prescribing quality during the study period; and 3) to propose appropriate interventions in Zagreb on the basis of the results obtained. Data on drug utilization were obtained from all Zagreb pharmacies. The number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day) were calculated from the number of particular drug packages. The Drug Utilization 90% (DU90%) method was used as a criterion of prescribing quality. Outpatient utilization of psychopharmaceuticals showed a declining pattern from 115.40 DDD/1000/day in 2001 to 93.15 DDD/1000/day in 2006. Anxiolytics accounted for the majority of this drug group utilization in the City of Zagreb, although the anxiolytic/antidepressant ratio decreased from 7.19 in 2001 to 3.86 in 2006. The utilization of selective serotonin reuptake inhibitors showed a 2.5-fold increase and accounted for 90% of overall antidepressant utilization. A 2.5-fold decrease was recorded in the utilization of antipsychotics, while the atypical/typical antipsychotic ratio changed from 1:2 in 2001 to 1.1:1 in 2006. Despite some improvement observed in the prescribing quality, the predominance of benzodiazepines in the utilization of psychopharmaceuticals points to the need of additional rationalization in the field.

Resource utilization with insulin pump therapy for type 2 diabetes mellitus.

PubMed

Lynch, Peter M; Riedel, Aylin Altan; Samant, Navendu; Fan, Ying; Peoples, Tim; Levinson, Jennifer; Lee, Scott W

2010-01-01

To evaluate the effects of switching from multiple daily injection (MDI) therapy to insulin pump therapy, also called continuous subcutaneous insulin infusion (CSII), on antidiabetic drug and healthcare resource utilization. This study was a retrospective analysis of administrative claims data from a large geographically diverse health plan in the United States from January 1, 2005, through April 30, 2008. Changes in antidiabetic drug use, antidiabetic drug switching and augmentation, and healthcare utilization during the baseline period and after CSII initiation were assessed using paired t test. There were 3649 possible subjects, of whom 943 met the criteria for analysis. The mean number of antidiabetic drugs used decreased by 46% after CSII initiation, and the mean reduction in antidiabetic drug utilization was 0.67; both were statistically significant. More than one-third of subjects who were taking antidiabetic drugs before CSII initiation discontinued oral therapy after CSII initiation. The number of subjects using multiple antidiabetic drugs significantly decreased after CSII initiation by 58%, and rates of switching or augmenting significantly decreased from 42% at baseline to 25% after CSII initiation.The rates of emergency department visits and inpatient admissions significantly decreased, and the rate of ambulatory visits significantly increased. CSII was associated with significant decreases in antidiabetic drug and healthcare resource utilization, contributing to stability of care. The evidence from this study indicates that CSII should be considered as an option for patients with type 2 diabetes mellitus who are using MDI and are experiencing a high degree of antidiabetic drug and healthcare resource utilization.

Methods for comparing drug policies--the utility of composite drug harm indexes.

PubMed

Ritter, Alison

2009-11-01

One of the challenges for drug policy research is being able to compare policy options and outcomes. The development of indexes, such as the UK Drug Harm Index or the UNODC Illicit Drug Index is a way to systematically enable such comparisons. An Index is a single common metric that represents the diverse outcomes or consequences of drug use. An Index may be used for performance monitoring within one country/region over time; to establish societal benefit of drug policies as expressed in social costs saved; to compare countries or regions; or for comparative policy analysis. Clarity of purpose is important in how an Index is used. The consequences or outcomes that can be combined into a single Index include health consequences, crime consequences, public amenity, pain and suffering, labour market outcomes, and drug manufacture and trafficking activity. The choice of outcomes for inclusion is driven by the purpose but also often by practical considerations, such as data availability. The weighting of the consequences is an important consideration in translating the outcomes into a common metric. A monetary unit has a number of advantages: it is a unit that can be measured across diverse impacts; it gives implicit "weighting" of harms; and it is intuitive for policy makers and community. On the other hand, it represents an economic perspective. No one Index will be regarded as suitable and appropriate by every stakeholder and ongoing research effort on Indexes is an important foundational research activity to advance illicit drug policy.

Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

PubMed

Wang, Bo; Canestaro, William J; Choudhry, Niteesh K

2014-12-01

Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process. To evaluate the evidence that supports pharmacogenomic biomarker testing in drug labels and how frequently testing is recommended. Publicly available US Food and Drug Administration databases. We identified drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (ie, the ability to predict phenotype) and clinical utility (ie, the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention Working Group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision making. Of the 119 drug-biomarker combinations, only 43 (36.1%) had labels that provided convincing clinical validity evidence, whereas 18 (15.1%) provided convincing evidence of clinical utility. Sixty-one labels (51.3%) made recommendations about how clinical decisions should be based on the results of a biomarker test; 36 (30.3%) of these contained convincing clinical utility data. A full description of supporting studies was included in 13 labels (10.9%). Fewer than one-sixth of drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas more than half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.

Impact of Doctors' Resistance on Success of Drug Utilization Review System

PubMed Central

Choi, Jong Soo; Yun, Seong Hyeon; Kim, Dongsoo

2014-01-01

Objectives The drug utilization review (DUR) system, which checks any conflict event of medications, contributes to improve patient safety. One of the important barriers in its adoption is doctors' resistance. This study aimed to analyze the impacts of doctors' resistance on the success of the DUR system. Methods This study adopted an augmented the DeLone and McLean Information System (D&M IS) Success Model (2003), which used doctors' resistance as a socio-technological measure. This study framework is the same as that of the D&M IS Success Model in that it is based on qualities, such as system, information, and services. The major difference is that this study excluded the variable 'use' because it was not statistically significant for mandatory systems. A survey of doctors who used computers to enter prescriptions was conducted at a Korean tertiary hospital in February 2012. Results This study is very meaningful in that it is the first study to explore the success factors of the DUR system associated with doctors' resistance. Doctors' resistance to the DUR system was not statistically associated with user usefulness, whereas it affected user satisfaction. Conclusions The results indicate that doctors still complain of discomfort in using the DUR system in the outpatient clinical setting, even though they admit that it contributes to patient safety. To mitigate doctors' resistance and raise user satisfaction, more opinions from doctors regarding the DUR system have to be considered and have to be reflected in the system. PMID:24872908

[Prescribing and drug utilization at community health centers].

PubMed

Diawara, A; Sangho, H; Maiga, D; Kone, A B D; Maiga, M D; Simaga, S Y

2007-01-01

The rationalization of the prescription and the good use of the drugs generally constitute a major problem in the health facilities. The present survey led in November 2002 in Mali assessed the practices of prescription and the use of the drugs by the populations. The indicators of drugs use rational have been measured from 600 drawn prescriptions randomly select at the level of 20 community health center (CSCOM) retained at random in the regions of Ségou, Sikasso, Mopti and the District of Bamako. The means of drugs by order (2.8), the percentages of prescription with antibiotic (61.6%) and injectable drugs (35%) are raised in relation to the normative values of WHO (Wold Health Organization). The rate of conformity to the treatments standardized estimated on exploitation of consultations registers in the centers is estimated to 0.5% for the simple diarrhoea, 13.5% for the acute respiratory infections (ARI) without pneumonia and 60.5% for the pneumonia. On 293 patients in the households our survey permitted to estimate to 84.6% the observance of the treatment by the persons having bought the prescribed drugs totality. The percentage of antibiotics prescription and injectable drugs, and the big insufficiency in the non respect of the treatment standard constitutes some practices potentially to high risk justifying the necessity of an urgent training to the rational prescription.

Drug metabolism and hypersensitivity reactions to drugs.

PubMed

Agúndez, José A G; Mayorga, Cristobalina; García-Martin, Elena

2015-08-01

The aim of the present review was to discuss recent advances supporting a role of drug metabolism, and particularly of the generation of reactive metabolites, in hypersensitivity reactions to drugs. The development of novel mass-spectrometry procedures has allowed the identification of reactive metabolites from drugs known to be involved in hypersensitivity reactions, including amoxicillin and nonsteroidal antiinflammatory drugs such as aspirin, diclofenac or metamizole. Recent studies demonstrated that reactive metabolites may efficiently bind plasma proteins, thus suggesting that drug metabolites, rather than - or in addition to - parent drugs, may elicit an immune response. As drug metabolic profiles are often determined by variability in the genes coding for drug-metabolizing enzymes, it is conceivable that an altered drug metabolism may predispose to the generation of reactive drug metabolites and hence to hypersensitivity reactions. These findings support the potential for the use of pharmacogenomics tests in hypersensitivity (type B) adverse reactions, in addition to the well known utility of these tests in type A adverse reactions. Growing evidence supports a link between genetically determined drug metabolism, altered metabolic profiles, generation of highly reactive metabolites and haptenization. Additional research is required to developing robust biomarkers for drug-induced hypersensitivity reactions.

How do researchers categorize drugs, and how do drug users categorize them?

PubMed Central

Lee, Juliet P.; Antin, Tamar M.J.

2011-01-01

This paper considers drug classifications and terms widely used in US survey research, and compares these to classifications and terms used by drug users. We begin with a critical review of drug classification systems, including those oriented to public policy and health services as well as survey research. We then consider the results of a pile sort exercise we conducted with 76 respondents within a mixed method study of Southeast Asian American adolescent and young adult drug users in urban Northern California, USA. We included the pile sort to clarify how respondents handled specific terms which we understood to be related to Ecstasy and methamphetamines. Results of the pile sort were analyzed using graphic layout algorithms as well as content analysis of pile labels. Similar to the national surveys, our respondents consistently differentiated Ecstasy terms from methamphetamine terms. We found high agreement between some specific local terms (thizz, crystal) and popular drug terms, while other terms thought to be mainstream (crank, speed) were reported as unknown by many respondents. In labeling piles, respondents created taxonomies based on consumption method (in particular, pill) as well as the social contexts of use. We conclude by proposing that divergences between drug terms utilized in survey research and those used by drug users may reflect two opposing tendencies: the tendency of survey researchers to utilize standardized language that constructs persons and experiences as relatively homogeneous, varying only within measurable degrees, and the tendency of drug users to utilize specialized language (argot) that reflects their understandings of their experiences as hybrid and diverse. The findings problematize the validity of drug terms and categories used in survey research. PMID:24431475

How do researchers categorize drugs, and how do drug users categorize them?

PubMed

Lee, Juliet P; Antin, Tamar M J

2012-01-01

This paper considers drug classifications and terms widely used in US survey research, and compares these to classifications and terms used by drug users. We begin with a critical review of drug classification systems, including those oriented to public policy and health services as well as survey research. We then consider the results of a pile sort exercise we conducted with 76 respondents within a mixed method study of Southeast Asian American adolescent and young adult drug users in urban Northern California, USA. We included the pile sort to clarify how respondents handled specific terms which we understood to be related to Ecstasy and methamphetamines. Results of the pile sort were analyzed using graphic layout algorithms as well as content analysis of pile labels. Similar to the national surveys, our respondents consistently differentiated Ecstasy terms from methamphetamine terms. We found high agreement between some specific local terms ( thizz , crystal ) and popular drug terms, while other terms thought to be mainstream ( crank , speed ) were reported as unknown by many respondents. In labeling piles, respondents created taxonomies based on consumption method (in particular, pill ) as well as the social contexts of use. We conclude by proposing that divergences between drug terms utilized in survey research and those used by drug users may reflect two opposing tendencies: the tendency of survey researchers to utilize standardized language that constructs persons and experiences as relatively homogeneous, varying only within measurable degrees, and the tendency of drug users to utilize specialized language (argot) that reflects their understandings of their experiences as hybrid and diverse. The findings problematize the validity of drug terms and categories used in survey research.

High-throughput screening of PLGA thin films utilizing hydrophobic fluorescent dyes for hydrophobic drug compounds.

PubMed

Steele, Terry W J; Huang, Charlotte L; Kumar, Saranya; Widjaja, Effendi; Chiang Boey, Freddy Yin; Loo, Joachim S C; Venkatraman, Subbu S

2011-10-01

Hydrophobic, antirestenotic drugs such as paclitaxel (PCTX) and rapamycin are often incorporated into thin film coatings for local delivery using implantable medical devices and polymers such as drug-eluting stents and balloons. Selecting the optimum coating formulation through screening the release profile of these drugs in thin films is time consuming and labor intensive. We describe here a high-throughput assay utilizing three model hydrophobic fluorescent compounds: fluorescein diacetate (FDAc), coumarin-6, and rhodamine 6G that were incorporated into poly(d,l-lactide-co-glycolide) (PLGA) and PLGA-polyethylene glycol films. Raman microscopy determined the hydrophobic fluorescent dye distribution within the PLGA thin films in comparison with that of PCTX. Their subsequent release was screened in a high-throughput assay and directly compared with HPLC quantification of PCTX release. It was observed that PCTX controlled-release kinetics could be mimicked by a hydrophobic dye that had similar octanol-water partition coefficient values and homogeneous dissolution in a PLGA matrix as the drug. In particular, FDAc was found to be the optimal hydrophobic dye at modeling the burst release as well as the total amount of PCTX released over a period of 30 days. Copyright © 2011 Wiley-Liss, Inc.

Towards 90-90-90 Target: Factors Influencing Availability, Access, and Utilization of HIV Services—A Qualitative Study in 19 Ugandan Districts

PubMed Central

Tumwebaze, Flora; Akakimpa, Denis; Kityo, Cissy; Mugyenyi, Peter; Abongomera, George

2018-01-01

Background UNAIDS has set a new target 90-90-90 by 2020. To achieve this target, current programs need to address challenges that limit access, availability, and utilization of HIV testing and treatment services. Therefore, the aim of this study was to identify the barriers that influence access, availability, and utilization of HIV services in rural Uganda within the setting of a large donor funded program. Methods We conducted key informant interviews with stakeholders at the district level, staff of existing HIV/AIDS projects, and health facilities in 19 districts. Data were also collected from focus group discussions comprised of clients presenting for HIV care and treatment. Data were transcribed and analyzed using content analysis. Results. Barriers identified were as follows: (1) drug shortages including antiretroviral drugs at health facilities. Some patients were afraid to start ART because of worrying about shortages; (2) distance and (3) staffing shortages; (4) stigma persistence; (5) lack of social and economic support initiatives that enhance retention in treatment. Conclusions In conclusion, our study has identified several factors that influence access, availability, and utilization of HIV services. Programs need to address drug and staff shortages, HIV stigma, and long distances to health facilities to broaden access and utilization in order to realize the UNAIDS target. PMID:29750175

Utility of patch testing for patients with drug eruption.

PubMed

Ohtoshi, S; Kitami, Y; Sueki, H; Nakada, T

2014-04-01

Patch testing is less dangerous than oral provocation testing for identification of the causative drug for patients with drug eruption; however, its usefulness for such identification is controversial. To clarify the rates of positive patch testing for patients with drug eruption, classified by causative drugs and clinical features. We analysed results during the period 1990-2010 for 444 patients (151 men, 293 women; mean ± SD age 49.9 ± 18.6 years) who were tested for drug eruption. In the patient group, there were 309 people (69.1%) with maculopapular eruption and 31 (6.9%) with severe drug eruption. The test materials were applied to the back and left for 2 days under occlusion, then results were assessed by the International Contact Dermatitis Research Group (ICDRG) scoring system 3 days after application. Reactions of + to +++ were regarded as positive. Of the 444 patients, 100 (22.4%) had a positive patch test result to a suspected drug. Positive rates were 23.6% and 20.0% for maculopapular eruption and fixed drug eruption, respectively. The class of materials to which most patients reacted positively was contrast medium (n = 53; 41.1%), followed by drugs acting on the central nervous system (n = 18; 28.6%). In the latter group, 16 of the 18 patients were positive to antiepileptics. Positive rates depend on the causative drug rather than the clinical features of the drug eruption. Patch testing is useful when contrast medium or antiepileptics are suspected to be the causative drugs. However, standardization of patch test materials and method of reading is needed, as well as guidelines regarding when testing should be performed. Although patch testing for drug eruption has significant potential, it requires further validation. © 2014 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

"A'ole" Drugs! Cultural Practices and Drug Resistance of Rural Hawai'ian Youths

ERIC Educational Resources Information Center

Po'A-Kekuawela, Ka'Ohinani; Okamoto, Scott K.; Nebre, La Risa H.; Helm, Susana; Chin, Coralee I. H.

2009-01-01

This qualitative study examined how Native Hawai'ian youths from rural communities utilized cultural practices to promote drug resistance and/or abstinence. Forty-seven students from five different middle schools participated in gender-specific focus groups that focused on the cultural and environmental contexts of drug use for Native Hawai'ian…

Moving on From Representativeness: Testing the Utility of the Global Drug Survey.

PubMed

Barratt, Monica J; Ferris, Jason A; Zahnow, Renee; Palamar, Joseph J; Maier, Larissa J; Winstock, Adam R

2017-01-01

A decline in response rates in traditional household surveys, combined with increased internet coverage and decreased research budgets, has resulted in increased attractiveness of web survey research designs based on purposive and voluntary opt-in sampling strategies. In the study of hidden or stigmatised behaviours, such as cannabis use, web survey methods are increasingly common. However, opt-in web surveys are often heavily criticised due to their lack of sampling frame and unknown representativeness. In this article, we outline the current state of the debate about the relevance of pursuing representativeness, the state of probability sampling methods, and the utility of non-probability, web survey methods especially for accessing hidden or minority populations. Our article has two aims: (1) to present a comprehensive description of the methodology we use at Global Drug Survey (GDS), an annual cross-sectional web survey and (2) to compare the age and sex distributions of cannabis users who voluntarily completed (a) a household survey or (b) a large web-based purposive survey (GDS), across three countries: Australia, the United States, and Switzerland. We find that within each set of country comparisons, the demographic distributions among recent cannabis users are broadly similar, demonstrating that the age and sex distributions of those who volunteer to be surveyed are not vastly different between these non-probability and probability methods. We conclude that opt-in web surveys of hard-to-reach populations are an efficient way of gaining in-depth understanding of stigmatised behaviours and are appropriate, as long as they are not used to estimate drug use prevalence of the general population.

Moving on From Representativeness: Testing the Utility of the Global Drug Survey

PubMed Central

Barratt, Monica J; Ferris, Jason A; Zahnow, Renee; Palamar, Joseph J; Maier, Larissa J; Winstock, Adam R

2017-01-01

A decline in response rates in traditional household surveys, combined with increased internet coverage and decreased research budgets, has resulted in increased attractiveness of web survey research designs based on purposive and voluntary opt-in sampling strategies. In the study of hidden or stigmatised behaviours, such as cannabis use, web survey methods are increasingly common. However, opt-in web surveys are often heavily criticised due to their lack of sampling frame and unknown representativeness. In this article, we outline the current state of the debate about the relevance of pursuing representativeness, the state of probability sampling methods, and the utility of non-probability, web survey methods especially for accessing hidden or minority populations. Our article has two aims: (1) to present a comprehensive description of the methodology we use at Global Drug Survey (GDS), an annual cross-sectional web survey and (2) to compare the age and sex distributions of cannabis users who voluntarily completed (a) a household survey or (b) a large web-based purposive survey (GDS), across three countries: Australia, the United States, and Switzerland. We find that within each set of country comparisons, the demographic distributions among recent cannabis users are broadly similar, demonstrating that the age and sex distributions of those who volunteer to be surveyed are not vastly different between these non-probability and probability methods. We conclude that opt-in web surveys of hard-to-reach populations are an efficient way of gaining in-depth understanding of stigmatised behaviours and are appropriate, as long as they are not used to estimate drug use prevalence of the general population. PMID:28924351

Differential effects of ibogaine on local cerebral glucose utilization in drug-naive and morphine-dependent rats.

PubMed

Levant, Beth; Pazdernik, Thomas L

2004-04-02

Ibogaine, a hallucinogenic indole alkaloid, has been proposed as a treatment for addiction to opioids and other drugs of abuse. The mechanism for its putative anti-addictive effects is unknown. In this study, the effects of ibogaine on local cerebral glucose utilization (LCGU) were determined in freely moving, drug-naive, or morphine-dependent adult, male, Sprague-Dawley rats using the [(14)C]2-deoxyglucose (2-DG) method. Morphine-dependent rats were treated with increasing doses of morphine (5-25 mg/kg, s.c., b.i.d.) and then maintained at 25 mg/kg (b.i.d.) for 4-7 days. For the 2-DG procedure, rats were injected with saline or ibogaine (40 mg/kg, i.p.). 2-DG was administered 1 h after administration of ibogaine. The rate of LCGU was determined by quantitative autoradiography in 46 brain regions. In drug-naive animals, ibogaine produced significant increases in LCGU in the parietal, cingulate, and occipital cortices and cerebellum compared to controls consistent with its activity as a hallucinogen and a tremorogen. Morphine-dependent rats had only minor alterations in LCGU at the time assessed in this experiment. However, in morphine-dependent animals, ibogaine produced a global decrease in LCGU that was greatest in brain regions such as the lateral and medial preoptic areas, nucleus of the diagonal band, nucleus accumbens shell, inferior colliculus, locus coeruleus, and flocculus compared to morphine-dependent animals treated with saline. These findings indicate that ibogaine produces distinctly different effects on LCGU in drug-naive and morphine-dependent rats. This suggests that different mechanisms may underlie ibogaine's hallucinogenic and anti-addictive effects.

Prescription Drugs: HCFA’s Proposed Drug Utilization Review System Ignores Quality of Care Issues

DTIC Science & Technology

1989-07-13

Parkinsonism , 32,000 with hip fractures attributable to dOfg-induced falls, 163,000 with drug-induced memory loss or impaired thinking, and 243,000...year there are approximately 61,000 older adults with drug-induced Parkinsonism , 32,000 with hip fractures attributable to drug-induced falls, 163,000...particu- larly phenytoin and warfarin). A drug in one category may interact with a drug in another category to raise the concentration of the drugs in the

Utility and importance of animal data in drug product labels.

PubMed

Baldrick, Paul

2014-08-01

Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

Trends in Florida's Prescription Drug Monitoring Program registration and utilization: Implications for increasing voluntary use.

PubMed

Delcher, Chris; Wang, Yanning; Young, Henry W; Goldberger, Bruce A; Schmidt, Siegfried; Reisfield, Gary M

Effective use of state prescription drug monitoring programs (PDMPs) to track controlled substance prescribing and dispensing may help mitigate the current opioid crisis. Our objective was to examine trends in registration for and use of Florida's PDMP by physicians and pharmacists, from 2013 to 2016. We discuss implications for PDMP uptake and policy. Key measures, such as cumulative number of registrants per license type and monthly utilization intensity, are presented. A time series forecasting approach was used to (1) model the monthly count of new PDMP registrants and users from January 2013 to December 2016 and (2) estimate cumulative registration totals after 1 year. Florida. As of November 2016, there were 16,498 physicians (representing 31 percent of Drug Enforcement Administration licensees) and 17,241 pharmacists registered with the PDMP, representing 21 and 57 percent of professional licensees, respectively. Of note, the PDMP's designation as a "specialized registry" for electronic medical record "meaningful use" criteria led to a nearly sevenfold increase in physician registrations in a single month. In November 2016, pharmacists displayed a higher past-month PDMP utilization rate (52.2 percent vs 30.1 percent), while physicians displayed a higher past-month PDMP utilization intensity (58.1 vs. 36.1 queries per user). Approximately 25,000 physicians and 31,000 pharmacists must register by the end of 2017 to meet national policy goals. PDMP registration among physicians and pharmacists is limited, and the use of the PDMP among registrants is more limited still. Our findings suggest that Florida will not meet national policy goals for registrants by the end of 2017, although new initiatives may alter this trend. Allowing the PDMP to help prescribers meet other professional needs, such as "meaningful use" or similar efforts, may be effective in increasing PDMP use.

Utilization of the Arkansas Prescription Monitoring Program to combat prescription drug abuse

PubMed Central

Rittenhouse, Rebecca; Wei, Feifei; Robertson, Denise; Ryan, Kevin

2015-01-01

Objective The Arkansas Prescription Monitoring Program (AR PMP) was implemented in 2013 to combat prescription drug abuse. All enrollees were invited to participate in a user survey available in February 2014, to identify makeup of users, utilization of the program, and changes made to health care practices after implementation of the program. Methods Of the 3694 individual enrollees invited to participate, 1541 (41.7%) completed the survey. Data collected were analyzed to identify changes in health care practices by program frequency of use and user profession. Results Medical doctors, advanced practice nurses, and pharmacists are the professions who use the program most frequently. Daily AR PMP users are considerably more likely than infrequent users to be prompted to access the program by the involvement of a controlled substance (CS) prescription or by office/facility policy requirements. Increased frequency of use of the AR PMP results in positive impacts on CS prescribing and dispensing practices. Conclusion Compelling more users of the AR PMP to be prompted to access the program by the involvement of a CS prescription or by requirements per office/facility policy may increase frequency of use of the program and thereby changes in health care practices to combat prescription drug abuse. PMID:26191489

The utilization of drug-polymer interactions for improving the chemical stability of hot-melt extruded solid dispersions.

PubMed

Guo, Zhefei; Lu, Ming; Li, Yongcheng; Pang, Huishi; Lin, Ling; Liu, Xu; Wu, Chuanbin

2014-02-01

Interactions between drugs and polymers were utilized to lower the processing temperature of hot-melt extrusion (HME), and thus minimize the thermal degradation of heat-sensitive drugs during preparation of amorphous solid dispersions. Diflunisal (DIF), which would degrade upon melting, was selected as a model drug. Hydrogen bonds between DIF and polymeric carriers (PVP K30, PVP VA64, hydroxypropyl methylcellulose and Soluplus) were revealed by differential scanning calorimetry and Fourier transform infrared spectroscopy. The hot-melt extruded solid dispersion was characterized by powder X-ray diffraction (XRD), scanning electron microscopy (SEM) and high-performance liquid chromatography (HPLC). The results of hot-stage polar microscopy indicated that DIF was dissolved in molten polymers at 160°C, much lower than the melting point of DIF (215°C). At this temperature, amorphous solid dispersions were successfully produced by HME, as confirmed by XRD and SEM. The related impurities in amorphous solid dispersions detected by HPLC were lower than 0.3%, indicating that thermal degradation was effectively minimized. The dissolution of DIF from amorphous solid dispersions was significantly enhanced as compared with the pure crystalline drug. This technique based on drug-polymer interactions to prepare chemically stable amorphous solid dispersions by HME provides an attractive opportunity for development of heat-sensitive drugs. © 2013 Royal Pharmaceutical Society.

Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.

PubMed

Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji

2017-11-01

Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.

[Quality assessment of drug use in the elderly].

PubMed

Mosegui, G B; Rozenfeld, S; Veras, R P; Vianna, C M

1999-10-01

The objective is to evaluate the quality of medication utilization through the analysis of the pattern of usage, the degree of compliance to essential drug lists, therapeutic value and by drug interactions found among women over 60 years of age. Six hundred thirty-four women enrolled at the Open University of the Third Age were studied. Data was collected through pattern-oriented, tested questionnaires. The variables examined were related to drugs and to drug utilization. The units of analysis used were the drugs and the individual. Of 634 women that participated in the study, 9,1% did not use drugs. The number of medications taken vary from 1 to 17. The average is 4,0 drugs/woman. Among the 2.510 pharmaceutical specialties mentioned by the interviewed, 538 different substances were identified. About 26% of the medications were in agreement with the recommendations of the World Health Organization and 17% with recommendations of the "Relação Nacional de Medicamentos Essenciais". Seventeen percent of the drugs are inappropriate for use in seniors; 14,1% of the women may suffer consequences for taking drugs of the same therapeutic class, and 15, 5% are exposed to interactions. The data suggest that the pattern of the medication utilization is considerably influenced by the medical prescription and that their quality is harmed by the low selectiveness of the pharmaceutical market

Emergency Department Frequent Utilization for Non-Emergent Presentments: Results from a Regional Urban Trauma Center Study

PubMed Central

2016-01-01

Objectives First, to test a model of the drivers of frequent emergency department utilization conceptualized as falling within predisposing, enabling, and need dimensions. Second, to extend the model to include social networks and service quality as predictors of frequent utilization. Third, to illustrate the variation in thresholds that define frequent utilization in terms of the number of emergency department encounters by the predictors within the model. Data Source Primary data collection over an eight week period within a level-1 trauma urban hospital’s emergency department. Study Design Representative randomized sample of 1,443 adult patients triaged ESI levels 4–5. Physicians and research staff interviewed patients as they received services. Relationships with the outcome variable, utilization, were tested using logistic regression to establish odds-ratios. Principal Findings 70.6 percent of patients have two or more, 48.3 percent have three or more, 25.3 percent have four or more, and 14.9 percent have five or more emergency department visits within 12 months. Factors associated with frequent utilization include gender, race, poor mental health, mental health drugs, prescription drug abuse, social networks, employment, perceptions of service quality, seriousness of condition, persistence of condition, and previous hospital admittance. Conclusions Interventions targeting associated factors will change global emergency department encounters, although the mutability varies. Policy interventions to address predisposing factors such as substance abuse or access to mental health treatment as well as interventions that speak to enabling factors such as promoting the resiliency of social networks may result in decreased frequency of emergency department utilization. PMID:26784515

Participatory design for drug-drug interaction alerts.

PubMed

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

2015-01-01

The utilization of decision support systems, in the point of care, to alert drug-drug interactions has been shown to improve quality of care. Still, the use of these systems has not been as expected, it is believed, because of the difficulties in their knowledge databases; errors in the generation of the alerts and the lack of a suitable design. This study expands on the development of alerts using participatory design techniques based on user centered design process. This work was undertaken in three stages (inquiry, participatory design and usability testing) it 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 in the system.

Racial and ethnic disparities in antidepressant drug use.

PubMed

Chen, Jie; Rizzo, John A

2008-12-01

Little is known about racial and ethnic disparities in health care utilization, expenditures and drug choice in the antidepressant market. This study investigates factors associated with the racial and ethnic disparities in antidepressant drug use. We seek to determine the extent to which disparities reflect differences in observable population characteristics versus heterogeneity across racial and ethnic groups. Among the population characteristics, we are interested in identifying which factors are most important in accounting for racial and ethnic disparities in antidepressant drug use. Using Medical Expenditure Panel Survey (MEPS) data from 1996-2003, we have an available sample of 10,416 Caucasian, 1,089 African American and 1,539 Hispanic antidepressant drug users aged 18 to 64 years. We estimate individual out-of-pocket payments, total prescription drug expenditures, drug utilization, the probability of taking generic versus brand name antidepressants, and the share of drugs that are older types of antidepressants (e.g., TCAs and MAOIs) for these individuals during a calendar year. Blinder-Oaxaca decomposition techniques are employed to determine the extent to which disparities reflect differences in observable population characteristics versus unobserved heterogeneity across racial and ethnic groups. Caucasians have the highest antidepressant drug expenditures and utilization. African-Americans have the lowest drug expenditures and Hispanics have the lowest drug utilization. Relative to Caucasians and Hispanics, African-Americans are more likely to purchase generics and use a higher share of older drugs (e.g., TCAs and MAOIs). Differences in observable characteristics explain most of the racial/ethnic differences in these outcomes, with the exception of drug utilization. Differences in health insurance and education levels are particularly important factors in explaining disparities. In contrast, differences in drug utilization largely reflect unobserved

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Regenerated cellulose capsules for controlled drug delivery: Part III. Developing a fabrication method and evaluating extemporaneous utility for controlled-release.

PubMed

Bhatt, Bhavik; Kumar, Vijay

2016-08-25

In this article, we describe a method to utilize cellulose dissolved in dimethyl sulfoxide and paraformaldehyde solvent system to fabricate two-piece regenerated cellulose hard shell capsules for their potential use as an oral controlled drug delivery a priori vehicle. A systematic evaluation of solution rheology as well as resulting capsule mechanical, visual and thermal analysis was performed to develop a suitable method to repeatedly fabricate RC hard shell capsule halves. Because of the viscoelastic nature of the cellulose solution, a combination of dip-coating and casting method, herein referred to as dip-casting method, was developed. The dip-casting method was formalized by utilizing two-stage 2(2) full factorial design approach in order to determine a suitable approach to fabricate capsules with minimal variability. Thermal annealing is responsible for imparting shape rigidity of the capsules. Proof-of-concept analysis for the utility of these capsules in controlled drug delivery was performed by evaluating the release of KCl from them as well as from commercially available USP equivalent formulations. Release of KCl from cellulose capsules was comparable to extended release capsule formulation. Copyright © 2016 Elsevier B.V. All rights reserved.

California drug courts: outcomes, costs and promising practices: an overview of Phase II in a statewide study.

PubMed

Carey, Shannon M; Finigan, Michael; Crumpton, Dave; Waller, Mark

2006-11-01

The rapid expansion of drug courts in California and the state's uncertain fiscal climate highlighted the need for definitive cost information on drug court programs. This study focused on creating a research design that can be utilized for statewide and national cost-assessment of drug courts by conducting in-depth case studies of the costs and benefits in nine adult drug courts in California. A Transactional Institutional Costs Analysis (TICA) approach was used, allowing researchers to calculate costs based on every individual's transactions within the drug court or the traditional criminal justice system. This methodology also allows the calculation of costs and benefits by agency (e.g., Public Defender's office, court, District Attorney). Results in the nine sites showed that the majority of agencies save money in processing an offender though drug court. Overall, for these nine study sites, participation in drug court saved the state over 9 million dollars in criminal justice and treatment costs due to lower recidivism in drug court participants. Based on the lessons learned in Phases I and II, Phase III of this study focuses on the creation of a web-based drug court cost self-evaluation tool (DC-CSET) that drug courts can use to determine their own costs and benefits.

Utilizing Social Action Theory as a Framework to Determine Correlates of Illicit Drug Use Among Young Men Who Have Sex with Men

PubMed Central

Traube, Dorian E.; Holloway, Ian W.; Schrager, Sheree M.; Kipke, Michele D.

2011-01-01

Background Young men who have sex with men (YMSM) continue to be at elevated risk for substance use; however, models explaining this phenomenon have often focused on a limited array of explanatory constructs. Purpose This study utilizes Social Action Theory (SAT) as a framework to address gaps in research by documenting the social, behavioral, and demographic risk factors associated with illicit drug use among YMSM. Methods Structural equation modeling was used to apply SAT to a cross-sectional sample of 526 men from the Healthy Young Men Study, a longitudinal study of substance use and sexual risk behavior among YMSM in Los Angeles. Results The final model possessed very good fit statistics (CFI = 0.936, TLI = 0.925, RMSEA = 0.040) indicating that SAT is appropriate for use with YMSM. Conclusions Substance use interventions for YMSM could be enhanced by employing SAT as conceptualized in this study and using a multi-targeted strategy for impacting illicit drug use. PMID:21644802

Tools for studying drug transport and metabolism in the brain.

PubMed

Pitcher, Meagan R; Quevedo, João

2016-01-01

Development of xenobiotics that cross the blood-brain barrier in therapeutically-relevant quantities is an expensive and time-consuming undertaking. However, central nervous system diseases are an under-addressed cause of high mortality and morbidity, and drug development in this field is a worthwhile venture. We aim to familiarize the reader with available methodologies for studying drug transport into the brain. Current understanding of the blood-brain barrier structure has been well-described in other manuscripts, and first we briefly review the path that xenobiotics take through the brain - from bloodstream, to endothelial cells of the blood-brain barrier, to interstitial space, to brain parenchymal cells, and then to an exit point from the central nervous system. The second half of the review discusses research tools available to determine if xenobiotics are making the journey through the brain successfully and offers commentary on the translational utility of each methodology. Theoretically, non-human mammalian and human blood-brain barriers are similar in composition; however, some findings demonstrate important differences across species. Translational methodologies may provide more reliable information about how a drug may act across species. The recent finding of lymphatic vessels within the central nervous system may provide new tools and strategies for drug delivery to the brain.

Decomposition of Economic Inequality in Needle and Syringe Programs Utilization to its Determinants among Men Who Inject Drugs in Tehran using Blinder-Oaxaca Decomposition Method.

PubMed

Noroozi, Mehdi; Rahimi, Ebrahim; Ghisvand, Hessam; Qorbani, Mostafa; Sharifi, Hamid; Noroozi, Alireza; Farhoudian, Ali; Marshall, Brandon D L; Jorjoran Shoshtari, Zahra; Karimi, Salah Eddin; Rezaei, Omid; Armoon, Bahram

2018-06-07

According to latest available data there are more of 300,000 people injects drug users (PWID) in Iran. In this study, we used a Blinder-Oaxaca (BO) decomposition to explore the relative contributions of inequality in utilization of NSPs and to decompose it to its determinants in Teheran. We used data from a cross-sectional survey using snowball sampling to recruit 500 PWID from June to July 2016 in Tehran. Participants were reported injecting drug use in the past month, were able to speak and comprehend Farsi enough to respond to survey questions, and were able to provide informed consent to complete the interview. We used a BO method to decompose the role of economic inequality on utilization of needle and syringe programs. A total 520 of clients participated in the study of which data was fully complete for 500. The selected predictor variables (age, education level, marital status, homelessness, HIV risk perception, and HIV knowledge) together explain 54% (8.5% out of 16%) of total inequality in utilization of needle and syringe programs and the remaining 46% constitute the unexplained residual. HIV risk perception status contributed about 38% (3.3% out of 8.5%) to the total health inequality, followed by HIV knowledge (26%) and education level were contributed 20% each, respectively. The results showed that contribution of economic inequalities in utilization of NSPs was primarily explained by the differential effects of HIV risk perception and HIV knowledge among PWID. Reducing HIV risk perception and increasing HIV knowledge might be essential to efforts to eliminate inequalities in access to NSPs among PWID.

Alcohol and drug treatment outcome studies: new methodological review (2005-2010) and comparison with past reviews.

PubMed

Robinson, Sean M; Sobell, Linda Carter; Sobell, Mark B; Arcidiacono, Steven; Tzall, David

2014-01-01

Several methodological reviews of alcohol treatment outcome studies and one review of drug studies have been published over the past 40 years. Although past reviews demonstrated methodological improvements in alcohol studies, they also found continued deficiencies. The current review allows for an updated evaluation of the methodological rigor of alcohol and drug studies and, by utilizing inclusion criteria similar to previous reviews, it allows for a comparative review over time. In addition, this is the first review that compares the methodology of alcohol and drug treatment outcome studies published during the same time period. The methodology for 25 alcohol and 11 drug treatment outcome studies published from 2005 through 2010 that met the review's inclusion criteria was evaluated. The majority of variables evaluated were used in prior reviews. The current review found that more alcohol and drug treatment outcome studies are now using continuous substance use measures and assessing problem severity. Although there have been methodological improvements over time, the current reviews differed little from their most recent past counterpart. Despite this finding, some areas, particularly the continued low reporting of demographic data, needs strengthening. Improvement in the methodological rigor of alcohol and drug treatment outcome studies has occurred over time. The current review found few differences between alcohol and drug study methodologies as well as few differences between the current review and the most recent past alcohol and drug reviews. © 2013 Elsevier Ltd. All rights reserved.

[Drug management of agitation in emergency departments: theoretical recommendations and studies of practices].

PubMed

Horn, Mathilde; Vaiva, Guillaume; Dumais, Alexandre

2015-01-01

Management of agitation is a frequent problematic of emergency departments that often leads to feelings of insecurity among clinicians. There are various practices regarding the drugs to be used in the management of agitations. Guidelines have been proposed by different groups of experts concerning the antipsychotic drugs that should be used for agitations in psychiatric conditions. Nevertheless, there is no clear-cut procedure referring to the utilization of intramuscular drugs in this situation. Moreover, there is no comparison available between the commonly used medications and other drugs, both in terms of superiority of efficacy and tolerance. In order to accurately assess these practices, evaluation protocols must minimize the interference with the service organization and the routine care. Further studies are required in order to develop guidelines about medications that have to be used to handle agitations, which must be based on robust evidence and applicable to emergency services. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Cost-utility analyses of drug therapies in breast cancer: a systematic review.

PubMed

Nerich, Virginie; Saing, Sopany; Gamper, Eva Maria; Kemmler, Georg; Daval, Franck; Pivot, Xavier; Holzner, Bernhard

2016-10-01

The economic evaluation (EE) of health care products has become a necessity. Their quality must be high in order to trust the results and make informed decisions. While cost-utility analyses (CUAs) should be preferred to cost-effectiveness analyses in the oncology area, the quality of breast cancer (BC)-related CUA has been given little attention so far. Thus, firstly, a systematic review of published CUA related to drug therapies for BC, gene expression profiling, and HER2 status testing was performed. Secondly, the quality of selected CUA was assessed and the factors associated with a high-quality CUA identified. The systematic literature search was conducted in PubMed, MEDLINE/EMBASE, and Cochrane to identify published CUA between 2000 and 2014. After screening and data extraction, the quality of each selected CUA was assessed by two independent reviewers, using the checklist proposed by Drummond et al. The analysis of factors associated with a high-quality CUA (defined as a Drummond score ≥7) was performed using a two-step approach. Our systematic review was based on 140 CUAs and showed a wide variety of methodological approaches, including differences in the perspective adopted, the time horizon, measurement of cost and effectiveness, and more specially health-state utility values (HSUVs). The median Drummond score was 7 [range 3-10]. Only one in two of the CUA (n = 74) had a Drummond score ≥7, synonymous of "high quality." The statistically significant predictors of a high-quality CUA were article with "gene expression profiling" topic (p = 0.001), consulting or pharmaceutical company as main location of first author (p = 0.004), and articles with both incremental cost-utility ratio and incremental cost-effectiveness ratio as outcomes of EE (p = 0.02). Our systematic review identified only 140 CUAs published over the past 15 years with one in two of high quality. It showed a wide variety of methodological approaches, especially focused on HSUVs. A

Utility of spatially-resolved atmospheric pressure surface sampling and ionization techniques as alternatives to mass spectrometric imaging (MSI) in drug metabolism.

PubMed

Blatherwick, Eleanor Q; Van Berkel, Gary J; Pickup, Kathryn; Johansson, Maria K; Beaudoin, Marie-Eve; Cole, Roderic O; Day, Jennifer M; Iverson, Suzanne; Wilson, Ian D; Scrivens, James H; Weston, Daniel J

2011-08-01

Tissue distribution studies of drug molecules play an essential role in the pharmaceutical industry and are commonly undertaken using quantitative whole body autoradiography (QWBA) methods. The growing need for complementary methods to address some scientific gaps around radiography methods has led to increased use of mass spectrometric imaging (MSI) technology over the last 5 to 10 years. More recently, the development of novel mass spectrometric techniques for ambient surface sampling has redefined what can be regarded as "fit-for-purpose" for MSI in a drug metabolism and disposition arena. Together with a review of these novel alternatives, this paper details the use of two liquid microjunction (LMJ)-based mass spectrometric surface sampling technologies. These approaches are used to provide qualitative determination of parent drug in rat liver tissue slices using liquid extraction surface analysis (LESA) and to assess the performance of a LMJ surface sampling probe (LMJ-SSP) interface for quantitative assessment of parent drug in brain, liver and muscle tissue slices. An assessment of the utility of these spatially-resolved sampling methods is given, showing interdependence between mass spectrometric and QWBA methods, in particular there emerges a reason to question typical MSI workflows for drug metabolism; suggesting the expedient use of profile or region analysis may be more appropriate, rather than generating time-intensive molecular images of the entire tissue section.

The impact of physician-level drug budgets on prescribing behavior.

PubMed

Fischer, Katharina Elisabeth; Koch, Taika; Kostev, Karel; Stargardt, Tom

2018-03-01

To contain pharmaceutical spending, drug budgets have been introduced across health systems. Apart from analyzing whether drug budgets fulfill their overall goal of reducing spending, changes in the cost and quality of prescribing and the enforcement mechanisms put in place need evaluation to assess the effectiveness of drug budgets at the physician level. In this study, we aim to analyze the cost and quality of prescribing conditional on the level of utilization of the drug budget and in view of varying levels of enforcement in cases of overspending. We observed drug budget utilization in a panel of 440 physicians in three federal states of Germany from 2005 to 2011. At the physician level, we retrospectively calculated drug budgets, the level of drug budget utilization, and differentiated by varying levels of enforcement where physicians overspent their budgets (i.e., more than 115/125% of the drug budget). Using lagged dependent-variable regression models, we analyzed whether the level of drug budget utilization in the previous year affected current prescribing in terms of various indicators to describe the cost and quality of prescribing. We controlled for patient and physician characteristics. The mean drug budget utilization is 92.3%. The level of drug budget utilization influences selected dimensions of cost and quality of prescribing (i.e., generic share (estimate 0.000215; p = 0.0246), concentration of generic brands (estimate 0.000585; p = 0.0056) and therapeutic substances (estimate -0.000060; p < 0.0001) and the share of potentially inappropriate medicines in the elderly (estimate 0.001; p < 0.0001)), whereas the level of enforcement does not. Physicians seem to gradually adjust their prescription patterns, especially in terms of generic substitution.

Turning the gun on cancer: Utilizing lysosomal P-glycoprotein as a new strategy to overcome multi-drug resistance.

PubMed

Seebacher, Nicole; Lane, Darius J R; Richardson, Des R; Jansson, Patric J

2016-07-01

Oxidative stress plays a role in the development of drug resistance in cancer cells. Cancer cells must constantly and rapidly adapt to changes in the tumor microenvironment, due to alterations in the availability of nutrients, such as glucose, oxygen and key transition metals (e.g., iron and copper). This nutrient flux is typically a consequence of rapid growth, poor vascularization and necrosis. It has been demonstrated that stress factors, such as hypoxia and glucose deprivation up-regulate master transcription factors, namely hypoxia inducible factor-1α (HIF-1α), which transcriptionally regulate the multi-drug resistance (MDR), transmembrane drug efflux transporter, P-glycoprotein (Pgp). Interestingly, in addition to the established role of plasma membrane Pgp in MDR, a new paradigm of intracellular resistance has emerged that is premised on the ability of lysosomal Pgp to transport cytotoxic agents into this organelle. This mechanism is enabled by the topological inversion of Pgp via endocytosis resulting in the transporter actively pumping agents into the lysosome. In this way, classical Pgp substrates, such as doxorubicin (DOX), can be actively transported into this organelle. Within the lysosome, DOX becomes protonated upon acidification of the lysosomal lumen, causing its accumulation. This mechanism efficiently traps DOX, preventing its cytotoxic interaction with nuclear DNA. This review discusses these effects and highlights a novel mechanism by which redox-active and protonatable Pgp substrates can utilize lysosomal Pgp to gain access to this compartment, resulting in catastrophic lysosomal membrane permeabilization and cell death. Hence, a key MDR mechanism that utilizes Pgp (the "gun") to sequester protonatable drug substrates safely within lysosomes can be "turned on" MDR cancer cells to destroy them from within. Copyright © 2016 Elsevier Inc. All rights reserved.

[Prescribed and reported drug use during pregnancy].

PubMed

Osorio-de-Castro, Claudia Garcia Serpa; Pepe, Vera Lucia Edais; Luiza, Vera Lucia; Cosendey, Marly Aparecida Elias; Freitas, Aline Matias de; Miranda, Frederico Fonseca; Bermudez, Jorge Antonio Zepeda; Leal, Maria do Carmo

2004-01-01

Few studies describe drug utilization in pregnancy focusing on prescribing practices. This study is part of a larger survey on perinatal care in the City of Rio de Janeiro, Brazil. The type of hospital (public, contracted out by the Unified National Health System, or private) determined the stratification of 10,072 hospitalized post-partum women, who were asked about medication used during pregnancy. Hospital records supplied information on drugs prescribed during labor. Drugs were classified according to the Anatomical Therapeutic Chemical (ATC) system. Another system was used for specific cases of referred use. A mean of 2.08 drugs was prescribed during labor, and a mean of 2.3 was reported during pregnancy. Anesthetics, antibiotics, oxytocin, and analgesics were the most frequently prescribed during labor, with significant differences between strata. Ferrous sulfate, vitamins, scopolamine, and acetaminophen were the main drugs reported during pregnancy. Women who had attempted abortion referred use of various kinds of tea (49.7%) and misoprostol (9.2%). The drug utilization pattern was consistent with the literature. This study offers knowledge on prescribing patterns during labor and self-reported use during pregnancy in both the public and private sectors.

Liability and ophthalmic drug use.

PubMed

Classé, J G

1992-01-01

Ophthalmic drug use has been an aspect of optometry for more than two decades. Although utilization of these drugs has produced significant changes in the clinical and legal responsibilities of optometrists, the liability posture of the profession has remained unaltered. Studies of malpractice claims against optometrists and ophthalmologists have demonstrated that ophthalmologists are much more likely to be charged with negligence for adverse drug reactions and that drug-related malpractice claims are not a liability issue for optometrists. Based on the experiences of both professions, this paper describes the adverse effects of common ophthalmic drugs, with emphasis on those drug reactions that have resulted in litigation.

Physician drug dispensing in Switzerland: association on health care expenditures and utilization.

PubMed

Trottmann, Maria; Frueh, Mathias; Telser, Harry; Reich, Oliver

2016-07-08

Several countries recently reassessed the roles of drug prescribing and dispensing, either by enlarging pharmacists' rights to prescribe (e.g. the US and the United Kingdom) or by limiting physicians' rights to dispense (e.g. Taiwan and South Korea). While integrating the two roles might increase supply and be convenient for patients, concern is that drug mark-ups incite providers to prescribe unnecessary drugs. We aimed to assess the association of physician dispensing (PD) in Switzerland on various outcomes. We performed a retrospective cohort study, using health care claims data for patients in the year 2013. The analysis of the association of PD was perfomed using a large patient level dataset and several target variables, including the number of different chemical agents, share of generic drugs, number of visits to physicians and expenditures. Different multivariate econometric models were applied in order to capture the association PD on the target variables. A total of 101'784 patients were enrolled in 2013, whereas 54 % were PD patients. We find that PD is associated with lower pharmaceutical expenditure per patient, which can be explained by an increased use of generic drugs. The decrease is compensated by higher use of physician services. We find no significant impact of physician dispensing on total health care expenditure. Our study offers insights for policy makers who are (re-)considering the separation between drug prescribing and dispensing, either by allowing physicians to dispense or pharmacists to prescribe certain drugs. In terms of total health care expenditures, we find no difference between the two systems, so we are doubtful that changing dispensing rights are a good measure to contain cost, at least in Switzerland.

Effect of educational and policy interventions on institutional utilization of wet nebulization respiratory drugs and portable inhalers.

PubMed

Lowe, Donna O; Lummis, Heather; Zhang, Ying; Sketris, Ingrid S

2008-01-01

Asthma and chronic obstructive pulmonary disease treatment guidelines support the preferential use of portable inhalers (PIs) over wet nebulization (WN) respiratory therapy. Hospital- and community-based educational initiatives and a community-based provincial drug program policy change were previously implemented to promote the conversion of WN therapy to PI and spacer device use in Nova Scotia. To examine the effect of these interventions on salbutamol, ipratropium bromide, and spacer device (Aerochamber) use at the Queen Elizabeth II Health Sciences Centre (QEII HSC). We conducted a time-series analysis of drug utilization data from August 1998 to July 2005. We used two intervention phases compared to the pre-intervention phase to determine whether the educational and policy interventions were associated with significant changes in monthly drug and spacer device utilization rates at the QEII HSC (1000-bed teaching hospital; Halifax, Nova Scotia). Salbutamol and ipratropium bromide PI use significantly increased in both intervention phases, compared to the pre-intervention phase. Mean (SD) defined daily doses/100 bed-days for salbutamol PI increased from 30.4 (0.4) in the pre-intervention phase to 34.6 (0.9) and 37.0 (0.4) in intervention phases I and II respectively (p<0.001 for both), and ipratropium bromide PI increased from 27.3 (3.5) to 32.8 (2.5) in intervention phase I (p=0.004) and 35.6 (3.5) in intervention phase II (p<0.001). However, a significant corresponding decrease was observed with salbutamol WN only. Mean (SD) Aerochamber units/100 bed-days significantly increased. Educational and policy interventions had limited effects on converting WN to PI use at the QEII HSC.

Pharmacy Utilization and the Medicare Modernization Act

PubMed Central

Maio, Vittorio; Pizzi, Laura; Roumm, Adam R; Clarke, Janice; Goldfarb, Neil I; Nash, David B; Chess, David

2005-01-01

To control expenditures and use medications appropriately, the Medicare drug coverage program has established pharmacy utilization management (PUM) measures. This article assesses the effects of these strategies on the care of seniors. The literature suggests that although caps on drug benefits lower pharmaceutical costs, they may also increase the use of other health care services and hurt health outcomes. Our review raises concerns regarding the potential unintended effects of the Medicare drug program's PUM policies for beneficiaries. Therefore, the economic and clinical impact of PUM measures on seniors should be studied further to help policymakers design better drug benefit plans. PMID:15787955

CLINICALLY SIGNIFICANT PSYCHOTROPIC DRUG-DRUG INTERACTIONS IN THE PRIMARY CARE SETTING

PubMed Central

English, Brett A.; Dortch, Marcus; Ereshefsky, Larry; Jhee, Stanford

2014-01-01

In recent years, the growing numbers of patients seeking care for a wide range of psychiatric illnesses in the primary care setting has resulted in an increase in the number of psychotropic medications prescribed. Along with the increased utilization of psychotropic medications, considerable variability is noted in the prescribing patterns of primary care providers and psychiatrists. Because psychiatric patients also suffer from a number of additional medical comorbidities, the increased utilization of psychotropic medications presents an elevated risk of clinically significant drug interactions in these patients. While life-threatening drug interactions are rare, clinically significant drug interactions impacting drug response or appearance of serious adverse drug reactions have been documented and can impact long-term outcomes. Additionally, the impact of genetic variability on the psychotropic drug’s pharmacodynamics and/or pharmacokinetics may further complicate drug therapy. Increased awareness of clinically relevant psychotropic drug interactions can aid clinicians to achieve optimal therapeutic outcomes in patients in the primary care setting. PMID:22707017

Identifying Programmatic Gaps: Inequities in Harm Reduction Service Utilization among Male and Female Drug Users in Dar es Salaam, Tanzania

PubMed Central

Lambdin, Barrot H.; Bruce, R. Douglas; Chang, Olivia; Nyandindi, Cassian; Sabuni, Norman; Zamudio-Haas, Sophia; McCurdy, Sheryl; Masao, Frank; Ivo, Yovin; Msami, Amani; Ubuguy, Omar; Mbwambo, Jessie

2013-01-01

Introduction Current estimates suggest an HIV prevalence of 42% among people who inject drugs (PWIDs) in Dar es Salaam, while HIV prevalence is estimated to be 8.8% among the general population in the city. To address the HIV epidemic in this population, the government of Tanzania began establishing HIV prevention, treatment and care services including outreach and medication assisted treatment (MAT) for PWIDs in 2010. We assessed gender inequities in utilization of outreach and MAT services and evaluated differences in HIV risk behaviors between female and male PWIDs. Materials and Methods Routine outreach data between December 2010 to mid-August 2012 and baseline data on clients enrolling in methadone from February 2011 to August 2012 were utilized. Binomial regression was used to estimate adjusted relative risk estimates comparing females to males. Results From December 2010 to August 2012, 8,578 contacts were made to drug users; among them 1,898 were injectors. A total of 453 injectors were eligible and referred to MAT, of which, 443 enrolled in treatment. However, regarding total outreach contacts, outreach to PWID, referral to MAT and enrollment in MAT, 8% or less of drug users accessing services were women. In contrast, weighted estimations from surveys suggest that 34% of PWIDs are female, and this approximation is similar to recent population size estimations. Overall, 43% of traditional outreach workers conducting outreach with drug users were female. Though reporting higher levels of condom usage, female PWID were more likely to report multiple sex partners, anal sex, commercial sex work and struggle under a higher burden of addiction, mental disorders and abuse. Conclusions Services have not been mobilized adequately to address the clear needs of females who inject drugs. A clear and urgent need exists for women-centered strategies that effectively engage female PWID into HIV prevention services. PMID:23825620

Changes in drug utilization during a gap in insurance coverage: an examination of the medicare Part D coverage gap.

PubMed

Polinski, Jennifer M; Shrank, William H; Huskamp, Haiden A; Glynn, Robert J; Liberman, Joshua N; Schneeweiss, Sebastian

2011-08-01

-containment features such as the coverage gap have an adverse impact on drug utilization that may conceivably affect health outcomes.

Design and mechanistic study of a novel gold nanocluster-based drug delivery system.

PubMed

Li, Qinzhen; Pan, Yiting; Chen, Tiankai; Du, Yuanxin; Ge, Honghua; Zhang, Buchang; Xie, Jianping; Yu, Haizhu; Zhu, Manzhou

2018-05-22

Chemically-triggered drug delivery systems (DDSs) have been extensively studied as they do not require specialized equipment to deliver the drug and can deeply penetrate human tissue. However, their syntheses are complicated and they tend to be cytotoxic, which restricts their clinical utility. In this work, the self-regulated drug loading and release capabilities of peptide-protected gold nanoclusters (Pep-Au NCs) are investigated using vancomycin (Van) as the model drug. Gold nanoclusters (Au NCs) coated with a custom-designed pentapeptide are synthesized as drug delivery nanocarriers and loaded with Van - a spontaneous process reliant on the specific binding between Van and the custom-designed peptide. The Van-loaded Au NCs show comparable antimicrobial activity with Van on its own, and the number of Van released by the Pep-Au NCs is found to be proportional to the amount of bacteria present. The controlled nature of the Van release is very encouraging, and predominantly due to the stronger binding affinity of Van with bacteria than that with Au NCs. In addition, these fluorescent Au NCs could also be used to construct temperature sensors, which enable the in vitro and in vivo bioimaging.

An explanatory model for state Medicaid per capita prescription drug expenditures.

PubMed

Roy, Sanjoy; Madhavan, S Suresh

2012-01-01

Rising prescription drug expenditure is a growing concern for publicly funded drug benefit programs like Medicaid. To be able to contain drug expenditures in Medicaid, it is important that cause(s) for such increases are identified. This study attempts to establish an explanatory model for Medicaid prescription drugs expenditure based on the impacts of key influencers/predictors identified using a comprehensive framework of drug utilization. A modified Andersen's behavior model of health services utilization is employed to identify potential determinants of pharmaceutical expenditures in state Medicaid programs. Level of federal matching funds, access to primary care, severity of diseases, unemployment, and education levels were found to be key influencers of Medicaid prescription drug expenditure. Increases in all, except education levels, were found to result in increases in drug expenditures. Findings from this study could better inform intervention policies and cost-containment strategies for state Medicaid drug benefit programs.

Effects of managerial intervention on drug utilization pattern at King Chulalongkorn Memorial Hospital.

PubMed

Limpanasithikul, Wacharee; Wangsaturaka, Danai; Nantawan, Patra; Itthipanichapong, Chandhanee; Thamaree, Sopit; Wittayalertpanya, Supeecha; Ketcharoen, Aurawan; Taworn, Nongnuch; Kemsri, Wandee; Kusolsomboon, Thammarat; Tangphao, Oranee

2002-06-01

The economic crisis in Thailand since 1997 has a major impact on all sections of the country including health care. There were several suggestions for reducing the drug expenditure budget including restriction of hospital formulary, generic prescribing and generic dispensing. At King Chulalongkorn Memorial hospital, the new hospital formulary was established and implemented in March 1998. The generic dispensing policy was also in place at the same time. This study aimed to evaluate the impact of the new implementation by comparing the prescription patterns in out patient departments (OPDs) of the hospital before and after the new hospital formulary implementation. The prescriptions from several OPDs were systematically stratified samplings 5 weeks before and 5 weeks after March 1st, 1998. The information from the prescriptions including drug category, drug name, amount of dispensed drug, drug cost, etc. was collected and analyzed. The total number of prescriptions and the average number of drug items/prescription before and after the implementation were similar (2,049 vs 2,052, and 2.52 +/- 0.048 vs 2.45 +/- 0.03 respectively). The total cost of the prescription, the cost/prescription and the cost/item seemed to be different (1,690,484 baht vs 1,282,343 baht, 844 +/- 54.04 vs 633 +/- 41.11 and 332.58 +/- 29.59 vs 255.29 +/- 19.98 respectively). After the implementation, physicians in the hospital increasingly prescribed drugs by generic name (37.1% vs 44.85%). Locally made drugs were also prescribed by physicians and received by patients more than before (9.56% vs 84.27% and 28.15% vs 60.72%, respectively). Anti-infective agents were studied in depth as they contribute to significant amount of drug expenditure. The total cost of prescribed anti-infective agents and the cost/prescription were increased after the implementation (223,529 vs 274,435 Baht and 585.38 +/- 102.84 vs 772.71 +/- 147.59). The increased cost mainly came from the cost of anti-HIV drugs. Our

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.

[Improvement and prediction of intestinal drug absorption].

PubMed

Miyake, Masateru

2013-01-01

The suppository preparation, which can improve the absorption of poorly absorbable drugs safer than commercially available suppositories, was developed by utilizing sodium laurate and taurine. Additionally, the novel oral absorption-improving system was also established by utilizing polyamines and bile acids. Furthermore, to evaluate the efficacy of these new formulations and estimate the absorbability of new drug candidates in humans, the in vitro prediction system utilizing an isolated human intestinal tissues was developed and successfully predicted the fraction of dose absorbed for several model drugs. These findings would contribute to the development of new dosage forms and new drugs for oral administration.

Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience.

PubMed

Rosa, Carmen; Ghitza, Udi; Tai, Betty

2012-07-17

Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.

Family Therapy for the Drug User: Conceptual and Practical Considerations

ERIC Educational Resources Information Center

Davis, Donald I.; And Others

1978-01-01

National surveys suggest that many drug treatment programs are utilizing family therapy. It is frequently the choice of treatment. Controlled studies of family therapy in drug abuse are sparce but encouraging. (MFD)

FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science.

PubMed

Fang, Hong; Harris, Stephen C; Liu, Zhichao; Zhou, Guangxu; Zhang, Guoping; Xu, Joshua; Rosario, Lilliam; Howard, Paul C; Tong, Weida

2016-10-01

Here, we provide a concise overview of US Food and Drug Administration (FDA) drug labeling, which details drug products, drug-drug interactions, adverse drug reactions (ADRs), and more. Labeling data have been collected over several decades by the FDA and are an important resource for regulatory research and decision making. However, navigating through this data is challenging. To aid such navigation, the FDALabel database was developed, which contains a set of approximately 80000 labeling data. The full-text searching capability of FDALabel and querying based on any combination of specific sections, document types, market categories, market date, and other labeling information makes it a powerful and attractive tool for a variety of applications. Here, we illustrate the utility of FDALabel using case scenarios in pharmacogenomics biomarkers and ADR studies. Published by Elsevier Ltd.

Gratitude and Drug Misuse: Role of Coping as Mediator.

PubMed

Leung, Chi-Ching; Tong, Eddie M W

2017-12-06

Positive emotions, such as gratitude has been found to be beneficial to both physical and mental well-being but so far, drug misuse research has yet to identify important emotive predictors related to drug use. This study aimed to examine the relationship between gratitude and drug use among a group of drug misusers. It was hypothesized that greater dispositional gratitude was associated with lesser drug use through greater use of adaptive coping methods and lesser use of maladaptive coping methods. This study utilized a cross-sectional design to examine the relationship between gratitude, coping, and drug use among a sample of drug misusers (N = 105) at a drug rehabilitation center. Participants completed the gratitude questionnaire (GQ-6), the joy subscale of the Dispositional Positive Emotion Scale (DPES), the Brief COPE, and a questionnaire on their drug use. Data were collected in 2015. Mediation analysis supported the hypothesis and found that adaptive coping mediated the relationship between gratitude and drug use. However, mediation was not found for maladaptive coping. Additional analysis found that adaptive coping as a mediator was not found for joy. Results suggested that gratitude has utility in reducing drug use through the use of more adaptive coping strategies and this relationship was not simply due to positive affect. Interventions targeting drug use behavior could consider introducing gratitude to increase adaptive coping abilities to reduce drug use.

Georgia harvest and utilization study, 2015

Treesearch

David J. Wall; James W. Bentley; James A. Gray; Jason A. Cooper

2018-01-01

In 2014, a harvest and utilization study was conducted on 91 operations throughout Georgia. There were 2,129 total trees measured: 1,842 or 87 percent were softwood, while 287 or 13 percent were hardwood. Results from this study showed that 87 percent of the total softwood volume measured was utilized for a product, and 13 percent was left as logging residue. Seventy-...

Georgia harvest and utilization study, 2009

Treesearch

James W. Bentley

2011-01-01

In 2009, a harvest and utilization study was conducted on 80 operations throughout Georgia. There were 1,981 total trees measured: 1,453 or 73 percent were softwood, while 528 or 27 percent were hardwood. Results from this study showed that 88 percent of the total softwood volume measured was utilized for a product, and 12 percent was left as logging residue. Seventy-...

Georgia harvest and utilization study, 2004

Treesearch

James W. Bentley; Richard a. Harper

2006-01-01

In 2004, a harvest and utilization study was conducted on 96 operations throughout Georgia. There were 2,368 total trees measured, 1,581 or 67 percent were softwood, while 787 or 33 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, while the other 14 percent was left as logging...

Alabama harvest and utilization study, 2008

Treesearch

James W. Bentley; Tony G. Johnson

2008-01-01

In 2008, a harvest and utilization study was conducted on 80 operations throughout Alabama. There were 2,100 total trees measured; 1,433 or 68 percent were softwood, while 667 or 32 percent were hardwood. Results from this study showed that 88 percent of the total softwood volume measured was utilized for a product, and 12 percent was left as logging residue. Seventy-...

A Qualitative Study of Underutilization of the AIDS Drug Assistance Program

PubMed Central

Olson, Kristin M.; Godwin, Noah C.; Wilkins, Sara Anne; Mugavero, Michael J.; Moneyham, Linda D.; Slater, Larry Z.; Raper, James L.

2014-01-01

In our previous work, we demonstrated underutilization of the AIDS Drug Assistance Program (ADAP) at an HIV clinic in Alabama. In order to understand barriers and facilitators to utilization of ADAP, we conducted focus groups of ADAP enrollees. Focus groups were stratified by sex, race, and historical medication possession ratio as a measure of program utilization. We grouped factors according to the social-ecological model. We found that multiple levels of influence, including patient and clinic-related factors, influenced utilization of antiretroviral medications. Patients introduced issues that illustrated high-priority needs for ADAP policy and implementation, suggesting that in order to improve ADAP utilization, the following issues must be addressed: patient transportation, ADAP medication refill schedules and procedures, mailing of medications, and the ADAP recertification process. These findings can inform a strategy of approaches to improve ADAP utilization, which may have widespread implications for ADAP programs across the United States. PMID:24503498

Use of multiattribute utility theory for formulary management in a health system.

PubMed

Chung, Seonyoung; Kim, Sooyon; Kim, Jeongmee; Sohn, Kieho

2010-01-15

The application, utility, and flexibility of the multiattribute utility theory (MAUT) when used as a formulary decision methodology in a Korean medical center were evaluated. A drug analysis model using MAUT consisting of 10 steps was designed for two drug classes of dihydropyridine calcium channel blockers (CCBs) and angiotensin II receptor blockers (ARBs). These two drug classes contain the most diverse agents among cardiovascular drugs on Samsung Medical Center's drug formulary. The attributes identified for inclusion in the drug analysis model were effectiveness, safety, patient convenience, and cost, with relative weights of 50%, 30%, 10%, and 10%, respectively. The factors were incorporated into the model to quantify the contribution of each attribute. For each factor, a utility scale of 0-100 was established, and the total utility score for each alternative was calculated. An attempt was made to make the model adaptable to changing health care and regulatory circumstances. The analysis revealed amlodipine besylate to be an alternative agent, with the highest total utility score among the dihydropyridine CCBs, while barnidipine hydrochloride had the lowest score. For ARBs, losartan potassium had the greatest total utility score, while olmesartan medoxomil had the lowest. A drug analysis model based on the MAUT was successfully developed and used in making formulary decisions for dihydropyridine CCBs and ARBs for a Korean health system. The model incorporates sufficient utility and flexibility of a drug's attributes and can be used as an alternative decision-making tool for formulary management in health systems.

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.

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications

PubMed Central

Krasowski, Matthew D.

2010-01-01

In the past twenty years, 14 new antiepileptic drugs have been approved for use in the United States and/or Europe. These drugs are eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, rufinamide, stiripentol, tiagabine, topiramate, vigabatrin and zonisamide. In general, the clinical utility of therapeutic drug monitoring has not been established in clinical trials for these new anticonvulsants, and clear guidelines for drug monitoring have yet to be defined. The antiepileptic drugs with the strongest justifications for drug monitoring are lamotrigine, oxcarbazepine, stiripentol, and zonisamide. Stiripentol and tiagabine are strongly protein bound and are candidates for free drug monitoring. Therapeutic drug monitoring has lower utility for gabapentin, pregabalin, and vigabatrin. Measurement of salivary drug concentrations has potential utility for therapeutic drug monitoring of lamotrigine, levetiracetam, and topiramate. Therapeutic drug monitoring of the new antiepileptic drugs will be discussed in managing patients with epilepsy. PMID:20640233

Kentucky harvest and utilization study, 2007

Treesearch

Jason A. Cooper; James W. Bentley

2013-01-01

In 2007, a harvest and utilization study was conducted on 53 operations in Kentucky. There were 1,310 total trees measured: 263 or 20 percent were softwood, while 1,047 or 80 percent were hardwood. Results from this study showed that 82 percent of the total softwood volume measured was utilized for a product, and 18 percent was left as logging residue. Seventy-two...

Comparison of MDCK-MDR1 and Caco-2 cell based permeability assays for anti-malarial drug screening and drug investigations.

PubMed

Jin, Xiannu; Luong, Thu-Lan; Reese, Necole; Gaona, Heather; Collazo-Velez, Vanessa; Vuong, Chau; Potter, Brittney; Sousa, Jason C; Olmeda, Raul; Li, Qigui; Xie, Lisa; Zhang, Jing; Zhang, Ping; Reichard, Greg; Melendez, Victor; Marcsisin, Sean R; Pybus, Brandon S

2014-01-01

Malaria is a major health concern and affects over 300million people a year. Accordingly, there is an urgent need for new efficacious anti-malarial drugs. A major challenge in developing new anti-malarial drugs is to design active molecules that have preferable drug-like characteristics. These "drug-like" characteristics include physiochemical properties that affect drug absorption, distribution, metabolism, and excretion (ADME). Compounds with poor ADME profiles will likely fail in vivo due to poor pharmacokinetics and/or other drug delivery related issues. There have been numerous assays developed in order to pre-screen compounds that would likely fail in further development due to poor absorption properties including PAMPA, Caco-2, and MDCK permeability assays. The use of cell-based permeability assays such as Caco-2 and MDCK serve as surrogate indicators of drug absorption and transport, with the two approaches often used interchangeably. We sought to evaluate both approaches in support of anti-malarial drug development. Accordingly, a comparison of both assays was conducted utilizing apparent permeability coefficient (Papp) values determined from liquid chromatography/tandem mass spectrometry (LC-MS) analyses. Both Caco-2 and MDCK permeability assays produced similar Papp results for potential anti-malarial compounds with low and medium permeability. Differences were observed for compounds with high permeability and compounds that were P-gp substrates. Additionally, the utility of MDCK-MDR1 permeability measurements was demonstrated in probing the role of P-glycoprotein transport in Primaquine-Chloroquine drug-drug interactions in comparison with in vivo pharmacokinetic changes. This study provides an in-depth comparison of the Caco-2 and MDCK-MDR1 cell based permeability assays and illustrates the utility of cell-based permeability assays in anti-malarial drug screening/development in regard to understanding transporter mediated changes in drug absorption

The anti-hepatitis drug use effect and inventory management optimization from the perspective of hospital drug supply chain.

PubMed

Liu, Zhanyu

2017-09-01

By analyzing the current hospital anti hepatitis drug use, dosage, indications and drug resistance, this article studied the drug inventory management and cost optimization. The author used drug utilization evaluation method, analyzed the amount and kind distribution of anti hepatitis drugs and made dynamic monitoring of inventory. At the same time, the author puts forward an effective scheme of drug classification management, uses the ABC classification method to classify the drugs according to the average daily dose of drugs, and implements the automatic replenishment plan. The design of pharmaceutical services supply chain includes drug procurement platform, warehouse management system and connect to the hospital system through data exchange. Through the statistical analysis of drug inventory, we put forward the countermeasures of drug logistics optimization. The results showed that drug replenishment plan can effectively improve drugs inventory efficiency.

Botanical drugs in Ayurveda and Traditional Chinese Medicine.

PubMed

Jaiswal, Yogini; Liang, Zhitao; Zhao, Zhongzhen

2016-12-24

China and India have a long history in the therapeutic application of botanical drugs in traditional medicine. Traditional Chinese Medicine (TCM) and Ayurveda are considered as two of the most ancient systems of medicine, with history of more than two millennia. Medicinal plants are the principal medicinal materials used in both these systems. This review discusses about the histories of Ayurveda and TCM, the common medicinal plants species, the drug processing strategies used, and the current statuses of these traditional systems of medicine (TSM). Through the views presented in this article, we aim to provide a new perspective to herbal drug researchers for expanding and improving the utilization of botanical drugs and their therapeutic applications. A bibliographic investigation of Chinese and Indian pharmacopoeias, monographs and official websites was performed. Furthermore, information was obtained from scientific databases on ethnobotany and ethno medicines. The review of Ayurveda and TCM ethno medicine indicates that both these systems have many medicinal materials in common. The studies carried out by the authors for comparison of plants from same genus from both these TSM's have been discussed to further bring focus to the utilization of "qualitatively" similar species which can be utilized and substituted for endangered or economically valued species. The overview of ancient literature and scientific findings for drugs in both these systems suggests that, the botanical drugs used in common and their processing methods can be explored further for extensive utilization in traditional medicine. This review describes the histories, common medicinal plant species, their processing methods and therapeutic applications in Ayurveda and TCM. The insights provided through this article may be used by herbal drug researchers and pharmacologists for further exploration of botanical drugs from these two traditional systems of medicine. Copyright © 2016. Published by

Identifying high risk medications causing potential drug-drug interactions in outpatients: A prescription database study based on an online surveillance system.

PubMed

Toivo, T M; Mikkola, J A V; Laine, K; Airaksinen, M

2016-01-01

Drug-drug interactions (DDIs) are a significant cause for adverse drug events (ADEs). DDIs are often predictable and preventable, but their prevention and management require systematic service development. Most DDI studies focus on interaction rates in hospitalized patients. Less is known of DDIs in outpatients, particularly how community pharmacists could contribute to DDI management by applying their surveillance systems for identifying high-risk medications. The study was related to the implementation of the first online DDI surveillance system in Finnish community pharmacies. The goal was to demonstrate how community pharmacies can utilize their prospective surveillance system 1) for identifying high risk medications causing potential DDIs in outpatients, 2) for collaborative service development with local physicians, and 3) for academic risk management research purposes. All DDI alerts given by the online surveillance system were collected during a one-month period in 16 out of 17 University Pharmacy outlets in Finland, covering approximately 10% of the national outpatient prescription volume. The surveillance system was based on the FASS database, which categorizes DDIs into four classes (A-D) according to their clinical significance. Potential drug-drug DDIs were analyzed for 276,891 dispensed community pharmacy prescriptions. Potential DDIs were associated with 10.8%, or 31,110 of these prescriptions. Clinically significant interaction alerts categorized as FASS classes D (most severe, should be avoided) and C (clinically significant but controllable) were associated with 0.5% and 7.0% of the prescriptions, respectively. Methotrexate and warfarin had the highest risk of causing potentially serious (class D) interactions. These interaction alerts were most frequently between methotrexate and NSAIDs and warfarin and NSAIDs. In general, NSAIDs were the most commonly interacting drugs in this study. This study demonstrates that community pharmacies can actively

How the blind cope with problems of medicine utilization: a study in Bangkok, Thailand.

PubMed

Riewpaiboon, Arthorn

2009-08-01

This project is aimed at studying medicine utilization among blind people in Bangkok, Thailand. The study was designed as a cross-sectional descriptive research. The study group comprised visually impaired persons, aged at least 18 years, and living in Bangkok. Data were collected via face-to-face interviews in 2007. The study included 86 people. The majority of the subjects were 31-50 years old (65%) and male (61%). During the two weeks before the interview, the most frequently used medicines were anti-inflammatory drugs and muscle relaxants (26%), followed by antipyretics. Most of the subjects received their medicines from drugstores. During the three months before the interview, 75% of the subjects received pharmacy information through various channels. The major source was drugstores, followed by radio. With regard to procurement of medication, 79% of the subjects went to hospitals and 57% acquired the medicines by themselves. Approximately 20% of the subjects received medicines with touchable-differentiated packaging. For purposes of self-medication, the subjects were able to differentiate types, doses, and durations of drug use based on memory. Regarding pharmaceutical services, 81% of the subjects required special services intended for the disabled, as well as further explanation of the medicine's use, including drug labeling. Based on the study results, most of the blind did not receive assistance regarding medicine use. Their use of medicine was based on memory, and they were in need of improved pharmaceutical services. Copyright 2009 John Wiley & Sons, Ltd.

Identifying genomic and developmental causes of adverse drug reactions in children

PubMed Central

Becker, Mara L; Leeder, J Steven

2011-01-01

Adverse drug reactions are a concern for all clinicians who utilize medications to treat adults and children; however, the frequency of adult and pediatric adverse drug reactions is likely to be under-reported. In this age of genomics and personalized medicine, identifying genetic variation that results in differences in drug biotransformation and response has contributed to significant advances in the utilization of several commonly used medications in adults. In order to better understand the variability of drug response in children however, we must not only consider differences in genotype, but also variation in gene expression during growth and development, namely ontogeny. In this article, recommendations for systematically approaching pharmacogenomic studies in children are discussed, and several examples of studies that investigate the genomic and developmental contribution to adverse drug reactions in children are reviewed. PMID:21121777

Stevens-Johnson syndrome and toxic epidermal necrolysis: an update on pharmacogenetics studies in drug-induced severe skin reaction.

PubMed

Rufini, Sara; Ciccacci, Cinzia; Politi, Cristina; Giardina, Emiliano; Novelli, Giuseppe; Borgiani, Paola

2015-11-01

Stevens-Johnson syndrome and toxic epidermal necrolysis are severe, life-threatening drug reactions involving skin and membranes mucous, which are associated with significant morbidity and mortality and triggered, especially by drug exposure. Different studies have demonstrated that drug response is a multifactorial character and that the interindividual variability in this response depends on both environmental and genetic factors. The last ones have a relevant significance. In fact, the identification of new specific genetic markers involved in the response to drugs, will be of great utility to establish a more personalized therapeutic approach and to prevent the appearance of these adverse reactions. In this review, we summarize recent progresses in the Pharmacogenetics studies related to Stevens-Johnson syndrome/toxic epidermal necrolysis reporting the major genetic factors identified in the last years as associated with the disease and highlighting the use of some of these genomic variants in the clinical practice.

Drug Courts and Adolescents.

ERIC Educational Resources Information Center

Schwebel, Robert

2002-01-01

The narrow preoccupation with abstinence causes many substance-abusing youth to react either with dishonesty or resistance. Drug education and treatment programs need to help youth rethink their use of drugs, rather than utilize harshly confrontational tactics. Drug courts can provide sanctions, while treatment interventions such as the Seven…

Drug-nutrient interactions.

PubMed

Trovato, A; Nuhlicek, D N; Midtling, J E

1991-11-01

Drug-nutrient interactions are a commonly overlooked aspect of the prescribing practices of physicians. As more pharmaceutical agents become available, attention should be focused on interactions of drugs with foods and nutrients. Although drug-nutrient interactions are not as common as drug-drug interactions, they can have an impact on therapeutic outcome. Drugs can affect nutritional status by altering nutrient absorption, metabolism, utilization or excretion. Food, beverages and mineral or vitamin supplements can affect the absorption and effectiveness of drugs. Knowledge of drug-nutrient interactions can help reduce the incidence of these effects. Physicians should question patients about their dietary habits so that patients can be informed about possible interactions between a prescribed drug and foods and nutrients.

Emergency Department Frequent Utilization for Non-Emergent Presentments: Results from a Regional Urban Trauma Center Study.

PubMed

Behr, Joshua G; Diaz, Rafael

2016-01-01

First, to test a model of the drivers of frequent emergency department utilization conceptualized as falling within predisposing, enabling, and need dimensions. Second, to extend the model to include social networks and service quality as predictors of frequent utilization. Third, to illustrate the variation in thresholds that define frequent utilization in terms of the number of emergency department encounters by the predictors within the model. Primary data collection over an eight week period within a level-1 trauma urban hospital's emergency department. Representative randomized sample of 1,443 adult patients triaged ESI levels 4-5. Physicians and research staff interviewed patients as they received services. Relationships with the outcome variable, utilization, were tested using logistic regression to establish odds-ratios. 70.6 percent of patients have two or more, 48.3 percent have three or more, 25.3 percent have four or more, and 14.9 percent have five or more emergency department visits within 12 months. Factors associated with frequent utilization include gender, race, poor mental health, mental health drugs, prescription drug abuse, social networks, employment, perceptions of service quality, seriousness of condition, persistence of condition, and previous hospital admittance. Interventions targeting associated factors will change global emergency department encounters, although the mutability varies. Policy interventions to address predisposing factors such as substance abuse or access to mental health treatment as well as interventions that speak to enabling factors such as promoting the resiliency of social networks may result in decreased frequency of emergency department utilization.

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

PubMed Central

2014-01-01

of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety. PMID:25559675

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

PubMed

Yu, Ke; Zhang, Jie; Chen, Minjun; Xu, Xiaowei; Suzuki, Ayako; Ilic, Katarina; Tong, Weida

2014-01-01

confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety.

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

PubMed

Frueh, Felix W; Amur, Shashi; Mummaneni, Padmaja; Epstein, Robert S; Aubert, Ronald E; DeLuca, Teresa M; Verbrugge, Robert R; Burckart, Gilbert J; Lesko, Lawrence J

2008-08-01

To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. Retrospective analysis. The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data. Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label. Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.

Boston Collaborative Drug Surveillance Program

Cancer.gov

The Boston Collaborative Drug Surveillance Program started in 1966 and conducted epidemiologic research to quantify the potential adverse effects of prescription drugs, utilizing in-hospital monitoring.

Prescription drug use during pregnancy in Southern Tigray region, North Ethiopia.

PubMed

Molla, Fantahun; Assen, Admassu; Abrha, Solomon; Masresha, Birhanetensay; Gashaw, Arega; Wondimu, Abrham; Belete, Yared; Melkam, Wondim

2017-06-05

Judicious utilization of drugs rescues the fetus from the harmful effects while treating the health problems of the pregnant women. This study aimed at evaluating drug utilization pattern and its associated factors among pregnant women in Southern Tigray, Ethiopia. Institution based cross-sectional study was conducted among 647 pregnant women who had been attending obstetrics-gynecology and antenatal care units in different health facilities of Southern Tigray region. The study participants were selected using multistage sampling technique. Data collection was done using pre-tested semi-structured questionnaires and by reviewing antenatal follow-up cards. Descriptive and inferential statistics were analyzed, to assess drug utilization pattern and its associated factors among pregnant women, using SPSS version 20 software. Of 647 pregnant women, 87.5% were prescribed with at least one medication. As per the United States Food and Drug Administration (US-FDA) risk classification system, 87.7, 7.9, 3.9, and 0.5% of the prescribed drug were from category A, B, C and D, respectively. Prescription drug use was more likely among gynecology ward visitors [AOR = 8.97, 95% Cl (2.69-29.88)] and among those who visited health facilities for the first time during their first [AOR =2.65, 95% Cl (1.44-4.84)] and second [AOR = 2.50, 95% Cl (1.36-4.61)] trimesters. Majority of the study population used safe and appropriate medications according to US-FDA risk classification system, with the exception of low proportion (0.5%) of medication with potential risk for the fetus. The average number of drug prescribed per pregnant women was in the recommended range of WHO drug use indicators guideline.

Neuroimaging and Drug Taking in Primates Abbreviated title: Neuroimaging and Drug taking

PubMed Central

Murnane, Kevin S.; Howell, Leonard L.

2011-01-01

Rationale Neuroimaging techniques have led to significant advances in our understanding of the neurobiology of drug-taking and the treatment of drug addiction in humans. Neuroimaging approaches provide a powerful translational approach that can link findings from humans and laboratory animals. Objective This review describes the utility of neuroimaging toward understanding the neurobiological basis of drug taking, and documents the close concordance that can be achieved among neuroimaging, neurochemical and behavioral endpoints. Results The study of drug interactions with dopamine and serotonin transporters in vivo has identified pharmacological mechanisms of action associated with the abuse liability of stimulants. Neuroimaging has identified the extended limbic system, including the prefrontal cortex and anterior cingulate, as important neuronal circuitry that underlies drug taking. The ability to conduct within-subject, longitudinal assessments of brain chemistry and neuronal function has enhanced our efforts to document long-term changes in dopamine D2 receptors, monoamine transporters, and prefrontal metabolism due to chronic drug exposure. Dysregulation of dopamine function and brain metabolic changes in areas involved in reward circuitry have been linked to drug-taking behavior, cognitive impairment and treatment response. Conclusions Experimental designs employing neuroimaging should consider well-documented determinants of drug taking, including pharmacokinetic considerations, subject history and environmental variables. Methodological issues to consider include limited molecular probes, lack of neurochemical specificity in brain activation studies, and the potential influence of anesthetics in animal studies. Nevertheless, these integrative approaches should have important implications for understanding drug-taking behavior and the treatment of drug addiction. PMID:21360099

Female Ex-Offender Perspectives on Drug Initiation, Relapse, and Desire to Remain Drug Free

PubMed Central

Nyamathi, Adeline M.; Srivastava, Neha; Salem, Benissa E.; Wall, Sarah; Kwon, Jordan; Ekstrand, Maria; Hall, Elizabeth; Turner, Susan F.; Faucette, Mark

2016-01-01

Recently-released homeless women residing in temporary residential drug treatment programs are at a critical juncture in the process of recovery, transition and reentry. The purpose of this study was to explore factors influencing initial use of drugs and relapse triggers among a sample of incarcerated women exiting jails and prisons, and who are residing in a residential drug treatment (RDT) program and preparing for reentry into their communities. Among this population, relapse to drug use and recidivism are common. A qualitative study was conducted utilizing focus groups to understand the perspectives of formerly incarcerated, currently homeless women residing in a RDT program. Content analysis generated the development of three broad categories: a) factors associated with first drug use; b) factors involved in relapse; c) factors influencing desire to remain drug free. A discussion follows highlighting the importance of targeted interventions at RDT sites that integrate physical, psychological and social needs to optimize reentry into communities. This would include a focus on building self-esteem, life skills, and providing access to resources such as housing, employment, and healthcare. PMID:27195929

Intracranial Self-Stimulation to Evaluate Abuse Potential of Drugs

PubMed Central

Miller, Laurence L.

2014-01-01

Intracranial self-stimulation (ICSS) is a behavioral procedure in which operant responding is maintained by pulses of electrical brain stimulation. In research to study abuse-related drug effects, ICSS relies on electrode placements that target the medial forebrain bundle at the level of the lateral hypothalamus, and experimental sessions manipulate frequency or amplitude of stimulation to engender a wide range of baseline response rates or response probabilities. Under these conditions, drug-induced increases in low rates/probabilities of responding maintained by low frequencies/amplitudes of stimulation are interpreted as an abuse-related effect. Conversely, drug-induced decreases in high rates/probabilities of responding maintained by high frequencies/amplitudes of stimulation can be interpreted as an abuse-limiting effect. Overall abuse potential can be inferred from the relative expression of abuse-related and abuse-limiting effects. The sensitivity and selectivity of ICSS to detect abuse potential of many classes of abused drugs is similar to the sensitivity and selectivity of drug self-administration procedures. Moreover, similar to progressive-ratio drug self-administration procedures, ICSS data can be used to rank the relative abuse potential of different drugs. Strengths of ICSS in comparison with drug self-administration include 1) potential for simultaneous evaluation of both abuse-related and abuse-limiting effects, 2) flexibility for use with various routes of drug administration or drug vehicles, 3) utility for studies in drug-naive subjects as well as in subjects with controlled levels of prior drug exposure, and 4) utility for studies of drug time course. Taken together, these considerations suggest that ICSS can make significant contributions to the practice of abuse potential testing. PMID:24973197

Inkjet Printing of Drug-Loaded Mesoporous Silica Nanoparticles-A Platform for Drug Development.

PubMed

Wickström, Henrika; Hilgert, Ellen; Nyman, Johan O; Desai, Diti; Şen Karaman, Didem; de Beer, Thomas; Sandler, Niklas; Rosenholm, Jessica M

2017-11-21

Mesoporous silica nanoparticles (MSNs) have shown great potential in improving drug delivery of poorly water soluble (BCS class II, IV) and poorly permeable (BCS class III, IV) drugs, as well as facilitating successful delivery of unstable compounds. The nanoparticle technology would allow improved treatment by reducing adverse reactions of currently approved drugs and possibly reintroducing previously discarded compounds from the drug development pipeline. This study aims to highlight important aspects in mesoporous silica nanoparticle (MSN) ink formulation development for digital inkjet printing technology and to advice on choosing a method (2D/3D) for nanoparticle print deposit characterization. The results show that both unfunctionalized and polyethyeleneimine (PEI) surface functionalized MSNs, as well as drug-free and drug-loaded MSN-PEI suspensions, can be successfully inkjet-printed. Furthermore, the model BCS class IV drug remained incorporated in the MSNs and the suspension remained physically stable during the processing time and steps. This proof-of-concept study suggests that inkjet printing technology would be a flexible deposition method of pharmaceutical MSN suspensions to generate patterns according to predefined designs. The concept could be utilized as a versatile drug screening platform in the future due to the possibility of accurately depositing controlled volumes of MSN suspensions on various materials.

Phenotypic drug profiling in droplet microfluidics for better targeting of drug-resistant tumors.

PubMed

Sarkar, S; Cohen, N; Sabhachandani, P; Konry, T

2015-12-07

Acquired drug resistance is a key factor in the failure of chemotherapy. Due to intratumoral heterogeneity, cancer cells depict variations in intracellular drug uptake and efflux at the single cell level, which may not be detectable in bulk assays. In this study we present a droplet microfluidics-based approach to assess the dynamics of drug uptake, efflux and cytotoxicity in drug-sensitive and drug-resistant breast cancer cells. An integrated droplet generation and docking microarray was utilized to encapsulate single cells as well as homotypic cell aggregates. Drug-sensitive cells showed greater death in the presence or absence of Doxorubicin (Dox) compared to the drug-resistant cells. We observed heterogeneous Dox uptake in individual drug-sensitive cells while the drug-resistant cells showed uniformly low uptake and retention. Dox-resistant cells were classified into distinct subsets based on their efflux properties. Cells that showed longer retention of extracellular reagents also demonstrated maximal death. We further observed homotypic fusion of both cell types in droplets, which resulted in increased cell survival in the presence of high doses of Dox. Our results establish the applicability of this microfluidic platform for quantitative drug screening in single cells and multicellular interactions.

Racial and ethnic disparities in the financial burden of prescription drugs among older Americans.

PubMed

Xu, K Tom; Borders, Tyrone F

2007-01-01

This study examines racial and ethnic disparities in the financial burden of prescription drugs among older Americans using a market and an egalitarian model. A nationally representative data set, the Medical Expenditure Panel Survey 2002, was used. The financial burden of prescription drugs was measured by the out-of-pocket expenditure and proportion. In the market model (utilization adjustment)., utilization was measured at the annual aggregate level by the total number of prescription drugs, the average refills and the average quantity per prescription drug. In the egalitarian model (need adjustment)., health was measured by 15 chronic and costly diseases and the SF-12. Individuals 65 years or older were included. Nationally representative estimates were calculated. Raw racial and ethnic disparities were observed in the bivariate analyses between non-Hispanic whites and Hispanics in the out-of-pocket expenditure and proportion, and between non-Hispanic whites and non-Hispanic blacks in the out-of-pocket proportion. However, these disparities disappeared after controlling for utilization or health needs. Insurance status contributed the most to the disparities in the financial burden of prescription drugs. In conclusion, The disparities in the financial burden of prescription drugs between non-Hispanic elderly whites and Hispanics may be attributable to differences in utilization patterns. However, whether health disparities contribute to disparities in the financial burden of prescription drugs requires studies of specific diseases.

Low-dose naltrexone and opioid consumption: a drug utilization cohort study based on data from the Norwegian prescription database.

PubMed

Raknes, Guttorm; Småbrekke, Lars

2017-06-01

Low-dose naltrexone (LDN) is used in a wide range of conditions, including chronic pain and fibromyalgia. Because of the opioid antagonism of naltrexone, LDN users are probably often warned against concomitant use with opioids. In this study, based on data from the Norwegian prescription database, we examine changes in opioid consumption after starting LDN therapy. We included all Norwegian patients (N = 3775) with at least one recorded LDN prescription in 2013 and at least one dispensed opioid prescription during the 365 days preceding the first LDN prescription. We allocated the patients into three subgroups depending on the number of collected LDN prescriptions and recorded the number of defined daily doses (DDDs) on collected prescriptions on opioids, nonsteroidal anti-inflammatory drugs and other analgesics and antipyretics from the same patients. Among the patients collecting ≥4 LDN prescriptions, annual average opioid consumption was reduced by 41 DDDs per person (46%) compared with that of the previous year. The reduction was 12 DDDs per person (15%) among users collecting two to three prescriptions and no change among those collecting only one LDN prescription. We observed no increase in the number of DDDs in nonsteroidal anti-inflammatory drugs or other analgesics and antipyretics corresponding to the decrease in opioid use. Possibly, LDN users avoided opioids because of warnings on concomitant use or the patients continuing on LDN were less opioid dependent than those terminating LDN. Therapeutic effects of LDN contributing to lower opioid consumption cannot be ruled out. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

State Network Utilization Study: Mississippi Educational Television.

ERIC Educational Resources Information Center

Wilson, Savan; And Others

This document is the result of a utilization study of Mississippi Educational Television where 27 target audiences were identified and surveyed. The following information is included: a draft of and updated state network utilization studies; planning and management strategies; a profile of the survey populations; a distance learning survey report;…

Retrospective study on the utilization and cost of immunosuppressive agents among kidney transplant recipients in Taiwan: a 5-year review.

PubMed

Lee, E K L; Tseng, P L

2008-09-01

This study examined the utilization and cost of immunosuppressive agents among kidney transplant recipients in view of the growth under the Taiwan National Health Insurance payment system. Using inpatient expenditures by admissions and the files of the Registry for contracted medical facilities released from the Taiwan National Health Insurance Research Database, we totalled all renal implantations from 1999--2003, sorting them by drug expenditures reimbursed by contracted hospitals. The systematic sampling files of ambulatory care files were used to compute the Defined Daily Dose (DDD) and track drug utilization. The batch analysis was completed using the SPSS English version 13.0 for Windows. During the 5-year period, a total of 663 kidney transplantation surgeries were identified at 26 hospitals. Up to 90% of transplantation surgeries were performed at medical centers with about 55% in Northern Taiwan. Ninety-nine percent of drug expenditures were claimed by the top 12 hospitals. According to the Anatomical Therapeutic Chemical Classification, the most frequently prescribed immunosuppressive agents were Sandimmum Neoral cyclosporine (43%), mycophenolate (30.8%), and tacrolimus (21.3%) with DDDs of 137.5, 1187, and 5.54 mg, respectively. The ambulatory drug expenditure for patients increased 2-fold within the first 5 years, and 11.8 million in 2003 was estimated to be approximately 20 million Taiwanese dollars in 2010.

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…

Sample preparation composite and replicate strategy case studies for assay of solid oral drug products.

PubMed

Nickerson, Beverly; Harrington, Brent; Li, Fasheng; Guo, Michele Xuemei

2017-11-30

Drug product assay is one of several tests required for new drug products to ensure the quality of the product at release and throughout the life cycle of the product. Drug product assay testing is typically performed by preparing a composite sample of multiple dosage units to obtain an assay value representative of the batch. In some cases replicate composite samples may be prepared and the reportable assay value is the average value of all the replicates. In previously published work by Harrington et al. (2014) [5], a sample preparation composite and replicate strategy for assay was developed to provide a systematic approach which accounts for variability due to the analytical method and dosage form with a standard error of the potency assay criteria based on compendia and regulatory requirements. In this work, this sample preparation composite and replicate strategy for assay is applied to several case studies to demonstrate the utility of this approach and its application at various stages of pharmaceutical drug product development. Copyright © 2017 Elsevier B.V. All rights reserved.

Chimeric mice with humanized liver: Application in drug metabolism and pharmacokinetics studies for drug discovery.

PubMed

Naritomi, Yoichi; Sanoh, Seigo; Ohta, Shigeru

2018-02-01

Predicting human drug metabolism and pharmacokinetics (PK) is key to drug discovery. In particular, it is important to predict human PK, metabolite profiles and drug-drug interactions (DDIs). Various methods have been used for such predictions, including in vitro metabolic studies using human biological samples, such as hepatic microsomes and hepatocytes, and in vivo studies using experimental animals. However, prediction studies using these methods are often inconclusive due to discrepancies between in vitro and in vivo results, and interspecies differences in drug metabolism. Further, the prediction methods have changed from qualitative to quantitative to solve these issues. Chimeric mice with humanized liver have been developed, in which mouse liver cells are mostly replaced with human hepatocytes. Since human drug metabolizing enzymes are expressed in the liver of these mice, they are regarded as suitable models for mimicking the drug metabolism and PK observed in humans; therefore, these mice are useful for predicting human drug metabolism and PK. In this review, we discuss the current state, issues, and future directions of predicting human drug metabolism and PK using chimeric mice with humanized liver in drug discovery. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

Results of a Doravirine-Atorvastatin Drug-Drug Interaction Study.

PubMed

Khalilieh, Sauzanne; Yee, Ka Lai; Sanchez, Rosa I; Triantafyllou, Ilias; Fan, Li; Maklad, Noha; Jordan, Heather; Martell, Maureen; Iwamoto, Marian

2017-02-01

Doravirine is a novel, highly potent, nonnucleoside reverse transcriptase inhibitor that is administered once daily and that is in development for the treatment of HIV-1 infection. In vitro and clinical data suggest that doravirine is unlikely to cause significant drug-drug interactions via major drug-metabolizing enzymes or transporters. As a common HIV-1 infection comorbidity, hypercholesterolemia is often treated with statins, including the commonly prescribed atorvastatin. Atorvastatin is subject to drug-drug interactions with cytochrome P450 3A4 (CYP3A4) inhibitors. Increased exposure due to CYP3A4 inhibition may lead to serious adverse events (AEs), including rhabdomyolysis. Furthermore, atorvastatin is a substrate for breast cancer resistance protein (BCRP), of which doravirine may be a weak inhibitor; this may increase atorvastatin exposure. The potential of doravirine to affect atorvastatin pharmacokinetics was investigated in a two-period, fixed-sequence study in healthy individuals. In period 1, a single dose of atorvastatin at 20 mg was administered followed by a 72-h washout. In period 2, doravirine at 100 mg was administered once daily for 8 days, with a single dose of atorvastatin at 20 mg concomitantly being administered on day 5. Sixteen subjects were enrolled, and 14 completed the trial; 2 discontinued due to AEs unrelated to the treatment. The atorvastatin area under the curve from time zero to infinity was similar with and without doravirine (geometric mean ratio [GMR] for doravirine-atorvastatin/atorvastatin, 0.98; 90% confidence interval [CI], 0.90 to 1.06), while the maximum concentration decreased by 33% (GMR for doravirine-atorvastatin/atorvastatin, 0.67; 90% CI, 0.52 to 0.85). These changes were deemed not to be clinically meaningful. Both of the study drugs were generally well tolerated. Doravirine had no clinically relevant effect on atorvastatin pharmacokinetics in healthy subjects, providing support for the coadministration of

Results of a Doravirine-Atorvastatin Drug-Drug Interaction Study

PubMed Central

Yee, Ka Lai; Sanchez, Rosa I.; Triantafyllou, Ilias; Fan, Li; Maklad, Noha; Jordan, Heather; Martell, Maureen; Iwamoto, Marian

2016-01-01

ABSTRACT Doravirine is a novel, highly potent, nonnucleoside reverse transcriptase inhibitor that is administered once daily and that is in development for the treatment of HIV-1 infection. In vitro and clinical data suggest that doravirine is unlikely to cause significant drug-drug interactions via major drug-metabolizing enzymes or transporters. As a common HIV-1 infection comorbidity, hypercholesterolemia is often treated with statins, including the commonly prescribed atorvastatin. Atorvastatin is subject to drug-drug interactions with cytochrome P450 3A4 (CYP3A4) inhibitors. Increased exposure due to CYP3A4 inhibition may lead to serious adverse events (AEs), including rhabdomyolysis. Furthermore, atorvastatin is a substrate for breast cancer resistance protein (BCRP), of which doravirine may be a weak inhibitor; this may increase atorvastatin exposure. The potential of doravirine to affect atorvastatin pharmacokinetics was investigated in a two-period, fixed-sequence study in healthy individuals. In period 1, a single dose of atorvastatin at 20 mg was administered followed by a 72-h washout. In period 2, doravirine at 100 mg was administered once daily for 8 days, with a single dose of atorvastatin at 20 mg concomitantly being administered on day 5. Sixteen subjects were enrolled, and 14 completed the trial; 2 discontinued due to AEs unrelated to the treatment. The atorvastatin area under the curve from time zero to infinity was similar with and without doravirine (geometric mean ratio [GMR] for doravirine-atorvastatin/atorvastatin, 0.98; 90% confidence interval [CI], 0.90 to 1.06), while the maximum concentration decreased by 33% (GMR for doravirine-atorvastatin/atorvastatin, 0.67; 90% CI, 0.52 to 0.85). These changes were deemed not to be clinically meaningful. Both of the study drugs were generally well tolerated. Doravirine had no clinically relevant effect on atorvastatin pharmacokinetics in healthy subjects, providing support for the coadministration of

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.

Space platform utilities distribution study

NASA Technical Reports Server (NTRS)

Lefever, A. E.

1980-01-01

Generic concepts for the installation of power data and thermal fluid distribution lines on large space platforms were discussed. Connections with central utility subsystem modules and pallet interfaces were also considered. Three system concept study platforms were used as basepoints for the detail development. The tradeoff of high voltage low voltage power distribution and the impact of fiber optics as a data distribution mechanism were analyzed. Thermal expansion and temperature control of utility lines and ducts were considered. Technology developments required for implementation of the generic distribution concepts were identified.

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.

Examination of psychosocial predictors of Virginia pharmacists' intention to utilize a prescription drug monitoring program using the theory of planned behavior.

PubMed

Gavaza, Paul; Fleming, Marc; Barner, Jamie C

2014-01-01

Little is known about the main drivers of pharmacists' intention to utilize prescription drug monitoring programs (PDMPs) when making care decisions and the actual contribution of these factors in explaining intention and behavior. This study examined what theory of planned behavior (TPB) model constructs (i.e., attitude, subjective norm [SN], perceived behavioral control [PBC]), past utilization behavior (PUB) and perceived moral obligation (PMO) were significant predictors of Virginia community pharmacists' intention to utilize a PDMP. A cover letter with a link to a 28-item online survey was e-mailed to 600 members of the Virginia Pharmacists Association. Multiple regression analyses were used to determine the association between pharmacists' intention to utilize the PDMP database and attitude, SN, PBC, PUB and PMO. Ninety-seven usable responses were received, for a response rate of 16.2%. A majority of the respondents were Caucasian (96.4%), female (50.5%), working in independent community pharmacies (60.4%) with an average age of 49.5 ± 13.4 years. Overall, pharmacists intended to utilize a PDMP (mean = 5.3 ± 4.6; possible range: -9 to 9), had a positive attitude toward utilizing PDMP (mean = 6.3 ± 5.3; possible range: -12 to 12), perceived that others wanted them to utilize a PDMP (SN score = 3.7 ± 2.4; range: -6 to 6), and believed that they had control over utilization behavior (PBC score = 4.5 ± 4.0; range: -9 to 9). Attitude (β = 0.723, P < 0.001), SN (β = 0.230, P = 0.014) and PBC (β = -0.215, P = 0.026) significantly predicted pharmacists' intent, accounting for 56.7% of the variance in intention to utilize the PDMP database (P < 0.001). The addition of PMO (P < 0.001) significantly contributed to explaining the variance in intention but PUB did not. Members of the Virginia Pharmacists Association who responded to the survey showed a strong positive intent to utilize PDMP database. Pharmacists' attitudes, subjective norm, perceived behavioral

Return to drug use and overdose after release from prison: a qualitative study of risk and protective factors.

PubMed

Binswanger, Ingrid A; Nowels, Carolyn; Corsi, Karen F; Glanz, Jason; Long, Jeremy; Booth, Robert E; Steiner, John F

2012-01-01

Former inmates are at high risk for death from drug overdose, especially in the immediate post-release period. The purpose of the study is to understand the drug use experiences, perceptions of overdose risk, and experiences with overdose among former prisoners. This qualitative study included former prison inmates (N=29) who were recruited within two months after their release. Interviewers conducted in-person, semi-structured interviews which explored participants' experiences and perceptions. Transcripts were analyzed utilizing a team-based method of inductive analysis. The following themes emerged: 1) Relapse to drugs and alcohol occurred in a context of poor social support, medical co-morbidity and inadequate economic resources; 2) former inmates experienced ubiquitous exposure to drugs in their living environments; 3) intentional overdose was considered "a way out" given situational stressors, and accidental overdose was perceived as related to decreased tolerance; and 4) protective factors included structured drug treatment programs, spirituality/religion, community-based resources (including self-help groups), and family. Former inmates return to environments that strongly trigger relapse to drug use and put them at risk for overdose. Interventions to prevent overdose after release from prison may benefit from including structured treatment with gradual transition to the community, enhanced protective factors, and reductions of environmental triggers to use drugs.

Potential Drug-Drug Interactions among Patients prescriptions collected from Medicine Out-patient Setting.

PubMed

Farooqui, Riffat; Hoor, Talea; Karim, Nasim; Muneer, Mehtab

2018-01-01

To identify and evaluate the frequency, severity, mechanism and common pairs of drug-drug interactions (DDIs) in prescriptions by consultants in medicine outpatient department. This cross sectional descriptive study was done by Pharmacology department of Bahria University Medical & Dental College (BUMDC) in medicine outpatient department (OPD) of a private hospital in Karachi from December 2015 to January 2016. A total of 220 prescriptions written by consultants were collected. Medications given with patient's diagnosis were recorded. Drugs were analyzed for interactions by utilizing Medscape drug interaction checker, drugs.com checker and stockley`s drug interactions index. Two hundred eleven prescriptions were selected while remaining were excluded from the study because of unavailability of the prescribed drugs in the drug interaction checkers. In 211 prescriptions, two common diagnoses were diabetes mellitus (28.43%) and hypertension (27.96%). A total of 978 medications were given. Mean number of medications per prescription was 4.6. A total of 369 drug-drug interactions were identified in 211 prescriptions (175%). They were serious 4.33%, significant 66.12% and minor 29.53%. Pharmacokinetic and pharmacodynamic interactions were 37.94% and 51.21% respectively while 10.84% had unknown mechanism. Number wise common pairs of DDIs were Omeprazole-Losartan (S), Gabapentine- Acetaminophen (M), Losartan-Diclofenac (S). The frequency of DDIs is found to be too high in prescriptions of consultants from medicine OPD of a private hospital in Karachi. Significant drug-drug interactions were more and mostly caused by Pharmacodynamic mechanism. Number wise evaluation showed three common pairs of drugs involved in interactions.

Potential Drug-Drug Interactions among Patients prescriptions collected from Medicine Out-patient Setting

PubMed Central

Farooqui, Riffat; Hoor, Talea; Karim, Nasim; Muneer, Mehtab

2018-01-01

Objective: To identify and evaluate the frequency, severity, mechanism and common pairs of drug-drug interactions (DDIs) in prescriptions by consultants in medicine outpatient department. Methods: This cross sectional descriptive study was done by Pharmacology department of Bahria University Medical & Dental College (BUMDC) in medicine outpatient department (OPD) of a private hospital in Karachi from December 2015 to January 2016. A total of 220 prescriptions written by consultants were collected. Medications given with patient's diagnosis were recorded. Drugs were analyzed for interactions by utilizing Medscape drug interaction checker, drugs.com checker and stockley`s drug interactions index. Two hundred eleven prescriptions were selected while remaining were excluded from the study because of unavailability of the prescribed drugs in the drug interaction checkers. Results: In 211 prescriptions, two common diagnoses were diabetes mellitus (28.43%) and hypertension (27.96%). A total of 978 medications were given. Mean number of medications per prescription was 4.6. A total of 369 drug-drug interactions were identified in 211 prescriptions (175%). They were serious 4.33%, significant 66.12% and minor 29.53%. Pharmacokinetic and pharmacodynamic interactions were 37.94% and 51.21% respectively while 10.84% had unknown mechanism. Number wise common pairs of DDIs were Omeprazole-Losartan (S), Gabapentine- Acetaminophen (M), Losartan-Diclofenac (S). Conclusion: The frequency of DDIs is found to be too high in prescriptions of consultants from medicine OPD of a private hospital in Karachi. Significant drug-drug interactions were more and mostly caused by Pharmacodynamic mechanism. Number wise evaluation showed three common pairs of drugs involved in interactions. PMID:29643896

Illicit drugs: contaminants in the environment and utility in forensic epidemiology.

PubMed

Daughton, Christian G

2011-01-01

bioconcentration i tissues. In contrast to pharmaceuticals, chemical monitoring surveys have revealed the presence of certain IDIs in air and monetary currencies--the latter being of interest for the forensic tracking of money used in drug trafficking. Another unknown with regard to IDIs is the accuracy of current knowledge regarding the complete scope of chemical identities of the numerous types of IDIs in actual use (particularly some of the continually evolving designer drugs new to forensic chemistry) as well as the total quantities being trafficked, consumed, or disposed. The major aspect unique to the study of IDI's in the environment is making use of their presence in the environment as a tool to obtain better estimates of the collective usage of illicit drugs across entire communities. First proposed in 2001, but under investigation with field applications only since 2005, this new modeling approach for estimating drug usage by monitoring the concentrations of IDIs (or certain unique metabolites) in untreated sewage has potential as an additional source of data to augment or corroborate the information-collection ability of conventional written and oral surveys of drug-user populations. This still evolving monitoring tool has been called "sewer epidemiology" but is referred to in this chapter by a more descriptive proposed term "FEUDS" (Forensic Epidemiology Using Drugs in Sewage). The major limitation of FEUDS surrounds the variables involved at various steps performed in FEUDS calculations. These variables are summarized and span sampling and chemical analysis to the final numeric calculations, which particularly require a better understanding of IDI pharmacokinetics than currently exists. Although little examined in the literature, the potential for abuse of FEUDS as a tool in law enforcement is briefly discussed. Finally, the growing interest in FEUDS as a methodological approach for estimating collective public usage of illicit drugs points to the feasibility of

Feasibility study of a Raman spectroscopic route to drug detection

NASA Astrophysics Data System (ADS)

Wróbel, Maciej S.; Siddhanta, Soumik; Jedrzejewska-Szczerska, Małgorzata; Smulko, Janusz; Barman, Ishan

2017-02-01

We present an surface-enhanced Raman spectroscopy (SERS) approach for detection of drugs of abuse in whole human blood. We utilize a near infrared laser with 830 nm excitation wavelength in order to reduce the influence of fluorescence on the spectra of blood. However, regular plasmon resonance peak of plasmonic nanoparticles, such as silver or gold fall in a much lower wavelength regime about 400 nm. Therefore, we have shifted the plasmon resonance of nanoparticles to match that of an excitation laser wavelength, by fabrication of the silver-core gold-shell nanoparticles. By combining the laser and plasmon resonance shift towards longer wavelengths we have achieved a great reduction in background fluorescence of blood. Great enhancement of Raman signal coming solely from drugs was achieved without any prominent lines coming from the erythrocytes. We have applied chemometric processing methods, such as Principal Component Analysis (PCA), to detect the elusive differences in the Raman bands which are specific for the investigated drugs. We have achieved good classification for the samples containing particular drugs (e.g., butalbital, α-hydroxyalprazolam). Furthermore, a quantitative analysis was carried out to assess the limit of detection (LOD) using Partial Least Squares (PLS) regression method. In conclusion, our LOD values obtained for each class of drugs was competitive with the gold standard GC/MS method.

South Carolina harvest and utilization study, 2011

Treesearch

Kerry J.W. Dooley; Jason A. Cooper; James W. Bentley

2015-01-01

In 2011, a harvest and utilization study was conducted on 80 operations throughout South Carolina. There were 1,974 total trees measured; 1,317 or 67 percent were softwood, while 657 or 33 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging residue....

North Carolina harvest and utilization study, 2015

Treesearch

David J. Wall; Jason A. Cooper; James W. Bentley; James A. Gray

2018-01-01

In 2015, a harvest and utilization study was completed on 95 operations throughout North Carolina. There were 2,125 total trees measured: 1,284 or 60 percent were softwood, while 841 or 40 percent were hardwood. Results from this study showed that 85 percent of the total softwood volume measured was utilized for a product, and 15 percent was left as logging residue....

North Carolina harvest and utilization study, 2007

Treesearch

James W. Bentley; Tony G. Johnson

2010-01-01

In 2007, a harvest and utilization study was conducted on 83 operations throughout North Carolina. There were 2,119 total trees measured: 1,323 or 62 percent were softwood, while 796 or 38 percent were hardwood. Results from this study showed that 85 percent of the total softwood volume measured was utilized for a product, and 15 percent was left as logging residue....

North Carolina harvest and utilization study, 2002

Treesearch

James W. Bentley; Tony G. Johnson

2006-01-01

In 2002, a harvest and utilization study was conducted on 108 operations throughout North Carolina. There were 2,926 total trees measured; 1,693, or 58 percent, were softwood, while 1,233, or 42 percent, were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging...

East Texas harvest and utilization study, 2014

Treesearch

Jason A. Cooper; James W. Bentley; James A. Gray; David J. Wall

2017-01-01

In 2014, a harvest and utilization study was completed on 68 logging operations throughout eastern Texas. There were 1,464 total trees measured: 1,149 or 78 percent were softwood, while 315 or 22 percent were hardwood. Results from this study showed that 81 percent of the total softwood volume measured was utilized for a product, and 19 percent was left as logging...

East Texas harvest and utilization study, 2008

Treesearch

Rhonda M. Mathison; James W. Bentley; Tony G. Johnson

2009-01-01

In 2008, a harvest and utilization study was conducted on 80 operations throughout eastern Texas. There were 2,024 total trees measured: 1,335 or 66 percent were softwood, while 689 or 34 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging...

East Oklahoma harvest and utilization study, 2008

Treesearch

Jason A. Cooper; James W. Bentley

2013-01-01

In 2008, a harvest and utilization study was conducted on 28 operations in eastern Oklahoma. There were 682 total trees measured: 509 or 75 percent were softwood, while 173 or 25 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging residue. Seventy-four...

In Silico Augmentation of the Drug Development Pipeline: Examples from the study of Acute Inflammation.

PubMed

An, Gary; Bartels, John; Vodovotz, Yoram

2011-03-01

The clinical translation of promising basic biomedical findings, whether derived from reductionist studies in academic laboratories or as the product of extensive high-throughput and -content screens in the biotechnology and pharmaceutical industries, has reached a period of stagnation in which ever higher research and development costs are yielding ever fewer new drugs. Systems biology and computational modeling have been touted as potential avenues by which to break through this logjam. However, few mechanistic computational approaches are utilized in a manner that is fully cognizant of the inherent clinical realities in which the drugs developed through this ostensibly rational process will be ultimately used. In this article, we present a Translational Systems Biology approach to inflammation. This approach is based on the use of mechanistic computational modeling centered on inherent clinical applicability, namely that a unified suite of models can be applied to generate in silico clinical trials, individualized computational models as tools for personalized medicine, and rational drug and device design based on disease mechanism.

Studies of Drug Delivery and Drug Release of Dendrimer by Dissipative Particle Dynamics

NASA Astrophysics Data System (ADS)

Lin, Chun-Min; Wu, Yi-Fan; Tsao, Heng-Kwong; Sheng, Yu-Jane

2008-02-01

Dendrimers, like unimolecular micelles, may encapsulate guest biomolecules (drug) and therefore are attractive candidates as carriers in drug delivery applications. Hydrophobic drugs can be complexed within the hydrophobic dendrimer interior to make them water-soluble. The equilibrium partition of hydrophobic solutes into a dendrimer with hydrophobic interior from aqueous solutions is studied by dissipative particle dynamics. The drug is mainly distributed in the vicinity of the interface between hydrophobic interior and hydrophilic exterior within a dendrimer. The partition coefficient, which is defined as the concentration ratio of the drug distributed within dendrimer to aqueous phases, depends on the interaction between drug and hydrophilic dendrimer exterior. Increasing the repulsion between them reduces the solubilization ability associated with the dendrimer.

Use of topical ocular antibiotics in young children: a Scandinavian drug utilization study.

PubMed

Andersson, Jasmine; Hofsli, Mikael; Gade, Uffe Lomholt; Heegaard, Steffen; Pottegård, Anton

2018-06-09

Acute infectious conjunctivitis is a common disease. While usually self-limiting, children often receive treatment to be accepted back into nursery, day care or school. We aimed to describe trends in the utilization of topical ocular antibiotics in young children aged 0-4 years in Denmark, Norway and Sweden. Using individual-level data from the Danish National Prescription Registry (2000-2015), we provided detailed descriptions of treatment patterns at the individual level, stratified by age (0-1 years, 2-4 years) and antibiotic substance. Aggregate-level data for Danish, Norwegian and Swedish children (0-4 years) were obtained from publicly available data sources (2000-2016). We identified 107 581 Danish children aged 0-4 years receiving 271 980 treatment episodes. The incidence rate was relatively stable between 2000 and 2010 (on average, 637 and 283/1000 person-years for 0- to 1- and 2- to 4-year-olds, respectively), after which it dropped by 37% until 2015. In the aggregated data, a markedly higher use was seen in Denmark (211/1000 children in 2016) compared with Sweden (42) and Norway (151). The decrease from 2010 onwards was observed in all three countries. Chloramphenicol and fusidic acid were the most commonly used topical ocular antibiotics across Scandinavia. Tobramycin was rarely used in Norway and Sweden (≤1/1000 children in 2016) compared with Denmark (24/1000 children). Considerable variation is seen in the utilization of topical ocular antibiotics among children in Scandinavia, with Denmark having the highest use. Across the Scandinavian countries, however, a decline was noted from 2010 onwards. © 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Computer-Aided Drug Design Methods.

PubMed

Yu, Wenbo; MacKerell, Alexander D

2017-01-01

Computational approaches are useful tools to interpret and guide experiments to expedite the antibiotic drug design process. Structure-based drug design (SBDD) and ligand-based drug design (LBDD) are the two general types of computer-aided drug design (CADD) approaches in existence. SBDD methods analyze macromolecular target 3-dimensional structural information, typically of proteins or RNA, to identify key sites and interactions that are important for their respective biological functions. Such information can then be utilized to design antibiotic drugs that can compete with essential interactions involving the target and thus interrupt the biological pathways essential for survival of the microorganism(s). LBDD methods focus on known antibiotic ligands for a target to establish a relationship between their physiochemical properties and antibiotic activities, referred to as a structure-activity relationship (SAR), information that can be used for optimization of known drugs or guide the design of new drugs with improved activity. In this chapter, standard CADD protocols for both SBDD and LBDD will be presented with a special focus on methodologies and targets routinely studied in our laboratory for antibiotic drug discoveries.

Eastern Texas harvest and utilization study, 2003

Treesearch

James W. Bentley; Tony G. Johnson

2004-01-01

In 2003, a harvest and utilization study was conducted on 81 operations throughout eastern Texas. There were 2,072 total trees measured, 1,557 or 75 percent were softwood, while 515 or 25 percent were hardwood. Results from this study showed that 87 percent of the total softwood volume measured was utilized for a product, while the other 13 percent was left as logging...

South Carolina harvest and utilization study, 2006

Treesearch

James W. Bentley; Tony G. Johnson

2008-01-01

In 2006, a harvest and utilization study was conducted on 99 operations throughout South Carolina. There were 2,904 total trees measured; 1,763 or 61 percent were softwood, while 1,141 or 39 percent were hardwood. Results from this study showed that 87 percent of the total softwood volume measured was utilized for a product, and 13 percent was left as logging residue....

Hair drug testing results and self-reported drug use among primary care patients with moderate-risk illicit drug use.

PubMed

Gryczynski, Jan; Schwartz, Robert P; Mitchell, Shannon Gwin; O'Grady, Kevin E; Ondersma, Steven J

2014-08-01

This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally validated Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse, in which 360 adults with moderate-risk drug use were recruited from two community clinics in New Mexico, USA. The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially available 5-panel test with assay screening and gas chromatography/mass spectrometry (GC/MS) confirmation. Both self-report and hair testing covered a 3-month period. Overall concordance between hair testing and self-report was 57.5% (marijuana), 86.5% (cocaine), 85.8% (amphetamines), and 74.3% (opioids). Specificity of hair testing at standard laboratory cut-offs exceeded 90% for all drugs, but sensitivity of hair testing relative to self-report was low, identifying only 52.3% (127/243) of self-disclosed marijuana users, 65.2% (30/46) of cocaine users, 24.2% (8/33) of amphetamine users, and 2.9% (2/68) of opioid users. Among participants who disclosed using marijuana or cocaine in the past 3 months, participants with a negative hair test tended to report lower-frequency use of those drugs (p<.001 for marijuana and cocaine). Hair testing can be useful in studies with moderate-risk drug users, but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Hair Drug Testing Results and Self-reported Drug Use among Primary Care Patients with Moderate-risk Illicit Drug Use

PubMed Central

Gryczynski, Jan; Schwartz, Robert P.; Mitchell, Shannon Gwin; O’Grady, Kevin E.; Ondersma, Steven J.

2014-01-01

Background This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally-validated Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Methods This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse, in which 360 adults with moderate-risk drug use were recruited from two community clinics in New Mexico, USA. The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially-available 5-panel test with assay screening and gas chromatography/mass spectrometry (GC/MS) confirmation. Both self-report and hair testing covered a 3 month period. Results Overall concordance between hair testing and self-report was 57.5% (marijuana), 86.5% (cocaine), 85.8% (amphetamines), and 74.3% (opioids). Specificity of hair testing at standard laboratory cut-offs exceeded 90% for all drugs, but sensitivity of hair testing relative to self-report was low, identifying only 52.3% (127/243) of self-disclosed marijuana users, 65.2% (30/46) of cocaine users, 24.2% (8/33) of amphetamine users, and 2.9% (2/68) of opioid users. Among participants who disclosed using marijuana or cocaine in the past 3 months, participants with a negative hair test tended to report lower-frequency use of those drugs (p< .001 for marijuana and cocaine). Conclusions Hair testing can be useful in studies with moderate-risk drug users, but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report. PMID:24932945

Synergistic drug-cytokine induction of hepatocellular death as an in vitro approach for the study of inflammation-associated idiosyncratic drug hepatotoxicity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cosgrove, Benjamin D.; Cell Decision Processes Center, Massachusetts Institute of Technology, Cambridge, MA; Biotechnology Process Engineering Center, Massachusetts Institute of Technology, Cambridge, MA

Idiosyncratic drug hepatotoxicity represents a major problem in drug development due to inadequacy of current preclinical screening assays, but recently established rodent models utilizing bacterial LPS co-administration to induce an inflammatory background have successfully reproduced idiosyncratic hepatotoxicity signatures for certain drugs. However, the low-throughput nature of these models renders them problematic for employment as preclinical screening assays. Here, we present an analogous, but high-throughput, in vitro approach in which drugs are administered to a variety of cell types (primary human and rat hepatocytes and the human HepG2 cell line) across a landscape of inflammatory contexts containing LPS and cytokines TNF,more » IFN{gamma}, IL-1{alpha}, and IL-6. Using this assay, we observed drug-cytokine hepatotoxicity synergies for multiple idiosyncratic hepatotoxicants (ranitidine, trovafloxacin, nefazodone, nimesulide, clarithromycin, and telithromycin) but not for their corresponding non-toxic control compounds (famotidine, levofloxacin, buspirone, and aspirin). A larger compendium of drug-cytokine mix hepatotoxicity data demonstrated that hepatotoxicity synergies were largely potentiated by TNF, IL-1{alpha}, and LPS within the context of multi-cytokine mixes. Then, we screened 90 drugs for cytokine synergy in human hepatocytes and found that a significantly larger fraction of the idiosyncratic hepatotoxicants (19%) synergized with a single cytokine mix than did the non-hepatotoxic drugs (3%). Finally, we used an information theoretic approach to ascertain especially informative subsets of cytokine treatments for most highly effective construction of regression models for drug- and cytokine mix-induced hepatotoxicities across these cell systems. Our results suggest that this drug-cytokine co-treatment approach could provide a useful preclinical tool for investigating inflammation-associated idiosyncratic drug hepatotoxicity.« less

Social Studies. Health: Drugs, Society and You.

ERIC Educational Resources Information Center

Faulkner, Brenda F.

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

Club Drugs. The DAWN Report.

ERIC Educational Resources Information Center

Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Office of Applied Studies.

This report was prepared in response to requests from the media, law enforcement, and community leaders for information about club drugs. By being able to utilize statistics from hospital emergency departments and by compiling statistics on drug-related deaths, the Drug Abuse Warning Network (DAWN) is able to alert parents, educators, and others…

21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... Human Prescription Drugs § 14.171 Utilization of an advisory committee on the initiative of FDA. (a) Any...

Drug-Target Kinetics in Drug Discovery.

PubMed

Tonge, Peter J

2018-01-17

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

Structure based drug discovery for designing leads for the non-toxic metabolic targets in multi drug resistant Mycobacterium tuberculosis.

PubMed

Kaur, Divneet; Mathew, Shalu; Nair, Chinchu G S; Begum, Azitha; Jainanarayan, Ashwin K; Sharma, Mukta; Brahmachari, Samir K

2017-12-21

The problem of drug resistance and bacterial persistence in tuberculosis is a cause of global alarm. Although, the UN's Sustainable Development Goals for 2030 has targeted a Tb free world, the treatment gap exists and only a few new drug candidates are in the pipeline. In spite of large information from medicinal chemistry to 'omics' data, there has been a little effort from pharmaceutical companies to generate pipelines for the development of novel drug candidates against the multi drug resistant Mycobacterium tuberculosis. In the present study, we describe an integrated methodology; utilizing systems level information to optimize ligand selection to lower the failure rates at the pre-clinical and clinical levels. In the present study, metabolic targets (Rv2763c, Rv3247c, Rv1094, Rv3607c, Rv3048c, Rv2965c, Rv2361c, Rv0865, Rv0321, Rv0098, Rv0390, Rv3588c, Rv2244, Rv2465c and Rv2607) in M. tuberculosis, identified using our previous Systems Biology and data-intensive genome level analysis, have been used to design potential lead molecules, which are likely to be non-toxic. Various in silico drug discovery tools have been utilized to generate small molecular leads for each of the 15 targets with available crystal structures. The present study resulted in identification of 20 novel lead molecules including 4 FDA approved drugs (droxidropa, tetroxoprim, domperidone and nemonapride) which can be further taken for drug repurposing. This comprehensive integrated methodology, with both experimental and in silico approaches, has the potential to not only tackle the MDR form of Mtb but also the most important persister population of the bacterium, with a potential to reduce the failures in the Tb drug discovery. We propose an integrated approach of systems and structural biology for identifying targets that address the high attrition rate issue in lead identification and drug development We expect that this system level analysis will be applicable for identification of drug

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

PubMed

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

University of Michigan Drug Education Questionnaire.

ERIC Educational Resources Information Center

Francis, John Bruce; Patch, David J.

This questionnaire assesses attitudes toward potential drug education programs and drug use practices in college students. The 87 items (multiple choice or free response) pertain to the history and extent of usage of 27 different drugs, including two non-existent drugs which may be utilized as a validity check; attitude toward the content, format,…

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.

Microfluidics‐based 3D cell culture models: Utility in novel drug discovery and delivery research

PubMed Central

Gupta, Nilesh; Liu, Jeffrey R.; Patel, Brijeshkumar; Solomon, Deepak E.; Vaidya, Bhuvaneshwar

2016-01-01

Abstract The implementation of microfluidic devices within life sciences has furthered the possibilities of both academic and industrial applications such as rapid genome sequencing, predictive drug studies, and single cell manipulation. In contrast to the preferred two‐dimensional cell‐based screening, three‐dimensional (3D) systems have more in vivo relevance as well as ability to perform as a predictive tool for the success or failure of a drug screening campaign. 3D cell culture has shown an adaptive response to the recent advancements in microfluidic technologies which has allowed better control over spheroid sizes and subsequent drug screening studies. In this review, we highlight the most significant developments in the field of microfluidic 3D culture over the past half‐decade with a special focus on their benefits and challenges down the lane. With the newer technologies emerging, implementation of microfluidic 3D culture systems into the drug discovery pipeline is right around the bend. PMID:29313007

Genetically engineered nanocarriers for drug delivery.

PubMed

Shi, Pu; Gustafson, Joshua A; MacKay, J Andrew

2014-01-01

Cytotoxicity, low water solubility, rapid clearance from circulation, and off-target side-effects are common drawbacks of conventional small-molecule drugs. To overcome these shortcomings, many multifunctional nanocarriers have been proposed to enhance drug delivery. In concept, multifunctional nanoparticles might carry multiple agents, control release rate, biodegrade, and utilize target-mediated drug delivery; however, the design of these particles presents many challenges at the stage of pharmaceutical development. An emerging solution to improve control over these particles is to turn to genetic engineering. Genetically engineered nanocarriers are precisely controlled in size and structure and can provide specific control over sites for chemical attachment of drugs. Genetically engineered drug carriers that assemble nanostructures including nanoparticles and nanofibers can be polymeric or non-polymeric. This review summarizes the recent development of applications in drug and gene delivery utilizing nanostructures of polymeric genetically engineered drug carriers such as elastin-like polypeptides, silk-like polypeptides, and silk-elastin-like protein polymers, and non-polymeric genetically engineered drug carriers such as vault proteins and viral proteins.

Genetically engineered nanocarriers for drug delivery

PubMed Central

Shi, Pu; Gustafson, Joshua A; MacKay, J Andrew

2014-01-01

Cytotoxicity, low water solubility, rapid clearance from circulation, and off-target side-effects are common drawbacks of conventional small-molecule drugs. To overcome these shortcomings, many multifunctional nanocarriers have been proposed to enhance drug delivery. In concept, multifunctional nanoparticles might carry multiple agents, control release rate, biodegrade, and utilize target-mediated drug delivery; however, the design of these particles presents many challenges at the stage of pharmaceutical development. An emerging solution to improve control over these particles is to turn to genetic engineering. Genetically engineered nanocarriers are precisely controlled in size and structure and can provide specific control over sites for chemical attachment of drugs. Genetically engineered drug carriers that assemble nanostructures including nanoparticles and nanofibers can be polymeric or non-polymeric. This review summarizes the recent development of applications in drug and gene delivery utilizing nanostructures of polymeric genetically engineered drug carriers such as elastin-like polypeptides, silk-like polypeptides, and silk-elastin-like protein polymers, and non-polymeric genetically engineered drug carriers such as vault proteins and viral proteins. PMID:24741309

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

Application of PBPK modelling in drug discovery and development at Pfizer.

PubMed

Jones, Hannah M; Dickins, Maurice; Youdim, Kuresh; Gosset, James R; Attkins, Neil J; Hay, Tanya L; Gurrell, Ian K; Logan, Y Raj; Bungay, Peter J; Jones, Barry C; Gardner, Iain B

2012-01-01

Early prediction of human pharmacokinetics (PK) and drug-drug interactions (DDI) in drug discovery and development allows for more informed decision making. Physiologically based pharmacokinetic (PBPK) modelling can be used to answer a number of questions throughout the process of drug discovery and development and is thus becoming a very popular tool. PBPK models provide the opportunity to integrate key input parameters from different sources to not only estimate PK parameters and plasma concentration-time profiles, but also to gain mechanistic insight into compound properties. Using examples from the literature and our own company, we have shown how PBPK techniques can be utilized through the stages of drug discovery and development to increase efficiency, reduce the need for animal studies, replace clinical trials and to increase PK understanding. Given the mechanistic nature of these models, the future use of PBPK modelling in drug discovery and development is promising, however, some limitations need to be addressed to realize its application and utility more broadly.

Review of Utilization of Cardiovascular Medicines by Daily Defined Dose in the Czech Republic and Slovak Republic.

PubMed

Szilágyiová, Petra; Slušná, Jana; Babela, Robert

2017-11-01

To the Editor, Drug utilization is an important field of drug policy and an integral part of public health internationally. This area of research attracts increasing interest but the pioneering work was done 50 years ago when the first drug consumption report from six European countries for the period of 1966-1967 showed great differences in drug utilization between population groups (WHO, 1968). These results gave important stimulus for creation of Anatomical Therapeutic Chemical (ATC) classification and technical unit of measurement called the Defined Daily Dose (DDD) which is specified as "the assumed average maintenance dose per day for a drug used for its main indication in adults" that dealt with the objections against traditional units of measurement in drug utilization studies (WHO, 2016). The ATC/DDD methodology has in the meantime proved its suitability in drug utilization monitoring and research. As mentioned previously, consumption of pharmaceuticals is often used as a basis for comparison between countries. Based on our professional expertise, we decided to analyze the consumption of cardiovascular medicines by DDD in the Czech Republic and Slovak Republic within all ATC groups reported to OECD (OECD, 2016a). According to OECD indicator results, the Slovak Republic showed in 2014 a higher pharmaceutical consumption by DDD in ATC group C (cardiovascular system) compared to the Czech Republic (OECD, 2016a).

Utilization of Substance Abuse Treatment: Gender Differences among Participants in an Aftercare Program.

PubMed

Yeom, Hyong Suk

2015-01-01

This study examined gender differences in the utilization of substance abuse treatment including inpatient, outpatient, and self-help services, using existing data sets from a National Institute on Drug Abuse study that enrolled 78 females and 141 males in a mixed-gender aftercare program in Massachusetts for a 2-year follow-up period. This study found that women came to the study in greater need of treatment than men. Women utilized significantly more outpatient treatment services than men. The characteristic of female per se led to more utilization of outpatient services, whereas the baseline characteristics of employed status and alcohol use led to less utilization of outpatient services.

Access to linked administrative healthcare utilization data for pharmacoepidemiology and pharmacoeconomics research in Canada: anti-viral drugs as an example.

PubMed

Rawson, Nigel S B

2009-11-01

Administrative healthcare utilization data from Canadian provinces have been used for pharmacoepidemiology and pharmacoeconomics research, but limited transparency exists about opportunities for data access, who can access them, and processes to obtain data. An attempt was made to obtain data from all 10 provinces to evaluate access and its complexity. An initial enquiry about the process and requirements to obtain data on individual, anonymized patients dispensed any of four anti-viral drugs in the ambulatory setting, linked with data from hospital and physician service claims, was sent to each province. Where a response was encouraging, a technical description of the data of interest was submitted. Data were unavailable from the provinces of New Brunswick, Newfoundland and Labrador, and Prince Edward Island, and inaccessible from British Columbia, Manitoba and Ontario due to policies that prohibit collaborative work with pharmaceutical industry researchers. In Nova Scotia, patient-level data were available but only on site. Data were accessible in Alberta, Quebec and Saskatchewan, although variation exists in the currency of the data, time to obtain data, approval requirements and insurance coverage eligibility. As Canada moves towards a life-cycle management approach to drug regulation, more post-marketing studies will be required, potentially using administrative data. Linked patient-level drug and healthcare data are presently accessible to pharmaceutical industry researchers in four provinces, although only logistically realistic in three and limited to seniors and low-income individuals in two. Collaborative endeavours to improve access to provincial data and to create other data resources should be encouraged. (c) 2009 John Wiley & Sons, Ltd.

Ribonucleotide reductase as a drug target against drug resistance Mycobacterium leprae: A molecular docking study.

PubMed

Mohanty, Partha Sarathi; Bansal, Avi Kumar; Naaz, Farah; Gupta, Umesh Datta; Dwivedi, Vivek Dhar; Yadava, Umesh

2018-06-01

Leprosy is a chronic infection of skin and nerve caused by Mycobacterium leprae. The treatment is based on standard multi drug therapy consisting of dapsone, rifampicin and clofazamine. The use of rifampicin alone or with dapsone led to the emergence of rifampicin-resistant Mycobacterium leprae strains. The emergence of drug-resistant leprosy put a hurdle in the leprosy eradication programme. The present study aimed to predict the molecular model of ribonucleotide reductase (RNR), the enzyme responsible for biosynthesis of nucleotides, to screen new drugs for treatment of drug-resistant leprosy. The study was conducted by retrieving RNR of M. leprae from GenBank. A molecular 3D model of M. leprae was predicted using homology modelling and validated. A total of 325 characters were included in the analysis. The predicted 3D model of RNR showed that the ϕ and φ angles of 251 (96.9%) residues were positioned in the most favoured regions. It was also conferred that 18 α-helices, 6 β turns, 2 γ turns and 48 helix-helix interactions contributed to the predicted 3D structure. Virtual screening of Food and Drug Administration approved drug molecules recovered 1829 drugs of which three molecules, viz., lincomycin, novobiocin and telithromycin, were taken for the docking study. It was observed that the selected drug molecules had a strong affinity towards the modelled protein RNR. This was evident from the binding energy of the drug molecules towards the modelled protein RNR (-6.10, -6.25 and -7.10). Three FDA-approved drugs, viz., lincomycin, novobiocin and telithromycin, could be taken for further clinical studies to find their efficacy against drug resistant leprosy. Copyright © 2018 Elsevier B.V. All rights reserved.

Acute care hospital utilization among medical inpatients discharged with a substance use disorder diagnosis.

PubMed

Walley, Alexander Y; Paasche-Orlow, Michael; Lee, Eugene C; Forsythe, Shaula; Chetty, Veerappa K; Mitchell, Suzanne; Jack, Brian W

2012-03-01

Hospital discharge may be an opportunity to intervene among patients with substance use disorders to reduce subsequent hospital utilization. This study determined whether having a substance use disorder diagnosis was associated with subsequent acute care hospital utilization. We conducted an observational cohort study among 738 patients on a general medical service at an urban, academic, safety-net hospital. The main outcomes were rate and risk of acute care hospital utilization (emergency department visit or hospitalization) within 30 days of discharge. The main independent variable was presence of a substance use disorder primary or secondary discharge diagnosis code at the index hospitalization. At discharge, 17% of subjects had a substance use disorder diagnosis. These patients had higher rates of recurrent acute care hospital utilization than patients without substance use disorder diagnoses (0.63 vs 0.32 events per subject at 30 days, P < 0.01) and increased risk of any recurrent acute care hospital utilization (33% vs 22% at 30 days, P < 0.05). In adjusted Poisson regression models, the incident rate ratio at 30 days was 1.49 (95% confidence interval, 1.12-1.98) for patients with substance use disorder diagnoses compared with those without. In subgroup analyses, higher utilization was attributable to those with drug diagnoses or a combination of drug and alcohol diagnoses, but not to those with exclusively alcohol diagnoses. Medical patients with substance use disorder diagnoses, specifically those with drug use-related diagnoses, have higher rates of recurrent acute care hospital utilization than those without substance use disorder diagnoses.

Patterns of harm reduction service utilization and HIV incidence among people who inject drugs in Ukraine: A two-part latent profile analysis.

PubMed

Ompad, Danielle C; Wang, Jiayu; Dumchev, Konstantin; Barska, Julia; Samko, Maria; Zeziulin, Oleksandr; Saliuk, Tetiana; Varetska, Olga; DeHovitz, Jack

2017-05-01

Program utilization patterns are described within a large network of harm reduction service providers in Ukraine. The relationship between utilization patterns and HIV incidence is determined among people who inject drugs (PWID) controlling for oblast-level HIV incidence and treatment/syringe coverage. Data were extracted from the network's monitoring and evaluation database (January 2011-September 2014, n=327,758 clients). Latent profile analysis was used to determine harm reduction utilization patterns using the number of HIV tests received annually and the number of condoms, syringes, and services (i.e., information and counseling sessions) received monthly over a year. Cox proportional hazards regression determined the relations between HIV seroconversion and utilization class membership. In the final 4-class model, class 1 (34.0% of clients) received 0.1 HIV tests, 1.3 syringes, 0.6 condom and minimal counseling and information sessions per month; class 2 (33.6%) received 8.6 syringes, 3.2 condoms, and 0.5 HIV tests and counseling and information sessions; class 3 (19.1%) received 1 HIV test, 11.9 syringes, 4.3 condoms, and 0.7 information and counseling sessions; class 4 (13.3%) received 1 HIV test, 26.1 syringes, 10.3 condoms, and 1.8 information and 1.9 counseling sessions. Class 4 clients had significantly decreased risk for HIV seroconversion as compared to those in class 1 after controlling for oblast-level characteristics. Injection drug use continues to be a major mode of HIV transmission in Ukraine, making evaluation of harm reduction efforts in reducing HIV incidence among PWID critical. These analyses suggest that receiving more syringes and condoms decreased risk of HIV. Scaling up HIV testing and harm reduction services is warranted. Copyright © 2016. Published by Elsevier B.V.

Automated potentiometric procedure for studying dissolution kinetics acidic drugs under sink conditions.

PubMed

Underwood, F L; Cadwallader, D E

1978-08-01

An automated potentiometric procedure was used for studying in vitro dissolution kinetics of acidic drugs. Theoretical considerations indicated that the pH-stat method could be used to establish approximate sink conditions or, possibly, a perfect sink. Data obtained from dissolution studies using the pH-stat method were compared with data obtained from known sink and nonsink conditions. These comparisons indicated that the pH-stat method can be used to establish a sink condition for dissolution studies. The effective diffusion layer thicknesses for benzoic and salicylic acids dissolving in water were determined, and a theoretical dissolution rate was calculated utilizing these values. The close agreement between the experimental dissolution rates obtained under pH-stat conditions and theoretical dissolution rates indicated that perfect sink conditions were established under the experimental conditions used.

Organ utilization from increased infectious risk donors: An observational study.

PubMed

L'Huillier, Arnaud G; Humar, Atul; Payne, Clare; Kumar, Deepali

2017-12-01

Donors with an increased risk of transmitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) (increased risk donors [IRDs]) are a potential source of organs for transplant. Organs from IRDs can be utilized with appropriate recipient consent and post-transplant follow-up. We reviewed the characteristics and utilization of IRDs in our Organ Procurement Organization (OPO) over a 2-year period. Donor information from April 1, 2013 to March 31, 2015 was obtained through the OPO database. Only consented donors were included. Donors were categorized as IRDs according to Health Canada/Canadian Standards Association (CSA) criteria. A total of 494 potential donors were identified, of which 92 (18.6%) were IRDs. Of these, at least one organ was transplanted from 76 (82.6%). Risk factors for IRDs included injection drug user (IDU) (12%), men having sex with men (MSM) (7%), commercial sex worker (CSW) (4%), and incarceration (24%). Fifty-nine percent (253/429) of IRD organs were utilized. The most frequently used organ was kidney, followed by liver. Median number of organs recovered per IRD was 3 (interquartile range: 2-5). Nucleic acid testing (NAT) was performed in 18.5% (17/92) of IRDs. Reasons for NAT were IDU (n = 2), MSM (n = 2), CSW (n = 2), and previous incarceration (n = 7). Organ utilization from donors that had NAT was similar to donors who did not (94% vs 80%, P = .29). Follow-up NAT was done in <5% of recipients from IRDs. In our cohort, IRDs comprised a significant proportion of donors. Utilization of IRD organs occurred at a significant rate regardless of pre-transplant NAT. These data suggest that multiple factors contribute to the perception of infectious risk from such organs. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Assessment of function and clinical utility of alcohol and other drug web sites: An observational, qualitative study

PubMed Central

2011-01-01

Background The increasing popularity and use of the internet makes it an attractive option for providing health information and treatment, including alcohol/other drug use. There is limited research examining how people identify and access information about alcohol or other drug (AOD) use online, or how they assess the usefulness of the information presented. This study examined the strategies that individuals used to identify and navigate a range of AOD websites, along with the attitudes concerning presentation and content. Methods Members of the general community in Brisbane and Roma (Queensland, Australia) were invited to participate in a 30-minute search of the internet for sites related to AOD use, followed by a focus group discussion. Fifty one subjects participated in the study across nine focus groups. Results Participants spent a maximum of 6.5 minutes on any one website, and less if the user was under 25 years of age. Time spent was as little as 2 minutes if the website was not the first accessed. Participants recommended that AOD-related websites should have an engaging home or index page, which quickly and accurately portrayed the site's objectives, and provided clear site navigation options. Website content should clearly match the title and description of the site that is used by internet search engines. Participants supported the development of a portal for AOD websites, suggesting that it would greatly facilitate access and navigation. Treatment programs delivered online were initially viewed with caution. This appeared to be due to limited understanding of what constituted online treatment, including its potential efficacy. Conclusions A range of recommendations arise from this study regarding the design and development of websites, particularly those related to AOD use. These include prudent use of text and information on any one webpage, the use of graphics and colours, and clear, uncluttered navigation options. Implications for future website

Cost-utility analysis of competing treatment strategies for drug-resistant epilepsy in children with Tuberous Sclerosis Complex.

PubMed

Fallah, Aria; Weil, Alexander G; Wang, Shelly; Lewis, Evan; Baca, Christine B; Mathern, Gary W

2016-10-01

The management of drug-resistant epilepsy in children with Tuberous Sclerosis Complex (TSC) is challenging because of the multitude of treatment options, wide range of associated costs, and uncertainty of seizure outcomes. The most cost-effective approach for children whose epilepsy has failed to improve with first-line medical therapy is uncertain. A review of MEDLINE from 1990 to 2015 was conducted. A cost-utility analysis, from a third-party payer perspective, was performed for children with drug-resistant epilepsy that had failed to improve with 2 antiseizure drugs (ASDs) and that was amenable to resective epilepsy surgery, across a time-horizon of 5years. Four strategies were included: (1) resective epilepsy surgery, (2) vagus nerve stimulator (VNS) implantation, (3) ketogenic diet, and (4) addition of a third ASD (specifically, carbamazepine). The incremental cost per quality-adjusted life year (QALY) gained was analyzed. Given a willingness-to-pay (WTP) of $100,000 per QALY, the addition of a third ASD ($6600 for a gain of 4.14 QALYs) was the most cost-effective treatment strategy. In a secondary analysis, if the child whose epilepsy had failed to improve with 3 ASDs, ketogenic diet, addition of a fourth ASD, and resective epilepsy surgery were incrementally cost-effective treatment strategies. Vagus nerve stimulator implantation was more expensive yet less effective than alternative strategies and should not be prioritized. The addition of a third ASD is a universally cost-effective treatment option in the management of children with drug-resistant epilepsy that has failed to improve with 2 ASDs. For children whose epilepsy has failed to improve with 3 ASDs, the most cost-effective treatment depends on the health-care resources available reflected by the WTP. Copyright © 2016 Elsevier Inc. All rights reserved.

42 CFR 456.705 - Prospective drug review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Prospective drug review. 456.705 Section 456.705... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.705 Prospective drug review. (a) General...

42 CFR 456.705 - Prospective drug review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Prospective drug review. 456.705 Section 456.705... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.705 Prospective drug review. (a) General...

42 CFR 456.705 - Prospective drug review.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Prospective drug review. 456.705 Section 456.705... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.705 Prospective drug review. (a) General...

42 CFR 456.705 - Prospective drug review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Prospective drug review. 456.705 Section 456.705... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.705 Prospective drug review. (a) General...

Modification of Tamoxifen Effectiveness by Gene Polymorphisms and Other Drugs

DTIC Science & Technology

2010-05-01

study) Mr. Ahern’s three dissertation studies utilize the nationwide medical registries of Denmark to evaluate associations between prescription drugs...K Antagonists and Cancer Risk” component of the SOW. This study utilizes heart valve transplant as a proxy for treatment with a VKA, since actual...after a medication has been paid for and dispensed, we expect prescription compliance to be high. An earlier validation study of hor- mone replacement

Drug Use, the Drug Environment, and Child Physical Abuse and Neglect.

PubMed

Freisthler, Bridget; Wolf, Jennifer Price; Wiegmann, Wendy; Kepple, Nancy J

2017-08-01

Although drug use is considered a risk factor for child maltreatment, very little work has examined how the drug environment may affect physical abuse and neglect by parents. Utilizing information from a telephone survey with 2,597 respondents from 43 cities with valid police data on narcotics incidents, we analyzed the relationship between drug use, drug availability, and child maltreatment using multilevel models. City-level rates of drug abuse and dependence were related to more frequent physical abuse. Parents who use drugs in areas with greater availability of drugs reported more physical abuse and physical neglect. Emotional support was protective of all types of maltreatment. While most child welfare interventions focus on reducing parental drug use in order to reduce child abuse, these findings suggest environmental prevention or neighborhood strengthening approaches designed to reduce the supply of illicit drugs may also reduce child abuse through multiple mechanisms.

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.

Study the efficacy of neuroprotective drugs on brain physiological properties during focal head injury using optical spectroscopy data analysis

NASA Astrophysics Data System (ADS)

Abookasis, David; Shochat, Ariel

2016-03-01

We present a comparative evaluation of five different neuroprotective drugs in the early phase following focal traumatic brain injury (TBI) in mouse intact head. The effectiveness of these drugs in terms of changes in brain tissue morphology and hemodynamic properties was experimentally evaluated through analysis of the optical absorption coefficient and spectral reduced scattering parameters in the range of 650-1000 nm. Anesthetized male mice (n=50 and n=10 control) were subjected to weight drop model mimics real life focal head trauma. Monitoring the effect of injury and neuroprotective drugs was obtained by using a diffuse reflectance spectroscopy system utilizing independent source-detector separation and location. Result indicates that administration of minocycline improve hemodynamic and reduced the level of tissue injury at an early phase post-injury while hypertonic saline treatment decrease brain water content. These findings highlight the heterogeneity between neuroprotective drugs and the ongoing controversy among researchers regarding which drug therapy is preferred for treatment of TBI. On the other hand, our results show the capability of optical spectroscopy technique to noninvasively study brain function following injury and drug therapy.

Health care service utilization and associated factors among heroin users in northern Taiwan.

PubMed

Chen, Yi-Chih; Chen, Chih-Ken; Lin, Shih-Ku; Chiang, Shu-Chuan; Su, Lien-Wen; Wang, Liang-Jen

2013-11-01

Due to the needs of medical care, the probability of using health care service from heroin users is high. This cross-sectional study investigated the frequency and correlates of health service utilization among heroin users. From June to September 2006, 124 heroin users (110 males and 14 females, mean age: 34.2 ± 8.3 years) who entered two psychiatric hospitals (N = 83) and a detention center (N = 41) in northern Taiwan received a face-to-face interview. Therefore, socio-demographic characteristics, patterns of drug use, psychiatric comorbidities, blood-borne infectious diseases and health service utilization were recorded. The behaviors of health service utilization were classified into the frequency of out-patient department visit and hospitalization, as well as the purchase of over-the-counter drugs. During 12 months prior to interview, 79.8% of the participants attended health care service at least once. The rate of having any event in out-patients service visit, hospitalization, and over-the-counter drugs were 66.1%, 29.8% and 25.8% respectively. The frequency of health service utilization was associated with numerous factors. Among these factors, patients who were recruited from hospital and having a mood disorder were conjoint predictors of out-patient department visit, hospitalization and purchase of over-the-counter drugs. According to the results of this study, social education and routine screening for mood disorders can help heroin users to obtain adequate health care service. The findings of this study are useful references for targeting the heroin users for whom a successful intervention represents the greatest cost benefit. © 2013 Elsevier Ltd. All rights reserved.

Nucleoside Derived Antibiotics to Fight Microbial Drug Resistance: New Utilities for an Established Class of Drugs?

PubMed

Serpi, Michaela; Ferrari, Valentina; Pertusati, Fabrizio

2016-12-08

Novel antibiotics are urgently needed to combat the rise of infections due to drug-resistant microorganisms. Numerous natural nucleosides and their synthetically modified analogues have been reported to have moderate to good antibiotic activity against different bacterial and fungal strains. Nucleoside-based compounds target several crucial processes of bacterial and fungal cells such as nucleoside metabolism and cell wall, nucleic acid, and protein biosynthesis. Nucleoside analogues have also been shown to target many other bacterial and fungal cellular processes although these are not well characterized and may therefore represent opportunities to discover new drugs with unique mechanisms of action. In this Perspective, we demonstrate that nucleoside analogues, cornerstones of anticancer and antiviral treatments, also have great potential to be repurposed as antibiotics so that an old drug can learn new tricks.

Studies and methodologies on vaginal drug permeation.

PubMed

Machado, Rita Monteiro; Palmeira-de-Oliveira, Ana; Gaspar, Carlos; Martinez-de-Oliveira, José; Palmeira-de-Oliveira, Rita

2015-09-15

The vagina stands as an important alternative to the oral route for those systemic drugs that are poorly absorbed orally or are rapidly metabolized by the liver. Drug permeation through the vaginal tissue can be estimated by using in vitro, ex vivo and in vivo models. The latter ones, although more realistic, assume ethical and biological limitations due to animal handling. Therefore, in vitro and ex vivo models have been developed to predict drug absorption through the vagina while allowing for simultaneous toxicity and pathogenesis studies. This review focuses on available methodologies to study vaginal drug permeation discussing their advantages and drawbacks. The technical complexity, costs and the ethical issues of an available model, along with its accuracy and reproducibility will determine if it is valid and applicable. Therefore every model shall be evaluated, validated and standardized in order to allow for extrapolations and results presumption, and so improving vaginal drug research and stressing its benefits. Copyright © 2015 Elsevier B.V. All rights reserved.

Validation of a microdose probe drug cocktail for clinical drug interaction assessments for drug transporters and CYP3A.

PubMed

Prueksaritanont, T; Tatosian, D A; Chu, X; Railkar, R; Evers, R; Chavez-Eng, C; Lutz, R; Zeng, W; Yabut, J; Chan, G H; Cai, X; Latham, A H; Hehman, J; Stypinski, D; Brejda, J; Zhou, C; Thornton, B; Bateman, K P; Fraser, I; Stoch, S A

2017-04-01

A microdose cocktail containing midazolam, dabigatran etexilate, pitavastatin, rosuvastatin, and atorvastatin has been established to allow simultaneous assessment of a perpetrator impact on the most common drug metabolizing enzyme, cytochrome P450 (CYP)3A, and the major transporters organic anion-transporting polypeptides (OATP)1B, breast cancer resistance protein (BCRP), and MDR1 P-glycoprotein (P-gp). The clinical utility of these microdose cocktail probe substrates was qualified by conducting clinical drug interaction studies with three inhibitors with different in vitro inhibitory profiles (rifampin, itraconazole, and clarithromycin). Generally, the pharmacokinetic profiles of the probe substrates, in the absence and presence of the inhibitors, were comparable to their reported corresponding pharmacological doses, and/or in agreement with theoretical expectations. The exception was dabigatran, which resulted in an approximately twofold higher magnitude for microdose compared to conventional dosing, and, thus, can be used to flag a worst-case scenario for P-gp. Broader application of the microdose cocktail will facilitate a more comprehensive understanding of the roles of drug transporters in drug disposition and drug interactions. © 2016 American Society for Clinical Pharmacology and Therapeutics.

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

[Placental transfer of drugs].

PubMed

Evain-Brion, Danièle; Berveiller, Paul; Gil, Sophie

2014-01-01

With more than 830,000 live births in France, a great number of pregnant women are concerned by a treatment during pregnancy and many questions revolve around appreciating medication-related risks during pregnancy. The human placenta is the interface between mother and fetus and remains difficult to study for ethical reasons. Placental transfer of drugs from mother to fetus is dependent on their physicochemical properties, maternal and fetal factors and placental factors. The human placental perfusion model is the only experimental model to study human placental transfer of drugs in organized placental tissue. In vitro models utilizing cell cultures are mostly limited to the investigation of cellular toxicity along pregnancy or specific transfer mechanisms, such as their interaction with transporters. Taking advantage of the complementarity of these models, it will be possible to develop a rational use of drugs during this period. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Defining personal utility in genomics: A Delphi study.

PubMed

Kohler, J N; Turbitt, E; Lewis, K L; Wilfond, B S; Jamal, L; Peay, H L; Biesecker, L G; Biesecker, B B

2017-09-01

Individual genome sequencing results are valued by patients in ways distinct from clinical utility. Such outcomes have been described as components of "personal utility," a concept that broadly encompasses patient-endorsed benefits, that is operationally defined as non-clinical outcomes. No empirical delineation of these outcomes has been reported. To address this gap, we administered a Delphi survey to adult participants in a National Institute of Health (NIH) clinical exome study to extract the most highly endorsed outcomes constituting personal utility. Forty research participants responded to a Delphi survey to rate 35 items identified by a systematic literature review of personal utility. Two rounds of ranking resulted in 24 items that represented 14 distinct elements of personal utility. Elements most highly endorsed by participants were: increased self-knowledge, knowledge of "the condition," altruism, and anticipated coping. Our findings represent the first systematic effort to delineate elements of personal utility that may be used to anticipate participant expectation and inform genetic counseling prior to sequencing. The 24 items reported need to be studied further in additional clinical genome sequencing studies to assess generalizability in other populations. Further research will help to understand motivations and to predict the meaning and use of results. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Identification of drug-resistant subpopulations in canine hemangiosarcoma.

PubMed

Khammanivong, A; Gorden, B H; Frantz, A M; Graef, A J; Dickerson, E B

2016-09-01

Canine hemangiosarcoma is a rapidly progressive disease that is poorly responsive to conventional chemotherapy. Despite numerous attempts to advance treatment options and improve outcomes, drug resistance remains a hurdle to successful therapy. To address this problem, we used recently characterized progenitor cell populations derived from canine hemangiosarcoma cell lines and grown as non-adherent spheres to identify potential drug resistance mechanisms as well as drug-resistant cell populations. Cells from sphere-forming cultures displayed enhanced resistance to chemotherapy drugs, expansion of dye-excluding side populations and altered ATP-binding cassette (ABC) transporter expression. Invasion studies demonstrated variability between cell lines as well as between sphere and monolayer cell populations. Collectively, our results suggest that sphere cell populations contain distinct subpopulations of drug-resistant cells that utilize multiple mechanisms to evade cytotoxic drugs. Our approach represents a new tool for the study of drug resistance in hemangiosarcoma, which could alter approaches for treating this disease. © 2014 John Wiley & Sons Ltd.

Identification of drug-resistant subpopulations in canine hemangiosarcoma

PubMed Central

Khammanivong, A.; Gorden, B. H.; Frantz, A. M.; Graef, A. J.; Dickerson, E. B.

2017-01-01

Canine hemangiosarcoma is a rapidly progressive disease that is poorly responsive to conventional chemotherapy. Despite numerous attempts to advance treatment options and improve outcomes, drug resistance remains a hurdle to successful therapy. To address this problem, we used recently characterized progenitor cell populations derived from canine hemangiosarcoma cell lines and grown as non-adherent spheres to identify potential drug resistance mechanisms as well as drug-resistant cell populations. Cells from sphere-forming cultures displayed enhanced resistance to chemotherapy drugs, expansion of dye-excluding side populations and altered ATP-binding cassette (ABC) transporter expression. Invasion studies demonstrated variability between cell lines as well as between sphere and monolayer cell populations. Collectively, our results suggest that sphere cell populations contain distinct subpopulations of drug-resistant cells that utilize multiple mechanisms to evade cytotoxic drugs. Our approach represents a new tool for the study of drug resistance in hemangiosarcoma, which could alter approaches for treating this disease. PMID:25112808

Drug transporters in tissues and cells relevant to sexual transmission of HIV: Implications for drug delivery.

PubMed

Hu, Minlu; Patel, Sravan Kumar; Zhou, Tian; Rohan, Lisa C

2015-12-10

Efflux and uptake transporters of drugs are key regulators of the pharmacokinetics of many antiretroviral drugs. A growing body of literature has revealed the expression and functionality of multiple transporters in female genital tract (FGT), colorectal tissue, and immune cells. Drug transporters could play a significant role in the efficacy of preventative strategies for HIV-1 acquisition. Pre-exposure prophylaxis (PrEP) is a promising strategy, which utilizes topically (vaginally or rectally), orally or other systemically administered antiretroviral drugs to prevent the sexual transmission of HIV to receptive partners. The drug concentration in the receptive mucosal tissues and target immune cells for HIV is critical for PrEP effectiveness. Hence, there is an emerging interest in utilizing transporter information to explain tissue disposition patterns of PrEP drugs, to interpret inter-individual variability in PrEP drug pharmacokinetics and effectiveness, and to improve tissue drug exposure through modulation of the cervicovaginal, colorectal, or immune cell transporters. In this review, the existing literature on transporter expression, functionality and regulation in the transmission-related tissues and cells is summarized. In addition, the relevance of transporter function for drug delivery and strategies that could exploit transporters for increased drug concentration at target locales is discussed. The overall goal is to facilitate an understanding of drug transporters for PrEP optimization. Copyright © 2015 Elsevier B.V. All rights reserved.

Drugs and the dance music scene: a survey of current drug use patterns among a sample of dance music enthusiasts in the UK.

PubMed

Winstock, A R; Griffiths, P; Stewart, D

2001-09-01

This study explores the utility of a self-completion survey method to quickly and cheaply generate information on patterns and trends among regular "recreational" drug consumers. Data is reported here from 1151 subjects accessed through a dance music publication. In keeping with previous studies of drug use within the dance scene polysubstance use was the norm. Many of those reporting use of "ecstasy" were regularly using multiple tablets often consumed in combination with other substances thus exposing themselves to serious health risks, in particular the risk of dose related neurotoxic effects. Seventy percent were drinking alcohol at hazardous levels. Subjects' patterns of drug purchasing also put them at risk of severe criminal sanction. Data supported evidence that cocaine use had become increasing popular in the UK, but contrasted with some commentators' views that ecstasy use was in decline. The utility of this method and how the results should be interpreted is discussed, as are the data's implications for harm and risk reduction activities.

Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

PubMed

Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

2014-04-01

The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

Advantageous use of HepaRG cells for the screening and mechanistic study of drug-induced steatosis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tolosa, Laia

Only a few in vitro assays have been proposed to evaluate the steatotic potential of new drugs. The present study examines the utility of HepaRG cells as a cell-based assay system for screening drug-induced liver steatosis. A high-content screening assay was run to evaluate multiple toxicity-related cell parameters in HepaRG cells exposed to 28 compounds, including drugs reported to cause steatosis through different mechanisms and non-steatotic compounds. Lipid content was the most sensitive parameter for all the steatotic drugs, whereas no effects on lipid levels were produced by non-steatotic compounds. Apart from fat accumulation, increased ROS production and altered mitochondrialmore » membrane potential were also found in the cells exposed to steatotic drugs, which indicates that all these cellular events contributed to drug-induced hepatotoxicity. These findings are of clinical relevance as most effects were observed at drug concentrations under 100-fold of the therapeutic peak plasmatic concentration. HepaRG cells showed increased lipid overaccumulation vs. HepG2 cells, which suggests greater sensitivity to drug-induced steatosis. An altered expression profile of transcription factors and the genes that code key proteins in lipid metabolism was also found in the cells exposed to drugs capable of inducing liver steatosis. Our results generally indicate the value of HepaRG cells for assessing the risk of liver damage associated with steatogenic compounds and for investigating the molecular mechanisms involved in drug-induced steatosis. - Highlights: • HepaRG cells were explored as an in vitro model to detect steatogenic potential. • Multiple toxicity-related endpoints were analysed by HCS. • HepaRG showed a greater sensitivity to drug-induced steatosis than HepG2 cells. • Changes in the expression of genes related to lipid metabolism were revealed. • HepaRG allow mechanistic understanding of liver damage induced by steatogenic drugs.« less

E-learning to improve the drug prescribing in the hospitalized elderly patients: the ELICADHE feasibility pilot study.

PubMed

Franchi, C; Mari, D; Tettamanti, M; Pasina, L; Djade, C D; Mannucci, P M; Onder, G; Bernabei, R; Gussoni, G; Bonassi, S; Nobili, A

2014-08-01

E-learning is an efficient and cost-effective educational method. This study aimed at evaluating the feasibility of an educational e-learning intervention, focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment, to improve drug prescribing to hospitalized elderly patients. Eight geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control. Clinicians of the two groups had to complete a specific per group e-learning program in 30 days. Then, ten patients (aged ≥75 years) had to be consecutively enrolled collecting clinical data at hospital admission, discharge, and 3 months later. The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer's criteria and of potential drug-drug interactions through a specific computerized database. The study feasibility was confirmed by the high percentage (90 %) of clinicians who completed the e-learning program, the recruitment, and follow-up of all planned patients. The intervention was well accepted by all participating clinicians who judged positively (a mean score of >3 points on a scale of 5 points: 0 = useless; 5 = most useful) the specific contents, the methodology applied, the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing. The pilot study met all the requested goals. The main study is currently ongoing and is planned to finish on July 2015.

In Silico Augmentation of the Drug Development Pipeline: Examples from the study of Acute Inflammation

PubMed Central

An, Gary; Bartels, John; Vodovotz, Yoram

2011-01-01

The clinical translation of promising basic biomedical findings, whether derived from reductionist studies in academic laboratories or as the product of extensive high-throughput and –content screens in the biotechnology and pharmaceutical industries, has reached a period of stagnation in which ever higher research and development costs are yielding ever fewer new drugs. Systems biology and computational modeling have been touted as potential avenues by which to break through this logjam. However, few mechanistic computational approaches are utilized in a manner that is fully cognizant of the inherent clinical realities in which the drugs developed through this ostensibly rational process will be ultimately used. In this article, we present a Translational Systems Biology approach to inflammation. This approach is based on the use of mechanistic computational modeling centered on inherent clinical applicability, namely that a unified suite of models can be applied to generate in silico clinical trials, individualized computational models as tools for personalized medicine, and rational drug and device design based on disease mechanism. PMID:21552346

Advanced cell culture techniques for cancer drug discovery.

PubMed

Lovitt, Carrie J; Shelper, Todd B; Avery, Vicky M

2014-05-30

Human cancer cell lines are an integral part of drug discovery practices. However, modeling the complexity of cancer utilizing these cell lines on standard plastic substrata, does not accurately represent the tumor microenvironment. Research into developing advanced tumor cell culture models in a three-dimensional (3D) architecture that more prescisely characterizes the disease state have been undertaken by a number of laboratories around the world. These 3D cell culture models are particularly beneficial for investigating mechanistic processes and drug resistance in tumor cells. In addition, a range of molecular mechanisms deconstructed by studying cancer cells in 3D models suggest that tumor cells cultured in two-dimensional monolayer conditions do not respond to cancer therapeutics/compounds in a similar manner. Recent studies have demonstrated the potential of utilizing 3D cell culture models in drug discovery programs; however, it is evident that further research is required for the development of more complex models that incorporate the majority of the cellular and physical properties of a tumor.

Advanced Cell Culture Techniques for Cancer Drug Discovery

PubMed Central

Lovitt, Carrie J.; Shelper, Todd B.; Avery, Vicky M.

2014-01-01

Human cancer cell lines are an integral part of drug discovery practices. However, modeling the complexity of cancer utilizing these cell lines on standard plastic substrata, does not accurately represent the tumor microenvironment. Research into developing advanced tumor cell culture models in a three-dimensional (3D) architecture that more prescisely characterizes the disease state have been undertaken by a number of laboratories around the world. These 3D cell culture models are particularly beneficial for investigating mechanistic processes and drug resistance in tumor cells. In addition, a range of molecular mechanisms deconstructed by studying cancer cells in 3D models suggest that tumor cells cultured in two-dimensional monolayer conditions do not respond to cancer therapeutics/compounds in a similar manner. Recent studies have demonstrated the potential of utilizing 3D cell culture models in drug discovery programs; however, it is evident that further research is required for the development of more complex models that incorporate the majority of the cellular and physical properties of a tumor. PMID:24887773

[Multilateral Strategies Utilizing Exosomes for Cancer Therapy].

PubMed

Nishida-Aoki, Nao; Ochiya, Takahiro

2017-05-01

Exosomes are nano-sized extracellular vesicles which transfer their components such as RNA, DNA, and proteins from one cell to another cell. The components are released to the cytoplasm of the recipient cells, having an effect on the cells. Cancerderived exosomes promote cancer progression, invasion, gain of drug resistance, and metastasis. Recently, according to their characteristics, it is expected to apply exosomes to cancer therapies, such as utilizing exosomes as drug delivery systems(DDS) for anticancer drugs and as cancer vaccines to enhance immunity to cancer cells. More, as the cancer-derived exosomes have cancer-promoting effects on multiple stages, inhibiting the function of the cancer-derived exosomes would be helpful to cancer therapies by suppressing cancer progression. DDS and cancer vaccines utilizing exosomes are now undergoing clinical studies, although DDS is suffering from loading efficiency. Treatments by inhibiting the functions of cancer-derived exosomes have still only few reports at experimental levels. Recently, we showed in a mouse model that disruption of cancer-derived exosomes by antibodies could suppress lung metastasis of the human breast cancer cells. Exosomes will provide us the multiple strategies to fight with cancer, which can be applied to cancers from many organs. It is important to confirm safety and overcome technical problems to bring exosomes in practical use.

Photovoltaic utility/customer interface study

NASA Astrophysics Data System (ADS)

Eichler, C. H.; Hayes, T. P.; Matthews, M. M.; Wilraker, V. F.

1980-12-01

The technical, economic, and legal and regulatory issues of interconnecting small, privately-owned, on-site photovoltaic generating systems to an electric utility are addressed. Baseline residential, commercial and industrial class photovoltaic systems were developed. Technical issues of concern affecting this interconnection were identified and included fault protection, undervoltage protection, lamp flicker, revenue metering, loss of synchromism, electrical safety, prevention of backfeeding a de-energized utility feeder, effects of on-site generation on utility relaying schemes, effects of power conditioner harmonic distortion on the electric utility, system isolation, electromagnetic interference and site power factor as seen by the utility. Typical interconnection wiring diagrams were developed for interconnecting each class of baseline photovoltaic generating system.

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 1 2010-10-01 2010-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 1 2014-10-01 2014-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 1 2012-10-01 2012-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 1 2013-10-01 2013-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

46 CFR 16.113 - Chemical drug testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 1 2011-10-01 2011-10-01 false Chemical drug testing. 16.113 Section 16.113 Shipping... General § 16.113 Chemical drug testing. (a) Drug testing programs required by this part must be conducted... should be consulted to determine the specific procedures which must be established and utilized. Drug...

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

Cartilage-targeting drug delivery: can electrostatic interactions help?

PubMed

Bajpayee, Ambika G; Grodzinsky, Alan J

2017-03-01

Current intra-articular drug delivery methods do not guarantee sufficient drug penetration into cartilage tissue to reach cell and matrix targets at the concentrations necessary to elicit the desired biological response. Here, we provide our perspective on the utilization of charge-charge (electrostatic) interactions to enhance drug penetration and transport into cartilage, and to enable sustained binding of drugs within the tissue's highly negatively charged extracellular matrix. By coupling drugs to positively charged nanocarriers that have optimal size and charge, cartilage can be converted from a drug barrier into a drug reservoir for sustained intra-tissue delivery. Alternatively, a wide variety of drugs themselves can be made cartilage-penetrating by functionalizing them with specialized positively charged protein domains. Finally, we emphasize that appropriate animal models, with cartilage thickness similar to that of humans, must be used for the study of drug transport and retention in cartilage.

Application of Model Animals in the Study of Drug Toxicology

NASA Astrophysics Data System (ADS)

Song, Yagang; Miao, Mingsan

2018-01-01

Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

Drug Release from ß-Cyclodextrin Complexes and Drug Transfer into Model Membranes Studied by Affinity Capillary Electrophoresis.

PubMed

Darwish, Kinda A; Mrestani, Yahya; Rüttinger, Hans-Hermann; Neubert, Reinhard H H

2016-05-01

Is to characterize the drug release from the ß-cyclodextrin (ß-CD) cavity and the drug transfer into model membranes by affinity capillary electrophoresis. Phospholipid liposomes with and without cholesterol were used to mimic the natural biological membrane. The interaction of cationic and anionic drugs with ß-CD and the interaction of the drugs with liposomes were detected separately by measuring the drug mobility in ß-CD containing buffer and liposome containing buffer; respectively. Moreover, the kinetics of drug release from ß-CD and its transfer into liposomes with or without cholesterol was studied by investigation of changes in the migration behaviours of the drugs in samples, contained drug, ß-CD and liposome, at 1:1:1 molar ratio at different time intervals; zero time, 30 min, 1, 2, 4, 6, 8, 10 and 24 h. Lipophilic drugs such as propranolol and ibuprofen were chosen for this study, because they form complexes with ß-CD. The mobility of the both drug liposome mixtures changed with time to a final state. For samples of liposomal membranes with cholesterol the final state was faster reached than without cholesterol. The study confirmed that the drug release from the CD cavity and its transfer into the model membrane was more enhanced by the competitive displacement of the drug from the ß-CD cavity by cholesterol, the membrane component. The ACE method here developed can be used to optimize the drug release from CD complexes and the drug transfer into model membranes.

Ready Reserve Civilian Skills Utilization Study (RESCON).

DTIC Science & Technology

1975-11-10

brokers, insurance, business, etc.) 6 Special Skills/Talents 7 Pilots 10 Engineers, Industrial 10 Petrol & Chem 10 Aero 11 EE 12 19 Civil 13- Math ...AD-A123 132 READY RESERVE CIVILIAN SKILLS UTILIZATION STUDY (RESCON)(U) MARINE CORPS VTU 12 -3 NAS MOFFETT FIELD CA E O AGEE ET ALS 10 NOV 75...Nov 7! ?-~1UTILIZATION STUDY (RESCON) 6. PEaRORMING OR011. REPORT MNMER VTU 12 -3 0/F 1. AUTNOR(#) CoB CONTRACT ON GRANT MUMMER(@) Lto R. J. to~r C

Liquefaction chemistry and kinetics: Hydrogen utilization studies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rothenberger, K.S.; Warzinski, R.P.; Cugini, A.V.

1995-12-31

The objectives of this project are to investigate the chemistry and kinetics that occur in the initial stages of coal liquefaction and to determine the effects of hydrogen pressure, catalyst activity, and solvent type on the quantity and quality of the products produced. The project comprises three tasks: (1) preconversion chemistry and kinetics, (2) hydrogen utilization studies, and (3) assessment of kinetic models for liquefaction. The hydrogen utilization studies work will be the main topic of this report. However, the other tasks are briefly described.

Feasibility study of solar energy utilization in modular integrated utility systems

NASA Technical Reports Server (NTRS)

1975-01-01

The feasibility and benefits were evaluated of solar thermal energy systems on Integrated Utility Systems. The effort included the identification of potential system concepts, evaluation of hardware status, and performance of weighted system evaluations to select promising system concepts deserving of further study.

1977 Nationwide Personal Transportation Study : household vehicle utilization

DOT National Transportation Integrated Search

1981-04-01

This report is part of a series that presents findings from the 1977 Nationwide Personal Transportation Study (NPTS). This report describes patterns of utilization of private vehicles (annual miles driven) in 1977. Utilization is keyed to estimates p...

Automated Drug Identification for Urban Hospitals

NASA Technical Reports Server (NTRS)

Shirley, Donna L.

1971-01-01

Many urban hospitals are becoming overloaded with drug abuse cases requiring chemical analysis for identification of drugs. In this paper, the requirements for chemical analysis of body fluids for drugs are determined and a system model for automated drug analysis is selected. The system as modeled, would perform chemical preparation of samples, gas-liquid chromatographic separation of drugs in the chemically prepared samples, infrared spectrophotometric analysis of the drugs, and would utilize automatic data processing and control for drug identification. Requirements of cost, maintainability, reliability, flexibility, and operability are considered.

Effects of a recovery management intervention on Chinese heroin users' community recovery through the mediation effect of enhanced service utilization

PubMed Central

Wu, F.; Fu, L.M.; Hser, Y.H.

2015-01-01

Background This study investigates whether a recovery management intervention (RMI) can improve the utilization of community drug treatment and wraparound services among heroin users in China and subsequently lead to positive recovery outcomes. Methods Secondary analysis was conducted drawing data from a randomized controlled trial; 100 heroin users with no severe mental health problems were recruited in two Shanghai districts (Hongkou and Yangpu) upon their release from compulsory rehabilitation facilities. A latent variable modeling approach was utilized to test whether the RMI influences heroin users' perceived motivation and readiness for treatment, enhances treatment and wraparound service participation, and, in turn, predicts better recovery outcomes. Results Enrollment in drug treatment and other social service utilization increased significantly as a result of RMI rather than an individual drug user's motivation and readiness for treatment. Increased service utilization thus led to more positive individual recovery outcomes. In addition to this mediation effect through service utilization, the RMI also improved participants' community recovery directly. Conclusions Findings suggest that better drug treatment enrollment, community service utilization and recovery outcomes can be potentially achieved among heroin users in China with carefully designed case management interventions. PMID:24990956

Heat effects on drug delivery across human skin

PubMed Central

Hao, Jinsong; Ghosh, Priyanka; Li, S. Kevin; Newman, Bryan; Kasting, Gerald B.; Raney, Sam G.

2016-01-01

Introduction Exposure to heat can impact the clinical efficacy and/or safety of transdermal and topical drug products. Understanding these heat effects and designing meaningful in vitro and in vivo methods to study them are of significant value to the development and evaluation of drug products dosed to the skin. Areas covered This review provides an overview of the underlying mechanisms and the observed effects of heat on the skin and on transdermal/topical drug delivery, thermoregulation and heat tolerability. The designs of several in vitro and in vivo heat effect studies and their results are reviewed. Expert opinion There is substantial evidence that elevated temperature can increase transdermal/topical drug delivery. However, in vitro and in vivo methods reported in the literature to study heat effects of transdermal/topical drug products have utilized inconsistent study conditions, and in vitro models require better characterization. Appropriate study designs and controls remain to be identified, and further research is warranted to evaluate in vitro-in vivo correlations and the ability of in vitro models to predict in vivo effects. The physicochemical and pharmacological properties of the drug(s) and the drug product, as well as dermal clearance and heat gradients may require careful consideration. PMID:26808472

[Cutaneous adverse drug reaction: prospective study of 118 cases].

PubMed

Chaabane, Hend; Masmoudi, Abderrahmen; Amouri, Meriem; Ghorbel, Sonda; Boudaya, Sonia; Hammami, Serriya; Zghal, Khaled; Turki, Hamida

2013-01-01

Few prospective studies are available on the incidence and analysis of the characteristics of adverse cutaneous drug reactions. To describe the adverse cutaneous reactions, their epidemiologic characteristics as well as the different causative drugs through a prospective hospital study. A 12-month prospective study was managed in our department of dermatology of the teaching hospital Hedi Chaker of Sfax. Requested information included patient characteristics (associated disorders), drug intake (list and chronology of the drug intake during the 3 weeks preceding the adverse reaction) and characteristics of the skin reaction (type, course). The diagnosis was based on a beam of clinical and anamnestic arguments. The drug imputability was evaluated according to the Begaud's French method. One hundred eighteen cases were collected. A prevalence of 1.08/100 among patients consulting in dermatology department was estimated. The macular and papular exanthema represented the most frequent clinical aspects (42 cases) followed by acute urticaria (23 cases), photosensitivity (19 cases) and fixed drug eruption (15 cases). Principal imputable drugs were antibiotics, mainly penicillins followed by analgesics and non-steroidal anti-inflammatory. Although it was monocentric, this study revealed a high frequency of drug-induced dermatitis with different clinical presentation. The high incidence of drug-induced dermatitis induced by antibiotics, analgesics and anti-inflammatory is due to their widespread use, often in self-medication.

Controlling prescription drug expenditures: a report of success.

PubMed

Miller, David P; Furberg, Curt D; Small, Ronald H; Millman, Franklyn M; Ambrosius, Walter T; Harshbarger, Julia S; Ohl, Christopher A

2007-08-01

To determine whether a multi-interventional program can limit increases in prescription drug expenditures while maintaining utilization of needed medications. Quasi-experimental, pre-post design. The program included formulary changes, quantity limits, and mandatory pill splitting for select drugs implemented in phases. We assessed the short-term effects of each intervention by comparing class-specific drug spending and generic medication use before and after benefit changes. Long-term effects were determined by comparing overall spending with projected spending estimates, and by examining changes in the planwide use of generic medications over time. Effects on medication utilization were assessed by examining members' use of selected classes of chronic medications before and after the policy changes. Over 3 years, the plan and members saved $6.6 million attributed to the interventions. Most of the savings were due to the reclassification of select brand-name drugs to nonpreferred status (estimated annual savings, $941,000), followed by the removal of nonsedating antihistamines from the formulary (annual savings, $565,000), and the introduction of pill splitting (annual savings, $342,000). Limiting quantities of select medications had the smallest impact (annual savings, $135,000). Members' use of generic medications steadily increased from 40% to 57%. Although 17.5% of members stopped using at least 1 class of selected medications, members' total use of chronic medications remained constant. A combination of interventions can successfully manage prescription drug spending while preserving utilization of chronic medications. Additional studies are needed to determine the effect of these cost-control interventions on other health outcomes.

Utilization of Rural Primary Care Physicians' Visit Services for Diabetes Management of Public Health in Southwestern China: A Cross-Sectional Study from Patients' View.

PubMed

Miao, Yudong; Ye, Ting; Qian, Dongfu; Li, Jinlong; Zhang, Liang

2014-06-01

Primary care physicians' visit services for diabetes management are now widely delivered in China's rural public health care. Current studies mainly focus on supply but risk factors from patients' view have not been previously explored. This study aims to present the utilization of rural primary care physicians' visit services for diabetes management in the last 12 months in southwestern China, and to explore risk factors from patients' view. This cross sectional study selected six towns at random and all 385 diabetics managed by primary care physicians were potential participants. Basing on the inclusion and exclusion criteria, 374 diabetics were taken as valid subjects and their survey responses formed the data resource of analyses. Descriptive indicators, χ2 contingency table analyses and Logistic regression were used. 54.8% respondents reported the utilization of visit services. According to the multivariate analysis, the positive factors mainly associated with utilization of visit services include disease duration (OR=1.654), use of diabetic drugs (OR=1.869), consulting diabetes care knowledge (OR=1.602), recognition of diabetic complications (OR=1.662), needs of visit services (OR=2.338). The utilization of rural primary care physicians' visit services still remains unsatisfactory. Mass rural health policy awareness, support, and emphasis are in urgent need and possible risk factors including disease duration, use of diabetic drugs, consulting diabetes care knowledge, recognition of diabetic complications and needs of visit services should be taken into account when making rural health policy of visit services for diabetes management in China and many other low- and middle-income countries.

Urine drug screening in the medical setting.

PubMed

Hammett-Stabler, Catherine A; Pesce, Amadeo J; Cannon, Donald J

2002-01-01

The term drug screen is a misnomer since it implies screening for all drugs, which is not possible. Current practice is to limit the testing to the examination of serum for several drugs such as ethanol, acetaminophen, salicylate, and of urine for several specific drugs or classes of drugs. In the emergency setting the screen should be performed in less than one hour. Controversies continue to exist regarding the value of urine drug testing in the medical setting. The reasons for these include the drugs involved, the sample, the methods utilized to perform the tests, and the level of understanding of the physician using the data, all of which are closely related to the other. Current automated methods provide rapid results demanded in emergency situations, but are often designed for, or adapted from, workplace testing and are not necessarily optimized for clinical applications. Furthermore, the use of these methods without consideration of the frequency in which the drugs are found in a given area is not cost-effective. The laboratory must understand the limitations of the assays used and provide this information to the physician. Additionally, the laboratory and the physicians using the data must cooperate to determine which drugs are appropriate and necessary to measure for their institution and clinical setting. In doing so it should be remembered that for many drugs, the sample, urine, contains the end product(s) of drug metabolism, not the parent drug. Furthermore, it is necessary to understand the pharmacokinetic parameters of the drug of interest when interpreting data. Finally, while testing for some drugs may not appear cost-effective, the prevention or reduction of morbidity and mortality may offset any laboratory costs. While the literature is replete with studies concerning new methods and a few regarding physician understanding, there are none that we could find that thoroughly, objectively, and fully addressed the issues of utility and cost-effectiveness.

A New Screen for Tuberculosis Drug Candidates Utilizing a Luciferase-Expressing Recombinant Mycobacterium bovis Bacillus Calmette-Guéren.

PubMed

Ozeki, Yuriko; Igarashi, Masayuki; Doe, Matsumi; Tamaru, Aki; Kinoshita, Naoko; Ogura, Yoshitoshi; Iwamoto, Tomotada; Sawa, Ryuichi; Umekita, Maya; Enany, Shymaa; Nishiuchi, Yukiko; Osada-Oka, Mayuko; Hayashi, Tetsuya; Niki, Mamiko; Tateishi, Yoshitaka; Hatano, Masaki; Matsumoto, Sohkichi

2015-01-01

Tuberculosis (TB) is a serious infectious disease caused by a bacterial pathogen. Mortality from tuberculosis was estimated at 1.5 million deaths worldwide in 2013. Development of new TB drugs is needed to not only to shorten the medication period but also to treat multi-drug resistant and extensively drug-resistant TB. Mycobacterium tuberculosis (Mtb) grows slowly and only multiplies once or twice per day. Therefore, conventional drug screening takes more than 3 weeks. Additionally, a biosafety level-3 (BSL-3) facility is required. Thus, we developed a new screening method to identify TB drug candidates by utilizing luciferase-expressing recombinant Mycobacterium bovis bacillus Calmette-Guéren (rBCG). Using this method, we identified several candidates in 4 days in a non-BSL-3 facility. We screened 10,080 individual crude extracts derived from Actinomyces and Streptomyces and identified 137 extracts which possessed suppressive activity to the luciferase of rBCG. Among them, 41 compounds inhibited the growth of both Mtb H37Rv and the extensively drug-resistant Mtb (XDR-Mtb) strains. We purified the active substance of the 1904-1 extract, which possessed strong activity toward rBCG, Mtb H37Rv, and XDR-Mtb but was harmless to the host eukaryotic cells. The MIC of this substance was 0.13 μg/ml, 0.5 μg/ml, and 2.0-7.5 μg/ml against rBCG, H37Rv, and 2 XDR-strains, respectively. Its efficacy was specific to acid-fast bacterium except for the Mycobacterium avium intracellular complex. Mass spectrometry and nuclear magnetic resonance analyses revealed that the active substance of 1904-1 was cyclomarin A. To confirm the mode of action of the 1904-1-derived compound, resistant BCG clones were used. Whole genome DNA sequence analysis showed that these clones contained a mutation in the clpc gene which encodes caseinolytic protein, an essential component of an ATP-dependent proteinase, and the likely target of the active substance of 1904-1. Our method provides a rapid and

Pharmacogenetics in drug regulation: promise, potential and pitfalls

PubMed Central

Shah, Rashmi R

2005-01-01

Pharmacogenetic factors operate at pharmacokinetic as well as pharmacodynamic levels—the two components of the dose–response curve of a drug. Polymorphisms in drug metabolizing enzymes, transporters and/or pharmacological targets of drugs may profoundly influence the dose–response relationship between individuals. For some drugs, although retrospective data from case studies suggests that these polymorphisms are frequently associated with adverse drug reactions or failure of efficacy, the clinical utility of such data remains unproven. There is, therefore, an urgent need for prospective data to determine whether pre-treatment genotyping can improve therapy. Various regulatory guidelines already recommend exploration of the role of genetic factors when investigating a drug for its pharmacokinetics, pharmacodynamics, dose–response relationship and drug interaction potential. Arising from the global heterogeneity in the frequency of variant alleles, regulatory guidelines also require the sponsors to provide additional information, usually pharmacogenetic bridging data, to determine whether data from one ethnic population can be extrapolated to another. At present, sponsors explore pharmacogenetic influences in early clinical pharmacokinetic studies but rarely do they carry the findings forward when designing dose–response studies or pivotal studies. When appropriate, regulatory authorities include genotype-specific recommendations in the prescribing information. Sometimes, this may include the need to adjust a dose in some genotypes under specific circumstances. Detailed references to pharmacogenetics in prescribing information and pharmacogenetically based prescribing in routine therapeutics will require robust prospective data from well-designed studies. With greater integration of pharmacogenetics in drug development, regulatory authorities expect to receive more detailed genetic data. This is likely to complicate the drug evaluation process as well as

Florida harvest and utilization study, 2008

Treesearch

James W. Bentley; Tony G. Johnson

2009-01-01

In 2008, a harvest and utilization study was conducted on 82 operationsthroughout Florida. There were 2,114 total trees measured: 1,670 or79 percent were softwood, while 444 or 21 percent were hardwood. Resultsfrom this study showed that 85 percent of the total softwood volumemeasured was...

Virginia harvest and utilization study, 2007

Treesearch

James W. Bentley; Tony G. Johnson

2009-01-01

In 2007, a harvest and utilization study was conducted on 81 operationsthroughout Virginia. There were 2,016 total trees measured; 1,086 or54 percent were softwood, while 930 or 46 percent were hardwood. Resultsfrom this study showed that 86 percent of the total softwood volumemeasured was...

The effect of garlic supplements and phytochemicals on the ADMET properties of drugs.

PubMed

Berginc, Katja; Kristl, Albin

2012-03-01

Garlic supplements have received wide public attention because of their health-beneficial effects. Although these products are considered as innocuous, several case reports and studies have shown the capacity of individual garlic phytochemicals/supplements to interfere with drug pharmacokinetics. This review covers recently published literature on garlic chemistry and composition, and provides a thorough review of published studies evaluating drug-garlic interactions. The authors illustrate the mechanisms underlying pharmacokinetic interactions, which could serve as important highlights in further research to explain results for drugs with narrow therapeutic indices or for drugs, utilizing multiple absorption, distribution and metabolism pathways. To increase the relevance of further research on safety and efficacy of garlic supplements and phytochemicals, their composition should be addressed before conducting in vitro or in vivo research. It is also strongly recommended to characterize in vitro formulation performance to assess the rate and extent of garlic phytochemical release in order to anticipate the in vivo impact on the pharmacokinetics of concomitantly consumed drugs. The main conclusion of this review is that the impact of garlic on different stages of pharmacokinetics, especially on drug absorption and metabolism, is drug specific and dependent on the type/quality of utilized supplement.

Glutamate-Modulating Drugs as a Potential Therapeutic Strategy in Obsessive-Compulsive Disorder

PubMed Central

Marinova, Zoya; Chuang, De-Maw; Fineberg, Naomi

2017-01-01

Objective: Abstract: Obsessive-compulsive disorder (OCD) is a mental disease commonly associated with severe distress and impairment of social functioning. Serotonin reuptake inhibitors and/or cognitive behavioural therapy are the therapy of choice, however up to 40% of patients do not respond to treatment. Glutamatergic signalling has also been implicated in OCD. The aim of the current study was to review the clinical evidence for therapeutic utility of glutamate-modulating drugs as an augmentation or monotherapy in OCD patients. Methods: We conducted a search of the MEDLINE database for clinical studies evaluating the effect of glutamate-modulating drugs in OCD. Results: Memantine is the compound most consistently showing a positive effect as an augmentation therapy in OCD. Anti-convulsant drugs (lamotrigine, topiramate) and riluzole may also provide therapeutic benefit to some OCD patients. Finally, ketamine may be of interest due to its potential for a rapid onset of action. Conclusion: Further randomized placebo-controlled trials in larger study populations are necessary in order to draw definitive conclusions on the utility of glutamate-modulating drugs in OCD. Furthermore, genetic and epigenetic factors, clinical symptoms and subtypes predicting treatment response to glutamate-modulating drugs need to be investigated systematically. PMID:28322166

Utilization of gastroprotective strategies for nonsteroidal anti-inflammatory drug-induced gastrointestinal events in a major teaching hospital

PubMed Central

Lee, Hooi Leng; Chua, Siew Siang; Mahadeva, Sanjiv

2016-01-01

Background and purpose Clinical guidelines recommend the prescribing of gastroprotective strategies in nonsteroidal anti-inflammatory drug (NSAID) users with risk factors for gastrointestinal (GI) ulcer or ulcer complications. However, these guidelines are not often translated into clinical practice. Therefore, the aim of this study was to investigate the utilization of gastroprotective strategies for NSAID-induced upper GI events in at-risk users in a major teaching hospital. Patients and methods A cross-sectional, observational, pharmacy-based study was conducted in a major Asian institution with both primary and secondary health care services. This study involved the screening of prescriptions for regular NSAIDs, and patients who met the inclusion criteria were recruited and interviewed using a questionnaire. Results Of the 409 participants recruited, 83.1% had at least one GI risk factor, of whom 70.3% did not receive appropriate gastroprotection. The most common GI risk factor was the use of high-dose NSAIDs (69.2%), followed by participants aged 65 years and older (22%) and concomitant use of low-dose aspirin (11.7%). Appropriate gastroprotective strategies utilized consisted of the use of a cyclooxygenase (COX)-2 inhibitor alone or a nonselective NSAID plus a proton pump inhibitor (PPI) in the moderate-risk group and a COX-2 inhibitor plus a PPI in the high-risk group. Gastroprotective strategies were underutilized in 67.1% of at-risk participants and overutilized in 59.4% of those without risk factors. Co-prescription of a histamine-2 receptor antagonist at lower-than-recommended doses constituted 59% of the inappropriate gastroprotective agents used. Logistic regression analysis revealed patients aged 65 years and older (odds ratio, 1.89; 95% CI =1.15–3.09) as a predictor for the prescribing of gastroprotection by the clinicians. Conclusion Approximately 70% of at-risk NSAID users, mainly on high-dose NSAIDs, were not prescribed appropriate

Hospital ownership and drug utilization under a global budget: a quantile regression analysis.

PubMed

Zhang, Jing Hua; Chou, Shin-Yi; Deily, Mary E; Lien, Hsien-Ming

2014-03-01

A global budgeting system helps control the growth of healthcare spending by setting expenditure ceilings. However, the hospital global budget implemented in Taiwan in 2002 included a special provision: drug expenditures are reimbursed at face value, while other expenditures are subject to discounting. That gives hospitals, particularly those that are for-profit, an incentive to increase drug expenditures in treating patients. We calculated monthly drug expenditures by hospital departments from January 1997 to June 2006, using a sample of 348 193 patient claims to Taiwan National Health Insurance. To allow for variation among responses by departments with differing reliance on drugs and among hospitals of different ownerships, we used quantile regression to identify the effect of the hospital global budget on drug expenditures. Although drug expenditure increased in all hospital departments after the enactment of the hospital global budget, departments in for-profit hospitals that rely more heavily on drug treatments increased drug spending more, relative to public hospitals. Our findings suggest that a global budgeting system with special reimbursement provisions for certain treatment categories may alter treatment decisions and may undermine cost-containment goals, particularly among for-profit hospitals.

2013–2014 National Roadside Study of alcohol and drug use by drivers: drug results.

DOT National Transportation Integrated Search

2017-05-01

This was a nationally representative study to estimate the prevalence of alcohol and other drug use among drivers. : Drugs studied included 98 over-the-counter, prescription, and illegal substances. Drivers were randomly selected at : 60 sites (300 l...

A Review: The Current In Vivo Models for the Discovery and Utility of New Anti-leishmanial Drugs Targeting Cutaneous Leishmaniasis

PubMed Central

Mears, Emily Rose; Modabber, Farrokh; Don, Robert; Johnson, George E.

2015-01-01

The current in vivo models for the utility and discovery of new potential anti-leishmanial drugs targeting Cutaneous Leishmaniasis (CL) differ vastly in their immunological responses to the disease and clinical presentation of symptoms. Animal models that show similarities to the human form of CL after infection with Leishmania should be more representative as to the effect of the parasite within a human. Thus, these models are used to evaluate the efficacy of new anti-leishmanial compounds before human clinical trials. Current animal models aim to investigate (i) host–parasite interactions, (ii) pathogenesis, (iii) biochemical changes/pathways, (iv) in vivo maintenance of parasites, and (v) clinical evaluation of drug candidates. This review focuses on the trends of infection observed between Leishmania parasites, the predictability of different strains, and the determination of parasite load. These factors were used to investigate the overall effectiveness of the current animal models. The main aim was to assess the efficacy and limitations of the various CL models and their potential for drug discovery and evaluation. In conclusion, we found that the following models are the most suitable for the assessment of anti-leishmanial drugs: L. major–C57BL/6 mice (or–vervet monkey, or–rhesus monkeys), L. tropica–CsS-16 mice, L. amazonensis–CBA mice, L. braziliensis–golden hamster (or–rhesus monkey). We also provide in-depth guidance for which models are not suitable for these investigations. PMID:26334763

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

PubMed

Facchin, Federica; Margola, Davide

2016-10-01

This study identified the main components of the drugs and crime experience of a sample of 25 drug-dependent inmates interviewed in prison. Text analyses were conducted using a phenomenological method. The sample was characterized by a disruptive childhood in multi-problematic families and deviant social contexts where drug use and crime were considered normal since early adolescence. Drug initiation involved recreational use of dance drugs and/or cocaine, and the pleasure experienced was identified as the cause of subsequent persistent use. Three pathways that led to dependence were identified: The narcissistic pathway was defined as involving uncontrolled cocaine and amphetamines to feel powerful and limitless. The posttraumatic pathway was defined as involving post-trauma self-destructive drug use, while the pain relief pathway was defined as involving multiple substances to relieve pain. The second and third pathways were more directly associated with crime aimed at sustaining drug use. © The Author(s) 2015.

Drug prescribing and use among elderly people in Spain.

PubMed

Mas, X; Laporte, J R; Frati, M E; Busquet, L; Arnau, J M; Ibañez, L; Séculi, E; Capellà, D; Arbonés, G

1983-05-01

As a result of the lack of an adequate regulation, the supply and the use of medicines is irrational in Spain. In order to know the characteristics of the prescription and use of drugs among the elderly, two drug utilization studies were carried out. The first study was an analysis of 981 prescriptions from an outpatient clinic of the Spanish Social Security. The results show that a high proportion of fixed-dose combinations were prescribed and that drugs without any demonstrated therapeutic value are often prescribed for the elderly. The second study was a survey of 389 individuals randomly chosen among people affiliated with a pensioners' club. The results show that drug use is highly prevalent among the elderly, that many medicines without any demonstrated benefit are being taken, and that potentially harmful drugs were being used by a high proportion of patients without medical follow-up. The prevalence of the use of some particular groups of drugs is also presented.

Opportunities and Challenges for Niosomes as Drug Delivery Systems.

PubMed

Thakkar, Miloni; Brijesh, S

2016-01-01

With the increase in drug resistance observed in most infectious diseases as well as some forms of cancer, and with the chances of development of new drug molecules to address this issue looking bleak, one of the most plausible ways to disease treatment is combination therapy. Combination therapy would ensure delay in drug resistance, if utilized rationally. However, the biggest difficulty in employing combination therapy are adverse effects due to potential drug-drug interactions and patient compliance due to multiple routes of administration or multiple dosing that may be required. To overcome these issues, researchers have utilized nanoparticle-based systems that can hold multiple drugs in a single carrier. There are several nanocarrier systems available for such purposes. However, the focus of this review will be non-ionic surfactant-based systems (niosomes) for delivery of multiple therapeutic agents. Niosomes are artificially prepared drug delivery carriers. They are structurally similar to liposomes albeit more stable than them. Literature pertaining to combination drug delivery and various drug delivery systems was reviewed. It was conceptualized that many of the methods used to prepare various types of carriers for combination delivery of drugs may be used for niosomal systems as well. We envisage that niosomes may effectively be utilized to package older drugs in newer ways. The review will thus focus on techniques that may be used for the formulation of niosomes, ways to encapsulate multiple-drug moieties, and challenges associated in preparing and optimizing such systems.

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

PubMed Central

Ramli, Azuana; Aljunid, Syed Mohamed; Sulong, Saperi; Md Yusof, Faridah Aryani

2013-01-01

Purpose HMG-CoA reductase inhibitors (statins) are extensively used in treating hypercholesterolemia. The statins available in Malaysia include atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, and fluvastatin. Over the years, they have accumulated in the National Drug Formulary; hence, the need for review. Effective selection of the best drugs to remain in the formulary can become complex due to the multiple drug attributes involved, and is made worse by the limited time and resources available. The multiattribute scoring tool (MAST) systematizes the evaluation of the drug attributes to facilitate the drug selection process. In this study, a MAST framework was developed to rank the statins based on their utilities or benefits. Methods Published literature on multicriteria decision analysis (MCDA) were studied and five sessions of expert group discussions were conducted to build the MAST framework and to review the evidence. The attributes identified and selected for analysis were efficacy (clinical efficacy, clinical endpoints), safety (drug interactions, serious side effects and documentation), drug applicability (drug strength/formulation, indications, dose frequency, side effects, food–drug interactions, and dose adjustments), and cost. The average weights assigned by the members for efficacy, safety, drug applicability and cost were 32.6%, 26.2%, 24.1%, and 17.1%, respectively. The utility values of the attributes were scored based on the published evidence or/and agreements during the group discussions. The attribute scores were added up to provide the total utility score. Results Using the MAST, the six statins under review were successfully scored and ranked. Atorvastatin scored the highest total utility score (TUS) of 84.48, followed by simvastatin (83.11). Atorvastatin and simvastatin scored consistently high, even before drug costs were included. The low scores on the side effects for atorvastatin were compensated for by the higher

Preclinical Determinants of Drug Choice under Concurrent Schedules of Drug Self-Administration

PubMed Central

Banks, Matthew L.; Negus, S. Stevens

2012-01-01

Drug self-administration procedures have played a critical role in the experimental analysis of psychoactive compounds, such as cocaine, for over 50 years. While there are numerous permutations of this procedure, this paper will specifically focus on choice procedures using concurrent schedules of intravenous drug self-administration. The aims of this paper are to first highlight the evolution of drug choice procedures and then review the subsequent preclinical body of literature utilizing these choice procedures to understand the environmental, pharmacological, and biological determinants of the reinforcing stimulus effects of drugs. A main rationale for this paper is our proposition that choice schedules are underutilized in investigating the reinforcing effects of drugs in assays of drug self-administration. Moreover, we will conclude with potential future directions and unexplored scientific space for the use of drug choice procedures. PMID:23243420

Antiepileptic drug utilization in Bangladesh: experience from Dhaka Medical College Hospital.

PubMed

Habib, Mansur; Khan, Sharif Uddin; Hoque, Azhahul; Mondal, Badrul Alam; Hasan, A T M Hasibul; Chowdhury, Rajib Nayan; Haque, Badrul; Rahman, Kazi Mohibur; Chowdhury, Ahmed Hossain; Ghose, Swapon Kumar; Mohammad, Quazi Deen

2013-11-18

Epilepsy is a common health problem which carries a huge medical social psychological and economic impact for a developing country. The aim of this hospital-based study was to get an insight into the effectiveness and tolerability of low cost antiepileptic drugs (AEDs) in Bangladeshi people with epilepsy. This retrospective chart review was done from hospital records in weekly Epilepsy outdoor clinic of Department of Neurology, Dhaka Medical College Hospital (DMCH) from October 1998 to February 2013. A total of 854 epilepsy patients met the eligibility criteria (had a complete record of two years of follow up data) from hospital database. A checklist was used to take demographics (age and gender), epilepsy treatment and adverse event related data. At least two years of follow up data were considered for analysis. Out of 854 patients selected, majority of the patients attending outdoor clinic were >11-30 years age group (55.2%) with a mean age of 20.3 ± 9 years and with a male (53%) predominance. Focal epilepsy were more common (53%), among whom secondary generalized epilepsy was the most frequent diagnosis (67%) followed by complex partial seizure (21%). Among those with Idiopathic Generalized Epilepsy (46%), generalized tonic clonic seizure was encountered in 74% and absence seizure was observed in 13%. The number of patients on monotherapy and dual AED therapy were 67% and 24% respectively and polytherapy (i.e. >3 AEDs) was used only in 9%. CBZ (67%) was the most frequently prescribed AED, followed by VPA (43%), PHB (17%), and PHT (8%). CBZ was prescribed in 37% patients as monotherapy followed by VPA in 21% and PHB in 8% patients. Newer generation drugs eg lemotrigine and topiramate were used only as add on therapy in combination with CBZ and VPA in only 2% patients. The treatment retention rates over the follow up period for the AEDs in monotherapy varied between 86 and 91% and were highest for CBZ, followed by VPA. Most of the combination regimens had a

Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

DOT National Transportation Integrated Search

1980-06-01

This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.709 - Retrospective drug use review.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Retrospective drug use review. 456.709 Section 456... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.709 Retrospective drug use review. (a) General...

42 CFR 456.709 - Retrospective drug use review.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Retrospective drug use review. 456.709 Section 456... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.709 Retrospective drug use review. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.703 - Drug use review program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

42 CFR 456.709 - Retrospective drug use review.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Retrospective drug use review. 456.709 Section 456... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.709 Retrospective drug use review. (a) General...

42 CFR 456.709 - Retrospective drug use review.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Retrospective drug use review. 456.709 Section 456... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.709 Retrospective drug use review. (a) General...

Diabetes diagnosis, resource utilization, and health outcomes.

PubMed

Gulliford, Martin C; Latinovic, Radoslav; Charlton, Judith

2008-01-01

To determine the effect of a clinical diagnosis of diabetes mellitus (DM) on healthcare utilization and health outcomes. Cohort study. A total of 197 United Kingdom family practices with 4974 subjects (mean age, 62.8 years; 52.2% men) with type 2 DM and 9948 matched nondiabetic control subjects. Healthcare utilization and the occurrence of complications were estimated from 2 years before to 2 years after the first clinical diagnosis of DM. From 24 months before the DM diagnosis, primary care consultations were increased in prediagnosis cases compared with controls (relative rate [RR], 1.31; 95% confidence interval [CI], 1.27-1.35), as were emergency and hospital care consultations, hospital specialist referrals, and prescription drug items. At diagnosis of DM, utilization of all forms of healthcare was increased (RR, 4.27; 95% CI, 4.17-4.36 for primary care consultations; RR, 2.49; 95% CI, 2.46-2.52 for prescription drug items). In the quarter following diagnosis, healthcare utilization was increased for acute myocardial infarction (RR, 6.29; 95% CI, 2.69-14.73), cerebrovascular disease (RR, 5.14; 95% CI, 3.37-7.84), ischemic heart disease (RR, 3.65; 95% CI, 2.77-4.80), and peripheral nerve disorders (RR, 5.01; 95% CI, 2.81-8.95). First diagnoses of myocardial infarction, cerebrovascular disease, and peripheral nerve disorders were increased during the period from 6 months before to 6 months after diagnosis. Clinical diagnosis of DM is often the end of a process leading to established complications and is associated with greatly increased utilization of care. This adds to the justification of strategies for earlier detection of hyperglycemic states.

Effects of a consumer driven health plan on pharmaceutical spending and utilization.

PubMed

Parente, Stephen T; Feldman, Roger; Chen, Song

2008-10-01

To compare pharmaceutical spending and utilization in a consumer driven health plan (CDHP) with a three-tier pharmacy benefit design, and to examine whether the CDHP creates incentives to reduce pharmaceutical spending and utilization for chronically ill patients, generic or brand name drugs, and mail-order drugs. Retrospective insurance claims analysis from a large employer that introduced a CDHP in 2001 in addition to a point of service (POS) plan and a preferred provider organization (PPO), both of which used a three-tier pharmacy benefit. Difference-in-differences regression models were estimated for drug spending and utilization. Control variables included the employee's income, age, and gender, number of covered lives per contract, election of flexible spending account, health status, concurrent health shock, cohort, and time trend. Results. CDHP pharmaceutical expenditures were lower than those in the POS cohort in 1 year without differences in the use of brand name drugs. We find limited evidence of less drug consumption by CDHP enrollees with chronic illnesses, and some evidence of less generic drug use and more mail-order drug use among CDHP members. The CDHP is cost-neutral or cost-saving to both the employer and the employee compared with three-tier benefits with no differences in brand name drug use. © Health Research and Educational Trust.

A critical assessment of antipsychotic drug monitoring.

PubMed

Waraska, J; Nagle, J D

1987-06-01

Analytic problems associated with monitoring antipsychotic drug levels have largely been resolved. Despite the establishment of target values for some drugs, the clinical utility of such levels remains to be determined.

Epidemiology and risk factors for drug allergy

PubMed Central

Thong, Bernard Y-H; Tan, Teck-Choon

2011-01-01

The aim of this review was to describe the current evidence-based knowledge of the epidemiology, prevalence, incidence, risk factors and genetic associations of drug allergy. Articles published between 1966 and 2010 were identified in MEDLINE using the key words adult, adverse drug reaction reporting systems, age factors, anaphylactoid, anaphylaxis, anaesthetics, antibiotics, child, drug allergy, drug eruptions, ethnic groups, hypersensitivity, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, sex factors, Stevens Johnson syndrome and toxic epidermal necrolysis. Additional studies were identified from article reference lists. Relevant, peer-reviewed original research articles, case series and reviews were considered for review. Current epidemiological studies on adverse drug reactions (ADRs) have used different definitions for ADR-related terminology, often do not differentiate immunologically and non-immunologically mediated drug hypersensitivity, study different study populations (different ethnicities, inpatients or outpatients, adults or children), utilize different methodologies (spontaneous vs. non-spontaneous reporting, cohort vs. case-control studies), different methods of assessing drug imputability and different methods of data analyses. Potentially life-threatening severe cutaneous adverse reactions (SCAR) are associated with a high risk of morbidity and mortality. HLA associations for SCAR associated with allopurinol, carbamazepine and abacavir have been reported with the potential for clinical use in screening prior to prescription. Identification of risk factors for drug allergy and appropriate genetic screening of at-risk ethnic groups may improve the outcomes of drug-specific SCAR. Research and collaboration are necessary for the generation of clinically-relevant, translational pharmacoepidemiological and pharmacogenomic knowledge, and success of health outcomes research and policies on drug allergies. PMID:21480948

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

2017-11-01

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.

Chronic Health Outcomes and Prescription Drug Copayments in Medicaid.

PubMed

Kostova, Deliana; Fox, Jared

2017-05-01

Prescription drug copayments and cost-sharing have been linked to reductions in prescription drug use and expenditures. However, little is known about their effect on specific health outcomes. To evaluate the association between prescription drug copayments and uncontrolled hypertension, uncontrolled hypercholesterolemia, and prescription drug utilization among Medicaid beneficiaries with these conditions. Select adults aged 20-64 from NHANES 1999-2012 in 18 states. Uncontrolled hypertension, uncontrolled hypercholesterolemia, and taking medication for each of these conditions. A differencing regression model was used to evaluate health outcomes among Medicaid beneficiaries in 4 states that introduced copayments during the study period, relative to 2 comparison groups-Medicaid beneficiaries in 14 states unaffected by shifts in copayment policy, and a within-state counterfactual group of low-income adults not on Medicaid, while controlling for individual demographic factors and unobserved state-level characteristics. Although uncontrolled hypertension and hypercholesterolemia declined among all low-income persons during the study period, the trend was less pronounced in Medicaid beneficiaries affected by copayments. After netting out concurrent trends in health outcomes of low-income persons unaffected by Medicaid copayment changes, we estimated that introduction of drug copayments in Medicaid was associated with an average rise in uncontrolled hypertension and uncontrolled hypercholesterolemia of 7.7 and 13.2 percentage points, respectively, and with reduced drug utilization for hypercholesterolemia. As Medicaid programs change in the years following the Affordable Care Act, prescription drug copayments may play a role as a lever for controlling hypertension and hypercholesterolemia at the population level.

7 CFR 1710.127 - Drug free workplace.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 11 2012-01-01 2012-01-01 false Drug free workplace. 1710.127 Section 1710.127 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... and Basic Policies § 1710.127 Drug free workplace. Borrowers are required to comply with the Drug Free...

7 CFR 1710.127 - Drug free workplace.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 11 2014-01-01 2014-01-01 false Drug free workplace. 1710.127 Section 1710.127 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... and Basic Policies § 1710.127 Drug free workplace. Borrowers are required to comply with the Drug Free...

7 CFR 1710.127 - Drug free workplace.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 11 2013-01-01 2013-01-01 false Drug free workplace. 1710.127 Section 1710.127 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... and Basic Policies § 1710.127 Drug free workplace. Borrowers are required to comply with the Drug Free...

7 CFR 1710.127 - Drug free workplace.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 11 2011-01-01 2011-01-01 false Drug free workplace. 1710.127 Section 1710.127 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... and Basic Policies § 1710.127 Drug free workplace. Borrowers are required to comply with the Drug Free...

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.

The application of ATR-FTIR spectroscopy and multivariate data analysis to study drug crystallisation in the stratum corneum.

PubMed

Goh, Choon Fu; Craig, Duncan Q M; Hadgraft, Jonathan; Lane, Majella E

2017-02-01

Drug permeation through the intercellular lipids, which pack around and between corneocytes, may be enhanced by increasing the thermodynamic activity of the active in a formulation. However, this may also result in unwanted drug crystallisation on and in the skin. In this work, we explore the combination of ATR-FTIR spectroscopy and multivariate data analysis to study drug crystallisation in the skin. Ex vivo permeation studies of saturated solutions of diclofenac sodium (DF Na) in two vehicles, propylene glycol (PG) and dimethyl sulphoxide (DMSO), were carried out in porcine ear skin. Tape stripping and ATR-FTIR spectroscopy were conducted simultaneously to collect spectral data as a function of skin depth. Multivariate data analysis was applied to visualise and categorise the spectral data in the region of interest (1700-1500cm -1 ) containing the carboxylate (COO - ) asymmetric stretching vibrations of DF Na. Spectral data showed the redshifts of the COO - asymmetric stretching vibrations for DF Na in the solution compared with solid drug. Similar shifts were evident following application of saturated solutions of DF Na to porcine skin samples. Multivariate data analysis categorised the spectral data based on the spectral differences and drug crystallisation was found to be confined to the upper layers of the skin. This proof-of-concept study highlights the utility of ATR-FTIR spectroscopy in combination with multivariate data analysis as a simple and rapid approach in the investigation of drug deposition in the skin. The approach described here will be extended to the study of other actives for topical application to the skin. Copyright © 2016 Elsevier B.V. All rights reserved.

Scoping study of integrated resource planning needs in the public utility sector

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garrick, C J; Garrick, J M; Rue, D R

Integrated resource planning (IRP) is an approach to utility resource planning that integrates the evaluation of supply- and demand-site options for providing energy services at the least cost. Many utilities practice IRP; however, most studies about IRP focus on investor-owned utilities (IOUs). This scoping study investigates the IRP activities and needs of public utilities (not-for-profit utilities, including federal, state, municipal, and cooperative utilities). This study (1) profiles IRP-related characteristics of the public utility sector, (2) articulates the needs of public utilities in understanding and implementing IRP, and (3) identifies strategies to advance IRP principles in public utility planning.

Risk-taking related to drug use: an application of the shift-to-risk design.

PubMed

Deren, S; Des Jarlais, D C

1977-01-01

The utility of the shift-to-risk design for studying the influence of peer groups on drug taking was investigated. Two studies using this design with drug content were conducted, varying the level of information provided about a drug. Subjects were from two college classes consisting of 26 and 28 students. Results indicated that the specification of possible harmful drug effects which are somewhat minimal lead to a significantly greater willingness to recommend trying the drug. In addition, a tendency for a shift-to-caution was found. It was concluded that the shift-to-risk designwas useful for studying decision-making regarding drug use, and that both users and nonusers of drugs should be included in future research.

Assessment of nonsteroidal anti-inflammatory drug use pattern using World Health Organization indicators: A cross-sectional study in a tertiary care teaching hospital of Chhattisgarh.

PubMed

R Vaishnavi, P R; Gaikwad, Nitin; Dhaneria, S P

2017-01-01

The objective of this study is to assess drug utilization pattern of nonsteroidal anti-inflammatory drugs (NSAIDs) in a tertiary care teaching hospital, Raipur, Chhattisgarh. A prospective, cross-sectional observational study was conducted in the outpatient department during 2-month period. After informed consent, the patients visiting pharmacy shop with a prescription were enrolled in the study. Their demographic details and prescription data were recorded in a case record form. The data were analyzed to determine the drug utilization pattern of NSAIDs, using the World Health Organization (WHO) prescribing indicators. A total of 600 prescriptions were analyzed. Of them, NSAIDs were prescribed in 30.83% encounters. In general, nonselective COX inhibitors were most commonly prescribed. The most commonly prescribed form of NSAID was paracetamol (39.45%). The percentage of NSAIDs prescribed with generic names were almost identical (91.15%), whereas the percentage of NSAIDs prescribed from the National List of Essential Medicine (India) - 2015 (49.72%) was not identical with the WHO standard (100%) which serves as an ideal. In 13.51% encounters, a fixed-dose combination (FDC) of NSAIDs was prescribed. Co-administration of gastroprotective agent with NSAIDs was observed in 24.32% encounters. The prescribing practices of NSAIDs indicate some deviation from the WHO standard. In addition, FDCs of NSAIDs with gastroprotective agents as well as other NSAIDs was also prescribed, which are irrational. This baseline data will be useful to plan further targeted research and to improve prescribing practices at the center. Various strategies such as face-to-face periodic training programs of prescribers, establishing drug and therapeutic committee; drug information centers; and drug bulletins can serve beneficial in improving prescribing practices.

Work-related injuries in a state trauma registry: relationship between industry and drug screening.

PubMed

Bunn, Terry L; Slavova, Svetla; Bernard, Andrew C

2014-08-01

Work-related injuries exert a great financial and economic burden on the US population. The study objectives were to identify the industries and occupations associated with worker injuries and to determine the predictors for injured worker drug screening in trauma centers. Work-related injury cases were selected using three criteria (expected payer source of workers' compensation, industry-related e-codes, and work-related indicator) from the Kentucky Trauma Registry data set for years 2008 to 2012. Descriptive analyses and multiple logistic regression were performed on the work-related injury cases. The "other services" and construction industry sectors accounted for the highest number of work-related cases. Drugs were detected in 55% of all drug-screened work-related trauma cases. Higher percentages of injured workers tested positive for drugs in the natural resources and mining, transportation and public utilities, and construction industries. In comparison, higher percentages of injured workers in the other services as well as transportation and public utilities industries were drug screened. Treatment at Level I trauma centers and Glasgow Coma Scale (GCS) scores indicating a coma or severe brain injury were both significant independent predictors for being screened for drugs; industry was not a significant predictor for being drug screened. The injured worker was more likely to be drug screened if the worker had a greater than mild injury, regardless of whether the worker was an interfacility transfer. These findings indicate that there may be elevated drug use or abuse in natural resources and mining, transportation and public utilities, as well as construction industry workers; improved identification of the specific drug types in positive drug screen results of injured workers is needed to better target prevention efforts. Epidemiologic study, level III.

Drug delivery systems--2. Site-specific drug delivery utilizing monoclonal antibodies.

PubMed

Ranade, V V

1989-10-01

for studies of chromosome structure and function, gene mapping, embryogenesis, characterization and biosynthesis of developmental and differentiation antigens. These antigens are those that are specific for various cell types and tissues, species specific antigen, antigens involved in chemotaxis, immunogenetics and clinical genetics including genetically inherited disorders, chromosome aberrations and transplantation antigens. Besides these monoclonal antibodies, their complexes have recently been investigated as exquisitely sensitive probes to be guided to target cells or organs. They have been used to deliver cytotoxic drugs to malignant cells or enzymes to specific cell types.(ABSTRACT TRUNCATED AT 400 WORDS)

Drug use in pregnant women-a pilot study of the coherence between reported use of drugs and presence of drugs in plasma.

PubMed

Wolgast, Emelie; Josefsson, Ann; Josefsson, Martin; Lilliecreutz, Caroline; Reis, Margareta

2018-04-01

In Sweden, information on drug use during pregnancy is obtained through an interview and recorded in a standardized medical record at every visit to the antenatal care clinic throughout the pregnancy. Antenatal, delivery, and neonatal records constitute the basis for the Swedish Medical Birth Register (MBR). The purpose of this exploratory study was to investigate the reliability of reported drug use by simultaneous screening for drug substances in the blood stream of the pregnant woman and thereby validate self-reported data in the MBR. Plasma samples from 200 women were obtained at gestational weeks 10-12 and 25 and screened for drugs by using ultra-high performance liquid chromatography with time of flight mass spectrometry (UHPLC-TOF-MS). The results from the analysis were then compared to medical records. At the first sampling occasion, the drugs found by screening had been reported by 86% of the women and on the second sampling, 85.5%. Missed reported information was clearly associated with drugs for occasional use. The most common drugs in plasma taken in early and mid-pregnancy were meclizine and paracetamol. Two types of continuously used drugs, selective serotonin reuptake inhibitors and propranolol, were used. All women using them reported it and the drug screening revealed a 100% coherence. This study shows good coherence between reported drug intake and the drugs found in plasma samples, which in turn positively validates the MBR.

Identifying Drug-Drug Interactions by Data Mining: A Pilot Study of Warfarin-Associated Drug Interactions.

PubMed

Hansen, Peter Wæde; Clemmensen, Line; Sehested, Thomas S G; Fosbøl, Emil Loldrup; Torp-Pedersen, Christian; Køber, Lars; Gislason, Gunnar H; Andersson, Charlotte

2016-11-01

Knowledge about drug-drug interactions commonly arises from preclinical trials, from adverse drug reports, or based on knowledge of mechanisms of action. Our aim was to investigate whether drug-drug interactions were discoverable without prior hypotheses using data mining. We focused on warfarin-drug interactions as the prototype. We analyzed altered prothrombin time (measured as international normalized ratio [INR]) after initiation of a novel prescription in previously INR-stable warfarin-treated patients with nonvalvular atrial fibrillation. Data sets were retrieved from clinical work. Random forest (a machine-learning method) was set up to predict altered INR levels after novel prescriptions. The most important drug groups from the analysis were further investigated using logistic regression in a new data set. Two hundred and twenty drug groups were analyzed in 61 190 novel prescriptions. We rediscovered 2 drug groups having known interactions (β-lactamase-resistant penicillins [dicloxacillin] and carboxamide derivatives) and 3 antithrombotic/anticoagulant agents (platelet aggregation inhibitors excluding heparin, direct thrombin inhibitors [dabigatran etexilate], and heparins) causing decreasing INR. Six drug groups with known interactions were rediscovered causing increasing INR (antiarrhythmics class III [amiodarone], other opioids [tramadol], glucocorticoids, triazole derivatives, and combinations of penicillins, including β-lactamase inhibitors) and two had a known interaction in a closely related drug group (oripavine derivatives [buprenorphine] and natural opium alkaloids). Antipropulsives had an unknown signal of increasing INR. We were able to identify known warfarin-drug interactions without a prior hypothesis using clinical registries. Additionally, we discovered a few potentially novel interactions. This opens up for the use of data mining to discover unknown drug-drug interactions in cardiovascular medicine. © 2016 American Heart Association

Studies on stercuia gum formulations in the form of osmotic core tablet for colon-specific drug delivery of azathioprine.

PubMed

Nath, Bipul; Nath, Lila Kanta

2013-01-01

The purpose of this research is to evaluate Sterculia urens gum as a carrier for a colon-targeted drug delivery system. Microflora degradation studies of Sterculia gum was conducted in phosphate-buffered saline pH 7.4 containing rat caecal medium under an anaerobic environment. Solubility, swelling index, viscosity, and pH of the polymer solution were determined. Different formulation aspects considered were gum concentration (10-40%) and concentration of citric acid (10-30%) on the swelling index and in-vitro dissolution release. The results of the isothermal stress testing showed that there is no degradation of samples of model drug, azathioprine, the drug polymer mixture, and the core tablet excipients. Differential scanning calorimetry and Fourier transform infrared spectroscopy study proved the compatibility of the drug with Sterculia gum and other tablet excipients. Microflora degradation study revealed that Sterculia gum can be used as tablet excipient for drug release in the colonic region by utilizing the action of enterobacteria. The swelling force of the Sterculia gum could concurrently drive the drug out of the polysaccharide core due to the rupture of the mixed film coating under colonic microflora-activated environment. Sterculia gum gives premature drug release in the upper gastrointestinal tract without enteric coating and may not reach the colonic region. Sterculia gum as a colon-targeting carrier is possible via double-layer coating with chitosan/Eudragit RLPO (ammonio-methacrylate copolymer) mixed blend as well as enteric polymers, which would provide acid as well as intestinal resistance but undergo enzymatic degradation once reaching the colon. The aim of the research is to evaluate wheather Sterculia urens, which is a polysaccharide, is suitable as a carrier for colonic delivery of drugs acting locally in the colon. Sterculia gum has been reported to have wide pharmaceutical applications such as tablet binder, disintegrant, gelling agent, and

Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

PubMed

Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

2017-01-28

Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be

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.

Effects of a recovery management intervention on Chinese heroin users' community recovery through the mediation effect of enhanced service utilization.

PubMed

Wu, F; Fu, L M; Hser, Y H

2015-09-01

This study investigates whether a recovery management intervention (RMI) can improve the utilization of community drug treatment and wraparound services among heroin users in China and subsequently lead to positive recovery outcomes. Secondary analysis was conducted drawing data from a randomized controlled trial; 100 heroin users with no severe mental health problems were recruited in two Shanghai districts (Hongkou and Yangpu) upon their release from compulsory rehabilitation facilities. A latent variable modeling approach was utilized to test whether the RMI influences heroin users' perceived motivation and readiness for treatment, enhances treatment and wraparound service participation, and, in turn, predicts better recovery outcomes. Enrollment in drug treatment and other social service utilization increased significantly as a result of RMI rather than an individual drug user's motivation and readiness for treatment. Increased service utilization thus led to more positive individual recovery outcomes. In addition to this mediation effect through service utilization, the RMI also improved participants' community recovery directly. Findings suggest that better drug treatment enrollment, community service utilization and recovery outcomes can be potentially achieved among heroin users in China with carefully designed case management interventions. © The Author 2014. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Unique and potent effects of acute ibogaine on zebrafish: the developing utility of novel aquatic models for hallucinogenic drug research.

PubMed

Cachat, Jonathan; Kyzar, Evan J; Collins, Christopher; Gaikwad, Siddharth; Green, Jeremy; Roth, Andrew; El-Ounsi, Mohamed; Davis, Ari; Pham, Mimi; Landsman, Samuel; Stewart, Adam Michael; Kalueff, Allan V

2013-01-01

An indole alkaloid, ibogaine is the principal psychoactive component of the iboga plant, used by indigenous peoples in West Africa for centuries. Modulating multiple neurotransmitter systems, the drug is a potent hallucinogen in humans, although its psychotropic effects remain poorly understood. Expanding the range of model species is an important strategy for translational neuroscience research. Here we exposed adult zebrafish (Danio rerio) to 10 and 20mg/L of ibogaine, testing them in the novel tank, light-dark box, open field, mirror stimulation, social preference and shoaling tests. In the novel tank test, the zebrafish natural diving response (geotaxis) was reversed by ibogaine, inducing initial top swimming followed by bottom dwelling. Ibogaine also attenuated the innate preference for dark environments (scototaxis) in the light-dark box test. While it did not exert overt locomotor or thigmotaxic responses in the open field test, the drug altered spatiotemporal exploration of novel environment, inducing clear preference of some areas over others. Ibogaine also promoted 'mirror' exploration in the mirror stimulation test, disrupted group cohesion in the shoaling test, and evoked strong coloration responses due to melanophore aggregation, but did not alter brain c-fos expression or whole-body cortisol levels. Overall, our results support the complex pharmacological profile of ibogaine and its high sensitivity in zebrafish models, dose-dependently affecting multiple behavioral domains. While future investigations in zebrafish may help elucidate the mechanisms underlying these unique behavioral effects, our study strongly supports the developing utility of aquatic models in hallucinogenic drug research. High sensitivity of three-dimensional phenotyping approaches applied here to behavioral effects of ibogaine in zebrafish provides further evidence of how 3D reconstructions of zebrafish swimming paths may be useful for high-throughput pharmacological screening

An ex vivo approach to botanical-drug interactions: a proof of concept study.

PubMed

Wang, Xinwen; Zhu, Hao-Jie; Munoz, Juliana; Gurley, Bill J; Markowitz, John S

2015-04-02

Botanical medicines are frequently used in combination with therapeutic drugs, imposing a risk for harmful botanical-drug interactions (BDIs). Among the existing BDI evaluation methods, clinical studies are the most desirable, but due to their expense and protracted time-line for completion, conventional in vitro methodologies remain the most frequently used BDI assessment tools. However, many predictions generated from in vitro studies are inconsistent with clinical findings. Accordingly, the present study aimed to develop a novel ex vivo approach for BDI assessment and expand the safety evaluation methodology in applied ethnopharmacological research. This approach differs from conventional in vitro methods in that rather than botanical extracts or individual phytochemicals being prepared in artificial buffers, human plasma/serum collected from a limited number of subjects administered botanical supplements was utilized to assess BDIs. To validate the methodology, human plasma/serum samples collected from healthy subjects administered either milk thistle or goldenseal extracts were utilized in incubation studies to determine their potential inhibitory effects on CYP2C9 and CYP3A4/5, respectively. Silybin A and B, two principal milk thistle phytochemicals, and hydrastine and berberine, the purported active constituents in goldenseal, were evaluated in both phosphate buffer and human plasma based in vitro incubation systems. Ex vivo study results were consistent with formal clinical study findings for the effect of milk thistle on the disposition of tolbutamide, a CYP2C9 substrate, and for goldenseal׳s influence on the pharmacokinetics of midazolam, a widely accepted CYP3A4/5 substrate. Compared to conventional in vitro BDI methodologies of assessment, the introduction of human plasma into the in vitro study model changed the observed inhibitory effect of silybin A, silybin B and hydrastine and berberine on CYP2C9 and CYP3A4/5, respectively, results which more