["When the ad is good, the product is sold." The MonitorACAO Project and drug advertising in Brazil].

PubMed

Soares, Jussara Calmon Reis de Souza

2008-04-01

This paper presents an analysis on drug advertising in Brazil, based on the final report of the MonitorACAO Project, by the group from the Universidade Federal Fluminense, Niterói, Rio de Janeiro. Due to a partnership between the university and the National Agency for Health Surveillance (ANVISA), drug advertisements were monitored and analyzed for one year, according to the methodology defined by the Agency. The samples were collected in medical practices and hospitals, drugstores, pharmacies and in scientific magazines. TV and radio programs were monitored, in the case of OTC drugs. 159 advertisements referring to pharmaceuticals were sent to ANVISA,from a total of 263 irregular ads analyzed between October 2004 and August 2005. The main problems found were the poor quality of drug information to health professionals, as well as misleading drug use to lay population. Based on the results of this project and on other studies, the banning of drug advertising in Brazil is proposed.

The Gendered Nature of Drug Acquisition Behavior within Marijuana and Crack Drug Markets

ERIC Educational Resources Information Center

Griffin, Marie L.; Rodriguez, Nancy

2011-01-01

Previous studies examining how gender structures women's opportunities to engage in the street-level drug economy have provided insight into the changing nature of illicit drug markets and women's roles within this illegitimate economy. Using national data from the Arrestee Drug Abuse Monitoring program, this study adds to the existing body of…

Monitoring the Future National Survey Results on Drug Use, 1975-2013. Volume 2, College Students & Adults Ages 19-55

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.; Miech, Richard A.

2014-01-01

Monitoring the Future (MTF) is a research program conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse--one of the National Institutes of Health. The study comprises several ongoing series of annual surveys of nationally…

National Survey Results on Drug Use from the Monitoring the Future Study, 1975-1993. Volume 1, Secondary School Students.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

This report summarizes a national survey of drug use and related attitudes among American secondary school students. All of its data came from an ongoing national research and reporting program entitled, "Monitoring the Future: A Continuing Study of the Lifestyles and Values of Youth." These surveys address two major topics: (1) the…

A Comparison of Drug Use between Prostitutes and Other Female Arrestees.

ERIC Educational Resources Information Center

Yacoubian, George S., Jr.; Urbach, Blake J.; Larsen, Kristine L.; Johnson, Regina J.; Peters, Ronald J., Jr.

2000-01-01

In this study, drug use data were collected from 3,587 female arrestees surveyed through Houston's Arrestee Drug Abuse Monitoring (ADAM) Program. Chi-square statistics indicated females arrested for prostitution were significantly more likely to test positive for cocaine than the non-prostitutes. Implications for drug treatment and public health…

Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

PubMed

Manchikanti, Laxmaiah; Manchukonda, Rajeev; Pampati, Vidyasagar; Damron, Kim S; Brandon, Doris E; Cash, Kim A; McManus, Carla D

2006-04-01

Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance. To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study. A prospective, consecutive study. Interventional pain management practice setting in the United States. A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present. Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent. The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.

Monitoring the Future National Survey Results on Drug Use, 1975-2016. Volume II, College Students & Adults Ages 19-55

ERIC Educational Resources Information Center

Schulenberg, John E.; Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Miech, Richard A.; Patrick, Megan E.

2017-01-01

Monitoring the Future (MTF), now in its 42nd year, is a research program conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated, competing research grants from the National Institute on Drug Abuse--one of the National Institutes of Health. The study comprises several ongoing series of…

Monitoring the Future National Survey Results on Drug Use, 1975-2015. Volume 2, College Students & Adults Ages 19-55

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.; Miech, Richard A.

2016-01-01

Monitoring the Future (MTF), now in its 41st year, is a research program conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated, competing research grants from the National Institute on Drug Abuse--one of the National Institutes of Health. The study comprises several ongoing series of…

Monitoring the Future National Survey Results on Drug Use, 1975-2014. Volume 2, College Students & Adults Ages 19-55

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.; Miech, Richard A.

2015-01-01

Monitoring the Future (MTF), now in its 40th year, is a research program conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse--one of the National Institutes of Health. The study comprises several ongoing series of annual surveys…

Reasons for misuse of prescription medication among physicians undergoing monitoring by a physician health program.

PubMed

Merlo, Lisa J; Singhakant, Supachoke; Cummings, Simone M; Cottler, Linda B

2013-01-01

Substance-related impairment of physicians is a small but serious problem, with significant consequences for patient safety and public health. The purpose of this study was to identify reasons for prescription drug misuse among physicians referred to a physician health program for monitoring because of substance-related impairment, to develop better mechanisms for prevention and intervention. A total of 55 physicians (94.5% male) who were being monitored by their State physician health program because of substance-related impairment participated in guided focus group discussions. Participation was anonymous. Discussions were transcribed from 9 separate focus groups, lasting 60 to 90 minutes each. Qualitative analyses were conducted to examine themes. All participants were diagnosed with substance dependence, and 69.1% of them endorsed a history of misusing prescription drugs. Participants documented the following 5 primary reasons for prescription drug misuse: (1) to manage physical pain, (2) to manage emotional/psychiatric distress, (3) to manage stressful situations, (4) to serve recreational purposes, and (5) to avoid withdrawal symptoms. Our results emphasize the importance of self-medication as a leading reason for misusing prescription medications, although recreational use was also an important factor. Prevention efforts targeting prescription drug misuse among physicians should be initiated during medical training, with continuing education requirements throughout the physicians' careers.

46 CFR 5.205 - Return or issuance of a credential or endorsement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... on incompetence due to drug abuse, the deposit agreement shall provide that the credential or endorsement will not be returned until the person: (1) Successfully completes a bona fide drug abuse... drug abuse monitoring program. (c) Where the voluntary deposit is based on incompetence due to alcohol...

46 CFR 5.205 - Return or issuance of a credential or endorsement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... on incompetence due to drug abuse, the deposit agreement shall provide that the credential or endorsement will not be returned until the person: (1) Successfully completes a bona fide drug abuse... drug abuse monitoring program. (c) Where the voluntary deposit is based on incompetence due to alcohol...

46 CFR 5.205 - Return or issuance of a credential or endorsement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... on incompetence due to drug abuse, the deposit agreement shall provide that the credential or endorsement will not be returned until the person: (1) Successfully completes a bona fide drug abuse... drug abuse monitoring program. (c) Where the voluntary deposit is based on incompetence due to alcohol...

46 CFR 5.205 - Return or issuance of a credential or endorsement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... on incompetence due to drug abuse, the deposit agreement shall provide that the credential or endorsement will not be returned until the person: (1) Successfully completes a bona fide drug abuse... drug abuse monitoring program. (c) Where the voluntary deposit is based on incompetence due to alcohol...

46 CFR 5.205 - Return or issuance of a credential or endorsement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... on incompetence due to drug abuse, the deposit agreement shall provide that the credential or endorsement will not be returned until the person: (1) Successfully completes a bona fide drug abuse... drug abuse monitoring program. (c) Where the voluntary deposit is based on incompetence due to alcohol...

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

Animal NARMS Surveillance Data

USDA-ARS?s Scientific Manuscript database

The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

Monitoring the Future. National Survey Results on Drug Use, 1975-2009. Volume II, College Students & Adults Ages 19-50. NIH Publication Number 10-7585

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2010-01-01

Now in its 35th year, Monitoring the Future (MTF) is a long-term program of research conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse. The study is comprised of several ongoing series of annual surveys of nationally…

Monitoring the Future: National Survey Results on Drug Use, 1975-2006. Volume II: College Students & Adults Ages 19-25. NIH Publication No. 07-6206

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2007-01-01

Monitoring the Future is a long-term program of research being conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse. Now in its 32nd year, the study is comprised of several ongoing series of annual surveys of nationally…

Normalization of urinary drug concentrations with specific gravity and creatinine.

PubMed

Cone, Edward J; Caplan, Yale H; Moser, Frank; Robert, Tim; Shelby, Melinda K; Black, David L

2009-01-01

Excessive fluid intake can substantially dilute urinary drug concentrations and result in false-negative reports for drug users. Methods for correction ("normalization") of drug/metabolite concentrations in urine have been utilized by anti-doping laboratories, pain monitoring programs, and in environmental monitoring programs to compensate for excessive hydration, but such procedures have not been used routinely in workplace, legal, and treatment settings. We evaluated two drug normalization procedures based on specific gravity and creatinine. These corrections were applied to urine specimens collected from three distinct groups (pain patients, heroin users, and marijuana/ cocaine users). Each group was unique in characteristics, study design, and dosing conditions. The results of the two normalization procedures were highly correlated (r=0.94; range, 0.78-0.99). Increases in percent positives by specific gravity and creatinine normalization were small (0.3% and -1.0%, respectively) for heroin users (normally hydrated subjects), modest (4.2-9.8%) for pain patients (unknown hydration state), and substantial (2- to 38-fold increases) for marijuana/cocaine users (excessively hydrated subjects). Despite some limitations, these normalization procedures provide alternative means of dealing with highly dilute, dilute, and concentrated urine specimens. Drug/metabolite concentration normalization by these procedures is recommended for urine testing programs, especially as a means of coping with dilute specimens.

Drugs and the Nation's High School Students: Five Year National Trends. 1979 Highlights.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

The current prevalence of drug use among American high school seniors, and trends in drug use since 1975, were investigated as part of the program entitled "Monitoring the Future: A Continuing Study of the Lifestyles and Values of Youth," funded by the National Institute on Drug Abuse. The basic research design involved data collection from high…

Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015.

PubMed

Lee, Hsin-Chun; Chen, Chi-Min; Wei, Jen-Ting; Chiu, Hsiu-Yi

2018-04-01

Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011-2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA) inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management. Copyright © 2017. Published by Elsevier B.V.

Impact of legislation and a prescription monitoring program on the prevalence of potentially inappropriate prescriptions for monitored drugs in Ontario: a time series analysis.

PubMed

Gomes, Tara; Juurlink, David; Yao, Zhan; Camacho, Ximena; Paterson, J Michael; Singh, Samantha; Dhalla, Irfan; Sproule, Beth; Mamdani, Muhammad

2014-10-01

The increased use of opioid analgesics, sedative hypnotics and stimulants, coupled with the associated risks of overdose have raised concerns around the inappropriate prescribing of these monitored drugs. We assessed the impact of new legislation, the Narcotics Safety and Awareness Act, and a centralized Narcotics Monitoring System (implemented November 2011 and May 2012, respectively), on the dispensing of prescriptions suggestive of misuse. We conducted a time series analysis of publicly funded prescriptions for opioids, benzodiazepines and stimulants dispensed monthly in Ontario from January 2007 to May 2013, based on information in the Ontario Public Drug Benefit Database. In the primary analysis, a prescription was deemed potentially inappropriate if it was dispensed within 7 days of an earlier prescription and was for at least 30 tablets of a drug in the same class as the earlier prescription, but originated from a different physician and a different pharmacy. After enactment of the new legislation, the prevalence of potentially inappropriate opioid prescriptions decreased by 12.5% in 6 months (from 1.6% in October 2011 to 1.4% in April 2012; p = 0.01). No further significant change was observed after the introduction of the narcotic monitoring system (p = 0.8). By May 2013, the prevalence had dropped to 1.0%. Inappropriate benzodiazepine prescribing was significantly influenced by both the legislation (p < 0.001) and the monitoring system (p = 0.05), which together reduced potentially inappropriate prescribing by 50.0% between October 2011 and May 2013 (from 0.4% to 0.2%). The prevalence of potentially inappropriate prescribing of stimulants was significantly influenced by the introduction of the monitoring system in May 2012, falling from 0.7% in April 2012 to 0.3% in May 2013 (p = 0.02). For a select group of drugs prone to misuse and diversion, legislation and a prescription monitoring program reduced the prevalence of prescriptions suggestive of misuse. This suggests that regulatory interventions can promote appropriate prescribing which could potentially be applied to other jurisdictions and drugs of concern.

Monitoring the Future: National Survey Results on Drug Use, 1975-2007. Volume II, College Students and Adults Ages 19-45, 2007. NIH Publication No. 08-6418B

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2008-01-01

Monitoring the Future is a long-term program of research being conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse. Now in its 33rd year, the study is comprised of several ongoing series of annual surveys of nationally…

Monitoring the Future: National Survey Results on Drug Use, 1975-2008. Volume II, College Students and Adults Ages 19-50. NIH Publication No. 09-7403

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2009-01-01

Monitoring the Future is a long-term program of research being conducted at the University of Michigan's Institute for Social Research under a series of investigator-initiated research grants from the National Institute on Drug Abuse. Now in its 34th year, the study is comprised of several ongoing series of annual surveys of nationally…

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

PubMed

Skledar, S J; Hess, M M

2000-12-15

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

Therapeutic drug monitoring in pregnancy.

PubMed

Matsui, Doreen M

2012-10-01

Therapeutic drug monitoring (TDM) is commonly recommended to optimize drug dosing regimens of various medications. It has been proposed to guide therapy in pregnant women, in whom physiological changes may lead to altered pharmacokinetics resulting in difficulty in predicting the appropriate drug dosage. Ideally, TDM may play a role in enhancing the effectiveness of treatment while minimizing toxicity of both the mother and fetus. Monitoring of drug levels may also be helpful in assessing adherence to prescribed therapy in selected cases. Limitations exist as therapeutic ranges have only been defined for a limited number of drugs and are based on data obtained in nonpregnant patients. TDM has been suggested for anticonvulsants, antidepressants, and antiretroviral drugs, based on pharmacokinetic studies that have shown reduced drug concentrations. However, there is only relatively limited (and sometimes inconsistent) information regarding the clinical impact of these pharmacokinetic changes during pregnancy and the effect of subsequent dose adjustments. Further studies are required to determine whether implementation of TDM during pregnancy improves outcome and is associated with any benefit beyond that achieved by clinical judgment alone. The cost effectiveness of TDM programs during pregnancy also remains to be examined.

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

PubMed

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

The Aims and Objectives of the Monitoring the Future Study and Progress toward Fulfilling Them as of 2001. Monitoring the Future Occasional Paper 52.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Schulenberg, John E.; Bachman, Jerald G.

Monitoring the Future is an ongoing program of research intended to assess the changing lifestyles, values, and preferences of American youth. This publication, from the occasional paper series, describes a study that monitors drug use and potential explanatory factors among American secondary school students, college students, and young adults.…

Piloting the future: Results from a pilot study for changes in the animal sampling program for the national antibiotic resistance monitoring system (NARMS)

USDA-ARS?s Scientific Manuscript database

A well recognized monitoring system for antimicrobial resistance in the U. S. is the National Antimicrobial Resistance Monitoring System (NARMS). It was established in 1996 among the Food and Drug Administration (FDA), USDA, and Centers for Disease Control and Prevention (CDC). FDA coordinates the ...

Diversion of prescription drugs to the black market: what the states are doing to curb the tide.

PubMed

Forgione, D A; Neuenschwander, P; Vermeer, T E

2001-01-01

The diversion of legitimate controlled substances to the black market is a major cause of medical emergencies, fatalities, and drug-related dependencies. The effects harm not only the illegal user, but also the legitimate patient who may be getting shorted on treatments and innocent medical providers who may be charged with false claim offenses or other professional failures because of diversions that take place during their watch. The dollar magnitude of this crime is estimated to rival the black markets for both crack cocaine and heroine combined. This article addresses the various ways prescription drugs are diverted to the black market, some monitoring programs employed by the states, and guidelines that doctors, pharmacists, and other providers can use to protect themselves against possible liabilities arising from the diversion of prescription drugs. We will also address some of the oppositions to monitoring programs that have been asserted and replies to these oppositions.

48 CFR 1523.7003 - Contract clause.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient...-103, Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors, and...

48 CFR 1523.7003 - Contract clause.

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient...-103, Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors, and...

48 CFR 1523.7003 - Contract clause.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient...-103, Acquisition of Energy Star Compliant Microcomputers, Including Personal Computers, Monitors, and...

The International Interlaboratory Quality Control Program for Measurement of Antiretroviral Drugs in Plasma: a global proficiency testing program.

PubMed

Burger, David; Teulen, Marga; Eerland, Jaco; Harteveld, Anneke; Aarnoutse, Rob; Touw, Daan

2011-04-01

The International Interlaboratory Quality Control Program for Measurement of Antiretroviral Drugs in Plasma was initiated in 1999 by Radboud University Nijmegen Medical Center, The Netherlands, and continued later on in collaboration with the Dutch Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (www.kkgt.nl). The aim of this analysis was to evaluate the first 10 years of the Program and to determine variables associated with reporting of less accurate results. Two rounds are organized annually in which blind samples are shipped to participants containing a low, medium, or high concentration of each antiretroviral drug. Any reported result that deviates more than 20% from the spiked concentration is defined as inaccurate. By the end of 2009, the number of laboratories participating in the Program had increased to 56; 44 (79%) are located in Europe. A total of 12,798 test results was available for analysis, of which 2104 (16.4%) were reported as inaccurate. Performance was best for samples containing nevirapine (mean of inadequate scores per round: 11.1%) and lopinavir (11.9%) and worst for indinavir (18.7%), atazanavir (18.9%), saquinavir (19.6%), and nelfinavir (21.3%). High and medium concentrations were less frequently reported as inaccurate than low concentrations: 13.5%, 13.0%, and 22.4%, respectively. Although the overall performance of the laboratories varied per year, a trend was visible for improvement over time with 19.9% of the results being inaccurate in 2002 (n = 20 laboratories) to 15.7% in 2009 (n = 56 laboratories). The Program provides a proficiency testing program in which laboratories are alerted to potential analytical errors while performing therapeutic drug monitoring in HIV-infected patients. Laboratories should put more effort in adequately analyzing concentrations of antiretroviral drugs with low minimum effective concentrations.

Preparing a prescription drug monitoring program data set for research purposes.

PubMed

O'Kane, Nicole; Hallvik, Sara E; Marino, Miguel; Van Otterloo, Joshua; Hildebran, Christi; Leichtling, Gillian; Deyo, Richard A

2016-09-01

To develop a complete and consistent prescription drug monitoring program (PDMP) data set for use by drug safety researchers in evaluating patterns of high-risk use and potential abuse of scheduled drugs. Using publically available data references from the US Food and Drug Administration and the Centers for Disease Control and Prevention, we developed a strategic methodology to assign drug categories based on pharmaceutical class for the majority of prescriptions in the PDMP data set. We augmented data elements required to calculate morphine milligram equivalents and assigned duration of action (short-acting or long acting) properties for a majority of opioids in the data set. About 10% of prescriptions in the PDMP data set did not have a vendor-assigned drug category, and 20% of opioid prescriptions were missing data needed to calculate risk metrics. Using inclusive methods, 19 133 167 (>99.9%) of prescriptions in the PDMP data set were assigned a drug category. For the opioid category, augmenting data elements resulted in 10 760 669 (99.8%) having required values to calculate morphine milligram equivalents and evaluate duration of action properties. Drug safety researchers who require a complete and consistent PDMP data set can use the methods described here to ensure that prescriptions of interest are assigned consistent drug categories and complete opioid risk variable values. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Prevalence of HIV Drug Resistance Before and 1 Year After Treatment Initiation in 4 Sites in the Malawi Antiretroviral Treatment Program

PubMed Central

Bennett, Diane; van Oosterhout, Joep J.; Moyo, Kundai; Hosseinipour, Mina; DeVos, Josh; Zhou, Zhiyong; Aberle-Grasse, John; Warne, Thomas R.; Mtika, Clement; Chilima, Ben; Banda, Richard; Pasulani, Olesi; Porter, Carol; Phiri, Sam; Jahn, Andreas; Kamwendo, Debbie; Jordan, Michael R.; Kabuluzi, Storn; Chimbwandira, Frank; Kagoli, Mathew; Matatiyo, Blackson; Demby, Austin; Yang, Chunfu

2012-01-01

Since 2004, the Malawi antiretroviral treatment (ART) program has provided a public health–focused system based on World Health Organization clinical staging, standardized first-line ART regimens, limited laboratory monitoring, and no patient-level monitoring of human immunodeficiency virus drug resistance (HIVDR). The Malawi Ministry of Health conducts periodic evaluations of HIVDR development in prospective cohorts at sentinel clinics. We evaluated viral load suppression, HIVDR, and factors associated with HIVDR in 4 ART sites at 12–15 months after ART initiation. More than 70% of patients initiating ART had viral suppression at 12 months. HIVDR prevalence (6.1%) after 12 months of ART was low and largely associated with baseline HIVDR. Better follow-up, removal of barriers to on-time drug pickups, and adherence education for patients 16–24 years of age may further prevent HIVDR. PMID:22544204

Research to support optimization of prescription drug monitoring programs.

PubMed

Doyle, Sheri; Leichtling, Gillian; Hildebran, Christi; Reilly, Cynthia

2017-11-01

Research is needed to evaluate the impact of prescription drug monitoring programs (PDMPs). This paper describes research priorities for PDMPs that were initially discussed at a 2015 meeting of PDMP administrators, researchers, public health officials, and other stakeholders. Meeting participants defined the current landscape of PDMP research and identified research gaps. Research priorities were grouped by theme. Prescription drug monitoring program research priorities were identified for 3 key areas: individual patient health outcomes, prescriber use and decision making, and population-level outcomes. Research areas for individual patient outcomes include examining drug-use thresholds that best predict risk for overdose or substance use disorder and unintended consequences of PDMP use. Proposed research on prescriber PDMP use include evaluating how enhancements to the content and format of PDMP reports informs clinical decision making and optimal clinician actions in response to a concerning PDMP report. Finally, research topics related to population-level outcomes include measuring the impact of PDMP policies on the incidence of substance misuse and harms and assessing the return on investment for these databases. The clinical, public health, and economic impacts of PDMPs must be evaluated, using both quantitative and qualitative methods. In addition to assessing patient outcomes, qualitative research should examine how clinicians use and interpret PDMP information. Research should also examine the impact of PDMP features and policies on prescriber utilization. Comparative analyses across states with differing PDMP policies should be conducted to inform best practices. Copyright © 2017 John Wiley & Sons, Ltd.

A Novel Use of Computer Simulation in an Applied Pharmacokinetics Course.

ERIC Educational Resources Information Center

Sullivan, Timothy J.

1982-01-01

The use of a package of interactive computer programs designed to simulate pharmacokinetic monitoring of drug therapy in a required undergraduate applied pharmacokinetics course is described. Students were assigned the problem of maintaining therapeutic drug concentrations in a computer generated "patient" as an adjunct to classroom instruction.…

Epidemiology, ecology, and molecular genetics of antimicrobial resistance in pathogenic and commensal bacteria from food animals

USDA-ARS?s Scientific Manuscript database

The National Antimicrobial Resistance Monitoring System (NARMS) is a collaborative program between the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), and the United States Department of Agriculture to prospectively monitor changes in antimicrobial susceptibilities of zoon...

Urine Creatinine Concentrations in Drug Monitoring Participants and Hospitalized Patients.

PubMed

Love, Sara A; Seegmiller, Jesse C; Kloss, Julie; Apple, Fred S

2016-10-01

Urine drug testing is commonly performed in both clinical and forensic arenas for screening, monitoring and compliance purposes. We sought to determine if urine creatinine concentrations in monitoring program participants were significantly different from hospital in-patients and out-patients undergoing urine drug testing. We retrospectively reviewed urine creatinine submitted in June through December 2015 for all specimens undergoing urine drug testing. The 20,479 creatinine results were categorized as hospitalized patients (H) and monitoring/compliance groups for pain management (P), legal (L) or recovery (R). Median creatinine concentrations (interquartile range, mg/dL) were significantly different (P < 0.001) between groups: H 126 (122-136); P 138 (137-143); L 147 (144-154); R 95 (92-97). In the two groups subject to on-demand sampling time pressures, median creatinine concentrations were significantly lower in the R vs. L group (P<0.001). In conclusion, recovery (R) participants have more dilute specimens, reflected by significantly lower creatinine concentration and may indicate participants' attempts to tamper with their drug test results through dilution means. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A web-based quantitative signal detection system on adverse drug reaction in China.

PubMed

Li, Chanjuan; Xia, Jielai; Deng, Jianxiong; Chen, Wenge; Wang, Suzhen; Jiang, Jing; Chen, Guanquan

2009-07-01

To establish a web-based quantitative signal detection system for adverse drug reactions (ADRs) based on spontaneous reporting to the Guangdong province drug-monitoring database in China. Using Microsoft Visual Basic and Active Server Pages programming languages and SQL Server 2000, a web-based system with three software modules was programmed to perform data preparation and association detection, and to generate reports. Information component (IC), the internationally recognized measure of disproportionality for quantitative signal detection, was integrated into the system, and its capacity for signal detection was tested with ADR reports collected from 1 January 2002 to 30 June 2007 in Guangdong. A total of 2,496 associations including known signals were mined from the test database. Signals (e.g., cefradine-induced hematuria) were found early by using the IC analysis. In addition, 291 drug-ADR associations were alerted for the first time in the second quarter of 2007. The system can be used for the detection of significant associations from the Guangdong drug-monitoring database and could be an extremely useful adjunct to the expert assessment of very large numbers of spontaneously reported ADRs for the first time in China.

Web-Based Cognitive Behavioral Relapse Prevention Program With Tailored Feedback for People With Methamphetamine and Other Drug Use Problems: Development and Usability Study.

PubMed

Takano, Ayumi; Miyamoto, Yuki; Kawakami, Norito; Matsumoto, Toshihiko

2016-01-06

Although drug abuse has been a serious public health concern, there have been problems with implementation of treatment for drug users in Japan because of poor accessibility to treatment, concerns about stigma and confidentiality, and costs. Therapeutic interventions using the Internet and computer technologies could improve this situation and provide more feasible and acceptable approaches. The objective of the study was to show how we developed a pilot version of a new Web-based cognitive behavioral relapse prevention program with tailored feedback to assist people with drug problems and assessed its acceptance and usability. We developed the pilot program based on existing face-to-face relapse prevention approaches using an open source Web application to build an e-learning website, including relapse prevention sessions with videos, exercises, a diary function, and self-monitoring. When users submitted exercise answers and their diary, researchers provided them with personalized feedback comments using motivational interviewing skills. People diagnosed with drug dependence were recruited in this pilot study from a psychiatric outpatient ward and nonprofit rehabilitation facilities and usability was evaluated using Internet questionnaires. Overall, website usability was assessed by the Web Usability Scale. The adequacy of procedures in the program, ease of use, helpfulness of content, and adverse effects, for example, drug craving, mental distress, were assessed by original structured questionnaires and descriptive form questions. In total, 10 people participated in the study and completed the baseline assessment, 60% completed all relapse prevention sessions within the expected period. The time needed to complete one session was about 60 minutes and most of the participants took 2 days to complete the session. Overall website usability was good, with reasonable scores on subscales of the Web Usability Scale. The participants felt that the relapse prevention sessions were easy to use and helpful, but that the length of the videos was too long. The participant who until recently used drugs was satisfied with the self-monitoring, but others that had already maintained abstinence for more than a year felt this activity was unhelpful and were bored tracking and recording information on daily drug use. Feedback comments from researchers enhanced participants' motivation and further insight into the disease. Serious adverse effects caused by the intervention were not observed. Some possible improvements to the program were suggested. The Web-based relapse prevention program was easy to use and acceptable to drug users in this study. This program will be helpful for drug users who do not receive behavioral therapy. After the pilot program is revised, further large-scale research is needed to assess its efficacy among drug users who have recently used drugs.

78 FR 9589 - Disclosures To Participate in State Prescription Drug Monitoring Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... patient information in order to implement VA's authority to participate in State Prescription Drug... the Act amended 38 U.S.C. 5701, which governs the confidential nature of VA claims and information of present and former members of the Armed Forces and their dependents in VA's possession, by adding a new...

National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.

PubMed

Butler, Stephen F; Budman, Simon H; Licari, Andrea; Cassidy, Theresa A; Lioy, Katherine; Dickinson, James; Brownstein, John S; Benneyan, James C; Green, Traci Craig; Katz, Nathaniel

2008-12-01

The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. We evaluate population characteristics for data collected through the ASI-MV Connect in 2007 and 2008 and assess the representativeness, geographic coverage, and timeliness of report of the data. Analyses based on 41,923 admissions to 265 treatment centers in 29 states were conducted on product-specific opioid abuse rates, source of drug, and route of administration. ASI-MV Connect data revealed that 11.5% of patients reported abuse of at least one opioid analgesic product in the 30 days prior to entering substance abuse treatment; differences were observed among sub-populations of prescription opioid abusers, among products, and also within various geographic locations. The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs. Copyright (c) 2008 John Wiley & Sons, Ltd.

A modular, prospective, semi-automated drug safety monitoring system for use in a distributed data environment.

PubMed

Gagne, Joshua J; Wang, Shirley V; Rassen, Jeremy A; Schneeweiss, Sebastian

2014-06-01

The aim of this study was to develop and test a semi-automated process for conducting routine active safety monitoring for new drugs in a network of electronic healthcare databases. We built a modular program that semi-automatically performs cohort identification, confounding adjustment, diagnostic checks, aggregation and effect estimation across multiple databases, and application of a sequential alerting algorithm. During beta-testing, we applied the system to five databases to evaluate nine examples emulating prospective monitoring with retrospective data (five pairs for which we expected signals, two negative controls, and two examples for which it was uncertain whether a signal would be expected): cerivastatin versus atorvastatin and rhabdomyolysis; paroxetine versus tricyclic antidepressants and gastrointestinal bleed; lisinopril versus angiotensin receptor blockers and angioedema; ciprofloxacin versus macrolide antibiotics and Achilles tendon rupture; rofecoxib versus non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs) and myocardial infarction; telithromycin versus azithromycin and hepatotoxicity; rosuvastatin versus atorvastatin and diabetes and rhabdomyolysis; and celecoxib versus ns-NSAIDs and myocardial infarction. We describe the program, the necessary inputs, and the assumed data environment. In beta-testing, the system generated four alerts, all among positive control examples (i.e., lisinopril and angioedema; rofecoxib and myocardial infarction; ciprofloxacin and tendon rupture; and cerivastatin and rhabdomyolysis). Sequential effect estimates for each example were consistent in direction and magnitude with existing literature. Beta-testing across nine drug-outcome examples demonstrated the feasibility of the proposed semi-automated prospective monitoring approach. In retrospective assessments, the system identified an increased risk of myocardial infarction with rofecoxib and an increased risk of rhabdomyolysis with cerivastatin years before these drugs were withdrawn from the market. Copyright © 2014 John Wiley & Sons, Ltd.

DUE (drug usage evaluation) of ticarcillin and clavulanate potassium: determining appropriate and cost-effective therapeutic options.

PubMed

Lomaestro, B M; Lesar, T S

1988-11-01

The initial 46 patients who were prescribed the combination drug ticarcillin disodium and clavulanate potassium in a 640-bed teaching hospital were evaluated to determine the potential usefulness of the drug in the institution. The review revealed frequent use of the drug for inappropriate indications and in situations for which less expensive antimicrobials were appropriate. The results demonstrate that an increase in costs can occur when an agent that is being considered for formulary addition--because of its cost-saving potential--is not used as expected. In order to optimally utilize the clinical or cost advantages of newer antimicrobials, a program of prescriber education, drug use controls or guidelines, and a concurrent monitoring program may be required and should be implemented at the time of initial drug use within an institution.

Assessment of the use of oral fluid as a matrix for drug monitoring in patients undergoing treatment for opioid addiction.

PubMed

Kunkel, Frank; Fey, Elizabeth; Borg, Damon; Stripp, Richard; Getto, Christine

2015-01-01

Drug testing is an important clinical tool that is available to physicians who are assessing the effectiveness of drug treatment as well as patient compliance to the administered program. While urine has traditionally been the matrix of choice for drug monitoring, oral fluid, a filtrate of the blood, has shown great promise as an alternative matrix for such applications. Oral fluid collection can be accomplished without the need for highly trained medical staff through the use of a simple, noninvasive oral fluid collection device, which obtains an adequate sample in only a few minutes. There has been a significant amount of research performed on the use of oral fluid for forensic toxicology application; however, more studies assessing the use of oral fluid drug testing are required to validate its ability to achieve clinical drug monitoring goals. Testing for various drugs in oral fluid may yield a different result when compared to the same drugs in urine, requiring an assessment of the utility of oral fluid for such practices. The purpose of this study was to examine the application of oral fluid drug testing in patients undergoing buprenorphine treatment for opioid dependence. A retrospective analysis of drug testing results obtained from 6,928 patients (4,560 unobserved urine collections and 2,368 observed oral fluid collections) monitored for heroin metabolite, amphetamine, benzodiazepines, buprenorphine, tetrahydrocannabinol, cocaine, codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and oxymorphone was completed. Results of this statistical exercise indicated that patients undergoing observed oral fluid collection tested positive more frequently than those unobserved urine collections for several illicit drugs and prescription medications targeted. Oral fluid was shown to detect illicit drug use as well as noncompliance in this patient population under the studied conditions more often than the urine specimens.

77 FR 65938 - Privacy Act of 1974; System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-31

... social security number, to a state prescription drug monitoring program (PDMP), or similar program, for... organizations in connection with the audit of claims or other review activities to determine quality of care or.... VA may disclose relevant information, including but not limited to, patient name, address, and social...

A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras

PubMed Central

Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

2014-01-01

Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt “CVMNK” genotype in codons 72-76. PMID:25075788

A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras.

PubMed

Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

2014-07-01

Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt "CVMNK" genotype in codons 72-76.

Perceptions of practicing pharmacists in Idaho about a potential behind-the-counter drug program.

PubMed

Hunt, Timothy L; Culbertson, Vaughn L; Erramouspe, John; Casperson, Kerry

2010-09-01

In late 2007, the Food and Drug Administration (FDA) held public hearings exploring the establishment of a new behind-the-counter (BTC) drug program. However, little is known about the views of pharmacists regarding such a program. To assess the overall perceptions of Idaho's practicing pharmacists about the creation of a formal BTC drug program, the appropriateness of including certain drug categories, specific barriers to its adoption, and the impact of the new program on access to medicines. A survey of practicing pharmacists in Idaho was conducted by mail, utilizing anonymous responses. Key questions exploring the views of pharmacists about the new BTC drug program utilized 5-point Likert scales. Data were also collected on respondent characteristics. A total of 357 practicing pharmacists in Idaho (31% response rate) returned the mail survey; 84% of pharmacists agreed that the FDA should be exploring an expanded BTC program, and 88% of pharmacists agreed that this program would improve access to some prescription-only products and convenience for patients. Almost 71% of pharmacists reported a personal willingness to both initiate and monitor certain BTC drug therapies. When focusing on specific drug categories for BTC status, the highest support was for selected agents within smoking cessation therapies (85%), nasal corticosteroids for allergies (81%), and vaccines (75%). Pharmacists who reported low barriers to the adoption of a new BTC program were significantly more likely to support this program than were those reporting high barriers. Only 39% of pharmacists agreed that adequate facilities were currently available for private evaluation and counseling of BTC patients. Pharmacists in a statewide survey of perceptions regarding a new BTC drug program overwhelmingly believe that patients would benefit. Pharmacists strongly support the development of the new program, and more than two thirds indicate that they would likely participate, given the necessary supporting institutional framework. Perceived barriers are related to willingness to participate and likely can be minimized through education and provision of private consulting areas.

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

PubMed Central

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

2006-01-01

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

Club Drugs -- Facts and Figures

MedlinePlus

... Programs Bureau of Justice Assistance Bureau of Justice Statistics National Institute of Justice Office for Victims of Crime Office of Juvenile Justice and Delinquency Prevention Office of Sex Offender Sentencing, Monitoring, Apprehending, ...

Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

PubMed

Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

2015-01-01

Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

Drugs and American High School Students 1975-1983. Highlights.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

This report is the seventh in an annual series reporting the drug use and related attitudes of America's high school seniors; the findings come from an ongoing national research and reporting program, "Monitoring the Future: A Continuing Study of Lifestyles and Values of Youth," also known as the High School Senior Survey. Data on two major topics…

Heroin Use among Southern Arrestees: Regional Findings from the Arrestee Drug Abuse Monitoring Program.

ERIC Educational Resources Information Center

Peters, Ronald J., Jr.; Yacoubian, George S., Jr.; Baumler, Elizabeth R.; Ross, Michael W.; Johnson, Regina J.

2002-01-01

To be effective with rehabilitation counseling, counselors need to be aware of cultural patterns of drug use. This study analyzed trends in heroin use between 1990 and 1997 among the arrestee population in some parts of the South. Findings suggest geographic, ethnic, and age-related variables for heroin use. (JDM)

Highlights from Drugs and the Class of '78: Behaviors, Attitudes, and Recent National Trends.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

The current prevalence of drug use among American high school seniors (classes of 1975 through 1978) was investigated through a program entitled "Monitoring the Future: A Continuing Study of the Lifestyles and Values of Youth," conducted by the University of Michigan's Institute for Social Research and funded by the National Institute on Drug…

Antiretroviral treatment sequencing strategies to overcome HIV type 1 drug resistance in adolescents and adults in low-middle-income countries.

PubMed

De Luca, Andrea; Hamers, Raphael L; Schapiro, Jonathan M

2013-06-15

Antiretroviral treatment (ART) is expanding to human immunodeficiency virus type 1 (HIV-1)-infected persons in low-middle income countries, thanks to a public health approach. With 3 available drug classes, 2 ART sequencing lines are programmatically foreseen. The emergence and transmission of viral drug resistance represents a challenge to the efficacy of ART. Knowledge of HIV-1 drug resistance selection associated with specific drugs and regimens and the consequent activity of residual drug options are essential in programming ART sequencing options aimed at preserving ART efficacy for as long as possible. This article determines optimal ART sequencing options for overcoming HIV-1 drug resistance in resource-limited settings, using currently available drugs and treatment monitoring opportunities. From the perspective of drug resistance and on the basis of limited virologic monitoring data, optimal sequencing seems to involve use of a tenofovir-containing nonnucleoside reverse-transcriptase inhibitor-based first-line regimen, followed by a zidovudine-containing, protease inhibitor (PI)-based second-line regimen. Other options and their consequences are explored by considering within-class and between-class sequencing opportunities, including boosted PI monotherapies and future options with integrase inhibitors. Nucleoside reverse-transcriptase inhibitor resistance pathways in HIV-1 subtype C suggest an additional reason for accelerating stavudine phase out. Viral load monitoring avoids the accumulation of resistance mutations that significantly reduce the activity of next-line options. Rational use of resources, including broader access to viral load monitoring, will help ensure 3 lines of fully active treatment options, thereby increasing the duration of ART success.

Surveillance of drug use among young people attending a music festival in Australia, 2005-2008.

PubMed

Lim, Megan S C; Hellard, Margaret E; Hocking, Jane S; Spelman, Tim D; Aitken, Campbell K

2010-03-01

In order to monitor trends in illicit drug use among youth, surveillance of drug use behaviours among a variety of populations in different settings is required. We monitored drug use among music festival attendees. Cross-sectional studies of young people's reported drug use were performed at a music festival in Melbourne from 2005 to 2008. Self-administered questionnaires collected information on drug use, demographics and other risk behaviour. From 2005 to 2008, over 5000 questionnaires were completed by people aged 16-29; 2273 men and 3011 women. Overall, use of any illicit drug in the past month was reported by 44%. After adjusting for demographic and behavioural characteristics, the prevalence of recent illicit drug use decreased significantly from 46% in 2005 to 43% in 2008 (OR 0.92, 95% CI 0.87-0.97). After adjusting for age and sex the downwards trend was repeated for amphetamines and cannabis, but a significant increase in prevalence was observed in hallucinogen, ecstasy and inhalant use. Drug use was more common among men, older participants and those engaging in high-risk sexual behaviour. Illicit drug use was much more common in this sample than in the National Drug Strategy Household survey, but the direction of trends in drug use were similar; drug use prevalences were much lower than in the Ecstasy and Related Drugs Reporting System, the Illicit Drug Reporting System or National Needle and Syringe Program Survey. Music festival attendees are a potentially useful group for monitoring trends in illicit drug use.

Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

PubMed

Sheth, Neha

2009-01-01

Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.

Phenelzine as a stimulant drug antagonist: a preliminary report.

PubMed

Maletzky, B M

1977-08-01

Phenelzine administration, monitored via a pharmacy-controlled program, was employed in 38 subjects over a 6-month period to prevent amphetamine-type drug abuse, in much the same manner as disulfiram programs are employed against alcohol abuse. Advantages of the program were apparent, with a majority of subjects abstaining during the enforced phenelzine trial. Subjects generally made use of this abstinent period to benefit from a variety of psychotherapeutic modes, and demonstrated enhanced job and school performance and improved marital relationships. Results based on subject and observer reports, reports from dispensing pharmacies, and random urinalyses for drugs were encouraging. However, the study was uncontrolled and observational, and thus results are merely suggestive at present. Potential dangers as well as benefits of administering phenelzine to such a population are discussed.

Doctor and pharmacy shopping for controlled substances.

PubMed

Peirce, Gretchen L; Smith, Michael J; Abate, Marie A; Halverson, Joel

2012-06-01

Prescription drug abuse is a major health concern nationwide, with West Virginia having one of the highest prescription drug death rates in the United States. Studies are lacking that compare living subjects with persons who died from drug overdose for evidence of doctor and pharmacy shopping for controlled substances. The study objectives were to compare deceased and living subjects in West Virginia for evidence of prior doctor and pharmacy shopping for controlled substances and to identify factors associated with drug-related death. A secondary data study was conducted using controlled substance, Schedule II-IV, prescription data from the West Virginia Controlled Substance Monitoring Program and drug-related death data compiled by the Forensic Drug Database between July 2005 and December 2007. A case-control design compared deceased subjects 18 years and older whose death was drug related with living subjects for prior doctor and pharmacy shopping. Logistic regression identified factors related to the odds of drug-related death. A significantly greater proportion of deceased subjects were doctor shoppers (25.21% vs. 3.58%) and pharmacy shoppers (17.48% vs. 1.30%) than living subjects. Approximately 20.23% of doctor shoppers were also pharmacy shoppers, and 55.60% of pharmacy shoppers were doctor shoppers. Younger age, greater number of prescriptions dispensed, exposure to opioids and benzodiazepines, and doctor and pharmacy shopping were factors with greater odds of drug-related death. Doctor and pharmacy shopping involving controlled substances were identified, and shopping behavior was associated with drug-related death. Prescription monitoring programs may be useful in identifying potential shoppers at the point of care.

A protocol to evaluate drug-related workplace impairment.

PubMed

Reisfield, Gary M; Shults, Theodore; Demery, Jason; Dupont, Robert

2013-03-01

The dramatic increase in the use and abuse of prescription controlled substances, cannabis, and a rapidly evolving array of legal and illegal psychotropic drugs has led to a growing concern by employers about workplace impairment, incidents, and accidents. The Federal Workplace Drug Testing Programs, which serve as a template for most private sector programs, focus on a small group of illicit drugs, but disregard the wider spectrum of legal and illegal psychotropic drugs and prescription controlled substances. We propose a protocol for the evaluation of workplace impairment, based on comprehensive drug and alcohol testing at the time of suspected impairment, followed expeditiously by a comprehensive physician evaluation, including a focused medical history with an emphasis on controlled substance use, physical and mental status examinations, evaluation of employee adherence to prescription medication instructions, additional drug testing if indicated, use of collateral sources of information, and querying of state prescription monitoring databases. Finally, we propose suggestions for optimizing the evaluation of drug-related workplace impairment.

78 FR 38055 - Building Research Capacity in Global Tobacco Product Regulation Program (U18)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-25

... Monitoring Database. Examples of Global Tobacco Research Reports/White Papers: [cir] WHO report on the global...] Building Research Capacity in Global Tobacco Product Regulation Program (U18) AGENCY: Food and Drug... availability of grant funds for the support of the Center for Tobacco Product's (CTP's) Building Research...

Raising suspicions with the Food and Drug Administration: detecting misconduct.

PubMed

Hamrell, Michael R

2010-12-01

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

Randomized clinical trial to change parental practices for drug use in a telehealth prevention program: a pilot study.

PubMed

Valente, Juliana Y; Moreira, Tais Campos; Ferigolo, Maristela; Barros, Helena M T

2018-03-21

Programs for parents have been found to have a direct positive impact on reducing the consumption of psychoactive substances by adolescents, as well as having an indirect impact on reducing risk factors and increasing protective factors. The present study aimed to verify if a telehealth prevention program based on a brief motivational intervention helps to reduce parental risk practices and increase parental protective practices for drug use in comparison with psychoeducation. A pilot randomized controlled trial was performed at the National Service of Guidance and Information on Drug Use (Ligue 132), from September 2014 to December 2015, with the parents of adolescents (n=26). The outcome measures were parental style, risk, and protective parental practices. The brief motivational intervention was found to be more effective than psychoeducation in reducing the negligent behavior of parents. Furthermore, when comparing pre- and post-intervention data, the brief motivational intervention helped to change parental style and the large majority of parental practices: increasing positive monitoring, as well as decreasing physical abuse, relaxed discipline, inconsistent punishment, and negative monitoring. These results demonstrate that the telehealth intervention is effective in modifying the parental practices known to help in preventing drug use. Studies with more number of subjects are required so that the results can be substantiated and generalized. Copyright © 2018 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Student Drug Use, Attitudes, and Beliefs: National Trends 1975-1982.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

This report presents findings from the national research and reporting program, Monitoring the Future: A Continuing Study of the Lifestyle and Values of Youth, and is the sixth in an annual series reporting the drug use and related attitudes of high school seniors; the report covers the high school classes of 1975-1982. Two of the major topics…

Who Uses a Prescription Drug Monitoring Program and How? Insights from a Statewide Survey of Oregon Clinicians

PubMed Central

Irvine, Jessica M.; Hallvik, Sara E.; Hildebran, Christi; Marino, Miguel; Beran, Todd; Deyo, Richard A.

2014-01-01

Prescription drug monitoring programs (PDMP) are relatively new but potentially useful tools to enhance prudent prescribing of controlled substances. However, little is known about the types of clinicians who make most use of PDMPs, how they are incorporated into workflow, or how clinicians and patients respond to the information. We therefore surveyed a random sample of Oregon providers, with 1065 respondents. Clinicians in emergency medicine, primary care, and pain and addiction specialties were the largest number of registrants but many frequent prescribers of controlled substances were not registered to use the PDMP. Among users, 95% reported accessing the PDMP when they suspected a patient of abuse or diversion, but fewer than half would check it for every new patient or every time they prescribe a controlled drug. Nearly all PDMP users reported that they discuss worrisome PDMP data with patients; 54% reported making mental health or substance abuse referrals, and 36% reported sometimes discharging patients from the practice. Clinicians reported frequent patient denial or anger, and only occasional requests for help with drug dependence. More research is needed to optimize how clinicians use PDMPs across settings, and how clinicians and patients respond to the data. PMID:24787089

[Drug-drug interactions: interactions between xenobiotics].

PubMed

Haen, E

2014-04-01

Drug-drug interactions (DDI) are a major topic in programs for continuous medical education (CME). Many physicians are afraid of being trapped into charges of malpractice; however, DDI cannot be avoided in many cases. They belong to routine medical practice and it is often impossible to avoid them. Moreover, they do not just occur between drugs but between any kind of foreign substance (xenobiotica), such as food (e.g. grapefruit juice, broccoli, barbecue) as well as legal (e.g. tobacco smoke, caffeine and alcohol) and illegal drugs. Therefore, the medical challenge is not just to avoid any interaction. Instead the physician faces the question of how to proceed with drug treatment in the presence of such interactions. Based on the medical education a physician has to judge first of all whether there is a risk for interactions in the prescription being planned for an individual patient. The classification of interactions proposed in this article (PD1-PD4, PK1-PK3) might help as a sort of check list. For more detailed information the physician can then consult one of the many databases available on the internet, such as PSIAConline (http://www.psiac.de) and MediQ (http://www.mediq.ch). Pharmacokinetic interactions can be easily assessed, monitored and controlled by therapeutic drug monitoring (TDM). Besides these tools it is important to keep in mind that nobody knows everything; even physicians do not know everything. So take pride in asking someone who might help and for this purpose AGATE offers a drug information service AID (http://www.amuep-agate.de). Just good for nothing, without being based on any kind of medical approach are computer programs that judge prescriptions without taking into account a patient's individual peculiarities. In case these types of programs produce red exclamation marks or traffic lights to underline their judgment, they might even work in a contrapuntal way by just eliciting insecurity and fear.

Drug-usage evaluation and the patient-care pharmacist: a synergistic combination.

PubMed

Gayman, J; Tapley, D J

1991-07-01

The Joint Commission requires a continuous monitoring program to assure quality pharmaceutical care. The only way to achieve compliance with this standard is to enlist the help of the patient-care pharmacists. Equally important to the pharmacy manager is the way a DUE program can benefit the patient-care pharmacists. The key to an effective program is to assist the patient-care pharmacists in taking responsibility for the quality of drug therapy provided to their patients. Through education, encouragement, and recognition, the DUE Coordinator can elevate the practice of the patient-care pharmacists. The outcome is a synergistic program that enriches the practice of the patient-care pharmacists who, in turn, enrich the quality of pharmaceutical care received by their patients.

HIV Infection and HIV-Associated Behaviors Among Persons Who Inject Drugs - 20 Cities, United States, 2015.

PubMed

Burnett, Janet C; Broz, Dita; Spiller, Michael W; Wejnert, Cyprian; Paz-Bailey, Gabriela

2018-01-12

In the United States, 9% of human immunodeficiency virus (HIV) infections diagnosed in 2015 were attributed to injection drug use (1). In 2015, 79% of diagnoses of HIV infection among persons who inject drugs occurred in urban areas (2). To monitor the prevalence of HIV infection and associated behaviors among persons who inject drugs, CDC's National HIV Behavioral Surveillance (NHBS) conducts interviews and HIV testing in selected metropolitan statistical areas (MSAs) (3). The prevalence of HIV infection among persons who inject drugs in 20 MSAs in 2015 was 7%. In a behavioral analysis of HIV-negative persons who inject drugs, an estimated 27% receptively shared syringes and 67% had condomless vaginal sex in the previous 12 months. During the same period, 58% had tested for HIV infection and 52% received syringes from a syringe services program. Given the increased number of persons newly injecting drugs who are at risk for HIV infection because of the recent opioid epidemic (2,4), these findings underscore the importance of continuing and expanding health services, HIV prevention programs, and community-based strategies, such as those provided by syringe services programs, for this population.

Targeting α-synuclein oligomers by protein-fragment complementation for drug discovery in synucleinopathies.

PubMed

Moussaud, Simon; Malany, Siobhan; Mehta, Alka; Vasile, Stefan; Smith, Layton H; McLean, Pamela J

2015-05-01

Reducing the burden of α-synuclein oligomeric species represents a promising approach for disease-modifying therapies against synucleinopathies such as Parkinson's disease and dementia with Lewy bodies. However, the lack of efficient drug discovery strategies that specifically target α-synuclein oligomers has been a limitation to drug discovery programs. Here we describe an innovative strategy that harnesses the power of bimolecular protein-fragment complementation to monitor synuclein-synuclein interactions. We have developed two robust models to monitor α-synuclein oligomerization by generating novel stable cell lines expressing α-synuclein fusion proteins for either fluorescent or bioluminescent protein-fragment complementation under the tetracycline-controlled transcriptional activation system. A pilot screen was performed resulting in the identification of two potential hits, a p38 MAPK inhibitor and a casein kinase 2 inhibitor, thereby demonstrating the suitability of our protein-fragment complementation assay for the measurement of α-synuclein oligomerization in living cells at high throughput. The application of the strategy described herein to monitor α-synuclein oligomer formation in living cells with high throughput will facilitate drug discovery efforts for disease-modifying therapies against synucleinopathies and other proteinopathies.

Adolescent Ecstasy and other drug use in the National Survey of Parents and Youth: the role of sensation-seeking, parental monitoring and peer’s drug use

PubMed Central

Martins, Silvia S.; Storr, Carla L.; Alexandre, Pierre K.; Chilcoat, Howard D.

2008-01-01

The association between high sensation-seeking, close friends’ drug use and low parental monitoring with Ecstasy (MDMA) use in adolescence was examined in a sample of US household-dwelling adolescents aged 12–18 years (N=5,049). We also tested whether associations were of stronger magnitude than associations between these correlates and marijuana or alcohol/tobacco use in adolescence. Data from Round 2 of the National Survey of Parents and Youth (NSPY) Restricted Use Files (RUF) was analyzed via Jackknife weighted multinomial logistic regression models. High sensation-seekers were more likely to be ecstasy, marijuana, and alcohol/tobacco users, respectively, as compared to low sensation-seekers. High sensation-seeking and close friends’ drug use were more strongly associated with ecstasy as compared to marijuana and alcohol/tobacco use. Low parental monitoring was associated with marijuana use and alcohol/tobacco use and there was a trend for it to be associated with ecstasy use. Ecstasy use is strongly associated with peer drug use and more modestly associated with high sensation-seeking. School prevention programs should target high-sensation-seeking adolescents and also encourage them to affiliate with non-drug using peers. PMID:18355973

An analysis of moderate sedation protocols used in dental specialty programs: a retrospective observational study.

PubMed

Setty, Madhavi; Montagnese, Thomas A; Baur, Dale; Aminoshariae, Anita; Mickel, Andre

2014-09-01

Pain and anxiety control is critical in dental practice. Moderate sedation is a useful adjunct in managing a variety of conditions that make it difficult or impossible for some people to undergo certain dental procedures. The purpose of this study was to analyze the sedation protocols used in 3 dental specialty programs at the Case Western Reserve University School of Dental Medicine, Cleveland, OH. A retrospective analysis was performed using dental school records of patients receiving moderate sedation in the graduate endodontic, periodontic, and oral surgery programs from January 1, 2010, to December 31, 2012. Information was gathered and the data compiled regarding the reasons for sedation, age, sex, pertinent medical conditions, American Society of Anesthesiologists physical status classifications, routes of administration, drugs, dosages, failures, complications, and other information that was recorded. The reasons for the use of moderate sedation were anxiety (54%), local anesthesia failures (15%), fear of needles (15%), severe gag reflex (8%), and claustrophobia with the rubber dam (8%). The most common medical conditions were hypertension (17%), asthma (15%), and bipolar disorder (8%). Most patients were classified as American Society of Anesthesiologists class II. More women (63.1%) were treated than men (36.9%). The mean age was 45 years. Monitoring and drugs varied among the programs. The most common tooth treated in the endodontic program was the mandibular molar. There are differences in the moderate sedation protocols used in the endodontic, periodontic, and oral surgery programs regarding monitoring, drugs used, and record keeping. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The use of a prescription drug monitoring program to develop algorithms to identify providers with unusual prescribing practices for controlled substances.

PubMed

Ringwalt, Christopher; Schiro, Sharon; Shanahan, Meghan; Proescholdbell, Scott; Meder, Harold; Austin, Anna; Sachdeva, Nidhi

2015-10-01

The misuse, abuse and diversion of controlled substances have reached epidemic proportion in the United States. Contributing to this problem are providers who over-prescribe these substances. Using one state's prescription drug monitoring program, we describe a series of metrics we developed to identify providers manifesting unusual and uncustomary prescribing practices. We then present the results of a preliminary effort to assess the concurrent validity of these algorithms, using death records from the state's vital records database pertaining to providers who wrote prescriptions to patients who then died of a medication or drug overdose within 30 days. Metrics manifesting the strongest concurrent validity with providers identified from these records related to those who co-prescribed benzodiazepines (e.g., valium) and high levels of opioid analgesics (e.g., oxycodone), as well as those who wrote temporally overlapping prescriptions. We conclude with a discussion of a variety of uses to which these metrics may be put, as well as problems and opportunities related to their use.

Development and validation of a streamlined method designed to detech residues of 62 veterinary drugs in bovine kidney using ultrahigh performance liquid chromatography - tandem mass spectrometry

USDA-ARS?s Scientific Manuscript database

In the USA, the US Department of Agriculture’s Food Safety Inspection Service (FSIS) conducts the National Residue Program designed to monitor veterinary drug and other chemical residues in beef and other slaughtered food animals. Currently, FSIS uses a 7-plate bioassay in the laboratory to screen f...

Simultaneous analysis of aminoglycosides with many other classes of drug residues in bovine tissues by ultrahigh-performance liquid chromatography-tandem mass spectrometry using an ion-pairing reagent added to final extracts.

PubMed

Lehotay, Steven J; Lightfield, Alan R

2018-01-01

The way to maximize scope of analysis, sample throughput, and laboratory efficiency in the monitoring of veterinary drug residues in food animals is to determine as many analytes as possible as fast as possible in as few methods as possible. Capital and overhead expenses are also reduced by using fewer instruments in the overall monitoring scheme. Traditionally, the highly polar aminoglycoside antibiotics require different chromatographic conditions from other classes of drugs, but in this work, we demonstrate that an ion-pairing reagent (sodium 1-heptanesulfonate) added to the combined final extracts from two sample preparation methods attains good separation of 174 targeted drugs, including 9 aminoglycosides, in the same 10.5-min ultrahigh-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) analysis. The full method was validated in bovine kidney, liver, and muscle tissues according to US regulatory protocols, and 137-146 (79-84%) of the drugs gave between 70 and 120% average recoveries with ≤ 25% RSDs in the different types of tissues spiked at 0.5, 1, and 2 times the regulatory levels of interest (10-1000 ng/g depending on the drug). This method increases sample throughput and the possible number of drugs monitored in the US National Residue Program, and requires only one UHPLC-MS/MS method and instrument for analysis rather than two by the previous scheme. Graphical abstract Outline of the streamlined approach to monitor 174 veterinary drugs, including aminoglycosides, in bovine tissues by combining two extracts of the same sample with an ion-pairing reagent for analysis by UHPLC-MS/MS.

Application of artificial intelligence to pharmacy and medicine.

PubMed

Dasta, J F

1992-04-01

Artificial intelligence (AI) is a branch of computer science dealing with solving problems using symbolic programming. It has evolved into a problem solving science with applications in business, engineering, and health care. One application of AI is expert system development. An expert system consists of a knowledge base and inference engine, coupled with a user interface. A crucial aspect of expert system development is knowledge acquisition and implementing computable ways to solve problems. There have been several expert systems developed in medicine to assist physicians with medical diagnosis. Recently, several programs focusing on drug therapy have been described. They provide guidance on drug interactions, drug therapy monitoring, and drug formulary selection. There are many aspects of pharmacy that AI can have an impact on and the reader is challenged to consider these possibilities because they may some day become a reality in pharmacy.

What predicts retention on an in-prison drug treatment program?

PubMed

Casares-López, María José; González-Menéndez, Ana; Fernández, Paula; Secades-Villa, Roberto; Fernández-Hermida, José Ramón

2012-11-01

The effectiveness of treatments for substance use disorders is strongly related to retention, since early dropout from treatment is associated with greater likelihood of relapse. The purpose of this prospective, ex post facto study is to analyze the effect of individual variables on retention in a treatment program carried out in a prison drug-free unit. The Addiction Severity Index, motivation and personality profile of fifty inmates were assessed on entry to the prison. Inmates were monitored for a year to identify length of stay. Motivation variables at intake play a vital role in the prediction of retention in a prison drug-free unit; scores on the Aggressive-Sadistic and Narcissistic scales are also strong predictors of treatment retention.

48 CFR 1523.7000 - Background.

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient... purchase only microcomputers, including personal computers, monitors and printers, which meet “EPA Energy Star” requirements for energy efficiency. This equipment is often identified by the Energy StarTM logo...

48 CFR 1523.7000 - Background.

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient... purchase only microcomputers, including personal computers, monitors and printers, which meet “EPA Energy Star” requirements for energy efficiency. This equipment is often identified by the Energy StarTM logo...

48 CFR 1523.7000 - Background.

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROGRAMS ENVIRONMENTAL, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy-Efficient... purchase only microcomputers, including personal computers, monitors and printers, which meet “EPA Energy Star” requirements for energy efficiency. This equipment is often identified by the Energy StarTM logo...

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

Prenatal care and counseling of female drug-abusers: effects on drug abuse and perinatal outcome.

PubMed

Kukko, H; Halmesmäki, E

1999-01-01

To evaluate the efficacy of a specific counseling and withdrawal program for drug-abusing pregnant women and its effect on perinatal outcome. An analysis of 120 pregnancies followed in 111 drug-abusing women giving birth at the Department of Obstetrics and Gynecology, Helsinki University Central Hospital, in 1985-95. Personnel responsible for local maternity care in the Helsinki area were trained to identify pregnant drug-abusers and to refer them to our hospital for clinical antenatal care and counseling with psychological and social support. Substance abuse during pregnancy was monitored by self-report and serial urine screenings. Obstetric and perinatal outcome were compared between those who succeeded in quitting totally or reducing drug use, and those who continued their drug use throughout pregnancy. The significance of the differences was tested by Student's unpaired t-test and binomial t-test. Of the women, 62% registered before the 20th week of pregnancy and 32% during the 20th-29th week of pregnancy (mean 18.4+/-6.6 weeks). Twelve women were admitted to an obstetric ward for withdrawal. In 73 of the 120 (61%) pregnancies the woman succeeded either in quitting totally or reducing drug abuse. Among this group, incidence of preterm birth (4.1%) was smaller (p<0.001), and gestational age (39.8+/-2.2 weeks) and birth weight (3393+/-605 gr) higher (p<0.05) than those (19.6%, 38.3+/-3.4 wk and 3049+/-728 gr, respectively) in the group continuing their drug abuse. Additionally, the percentage of normal delivery (80.8%) was higher (p<0.05), and incidence of withdrawal symptoms (19.2%), lower (p<0.001) than for those who continued drug abuse (65.2% and 47.8%, respectively). Carefully monitored counseling program for pregnant drug abusers is effective in reducing the amount of drugs used and improves perinatal outcome.

Prescription Monitoring Program Trends Among Individuals Arrested in Maine for Trafficking Prescription Drugs in 2014.

PubMed

McCall, Kenneth; Nichols, Stephanie D; Holt, Christina; Ochs, Leslie; Cattabriga, Gary; Tu, Chunhao

2016-06-01

To evaluate controlled substance prescribing trends available in the Maine Prescription Monitoring Program (PMP) among individuals arrested for prescription drug "trafficking." The demographic characteristics of the individuals who had matching prescription records in the PMP within 90 days of the arrest were identified. A population-based, retrospective cohort study using data from the Maine Diversion Alert Program (DAP) and the Maine PMP. The study population consisted of persons arrested for trafficking prescription drugs in Maine during the 2014 calendar year from January 1 to December 31. There were 594 trafficking arrests reported by the Maine DAP in 2014. The study population consisted of the 235 persons (40%) with arrests involving controlled prescription medications. The mean age of these persons was 33 years (range 18-77 yrs), and 156 (66%) were male. Arrests involved 154 prescription opioids (65%), seven stimulants (3%), seven benzodiazepines (3%), and 77 unspecified controlled prescription drugs (33%). A minority of individuals (n=57, 24%) had a prescription record in the PMP that matched the substance involved in the arrest. Only one person with matching PMP and arrest records utilized ≥ 5 prescribers, while none used ≥ 5 pharmacies within 90 days before the arrest. Payment methods for matching prescriptions were commercial insurance (n=28, 49%), Medicaid (n=19, 33%), Medicare (n=5, 9%), and cash (n=5, 9%). The majority (76%) of persons arrested for prescription drug trafficking did not have PMP records and did not directly obtain the diverted medication from a licensed pharmacy. Traditional red flags, like cash payment and using multiple prescribers or pharmacies, were uncommon. Therefore, arrest records for diversion and PMPs are distinct and complementary tools for identifying individuals at risk for substance misuse. © 2016 Pharmacotherapy Publications, Inc.

HIV Drug Resistance Early Warning Indicators in Namibia for Public Health Action

PubMed Central

Jonas, Anna; Gweshe, Justice; Siboleka, Milner; DeKlerk, Michael; Gawanab, Michael; Badi, Alfons; Sumbi, Victor; Pereko, Dawn; Blom, Abraham; Mwinga, Samson; Jordan, Michael R.; Jerger, Logan; Lau, Kiger; Hong, Steven Y.

2013-01-01

Background HIV drug resistance (HIVDR) testing is not routinely available in many resource-limited settings, therefore antiretroviral therapy (ART) program and site factors known to be associated with emergence of HIVDR should be monitored to optimize the quality of patient care and minimize the emergence of preventable HIVDR. Methods In 2010, Namibia selected five World Health Organization Early Warning Indicators (EWIs) and scaled-up monitoring from 9 to 33 ART sites: ART prescribing practices, Patients lost to follow-up (LTFU) at 12 months, Patients switched to a second-line regimen at 12 months, On-time antiretroviral (ARV) drug pick-up, and ARV drug-supply continuity. Results Records allowed reporting on three of the five selected EWIs. 22 of 33 (67%) sites met the target of 100% initiated on appropriate first-line regimens. 17 of 33 (52%) sites met the target of ≤20% LTFU. 15 of 33 (45%) sites met the target of 0% switched to a second-line regimen. Conclusions EWI monitoring directly resulted in public health action which will optimize the quality of care, specifically the strengthening of ART record systems, engagement of ART sites, and operational research for improved adherence assessment and ART patient defaulter tracing. PMID:23762406

National Antimicrobial Resistance Monitoring System: Two Decades of Advancing Public Health Through Integrated Surveillance of Antimicrobial Resistance.

PubMed

Karp, Beth E; Tate, Heather; Plumblee, Jodie R; Dessai, Uday; Whichard, Jean M; Thacker, Eileen L; Hale, Kis Robertson; Wilson, Wanda; Friedman, Cindy R; Griffin, Patricia M; McDermott, Patrick F

2017-10-01

Drug-resistant bacterial infections pose a serious and growing public health threat globally. In this review, we describe the role of the National Antimicrobial Resistance Monitoring System (NARMS) in providing data that help address the resistance problem and show how such a program can have broad positive impacts on public health. NARMS was formed two decades ago to help assess the consequences to human health arising from the use of antimicrobial drugs in food animal production in the United States. A collaboration among the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the United States Department of Agriculture, and state and local health departments, NARMS uses an integrated "One Health" approach to monitor antimicrobial resistance in enteric bacteria from humans, retail meat, and food animals. NARMS has adapted to changing needs and threats by expanding surveillance catchment areas, examining new isolate sources, adding bacteria, adjusting sampling schemes, and modifying antimicrobial agents tested. NARMS data are not only essential for ensuring that antimicrobial drugs approved for food animals are used in ways that are safe for human health but they also help address broader food safety priorities. NARMS surveillance, applied research studies, and outbreak isolate testing provide data on the emergence of drug-resistant enteric bacteria; genetic mechanisms underlying resistance; movement of bacterial populations among humans, food, and food animals; and sources and outcomes of resistant and susceptible infections. These data can be used to guide and evaluate the impact of science-based policies, regulatory actions, antimicrobial stewardship initiatives, and other public health efforts aimed at preserving drug effectiveness, improving patient outcomes, and preventing infections. Many improvements have been made to NARMS over time and the program will continue to adapt to address emerging resistance threats, changes in clinical diagnostic practices, and new technologies, such as whole genome sequencing.

National Antimicrobial Resistance Monitoring System: Two Decades of Advancing Public Health Through Integrated Surveillance of Antimicrobial Resistance

PubMed Central

Tate, Heather; Plumblee, Jodie R.; Dessai, Uday; Whichard, Jean M.; Thacker, Eileen L.; Hale, Kis Robertson; Wilson, Wanda; Friedman, Cindy R.; Griffin, Patricia M.; McDermott, Patrick F.

2017-01-01

Abstract Drug-resistant bacterial infections pose a serious and growing public health threat globally. In this review, we describe the role of the National Antimicrobial Resistance Monitoring System (NARMS) in providing data that help address the resistance problem and show how such a program can have broad positive impacts on public health. NARMS was formed two decades ago to help assess the consequences to human health arising from the use of antimicrobial drugs in food animal production in the United States. A collaboration among the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the United States Department of Agriculture, and state and local health departments, NARMS uses an integrated “One Health” approach to monitor antimicrobial resistance in enteric bacteria from humans, retail meat, and food animals. NARMS has adapted to changing needs and threats by expanding surveillance catchment areas, examining new isolate sources, adding bacteria, adjusting sampling schemes, and modifying antimicrobial agents tested. NARMS data are not only essential for ensuring that antimicrobial drugs approved for food animals are used in ways that are safe for human health but they also help address broader food safety priorities. NARMS surveillance, applied research studies, and outbreak isolate testing provide data on the emergence of drug-resistant enteric bacteria; genetic mechanisms underlying resistance; movement of bacterial populations among humans, food, and food animals; and sources and outcomes of resistant and susceptible infections. These data can be used to guide and evaluate the impact of science-based policies, regulatory actions, antimicrobial stewardship initiatives, and other public health efforts aimed at preserving drug effectiveness, improving patient outcomes, and preventing infections. Many improvements have been made to NARMS over time and the program will continue to adapt to address emerging resistance threats, changes in clinical diagnostic practices, and new technologies, such as whole genome sequencing. PMID:28792800

A Study on Drug Safety Monitoring Program in India

PubMed Central

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

2014-01-01

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

A study on drug safety monitoring program in India.

PubMed

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

2014-09-01

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

The Potential Role of Oral Fluid in Antidoping Testing

PubMed Central

Anizan, Sebastien; Huestis, Marilyn A.

2015-01-01

BACKGROUND Currently, urine and blood are the only matrices authorized for antidoping testing by the World Anti-Doping Agency (WADA). Although the usefulness of urine and blood is proven, issues remain for monitoring some drug classes and for drugs prohibited only in competition. The alternative matrix oral fluid (OF) may offer solutions to some of these issues. OF collection is easy, noninvasive, and sex neutral and is directly observed, limiting potential adulteration, a major problem for urine testing. OF is used to monitor drug intake in workplace, clinical toxicology, criminal justice, and driving under the influence of drugs programs and potentially could complement urine and blood for antidoping testing in sports. CONTENT This review outlines the present state of knowledge and the advantages and limitations of OF testing for each of the WADA drug classes and the research needed to advance OF testing as a viable alternative for antidoping testing. SUMMARY Doping agents are either prohibited at all times or prohibited in competition only. Few OF data from controlled drug administration studies are available for substances banned at all times, whereas for some agents prohibited only in competition, sufficient data may be available to suggest appropriate analytes and cutoffs (analytical threshold concentrations) to identify recent drug use. Additional research is needed to characterize the disposition of many banned substances into OF; OF collection methods and doping agent stability in OF also require investigation to allow the accurate interpretation of OF tests for antidoping monitoring. PMID:24153253

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 methodology transparency, which is important, because lack of transparency hinders states from learning from each other. Ultimately, the federal government needs to evaluate and improve its DUR program.

Impact of a drug-free program on broiler chicken growth performances, gut health, Clostridium perfringens and Campylobacter jejuni occurrences at the farm level.

PubMed

Gaucher, M-L; Quessy, S; Letellier, A; Arsenault, J; Boulianne, M

2015-08-01

The use of antimicrobial agents as feed additives in poultry production is a public health concern due to the overall increase in antimicrobial resistance. Although some alternative products are commercially available, little is known on their potential impact on flock health and productivity. A prospective study involving 1.55 million birds was conducted on eight commercial broiler farms in Québec, Canada, to evaluate the impact of replacing antibiotic growth promoters and anticoccidial drugs by a drug-free program including improved brooding conditions, anticoccidial vaccination, essential oil-based feed additives, and water acidification. Various productivity and health parameters were compared between barns allocated to the conventional and the drug-free program. Zootechnical performances were monitored as productivity criteria. Clinical necrotic enteritis and subclinical enteritis occurrences, litter and fecal moistures content were measured, and microscopic gut health was evaluated. Clostridium perfringens and Campylobacter spp. strains were recovered from fecal samples collected during farm visits. Clostridium perfringens counts were used as poultry health indicators and Campylobacter prevalence was noted as well. The drug-free program was associated with a significant increase in feed conversion ratio and a decrease in mean live weight at slaughter and in daily weight gain. An increased incidence of necrotic enteritis outbreaks and subclinical enteritis cases, as well as an increase in litter moisture content at the end of the rearing period were also observed for this program. Mean microscopic intestinal lesion scores and prevalence of Campylobacter colonization were not statistically different between the two groups but the drug-free program was associated with higher Clostridium perfringens isolation rates. According to the current study design, the results suggest that substitution of antibiotic growth promoters and anticoccidial drugs by a drug-free program impacts various broiler chicken production parameters and Clostridium perfringens carriage levels. © 2015 Poultry Science Association Inc.

[Risk/protective factors and prevention programs for drug dependence in Peru].

PubMed

Cabanillas-Rojas, William

2012-03-01

Risk/ protective factors (RPF) are main elements for the analysis, understanding and formulation of answers for the prevention of drug dependences. The objective of this article is to present a literature review about the RPF and their implications in the design of preventive programs. It will focus on individual (genetic aspects, early experiences and psicosocial skills), family (parental control and monitoring, permissiveness, parenting styles), peer (group pressure and social norms) and communitarian (disorganization) RPF. On the other hand, the need of incorporating a multifactor conceptual framework for the preventive approach to drug dependences, articulating the intervention spaces (school, family and community), assuming and evolving perspective allowing the implementations of sustained actions is evidenced. On top, the implications for future research and public policy formulation are discussed.

Benefits and Limits of Abuse-Deterrent Painkillers.

PubMed

Hendrikson, Hollie; Hanson, Karmen

2016-02-01

Abuse of opioid prescription products, meant to reduce pain, has been making headlines in recent years as a growing problem not only in rural and urban areas, but also across population groups. Policymakers looking for effective ways to reduce such abuse are employing various strategies, including setting up prescription drug monitoring programs. Another approach gaining attention involves encouraging or requiring the use of prescription drug formulas that can help deter abuse of opioid painkiller products.

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

Police Encounters Among Needle Exchange Clients in Baltimore: Drug Law Enforcement as a Structural Determinant of Health.

PubMed

Beletsky, Leo; Cochrane, Jess; Sawyer, Anne L; Serio-Chapman, Chris; Smelyanskaya, Marina; Han, Jennifer; Robinowitz, Natanya; Sherman, Susan G

2015-09-01

We piloted a monitoring mechanism to document police encounters around programs targeting people who inject drugs (PWID), and assessed their demographic predictors at 2 Baltimore, Maryland, needle exchange program (NEP) sites. In a brief survey, 308 clients quantified, characterized, and sited recent police encounters. Multivariate linear regression determined encounter predictors, and we used geocoordinate maps to illustrate clusters. Within the past 6 months, clients reported a median of 3 stops near NEP sites (interquartile range [IQR] = 0-7.5) and a median of 1 arrest in any location (IQR = 0-2). Three respondents reported police referral to the NEP. Being younger (P = .009), being male (P = .033), and making frequent NEP visits (P = .02) were associated with reported police stops. Among clients reporting arrest or citation for syringe possession, Whites were significantly less likely than non-Whites to report being en route to or from an NEP (P < .001). Reported encounters were clustered around NEPs. Systematic surveillance of structural determinants of health for PWID proved feasible when integrated into service activities. Improved monitoring is critical to informing interventions to align policing with public health, especially among groups subject to disproportionate levels of drug law enforcement.

Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis.

PubMed

Chang, Hsien-Yen; Murimi, Irene; Faul, Mark; Rutkow, Lainie; Alexander, G Caleb

2018-04-01

We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012. We identified 3 types of high-risk patients: (1) concomitant users: patients with concomitant use of benzodiazepines and opioids; (2) chronic users: long-term, high-dose, opioid users; and (3) opioid shoppers: patients receiving opioids from multiple sources. We compared changes in opioid prescriptions between Florida and Georgia before and after policy implementation among high-risk/low-risk patients. Our monthly measures included (1) average morphine milligram equivalent per transaction, (2) total opioid volume across all prescriptions, (3) average days supplied per transaction, and (4) total number of opioid prescriptions dispensed. Among opioid-receiving individuals in Florida, 6.62% were concomitant users, 1.96% were chronic users, and 0.46% were opioid shoppers. Following policy implementation, Florida's high-risk patients experienced relative reductions in morphine milligram equivalent (opioid shoppers: -1.08 mg/month, 95% confidence interval [CI] -1.62 to -0.54), total opioid volume (chronic users: -4.58 kg/month, CI -5.41 to -3.76), and number of dispensed opioid prescriptions (concomitant users: -640 prescriptions/month, CI -950 to -340). Low-risk patients generally did not experience statistically significantly relative reductions. Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients. Copyright © 2018 John Wiley & Sons, Ltd.

Energy drink consumption and the perceived risk and disapproval of drugs: Monitoring the Future, 2010-2016.

PubMed

Jackson, Dylan B; Leal, Wanda E

2018-07-01

Energy drinks have become quite popular in recent years among adolescents, prompting a wealth of recent research examining the potential deleterious consequences of energy drink consumption among youth. The present study adds to this body of work by exploring perceptions of risk and disapproval of soft and hard drugs among adolescents and whether such attitudes are predicted by patterns of energy drink/shot consumption. Data were derived from the seven most recent cohorts (2010-2016) of the Monitoring the Future (MTF) study, a nationally representative survey of U.S. youth. The significance of associations between energy drink/shot consumption and drug perceptions/attitudes was tested using logistic regression techniques employing adjustments for covariates and cohort-specific fixed effects. Energy drink/shot consumption was largely associated with significant increases in the odds of failing to perceive any risk of drug use and failing to disapprove of drug use among youths, regardless of whether attitudes concerning soft or hard drugs were examined. These associations were particularly robust in the case of habitual energy drink/shot consumers (relative to occasional consumers or abstainers). Additional efforts should be made to heighten awareness and education concerning the potential dangers of energy drink consumption among youth, particularly as it pertains to drug attitudes and diminished perceptions of substance use risk. Policies that minimize energy drink consumption among youth as well as programs that educate parents and teachers about the drug attitudes of youths who regularly consume energy drinks and promote active monitoring of these adolescents may be worthwhile. Copyright © 2018 Elsevier B.V. All rights reserved.

Novel Insights in the Fecal Egg Count Reduction Test for Monitoring Drug Efficacy against Soil-Transmitted Helminths in Large-Scale Treatment Programs

PubMed Central

Levecke, Bruno; Speybroeck, Niko; Dobson, Robert J.; Vercruysse, Jozef; Charlier, Johannes

2011-01-01

Background The fecal egg count reduction test (FECRT) is recommended to monitor drug efficacy against soil-transmitted helminths (STHs) in public health. However, the impact of factors inherent to study design (sample size and detection limit of the fecal egg count (FEC) method) and host-parasite interactions (mean baseline FEC and aggregation of FEC across host population) on the reliability of FECRT is poorly understood. Methodology/Principal Findings A simulation study was performed in which FECRT was assessed under varying conditions of the aforementioned factors. Classification trees were built to explore critical values for these factors required to obtain conclusive FECRT results. The outcome of this analysis was subsequently validated on five efficacy trials across Africa, Asia, and Latin America. Unsatisfactory (<85.0%) sensitivity and specificity results to detect reduced efficacy were found if sample sizes were small (<10) or if sample sizes were moderate (10–49) combined with highly aggregated FEC (k<0.25). FECRT remained inconclusive under any evaluated condition for drug efficacies ranging from 87.5% to 92.5% for a reduced-efficacy-threshold of 90% and from 92.5% to 97.5% for a threshold of 95%. The most discriminatory study design required 200 subjects independent of STH status (including subjects who are not excreting eggs). For this sample size, the detection limit of the FEC method and the level of aggregation of the FEC did not affect the interpretation of the FECRT. Only for a threshold of 90%, mean baseline FEC <150 eggs per gram of stool led to a reduced discriminatory power. Conclusions/Significance This study confirms that the interpretation of FECRT is affected by a complex interplay of factors inherent to both study design and host-parasite interactions. The results also highlight that revision of the current World Health Organization guidelines to monitor drug efficacy is indicated. We, therefore, propose novel guidelines to support future monitoring programs. PMID:22180801

A phenomenological approach to assessing a DUI/DWI program.

PubMed

Narag, Raymund E; Maxwell, Sheila Royo; Lee, Byung

2013-02-01

In an effort to find a more proactive solution to the problem of drunk driving, a midwestern city has implemented a Driving Under the Influence or Driving While Impaired (DUI/DWI) Court program, a derivative of the popular drug courts. Eligible participants are those who have had two or more drunk-driving offenses but who have not been convicted of a violent offense. Participants volunteer for a 36-week program in exchange for a suspension of their prison sentence. Program elements include drug/alcohol monitoring, support groups, counseling, and extensive supervision. Using a phenomenological approach, this article describes the challenges faced by 20 participants, how they navigated the program requirements, their key realizations about their conditions, and their views on the viability and effectiveness of the program. The article uses qualitative interviews of participants and stakeholders collected for a process evaluation of the DUI program, and official records collected for programming purposes. Findings from this research can be used broadly for programming purposes and can be used by other court jurisdictions that are developing similar programs.

Prescription drug abuse: problem, policies, and implications.

PubMed

Phillips, Janice

2013-01-01

This article provides an overview on prescription drug abuse and highlights a number of related legislative bills introduced during the 112th Congress in response to this growing epidemic. Prescription drug abuse has emerged as the nation's fastest growing drug problem. Although prescription drugs have been used effectively and appropriately for decades, deaths from prescription pain medicine in particular have reached epidemic proportions. Bills related to prescription drug abuse introduced during the 112th Congress focus on strengthening provider and consumer education, tracking and monitoring prescription drug abuse, improving data collection on drug overdose fatalities, combating fraud and abuse in Medicare and Medicaid programs, reclassifying drugs to make them more difficult to prescribe and obtain, and enforcing stricter penalties for individuals who operate scam pain clinics and sell pain pills illegitimately. This article underscores the importance of a multifaceted approach to combating prescription drug abuse and concludes with implications for nursing. Copyright © 2013. Published by Mosby, Inc.

Quality-improvement analytics for intravenous infusion pumps.

PubMed

Skledar, Susan J; Niccolai, Cynthia S; Schilling, Dennis; Costello, Susan; Mininni, Nicolette; Ervin, Kelly; Urban, Alana

2013-04-15

The implementation of a smart-pump continuous quality-improvement (CQI) program across a large health system is described, with an emphasis on key metrics for outcomes analyses and program refinement. Three years ago, the University of Pittsburgh Medical Center health system launched a CQI initiative to help ensure the safe use of 6000 smart pumps in its 14 inpatient facilities. A centralized team led by pharmacists is responsible for the retrieval and interpretation of smart-pump data, which is continuously transmitted to a main server. CQI findings are regularly posted on the health system's interdisciplinary intranet. Monitored metrics include rates of compliance with preprogrammed infusion limits, the top 20 drugs involved in alerts, drugs associated with alert-override rates of ≥90%, numbers of alerts by infusion type, nurse responses to alerts, and alert rate per drug library update. Based on the collected CQI data and site-specific requests, four systemwide updates of the smart-pump drug library were performed during the first 18 months of the program, reducing "nuisance alerts" by about 10% per update cycle and enabling targeted interventions to reduce rapid-infusion errors, other adverse drug events (ADEs), and pump-programming workarounds. Over one 12-month period, bedside alerts prompted nurses to reprogram or cancel continuous infusions an average of 400 times per month, potentially averting i.v. medication ADEs. A smart-pump CQI program is an effective tool for enhancing the safety of i.v. medication administration. The ongoing refinement of the drug library through the development and implementation of key interventions promotes the growth and sustainability of the smart-pump initiative systemwide.

Changes in drug use patterns reported on the web after the introduction of ADF OxyContin: findings from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Web Monitoring Program.

PubMed

Vosburg, Suzanne K; Haynes, Colleen; Besharat, Andrea; Green, Jody L

2017-09-01

This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use. Data were collected with the Researched Abuse, Diversion, and Addiction-Related Surveillance System Web Monitoring Program, an online surveillance system that collects and organizes posts about prescription drugs from social media websites, blogs, and forums from 3Q2009 to 4Q2014 using a commercially available web platform. Posts were categorized by whether they conveyed a switch to drugs other than reformulated OxyContin or a continuation of reformulated OxyContin abuse. "Switch posts" primarily discussed switching to immediate-release opioids. "Continue abusing" posts identified tampering strategies for alternate routes of administration, oral use, and continued use although post authors were generally unhappy with the experience. No reference to OxyContin cessation as a function of the introduction of the ADF was found; however, discontinued use was discussed. Web Monitoring data are useful for capturing cross sections of Internet conversation reflecting reactions to new drug formulations. These data support the notion that users will gravitate to non-ADFs generally, and to immediate-release non-ADF opioid formulations, specifically, as long as these options remain on the market. Copyright © 2017 John Wiley & Sons, Ltd.

Tramadol post-marketing surveillance in health care professionals.

PubMed

Knisely, Janet S; Campbell, Eleanor D; Dawson, Kathryn S; Schnoll, Sidney H

2002-09-01

Tramadol has been marketed in the US since 1995. The US Food and Drug Administration agreed to release tramadol as a non-scheduled drug if proactive post-marketing surveillance studies would be conducted. This study was one of two phase IV protocols that were part of the overall surveillance program. It focused on impaired health professionals who are a high risk/high access population for drug abuse. All active participants in four state monitoring programs between November 1, 1995 and August 15, 1998 (n = 1,601) were recruited for the study. With the exceptions of implementing a standardized intake interview and urine testing for tramadol metabolites, all states operated their programs in the usual fashion. The programs were alerted to persistent non-prescribed tramadol use so that appropriate interventions could be employed. Despite availability of tramadol and the conditions that might lead to its abuse, the incidence rate for tramadol use in the study population was only 69 per thousand persons per year and the incidence rate for tramadol abuse or dependence was 6.9 per thousand persons per year.

Evaluation of a continual compliance monitoring program for dapsone in an outpatient Hansen's disease clinic.

PubMed

Fischer, J H; West, D P; Worobec, S M

1986-12-01

Guidelines for the assessment of patient compliance to dapsone were developed and evaluated. The urinary dapsone-to-creatinine (D/C) ratio following standardization by dose, ideal body weight, and time since last dose was used for assessment of compliance. Compliance standards were established in 12 patients of known compliance and confirmed prospectively in nine inpatients on 14 occasions. Compliance increased significantly among outpatients (N = 30) attending the University of Illinois Hansen's Disease Clinic from 47% at base line to 73% at 6 months and 80% at 18 months after establishing the monitoring program. In a subgroup of 18 patients, a similar increase in compliance was observed from 50% to 80%. A good therapeutic response was seen in the subgroup patients who were compliant. A poor therapeutic response was seen in the consistently noncompliant patients. These results demonstrate that use of a continual compliance monitoring program can improve patient drug compliance in an outpatient Hansen's disease clinic.

The AGNP-TDM Expert Group Consensus Guidelines: focus on therapeutic monitoring of antidepressants

PubMed Central

Baumann, Pierre; Ulrich, Sven; Eckermann, Gabriel; Gerlach, Manfred; Kuss, Hans-Joachim; Laux, Gerd; Müller-Oerlinghausen, Bruno; Rao, Marie Luise; Riederer, Peter; Zernig, Gerald; Hiemke, Christoph

2005-01-01

Therapeutic drug monitoring (TDM) of psychotropic drugs such as antidepressants has been widely introduced for optimization of pharmacotherapy in psychiatric patients. The interdisciplinary TDM group of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) has worked out consensus guidelines with the aim of providing psychiatrists and TDM laboratories with a tool to optimize the use of TDM. Five research-based levels of recommendation were defined with regard to routine monitoring of drug plasma concentrations: (i) strongly recommended; (ii) recommended; (iii) useful; (iv) probably useful; and (v) not recommended. In addition, a list of indications that justify the use of TDM is presented, eg, control of compliance, lack of clinical response or adverse effects at recommended doses, drug interactions, pharmacovigilance programs, presence of a genetic particularity concerning drug metabolism, and children, adolescents, and elderly patients. For some drugs, studies on therapeutic ranges are lacking, but target ranges for clinically relevant plasma concentrations are presented for most drugs, based on pharmacokinetic studies reported in the literature. For many antidepressants, a thorough analysis of the literature on studies dealing with the plasma concentration–clinical effectiveness relationship allowed inclusion of therapeutic ranges of plasma concentrations. In addition, recommendations are made with regard to the combination of pharmacogenetic (phenotyping or genotyping) tests with TDM, Finally, practical instructions are given for the laboratory practitioners and the treating physicians how to use TDM: preparation of TDM, drug analysis, reporting and interpretation of results, and adequate use of information for patient treatment. TDM is a complex process that needs optimal interdisciplinary coordination of a procedure implicating patients, treating physicians, clinical pharmacologists, and clinical laboratory specialists. These consensus guidelines should be helpful for optimizing TDM of antidepressants. PMID:16156382

An inevitable wave of prescription drug monitoring programs in the context of prescription opioids: pros, cons and tensions.

PubMed

Islam, M Mofizul; McRae, Ian S

2014-08-16

In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriate therapeutic uses of these drugs with the risk of developing dependence. This article discusses pros and cons of PDMP in reducing diversion of prescription opioids, without hampering access to those medications for those with genuine needs, and highlights tensions around PDMP implementation. PDMPs may help alleviate diversion, over-prescription and fraudulent prescribing/dispensing; prompt drug treatment referrals; avoid awkward drug urine test; and inform spatial changes in prescribing practices and help designing tailored interventions. Fear of legal retribution, privacy and data security, potential confusion about addiction and pseudo-addiction, and potential undue pressure of detecting misuse/diversion - are the major problems. There are tensions about unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP. In this era of information technology PDMP is likely to flourish and remain with us for a long time. A clear standard of practice against which physicians' care will be judged may expedite the utilisation of PDMP. In addition, adequate training on addiction and pain management along with public awareness, point-of-supply data entry from pharmacy, point-of-care real-time access to data, increasing access to addiction treatment and appropriate regulatory enforcement preferably through healthcare administration, together, may help remove barriers to PDMP use.

An inevitable wave of prescription drug monitoring programs in the context of prescription opioids: pros, cons and tensions

PubMed Central

2014-01-01

Background In an effort to control non-medical use and/or medical abuse of prescription drugs, particularly prescription opioids, electronic prescription drug monitoring programs (PDMP) have been introduced in North-American countries, Australia and some parts of Europe. Paradoxically, there are simultaneous pressures to increase opioid prescribing for the benefit of individual patients and to reduce it for the sake of public health, and this pressure warrants a delicate balance of appropriate therapeutic uses of these drugs with the risk of developing dependence. This article discusses pros and cons of PDMP in reducing diversion of prescription opioids, without hampering access to those medications for those with genuine needs, and highlights tensions around PDMP implementation. Discussion PDMPs may help alleviate diversion, over-prescription and fraudulent prescribing/dispensing; prompt drug treatment referrals; avoid awkward drug urine test; and inform spatial changes in prescribing practices and help designing tailored interventions. Fear of legal retribution, privacy and data security, potential confusion about addiction and pseudo-addiction, and potential undue pressure of detecting misuse/diversion - are the major problems. There are tensions about unintended consequence of excessive regulatory enforcements, corresponding collateral damages particularly about inadequate prescribing for patients with genuine needs, and mandatory consultation requirements of PDMP. Summary In this era of information technology PDMP is likely to flourish and remain with us for a long time. A clear standard of practice against which physicians’ care will be judged may expedite the utilisation of PDMP. In addition, adequate training on addiction and pain management along with public awareness, point-of-supply data entry from pharmacy, point-of-care real-time access to data, increasing access to addiction treatment and appropriate regulatory enforcement preferably through healthcare administration, together, may help remove barriers to PDMP use. PMID:25127880

Impact of prescription drug-monitoring program on controlled substance prescribing in the ED.

PubMed

McAllister, Matthew W; Aaronson, Patrick; Spillane, Joe; Schreiber, Mark; Baroso, Genelyn; Kraemer, Dale; Smotherman, Carmen; Gray-Eurom, Kelly

2015-06-01

In 2009, Florida initiated a statewide prescription drug-monitoring program (PDMP) to encourage safer prescribing of controlled substances and reduce drug abuse and diversion. Data supporting the utility of such programs in the emergency department (ED) is scarce. This study sought to determine the effect of PDMP data on controlled substance prescribing from the ED. In this pre-post study utilizing a historical control, pharmacists in the ED provided prescribers with a summary of the PDMP data for their patients. The number of controlled substances prescribed in the intervention group was compared with that prescribed in the historical control to determine if the intervention resulted in a change in the average number of controlled substance prescribed. Among the 710 patients evaluated, providing prescribers with PDMP data did not alter the average number of controlled substance per patient prescribed (0.23 controlled substances per patient in the historical control compared with 0.28 controlled substances per patient in the intervention group; 95% confidence interval [CI], -0.016 to 0.116; P = .125). All prescribers surveyed indicated that having PDMP data altered their controlled substance prescribing and felt more comfortable prescribing controlled substances. Although the results did not demonstrate a change in the average number of controlled substances prescribed when prescribers were provided with PDMP data, results from the survey indicate that prescribers felt the data altered their prescribing of controlled substances, and thus were more contented prescribing controlled substances. Copyright © 2015 Elsevier Inc. All rights reserved.

Police Encounters Among Needle Exchange Clients in Baltimore: Drug Law Enforcement as a Structural Determinant of Health

PubMed Central

Cochrane, Jess; Sawyer, Anne L.; Serio-Chapman, Chris; Smelyanskaya, Marina; Han, Jennifer; Robinowitz, Natanya; Sherman, Susan G.

2015-01-01

Objectives. We piloted a monitoring mechanism to document police encounters around programs targeting people who inject drugs (PWID), and assessed their demographic predictors at 2 Baltimore, Maryland, needle exchange program (NEP) sites. Methods. In a brief survey, 308 clients quantified, characterized, and sited recent police encounters. Multivariate linear regression determined encounter predictors, and we used geocoordinate maps to illustrate clusters. Results. Within the past 6 months, clients reported a median of 3 stops near NEP sites (interquartile range [IQR] = 0–7.5) and a median of 1 arrest in any location (IQR = 0–2). Three respondents reported police referral to the NEP. Being younger (P = .009), being male (P = .033), and making frequent NEP visits (P = .02) were associated with reported police stops. Among clients reporting arrest or citation for syringe possession, Whites were significantly less likely than non-Whites to report being en route to or from an NEP (P < .001). Reported encounters were clustered around NEPs. Conclusions. Systematic surveillance of structural determinants of health for PWID proved feasible when integrated into service activities. Improved monitoring is critical to informing interventions to align policing with public health, especially among groups subject to disproportionate levels of drug law enforcement. PMID:26180948

Evaluation of Florida physicians' knowledge and attitudes toward accessing the state prescription drug monitoring program as a prescribing tool.

PubMed

Gershman, Jennifer A; Gershman, Jason A; Fass, Andrea D; Popovici, Ioana

2014-12-01

The purpose of this study is to assess Florida physicians' attitudes and knowledge toward accessing the state's prescription drug monitoring program (PDMP). Five thousand medical doctors and osteopathic physicians licensed in Florida were randomly selected for a voluntary and anonymous 15-question self-administered survey approved by the Institutional Review Board. Surveys were distributed through U.S. postal service mail. Likert-scale questions were used to assess prior knowledge (1 = none to 5 = excellent) and attitudes toward accessing the PDMP (1 = strongly disagree to 5 = strongly agree). The study yielded a response rate of 7.8%, 71.5% of whom agreed or strongly agreed that the PDMP is a useful tool. Among participants that have access and answered the PDMP usefulness question, 94.8% agree or strongly agree that it is a useful tool. There were 63 out of 64 physicians (98.4%) who conducted 25 or more searches who agreed or strongly agreed that the PDMP is a useful tool for monitoring patients' controlled substance histories. There were 72.5% of participants with access that answered the "doctor shopping" question who agreed that "doctor shopping" will decrease. Among the 64 most frequent PDMP users, 69.4% agreed or strongly agreed that they have prescribed fewer controlled substances after accessing the PDMP. The study revealed that a majority of participants believe that the PDMP is a useful tool for monitoring patients' controlled substance histories. More continuing education programs should be provided to Florida physicians to enhance their knowledge regarding PDMPs. Wiley Periodicals, Inc.

[Post-marketing surveillance systems for psychoactive prescription drug abuse].

PubMed

Nordmann, Sandra; Frauger, Elisabeth; Pauly, Vanessa; Rouby, Frank; Mallaret, Michel; Micallef, Joëlle; Thirion, Xavier

2011-01-01

Drugs affecting the central nervous system form a unique group of products for surveillance because they could be misused, abused or diverted. Considering the characteristics of this behaviour that is often concealed, specific post-marketing surveillance systems have been developed to monitor abuse of prescription drugs in some countries. The purpose of this review is to list and to describe post-marketing surveillance systems, according their methodology, in France and in foreign countries. These programs are based on adverse effect notifications, medical or legal consequences of abuse, general or specific population-based survey, professional networks or medication databases. Some programs use simultaneously several information sources. In conclusion, the multifaceted nature, the diversity and the inventiveness of post-marketing surveillance systems reflects the complexity of the abuse issue. © 2011 Société Française de Pharmacologie et de Thérapeutique.

Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.

PubMed

Roberts, Andrew W; Farley, Joel F; Holmes, G Mark; Oramasionwu, Christine U; Ringwalt, Chris; Sleath, Betsy; Skinner, Asheley C

2016-10-01

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse. Project HOPE—The People-to-People Health Foundation, Inc.

Development and validation of a solid-phase extraction gas chromatography–mass spectrometry method for the simultaneous quantification of methadone, heroin, cocaine and metabolites in sweat

PubMed Central

Brunet, Bertrand R.; Barnes, Allan J.; Scheidweiler, Karl B.; Mura, Patrick

2009-01-01

A sensitive and specific method is presented to simultaneously quantify methadone, heroin, cocaine and metabolites in sweat. Drugs were eluted from sweat patches with sodium acetate buffer, followed by SPE and quantification by GC/MS with electron impact ionization and selected ion monitoring. Daily calibration for anhydroecgonine methyl ester, ecgonine methyl ester, cocaine, benzoylecgonine (BE), codeine, morphine, 6-acetylcodeine, 6-acetylmorphine (6AM), heroin (5–1000 ng/patch) and methadone (10–1000 ng/patch) achieved determination coefficients of >0.995, and calibrators quantified to within ±20% of the target concentrations. Extended calibration curves (1000–10,000 ng/patch) were constructed for methadone, cocaine, BE and 6AM by modifying injection techniques. Within (N=5) and between-run (N=20) imprecisions were calculated at six control levels across the dynamic ranges with coefficients of variation of <6.5%. Accuracies at these concentrations were ±11.9% of target. Heroin hydrolysis during specimen processing was <11%. This novel assay offers effective monitoring of drug exposure during drug treatment, workplace and criminal justice monitoring programs. PMID:18607576

Impact of a Mandatory Prescription Drug Monitoring Program on Prescription of Opioid Analgesics by Dentists.

PubMed

Rasubala, Linda; Pernapati, Lavanya; Velasquez, Ximena; Burk, James; Ren, Yan-Fang

2015-01-01

Prescription Drug Monitoring Programs (PDMP) are statewide databases that collect data on prescription of controlled substances. New York State mandates prescribers to consult the PDMP registry before prescribing a controlled substance such as opioid analgesics. The effect of mandatory PDMP on opioid drug prescriptions by dentists is not known. This study investigates the impact of mandatory PDMP on frequency and quantity of opioid prescriptions by dentists in a dental urgent care center. Based on the sample size estimate, we collected patient records of a 3-month period before and two consecutive 3-month periods after the mandatory PDMP implementation and analyzed the data on number of visits, treatment types and drug prescriptions using Chi-square tests. For patients who were prescribed pain medications, 452 (30.6%), 190 (14.1%), and 140 (9.6%) received opioid analgesics in the three study periods respectively, signifying a statistically significant reduction in the number of opioid prescriptions after implementation of the mandatory PDMP (p<0.05). Total numbers of prescribed opioid pills in a 3-month period decreased from 5096 to 1120, signifying a 78% reduction in absolute quantity. Prescriptions for non-opioid analgesics acetaminophen increased during the same periods (p<0.05). We conclude that the mandatory PDMP significantly affected the prescription pattern for pain medications by dentists. Such change in prescription pattern represents a shift towards the evidence-based prescription practices for acute postoperative pain.

Impact of a Mandatory Prescription Drug Monitoring Program on Prescription of Opioid Analgesics by Dentists

PubMed Central

Rasubala, Linda; Pernapati, Lavanya; Velasquez, Ximena; Burk, James; Ren, Yan-Fang

2015-01-01

Prescription Drug Monitoring Programs (PDMP) are statewide databases that collect data on prescription of controlled substances. New York State mandates prescribers to consult the PDMP registry before prescribing a controlled substance such as opioid analgesics. The effect of mandatory PDMP on opioid drug prescriptions by dentists is not known. This study investigates the impact of mandatory PDMP on frequency and quantity of opioid prescriptions by dentists in a dental urgent care center. Based on the sample size estimate, we collected patient records of a 3-month period before and two consecutive 3-month periods after the mandatory PDMP implementation and analyzed the data on number of visits, treatment types and drug prescriptions using Chi-square tests. For patients who were prescribed pain medications, 452 (30.6%), 190 (14.1%), and 140 (9.6%) received opioid analgesics in the three study periods respectively, signifying a statistically significant reduction in the number of opioid prescriptions after implementation of the mandatory PDMP (p<0.05). Total numbers of prescribed opioid pills in a 3-month period decreased from 5096 to 1120, signifying a 78% reduction in absolute quantity. Prescriptions for non-opioid analgesics acetaminophen increased during the same periods (p<0.05). We conclude that the mandatory PDMP significantly affected the prescription pattern for pain medications by dentists. Such change in prescription pattern represents a shift towards the evidence-based prescription practices for acute postoperative pain. PMID:26274819

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed.

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions: The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed. PMID:19342468

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

Johnson, W.A.

The Food Safety and Inspection Service (FSIS) is responsible for the wholesomeness, safety, and adulteration-free status of meat and poultry. The agency developed the National Residue Program (NRP) to monitor these products for residue of drugs, pesticides, and environmental contaminants. Today, few chemical residues are detected in meat and poultry because of the success of the NRP. 3 figs.

The Jailing of America's Homeless: Evaluating the Rabble Management Thesis

ERIC Educational Resources Information Center

Fitzpatrick, Kevin M.; Myrstol, Brad

2011-01-01

The authors of this article test hypotheses derived from Irwin's rabble management thesis. The analysis uses data from 47,592 interviews conducted with jailed adults in 30 U.S. cities as part of the Arrestee Drug Abuse Monitoring program. Clearly, homeless persons are overrepresented among those arrested and booked into local jails. Bivariate…

Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

PubMed

Gould, A Lawrence

2016-12-30

Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Adulterants in Urine Drug Testing.

PubMed

Fu, S

Urine drug testing plays an important role in monitoring licit and illicit drug use for both medico-legal and clinical purposes. One of the major challenges of urine drug testing is adulteration, a practice involving manipulation of a urine specimen with chemical adulterants to produce a false negative test result. This problem is compounded by the number of easily obtained chemicals that can effectively adulterate a urine specimen. Common adulterants include some household chemicals such as hypochlorite bleach, laundry detergent, table salt, and toilet bowl cleaner and many commercial products such as UrinAid (glutaraldehyde), Stealth® (containing peroxidase and peroxide), Urine Luck (pyridinium chlorochromate, PCC), and Klear® (potassium nitrite) available through the Internet. These adulterants can invalidate a screening test result, a confirmatory test result, or both. To counteract urine adulteration, drug testing laboratories have developed a number of analytical methods to detect adulterants in a urine specimen. While these methods are useful in detecting urine adulteration when such activities are suspected, they do not reveal what types of drugs are being concealed. This is particularly the case when oxidizing urine adulterants are involved as these oxidants are capable of destroying drugs and their metabolites in urine, rendering the drug analytes undetectable by any testing technology. One promising approach to address this current limitation has been the use of unique oxidation products formed from reaction of drug analytes with oxidizing adulterants as markers for monitoring drug misuse and urine adulteration. This novel approach will ultimately improve the effectiveness of the current urine drug testing programs. © 2016 Elsevier Inc. All rights reserved.

National drug control policy and prescription drug abuse: facts and fallacies.

PubMed

Manchikanti, Laxmaiah

2007-05-01

In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects, addiction and abuse. The multiple reasons for continued escalation of prescription drug abuse and overuse are lack of education among all segments including physicians, pharmacists, and the public; ineffective and incoherent prescription monitoring programs with lack of funding for a national prescription monitoring program NASPER; and a reactive approach on behalf of numerous agencies. This review focuses on the problem of prescription drug abuse with a discussion of facts and fallacies, along with proposed solutions.

Banned -- Select: "a drug to alter the sex of the foetus".

PubMed

Unnikrishnan, P V

1993-04-01

In 1991, the Government of Gujarat State, India, banned the manufacture and sale of an Ayurvedic drug called Select. This was the first time an Ayurvedic product had ever been banned. The manufacturer claimed that if a pregnant woman took Select for 45 days after her last menstrual period, she would have a male fetus. Further, the manufacturer marketed the drug as a tool which would change the dowry system (i.e., it would reduce the number of girls in the population). Select's high cost did not deter the naive and trusting public in Gujarat and other states. Drug activists and consumer groups called for the ban and noted that the marketing claims were typical of the unethical behavior of the Ayurvedic market. These consumer groups brought the existence of Select to the attention of the government which admittedly cannot adequately monitor and control the drug market. Groups ranging from illegal smugglers to multinational giants use loopholes in the Drugs and Cosmetics Act and Excise Laws to license their drugs as Ayurvedic/Herbal, but most drugs are hazardous. Policy makers, physicians, nongovernmental and consumer groups, the media, and others should join together to rid India of this unethical practice. They should help the government to implement a rational policy for traditional systems of medicine and, once the policy has been developed to select an essential drug list of Ayurvedic drugs needed for national health programs; monitor and minimize misleading advertisements; screen all existing Ayurvedic drugs and drugs of other traditional medicine systems; and require thorough research on the relevance, usefulness, and safety of new patent drugs of other traditional medicine systems; and require thorough research on the relevance, usefulness, and safety of new patent drugs. The government should declare any products with more than 12% alcohol to be liquor.

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 there is still room for improvement in terms of methodology transparency, which is important, because lack of transparency hinders states from learning from each other. Ultimately, the federal government needs to evaluate and improve its DUR program. PMID:29403573

A history of being prescribed controlled substances and risk of drug overdose death.

PubMed

Paulozzi, Leonard J; Kilbourne, Edwin M; Shah, Nina G; Nolte, Kurt B; Desai, Hema A; Landen, Michael G; Harvey, William; Loring, Larry D

2012-01-01

The abuse of prescription drugs has increased dramatically since 1990. Persons who overdose on such drugs frequently consume large doses and visit multiple providers. The risk of fatal overdose for different patterns of use of opioid analgesics and sedative/hypnotics has not been fully quantified. Matched case-control study. Cases were 300 persons who died of unintentional drug overdoses in New Mexico during 2006-2008, and controls were 5,993 patients identified through the state prescription monitoring program with matching 6-month exposure periods. Death from drug overdose or death from opioid overdose. Exposures were demographic variables and characteristics of prescription history. Crude and adjusted odds ratios (AOR) were calculated. Increased risk was associated with male sex (AOR 2.4, 95% confidence interval [CI] 1.8-3.1), one or more sedative/hypnotic prescriptions (AOR 3.0, CI 2.2-4.2), greater age (AOR 1.3, CI 1.2-1.4 for each 10-year increment), number of prescriptions (AOR 1.1, CI 1.1-1.1 for each additional prescription), and a prescription for buprenorphine (AOR 9.5, CI 3.0-30.0), fentanyl (AOR 3.5, CI 1.7-7.0), hydromorphone (AOR 3.3, CI 1.4-7.5), methadone (AOR 4.9, CI 2.5-9.6), or oxycodone (AOR 1.9, CI 1.4-2.6). Patients receiving a daily average of >40 morphine milligram equivalents had an OR of 12.2 (CI 9.2-16.0). Patients being prescribed opioid analgesics frequently or at high dosage face a substantial overdose risk. Prescription monitoring programs might be the best way for prescribers to know their patients' prescription histories and accurately assess overdose risk. Wiley Periodicals, Inc.

Effects of therapeutic goal management (TGM) on treatment attendance and drug abstinence among men with co-occurring substance use and axis I mental disorders who are homeless: results of the Birmingham EARTH program

PubMed Central

2013-01-01

Purpose This study describes the implementation and impact of Therapeutic Goal Management (TGM) in a Substance Abuse and Mental Health Services Administration (SAMHSA)-sponsored demonstration project entitled Enhanced Addiction Recovery through Housing (EARTH). Participants The sample included 28 male participants followed at six months who completed some treatment. Forty-three percent were Caucasian, and 57% were African American. The average age of participants was 42 years. Design The relationships between TGM goal achievement, treatment attendance, and drug abstinence outcomes were studied among EARTH program participants who were homeless and met criteria for co-occurring substance use and severe DSM-IV Axis I mental disorders. Results The results revealed an overall drug abstinence rate of 72.4% over six months and significant positive relationships between TGM goal achievement and drug abstinence (r = 0.693) and TGM goal achievement and treatment attendance (r = 0.843). Conclusions This research demonstrated the relationship and potential positive impact of systematically setting, monitoring, and reinforcing personalized goals in multiple life areas on drug abstinence and treatment attendance outcomes among persons who are homeless with co-occurring substance use and other Axis I disorders in a integrated community service delivery program. PMID:24499617

Ensuring safe access to medication for palliative care while preventing prescription drug abuse: innovations for American inner cities, rural areas, and communities overwhelmed by addiction

PubMed Central

Francoeur, Richard B

2011-01-01

This article proposes and develops novel components of community-oriented programs for creating and affording access to safe medication dispensing centers in existing retail pharmacies and in permanent or travelling pharmacy clinics that are guarded by assigned or off-duty police officers. Pharmacists at these centers would work with police, medical providers, social workers, hospital administrators, and other professionals in: planning and overseeing the safe storage of controlled substance medications in off-site community safe-deposit boxes; strengthening communication and cooperation with the prescribing medical provider; assisting the prescribing medical provider in patient monitoring (checking the state prescription registry, providing pill counts and urine samples); expanding access to lower-cost, and in some cases, abuse-resistant formulations of controlled substance medications; improving transportation access for underserved patients and caregivers to obtain prescriptions; and integrating community agencies and social networks as resources for patient support and monitoring. Novel components of two related community-oriented programs, which may be hosted outside of safe medication dispensing centers, are also suggested and described: (1) developing medication purchasing cooperatives (ie, to help patients, families, and health institutions afford the costs of medications, including tamper-or abuse-resistant/deterrent drug formulations); and (2) expanding the role of inner-city methadone maintenance treatment programs in palliative care (ie, to provide additional patient monitoring from a second treatment team focusing on narcotics addiction, and potentially, to serve as an untapped source of opioid medication for pain that is less subject to abuse, misuse, or diversion). PMID:22312232

Ensuring safe access to medication for palliative care while preventing prescription drug abuse: innovations for American inner cities, rural areas, and communities overwhelmed by addiction.

PubMed

Francoeur, Richard B

2011-01-01

This article proposes and develops novel components of community-oriented programs for creating and affording access to safe medication dispensing centers in existing retail pharmacies and in permanent or travelling pharmacy clinics that are guarded by assigned or off-duty police officers. Pharmacists at these centers would work with police, medical providers, social workers, hospital administrators, and other professionals in: planning and overseeing the safe storage of controlled substance medications in off-site community safe-deposit boxes; strengthening communication and cooperation with the prescribing medical provider; assisting the prescribing medical provider in patient monitoring (checking the state prescription registry, providing pill counts and urine samples); expanding access to lower-cost, and in some cases, abuse-resistant formulations of controlled substance medications; improving transportation access for underserved patients and caregivers to obtain prescriptions; and integrating community agencies and social networks as resources for patient support and monitoring. Novel components of two related community-oriented programs, which may be hosted outside of safe medication dispensing centers, are also suggested and described: (1) developing medication purchasing cooperatives (ie, to help patients, families, and health institutions afford the costs of medications, including tamper-or abuse-resistant/deterrent drug formulations); and (2) expanding the role of inner-city methadone maintenance treatment programs in palliative care (ie, to provide additional patient monitoring from a second treatment team focusing on narcotics addiction, and potentially, to serve as an untapped source of opioid medication for pain that is less subject to abuse, misuse, or diversion).

Rationale for Quality Assurance in Fecal Egg Monitoring of Soil-Transmitted Helminthiasis

PubMed Central

Hoekendijk, David J. L.; Hill, Philip C.; Sowerby, Stephen J.

2016-01-01

Substantial investment has been made into the once “neglected” tropical disease, soil-transmitted helminthiasis, and into control programs that operate within a framework of mapping baseline disease distribution, measuring the effectiveness of applied interventions, establishing when to cease drug administration, and for posttreatment evaluations. However, critical to each of these stages is the determination of helminth infection. The limitations of traditional microscope-based fecal egg diagnostics have not provided quality assurance in the monitoring of parasite disease and suboptimal treatment regimes provide for the potential development of parasite resistance to anthelmintic drugs. Improved diagnostic and surveillance tools are required to protect therapeutic effectiveness and to maintain funder confidence. Such tools may be on the horizon with emergent technologies that offer potential for enhanced visualization and quality-assured quantitation of helminth eggs. PMID:27352875

Association of melanoma and natalizumab therapy in the Italian MS population: a second case report.

PubMed

Laroni, A; Bedognetti, M; Uccelli, A; Capello, E; Mancardi, G L

2011-02-01

There is debate about a possible association between natalizumab treatment and higher risk of melanoma. Here we report a case of melanoma in a patient who developed melanoma after 77 infusions of natalizumab, without known risk factors. Pharmacovigilance programs of new drugs can help to monitor adverse events in patients at risk.

Drug and chemical residues in domestic animals.

PubMed

Mussman, H C

1975-02-01

Given the large number of chemical substances that may find their way into the food supply, a system is needed to monitor their presence. The U. S. Department of Agriculture's Meat and Poultry Inspection Program routinely tests for chemical residues in animals coming to slaughter. Pesticides, heavy metals, growth promotants (hormones and hormonelike agents), and antibiotics are included. Samples are taken statistically so that inferences as to national incidence of residues can be drawn. When a problem is identified, a more selective sampling is designed to help follow up on the initial regulatory action. In testing for pesticides, only DDT and dieldrin are found with any frequency and their levels are decreasing; violative residues of any chlorinated hydrocarbon are generally a result of an industrial accident rather than agricultural usage. Analyses for heavy metals have revealed detectable levels of mercury, lead, and others, but none at levels that are considered a health hazard. Of the hormone or hormonelike substances, only diethylstilbestrol has been a residue problem and its future is uncertain. The most extensive monitoring for veterinary drugs is on the antimicrobials, including sulfonamides, streptomycin, and the tetracycline group of antibiotics that constitute the bulk of the violations; their simultaneous use prophylactically and therapeutically has contributed to the problem in certain cases. A strong, well-designed user education program on proper application of pesticides, chemicals, and veterinary drugs appears to be one method of reducing the incidence of unwanted residues.

Methylxanthine Drug Monitoring with Wearable Sweat Sensors.

PubMed

Tai, Li-Chia; Gao, Wei; Chao, Minghan; Bariya, Mallika; Ngo, Quynh P; Shahpar, Ziba; Nyein, Hnin Y Y; Park, Hyejin; Sun, Junfeng; Jung, Younsu; Wu, Eric; Fahad, Hossain M; Lien, Der-Hsien; Ota, Hiroki; Cho, Gyoujin; Javey, Ali

2018-06-01

Drug monitoring plays crucial roles in doping control and precision medicine. It helps physicians tailor drug dosage for optimal benefits, track patients' compliance to prescriptions, and understand the complex pharmacokinetics of drugs. Conventional drug tests rely on invasive blood draws. While urine and sweat are attractive alternative biofluids, the state-of-the-art methods require separate sample collection and processing steps and fail to provide real-time information. Here, a wearable platform equipped with an electrochemical differential pulse voltammetry sensing module for drug monitoring is presented. A methylxanthine drug, caffeine, is selected to demonstrate the platform's functionalities. Sweat caffeine levels are monitored under various conditions, such as drug doses and measurement time after drug intake. Elevated sweat caffeine levels upon increasing dosage and confirmable caffeine physiological trends are observed. This work leverages a wearable sweat sensing platform toward noninvasive and continuous point-of-care drug monitoring and management. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Strategic information is everyone's business: perspectives from an international stakeholder meeting to enhance strategic information data along the HIV Cascade for people who inject drugs.

PubMed

Pierce, Richard D; Hegle, Jennifer; Sabin, Keith; Agustian, Edo; Johnston, Lisa G; Mills, Stephen; Todd, Catherine S

2015-10-16

People who inject drugs (PWID) are at increased HIV transmission risk because of unsafe injecting practices and a host of other individual, network, and structural factors. Thus, PWID have a great need for services within the Cascade of HIV prevention, diagnosis, care, and treatment (HIV Cascade). Yet the systems that monitor their progress through the Cascade are often lacking. Subsequently, fewer reliable data are available to guide programs targeting this key population (KP). Programmatic data, which are helpful in tracking PWID through the Cascade, also are limited because not all countries have harm reduction programming from which to estimate Cascade indicators. Also, due to stigma and the illegal nature of drug use, PWID may not disclose their drug use behavior or HIV status when accessing services. Consequently, PWID appear to have low HIV testing rates and, for those living with HIV, lower access to health services and lower viral suppression rates than do other KP groups. This commentary, based on outcomes from an international stakeholder meeting, identifies data gaps and proposes solutions to strengthen strategic information (SI), the systematic collection, analysis, and dissemination of information, to optimize HIV prevention, care, and treatment programming for PWID.

Pharmacovigilance in resource-limited countries.

PubMed

Olsson, Sten; Pal, Shanthi N; Dodoo, Alex

2015-01-01

In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO's global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

The Last State to Grant Nurse Practitioners DEA Licensure: An Education Improvement Initiative on the Florida Prescription Drug Monitoring Program.

PubMed

Kellams, Joni R; Maye, John P

Nurse practitioners (NPs) now have prescriptive authority for controlled substances in all 50 states in the United States. Florida, the last state to grant NPs DEA licensure, has been wrought with prescription diversion practices for a number of years as pill mills, doctor shopping, and overprescribing proliferated. Prescription Drug Monitoring Programs (PDMPs) help curb drug diversion activity and play a key role in reducing the abuse of controlled substances. The primary objective of this education improvement initiative was to increase knowledge of actively licensed NPs in the state of Florida regarding the state's PDMP. The main themes included the drug abuse problem, description and progression of the PDMP, and how to use the Florida PDMP. Upon approval from the institutional review board, this education improvement initiative gauged NP knowledge of the PDMP and main themes before and after an educational PowerPoint intervention. A pretest/posttest questionnaire was administered for assessment of all knowledge questions. One hundred forty-five NPs with active advanced registered NP licenses in Florida completed both the pretest and posttest questionnaires. Descriptive statistics and paired t tests were used for statistical significance testing. Knowledge of the PDMP and the main themes of the education improvement initiative significantly increased (p < .001) from pretest to posttest results. This education improvement initiative had positive effects for NPs on the knowledge of the Florida PDMP and the main themes. This indicated that Florida NPs are able to acquire greater comprehension of the PDMP by an education intervention.

Clinical services provided by staff pharmacists in a community hospital.

PubMed

Garrelts, J C; Smith, D F

1990-09-01

A program for developing staff pharmacists' clinical skills and documenting pharmacists' clinical interventions in a large community teaching hospital is described. A coordinator hired in 1984 to develop clinical pharmacy services began a didactic and experiential program for baccalaureate-level staff pharmacists. Fourteen educational modules are supplemented by journal and textbook articles and small-group discussions of clinical cases, and the clinical coordinator provides individual training on the patient-care units for each pharmacist. Monitoring of clinical pharmacy services began in June 1987; each intervention provided by a pharmacist is recorded on a specially designed form. A target-drug program is used to document cost avoidance achieved through clinical services. Information collected through these monitoring activities is used to educate the pharmacy staff, shared with the pharmacy and therapeutics committee, and used to monitor prescribing patterns of individual physicians. The data are used in the hospital's productivity-monitoring system. All pharmacists who were on staff in 1984 have completed the educational modules, and all new employees are in the process. Since monitoring began, the number of clinical interventions has averaged 2098 per month. Cost avoidance has averaged $9306 per month. Over a five-year period, the development of staff pharmacists' clinical services raised the level of professional practice, produced substantial cost avoidance, and increased the number of pharmacist interventions in medication use.

How Parents of Teens Store and Monitor Prescription Drugs in the Home

ERIC Educational Resources Information Center

Friese, Bettina; Moore, Roland S.; Grube, Joel W.; Jennings, Vanessa K.

2013-01-01

Qualitative interviews were conducted with parents of teens to explore how parents store and monitor prescription drugs in the home. Most parents had prescription drugs in the house, but took few precautions against teens accessing these drugs. Strategies for monitoring included moving the drugs to different locations, remembering how many pills…

21 CFR 868.2600 - Airway pressure monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Airway pressure monitor. 868.2600 Section 868.2600 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2600 Airway pressure monitor. (a) Identification. An airway pressure monitor is a devic...

Utilization of Collaborative Practice Agreements between Physicians and Pharmacists as a Mechanism to Increase Capacity to Care for Hematopoietic Stem Cell Transplant Recipients

PubMed Central

Merten, Julianna A.; Shapiro, Jamie F.; Gulbis, Alison M.; Rao, Kamakshi V.; Bubalo, Joseph; Lanum, Scott; Engemann, Ashley Morris; Shayani, Sepideh; Williams, Casey; Leather, Helen; Walsh-Chocolaad, Tracey

2013-01-01

Survival following hematopoietic stem cell transplantation (HSCT) has improved and the number of allogeneic HSCTs performed annually in the United States is expected to reach 10,000 by 2015. The National Marrow Donor Program created the System Capacity Initiative to formulate mechanisms to care for the growing number of HSCT recipients. One proposed method to increase capacity is utilization of pharmacists to manage drug therapy via collaborative practice agreements (CPAs). Pharmacists have managed drug therapy in oncology patients with CPAs for decades; however, there are limited HSCT centers that employ this practice. Engaging in collaborative practice and billing agreements with credentialed pharmacists to manage therapeutic drug monitoring, chronic medical conditions and supportive care in HSCT recipients may be cost-effective and enable physicians to spend more time on new or more complex patients. The goal of this paper is to provide a framework for implementation of a CPA and address how it may improve HSCT program capacity. PMID:23419976

Harmonizing disease prevention and police practice in the implementation of HIV prevention programs: Up-stream strategies from Wilmington, Delaware

PubMed Central

2012-01-01

Introduction Improving access to sterile injection equipment is a key component in community-based infectious disease prevention. Implementation of syringe access programs has sometimes been complicated by community opposition and police interference. Case description In 2006, the Delaware legislature authorized a pilot syringe exchange program (SEP). A program designed to prevent, monitor, and respond to possible policing and community barriers before they had a chance to effect program implementation and operation. A program designed to prevent, monitor, and respond to these barriers was planned and implemented by a multidisciplinary team of legal practitioners and public health professionals. Discussion We report on an integrated intervention to address structural barriers to syringe exchange program utilization. This intervention employs community, police and client education combined with systematic surveillance of and rapid response to police interference to preempt the kinds of structural barriers to implementation observed elsewhere. The intervention addresses community concerns and stresses the benefits of syringe exchange programs to officer occupational safety. Conclusions A cohesive effort combining collaboration with and educational outreach to police and community members based on the needs and concerns of these groups as well as SEP clients and potential clients helped establish a supportive street environment for the SEP. Police-driven structural barriers to implementation of public health programs targeting populations engaged in drug use and other illicit behavior can be addressed by up-stream planning, prevention, monitoring and intervention strategies. More research is needed to inform the tailoring of interventions to address police-driven barriers to HIV prevention services, especially among marginalized populations. PMID:22591836

Techniques for Monitoring Drug Efficacy.

PubMed

Visser, Marike

2018-05-01

The efficacy of drugs can vary greatly between species and individuals. Establishing efficacious drug doses for a species requires integration of population pharmacokinetic and pharmacodynamic data into a dose-response curve. Unfortunately, these data sets are rarely available for exotic species. The use of alternative monitoring techniques is required to determine drug efficacy and safety. This article discusses methods to integrate efficacy monitoring into clinical practice, including the use of diagnostic testing and therapeutic drug monitoring. Copyright © 2018 Elsevier Inc. All rights reserved.

Impacts of a disease management program for dually eligible beneficiaries.

PubMed

Esposito, Dominick; Brown, Randall; Chen, Arnold; Schore, Jennifer; Shapiro, Rachel

2008-01-01

The LifeMasters Supported SelfCare demonstration program provides disease management (DM) services to Florida Medicare beneficiaries who are also enrolled in Medicaid and have congestive heart failure (CHF), diabetes, or coronary artery disease (CAD). The population-based program provides primarily telephonic patient education and monitoring services. Findings from the randomized, intent-to-treat design over the first 18 months of operations show virtually no overall impacts on hospital or emergency room (ER) use, Medicare expenditures, quality of care, or prescription drug use for the 33,000 enrollees. However, for beneficiaries with CHF who resided in high-cost South Florida counties, the program reduced Medicare expenditures by 9.6 percent.

C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

PubMed Central

Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

2010-01-01

Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

Evolution and Convergence of State Laws Governing Controlled Substance Prescription Monitoring Programs, 1998-2011

PubMed Central

Pierce, Matthew; Dasgupta, Nabarun

2014-01-01

Objectives. We sought to collect and characterize all laws governing the operation of prescription monitoring programs (PMPs), state-level databases that collect patient-specific prescription information, which have been suggested as a tool for reducing prescription drug overdose fatalities. Methods. We utilized a structured legal research protocol to systematically identify, review, and code all PMP statutes and regulations effective from 1998 through 2011. These laws were then abstracted along eleven domains, including reporting provisions, data sharing, and data access. Results. PMP characteristics vary greatly among states and across time. We observed an increase in the types and frequency of data required to be reported, the types of individuals permitted to access PMP data, and the percentage of PMPs authorized to proactively identify outlier prescribers and patients. As of 2011, 10 states required PMPs to report suspicious activity to law enforcement, while only 3 required reporting to the patient’s physician. None required linkage to drug treatment or required all prescribers to review PMP data before prescribing. Few explicitly address data retention. Conclusions. State PMP laws are heterogeneous and evolving. Future studies of PMP effectiveness should take these variations into account. PMID:24922132

21 CFR 870.2620 - Line isolation monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Line isolation monitor. 870.2620 Section 870.2620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2620 Line isolation monitor...

21 CFR 870.2620 - Line isolation monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Line isolation monitor. 870.2620 Section 870.2620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2620 Line isolation monitor...

Long-acting penicillins: historical perspectives.

PubMed

Markowitz, M

1985-01-01

For the more than three decades since benzathine penicillin G was discovered it remains unique as the only antibiotic formulation that can provide serum drug concentrations for several weeks following a single intramuscular injection. Benzathine penicillin G has withstood the test of time as the ideal drug to treat early, infectious syphilis and to prevent and treat Group A streptococcal infections. It has proved to be extraordinarily effective for the prevention of rheumatic fever recurrences and is a major reason for the marked reduction in the morbidity and mortality in countries where carefully monitored prophylaxis programs have been established.

Development of a computerized monitoring program to identify narcotic diversion in a pediatric anesthesia practice.

PubMed

Brenn, B Randall; Kim, Margaret A; Hilmas, Elora

2015-08-15

Development of an operational reporting dashboard designed to correlate data from multiple sources to help detect potential drug diversion by automated dispensing cabinet (ADC) users is described. A commercial business intelligence platform was used to create a dashboard tool for rapid detection of unusual patterns of ADC transactions by anesthesia service providers at a large pediatric hospital. By linking information from the hospital's pharmacy information management system (PIMS) and anesthesia information management system (AIMS) in an associative data model, the "narcotic reconciliation dashboard" can generate various reports to help spot outlier activity associated with ADC dispensing of controlled substances and documentation of medication waste processing. The dashboard's utility was evaluated by "back-testing" the program with historical data on an actual episode of diversion by an anesthesia provider that had not been detected through traditional methods of PIMS and AIMS data monitoring. Dashboard-generated reports on key metrics (e.g., ADC transaction counts, discrepancies in dispensed versus reconciled amounts of narcotics, PIMS-AIMS documentation mismatches) over various time frames during the period of known diversion clearly indicated the diverter's outlier status relative to other authorized ADC users. A dashboard program for correlating ADC transaction data with pharmacy and patient care data may be an effective tool for detecting patterns of ADC use that suggest drug diversion. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Pain management and opioid risk mitigation in the military.

PubMed

Sharpe Potter, Jennifer; Bebarta, Vikhyat S; Marino, Elise N; Ramos, Rosemarie G; Turner, Barbara J

2014-05-01

Opioid analgesics misuse is a significant military health concern recognized as a priority issue by military leadership. Opioids are among those most commonly prescribed medications in the military for pain management. The military has implemented opioid risk mitigation strategies, including the Sole Provider Program and the Controlled Drug Management Analysis and Reporting Tool, which are used to identify and monitor for risk and misuse. However, there are substantial opportunities to build on these existing systems to better ensure safer opioid prescribing and monitor for misuse. Opioid risk mitigation strategies implemented by the civilian sector include establishing clinical guidelines for opioid prescribing and prescription monitoring programs. These strategies may help to inform opioid risk mitigation in the military health system. Reducing the risk of opioid misuse and improving quality of care for our Warfighters is necessary. This must be done through evidence-based approaches with an investment in research to improve patient care and prevent opioid misuse as well as its sequelae. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

High-Risk Obtainment of Prescription Drugs by Older Adults in New Jersey: The Role of Prescription Opioids.

PubMed

Gold, Sarah L; Powell, Kristen Gilmore; Eversman, Michael H; Peterson, N Andrew; Borys, Suzanne; Hallcom, Donald K

2016-10-01

To explore the high-risk ways in which older adults obtain prescription opioids and to identify predictors of obtaining prescription opioids from high-risk sources, such as obtaining the same drug from multiple doctors, sharing drugs, and stealing prescription pads. Logistic regression analyses of cross-sectional survey data from the New Jersey Older Adult Survey on Drug Use and Health, a representative random-sample survey. Adults aged 60 and older (N = 725). Items such as obtaining prescriptions for the same drug from more than one doctor and stealing prescription drugs were measured to determine high-risk obtainment of prescription opioids. Almost 15% of the sample used high-risk methods of obtaining prescription opioids. Adults who previously used a prescription opioid recreationally had three times the risk of high-risk obtainment of prescription opioids. These findings illustrate the importance of strengthening prescription drug monitoring programs to reduce high-risk use of prescription drugs in older adults by alerting doctors and pharmacists to potential prescription drug misuse and interactions. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Rationale for Quality Assurance in Fecal Egg Monitoring of Soil-Transmitted Helminthiasis.

PubMed

Hoekendijk, David J L; Hill, Philip C; Sowerby, Stephen J

2016-09-07

Substantial investment has been made into the once "neglected" tropical disease, soil-transmitted helminthiasis, and into control programs that operate within a framework of mapping baseline disease distribution, measuring the effectiveness of applied interventions, establishing when to cease drug administration, and for posttreatment evaluations. However, critical to each of these stages is the determination of helminth infection. The limitations of traditional microscope-based fecal egg diagnostics have not provided quality assurance in the monitoring of parasite disease and suboptimal treatment regimes provide for the potential development of parasite resistance to anthelmintic drugs. Improved diagnostic and surveillance tools are required to protect therapeutic effectiveness and to maintain funder confidence. Such tools may be on the horizon with emergent technologies that offer potential for enhanced visualization and quality-assured quantitation of helminth eggs. © The American Society of Tropical Medicine and Hygiene.

Cocaine use and syphilis trends: findings from the arrestee drug abuse monitoring (ADAM) program and syphilis epidemiology in Houston.

PubMed

Ross, Michael W; Risser, Jan; Peters, Ronald J; Johnson, Regina J

2006-01-01

There has been speculation that trends in syphilis have been fueled by crack cocaine use. This study examined the data on syphilis notifications and arrestee drug abuse monitoring (ADAM) to ascertain the relationships between syphilis and cocaine use trends in three racial/ethnic groups. Syphilis notifications and data from the ADAM project were compared in Houston/Harris County, Texas, from 1991-1998 using a linear regression equation. Data indicated significant relationships between the data for cocaine use and syphilis in African Americans but not Hispanics or non-Hispanic whites. For African Americans, 58% of the variance between cocaine use and syphilis was explained. When data limited to jail syphilis notifications and ADAM cocaine in African Americans were examined, the association was stronger for males than for females. For African Americans, cocaine (probably crack cocaine) use trends were significantly associated with syphilis trends in this population. These data suggest that control of crack cocaine may have an impact on syphilis rates and that there may be close relationships between some STDs and drug abuse.

A review on therapeutic drug monitoring of immunosuppressant drugs.

PubMed

Mohammadpour, Niloufar; Elyasi, Sepideh; Vahdati, Naser; Mohammadpour, Amir Hooshang; Shamsara, Jamal

2011-11-01

: Immunosuppressants require therapeutic drug monitoring because of their narrow therapeutic index and significant inter-individual variability in blood concentrations. This variability can be because of factors like drug-nutrient interactions, drug-disease interactions, renal-insufficiency, inflammation and infection, gender, age, polymorphism and liver mass. Drug monitoring is widely practiced especially for cyclosporine, tacrolimus, sirolimus and mycophenolic acid. CYCLOSPORINE: Therapeutic monitoring of immunosuppressive therapy with cyclosporine is a critical requirement because of intra- and inter-patient variability of drug absorption, narrow therapeutic window and drug induced nephrotoxicity. MYCOPHENOLIC ACID MPA: Some reasons for therapeutic drug monitoring of MPA during post-transplant period include: relationship between MPA pharmacokinetic parameters and clinical outcomes, Inter-patient pharmacokinetic variability for MPA despite fixed MMF doses, alternations of MPA pharmacokinetics during the first months after transplantation, drug- drug interaction and influence of kidney function on MPA pharmacokinetic. SIROLIMUS: A recent review of the pharmacokinetics of sirolimus suggested a therapeutic range of 5 to 10 μg l(-1) in whole blood. However, the only consensus guidelines published on the therapeutic monitoring of sirolimus concluded that there was not enough information available about the clinical use of the drug to make recommendations. TACROLIMUS: Sudies have shown, in kidney and liver transplant patients, significant associations of low tacrolimus concentrations with rejection and of high concentrations with nephrotoxicity. Although the feasibility of a limited sampling scheme to predict AUC has been demonstrated, as yet, trough, or pre-dose, whole blood concentration monitoring is still the method of choice.

21 CFR 880.2400 - Bed-patient monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bed-patient monitor. 880.2400 Section 880.2400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Devices § 880.2400 Bed-patient monitor. (a) Identification. A bed-patient monitor is a battery-powered...

21 CFR 868.2375 - Breathing frequency monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Breathing frequency monitor. 868.2375 Section 868.2375 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2375 Breathing frequency monitor. (a) Identification. A breathing (ventilatory)...

Digoxin therapeutic drug monitoring practices. A College of American Pathologists Q-Probes study of 666 institutions and 18,679 toxic levels.

PubMed

Howanitz, P J; Steindel, S J

1993-07-01

We investigated digoxin therapeutic drug monitoring practices in 666 institutions participating in Q-Probes, a quality improvement program of the College of American Pathologists. Participants used 13 different lower and 16 different upper limits for their therapeutic range. More than 280,000 digoxin levels were studied, and 6.7% (n = 8679) of results were in the toxic range (> 2.6 nmol/L). For the 77% of patients with toxic levels, the last digoxin dose was given orally; for 23% of patients, it was given intravenously; and for less than 1%, it was given intramuscularly. Between 22% and 31% of specimens in the toxic range were obtained before steady state had occurred, depending on the criteria used. Small institutions (less than 150 beds), outpatients, stat specimens, and laboratory policies not requiring the time of the last dose before measurement were associated with higher percentages of specimens drawn before the recommended time had elapsed. We describe digoxin monitoring practice patterns and provide suggestions for improvement.

Surveillance of drug abuse in Hong Kong by hair analysis using LC-MS/MS.

PubMed

Leung, K Wing; Wong, Zack C F; Ho, Janet Y M; Yip, Ada W S; Cheung, Jerry K H; Ho, Karen K L; Duan, Ran; Tsim, Karl W K

2018-06-01

The aim of this study is to reveal the habits of drug abusers in hair samples from drug rehabilitation units in Hong Kong. With the application of liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology, a total of 1771 hair samples were analyzed during the period of hair testing service (January 2012 to March 2016) provided to 14 drug rehabilitation units including non-governmental organizations (NGOs), rehabilitation centers, and medical clinics. Hair samples were analyzed for abused drugs and their metabolites simultaneously, including ketamine, norketamine, cocaine, benzoylecgonine, cocaethylene, norcocaine, codeine, MDMA, MDA, MDEA, amphetamine, methamphetamine, morphine, 6-acetylmorphine, phencyclidine, and methadone. The results showed that ketamine (77.2%), cocaine (21.3%), and methamphetamine (16.5%) were the frequently detected drugs among those drug abusers, which is consistent with the reported data. In addition, the usage of multiple drugs was also observed in the hair samples. About 29% of drug-positive samples were detected with multiple drug use. Our studies prove that our locally developed hair drug-testing method and service can be a valid tool to monitor the use of abused drugs, and which could facilitate rehabilitation program management. Copyright © 2017 John Wiley & Sons, Ltd.

Antimicrobial formulary management: meeting the challenge in the community hospital.

PubMed

Rush, D R

1991-01-01

We established a casework approach to develop an antibiotic formulary for a large community hospital. The program consists of a combination of comprehensive clinical and administrative strategies designed to reduce antimicrobial expenditures and improve the quality of antibiotic prescribing. Strategies included a background document summarizing each pharmacologic group of antimicrobial drugs and formulary preferences, presentations to medical and surgical departments, development of drug use evaluation strategies that complement the development of the formulary, and a monitoring program for nonformulary antibiotic use. The development of a customized microbiologic/antibiotic susceptibility report card specific to the institution's inpatient and outpatient microflora was an integral part of the program. This tool also allowed for the continuous compilation of comparison data and development of prescribing tips. Predetermined criteria were established providing physicians with microorganism susceptibility reports and preferred treatment alternatives linked to pharmacoeconomic concerns. These strategies can be implemented with or without direct clinical pharmacotherapy specialist involvement at the individual patient care level.

Medical prescriptions falsified by the patients: a 12-year national monitoring to assess prescription drug diversion.

PubMed

Jouanjus, Emilie; Guernec, Grégory; Lapeyre-Mestre, Maryse

2018-06-01

Diversion of prescription drugs is difficult to assess in quality and quantity. This study aimed to characterize diversion of prescription drugs in France through a comparative analysis of falsified prescriptions collected during three periods from 2001 to 2012. The data recorded in a national program which records all falsified prescriptions presented to community pharmacies were studied. Included data regarded: subjects, prescription forms, and drugs. Description of the dataset in three periods (2001-2004, 2005-2008, and 2009-2012) was completed with clustering analyses to characterize profiles of prescriptions and subjects associated with the most reported drugs. The 4469 falsified prescriptions concerned most often females (51.6%). Average age was 46.5 years. Zolpidem, bromazepam, and buprenorphine were the most frequent drugs. Alone, 13 drugs (1.7%, 13/772) represented more than 40% of the total reports (3055/7272). They were associated with three diversion profiles: (i) buprenorphine, flunitrazepam, and morphine were mentioned on overlapping secure prescription forms presented by young men; (ii) alprazolam, bromazepam, zolpidem, codeine/acetaminophen were mentioned on simple prescription forms presented by experienced women; and (iii) acetaminophen and lorazepam were mentioned on modified prescription forms presented by elderly subjects. Clonazepam, clorazepate, dextropropoxyphene, zopiclone moved between those profiles. The patterns of falsified prescriptions provided in this study contribute to enhance the scientific knowledge on the most diverted prescription drugs. The latter follow distinct trajectories across time depending on their pharmacology (including their abuse/addiction potential) and on their regulation's history. The close and continuous analysis of falsified prescriptions is an excellent way to monitor prescription drug diversion. © 2018 Société Française de Pharmacologie et de Thérapeutique.

Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults.

PubMed

McCollister, Kathryn; Yang, Xuan; McKay, James R

2016-01-01

The study conducts a cost-effectiveness analysis (CEA) of a continuing care Telephone Monitoring and Counseling (TMC) intervention for adults diagnosed with cocaine dependence. Participants were randomly assigned to a control condition of intensive outpatient treatment only (treatment-as-usual, or TAU; N=108), or to one of two treatment conditions featuring TMC (N=106) and TMC plus incentives (TMC-plus; N=107). Follow-up assessments were conducted over a 2-year period. Intervention and client costs were collected with the program and client versions of the Drug Abuse Treatment Cost Analysis Program (DATCAP). Effectiveness was measured as the number of days abstinent during follow-up. Secondary analyses consider alternative measures of effectiveness and the reduced societal costs of physical and mental health problems and criminal justice involvement. From the societal perspective, TMC dominates both TAU and TMC-plus as a cost-effective and cost-saving intervention. Results varied by substance-using status, however, with the subgroup of participants in TMC-plus that were using drugs at intake and early in treatment having the greatest number of days of abstinence and generating similar savings during follow-up than the TMC subgroup using drugs at intake. Telephone monitoring and counseling appears to be a cost-effective and potentially cost-saving strategy for reducing substance use among chronic substance users. Providing client incentives added to total intervention costs but did not improve overall effectiveness. Clinical Trials.gov Number: NCT00685659. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance.

PubMed

LaPointe, Nancy M Allen; Pamer, Carol A; Kramer, Judith M

2003-10-01

To determine how well dofetilide and Betapace AF (sotalol, approved solely for atrial fibrillation and atrial flutter), with their detailed dosing and monitoring guidelines for safety, were accepted into clinical practice during the 2 calendar years after their introduction. We reviewed the number of new, refill, and total prescriptions of all antiarrhythmic agents in the United States from April 2000-December 2001 to assess use of dofetilide and Betapace AF in the drug market. Both were prescribed very infrequently throughout the study period. In addition, the infrequent reported use of these drugs for patients with atrial fibrillation and flutter indicated poor acceptance of these agents by prescribing physicians. We speculated that the restricted distribution and required educational program for dofetilide, as well as the availability of generic sotalol products, may have discouraged physicians from prescribing both dofetilide and Betapace AE CONCLUSION: A common goal for both the dofetilide risk-management program and the creation of a sotalol product indicated solely for atrial fibrillation and atrial flutter was to provide safer treatment for patients with these arrhythmias. Unfortunately, limited penetration of dofetilide and Betapace AF into the U.S. market suggests that drugs without a risk-management program or detailed dosing guidelines were more likely than dofetilide or Betapace AF to be selected for treatment of atrial fibrillation and atrial flutter.

Active surveillance of abused and misused prescription opioids using poison center data: a pilot study and descriptive comparison.

PubMed

Hughes, Alice A; Bogdan, Gregory M; Dart, Richard C

2007-01-01

Prescription opioids are abused throughout the United States. Several monitoring programs are in existence, however, none of these systems provide up-to-date information on prescription opioid abuse. This article describes the use of poison centers as a real-time, geographically specific, surveillance system for prescription opioid abuse and compares our system with an existing prescription drug abuse monitoring program, the Drug Abuse Warning Network (DAWN). Data were collected from eight geographically dispersed poison centers for a period of twelve months. Any call involving buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, and oxycodone was considered a case. Any case coded as intentional exposure (abuse, intentional misuse, suicide, or intentional unknown) was regarded as misuse and abuse. Comparative data were obtained from DAWN. Poison center rates of abuse and misuse were highest for hydrocodone at 3.75 per 100,000 population, followed by oxycodone at 1.81 per 100,000 population. DAWN emergency department (ED) data illustrate a similar pattern of abuse with most mentions involving hydrocodone and oxycodone. Poison center data indicate that people aged 18 to 25 had the highest rates of abuse. DAWN reported the majority of ED mentions among 35 to 44-year-olds. Geographically, Kentucky had the uppermost rates of abuse and misuse for all opioids combined at 20.69 per 100,000 population. CONCLUSIONS. Comparing poison center data to DAWN yielded mostly comparable results, including hydrocodone as the most commonly mentioned drug. Our results suggest poison center data can be used as an indicator for prescription opioid abuse and misuse and can provide timely, geographically specific information on prescription drug abuse.

Forensic toxicology.

PubMed

Drummer, Olaf H

2010-01-01

Forensic toxicology has developed as a forensic science in recent years and is now widely used to assist in death investigations, in civil and criminal matters involving drug use, in drugs of abuse testing in correctional settings and custodial medicine, in road and workplace safety, in matters involving environmental pollution, as well as in sports doping. Drugs most commonly targeted include amphetamines, benzodiazepines, cannabis, cocaine and the opiates, but can be any other illicit substance or almost any over-the-counter or prescribed drug, as well as poisons available to the community. The discipline requires high level skills in analytical techniques with a solid knowledge of pharmacology and pharmacokinetics. Modern techniques rely heavily on immunoassay screening analyses and mass spectrometry (MS) for confirmatory analyses using either high-performance liquid chromatography or gas chromatography as the separation technique. Tandem MS has become more and more popular compared to single-stage MS. It is essential that analytical systems are fully validated and fit for the purpose and the assay batches are monitored with quality controls. External proficiency programs monitor both the assay and the personnel performing the work. For a laboratory to perform optimally, it is vital that the circumstances and context of the case are known and the laboratory understands the limitations of the analytical systems used, including drug stability. Drugs and poisons can change concentration postmortem due to poor or unequal quality of blood and other specimens, anaerobic metabolism and redistribution. The latter provides the largest handicap in the interpretation of postmortem results.

Medication-use evaluation with a Web application.

PubMed

Burk, Muriel; Moore, Von; Glassman, Peter; Good, Chester B; Emmendorfer, Thomas; Leadholm, Thomas C; Cunningham, Francesca

2013-12-15

A Web-based application for coordinating medication-use evaluation (MUE) initiatives within the Veterans Affairs (VA) health care system is described. The MUE Tracker (MUET) software program was created to improve VA's ability to conduct national medication-related interventions throughout its network of 147 medical centers. MUET initiatives are centrally coordinated by the VA Center for Medication Safety (VAMedSAFE), which monitors the agency's integrated databases for indications of suboptimal prescribing or drug therapy monitoring and adverse treatment outcomes. When a pharmacovigilance signal is detected, VAMedSAFE identifies "trigger groups" of at-risk veterans and uploads patient lists to the secure MUET application, where locally designated personnel (typically pharmacists) can access and use the data to target risk-reduction efforts. Local data on patient-specific interventions are stored in a centralized database and regularly updated to enable tracking and reporting for surveillance and quality-improvement purposes; aggregated data can be further analyzed for provider education and benchmarking. In a three-year pilot project, the MUET program was found effective in promoting improved prescribing of erythropoiesis-stimulating agents (ESAs) and enhanced laboratory monitoring of ESA-treated patients in all specified trigger groups. The MUET initiative has since been expanded to target other high-risk drugs, and efforts are underway to refine the tool for broader utility. The MUET application has enabled the increased standardization of medication safety initiatives across the VA system and may serve as a useful model for the development of pharmacovigilance tools by other large integrated health care systems.

Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application.

PubMed

Jha, Ashish K; Laguette, Julia; Seger, Andrew; Bates, David W

2008-01-01

Computerized monitors can effectively detect and potentially prevent adverse drug events (ADEs). Most monitors have been developed in large academic hospitals and are not readily usable in other settings. We assessed the ability of a commercial program to identify and prevent ADEs in a community hospital. and Measurement We prospectively evaluated the commercial application in a community-based hospital. We examined the frequency and types of alerts produced, how often they were associated with ADEs and potential ADEs, and the potential financial impact of monitoring for ADEs. Among 2,407 patients screened, the application generated 516 high priority alerts. We were able to review 266 alerts at the time they were generated and among these, 30 (11.3%) were considered substantially important to warrant contacting the physician caring for the patient. These 30 alerts were associated with 4 ADEs and 11 potential ADEs. In all 15 cases, the responsible physician was unaware of the event, leading to a change in clinical care in 14 cases. Overall, 23% of high priority alerts were associated with an ADE (95% confidence interval [CI] 12% to 34%) and another 15% were associated with a potential ADE (95% CI 6% to 24%). Active surveillance used approximately 1.5 hours of pharmacist time daily. A commercially available, computer-based ADE detection tool was effective at identifying ADEs. When used as part of an active surveillance program, it can have an impact on preventing or ameliorating ADEs.

Mediation of a Preventive Intervention’s Six-Year Effects on Health Risk Behaviors

PubMed Central

Soper, Ana C.; Wolchik, Sharlene A.; Tein, Jenn-Yun; Sandler, Irwin N.

2010-01-01

Using data from a 6-year longitudinal follow-up sample of 240 youth who participated in a randomized experimental trial of a preventive intervention for divorced families with children ages 9 -12, the current study tested mechanisms by which the intervention reduced substance use and risky sexual behavior in mid to late adolescence (15–19 years old). Mechanisms tested included parental monitoring, adaptive coping, and negative errors. Parental monitoring at 6-year follow-up mediated program effects to reduce alcohol and marijuana use, polydrug use, and other drug use for those with high pre-test risk for maladjustment. In the condition that included a program for mothers only, increases in youth adaptive coping at 6-year follow-up mediated program effects on risky sexual behavior for those with high pre-test risk for maladjustment. Contrary to expectation, program participation increased negative errors and decreased adaptive coping among low risk youth in some of the analyses. Ways in which this study furthers our understanding of pathways through which evidence-based preventive interventions affect health risk behaviors are discussed. PMID:20565156

Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS).

PubMed

Manchikanti, Laxmaiah; Malla, Yogesh; Wargo, Bradley W; Cash, Kimberly A; Pampati, Vidyasagar; Damron, Kim S; McManus, Carla D; Brandon, Doris E

2010-01-01

Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. A diagnostic accuracy study of urine drug testing. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. The limitations include lack of availability of POC testing with lower cutoff levels. This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. NCT 01052155.

Physicians' Perspectives Regarding Prescription Drug Monitoring Program Use Within the Department of Veterans Affairs: a Multi-State Qualitative Study.

PubMed

Radomski, Thomas R; Bixler, Felicia R; Zickmund, Susan L; Roman, KatieLynn M; Thorpe, Carolyn T; Hale, Jennifer A; Sileanu, Florentina E; Hausmann, Leslie R M; Thorpe, Joshua M; Suda, Katie J; Stroupe, Kevin T; Gordon, Adam J; Good, Chester B; Fine, Michael J; Gellad, Walid F

2018-03-08

The Department of Veterans Affairs (VA) has implemented robust strategies to monitor prescription opioid dispensing, but these strategies have not accounted for opioids prescribed by non-VA providers. State-based prescription drug monitoring programs (PDMPs) are a potential tool to identify VA patients' receipt of opioids from non-VA prescribers, and recent legislation requires their use within VA. To evaluate VA physicians' perspectives and experiences regarding use of PDMPs to monitor Veterans' receipt of opioids from non-VA prescribers. Qualitative study using semi-structured interviews. Forty-two VA primary care physicians who prescribed opioids to 15 or more Veterans in 2015. We sampled physicians from two states with PDMPs (Massachusetts and Illinois) and one without prescriber access to a PDMP at the time of the interviews (Pennsylvania). From February to August 2016, we conducted semi-structured telephone interviews that addressed the following topics regarding PDMPs: overall experiences, barriers to optimal use, and facilitators to improve use. VA physicians broadly supported use of PDMPs or desired access to one, while exhibiting varying patterns of PDMP use dictated by state laws and their clinical judgment. Physicians noted administrative burdens and incomplete or unavailable prescribing data as key barriers to PDMP use. To facilitate use, physicians endorsed (1) linking PDMPs with the VA electronic health record, (2) using templated notes to document PDMP use, and (3) delegating routine PDMP queries to ancillary staff. Despite the time and administrative burdens associated with their use, VA physicians in our study broadly supported PDMPs. The application of our findings to ongoing PDMP implementation efforts may strengthen PDMP use both within and outside VA and improve the safe prescribing of opioids.

Monitoring compliance to therapy during addiction treatments by means of hair analysis for drugs and drug metabolites using capillary zone electrophoresis coupled to time-of-flight mass spectrometry.

PubMed

Gottardo, Rossella; Fanigliulo, Ameriga; Sorio, Daniela; Liotta, Eloisa; Bortolotti, Federica; Tagliaro, Franco

2012-03-10

Capillary electrophoresis coupled to time-of-flight mass spectrometry was used in the present work for the determination of therapeutic and abused drugs and their metabolites in the hair of subjects undergoing addiction treatments, in order to monitor their compliance to therapy. For this purpose a rapid, qualitative drug screening method was adopted based on capillary electrophoresis hyphenated with time-of-flight mass spectrometry, which had earlier been developed and validated for the forensic-toxicological analysis of hair, limitedly to illicit/abused drugs [1]. Sampling of hair was carried out in order to refer to a time window of about two months from the date of sampling (i.e. 2cm ca. from cortex). A single extraction procedure was applied, allowing the determination in the hair matrix of "drugs of abuse" referred to the past abuses, and therapeutic drugs prescribed in the detoxification program as well as their metabolites. Analyte identification was based on accurate mass measurements and comparison of isotope patterns, providing the most likely matching between accurate mass value and elemental formula. Small molecules (<500Da) of forensic and toxicological interest could be identified unambiguously using mass spectrometric conditions tailored to meet a mass accuracy ≤5ppm. In the present study, the proposed approach proved suitable for the rapid broad spectrum screening of hair samples, although needing further confirmation of results by using fragmentation mass spectrometry. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

A Bioinformatic Pipeline for Monitoring of the Mutational Stability of Viral Drug Targets with Deep-Sequencing Technology.

PubMed

Kravatsky, Yuri; Chechetkin, Vladimir; Fedoseeva, Daria; Gorbacheva, Maria; Kravatskaya, Galina; Kretova, Olga; Tchurikov, Nickolai

2017-11-23

The efficient development of antiviral drugs, including efficient antiviral small interfering RNAs (siRNAs), requires continuous monitoring of the strict correspondence between a drug and the related highly variable viral DNA/RNA target(s). Deep sequencing is able to provide an assessment of both the general target conservation and the frequency of particular mutations in the different target sites. The aim of this study was to develop a reliable bioinformatic pipeline for the analysis of millions of short, deep sequencing reads corresponding to selected highly variable viral sequences that are drug target(s). The suggested bioinformatic pipeline combines the available programs and the ad hoc scripts based on an original algorithm of the search for the conserved targets in the deep sequencing data. We also present the statistical criteria for the threshold of reliable mutation detection and for the assessment of variations between corresponding data sets. These criteria are robust against the possible sequencing errors in the reads. As an example, the bioinformatic pipeline is applied to the study of the conservation of RNA interference (RNAi) targets in human immunodeficiency virus 1 (HIV-1) subtype A. The developed pipeline is freely available to download at the website http://virmut.eimb.ru/. Brief comments and comparisons between VirMut and other pipelines are also presented.

Sequential Delivery of Cyclopeptide RA-V and Doxorubicin for Combination Therapy on Resistant Tumor and In Situ Monitoring of Cytochrome c Release

PubMed Central

Chen, Huachao; Wang, Yurong; Yao, Yongrong; Qiao, Shenglin; Wang, Hao; Tan, Ninghua

2017-01-01

A programmed drug delivery system that can achieve sequential release of multiple therapeutics under different stimulus holds great promise to enhance the treatment efficacy and overcome multi-drug resistance (MDR) in tumor. Herein, multi-organelle-targeted and pH/ cytochrome c (Cyt c) dual-responsive nanoparticles were designed for combination therapy on resistant tumor. In this system (designated DGLipo NPs), doxorubicin (Dox) was intercalated into the DNA duplex containing a Cyt c aptamer, which subsequently loaded in the dendrigraftpoly-L-lysines (DGL) cores of DGLipo NPs, while cyclopeptide RA-V was doped into the pH-sensitive liposomal shells. After dual modification with c(RGDfK) and mitochondria-penetrating peptide (MPP), DGLipo NPs could successively deliver the two drugs into lysosome and mitochondria of cancer cells, and achieve sequential drug release in virtue of the unique characteristic of these two organelles. The organelle-specific and spatiotemporally controlled release of Dox and RA-V led to enhanced therapeutic outcomes in MDR tumor. More significantly, the DGLipo NPs were successfully applied to monitor Cyt c release during mitochondria-mediated apoptotic process. This work represents a versatile strategy for precise combination therapy against resistant tumor with spatiotemporal control, and provides a potential tool for Cyt c-related apoptotic studies. PMID:29109776

Oral Fluid as an Alternative Matrix to Monitor Opiate and Cocaine Use in Substance-Abuse Treatment Patients

PubMed Central

Dams, Riet; Choo, Robin E.; Lambert, Willy E.; Jones, Hendree; Huestis, Marilyn A.

2007-01-01

Interest in oral fluid as an alternative matrix for monitoring drug use is due to its ease-of-collection and non-invasiveness; however, limited data are available on the disposition of drugs into oral fluid. The objective of this research was to provide data on the presence and concentrations of heroin, cocaine and multiple metabolites in oral fluid after illicit opioid and cocaine use. Thrice weekly oral fluid specimens (N=403) from 16 pregnant opiate-dependent women were obtained with the Salivette® oral fluid collection device. Evidence of heroin (N=62) and cocaine (N=130) use was detected in oral fluid by LC-APCI-MS/MS. 6-Acetylmorphine (6-AM), heroin and morphine were the major opiates detected, with median concentrations of 5.2, 2.3, and 7.5 μg/L, respectively. Cocaine and benzoylecgonine (BE) had median concentrations of 6.4 and 3.4 μg/L. Application of the Substance Abuse Mental Health Services Administration (SAMHSA) recommended cutoffs for morphine and codeine (40 μg/L), 6-AM (4 μg/L) and cocaine and BE (8 μg/L), yielded 28 opiate- and 50 cocaine-positive specimens. Oral fluid is a promising alternative matrix to monitor opiate and cocaine use in drug testing programs. These data guide interpretation of oral fluid test results and evaluate currently proposed SAMHSA oral fluid testing cutoffs. PMID:17008030

Shifting blame: Buprenorphine prescribers, addiction treatment, and prescription monitoring in middle-class America.

PubMed

Mendoza, Sonia; Rivera-Cabrero, Allyssa S; Hansen, Helena

2016-08-01

Growing nonmedical prescription opioid analgesic use among suburban and rural Whites has changed the public's perception of the nature of opioid addiction, and of appropriate interventions. Opioid addiction has been recast as a biological disorder in which patients are victims of their neurotransmitters and opioid prescribers are irresponsible purveyors of dangerous substances requiring controls. This framing has led to a different set of policy responses than the "War on Drugs" that has focused on heroin trade in poor urban communities; in response to prescription opioid addiction, prescription drug monitoring programs and tamper-resistant opioid formulations have arisen as primary interventions in place of law enforcement. Through the analysis of preliminary findings from interviews with physicians who are certified to manage opioid addiction with the opioid pharmaceutical buprenorphine, we argue that an increase in prescriber monitoring has shifted the focus from addicted people to prescribers as a threat, paradoxically driving users to illicit markets and constricting their access to pharmaceutical treatment for opioid addiction. Prescriber monitoring is also altering clinical cultures of care, as general physicians respond to heightened surveillance and the psychosocial complexities of treating addiction with either rejection of opioid dependent patients, or with resourceful attempts to create support systems for their treatment where none exists. © The Author(s) 2016.

Antipsychotic polypharmacy prescribing patterns and costs in the Florida adult and child Medicaid populations.

PubMed

Becker, Edmund R; Constantine, Robert J; McPherson, Marie A; Jones, Mary Elizabeth

2013-01-01

The rapid growth in the use of antipsychotic medications and their related costs have resulted in states developing programs to measure, monitor, and insure their beneficial relevance to public program populations. One such program developed in the state of Florida has adopted an evidence-based approach to identify prescribers with unusual psychotherapeutic prescription patterns and track their utilization and costs among Florida Medicaid patients. This study reports on the prescriber prescription and cost patterns for adults and children using three measures of unusual antipsychotic prescribing patterns: (1) two antipsychotics for 60 days (2AP60), (2) three antipsychotics for 60 days (3AP60), and (2) two antipsychotics for 90 or more days (2AP90). We find that over the four-year study period there were substantial increases in several aspects of the Florida Medicaid behavioral drug program. Overall, for adults and children, patient participation increased by 29 percent, the number of prescriptions grew by 30 percent, and the number of prescribers that wrote at least one prescription grew 48.5 percent, while Medicaid costs for behavioral drugs increased by 32 percent. But the results are highly skewed. We find that a relatively small number of prescribers account for a disproportionately large share of prescriptions and costs of the unusual antipsychotic prescriptions. In general, the top 350 Medicaid prescribers accounted for more than 70 percent of the unusual antipsychotic prescriptions, and we find that this disparity in unusual prescribing patterns appears to be substantially more pronounced in adults than in children prescribers. For just the top 13 adult and children prescribers, their practice patterns accounted for 11 percent to 21 percent of the unusual prescribing activity and, overall, these 13 top prescribers accounted for 13 percent of the total spent on antipsychotics by the Florida Medicaid program and 9.3 percent of the total expenditure by the state for all drugs. Our findings suggest that a strategy to monitor and ensure patient safety and prescribing patterns that targets a relatively small number of Medicaid providers could have a substantial benefit and prove to be cost effective.

21 CFR 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cutaneous carbon dioxide (PcCO2) monitor. 868.2480 Section 868.2480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Monitoring Devices § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor. (a) Identification. A...

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

PubMed Central

Capoor, Malini R; Bhowmik, Kumar Tapas

2017-01-01

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

Self-Monitoring of Blood Glucose: Impact of Quantity Limits in Public Drug Formularies on Provincial Costs Across Canada.

PubMed

Knowles, Sandra R; Lee, Kathy; Paterson, J Michael; Shah, Baiju R; Mamdani, Muhammad M; Juurlink, David N; Gomes, Tara

2017-04-01

For most patients with diabetes, routine use of blood glucose test strips (BGTS) has not been shown to be beneficial, yet the economic implications of broad publicly funded reimbursement for BGTS are substantial. We assessed the potential impact of BGTS quantity limits on utilization and costs for 6 publicly funded drug plans across Canada. A cross-sectional analysis was conducted in 6 provinces (Alberta, Saskatchewan, Manitoba, Nova Scotia, Newfoundland and Labrador and Prince Edward Island) for patients who received at least 1 prescription for BGTS in 2014 through the public drug program. We determined the number of BGTS that would have exceeded the quantity limits and the associated costs to the provincial drug program. A total of $38,051,026 was spent on BGTS reimbursed through public drug programs among the 6 provinces. In provinces where BGTS use is largely restricted to patients using insulin, the potential annual savings were minimal, ranging from 0.4% to 2.3%, whereas in provinces with more liberal listings, potential savings ranged from 12.4% to 19.8%. Combining these results with data from a previous analysis in Ontario and British Columbia, the cost savings associated with BGTS quantity limits for 8 provinces across Canada (capturing approximately three-quarters of the Canadian population) is estimated to be $30.3 million annually. The national implementation of a quantity limit policy for BGTS that aligns with evidence of efficacy, optimal prescribing and patient safety can lead to considerable savings for most public drug plans across Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

New technology in electrophysiology: FDA process and perspective.

PubMed

Selzman, Kimberly A; Fellman, Mark; Farb, Andrew; de Del Castillo, Sergio; Zuckerman, Bram

2016-10-01

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

The development of a comprehensive risk-management program for prescription opioid analgesics: researched abuse, diversion and addiction-related surveillance (RADARS).

PubMed

Cicero, Theodore J; Dart, Richard C; Inciardi, James A; Woody, George E; Schnoll, Sidney; Muñoz, Alvaro

2007-03-01

OBJECTIVE. Beginning in the late 1990's a marked increase in abuse of OxyContin emerged, which led to the development and establishment of a proactive surveillance program to monitor and characterize abuse, named the Researched Abuse, Diversion and Addiction Related Surveillance (RADARS) System. The main goal of RADARS was to develop proactive, timely and geographically sensitive methods to assess the abuse and diversion of OxyContin, along with a number of other Schedule II and III opioids with the aim of using this information to guide risk reduction interventions. Thus, its major focus was the detection of abuse of OxyContin and other commonly prescribed opioid analgesics at the three-digit ZIP code level across the country utilizing a number of different detection systems. The detection systems selected were: (1) Quarterly-surveys of drug abuse experts who are knowledgeable about cases of prescription drug abuse; (2) Surveys of law enforcement agencies that detect diversion of prescription drugs; and (3) Poison Control Center reports of intentional misuse or abuse of prescription opioids. Collectively, the three systems provide overlapping coverage of over 80% of the nation's 973 three-digit ZIP codes. Preliminary results indicate that prescription drug abuse is prevalent nationwide, but it seems to be heavily localized in rural, suburban and small urban areas. Our results also indicate that hydrocodone and extended and immediate release oxycodone products are by far the most widely abused drugs in the country, but the abuse of all prescription opioids seems to have grown over the 14 quarters since the inception of RADARS. The next step in these studies is to develop regionally specific, risk-minimization-strategies, which is the goal of all risk-management programs. If successful, RADARS will serve as a prototype of such programs for any new drug approved that has measurable abuse potential.

Repeated applications of a transdermal patch: analytical solution and optimal control of the delivery rate.

PubMed

Simon, L

2007-10-01

The integral transform technique was implemented to solve a mathematical model developed for percutaneous drug absorption. The model included repeated application and removal of a patch from the skin. Fick's second law of diffusion was used to study the transport of a medicinal agent through the vehicle and subsequent penetration into the stratum corneum. Eigenmodes and eigenvalues were computed and introduced into an inversion formula to estimate the delivery rate and the amount of drug in the vehicle and the skin. A dynamic programming algorithm calculated the optimal doses necessary to achieve a desired transdermal flux. The analytical method predicted profiles that were in close agreement with published numerical solutions and provided an automated strategy to perform therapeutic drug monitoring and control.

Progress of the National Pediatric Free Antiretroviral Therapy program in China.

PubMed

Zhao, Yan; Sun, Xin; He, Yun; Tang, Zhirong; Peng, Guoping; Liu, Aiwen; Qiao, Xiaochun; Li, Huiqin; Chen, Zhiqiang; Dou, Zhihui; Ma, Ye; Liu, Zhongfu; Zhang, Fujie

2010-10-01

In 2003, the Chinese Government initiated a free antiretroviral therapy (ART) program focusing on adult AIDS patients. Pediatric antiretroviral (ARV) formulations were yet unavailable. It was not until July 2005, with the initiation of a two-stage program implemented by the Chinese Ministry of Health, that pediatric formulations became accessible in China. Initially, the pediatric ART program was piloted in six provinces with the highest incidences of pediatric HIV/AIDS. The pilot stage allowed the Chinese Center for Disease Control and Prevention (CCDC) to finalize entry criteria, treatment regimen, and patient monitoring and follow-up procedures. The second stage commenced at the end of 2006 when the program was scaled-up nationally. In order to guarantee treatment of pediatric patients, extensive training in the selection of appropriate ARV drug regimen and dosage was provided to doctors, often through on-site collaboration with domestic and international experts. The CCDC simultaneously established a pediatric ARV management system and a pediatric ART information system. CD4 count and other laboratory tests are being routinely performed on these pediatric patients. By the end of June 2009, 1529 pediatric patients had received ARV under the national program. However, challenges remain. Firstly, many children infected with HIV/AIDS live in rural areas where the treatment quality is hindered by the limited number of medical facilities and skilled medical workers. Secondly, much of the pediatric ARV drug supply depends on donation. An effort needs to be made by the Chinese Government to establish China's own drug procurement and supply system.

21 CFR 882.1610 - Alpha monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha...

21 CFR 882.1610 - Alpha monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha...

Rule Based Expert System for Monitoring Real Time Drug Supply in Hospital Using Radio Frequency Identification Technology

NASA Astrophysics Data System (ADS)

Driandanu, Galih; Surarso, Bayu; Suryono

2018-02-01

A radio frequency identification (RFID) has obtained increasing attention with the emergence of various applications. This study aims to examine the implementation of rule based expert system supported by RFID technology into a monitoring information system of drug supply in a hospital. This research facilitates in monitoring the real time drug supply by using data sample from the hospital pharmacy. This system able to identify and count the number of drug and provide warning and report in real time. the conclusion is the rule based expert system and RFID technology can facilitate the performance in monitoring the drug supply quickly and precisely.

Managing and monitoring tuberculosis using web-based tools in combination with traditional approaches

PubMed Central

Chapman, Ann LN; Darton, Thomas C; Foster, Rachel A

2013-01-01

Tuberculosis (TB) remains a global health emergency. Ongoing challenges include the coordination of national and international control programs, high levels of drug resistance in many parts of the world, and availability of accurate and rapid diagnostic tests. The increasing availability and reliability of Internet access throughout both affluent and resource-limited countries brings new opportunities to improve TB management and control through the integration of web-based technologies with traditional approaches. In this review, we explore current and potential future use of web-based tools in the areas of TB diagnosis, treatment, epidemiology, service monitoring, and teaching and training. PMID:24294008

Quality assurance in nuclear medicine facilities; availability of final recommendations--FDA. Notice.

PubMed

1985-05-13

The Food and Drug Administration (FDA) is announcing the availability of final recommendations prepared by its Center for Devices and Radiological Health (CDRH) on quality assurance programs in nuclear medicine facilities. The final recommendations include the agency's rationale for the recommendations as well as references that can be used as well as references that can be used as guides in conducting quality control monitoring. These final recommendations are available as a technical report in CDRH's radiation recommendations series. They are intended to encourage and promote the development of voluntary quality assurance programs in nuclear medicine facilities.

WE-H-209-01: Advances in Ultrasound Therapy

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

Hynynen, K.

Focused ultrasound has been shown to be the only method that allows noninvasive thermal coagulation of tissues and recently this potential has been explored for image-guided drug delivery. In this presentation, the advances in ultrasound phased array technology for energy delivery, exposure monitoring and control will be discussed. Experimental results from novel multi-frequency transmit/receive arrays will be presented. In addition, the feasibility of fully electronically focused and steered high power arrays with many thousands of transducer elements will be discussed. Finally, some of the recent clinical and preclinical results for the treatment of brain disease will be reviewed. Learning Objectives:more » Introduce FUS therapy principles and modern techniques Discuss use of FUS for drug delivery Cover the technology required to deliver FUS and monitor therapy Present clinical examples of the uses of these techniques This research was supported by funding from The Canada Research Chair Program, Grants from CIHR and NIH (no. EB003268).; K. Hynynen, Canada Foundation for Innovation; Canadian Institutes of Health Research; Focused Ultrasound Surgery Foundation; Canada Research Chair Program; Natural Sciences and Engineering Research Council of Canada; Ontario Research Fund; National Institutes of Health; Canadian Cancer Society Research Institute; The Weston Brain Institute; Harmonic Medical; Focused Ultrasound Instruments.« less

WE-H-209-00: Carson/Zagzebski Distinguished Lectureship: Image Guided Ultrasound Therapy

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

NONE

Focused ultrasound has been shown to be the only method that allows noninvasive thermal coagulation of tissues and recently this potential has been explored for image-guided drug delivery. In this presentation, the advances in ultrasound phased array technology for energy delivery, exposure monitoring and control will be discussed. Experimental results from novel multi-frequency transmit/receive arrays will be presented. In addition, the feasibility of fully electronically focused and steered high power arrays with many thousands of transducer elements will be discussed. Finally, some of the recent clinical and preclinical results for the treatment of brain disease will be reviewed. Learning Objectives:more » Introduce FUS therapy principles and modern techniques Discuss use of FUS for drug delivery Cover the technology required to deliver FUS and monitor therapy Present clinical examples of the uses of these techniques This research was supported by funding from The Canada Research Chair Program, Grants from CIHR and NIH (no. EB003268).; K. Hynynen, Canada Foundation for Innovation; Canadian Institutes of Health Research; Focused Ultrasound Surgery Foundation; Canada Research Chair Program; Natural Sciences and Engineering Research Council of Canada; Ontario Research Fund; National Institutes of Health; Canadian Cancer Society Research Institute; The Weston Brain Institute; Harmonic Medical; Focused Ultrasound Instruments.« less

21 CFR 884.2620 - Fetal electroencephalographic monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fetal electroencephalographic monitor. 884.2620 Section 884.2620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Monitoring Devices § 884.2620 Fetal...

Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy

PubMed Central

Albonico, M.; Levecke, B.; LoVerde, P.T.; Montresor, A.; Prichard, R.; Vercruysse, J.; Webster, J.P.

2017-01-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. PMID:27842865

RFID Tag Helix Antenna Sensors for Wireless Drug Dosage Monitoring

PubMed Central

Huang, Haiyu; Zhao, Peisen; Chen, Pai-Yen; Ren, Yong; Liu, Xuewu; Ferrari, Mauro; Hu, Ye; Akinwande, Deji

2014-01-01

Miniaturized helix antennas are integrated with drug reservoirs to function as RFID wireless tag sensors for real-time drug dosage monitoring. The general design procedure of this type of biomedical antenna sensors is proposed based on electromagnetic theory and finite element simulation. A cost effective fabrication process is utilized to encapsulate the antenna sensor within a biocompatible package layer using PDMS material, and at the same time form a drug storage or drug delivery unit inside the sensor. The in vitro experiment on two prototypes of antenna sensor-drug reservoir assembly have shown the ability to monitor the drug dosage by tracking antenna resonant frequency shift from 2.4–2.5-GHz ISM band with realized sensitivity of 1.27 \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\mu~{\\rm l}/{\\rm MHz}$\\end{document} for transdermal drug delivery monitoring and 2.76-\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{upgreek} \\usepackage{mathrsfs} \\setlength{\\oddsidemargin}{-69pt} \\begin{document} }{}$\\mu~{\\rm l}/{\\rm MHz}$\\end{document} sensitivity for implanted drug delivery monitoring. PMID:27170865

Adapting the Illicit Drug Reporting System (IDRS) to examine the feasibility of monitoring trends in the markets for 'party drugs'.

PubMed

Topp, Libby; Breen, Courtney; Kaye, Sharlene; Darke, Shane

2004-02-07

Since 1996, the Illicit Drug Reporting System (IDRS), Australia's strategic early warning system for illicit drug trends, has monitored annual trends in the markets for the four main illicit drug classes, cannabis, methamphetamine, cocaine and heroin. In 2000, a 2-year trial was implemented to examine the feasibility of using similar methodology to monitor trends in the markets for 'party drugs'. A triangulation of three data sources was sought: (1) quantitative interviews with a 'sentinel' population of drug users; (2) qualitative interviews with key informants (KIs), or those who have contact with drug users through their work; (3) extant indicator data sources such as the purity of illicit drugs seized by law enforcement agencies. The results suggested that the feasibility of collecting detailed, reliable and valid data about party drug markets is a direct function of the size of those markets. The trial demonstrated that the system would allow the successful monitoring of markets for party drugs that are relatively widely used, such as ecstasy, but would be less sensitive in monitoring markets for party drugs that are used by small proportions of the total population, such as gamma-hydroxy-butyrate (GHB) and ketamine. Methodological issues encountered during the conduct of this trial are discussed, including defining the appropriate sentinel population of drug users, identifying relevant key informants, and the relative absence of extant indicator data sources that could inform our understanding of party drug markets.

Estimating the Prevalence of Opioid Diversion by “Doctor Shoppers” in the United States

PubMed Central

McDonald, Douglas C.; Carlson, Kenneth E.

2013-01-01

Background Abuse of prescription opioid analgesics is a serious threat to public health, resulting in rising numbers of overdose deaths and admissions to emergency departments and treatment facilities. Absent adequate patient information systems, “doctor shopping” patients can obtain multiple opioid prescriptions for nonmedical use from different unknowing physicians. Our study estimates the prevalence of doctor shopping in the US and the amounts and types of opioids involved. Methods and Findings The sample included records for 146.1 million opioid prescriptions dispensed during 2008 by 76% of US retail pharmacies. Prescriptions were linked to unique patients and weighted to estimate all prescriptions and patients in the nation. Finite mixture models were used to estimate different latent patient populations having different patterns of using prescribers. On average, patients in the extreme outlying population (0.7% of purchasers), presumed to be doctor shoppers, obtained 32 opioid prescriptions from 10 different prescribers. They bought 1.9% of all opioid prescriptions, constituting 4% of weighed amounts dispensed. Conclusions Our data did not provide information to make a clinical diagnosis of individuals. Very few of these patients can be classified with certainty as diverting drugs for nonmedical purposes. However, even patients with legitimate medical need for opioids who use large numbers of prescribers may signal dangerously uncoordinated care. To close the information gap that makes doctor shopping and uncoordinated care possible, states have created prescription drug monitoring programs to collect records of scheduled drugs dispensed, but the majority of physicians do not access this information. To facilitate use by busy practitioners, most monitoring programs should improve access and response time, scan prescription data to flag suspicious purchasing patterns and alert physicians and pharmacists. Physicians could also prevent doctor shopping by adopting procedures to screen new patients for their risk of abuse and to monitor patients' adherence to prescribed treatments. PMID:23874923

Laboratory Safety Monitoring of Chronic Medications in Ambulatory Care Settings

PubMed Central

Hurley, Judith S; Roberts, Melissa; Solberg, Leif I; Gunter, Margaret J; Nelson, Winnie W; Young, Linda; Frost, Floyd J

2005-01-01

OBJECTIVE To evaluate laboratory safety monitoring in patients taking selected chronic prescription drugs. DESIGN Retrospective study using 1999–2001 claims data to calculate rates of missed laboratory tests (potential laboratory monitoring errors). Eleven drugs/drug groups and 64 laboratory tests were evaluated. SETTING Two staff/network model health maintenance organizations. PATIENTS Continuously enrolled health plan members age≥19 years taking ≥1 chronic medications. MEASUREMENTS AND MAIN RESULTS Among patients taking chronic medications (N=29,823 in 1999, N=32,423 in 2000, and N=36,811 in 2001), 47.1% in 1999, 45.0% in 2000, and 44.0% in 2001 did not receive ≥1 test recommended for safety monitoring. Taking into account that patients were sometimes missing more than 1 test for a given drug and that patients were frequently taking multiple drugs, the rate of all potential laboratory monitoring errors was 849/1,000 patients/year in 1999, 810/1,000 patients/year in 2000, and 797/1,000 patients/year in 2001. Rates of potential laboratory monitoring errors varied considerably across individual drugs and laboratory tests. CONCLUSIONS Lapses in laboratory monitoring of patients taking selected chronic medications were common. Further research is needed to determine whether, and to what extent, this failure to monitor patients is associated with adverse clinical outcomes. PMID:15857489

HOW PARENTS OF TEENS STORE AND MONITOR PRESCRIPTION DRUGS IN THE HOME*

PubMed Central

FRIESE, BETTINA; MOORE, ROLAND S.; GRUBE, JOEL W.; JENNINGS, VANESSA K.

2014-01-01

Qualitative interviews were conducted with parents of teens to explore how parents store and monitor prescription drugs in the home. Most parents had prescription drugs in the house, but took few precautions against teens accessing these drugs. Strategies for monitoring included moving the drugs to different locations, remembering how many pills were left, and how medication containers were positioned. Reasons given for not securing drugs were that parents did not think that their teens would be interested in their prescription drugs and did not believe that they could be used to get high. This study highlights the need for parents to be educated about securing prescription drugs, the dangers of non-medical prescription drug use by teens, and which drugs might be used for non-medical purposes. PMID:25429166

Laboratory monitoring of patients treated with antihypertensive drugs and newly exposed to non steroidal anti-inflammatory drugs: a cohort study.

PubMed

Fournier, Jean-Pascal; Lapeyre-Mestre, Maryse; Sommet, Agnès; Dupouy, Julie; Poutrain, Jean-Christophe; Montastruc, Jean-Louis

2012-01-01

Drug-Drug Interactions between Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and Angiotensin Converting Enzyme Inhibitors (ACEIs), Angiotensin Receptor Blocker (ARBs) or diuretics can lead to renal failure and hyperkalemia. Thus, monitoring of serum creatinine and potassium is recommended when a first dispensing of NSAID occur in patients treated with these drugs. We conducted a pharmacoepidemiological retrospective cohort study using data from the French Health Insurance Reimbursement Database to evaluate the proportion of serum creatinine and potassium laboratory monitoring in patients treated with ACEI, ARB or diuretic and receiving a first dispensing of NSAID. We described the first dispensing of NSAID among 3,500 patients of a 4-year cohort (6,633 patients treated with antihypertensive drugs) and analyzed serum creatinine and potassium laboratory monitoring within the 3 weeks after the first NSAID dispensing. General Practitioners were the most frequent prescribers of NSAIDs (85.5%, 95% CI: 84.3-86.6). The more commonly prescribed NSAIDs were ibuprofen (20%), ketoprofen (15%), diclofenac (15%) and piroxicam (12%). Serum creatinine and potassium monitoring was 10.7% (95% CI: 9.5-11.8) in patients treated by ACEIs, ARBs or diuretics. Overall, monitoring was more frequently performed to women aged over 60, treated with digoxin or glucose lowering drugs, but not to patients treated with ACEIs, ARBs or diuretics. Monitoring was more frequent when NSAIDs' prescribers were cardiologists or anesthesiologists. Monitoring of serum creatinine and potassium of patients treated with ACEIs, ARBs or diuretics and receiving a first NSAID dispensing is insufficiently performed and needs to be reinforced through specific interventions.

Quantitative Laser Biospeckle Method for the Evaluation of the Activity of Trypanosoma cruzi Using VDRL Plates and Digital Analysis.

PubMed

Grassi, Hilda Cristina; García, Lisbette C; Lobo-Sulbarán, María Lorena; Velásquez, Ana; Andrades-Grassi, Francisco A; Cabrera, Humberto; Andrades-Grassi, Jesús E; Andrades, Efrén D J

2016-12-01

In this paper we report a quantitative laser Biospeckle method using VDRL plates to monitor the activity of Trypanosoma cruzi and the calibration conditions including three image processing algorithms and three programs (ImageJ and two programs designed in this work). Benznidazole was used as a test drug. Variable volume (constant density) and variable density (constant volume) were used for the quantitative evaluation of parasite activity in calibrated wells of the VDRL plate. The desiccation process within the well was monitored as a function of volume and of the activity of the Biospeckle pattern of the parasites as well as the quantitative effect of the surface parasite quantity (proportion of the object's plane). A statistical analysis was performed with ANOVA, Tukey post hoc and Descriptive Statistics using R and R Commander. Conditions of volume (100μl) and parasite density (2-4x104 parasites/well, in exponential growth phase), assay time (up to 204min), frame number (11 frames), algorithm and program (RCommander/SAGA) for image processing were selected to test the effect of variable concentrations of benznidazole (0.0195 to 20μg/mL / 0.075 to 76.8μM) at various times (1, 61, 128 and 204min) on the activity of the Biospeckle pattern. The flat wells of the VDRL plate were found to be suitable for the quantitative calibration of the activity of Trypanosoma cruzi using the appropriate algorithm and program. Under these conditions, benznidazole produces at 1min an instantaneous effect on the activity of the Biospeckle pattern of T. cruzi, which remains with a similar profile up to 1 hour. A second effect which is dependent on concentrations above 1.25μg/mL and is statistically different from the effect at lower concentrations causes a decrease in the activity of the Biospeckle pattern. This effect is better detected after 1 hour of drug action. This behavior may be explained by an instantaneous effect on a membrane protein of Trypanosoma cruzi that could mediate the translocation of benznidazole. At longer times the effect may possibly be explained by the required transformation of the pro-drug into the active drug.

Beyond the Dose-Limiting Toxicity Period: Dermatologic Adverse Events of Patients on Phase 1 Trials of the Cancer Therapeutics Evaluation Program

PubMed Central

Drilon, Alexander; Eaton, Anne A.; Schindler, Katja; Gounder, Mrinal M.; Spriggs, David R.; Harris, Pamela; Ivy, S. Percy; Iasonos, Alexia; Lacouture, Mario E.; Hyman, David M.

2017-01-01

BACKGROUND Dermatologic adverse events (AEs) can be key determinants of overall drug tolerability and of the maximum tolerated and recommended phase 2 doses in phase 1 trials. The authors present the largest dedicated analysis of dermatologic AEs on phase 1 trials to date. METHODS Data from a prospectively maintained database of patients with solid tumors who were enrolled onto Cancer Therapeutics Evaluation Program (CTEP)-sponsored phase 1 trials of cytotoxic or molecularly targeted agents (MTAs) from 2000 to 2010 were analyzed. Cumulative incidence, site, and type of drug-related dermatologic AEs were described and compared. The timing of worst drug-related dermatologic AEs was summarized. RESULTS In total, 3517 patients with solid tumors and 6165 unique, drug-related dermatologic AEs were analyzed, including 1545 patients on MTA-only trials, 671 on cytotoxic-only trials, and 1392 on combination MTA and cytotoxic trials. Of 1270 patients who had drug-related dermatologic events, the timing of the worst AE was as follows: 743 (cycle 1), 303 (cycle 2), and 224 (cycle 3 or later). Although the cumulative incidence of grade ≥3 drug-related AEs increased to 2.4% by cycle 6, it was only 1.6% at the end of cycle 1. The cumulative incidence of drug-related AEs was highest in patients who received MTA-only therapy (P <.001) and differed by dose level (P <.001). In patients who received MTA-only therapy, drug-related AEs were most common for combination kinase inhibitor-containing therapy (P <.001). CONCLUSIONS A substantial proportion of drug-related dermatologic AEs occur after the traditional dose-limiting toxicity monitoring period of phase 1 clinical trials. Future designs should account for late toxicities. PMID:26916138

Beyond the dose-limiting toxicity period: Dermatologic adverse events of patients on phase 1 trials of the Cancer Therapeutics Evaluation Program.

PubMed

Drilon, Alexander; Eaton, Anne A; Schindler, Katja; Gounder, Mrinal M; Spriggs, David R; Harris, Pamela; Ivy, S Percy; Iasonos, Alexia; Lacouture, Mario E; Hyman, David M

2016-04-15

Dermatologic adverse events (AEs) can be key determinants of overall drug tolerability and of the maximum tolerated and recommended phase 2 doses in phase 1 trials. The authors present the largest dedicated analysis of dermatologic AEs on phase 1 trials to date. Data from a prospectively maintained database of patients with solid tumors who were enrolled onto Cancer Therapeutics Evaluation Program (CTEP)-sponsored phase 1 trials of cytotoxic or molecularly targeted agents (MTAs) from 2000 to 2010 were analyzed. Cumulative incidence, site, and type of drug-related dermatologic AEs were described and compared. The timing of worst drug-related dermatologic AEs was summarized. In total, 3517 patients with solid tumors and 6165 unique, drug-related dermatologic AEs were analyzed, including 1545 patients on MTA-only trials, 671 on cytotoxic-only trials, and 1392 on combination MTA and cytotoxic trials. Of 1270 patients who had drug-related dermatologic events, the timing of the worst AE was as follows: 743 (cycle 1), 303 (cycle 2), and 224 (cycle 3 or later). Although the cumulative incidence of grade ≥3 drug-related AEs increased to 2.4% by cycle 6, it was only 1.6% at the end of cycle 1. The cumulative incidence of drug-related AEs was highest in patients who received MTA-only therapy (P < .001) and differed by dose level (P < .001). In patients who received MTA-only therapy, drug-related AEs were most common for combination kinase inhibitor-containing therapy (P < .001). A substantial proportion of drug-related dermatologic AEs occur after the traditional dose-limiting toxicity monitoring period of phase 1 clinical trials. Future designs should account for late toxicities. © 2016 American Cancer Society.

Improved Long-term Outcomes of Patients With Inflammatory Bowel Disease Receiving Proactive Compared With Reactive Monitoring of Serum Concentrations of Infliximab.

PubMed

Papamichael, Konstantinos; Chachu, Karen A; Vajravelu, Ravy K; Vaughn, Byron P; Ni, Josephine; Osterman, Mark T; Cheifetz, Adam S

2017-10-01

Monitoring serum concentrations of tumor necrosis factor antagonists in patients receiving these drugs as treatment for inflammatory bowel disease (IBD), also called therapeutic drug monitoring, is performed either after patient loss of response (reactive drug monitoring) or in patients in clinical remission in which the drug is titrated to a target concentration (proactive drug monitoring). We compared long-term outcomes of patients with IBD undergoing proactive vs reactive monitoring of serum concentrations of infliximab. We performed a multicenter, retrospective study of 264 consecutive patients with IBD (167 with Crohn's disease) receiving infliximab maintenance therapy. The subjects received proactive (n = 130) or reactive (n = 134) drug monitoring, based on measurements of first infliximab concentration and antibodies to infliximab, from September 2006 to January 2015; they were followed through December 2015 (median time of 2.4 years). We analyzed time to treatment failure, first IBD-related surgery or hospitalization, serious infusion reaction, and detection of antibodies to infliximab. Treatment failure was defined as drug discontinuation for loss of response or serious adverse event, or need for surgery. Multiple Cox regression analysis independently associated proactive drug monitoring, compared with reactive monitoring, with reduced risk for treatment failure (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.09-0.27; P < .001), IBD-related surgery (HR, 0.30; 95% CI, 0.11-0.80; P = .017), IBD-related hospitalization (HR, 0.16; 95% CI, 0.07-0.33; P < .001), antibodies to infliximab (HR, 0.25; 95% CI, 0.07-0.84; P = .025), and serious infusion reaction (HR, 0.17; 95% CI, 0.04-0.78; P = .023). In a retrospective analysis of patients with IBD receiving proactive vs reactive monitoring of serum concentration of infliximab, proactive monitoring was associated with better clinical outcomes, including greater drug durability, less need for IBD-related surgery or hospitalization, and lower risk of antibodies to infliximab or serious infusion reactions. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

How much do Manhattan-arrestees spend on drugs?

PubMed

Golub, Andrew; Johnson, Bruce D

2004-12-07

Information about individuals' drug expenses can indicate much about the size of drug markets, the financial burden of use, drug-related crime, and potential challenges for treatment. Most often, expenses have been estimated holistically by asking respondents to report how much they spent. In 2000, the Arrestee Drug Abuse Monitoring (ADAM) program introduced an advanced questionnaire using a series of highly specific questions like, "how much cash did you pay for crack that last time you bought it?" This paper describes a procedure for estimating arrestees' drug expenses with the new ADAM questionnaire, discusses pitfalls in interpretation, presents findings for 2979 ADAM-Manhattan respondents interviewed 2000-2002, examines covariates of drug expense, and compares the 2000-2002 findings with those obtained from 2256 respondents interviewed 1998-1999 with the previous questionnaire. Among 2000-2002 arrestees, median drug expense in the past 30 days varied widely with frequency of use and drug-user type. Infrequent marijuana-only users spent as little as $5, daily marijuana-only users spent about $600. Arrestees that used both heroin and cocaine spent over $1000. Estimates with the 1998-1999 data were about half as large. ADAM's new drug market questions may greatly advance the quality of estimates of drug expenses. However, further research is needed to better establish the estimator's accuracy.

Application of drug testing using exhaled breath for compliance monitoring of drug addicts in treatment.

PubMed

Carlsson, Sten; Olsson, Robert; Lindkvist, Irene; Beck, Olof

2015-04-01

Exhaled breath has recently been identified as a possible matrix for drug testing. This study explored the potential of this new method for compliance monitoring of patients being treated for dependence disorders. Outpatients in treatment programs were recruited for this study. Urine was collected as part of clinical routine and a breath sample was collected in parallel together with a questionnaire about their views of the testing procedure. Urine was analyzed for amphetamines, benzodiazepines, cannabis, cocaine, buprenorphine, methadone and opiates using CEDIA immunochemical screening and mass spectrometry confirmation. The exhaled breath was collected using the SensAbues device and analyzed by mass spectrometry for amphetamine, methamphetamine, diazepam, oxazepam, tetrahydrocannabinol, cocaine, benzoylecgonine, buprenorphine, methadone, morphine, codeine and 6-acetylmorphine. A total of 122 cases with parallel urine and breath samples were collected; 34 of these were negative both in urine and breath. Out of 88 cases with positive urine samples 51 (58%) were also positive in breath. Among the patients on methadone treatment, all were positive for methadone in urine and 83% were positive in breath. Among patients in treatment with buprenorphine, 92% were positive in urine and among those 80% were also positive in breath. The questionnaire response documented that in general, patients accepted drug testing well and that the breath sampling procedure was preferred. Compliance testing for the intake of prescribed and unprescribed drugs among patients in treatment for dependence disorders using the exhaled breath sampling technique is a viable method and deserves future attention.

21 CFR 884.2660 - Fetal ultrasonic monitor and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fetal ultrasonic monitor and accessories. 884.2660 Section 884.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring...

21 CFR 884.2720 - External uterine contraction monitor and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External uterine contraction monitor and accessories. 884.2720 Section 884.2720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Obstetrical and Gynecological Monitoring Devices § 884.2720 External...

[The therapeutic drug monitoring network server of tacrolimus for Chinese renal transplant patients].

PubMed

Deng, Chen-Hui; Zhang, Guan-Min; Bi, Shan-Shan; Zhou, Tian-Yan; Lu, Wei

2011-07-01

This study is to develop a therapeutic drug monitoring (TDM) network server of tacrolimus for Chinese renal transplant patients, which can facilitate doctor to manage patients' information and provide three levels of predictions. Database management system MySQL was employed to build and manage the database of patients and doctors' information, and hypertext mark-up language (HTML) and Java server pages (JSP) technology were employed to construct network server for database management. Based on the population pharmacokinetic model of tacrolimus for Chinese renal transplant patients, above program languages were used to construct the population prediction and subpopulation prediction modules. Based on Bayesian principle and maximization of the posterior probability function, an objective function was established, and minimized by an optimization algorithm to estimate patient's individual pharmacokinetic parameters. It is proved that the network server has the basic functions for database management and three levels of prediction to aid doctor to optimize the regimen of tacrolimus for Chinese renal transplant patients.

Preventing deaths from rising opioid overdose in the US – the promise of naloxone antidote in community-based naloxone take-home programs

PubMed Central

Straus, Michele M; Ghitza, Udi E; Tai, Betty

2013-01-01

The opioid overdose epidemic is an alarming and serious public health problem in the United States (US) that has been escalating for 11 years. The 2011 National Survey on Drug Use and Health (NSDUH) demonstrated that 1 in 20 persons in the US aged 12 or older reported nonmedical use of prescription painkillers in the past year. Prescription drug overdose is now the leading cause of accidental death in the United States – surpassing motor vehicle accidents. Great efforts have been initiated to curb the overdose crisis. Notable examples of these efforts are (1) the Drug Enforcement Administration’s (DEA) National Take-Back Initiative instituted in 2010; (2) the Prescription Drug Monitoring Programs (PDMPs) implemented in most US states to provide practitioners with point-of-care information regarding a patient’s controlled substance use; (3) the naloxone rescue programs initiated in the community to avert mortality resulting from overdose. The use of naloxone rescue strategies has gained traction as an effective measure to prevent fatal opioid overdose. Many US federal-government agencies are working to make these strategies more accessible to first responders and community participants. This new approach faces many challenges, such as accessibility to naloxone and the equipment and training needed to administer it, but none is more challenging than the fear of legal repercussions. US federal-government agencies, local governments, health care institutions, and community-based organizations have begun to tackle these barriers, and naloxone take-home programs have gained recognition as a feasible and sensible preventive strategy to avoid a fatal result from opioid overdose. Although many challenges still need to be overcome, it is important for federal government research agencies to initiate and support independent and rigorous evaluation of these programs to inform policymakers how effective these programs can be to save lives and curb the opioid overdose public health crisis. PMID:24273417

Risk assessment and risk management at the Canadian Food Inspection Agency (CFIA): a perspective on the monitoring of foods for chemical residues.

PubMed

Bietlot, Henri P; Kolakowski, Beata

2012-08-01

The Canadian Food Inspection Agency (CFIA) uses 'Ranked Risk Assessment' (RRA) to prioritize chemical hazards for inclusion in monitoring programmes or method development projects based on their relative risk. The relative risk is calculated for a chemical by scoring toxicity and exposure in the 'risk model scoring system' of the Risk Priority Compound List (RPCL). The relative ranking and the risk management options are maintained and updated in the RPCL. The ranking may be refined by the data generated by the sampling and testing programs. The two principal sampling and testing programmes are the National Chemical Residue Monitoring Program (NCRMP) and the Food Safety Action Plan (FSAP). The NCRMP sampling plans focus on the analysis of federally registered products (dairy, eggs, honey, meat and poultry, fresh and processed fruit and vegetable commodities, and maple syrup) for residues of veterinary drugs, pesticides, environmental contaminants, mycotoxins, and metals. The NCRMP is complemented by the Food Safety Action Plan (FSAP) targeted surveys. These surveys focus on emerging chemical hazards associated with specific foods or geographical regions for which applicable maximum residue limits (MRLs) are not set. The data from the NCRMP and FSAP also influence the risk management (follow-up) options. Follow-up actions vary according to the magnitude of the health risk, all with the objective of preventing any repeat occurrence to minimize consumer exposure to a product representing a potential risk to human health. © Her Majesty the Queen in Right of Canada 2012. Drug Testing and Analysis © 2012 John Wiley & Sons, Ltd.

Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy.

PubMed

Albonico, M; Levecke, B; LoVerde, P T; Montresor, A; Prichard, R; Vercruysse, J; Webster, J P

2015-12-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. Copyright © 2015 International Society for Chemotherapy of Infection and Cancer. Published by Elsevier Ltd. All rights reserved.

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.

Current practices in laboratory monitoring of HIV infection

PubMed Central

Vajpayee, Madhu; Mohan, Teena

2011-01-01

After a diagnosis of HIV infection is made, the patient needs to be monitored using both clinical assessment and laboratory markers. HIV/AIDS monitoring is essential in guiding when to recommend initiation of therapy. Clinical monitoring will include staging of the HIV/AIDS disease using either the presence or absence of HIV-related signs and symptoms using the WHO staging system. Various laboratory methods can be used to monitor the disease progression and to guide whether the patient will need antiretroviral therapy or not. Laboratory monitoring for patients who are not on drugs is done to provide information about the stage of illness; to enable the clinician to make decisions on treatment and to give information on prognosis of the patient. Patients on drugs are monitored to assess their response to treatment with antiretroviral drugs and to detect any possible toxicity and improvement associated with the antiretroviral drugs. PMID:22310815

Role of Therapeutic Drug Monitoring of Voriconazole in the Treatment of Invasive Fungal Infections

PubMed Central

Kuo, I fan; Ensom, Mary H H

2009-01-01

Background: Voriconazole is a broad-spectrum, second-generation triazole antifungal agent with demonstrated efficacy in the treatment of invasive fungal infections caused by Aspergillus spp. and Candida spp. Given the characteristically poor prognosis of patients with invasive fungal infections and the protracted duration of treatment required, therapeutic monitoring of voriconazole is, in theory, an attractive method to optimize antifungal therapy. Objective: To determine the utility of therapeutic drug monitoring for voriconazole. Methods: A previously published decision-making algorithm was used to assess the currently available literature on therapeutic drug monitoring of voriconazole. Results: Several analytical methods can be used to quantify plasma or serum concentrations of voriconazole. Reasons for therapeutic monitoring of this drug include wide variability both within and between individuals secondary to drug properties, drug–drug interactions, and disease states. Furthermore, voriconazole follows nonlinear pharmacokinetics with saturable hepatic clearance. Another potential factor in favour of therapeutic drug monitoring for voriconazole is genetic polymorphism of CYP2C19, whereby patients who are homozygous for poor metabolism (about 19% of non-Indian Asians) can have 4-fold greater exposure to voriconazole. The concentrations of this drug are also greater in patients with hepatic impairment. Drug–drug interactions with other substrates of CYP2C9, CYP2C19, and CYP3A4 can also alter voriconazole concentrations. However, the correlations between plasma concentrations of voriconazole and its efficacy and toxicity are not well defined. Although lower and upper target thresholds of 0.25–2 mg/L and 4–6 mg/L, respectively, have been suggested, studies to date have not been appropriately designed or powered to reveal any definitive association. Conclusions: Routine therapeutic drug monitoring of voriconazole is not recommended except in certain circumstances, such as lack of response to therapy or evidence of toxicity, in which case selective monitoring of voriconazole concentrations may be of clinical utility. PMID:22478935

Towards an implantable bio-sensor platform for continuous real-time monitoring of anti-epileptic drugs.

PubMed

Hammoud, Abbas; Chamseddine, Ahmad; Nguyen, Dang K; Sawan, Mohamad

2016-08-01

The need of continuous real-time monitoring device for in-vivo drug level detection has been widely articulated lately. Such monitoring could guide drug posology and timing of intake, detect low or high drug levels, in order to take adequate measures, and give clinicians a valuable window into patients' health and their response to therapeutics. This paper presents a novel implantable bio-sensor based on impedance measurement capable of continuously monitoring various antiepileptic drug levels. This portable point-of-care microsystem replaces large and stationary conventional macrosystems, and is a one of a kind system designed with an array of electrodes to monitor various anti-epileptic drugs rather than one drug. The micro-system consists of (i) the front-end circuit including an inductive coil to receive energy from an external base station, and to exchange data with the latter; (ii) the power management block; (iii) the readout and control block; and (iv) the biosensor array. The electrical circuitry was designed using the 0.18-um CMOS process technology intended to be miniature and consume ultra-low power.

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

21 CFR 880.2460 - Electrically powered spinal fluid pressure monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrically powered spinal fluid pressure monitor. 880.2460 Section 880.2460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2460...

Therapeutic drug monitoring of antimetabolic cytotoxic drugs

PubMed Central

Lennard, L

1999-01-01

Therapeutic drug monitoring is not routinely used for cytotoxic agents. There are several reasons, but one major drawback is the lack of established therapeutic concentration ranges. Combination chemotherapy makes the establishment of therapeutic ranges for individual drugs difficult, the concentration-effect relationship for a single drug may not be the same as that when the drug is used in a drug combination. Pharmacokinetic optimization protocols for many classes of cytotoxic compounds exist in specialized centres, and some of these protocols are now part of large multicentre trials. Nonetheless, methotrexate is the only agent which is routinely monitored in most treatment centres. An additional factor, especially in antimetabolite therapy, is the existence of pharmacogenetic enzymes which play a major role in drug metabolism. Monitoring of therapy could include assay of phenotypic enzyme activities or genotype in addition to, or instead of, the more traditional measurement of parent drug or drug metabolites. The cytotoxic activities of mercaptopurine and fluorouracil are regulated by thiopurine methyltransferase (TPMT) and dihydropyrimidine dehydrogenase (DPD), respectively. Lack of TPMT functional activity produces life-threatening mercaptopurine myelotoxicity. Very low DPD activity reduces fluorouracil breakdown producing severe cytotoxicity. These pharmacogenetic enzymes can influence the bioavailability, pharmacokinetics, toxicity and efficacy of their substrate drugs. PMID:10190647

Laboratory Monitoring of Patients Treated with Antihypertensive Drugs and Newly Exposed to Non Steroidal Anti-Inflammatory Drugs: A Cohort Study

PubMed Central

Fournier, Jean-Pascal; Lapeyre-Mestre, Maryse; Sommet, Agnès; Dupouy, Julie; Poutrain, Jean-Christophe; Montastruc, Jean-Louis

2012-01-01

Background Drug-Drug Interactions between Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and Angiotensin Converting Enzyme Inhibitors (ACEIs), Angiotensin Receptor Blocker (ARBs) or diuretics can lead to renal failure and hyperkalemia. Thus, monitoring of serum creatinine and potassium is recommended when a first dispensing of NSAID occur in patients treated with these drugs. Methods We conducted a pharmacoepidemiological retrospective cohort study using data from the French Health Insurance Reimbursement Database to evaluate the proportion of serum creatinine and potassium laboratory monitoring in patients treated with ACEI, ARB or diuretic and receiving a first dispensing of NSAID. We described the first dispensing of NSAID among 3,500 patients of a 4-year cohort (6,633 patients treated with antihypertensive drugs) and analyzed serum creatinine and potassium laboratory monitoring within the 3 weeks after the first NSAID dispensing. Results General Practitioners were the most frequent prescribers of NSAIDs (85.5%, 95% CI: 84.3–86.6). The more commonly prescribed NSAIDs were ibuprofen (20%), ketoprofen (15%), diclofenac (15%) and piroxicam (12%). Serum creatinine and potassium monitoring was 10.7% (95% CI: 9.5–11.8) in patients treated by ACEIs, ARBs or diuretics. Overall, monitoring was more frequently performed to women aged over 60, treated with digoxin or glucose lowering drugs, but not to patients treated with ACEIs, ARBs or diuretics. Monitoring was more frequent when NSAIDs' prescribers were cardiologists or anesthesiologists. Conclusion Monitoring of serum creatinine and potassium of patients treated with ACEIs, ARBs or diuretics and receiving a first NSAID dispensing is insufficiently performed and needs to be reinforced through specific interventions. PMID:22479557

Opposite effects of cannabis and cocaine on performance monitoring.

PubMed

Spronk, Desirée B; Verkes, Robbert J; Cools, Roshan; Franke, Barbara; Van Wel, Janelle H P; Ramaekers, Johannes G; De Bruijn, Ellen R A

2016-07-01

Drug use is often associated with risky and unsafe behavior. However, the acute effects of cocaine and cannabis on performance monitoring processes have not been systematically investigated. The aim of the current study was to investigate how administration of these drugs alters performance monitoring processes, as reflected in the error-related negativity (ERN), the error positivity (Pe) and post-error slowing. A double-blind placebo-controlled randomized three-way crossover design was used. Sixty-one subjects completed a Flanker task while EEG measures were obtained. Subjects showed diminished ERN and Pe amplitudes after cannabis administration and increased ERN and Pe amplitudes after administration of cocaine. Neither drug affected post-error slowing. These results demonstrate diametrically opposing effects on the early and late phases of performance monitoring of the two most commonly used illicit drugs of abuse. Conversely, the behavioral adaptation phase of performance monitoring remained unaltered by the drugs. Copyright © 2016. Published by Elsevier B.V.

Illicit drugs and pharmaceuticals in the environment--forensic applications of environmental data, Part 2: Pharmaceuticals as chemical markers of faecal water contamination.

PubMed

Kasprzyk-Hordern, Barbara; Dinsdale, Richard M; Guwy, Alan J

2009-06-01

This manuscript is part two of a two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. In this paper pharmaceuticals were investigated as potential chemical indicators of water contamination with sewage. The monitoring program carried out in Wales revealed that some pharmaceuticals are particularly persistent and/or ubiquitous in contaminated river water and therefore might be considered as potential conservative or labile wastewater indicators. In particular, these include some anti-inflammatory/analgesics, antiepileptics, beta-blockers, some H2-receptor antagonists and antibacterial drugs.

A call for a statewide medication reconciliation program.

PubMed

Askin, Elizabeth; Margolius, David

2016-10-01

In the outpatient setting, it is exceedingly difficult to know what medications our patients have been prescribed and are taking. Each encounter with a specialist, hospital, or pharmacy can generate a change to a patient's list of medications, and in most systems, this information is not communicated back to the primary care practice's electronic health record-the exception being opiate prescriptions. Prescription drug monitoring programs in 48 states list every opiate prescription, the name of the prescriber, and the date and location the prescription was picked up. We propose that policy makers act to expand these programs to all medications, thus improving the likelihood that any provider prescribing a new medication would know what medicines their patient is already taking.

21 CFR 1271.195 - Environmental control and monitoring.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Environmental control and monitoring. 1271.195 Section 1271.195 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS...

21 CFR 884.2800 - Computerized Labor Monitoring System.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Computerized Labor Monitoring System. 884.2800 Section 884.2800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Predictors of loss to follow-up among children registered in an HIV prevention mother-to-child transmission cohort study in Pernambuco, Brazil.

PubMed

Gouveia, Pedro Alves da Cruz; da Silva, Gerlane Alves Pontes; de Albuquerque, Maria de Fatima Pessoa Militão

2014-11-27

Mother-to-child transmission of HIV (MTCT) is the major form of acquiring the disease among children. The loss to follow-up (LTF) of mothers and their children is a problem that affects the effectiveness of programs for the prevention of mother-to-child transmission (PMTCT). The aim of this study is to identify risk factors associated with the LTF of HIV-exposed children in the state of Pernambuco, Brazil. A retrospective cohort study was carried out with 1200 HIV-exposed children born between 2000 and 2009, registered up to the age of 2 months in a public health PMTCT program. Children were considered LTF if they did not return for scheduled visits to monitor infection status. Univariate and multivariate logistic regression analyses were conducted to identify risk factors for LTF. A total of 185 children (15.4%; CI: 95%: 13.4-17.4%) met the case definition of LTF before the determination of serological HIV status. Risk factors independently associated with LTF were mother-child pairs who reside in rural and remote areas (OR 1.86; 95% CI: 1.30-2.66) and mothers who use illicit drugs (OR 1.8; 95% CI: 1.08-3.0). Initiation of the PMTCT during pregnancy was a protective factor for LTF (OR 0.69; 95% CI: 0.49-0.96). The decentralization of support services for HIV-exposed children to other cities in the state seems to be crucial for the accurate monitoring of outcomes. It is also important to introduce additional measures addressing mothers who are drug users so that they remain in the program: an intensive follow-up program that actively searches for absentee mother-child pairs, support from social services and treatment for drug-dependency. The findings of this study highlight the importance of diagnosing mothers as early as possible in order to conduct a more complete follow-up period of the children. Solving the above-mentioned problems is a challenge, which must be overcome so as to improve the quality of PMTCT.

21 CFR 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cutaneous carbon dioxide (PcCO2) monitor. 868.2480 Section 868.2480 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the...

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

PubMed

Rodwin, Marc A

2013-01-01

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

Nails in Forensic Toxicology: An Update.

PubMed

Solimini, Renata; Minutillo, Adele; Kyriakou, Chrystalla; Pichini, Simona; Pacifici, Roberta; Busardo, Francesco Paolo

2017-01-01

The analysis of nails as a keratinized matrix to detect drugs or illicit substances has been increasingly used in forensic and clinical toxicology as a complementary test, especially for the specific characteristics of stably accumulating substances for long periods of time. This allows a retrospective investigation of chronic drug abuse, monitoring continuous drug or pharmaceutical use, reveal in utero drug exposure or environmental exposures. We herein review the recent literature investigating drug incorporation mechanisms and drug detection in nails for forensic toxicological purposes. Mechanisms of drug incorporation have not yet been fully elucidated. However, some research has lately contributed to a better understanding of how substances are incorporated into nails, suggesting three potential mechanisms of drug incorporation: contamination from sweat, incorporation from nail bed and incorporation from germinal matrix. In addition, numerous methods dealing with the determination of drugs of abuse, medications and alcohol biomarkers in nails have been reported in studies over the years. The latter methods could find application in clinical and forensic toxicology. The studies herein reviewed point out how important it is to standardize and harmonize the methodologies (either pre-analytical or analytical) for nails analysis and the optimization of sampling as well as the development of proficiency testing programs and the determination of cut-off values. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Quality control of antibiotics before the implementation of an STD program in Northern Myanmar.

PubMed

Prazuck, Thierry; Falconi, Isabelle; Morineau, Guy; Bricard-Pacaud, Véronique; Lecomte, Antoine; Ballereau, Francoise

2002-11-01

The ready availability of poor-quality drugs in developing countries leads to treatment failure and, consequently, excess mortality and morbidity. Moreover, the widespread availability of substandard drugs plays a key role in increasing the resistance to antimicrobial drugs.GOAL As a prerequisite to the establishment of a sexually transmitted disease (STD) control program, this study aimed to evaluate the quality of antibiotics recommended for treatment of STDs that were locally available in the capital of a province of Northern Myanmar. In addition to the hospital pharmacy, we selected at random 5 of the 41 drug sellers and 5 of the 40 general practitioners who sell antibiotics in the city of Myitkyina. Twenty-one marketing products corresponding to nine different antibiotics used for STD treatment were purchased (benzathine benzylpenicillin, benzylpenicillin, ceftriaxone, chlortetracycline, ciprofloxacin, clotrimazole, co-trimoxazole, doxycycline, and erythromycin). Drugs were sent to France, where they were analyzed according to the WHO guidelines. Drugs were considered to be standard if their dosage remained in the 10% range of the expected value. Among the 21 different specialty products, only three displayed the official "registered" label. Three drugs were expired and the expiration date was not available for six others. One product did not contain the active drug declared (chlortetracycline; Lombisin, Unicorn, China) and did not show any in vitro activity against bacteria. Seven of 21 products (33%) did not contain the stated dosage (1, more than stated dosage; 6, less than stated dosage). The highest deficit observed was 48% in two products (co-trimoxazole, Yong Fong, Myanmar; benzylpenicillin, China [city and manufacturer unknown]). The dosage was not available for five drugs. As a result, only 8 of 21 products (38%) did not contain the stated dosage of active drug. These findings suggest that public health policies based on national treatment guidelines should rigorously include the monitoring of quality control of available antimicrobial products. In the absence of such measures, specific treatment strategies are likely to fail and to generate drug resistance.

How molecular epidemiology studies can support the National Malaria Control Program in Papua New Guinea.

PubMed

Koepfli, Cristian; Barry, Alyssa; Javati, Sarah; Timinao, Lincoln; Nate, Elma; Mueller, Ivo; Barnadas, Celine

2014-01-01

Papua New Guinea (PNG) is undertaking intensified efforts to control malaria. The National Malaria Control Program aims to reduce the burden of disease by large-scale distribution of insecticide-treated bednets, improved diagnosis and implementation of new treatments. A scientific program monitoring the effect of these interventions, including molecular epidemiology studies, closely accompanies the program. Laboratory assays have been developed in (or transferred to) PNG to measure prevalence of infection and intensity of transmission as well as potential resistance to currently used drugs. These assays help to assess the impact of the National Malaria Control Program, and they reveal a much clearer picture of malaria epidemiology in PNG. In addition, analysis of the geographical clustering of parasites aids in selecting areas where intensified control will be most successful. This paper gives an overview of current research and recently completed studies in the molecular epidemiology of malaria conducted in Papua New Guinea.

Increasing Access to Subsidized Artemisinin-based Combination Therapy through Accredited Drug Dispensing Outlets in Tanzania

PubMed Central

2011-01-01

Background In Tanzania, many people seek malaria treatment from retail drug sellers. The National Malaria Control Program identified the accredited drug dispensing outlet (ADDO) program as a private sector mechanism to supplement the distribution of subsidized artemisinin-based combination therapies (ACTs) from public facilities and increase access to the first-line antimalarial in rural and underserved areas. The ADDO program strengthens private sector pharmaceutical services by improving regulatory and supervisory support, dispenser training, and record keeping practices. Methods The government's pilot program made subsidized ACTs available through ADDOs in 10 districts in the Morogoro and Ruvuma regions, covering about 2.9 million people. The program established a supply of subsidized ACTs, created a price system with a cost recovery plan, developed a plan to distribute the subsidized products to the ADDOs, trained dispensers, and strengthened the adverse drug reactions reporting system. As part of the evaluation, 448 ADDO dispensers brought their records to central locations for analysis, representing nearly 70% of ADDOs operating in the two regions. ADDO drug register data were available from July 2007-June 2008 for Morogoro and from July 2007-September 2008 for Ruvuma. This intervention was implemented from 2007-2008. Results During the pilot, over 300,000 people received treatment for malaria at the 448 ADDOs. The percentage of ADDOs that dispensed at least one course of ACT rose from 26.2% during July-September 2007 to 72.6% during April-June 2008. The number of malaria patients treated with ACTs gradually increased after the start of the pilot, while the use of non-ACT antimalarials declined; ACTs went from 3% of all antimalarials sold in July 2007 to 26% in June 2008. District-specific data showed substantial variation among the districts in ACT uptake through ADDOs, ranging from ACTs representing 10% of all antimalarial sales in Kilombero to 47% in Morogoro Rural. Conclusions The intervention increased access to affordable ACTs for underserved populations. Indications are that antimalarial monotherapies are being "crowded out" of the market. Importantly, the transition to ACTs has been accomplished in an environment where the safety and efficacy of the drugs and the quality of services are being monitored and regulated. This paper presents a description of the pilot program implementation, results of the program evaluation, and a discussion of the challenges and recommendations that will be used to guide rollout of subsidized ACT in ADDOs in the rest of Tanzania and possibly in other countries. PMID:21658259

Demographic Subgroup Trends for Various Licit and Illicit Drugs, 1975-2009. Monitoring the Future Occasional Paper Series. Paper 73

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2010-01-01

This occasional paper serves as a supplement to one of four annual monographs from the Monitoring the Future (MTF) study, written by the study's investigators and published by the study's sponsor, the National Institute on Drug Abuse. The full 2009 survey results are reported in "Monitoring the Future National Survey Results on Drug Use,…

The relevance of the psychological evaluation in drug dependence.

PubMed

Popescu, G; Negrei, C; Bălălău, D; Ciobanu, A M; Baconi, D

2014-01-01

Psychological interventions are considered a central part of the individual psychotherapy in the rehabilitation counseling of psychiatrically symptomatic drug-dependent patients during methadone maintenance treatment in community programs. The need for psychological counseling should be evaluated for each individual patient. Medication is an important part of the treatment and individual psychotherapy focuses on the reduction or total cessation of drug use. The Recipient is G.M. 31, sentenced to a seven-year term of imprisonment for trafficking and use of and high-risk drugs, diagnosed on admission with opioid and methadone dependence, withdrawal syndrome. Following the observation and psychological evaluation, psychiatric and clinical examination, initiation of methadone substitution treatment was recommended, according to the following regimen: twelve 2.5 mg tablets for the first 2 days, followed by increase with about 5 mg per week until the complete remission of withdrawal symptoms, stabilization of the dose but not exceeding 200 mg methadone hydrochloride per day. Specialist monitoring, specialized counseling and individual and group psychotherapy were provided.

[Customizing dosage drugs what contribution in therapeutic drug monitoring?].

PubMed

Abdessadek, Mohammed; Magoul, Rabia; Amarti, Afaf; El Ouezzani, Seloua; Khabbal, Youssef

2014-01-01

Drug response is often variable from an individual to another: the same dose of drug administered to different patients could cause variable pharmacological effects in nature and intensity. Those effects are often the result of variability in drugs pharmacokinetics (absorption, distribution, metabolism and elimination) which alter their bioavailability. In fact, two factors should be taken into account: the disease(s) from which the patient suffers, and the associated drugs, because many drug interactions may alter their pharmacokinetics causing consequently quite enough of different therapeutic effects. The choice of the assay of the drug subject in monitoring is crucial, it allows quantifying the in vivo dose of the drug and the quality of compliance thereof, the pharmacokinetic characteristics allows the clinician to adjust the dosage by different approaches so that plasma concentrations are included in the therapeutic range. Therapeutic monitoring aims to increase clinical efficacy and to minimize toxicity.

Addiction research centres and the nurturing of creativity. Monitoring the European drug situation: the ongoing challenge for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

PubMed

Griffiths, Paul; Mounteney, Jane; Lopez, Dominique; Zobel, Frank; Götz, Wolfgang

2012-02-01

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the designated hub for drug-related information in the European Union. The organization's role is to provide the European Union (EU) and its Member States with a factual overview of European drug problems and a common information framework to support the drugs debate. In order to achieve its mission, the EMCDDA coordinates and relies on a network of 30 national monitoring centres, the Reitox National Focal Points. The Centre publishes on a wide range of drug-related topics, across epidemiology, interventions, laws and policies. Every November, the EMCDDA publishes its Annual Report, providing a yearly update on the European drug situation, translated into 23 EU languages. In line with its founding regulation, the EMCDDA has a role acting as an interface between the worlds of science and policy. While not a research centre in the formal sense, the results the Centre generates serve as catalysts for new research questions and help to identify priorities. Current challenges facing the agency include continuing to increase scientific standards while maintaining a strong institutional role, as well as supporting European efforts to identify, share and codify best practice in the drugs field. © 2011 EMCDDA.

WHO: World Health Assembly.

PubMed

McGregor, A

1992-05-23

1200 delegates from 175 member countries attended the 45th World Health Assembly in Geneva. Everyone at the Assembly ratified measures to prevent and control AIDS. 12 countries intended to do long term planning for community based care for AIDS patients. Further the Assembly denounced instances where countries and individuals denied the gravity of the AIDS pandemic. In fact, it expressed the importance for urgent and intensive action against HIV/AIDS. The assembly backed proposals to prevent and control sexually transmitted diseases that affect AIDS patients, especially hepatitis B. For example, in countries with hepatitis B prevalence 8% (many countries in Sub-Sahara Africa, Asia, the Pacific region, and South America), health officials should introduce hepatitis B vaccine into their existing immunization programs by 1995. By 1997, this vaccine should be part of all immunization programs. The Assembly was aware of the obstacles of establishing reliable cold chains for nationwide distribution, however. Delegates in Committee A objected to the fact that 50% of the populations of developing countries continued to have limited access to essential drugs. They also expressed disapproval in implementation of WHO's 1988 ethical criteria for promotion of drugs which WHO entrusted to the Council for International Organisations of Medical Sciences (CIOMS). CIOMS lacked WHO's status and thus could not effectively monitor drug advertising. In fact, the pharmaceutical industry as well as WHO provided the funds for a meeting of 25 experts to discuss principles included in the ethical criteria. At least 4 countries insisted that WHO have the ultimate authority in monitoring drug advertising. Delegates did adopt a compromise resolution on this topic which required that industry promotion methods be reported to the 1994 Assembly via the Executive Board. The Assembly requested WHO to establish an international advisory committee on nursing and midwifery and to improve the network of WHO collaborating centers which help national nursing groups.

Development and validation of a streamlined method designed to detect residues of 62 veterinary drugs in bovine kidney using ultra-high performance liquid chromatography--tandem mass spectrometry.

PubMed

Lehotay, Steven J; Lightfield, Alan R; Geis-Asteggiante, Lucía; Schneider, Marilyn J; Dutko, Terry; Ng, Chilton; Bluhm, Louis; Mastovska, Katerina

2012-08-01

In the USA, the US Department of Agriculture's Food Safety and Inspection Service (FSIS) conducts the National Residue Program designed to monitor veterinary drug and other chemical residues in beef and other slaughtered food animals. Currently, FSIS uses a 7-plate bioassay in the laboratory to screen for antimicrobial drugs in bovine kidneys from those animals tested positive by inspectors in the slaughter establishments. The microbial inhibition bioassay has several limitations in terms of monitoring scope, sensitivity, selectivity, and analysis time. Ultra-high performance liquid chromatography - tandem mass spectrometry (UHPLC-MS/MS) has many advantages over the bioassay for this application, and this study was designed to develop, evaluate, and validate a fast UHPLC-MS/MS method for antibiotics and other high-priority veterinary drugs in bovine kidney. Five existing multi-class, multi-residue methods from the literature were tested and compared, and each performed similarly. Experiments with incurred samples demonstrated that a 5-min shake of 2 g homogenized kidney with 10 ml of 4/1 (v/v) acetonitrile/water followed by simultaneous clean-up of the initial extract with 0.5 g C18 and 10 ml hexane gave a fast, simple, and effective sample preparation method for the <10 min UHPLC-MS/MS analysis. An extensive 5-day validation process demonstrated that the final method could be used to acceptably screen for 54 of the 62 drugs tested, and 50 of those met qualitative MS identification criteria. Quantification was not needed in the application, but the method gave ≥ 70% recoveries and ≤ 25% reproducibilities for 30 of the drugs. Published 2012. This article is a U.S. Government work and is in the public domain of the USA.

Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program

DTIC Science & Technology

2011-01-01

central nervous system, optic neuritis, chronic inflammatory demyelinating polyneuropathy ) 340, 341.0, 341.8, 341.9, 377.30, 377.31, 377.32, 377.34...neuropathy, polyneuropathy due to drugs or other toxic agents, critical illness polyneuropathy , other inflammatory and toxic neuropathy) 337.0, 337.9, 354.1...Popula- tions at high risk, such as those with chronic diseases, are sometimes not well represented in clinical studies; however, additional efforts

Software for Dosage Individualization of Voriconazole for Immunocompromised Patients

PubMed Central

VanGuilder, Michael; Donnelly, J. Peter; Blijlevens, Nicole M. A.; Brüggemann, Roger J. M.; Jelliffe, Roger W.; Neely, Michael N.

2013-01-01

The efficacy of voriconazole is potentially compromised by considerable pharmacokinetic variability. There are increasing insights into voriconazole concentrations that are safe and effective for treatment of invasive fungal infections. Therapeutic drug monitoring is increasingly advocated. Software to aid in the individualization of dosing would be an extremely useful clinical tool. We developed software to enable the individualization of voriconazole dosing to attain predefined serum concentration targets. The process of individualized voriconazole therapy was based on concepts of Bayesian stochastic adaptive control. Multiple-model dosage design with feedback control was used to calculate dosages that achieved desired concentration targets with maximum precision. The performance of the software program was assessed using the data from 10 recipients of an allogeneic hematopoietic stem cell transplant (HSCT) receiving intravenous (i.v.) voriconazole. The program was able to model the plasma concentrations with a high level of precision, despite the wide range of concentration trajectories and interindividual pharmacokinetic variability. The voriconazole concentrations predicted after the last dosages were largely concordant with those actually measured. Simulations provided an illustration of the way in which the software can be used to adjust dosages of patients falling outside desired concentration targets. This software appears to be an extremely useful tool to further optimize voriconazole therapy and aid in therapeutic drug monitoring. Further prospective studies are now required to define the utility of the controller in daily clinical practice. PMID:23380734

Associations between statewide prescription drug monitoring program (PDMP) requirement and physician patterns of prescribing opioid analgesics for patients with non-cancer chronic pain.

PubMed

Lin, Hsien-Chang; Wang, Zhi; Boyd, Carol; Simoni-Wastila, Linda; Buu, Anne

2018-01-01

State-level prescription drug monitoring programs (PDMPs) have been implemented in most states. PDMPs enable registered prescribers to obtain real-time information on patients' prescription history to reduce non-medical use of controlled drugs. This study examined whether PDMP implementation and different levels of PDMP requirements were associated with physicians' patterns of prescribing opioid analgesics for patients with non-cancer chronic pain. This is a secondary analysis study using cross-sectional national data. Patients with non-cancer chronic pain from the 2012 National Ambulatory Medical Care Survey were included (weighted N=81,018,131; unweighted N=3295). Heckman two-step selection procedure employing two logistic regressions was used to explore the associations between PDMP requirements and physicians' prescribing behaviors, controlling for physician characteristics, patient characteristics, physician-healthcare system interaction, and physician-patient relationship, guided by the Eisenberg's model of physician decision making. State PDMP implementation status and requirement levels were not associated with physician opioid prescribing for non-cancer chronic pain treatment (p's ranged 0.30-0.32). Patients with Medicare coverage were more likely to be prescribed opioid analgesics than those with private health insurance (OR=1.55, p<0.01). Hispanic patients were less likely to be prescribed opioid analgesics than non-Hispanic white patients (OR=0.61, p<0.05). Findings indicated that the effectiveness of PDMPs on physicians' opioid prescribing tendency for non-cancer chronic pain treatment could not be supported. Policy makers should be aware of the need for redesigning PDMPs regarding requirements and enforcement for prescribers and related stakeholders. Future studies also are needed to identify characteristics contributing to PDMP effectiveness in reducing non-medical use of prescription opioids. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improved Completion Rates and Characterization of Drug Reactions with an Intensive Chagas Disease Treatment Program in Rural Bolivia

PubMed Central

Tornheim, Jeffrey A.; Lozano Beltran, Daniel F.; Gilman, Robert H.; Castellon, Mario; Solano Mercado, Marco A.; Sullca, Walter; Torrico, Faustino; Bern, Caryn

2013-01-01

Background Chagas disease treatment is limited by drug availability, adverse side effect profiles of available medications, and poor adherence. Methods Adult Chagas disease patients initiating 60-days of benznidazole were randomized to weekly or twice-weekly evaluations of medication adherence and screening for adverse drug events (ADEs). Mid-week evaluations employed phone-based evaluations. Adherence was measured by self-report, pill counts with intentional over-distribution, and Medication Event Monitoring Systems (MEMS). Prospective data were compared to historical controls treated with benznidazole at the same hospital. Results 162 prospective patients were compared to 172 historical patients. Pill counts correlated well with MEMS data (R = 0.498 for 7-day intervals, R = 0.872 for intervals >7 days). Treatment completion rates were higher among prospective than historical patients (82.1% vs. 65.1%), primarily due to lower abandonment rates. Rates of ADEs were lower among prospective than historical patients (56.8% vs. 66.9%). Twice-weekly evaluations increased identification of mild ADEs, prompting higher suspension rates than weekly evaluations. While twice-weekly evaluations identified ADEs earlier, they did not reduce incidence of moderate or severe ADEs. Many dermatologic ADEs were moderately severe upon presentation (35.6%), were not reduced by use of antihistamines, occurred among adult patients of all ages, and occurred throughout treatment, rather than the first few weeks alone. Conclusions Intensive management improved completion and identified more ADEs, but did not reduce moderate or severe ADEs. Risk of dermatologic ADEs cannot be reduced by selecting younger adults or monitoring only during the first few weeks of treatment. Pill counts and phone-based encounters are reliable tools for treatment programming in rural Bolivia. PMID:24069472

How does use of a prescription monitoring program change pharmacy practice?

PubMed

Green, Traci C; Mann, Marita R; Bowman, Sarah E; Zaller, Nickolas; Soto, Xaviel; Gadea, John; Cordy, Catherine; Kelly, Patrick; Friedmann, Peter D

2013-01-01

To assess differences in prescription monitoring program (PMP) use between two states with different PMP accessibility (Connecticut [CT] and Rhode Island [RI]), to explore use of PMPs in pharmacy practice, and to examine associations between PMP use and pharmacists' responses to suspected diversion or "doctor shopping." Descriptive nonexperimental study. CT and RI from March through August 2011. Licensed pharmacists in CT and RI. Anonymous surveys e-mailed to pharmacists PMP use, use of patient reports in pharmacy practice, and responses to suspected doctor shopping or diversion. Responses from 294 pharmacists were received (CT: 198; RI: 96). PMP users were more likely to use the PMP to detect drug abuse (CT: 79%; RI: 21.9%; P < 0.01) and doctor shopping (67%; 7%; P < 0.01). When faced with suspicious medication use behavior, PMP users were less likely than nonusers to discuss their concerns with the patient (adjusted odds ratio 0.48 [95% CI 0.25-0.92]) but as likely to contact the provider (0.86 [0.21-3.47]), refer the patient back to the prescriber (1.50 [0.79-2.86]), and refuse to fill the prescription (0.63 [0.30-1.30]). PMP users were less likely to state they were out of stock of the drug (0.27 [0.12-0.60]) compared with nonusers. Pharmacists reported high interest in attending continuing education on safe dispensing (72.8%). Pharmacists are important participants in the effort to address prescription drug misuse and abuse. Current PMP use with prevailing systems had limited influence on pharmacy practice. Findings point to future research and needed practice and education innovations to improve patient safety and safer opioid dispensing for pharmacists.

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.

Prescription drug monitoring program data tracking of opioid addiction treatment outcomes in integrated dual diagnosis care involving injectable naltrexone

PubMed Central

Sajid, Ayesha; Whiteman, Aaron; Bell, Richard L.; Greene, Marion S.; Engleman, Eric A.

2016-01-01

Background and Objectives Fourfold increases in opioid prescribing and dispensations over 2 decades in the U.S. has paralleled increases in opioid addictions and overdoses, requiring new preventative, diagnostic, and treatment strategies. This study examines Prescription Drug Monitoring Program (PDMP) tracking as a novel measure of opioid addiction treatment outcomes in a university‐affiliated integrated mental health‐addiction treatment clinic. Methods Repeated measure parametrics examined PDMP and urine drug screening (UDS) data before and after first injection for all patients (N = 68) who received at least one long‐acting naltrexone injection (380 mg/IM) according to diagnostic groupings of having either (i) alcohol (control); (ii) opioid; or (iii) combined alcohol and opioid use disorders. Results There were no group differences post‐injection in treatment days, injections delivered, or treatment service encounters. UDS and PDMP measures of opioid exposures were greater in opioid compared to alcohol‐only patients. Post‐first injection, UDS's positive for opioids declined (p < .05) along with PDMP measures of opioid prescriptions (p < .001), doses (p < .01), types (p < .001), numbers of dispensing prescribers (p < .001) and pharmacies (p < .001). Opioid patients without alcohol disorders showed the best outcomes with 50% to 80% reductions in PDMP‐measures of opioids, down to levels of alcohol‐only patients. Conclusions This study shows PDMP utility for measuring opioid addiction treatment outcomes, supporting the routine use of PDMPs in clinical and research settings. Scientific Significance These findings demonstrate that opioid addiction in patients with complex addictions and mental illnesses comorbidities can show effective treatment responses as measured by PDMP tracking of decreases in opioid prescriptions to those patients. (Am J Addict 2016;25:557–564) PMID:27647699

A national program for control of acute respiratory tract infections: the Philippine experience.

PubMed

Dayrit, E S

1999-02-01

Maturing programs on child immunization and diarrheal diseases, a community-based research project, and a rational drug-use program facilitated the launching in 1989 of a nationwide Philippine Control of Acute Respiratory Infections program (Phil-CARI). From 1990 to 1991 the Phil-CARI expanded rapidly, training >80% of its middle managers and frontline health care providers on the case-management protocols of the World Health Organization for acute respiratory infection. Multiple donors and good collaboration with various societies and medical schools assisted the program. However, by 1992, there were difficulties in maintaining training quality, follow-up, and supervision. Donor assistance dwindled and the health care delivery system decentralized. Government procurement systems were unable to meet the logistics demands of the program. The monitoring and evaluation system was inadequate to measure impact. The Phil-CARI provides lessons in searching for more sustainable approaches and systems to meet the various demands of a nationwide ARI control program and to create the desired impact.

Cancer Phenotype Diagnosis and Drug Efficacy within Japanese Health Care

PubMed Central

Nishimura, Toshihide; Kato, Harubumi; Ikeda, Norihiko; Kihara, Makoto; Nomura, Masaharu; Kato, Yasufumi; Marko-Varga, György

2012-01-01

An overview on targeted personalized medicine is given describing the developments in Japan of lung cancer patients. These new targeted therapies with novel personalized medicine drugs require new implementations, in order to follow and monitor drug efficacy and outcome. Examples from IRESSA (Gefitinib) and TARCEVA (Erlotinib) treatments used in medication of lung cancer patients are presented. Lung cancer is one of the most common causes of cancer mortality in the world. The importance of both the quantification of disease progression, where diagnostic-related biomarkers are being implemented, in addition to the actual measurement of disease-specific mechanisms relating to pathway signalling activation of disease-progressive protein targets is summarised. An outline is also presented, describing changes and adaptations in Japan, meeting the rising costs and challenges. Today, urgent implementation of programs to address these needs has led to a rebuilding of the entire approach of medical evaluation and clinical care. PMID:22685658

Postmarketing surveillance: perspectives of a journal editor.

PubMed

Gelenberg, A J

1993-01-01

In the absence of a systematic monitoring program for drugs newly approved by the Food and Drug Administration (FDA), reports in clinical journals provide a legitimate forum for disseminating information about unexpected pharmacologic events. A journal editor bears the responsibility for publishing educated clinical observations that meet standards of scientific rigor while not giving premature credibility to chance and dubious reports of side effects of new drugs. Often this responsibility involves overcoming the fear of bad publicity and withstanding pressures from pharmaceutical companies to print only positive information about new products. Published preliminary observations may contribute to the problem of product liability, but they also generate testable hypotheses and healthy debate. If hypotheses later prove to be incorrect, they can be refuted by systematic studies and clarified in reviews and editorials. Our goal of effective education will be reached not by self-censorship but by scientific openness.

Real-Time Two-Dimensional Magnetic Particle Imaging for Electromagnetic Navigation in Targeted Drug Delivery.

PubMed

Le, Tuan-Anh; Zhang, Xingming; Hoshiar, Ali Kafash; Yoon, Jungwon

2017-09-07

Magnetic nanoparticles (MNPs) are effective drug carriers. By using electromagnetic actuated systems, MNPs can be controlled noninvasively in a vascular network for targeted drug delivery (TDD). Although drugs can reach their target location through capturing schemes of MNPs by permanent magnets, drugs delivered to non-target regions can affect healthy tissues and cause undesirable side effects. Real-time monitoring of MNPs can improve the targeting efficiency of TDD systems. In this paper, a two-dimensional (2D) real-time monitoring scheme has been developed for an MNP guidance system. Resovist particles 45 to 65 nm in diameter (5 nm core) can be monitored in real-time (update rate = 2 Hz) in 2D. The proposed 2D monitoring system allows dynamic tracking of MNPs during TDD and renders magnetic particle imaging-based navigation more feasible.

Real-Time Two-Dimensional Magnetic Particle Imaging for Electromagnetic Navigation in Targeted Drug Delivery

PubMed Central

Le, Tuan-Anh; Zhang, Xingming; Hoshiar, Ali Kafash; Yoon, Jungwon

2017-01-01

Magnetic nanoparticles (MNPs) are effective drug carriers. By using electromagnetic actuated systems, MNPs can be controlled noninvasively in a vascular network for targeted drug delivery (TDD). Although drugs can reach their target location through capturing schemes of MNPs by permanent magnets, drugs delivered to non-target regions can affect healthy tissues and cause undesirable side effects. Real-time monitoring of MNPs can improve the targeting efficiency of TDD systems. In this paper, a two-dimensional (2D) real-time monitoring scheme has been developed for an MNP guidance system. Resovist particles 45 to 65 nm in diameter (5 nm core) can be monitored in real-time (update rate = 2 Hz) in 2D. The proposed 2D monitoring system allows dynamic tracking of MNPs during TDD and renders magnetic particle imaging-based navigation more feasible. PMID:28880220

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

PubMed

Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

2016-12-30

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

The three missing elements in the treatment of substance use disorders: Lessons from the physician health programs.

PubMed

DuPont, Robert L; Seppala, Marvin D; White, William L

2016-01-01

To make recovery, and not relapse, the expected outcome of the treatment of moderate to severe substance use disorders, 3 currently missing elements would need to be emphasized: (1) the definition of long-term recovery as the goal of all treatment and post-treatment interventions; (2) the provision of sustained post-treatment monitoring and professional and peer support, including drug testing; and (3) the insistence by others around the patients on sustained abstinence as crucial for those suffering from moderate to severe and prolonged substance use disorders. Each of these 3 elements is central to the distinctive care management system of the state physician health programs. This approach to the long-term management of substance use disorders fits with the new direction of healthcare for serious, chronic diseases-away from isolated, and expensive acute care episodes of care and toward sustained chronic disease management with long-term monitoring, support, and early re-intervention if and when needed.

Current Status of Human Resource Training Program for Fostering RIBiomics Professionals

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

Lee, Dong-Eun; Jang, Beom-Su; Choi, Dae Seong

RI-Biomics is a state-of-the-art radiation fusion technology for evaluating in-vivo dynamics such as absorption, distribution, metabolism and excretion (ADME) of new drug candidates and biomaterials using radioisotope (RI), and quantitative evaluation of their efficacy via molecular imaging techniques and animal models. The RI-Biomics center is the sole comprehensive research and experiment complex in Korea that can simultaneously perform the radio-synthesis of drug candidate with radioisotope, analysis, and molecular imaging evaluation with animal model. Molecular imaging techniques, including nuclear imaging (SPECT and PET), near-infrared fluorescent (NIRF) imaging, and magnetic resonance imaging (MRI), are the cutting-edge technologies for evaluating drug candidates. Sincemore » they allow in vivo real-time imaging of the diseased site, monitoring the biodistribution of drug and determining the optimal therapeutic efficacy following treatments, we have integrated RI-ADME and molecular imaging to provide useful information for drug evaluation and to accelerate the development of new drugs and biomaterials. The RI-Biomics center was established with total investment of 18 million $ during four years from 2009 to 2012 in order to develop a comprehensive analyzing system using RI for new drug development as an axis for national growth in the next generation. The RI-Biomics center has labeling synthesis facility for the radiosynthesis of drug candidate with radioisotope such as Tc-99m, I-125, I-131, F-18, H-3 and C-14 using hot cell. It also includes RI-general analysis facilities, such as Radio-HPLC, LC/MS, GC/MS, gamma counter that can analyzing the radio-synthesized materials, and animal image analysis facilities that developed small animal imaging equipment such as SPECT/PET/CT, 7 T MRI, in-vivo optical imaging system and others. In order to achieve the system to verify safety and effectiveness of the new drugs using RI, it is necessary to establish a human resource training program for fostering RI-Biomics professionals in the following key fields; (1) Radio-pharmaceuticals synthesis and labeled compound development, (2) Development of RI-ADME in the living object and image assessment technology. Personnel training program that carries out theoretical education and practical training in the field related to RI-Biomics in parallel is being conducted. Internship training for university students has been administered twice already while educational program for the existing professionals in the RI-Biomics field will be carried out during the summer of 2014. The human resource training program for combination of RIADME and different molecular imaging techniques can offer synergistic advantages to facilitate understanding RIADME and fostering RI-ADME professionals. (authors)« less

Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring Programme.

PubMed

Coulter, D M

2001-12-01

The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information.

21 CFR 882.5500 - Lesion temperature monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Lesion temperature monitor. 882.5500 Section 882.5500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5500 Lesion temperature...

21 CFR 870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass level sensing monitor and/or control. 870.4340 Section 870.4340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... value. (b) Classification. Class II (performance standards). ...

21 CFR 870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass level sensing monitor and/or control. 870.4340 Section 870.4340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... value. (b) Classification. Class II (performance standards). ...

Quantitative electrophysiological monitoring of anti-histamine drug effects on live cells via reusable sensor platforms.

PubMed

Pham Ba, Viet Anh; Cho, Dong-Guk; Kim, Daesan; Yoo, Haneul; Ta, Van-Thao; Hong, Seunghun

2017-08-15

We demonstrated the quantitative electrophysiological monitoring of histamine and anti-histamine drug effects on live cells via reusable sensor platforms based on carbon nanotube transistors. This method enabled us to monitor the real-time electrophysiological responses of a single HeLa cell to histamine with different concentrations. The measured electrophysiological responses were attributed to the activity of histamine type 1 receptors on a HeLa cell membrane by histamine. Furthermore, the effects of anti-histamine drugs such as cetirizine or chlorphenamine on the electrophysiological activities of HeLa cells were also evaluated quantitatively. Significantly, we utilized only a single device to monitor the responses of multiple HeLa cells to each drug, which allowed us to quantitatively analyze the antihistamine drug effects on live cells without errors from the device-to-device variation in device characteristics. Such quantitative evaluation capability of our method would promise versatile applications such as drug screening and nanoscale bio sensor researches. Copyright © 2017 Elsevier B.V. All rights reserved.

Characteristics of self-inflicted drug overdose deaths in North Carolina.

PubMed

Austin, Anna E; Proescholdbell, Scott K; Creppage, Kathleen E; Asbun, Alex

2017-12-01

Drug overdose mortality is a major public health concern in the United States, with prescription opioids contributing substantially to recent increases in drug overdose deaths. Compared to unintentional drug overdose deaths, relatively little data describes intentional self-inflicted drug overdose deaths (i.e., suicide by drug overdose). The aim of this study was to examine the characteristics of self-inflicted drug overdose deaths, overall and in comparison to unintentional drug overdose deaths. We linked vital statistics, prescription drug monitoring program, and toxicology data for self-inflicted and unintentional drug overdose deaths among North Carolina residents in 2012. Most self-inflicted (79.2%) and unintentional (75.6%) drug overdose decedents had a prescription for a controlled substance within one year of death. Toxicology results revealed that antidepressants contributed to a significantly higher percent of self-inflicted compared to unintentional drug overdose deaths (45.0% vs. 8.1%). Among deaths in which commonly prescribed opioids (oxycodone, hydrocodone) or benzodiazepines (alprazolam, clonazepam) contributed to death, a significantly higher percent of self-inflicted drug overdose decedents had a prescription for the substance within 30days of death compared to unintentional drug overdose decedents. The results highlight the use of prescription opioids, benzodiazepines, and antidepressants among self-inflicted drug overdose decedents. Importantly, the results indicate that self-inflicted drug overdose decedents were more likely than unintentional drug overdose decedents to have potential contact with the health care system in the weeks preceding death, offering an opportunity for professionals to identify and intervene on risk factors or signs of distress and potential for self-harm. Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized Multi-site Trial of the Job Seekers’ Workshop in Patients with Substance Use Disorders

PubMed Central

Svikis, Dace S.; Keyser-Marcus, Lori; Stitzer, Maxine; Rieckmann, Traci; Safford, Lauretta; Loeb, Peter; Allen, Tim; Luna-Anderson, Carol; Back, Sudie E.; Cohen, Judith; DeBernardi, Michael A.; Dillard, Bruce; Forcehimes, Alyssa; Jaffee, William; Killeen, Therese; Kolodner, Ken; Levy, Michael; Pallas, Diane; Perl, Harold I.; Potter, Jennifer Sharpe; Provost, Scott; Reese, Karen; Sampson, Royce R.; Sepulveda, Allison; Snead, Ned; Wong, Conrad J.; Zweben, Joan

2012-01-01

Background Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers’ Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. Method Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-hr small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. Results JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program), Specifically, one-fifth of participants at 12 weeks (20.1 – 24.3%) and nearly one-third at 24 weeks (31.4–31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases. Conclusion JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. PMID:21802222

High-performance liquid chromatographic analysis of vigabatrin enantiomers in human serum by precolumn derivatization with o-phthaldialdehyde-N-acetyl-L-cysteine and fluorescence detection.

PubMed

Vermeij, T A; Edelbroek, P M

1998-09-25

A rapid and simple method is presented for the determination of vigabatrin enantiomers in human serum by high-performance liquid chromatography. Serum is deproteinized with trichloroacetic acid and aliquots of the supernatant are precolumn derivatized with o-phthaldialdehyde and N-acetyl-L-cysteine, resulting in the formation of diastereomeric isoindoles. Separation was achieved on a Spherisorb 3ODS2 column using a gradient solvent program and the column eluent is monitored using fluorescence detection. L-Homoarginine was used as an internal standard. Within-day precisions (C.V.; n=8) were 2.8 and 1.1%, respectively, for the (R)-(-)- and (S)-(+)-enantiomer in serum containing 15.4 mg/l (RS)-vigabatrin. The method was linear in the 0-45 mg/l range for both enantiomers and the minimum quantitation limit was 0.20 mg/l for (R)-(-)-vigabatrin and 0.14 mg/l for (S)-(+)-vigabatrin. No interferences were found from commonly co-administered antiepileptic drugs and from endogenous amino acids. The method is suitable for routine therapeutic drug monitoring and for pharmacokinetic studies.

Rivaroxaban in the treatment of venous thromboembolism and the prevention of recurrences: a practical approach.

PubMed

Arcelus, Juan I; Domènech, Pere; Fernández-Capitan, Ma Del Carmen; Guijarro, Ricardo; Jiménez, David; Jiménez, Sonia; Lozano, Francisco S; Monreal, Manel; Nieto, José A; Páramo, José A

2015-05-01

Anticoagulation therapy is the standard treatment of patients with symptomatic venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. Until recently, treatment of VTE was based on parenteral or low-molecular-weight heparin for initial therapy (5-10 days) and oral vitamin K antagonists for long-term therapy. Those treatments have some limitations, including parenteral administration (heparins), the need for frequent monitoring and dose adjustments, interactions with several medications, and dietary restrictions (vitamin K antagonists). Rivaroxaban is a new oral direct factor Xa inhibitor with a wide therapeutic window, predictable anticoagulant effect, no food interactions, and few drug interactions. Consequently, no periodic monitoring of anticoagulation is needed, and fixed doses can be prescribed. EINSTEIN program demonstrated that rivaroxaban was as effective as and significantly safer than standard therapy for treatment of VTE. Rivaroxaban was recently authorized so doubts exist about how to use it in daily clinical practice. This document aims to clarify common questions formulated by clinicians regarding the use of this new drug. © The Author(s) 2014.

HIV-1 pol Diversity among Female Bar and Hotel Workers in Northern Tanzania

PubMed Central

Kiwelu, Ireen E.; Novitsky, Vladimir; Kituma, Elimsaada; Margolin, Lauren; Baca, Jeannie; Manongi, Rachel; Sam, Noel; Shao, John; McLane, Mary F.; Kapiga, Saidi H.; Essex, M.

2014-01-01

A national ART program was launched in Tanzania in October 2004. Due to the existence of multiple HIV-1 subtypes and recombinant viruses co-circulating in Tanzania, it is important to monitor rates of drug resistance. The present study determined the prevalence of HIV-1 drug resistance mutations among ART-naive female bar and hotel workers, a high-risk population for HIV-1 infection in Moshi, Tanzania. A partial HIV-1 pol gene was analyzed by single-genome amplification and sequencing in 45 subjects (622 pol sequences total; median number of sequences per subject, 13; IQR 5–20) in samples collected in 2005. The prevalence of HIV-1 subtypes A1, C, and D, and inter-subtype recombinant viruses, was 36%, 29%, 9% and 27%, respectively. Thirteen different recombination patterns included D/A1/D, C/A1, A1/C/A1, A1/U/A1, C/U/A1, C/A1, U/D/U, D/A1/D, A1/C, A1/C, A2/C/A2, CRF10_CD/C/CRF10_CD and CRF35_AD/A1/CRF35_AD. CRF35_AD was identified in Tanzania for the first time. All recombinant viruses in this study were unique, suggesting ongoing recombination processes among circulating HIV-1 variants. The prevalence of multiple infections in this population was 16% (n = 7). Primary HIV-1 drug resistance mutations to RT inhibitors were identified in three (7%) subjects (K65R plus Y181C; N60D; and V106M). In some subjects, polymorphisms were observed at the RT positions 41, 69, 75, 98, 101, 179, 190, and 215. Secondary mutations associated with NNRTIs were observed at the RT positions 90 (7%) and 138 (6%). In the protease gene, three subjects (7%) had M46I/L mutations. All subjects in this study had HIV-1 subtype-specific natural polymorphisms at positions 36, 69, 89 and 93 that are associated with drug resistance in HIV-1 subtype B. These results suggested that HIV-1 drug resistance mutations and natural polymorphisms existed in this population before the initiation of the national ART program. With increasing use of ARV, these results highlight the importance of drug resistance monitoring in Tanzania. PMID:25003939

HIV-1 pol diversity among female bar and hotel workers in Northern Tanzania.

PubMed

Kiwelu, Ireen E; Novitsky, Vladimir; Kituma, Elimsaada; Margolin, Lauren; Baca, Jeannie; Manongi, Rachel; Sam, Noel; Shao, John; McLane, Mary F; Kapiga, Saidi H; Essex, M

2014-01-01

A national ART program was launched in Tanzania in October 2004. Due to the existence of multiple HIV-1 subtypes and recombinant viruses co-circulating in Tanzania, it is important to monitor rates of drug resistance. The present study determined the prevalence of HIV-1 drug resistance mutations among ART-naive female bar and hotel workers, a high-risk population for HIV-1 infection in Moshi, Tanzania. A partial HIV-1 pol gene was analyzed by single-genome amplification and sequencing in 45 subjects (622 pol sequences total; median number of sequences per subject, 13; IQR 5-20) in samples collected in 2005. The prevalence of HIV-1 subtypes A1, C, and D, and inter-subtype recombinant viruses, was 36%, 29%, 9% and 27%, respectively. Thirteen different recombination patterns included D/A1/D, C/A1, A1/C/A1, A1/U/A1, C/U/A1, C/A1, U/D/U, D/A1/D, A1/C, A1/C, A2/C/A2, CRF10_CD/C/CRF10_CD and CRF35_AD/A1/CRF35_AD. CRF35_AD was identified in Tanzania for the first time. All recombinant viruses in this study were unique, suggesting ongoing recombination processes among circulating HIV-1 variants. The prevalence of multiple infections in this population was 16% (n = 7). Primary HIV-1 drug resistance mutations to RT inhibitors were identified in three (7%) subjects (K65R plus Y181C; N60D; and V106M). In some subjects, polymorphisms were observed at the RT positions 41, 69, 75, 98, 101, 179, 190, and 215. Secondary mutations associated with NNRTIs were observed at the RT positions 90 (7%) and 138 (6%). In the protease gene, three subjects (7%) had M46I/L mutations. All subjects in this study had HIV-1 subtype-specific natural polymorphisms at positions 36, 69, 89 and 93 that are associated with drug resistance in HIV-1 subtype B. These results suggested that HIV-1 drug resistance mutations and natural polymorphisms existed in this population before the initiation of the national ART program. With increasing use of ARV, these results highlight the importance of drug resistance monitoring in Tanzania.

Authoritative parenting and issue involvement as indicators of ad recall: an empirical investigation of anti-drug ads for parents.

PubMed

Quick, Brian L; Stephenson, Michael T

2007-01-01

This investigation explores the role of authoritative parenting and issue involvement in regard to the recall of parental anti-drug ads encouraging child monitoring. In addition, the study tested whether issue involvement mediates the association between authoritative parenting and recall of parental anti-drug television ads among parents (N = 185) with adolescents in Grades 6, 7, and 8. The results indicate that (a) authoritative parenting is positively associated with favorable attitudes toward monitoring children and issue involvement regarding adolescent drug use, (b) issue involvement is associated with ad recall, (c) issue involvement mediates the relationship between authoritative parenting and ad recall, (d) ad recall is not associated with favorable attitudes toward parental monitoring, and (e) favorable attitudes regarding parental monitoring are positively associated with intentions to engage in monitoring within the next 6 months.

21 CFR 882.1620 - Intracranial pressure monitoring device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

21 CFR 882.1620 - Intracranial pressure monitoring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

21 CFR 866.2560 - Microbial growth monitor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Microbial growth monitor. 866.2560 Section 866.2560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2560 Microbial growth...

21 CFR 866.2560 - Microbial growth monitor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microbial growth monitor. 866.2560 Section 866.2560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2560 Microbial growth...

21 CFR 866.2560 - Microbial growth monitor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Microbial growth monitor. 866.2560 Section 866.2560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2560 Microbial growth...

Functional neuroimaging for addiction medicine: From mechanisms to practical considerations.

PubMed

Ekhtiari, Hamed; Faghiri, Ashkan; Oghabian, Mohammad-Ali; Paulus, Martin P

2016-01-01

During last 20 years, neuroimaging with functional magnetic resonance imaging (fMRI) in people with drug addictions has introduced a wide range of quantitative biomarkers from brain's regional or network level activities during different cognitive functions. These quantitative biomarkers could be potentially used for assessment, planning, prediction, and monitoring for "addiction medicine" during screening, acute intoxication, admission to a program, completion of an acute program, admission to a long-term program, and postgraduation follow-up. In this chapter, we have briefly reviewed main neurocognitive targets for fMRI studies associated with addictive behaviors, main study types using fMRI among drug dependents, and potential applications for fMRI in addiction medicine. Main challenges and limitations for extending fMRI studies and evidences aiming at clinical applications in addiction medicine are also discussed. There is still a significant gap between available evidences from group-based fMRI studies and personalized decisions during daily practices in addiction medicine. It will be important to fill this gap with large-scale clinical trials and longitudinal studies using fMRI measures with a well-defined strategic plan for the future. © 2016 Elsevier B.V. All rights reserved.

[Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit: A major challenge for the different actors].

PubMed

Peyrilles, Elodie; Lepage-Seydoux, Coralie; Sejean, Karine; Bonan, Brigitte

2018-04-01

The development of outpatient departments requires health professionals to reorganize practices for a better patient monitoring and a better patient care pathway. To evaluate, using indicators, the impact of an oncology-monitoring program on activity and organizational fluidity in a Cytotoxic Preparation Unit and clinical departments. Method the clinical and biological data are collected between two injections by calling the patient two days prior chemotherapy is performed by a specialist nurse of an outsourced medical call center. After medical and pharmaceutical validation, early preparations (D-1) for expensive and non-expensive molecules are performed. The program is started in February 2016. After 3 months, 382 patients were included into the program. Twenty-three patients on average are called per day related to 1162 completed clinical questionnaires (87%). Among the files, 47% are complete at D-2 (biological and clinical data). The early preparation rate of expensive drugs, zero before the program for financial reasons, has reached 40% at 3 months. The destroyed preparation rate because of non-administration decreased from 5 to 2%. Preliminary results show a significant patient compliance, feasibility of early preparation of expensive and non-expensive chemotherapy. These are preliminary results of a one-year study. They will be completed by an evaluation of patients' and health professionals' satisfaction, evaluation of length of stay, optimization of operations for clinical departments and CPU. The D-2 biological data collection must be improved. A strong doctor/pharmacist collaboration is essential for better patient care pathway. Copyright © 2018 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Pharmacist care plans and documentation of follow-up before the Iowa Pharmaceutical Case Management program.

PubMed

Becker, CoraLynn; Bjornson, Darrel C; Kuhle, Julie W

2004-01-01

To document drug therapy problems and their causes and assess pharmacist follow-up of patients with identified drug therapy problems. Cross-sectional analysis. Iowa. 160 pharmacists who submitted 754 pharmaceutical care plans in an effort to qualify for participation in the Iowa Pharmaceutical Case Management program. Care plans were assessed for drug therapy problems and causes and for documentation of pharmacist follow-up (actual, none, or intent to follow up). Pharmacists documented a wide variety of drug therapy problems and causes, including adverse drug reactions (20.1% of care plans), need for additional drug therapy (18.9%), lack of patient adherence to therapy (16.3%), incorrect medication being prescribed (14.1%), and drug dose too high (10.0%). Pharmacist follow-up with patients was not optimal, with 31% of care plans providing documentation of actual follow-up. Another 42.2% of plans indicated that the pharmacist intended to contact the patient for follow-up but either did not do so or did not record the intervention. No actual follow-up or intent to follow up was recorded in 26.8% of care plans. Pharmacists practicing in independent pharmacies followed up with patients more frequently than those in other settings (36.4% of care plans, compared with 22.7%, 23.2%, and 28.4% for chain, clinic, and franchise pharmacies). Pharmacists were more likely to follow up when the identified problem involved drug safety rather than effectiveness (36.2% versus 28.3% of care plans). Documentation of pharmacist follow-up with patients was less than optimal. In addition to identifying drug therapy problems and causes, pharmacists must complete the care continuum through documentation of patient monitoring and follow-up to transform the philosophy and vision of the pharmaceutical care concept into a practice of pharmacy recognized and rewarded by patients and payers.

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 456.703 - 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...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing.... (4) A part 145 certificate holder who has your own drug testing program Obtain an Antidrug and...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... Specification, Letter of Authorization, or Drug and Alcohol Testing Program Registration from the FAA: If you...

14 CFR 120.117 - Implementing a drug testing program.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

Preventing substance use among early Asian-American adolescent girls: initial evaluation of a web-based, mother-daughter program.

PubMed

Fang, Lin; Schinke, Steven P; Cole, Kristin C A

2010-11-01

This study examined the efficacy and generalizability of a family-oriented, web-based substance use prevention program to young Asian-American adolescent girls. Between September and December 2007, a total of 108 Asian-American girls aged 10-14 years and their mothers were recruited through online advertisements and from community service agencies. Mother-daughter dyads were randomly assigned to an intervention arm or to a test-only control arm. After pretest measurement, intervention-arm dyads completed a 9-session web-based substance use prevention program. Guided by family interaction theory, the program aimed to improve girls' psychological states, strengthen substance use prevention skills, increase mother-daughter interactions, enhance maternal monitoring, and prevent girls' substance use. Study outcomes were assessed using generalized estimating equations. At posttest, relative to control-arm girls, intervention-arm girls showed less depressed mood; reported improved self-efficacy and refusal skills; had higher levels of mother-daughter closeness, mother-daughter communication, and maternal monitoring; and reported more family rules against substance use. Intervention-arm girls also reported fewer instances of alcohol, marijuana, and illicit prescription drug use, and expressed lower intentions to use substances in the future. A family-oriented, web-based substance use prevention program was efficacious in preventing substance use behavior among early Asian-American adolescent girls. Copyright © 2010 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

[Adherence and fidelity in patients treated with intragastric balloon].

PubMed

Mazure, R A; Cancer, E; Martínez Olmos, M A; De Castro, M L; Abilés, V; Abilés, J; Bretón, I; Álvarez, V; Peláez, N; Culebras, J M

2014-01-01

A correct treatment of obesity needs a program of habits modification regardless of the selected technique, especially if it is minimally invasive as the intragastric balloon (BIG). The adherence of the obese patients with regard to recommended drugs measures to medium- and long-term is less than 50%. Given that the results obtained using the technique of gastric balloon must be seen influenced by adherence to the modification of habits program and its fulfillment, we reviewed series published in attention to the program proposed with the BIG. The series published to date provide few details about the used Therapeutic Programs as well as the adherence of patients to them, and even less concerning the Monitoring Plan and the loyalty of the patient can be seen. We conclude the convenience to agree on a follow-up strategy, at least the 6 months during which the BIG remain in the stomach.

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

21 CFR 892.1540 - Nonfetal ultrasonic monitor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nonfetal ultrasonic monitor. 892.1540 Section 892.1540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... tissues in motion. This generic type of device may include signal analysis and display equipment, patient...

21 CFR 884.2700 - Intrauterine pressure monitor and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intrauterine pressure monitor and accessories. 884.2700 Section 884.2700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... include the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Fetal phonocardiographic monitor and accessories. 884.2640 Section 884.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... includes the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Fetal phonocardiographic monitor and accessories. 884.2640 Section 884.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... includes the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2700 - Intrauterine pressure monitor and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intrauterine pressure monitor and accessories. 884.2700 Section 884.2700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... include the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Fetal phonocardiographic monitor and accessories. 884.2640 Section 884.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... includes the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Fetal phonocardiographic monitor and accessories. 884.2640 Section 884.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... includes the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Fetal phonocardiographic monitor and accessories. 884.2640 Section 884.2640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... includes the following accessories: signal analysis and display equipment, patient and equipment supports...

21 CFR 892.1540 - Nonfetal ultrasonic monitor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonfetal ultrasonic monitor. 892.1540 Section 892.1540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... tissues in motion. This generic type of device may include signal analysis and display equipment, patient...

21 CFR 892.1540 - Nonfetal ultrasonic monitor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonfetal ultrasonic monitor. 892.1540 Section 892.1540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... tissues in motion. This generic type of device may include signal analysis and display equipment, patient...

21 CFR 884.2700 - Intrauterine pressure monitor and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Intrauterine pressure monitor and accessories. 884.2700 Section 884.2700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... include the following accessories: signal analysis and display equipment, patient and equipment supports...

Prescription drug coverage and effects on drug expenditures among elderly Medicare beneficiaries.

PubMed

Huh, Soonim; Rice, Thomas; Ettner, Susan L

2008-06-01

To identify determinants of drug coverage among elderly Medicare beneficiaries and to investigate the impact of drug coverage on drug expenditures with and without taking selection bias into account. The primary data were from the 2000 Medicare Current Beneficiary Survey (MCBS) Cost and Use file, linked to other data sources at the county or state-level that provided instrumental variables. Community-dwelling elderly Medicare beneficiaries who completed the survey were included in the study (N=7,525). A probit regression to predict the probability of having drug coverage and the effects of drug coverage on drug expenditures was estimated by a two-part model, assuming no correlation across equations. In addition, the discrete factor model estimated choice of drug coverage and expenditures for prescription drugs simultaneously to control for self-selection into drug coverage, allowing for correlation of error terms across equations. Findings indicated that unobservable characteristics leading elderly Medicare beneficiaries to purchase drug coverage also lead them to have higher drug expenditures on conditional use (i.e., adverse selection), while the same unobservable factors do not influence their decisions whether to use any drugs. After controlling for potential selection bias, the probability of any drug use among persons with drug coverage use was 4.5 percent higher than among those without, and drug coverage led to an increase in drug expenditures of $308 among those who used prescription drugs. Given significant adverse selection into drug coverage before the implementation of the Medicare Prescription Drug Improvement and Modernization Act, it is essential that selection effects be monitored as beneficiaries choose whether or not to enroll in this voluntary program.

Benzodiazepines: a major component in unintentional prescription drug overdoses with opioid analgesics.

PubMed

Jann, Michael; Kennedy, William Klugh; Lopez, Gaylord

2014-02-01

The misuse and abuse of prescription medications in the United States continues to increase despite interventions by health care professionals, regulatory, and law enforcement agencies. Opioid analgesics are the leading class of prescription drugs that have caused unintentional overdose deaths. Benzodiazepines when taken alone are relatively safe agents in overdose. However, a 5-fold increase in deaths attributed to benzodiazepines occurred from 1999 to 2009. Emergency department visits related to opioid analgesics increased by 111% followed by benzodiazepines 89%. During 2003 to 2009, the 2 prescriptions drugs with the highest increase in death rates were oxycodone 264.6% and alprazolam 233.8%. Therefore, benzodiazepines have a significant impact on prescription drug unintentional overdoses second only to the opioid analgesics. The combination prescribing of benzodiazepines and opioid analgesics commonly takes place. The pharmacokinetic drug interactions between benzodiazepines and opioid analgesics are complex. The pharmacodynamic actions of these agents differ as their combined effects produce significant respiratory depression. Physician and pharmacy shopping by patients occurs, and prescription drug-monitoring programs can provide important information on benzodiazepine and opioid analgesic prescribing patterns and patient usage. Health care professionals need to inform patients and work closely with regulatory agencies and legislatures to stem the increasing fatalities from prescription drug unintentional overdoses.

Meta-analysis and time series modeling allow a systematic review of primary HIV-1 drug-resistant prevalence in Latin America and Caribbean.

PubMed

Coelho, Antonio Victor Campos; De Moura, Ronald Rodrigues; Da Silva, Ronaldo Celerino; Kamada, Anselmo Jiro; Guimarães, Rafael Lima; Brandão, Lucas André Cavalcanti; Coelho, Hemílio Fernandes Campos; Crovella, Sergio

2015-01-01

Here we review the prevalence of HIV-1 primary drug resistance in Latin America and Caribbean using meta-analysis as well as time-series modeling. We also discuss whether there could be a drawback to HIV/AIDS programs due to drug resistance in Latin America and Caribbean in the next years. We observed that, although some studies report low or moderate primary drug resistance prevalence in Caribbean countries, this evidence needs to be updated. In other countries, such as Brazil and Argentina, the prevalence of drug resistance appears to be rising. Mutations conferring resistance against reverse transcriptase inhibitors were the most frequent in the analyzed populations (70% of all mutational events). HIV-1 subtype B was the most prevalent in Latin America and the Caribbean, although subtype C and B/F recombinants have significant contributions in Argentina and Brazil. Thus, we suggest that primary drug resistance in Latin America and the Caribbean could have been underestimated. Clinical monitoring should be improved to offer better therapy, reducing the risk for HIV-1 resistance emergence and spread, principally in vulnerable populations, such as men who have sex with men transmission group, sex workers and intravenous drug users.

Conception, realization and qualification of a radioactive clean room lab facility dedicated to the synthesis of radiolabeled API for human ADME studies.

PubMed

Loewe, Claudia; Atzrodt, Jens; Reschke, Kai; Schofield, Joe

2016-12-01

The human absorption, distribution, metabolism and elimination study administering radiolabeled drugs to human volunteers is an important clinical study in the development program of new drug candidates. The manufacture of radiolabeled Active Pharmaceutical Ingredients is covered by national drug laws and may come within the scope of regulatory GMP requirements. Additionally, authorities may request an appropriate environmental zoning to minimize the risk of microbiological contaminations particularly during the synthesis of radiolabeled Active Pharmaceutical Ingredients intended for parenteral application. Thus, a radioactive clean room lab facility in line with both GMP and radiation safety regulations was installed and the environmental zoning validated by appropriate testing of technical parameters and microbial and particle monitoring. The considerations detailed in this paper cover only GMP aspects related to the synthesis of radioactive drug substance. The subsequent, final formulation step in the overall process for manufacturing of radioactive drug product for any kind of administration is not within the scope of this paper. Under these qualified and controlled environmental conditions, we are now in a position to provide radiolabeled drug substances for all kinds of drug administration including both po and iv. Copyright © 2016 John Wiley & Sons, Ltd.

Analytical Pitfalls of Therapeutic Drug Monitoring of Thiopurines in Patients With Inflammatory Bowel Disease

PubMed Central

Meijer, Berrie; Mulder, Chris J. J.; van Bodegraven, Adriaan A.; de Boer, Nanne K. H.

2017-01-01

Abstract: The use of thiopurines in the treatment of inflammatory bowel disease (IBD) can be optimized by the application of therapeutic drug monitoring. In this procedure, 6-thioguanine nucleotides (6-TGN) and 6-methylmercaptopurine (6-MMP) metabolites are monitored and related to therapeutic response and adverse events, respectively. Therapeutic drug monitoring of thiopurines, however, is hampered by several analytical limitations resulting in an impaired translation of metabolite levels to clinical outcome in IBD. Thiopurine metabolism is cell specific and requires nucleated cells and particular enzymes for 6-TGN formation. In the current therapeutic drug monitoring, metabolite levels are assessed in erythrocytes, whereas leukocytes are considered the main target cells of these drugs. Furthermore, currently used methods do not distinguish between active nucleotides and their unwanted residual products. Last, there is a lack of a standardized laboratorial procedure for metabolite assessment regarding the substantial instability of erythrocyte 6-TGN. To improve thiopurine therapy in patients with IBD, it is necessary to understand these limitations and recognize the general misconceptions in this procedure. PMID:29040228

A continuous quality improvement approach to improving clinical practice in the areas of sedation, analgesia, and neuromuscular blockade.

PubMed

Arbour, Richard

2003-01-01

Practice concerns associated with the medical prescription and nurses' administration and monitoring of sedatives, analgesics, and neuromuscular blocking agents were identified by the clinical nurse specialist within a surgical intensive care unit of a large, tertiary-care referral center. These concerns were identified using a variety of needs assessment strategies. Results of the needs assessment were used to develop a program of care, including a teaching initiative, specific to these practice areas. The teaching initiative incorporated principles of andragogy, the theory of adult learning. Educational techniques included inservice education, bedside instruction using "teaching moments," competency-based education modules, and integration of instruction into critical care orientation. Content and approach were based on the background and level of experience of participants. Educational program outcomes included increased consistency in monitoring neuromuscular blockade by clinical assessment and peripheral nerve stimulation. A second outcome was more accurate patient assessment leading to the provision of drug therapy specific to the patients' clinical states, including anxiety or pain. The continuous quality improvement approach offers a model for improving patient care using individualized needs assessment, focused educational interventions, and program evaluation strategies.

A successful strategy for estimating the consumption of needles and syringes by injecting drug users in the Czech Republic.

PubMed

Gabrhelík, Roman; Vacek, Jaroslav; Mista, Jan

2014-01-01

The objectives were to: (i) estimate the extent of the injecting equipment (IE) provided by needle exchange programs (NEPs) to injecting drug users (IDUs) in the Czech Republic in 2010; (ii) subsequently validate the recent methodology used for data collection by the Czech National Monitoring Centre for Drugs and Drug Addiction (CMC), and (iii) estimate the number of syringes provided to Czech IDUs. A simple document analysis was performed in order to collect data on the production, sale, and consumption of injecting equipment in the Czech Republic in combination with questionnaire screening in the NEPs and 21 brief interviews with key informants. Ten types of IE most commonly used for drug injecting by the Czech drug users were identified. Approximately 5,038,000 pieces of sterile IE were marketed in the Czech Republic in 2010. According to four manufacturers (with a market share of 96%) and with reference to the year 2010, 5,430,694 pieces of sterile IE were provided to Czech injecting drug users (487,694 pieces of IE were sold to IDUs in pharmacies and 5,038,000 pieces of IE were distributed by NEPs in 2010). We compared the amount of IE provided to IDUs as reported to the CMC National registry by NEPs (4,943,000) with that of IE distributed by manufacturers and distributors (5,038,000) in the country in 2010 and found a difference of less than two percent using two different methodologies. This study confirms the accuracy of the data on the amount of IE exchanged as collected by the CMC monitoring system. This study opens up important public health practice and policy-making issues. The methodology of this study may be used in regions where no data collection system is present or where confirmation of the data related to IE is needed.

Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: current data and future directions.

PubMed

Ward, Mark G; Sparrow, Miles P; Roblin, Xavier

2018-01-01

The introduction of vedolizumab, a lymphocyte adhesion inhibitor, has expanded the relatively limited therapeutic armamentarium available for Crohn's disease and ulcerative colitis. Despite its effectiveness, both primary nonresponse and secondary loss of response to vedolizumab do occur, as is observed with the use of anti-tumour necrosis factor (TNF) therapy. Further, in a proportion, onset of efficacy may be relatively slow. A large body of data support an exposure-response relationship with anti-TNF drug levels, which has led to therapeutic drug monitoring becoming incorporated into everyday clinical management. The influence of patient and disease factors on the pharmacokinetics of anti-TNF levels, including immunogenicity, has also been examined. The role of therapeutic drug monitoring with vedolizumab is less clear. This review summarizes the available evidence on the pharmacokinetics and pharmacodynamics of vedolizumab in inflammatory bowel disease and how drug levels, immunogenicity and other factors influence clinical outcomes. Vedolizumab clearance is increased with very high body weight and hypoalbuminaemia, but is not influenced by the addition of an immunomodulator. Immunogenicity is uncommon. α4β7 receptor saturation occurs at low serum vedolizumab drug levels, and measuring it alone is insufficient to predict clinical outcomes. Using quartile analysis of vedolizumab drug levels, there appears to be a modest exposure-response relationship during induction. Drug levels at week 6 of approximately >20 μg/ml have been shown to be associated with improved clinical outcomes, including subsequent mucosal healing rates during maintenance and avoiding the need to dose escalate due to lack of response. There are currently insufficient data to support the routine use of therapeutic drug monitoring during maintenance therapy. Further studies to elucidate the role of therapeutic drug monitoring of vedolizumab are needed.

The Prevalence of Employed Nurses Identified or Enrolled in Substance Use Monitoring Programs

PubMed Central

Monroe, Todd B.; Kenaga, Heidi; Dietrich, Mary S.; Carter, Michael A.; Cowan, Ronald L.

2017-01-01

Background For over 100 years, nurses’ particular work conditions have been anecdotally associated with increases in substance abuse. Reasons include job-related stress and easy access to medications. Current research has suggested that prevalence of nurses with substance use problems is actually similar to, if not less than, that seen in the general population. However, given nurses’ proximity to critical patient care, the potential threat to public health, as well as the current shortage of practitioners and problems related to retention, the lack of research on the effectiveness of the two existing treatment protocols (disciplinary and alternative-to-discipline [ATD]) is a pressing issue of concern to the nursing profession. Objectives The aims of this study were to estimate the 1-year prevalence of employed nurses requiring an intervention for substance use problems in the United States and the 1-year prevalence of nurses enrolled in substance abuse monitoring programs and to compare the sum total of nurses identified in disciplinary and alternative programs with the general population. Methods This was a balanced stratified sampling design study. Measurements included the National Council of State Boards of Nursing 2010 Survey of Regulatory Boards Disciplinary Actions on Nurses, the 2009 annual reports of alternative programs, the 2008 National Sample Survey of Registered Nurses, and the 2009 National Survey on Drug Use and Health. Results The 2009 1-year prevalence of employed nurses identified with substance use problems in the United States and its territories was 17,085 or 0.51% of the employed nursing population. The 1-year prevalence of nurses newly enrolled in substance abuse monitoring programs in the United States and its territories was 12,060 or 0.36%. Although every National Council of State Boards of Nursing jurisdiction has a disciplinary monitoring program, only 73% (n = 43) of these jurisdictions have alternative programs. Despite this, on average, alternative programs had nearly 75% more new enrollees (9,715) when compared with disciplinary programs (2,345). The prevalence of nurses identified with a substance use problem requiring an intervention (and likely treatment) is lower than the prevalence of those who report receiving substance abuse treatment in the general population (0.51% vs. 1.0%). Conclusions The ATD programs potentially have a greater impact on protecting the public than disciplinary programs because ATD programs identify and/or enroll more nurses with substance use problems, thereby initially removing more nurses with substance use problems from direct patient care. PMID:22960589

Active pharmacovigilance in China: recent development and future perspectives.

PubMed

Li, Xinling; Li, Haona; Deng, Jianxiong; Zhu, Feng; Liu, Ying; Chen, Wenge; Yue, Zhihua; Ren, Xuequn; Xia, Jielai

2018-04-10

The effectiveness of active pharmacovigilance depends on the specific methods adopted and the work patterns put into place. Over the past few years, much attention has been paid to the importance of implementing such systems in China. However, less has been done to evaluate the state of implementation and future needs of such systems. This paper reviews China's recent approaches to active pharmacovigilance by examining: (1) information collected from scientific articles and the websites of the China Food and Drug Administration and the China National Center for Adverse Drug Reaction Monitoring, (2) information available on China's spontaneous reporting systems (SRS) and active pharmacovigilance system, and (3) annual reports and internal reports on this subject. Areas that improved most meaningfully for China's active pharmacovigilance in recent years appear to include: (1) quicker reporting and more intelligent scanning methods for adverse drug reactions (ADRs), (2) the use of pharmacovigilance approaches to mine electronic hospital records, and (3) the development of integrated systems including the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program. Not only has the national online SRS system provided a platform for passive pharmacovigilance, it has also become an important platform for various explorations of active pharmacovigilance in China. Quick reporting and intelligent scanning of ADRs, facilitated by automated ADR detection based on electronic hospital records, have accelerated to capabilities for active pharmacovigilance. The outcomes of the programs, such as the China Hospital Pharmacovigilance System and China Sentinel Hospital Alliance Program, usher in a new era for China's active pharmacovigilance. These are particularly important to bridge the information system of sentinel hospitals and ADR research centers, but gaps remain. Thus, much work needs to be done before a high-level active pharmacovigilance system is sufficiently mature to ensure drug safety in the country.

Effectiveness of surface enhanced Raman spectroscopy of tear fluid with soft substrate for point-of-care therapeutic drug monitoring

NASA Astrophysics Data System (ADS)

Yamada, K.; Endo, T.; Imai, H.; Kido, M.; Jeong, H.; Ohno, Y.

2016-03-01

We have developed the point-of-care therapeutic drug monitoring kit based on Raman Spectroscopy of tear fluid. In this study, we were examined a soft substrate for an optimal lattice based on nanoimprint lithography using cyclo-olefin polymer to improve the sensitivity for measuring drug concentration in tear fluid. This is photonics crystal which is one of the nano-photonics based device was fabricated. Target is Sodium Phenobarbital which is an anticonvulsant agent. We show the effectiveness of Surface Enhanced Raman Spectroscopy of tear fluid with soft substrate for point-of-care therapeutic drug monitoring.

Antipsychotic drug poisoning monitoring of clozapine in urine by using coffee ring effect based surface-enhanced Raman spectroscopy.

PubMed

Zhu, Qingxia; Yu, Xiaoyan; Wu, Zebing; Lu, Feng; Yuan, Yongfang

2018-07-19

Antipsychotics are the drugs most often involved in drug poisoning cases, and therefore, therapeutic drug monitoring (TDM) is necessary for safe and effective medication administration of these drugs. In this study, a coffee ring effect-based surface-enhanced Raman spectroscopy (CRE-SERS) method was developed and successfully used to monitor antipsychotic poisoning by using urine samples for the first time. The established method exhibited excellent SERS performance since more hot spots were obtained in the "coffee ring". Using the optimized CRE-SERS method, the sensitivity was improved one order more than that of the conventional method with reasonable reproducibility. The antipsychotic drug clozapine (CLO) spiked into urine samples at 0.5-50 μg mL -1 was quantitatively detected, at concentrations above the thresholds for toxicity. The CRE-SERS method allowed CLO and its metabolites to be ultimately distinguished from real poisoning urine samples. The coffee-ring effect would provide more opportunities for practical applications of the SERS-based method. The frequent occurrence of drug poisoning may have created a new area for the application of the CRE-SERS method. It is anticipated that the developed method will also have great potential for other drug poisoning monitoring. Copyright © 2018 Elsevier B.V. All rights reserved.

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

Drug supply indicators: Pitfalls and possibilities for improvements to assist comparative analysis.

PubMed

Singleton, Nicola; Cunningham, Andrew; Groshkova, Teodora; Royuela, Luis; Sedefov, Roumen

2018-06-01

Interventions to tackle the supply of drugs are seen as standard components of illicit drug policies. Therefore drug market-related administrative data, such as seizures, price, purity and drug-related offending, are used in most countries for policy monitoring and assessment of the drug situation. International agencies, such as the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the UN Office of Drugs and Crime, also monitor and report on the drug situation cross-nationally and therefore seek to collect and make available key data in a uniform manner from the countries they cover. However, these data are not primarily collected for this purpose, which makes interpretation and comparative analysis difficult. Examples of limitations of these data sources include: the extent to which they reflect operational priorities rather than market changes; question marks over the robustness of and consistency in data collection methods, and issues around the timeliness of data availability. Such problems are compounded by cultural, social and contextual differences between countries. Making sense of such data is therefore challenging and extreme care needs to be taken using it. Nevertheless, these data provide an important window on a hidden area, so improving the quality of the data collected and expanding its scope should be a priority for those seeking to understand or monitor drug markets and supply reduction. In addition to highlighting some of the potential pitfalls in using supply indicators for comparative analysis, this paper presents a selection of options for improvements based on the current EMCDDA programme of work to improve their supply-related monitoring and analysis. The conceptual framework developed to steer this work may have wider application. Adopting this approach has the potential to provide a richer picture of drug markets, at both national and international levels, and make it easier to compare data between countries. Copyright © 2018 Elsevier B.V. All rights reserved.

How States Are Tackling the Opioid Crisis

PubMed Central

Zur, Julia; Mulvaney-Day, Norah; von Klimo, Melinda Campopiano; Selmi, Elizabeth; Harwood, Henrick

2017-01-01

Objectives: We used data from the 2015 National Association of State Alcohol and Drug Abuse Directors Web-based questionnaire and other sources to demonstrate the range and scope of state initiatives being used to deal with the opioid crisis in the United States. Methods: State alcohol and drug agency directors and designated senior agency managers responded to the questionnaire, which asked respondents about recent opioid-related state-level public health initiatives at their agencies. Results: State alcohol and drug agencies in all 50 states and the District of Columbia responded, all of which reported that prescription drug misuse was a high priority or the highest priority area for their agencies. Of the 51 respondents, states reported initiatives to educate the general public (n = 48), prescribers (n = 31), patients and families (n = 24), and pharmacists (n = 22) about the risks of opioids. In addition, 29 states had increased funding for medication-assisted treatment of opioid addiction, 28 had expanded the availability of naloxone (an opioid antidote), 26 had established guidelines for safe opioid prescribing, 23 had launched requirements for prescriber use of prescription monitoring programs, 23 had passed Good Samaritan laws to protect those helping treat overdoses, and 14 had enacted legislation to regulate pain clinics. Conclusions: US state alcohol and drug agencies demonstrated a robust response to the opioid crisis in the United States. They have pursued and expanded on an array of evidence-based initiatives aimed at the opioid crisis. Future public health efforts should focus on maintenance and further expansion of high-quality, evidence-based practices, policies, and programs. PMID:28152337

How States Are Tackling the Opioid Crisis.

PubMed

Wickramatilake, Shalini; Zur, Julia; Mulvaney-Day, Norah; Klimo, Melinda Campopiano von; Selmi, Elizabeth; Harwood, Henrick

We used data from the 2015 National Association of State Alcohol and Drug Abuse Directors Web-based questionnaire and other sources to demonstrate the range and scope of state initiatives being used to deal with the opioid crisis in the United States. State alcohol and drug agency directors and designated senior agency managers responded to the questionnaire, which asked respondents about recent opioid-related state-level public health initiatives at their agencies. State alcohol and drug agencies in all 50 states and the District of Columbia responded, all of which reported that prescription drug misuse was a high priority or the highest priority area for their agencies. Of the 51 respondents, states reported initiatives to educate the general public (n = 48), prescribers (n = 31), patients and families (n = 24), and pharmacists (n = 22) about the risks of opioids. In addition, 29 states had increased funding for medication-assisted treatment of opioid addiction, 28 had expanded the availability of naloxone (an opioid antidote), 26 had established guidelines for safe opioid prescribing, 23 had launched requirements for prescriber use of prescription monitoring programs, 23 had passed Good Samaritan laws to protect those helping treat overdoses, and 14 had enacted legislation to regulate pain clinics. US state alcohol and drug agencies demonstrated a robust response to the opioid crisis in the United States. They have pursued and expanded on an array of evidence-based initiatives aimed at the opioid crisis. Future public health efforts should focus on maintenance and further expansion of high-quality, evidence-based practices, policies, and programs.

Prescription Drug Monitoring Programs and Pharmacist Orientation Toward Dispensing Controlled Substances.

PubMed

Fendrich, Michael; Bryan, Janelle K; Hooyer, Katinka

2018-01-03

We sought to understand how pharmacists viewed and used a newly implemented prescription drug monitoring program (PDMP). We also sought to understand pharmacist orientation toward dispensing of controlled substances and the people who obtain them. We conducted three mini focus groups. The focus group findings were used to inform the design of a structured survey. We emailed a survey to 160 pharmacists who were employed in one statewide community chain store; we obtained 48 survey responses. Focus groups findings suggested that, in relation to the dispensing of scheduled prescription medication, pharmacists were either "healthcare" oriented, "law-enforcement" oriented, or an orientation that combined these two perspectives. Surveys suggested that pharmacists found PDMPs easy to use and that they used them frequently - often to contact physicians directly. Surveys suggested that pharmacists were typically either "healthcare" oriented or "mixed" (combined perspectives). Pharmacist orientation was associated with the frequency with which they counseled patients about medication risk and the frequency with which they used the PDMP as the basis for contacting prescribers. Ongoing tracking of pharmacists' use of PDMPs is important both at the implementation stage and as PDMPs develop over time. The orientation construct developed here is useful in understanding pharmacist behavior and attitudes towards patients potentially at risk for misuse of controlled substance medications. Further research on this construct could shed light on barriers and incentives for pharmacist PDMP participation and use and provide guidance for pharmacist training, ultimately enhancing patient care.

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

Mildronate (Meldonium) in professional sports – monitoring doping control urine samples using hydrophilic interaction liquid chromatography – high resolution/high accuracy mass spectrometry

PubMed Central

Görgens, Christian; Dib, Josef; Geyer, Hans; Schänzer, Wilhelm; Thevis, Mario

2015-01-01

To date, substances such as Mildronate (Meldonium) are not on the radar of anti‐doping laboratories as the compound is not explicitly classified as prohibited. However, the anti‐ischemic drug Mildronate demonstrates an increase in endurance performance of athletes, improved rehabilitation after exercise, protection against stress, and enhanced activations of central nervous system (CNS) functions. In the present study, the existing evidence of Mildronate's usage in sport, which is arguably not (exclusively) based on medicinal reasons, is corroborated by unequivocal analytical data allowing the estimation of the prevalence and extent of misuse in professional sports. Such data are vital to support decision‐making processes, particularly regarding the ban on drugs in sport. Due to the growing body of evidence (black market products and athlete statements) concerning its misuse in sport, adequate test methods for the reliable identification of Mildronate are required, especially since the substance has been added to the 2015 World Anti‐Doping Agency (WADA) monitoring program. In the present study, two approaches were established using an in‐house synthesized labelled internal standard (Mildronate‐D3). One aimed at the implementation of the analyte into routine doping control screening methods to enable its monitoring at the lowest possible additional workload for the laboratory, and another that is appropriate for the peculiar specifics of the analyte, allowing the unequivocal confirmation of findings using hydrophilic interaction liquid chromatography‐high resolution/high accuracy mass spectrometry (HILIC‐HRMS). Here, according to applicable regulations in sports drug testing, a full qualitative validation was conducted. The assay demonstrated good specificity, robustness (rRT=0.3%), precision (intra‐day: 7.0–8.4%; inter‐day: 9.9–12.9%), excellent linearity (R>0.99) and an adequate lower limit of detection (<10 ng/mL). © 2015 The Authors. Drug Testing and Analysis published by John Wiley & Sons, Ltd. PMID:25847280

NHI-PharmaCloud in Taiwan--A preliminary evaluation using the RE-AIM framework and lessons learned.

PubMed

Huang, San-Kuei; Wang, Pen-Jen; Tseng, Wen-Fuh; Syu, Fei-Kai; Lee, Miaw-Chwen; Shih, Ru-Liang; Sheen, Mao-Ting; Chen, Michael S

2015-10-01

The aim of this article is to present the preliminary impact of a medication monitoring program, PharmaCloud, in Taiwan and analyze the embedded factors that have contributed to the performance thereof. This article also compared PharmaCloud with similar international programs in order to draw lessons learned. The five domains of the RE-AIM framework - reach, effectiveness, adoption, implementation, and maintenance - were examined using qualitative and quantitative data. A difference-in-differences model was applied to analyze the quantitative impact of PharmaCloud on drug utilization and drug expenses. The qualitative impact was evaluated by document analysis based on field reports from the participating medical institutions. Reach and adoption: although all of the major hospitals adopted PharmaCloud and some of the hospitals had high inquiry rates, more time and incentives are needed to raise the overall inquiry rate. Effectiveness: during the study period of 3 months, the number of medications per prescription declined in the intervention group was 0.15 more than that of the general population, and the drug expense per person declined in the intervention group was NT $567 (US $18.9) more than that of the general population. The potential savings could be between 2% and 5% of the total pharmaceutical expenditure. Medication duplication was found to have decreased more in the intervention group. a variety of innovations in care delivery are being developed in which the pharmacists play a more significant role. Maintenance: the embedded National Health Insurance would lend strong support for PharmaCloud to grow and thrive. PharmaCloud owes its effectiveness to the embedded National Health Insurance (NHI) program, which is universal and provides a comprehensive benefit package including more than 16,000 prescription drugs. An effective medication program is one that operates under the principle of universality and comprehensiveness, facilitates innovations, and has a substantial level of interoperability with the intra-hospital health information systems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Assessing the present state and potential of Medicaid controlled substance lock-in programs.

PubMed

Roberts, Andrew W; Skinner, Asheley Cockrell

2014-05-01

Nonmedical use of prescription medications--particularly controlled substances--has risen dramatically in recent decades, resulting in alarming increases in overdose-related health care utilization, costs, and mortality. The Centers for Disease Control and Prevention estimate that 80% of abused and misused controlled substances originate as legal prescriptions. As such, policymakers and payers have the opportunity to combat nonmedical use by regulating controlled substance accessibility within legal prescribing and dispensing processes. One common policy strategy is found in Medicaid controlled substance lock-in programs. Lock-in programs identify Medicaid beneficiaries exhibiting high-risk controlled substance seeking behavior and "lock in" these patients to, typically, a single prescriber and pharmacy from which they may obtain Medicaid-covered controlled substance prescriptions. Lock-in restrictions are intended to improve care coordination between providers, reduce nonmedical use behaviors, and limit Medicaid costs stemming from nonmedical use and diversion. Peer-reviewed and gray literature have been examined to assess the current prevalence and design of Medicaid lock-in programs, as well as the current evidence base for informing appropriate program design and understanding program effectiveness. Forty-six state Medicaid agencies currently operate lock-in programs. Program design varies widely between states in terms of defining high-risk controlled substance use, the scope of actual lock-in restrictions, and length of program enrollment. Additionally, there is a remarkable dearth of peer-reviewed literature evaluating the design and effectiveness of Medicaid lock-in programs. Nearly all outcomes evidence stemmed from publicly accessible internal Medicaid program evaluations, which largely investigated cost savings to the state. Lock-in programs are highly prevalent and poised to play a meaningful role in curbing the prescription drug abuse epidemic. However, achieving these ends requires a concerted effort from the academic and policy communities to rigorously evaluate the effect of lock-in programs on patient outcomes, determine optimal program design, and explore opportunities to enhance lock-in program impact through coordination with parallel controlled substance policy efforts, namely prescription drug-monitoring programs.

Pharmacist-managed dose adjustment feedback using therapeutic drug monitoring of vancomycin was useful for patients with methicillin-resistant Staphylococcus aureus infections: a single institution experience

PubMed Central

Hirano, Ryuichi; Sakamoto, Yuichi; Kitazawa, Junichi; Yamamoto, Shoji; Tachibana, Naoki

2016-01-01

Background Vancomycin (VCM) requires dose adjustment based on therapeutic drug monitoring. At Aomori Prefectural Central Hospital, physicians carried out VCM therapeutic drug monitoring based on their experience, because pharmacists did not participate in the dose adjustment. We evaluated the impact of an Antimicrobial Stewardship Program (ASP) on attaining target VCM trough concentrations and pharmacokinetics (PK)/pharmacodynamics (PD) parameters in patients with methicillin-resistant Staphylococcus aureus (MRSA) infections. Materials and methods The ASP was introduced in April 2012. We implemented a prospective audit of prescribed VCM dosages and provided feedback based on measured VCM trough concentrations. In a retrospective pre- and postcomparison study from April 2007 to December 2011 (preimplementation) and from April 2012 to December 2014 (postimplementation), 79 patients were treated for MRSA infection with VCM, and trough concentrations were monitored (pre, n=28; post, n=51). In 65 patients (pre, n=15; post, n=50), 24-hour area under the concentration–time curve (AUC 0–24 h)/minimum inhibitory concentration (MIC) ratios were calculated. Results Pharmacist feedback, which included recommendations for changing dose or using alternative anti-MRSA antibiotics, was highly accepted during postimplementation (88%, 29/33). The number of patients with serum VCM concentrations within the therapeutic range (10–20 μg/mL) was significantly higher during postimplementation (84%, 43/51) than during preimplementation (39%, 11/28) (P<0.01). The percentage of patients who attained target PK/PD parameters (AUC 0–24 h/MIC >400) was significantly higher during postimplementation (84%, 42/50) than during preimplementation (53%, 8/15; P=0.013). There were no significant differences in nephrotoxicity or mortality rate. Conclusion Our ASP increased the percentage of patients that attained optimal VCM trough concentrations and PK/PD parameters, which contributed to the appropriate use of VCM in patients with MRSA infections. PMID:27789965

Advantages and Limitations of Androgen Receptor-Based Methods for Detecting Anabolic Androgenic Steroid Abuse as Performance Enhancing Drugs.

PubMed

Bailey, Kathy; Yazdi, Tahmineh; Masharani, Umesh; Tyrrell, Blake; Butch, Anthony; Schaufele, Fred

2016-01-01

Testosterone (T) and related androgens are performance enhancing drugs (PEDs) abused by some athletes to gain competitive advantage. To monitor unauthorized androgen abuse, doping control programs use mass spectrometry (MS) to detect androgens, synthetic anabolic-androgenic steroids (AASs) and their metabolites in an athlete's urine. AASs of unknown composition will not be detected by these procedures. Since AASs achieve their anabolic effects by activating the Androgen Receptor (AR), cell-based bioassays that measure the effect of a urine sample on AR activity are under investigation as complementary, pan-androgen detection methods. We evaluated an AR BioAssay as a monitor for androgen activity in urine pre-treated with glucuronidase, which releases T from the inactive T-glucuronide that predominates in urine. AR BioAssay activity levels were expressed as 'T-equivalent' concentrations by comparison to a T dose response curve. The T-equivalent concentrations of androgens in the urine of hypogonadal participants supplemented with T (in whom all androgenic activity should arise from T) were quantitatively identical to the T measurements conducted by MS at the UCLA Olympic Analytical Laboratory (0.96 ± 0.22). All 17 AASs studied were active in the AR BioAssay; other steroids were inactive. 12 metabolites of 10 commonly abused AASs, which are used for MS monitoring of AAS doping because of their prolonged presence in urine, had reduced or no AR BioAssay activity. Thus, the AR BioAssay can accurately and inexpensively monitor T, but its ability to monitor urinary AASs will be limited to a period immediately following doping in which the active AASs remain intact.

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

49 CFR 219.601 - Railroad random drug testing programs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

Genotyping External Quality Assurance in the World Health Organization HIV Drug Resistance Laboratory Network During 2007–2010

PubMed Central

Bremer, James; Bertagnolio, Silvia

2012-01-01

The World Health Organization (WHO) has developed a global laboratory network to support human immunodeficiency virus drug resistance genotyping for public health surveillance in resource-limited countries. Blinded proficiency panels are an essential part of a genotyping quality-assurance program and are used to monitor the reliability of genotyping data in the WHO laboratory network. Laboratories in Europe, North America, Asia, Africa, and the Caribbean have tested panels annually since 2007; 103 of 131 submissions (79%) had >99% nucleotide sequence identity and resistance mutation concordance, compared with consensus. Most errors were associated with mixtures in the test specimen, leading to subjectivity in base-calling or amplification bias. Overall, genotyping assays used by the WHO laboratory network are reliable. PMID:22544186

[Rapid identification of 22 abused drugs and organophosphorus pesticides in blood by LC-MS/MS].

PubMed

Liu, Hong-tao; Ma, An-de

2009-08-01

To develop a method for rapid identification of 22 abused drugs and organophosphorus pesticides in the blood. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) in multiple-reaction monitoring mode (MRM) was employed for detecting the drugs and pesticides in the blood. The MRM database and criteria for identification were established, and ethyl acetate was used for extraction of the drugs. After 3 rounds of extractions of the blood sample (1 mL) using 2 mL ethyl acetate, the extract was vortexed for 3 min and centrifuged at 5000 r/min. Each organic phase was combined and evaporated by gentle N2 gas. The residue was re-dissolved in 100 L mobile phase, from which 5 L was taken for LC-MS/MS detection. The detection of the 22 target compounds could be completed within 10 min. The limit of detection of the target compound ranged from 0.03 to 6.00 ng/ml. Satisfactory results were obtained in proficiency testing program organized by China National Accreditation Service for Conformity Assessment. The method we established is rapid, selective and sensitive for detecting the 22 abused drugs and organophosphorus pesticides.

Current status of therapeutic drug monitoring in Australia and New Zealand: a need for improved assay evaluation, best practice guidelines, and professional development.

PubMed

Norris, Ross L; Martin, Jennifer H; Thompson, Erin; Ray, John E; Fullinfaw, Robert O; Joyce, David; Barras, Michael; Jones, Graham R; Morris, Raymond G

2010-10-01

The measurement of drug concentrations, for clinical purposes, occurs in many diagnostic laboratories throughout Australia and New Zealand. However, the provision of a comprehensive therapeutic drug monitoring (TDM) service requires the additional elements of pre- and postanalytical advice to ensure that concentrations reported are meaningful, interpretable, and clinically applicable to the individual patient. The aim of this project was to assess the status of TDM services in Australia and New Zealand. A range of professions involved in key aspects of TDM was surveyed by questionnaire in late 2007. Information gathered included: the list of drugs assayed; analytical methods used; interpretation services offered; interpretative methods used; and further monitoring advice provided. Fifty-seven responses were received, of which 42% were from hospitals (public and/or private); 11% a hospital (public and/or private) and pathology provider; and 47% a pathology provider only (public and/or private). Results showed that TDM is applied to a large number of different drugs. Poorly performing assay methods were used in some cases, even when published guidelines recommended alternative practices. Although there was a wide array of assays available, the evidence suggested a need for better selection of assay methods. In addition, only limited advice and/or interpretation of results was offered. Of concern, less than 50% of those providing advice on aminoglycoside dosing in adults used pharmacokinetic tools with six of 37 (16.2%) respondents using Bayesian pharmacokinetic tools, the method recommended in the Australian Therapeutic Guidelines: Antibiotic. In conclusion, the survey highlighted deficiencies in the provision of TDM services, in particular assay method selection and both quality and quantity of postanalytical advice. A range of recommendations, some of which may have international implications, are discussed. There is a need to include measures of impact on clinical decision-making when assessing assay methodologies. Best practice guidelines and professional standards of practice in TDM are needed, supported by an active program of professional development to ensure the benefits of TDM are realized. This will require significant partnerships between the various professions involved.

Analytical interference in the therapeutic drug monitoring of methotrexate.

PubMed

Oudart, Jean-Baptiste; Marquet, Benjamin; Feliu, Catherine; Gozalo, Claire; Djerada, Zoubir; Millart, Hervé

2016-06-01

High-dose of methotrexate chemotherapy is used in the treatment of some tumors. It presents several side effects that required therapeutic drug monitoring, which is commonly performed on 24, 48 and 72h after the beginning of the methotrexate infusion. Treatment of overexposure to methotrexate is based on injection of carboxypeptidase G2, which specifically degrades methotrexate into inactive metabolite: DAMPA. FPIA immunoassay on TDx automated analyzer (Abbott™) was used for therapeutic drug monitoring of methotrexate. This immunoassay presented a significant cross-reactivity between methotrexate and DAMPA, which widely overestimate the residual concentration compared to the gold standard HPLC/MS. TDx automated analyzer was substituted by a new immunoassay on Architect automated analyzer (Abbott™). However, this immunoassay has the same cross-reactivity, which needs to be careful when monitoring methotrexate after an injection of carboxypeptidase G2. In order to determine the most suitable assay for the therapeutic drug monitoring of methotrexate, the knowledge of injection of carboxypeptidase G2 remains essential.

Fluorescent sensors of protein kinases: from basics to biomedical applications.

PubMed

Nhu Ngoc Van, Thi; Morris, May C

2013-01-01

Protein kinases constitute a major class of enzymes underlying essentially all biological processes. These enzymes present similar structural folds, yet their mechanism of action and of regulation vary largely, as well as their substrate specificity and their subcellular localization. Classical approaches to study the function/activity of protein kinases rely on radioactive endpoint assays, which do not allow for characterization of their dynamic activity in their native environment. The development of fluorescent biosensors has provided a whole new avenue for studying protein kinase behavior and regulation in living cells in real time with high spatial and temporal resolution. Two major classes of biosensors have been developed: genetically encoded single-chain fluorescence resonance energy transfer biosensors and peptide/protein biosensors coupled to small synthetic fluorophores which are sensitive to changes in their environment. In this review, we discuss the developments in fluorescent biosensor technology related to protein kinase sensing and the different strategies employed to monitor protein kinase activity, conformation, or relative abundance, as well as kinase regulation and subcellular dynamics in living cells. Moreover, we discuss their application in biomedical settings, for diagnostics and therapeutics, to image disease progression and monitor response to therapeutics, in drug discovery programs, for high-throughput screening assays, for postscreen characterization of drug candidates, and for clinical evaluation of novel drugs. Copyright © 2013 Elsevier Inc. All rights reserved.

Strategies and policies to address the opioid epidemic: A case study of Ohio.

PubMed

Penm, Jonathan; MacKinnon, Neil J; Boone, Jill M; Ciaccia, Antonio; McNamee, Cameron; Winstanley, Erin L

To describe the strategies and policies implemented in Ohio to improve opioid safety and to discuss the role that pharmacists can play in implementing, promoting, and enhancing the effectiveness of these policies. Ohio has the fifth highest rate of drug overdose deaths (24.6 deaths per 100,000) in the United States. Unintentional drug overdose has become the leading cause of injury-related death in Ohio. In 2015, there were 3050 overdose deaths in Ohio, and in 2014 there were an estimated 12,847 overdose events reversed by emergency medical services with naloxone. Not applicable. In 2011, the Governor's Cabinet Opiate Action Team was created to implement a multifaceted strategy, in part (1) to promote the responsible use of opioids, (2) to reduce the supply of opioids, and (3) to support overdose prevention and expand access to naloxone. Innovations to assist these goals include the development of Ohio guidelines on the responsible use of opioids, mandatory use of Ohio's prescription drug monitoring program, closing pill mills, promotion of drug take-back programs and increased access to naloxone and public health campaigns. Not applicable. Since the development of the Governor's Cabinet Opiate Action Team, there were 81 million fewer doses of opioids dispensed to Ohio patients in 2015 compared with 782 million doses dispensed in 2011. As such, the proportion of unintentional drug overdose deaths involving prescription opioids has reduced from 45% in 2011 to 22% in 2015. Strong political support was crucial in Ohio to facilitate the rapid implementation opioid overdose prevention programs and the promotion of public awareness campaigns. However, the misuse and abuse of prescription opioids are complex problems requiring a comprehensive and multifaceted approach. Pharmacists are identified as a crucial component of the state strategy to addressing opioid abuse by promoting responsible prescribing and adopting prevention practices. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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

PubMed

Caplan, Arthur; Zink, Amanda

2014-03-01

The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of and rote response to AEs and SAEs. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Student Drug Use, Attitudes, and Beliefs in the Department of Defense Dependent Schools Class of 1982. Monitoring the Future. Occasional Paper Series, Paper 15.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; And Others

This paper compared findings from a drug use and related attitudes survey with those from the Monitoring the Future study. The comparison group consisted of high school seniors who attended the Department of Defense Dependents Schools (DoDDS) in 1982. The current prevalence of drug use among high school seniors in DoDDS and comparisons of drug use…

Authoritative parenting and drug-prevention practices: implications for antidrug ads for parents.

PubMed

Stephenson, Michael T; Quick, Brian L; Atkinson, Joshua; Tschida, David A

2005-01-01

This research employed the theory of reasoned action to investigate the role of authoritative parenting in 3 drug-prevention behaviors: (a) parental monitoring, (b) parent-child discussions, and (c) awareness of the child's environment. A phone survey of 158 parents of adolescents in 7th, 9th, and 11th grades revealed that authoritative parenting was correlated with parenting practices that reduce the likelihood of adolescent drug use, including discussing family rules about drugs, discussing strategies to avoid drugs, discussing those in trouble with drugs, parental monitoring, knowing the child's plans for the coming day, and personally knowing the child's friends well. Additionally, authoritative parenting moderated the attitude-behavioral intention relation for parental monitoring and awareness of the child's environment, with the weakest relation detected for low-authoritative parents. The utility of these findings in helping design and target antidrug messages for parents more effectively is discussed.

Gas chromatography-mass spectrometry assay method for the therapeutic drug monitoring of the antiepileptic drug tiagabine.

PubMed

Chollet, D F; Castella, E; Goumaz, L; Anderegg, G

1999-11-01

A gas chromatography-mass spectrometry assay method suitable for the therapeutic drug monitoring of the antiepileptic drug tiagabine is described. Tiagabine and its desmethylated analogue used as internal standard were first extracted from serum by liquid-liquid extraction using an ethyl ether-isobutanol 98:2 mixture. Tiagabine and the internal standard were then methylated in the organic phase in presence of methanol by means of a safe and stable diazomethane derivative. After evaporation, the reconstituted extracts were chromatographed on a crosslinked phenyl methyl siloxane capillary column and detected by mass fragmentometry at m/z = 156. No other antiepileptic drug possibly administrated in polytherapy and no metabolite were found to interfere in the assay. The limit of quantification was 5 ng/ml. The precision and the accuracy were found to be suitable for the therapeutic drug monitoring of tiagabine.

HOLDING THE LINE WITH A WATCHFUL EYE: THE IMPACT OF PERCEIVED PARENTAL PERMISSIVENESS AND PARENTAL MONITORING ON RISKY SEXUAL BEHAVIOR AMONG ADOLESCENTS IN PSYCHIATRIC CARE

PubMed Central

Donenberg, Geri R.; Wilson, Helen W.; Emerson, Erin; Bryant, Fred B.

2005-01-01

Adolescents in psychiatric care are at increased risk of HIV, yet little is known about the family factors related to sexual risk taking among these youth. We explored whether perceived parental monitoring and perceived parental permissiveness were linked to high-risk sexual behavior in 169 ethnically diverse urban youth seeking mental health services in Chicago, and we tested whether adolescent gender moderated these associations. We evaluated sexual risk taking at a global level and for specific risk behaviors (e.g., sex without a condom, sex while using drugs and alcohol). Girls reported more risky sex overall than boys, and girls were more likely than boys to report having sex without a condom. At low levels of parental permissiveness, rates of risky sex among boys and girls’ did not differ, but at high levels of permissiveness girls reported more sexual risk taking than boys, and girls were more likely than boys to report having sex while using drugs and alcohol and having sex without a condom. Findings highlight the complexity of adolescent sexual behavior and the need for multilevel assessment of risk taking. Results suggest that parental monitoring and permissiveness are more strongly associated with sexual risk taking in troubled girls than troubled boys, and they underscore a need for gender-sensitive, family-focused HIV-prevention programs. PMID:12000232

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

PubMed Central

Meyer, Keith C; Nathanson, Ian; Angel, Luis; Bhorade, Sangeeta M; Chan, Kevin M; Culver, Daniel; Harrod, Christopher G; Hayney, Mary S; Highland, Kristen B; Limper, Andrew H; Patrick, Herbert; Strange, Charlie; Whelan, Timothy

2012-01-01

Objectives: Immunosuppressive pharmacologic agents prescribed to patients with diffuse interstitial and inflammatory lung disease and lung transplant recipients are associated with potential risks for adverse reactions. Strategies for minimizing such risks include administering these drugs according to established, safe protocols; monitoring to detect manifestations of toxicity; and patient education. Hence, an evidence-based guideline for physicians can improve safety and optimize the likelihood of a successful outcome. To maximize the likelihood that these agents will be used safely, the American College of Chest Physicians established a committee to examine the clinical evidence for the administration and monitoring of immunosuppressive drugs (with the exception of corticosteroids) to identify associated toxicities associated with each drug and appropriate protocols for monitoring these agents. Methods: Committee members developed and refined a series of questions about toxicities of immunosuppressives and current approaches to administration and monitoring. A systematic review was carried out by the American College of Chest Physicians. Committee members were supplied with this information and created this evidence-based guideline. Conclusions: It is hoped that these guidelines will improve patient safety when immunosuppressive drugs are given to lung transplant recipients and to patients with diffuse interstitial lung disease. PMID:23131960

Does adherence monitoring reduce controlled substance abuse in chronic pain patients?

PubMed

Manchikanti, Laxmaiah; Manchukonda, Rajeev; Damron, Kim S; Brandon, Doris; McManus, Carla D; Cash, Kim

2006-01-01

Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Given that controlled substance abuse and illicit drug use are prevalent phenomena, adherence monitoring of patients that are prescribed opioids is becoming common. Adherence monitoring is carried out by an appropriate history, periodic evaluation of appropriate intake of drugs, random drug testing, and pill counts. Crucial to adherence monitoring is an initial controlled substance agreement and repeated review of the terms of this agreement with on-going education. However, the effect of adherence monitoring on drug abuse is unclear. To identify controlled substance abuse through implementation of the terms of a controlled substance agreement, including periodic review and monitoring outside the organization. Prospective evaluation with historical controls. Five hundred consecutive patients receiving prescription controlled substances were followed in a prospective manner. The evaluation consisted of a chart review to monitor controlled substance intake, with special attention to drugs obtained from outside the organization. Data collection for this purpose included information from records, pharmacies, referring physicians, and all the physicians involved in the treatment of the patient. Results from 500 consecutive patients were evaluated. Controlled substance abuse was seen in 9% of patients; overall, 5% of patients were obtaining controlled substances from other physicians, and 4% from illegal sources. Adherence monitoring, including controlled substance agreements and various periodic measures of compliance was associated with a 50% reduction in opioid abuse.

Professional ideologies and the development of syringe exchange: Wales as a case study.

PubMed

Keene, J M; Stimson, G V

1997-12-01

This paper is derived from an evaluative study of HIV prevention programs for drug injectors across Wales. It considers how different professional territories and ideologies, concepts of drug misuse and models of HIV prevention may influence policy development. The research involved monitoring the introduction and development of agency and community based syringe exchange schemes and initiatives taken by community pharmacists. Interviews with staff, managers and administrators, and descriptions of service history, development and delivery inform the discussion. HIV prevention varied in different areas of Wales depending on the particular professional group involved, local ideologies regarding drug use treatment, and the extent to which HIV prevention was seen either as a specialist area of expertise and specific remit of drug workers or a generic health care task. Drug agencies with an abstinence policy rejected syringe exchange; instead, prevention in those areas developed in ad hoc ways as health care workers and pharmacists attempted to develop a community based service. Drug agencies with a pre-existing harm minimisation model easily integrated syringe exchange into their work and played the major part in establishing the service, but there was difficulty in extending it beyond their professional caseloads. As there were disincentives to use treatment agencies, and their catchment areas were limited, these factors influenced effective service provision.

Depth-resolved monitoring of analytes diffusion in ocular tissues

NASA Astrophysics Data System (ADS)

Larin, Kirill V.; Ghosn, Mohamad G.; Tuchin, Valery V.

2007-02-01

Optical coherence tomography (OCT) is a noninvasive imaging technique with high in-depth resolution. We employed OCT technique for monitoring and quantification of analyte and drug diffusion in cornea and sclera of rabbit eyes in vitro. Different analytes and drugs such as metronidazole, dexamethasone, ciprofloxacin, mannitol, and glucose solution were studied and whose permeability coefficients were calculated. Drug diffusion monitoring was performed as a function of time and as a function of depth. Obtained results suggest that OCT technique might be used for analyte diffusion studies in connective and epithelial tissues.

Diagnostic value of different adherence measures using electronic monitoring and virologic failure as reference standards.

PubMed

Deschamps, Ann E; De Geest, Sabina; Vandamme, Anne-Mieke; Bobbaers, Herman; Peetermans, Willy E; Van Wijngaerden, Eric

2008-09-01

Nonadherence to antiretroviral therapy is a substantial problem in HIV and jeopardizes the success of treatment. Accurate measurement of nonadherence is therefore imperative for good clinical management but no gold standard has been agreed on yet. In a single-center prospective study nonadherence was assessed by electronic monitoring: percentage of doses missed and drug holidays and by three self reports: (1) a visual analogue scale (VAS): percentage of overall doses taken; (2) the Swiss HIV Cohort Study Adherence Questionnaire (SHCS-AQ): percentage of overall doses missed and drug holidays and (3) the European HIV Treatment Questionnaire (EHTQ): percentage of doses missed and drug holidays for each antiretroviral drug separately. Virologic failure prospectively assessed during 1 year, and electronic monitoring were used as reference standards. Using virologic failure as reference standard, the best results were for (1) the SHCS-AQ after electronic monitoring (sensitivity, 87.5%; specificity, 78.6%); (2) electronic monitoring (sensitivity, 75%; specificity, 85.6%), and (3) the VAS combined with the SHCS-AQ before electronic monitoring (sensitivity, 87.5%; specificity, 58.6%). The sensitivity of the complex EHTQ was less than 50%. Asking simple questions about doses taken or missed is more sensitive than complex questioning about each drug separately. Combining the VAS with the SHCS-AQ seems a feasible nonadherence measure for daily clinical practice. Self-reports perform better after electronic monitoring: their diagnostic value could be lower when given independently.

Insights from internet-based remote intrathoracic impedance monitoring as part of a heart failure disease management program.

PubMed

Mullens, Wilfried; Oliveira, Leonardo P J; Verga, Tanya; Wilkoff, Bruce L; Tang, Wai Hong Wilson

2010-01-01

Changes in intrathoracic impedance (Z) leading to crossing of a derived fluid index (FI) threshold has been associated with heart failure (HF) hospitalization. The authors developed a remote monitoring program as part of HF disease management and prospectively examined the feasibility and resource utilization of monitoring individuals with an implanted device capable of measuring Z. An HF nurse analyzed all transmitted data daily, as they were routinely uploaded as part of quarterly remote device monitoring, and called the patient if the FI crossed the threshold (arbitrarily defined at 60 Omega) to identify clinically relevant events (CREs) that occurred during this period (eg, worsening dyspnea or increase in edema or weight). A total of 400 uploads were completed during the 4-month study period. During this period, 34 patients (18%) had an FI threshold crossing, averaging 0.52 FI threshold crossings per patient-year. Thirty-two of 34 patients contacted by telephone (94%) with FI threshold crossing had evidence of CREs during this period. However, only 6 (18%) had HF hospitalizations, 19 (56%) had reported changes in HF therapy, and 13 (38%) reported drug and/or dietary plan nonadherence. The average data analysis time required was 30 min daily when focusing on those with FI threshold crossing, averaging 8 uploads for review per working day and 5 telephone follow-ups per week. Our pilot observations suggested that Internet-based remote monitoring of Z trends from existing device interrogation uploads is feasible as part of a daily routine of HF disease management. 2010 Wiley Periodicals, Inc.

Drug Safety

MedlinePlus

... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

A Guide for the Management of Special Education Programs. 1.0 Program Organization. Newday Operations Guide for Drug Dependent Minor Programs.

ERIC Educational Resources Information Center

Santa Cruz County Superintendent of Schools, CA.

Presented is the first component, Program Organization, of a special day class educational program emphasizing rehabilitation, remedial instruction, and return to regular school programs for drug dependent minors. Included are statistics on drug use in California and the administrative code under which drug dependent minors are eligible for…

Gender-specific intervention to reduce underage drinking among early adolescent girls: a test of a computer-mediated, mother-daughter program.

PubMed

Schinke, Steven P; Cole, Kristin C A; Fang, Lin

2009-01-01

This study evaluated a gender-specific, computer-mediated intervention program to prevent underage drinking among early adolescent girls. Study participants were adolescent girls and their mothers from New York, New Jersey, and Connecticut. Participants completed pretests online and were randomly divided between intervention and control arms. Intervention-arm girls and their mothers interacted with a computer program aimed to enhance mother-daughter relationships and to teach girls skills for managing conflict, resisting media influences, refusing alcohol and drugs, and correcting peer norms about underage drinking, smoking, and drug use. After intervention, all participants (control and intervention) completed posttest and follow-up measurements. Two months following program delivery and relative to control-arm participants, intervention-arm girls and mothers had improved their mother-daughter communication skills and their perceptions and applications of parental monitoring and rule-setting relative to girls' alcohol use. Also at follow-up, intervention-arm girls had improved their conflict management and alcohol use-refusal skills; reported healthier normative beliefs about underage drinking; demonstrated greater self-efficacy about their ability to avoid underage drinking; reported less alcohol consumption in the past 7 days, 30 days, and year; and expressed lower intentions to drink as adults. Study findings modestly support the viability of a mother-daughter, computer-mediated program to prevent underage drinking among adolescent girls. The data have implications for the further development of gender-specific approaches to combat increases in alcohol and other substance use among American girls.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

PubMed

Manchikanti, Laxmaiah; Abdi, Salahadin; Atluri, Sairam; Balog, Carl C; Benyamin, Ramsin M; Boswell, Mark V; Brown, Keith R; Bruel, Brian M; Bryce, David A; Burks, Patricia A; Burton, Allen W; Calodney, Aaron K; Caraway, David L; Cash, Kimberly A; Christo, Paul J; Damron, Kim S; Datta, Sukdeb; Deer, Timothy R; Diwan, Sudhir; Eriator, Ike; Falco, Frank J E; Fellows, Bert; Geffert, Stephanie; Gharibo, Christopher G; Glaser, Scott E; Grider, Jay S; Hameed, Haroon; Hameed, Mariam; Hansen, Hans; Harned, Michael E; Hayek, Salim M; Helm, Standiford; Hirsch, Joshua A; Janata, Jeffrey W; Kaye, Alan D; Kaye, Adam M; Kloth, David S; Koyyalagunta, Dhanalakshmi; Lee, Marion; Malla, Yogesh; Manchikanti, Kavita N; McManus, Carla D; Pampati, Vidyasagar; Parr, Allan T; Pasupuleti, Ramarao; Patel, Vikram B; Sehgal, Nalini; Silverman, Sanford M; Singh, Vijay; Smith, Howard S; Snook, Lee T; Solanki, Daneshvari R; Tracy, Deborah H; Vallejo, Ricardo; Wargo, Bradley W

2012-07-01

Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. ( good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. ( limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. ( good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. ( good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. ( good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. ( good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. ( fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. ( good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. ( good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. ( fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. ( fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. ( fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. ( fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. ( fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. ( good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. ( limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. ( fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. ( fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. ( good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. ( fair). The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective.

PubMed

Zhang, Li; Yan, Jingbo; Liu, Xinmin; Ye, Zuguang; Yang, Xiaohui; Meyboom, Ronald; Chan, Kelvin; Shaw, Debbie; Duez, Pierre

2012-04-10

Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA). The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management. About 10-15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China. The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Reasons for Use, Abstention, and Quitting Illicit Drug Use by American Adolescents: A Report Commissioned by the Drugs-Violence Task Force of the National Sentencing Commission. Monitoring the Future Occasional Paper No. 44.

ERIC Educational Resources Information Center

Johnston, Lloyd D.

The data for this report were obtained from the Monitoring the Future study. Surveys from eighth, tenth, and twelfth grade respondents were used to examine adolescents' reasons for use, abstention, and quitting illicit drug use. Many reasons were found for drug use. Abstainers provided more reasons for their abstention than quitters gave for their…

Developing an Occupational Drug Abuse Program: Considerations and Approaches. Services Research Monograph Series.

ERIC Educational Resources Information Center

Stephen, Mae; Prentice, Robert

This monograph, developed as a guide for companies interested in establishing drug abuse programs, begins with a brief summary of studies assessing the extent and costs of employee drug use. The next section addresses some practical and conceptual issues about establishing a drug abuse program. Suggestions for implementing a drug abuse program are…

Point-of-care detection and real-time monitoring of intravenously delivered drugs via tubing with an integrated SERS sensor.

PubMed

Wu, Hsin-Yu; Cunningham, Brian T

2014-05-21

We demonstrate an approach for detection, identification, and kinetic monitoring of drugs flowing within tubing, through the use of a plasmonic nanodome array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon a flexible plastic substrate that is subsequently integrated with a flow cell that connects in series with ordinary intravenous (IV) drug delivery tubing. To investigate the potential clinical applications for point-of-care detection and real-time monitoring, we perform SERS detection of ten pharmaceutical compounds (hydrocodone, levorphanol, morphine, oxycodone, methadone, phenobarbital, dopamine, diltiazem, promethazine, and mitoxantrone). We demonstrate dose-dependent SERS signal magnitude, resulting in detection limits (ng ml(-1)) well below typical administered dosages (mg ml(-1)). Further, we show that the detected drugs are not permanently attached to the PNA surface, and thus our approach is capable of performing continuous monitoring of drug delivery as materials flow through IV tubing that is connected in series with the sensor. Finally, we demonstrate the potential co-detection of multiple drugs when they are mixed together, and show excellent reproducibility and stability of SERS measurements for periods extending at least five days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing the safety of IV drug delivery.

Prescription-event monitoring: methodology and recent progress.

PubMed

Rawson, N S; Pearce, G L; Inman, W H

1990-01-01

Event monitoring was first suggested 25 years ago as a way of detecting adverse reactions to drugs. Prescription-event monitoring (PEM), which has been developed by the Drug Safety Research Unit, is the first large-scale systematic post-marketing surveillance method to use event monitoring in the U.K. PEM identifies patients, who have been prescribed a particular drug, and their doctors from photocopies of National Health Service prescriptions which are processed centrally in England. A personalized follow-up questionnaire ("green form") is mailed to each patient's general practitioner, usually on the first anniversary of the initial prescription, asking for information about the patient, especially any "events" that he or she may have experienced since beginning treatment with the drug. The methodology of PEM is presented, together with examples of analyses that can be performed using results from recent studies. The problems and benefits of PEM are discussed.

42 CFR 423.159 - Electronic prescription drug program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 3 2012-10-01 2012-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

42 CFR 423.159 - Electronic prescription drug program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 3 2014-10-01 2014-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

42 CFR 423.159 - Electronic prescription drug program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 3 2013-10-01 2013-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

Postmarketing surveillance in developing countries.

PubMed

Meirik, O

1988-01-01

Authorities in developing countries need to monitor the possible adverse consequences of the increasing use of drugs in their countries. Definite differences exist in the risk-benefit ratios for developed and developing countries, particularly with fertility-regulating drugs. Some physicians believe that the increased risk of thrombosis associated with oral contraceptives (OCs) should not be considered as important in developing countries due to the fact that the background level of venous thrombosis is so low in developing countries that even a 50- or 100-fold increase in relative risk would neither be detectable nor important compared to the risk of unwanted pregnancy. In addition, evidence exists of geographically linked factors in the etiology of some adverse drug reactions (ADRs). Authorities in Brazil, India, Indonesia, Pakistan, the Philippines, Thailand, and Venezuela have established voluntary ADR reporting systems. Several developing countries also actively follow the World Health Organization's International Drug Monitoring Program and have access to its data base. A number of other methodological approaches to postmarketing surveillance are in use in addition to voluntary ADR reporting systems. These include cross-sectional surveys, studies of temporal and geographic correlations of diseases and drug use, and case-control and cohort studies. Each of these approaches offers specific advantages. Postmarketing surveillance should begin at the time new drugs, including contraceptive methods are introduced. Surveillance needs to be an integral part of plans for the introduction of new contraceptive methods in settings where the infrastructure to carry out such surveillance is in place. 3 major public sector agencies, Family Health International, the Population Council, and the World Health Organization, developed a plan to obtain funding for the postmarketing surveillance of a contraceptive implant, Norplant-R. A controlled cohort study will be conducted in 6-10 developing countries. The pilot phase of the surveillance began in 1987. The project objective is to detect possible adverse effects of Norplant-R as well as any health benefits of the method. It also will assess the feasibility of the cohort methodology for postmarketing surveillance in developing countries.

Past-year Prescription Drug Monitoring Program Opioid Prescriptions and Self-reported Opioid Use in an Emergency Department Population With Opioid Use Disorder.

PubMed

Hawk, Kathryn; D'Onofrio, Gail; Fiellin, David A; Chawarski, Marek C; O'Connor, Patrick G; Owens, Patricia H; Pantalon, Michael V; Bernstein, Steven L

2017-11-22

Despite increasing reliance on prescription drug monitoring programs (PDMPs) as a response to the opioid epidemic, the relationship between aberrant drug-related behaviors captured by the PDMP and opioid use disorder is incompletely understood. How PDMP data should guide emergency department (ED) assessment has not been studied. The objective was to evaluate a relationship between PDMP opioid prescription records and self-reported nonmedical opioid use of prescription opioids in a cohort of opioid-dependent ED patients enrolled in a treatment trial. PDMP opioid prescription records during 1 year prior to study enrollment on 329 adults meeting Diagnostic and Statistical Manual IV criteria for opioid dependence entering a randomized clinical trial in a large, urban ED were cross-tabulated with data on 30-day nonmedical prescription opioid use self-report. The association among these two types of data was assessed by the Goodman and Kruskal's gamma; a logistic regression was used to explore characteristics of participants who had PDMP record of opioid prescriptions. During 1 year prior to study enrollment, 118 of 329 (36%) patients had at least one opioid prescription (range = 1-51) in our states' PDMP. Patients who reported ≥15 of 30 days of nonmedical prescription opioid use were more likely to have at least four PDMP opioid prescriptions (20/38; 53%) than patients reporting 1 to 14 days (14/38, 37%) or zero days of nonmedical prescription opioid use (4/38, 11%; p = 0.002). Female sex and having health insurance were significantly more represented in the PDMP (p < 0.05 for both). PDMPs may be helpful in identifying patients with certain aberrant drug-related behavior, but are unable to detect many patients with opioid use disorder. The majority of ED patients with opioid use disorder were not captured by the PDMP, highlighting the importance of using additional methods such as screening and clinical history to identify opioid use disorders in ED patients and the limitations of PDMPs to detect opioid use disorders. © 2017 by the Society for Academic Emergency Medicine.

Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

PubMed

Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

2014-01-16

Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of specialists is a common problem in resource-scarce areas in China and other developing countries. The results of this experiment will provide high level evidence on the role of health workers with relatively limited medical training in managing severe psychiatric disease and other chronic conditions in developing countries. ChiCTR-TRC-13003263.

Substance abuse prevention infrastructure: a survey-based study of the organizational structure and function of the D.A.R.E. program

PubMed Central

Merrill, Jeffrey C; Pinsky, Ilana; Killeya-Jones, Ley A; Sloboda, Zili; Dilascio, Tracey

2006-01-01

Background The only national drug abuse prevention delivery system that supports the rapid diffusion of new prevention strategies and includes uniform training and credentialing of instructors who are monitored for quality implementation of prevention programming is the Drug Abuse Resistance Education network (D.A.R.E.) linking community law enforcement to schools. Analysis of the organizational structure and function of D.A.R.E. provides an understanding of the essential parameters of this successful delivery system that can be used in the development of other types of national infrastructures for community-based prevention services. Information regarding organizational structure and function around funding issues, training, quality control and community relationships was gathered through telephone surveys with 50 state D.A.R.E. coordinators (including two major cities), focus groups with local D.A.R.E. officers and mentors, and interviews with national D.A.R.E. office staff. Results The surveys helped identify several strengths inherent in the D.A.R.E. program necessary for building a prevention infrastructure, including a well-defined organizational focus (D.A.R.E. America), uniform training and means for rapid dissemination (through its organized training structure), continuing education mechanisms (through the state and national conference and website), mechanisms for program monitoring and fidelity of implementation (formal and informal), branding and, for several states, predictable and consistent financing. Weaknesses of the program as currently structured include unstable funding and the failure to incorporate components for the continual upgrading of curricula reflecting research evidence and "principles of prevention". Conclusion The D.A.R.E. organization and service delivery network provides a framework for the rapid dissemination of evidence-based prevention strategies. The major strength of D.A.R.E. is its natural affiliation to local law enforcement agencies through state coordinators. Through these affiliations, it has been possible for D.A.R.E. to become established nationally within a few years and internationally within a decade. Understanding how this structure developed and currently functions provides insights into how other such delivery systems could be developed. PMID:16956400

Substance abuse prevention infrastructure: a survey-based study of the organizational structure and function of the D.A.R.E. program.

PubMed

Merrill, Jeffrey C; Pinsky, Ilana; Killeya-Jones, Ley A; Sloboda, Zili; Dilascio, Tracey

2006-09-06

The only national drug abuse prevention delivery system that supports the rapid diffusion of new prevention strategies and includes uniform training and credentialing of instructors who are monitored for quality implementation of prevention programming is the Drug Abuse Resistance Education network (D.A.R.E.) linking community law enforcement to schools. Analysis of the organizational structure and function of D.A.R.E. provides an understanding of the essential parameters of this successful delivery system that can be used in the development of other types of national infrastructures for community-based prevention services. Information regarding organizational structure and function around funding issues, training, quality control and community relationships was gathered through telephone surveys with 50 state D.A.R.E. coordinators (including two major cities), focus groups with local D.A.R.E. officers and mentors, and interviews with national D.A.R.E. office staff. The surveys helped identify several strengths inherent in the D.A.R.E. program necessary for building a prevention infrastructure, including a well-defined organizational focus (D.A.R.E. America), uniform training and means for rapid dissemination (through its organized training structure), continuing education mechanisms (through the state and national conference and website), mechanisms for program monitoring and fidelity of implementation (formal and informal), branding and, for several states, predictable and consistent financing. Weaknesses of the program as currently structured include unstable funding and the failure to incorporate components for the continual upgrading of curricula reflecting research evidence and "principles of prevention". The D.A.R.E. organization and service delivery network provides a framework for the rapid dissemination of evidence-based prevention strategies. The major strength of D.A.R.E. is its natural affiliation to local law enforcement agencies through state coordinators. Through these affiliations, it has been possible for D.A.R.E. to become established nationally within a few years and internationally within a decade. Understanding how this structure developed and currently functions provides insights into how other such delivery systems could be developed.

Monitoring the Future National Results on Adolescent Drug Use: Overview of Key Findings, 1999.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.

This booklet presents an overview of the findings pertaining to eighth, tenth, and twelfth grade students from the 1999 Monitoring the Future Study. This overview focuses on recent trends in the use of various licit and illicit drugs. It also examines trends in the levels of perceived risk and personal disapproval associated with each drug, which…

Demographic Subgroup Trends for Various Licit and Illicit Drugs, 1975-2006. Monitoring the Future Occasional Paper 67

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2007-01-01

This occasional paper is intended to serve as a supplement to the larger annual volume, "Monitoring the Future National Survey Results on Drug Use, 1975-2006: Volume I: Secondary School Students." This supplement contains the graphic presentation of the trends in drug use for various demographic subgroups, namely those defined by gender, college…

Demographic Subgroup Trends for Various Licit and Illicit Drugs, 1975-2007. Monitoring the Future Occasional Paper 69

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2008-01-01

This occasional paper is intended to serve as a supplement to the larger annual volume, "Monitoring the Future National Survey Results on Drug Use, 1975-2007: Volume I: Secondary School Students." This supplement contains the graphic presentation of the trends in drug use for various demographic subgroups, namely those defined by gender, college…

Demographic Subgroup Trends for Various Licit and Illicit Drugs, 1975-2000. Monitoring the Future Occasional Paper 53.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.

This occasional paper is intended to serve as a supplement to the larger annual volume, "Monitoring the Future National Survey Results on Drug Use, 1975-2000: Volume 1: Secondary School Students." This supplement contains the graphic presentation of the trends in drug use for various demographic subgroups, namely those defined by gender,…

Monitoring the Future National Survey Results on Drug Use, 1975-2010. Volume I, Secondary School Students

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2011-01-01

The Monitoring the Future (MTF) study involves an ongoing series of national surveys of American adolescents and adults that has provided the nation with a vital window into the important, but largely hidden, problem behaviors of illegal drug use, alcohol use, tobacco use, anabolic steroid use, and psychotherapeutic drug use. For more than a third…

42 CFR 423.159 - Electronic prescription drug program.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions. For purposes of this...

In vivo Raman measurement of levofloxacin lactate in blood using a nanoparticle-coated optical fiber probe

PubMed Central

Liu, Shupeng; Rong, Ming; Zhang, Heng; Chen, Na; Pang, Fufei; Chen, Zhenyi; Wang, Tingyun; Yan, Jianshe

2016-01-01

Monitoring drug concentrations in vivo is very useful for adjusting a drug dosage during treatment and for drug research. Specifically, cutting-edge “on-line” drug research relies on knowing how drugs are metabolized or how they interact with the blood in real-time. Thus, this study explored performing in vivo Raman measurements of the model drug levofloxacin lactate in the blood using a nanoparticle-coated optical fiber probe (optical fiber nano-probe). The results show that we were able to measure real-time changes in the blood concentration of levofloxacin lactate, suggesting that this technique could be helpful for performing drug analyses and drug monitoring in a clinical setting without repeatedly withdrawing blood from patients. PMID:27231590

Prevalence of HIV Antiretroviral Drug Resistance and Its Impacts on HIV-1 Virological Failures in Jiangsu, China: A Cross-Sectional Study.

PubMed

Zhou, Ying; Lu, Jing; Wang, Jinge; Yan, Hongjing; Li, Jianjun; Xu, Xiaoqin; Zhang, Zhi; Qiu, Tao; Ding, Ping; Fu, Gengfeng; Huan, Xiping; Hu, Haiyang

2016-01-01

Antiretroviral therapy (ART) has been shown to improve survival of patients with Human Immunodeficiency Virus (HIV) infection and to reduce HIV-1 transmission. Therefore, the Chinese central government initiated a national program to provide ART free of charge to HIV-1 patients. We conducted a cross-sectional survey in Jiangsu province to determine the level of drug resistance (DR) in HIV-1 infected patients and the correlates of DR in virological failures in 2012. Approximately 10.4% of the HIV-1 patients in the study experienced virological failure after one year of ART and were divided into drug sensitive and drug resistant groups based on genotype determination. The viral loads (VLs) in the drug resistant group were significantly lower than the drug sensitive group. There were two independent predictors of virological failure: male gender and increasing duration of treatment. The primary mutations observed in the study were against nucleoside reverse transcriptase inhibitors (NRTIs) which were M184V (79.45%) and K103N (33.70%) in nonnucleoside reverse transcriptase inhibitors (NNRTIs). The overall rate of DR in Jiangsu province is still relatively low among treated patients. However, close monitoring of drug resistance in male patients in the early stages of treatment is vital to maintaining and increasing the benefits of HIV ART achieved to date.

[Health technology assessment in Ecuador's ministry of public health as a tool for drug purchasing from 2012 to 2015].

PubMed

Armijos, Luciana; Escalante, Santiago; Villacrés, Tatiana

2017-06-08

Learn how the Ministry of Public Health (MSP, the Spanish acronym) of Ecuador uses health technology assessment (HTA) in decision-making on the purchase of drugs that are not on the National List of Essential Medicines (NLEM). Information from databases of the Health Intelligence Directorate (DIS, the Spanish acronym) and the National Directorate of Drugs and Medical Devices (DNMDM, the Spanish acronym), was used to compare decisions made by both entities, to learn about the use and consistency of HTA reports in decisions on purchasing drugs not included in the NLEM. From 2012 to 2015, 227 reports were issued, of which 87 cover drugs; 36, devices; 29: medical procedures; 34: health programs; and 41: other medical technologies. The DNMDM requested 59 of the reports on drugs. There was 80% agreement in decisions made by the two directorates that participate in the process. The MSP, through the DIS, began using HTA in 2012. Given that the majority of reports evaluate drugs, it is essential that reports be prepared for other types of medical technologies and that they be prepared and used as widely as possible. Despite a high level of agreement in decisions, it is important to continue to improve the reports' scope and quality, and to monitor adoption and dissemination of authorized and funded technologies to learn the effectiveness and impact of HTA in Ecuador.

Microdialysis Monitoring in Clinical Traumatic Brain Injury and Its Role in Neuroprotective Drug Development.

PubMed

Thelin, Eric Peter; Carpenter, Keri L H; Hutchinson, Peter J; Helmy, Adel

2017-03-01

Injuries to the central nervous system continue to be vast contributors to morbidity and mortality; specifically, traumatic brain injury (TBI) is the most common cause of death during the first four decades of life. Several modalities are used to monitor patients suffering from TBI in order to prevent detrimental secondary injuries. The microdialysis (MD) technique, introduced during the 1990s, presents the treating physician with a robust monitoring tool for brain chemistry in addition to conventional intracranial pressure monitoring. Nevertheless, some limitations remain, such as limited spatial resolution. Moreover, while there have been several attempts to develop new potential pharmacological therapies in TBI, there are currently no available drugs which have shown clinical efficacy that targets the underlying pathophysiology, despite various trials investigating a plethora of pharmaceuticals. Specifically in the brain, MD is able to demonstrate penetration of the drug through the blood-brain barrier into the brain extracellular space at potential site of action. In addition, the downstream effects of drug action can be monitored directly. In the future, clinical MD, together with other monitoring modalities, can identify specific pathological substrates which require tailored treatment strategies for patients suffering from TBI.

The benefits of antiepileptic drug (AED) blood level monitoring to complement clinical management of people with epilepsy.

PubMed

Stepanova, Daria; Beran, Roy G

2015-01-01

Some argue that there is no evidence to support the use of antiepileptic drug (AED) blood level monitoring when treating people with epilepsy (PWE). This paper identifies how AED monitoring can be invaluable in such treatment. SPECIFIC EXAMPLES: (i) Compliance: Antiepileptic drug blood levels often confirm noncompliance rather than adequate seizure control, confirming subtherapeutic levels in PWE attending hospitals due to seizures. Routine monitoring of AED levels may prevent breakthrough seizures by identifying noncompliance and instituting heightened compliance measures before experiencing breakthrough seizures without modifying dosages. For PWE attending hospitals due to seizures, loading with the AED shown to be subtherapeutic may be all that is required. (ii) Cluster seizures and status epilepticus: When using long-acting AEDs to complement benzodiazepines, blood level monitoring confirms that an adequate dosage was given and, if not, a further bolus can be administered with further monitoring. This is particularly useful when using rectal administration of AEDs. (iii) Polypharmacy: Polypharmacy provokes drug interactions in which case AED monitoring helps in differentiating adequate dosing, offending AED with toxicity and free level measuring benefits when total levels are unhelpful. (iv) Generic substitution: Generic AEDs can fluctuate considerably from a parent compound, and even a parent compound, sourced from an alternative supplier, may have altered bioavailability for which blood level monitoring is very useful. While therapeutic blood level monitoring is not a substitute for good clinical judgment, it offers a valuable adjunct to patient care. Copyright © 2014 Elsevier Inc. All rights reserved.

A Guide for the Management of Speical Education Programs. 4.0 Drug Information for Educators, Parents, and Students. Newday Operations Guide for Drug Dependent Minor Programs.

ERIC Educational Resources Information Center

Santa Cruz County Superintendent of Schools, CA.

Presented is the fourth component of a special day class program for drug dependent minors, Drug Information for Educators, Parents, and Students. The first section, intended for educators, includes a drug abuse chart, information on the drug subculture, information on patterns of drug abuse and misconceptions about drugs, and suggested activities…

Using a Drug Interaction Program (Drug Interactions Advisor™) in a Community Hospital

PubMed Central

Harvey, A. C.; Diehl, G. R.; Finlayson, W. B.

1987-01-01

To test the usefulness of a drugs-interaction program in a community hospital one hundred patients in three medical wards were surveyed with respect to their drug regime. The drugs listed for each patient were entered into Drug Interactions Advisor™ a commercial interactions program running on an Apple IIE. Interacting drugs were listed with the severity of the interaction in each case. Of one hundred patients fifty-one had drugs which could potentially interact and in fifty-one percent of cases a change in therapy would have been advised by Drug Interactions Advisor™. The completeness of the data base was assessed as to its inclusion of drugs actually given and it dealt with eighty-nine percent. The program was tested against ten known interactions and it identified six. Multiple drug therapy is a major problem nowadays and will increase with the aging of the population. Drug interactions programs exploit computer technology to make drug surveillance easier. Without computers such surveillance is difficult if not impossible.

The World Health Organization's Response to Emerging Human Immunodeficiency Virus Drug Resistance and a Call for Global Action.

PubMed

Bertagnolio, Silvia; Beanland, Rachel L; Jordan, Michael R; Doherty, Meg; Hirnschall, Gottfried

2017-12-01

The global community, including the World Health Organization (WHO), has committed to ending the AIDS epidemic and to ensuring that 90% of people living with human immunodeficiency virus (HIV) are diagnosed, 90% start treatment, and 90% achieve and maintain virological suppression. The emergence of HIV drug resistance (HIVDR) as antiretroviral treatment programs expand could preclude the 90-90-90 targets adopted by the United Nations General Assembly at the High-Level Meeting on Ending AIDS from being achieved. The Global Action Plan on HIVDR is a call for collective action grounded on normative guidance providing a standardized and robust approach to monitoring, preventing, and responding to HIVDR over the next 5 years (2017-2021). WHO is committed to supporting country, global, regional, and national partners to implement and monitor the progress of the Global Action Plan. This article outlines the key components of WHO's strategy to tackle HIVDR and the role the organization takes in leading the global response to HIVDR. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Methods for accurate cold-chain temperature monitoring using digital data-logger thermometers

NASA Astrophysics Data System (ADS)

Chojnacky, M. J.; Miller, W. M.; Strouse, G. F.

2013-09-01

Complete and accurate records of vaccine temperature history are vital to preserving drug potency and patient safety. However, previously published vaccine storage and handling guidelines have failed to indicate a need for continuous temperature monitoring in vaccine storage refrigerators. We evaluated the performance of seven digital data logger models as candidates for continuous temperature monitoring of refrigerated vaccines, based on the following criteria: out-of-box performance and compliance with manufacturer accuracy specifications over the range of use; measurement stability over extended, continuous use; proper setup in a vaccine storage refrigerator so that measurements reflect liquid vaccine temperatures; and practical methods for end-user validation and establishing metrological traceability. Data loggers were tested using ice melting point checks and by comparison to calibrated thermocouples to characterize performance over 0 °C to 10 °C. We also monitored logger performance in a study designed to replicate the range of vaccine storage and environmental conditions encountered at provider offices. Based on the results of this study, the Centers for Disease Control released new guidelines on proper methods for storage, handling, and temperature monitoring of vaccines for participants in its federally-funded Vaccines for Children Program. Improved temperature monitoring practices will ultimately decrease waste from damaged vaccines, improve consumer confidence, and increase effective inoculation rates.

Comparisons of Prevention Programs for Homeless Youth

PubMed Central

Rotheram-Borus, Mary Jane

2014-01-01

There are six HIV prevention programs for homeless youth whose efficacy has been or is currently being evaluated: STRIVE, the Community Reinforcement Approach, Strengths-Based Case Management, Ecologically-Based Family Therapy, Street Smart, and AESOP (street outreach access to resources). Programs vary in their underlying framework and theoretical models for understanding homelessness. All programs presume that the youths’ families lack the ability to support their adolescent child. Some programs deemphasize family involvement while others focus on rebuilding connections among family members. The programs either normalize current family conflicts or, alternatively, provide education about the importance of parental monitoring. All programs aim to reduce HIV-related sexual and drug use acts. A coping skills approach is common across programs: Problem-solving skills are specifically addressed in four of the six programs; alternatively, parents in other programs are encouraged to contingently reward their children. Each program also engineers ongoing social support for the families and the youth, either by providing access to needed resources or by substituting a new, supportive relationship for the existing family caretaker. All of the interventions provide access to health and mental health services as basic program resources. A comparison of HIV prevention programs for homeless youth identifies the robust components of each and suggests which programs providers may choose to replicate. PMID:19067164

Comparisons of prevention programs for homeless youth.

PubMed

Arnold, Elizabeth Mayfield; Rotheram-Borus, Mary Jane

2009-03-01

There are six HIV prevention programs for homeless youth whose efficacy has been or is currently being evaluated: STRIVE, the Community Reinforcement Approach, Strengths-Based Case Management, Ecologically-Based Family Therapy, Street Smart, and AESOP (street outreach access to resources). Programs vary in their underlying framework and theoretical models for understanding homelessness. All programs presume that the youths' families lack the ability to support their adolescent child. Some programs deemphasize family involvement while others focus on rebuilding connections among family members. The programs either normalize current family conflicts or, alternatively, provide education about the importance of parental monitoring. All programs aim to reduce HIV-related sexual and drug use acts. A coping skills approach is common across programs: Problem-solving skills are specifically addressed in four of the six programs; alternatively, parents in other programs are encouraged to contingently reward their children. Each program also engineers ongoing social support for the families and the youth, either by providing access to needed resources or by substituting a new, supportive relationship for the existing family caretaker. All of the interventions provide access to health and mental health services as basic program resources. A comparison of HIV prevention programs for homeless youth identifies the robust components of each and suggests which programs providers may choose to replicate.

HIV-1 drug resistance mutations among antiretroviral-naive HIV-1-infected patients in Asia: results from the TREAT Asia Studies to Evaluate Resistance-Monitoring Study.

PubMed

Sungkanuparph, Somnuek; Oyomopito, Rebecca; Sirivichayakul, Sunee; Sirisanthana, Thira; Li, Patrick C K; Kantipong, Pacharee; Lee, Christopher K C; Kamarulzaman, Adeeba; Messerschmidt, Liesl; Law, Matthew G; Phanuphak, Praphan

2011-04-15

Of 682 antiretroviral-naïve patients initiating antiretroviral therapy in a prospective, multicenter human immunodeficiency virus type 1 (HIV-1) drug resistance monitoring study involving 8 sites in Hong Kong, Malaysia, and Thailand, the prevalence of patients with ≥1 drug resistance mutation was 13.8%. Primary HIV drug resistance is emerging after rapid scaling-up of antiretroviral therapy use in Asia.

Cure of tuberculosis despite serum concentrations of antituberculosis drugs below published reference ranges.

PubMed

Meloni, Monica; Corti, Natascia; Müller, Daniel; Henning, Lars; Gutteck, Ursula; von Braun, Amrei; Weber, Rainer; Fehr, Jan

2015-01-01

Therapeutic target serum concentrations of first-line antituberculosis drugs have not been well defined in clinical studies in tuberculosis (TB) patients. We retrospectively investigated the estimated maximum serum concentrations (eC max) of antituberculosis drugs and clinical outcome of TB patients with therapeutic drug monitoring performed between 2010-2012 at our institution, and follow-up until March 2014. The eC max was defined as the highest serum concentration during a sampling period (2, 4 and 6 hours after drug ingestion). We compared the results with published eC max values, and categorised them as either "within reference range", "low eC max", or "very low eC max".Low/very low eC max-levels were defined as follows: isoniazid 2-3/<2 mg/l, rifampicin 4-8/<4 mg/l, rifabutin 0.2-0.3/<0.2 mg/l, ethambutol 1-2/<0.1 mg/l and pyrazinamide <20 mg/l. Concentrations of antituberculosis drugs in 175 serum samples of 17 patients with TB were analysed. In 12 (71%) patients, multiple therapeutic drug monitoring samples were collected over time, in 5 (29%) patients only one sample was available for therapeutic drug monitoring. Overall, 94% of all patients had at least one low antituberculosis drug concentration. Overall, 64% of all eC max levels were classified as "low" or "very low". The eC max was below the relevant reference range in 80% of isoniazid, 95% of rifampicin, 30% of pyrazinamide, and 30% of ethambutol measurements. All but one patient were cured of tuberculosis. Although many antituberculosis drug serum concentrations were below the widely used reference ranges, 16 of 17 patients were cured of tuberculosis. These results challenge the use of the published reference ranges for therapeutic drug monitoring.

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

PubMed Central

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

2015-01-01

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

Use of indicator items to monitor marine debris on a New Jersey beach from 1991 to 1996

USGS Publications Warehouse

Ribic, C.A.

1998-01-01

The US National Marine Debris Monitoring Program is using indicator items from beach surveys to identify whether amounts of marine debris are changing over time. Indicator items were selected through expert opinion and assumed to reflect the trend of all debris. We used monthly data from a 1991-1996 study of debris on a New Jersey beach to determine if indicator and non-indicator items showed similar trends. Total indicator debris levels did not change; this was true regardless of probable source. Non-indicator debris increased about 40% annually. Plastic non-indicator items increased regardless of whether items were whole items, cigarette filters, or pieces. Of the whole items, almost 50% were plastic lids, cups, and utensils, and about 25% were drug-related paraphernalia, tobacco-related products, plastic stirrers, pull rings, and fireworks. When indicator items are used in a monitoring programme to reflect total debris patterns, concordance of trends in indicator and non-indicator debris should be checked.

Documentation forms for monitoring occupational surveillance of healthcare workers who handle cytotoxic drugs.

PubMed

Parillo, V L

1994-01-01

To develop a procedure for medical surveillance of healthcare workers who handle cytotoxic drugs. Literature review and guidelines published by the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. INFORMATION SELECTION: Studies of possible exposure screening tests, congenital defects in offspring, and case studies. Some degree of risk exists in handling cytotoxic drugs, but no reliable screening test for cytotoxic drug exposure has been developed. Reproductive hazards are possible when protective equipment is not used. Areas to be addressed when devising surveillance procedures include who to cover, what baseline data to gather, what periodic monitoring will be necessary (and at what interval it will be conducted), how to handle exposure incidents, and what documentation system will be used. A procedure using a baseline risk factor form and a yearly monitoring questionnaire was devised and implemented. Forms contain documentation of worker teaching. Most often, nurses are the healthcare workers who handle cytotoxic drugs. A consistent approach to monitoring healthcare workers is facilitated by using a defined procedure and standardized forms.

Understanding Early-Onset Drug and Alcohol Outcomes among Youth: The Role of Family Structure, Social Factors, and Interpersonal Perceptions of Use

PubMed Central

Hemovich, Vanessa; Lac, Andrew; Crano, William D.

2011-01-01

Research on adolescents focuses increasingly on features of the family in predicting and preventing substance use. Multivariate analyses of data from the National Survey of Parents and Youth (N = 4,173) revealed numerous significant differences on risk variables associated with family structure on adolescent drug-related perceptions and illicit substance use. Youth from dual-parent households were least likely to use drugs and were monitored more closely than single-parent youth (p < .001). A path analytic model estimated to illuminate linkages among theoretically implicated variables revealed that family income and child’s gender (p < .001), along with family structure (p < .05), affected parental monitoring, but not parental warmth. Monitoring and warmth, in turn, predicted adolescents’ social and interpersonal perceptions of drug use (p < .001), and both variables anticipated adolescents’ actual drug use one year later (p < .001). Results reconfirm the importance of parental monitoring and warmth and demonstrate the link between these variables, adolescents’ social and intrapersonal beliefs, and their use of illicit substances. PMID:21491334

Potential of Surface Enhanced Raman Spectroscopy (SERS) in Therapeutic Drug Monitoring (TDM). A Critical Review

PubMed Central

Jaworska, Aleksandra; Fornasaro, Stefano; Sergo, Valter; Bonifacio, Alois

2016-01-01

Surface-Enhanced Raman Spectroscopy (SERS) is a label-free technique that enables quick monitoring of substances at low concentrations in biological matrices. These advantages make it an attractive tool for the development of point-of-care tests suitable for Therapeutic Drug Monitoring (TDM) of drugs with a narrow therapeutic window, such as chemotherapeutic drugs, immunosuppressants, and various anticonvulsants. In this article, the current applications of SERS in the field of TDM for cancer therapy are discussed in detail and illustrated according to the different strategies and substrates. In particular, future perspectives are provided and special concerns regarding the standardization of self-assembly methods and nanofabrication procedures, quality assurance, and technology readiness are critically evaluated. PMID:27657146

An Outreach Program in Drug Education; Teaching a Rational Approach to Drug Use

ERIC Educational Resources Information Center

Sorensen, James L.; Joffe, Stephen J.

1975-01-01

Aimed at encouraging rational decision making about drug use, a peer oriented drug education program was conducted in a community youth project. Youth and leaders shared feelings and knowledge about drugs. Compared with four program dropouts, six participants exhibited more positive attitudes toward the drug group, its leaders and themselves.…

76 FR 59574 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... 2105-AE13 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug...) published an interim final rule (IFR) authorizing the use of a new Federal Drug Testing Custody and Control Form (CCF) in its drug testing program. Use of the form is authorized beginning October 1, 2010. This...

28 CFR 550.50 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

28 CFR 550.50 - Purpose and scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

28 CFR 550.50 - Purpose and scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

28 CFR 550.50 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

28 CFR 550.50 - Purpose and scope.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

Comparison of veterinary drug residue results in animal tissues by ultrahigh-performance liquid chromatography coupled to triple quadrupole ... use of a commercial lipid removal product

USDA-ARS?s Scientific Manuscript database

Veterinary drug residues in animal-derived foods must be monitored to ensure food safety, verify proper veterinary practices, enforce legal limits in domestic and imported foods, and other purposes. A common goal in drug residue analysis in foods is to achieve acceptable monitoring results for as m...

Monitoring the Future National Results on Adolescent Drug Use: Overview of Key Findings, 2001.

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.

This report presents an overview of the key findings from the Monitoring the Future 2001 nationwide survey of 8th, 10th, and 12th grade students. A particular emphasis is placed on recent trends in the use of licit and illicit drugs. Trends in the levels of perceived risk and personal disapproval associated with each drug--which this study has…

Monitoring the Future: National Results on Adolescent Drug Use. Overview of Key Findings, 2002.

ERIC Educational Resources Information Center

Michigan Univ., Ann Arbor. Inst. for Social Research.

This report presents an overview of the key findings from the Monitoring the Future 2002 nationwide survey of 8th, 10th, and 12th grade students. A particular emphasis is placed on recent trends in the use of licit and illicit drugs. Trends in the levels of perceived risk and personal disapproval associated with each drug--which this study has…

Earlier warning: a multi-indicator approach to monitoring trends in the illicit use of medicines.

PubMed

Mounteney, Jane; Haugland, Siren

2009-03-01

The availability of medicines on the illicit drug market is currently high on the international policy agenda, linked to adverse health consequences including addiction, drug related overdoses and injection related problems. Continuous surveillance of illicit use of medicines allows for earlier identification and reporting of emerging trends and increased possibilities for earlier intervention to prevent spread of use and drug related harm. This paper aims to identify data sources capable of monitoring the illicit use of medicines; present trend findings for Rohypnol and Subutex using a multi-indicator monitoring approach; and consider the relevance of such models for policy makers. Data collection and analysis were undertaken in Bergen, Norway, using the Bergen Earlier Warning System (BEWS), a multi-indicator drug monitoring system. Data were gathered at six monthly intervals from April 2002 to September 2006. Drug indicator data from seizures, treatment, pharmacy sales, helplines, key informants and media monitoring were triangulated and an aggregated differential was used to plot trends. Results for the 4-year period showed a decline in the illicit use of Rohypnol and an increase in the illicit use of Subutex. Multi-indicator surveillance models can play a strategic role in the earlier identification and reporting of emerging trends in illicit use of medicines.

Prescription drug monitoring program data tracking of opioid addiction treatment outcomes in integrated dual diagnosis care involving injectable naltrexone.

PubMed

Sajid, Ayesha; Whiteman, Aaron; Bell, Richard L; Greene, Marion S; Engleman, Eric A; Chambers, R Andrew

2016-10-01

Fourfold increases in opioid prescribing and dispensations over 2 decades in the U.S. has paralleled increases in opioid addictions and overdoses, requiring new preventative, diagnostic, and treatment strategies. This study examines Prescription Drug Monitoring Program (PDMP) tracking as a novel measure of opioid addiction treatment outcomes in a university-affiliated integrated mental health-addiction treatment clinic. Repeated measure parametrics examined PDMP and urine drug screening (UDS) data before and after first injection for all patients (N = 68) who received at least one long-acting naltrexone injection (380 mg/IM) according to diagnostic groupings of having either (i) alcohol (control); (ii) opioid; or (iii) combined alcohol and opioid use disorders. There were no group differences post-injection in treatment days, injections delivered, or treatment service encounters. UDS and PDMP measures of opioid exposures were greater in opioid compared to alcohol-only patients. Post-first injection, UDS's positive for opioids declined (p < .05) along with PDMP measures of opioid prescriptions (p < .001), doses (p < .01), types (p < .001), numbers of dispensing prescribers (p < .001) and pharmacies (p < .001). Opioid patients without alcohol disorders showed the best outcomes with 50% to 80% reductions in PDMP-measures of opioids, down to levels of alcohol-only patients. This study shows PDMP utility for measuring opioid addiction treatment outcomes, supporting the routine use of PDMPs in clinical and research settings. These findings demonstrate that opioid addiction in patients with complex addictions and mental illnesses comorbidities can show effective treatment responses as measured by PDMP tracking of decreases in opioid prescriptions to those patients. (Am J Addict 2016;25:557-564). © 2016 The Authors. The American Journal on Addictions Published by Wiley Periodicals, Inc. on behalf of The American Academy of Addiction Psychiatry (AAAP).

When microchip implants do more than drug delivery: blending, blurring, and bundling of protected health information and patient monitoring.

PubMed

Bramstedt, Katrina A

2005-01-01

Although currently in the research stage, scientists argue that drug-releasing microchip implants are on the horizon for future patients. This paper presents ethical reflection on these implants and identifies specific areas of concern; namely, patient monitoring and tracking, and patient privacy and confidentiality. It is foreseeable that drug delivery chips could be multifunctional with the overt or covert addition of sensors that monitor more than just the bloodstream concentrations of prescribed drugs (e.g., cotinine and alcohol in non-compliant patients, patient location via radio frequency or global positioning satellite). Similarly, it is foreseeable that these chips could be embedded with a patient's protected health information that could potentially be accessed and used by unauthorized persons. While drug delivery microchips are theoretically convenient and accurate for dosing, and might offer faster drug delivery with fewer side effects, ethical issues loom and should be contemplated now, while the technology is still under development.

Graphical user interface simplifies infusion pump programming and enhances the ability to detect pump-related faults.

PubMed

Syroid, Noah; Liu, David; Albert, Robert; Agutter, James; Egan, Talmage D; Pace, Nathan L; Johnson, Ken B; Dowdle, Michael R; Pulsipher, Daniel; Westenskow, Dwayne R

2012-11-01

Drug administration errors are frequent and are often associated with the misuse of IV infusion pumps. One source of these errors may be the infusion pump's user interface. We used failure modes-and-effects analyses to identify programming errors and to guide the design of a new syringe pump user interface. We designed the new user interface to clearly show the pump's operating state simultaneously in more than 1 monitoring location. We evaluated anesthesia residents in laboratory and simulated environments on programming accuracy and error detection between the new user interface and the user interface of a commercially available infusion pump. With the new user interface, we observed the number of programming errors reduced by 81%, the number of keystrokes per task reduced from 9.2 ± 5.0 to 7.5 ± 5.5 (mean ± SD), the time required per task reduced from 18.1 ± 14.1 seconds to 10.9 ± 9.5 seconds and significantly less perceived workload. Residents detected 38 of 70 (54%) of the events with the new user interface and 37 of 70 (53%) with the existing user interface, despite no experience with the new user interface and extensive experience with the existing interface. The number of programming errors and workload were reduced partly because it took less time and fewer keystrokes to program the pump when using the new user interface. Despite minimal training, residents quickly identified preexisting infusion pump problems with the new user interface. Intuitive and easy-to-program infusion pump interfaces may reduce drug administration errors and infusion pump-related adverse events.

32 CFR 634.13 - Alcohol and drug abuse programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 4 2012-07-01 2011-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

32 CFR 634.13 - Alcohol and drug abuse programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

32 CFR 634.13 - Alcohol and drug abuse programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 4 2014-07-01 2013-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

32 CFR 634.13 - Alcohol and drug abuse programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 4 2013-07-01 2013-07-01 false Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

32 CFR 634.13 - Alcohol and drug abuse programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 4 2011-07-01 2011-07-01 false Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

Post-marketing studies: the work of the Drug Safety Research Unit.

PubMed

Mackay, F J

1998-11-01

The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.

No apparent reduction in schistosome burden or genetic diversity following four years of school-based mass drug administration in mwea, central kenya, a heavy transmission area.

PubMed

Lelo, Agola E; Mburu, David N; Magoma, Gabriel N; Mungai, Ben N; Kihara, Jimmy H; Mwangi, Ibrahim N; Maina, Geoffrey M; Kinuthia, Joseph M; Mutuku, Martin W; Loker, Eric S; Mkoji, Gerald M; Steinauer, Michelle L

2014-10-01

Schistosomiasis is a debilitating neglected tropical disease that infects over 200 million people worldwide. To combat this disease, in 2012, the World Health Organization announced a goal of reducing and eliminating transmission of schistosomes. Current control focuses primarily on mass drug administration (MDA). Therefore, we monitored transmission of Schistosoma mansoni via fecal egg counts and genetic markers in a typical school based MDA setting to ascertain the actual impacts of MDA on the targeted schistosome population. For 4 years, we followed 67 children enrolled in a MDA program in Kenya. Infection status and egg counts were measured each year prior to treatment. For 15 of these children, for which there was no evidence of acquired resistance, meaning they became re-infected following each treatment, we collected microsatellite genotype data from schistosomes passed in fecal samples as a representation of the force of transmission between drug treatments. We genotyped a total of 4938 parasites from these children, with an average of 329.2 parasites per child for the entire study, and an average of 82.3 parasites per child per annual examination. We compared prevalence, egg counts, and genetic measures including allelic richness, gene diversity (expected heterozygosity), adult worm burdens and effective number of breeders among time points to search for evidence for a change in transmission or schistosome populations during the MDA program. We found no evidence of reduced transmission or schistosome population decline over the course of the program. Although prevalence declined in the 67 children as it did in the overall program, reinfection rates were high, and for the 15 children studied in detail, schistosome egg counts and estimated adult worm burdens did not decline between years 1 and 4, and genetic diversity increased over the course of drug treatment. School based control programs undoubtedly improve the health of individuals; however, our data show that in an endemic area, such a program has had no obvious effect on reducing transmission or of significantly impacting the schistosome population as sampled by the children we studied in depth. Results like these, in combination with other sources of information, suggest more integrated approaches for interrupting transmission and significantly diminishing schistosome populations will be required to achieve sustainable control.

Characteristics of alprazolam-related deaths compiled by a centralized state medical examiner.

PubMed

Shah, Neel A; Abate, Marie A; Smith, Michael J; Kaplan, James A; Kraner, James C; Clay, David J

2012-11-01

Unintentional drug poisoning deaths represent a major health concern, particularly in rural areas. Although alprazolam is frequently detected in drug-related deaths, characterization of its involvement is limited. Our objective was to compare the characteristics of alprazolam-related deaths with nonalprazolam deaths in a predominantly rural state. A comprehensive forensic drug database (FDD) was developed in 2005 to compile demographic, toxicology, and co-morbidity information from all West Virginia (WV) drug-related deaths. All FDD data from 2005 to mid-November 2007 were analyzed. Alprazolam contributed to 204 (17.0%) of the 1,199 drug-related deaths and was identified in 7.2% of the 363 deaths occurring during 2005 and in 27.5% of the 422 deaths entered in the database during 2007. At least one other drug, predominantly an opioid, was identified in 97.5% of the alprazolam cases, with concurrent benzodiazepines also found. Compared to nonalprazolam deaths, alprazolam decedents were significantly more likely to be obese and to have preexisting cardiovascular disease, but were less likely to have documented substance abuse. An alprazolam prescription existed in 52.5% of the alprazolam deaths, with 77.6% having a prescription for all drugs identified. Alprazolam was a contributing cause of death in a substantial and increasing number of drug-related deaths. Prescriptions for alprazolam and the other drugs detected were often present in these cases. Controlled substance monitoring programs should be routinely used as one mechanism to help prevent potential drug misuse/abuse. Our findings provide a baseline for ongoing alprazolam-related death surveillance. Copyright © American Academy of Addiction Psychiatry.

Hospital management of outpatient oncology treatment decisions: a survey to identify strategies and concerns.

PubMed

Li, Edward; Schleif, Ron; Edelen, Bruce

2013-09-01

Historically, hospitals did not actively restrict or manage outpatient oncology drug use, because treatment options were few, and reimbursement was generous. Recent growth of novel agents coupled with reimbursement challenges may require a strategy change. The extent of hospital engagement in controlling outpatient oncology drug use is currently unknown. Our objective was to describe the extent of hospital outpatient oncology drug management, management strategies employed, and specific drugs/tumor types of most concern for inappropriate use and cost. A multiple choice-question survey assessed management strategies and the drugs/tumors of greatest concern in US hospitals that dispense outpatient chemotherapy. From June to July 2011, the survey was distributed electronically to members of the Hematology-Oncology Pharmacy Association, representing 281 institutions. The survey was completed by 93 respondents (33% institutional response rate). Most institutions (99%) use at least one form of control to manage outpatient oncology drug therapy; 89% establish preferred therapies, and most use a multidisciplinary management team consisting of oncologists, pharmacists, nurses, and other practitioners. Tumor types of most concern for inappropriate drug use and cost were: prostate, breast, non-small-cell lung, melanoma, and colorectal. Fifty-five percent were concerned about drugs used in supportive care management. Drugs most restricted were: cetuximab, bevacizumab, eribulin, panitumumab, and trastuzumab. There is active control, management, and restriction of outpatient oncology drugs by hospitals. A majority of these institutions use a multidisciplinary team with active involvement by an oncologist. Future evaluations of hospital programs should consider monitoring the evolution of how institutions manage outpatient oncology services.

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2014 CFR

2014-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2012 CFR

2012-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2013 CFR

2013-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2010 CFR

2010-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

Code of Federal Regulations, 2011 CFR

2011-10-01

... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

Harm reduction in the US: a movement for change.

PubMed

Greig, A

The War on Drugs in the United States has polarized the debate on how to deal effectively with drug use and prevention and makes it difficult to form an agenda to address the harm of drug use. Harm-reduction activists and drug-user groups need to establish common ground to develop programs acceptable to all parties. The harm-reduction approach is based on the premise that adverse consequences of a harmful act, drug use in this case, can be mitigated without necessarily reducing consumption. Needle exchange programs are a good example of this approach. There are 100 such programs in the United States, and the programs are seen as an effective means of reducing HIV transmission. However, the programs remain politically sensitive and Federal funding is outlawed. The War on Drugs programs can conflict with HIV prevention programs; programs that might reduce the incidence of HIV infection but do not criminalize or stigmatize drug use are rarely socially acceptable. In the U.S., about half of all new HIV cases can be attributed to drug use. One-third of the increase in prison populations since 1980 is a consequence of the number of drug-law violators in the prison system. The impact of moral conservatism and how the drug laws are affected by class, race, and gender are discussed. Groups involved with combating drug use and preventing HIV transmission will need to form alliances to develop programs mutually beneficial to their audiences.

Systems pharmacology augments drug safety surveillance

PubMed Central

Lorberbaum, Tal; Nasir, Mavra; Keiser, Michael J.; Vilar, Santiago; Hripcsak, George; Tatonetti, Nicholas P.

2014-01-01

Small molecule drugs are the foundation of modern medical practice yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on post-marketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology– the integration of systems biology and chemical genomics – can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

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

PubMed Central

Rathbun, R. Chris; Liedtke, Michelle D.

2011-01-01

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

How, why, and for whom do emergency medicine providers use prescription drug monitoring programs?

PubMed

Smith, Robert J; Kilaru, Austin S; Perrone, Jeanmarie; Paciotti, Breah; Barg, Frances K; Gadsden, Sarah M; Meisel, Zachary F

2015-06-01

The prescription opioid epidemic is currently responsible for the greatest number of unintentional deaths in the United States. One potential strategy for decreasing this epidemic is implementation of state-based Prescription Drug Monitoring Programs (PDMPs), which are designed for providers to identify patients who "doctor shop" for prescriptions. Emergency medicine physicians are some of the most frequent PDMP users and opioid prescribers, but little is known about how they actually use PDMPs, for which patients, and for what reasons. We conducted and transcribed semistructured qualitative interviews with 61 physicians at a national academic conference in October 2012. Deidentified transcripts were entered into QSR NVivo 10.0, coded, and analyzed for themes using modified grounded theory. There is variation in pattern and frequency of PDMP access by emergency physicians. Providers rely on both structural characteristics of the PDMP, such as usability, and also their own clinical gestalt impression when deciding to use PDMPs for a given patient encounter. Providers use the information in PDMPs to alter clinical decisions and guide opioid prescribing patterns. Physicians describe alternative uses for the databases, such as improving their ability to facilitate discussions on addiction and provide patient education. PDMPs are used for multiple purposes, including identifying opioid misuse and enhancing provider-patient communication. Given variation in practice, standards may help direct indication and manner of physician use. Steps to minimize administrative barriers to PDMP access are warranted. Finally, alternative PDMP uses should be further studied to determine their appropriateness and potentially expand their role in clinical practice. Wiley Periodicals, Inc.

The Effect of a Statewide Mandatory Prescription Drug Monitoring Program on Opioid Prescribing by Emergency Medicine Providers Across 15 Hospitals in a Single Health System.

PubMed

Suffoletto, Brian; Lynch, Michael; Pacella, Charissa B; Yealy, Donald M; Callaway, Clifton W

2018-04-01

Prescription drug monitoring programs (PDMPs) enable registered prescribers to obtain real-time information on patients' prescription history of controlled medications. We sought to describe the effect of a state-mandated PDMP on opioid prescribing by emergency medicine providers. We retrospectively analyzed electronic medical records of 122,732 adult patients discharged with an opioid prescription from 15 emergency departments in a single health system in Pennsylvania from July 2015 to March, 2017. We used an interrupted time series design to evaluate the percentage of patients discharged each month with an opioid prescription before and after state law-mandated PDMP use on August 25, 2016. From August (pre-PDMP) to September, 2016 (post-PDMP), the opioid prescribing rate decreased from 12.4% (95% confidence interval [CI], 10.8%-14.1%) to 10.2% (95% CI, 8.8%-11.8%). For each month between September 2016 to March 2017, there was a mean decline of .46% (95% CI, -.38% to -.53%) in the percentage of patients discharged with an opioid prescription. There was heterogeneity in opioid prescribing across hospitals as well as according to patient diagnosis. This study examined the effect of a state-mandated PDMP on opioid prescribing among emergency medicine providers from 15 different hospitals in a single health system. Findings support current PDMP mandates in reducing opioid prescriptions, which could curb the prescription opioid epidemic and may ultimately reduce abuse, misuse, and overdose death. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

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 should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. © Kesselheim et al 2015.

Monitoring of drug intake during pregnancy by questionnaires and LC-MS/MS drug urine screening: evaluation of both monitoring methods.

PubMed

Hoeke, Henrike; Roeder, Stefan; Bertsche, Thilo; Lehmann, Irina; Borte, Michael; von Bergen, Martin; Wissenbach, Dirk K

2015-08-01

Various studies pointed towards a relationship between chronic diseases such as asthma and allergy and environmental risk factors, which are one aspect of the so-called Exposome. These environmental risk factors include also the intake of drugs. One critical step in human development is the prenatal period, in which exposures might have critical impact on the child's health outcome. Thereby, the health effects of drugs taken during gestation are discussed controversially with regard to newborns' disease risk. Due to this, the drug intake of pregnant women in the third trimester was monitored by questionnaire, in addition to biomonitoring using a local birth cohort study, allowing correlations of drug exposure with disease risk. Therefore, 622 urine samples were analyzed by an untargeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) urine screening and the results were compared to self-administered questionnaires. In total, 48% (n = 296) reported an intake of pharmaceuticals, with analgesics as the most frequent reported drug class in addition to dietary supplements. 182 times compounds were detected by urine screening, with analgesics (42%; n = 66) as the predominantly drug class. A comparison of reported and detected drug intake was performed for three different time spans between completion of the questionnaires and urine sampling. Even if the level of accordance was low in general, similar percentages (~25%, ~19%, and ~ 20%) were found for all groups. This study illustrates that a comprehensive evaluation of drug intake is neither achieved by questionnaires nor by biomonitoring alone. Instead, a combination of both monitoring methods, providing complementary information, should be considered. Copyright © 2014 John Wiley & Sons, Ltd.

Point-of-care detection and real-time monitoring of intravenously delivered drugs via tubing with an integrated SERS sensor

NASA Astrophysics Data System (ADS)

Wu, Hsin-Yu; Cunningham, Brian T.

2014-04-01

We demonstrate an approach for detection, identification, and kinetic monitoring of drugs flowing within tubing, through the use of a plasmonic nanodome array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon a flexible plastic substrate that is subsequently integrated with a flow cell that connects in series with ordinary intravenous (IV) drug delivery tubing. To investigate the potential clinical applications for point-of-care detection and real-time monitoring, we perform SERS detection of ten pharmaceutical compounds (hydrocodone, levorphanol, morphine, oxycodone, methadone, phenobarbital, dopamine, diltiazem, promethazine, and mitoxantrone). We demonstrate dose-dependent SERS signal magnitude, resulting in detection limits (ng ml-1) well below typical administered dosages (mg ml-1). Further, we show that the detected drugs are not permanently attached to the PNA surface, and thus our approach is capable of performing continuous monitoring of drug delivery as materials flow through IV tubing that is connected in series with the sensor. Finally, we demonstrate the potential co-detection of multiple drugs when they are mixed together, and show excellent reproducibility and stability of SERS measurements for periods extending at least five days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing the safety of IV drug delivery.We demonstrate an approach for detection, identification, and kinetic monitoring of drugs flowing within tubing, through the use of a plasmonic nanodome array (PNA) surface. The PNA structures are fabricated using a low-cost nanoreplica molding process upon a flexible plastic substrate that is subsequently integrated with a flow cell that connects in series with ordinary intravenous (IV) drug delivery tubing. To investigate the potential clinical applications for point-of-care detection and real-time monitoring, we perform SERS detection of ten pharmaceutical compounds (hydrocodone, levorphanol, morphine, oxycodone, methadone, phenobarbital, dopamine, diltiazem, promethazine, and mitoxantrone). We demonstrate dose-dependent SERS signal magnitude, resulting in detection limits (ng ml-1) well below typical administered dosages (mg ml-1). Further, we show that the detected drugs are not permanently attached to the PNA surface, and thus our approach is capable of performing continuous monitoring of drug delivery as materials flow through IV tubing that is connected in series with the sensor. Finally, we demonstrate the potential co-detection of multiple drugs when they are mixed together, and show excellent reproducibility and stability of SERS measurements for periods extending at least five days. The capabilities reported here demonstrate the potential to use PNA SERS surfaces for enhancing the safety of IV drug delivery. Electronic supplementary information (ESI) available: Fabrication of PNA substrates, fabrication details of the flow cell, details of FDTD simulation, characterization of the scattering volume, and detection of diltiazem diluted in DI water and PBS. See DOI: 10.1039/c4nr00027g

Pharmacokinetics-on-a-Chip Using Label-Free SERS Technique for Programmable Dual-Drug Analysis.

PubMed

Fei, Jiayuan; Wu, Lei; Zhang, Yizhi; Zong, Shenfei; Wang, Zhuyuan; Cui, Yiping

2017-06-23

Synergistic effects of dual or multiple drugs have attracted great attention in medical fields, especially in cancer therapies. We provide a programmable microfluidic platform for pharmacokinetic detection of multiple drugs in multiple cells. The well-designed microfluidic platform includes two 2 × 3 microarrays of cell chambers, two gradient generators, and several pneumatic valves. Through the combined use of valves and gradient generators, each chamber can be controlled to infuse different kinds of living cells and drugs with specific concentrations as needed. In our experiments, 6-mercaptopurine (6MP) and methimazole (MMI) were chosen as two drug models and their pharmacokinetic parameters in different living cells were monitored through intracellular SERS spectra, which reflected the molecular structure of these drugs. The dynamic change of SERS fingerprints from 6MP and MMI molecules were recorded during drug metabolism in living cells. The results indicated that both 6MP and MMI molecules were diffused into the cells within 4 min and excreted out after 36 h. Moreover, the intracellular distribution of these drugs was monitored through SERS mapping. Thus, our microfluidic platform simultaneously accomplishes the functions to monitor pharmacokinetic action, distribution, and fingerprint of multiple drugs in multiple cells. Owing to its real-time, rapid-speed, high-precision, and programmable capability of multiple-drug and multicell analysis, such a microfluidic platform has great potential in drug design and development.

14 CFR 120.115 - Employee Assistance Program (EAP).

Code of Federal Regulations, 2014 CFR

2014-01-01

... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... the employee and supervisor EAP training in the employer's drug testing program. [Doc. No. FAA-2008...

A cross sectional pilot study on assessing the knowledge, attitude and behavior of community pharmacists to adverse drug reaction related aspects in the Sultanate of Oman.

PubMed

Jose, Jimmy; Jimmy, Beena; Al-Ghailani, Aliya Said Hamed; Al Majali, Maryam Abdullah

2014-04-01

Adverse drug reaction (ADR) monitoring and reporting requires a multidisciplinary approach and pharmacists have a major role to play in it. The present pilot study was conducted to assess the knowledge, attitude and behavior of community pharmacists to ADR related aspects in the Sultanate of Oman. A self-administered questionnaire comprising of 21 questions were distributed to a random sample of pharmacists in two Governorates in the Sultanate of Oman. It assessed the knowledge of pharmacists on some of the selected basic aspects of drug safety. Further, the knowledge and attitude of community pharmacists toward ADR reporting and their behavior on ADR related aspects were assessed. A scoring scheme was used to estimate the median total score of participants for various parameters. Obtained scores were correlated with the demographics of the respondents. A total of 107 community pharmacists participated in the survey giving a response rate of 72.3%. The responses of the pharmacists to the questions on the drug safety of individual drugs were incorrect for some important and practical questions. Consequently, total median score corresponding to these questions was 5 (Inter Quartile Range, IQR 2) out of a possible maximum score of 9, which was below the acceptable score. Total median score based on knowledge, attitude and behavior was 38 (IQR 8) out of a possible maximum of 50 which shows a moderate score. Lack of awareness on how to report an ADR and concern that the report may be wrong were the most common factors discouraging pharmacists from reporting ADRs. Qualification as well as years of experience were the only demographic parameters which had an influence on the score obtained by the pharmacists. Even though the pharmacists had an acceptable knowledge, attitude and behavior on ADR reporting and related aspects, a good number of them had below than acceptable knowledge on drug safety related aspects of specific drugs. Educational programs have to be continued to generate awareness on how to report ADR and stimulate pharmacists' more active participation in the pharmacovigilance program. There is a genuine need to have training programs to improve the knowledge of pharmacists on ADR related aspects which are of benefit on a daily basis which could greatly have an impact on patient safety.

A cross sectional pilot study on assessing the knowledge, attitude and behavior of community pharmacists to adverse drug reaction related aspects in the Sultanate of Oman

PubMed Central

Jose, Jimmy; Jimmy, Beena; Al-Ghailani, Aliya Said Hamed; Al Majali, Maryam Abdullah

2013-01-01

Background and objectives Adverse drug reaction (ADR) monitoring and reporting requires a multidisciplinary approach and pharmacists have a major role to play in it. The present pilot study was conducted to assess the knowledge, attitude and behavior of community pharmacists to ADR related aspects in the Sultanate of Oman. Methods A self-administered questionnaire comprising of 21 questions were distributed to a random sample of pharmacists in two Governorates in the Sultanate of Oman. It assessed the knowledge of pharmacists on some of the selected basic aspects of drug safety. Further, the knowledge and attitude of community pharmacists toward ADR reporting and their behavior on ADR related aspects were assessed. A scoring scheme was used to estimate the median total score of participants for various parameters. Obtained scores were correlated with the demographics of the respondents. Results A total of 107 community pharmacists participated in the survey giving a response rate of 72.3%. The responses of the pharmacists to the questions on the drug safety of individual drugs were incorrect for some important and practical questions. Consequently, total median score corresponding to these questions was 5 (Inter Quartile Range, IQR 2) out of a possible maximum score of 9, which was below the acceptable score. Total median score based on knowledge, attitude and behavior was 38 (IQR 8) out of a possible maximum of 50 which shows a moderate score. Lack of awareness on how to report an ADR and concern that the report may be wrong were the most common factors discouraging pharmacists from reporting ADRs. Qualification as well as years of experience were the only demographic parameters which had an influence on the score obtained by the pharmacists. Conclusions Even though the pharmacists had an acceptable knowledge, attitude and behavior on ADR reporting and related aspects, a good number of them had below than acceptable knowledge on drug safety related aspects of specific drugs. Educational programs have to be continued to generate awareness on how to report ADR and stimulate pharmacists’ more active participation in the pharmacovigilance program. There is a genuine need to have training programs to improve the knowledge of pharmacists on ADR related aspects which are of benefit on a daily basis which could greatly have an impact on patient safety. PMID:24648829

Estimating Community Drug Abuse by Wastewater Analysis

PubMed Central

Zuccato, Ettore; Chiabrando, Chiara; Castiglioni, Sara; Bagnati, Renzo; Fanelli, Roberto

2008-01-01

Background The social and medical problems of drug abuse are a matter of increasing global concern. To tackle drug abuse in changing scenarios, international drug agencies need fresh methods to monitor trends and patterns of illicit drug consumption. Objective We tested a sewage epidemiology approach, using levels of excreted drug residues in wastewater, to monitor collective use of the major drugs of abuse in near real time. Methods Selected drug target residues derived from use of cocaine, opiates, cannabis, and amphetamines were measured by mass spectrometry in wastewater collected at major sewage treatment plants in Milan (Italy), Lugano (Switzerland), and London (United Kingdom). The amounts of drug residues conveyed to the treatment plants, reflecting the amounts collectively excreted with urine, were used to estimate consumption of the active parent drugs. Results Reproducible and characteristic profiles of illicit drug use were obtained in the three cities, thus for the first time quickly revealing changes in local consumption (e.g., cocaine consumption rose significantly on weekends in Milan). Profiles of local drug consumption based on waste-water measurements are in line with national annual prevalence estimates. Conclusions Patterns and trends of drug abuse in local communities can be promptly monitored by this tool, a convenient new complement to more complex, lengthy survey methods. In principle, searching the sewage for excreted compounds relevant to public health issues appears to have the potential to become a convenient source of real-time epidemiologic information. PMID:18709161

Monitoring the Future: National Survey Results on Drug Use, 1975-2009. Volume I: Secondary School Students. NIH Publication No. 10-7584

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2010-01-01

The Monitoring the Future (MTF) study is an ongoing series of national surveys of American adolescents and adults that has provided the nation with a vital window into the important, but largely hidden, problem behaviors of illegal drug use, alcohol use, tobacco use, anabolic steroid use, and psychotherapeutic drug use. For more than a third of…

Continuing the Epidemiological Function of the Addicts Index--Evidence from Matching the Home Office Addicts Index with the National Drug Treatment Monitoring System

ERIC Educational Resources Information Center

Hickman, Matthew; Griffin, Maria; Mott, Joy; Corkery, John; Madden, Peter; Sondhi, Arun; Stimson, Gerry

2004-01-01

Aims: We discuss the Addicts Index (AI) and examine whether the epidemiological trends of the AI can be continued by the regional drug misuse databases (DMDs, now known as National Drug Treatment Monitoring System (NDTMS). Methods: (i) Matching individuals recorded as addicted to opiates and/or cocaine in the AI with those reported to the North…

Monitoring the Future. National Survey Results on Drug Use, 1975-2009. Volume I, Secondary School Students. NIH Publication Number 10-7584

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2010-01-01

The Monitoring the Future (MTF) study is an ongoing series of national surveys of American adolescents and adults that has provided the nation with a vital window into the important, but largely hidden, problem behaviors of illegal drug use, alcohol use, tobacco use, anabolic steroid use, and psychotherapeutic drug use. For more than a third of a…

Development of GUI Type On-Line Condition Monitoring Program for a Turboprop Engine Using Labview

NASA Astrophysics Data System (ADS)

Kong, Changduk; Kim, Keonwoo

2011-12-01

Recently, an aero gas turbine health monitoring system has been developed for precaution and maintenance action against faults or performance degradations of the advanced propulsion system which occurs in severe environments such as high altitude, foreign object damage particles, hot and heavy rain and snowy atmospheric conditions. However to establish this health monitoring system, the online condition monitoring program is firstly required, and the program must monitor the engine performance trend through comparison between measured engine performance data and base performance results calculated by base engine performance model. This work aims to develop a GUI type on-line condition monitoring program for the PT6A-67 turboprop engine of a high altitude and long endurance operation UAV using LabVIEW. The base engine performance of the on-line condition monitoring program is simulated using component maps inversely generated from the limited performance deck data provided by engine manufacturer. The base engine performance simulation program is evaluated because analysis results by this program agree well with the performance deck data. The proposed on-line condition program can monitor the real engine performance as well as the trend through precise comparison between clean engine performance results calculated by the base performance simulation program and measured engine performance signals. In the development phase of this monitoring system, a signal generation module is proposed to evaluate the proposed online monitoring system. For user friendly purpose, all monitoring program are coded by LabVIEW, and monitoring examples are demonstrated using the proposed GUI type on-condition monitoring program.

Attitudes of Florida pharmacists toward implementing a state prescription drug monitoring program for controlled substances.

PubMed

Fass, Jennifer A; Hardigan, Patrick C

2011-01-01

As of May 23, 2011, 35 states had an operational prescription drug monitoring program (PDMP), and 13 additional states, including Florida in 2009, had passed legislation to implement a PDMP. PDMPs, electronic databases that collect and track designated data on controlled substances and other commonly abused medications, are intended to serve as a tool for health care practitioners when prescribing and dispensing controlled substances to reduce drug abuse and diversion. In an analysis of 1,268 drug-caused deaths from January through June 2010 in Florida, the top 3 prescription drugs included the controlled substances oxycodone (56%), alprazolam (35%), and methadone (26%), all of which would be subject to reporting in Florida's PDMP when implemented. Because pharmacists are the health care professionals most affected by PDMP reporting requirements, evaluating their attitudes about PDMP implementation is important. To assess Florida pharmacists' attitudes toward implementing a PDMP in the state. This was a cross-sectional study conducted in Florida between February 2010 and June 2010 prior to the implementation of the proposed PDMP. A random sample of 5,000 of approximately 26,000 pharmacists licensed in Florida was invited to participate in a voluntary and anonymous 10-question self-administered mail survey of which 4 survey items assessed pharmacists' attitudes towards implementing a PDMP in the state. Of the 5,000 pharmacists contacted by mail, 911 (18.2%) completed the survey, of whom 836 responded to the items assessing opinions about PDMPs and provided practice site information. A majority of pharmacists across all practice settings agreed or strongly agreed with the statements that a PDMP "should be implemented in Florida" (chain 84.0%, hospital 74.2%, independent 77.9%, and other 71.1%) and that a PDMP would decrease "the incidence of doctor shopping" if implemented (chain 80.8%, hospital 67.2%, independent 71.7%, and other 63.3%). A majority of pharmacists across all practice settings disagreed or strongly disagreed with the statements that they would be "discouraged to dispense controlled substances" by the PDMP (chain 61.4%, hospital 50.0%, independent 60.2%, and other 63.8%) and that PDMP implementation would be "an invasion of patients' privacy" (chain 80.3%, hospital 67.7%, independent 67.3%, and other 69.3%). In a small-sample survey, a majority of Florida pharmacists across all practice settings were in favor of implementing a PDMP in Florida. This is the first study to examine Florida pharmacists' attitudes toward PDMP implementation, and the results should prompt future analyses of relevant outcomes, such as drug abuse, drug-related mortality, and doctor shopping.

An Introduction to the National DARE Parent Program. Program Brief.

ERIC Educational Resources Information Center

Illinois State Police, Springfield.

Drug Abuse Resistance Education (DARE) is a preventive drug education program intended to stop drug use before it begins. Its purpose is to help children say "no" to drug, alcohol, and tobacco use by teaching them techniques to resist peer pressure. The newest addition to the concept is the DARE Parent Program (DPP), created to stimulate…

Evidence-based decision on medical technologies in Asia Pacific: experiences from India, Malaysia, Philippines, and Pakistan.

PubMed

Thatte, Urmila; Hussain, Samsinah; de Rosas-Valera, Madeleine; Malik, Muhammad Ashar

2009-01-01

This paper discusses national programs implemented in India, Pakistan, Malaysia, and Philippines to generate and apply evidence in making informed policy decisions on the approval, pricing, reimbursement and financing of medicines, diagnostics, and medical devices. In all countries, the Ministries of Health are generally responsible for approval of health technologies through various agencies like the Central Drugs Standard Control Organisation in India, Bureau of Food and Drugs for medicines and Bureau of Health Devices and Technology for medical devices in the Philippines, the National Pharmaceutical Control Bureau, Health Technology Assessment Unit and Medical Device Bureau in Malaysia, and the Drug Control Organization in Pakistan. Product dossiers are evaluated while taking decisions. India has a strong price control mechanism through the National Pharmaceutical Pricing Authority. In the Philippines, the Essential Drug Price Monitoring System monitors prices of 37 essential drugs monthly from all drugstore outlets nationwide. In Malaysia and Pakistan registration pricing of new drugs is negotiated/fixed by the government with the vendor. A mix of social, voluntary private and community-based health insurance plans are available in India while the Philippine Health Insurance Corporation is responsible for reimbursement of drugs and medical devices in the Philippines. In Malaysia no formal reimbursement system is being practiced, and in Pakistan the government reimburses medical claims of its employees. In both India and the Philippines the bulk of health expenditure is out of pocket while the government pays for 20% and 28% respectively in both countries. The public health care services in Malaysia are heavily subsidized by the government with minimum fee being charged to the public. The government of Pakistan gives free medicines to its citizens at the public health facilities. In the region under discussion, one of the priority areas that the different regulatory agencies would benefit from is human resource development to facilitate the process of evidence based assessment of health technologies. Higher budgetary allocation and stronger legislation is also needed along with interagency and international coordination and cooperation to harmonize.

HIV infection and HIV-associated behaviors among persons who inject drugs--20 cities, United States, 2012.

PubMed

Spiller, Michael W; Broz, Dita; Wejnert, Cyprian; Nerlander, Lina; Paz-Bailey, Gabriela

2015-03-20

In the United States, an estimated 7% of new diagnoses of human immunodeficiency virus (HIV) infection in 2012 were attributed to injection drug use, and an additional 3% to male-to-male sexual contact and injection drug use. To monitor HIV prevalence and behaviors associated with HIV risk and prevention among persons who inject drugs (PWID), CDC's National HIV Behavioral Surveillance (NHBS) system conducts interviews and HIV testing in selected cities. This report summarizes HIV prevalence and behaviors among PWID interviewed and tested in 20 cities in 2012. Of the 10,002 PWID tested, 11% had a positive HIV test result. Among 9,425 PWID included in the behavioral analysis, 30% receptively shared syringes, 70% had vaginal sex without a condom, 25% had heterosexual anal sex without a condom, and 5% of males had male-to-male sexual contact without a condom in the previous 12 months. Fifty-one percent of PWID included in the behavioral analysis had been tested for HIV, 25% participated in an HIV behavioral intervention, and 39% participated in substance abuse treatment in the previous 12 months. Additional efforts are needed to reduce risk behaviors and increase access to HIV testing, drug treatment, and other HIV prevention programs to further reduce HIV infections among PWID.

Applying fiber optical methods for toxicological testing in vitro

NASA Astrophysics Data System (ADS)

Maerz, Holger K.; Buchholz, Rainer; Emmrich, Frank; Fink, Frank; Geddes, Clive L.; Pfeifer, Lutz; Raabe, Ferdinand; Scheper, Thomas-Helmut; Ulrich, Elizabeth; Marx, Uwe

1999-04-01

The new medical developments, e.g. immune therapy, patient oriented chemotherapy or even gene therapy, create a questionable doubt to the further requirement of animal test. Instead the call for humanitarian reproductive in vitro models becomes increasingly louder. Pharmaceutical usage of in vitro has a long proven history. In cancer research and therapy, the effect of chemostatica in vitro in the so-called oncobiogram is being tested; but the assays do not always correlate with in vivo-like drug resistance and sensitivity. We developed a drug test system in vitro, feasible for therapeutic drug monitoring by the combination of tissue cultivation in hollow fiber bioreactors and fiber optic sensors for monitoring the pharmaceutical effect. Using two fiber optic sensors - an optical oxygen sensor and a metabolism detecting Laserfluoroscope, we were able to successfully monitor the biological status of tissue culture and the drug or toxic effects of in vitro pharmaceutical testing. Furthermore, we developed and patented a system for monitoring the effect of minor toxic compounds which can induce Sick Building Syndrome.

Clozapine-associated neutropenia and agranulocytosis in Argentina (2007-2012).

PubMed

Balda, María V; Garay, Osvaldo U; Papale, Rosa M; Bignone, Inés; Bologna, Viviana G; Brandolini, Andrés; Prokopez, Cintia R; Balasini, Juan I; Baldessarini, Ross J; Daray, Federico M

2015-03-01

The risks of severe leukopenia and agranulocytosis have varied over time and among geographical regions and cultures, with little information available on South American populations. Accordingly, we reviewed and analyzed data from a 6-year experience monitored by an Argentine national registry to which reporting of adverse events reports is required. We analyzed data for 2007-2012 from the pharmacovigilance program of the Argentine drug-regulatory agency (ANMAT) using standard bivariate and multivariate statistical methods and survival analysis. We identified 378 cases of adverse hematological events over 6 years among an average of 12 305 individuals/year treated with clozapine (308±133 mg/day) to estimate the mean annualized rates of leukopenia [0.19 (95% confidence interval [CI] 0.11-0.27)], neutropenia [0.38 (95% CI 0.34-0.43)], and agranulocytosis [0.05 (95% CI 0.02-0.08)] % per year [median latency 2 (95% CI 1.3-2.1) months]; fatalities related to agranulocytosis averaged 4.2 (95% CI 0.0-9.2) per 100 000 treated individuals/year. Factors associated significantly and independently with agranulocytosis were female sex, older age, and use of other drugs in addition to clozapine. With monitoring by international standards, recent risks of clozapine-associated agranulocytosis in Argentina were lower, but fatality rates were higher than that in other regions of the world. Risk factors include the use of multiple psychotropic drugs, female sex, and older age.

The New Drug Conditional Approval Process in China: Challenges and Opportunities.

PubMed

Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

2017-05-01

Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

HIV-1 Drug Resistance Mutations Among Antiretroviral-Naïve HIV-1–Infected Patients in Asia: Results From the TREAT Asia Studies to Evaluate Resistance-Monitoring Study

PubMed Central

Oyomopito, Rebecca; Sirivichayakul, Sunee; Sirisanthana, Thira; Kantipong, Pacharee; Lee, Christopher K. C.; Kamarulzaman, Adeeba; Messerschmidt, Liesl; Law, Matthew G.; Phanuphak, Praphan

2011-01-01

(See editorial commentary by Jordan on pages 1058–1060.) Of 682 antiretroviral-naïve patients initiating antiretroviral therapy in a prospective, multicenter human immunodeficiency virus type 1 (HIV-1) drug resistance monitoring study involving 8 sites in Hong Kong, Malaysia, and Thailand, the prevalence of patients with ≥1 drug resistance mutation was 13.8%. Primary HIV drug resistance is emerging after rapid scaling-up of antiretroviral therapy use in Asia. PMID:21460324

Sericin/Dextran Injectable Hydrogel as an Optically Trackable Drug Delivery System for Malignant Melanoma Treatment.

PubMed

Liu, Jia; Qi, Chao; Tao, Kaixiong; Zhang, Jinxiang; Zhang, Jian; Xu, Luming; Jiang, Xulin; Zhang, Yunti; Huang, Lei; Li, Qilin; Xie, Hongjian; Gao, Jinbo; Shuai, Xiaoming; Wang, Guobin; Wang, Zheng; Wang, Lin

2016-03-01

Severe side effects of cancer chemotherapy prompt developing better drug delivery systems. Injectable hydrogels are an effective site-target system. For most of injectable hydrogels, once delivered in vivo, some properties including drug release and degradation, which are critical to chemotherapeutic effects and safety, are challenging to monitor. Developing a drug delivery system for effective cancer therapy with in vivo real-time noninvasive trackability is highly desired. Although fluorescence dyes are used for imaging hydrogels, the cytotoxicity limits their applications. By using sericin, a natural photoluminescent protein from silk, we successfully synthesized a hydrazone cross-linked sericin/dextran injectable hydrogel. This hydrogel is biodegradable and biocompatible. It achieves efficient drug loading and controlled release of both macromolecular and small molecular drugs. Notably, sericin's photoluminescence from this hydrogel is directly and stably correlated with its degradation, enabling long-term in vivo imaging and real-time monitoring of the remaining drug. The hydrogel loaded with Doxorubicin significantly suppresses tumor growth. Together, the work demonstrates the efficacy of this drug delivery system, and the in vivo effectiveness of this sericin-based optical monitoring strategy, providing a potential approach for improving hydrogel design toward optimal efficiency and safety of chemotherapies, which may be widely applicable to other drug delivery systems.

Drug-food interaction counseling programs in teaching hospitals.

PubMed

Wix, A R; Doering, P L; Hatton, R C

1992-04-01

The results of a survey to characterize drug-food interaction counseling programs in teaching hospitals and solicit opinions on these programs from pharmacists and dietitians are reported. A questionnaire was mailed to the pharmacy director and the director of dietary services at teaching hospitals nationwide. The questionnaire contained 33 questions relating to hospital characteristics, drug-food interaction counseling programs, and the standard calling for such programs issued by the Joint Commission on Accreditation of Healthcare Organizations. Of 792 questionnaires mailed, 425 were returned (response rate, 53.7). A majority of the pharmacists and dietitians (51.2%) did not consider their drug-food interaction counseling program to be formal; some had no program. The pharmacy department was involved more in program development than in the daily operation of such programs. The most frequent methods of identifying patients for counseling were using lists of patients' drugs and using physicians' orders. A mean of only five drugs were targeted per program. Slightly over half the respondents rated the Joint Commission standard less effective than other standards in its ability to improve patient care. A majority of teaching hospitals did not have formal drug-food interaction counseling programs. Pharmacists and dietitians did not view these programs as greatly beneficial and did not believe that the Joint Commission has clearly delineated the requirements for meeting its standard.

Exploring innovative ways to conduct coverage surveys for neglected tropical diseases in Malawi, Mali, and Uganda.

PubMed

Woodhall, Dana M; Mkwanda, Square; Dembele, Massitan; Lwanga, Harriet; Drexler, Naomi; Dubray, Christine; Harris, Jennifer; Worrell, Caitlin; Mathieu, Els

2014-04-01

Currently, a 30-cluster survey to monitor drug coverage after mass drug administration for neglected tropical diseases is the most common methodology used by control programs. We investigated alternative survey methodologies that could potentially provide an estimation of drug coverage. Three alternative survey methods (market, village chief, and religious leader) were conducted and compared to the 30-cluster method in Malawi, Mali, and Uganda. In Malawi, drug coverage for the 30-cluster, market, village chief, and religious leader methods were 66.8% (95% CI 60.3-73.4), 74.3%, 76.3%, and 77.8%, respectively. In Mali, results for round 1 were 62.6% (95% CI 54.4-70.7), 56.1%, 74.8%, and 83.2%, and 57.2% (95% CI 49.0-65.4), 54.5%, 72.2%, and 73.3%, respectively, for round 2. Uganda survey results were 65.7% (59.4-72.0), 43.7%, 67.2%, and 77.6% respectively. Further research is needed to test different coverage survey methodologies to determine which survey methods are the most scientifically rigorous and resource efficient. Published by Elsevier B.V.

Evaluation of the impact of the drug evaluation and classification program on enforcement and adjudication

DOT National Transportation Integrated Search

1992-12-01

This study examined the effect of the Drug Evaluation and Classification (DEC) Program on impaired driving (DWI) enforcement and adjudication. Drug Recognition Experts (DREs) in DEC programs evaluate suspects when drugs other than alcohol are suspect...

14 CFR 120.115 - Employee Assistance Program (EAP).

Code of Federal Regulations, 2012 CFR

2012-01-01

... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

14 CFR 120.115 - Employee Assistance Program (EAP).

Code of Federal Regulations, 2011 CFR

2011-01-01

... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

14 CFR 120.115 - Employee Assistance Program (EAP).

Code of Federal Regulations, 2013 CFR

2013-01-01

... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

14 CFR 120.115 - Employee Assistance Program (EAP).

Code of Federal Regulations, 2010 CFR

2010-01-01

... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

Prescription histories and dose strengths associated with overdose deaths.

PubMed

Hirsch, Anne; Proescholdbell, Scott K; Bronson, William; Dasgupta, Nabarun

2014-07-01

Misuse, abuse, and diversion of prescription drugs are large and growing public health problems that have resulted in an overdose epidemic. We investigated whether short-acting or extended-release opioids were more frequently prescribed to those who died of an overdose and whether there was a linear relationship between dose strength and associated overdose deaths. The study population was North Carolina residents in 2010. We conducted a retrospective, population-based, descriptive study of medication histories of overdose decedents using data from vital statistics, medical examiner records, and a prescription drug monitoring program. Unintentional or undetermined drug overdoses were responsible for 892 deaths. Out of 191 deaths involving methadone, only two were patients in opioid treatment programs. Immediate-release oxycodone was involved in the greatest number of opioid-related deaths. Out of 221 oxycodone deaths, 134 (61%) of the decedents filled a prescription for oxycodone in the 60 days prior to death. The most common strength dispensed within 60 days to a decedent who died of an oxycodone overdose was 10 mg for immediate-release (72 prescriptions). Immediate-release oxycodone products (rho = 1.00, P < 0.01) and extended-release fentanyl products (rho = 1.00, P < 0.01) showed strong increasing linear trends between dose strength and proportion of prescriptions dispensed to decedents. A significant proportion of overdose decedents had been prescribed the same type of drugs that contributed to their death, especially for decedents who died from overdoses involving oxycodone, hydrocodone, and alprazolam. Higher dose strengths for certain opioids had higher associated mortality, and certain immediate-release opioids may be considered for public health prevention efforts.

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

ERIC Educational Resources Information Center

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

1987-01-01

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

Application of programmable bio-nano-chip system for the quantitative detection of drugs of abuse in oral fluids.

PubMed

Christodoulides, Nicolaos; De La Garza, Richard; Simmons, Glennon W; McRae, Michael P; Wong, Jorge; Newton, Thomas F; Smith, Regina; Mahoney, James J; Hohenstein, Justin; Gomez, Sobeyda; Floriano, Pierre N; Talavera, Humberto; Sloan, Daniel J; Moody, David E; Andrenyak, David M; Kosten, Thomas R; Haque, Ahmed; McDevitt, John T

2015-08-01

There is currently a gap in on-site drug of abuse monitoring. Current detection methods involve invasive sampling of blood and urine specimens, or collection of oral fluid, followed by qualitative screening tests using immunochromatographic cartridges. While remote laboratories then may provide confirmation and quantitative assessment of a presumptive positive, this instrumentation is expensive and decoupled from the initial sampling making the current drug-screening program inefficient and costly. The authors applied a noninvasive oral fluid sampling approach integrated with the in-development chip-based Programmable bio-nano-chip (p-BNC) platform for the detection of drugs of abuse. The p-BNC assay methodology was applied for the detection of tetrahydrocannabinol, morphine, amphetamine, methamphetamine, cocaine, methadone and benzodiazepines, initially using spiked buffered samples and, ultimately, using oral fluid specimen collected from consented volunteers. Rapid (∼10min), sensitive detection (∼ng/mL) and quantitation of 12 drugs of abuse was demonstrated on the p-BNC platform. Furthermore, the system provided visibility to time-course of select drug and metabolite profiles in oral fluids; for the drug cocaine, three regions of slope were observed that, when combined with concentration measurements from this and prior impairment studies, information about cocaine-induced impairment may be revealed. This chip-based p-BNC detection modality has significant potential to be used in the future by law enforcement officers for roadside drug testing and to serve a variety of other settings, including outpatient and inpatient drug rehabilitation centers, emergency rooms, prisons, schools, and in the workplace. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

PubMed

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

Application of Programmable Bio-Nano-Chip System for the Quantitative Detection of Drugs of Abuse in Oral Fluids*

PubMed Central

Christodoulides, Nicolaos; De La Garza, Richard; Simmons, Glennon W.; McRae, Michael P.; Wong, Jorge; Newton, Thomas F.; Smith, Regina; Mahoney, James J.; Hohenstein, Justin; Gomez, Sobeyda; Floriano, Pierre N.; Talavera, Humberto; Sloan, Daniel J.; Moody, David E.; Andrenyak, David M.; Kosten, Thomas R.; Haque, Ahmed; McDevitt, John T.

2015-01-01

Objective There is currently a gap in on-site drug of abuse monitoring. Current detection methods involve invasive sampling of blood and urine specimens, or collection of oral fluid, followed by qualitative screening tests using immunochromatographic cartridges. While remote laboratories then may provide confirmation and quantitative assessment of a presumptive positive, this instrumentation is expensive and decoupled from the initial sampling making the current drug-screening program inefficient and costly. The authors applied a noninvasive oral fluid sampling approach integrated with the in-development chip-based Programmable Bio-Nano-Chip (p-BNC) platform for the detection of drugs of abuse. Method The p-BNC assay methodology was applied for the detection of tetrahydrocannabinol, morphine, amphetamine, methamphetamine, cocaine, methadone and benzodiazepines, initially using spiked buffered samples and, ultimately, using oral fluid specimen collected from consented volunteers. Results Rapid (~10 minutes), sensitive detection (~ng/ml) and quantitation of 12 drugs of abuse was demonstrated on the p-BNC platform. Furthermore, the system provided visibility to time-course of select drug and metabolite profiles in oral fluids; for the drug cocaine, three regions of slope were observed that, when combined with concentration measurements from this and prior impairment studies, information about cocaine-induced impairment may be revealed. Conclusions This chip-based p-BNC detection modality has significant potential to be used in the future by law enforcement officers for roadside drug testing and to serve a variety of other settings, including outpatient and inpatient drug rehabilitation centers, emergency rooms, prisons, schools, and in the workplace. PMID:26048639

Gender-Specific Intervention to Reduce Underage Drinking Among Early Adolescent Girls: A Test of a Computer-Mediated, Mother-Daughter Program*

PubMed Central

Schinke, Steven P.; Cole, Kristin C. A.; Fang, Lin

2009-01-01

Objective: This study evaluated a gender-specific, computer-mediated intervention program to prevent underage drinking among early adolescent girls. Method: Study participants were adolescent girls and their mothers from New York, New Jersey, and Connecticut. Participants completed pretests online and were randomly divided between intervention and control arms. Intervention-arm girls and their mothers interacted with a computer program aimed to enhance mother-daughter relationships and to teach girls skills for managing conflict, resisting media influences, refusing alcohol and drugs, and correcting peer norms about underage drinking, smoking, and drug use. After intervention, all participants (control and intervention) completed posttest and follow-up measurements. Results: Two months following program delivery and relative to control-arm participants, intervention-arm girls and mothers had improved their mother-daughter communication skills and their perceptions and applications of parental monitoring and rule-setting relative to girls' alcohol use. Also at follow-up, intervention-arm girls had improved their conflict management and alcohol use-refusal skills; reported healthier normative beliefs about underage drinking; demonstrated greater self-efficacy about their ability to avoid underage drinking; reported less alcohol consumption in the past 7 days, 30 days, and year; and expressed lower intentions to drink as adults. Conclusions: Study findings modestly support the viability of a mother-daughter, computer-mediated program to prevent underage drinking among adolescent girls. The data have implications for the further development of gender-specific approaches to combat increases in alcohol and other substance use among American girls. PMID:19118394

Perceived Drug Use Functions and Risk Reduction Practices Among High-Risk Nonmedical Users of Prescription Drugs

PubMed Central

Silva, Karol; Kecojevic, Aleksandar; Lankenau, Stephen E.

2014-01-01

Nonmedical use of prescription drugs has become the fastest growing drug problem in the United States, particularly among young adults. This study examines the reasons young polydrug users misuse prescription drugs, and explores how young users employ risk reduction strategies to minimize adverse consequences. The sample was recruited during 2008 and 2009 in Los Angeles and New York, and comprised 45 nonmedical users of prescription drugs, aged 16 to 25. Data from a semistructured interview were analyzed quantitatively and qualitatively. Participants reported nonmedical use of prescription drugs to change mood, to facilitate activity, and to monitor the intake of other substances. Commonly employed risk reduction strategies included calculating pill timing, dosage, and access, and monitoring frequency of use, particularly when combining different substances. Most study participants often planned drug use to occur within socially acceptable parameters, such that prescription drug misuse was a normalized feature of their everyday lives. PMID:25477621

The Social Construction of "Evidence-Based" Drug Prevention Programs: A Reanalysis of Data from the Drug Abuse Resistance Education (DARE) Program

ERIC Educational Resources Information Center

Gorman, Dennis M.; Huber, J. Charles, Jr.

2009-01-01

This study explores the possibility that any drug prevention program might be considered "evidence-based" given the use of data analysis procedures that optimize the chance of producing statistically significant results by reanalyzing data from a Drug Abuse Resistance Education (DARE) program evaluation. The analysis produced a number of…

10 CFR 607.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2010 CFR

2010-01-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 10 Energy 4 2010-01-01 2010-01-01 false What must I include in my drug-free awareness program? 607...

34 CFR 84.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2011 CFR

2011-07-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2011-07-01 2011-07-01 false What must I include in my drug-free awareness program...

34 CFR 84.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2010 CFR

2010-07-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2010-07-01 2010-07-01 false What must I include in my drug-free awareness program...

34 CFR 84.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2014 CFR

2014-07-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2014-07-01 2014-07-01 false What must I include in my drug-free awareness program...

34 CFR 84.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2013 CFR

2013-07-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2013-07-01 2013-07-01 false What must I include in my drug-free awareness program...

34 CFR 84.215 - What must I include in my drug-free awareness program?

Code of Federal Regulations, 2012 CFR

2012-07-01

... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2012-07-01 2012-07-01 false What must I include in my drug-free awareness program...

Monitoring the impact of a mebendazole mass drug administration initiative for soil-transmitted helminthiasis (STH) control in the Western Visayas Region of the Philippines from 2007 through 2011.

PubMed

Sanza, Megan; Totanes, Francis Isidore; Chua, Paul Lester; Belizario, Vicente Y

2013-08-01

School-aged children in tropical developing countries carry the highest burden of soil-transmitted helminth (STH) infections in the world. The Western Visayas region of the Philippines continues to struggle with this as a major public health issue in both private and public schools. The War on Worms-Western Visayas approach was launched in 2007 with school-based mass drug administration (MDA) as one of the strategies to control morbidity from STH in support of the Department of Health - Integrated Helminth Control Program. This study aimed to determine trends in prevalence and intensity of STH infections as well as to assess related morbidity and program sustainability through 2011. A cross-sectional parasitologic survey was conducted on three independent samples of Grade 3 students in 2007, 2009, and 2011. Supporting aggregate data were obtained for MDA coverage, National Achievement Test mean percentage scores, and nutritional status. Tests for trend were utilized to detect changes in prevalence over time, with a particular emphasis on trends seen between 2009 and 2011. The initial impact of the program was robust as cumulative prevalence, infection intensities, and parasite densities were all reduced four years following the launch. However, subsequent and significant increases in each were found from 2009 until 2011. These results implicate issues with program sustainability, despite consistent MDA, and existing frameworks for environmental sanitation, hygiene, and education. Copyright © 2013 Elsevier B.V. All rights reserved.

76 FR 3913 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse... individual investigators. Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns... Psychologist, Clinical Pharmacology Branch, Intramural Research Program, National Institute on Drug Abuse...

Noninvasive and real-time monitoring of molecular targeting therapy for lymph node and peritoneal metastasis in nude mice bearing xenografts of human colorectal cancer cells tagged with GFP and DsRed

NASA Astrophysics Data System (ADS)

Nakanishi, Hayao; Hara, Masayasu; Ikehara, Yuzuru; Tatematsu, Masae

2007-02-01

We have developed an in vivo imaging system consisting of GFP- and DsRed-tagged human colonic cancer cell line, which has peritoneal and lymph node metastatic potential and show high sensitivity to EGFR targeting drugs, and convenient detection devices for GFP and DsRed. The latter includes a small handy fluorescence detection device for external monitoring of the therapeutic effect of the drug and a convenient stereo fluorescent microscope for internal visualization of micrometastases. We applied this imaging system to investigate anti-metastatic effects of EGFR targeting drugs such as gefitinib (Iressa). This system allowed sensitive detection of the development of peritoneal and lymph node metastases from the micrometastasis stage at the cellular level and also permited noninvasive, non-anesthetic monitoring of anti-metastatic effect of the drug in an animal facility without any pretreatment. Significant decreases in the intraabdominal metastatic tumor growth and prevention of inguinal lymph node metastasis by gefitinib treatment could be clearly monitored. These results suggest that convenient, low-cost, true real-time monitoring of therapeutic effect using such a fluorescence-mediated whole body imaging system seems to enhance the speed of preclinical study for novel anti-cancer agents and will allow us to understand the action mechanism of molecular targeting drugs.

Demographic Subgroup Trends among Adolescents in the Use of Various Licit and Illicit Drugs, 1975-2015. Monitoring the Future Occasional Paper Series. Paper 86

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Miech, Richard A.; Bachman, Jerald G.; Schulenberg, John E.

2016-01-01

This occasional paper presents national demographic subgroup data for the 1975-2015 Monitoring the Future (MTF) national survey results on 8th, 10th, and 12th graders' use of drugs, alcohol, and tobacco. MTF is funded by the National Institute on Drug Abuse at the National Institutes of Health under a series of investigator-initiated, competitive…

Demographic Subgroup Trends among Adolescents in the Use of Various Licit and Illicit Drugs, 1975-2014. Monitoring the Future Occasional Paper Series. Paper 83

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Miech, Richard A.; Bachman, Jerald G.; Schulenberg, John E.

2015-01-01

This occasional paper presents national demographic subgroup data for the 1975-2014 Monitoring the Future (MTF) national survey results on 8th, 10th, and 12th graders' use of drugs, alcohol, and tobacco. MTF is funded by the National Institute on Drug Abuse at the National Institutes of Health under a series of investigator-initiated, competitive…

Demographic Subgroup Trends among Adolescents in the Use of Various Licit and Illicit Drugs, 1975-2016. Monitoring the Future Occasional Paper Series. Paper 88

ERIC Educational Resources Information Center

Johnston, Lloyd D.; O'Malley, Patrick M.; Miech, Richard A.; Bachman, Jerald G.; Schulenberg, John E.

2017-01-01

This occasional paper presents national demographic subgroup data for the 1975-2016 Monitoring the Future (MTF) national survey results on 8th , 10th, and 12th graders' use of drugs, alcohol, and tobacco. MTF is funded by the National Institute on Drug Abuse at the National Institutes of Health under a series of investigator-initiated, competitive…

Monitoring the Future: National Results on Adolescent Drug Use. Overview of Key Findings 2005. NIH Publication No. 06-5882

ERIC Educational Resources Information Center

Johnson, Lloyd D.; O'Malley, Patrick M.; Bachman, Jerald G.; Schulenberg, John E.

2006-01-01

Results from the Monitoring the Future's 2005 nationwide survey of 8th, 10th, and 12th grade students are given in this report. Recent trends in the use of licit and illicit drugs are emphasized, as well as trends in the levels of perceived risk and personal disapproval associated with each drug. This study has shown these beliefs and attitudes to…

Drug safety of macrolide and quinolone antibiotics in a tertiary care hospital: administration of interacting co-medication and QT prolongation.

PubMed

Niedrig, David; Maechler, Sarah; Hoppe, Liesa; Corti, Natascia; Kovari, Helen; Russmann, Stefan

2016-07-01

Some macrolide and quinolone antibiotics (MQABs) are associated with QT prolongation and life-threatening torsade de pointes (TdP) arrhythmia. MQAB may also inhibit cytochrome P450 isoenzymes and thereby cause pharmacokinetic drug interactions (DDIs). There is limited data on the frequency and management of such risks in clinical practice. We aimed to quantify co-administration of MQAB with interacting drugs and associated adverse drug reactions. We conducted an observational study within our pharmacoepidemiological database derived from electronic medical records of a tertiary care hospital. Among all users of MQAB associated with TdP, we determined the prevalence of additional QT-prolonging drugs and risk factors and identified contraindicated co-administrations of simvastatin, atorvastatin, or tizanidine. Electrocardiographic (ECG) monitoring and associated adverse events were validated in medical records. Among 3444 administered courses of clarithromycin, erythromycin, azithromycin, ciprofloxacin, levofloxacin, or moxifloxacin, there were 1332 (38.7 %) with concomitant use of additional QT-prolonging drugs. Among those, we identified seven cases of drug-related QT prolongation, but 49.1 % had no ECG monitoring. Of all MQAB users, 547 (15.9 %) had hypokalemia. Forty-four MQAB users had contraindicated co-administrations of simvastatin, atorvastatin, or tizanidine and three of those related adverse drug reactions. In the studied real-life setting, we found a considerable number of MQAB users with additional risk factors for TdP but no ECG monitoring. However, adverse drug reactions were rarely found, and costs vs. benefits of ECG monitoring have to be weighted. In contrast, avoidable risk factors and selected contraindicated pharmacokinetic interactions are clear targets for implementation as automated alerts in electronic prescribing systems.

Volunteer water monitoring: A guide for state managers

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

Not Available

1990-08-01

Contents: executive summary; volunteers in water monitoring; planning a volunteer monitoring program; implementing a volunteer monitoring program; providing credible information; costs and funding; and descriptions of five successful programs.

Identifying injection drug use and estimating population size of people who inject drugs using healthcare administrative datasets.

PubMed

Janjua, Naveed Zafar; Islam, Nazrul; Kuo, Margot; Yu, Amanda; Wong, Stanley; Butt, Zahid A; Gilbert, Mark; Buxton, Jane; Chapinal, Nuria; Samji, Hasina; Chong, Mei; Alvarez, Maria; Wong, Jason; Tyndall, Mark W; Krajden, Mel

2018-05-01

Large linked healthcare administrative datasets could be used to monitor programs providing prevention and treatment services to people who inject drugs (PWID). However, diagnostic codes in administrative datasets do not differentiate non-injection from injection drug use (IDU). We validated algorithms based on diagnostic codes and prescription records representing IDU in administrative datasets against interview-based IDU data. The British Columbia Hepatitis Testers Cohort (BC-HTC) includes ∼1.7 million individuals tested for HCV/HIV or reported HBV/HCV/HIV/tuberculosis cases in BC from 1990 to 2015, linked to administrative datasets including physician visit, hospitalization and prescription drug records. IDU, assessed through interviews as part of enhanced surveillance at the time of HIV or HCV/HBV diagnosis from a subset of cases included in the BC-HTC (n = 6559), was used as the gold standard. ICD-9/ICD-10 codes for IDU and injecting-related infections (IRI) were grouped with records of opioid substitution therapy (OST) into multiple IDU algorithms in administrative datasets. We assessed the performance of IDU algorithms through calculation of sensitivity, specificity, positive predictive, and negative predictive values. Sensitivity was highest (90-94%), and specificity was lowest (42-73%) for algorithms based either on IDU or IRI and drug misuse codes. Algorithms requiring both drug misuse and IRI had lower sensitivity (57-60%) and higher specificity (90-92%). An optimal sensitivity and specificity combination was found with two medical visits or a single hospitalization for injectable drugs with (83%/82%) and without OST (78%/83%), respectively. Based on algorithms that included two medical visits, a single hospitalization or OST records, there were 41,358 (1.2% of 11-65 years individuals in BC) recent PWID in BC based on health encounters during 3- year period (2013-2015). Algorithms for identifying PWID using diagnostic codes in linked administrative data could be used for tracking the progress of programing aimed at PWID. With population-based datasets, this tool can be used to inform much needed estimates of PWID population size. Copyright © 2018 Elsevier B.V. All rights reserved.

Recommendations for Optimizing Tuberculosis Treatment: Therapeutic Drug Monitoring, Pharmacogenetics, and Nutritional Status Considerations

PubMed Central

Choi, Rihwa; Jeong, Byeong-Ho

2017-01-01

Although tuberculosis is largely a curable disease, it remains a major cause of morbidity and mortality worldwide. Although the standard 6-month treatment regimen is highly effective for drug-susceptible tuberculosis, the use of multiple drugs over long periods of time can cause frequent adverse drug reactions. In addition, some patients with drug-susceptible tuberculosis do not respond adequately to treatment and develop treatment failure and drug resistance. Response to tuberculosis treatment could be affected by multiple factors associated with the host-pathogen interaction including genetic factors and the nutritional status of the host. These factors should be considered for effective tuberculosis control. Therefore, therapeutic drug monitoring (TDM), which is individualized drug dosing guided by serum drug concentrations during treatment, and pharmacogenetics-based personalized dosing guidelines of anti-tuberculosis drugs could reduce the incidence of adverse drug reactions and increase the likelihood of successful treatment outcomes. Moreover, assessment and management of comorbid conditions including nutritional status could improve anti-tuberculosis treatment response. PMID:28028995