The Standardization of Outpatient Procedure (STOP) Narcotics: A Prospective Health Systems Intervention to Reduce Opioid Use in Ambulatory Breast Surgery.

BACKGROUND: During the past 15 years, opioid-related overdose death rates for women have increased 471%. Many surgeons provide opioid prescriptions well in excess of what patients actually use. This study assessed a health systems intervention to control pain adequately while reducing opioid prescriptions in ambulatory breast surgery. METHODS: This prospective non-inferiority study included women 18-75 years of age undergoing elective ambulatory general surgical breast procedures. Pre- and postintervention groups were compared, separated by implementation of a multi-pronged, opioid-sparing strategy consisting of patient education, health care provider education and perioperative multimodal analgesic strategies. The primary outcome was average pain during the first 7 postoperative days on a numeric rating scale of 0-10. The secondary outcomes included medication use and prescription renewals. RESULTS: The average pain during the first 7 postoperative days was non-inferior in the postintervention group despite a significant decrease in median oral morphine equivalents (OMEs) prescribed (2.0/10 [100 OMEs] pre-intervention vs 2.1/10 [50 OMEs] post-intervention; p = 0.40 [p < 0.001]). Only 39 (44%) of the 88 patients in the post-intervention group filled their rescue opioid prescription, and 8 (9%) of the 88 patients reported needing an opioid for additional pain not controlled with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) postoperatively. Prescription renewals did not change. CONCLUSION: A standardized pain care bundle was effective in minimizing and even eliminating opioid use after elective ambulatory breast surgery while adequately controlling postoperative pain. The Standardization of Outpatient Procedure Narcotics (STOP Narcotics) initiative decreases unnecessary and unused opioid medication and may decrease risk of persistent opioid use. This initiative provides a framework for future analgesia guidelines in ambulatory breast surgery.

Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl for Pain Control in Children after Thoracic Surgery: A Randomized Study.

BACKGROUND: Although bupivacaine remains a standard local anesthetic for postoperative epidural infusions in pediatric patients, it is increasingly being replaced with ropivacaine by many anesthesiologists. Ropivacaine is associated with less risk for cardiac and central nervous system toxicity. AIMS: The purpose of this study was to compare analgesic efficacy and adverse events of postoperative epidural analgesia with ropivacaine/fentanyl versus bupivacaine/fentanyl in children after the Ravitch procedure and thoracotomy. DESIGN: This was a prospective randomized controlled study. SETTINGS: This study was conducted at the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Diseases in Rabka Zdroj, Poland. PARTICIPANTS/SUBJECTS: 94 patients undergoing elective thoracic surgery. METHODS: Patients aged 7-17 years were randomly allocated into a ropivacaine 0.2% (RF, n = 45) or bupivacaine 0.125% (BF, n = 45) group; 1 mL of each analgesic solution contained 5 µg fentanyl. All patients received acetaminophen and nonsteroidal anti-inflammatory drugs. Nurses assessed pain intensity and incidence of adverse events over 72 hours after surgery and modified analgesia if patient pain intensity was greater than 2 out of 10. RESULTS: There was no statistically significant difference in median pain scores and incidence of adverse events between the RF group and the BF group. The analgesia was excellent (median pain intensity scores at rest, during deep breathing, and when coughing was less than 1 out of 10 in all patients). Adverse events included incidents of desaturation (64/90), nausea (18/90), vomiting (31/90), pruritus (12/90), urinary retention (2/90), paresthesia (11/90), anisocoria (2/90), and Horner syndrome (2/90). CONCLUSIONS: Thoracic epidural analgesia using an RF and BF solution resulted in similar pain relief and adverse event profiles.

Linking algal growth inhibition to chemical activity: baseline toxicity required 1% of saturation.

Recently, high-quality data were published on the algal growth inhibition caused by 50 non-polar narcotic compounds, of which 39 were liquid compounds with defined water solubility. In the present study, the toxicity data for these liquids were applied to challenge the chemical activity range for baseline toxicity. First, the reported effective concentrations (EC50) were divided by the respective water solubilities (S water), since the obtained EC50/S water ratio essentially equals the effective chemical activity (Ea50). The majority of EC50/S water ratios were within the expected chemical activity range of 0.01-0.1 for baseline toxicity, and none of the ratios were significantly below 0.01. On a practical level, these findings suggest EC50 values for baseline toxicity to be at or above 1% of liquid solubility, which would have been accurate or conservative for all 39 liquids with defined water solubility in the applied dataset. On an environmental risk assessment level, predicted no-effect concentrations (PNECs) for baseline toxicity could even be set as a percentage of saturation, which can easily be extended to mixtures. However, EC50 values well below 1% of liquid saturation can still occur and would be a direct indication of excess toxicity.

Measurement of baseline toxicity and QSAR analysis of 50 non-polar and 58 polar narcotic chemicals for the alga Pseudokirchneriella subcapitata.

In this paper a set of homogenous experimental algal toxicity data was measured for 50 non-polar narcotic chemicals using the alga Pseudokirchneriella subcapitata in a closed test with a growth rate endpoint. Most of the tested compounds are high volume industrial chemicals that so far lacked published REACH-compliant algal growth inhibition values. The test protocol fulfilled the criteria set forth in the OECD guideline 201 and had the same sensitivity as the open test which allowed direct comparison of toxicity values. Baseline QSAR model for non-polar narcotic compounds was established and compared with previous analogous models. Multi-linear QSAR model was derived for the non-polar and 58 previously tested polar (anilines and phenols) narcotic compounds modulating hydrophobicity, molecular size, electronic and molecular stability effects coded in the molecular descriptors. Descriptors in the model were analyzed and applicability domain was assessed providing further guidelines for the in silico prediction purposes in decision support while performing risk assessment. QSAR models in the manuscript are available on-line through QsarDB repository for exploring and prediction services (http://hdl.handle.net/10967/106).

¿Cómo se organizan los grupos criminales según su actividad delictiva principal? Descripción desde una muestra española / How do criminal groups organize themselves according to the speci$c main activity? Description of a Spanish sampleir own

El artículo expone, en un análisis descriptivo, los resultados obtenidos sobre la actividad ilegal de 67 grupos del crimen organizado, según las características de la organización delictiva. Los grupos analizados corresponden a operaciones policiales desarrolladas por la Unidad Central Operativa (UCO) de la Guardia Civil, realizadas entre 1990 y el 2010. En estas agrupaciones criminales se han identificado 17 actividades delictivas diferentes, aunque los datos solo permiten establecer conclusiones de aquellas que presentan una mayor prevalencia, esto es: robos con fuerza (N=24), tráfico de hachís (N=9) y tráfico de cocaína (N=8). Los datos obtenidos muestran que la actividad ilegal principal por la cual los grupos organizados estudiados obtienen la mayor proporción de sus beneficios discrimina variables relacionadas con la organización delictiva y la dinámica interna, como estructura, criterios en la división de tareas, tipos de medios complejos empleados y países que traspasan, de cara al desarrollo de sus actividades.

In a descriptive analysis, the results obtained about the unlawful activity of 67 organized crime groups are exposed,according to the characteristics of each criminal organization. Groups under analysis pertain to police operations developed by the Civil Guard’s Operating Central Unit (“UCO”) carried out between 1990 and 2010. Although seventeen different criminal activities have been identified these groupings, conclusions drawn from data are exclusively related to those showing higher prevalence, such as robberies with assault (N=8),hashish trafficking (N=9) and cocaine trafficking (N=8). Information obtained shows that the main unlawful activity through which the analyzed organized groups get their largest share of profits makes some discrimination among variables relating to the criminal organization and internal dynamics such as structure, task distribution criteria, types of complex means used and countries they trespass, in the face of the development of their activities.

O artigo expõe, em uma análise descritiva, os resultados obtidos sobre a atividade ilegal de 67 grupos do crimeorganizado, de acordo com as características da organização criminosa. Os grupos analisados correspondem às operações policiais realizadas pela Unidade Central Operacional (UCO) da Guarda Civil, realizadas entre 1990 e 2010. Esses agrupamentos criminosos foram identificadas 17 diferentes atividades criminosas, embora os dados apenas permitam tirar conclusões daquelas que têm uma maior prevalência, ou seja: roubo com força (N=24), tráfico de haxixe (N=9) e tráfico de cocaína (N=8). Os dados obtidos mostram que a principal atividade ilegal pela qual os grupos organizados estudados obtêm a maior parte de seus lucros, discriminam variáveis relacionadas com a organização criminosa e dinâmica interna, como estrutura, critérios na divisão de tarefas, tipos de mídia complexos empregados e países que traspassam, face ao desenvolvimento de suas atividades.

[Preparation of standard protocol for cancer pain control and evaluation of its clinical effectiveness].

In order to promote the appropriate control of cancer pain by opioids, we distributed a pocket-sized protocol pamphlet on cancer pain control and opioid prescription to the medical staff of Nagoya University Hospital. In this study, we examined whether the prescription rate of opioids for rescue use, antiemetics for preventing adverse effects, and the rate of increase of regular opioid dosage were increased after distribution to evaluate its utility. Rescue opioid prescriptions, increase of regular opioid dosage and antiemetic prescription rate after distribution were all significantly increased, compared with before distribution. Furthermore, the frequency of nausea and vomiting was reduced by the use of prophylactic antiemetics. These results suggest that distribution of this protocol for cancer pain control may contribute to appropriate pain management.

The influence of prescription monitoring programs on chronic pain management.

BACKGROUND: Abuse of prescribed controlled substance has become a serious social as well as health care issue over the past decade. A particularly alarming trend exists among patients aged 12 to 17. Common abuse behaviors include doctor shopping, drug theft, feigned pain symptoms to gain health care access, drug sharing, prescription forgery, and improper prescription practices. In response to this epidemic of abuse, many states have adopted prescription monitoring programs (PMPs). Such programs first originated in the early twentieth century. As of 2006, 38 states had such programs, many of which are supported by federal grants. As PMPs become more widespread, they have also increased in sophistication. By keeping a record of the prescription and dispensing of narcotics, these programs are able to build a comprehensive data network for tracking prescription medications. These databases aid law enforcement agencies in investigations of narcotic trafficking; they also help state regulatory boards to monitor improper prescription practices. OBJECTIVE: This manuscript examines the basic structure of a PMP, including the way the data are collected and the way these data are stored and used. It also looks at the organizational differences amongst state programs. NASPER and Harold Rogers are two federal programs that provide funding to the state PMPs, and the current study examines the differences as well as similarities between these 2 programs. This study also compares the results of 2 reports: the U.S. General Accounting Office Study and the Twillman study.& Both studies have evaluated the efficiency of the PMPs. DISCUSSION: The U.S. General Accounting Office Study showed that while considerable differences exist among the state PMPs, these programs not only reduce the time and effort for law enforcement agencies to conduct investigations, but also cut the supply of prescription medications. However, the Twillman report suggests that prescription programs caused a shift in prescription practice, while the actual rate of abuse may not have been reduced. These 2 studies both point to the challenges the PMPs face. However, more recent data suggest that proactive use of the PMPs results in the decreased growth of prescription medication sales. Finally, a number of states have also begun to objectively evaluate the efficiencies of the system. CONCLUSION: Many states have developed PMPs to help regulatory agencies as well as physicians detect prescription drug abuse. Limited data so far suggest that such programs reduce abuse practices. In addition, proactive usage of the data further prevents abuse.

Farmacoterapia en mujeres gestantes y durante la lactancia / Drug therapy in pregnant women and during breastfeeding

El embarazo representa un proceso de organogénesis, maduración y crecimiento de un embrión, desde el momento de la fecundación hasta que éste nace. El proceso dura cerca de 280 días contados a partir del final de la última menstruación. Durante este período, debemos de tener en cuenta que se establece una comunicación íntima entre la vida de la madre y la del hijo, lo cual comprende además una donación de nutrientes a partir de la madre. Si bien es cierto, la comunicación sanguínea que se establece no estotalmente íntima, es porque existe una membrana o barrera que separa tanto a la circulación materna como a la embrionario o fetal: la barrera placentaria o placenta. Cualquier sustancia que ingrese al organismo de la gestante, pasará en mayor o menor medida a través de la placenta, ocasionanado probablemente daño embrionario o fetal, dependiendo de la naturaleza de la sustancia

Facsimile transmission of prescriptions for patients enrolled in hospice programs. Drug Enforcement Administration (DEA), Justice. Final rule.

DEA is finalizing, without change, the interim rule with request for comment published in the Federal Register on July 25, 2000 (65 FR 45712). The interim rule amended Title 21, Code of Federal Regulations (CFR) 1306.11(g) to clearly articulate that prescriptions for Schedule II narcotic substances for patients enrolled in hospice care certified by Medicare under Title XVIII or licensed by the state may be transmitted by facsimile. No comments to the interim rule were received. This final rule makes the clarification permanent.

Fluctuations in heroin purity and the incidence of fatal heroin overdose.

In order to determine the role played by heroin purity in fatal heroin overdoses, time series analyses were conducted on the purity of street heroin seizures in south western Sydney and overdose fatalities in that region. A total of 322 heroin samples were analysed in fortnightly periods between February 1993 to January 1995. A total of 61 overdose deaths occurred in the region in the study period. Cross correlation plots revealed a significant correlation of 0.57 at time lag zero between mean purity of heroin samples per fortnight and number of overdose fatalities. Similarly, there was a significant correlation of 0.50 at time lag zero between the highest heroin purity per fortnight and number of overdose fatalities. The correlation between range of heroin purity and number of deaths per fortnight was 0.40. A simultaneous multiple regression on scores adjusted for first order correlation indicated both the mean level of heroin purity and the range of heroin purity were independent predictors of the number of deaths per fortnight. The results indicate that the occurrence of overdose fatalities was moderately associated with both the average heroin purity and the range of heroin purity over the study period.

Analysis of organic volatile impurities as a forensic tool for the examination of bulk pharmaceuticals.

This discussion offers an overview of some formally accepted methodology in the USA for the determination of organic volatile impurities in pharmaceuticals. Particular advantages of equilibrium headspace sampling with capillary gas chromatography for this task are outlined and some important considerations are expressed. Specific adaptations which we have made for forensic applications are described along with mention of select applications within the context of the detection of the counterfeiting of bulk pharmaceuticals. Finally, a brief description is provided of statistical techniques which can be used to effectively manipulate multivariate data sets for purposes of distinguishing between the manufacturers of a product based upon impurity profiles.