Process to develop a State Model Law to reduce prescription drug trafficking while protecting pain management

This paper will discuss the intersection of pill mills and the under-treatment of pain, while addressing the unintended consequence that cracking down on pill mills actually has on medical professionals' treatment of legitimate pain in clinical settings. Moreover, the impact each issue has on the spectrum of related policy, regulatory issues and legislation will be analyzed while addressing the national impact on medical care. Lastly, this paper will outline a process to develop a State Model Law on this subject. This process will include suggestions for the future and how we can move forward to adequately address public safety needs and how we can attempt to mitigate the unintended impact prescription drug trafficking has had on a patient's right to appropriate pain management. This balance is achievable and this paper will address ways we can find this elusive balancing point through the development of a State Model Law. ^

Studies on behavioral regulations of morphine tolerance in rats

Opioids remain the drugs of choice in chronic pain treatment, but opioid tolerance, defined as a decrease in analgesic effect after prolonged or repeated use, dramatically limits their clinical utility. Opioid tolerance has classically been studied by implanting spinal catheters in animals for drug administration. This procedure has significant morbidity and mortality, as well as causing an inflammatory response which decreases the potency of opioid analgesia and possibly affects tolerance development. Therefore, we developed and validated a new method, intermittent lumbar puncture (Dautzenberg et al.), for the study of opioid analgesia and tolerance. Using this method, opioid tolerance was reliably induced without detectable morbidity. The dose of morphine needed to induce analgesia and tolerance using this method was about 100-fold lower than that required when using an intrathecal catheter. Only slight inflammation was found at the injection site, dissipated within seven mm. ^ DAMGO, an opioid μ receptor agonist, has been reported to inhibit morphine tolerance, but results from different studies are inconclusive. We evaluated the effect of DAMGO on morphine tolerance using our newly-developed ILP method, as well as other intrathecal catheter paradigms. We found that co-administration of sub-analgesic DAMGO with morphine using ILP did not inhibit morphine tolerance, but instead blocked the analgesic effects of morphine. Tolerance to morphine still developed. Tolerance to morphine can only be blocked by sub-analgesic dose of DAMGO when administered in a lumbar catheter, but not in cervical catheter settings. ^ Finally, we evaluated the effects of Gabapentin (GBP) on analgesia and morphine tolerance. We demonstrated that GBP enhanced analgesia mediated by both subanalgesic and analgesic doses of morphine although GBP itself was not analgesic. GBP increased potency and efficacy of morphine. GBP inhibited the expression, but not the development, of morphine tolerance. GBP blocked tolerance to analgesic morphine but not to subanalgesic morphine. GBP reversed the expression of morphine tolerance even after tolerance was established. These studies may begin to provide new insights into mechanisms of morphine tolerance development and improve clinical chronic pain management. ^

Why does low dose morphine augment fentanyl analgesia?

Opioids dominate the field of pain management because of their ability to provide analgesia in many medical circumstances. However, side effects including respiratory depression, constipation, tolerance, physical dependence, and the risk of addiction limit their clinical utility. Fear of these side effects results in the under-treatment of acute pain. For many years, research has focused on ways to improve the therapeutic index (the ratio of desirable analgesic effects to undesirable side effects) of opioids. One strategy, combining opioid agonists that bind to different opioid receptor types, may prove successful.^ We discovered that subcutaneous co-administration of a moderately analgesic dose of the mu-opioid receptor (MOR) selective agonist fentanyl (20μg/kg) with subanalgesic doses of the less MOR-specific agonist morphine (100ng/kg-100μg/kg), augmented acute fentanyl analgesia in rats. Parallel [35S]GTPγS binding studies using naïve rat substantia gelatinosa membrane treated with fentanyl (4μM) and morphine (1nM-1pM) demonstrated a 2-fold increase in total G-protein activation. This correlation between morphine-induced augmentation of fentanyl analgesia and G-protein activation led to our proposal that interactions between MORs and DORs underlie opioid-induced augmentation. We discovered that morphine-induced augmentation of fentanyl analgesia and G-protein activity was mediated by DORs. Adding the DOR-selective antagonist naltrindole (200ng/kg, 40nM) at doses that did not alter the analgesic or G-protein activation of fentanyl, blocked increases in analgesia and G-protein activation induced by fentanyl/morphine combinations. Equivalent doses of the MOR-selective antagonist cyprodime (20ng/kg, 4nM) did not block augmentation. Substitution of the DOR-selective agonist SNC80 for morphine yielded similar results, further supporting our conclusion that interactions between MORs and DORs are responsible for morphine-induced augmentation of fentanyl analgesia and G-protein activation. Confocal microscopy of rat substantia gelatinosa showed that changes in the rate of opioid receptor internalization did not account for these effects.^ In conclusion, fentanyl analgesia augmentation by subanalgesic morphine is mediated by increased G-protein activation resulting from functional interactions between MORs and DORs, not changes in MOR internalization. Additional animal and clinical studies are needed to determine whether side effect incidence changes following opioid co-administration. If side effect incidence decreases or remains unchanged, these findings could have important implications for clinical pain treatment. ^

Advanced Protein Modeling Method: Benchmarking and Applications in Computer-Aided Drug Discovery

Development of homology modeling methods will remain an area of active research. These methods aim to develop and model increasingly accurate three-dimensional structures of yet uncrystallized therapeutically relevant proteins e.g. Class A G-Protein Coupled Receptors. Incorporating protein flexibility is one way to achieve this goal. Here, I will discuss the enhancement and validation of the ligand-steered modeling, originally developed by Dr. Claudio Cavasotto, via cross modeling of the newly crystallized GPCR structures. This method uses known ligands and known experimental information to optimize relevant protein binding sites by incorporating protein flexibility. The ligand-steered models were able to model, reasonably reproduce binding sites and the co-crystallized native ligand poses of the β2 adrenergic and Adenosine 2A receptors using a single template structure. They also performed better than the choice of template, and crude models in a small scale high-throughput docking experiments and compound selectivity studies. Next, the application of this method to develop high-quality homology models of Cannabinoid Receptor 2, an emerging non-psychotic pain management target, is discussed. These models were validated by their ability to rationalize structure activity relationship data of two, inverse agonist and agonist, series of compounds. The method was also applied to improve the virtual screening performance of the β2 adrenergic crystal structure by optimizing the binding site using β2 specific compounds. These results show the feasibility of optimizing only the pharmacologically relevant protein binding sites and applicability to structure-based drug design projects.

Teaching Tuberculosis Content: Web-Based Resources for Nurse Educators

Introduction: Tuberculosis (TB) is a global health concern with one-third of the world’s population infected. With the goal of eliminating TB, a component of appropriate management of the disease is ensuring baccalaureate nursing students receive current and consistent TB education. [See PDF for complete abstract]

Patient satisfaction and nursing staff work satisfaction in an urban public teaching hospital

This study examined the level of patient satisfaction and nursing staff work satisfaction at an urban public hospital in the Southwestern United States. The primary objectives of this study were to determine: (1) the level of overall patient satisfaction and satisfaction with specific dimensions of hospital care; (2) the differences in patient satisfaction according to demographic characteristics (age, gender, ethnicity, and education completed) and predispositional factors (perceived health status, perceived level of pain, prior contact with the hospital, and hospital image) and the relative importance of each variable on patient satisfaction; (3) the level of overall work satisfaction and satisfaction with specific dimensions of work experienced by the medical/surgical nursing staff; (4) the differences in work satisfaction experienced by the nursing staff based on demographic variables (age, gender, ethnicity, and marital status) and professional factors (education completed, staff position, the number of years employed with the hospital, and number of years employed in nursing) and the relative importance of each variable on work satisfaction; and (5) to determine the effect of the nursing work milieu on patient and staff satisfaction.^ The study findings showed that patients experienced a moderate to low level of satisfaction with the dimensions of hospital care (admission process, daily care, information, nursing care, physician care, other hospital staff, living arrangements, and overall care). Of the eight dimensions of care, patients reported a relatively positive level of satisfaction (75 percent or better) with only one dimension: physician care. Ethnicity, perceived health status, and hospital image were significantly related to patient satisfaction. Hispanic patients, those who were in good health, and those who felt the hospital had a good image in their community were most satisfied with hospital care. Patients also reported areas of hospital care that needed the most improvement. Responses included: rude staff, better nursing care, and better communication.^ Findings from the nursing satisfaction survey indicated a low level of satisfaction with the dimensions of work (autonomy, pay, professional status, interaction, task requirements, and organizational policies). Only one dimension of work, professional status, received a mean satisfaction score in the positive range. Additionally, staff members were unanimously dissatisfied with their salaries. Frequently mentioned work-related problems reported by the staff included: staffing shortages, heavy patient loads. and excessive paperwork.^ The nursing milieu appeared to have had a significant effect on the satisfaction levels of patients nursing staff employees. The nursing staff were often short staffed, which increased the patient-to-nurse ratio. Consequently, patients did not receive the amount of attention and care they expected from the nursing staff. Crowded patient rooms allowed for little personal space and privacy. Dissatisfaction with living conditions served to influence patients' attitudes and satisfaction levels. These frustrations were often directed toward their primary caregivers, the nursing staff. Consequently, the nursing milieu appeared to directly affect and influence the satisfaction levels of both patients and staff. (Abstract shortened by UMI). ^

Outcomes and cost effectiveness of treating type 2 diabetes with a nurse case manager following treatment algorithms versus primary care physicians

Background. Diabetes places a significant burden on the health care system. Reduction in blood glucose levels (HbA1c) reduces the risk of complications; however, little is known about the impact of disease management programs on medical costs for patients with diabetes. In 2001, economic costs associated with diabetes totaled $100 billion, and indirect costs totaled $54 billion. ^ Objective. To compare outcomes of nurse case management by treatment algorithms with conventional primary care for glycemic control and cardiovascular risk factors in type 2 diabetic patients in a low-income Mexican American community-based setting, and to compare the cost effectiveness of the two programs. Patient compliance was also assessed. ^ Research design and methods. An observational group-comparison to evaluate a treatment intervention for type 2 diabetes management was implemented at three out-patient health facilities in San Antonio, Texas. All eligible type 2 diabetic patients attending the clinics during 1994–1996 became part of the study. Data were obtained from the study database, medical records, hospital accounting, and pharmacy cost lists, and entered into a computerized database. Three groups were compared: a Community Clinic Nurse Case Manager (CC-TA) following treatment algorithms, a University Clinic Nurse Case Manager (UC-TA) following treatment algorithms, and Primary Care Physicians (PCP) following conventional care practices at a Family Practice Clinic. The algorithms provided a disease management model specifically for hyperglycemia, dyslipidemia, hypertension, and microalbuminuria that progressively moved the patient toward ideal goals through adjustments in medication, self-monitoring of blood glucose, meal planning, and reinforcement of diet and exercise. Cost effectiveness of hemoglobin AI, final endpoints was compared. ^ Results. There were 358 patients analyzed: 106 patients in CC-TA, 170 patients in UC-TA, and 82 patients in PCP groups. Change in hemoglobin A1c (HbA1c) was the primary outcome measured. HbA1c results were presented at baseline, 6 and 12 months for CC-TA (10.4%, 7.1%, 7.3%), UC-TA (10.5%, 7.1%, 7.2%), and PCP (10.0%, 8.5%, 8.7%). Mean patient compliance was 81%. Levels of cost effectiveness were significantly different between clinics. ^ Conclusion. Nurse case management with treatment algorithms significantly improved glycemic control in patients with type 2 diabetes, and was more cost effective. ^

Blood-oxygen-level-dependent (BOLD) signal changes in total cortex and subcortex, pain, reward, and vigilance regions during mechanical pressure pain after morphine administration

Morphine is the most common clinical choice in the management of severe pain. Although the molecular mechanisms of morphine have already been characterized, the cerebral circuits by which it attenuates the sensation of pain have not yet been studied in humans. The objective of this two-arm (morphine versus placebo), between-subjects study was to examine whether morphine affects pain via pain-related cortical circuits, but also via reward regions that relate to the motivational state, as well as prefrontal regions that relate to vigilance as a result of morphine's sedative effects. Cortical activity was measured by the blood-oxygen-level-dependent (BOLD) signal changes using functional magnetic resonance imaging (fMRI). ^ The novelty of this study is at three levels: (i) to develop a methodology that will assess the average BOLD signal across subjects for the pain, reward, and vigilance cortical systems; (ii) to examine whether the reward and/or sedative effects of morphine are contributing factors to cortical regions associated with the motivational state and vigilance; and (iii) to propose a neuroanatomical model related to the opioid-sensitive effects of reward and sedation as a function of cortical activity related to pain in an effort to assess future analgesics. ^ Consistent with our hypotheses, our findings showed that the decrease in total pain-related volume activated between the post- and the pre-treatment morphine group was about 78%, while the post-treatment placebo group displayed only a 5% decrease when compared to pre-treatment levels of activation. The volume increase in reward regions was 451% in the post-treatment compared to the pre-treatment morphine condition. Finally, the volumetric decrease in vigilance regions was 63% in the posttreatment compared to the pre-treatment morphine condition. ^ These findings imply that changes in the blood flow of the reward and vigilance regions may be contributing factors in producing the analgesic effect under morphine administration. Future studies need to replicate this study in a higher resolution fMRI environment and to assess the proposed neuroanatomical model in patient populations. The necessity of pain research is apparent, since pain cuts across different diseases especially chronic ones, and thus, is recognized as a vital public health developing area. ^

Evaluation of the LBJ Hospital Ask Your Nurse Advice Line

This retrospective, case-control study investigated the effectiveness of the Houston, Texas Ask Your Nurse Advice Line (AYN) in diverting callers with non-emergent medical conditions away from the emergency department (ED). After asking callers a series of questions, AYN nurses evaluate the medical condition and make recommendations for appropriate care, e.g., home care, see a clinic physician, or visit the ED. To evaluate the AYN, the rate of caller ED visits before accessing the AYN for the first time was compared to the caller ED visit rate afterwards. The pre-post rate change was compared to that of a control group of similar caller age, race, gender, and insurance status drawn from a Harris County Hospital District HCHD database. ^ The treatment group (AYN caller) had a 66% reduction in ED visits after the first AYN call compared to an 18% drop in ED visits among control group subjects during the same time period. Study results were presented to HCHD staff on August 30th, 2007 and recommendations were made for future studies that would provide a basis for policy development. ^

Using service-learning to encourage community health advocacy among high school students

The project outlined throughout this program management plan aims to develop a health-focused student advocacy group in the San Antonio Independent School District (SAISD). At its core, this project will be an opportunity for SAISD students to engage in service-learning, through which they will learn and develop by designing, organizing and participating in meaningful public health service experiences. ^ This program management plan addresses the genuine need for public health community education by using the service-learning model as a framework to engage students to effect change. The plan delineates the process by which the student advocacy group is to be assembled, selection of service-learning project, project objectives, technical objectives, and communication requirements. Ideally, the plan should help to facilitate project coordination, communication, and planning, and to support the direction of resources. The appendices that follow also provide useful tools with which to follow through with project implementation. ^ The plan is about more than providing a tool to educate students about the health issues in their community. It is about providing a way to teach health advocacy and self-interest and encourage civic engagement via public health. Students have the potential to positively effect lasting change among their peers, in their schools and in the community.^

Policy analysis of Texas Senate Bill 532 and the regulation of nurse practitioners in the convenience care model

Background. Retail clinics, also called convenience care clinics, have become a rapidly growing trend since their initial development in 2000. These clinics are coupled within a larger retail operation and are generally located in "big-box" discount stores such as Wal-mart or Target, grocery stores such as Publix or H-E-B, or in retail pharmacies such as CVS or Walgreen's (Deloitte Center for Health Solutions, 2008). Care is typically provided by nurse practitioners. Research indicates that this new health care delivery system reduces cost, raises quality, and provides a means of access to the uninsured population (e.g., Deloitte Center for Health Solutions, 2008; Convenient Care Association, 2008a, 2008b, 2008c; Hansen-Turton, Miller, Nash, Ryan, Counts, 2007; Salinsky, 2009; Scott, 2006; Ahmed & Fincham, 2010). Some healthcare analysts even suggest that retail clinics offer a feasible solution to the shortage of primary care physicians facing the nation (AHRQ Health Care Innovations Exchange, 2010). ^ The development and performance of retail clinics is heavily dependent upon individual state policies regulating NPs. Texas currently has one of the most highly regulated practice environments for NPs (Stout & Elton, 2007; Hammonds, 2008). In September 2009, Texas passed Senate Bill 532 addressing the scope of practice of nurse practitioners in the convenience care model. In comparison to other states, this law still heavily regulates nurse practitioners. However, little research has been conducted to evaluate the impact of state laws regulating nurse practitioners on the development and performance of retail clinics. ^ Objectives. (1). To describe the potential impact that SB 532 has on retail clinic performance. (2). To discuss the effectiveness, efficiency, and equity of the convenience care model. (3). To describe possible alternatives to Texas' nurse practitioner scope of practice guidelines as delineated in Texas Senate Bill 532. (4). To describe the type of nurse practitioner state regulation (i.e. independent, light, moderate, or heavy) that best promotes the convenience care model. ^ Methods. State regulations governing nurse practitioners can be characterized as independent, light, moderate, and heavy. Four state NP regulatory types and retail clinic performance were compared and contrasted to that of Texas regulations using Dunn and Aday's theoretical models for conducting policy analysis and evaluating healthcare systems. Criteria for measurement included effectiveness, efficiency, and equity. Comparison states were Arizona (Independent), Minnesota (Light), Massachusetts (Moderate), and Florida (Heavy). ^ Results. A comparative states analysis of Texas SB 532 and alternative NP scope of practice guidelines among the four states: Arizona, Florida, Massachusetts, and Minnesota, indicated that SB 532 has minimal potential to affect the shortage of primary care providers in the state. Although SB 532 may increase the number of NPs a physician may supervise, NPs are still heavily restricted in their scope of practice and limited in their ability to act as primary care providers. Arizona's example of independent NP practice provided the best alternative to affect the shortage of PCPs in Texas as evidenced by a lower uninsured rate and less ED visits per 1,000 population. A survey of comparison states suggests that retail clinics thrive in states that more heavily restrict NP scope of practice as opposed to those that are more permissive, with the exception of Arizona. An analysis of effectiveness, efficiency, and equity of the convenience care model indicates that retail clinics perform well in the areas of effectiveness and efficiency; but, fall short in the area of equity. ^ Conclusion. Texas Senate 532 represents an incremental step towards addressing the problem of a shortage of PCPs in the state. A comparative policy analysis of the other four states with varying degrees of NP scope of practice indicate that a more aggressive policy allowing for independent NP practice will be needed to achieve positive changes in health outcomes. Retail clinics pose a temporary solution to the shortage of PCPs and will need to expand their locations to poorer regions and incorporate some chronic care to obtain measurable health outcomes. ^

A comparison of labor and delivery management activities in two settings

Similarities and differences in management activities and patient health outcomes between a traditional physician staffed labor and delivery setting and a certified nurse-midwife staffed Birth Center within the same hospital were described. The 950 study subjects, low income, minority women, were classified as low obstetrical risk by a POPRAS score of 25 points or less at time of admission for labor and delivery. The study subjects were similar in demographic, antepartum and intrapartum characteristics; the labor course was problem free for the majority in both settings. There were no remarkable differences in health outcomes between the groups. Management activities varied between settings; these variations were policy related rather than health related. The POPRAS rating system was an accurate predictor for 93% of BC subjects and 85% of LDU subjects. Charge for service was approximately $600 less for BC women; length of stay did not contribute to the difference in charge. Overall, BC respondents to the attitude survey were more satisfied with their labor and delivery experience than L\&DU women. ^

Assessing the impact of leadership on nurse job satisfaction and the desire for unionization in health care settings

This dissertation focuses on the leadership styles of managers, the impact these leadership styles have on the job satisfaction of staff nurses, and the proclivity of nurses to consider unionization. The aims of the dissertation include conducting a literature review on topics of leadership style, job satisfaction, and unionization; identifying and elucidating pertinent constructs with respect to shared interrelationships and how they could be measured; and developing a means of assessing if and to what extent transformational and transactional leadership styles affect nurse proclivity to unionize.^ The instrumentation selected includes the Multifactor Leadership Survey, Job Satisfaction Survey, and a newly created Union Preference Survey. Each survey instrument was evaluated as to its appropriateness to administer at a non-consultant level within a health care facility. Options other than self-administering the survey instruments include online access for participants, which provides confidentiality and encourages more responses. ^ The next part of the dissertation is a plan for health care facilities to use the survey tool by administering it themselves. The plan provides a general description of the survey tool, administering the instrument, rating the instrument, and leadership development. Integration of the three surveys is presented in a non-statistical format by coordinating the results of the three survey instrument responses. Recommendations are presented on how to improve leadership development warranted for improvement.^ The conclusions reached are that nurses’ preference for unions is influenced by the leadership style of direct report managers, as rated by staff nurses, and the nurses’ job satisfaction, which is in turn in part dependent on their managers’ leadership style. Thus, changes in leadership style can have a profound impact on nurse job satisfaction and on nurses’ preference for unionization.^

Nurse likelihood to report a pediatric medication error: Examination of the "pre-reporting" period

Each year, hospitalized patients experience 1.5 million preventable injuries from medication errors and hospitals incur an additional $3.5 billion in cost (Aspden, Wolcott, Bootman, & Cronenwatt; (2007). It is believed that error reporting is one way to learn about factors contributing to medication errors. And yet, an estimated 50% of medication errors go unreported. This period of medication error pre-reporting, with few exceptions, is underexplored. The literature focuses on error prevention and management, but lacks a description of the period of introspection and inner struggle over whether to report an error and resulting likelihood to report. Reporting makes a nurse vulnerable to reprimand, legal liability, and even threat to licensure. For some nurses this state may invoke a disparity between a person‘s belief about him or herself as a healer and the undeniable fact of the error.^ This study explored the medication error reporting experience. Its purpose was to inform nurses, educators, organizational leaders, and policy-makers about the medication error pre-reporting period, and to contribute to a framework for further investigation. From a better understanding of factors that contribute to or detract from the likelihood of an individual to report an error, interventions can be identified to help the nurse come to a psychologically healthy resolution and help increase reporting of error in order to learn from error and reduce the possibility of future similar error.^ The research question was: "What factors contribute to a nurse's likelihood to report an error?" The specific aims of the study were to: (1) describe participant nurses' perceptions of medication error reporting; (2) describe participant explanations of the emotional, cognitive, and physical reactions to making a medication error; (3) identify pre-reporting conditions that make it less likely for a nurse to report a medication error; and (4) identify pre-reporting conditions that make it more likely for a nurse to report a medication error.^ A qualitative research study was conducted to explore the medication error experience and in particular the pre-reporting period from the perspective of the nurse. A total of 54 registered nurses from a large private free-standing not-for-profit children's hospital in the southwestern United States participated in group interviews. The results describe the experience of the nurse as well as the physical, emotional, and cognitive responses to the realization of the commission of a medication error. The results also reveal factors that make it more and less likely to report a medication error.^ It is clear from this study that upon realization that he or she has made a medication error, a nurse's foremost concern is for the safety of the patient. Fear was also described by each group of nurses. The nurses described a fear of several things including physician reaction, manager reaction, peer reaction, as well as family reaction and possible lack of trust as a result. Another universal response was the description of a struggle with guilt, shame, imperfection, blaming oneself, and questioning one's competence.^