Impact of Hydrocodone Rescheduling on Dental Prescribing of Opioids.

INTRODUCTION: In the United States, dentists frequently prescribe hydrocodone. In October 2014, the US Drug Enforcement Administration rescheduled hydrocodone from controlled substance schedule III to II, introducing more restricted prescribing and dispensing regulations, which may have changed dental prescribing of opioids. OBJECTIVE: The study aim was to evaluate the impact of the hydrocodone rescheduling on dental prescribing of opioids in the United States. METHODS: This was a cross-sectional study of opioids prescribed by dentists between October 2012 and October 2016, using the IQVIA Longitudinal Prescription Dataset. Monthly dentist-based opioid prescribing rate (opioid prescription [Rx]/1,000 dentists) and monthly average opioid dosages per prescription (mean morphine milligram equivalent per day [MME/d]) were measured in the 24 mo before and after hydrocodone rescheduling in October 2014 (index or interruption). An interrupted time-series analysis was conducted using segmented ordinary least square regression models, with Newey-West standard errors to handle autocorrelation. RESULTS: Dentists prescribed 50,412,942 opioid prescriptions across the 49 mo. Hydrocodone was the most commonly prescribed opioid pre- and postindex (74.9% and 63.8%, respectively), followed by codeine (13.8% and 21.6%), oxycodone (8.1% and 9.5%), and tramadol (2.9% and 4.8%). At index, hydrocodone prescribing immediately decreased by -834.8 Rx/1,000 dentists (95% confidence interval [CI], -1,040.2 to -629.4), with increased prescribing of codeine (421.9; 95% CI, 369.7-474.0), oxycodone (85.3; 95% CI, 45.4-125.2), and tramadol (111.8; 95% CI, 101.4-122.3). The mean MME increased at index for all opioids except for hydrocodone, and dosages subsequently decreased during the postindex period. CONCLUSION: Following the rescheduling, dentist prescribing of hydrocodone declined while prescribing of nonhydrocodone opioids increased. Understanding the impact of this regulation informs strategies to ensure appropriate prescribing of opioids for dental pain. KNOWLEDGE TRANSFER STATEMENT: The study findings can be used by policy makers to make informed decisions in developing future risk mitigation strategies aimed to regulate opioid prescribing behaviors. Furthermore, dentist-specific resources and guidelines are needed subsequent to these policies in order to meet the dental population needs.

The association of stressful life events on weight loss efforts among African American breast cancer survivors.

OBJECTIVE: This study examined whether stressful life events were associated with weight loss, central adiposity, and health behavior changes of African American breast cancer survivors (AABCS) participating in a weight loss intervention. METHODS: We conducted a secondary-data analyses of Moving Forward, a weight loss efficacy trial for AABCS conducted in 2011-2014. Two-hundred forty-six eligible women were randomized to a 6-month interventionist-guided (IG) or self-guided (SG) weight loss intervention. Data was collected on height, weight, self-reported diet, and self-reported physical activity. Stress (e.g., financial, legal, employment, relationships, safety, prejudice) was measured using an abbreviated version of the Crisis in Family Systems (CRISYS) urban life stress measure. Generalized linear models stratified by group examined the degree to which stress was associated with weight loss or changes in central adiposity, physical activity, and diet during the intervention (Months 1-6) or maintenance (Months 7 to 12) phases. RESULTS: Participants reported a median of 3.0 life stressors (range 0 to 22) mostly relating to relationships, safety concerns, and financial problems. In the IG group during the intervention phase, exposure to life stressors was not associated with weight loss (p = 0.15) or change in central adiposity (p = 0.69), physical activity (p = 0.15), or diet (p = 0.26). We found similar associations for the maintenance phase and in the SG group. CONCLUSION/IMPLICATIONS: Despite facing stress across a myriad of domains (e.g., relationships, safety, finances), AABCS were successful at initiating and maintaining behaviors to achieve weight loss, reductions in central adiposity, and behavioral changes. Future randomized controlled trials are warranted that include more strategies to address the challenges that AABCS face, to determine whether AABCS in particular might benefit from interventions that address barriers (e.g., stress management) to weight loss. Such strategies are critical for improving quality of life and lowering the risk of cancer recurrence.

Identifying Barriers to Physical Activity Among African American Women with Asthma.

OBJECTIVE: African American Women (AAW) are disproportionately impacted by both physical inactivity and asthma. The aims of this study were to: 1) understand barriers to physical activity among AAW with asthma; 2) obtain feedback from AAW on an evidence-based walking intervention; and 3) modify the intervention using input from AAW with asthma. METHODS: Focus groups and interviews were conducted with sedentary AAW with uncontrolled asthma to identify barriers to walking. Women also suggestions for tailoring an existing walking intervention. Qualitative data were coded using domains from the Behavior Change Wheel and guided modifications of the existing walking intervention to tailor the content for sedentary AAW with asthma. RESULTS: Six focus groups (2-4 /group) and five interviews were completed. Women (n=20) represented an obese (37 kg/m2 ± 11), middle-aged (46 years ± 15) and low-income population. Barriers to physical activity were mapped to 8 theoretical domains: 1) Limited physical capability; 2) Lack of knowledge; 3) Lack of self-monitoring skills; 4) Complex decision making processes; 5) Lack of areas to walk; 6) Lack of social support; 7) Beliefs about consequences; 8) Beliefs about capability. To target these barriers, the existing walking intervention was modified to include an asthma education session, text messages, monthly group meetings, a walking session and informational materials. CONCLUSION: AAW with asthma reported unique barriers to engaging in physical activity. An assessment of the feasibility, acceptability and efficacy of a modified intervention that addresses these barriers is warranted to address physical inactivity and poor asthma outcomes among AAW with asthma.

Weight loss drugs and lifestyle modification: Perceptions among a diverse adult sample.

OBJECTIVES: Explore how adults from diverse racial and socioeconomic backgrounds perceive the use of weight loss drugs (prescription, over-the counter, herbals and supplements) and lifestyle modification. METHODS: Individual, face-to-face, semi-structured interviews were conducted with persons presenting to an academic hospital-affiliated outpatient pharmacy serving ethnic minorities and low income individuals. RESULTS: Fifty persons were interviewed, including 21 African Americans, 11 Hispanics and 17 low-income individuals (annual income <$20,000), of whom 33 self-reported as overweight or obese. Ever-users (14/50) and nonusers (36/50) of weight loss drugs expressed a belief in the importance of diet and exercise, but were not necessarily doing so themselves. Fear of side effects and skepticism towards efficacy of drugs deterred use. Some expressed concern over herbal product safety; others perceived herbals as natural and safe. Drugs were often viewed as a short-cut and not a long-term weight management solution. CONCLUSION: A range of concerns related to the safety and efficacy of weight loss drugs were expressed by this lower income, ethnically diverse population of underweight to obese adults. PRACTICE IMPLICATIONS: There is need and opportunity for healthcare providers to provide weight loss advice and accurate information regarding the safety and efficacy of various types of weight loss approaches.

Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature.

The excess burden of obesity among African-American women is well documented. However, the behavioural weight loss intervention literature often does not report results by ethnic group or gender. The purpose of this article is to conduct a systematic review of all behavioural weight loss intervention trials published between 1990 and 2010 that included and reported results separately for African-American women. The criteria for inclusion included (i) participants age ≥18 years; (ii) a behavioural weight loss intervention; (iii) weight as an outcome variable; (iv) inclusion of African-American women; and (v) weight loss results reported separately by ethnicity and gender. The literature search identified 25 studies that met inclusion criteria. Our findings suggest that more intensive randomized behavioural weight loss trials with medically at-risk populations yield better results. Well-designed and more intensive multi-site trials with medically at-risk populations currently offer the most promising results for African-American women. Still, African-American women lose less weight than other subgroups in behavioural weight loss interventions. It is now critical to expand on individual-level approaches and incorporate the biological, social and environmental factors that influence obesity. This will help enable the adoption of healthier behaviours for this group of women disproportionately affected by obesity.

Molecular mousetraps and the serpinopathies.

Members of the serine proteinase inhibitor or serpin superfamily inhibit their target proteinases by a remarkable conformational transition that involves the enzyme being translocated more than 70 A (1 A = 10(-10) m) from the upper to the lower pole of the inhibitor. This elegant mechanism is subverted by point mutations to form ordered polymers that are retained within the endoplasmic reticulum of secretory cells. The accumulation of polymers underlies the retention of mutants of alpha(1)-antitrypsin and neuroserpin within hepatocytes and neurons to cause cirrhosis and dementia respectively. The formation of polymers results in the failure to secrete mutants of other members of the serpin superfamily: antithrombin, C1 inhibitor and alpha1-antichymotrypsin, to cause a plasma deficiency that results in the clinical syndromes of thrombosis, angio-oedema and emphysema respectively. Understanding the common mechanism underlying the retention and deficiency of mutants of the serpins has allowed us to group these conditions as the serpinopathies. We review in this paper the molecular and structural basis of the serpinopathies and show how this has allowed the development of specific agents to block the polymerization that underlies disease.

From idea to market: the drug approval process.

BACKGROUND: Each year many new prescription drugs are approved by the Food and Drug Administration (FDA). The process of developing and bringing new drugs to market is important for primary care physicians to understand. METHODS: We describe the drug development process based on a review of the literature and Web sites addressing FDA processes and policies. RESULTS: The process starts with preclinical testing. For drugs that appear safe, an investigational new drug application is filed with the FDA. If approved, clinical trials begin with phase 1 studies that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application (NDA) to the FDA. An NDA contains all the information obtained during all phases of testing. Phase 4 studies, or postmarketing studies, are conducted after a product is approved. Recent changes in legislation have streamlined the approval process. Critics contend that these changes have compromised public safety, resulting in the need to recall several products from the market. Proponents claim that changes in the approval process help patients with debilitating diseases, such as acquired immunodeficiency syndrome, that were previously denied critical medication because of bureaucratic regulations.

Spouse ratings of quality of life in patients with metastatic prostate cancer of lower socioeconomic status: an assessment of feasibility, reliability, and validity.

OBJECTIVES: To examine the reliability and validity of spousal assessments by evaluating the collateral quality-of-life (QOL) ratings of patients of lower socioeconomic status with metastatic prostate cancer because collateral ratings provide supplemental information when advanced cancer limits patient self-report. METHODS: Patients with Stage D2 prostate cancer (n = 36) of lower socioeconomic status completed validated QOL instruments (Functional Assessment of Cancer Therapy-General [FACT-G], European Organization for Research and Treatment of Cancer-Quality of Life-30, and Quality of Life Index). Spouses completed a modified FACT-G, and physicians rated performance status using Karnofsky's scale. RESULTS: The internal consistency reliability was moderate to high for patient ratings on all FACT-G subscales and for spousal ratings on the modified FACT-G physical, functional, and emotional subscales. The spouses' ratings of the patients on the social and doctor relationship subscales were below the accepted criterion for a measure's use in group comparisons. The comparisons of the mean values of the FACT-G revealed agreement between patients and spouses, except that the spouses rated the patients as having poorer emotional function than did the patients. The intraclass correlations were moderate to high for the functional and emotional subscales and were low, but significant, for the physical and social subscales. The patient and spouse FACT-G ratings correlated with the patient ratings and physician ratings across the instruments for the functional and physical domains (r = 0.48 to 0.77, for patients; r = 0.31 to 0.70, for spouses), with less consistent relationships for the social and emotional domains. CONCLUSIONS: The collateral QOL assessments from spouses are potentially useful in assessing the functional status in patients of lower socioeconomic status with metastatic prostate cancer. For subjective domains, such as the social domain, direct patient assessments are needed.

A national survey of procedural skill requirements in family practice residency programs.

BACKGROUND AND OBJECTIVES: Procedural skill training is a controversial but important component of family practice residency programs. This study examines the use and composition of required procedure lists in US family practice residency programs. METHODS: The study used a cross-sectional nine-item questionnaire. This survey was sent to 467 residency program directors listed in the 1999 American Academy of Family Physicians Directory of Family Practice Residency Programs. RESULTS: A total of 326 programs (70%) responded to the survey. Of these, 242 programs (74% of respondents) reported use of a required procedure list. Sixty-six programs provided a list. Of these, 63 lists were interpretable. The number of required procedures on the lists ranged from a minimum of 3 procedures to a maximum of 117, with an average of 42. A total of 265 distinct procedures were identified, with 25 procedures named on more than half of the lists. Thirteen programs (21%) mandated competency in required procedures, but only five programs (8%) gave clear definitions of what constituted competency. There were no significant differences in lists among training program type, university affiliation, number of hospitals used for rotation, size of affiliated hospital, or number of residents. CONCLUSIONS: The expectations of individual programs vary greatly in terms of required procedures. Few programs define how to evaluate the technical competency of their residents.

Impact of vaginal antifungal products on utilization of health care services: evidence from physician visits.

BACKGROUND: Recently many medications formerly available only by prescription have been approved for over-the-counter (OTC) status. In 1990, clotrimazole became the first available OTC drug to treat candidal vaginitis. Subsequently several other prescription antifungal medications have also been available in OTC products. One proposed benefit of these switches from prescription to OTC status is a reduction in the utilization of health care services. METHODS: Using National Ambulatory Medical Care Survey data, the average numbers of annual visits for vaginal complaints were estimated for 1985, 1990, and 1994. These years were chosen because they represented periods before, close to, and after the approval of the OTC antifungal preparations. The estimated visits for each year were compared using a chi-square analysis with a sample weight correction. RESULTS: There was a 15% decline in the number of vaginitis visits from 1990 to 1994 that potentially could be attributed to the availability of the OTC antifungal preparations. The decrease in physician visits results in approximately $45 million in direct cost savings and another $18.75 million in indirect savings by reducing time lost from work. CONCLUSIONS: It appears that the availability of OTC anticandidal fungal preparations reduces the number of physician visits for vaginitis, resulting in cost savings.

The short-term impact of a continuing medical education program on providers' attitudes toward treating diabetes.

OBJECTIVE: The objective of this study was to evaluate the short-term impact of a 7-h type 2 diabetes continuing medical education (CME) program. Outcomes included a measure of health care providers' diabetes knowledge and the Diabetes Attitude Scale (DAS), a validated measure of attitudes toward diabetes. RESEARCH DESIGN AND METHODS: A CME program on type 2 diabetes was presented by an expert panel in Chicago during November 1998. A before-after trial with pre- and postintervention measurements of diabetes knowledge and attitudes toward diabetes was administered as part of the program. A convenience sample of the 129 health care providers in attendance resulted in 91 (71%) completed pre- and postintervention surveys. RESULTS: Within-subjects analysis revealed increases in knowledge and more favorable attitudes toward diabetes after the program. Between-subjects analysis revealed that attitude changes differed for physicians as compared with allied health care providers. CONCLUSIONS: A CME program was associated with an increase in knowledge of diabetes and more favorable attitudes toward diabetes as measured by the DAS. The DAS changes were subtly different for the physician group as compared with the allied health care provider group. These results suggest that the DAS can be a useful instrument for measuring the short-term impact of educational interventions.

Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments.

Few studies have evaluated Quality Of Life (QOL) among low-income patients with cancer. Information is needed about the feasibility and psychometric characteristics of QOL instruments in these populations. The purpose of this study was to examine the convergent and discriminant relationships between scales of three QOL instruments: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), Functional Assessment of Cancer Therapy--General (FACT), and Quality of Life Index (QLI). Participants included 110 men with metastatic prostate cancer of whom 94% were low income and 62% were African-American. Interviewers administered the questionnaires. Cronbach alpha internal consistency reliabilities were 0.57 to 0.90 for the EORTC, 0.65 to 0.86 for the FACT, and 0.63 for the QLI. Convergent validity was supported for the EORTC and FACT scales measuring emotional, physical, and role/functional dimensions (r = 0.54 to 0.72), but not on scales measuring social function (r = 0.12). Divergent validity was supported between dissimilar scales (r = 0.14 to 0.38). Analysis with receiver operating characteristics curves provided empirical support for the EORTC and FACT as multidimensional measures. These findings suggest that, even in busy clinical settings with low literacy patients, interviewer-administered EORTC and FACT QOL instruments can provide valid and reliable information.

Accelerating the coping process.

On the basis of previous work, freshmen should evidence improved health after writing about their thoughts and feelings associated with entering college. One hundred thirty subjects were assigned to write either about coming to college or about superficial topics for 20 min on 3 days. One fourth of the subjects in each group wrote during the 1st, 5th, 9th, or 14th week of classes. Physician visits for illness in the months after writing were lower for the experimental than for the control subjects. Self-reports of homesickness and anxiety were higher in the experimental group 2-3 months after writing. By year's end, experimental subjects were either superior or similar to control subjects in grade average and in positive moods. No effects emerged as a function of when people wrote, suggesting that the coping process can be accelerated. Implications for comparing insight treatments with catharsis and for distinguishing between objective and self-report indicators of distress are discussed.