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1.
J Clin Rheumatol ; 2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38446494

ABSTRACT

BACKGROUND/OBJECTIVE: To address high blood pressure (BP) in rheumatology patients, we previously implemented BP Connect, a brief staff-driven protocol to address high BP. Although timely follow-up and hypertension rates improved for patients with in-system primary care (PC), many receive PC and rheumatology care in separate health systems. In this cohort study, we compared rates of timely PC follow-up for high BP across-system health maintenance organizations (HMOs) before and after BP Connect implementation. METHODS: All adult patients with high rheumatology clinic BP and PC in that HMO were eligible. BP Connect's protocol engaged the staff in remeasuring high BP (≥140/90 mm Hg), advising cardiovascular disease risk, and connecting timely PC follow-up, which for patients with PC across system includes written follow-up instructions. After an eligible rheumatology visit, the next HMO PC visit with BP was used to determine rates and odds of timely follow-up before and after using multivariable logistic regression. RESULTS: Across 1327 rheumatology visits with high BP and across-system PC (2013-2019), 951 occurred after 2015 BP Connect implementation; 400 had confirmed high BP. Primary care follow-up rose from 20.5% to 23.5%. The odds of timely PC BP follow-up insignificantly changed (odds ratio, 1.19; confidence interval, 0.85-1.68). For visits with Black patients, the odds of timely follow-up did significantly increase (1.95; confidence interval, 1.02-3.79). CONCLUSIONS: Timely follow-up for Black patients did improve, highlighting protocol interventions for more equitable health care. In contrast to our prior in-system study, BP Connect did not significantly improve follow-up with an across-system PC, indicating a need for direct scheduling. Future directions include piloting direct across-system scheduling.

2.
J Community Health ; 48(5): 761-768, 2023 10.
Article in English | MEDLINE | ID: mdl-37097507

ABSTRACT

Little is known about adherence to COVID-19 masking mandates on college campuses or the relationship between weather-related variables and masking. This study aimed to (1) observe students' adherence to on-campus mask mandates and (2) estimate the effect of weather on mask-wearing. Temple University partnered in the Centers for Disease Control and Prevention's observational Mask Adherence Surveillance at Colleges and Universities Project. February-April 2021, weekly observations were completed at 12 on-campus locations to capture whether individuals wore masks, wore them correctly, and the type of mask worn. Fashion and university masks also were recorded. Weekly average temperature, humidity, and precipitation were calculated. Descriptive statistics were calculated for masking adherence overall, over time, and by location. Statistical significance was assessed between correct mask use and mask type and the linear relationships between weekly weather metrics and mask use. Overall, 3508 individuals were observed with 89.6% wearing masks. Of those, 89.4% correctly wore masks. Cloth (58.7%) and surgical masks (35.3%) were most commonly observed and 21.3% wore fashion masks. N95/KN95 masks were correctly worn in 98.3% of observations and surgical and cloth masks were correctly worn ~ 90% of the time. Weekly adherence varied over time and by campus location. Significant inverse linear relationships existed between weekly temperature (r = - 0.72; p < 0.05) and humidity (r = - 0.63; p ≤ 0.05) and masking. Mask adherence and correct use was high. Temperature and humidity inversely affected adherence. Adherence varied by on-campus location, which suggests the locations (e.g., academic buildings, recreational center) and possibly the characteristics of individuals who frequent certain areas impacted adherence.


Subject(s)
Benchmarking , COVID-19 , United States , Humans , COVID-19/prevention & control , Weather , Temperature , Masks
3.
J Am Coll Health ; : 1-9, 2023 Mar 28.
Article in English | MEDLINE | ID: mdl-36977341

ABSTRACT

Many students come to higher education with a history of trauma. College life may also expose students to traumatizing events. While the past decade has witnessed greater discussion of trauma-informed frameworks, it has not regularly been applied to the college environment. We advance the concept of a trauma-informed campus, where administrators, faculty, staff, and students from diverse disciplines create an environment that recognizes the widespread nature of trauma, integrates knowledge about trauma into practices and procedures, and minimizes further re-traumatization for all community members. A trauma-informed campus is prepared for students' past or future traumatic experiences, while also recognizing and responding to structural and historical harms. In addition, it recognizes the role of the surrounding community challenges, particularly how violence, substance use, hunger, poverty, and housing insecurity may contribute to further trauma or negatively impact healing. We use an ecological model to frame and shape the construct of trauma-informed campuses.

4.
Soc Work Public Health ; 38(2): 121-134, 2023 02 17.
Article in English | MEDLINE | ID: mdl-35833750

ABSTRACT

Social workers and public health professionals in the U.S. were profoundly impacted by COVID-19, systemic racism, and the 2020 U.S. presidential election. This study examined their external job support, burnout, and job satisfaction in the context of these circumstances. The findings suggest respondents, who had graduate degrees in social work or public health, overemphasized their job satisfaction and underemphasized their burnout. While social work and public health professionals felt satisfied with their labor, not acknowledging burnout limits the amount of support they may access to effectively continue the work. Interestingly, participants who had more administrative functions reported higher job satisfaction scores and lower burnout scores. Traditionally, those in administrative positions have more control over their schedule and work responsibilities. Findings suggest that more training, opportunities for self-care, and discussions about safety and systemic racism are needed in the workplace for social workers and public health professionals.


Subject(s)
Burnout, Professional , COVID-19 , Humans , Public Health , Social Work , Health Personnel , Job Satisfaction , Surveys and Questionnaires
5.
J Interpers Violence ; 38(5-6): 5164-5189, 2023 03.
Article in English | MEDLINE | ID: mdl-36120995

ABSTRACT

Intimate partner violence is a preventable public health problem affecting more than 12 million people in the United States annually. The immense burden of victimization is most often borne by women. Nearly one in two female homicide victims are killed by current or former partners (more than 50% of which involve firearms). Firearm-related morbidity and mortality are concentrated where firearm ownership is most prevalent and firearm laws are least restrictive, indicating the potential for law to serve as an intervention. Understanding intricacies within laws and how they vary is critical to studying their influence on health. This study is the first to use the scientific legal mapping technique of policy surveillance to create legal data by systematically collecting and coding laws that authorize or require courts to prohibit offenders subject to domestic violence restraining orders (DVROs) and temporary restraining orders (TROs) from purchasing and possessing firearms ("firearm prohibitor" laws). These data measure key provisions of federal and state laws from 1991 to 2016, including whether the law includes a firearm prohibition, who qualifies as an intimate partner, notice and hearing requirements, whether the prohibition occurs automatically or through judicial discretion, and if the law permits or requires the relinquishment or removal of firearms. The federal law, enacted in 1994 (and reauthorized in 2022), only protects qualifying victims that obtain final DVROs. States can mirror or go beyond federal measures. From 1991 to 2016, 38 states enacted a firearm prohibitor law through DVROs (37 states), TROs (20 states), or both (19 states). Today, survivors suffer from a sluggish and fragmented legal system leading to the unequal protection of victims based on where they happen to live. This research provides an in-depth descriptive analysis of this complex and nuanced legal system, recommendations to spur policy reform, and longitudinal data for future research.


Subject(s)
Criminals , Domestic Violence , Firearms , Intimate Partner Violence , Humans , Female , United States , Homicide , Domestic Violence/prevention & control
6.
Health Policy Plan ; 37(8): 990-999, 2022 Sep 13.
Article in English | MEDLINE | ID: mdl-35668650

ABSTRACT

Nineteen out of 22 countries in the Eastern Mediterranean region, including the Gulf Cooperation Council countries, have ratified the World Health Organization Framework Convention on Tobacco Control (FCTC) treaty. One of FCTC's provisions prohibits tobacco advertisement, promotion and sponsorship (TAPS). The TAPS provision requires nations to ban direct and indirect tobacco ads in media, as exposure to tobacco use in the media encourages smoking initiation. A limited number of studies have examined TAPS in Arabic media. This study examined the occurrence of tobacco use across Arabic television (TV) series released between January 2017 and December 2019 to assess compliance with the FCTC provision banning TAPS. The content analysis examined incidents of tobacco use in Arabic TV series, types of tobacco products used and the portrayal of second-hand smoking exposure. Out of 92 Arabic TV series (2952 episodes), there were 32 044 incidents of tobacco use. Incidents of tobacco use per episode fluctuated over time. During Ramadan, the median number of tobacco incidents declined from 6 in 2017 to 3 in 2019; however, it increased to 8 in 2018. Regular cigarettes and water pipes were the most common tobacco products used in TV series. While 27% of tobacco use showed characters who smoked tobacco products alone, 13% of the incidents portrayed characters who were smoking in the presence of children. This study concludes that tobacco imagery is not completely banned in Arabic media and its continued representation weakens tobacco control measures.


Subject(s)
Tobacco Industry , Tobacco Products , Advertising , Child , Humans , Smoking Prevention , Nicotiana , Tobacco Use/epidemiology , World Health Organization
7.
Prev Med Rep ; 26: 101711, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35145839

ABSTRACT

The Gulf Cooperation Council (GCC) countries - Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE) - ratified the Framework Convention on Tobacco Control (FCTC) in 2006. Yet, GCC countries predict a slight reduction in tobacco use compared to the Eastern Mediterranean region's significant downward trend. The purpose of this study was to examine changes in self-reported intention to initiating tobacco use (susceptibility) among youth over time in five GCC countries and the relationship between susceptibility and key FCTC provisions. Complex sample logistic regression analyses were conducted using data from the 2001 to 2018 Global Youth Tobacco Survey (n = 349,878 adolescents). Since the ratification of FCTC in GCC countries, susceptibility to initiate tobacco use significantly decreased in Bahrain and Qatar while it increased in UAE (P < 0.001). Exposure to smoking in public places increased the odds of susceptibility to tobacco use in Bahrain (AOR = 1.6, 95% CI = [1.2-2.2), Kuwait (AOR = 1.6, 95% CI = [1.2-2.0]), Qatar (AOR = 1.9, 95% CI = [1.4-2.6]), and UAE (AOR = 2.1, 95% CI = [1.6-2.7]). Susceptibility to tobacco use was significantly associated with exposure to tobacco imagery in media in the UAE (AOR = 1.7, 95% CI = [1.2-2.3]) and with tobacco industry activities like promotion in Bahrain (AOR = 2.8, 95% CI = [1.9-4.2]) and Kuwait (AOR = 2.2, 95% CI = [1.5-3.1]). In conclusion, the impact of FCTC provisions on tobacco use differs across countries. Findings suggested that the implementation of tobacco control policies may independently influence the initiation of tobacco use.

8.
J Interpers Violence ; 37(17-18): NP15620-NP15648, 2022 09.
Article in English | MEDLINE | ID: mdl-34076546

ABSTRACT

Intimate partner violence (IPV) research on immigrant women who are unauthorized is particularly scarce, despite unique vulnerabilities associated with their documentation status that may impact help-seeking and health outcomes. The purpose of this study was to document the frequency of lifetime IPV and related help-seeking behaviors, and examine the relationship between IPV, major depressive disorder (MDD), post-traumatic stress disorder (PTSD), and health-related quality of life (HRQL) among a community health center-based sample of unauthorized, Spanish-speaking immigrant women in Philadelphia. A clinic-based sample of unauthorized Spanish-speaking women (N = 200, ages 18-65) completed an anonymous, cross-sectional survey on IPV experiences, help-seeking behaviors, and self-reported health in 2013-2014. Chi-square tests assessed associations between sociodemographic variables and IPV. Multivariable logistic regression investigated whether IPV predicted mental health outcomes. Approximately one in three (34.5%) women reported lifetime IPV experiences. Of these, half (56.6%) sought help (formal n = 22; informal n = 25) because of the violence. Women identified not knowing where to go, believing that help was not necessary, and embarrassment as barriers to help-seeking. Symptoms consistent with MDD and PTSD were reported by 40.5% and 16% of the sample, respectively. In unadjusted logistic regression models, IPV survivors were more likely to endorse MDD and PTSD, and report low mental health HRQL scores than counterparts without IPV. In fully adjusted models, only the association between IPV and PTSD remained significant (OR: 3.80, p =.01). Study findings document high frequencies of IPV, MDD, and PTSD among this clinic-based sample of unauthorized immigrant women. Women who reported IPV also had a greater likelihood of reporting symptoms consistent with PTSD. Findings highlight the need for clinic-based mental health and trauma-informed services tailored to unauthorized immigrant women as well as interventions to decrease IPV.


Subject(s)
Depressive Disorder, Major , Intimate Partner Violence , Undocumented Immigrants , Adolescent , Adult , Aged , Cross-Sectional Studies , Female , Humans , Intimate Partner Violence/psychology , Male , Middle Aged , Quality of Life , Risk Factors , Young Adult
9.
Surg Obes Relat Dis ; 18(2): 271-280, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34753674

ABSTRACT

BACKGROUND: Insurance-mandated precertification requirements are barriers to bariatric surgery. The value of their prescription, based on insurance type rather that the clinical necessity, is unclear. OBJECTIVES: To determine whether there is an association between insurance-mandated precertification criteria for bariatric surgery and short-term inpatient healthcare utilization. SETTING: Pennsylvania Health Care Cost Containment Council's inpatient care databases for the years 2016-2017. METHODS: The study included 2717 adults who underwent bariatric surgery in Southeastern Pennsylvania in 2016. Postoperative length of stay and rehospitalizations for these individuals were followed using clinical and claims data during the first year after bariatric surgery. RESULTS: The requirements for 3- to 6-month preoperative medical weight management, as well as pulmonology and cardiology examinations, were not associated with the patient length of stay, number of all-cause rehospitalizations, or number of all-cause rehospitalization days after adjusting for patient age, sex, race, ethnicity, the Elixhauser comorbidity score, type of the surgery, facility where the surgery was performed, primary payer type, and the estimated median household income. Among commercially insured individuals (n = 1499), the mean number of all-cause rehospitalizations during the study period was lower in patients with no medical weight management requirement by a factor of .57 (lower by 43.1%; 95% confidence interval, .35-.94, P = .03) and higher in patients with no requirement for preoperative cardiology and pulmonology evaluations by a factor of 2.09 (95% confidence interval 1.09-4.02, P = .03). CONCLUSION: The findings suggest that the precertification requirement for preoperative medical weight management is not associated with a reduction in inpatient healthcare utilization in the first postoperative year.


Subject(s)
Bariatric Surgery , Inpatients , Adult , Humans , Insurance, Health , Patient Acceptance of Health Care , Pennsylvania , Retrospective Studies
10.
Subst Abuse Treat Prev Policy ; 16(1): 57, 2021 07 03.
Article in English | MEDLINE | ID: mdl-34217327

ABSTRACT

BACKGROUND: The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) was developed to assist nations in reducing the demand and supply of tobacco. As of 2020, 182 nations joined the FCTC, agreeing to implement the recommended tobacco control measures. The Gulf Cooperation Council (GCC) countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and United Arab Emirates (UAE) ratified the WHO FCTC by August 2006. Given the unique political, cultural, and religious context - and known tobacco industry efforts to influence tobacco use- in these nations, a careful examination of the translation of FCTC measures into policy is needed. This study aimed to assess the implementation of FCTC tobacco control measures at the national level within the six GCC countries. METHOD: We collected and coded the FCTC measures that were implemented in the GCC countries. We examined trends and variations of the implementation between 2008 and 2020. RESULTS: GCC countries implemented most FCTC measures targeting the demand for and supply of tobacco, with some variation among countries. Bahrain and Qatar were more comprehensively implementing FCTC measures while Kuwait and Oman implemented the least number of the FCTC measures. Implementing measures related to tobacco prices and eliminating the illicit tobacco trade has slowly progressed in GCC countries. All GCC countries entirely banned smoking in workplaces while three countries implemented a partial ban in restaurants. Only Oman has restrictions on tobacco ads shown in media. There is progress in implementing FCTC measures related to tobacco packaging, cessation, and sale to minors in most GCC countries. CONCLUSIONS: Given the influence of the tobacco industry in the Gulf region, the findings suggest a need for ongoing surveillance to monitor the proliferation of tobacco control measures and evaluate their effectiveness. Efforts required to address tobacco use should correspond to the unique political and cultural background of the GCC countries.


Subject(s)
Nicotiana , Tobacco Use , Humans , Kuwait , Oman/epidemiology , Qatar , Saudi Arabia
11.
Surg Obes Relat Dis ; 17(5): 860-868, 2021 May.
Article in English | MEDLINE | ID: mdl-33664010

ABSTRACT

BACKGROUND: Bariatric surgery is underutilized in the United States. OBJECTIVE: To examine temporal changes in patient characteristics and insurer type mix among adult bariatric surgery patients in southeastern Pennsylvania and to investigate the associations between payor type, insurance plan type, cost-sharing arrangements (among traditional Medicare beneficiaries), and bariatric surgery utilization. SETTING: Pennsylvania Health Care Cost Containment Council's databases in southeastern Pennsylvania during 2014-2018. METHODS: All adult patients who underwent the most common types of bariatric surgery and a 1:1 matched sample of surgery patients and those who were eligible for surgery but did not undergo surgery were identified. Contingency tables, Pearson χ2 tests, and logistic regression were used for statistical analysis. RESULTS: Over the 5 years, there was an increase in the proportion of Black individuals (37.1% in 2014 versus 43.0% in 2018), Hispanics (5.4% versus 8.0%), and Medicaid beneficiaries (19.2% in 2014 versus 28.5% in 2018) who underwent surgery. The odds of undergoing bariatric surgery based on payor type only between Medicare beneficiaries were statistically different (22% smaller odds) compared with privately insured individuals. There were significantly different odds of undergoing surgery based on insurance plan type within Medicare and private insurance payor categories. Individuals with traditional Medicare plans with no supplementary insurance and those with dual eligibility had smaller odds of undergoing surgery (42% and 32%, respectively) compared with those with private secondary insurance. CONCLUSIONS: Insurance plan design may be as important in determining the utilization of bariatric surgery as the general payor type after controlling for confounding socio-demographic factors.


Subject(s)
Bariatric Surgery , Medicare , Adult , Aged , Humans , Insurance, Health , Medicaid , Pennsylvania , United States
12.
Med Care ; 58(11): 952-957, 2020 11.
Article in English | MEDLINE | ID: mdl-32868693

ABSTRACT

BACKGROUND: Access to bariatric surgery is restricted by insurers in numerous ways, including by precertification criteria such as 3-6 months preoperative supervised medical weight management and documented 2-year weight history. OBJECTIVES: To investigate if there is an association between the aforementioned precertification criteria, insurance plan type, and the likelihood of undergoing bariatric surgery, after controlling for potential sociodemographic confounders. RESEARCH DESIGN: The study was conducted using the Pennsylvania Health Care Cost Containment Council's data in 5 counties of Pennsylvania in 2016 and records of preoperative insurance requirements maintained by the Temple University Bariatric Surgery Program.Privately insured bariatric surgery patients and individuals who met the eligibility criteria but did not undergo surgery were identified and 1:1 matched by sex, race, age group, and zip code (n=1054). Univariate tests and logistic regression analysis were utilized for data analysis. RESULTS: The insurance requirement for 3-6 months preoperative supervised medical weight management was associated with smaller odds of undergoing surgery [odds ratio (OR)=0.459; 95% confidence interval (CI), 0.253-0.832; P=0.010], after controlling for insurance plan type and the requirement for documented weight history.Preferred provider organization (OR=1.422; 95% CI, 1.063-1.902; P=0.018) and fee-for-service (OR=1.447; 95% CI, 1.021-2.050; P=0.038) plans were associated with greater odds of undergoing surgery, compared with health maintenance organization plans, after controlling for the studied precertification requirements. The documented weight history requirement was not a significant predictor of the odds of undergoing surgery (P=0.132). CONCLUSIONS: There is a need for consideration of insurance benefits design as a determinant of access to bariatric surgery.


Subject(s)
Bariatric Surgery/statistics & numerical data , Eligibility Determination/statistics & numerical data , Insurance Coverage/statistics & numerical data , Insurance, Health/standards , Obesity, Morbid/surgery , Adolescent , Adult , Age Factors , Aged , Female , Humans , Male , Middle Aged , Pennsylvania , Racial Groups , Residence Characteristics , Sex Factors , United States , Young Adult
13.
Mol Genet Metab ; 129(4): 278-285, 2020 04.
Article in English | MEDLINE | ID: mdl-32029355

ABSTRACT

Eliglustat is an oral substrate reduction therapy indicated for patients with Gaucher disease type 1. Based on in vitro data, clinical trials were conducted to assess the potential for drug-drug interactions between eliglustat and digoxin (P-glycoprotein substrate), metoprolol (sensitive CYP2D6 substrate), a combined oral contraceptive (CYP3A substrate), and acid-reducing agents. Healthy subjects were enrolled in four Phase 1 clinical studies to evaluate the effect of eliglustat on the pharmacokinetics, safety, and tolerability of digoxin (N = 28), metoprolol (N = 14), and a combined oral contraceptive (N = 30) and the effect of acid-reducing agents on eliglustat pharmacokinetics, safety, and tolerability (N = 24). Coadministration resulted in increased exposure to digoxin (1.49-fold) and metoprolol (2-fold) with eliglustat, negligible effects on oral contraceptive pharmacokinetics with eliglustat, and a negligible effect of acid-reducing agents on eliglustat pharmacokinetics. Across all studies, eliglustat was well-tolerated. One serious adverse event (spontaneous abortion) and one discontinuation due to an adverse event (urinary tract infection) were reported, both during the acid-reducing agents study. When eliglustat is coadministered with medications that are P-glycoprotein or CYP2D6 substrates, lower doses of these concomitant medications may be required. Eliglustat may be coadministered with oral contraceptives and acid-reducing agents without dose modifications for either drug.


Subject(s)
Contraceptives, Oral/pharmacokinetics , Digoxin/pharmacokinetics , Metoprolol/pharmacokinetics , Proton Pump Inhibitors/administration & dosage , Pyrrolidines/administration & dosage , Adolescent , Adult , Contraceptives, Oral/administration & dosage , Contraceptives, Oral/adverse effects , Cross-Over Studies , Digoxin/administration & dosage , Digoxin/adverse effects , Drug Interactions , Female , Humans , Male , Metoprolol/administration & dosage , Metoprolol/adverse effects , Middle Aged , Proton Pump Inhibitors/adverse effects , Young Adult
14.
Mol Genet Metab Rep ; 22: 100552, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31993325

ABSTRACT

Eliglustat is an oral glucosylceramide synthase inhibitor indicated for the long-term treatment of adults with Gaucher disease type 1 and CYP2D6 extensive, intermediate, or poor metabolizer phenotypes. Eliglustat is metabolized primarily by CYP2D6 and to a lesser extent by CYP3A4 and is a substrate of P-glycoprotein (P-gp). Three studies evaluated the effects of paroxetine (strong CYP2D6 inhibitor), ketoconazole (strong CYP3A4 and P-gp inhibitor), and rifampin (strong CYP3A4/P-gp inducer; OATP inhibitor) on the pharmacokinetics of orally administered eliglustat in healthy adults. An 8.9-fold increase in eliglustat exposure following co-administration of multiple-dose eliglustat and paroxetine is attributed to inhibition of CYP2D6-mediated metabolism of eliglustat by paroxetine. A 4.3-fold increase in eliglustat exposure following co-administration of multiple-dose eliglustat and ketoconazole is attributed to inhibition of CYP3A4-mediated metabolism and/or P-gp-mediated transport of eliglustat by ketoconazole. Co-administration of eliglustat with oral doses of rifampin reduced eliglustat exposure by >85% due to induction of CYP3A4/P-gp by rifampin, while a single intravenous dose of rifampin had no effect on eliglustat, confirming that eliglustat is not an OATP substrate. Depending on CYP2D6 metabolizer phenotype, co-administration of eliglustat with CYP2D6 and/or CYP3A inhibitors or CYP3A inducers may alter eliglustat exposure, warrant dosage adjustment or use with caution, or be contraindicated.

15.
Blood Cells Mol Dis ; 68: 185-191, 2018 02.
Article in English | MEDLINE | ID: mdl-28126395

ABSTRACT

Eliglustat, an oral substrate reduction therapy, is a first-line therapy for adults with Gaucher disease type 1 and a compatible CYP2D6 metabolizer phenotype. Clinicians have requested more information about frequency, timing, and duration of adverse events associated with eliglustat. Adverse event data as of January 31, 2013 for all patients who received at least one dose of eliglustat were pooled from four eliglustat clinical trials (393 patients representing 535 patient-years of exposure). The following 10 adverse events noted in the eliglustat US Prescribing Information (USPI) and EU Summary of Product Characteristics (SmPC) were evaluated with regard to frequency, drug-relatedness, severity, seriousness, duration, and timing of onset: headache, arthralgia, diarrhea, nausea, fatigue, flatulence, abdominal pain, upper abdominal pain, back pain, and extremity pain. Of 393 patients, 334 experienced one or more adverse events. Most patients (92%) continued taking eliglustat; 3% withdrew from a trial due to an adverse event. Among the 10 adverse events evaluated, none was reported as serious and none resulted in discontinuing treatment; most were mild or moderate, reported only once, and not considered eliglustat-related. The majority of adverse events noted in the eliglustat USPI and SmPC were non-serious, occasional, non-severe, and did not lead to drug discontinuation.


Subject(s)
Enzyme Inhibitors/adverse effects , Gaucher Disease/drug therapy , Pyrrolidines/adverse effects , Adult , Enzyme Inhibitors/administration & dosage , Enzyme Inhibitors/therapeutic use , Enzyme Replacement Therapy , Female , Humans , Male , Middle Aged , Pyrrolidines/administration & dosage , Pyrrolidines/therapeutic use , Young Adult
17.
Addiction ; 112(12): 2206-2216, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28696583

ABSTRACT

AIMS: (1) To describe open source legal data sets, created for research use, that capture the key provisions of US state medical marijuana laws. The data document how state lawmakers have regulated a medicine that remains, under federal law, a Schedule I illegal drug with no legitimate medical use. (2) To demonstrate the variability that exists across states in rules governing patient access, product safety and dispensary practice. METHODS: Two legal researchers collected and coded state laws governing marijuana patients, product safety and dispensaries in effect on 1 February 2017, creating three empirical legal data sets. We used summary tables to identify the variation in specific statutory provisions specified in each state's medical marijuana law as it existed on 1 February 2017. We compared aspects of these laws to the traditional Federal approach to regulating medicine. Full data sets, codebooks and protocols are available through the Prescription Drug Abuse Policy System (http://www.pdaps.org/; Archived at http://www.webcitation.org/6qv5CZNaZ on 2 June 2017). RESULTS: Twenty-eight states (including the District of Columbia) have authorized medical marijuana. Twenty-seven specify qualifying diseases, which differ across states. All states protect patient privacy; only 14 protect patients against discrimination. Eighteen states have mandatory product safety testing before any sale. While the majority have package/label regulations, states have a wide range of specific requirements. Most regulate dispensaries (25 states), with considerable variation in specific provisions such as permitted product supply sources number of dispensaries per state and restricting proximity to various types of location. CONCLUSIONS: The federal ban in the United States on marijuana has resulted in a patchwork of regulatory strategies that are not uniformly consistent with the approach usually taken by the Federal government and whose effectiveness remains unknown.


Subject(s)
Consumer Product Safety/legislation & jurisprudence , Drug and Narcotic Control/legislation & jurisprudence , Marijuana Use/legislation & jurisprudence , Medical Marijuana/economics , State Government , Commerce/economics , Commerce/legislation & jurisprudence , Drug and Narcotic Control/economics , Humans , Marijuana Use/adverse effects , Marijuana Use/economics , Medical Marijuana/adverse effects , United States
18.
J Public Health Manag Pract ; 23(6): 658-666, 2017.
Article in English | MEDLINE | ID: mdl-28538338

ABSTRACT

OBJECTIVE: Law powerfully influences health and can be a critical tool for promoting population well-being. Evaluation research is needed to measure the health effects of law and guide policy making and implementation. The purpose of this study was to assess trends in National Institutes of Health (NIH) funding for scientific public health law research (PHLR). METHODS: Using data from the UberResearch NIH grant repository, we collected and coded all grants with a focus on health law between FY'85 and FY'14 and then analyzed the grants by funding agency and topic areas. RESULTS: Between FY'85 and FY'14, NIH funded 510 research grants on health policy making, the health effects of laws or enforcement practices. On average, 4 PHLR grants were funded annually with a median total funding of $545 956 (range: $2535-$44 052 300) and a median annual funding of $205 223 (range: $2535-$7 019 517). CONCLUSIONS: National Institutes of Health has supported important PHLR but not nearly to the extent necessary to ensure that public health laws affecting the population are evaluated in a rigorous and timely manner. In addition to greater funding evaluation research, NIH can increase its support for creating legal datasets, fund training in PHLR, and work with the National Library of Medicine to create Medical Subject Headings (MeSH) terms related to PHLR.


Subject(s)
Evidence-Based Practice/legislation & jurisprudence , Financing, Government/economics , Health Policy/legislation & jurisprudence , Public Health/legislation & jurisprudence , Evidence-Based Practice/history , Financing, Government/legislation & jurisprudence , Financing, Government/methods , Health Policy/history , History, 20th Century , History, 21st Century , Humans , National Institutes of Health (U.S.)/economics , National Institutes of Health (U.S.)/organization & administration , Policy Making , Research/history , Research/trends , United States
19.
J Health Polit Policy Law ; 41(6): 1151-1173, 2016 12.
Article in English | MEDLINE | ID: mdl-27531941

ABSTRACT

Governments use statutes, regulations, and policies, often in innovative ways, to promote health and safety. Organizations outside government, from private schools to major corporations, create rules on matters as diverse as tobacco use and paid sick leave. Very little of this activity is systematically tracked. Even as the rest of the health system is working to build, share, and use a wide range of health and social data, legal information largely remains trapped in text files and pdfs, excluded from the universe of usable data. This article makes the case for the practice of policy surveillance to help end the anomalous treatment of law in public health research and practice. Policy surveillance is the systematic, scientific collection and analysis of laws of public health significance. It meets several important needs. Scientific collection and coding of important laws and policies creates data suitable for use in rigorous evaluation studies. Policy surveillance addresses the chronic lack of readily accessible, nonpartisan information about status and trends in health legislation and policy. It provides the opportunity to build policy capacity in the public health workforce. We trace its emergence over the past fifty years, show its value, and identify major challenges ahead.


Subject(s)
Health Policy , Public Health , Government Programs , Humans , Organizations , Policy
20.
Mol Genet Metab Rep ; 8: 17-9, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27408819

ABSTRACT

Eliglustat is a recently approved oral therapy in the United States and Europe for adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers (> 90% of patients) that has been shown to decrease spleen and liver volume and increase hemoglobin concentrations and platelet counts in untreated adults with Gaucher disease type 1 and maintain these parameters in patients previously stabilized on enzyme replacement therapy. In a post-hoc analysis, we compared the results of eliglustat treatment in treatment-naïve patients in two clinical studies with the results of imiglucerase treatment among a cohort of treatment-naïve patients with comparable baseline hematologic and visceral parameters in the International Collaborative Gaucher Group Gaucher Registry. Organ volumes and hematologic parameters improved from baseline in both treatment groups, with a time course and degree of improvement in eliglustat-treated patients similar to imiglucerase-treated patients.

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