Plastic Surgeons' Perspective on the FDA Breast Implant Regulatory Mandates.

BACKGROUND: In 2021, the US FDA issued a new checklist, labeling, and rupture-screening recommendations for breast implants to improve the decision-making process. OBJECTIVES: The aim of this study was to understand plastic surgeons' perspective on these changes and their perceived impact on clinical practice. METHODS: In September 2023, a 27-question multiple-choice cross-sectional survey was distributed to 4352 active members of the American Society of Plastic Surgeons to evaluate attitudes on the FDA's black-box warning, informed decision checklist, and updated rupture-screening recommendations. RESULTS: A total of 591 responses were collected (13.6%). The majority of respondents were between the ages of 45 and 64 years (58%) and had been in practice for more than 20 years (52%). Surgeons felt that some additions were appropriate; however, the majority (57%) stated that the informed decision checklist did not have a positive impact on workflow; 66% were also neutral or disagreed with the reported incidence rates related to complications and cancer. Nearly half of respondents (47%) did not feel the black-box warning improved their patients' understanding of the risks and benefits. Additionally, 47% of respondents also believed these requirements, in combination, did not improve the overall patient experience with implants. CONCLUSIONS: Respondents had an overall positive response towards the addition of risk information provided by the FDA-issued guidance and updates to rupture-screening recommendations. However, they remained divided as to whether the black-box warning and patient decision checklist had an overall positive impact on clinical practice patterns.

The 2017 North Carolina STOP Act is Associated With an Accelerated Decrease in Opioid Dispensing: A Statewide Analysis, 2013-2019.

Background: This study aimed to: 1) quantify the dispensing and days' supply of opioid prescriptions prior to and after the NC STOP Act went into effect among Medicare Part D beneficiaries; 2) evaluate how the STOP Act impacted physician assistant and nurse practitioner opioid prescribing; and 3) evaluate whether the NC STOP Act is associated with reductions in opioid prescriptions' days' supply among Medicare Part D beneficiaries. Methods: This was a secondary analysis of Medicare Part D Public Use Files for 2013-2019. Only North Carolina providers and select Schedule II (CII) and III (CIII) drugs and tramadol (CV) were included in the analysis. Multivariable Poisson regression models were used to analyze the data. Results: In 2013, there were population-adjusted 180,565.2/100,000 claims for the included CII and CIII opioids, which decreased to 79,329.12/100,000 claims in 2019. Each of the multivariable Poisson regression models indicates a reduction in per-provider populationadjusted claims and days' supply after the NC STOP Act went into effect for both selected CII and CIII medications and for tramadol. The results also indicate that the number of prescriptions for CII, CIII, and tramadol decreased over time. Limitations: Due to the nature of the observational study design, we cannot conclude that the 2017 legislation had an effect on populationadjusted claims for certain CII and CIII opioids. Conclusions: Since 2013 there has been a decreasing trend in certain CII and CIII opioids dispensations in Medicare beneficiaries, and the trend accelerated after the STOP Act went into effect.

Government Mandated Consent Dramatically Reduces Pediatric Urologist Opioid Utilization for Outpatient and Minor Emergency Surgeries.

PURPOSE: Postoperative opioids are overprescribed in the United States. In November 2016 the State of Pennsylvania required an opioid consent for minors. Our hypothesis is that this mandate decreased postoperative opioid prescriptions in our division. MATERIALS AND METHODS: All patients who received a urological outpatient or minor emergency procedure from August 2015 to August 2019 were identified. Surgeries performed within 6 months after mandate implementation were excluded to account for the transition period. Perioperative data including case type were extracted by a clinical data warehouse from preexisting fields within the health record. The frequencies of postoperative prescriptions, delayed prescriptions and emergency department encounters were assessed. A multivariable logistic regression to identify predictors of opioid prescription at discharge was performed. RESULTS: A total of 4,349 patients were analyzed. The frequency of postsurgical opioid prescriptions decreased from 45.3% to 2.6% (p <0.001). The median morphine milligram equivalent decreased by 22.5 among children prescribed an opioid (p <0.001). Rates of an emergency department visits (3% vs 2.7%) or delayed nonopioid prescriptions (0.8% vs 1.2%) within 30 days of discharge were unchanged (p >0.05). Fewer patients received a delayed opioid prescription after mandate implementation (0.03% vs 0.5%, p <0.001). Female patients were less likely (OR 0.309, 95% CI 0.195-0.491; p <0.001) to receive opioids prior to but not after the mandate (OR 0.309, 95% CI 0.544-2.035; p=0.122). Increasing age was predictive of receiving an opioid before (OR 1.187, 95% CI 1.157-1.218; p <0.001) and after (OR 1.241, 95% CI 1.186-1.299; p <0.001) the mandate. CONCLUSIONS: A state mandated opioid consent for minors greatly reduced post-urological surgery opioid prescription rates without increasing rates of readmission or delayed prescriptions.

Vascular surgery-related violations of the Emergency Medical Treatment and Labor Act.

OBJECTIVE: The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law established in 1986 to ensure that patients who present to an emergency department receive medical care regardless of means. Violations are reported to the Centers for Medicare and Medicaid Services and can result in significant financial penalties. Our objective was to assess all available EMTALA violations for vascular-related issues. METHODS: EMTALA violations in the Centers for Medicare and Medicaid Services publicly available hospital violations database from 2011 to 2018 were evaluated for vascular-related issues. Details recorded were case type, hospital type, hospital region, reasons for violation, disposition, and mortality. RESULTS: There were 7001 patients identified with any EMTALA violation and 98 (1.4%) were deemed vascular related. The majority (82.7%) of EMTALA violations occurred at urban/suburban hospitals. Based on the Association of American Medical Colleges United States region, vascular-related EMTALA violations occurred in the Northeast (7.1%), Southern (56.1%), Central (18.4%), and Western (18.4%) United States. Case types included cerebrovascular (28.6%), aortic related (22.4%; which consisted of ruptured aortic aneurysms [8.2%], aortic dissection [11.2%], and other aortic [3.1%]), vascular trauma (15.3%), venous-thromboembolic (15.3%), peripheral arterial disease (9.2%), dialysis access (5.1%), bowel ischemia (3.1%), and other (1%) cases. Patients were transferred to another facility in 41.8% of cases. The most common reasons for violation were specialty refusal or unavailability (30.6%), inappropriate documentation (29.6%), misdiagnosis (18.4%), poor communication (17.3%), inappropriate triage (13.3%), failure to obtain diagnostic laboratory tests or imaging (12.2%), and ancillary or nursing staff issues (7.1%). The overall mortality was 19.4% and 31.6% died during the index emergency department visit. Vascular conditions associated with death were venous thromboembolism (31.6%), ruptured aortic aneurysm (21.1%), aortic dissection (21.1%), other aortic causes (10.5%), vascular trauma (10.5%), and bowel ischemia (5.3%). CONCLUSIONS: Although the frequency of vascular-related EMTALA violations was low, improvements in communication, awareness of vascular disease among staff, specialty staffing, and the development of referral networks and processes are needed to ensure that patients receive adequate care and that institutions are not placed at undue risk.

Reasons for poor blood pressure control in Eastern Sub-Saharan Africa: looking into 4P's (primary care, professional, patient, and public health policy) for improving blood pressure control: a scoping review.

AIM: Hypertension control in Sub-Saharan Africa (SSA) is the worst (less than one out of ten) when compared to the rest of the world. Therefore, this scoping review was conducted to identify and describe the possible reasons for poor blood pressure (BP) control based on 4Ps' (patient, professional, primary healthcare system, and public health policy) factors. METHODS: PRISMA extension for scoping review protocol was used. We systematically searched articles written in the English language from January 2000 to May 2020 from the following databases: PubMed/Medline, Embase, Scopus, Web of Science, and Google scholar. RESULTS: Sixty-eight articles were included in this scoping review. The mean prevalence of hypertension, BP control, and patient adherence to prescribed medicines were 20.95%, 11.5%, and 60%, respectively. Only Kenya, Malawi, and Zambia out of ten countries started annual screening of the high-risk population for hypertension. Reasons for nonadherence to prescribed medicines were lack of awareness, lack of access to medicines and health services, professional inertia to intensify drugs, lack of knowledge on evidence-based guidelines, insufficient government commitment, and specific health behaviors related laws. Lack of screening for high-risk patients, non-treatment adherence, weak political commitment, poverty, maternal and child malnutrition were reasons for the worst BP control. CONCLUSION: In conclusion, the rate of BP treatment, control, and medication adherence was low in Eastern SSA. Screening for high-risk populations was inadequate. Therefore, it is crucial to improve government commitment, patient awareness, and access to medicines, design country-specific annual screening programs, and empower clinicians to follow individualized treatment and conduct medication adherence research using more robust tools.

Effects of State Law Limiting Postoperative Opioid Prescription in Patients After Cesarean Delivery.

BACKGROUND: The impact of the Florida State law House Bill 21 (HB 21) restricting the duration of opioid prescriptions for acute pain in patients after cesarean delivery is unknown. Our objective was to assess the association of the passage of Florida State law HB 21 with trends in discharge opioid prescription practices following cesarean delivery, necessity for additional opioid prescriptions, and emergency department visits at a large tertiary care center. METHODS: This was a retrospective cohort study conducted at a large, public hospital. The 2 cohorts represented the period before and after implementation of the law. Using a confounder-adjusted segmented regression analysis of an interrupted time series, we evaluated the association between HB 21 and trends in the proportions of patients receiving opioids on discharge, duration of opioid prescriptions, total opioid dose prescribed, and daily opioid dose prescribed. We also compared the need for additional opioid prescriptions within 30 days of discharge and the prevalence of emergency department visits within 7 days after discharge. RESULTS: Eight months after implementation of HB 21, the mean duration of opioid prescriptions decreased by 2.9 days (95% confidence interval [CI], 5.2-0.5) and the mean total opioid dose decreased by 20.1 morphine milligram equivalents (MME; 95% CI, 4-36.3). However, there was no change in the proportion of patients receiving discharge opioids (95% CI of difference, -0.1 to 0.16) or in the mean daily opioid dose (mean difference, 5.3 MME; 95% CI, -13 to 2.4). After implementation of the law, there were no changes in the proportion of patients who required additional opioid prescriptions (2.1% vs 2.3%; 95% CI of difference, -1.2 to 1.5) or in the prevalence of emergency department visits (2.4% vs 2.2%; 95% CI of difference, -1.6 to 1.1). CONCLUSIONS: Implementation of Florida Law HB 21 was associated with a lower total prescribed opioid dose and a shorter duration of therapy at the time of hospital discharge following cesarean delivery. These reductions were not associated with the need for additional opioid prescriptions or emergency department visits.

Peritoneal dialysis: Status report in South and South East Asia.

BACKGROUND: Peritoneal dialysis (PD) as a modality of kidney replacement therapy (KRT) is largely underutilized globally. We analyzed PD utilization, impact of economic status, projected growth and impact of state policy(s) on PD growth in South Asia and Southeast Asia (SA&SEA) region. METHODS: The National Nephrology Societies of the region responded to a questionnaire on KRT practices. The responses were based on the latest registry data, acceptable community-based studies and societal perceptions. The representative countries were divided into high income and higher-middle income (HI & HMI) and low income and lower-middle income (LI & LMI) groups. RESULTS: Data provided by 15 countries showed almost similar percentage of GDP as health expenditure (4%-7%). But there was a significant difference in per capita income (HI & HMI -US$ 28 129 vs. LI & LMI - US$ 1710.2) between the groups. Even after having no significant difference in monthly cost of haemodialysis (HD) and PD in LI & LMI countries, they have poorer PD utilization as compared to HI & HMI countries (3.4% vs. 10.1%); the reason being lack of formal training/incentives and time constraints for the nephrologist while lack of reimbursement and poor general awareness of modalities has been a snag for the patients. The region expects ≥10% PD growth in the near future. Hong Kong and Thailand with 'PD first' policy have the highest PD utilization. CONCLUSION: Important deterrents to PD underutilization were lack of PD centric policies, lackadaisical patient/physician's attitude, lack of structured patient awareness programs, formal training programs and affordability.

Florida's Opioid Crackdown and Mortality From Drug Overdose, Motor Vehicle Crashes, and Suicide: A Bayesian Interrupted Time-Series Analysis.

In 2011, Florida established a prescription drug monitoring program and adopted new regulations for independent pain-management clinics. We examined the association of those reforms with drug overdose deaths and other injury fatalities. Florida's postreform monthly mortality rates-for drug-involved deaths, motor vehicle crashes, and suicide by means other than poisoning-were compared with a counterfactual estimate of what those rates would have been absent reform. The counterfactual was estimated using a Bayesian structural time-series model based on mortality trends in similar states. By December 2013, drug overdose deaths were down 17% (95% credible interval: -21, -12), motor vehicle crash deaths were down 9% (95% credible interval: -14, -4), and suicide deaths were unchanged compared with what would be expected in the absence of reform. Florida's opioid prescribing reform substantially reduced drug overdose deaths. Reforms may also have reduced motor vehicle crash deaths but were not associated with a change in suicides. More research is needed to understand these patterns. Bayesian structural time-series modeling is a promising new approach to interrupted time-series studies.

State Opioid Limits and Volume of Opioid Prescriptions Received by Medicaid Patients.

BACKGROUND: Since early 2016, an increasing number of states passed legislations that limit the duration and/or dosage of initial opioid prescriptions or opioids for acute pain. OBJECTIVE: The objective of this study was to assess changes in the number of opioid prescriptions covered by Medicaid and received by Medicaid patients associated with state implementation of legislative limits on initial opioid prescriptions. RESEARCH DESIGN: We explored the natural experiment resulting from the staggered implementation of state legislative limits. The analysis adopted a Difference-in-Differences framework and controlled for other major state policies bearing implications for prescription opioid use. The main analysis included 26 states that implemented limits from early 2016 to late 2018. A secondary analysis included all 50 states and the District of Columbia. MEASURES: Population-adjusted state-quarter level counts of Schedule II and III opioid prescriptions received by Medicaid patients, based on data from the Medicaid State Drug Utilization Data and state Medicaid enrollment reports for 2013-2018. RESULTS: Implementation of legislative limits on initial opioid prescriptions was associated with a 7% reduction in the number of opioid prescriptions per 100 Medicaid enrollees. Such reduction was largely attributable to a reduction in Schedule II opioid prescriptions. Secondary analysis by including all jurisdictions and sensitivity checks supported the robustness of results. CONCLUSION: The recent implementation of state legislative limits on initial opioid prescriptions was associated with meaningful reductions in the volume of Schedule II opioid prescriptions received by Medicaid patients.

Opioid Prescribing Laws Are Not Associated with Short-term Declines in Prescription Opioid Distribution.

OBJECTIVE: To determine whether the adoption of laws that limit opioid prescribing or dispensing is associated with changes in the volume of opioids distributed in states. METHODS: State-level data on total prescription opioid distribution for 2015-2017 were obtained from the US Drug Enforcement Administration. We included in our analysis states that enacted an opioid prescribing law in either 2016 or 2017. We used as control states those that did not have an opioid prescribing law during the study period. To avoid confounding, we excluded from our analysis states that enacted or modified mandates to use prescription drug monitoring programs (PDMPs) during the study period. To estimate the effect of opioid prescription laws on opioid distribution, we ran ordinary least squares models with indicators for whether an opioid prescription law was in effect in a state-quarter. We included state and quarter fixed effects to control for time trends and time-invariant differences between states. RESULTS: With the exception of methadone and buprenorphine, the amount of opioids distributed in states fell during the study period. The adoption of opioid prescribing laws was not associated with additional decreases in opioids distributed. CONCLUSIONS: We did not detect an association between adoption of opioid prescribing laws and opioids distributed. States may instead wish to pursue evidence-based efforts to reduce opioid-related harm, with a particular focus on treatment access and harm reduction interventions.

The influence of a ban on outpatient intravenous antibiotic therapy among the secondary and tertiary hospitals in China.

BACKGROUND: Antimicrobial resistance (AMR) is a serious global public health challenge. Physicians' over-prescription of antibiotics is a major contributor, and intravenous (IV) antibiotic use has been a particular concern in China. To address the rapid fallout of antibiotic overuse, the Chinese government has piloted a ban of IV antibiotics in the outpatient department (OD) with the exemption of paediatrics, emergency department (ED), and inpatient ward of secondary and tertiary hospitals in several provinces. METHODS: To assess the potential impact of the policy, we conducted a mixed-methods study including 1) interviews about the ban of IV antibiotic use with 68 stakeholders, covering patients, health workers, and policy-makers, from two cities and 2) a hospital case study which collected routine hospital data and survey data with 207 doctors. RESULTS: Our analyses revealed that the ban of IV antibiotics in the OD led to a reduction in the total and IV antibiotic prescriptions and improved the rational antibiotic prescribing practice in the OD. Nevertheless, the policy has diverted patient flow from OD to ED, inpatient ward, and primary care for IV antibiotic prescriptions. We also found that irrational antibiotic use in paediatrics was neglected. Radical policy implementation, doctors circumvented the regulations, and lack of doctor-patient communication during patient encounters were barriers to the implementation of the ban. CONCLUSIONS: Future efforts may include 1) to de-escalate both oral and IV antibiotic therapy in paediatric and reduce oral antibiotic therapy among adults in outpatient clinics, 2) to reduce unnecessary referrals by OD doctors to ED, primary care, or inpatient services and better coordinate for patients who clinically need IV antibiotics, 3) to incorporate demand-side tailored measures, such as public education campaigns, and 4) to improve doctor-patient communication. Future research is needed to understand how primary care and other community clinics implement the ban.

Medicolegal Issues in Power Morcellation: Cautionary Rules for Gynecologists to Avoid Unfavorable Outcomes.

Power morcellation in laparoscopic surgery enables specialists to carry out minimally invasive procedures such as hysterectomies and myomectomies by cutting specimens into smaller pieces using a rotating blade and removing pieces through a laparoscope. Unexpected uterine sarcoma treated by surgery involving tumor disruption could be associated with poor prognosis. The current study aims to shed light on power morcellation from a medicolegal perspective: the procedure has resulted in adverse outcomes and litigation, and compensation for plaintiffs, as published in various journals cited in PubMed and MEDLINE, Cochrane Library, EMBASE, and GyneWeb. Considering the claims after the US Food and Drug Administration warnings on morcellation, the current study broadens the scope of research by including search engines, legal databases, and court filings (DeJure, Lexis Nexis, Justia, superior court of New Jersey, and US district court of Minnesota) between 1995 and 2019. Legal records show that courts determine professional responsibility regarding complications, making it essential to document adherence to safety protocols and specific guidelines, when available. Sound medical practices and clearly stated institute best practices result in better patient outcomes and are important when unfavorable clinical outcomes occur; adverse legal decisions can be avoided if there are grounds to prove professional conformity with specific guidelines and the unpredictability of an event.

Implementing Obstetrics Quality Improvement, Driven by Medico-legal Risk, is Associated With Improved Workplace Culture.

OBJECTIVE: This study implemented a quality improvement program based on knowledge of medico-legal risk in obstetrics and sought to evaluate the impact of this program on workplace culture. METHODS: The study conducted needs assessments with front-line providers working in the obstetrical unit of the Queensway Carleton Hospital, an urban community hospital in Ottawa, Ontario, and included the safety, communication, operational reliability, and engagement (SCORE) survey. The study investigators delivered training in quality improvement science and co-developed three projects that were based on their alignment with local needs and aggregate medico-legal risk data: an organized team response to the need for an immediate cesarean section, a protocol for managing patients who present at term with pre-labour rupture of membranes, and regular morning team briefings. Outcome measures were determined for each project from a quality improvement indicator framework, and coaching was provided to project leads. Participants completed the SCORE survey and a program effectiveness tool after the intervention. RESULTS: The majority of participants (75.2% of 153 pre-intervention and 63.1% of 157 post-intervention participants) completed the SCORE surveys. Post-intervention improvements were found in teamwork, learning environment, and safety climate, whereas levels of provider burnout remained high. Program effectiveness was highly rated, and most projects showed qualitative improvements. CONCLUSION: This study showed positive workplace culture change associated with the quality improvement intervention. Lessons learned from the implementation of this program can inform future quality improvement initiatives.

Adoption of the 275-patient buprenorphine treatment waiver for treating opioid use disorder: A state-level longitudinal analysis.

Background: Increasing access to buprenorphine treatment is a critical tool for addressing the opioid epidemic in the United States. In 2016, a federal policy change allowed physicians who meet specific requirements to treat up to 275 concurrent buprenorphine patients. This study examines state-level measures of buprenorphine treatment supply over 21 months since this policy change and estimates associations between the supply of 275-patient waivers and state characteristics. Methods: Monthly state-level measures of the number of physicians holding the 275-patient waiver per 100,000 residents were constructed from September 2016 to May 2018 using the Drug Enforcement Agency's Controlled Substance Act database. State characteristics were obtained from publicly available sources. Mixed-effects regression models were estimated to examine change over time. Results: During the 21-month period, the number of physicians waivered to treat 275 patients increased from 153 to 4009 physicians. The mean supply of 275-patient physicians per 100,000 state residents significantly increased from 0.07 (SD = 0.21) in September 2016 to 1.43 (SD = 1.08) in May 2018 (t = -9.84, df = 50, P < .001). The final mixed-effects regression model indicated that Census division and the preexisting supply of 100-patient waivered physicians were correlated with the rate of growth in 275-patient waivers over the study period. Conclusions: Although uptake of the 275-patient waiver has exceeded initial projections, growth is uneven across the United States. Unequal patterns of growth pose a challenge to efforts to increase treatment availability as a means of addressing the opioid epidemic.

Doctors that "doctor" sickness certificates: cunning intelligence as an ability and possibly a virtue among Swedish GPs.

The relations of power between healthcare-related institutions and the professionals that interact with them are changing. Generally, the institutions are gaining the upper hand. Consequently, the intellectual abilities necessary for professionals to pursue the internal goods of healthcare are changing as well. A concrete case is the struggle over sickness benefits in Sweden, in which the Swedish Social Insurance Agency (SSIA) and physicians are important stakeholders. The SSIA has recently consolidated its power over the sickness certificates that doctors issue for their patients. The result has been a stricter gatekeeping of sickness benefits. In order to combat the inroads made by state institutions into sickness certification, and into the sphere of medical practice, some doctors have developed cunning "techniques" to maximize the chance to have their sickness certificates accepted by the SSIA. This article attempts to demonstrate that cunning intelligence-the ability of the weak to "outsmart" a stronger adversary-plays an important role in the practice of medicine. Cunning intelligence is not merely a defective form of prudence (phronesis), nor is it simply an instance of instrumental reason (techne), but rather an ability that occupies a distinct place among the intellectual abilities generally ascribed to professionals.

[Health check-up guide for rural residents (T/CHAA 005-2019)].

This standard stipulates the principles, institutional requirements, inspection items, service modes, data management and utilization requirements for carrying out the health check-up for rural residents. It is applicable to the standardized management of the health check-up for rural residents aged 15 years old and above under the relevant national laws and regulations.

Should a fistula first policy be revisited in elderly haemodialysis patients?

Life-sustaining haemodialysis requires a durable vascular access (VA) to the circulatory system. The ideal permanent VA must provide longevity for use with minimal complication rate and supply sufficient blood flow to deliver the prescribed dialysis dosage. Arteriovenous fistulas (AVFs) have been endorsed by many professional societies as the VA of choice. However, the high prevalence of comorbidities, particularly diabetes mellitus, peripheral vascular disease and arterial hypertension in elderly people, usually make VA creation more difficult in the elderly. Many of these patients may have an insufficient vasculature for AVF maturation. Furthermore, many AVFs created prior to the initiation of haemodialysis may never be used due to the competing risk of death before dialysis is required. As such, an arteriovenous graft and, in some cases, a central venous catheter, become a valid alternative form of VA. Consequently, there are multiple decision points that require careful reflection before an AVF is placed in the elderly. The traditional metrics of access patency, failure and infection are now being seen in a broader context that includes procedure burden, quality of life, patient preferences, morbidity, mortality and cost. This article of the European Dialysis (EUDIAL) Working Group of ERA-EDTA critically reviews the current evidence on VA in elderly haemodialysis patients and concludes that a pragmatic patient-centred approach is mandatory, thus considering the possibility that the AVF first approach should not be an absolute.