The Current State of Opioid Prescribing and Drug Enforcement Agency (DEA) Action Against Physicians: An Analysis of DEA Database 2004-2017.

BACKGROUND: Prescribing opioids has become a challenge. The US Drug Enforcement Agency (DEA) and Centers for Disease Control and Prevention (CDC) have become more involved, culminating in the March 2016 release of the CDC's "Guidelines for Prescribing Opioids for Chronic Pain." OBJECTIVES: Given the new guidelines, we wanted to see if there have been any changes in the numbers, demographics, physician risk factors, charges, and sanctions involving the DEA against physicians who prescribe opioids, when compared to a previous DEA database review from 1998 to 2006. STUDY DESIGN: This study involved an analysis of the DEA database from 2004 to 2017. SETTING: The review was conducted at the Henry Ford Health System Division of Pain Medicine. METHOD: After institutional review board approval at Henry Ford Health System, an analysis of the DEA database of criminal prosecutions of physician registrants from 2004-2017 was performed. The database was reviewed for demographic information such as age, gender, type of degree (doctor of medicine [MD] or doctor of osteopathic medicine [DO]), years of practice, state, charges, and outcome of prosecution (probation, sentencing, and length of sentencing). An internet-based search was performed on each registrant to obtain demographic data on specialty, years of practice, type of medical school (US vs foreign), board certification, and type of employment (private vs employed). RESULTS: Between 2004 and 2017, Pain Medicine (PM) had the highest percentage of in-specialty action at 0.11% (n = 5). There was an average of 18 prosecutions per year vs 14 in the previous review. Demographic risk factors for prosecution demonstrated the significance of the type of degree (MD vs. DO), gender, type of employment (private vs. employed), and board certification status for rates of prosecution. Having a DO degree and being male were associated with significantly higher risk as well as being in private practice and not having board certification (P < .001). In terms of type of criminal charges as a percent of cases, possession with intent to distribute (n = 90) was most prevalent, representing 52.3% of charges, with new charges being prescribing without medical purpose outside the usual course of practice (n = 71) representing 41.3% of charges. Comparison of US graduates (MD/DO) vs. foreign graduates showed higher rates of DEA action for foreign graduates but this was of borderline significance (P = .072). LIMITATIONS: State-by-state comparisons could not be made. Specialty type was sometimes self-reported, and information on all opioid prosecutions could not be obtained. The previous study by Goldenbaum et al included data beyond DEA prosecution, so direct comparisons may be limited. CONCLUSION: The overall risk of DEA action as a percentage of total physicians is small but not insignificant. The overall rates of DEA prosecution have increased. New risk factors include type of degree (DO vs. MD) and being in private practice with a subtle trend toward foreign graduates at higher risk. With the trend toward less prescribing by previously high-risk specialties such as Family Medicine, there has been an increase in the relative risk of DEA action for specialties treating patients with pain such as PM, Physical Medicine and Rehabilitation, neurology, and neurosurgery bearing the brunt of prosecutions. New, more subtle charges have been added involving interpretation of the medical purpose of opioids and standard of care for their use. KEY WORDS: Certification, CDC, criminal, DEA, opioid, prescribing, prosecution, sanctions.

Management of Chronic Pain in Adults Living With Sickle Cell Disease in the Era of the Opioid Epidemic: A Qualitative Study.

Importance: The hallmark of sickle cell disease (SCD) is vaso-occlusive pain that may be acute and episodic or may progress to chronic, persistent pain with unpredictable and disabling exacerbations. Patients with SCD rely on opioids almost exclusively for acute and chronic pain management. Objective: To understand how the current opioid epidemic and subsequent guidelines from the Centers for Disease Control and Prevention are associated with the management of acute and chronic pain for patients with SCD. Design, Setting, and Participants: Qualitative study using semistructured interview guides. Interviews 1 hour or longer were conducted over the telephone. Participants were adults (aged ≥18 years) diagnosed with SCD who experienced pain on 3 or more days per week recruited from national SCD conferences, symposiums, and 2 sickle cell clinics. Open coding analysis facilitated thematic analysis of interview transcripts. Data collection took place from May 2017 to June 2018. Main Outcomes and Measures: Participant perspective of any changes to their pain management associated with the 2016 guidelines from the Centers for Disease Control and Prevention. Results: The 15 adults interviewed had a median (range) age of 32 (21-52) years; 13 (87%) were female; and all were of African American race/ethnicity. Participants reported that recently their opioid prescriptions had become more restrictive, were more closely monitored, and were increasingly difficult to fill in pharmacies. Participants also described increased stigmatization about opioid use and that their medical care was being affected by the physician's exclusive focus on reducing pain medication use. There was an emerging interest among adult patients in the consideration of the use of alternative therapies, including marijuana, to manage pain. Conclusions and Relevance: These findings suggest that from the perspective of adults living with SCD, the opioid epidemic may have negatively affected patients' care by increasing barriers to opioids. Patients reported decreased opioid dosing, increased stigmatization regarding opioid use, physician preoccupation with opioid dosage interfering with comprehensive care, and lack of access to alternative therapies.

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.

Complaints about chiropractors, osteopaths, and physiotherapists: a retrospective cohort study of health, performance, and conduct concerns.

Background: Recent media reports have highlighted the risks to patients that may occur when practitioners in the chiropractic, osteopathy and physiotherapy professions provide services in an unethical or unsafe manner. Yet research on complaints about chiropractors, osteopaths, and physiotherapists is limited. Our aim was to understand differences in the frequency and nature of formal complaints about practitioners in these professions in order to inform improvements in professional regulation and education. Methods: This retrospective cohort study analysed all formal complaints about all registered chiropractors, osteopaths, and physiotherapists in Australia lodged with health regulators between 2011 and 2016. Based on initial assessments by regulators, complaints were classified into 11 complaint issues across three domains: performance, professional conduct, and health. Differences in complaint rate were assessed using incidence rate ratios. A multivariate negative binomial regression model was used to identify predictors of complaints among practitioners in these professions. Results: Patients and their relatives were the most common source of complaints about chiropractors, osteopaths and physiotherapists. Concerns about professional conduct accounted for more than half of the complaints about practitioners in these three professions. Regulatory outcome of complaints differed by profession. Male practitioners, those who were older than 65 years, and those who practised in metropolitan areas were at higher risk of complaint. The overall rate of complaints was higher for chiropractors than osteopaths and physiotherapists (29 vs. 10 vs. 5 complaints per 1000 practice years respectively, p < 0.001). Among chiropractors, 1% of practitioners received more than one complaint - they accounted for 36% of the complaints within their profession. Conclusions: Our study demonstrates differences in the frequency of complaints by source, issue and outcome across the chiropractic, osteopathic and physiotherapy professions. Independent of profession, male sex and older age were significant risk factors for complaint in these professions. Chiropractors were at higher risk of being the subject of a complaint to their practitioner board compared with osteopaths and physiotherapists. These findings may assist regulatory boards, professional associations and universities in developing programs that avert patient dissatisfaction and harm and reduce the burden of complaints on practitioners.

Considerable variations in growth hormone policy and prescription in paediatric end-stage renal disease across European countries-a report from the ESPN/ERA-EDTA registry.

BACKGROUND: Growth retardation in paediatric end-stage renal disease (ESRD) has a serious impact on adult life. It is potentially treatable with recombinant growth hormone (rGH). In this study, we aimed to quantify the variation in rGH policies and actual provided care in these patients across Europe. METHODS: Renal registry representatives of 38 European countries received a structured questionnaire on rGH policy. Cross-sectional data on height and actual use of rGH on children with ESRD aged <18 years were retrieved from the ESPN/ERA-EDTA Registry. RESULTS: In 21 (75%) of 28 responding countries, rGH is reimbursed for children with ESRD. The specific conditions for reimbursement (minimum age, maximum age and chronic kidney disease stage) vary considerably. Mean height standard deviation scores (SDS) at renal replacement therapy (RRT) [95% confidence interval (CI)] were significantly higher in countries where rGH was reimbursed -1.80 (-2.06; -1.53) compared with countries in which it was not reimbursed [-2.34 (-2.49;-2.18), P < 0.001]. Comparison of the mean height SDS at onset of RRT and final height SDS yielded similar results. Among the 13 countries for which both data on actual rGH use between 2007 and 2011 and data from the questionnaire were available, 30.1% of dialysis and 42.3% of transplanted patients had a short stature, while only 24.1 and 7.6% of those short children used rGH, respectively. CONCLUSION: Reimbursement of rGH associates with a less compromised final stature of ESRD children. In many countries with full rGH reimbursement, the actual rGH prescription in growth-retarded ESRD children is low and obviously more determined by the doctor's and patients' attitude towards rGH therapy than by financial hurdles.

[Criteria for good prescribing practice in children]. / Inhaltliche Kriterien für eine gute Verordnung bei Kindern.

Paediatric prescribing is complex. A whole range of aspects needs to be considered to achieve an efficacious and safe drug therapy for children. Legal requirements for prescribing are clearly insufficient for this purpose. Children are immature individuals under constant growth and development. Consequently, based on age and cognitive abilities of the child individual drugs and dosing regimens have to be chosen. Frequent off-label use and a lack of age-appropriate formulation worsen the situation. Additionally, not all dosage forms are similarly adequate in different age groups. Taste significantly influences patient adherence. Dose calculations based on body weight are prone to errors, putting a point on the wrong place or mixing up measuring units easily result in ten-fold dosing errors. Computer-based tools to enhance prescribing are promising but, however, not yet widely implemented in paediatrics because of missing evidence-based data sources and the hugely complex process. Communication between clinicians and pharmacists as well as with the patient remains very important.

[Herbal medicines alternative to synthetical medicines]. / Phytopharmaka als Alternative zu Synthetika.

Herbal pharmaceuticals in medical practice are similarly used as chemically well defined drugs. Like other synthetical drugs, they are subject to pharmaceutical legislature (AMG) and EU directives. It is to differentiate between phytopharmaceuticals with effectiveness of proven indications and traditional registered herbal medicine. Through the Health Reform Act January 2004 and the policy of the Common Federal Committee (G-BA)on the contractual medical care from March 2009--with four exceptions--Non-prescription Phytopharmaka of the legal Health insurance is no longer (SHI) refundable and must be paid by the patients. The result is that more and more well-established preparations disappear from the market. This article gives an overview of practical relevant indications for herbal medicines, which according to its licensing status, the scientific assessment by the Cochrane Collaboration and the Institute for Quality and Efficiency in Health Care (IQWiG) and evidence-based Medicine (EBM)/ meta-analyzes as an alternative to synthetics can be used.

VBAC in the trenches: a community perspective.

Is vaginal birth after cesarean in the community a disappearing practice? Since 1996 the rate of trial of labor after cesarean for low-risk women has dropped precipitously. This paper reviews the current literature and summarizes opinions of community obstetricians and midwives. Descriptive data are presented to document the scope of the problem and identify barriers: liability concerns, provider biases, and institutional restrictions. Our perspective draws on experience in our community hospital with a previously high vaginal birth after cesarean rate and a subsequent ban. Strategies to reduce the skyrocketing cesarean rate and encourage trial of labor after cesarean for low-risk women are outlined.

Legal status and regulation of complementary and alternative medicine in Europe.

OBJECTIVE: The study aims to review the legal and regulatory status of complementary and alternative medicine (CAM) in the 27 European Union (EU) member states and 12 associated states, and at the EU/European Economic Association (EEA) level. METHODS: Contact was established with national Ministries of Health, Law or Education, members of national and European CAM associations, and CAMbrella partners. A literature search was performed in governmental and scientific/non-scientific websites as well as the EUROPA and EUR-lex websites/ databases to identify documents describing national CAM regulation and official EU law documents. RESULTS: The 39 nations have all structured legislation and regulation differently: 17 have a general CAM legislation, 11 of these have a specific CAM law, and 6 have sections on CAM included in their general healthcare laws. Some countries only regulate specific CAM treatments. CAM medicinal products are subject to the same market authorization procedures as other medicinal products with the possible exception of documentation of efficacy. The directives, regulations and resolutions in the EU that may influence the professional practice of CAM will also affect the conditions under which patients are receiving CAM treatment(s) in Europe. CONCLUSION: There is an extraordinary diversity with regard to the regulation of CAM practice, but not CAM medicinal products. This will influence patients, practitioners and researchers when crossing European borders. Voluntary harmonization is possible within current legislation. Individual states within culturally similar regions should harmonize their CAM legislation and regulation. This can probably safeguard against inadequately justified over- or underregulation at the national level.

Toward safer practice in otology: a report on 15 years of clinical negligence claims.

OBJECTIVES/HYPOTHESIS: To determine the characteristics of medical negligence claims arising from otological practice. STUDY DESIGN: Retrospective analysis of medical negligence claims contained in the National Health Service Litigation Authority (NHSLA) database. METHODS: Claims relating to otology and neurotology between 1995 and 2010 were obtained from the NHSLA database and analyzed for cause of injury, type of injury, outcome of claim and costs. RESULTS: Over 15 years there were 137 claims in otology, representing 26% of all the claims in otolaryngology. Of these, 116 have been closed, and 84% of closed claims resulted in payment. Of the 97 successful claims, 63 were related to operative complications. This included six cases of wrong side/site surgery, and 15 cases of inadequate informed consent. The most common injuries claimed were hearing loss, facial paralysis, and additional/unnecessary surgery. Middle ear ventilation and mastoid surgery were the procedures most commonly associated with a successful claim. There were 15 successful claims of misdiagnosis/delayed diagnosis, with chronic suppurative otitis media the condition most frequently missed. There were nine successful claims related to outpatient procedures, of which seven were for aural toilet and six claims of medical mismanagement, including three cases of ototoxicity from topical medications. There were also four successful claims for morbidity due to delayed surgery. CONCLUSIONS: This is the first study to report outcomes of negligence claims in otology. Claims in otology are associated with a high success rate. A significant proportion of claims are not related to surgery and represent areas where safety should also be addressed.

"But my doctor recommended pot": medical marijuana and the patient-physician relationship.

As the use of medical marijuana expands, it is important to consider its implications for the patient-physician relationship. In Colorado, a small cohort of physicians is recommending marijuana, with 15 physicians registering 49% of all medical marijuana patients and a single physician registering 10% of all patients. Together, they have registered more than 2% of the state to use medical marijuana in the last three years. We are concerned that this dramatic expansion is occurring in a setting rife with conflicts of interest despite insufficient scientific knowledge about marijuana. This system diminishes the patient-physician relationship to the recommendation of a single substance while unburdening physicians of their usual responsibilities to the welfare of their patients.

Nursing and midwifery education, practice, and issues in Israel.

Nurses deliver most of Israel's healthcare services, yet its nurse per population ratio is only 5.9 per 1000, one of the lowest in the developed world. For several years, the managers of the profession have been pushing to upgrade nursing and to move it into the academic sphere. The semiskilled qualification of the practical nurse has been eliminated and training programs for registered nurses are being transformed from diploma training to academic degree programs. A midwifery license is accessible only to registered nurses who take a further 1 year of advanced training and sit the State Midwifery Licensing Examination. Most deliveries in Israel are carried out by midwives. Alongside the Western-standard hospital system there operates both a well-developed community nursing network and a strong mother-and-child clinic system. The acute shortage of nurses in Israel is now coinciding with a rising number of academic job-seekers, which has encouraged the Ministry of Health to offer university graduates a career-change program. Special scholarships are on offer in return for a 4 year commitment to work in nursing after completing an accelerated training curriculum (2.5 years instead of the usual 3 years), plus a starting monthly wage that is higher than the national average wage.

Impact of Medicare Part D on osteopathic physicians.

CONTEXT: Although there is a wealth of information for patients and physicians on the Medicare Prescription Drug, Improvement, and Modernization Act, little research exists related to its impact on osteopathic physicians (DOs). OBJECTIVE: To examine the impact of Medicare's prescription drug benefit-or Part D-on DOs and their practices. METHODS: Two electronic surveys regarding Medicare Part D were e-mailed to DOs randomly selected from the American Osteopathic Association database. The first survey was sent January 31, 2006 (within the first month of Part D implementation), and the second was sent June 1, 2006 (6 months after implementation). Both surveys focused primarily on the challenges experienced by DOs and their staff regarding Part D. Responses were subjected to univariate, bivariate, and Pearson product moment correlation analysis. RESULTS: Of the 10,000 DOs contacted, 603 (6%) responded and met inclusion criteria for the first survey and 343 (3.4%) for the second survey. More than 60% of respondents to the first survey reported challenges such as increased workload, difficulties understanding Part D, difficulties with the physician appeals process, and lack of information and education. These challenges were also reported in the second survey but by approximately 30% fewer respondents. One challenge-changing medications as a result of formulary restrictions-was reported by 17% more respondents to the second survey (P<.01). Respondents in primary care, solo practice, and rural areas as well as those treating large Medicare populations and those who were their patients' primary source of information about Part D reported more challenges. CONCLUSION: Considering the numerous challenges respondents faced with Part D, it is important to remember the role of physicians in successfully implementing healthcare programs, particularly as the US healthcare reform debate progresses.

Physician collective bargaining.

Current antitrust enforcement policy unduly restricts physician collaboration, especially among small physician practices. Among other matters, current enforcement policy has hindered the ability of physicians to implement efficient healthcare delivery innovations, such as the acquisition and implementation of health information technology (HIT). Furthermore, the Federal Trade Commission and Department of Justice have unevenly enforced the antitrust laws, thereby fostering an increasingly severe imbalance in the healthcare market in which dominant health insurers enjoy the benefit of largely unfettered consolidation at the cost of both consumers and providers. This article traces the history of antitrust enforcement in healthcare, describe the current marketplace, and suggest the problems that must be addressed to restore balance to the healthcare market and help to ensure an innovative and efficient healthcare system capable of meeting the demands of the 21st century. Specifically, the writer explains how innovative physician collaborations have been improperly stifled by the policies of the federal antitrust enforcement agencies, and recommend that these policies be relaxed to permit physicians more latitude to bargain collectively with health insurers in conjunction with procompetitive clinical integration efforts. The article also explains how the unbridled consolidation of the health insurance industry has resulted in higher premiums to consumers and lower compensation to physicians, and recommends that further consolidation be prohibited. Finally, the writer discusses how health insurers with market power are improperly undermining the physician-patient relationship, and recommend federal antitrust enforcement agencies take appropriate steps to protect patients and their physicians from this anticompetitive conduct. The article also suggests such steps will require changes in three areas: (1) health insurers must be prohibited from engaging in anticompetitive activity; (2) the continuing improper consolidation of the health insurance industry must be curtailed; and (3) the physician community must be permitted to undertake the collaborative activity necessary for the establishment of a transparent, coordinated, and efficient delivery system.