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"Controlled Substances - administration "
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The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research
by
Fant, Reginald V.
,
Wang, Daniel W.
,
Henningfield, Jack E.
in
Analgesics, Opioid - therapeutic use
,
Analysis
,
Biomedical and Life Sciences
2018
Rationale
Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health.
Objective
The objective of the study is to provide a review of kratom abuse potential and its evaluation according to the 8 factors of the CSA.
Results
Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal. Kratom has some opioid effects but low respiratory depression and abuse potential compared to opioids of abuse. This appears due to its non-opioid-derived and resembling molecular structure recently referred to as biased agonists. By the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems.
Conclusions
Although kratom appears to have pharmacological properties that support some level of scheduling, if it was an approved drug, placing it into Schedule I, thus banning it, risks creating public health problems that do not presently exist. Furthermore, appropriate regulation by FDA is vital to ensure appropriate and safe use.
Journal Article
Provider Patient-Sharing Networks and Multiple-Provider Prescribing of Benzodiazepines
2016
BackgroundPrescription benzodiazepine overdose continues to cause significant morbidity and mortality in the US. Multiple-provider prescribing, due to either fragmented care or “doctor-shopping,” contributes to the problem.ObjectiveTo elucidate the effect of provider professional relationships on multiple-provider prescribing of benzodiazepines, using social network analytics.DesignA retrospective analysis of commercial healthcare claims spanning the years 2008 through 2011. Provider patient-sharing networks were modelled using social network analytics. Care team cohesion was measured using care density, defined as the ratio between the total number of patients shared by provider pairs within a patient’s care team and the total number of provider pairs in the care team. Relationships within provider pairs were further quantified using a range of network metrics, including the number and proportion of patients or collaborators shared.Main MeasuresThe relationship between patient-sharing network metrics and the likelihood of multiple prescribing of benzodiazepines.ParticipantsPatients between the ages of 18 and 64 years who received two or more benzodiazepine prescriptions from multiple providers, with overlapping coverage of more than 14 days.ResultsA total of 5659 patients and 1448 provider pairs were included in our study. Among these, 1028 patients (18.2 %) received multiple prescriptions of benzodiazepines, involving 445 provider pairs (30.7 %). Patients whose providers rarely shared patients had a higher risk of being prescribed overlapping benzodiazepines; the median care density was 8.1 for patients who were prescribed overlapping benzodiazepines and 10.1 for those who were not (p < 0.0001). Provider pairs who shared a greater number of patients and collaborators were less likely to co-prescribe overlapping benzodiazepines.ConclusionsOur findings demonstrate the importance of care team cohesion in addressing multiple-provider prescribing of controlled substances. Furthermore, we illustrate the potential of the provider network as a surveillance tool to detect and prevent adverse events that could arise due to fragmentation of care.
Journal Article
Controlled substance prescribing and education in orthopedic residencies: A program director survey
by
Bell, Anthony
,
Brat, Gabriel A.
,
Yorkgitis, Brian K.
in
Analgesics, Opioid - administration & dosage
,
Controlled Substances - administration & dosage
,
Drug and Narcotic Control
2020
Opioid misuse is currently plaguing the US. Efforts to reduce this include opioid prescribing education (OPE). Orthopaedic residents often prescribe opioids but, their education is unknown.
A survey was sent to orthoapedic residency program directors (PDs) regarding their program's controlled substance (CS) policies and knowledge of local CS regulations.
There were 60 (36.8%) completed surveys. 54 (90.0%) programs allow resident outpatient opioid prescribing. Nine (16.7%) programs require individual DEA registration and 7 (13.0%) were unsure about DEA registrations. State laws regarding PDMP utilization and OPE for fully licensed physicians were correctly answered by 52 (86.7%) and 43 (71.6%), respectively.
27 (45.0%) programs had a mandatory OPE. Six (10.0%) PDs were unsure about a mandatory OPE. 16 (48.5%) programs that did not confirm an OPE were considering adding one.
The majority of programs permit residents outpatient opioid prescribing; less than half provide mandatory OPE. Several PDs were unaware local CS prescribing regulations and education. This study demonstrates opportunities to improve OPE among orthopaedic residencies and PDs’ knowledge regarding CS regulations.
•Most orthopaedic residencies allow residents to prescribed controlled substances for outpatient use.•Less than half (45.0%) of residencies provide mandatory opioid prescribing education to their residents.•Almost half (48.5%) of programs without mandatory opioid prescribing education are considering adding this education.
Journal Article
Impact of prescription drug-monitoring program on controlled substance prescribing in the ED
2015
In 2009, Florida initiated a statewide prescription drug-monitoring program (PDMP) to encourage safer prescribing of controlled substances and reduce drug abuse and diversion. Data supporting the utility of such programs in the emergency department (ED) is scarce. This study sought to determine the effect of PDMP data on controlled substance prescribing from the ED.
In this pre-post study utilizing a historical control, pharmacists in the ED provided prescribers with a summary of the PDMP data for their patients. The number of controlled substances prescribed in the intervention group was compared with that prescribed in the historical control to determine if the intervention resulted in a change in the average number of controlled substance prescribed.
Among the 710 patients evaluated, providing prescribers with PDMP data did not alter the average number of controlled substance per patient prescribed (0.23 controlled substances per patient in the historical control compared with 0.28 controlled substances per patient in the intervention group; 95% confidence interval [CI], −0.016 to 0.116; P = .125). All prescribers surveyed indicated that having PDMP data altered their controlled substance prescribing and felt more comfortable prescribing controlled substances.
Although the results did not demonstrate a change in the average number of controlled substances prescribed when prescribers were provided with PDMP data, results from the survey indicate that prescribers felt the data altered their prescribing of controlled substances, and thus were more contented prescribing controlled substances.
Journal Article
Childhood Attention-Deficit/Hyperactivity Disorder Prescribing by Prescriber Type and Specialty in Oregon Medicaid
by
Odom-Maryon, Tamara
,
Klein, Tracy A.
,
Daratha, Kenn
in
Adolescent
,
Age Factors
,
Attention Deficit Disorder with Hyperactivity - drug therapy
2016
Objective:
This study compares nurse practitioner (NP) and physician (MD/DO) prescribing patterns for treatment of children with an attention-deficit/hyperactivity disorder (ADHD)-related diagnosis covered by Oregon Medicaid from 2012 to 2013.
Methods:
This study is a limited data set review of Oregon pharmacy claims for youth aged 3–18 at time of prescription fill, who were continuously enrolled for at least 10 months of the index year. Claims with selected ICD-9 codes (n = 197,364) were further defined by 30-day prescriptions and prescription drug events (PDE) linked to each prescriber type of interest. Descriptive statistical analysis of variables included prescriber type (NP vs. physician) and specialty (generalist vs. specialist), child age, and controlled versus noncontrolled drug type.
Results:
A total of 82,754 complete 30-day prescriptions for 10,753 children from 1785 unique prescribers (78 NP specialists; 303 NP generalists; 162 physician specialists; and 1242 physician generalist prescribers) and 16,669 PDE were analyzed. Physicians prescribed more than 81% of all ADHD medications, and physician generalists prescribed nearly 60% of all prescriptions. Sixty-four percent of 30-day supply prescriptions (n = 52,678) were controlled substances. Generalists, both NPs and physician prescribers, prescribed controlled medications more often than specialists. Physician specialists consistently prescribed controlled substances for all age groups, while NP specialists prescribed more controlled substances as child age increased. Rates of controlled medications prescribed generally increased, as children got older, regardless of provider type.
Conclusion:
NPs overall prescribe in a similar pattern to physicians when given the authority to prescribe controlled substances for ADHD. Comparisons between prescriber types for controlled substance prescribing by age should be explored further to identify possible variance from national guidelines.
Journal Article
Model of Current Practice Regarding Prescriptions of Controlled Substances and the Perceived Benefits of E-Prescribing in an Academic Medical Center
by
Vigil, Daniel
,
Kupperman, Eli
,
Yazdani, Arash
in
Academic Medical Centers - economics
,
Academic Medical Centers - statistics & numerical data
,
Attitude of Health Personnel
2016
To review current practices regarding prescribing controlled substances at an academic medical center and describe possible advantages of electronic prescribing of controlled substances (EPCS). A 10-question multiple choice survey was sent electronically to all house staff at an academic medical center. Aggregated data was analyzed for trends. 193 surveys (18.8 %) were completed. Of all respondents, 46.6 % were not able to write their own prescriptions. 70.0 % have used another provider’s prescription pad to write prescriptions. 53.4 % have had prescriptions rejected or not filled by a pharmacy for being written incorrectly. 59.6 % kept a patient as an inpatient for a longer period of time due to the inability to obtain a prescription, costing an estimated $3.28 million per year. 58.0 % needed to have a patient return to the hospital to pick up prescriptions for an estimated 1583 return trips to the hospital yearly. 35.1 % had a patient return to the emergency department due to uncontrolled pain, estimated at $139,000 in yearly emergency department patient charges. The authors’ survey highlights some of the financial, legal, efficiency, and satisfaction disadvantages due to the inability to use EPCS. Implementing EPCS and making it ubiquitous may limit some inefficiencies in academic hospital systems.
Journal Article
The Effects of North Carolina’s Prescription Drug Monitoring Program on the Prescribing Behaviors of the State’s Providers
by
Garrettson, Mariana
,
Alexandridis, Apostolos
,
Ringwalt, Chris
in
Accident Prevention
,
Analgesics
,
Analgesics, Opioid - administration & dosage
2015
State-level prescription drug monitoring programs (PDMPs) show promise as a key strategy to respond to the epidemic of the misuse and abuse of controlled substances (CS), particularly opioid analgesics, in the United States. Undocumented concerns have been expressed that these PDMPs may have a “chilling effect” on providers’ willingness to prescribe these substances to their patients. Using data from North Carolina’s PDMP for the 3-year period from 2009 through 2011, we examined whether rapid increases in (1) the number of providers who queried the system, and (2) the number of days on which they queried it, would be related to their prescribing practices in regards to CS. We hypothesized that neither marker of PDMP utilization would be associated with a decrease in either patients receiving CS prescriptions or CS prescriptions filled. We found no association between either of these variables and the number of patients who filled prescriptions for CS or the number of prescriptions for CS filled. However, we did find a slight
positive
relationship between the growth in the utilization of the PDMP and the number of prescriptions filled for opioid analgesics. Concerns that PDMPs may constrain prescribing behavior with regards to CS are not supported.
Journal Article
Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders
2016
In this trial involving adult ex-prisoners who had a history of opioid dependence, extended-release naltrexone resulted in a lower rate of opioid relapse than did usual treatment (brief counseling and referrals). The drug did not reduce rates of reincarceration or unsafe sex.
Opioid-use disorder is a chronic relapsing condition that has serious public health consequences. Opioid dependence disproportionately affects U.S. criminal justice system populations, and relapse and overdose deaths occur at high rates after release from incarceration.
1
Evidence-based opioid-agonist maintenance therapies for opioid dependence (methadone and buprenorphine) are effective in prison, jail, and community reentry (i.e., parole) settings
2
–
5
but have historically been unavailable or discouraged among criminal justice clients.
6
–
8
Extended-release naltrexone (Vivitrol, Alkermes), a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, was approved by the Food and Drug Administration in 2010 for the prevention of relapse to . . .
Journal Article
The STop UNhealthy substance use now (STUN II) trial: protocol for a 48-site cluster randomized 2 × 2 factorial implementation trial to improve evidence-based screening and interventions for substance use disorder within primary care
by
Wei, Lai
,
Vilensky, Michael
,
MacEwan, Sarah R.
in
Alcohol use
,
Care and treatment
,
Counseling
2025
Background
Despite substance use disorders (SUD) being a leading cause of preventable death in the US, most people who visit primary care in the US are not screened for SUD. There are multiple barriers to screening for, identifying, and managing SUD in primary care. However, there are also promising strategies available to address these barriers, including practice facilitation (PF), learning collaboratives (LC), and performance incentives (PI).
Methods
This study is a 48-site cluster-randomized 2 × 2 factorial implementation trial that aims to compare the effectiveness of several strategies for implementing evidence-based screening and interventions for SUDs in primary care. Practices will be randomized to one of four implementation strategies: (1) PF only, (2) PF + LC, (3) PF + PI, or (4) all three strategies. An estimated 144 participants from 48 primary care practices will be enrolled. All participants will receive PF to guide them in making changes to implement screening for SUD, focusing on a defined change package and associated tools. PF includes quality improvement (QI) coaching, as well as electronic health record (EHR) support, training, and expert consultation. LC includes monthly virtual education sessions led by content experts to support practice improvement and innovation with didactics on key topics as well as facilitating participant interactions to share experiences. PI includes financial incentives for performance. Primary care practices will be the unit of analysis for both the primary outcome (rate of SUD screening) and secondary outcomes (rates of evidence-based interventions for SUD). Assessments will be conducted during a 12-month implementation phase and 12-month sustainment phase.
Discussion
This study will produce evidence regarding the comparative effectiveness of several strategies on implementation and sustainment of evidence-based screening and interventions for SUD within primary care. It will also generate knowledge about mechanisms of change in primary care settings. The results are expected to have a positive impact by providing a nuanced understanding of the incremental benefits of LC and/or PI to inform primary care practices, health systems, policymakers, and payers about optimal implementation strategies for SUD screening and evidence-based interventions.
Trial registration
ClinicalTrials.gov NCT06524232. July 23, 2024 –registered.
Journal Article
Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial
by
Desmarais, Sarah L.
,
Burris, Elizabeth N.
,
Comfort, Megan L.
in
Adaptation
,
Adolescent
,
Adult
2017
Background
Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum.
Methods/design
Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections’ implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated.
Discussion
Findings have the potential to improve both jail- and community-based treatment services for adults with CODs as well as inform methods for conducting rigorous pilot implementation and evaluation research in correctional settings and as inmates re-enter the community. Findings will contribute to a growing area of work focused on interrupting the cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among adults with CODs.
Trial registration
ClinicalTrials.gov,
NCT02214667
. Registered on 10 August 2014.
Journal Article