The Impact of Controlled Substance Federal Regulation on the Practice of Pharmacy

1991 ◽  
Vol 4 (6) ◽  
pp. 372-379
Author(s):  
Frederick H. Branding

The federal Controlled Substances Act requires all registrants, including pharmacists, to keep complete, accurate, and detailed records of the acquisition and disposition of all controlled substances. These records are to be maintained in a readily retrievable manner in order that they may be inspected, verified, and copied by inspectors of the Drug Enforcement Administration. When dispensing controlled substances, pharmacists have a statutorily imposed corresponding responsibility to verify that all prescriptions for controlled substances have been issued by a prescriber in the usual course of that prescriber's legitimate medical practice. Violations of the Controlled Substances Act and regulations can subject pharmacists to a variety of sanctions, ranging from an administrative letter of admonition to a civil fine, forfeiture, or criminal prosecution.

1995 ◽  
Vol 8 (3) ◽  
pp. 130-137 ◽  
Author(s):  
Frederick H. Branding

The federal Controlled Substances Act requires all registrants, including pharmacists, to keep complete, accurate, and detailed records of the acquisition and disposition of all controlled substances. These records are to be maintained in a readily retrievable manner in order that they may be inspected, verified, and copied by inspectors of the Drug Enforcement Administration. When dispensing controlled substances, pharmacists have a statutorily imposed corresponding responsibility to verify that all prescriptions for controlled substances have been issued by a prescriber in the usual course of that prescriber's legitimate medical practice. Violations of the Controlled Substances Act and regulations can subject pharmacists to a variety of sanctions, ranging from an administrative letter of admoni tion to a civil fine, forfeiture, or criminal prosecution. Copyright © 1991 by W.B. Saunders Company


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e027117 ◽  
Author(s):  
Kevin J Simpson ◽  
Matthew T Moran ◽  
Michelle L Foster ◽  
Dipam T Shah ◽  
Daniel Y Chung ◽  
...  

ObjectivesThe Maine Diversion Alert Program grants healthcare providers access to law enforcement data on drug charges. The objectives of this report were to analyse variations in drug charges by demographics and examine recent trends in arrests, prescriptions of controlled substances and overdoses.DesignObservational.SettingArrests, controlled prescription medication distribution and overdoses in Maine.ParticipantsDrug arrestees (n=1272) and decedents (n=2432).Primary outcome measuresArrestees were analysed by sex and age. Substances involved in arrests were reported by schedule (I–V or non-controlled prescription) and into opioids, stimulants or other classes. Controlled substances reported to the Drug Enforcement Administration (2007–2017) were evaluated. Drug-induced deaths (2007–2017) reported to the medical examiner were examined by the substance(s) identified.ResultsMales were more commonly arrested for stimulants and schedule II substances. More than two-thirds of arrests involved individuals under the age of 40. Individuals age >60 were elevated for oxycodone arrests. Over three-fifths (63.38%) of arrests involved schedule II–IV substances. Opioids accounted for almost half (44.6%) of arrests followed by stimulants (32.5%) and sedatives (9.1%). Arrests involving buprenorphine exceeded those for oxycodone, hydrocodone, methadone, tramadol and morphine, combined. Prescriptions for hydrocodone (−56.0%) and oxycodone (−46.9%) declined while buprenorphine increased (+58.1%) between 2012 and 2017. Deaths from 2007 to 2017 tripled. Acetylfentanyl and furanylfentanyl were the most common fentanyl analogues identified.ConclusionsAlthough the overall profile of those arrested for drug crimes in 2017 involve males, age <40 and heroin, exceptions (oxycodone for older adults) were observed. Most prescription opioids are decreasing while deaths involving opioids continue to increase in Maine.


Author(s):  
John J. Coleman

This chapter discusses how opioids are diverted from legitimate to illegitimate channels and examines the systems that have been developed to keep track of these drugs by monitoring their prescribing and dispensing. Also covered are the regulations that enable authorities to scrutinize manufacturers and distributors for anomalous transactions that might signal diversion. The chapter also discusses potential strategies involving the private sector, which has a corresponding interest in curtailing waste, fraud, and abuse in the third-party healthcare payer systems that each year process billions of prescriptions for drugs, including controlled substances. The chapter looks at the role of pharmacy benefit managers in the dispensing of controlled substances. The potential benefits of adding pharmacy benefit managers to the present classes of business activities regulated by the Drug Enforcement Administration are explored.


2020 ◽  
Vol 35 (9) ◽  
pp. 403-403
Author(s):  
Paul Baldwin

The Drug Enforcement Administration has agreed to publish a proposed rule that, if approved, would give nurses the legal authority to contact the pharmacy on behalf of the prescriber concerning controlled substances.


1987 ◽  
Vol 16 (4) ◽  
pp. 359-372 ◽  
Author(s):  
Robert P. Climko ◽  
Herbert Roehrich ◽  
Donald R. Sweeney ◽  
Jamil Al-Razi

The Drug Enforcement Administration classified the drug methylenedioxymeth-amphetamine, MDMA, also known as Ecstacy, as a Schedule I controlled substance on July 1, 1985. The controversy surrounding the classification of MDMA is related to the question of its efficacy as an adjunct to psychotherapy and the larger issue of how to regulate the production and use of designer drugs. The authors review the literature on MDMA and its predecessor, MDA, a substance that differs from MDMA by one methyl group.


2020 ◽  
Vol 7 ◽  
Author(s):  
Brian J. Piper ◽  
Kenneth L. McCall ◽  
Lori R. Kogan ◽  
Peter Hellyer

Objective: To evaluate the changing pattern of distribution of Schedule II and III opioids, barbiturates, and stimulants to veterinary educational institutions in the United States.Design: Longitudinal study.Sample: Veterinary teaching institutions that use Schedule II and III drugs.Procedures: Distribution of controlled substances to veterinary teaching institutions was obtained from the Drug Enforcement Administration's Automated Reports and Consolidated Orders System (ARCOS) for opioids (e.g., methadone, fentanyl, codeine), barbiturates (pentobarbital, butalbital), and stimulants (amphetamine, methylphenidate, lisdexamfetamine) from 2006–2019. Opioids were converted to their morphine milligram equivalents (MME) for evaluation over time.Results: Controlled substance distribution to veterinary schools exhibited dynamic, and agent specific, changes. The total MME for 11 opioids peaked in 2013 and decreased by 17.3% in 2019. Methadone accounted for two-fifths (42.3%) and fentanyl over one-third (35.4%) of the total MME in 2019. Pentobarbital distribution was greatest by weight of all substances studied and peaked in 2011 at 69.4 kg. Stimulants underwent a pronounced decline and were very modest by 2014.Conclusions and Clinical Relevance: Opioids by total MME in veterinary teaching practice have undergone more modest changes than opioids used with humans. Hydrocodone, codeine and recently fentanyl use have declined while methadone increased. Stimulant distribution decreased to become negligible. Together, this pattern of findings warrant continued monitoring.


2021 ◽  
pp. 096853322110570
Author(s):  
Mary-Elizabeth Tumelty ◽  
Eimear Spain

In recent years, the prospect of the criminal prosecution of medical practitioners for patient safety incidents resulting in fatality which occur in the course of clinical practice has caused heightened anxiety among medical practitioners, particularly in England and Wales, where a number of high-profile cases have raised public consciousness of this issue. The full impact of this landscape on individual practitioners and the delivery of healthcare has yet to be ascertained, although research suggests that medical practice has been impacted. Of particular interest is the phenomenon of defensive medicine which occurs where physicians adopt assurance and/or avoidance behaviours in an attempt to minimise the risk of medical negligence litigation and/or to avoid complaints to regulatory bodies. While defensive medicine is traditionally conceived of in a civil context, the possibility of criminal prosecution for patient safety incidents resulting in fatality may also result in alterations to medical practice. Drawing on the findings of an empirical study (a survey), this research sought to explore the impact, if any, of the threat of criminal prosecution on surgical practice in the Republic of Ireland, including a potential rise in defensive practice.


Author(s):  
Craig S. Cleveland ◽  
Andrew Honeycutt

<p class="MsoNormal" style="text-align: justify; margin: 0in 0.5in 0pt; mso-layout-grid-align: none;"><span style="font-size: 10pt;"><span style="font-family: Times New Roman;">The purpose of the study was to determine the impact of leadership and managerial decision making within the Drug Enforcement Administration since September 11, 2001.<span style="mso-spacerun: yes;">&nbsp; </span>A web based survey questionnaire was used to collect the data.<span style="mso-spacerun: yes;">&nbsp; </span>Participants in the study were criminal justice professors from randomly selected colleges and universities located in the southeast and southwest region of the United States.<span style="mso-spacerun: yes;">&nbsp; </span>Qualitative and quantitative research methods were used. Each participant was asked to complete a post survey that addressed areas of leadership and decision-making based on opinions and knowledge related to criminal justice.<span style="mso-spacerun: yes;">&nbsp; </span>Paired samples t test was used to describe the data. In spite of the survey findings of change in knowledge, skills, and cultural behavior, these changes did not appear to lead to significant differences in determining leadership skills.<span style="mso-spacerun: yes;">&nbsp; </span>It is recommended that future studies use a survey sample instrument designed to measure attitudinal dimensions of decision-making among leaders and managers within the Drug Enforcement Administration.<span style="mso-spacerun: yes;">&nbsp; </span>One possible recommendation is to utilize a different type of comparison method or instrument that would measure certain dimensions of managerial levels between upper and lower management.</span></span></p>


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