Does Social Media Accelerate Product Recalls? Evidence from the Pharmaceutical Industry

Social media has become a vital platform for voicing product-related experiences that may not only reveal product defects, but also impose pressure on firms to act more promptly than before. This study scrutinizes the rarely studied relationship between these voices and the speed of product recalls in the context of the pharmaceutical industry in which social media pharmacovigilance is becoming increasingly important for the detection of drug safety signals. Using Federal Drug Administration drug enforcement reports and social media data crawled from online forums and Twitter, we investigate whether social media can accelerate the product recall process in the context of drug recalls. Results based on discrete-time survival analyses suggest that more adverse drug reaction discussions on social media lead to a higher hazard rate of the drug being recalled and, thus, a shorter time to recall. To better understand the underlying mechanism, we propose the information effect, which captures how extracting information from social media helps detect more signals and mine signals faster to accelerate product recalls, and the publicity effect, which captures how firms and government agencies are pressured by public concerns to initiate speedy recalls. Estimation results from two mechanism tests support the existence of these conceptualized channels underlying the acceleration hypothesis of social media. This study offers new insights for firms and policymakers concerning the power of social media and its influence on product recalls.

Rise, and pronounced regional variation, in methylphenidate, amphetamine, and lisdexamfetamine distribution in the United States

Background The prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine are sympathomimetic drugs with therapeutic use. They are designated in the United States as Schedule II substances, defined by the 1970 Controlled Substances Act as having a “high potential for abuse”. Changing criteria for the diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and the approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns. This report compared the pharmacoepidemiology of these stimulants in the United States from 2010–2017. Methods Distribution of amphetamine, methylphenidate, lisdexamfetamine were examined via weights extracted from the Drug Enforcement Administration’s (DEA) Automated Reports and Consolidated Ordering System (ARCOS). Median stimulant Daily Dosage per patient was determined for a regional analysis. The percent of cost and prescriptions attributable to each stimulant and atomoxetine in Medicaid from the “Drug Utilization 2018 - National Total” from the Centers for Medicare and Medicaid was determined. Results There was a rise in amphetamine (+67.5%) and lisdexamfetamine (+76.7%) from 2010–2017. The change in methylphenidate (−3.0%) was modest. Persons/day stimulant usage was lower in the West than in other US regions from 2014-2017. There was a negative correlation (r(48) = −0.43 to −0.65, p < .05) between the percent Hispanic population per state and the Daily Dosage/population per stimulant. Methylphenidate formulations accounted for over half (51.7%) of the $3.8 billion reimbursed by Medicaid and the plurality (45.4%) of the 22.0 million prescriptions. Amphetamine was responsible for less than one-fifth (18.4%) of cost but one-third of prescriptions (33.6%). Lisdexamfetamine’s cost (26.0%) exceeded prescriptions (16.3%). Conclusion The rising amphetamine and lisdexamfetamine distribution may correspond with a rise in adult ADHD diagnoses. Regional analysis indicates that stimulant distribution in the West may be distinct from that in other regions. The lower stimulant distribution in areas with greater Hispanic populations may warrant further study.

Between Prohibitionism and Religious Freedom: The Legal Disputes Concerning an Ayahuasca Church and the United States Government

This article focuses on the legal disputes between the U.S. government and the Centro Espírita Beneficente União do Vegetal (UDV), as well as on the regulation of the religious use of ayahuasca by the Drug Enforcement Agency (DEA). Our aim is to present the main issues that were at stake throughout the dispute, especially the relationship between the limits of religious freedom when associated with the use of controlled substances.

Navigating the US “Green Rush”: anti-money laundering and de-risking implications for banking cannabis-related businesses in Jamaica

Purpose This paper aims to illuminate the diverging approaches to marijuana-related drug enforcement at the federal and state levels in the USA, which have facilitated a boom in the US medical cannabis industry (i.e. the “Green Rush”). It further sheds light on how the USA’ aggressive extraterritorial approach to anti-money laundering (AML) enforcement might simultaneously suppress the banking of cannabis-related businesses in Jamaica due to the lingering fear of de-risking. Design/methodology/approach An international and comparative legal and policy analysis was conducted of the nexus among shifting drug enforcement policies, AML laws and the banking of cannabis-related businesses. Findings This study found that the constitutional relationship between the US federal government and states has created a de facto comparative advantage for the US medical cannabis-related businesses that benefit from limited access to financial services. This was found to pose far-reaching implications for the banking and development of the Jamaican cannabis sector due to the dependence of the country’s financial institutions on correspondent banking relationships with the US banks that are regulated by federal AML statutes. Originality/value To the best of the author’s knowledge, this paper is the first of its kind to examine the extraterritorial regulatory risks to the banking of cannabis-related businesses in Jamaica.

Comparative Reactive Oxidative Species (ROS) Content among Disposable Flavored Vape Bars

Studies have shown that aerosols generated from flavored e-cigarettes contain Reactive Oxygen Species (ROS), promoting oxidative stress-induced damage within pulmonary cells. Our lab investigated the ROS content of e-cigarette vapor generated from disposable vape bars, a product exempt from the Federal Drug Enforcement Agency’s (FDA) 2020 flavor ban. Specifically, we analyzed vape bars belonging to multiple flavor categories (Tobacco, Minty Fruit, Fruity, Minty/Menthol, Desserts, and Drinks), manufactured by various vendors and of various nicotine concentrations (0-6.8%). Aerosols from these flavored vape bars were generated by a single puff aerosol generator and individually bubbled through a fluorogenic solution to detect and semi-quantify ROS in H2O2 equivalents generated by the vape bars. We compared and contrasted the ROS levels generated by each flavor as an indirect determinant of oxidative stress potential by these disposable vape bars. Our results showed that ROS concentration (μM) of aerosols produced from the vape bars varied significantly between different flavors and a function of nicotine concentration. Likewise, our results suggest that flavoring chemicals and nicotine concentration play a role in alerting ROS production in e-cigarette aerosols. Our study provides insight into the differential health effects of flavored disposable vape bars and the need for their regulation.

Decline and Pronounced Regional Disparities in Medical Cocaine Usage in the United States

Background: Cocaine is a stimulant and Schedule II drug used as a local anesthetic and vasoconstrictor. Objective: This descriptive study characterized medical cocaine use in the United States. Methods: Retail drug distribution data from 2002 to 2017 were extracted for each state from the Drug Enforcement Administration, which reports on medical, research, and analytical chemistry use. The percentage of buyers (pharmacies, hospitals, and providers) was obtained. Use per state, corrected for population, was determined. Available cross-sectional data on cocaine use as reported by the Medicare and Medicaid programs for 2013-2017 and electronic medical records were examined. Results: Medical cocaine use decreased by −62.5% from 2002 to 2017. Hospitals accounted for 84.9% and practitioners for 9.9% of cocaine distribution in 2017. The number of pharmacies carrying cocaine dropped by −69.4%. The percentages of hospitals, practitioners, and pharmacies that carried cocaine in 2017 were 38.4%, 2.3%, and 0.3%, respectively. There was a 7-fold difference in 2002 (South Dakota, 76.1 mg/100 persons; Delaware, 10.1 mg/100 persons). Relative to the average state in 2017, those reporting the highest values (Montana, 20.1; North Dakota, 24.1 mg/100 persons) were significantly elevated. Cocaine use within the Medicare and Medicaid programs was negligible. Cocaine use within the Geisinger system was rare from 2002 to 2007 (<4 orders/100 000 patients per year) but increased to 48.7 in 2018. Conclusion and Relevance: If these pharmacoepidemiological patterns continue, licit cocaine may soon become a historical relic. The pharmacology and pharmacotherapeutics education of health care providers may need to be adjusted accordingly.

FEATURES OF THE DRUG ENFORCEMENT OF THE RURAL POPULATION OF THE REPUBLIC OF ADYGEA

Improving the availability of medical and medicinal care is the most important task of all levels of government and especially relevant in the context of modernization of the health system. The purpose of the work was to analyze the peculiarities of the functioning of the Drug Provision System of the Rural Population of the Republic of Adygea to identify reserves for its development and substantiate directions for further improvement, taking into account regional conditions. It was established that in the Republic of Adygea out of 160 units of medical organizations, the right of retail trade in drugs, 112 medical and obstetric items that have licenses for pharmaceutical activities are used by drug trading. A feature of the implementation of pharmaceutical activities in rural areas is the absence in most places of modern transport highways, which creates logistics problems and significantly complicates the regular delivery of drugs to the population. Among the positive points, the appearance of an additional way of delivering drugs to the feldsher-obstetric items located in hard-to-reach (mountainous) areas implemented in the federal population to ensure the necessary drugs is noted. The inclusion of pharmacies of partners in the system of ensuring the population did not require additional agreements and expenditures on their services, since this function does not carry additional costs, but at the same time increases their image. It has been established that over the past 2 years, the quality of drugs in the countryside residents decreased significantly. In the region, the number of current pharmaceutical activities has decreased by 21%, the number of operating paramedic-obstetric items has also decreased by 18%, and the number of pharmacies of the program has decreased by 2.8 times. Currently, unresolved problems of the organizational nature came to the fore, among which: the absence of working capital organizations for the acquisition of drugs, in the presence of extrabudgetary funds received from the implementation of paid medical services; insufficient legal training of individual officials of medical organizations in state procurement issues; the absence from the overwhelming number of retail trade licenses for transportation of goods of pharmacy assortment and others. The identified problems are based on the basis of the work plan of health authorities, pharmaceutical activities, medical and pharmaceutical organizations of the Republic of Adygea to improve the forms and working methods for the provision of agricultural drugs.

The Identification of Gamma-Butyrolactone in JUUL Liquids

Gamma-Butyrolactone (GBL), a commonly used industrial solvent, is used recreationally as a central nervous system (CNS) depressant and, therefore, a United States Drug Enforcement Agency (DEA) List 1 chemical of the Controlled Substances Act. GBL was identified presumptively in the liquid from JUUL Virginia Tobacco flavored pods during routine untargeted screening analysis of e-cigarette products by gas chromatography–mass spectrometry (GC–MS). Methods for the confirmation and quantitation of GBL were developed for GC–MS and liquid chromatography–tandem mass spectrometry (LC–MS-MS) in the liquids and the aerosol generated from the liquid. Three flavors of JUUL pods available at the time of analysis were obtained by direct purchase from the manufacturer, purchase from a local vape shop, and via submission from a 3rd party. The only liquid flavor to contain GBL was Virginia Tobacco, with an average of 0.37 mg/mL of GBL, and it was detected in the aerosol. Studies evaluating the pharmacological effects of inhaling GBL do not exist, however a case report of chronic oral GBL ingestion indicates acute lung injury. The identification of GBL in an e-cigarette product purportedly compliant with federal regulation continues to demonstrate public health and public safety concerns.