Opioid Sales Research Articles

Supply Base attributes and diversion risk in a supply chain for hazardous pharmaceutical products

AbstractWe develop a novel construct, diversion risk, defined as the potential for post‐retail diversion that results from increased sales of hazardous goods. We examine diversion risk in the context of prescription opioid sales in the United States. We ask how supply base attributes and nonprofit ownership influence the creation of opioid diversion risk. We use performance‐outcome expectancy theory to hypothesize that pharmacies organize supply bases to help them avoid negative evaluations and that nonprofit ownership alters expectancy concerning legal but questionable behavior. We develop and test multilevel hypotheses explaining how supply base complexity, chain size, and nonprofit ownership influence diversion risk. Our analysis of DEA data from 2006 to 2019 finds that after accounting for other attributes, supply base complexity is positively related to diversion risk, within and between firms. Retail chain size is negatively related to diversion risk in the within‐firm model, but positively in the between firm model. Testing our nonprofit hypothesis reveals that nonprofit pharmacies also use size and supply base complexity to manage diversion risk. This research sheds light on the dynamics of diversion risk in pharmaceutical supply chains. It has practical implications for the industry, potentially informing future policy and practice addressing this critical issue.

Opioid prescribing in the Netherlands during the COVID-19 pandemic: a national register-based study

ObjectivesThe COVID-19 pandemic and related lockdown measures disrupted global healthcare provision, including opioid prescribing. In North America, opioid sales declined while opioid-related deaths increased. In Europe, the effect of the...

Inside “Operation Change Agent”: Mallinckrodt's Plan for Capturing the Opioid Market

Context: The United States is deeply entangled in an opioid crisis that began with the overuse of prescription painkillers. At the height of the prescription opioid crisis (2006–2012), Mallinckrodt Pharmaceuticals was the nation's largest opioid manufacturer. This study explores Mallinckrodt's strategies for expanding its market share by promoting a new opioid. Methods: The authors used the Opioid Industry Document Archive to analyze the incentive structures, sales contests, and rhetorical strategy behind Mallinckrodt's “Operation Change Agent,” a campaign to switch patients from OxyContin to Mallinckrodt-manufactured painkillers. A structured search of the archive in October 2022 retrieved 464 documents dated between 2010 and 2020. Findings: The authors identified a range of Mallinckrodt's sales force motivational techniques, including hypertargeting high-decile prescribers, providing free trial kits, using emotion-based language to connect with prescribers, and strategies for opposing prescriber resistance. Throughout, managers used specific incentivization metaphors to frame strategies in terms of sport and ultramarathons. Conclusions: This research on internal corporate strategy joins the growing challenges to industry claims that opioid sales teams simply educated providers and helped fill existing demand for their products. It has important implications for regulatory policy and consumer protections that can better protect health in the face of competitive market forces.

Are we missing the opioid consumption in low- and middle-income countries?

The rise in opioid prescriptions with a parallel increase in opioid use disorders remains a significant challenge in some developed countries (opioid epidemic). However, little is known about opioid consumption in low- and middle-income countries (LMICs). In this short report, we aim to discuss the increase in opioid consumption in LMICs by providing an update on the opioid perspective in Brazil. We analyzed opioid sales on the publicly available Brazilian Health Regulatory Agency (ANVISA) database from 2015 to 2020. In Brazil, opioid sales increased 34.8 %, from 8,839,029 prescriptions in 2015 to 11,913,823 prescriptions in 2020, this represents an increase from 44 to 56 prescriptions for every 1,000 inhabitants. Codeine phosphate combined with paracetamol and tramadol hydrochloride were the most common opioids prescribed with an increase each year. The results suggest that opioid prescriptions are rising in Brazil in a 5 years period. Brazil may have a unique opportunity to learn from other countries and develop consistent policies and guidelines to better educate patients and prescribers and to prevent an opioid crisis.

Urine Drug Testing in Pain Medicine

The recent Institute of Medicine report declared that greater than 100 million Americans have chronic pain with an associated cost of up to $635 billion each year due to medical treatment and lost productivity.[1,2] The explosion in opioid prescribing since the 1990s has resulted in opioids being the most frequently prescribed medication in the United States.[3–5] Manchikanti et al.'s study revealed a 149% increase in retail opioid sales and a 402% increase in average sales of opioids per person in the United States from 1997 to 2007 [6]. Looking at 1999–2012, the National Center for Health Statistics found that among patients aged 20 or older prescription opioid use increased from 5% to 6.9% until 2006 and then stayed at 6.9% until 2012.7 However, the percentage of patients using an opioid stronger than morphine dramatically increased from 17% to 37% over the same period.[7] Among the top 25 dispensed prescriptions in the United States, hydrocodone, tramadol, and oxycodone accounted for 1, 21, and 22 dispensed prescriptions, respectively. 5 Opioids represent one of many therapeutic options for treating chronic nonmalignant pain (CNMP), but their widespread use has resulted in a concomitant increase in misuse, abuse, addiction, overdose, and diversion. While there is evidence of the short-term benefit of opioids for treating pain based on randomized trials lasting less than 3 months, there are few studies reporting outcomes at 12 months or longer [8,9].

Evidence-based perioperative opioid-sparing techniques during the United States opioid crisis.

The current United States opioid epidemic resulted from the overprescribing of opioids by physicians and surgeons in response to deceptive and unlawful marketing campaigns by pharmaceutical companies seeking to profit from opioid sales. Surgeons have a moral obligation to employ evidence-based opioid-sparing analgesia protocols for management of perioperative pain. Recent evidence strongly supports the use of NSAIDs in perioperative pain management, with large studies demonstrating no increased risk of postoperative hemorrhage or renal insult. We present an evidence-based approach for opioid-sparing perioperative pain management, including multimodal analgesia guidelines used at our center for patients undergoing free flap facial reanimation procedures.

Effects of prescription opioids on employment, earnings, marriage, disability and mortality: Evidence from state opioid control policies

This article presents estimates of the effects of state prescription opioid control policies on prescription opioid sales, mortality and socioeconomic outcomes of adults. Results indicate that state implementation of a “modern” Prescription Drug Monitoring Program (PDMP) is associated with decreases in opioid sales of between 5% and 20% and that pill mill laws are associated with a decrease in opioid sales of between 15% and 40%. While these policies were associated with reductions in prescription opioid sales they were not significantly associated with drug- and opioid-related mortality, although estimates consistently indicated that these policies reduced mortality. In the case of socioeconomic outcomes, we found consistent evidence that the adoption of a “modern” PDMP was associated with small, but statistically significant reductions in employment of 1% to 2%; small reductions in earnings that were not statistically significant for full sample, but were significant and larger for a low-educated sample; and similarly small, marginally significant increases in receipt of public assistance, particularly for women; and a significant, but small (1%) decline in the probability of being married among females. In contrast, pill mill laws were associated with marginally significant increases in employment of 1% to 2%, but only among those ages 18 to 25; small, but insignificant increases in earnings of males of between 2% to 4%; and a significant, but small (1%) decline in the probability of being married.

Prescription opioids and economic hardship in France

This paper studies how opioid analgesic sales are empirically related to socioeconomic disparities in France, with a focus on poverty. This analysis is made possible using the OpenHealth database, which provides retail sales data for opioid analgesics available on the French market. We exploit firm-level data for each of the 94 departments in Metropolitan France between 2008 and 2017. We show that increases in the poverty rate are associated with increases in sales: a one percentage point increase in poverty is associated with approximately a 5% increase in mild opioid sales. Our analysis further shows that opioid sales are positively related to the share of middle-aged people and individuals with basic education only, while they are negatively related to population density. The granularity and longitudinal nature of these data allow us to control for a large pool of potential confounding factors. Our results suggest that additional interventions should be more intensively addressed toward the most deprived areas. We conclude that a combination of policies aimed at improving economic prospects and strictly monitoring access to opioid medications would be beneficial for reducing opioid-related harm.

Industry strategies to market opioids to children and women in the USA: a content analysis of internal industry documents from 1999 to 2017 released in State of Oklahoma v. Purdue Pharma, L.P. et al

ObjectiveIdentify advertising strategies used to market opioids to women and children.DesignQualitative content analysis of internal pharmaceutical industry documents released in litigation, dated between 1999 and 2017.SettingUSA.ParticipantsOpioid manufacturers (Janssen, Ortho-McNeil, Purdue,...

Must‐access prescription drug monitoring programs and retail opioid sales

AbstractThis paper examines the effect of prescription drug monitoring programs (PDMPs) on the retail sales of eight commonly prescribed opioids in the United States. Specifically, we exploit variation in state‐level policies to identify states with “must‐access” versus voluntary PDMPs. Our results suggest that must‐access PDMP implementation does not uniformly reduce prescription retail opioid sales. We also find evidence that must‐access PDMP implementation does not affect the retail sales of two treatment drugs, methadone and buprenorphine. These results suggest that policymakers should consider PDMP implementation as part of a broader response to the opioid crisis rather than a singular policy intervention.

Overdose, opioid treatment admissions and prescription opioid pain reliever relationships: United States, 2010-2019.

Background“As part of the U.S. government's urgent response to the epidemic of overdose deaths (1)” the United States Centers for Disease Control and Prevention (CDC) issued the “CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016 (2)” (guideline) followed by the “CDC Clinical Practice Guideline for Prescribing Opioids–United States, 2022 (3) (guideline update). ” The guideline and guideline update cite a direct correlation between prescription opioids sales (POS) and opioid treatment admissions (OTA) and prescription opioid deaths (POD), which was based on data from 1999 to 2010. This paper updates those relationships and includes the correlations between prescription opioid sales (POS) and any opioid deaths (AOD) and total overdose deaths (TOD) from 2010 to 2019.MethodsLinear regression models were fit to each response separately. Opioid sales (measured as MME (morphine milligram equivalent) per capita) was the independent variable. Total overdose deaths (TOD), any opioid overdose deaths (AOD), prescription opioid overdose deaths (POD) and opioid treatment admissions (OTA) were the dependent, response variables. The models were assessed using three criteria: the statistical significance of the model (Overall P-Value), the quality of the fit (R2), and the sign of the slope coefficient (positive or negative).ResultsThe analyses revealed that the direct correlations (i.e., significant, positive slopes) reported by the CDC based on data from 1999 to 2010 no longer exist. Based on data from 2010 to 2019, the relationships either have reversed (i.e., significant, negative slopes) or are non-existent (i.e., no significant model).ConclusionsThe guideline, guideline update, CDC's public, medical profession, and intergovernmental communications should be corrected/updated to state no direct correlation has existed between POS to OTA, POD, AOD, and TOD since 2010. Individualized patient care and public health policy should be amended accordingly.

Opioid sales and opioid-related poisonings in Switzerland: A descriptive population-based time-series analysis.

SummaryBackgroundTo examine time trends and characteristics of calls related to opioid poisonings reported to the National Poison Centre and opioid sales in Switzerland.MethodsWe used population-level data from the Swiss National Poisons Information Centre on reported opioid-related poisonings and data provided by the Swiss Pharmacists’ Association (pharmaSuisse) based on IQVIA data to identify sold opioid packages. The rate of opioid-related poisoning calls and dispensed opioid packages per 100,000 Swiss inhabitants between 2000 and 2019 were plotted by year and annual trends were assessed. All analyses were stratified by individual opioid and potency (strong vs weak).FindingsThere was a significant 177% increase in the rate of calls for opioid-related poisonings (1·4 to 3·9 per 100,000 inhabitants, p<0·001) and a 91·3% increase in opioid sales (from 14,364·0 to 27,477·6 per 100,000 inhabitants, p<0.001). The increase associated with strong opioids was higher when compared to weak opioids, in both poison centre calls and sales. In 2019, tramadol was the most frequently reported opioid in the poison centre data (35·7%, n=133) and sales (37·5%, n=8,863,377), followed by oxycodone calls (24·4%, n=91) and sales 23·4%, n= 552,751). Poisoning calls and sales related to oxycodone increased substantially between 2009 and 2016, as did the rate of poison centre calls requiring medical care.InterpretationCalls to the Swiss National poison centre and sales for opioid have increased substantially in Switzerland in the last two-decades. Increases were primarily driven by oxycodone and tramadol; however, sales have attenuated since 2016. Our findings mirror other European countries and stress the importance of surveillance and monitoring.FundingThe research did not receive external funding. Translation of the abstract in German, French and Italian are available in the Supplementary section.

International trends in prescription opioid sales among developed and developing economies, and the impact of the COVID-19 pandemic: A cross-sectional analysis of 66 countries.

PurposeWe sought to compare trends in opioid purchasing between developed and developing economies to understand patterns of opioid consumption, and how they were impacted by the COVID‐19 pandemic.MethodsWe conducted a retrospective cross‐sectional study of retail pharmacy opioid sales from 66 jurisdictions between July 2014 and August 2020. We measured monthly population‐adjusted rate of opioid units purchased, stratified by development group and country, and used interventional time series analysis to assess the impact of the COVID‐19 pandemic on rates of opioid purchasing among developed and developing economies separately.ResultsRates of opioid purchasing were generally higher among developed economies, although trends differed considerably by development group. Rates of opioid purchasing declined 23.8% (95% confidence interval [CI] −34.7% to 3.6%) in the 5 years prior to the pandemic in developed economies, but rose 15.2% (95% CI 4.6%–35.6%) among developing economies. In March 2020 there was a short‐term increase in the rate of opioid purchases in both developing (10.9 units/1000 population increase; p < 0.0001) and developed (145.5 units/1000 population; p < 0.0001) economies, which was followed immediately by reduced opioid purchasing of a similar scale in April–May 2020 (−14.8 and −171.8 units/1000 population in developing and developed economies, respectively; p < 0.0001).ConclusionThe COVID‐19 pandemic led to disruptions in opioid purchasing around the world; although the specific impacts varied both between and among developed and developing economies. With global variation in opioid use, there is a need to monitor these trajectories to ensure the safety of opioid use, and adequate access to pain management globally.

Global, regional, and national trends in opioid analgesic consumption from 2015 to 2019: a longitudinal study

Previous studies have reported an extremely unbalanced global access to opioid analgesics. We aimed to determine contemporary trends and patterns of opioid analgesic consumption at the global, regional, and national levels. We analysed the global pharmaceutical sales data of 66 countries or regions from the IQVIA-Multinational Integrated Data Analysis System database on opioid analgesics between 2015 and 2019. Opioid analgesic consumption was measured in milligram morphine equivalent per 1000 inhabitants per day (MME per 1000/day). The global, regional, and national trend changes were estimated using linear regressions. Factors associated with consumption patterns and trend changes were explored in multivariable linear regression analyses. Overall opioid analgesic sales in the 66 countries or regions increased from 27·52 MME per 1000/day (16·63-45·54) in 2015 to 29·51 MME per 1000/day (17·85-48·79) in 2019 (difference per year 3·96%, 95% CI 0·26 to 7·80). Sales reduced yearly in North America (-12·84%; 95% CI -15·34 to -10·27) and Oceania (-2·96%; -4·20 to -1·70); increased in South America (28·69%; 7·18 to 54·53), eastern Europe (7·68%; 3·99 to 11·49), Asia (5·74%; 0·61 to 11·14), and western and central Europe (1·64%; 0·52 to 2·78); and did not differ in Africa or central America and the Caribbean. The global opioid consumption patterns were associated with country-level Human Development Index (p=0·040), cancer death rate excluding leukaemia (p=0·0072), and geographical location (p<0·0001). In 2019, opioid analgesic consumption ranged from 0·01 MME per 1000/day to 5·40 MME per 1000/day in the 17 countries and regions in the lowest consumption quartile, despite high income levels and cancer death rates in some of them. Global opioid analgesic consumption increased from 2015 to 2019. The trend changes were distinctive across regions, which could reflect the different actions in response to known issues of opioid use and misuse. Disparities in opioid analgesic consumption remained, indicating potential inadequate access to essential pain relief in countries with low consumption. None.

Urban scaling of opioid analgesic sales in the United States.

Opioid misuse is a public health crisis in the United States. The origin of this crisis is associated with a sharp increase in opioid analgesic prescribing. We used the urban scaling framework to analyze opioid prescribing patterns in US commuting zones (CZs), i.e., groups of counties based on commuting patterns. The urban scaling framework postulates that a set of scaling relations can be used to predict health outcomes and behaviors in cities. We used data from the Drug Enforcement Administration's Automated Reports and Consolidated Ordering System (ARCOS) to calculate counts of oxycodone/hydrocodone pills distributed to 607 CZs in the continental US from 2006 to 2014. We estimated the scaling coefficient of opioid pill counts by regressing log(pills) on log(population) using a piecewise linear spline with a single knot at 82,363. Our results show that CZs with populations below the knot scaled superlinearly (β = 1.36), i.e., larger CZs had disproportionally larger pill counts compared to smaller CZs. On the other hand, CZs with populations above the knot scaled sublinearly (β = 0.92), i.e., larger CZs had disproportionally smaller pill counts compared to smaller CZs. This dual scaling pattern was consistent across US census regions. For CZs with population below the knot, the superlinear scaling of pills is consistent with the explanation that an increased number of successful matches between prescribers and users will lead to higher prescribing rates. The non-linear scaling behavior observed could be the result of a combination of factors, including stronger health care systems and prescribing regulation in largely populated commuting zones, as well as high availability of other opioids such as heroin in these commuting zones. Future research should explore potential mechanisms for the non-linearity of prescription opioid pills.

Opioid use disorders national registries and opioids sales registries: A 10-year prevalence study from a middle-income country.

(1) To estimate the prevalence, geographic distribution, and demographic characteristics of patients diagnosed with mental and behavioral disorders due to the use of opioids in Colombia, between 2009 and 2018. (2) To describe the opioid sales trends in Colombia over the last few years. We conducted an observational study analyzing information from Individual National Registry of Health Services and the Colombian official database for pharmaceuticals prices and quantities sold. The included ICD-10 codes were mental and behavioral disorders due to the use of opioids (F11) codes subdivisions. 12,557 cases of mental and behavioral disorders due to opioid use were reported, with a rate of 3.0 per 100,000 inhabitants for the studied period. Men represented 74.2 percent, with a male:female ratio of 2.9:1. The highest prevalence was found between 20 and 24 years, in the northwest Colombian area. A progressive increase in the total number of opioid units sold during the study period was found, and the most frequently sold opioids were tramadol (55 percent) and codeine (20 percent). Recognition of opioid use disorders has increased in the last 10 years; it affects more males than females, mostly young adults, and is higher in certain affluent regions of Colombia. We found a progressive annual increase in the sales of opioids in the country, which could be related to the increase in the rate of registries. Studies that have analyzed opioid abuse in Latin America are limited, and further studies are needed to evaluate this situation in middle-income countries from the region.

Opioid availability statistics from the International Narcotics Control Board do not reflect the medical use of opioids: comparison with sales data from Scandinavia.

Opioid analgesics are essential in clinical practice, but their excessive use is associated with addiction risk. Increases in opioid prescription rates have fuelled an epidemic of opioid addiction in the USA, making statistics on medical opioid use a critical warning signal. A dramatic 150% increase in Swedish opioid access 2001-2013 was recently reported based on data from the International Narcotics Control Board (INCB; Berterame et al. 2016) in conflict with other studies of opioid use in the Nordic countries. This article aims to analyse to what degree published INCB statistics on opioids in Scandinavia (Denmark, Norway and Sweden) reflect actual medical use and study the methodological reasons for putative discrepancies. Data on aggregated total national sales of opioids for the whole population, including hospitals, were collected from the Swedish e-Health Authority. Total sales data for Denmark and drugs dispensed at pharmacies in Norway are publicly available through the relevant authorities' websites. INCB opioid statistics during the period 2001-2013 were markedly inconsistent with sales data from Scandinavia, calling the reliability of INCB data into question. INCB-data were flawed by (a) over-representing the volume of fentanyl, (b) under-reporting of codeine, and (c) by not including tramadol. Opioid availability, as expressed by INCB statistics, does not reflect medical opioid use. It is crucial to underline that INCB statistics are based on the manual compilation of national production, import and export data from manufacturers and drug companies. This is not the same amount that is prescribed and consumed within the health care system. Moreover, there are methodological problems in the INCB reports, in particular concerning fentanyl, codeine and tramadol. We suggest that INCB should carefully review the quality of their data on medical opioids.

Have Electronic Health Records Decreased Prescription Opioid Sales? Evidence from DEA Records

Have Electronic Health Records Decreased Prescription Opioid Sales? Evidence from DEA Records

New US pilot programme targets illegal online opioid sales

New US pilot programme targets illegal online opioid sales

Prescription opioids and population cardiovascular mortality in US South female non-Hispanic whites

Recent ecological studies have demonstrated that mid-life mortality rates in US American Indians and non-Hispanic whites (NHW) have been rising for the past 20 years and are correlated with prescription opioid sales. The study hypothesis was that temporal correlations exist between annual hydrocodone and oxycodone sales and female NHW CV mortality rates in the Deep South USA. Six states in the Deep South were studied across the 2000–2017 timeframe: Alabama, Arkansas, Louisiana, Mississippi, Oklahoma, and South Carolina. Female NHW mortality rates in the 35–44-, 45–54-, and 55–64-, and 65–74-year-old groups were obtained from the CDC Wonder Detailed Mortality database. Hydrocodone and oxycodone sales data were obtained from the State Health Access Data Assistance Center database. Time-series datasets were graphed and analyzed using Spearman rank correlation testing, after second differencing to control for trend. A 1-year adjustment was made to accommodate a 1-year temporal lag of mortality behind opioid sales. Annual CV mortality in 35–44-year-old NHW females was not associated with annual opioid sales. Annual CV mortality in 45–54-year-old NHW females was correlated with hydrocodone sales [rs(13) 0.650; P = 0.009], oxycodone [rs(13) 0.454; P = 0.090], and combined hydrocodone–oxycodone [rs(13) 0.764; P = 0.001]. Annual cardiovascular mortality in 55–64-year-old NHW females was associated with hydrocodone sales [rs(13) 0.499; P = 0.059], oxycodone [rs(13) 0.561; P = 0.030], and combined hydrocodone–oxycodone [rs(13) 0.545; P = 0.036]. Annual CV mortality in 65–74-year-old NHW females was associated with oxycodone [rs(13) 0.696; P = 0.004]. At the population level, prescription opioid sales are temporally correlated with cardiovascular mortality rates in NHW females of the Deep South.