After the CDC guidelines’ release, total opioid marketing spending and encounters per physician decreased, but spending per encounter subsequently increased.
Objectives: After the release of the CDC guidelines in March 2016, the rate of opioid prescriptions decreased. How or whether pharmaceutical companies changed their opioid marketing practices post release of the CDC guidelines is unknown. Our objectives were to (1) evaluate whether the release of the guidelines was associated with changes in total monthly marketing spending received per physician, monthly marketing encounter frequency per physician, and spending per encounter during opioid marketing; and (2) evaluate whether such changes in marketing differed between specialist physicians and primary care physicians (PCPs) and between urban and rural primary care service areas (PCSAs).
Study Design: Retrospective observational cross-sectional study using opioid marketing spending data from the CMS Open Payments database between August 2013 and December 2017.
Methods: Single-group and multiple-group interrupted time series analyses were used to evaluate differences in the immediate changes in level and trend over time in opioid marketing practices post release of the CDC guidelines.
Results: Post release of the CDC guidelines, the monthly number of marketing encounters per physician and total monthly amount received per physician decreased. However, the amount spent at each marketing encounter increased. The release of the CDC guidelines was associated with an immediate increase in level of opioid marketing spending per encounter by $0.59 (95% CI, $0.51-$0.68; P < .001) and an over-time increase in rate of spending per encounter of $0.04 per month (95% CI, $0.03-$0.05; P < .001). These changes differed between specialists and PCPs and between urban and rural PCSAs.
Conclusions: It is important to continue ongoing education for physicians on changes in pharmaceutical opioid marketing practices.
Am J Manag Care. 2022;28(10):507-513. https://doi.org/10.37765/ajmc.2022.89248
Death from drug overdose remains an important public health crisis in the United States and is the leading cause of death among those younger than 50 years.1 Two-thirds of the 63,632 drug overdose deaths in 2016 involved an opioid,2 and 40% of the 63,632 deaths involved prescription opioids specifically.3 Prescription opioid overdose deaths increased from 3442 in 1999 to 17,029 in 2017.4 After the onset of the COVID-19 pandemic in the United States in March 2020, there has been a further spike in drug overdose deaths; 107,270 drug overdose deaths were reported in 2021, with 80,816 of the deaths attributed to all opioids and 13,503 specifically to prescription opioids.5
About 20% of US adults reported experiencing chronic pain in 2016,6 and 20% of noncancer pain is treated with opioids.7 Although the prevalence of pain reported by Americans has not changed since the 1990s, opioid prescriptions for pain have increased.8,9 In an effort to reduce the burden of prescription opioid overdose, the CDC in March 2016 issued new guidelines on opioid prescription for chronic pain by primary care physicians (PCPs).10 The guidelines recommend initiating opioid treatment with immediate-release opioids at doses less than 50 morphine milligram equivalents (MME) per day. One of the guidelines also reads: “Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Physicians should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient.” The guidelines have in fact shown to be associated with a reduction in opioid prescription rate,11 but whether the pharmaceutical companies implemented different opioid marketing strategies to counter the reduction in prescriptions after the release of the CDC guidelines is unknown. Pharmaceutical marketing to physicians has been shown to be associated with increases in physician drug prescriptions and formulary addition requests by physicians for the promoted drugs.12-20 Pharmaceutical sales representatives meet with physicians to talk about their drugs and encourage prescriptions. They engage in promotional activities with physicians that may involve gifts, food and beverages, dinners, sponsorships for conferences, expense-paid travel and lodging, honoraria, consulting fees, compensation for serving as faculty or speaker, and the like.21,22 About 48% of physicians accepted industry-associated payments in 2015.23 In an article that discussed pharmaceutical marketing tactics, one of the authors, a former pharmaceutical sales representative, wrote, “It’s my job to figure out what a physician’s price is. For some it’s dinner at the finest restaurants…” and “During training, I was told, when you’re out to dinner with a doctor, ‘The physician is eating with a friend. You are eating with a client.’ ”24 Indeed, about 95% of nonresearch opioid marketing encounters involve food and beverages.25 Simple acts such as providing food enable marketing messages to be more positively received.26 When people receive gifts they feel indebted and have a tendency to return the favor,26 and in these cases of pharmaceutical opioid marketing, the return may be more opioid prescriptions.
In 2010, the Sunshine Act was passed into law through the Affordable Care Act and it required that medical product manufacturers report payments made to physicians to CMS, which publishes the data annually in a publicly searchable Open Payments database.27 Payments for such things as meals, gifts, and speaking fees started being reported in the Open Payments database in August 2013. The American Medical Association recommends that any gifts accepted by physicians should primarily be of benefit to patients and should not be of significant value.28 Although the majority of internal medicine program directors did not find pharmaceutical support desirable, more than half (56%) of them reported accepting support from the pharmaceutical industry.29
Between 2013 and 2015, nonresearch opioid-related marketing to physicians exceeded $46 million.25 In the Medicare Part D population, it has been shown that physicians who receive opioid-related payments prescribe more opioids than those who do not.30-33 Another study showed the association between increases in county-level pharmaceutical marketing of opioids and higher overdose mortality.34 However, to our knowledge, no study has evaluated whether the CDC guidelines have been linked with changes in pharmaceutical opioid marketing spending per encounter, changes in frequency of marketing encounters with physicians, or changes in total marketing amount spent per physician. Therefore, we evaluated whether the dollar value of food and beverages spent per physician encounter during opioid marketing, monthly number of encounters per physician, and total monthly amount received per physician changed post release of the CDC guidelines. We focused on food and beverage gifts because they account for about 95% of the opioid marketing encounters.25
Although the CDC guidelines on opioid prescribing were focused on PCPs, clinicians often adopt evidence-based recommendations from outside of their own areas of practice,35,36 and some specialist providers also adopted the CDC guidelines.36,37 Hence, we examined whether associated changes in opioid marketing post release of the CDC guidelines differed between PCPs and specialists. To our knowledge, these questions have not been previously examined.
Certain differences between rural and urban areas with regard to opioids have been documented, including rates of opioid prescriptions being higher in rural than urban areas,38,39 which may in turn influence pharmaceutical opioid marketing practices. However, whether postguideline changes in pharmaceutical marketing practices differed between urban and rural primary care service areas (PCSAs) is unknown. Hence, we also evaluated whether associated changes in postguideline opioid marketing differed between urban and rural PCSAs.
Overall, our study evaluates whether, post release of the CDC guidelines, the dollar value of food and beverage gifts per physician encounter for opioid marketing, monthly number of encounters per physician, and total monthly amount received per physician changed. Also, we evaluated whether these changes in marketing practices post release of the CDC guidelines differed between specialist physicians and PCPs, as well as between urban and rural PCSAs.
We used the CMS Open Payments database,22 a database that collects information on financial relationships between physicians and drug or device companies, which are required by the federal government to publicly report payments to provide transparency in the health care system. We extracted all opioid marketing spending on food and beverages for physicians between August 2013 and December 2017.
The outcome variables were the amount spent on each opioid marketing encounter with food and beverages, monthly number of encounters per physician, and total marketing amount spent on each physician per month. All yearly monetary values were converted to 2016 US$ equivalents using the 2016 consumer price index40 to address inflation during the study period.
Physicians receiving marketing spending were classified into PCPs and specialist physicians. PCSAs are standardized systems of geographical units that measure access to primary care resources, utilization, supply, and associated outcomes.41 Physicians’ practice locations were assigned to PCSAs using their zip codes according to the Dartmouth Atlas.42 A single PCSA is made up of several Census tracts. We calculated the population-weighted proportion of Census tracts classified with a US Department of Agriculture rural-urban commuting area code of 3 or lower.43 If the weighted proportion was greater than or equal to 0.75, that PCSA was considered to be urban; if less than 0.75, the PCSA was considered to be rural. Other cutoff values for population-weighted proportion of PCSAs different from 0.75 were explored and had no effect on the rural/urban classification or results.
We used single-group interrupted time series analysis (ITSA)44,45 with a linear probability model clustered on physicians to examine changes in opioid marketing pre- and post release of the CDC guidelines. We clustered SEs on physicians to account for repeated observation of physicians. The ITSA model allows for the evaluation of population-level interventions without case and control groups and is useful for teasing out immediate change in outcome measures, as well as changes in trajectory (slope) over time, following an intervention.44 We chose a linear probability model over a logit model to produce readily interpretable estimates46 and show how much opioid marketing practices changed post release of the CDC guidelines.
Changes in amount spent per opioid marketing encounter, monthly number of encounters per physician, and total monthly marketing amount received per physician were analyzed as a one-time change in level (intercept) at the time of exposure to the CDC guidelines and as change in trend over time after release of the CDC guidelines. The single-group ITSA was modeled in the form of equation 1. We used a multiple-group ITSA to evaluate whether changes in opioid marketing practices after release of the CDC guidelines are different when marketing to PCPs compared with specialist physicians, as well as when marketing in urban PCSAs compared with rural PCSAs. The multiple-group ITSA was modeled in the form of equation 2 using interaction terms.
yijt = β0 + β1*Monthst + β2*CDCguidelinet + β3*MonthsSinceCDCguidelinet + β4*Xj + εt
yijt = β0 + β5*Monthst + β6*Months#(group2−group1)t + β7*CDCguidelinet + β8*CDCguideline#(group2−group1)t + β9*MonthsSinceCDCguidelinet + β10*MonthsSinceCDCguideline#(group2−group1)t + β11*Xj + εt
where yijt is the outcome variable for physician i from pharmaceutical company j at month t, Months is a linear time trend in months that starts at the beginning of our sample period, CDCguideline is a binary indicator variable that equals 0 prior to the release of the CDC guidelines, and 1 after release of the CDC guidelines, MonthsSinceCDCguideline is a linear time trend that equals 0 prior to the release of the CDC guidelines and starts counting up each month afterward, (group2 – group1) is a binary indicator variable that is either equal to group 1 or group 2 (eg, specialist/PCP for physician types or rural/urban for PCSAs), # is an interaction term, Xj is a vector of pharmaceutical marketing company fixed effects entered as a categorical variable, and εt is the random error at observation t.
β0 is the intercept (starting level of the outcome), β1 is the slope or trajectory of the outcome until the introduction of the CDC guidelines, β2 represents the one-time change in level of outcome immediately at the time of implementation of the CDC guidelines (immediate treatment effect intercept change), β3 represents the difference in the post–CDC guidelines trend/slope and pre–CDC guidelines trend/slope of outcome variable (treatment effect over time after the CDC guidelines), β4 is a vector of the outcome variable by each pharmaceutical company, β5 is the slope or trajectory of the outcome until the introduction of the CDC guidelines in the reference group, β6 is the difference in slope or trajectory of outcome until the introduction of the CDC guidelines between groups compared, β7 represents the one-time change in level of outcome immediately at the time of implementation of the CDC guidelines in the reference group, β8 represents the difference in immediate one-time change in level of outcome at the time of implementation of the CDC guidelines in March 2016 between groups compared, β9 represents the difference in the post–CDC guidelines trend/slope and pre–CDC guidelines trend/slope of outcome variable in the reference group, β10 represents the difference between the 2 groups’ compared change in the post–CDC guidelines and pre–CDC guidelines trend/slope of the outcome variable (difference in treatment effect over time post CDC guidelines), β11 is a vector of the outcome variable by each pharmaceutical company, and ε is the error term.
We repeated the analysis using 1-month and 2-month washout periods and our findings remained unchanged (with similar directions and magnitudes of changes in intercept and slope post release of the CDC guidelines). A washout period is a time period that is excluded from the analysis with the aim of allowing for some time for implementation of the intervention. For example, with the release of the CDC guidelines in March 2016, a 1-month washout leaves out the month of March 2016 from the analysis, and a 2-month washout leaves out the months March and April 2016 from the analysis.
Systemic differences in dollar amount spent on food and beverages during marketing across pharmaceutical companies were accounted for by including an indicator variable for each company as controls in all models.
All analyses were performed using DbVisualizer version 10.0.15 (DbVis Software AB) and Stata 14 (StataCorp LLC).
During the study period, 94.8% of all opioid marketing encounter payments involved food and beverages and a total of 86,101 unique physicians received opioid marketing spending with food and beverages; 35.5% of the physicians were PCPs. A total of 684,343 opioid marketing encounters occurred during the study period. Of the total encounters, 89.9% occurred in urban PCSAs compared with 10.1% in rural PCSAs (eAppendix Table 1 [eAppendix available at ajmc.com]). Seven pharmaceutical companies accounted for 91% of all opioid marketing encounters. The mean (SD) amount spent on meals and beverages on each encounter was $16.6 ($25.7), the mean (SD) monthly number of encounters per physician was 1.5 (3.9), and the mean (SD) total monthly spending per physician per month was $25.3 ($75.5).
The Table shows the association of total monthly opioid marketing spending per physician, monthly number of encounters per physician, and spending per opioid marketing encounter with the release of the CDC guidelines. Prior to the release of the CDC guidelines, the total monthly opioid marketing spending and monthly number of encounters per physician were increasing at a rate of $0.32 (95% CI, $0.14-$0.49; P < .001) and 0.03 (95% CI, 0.02-0.04; P < .001), respectively. Post release of the CDC guidelines, the change in total monthly opioid marketing spending and monthly number of encounters per physician decreased over time by $1.07 per month (95% CI, –$2.09 to $0.05; P = .040) and 0.08 encounters (95% CI, –0.14 to –0.02; P = .008) per month, respectively. The direction of the change remained the same using 1-month and 2-month washout periods post release of the CDC guidelines (eAppendix Table 1 and eAppendix Table 2). In contrast, before the release of the CDC guidelines, the amount spent per opioid marketing encounter on food and beverage was declining at a rate of $0.03 per month (95% CI, –$0.03 to –$0.02; P < .001). Post release of the CDC guidelines, there was an immediate increase in level of spending per encounter by $0.58 (95% CI, $0.49-$0.67; P < .001) and the change in amount of spending per encounter increased at a rate of $0.04 per month (95% CI, $0.03-$0.05; P < .001). The direction of the change remained the same using 1-month and 2-month washout periods post release of the CDC guidelines, even though the magnitudes of increase in spending were slightly higher (eAppendix Tables 1 and 2).
Also, physicians who received higher marketing spending per encounter also received more encounters (Figure 1). For example, in January 2014, the top 1% of physicians who received the highest payment per encounter accounted for 3.5% of all opioid marketing encounters. The top 5% accounted for 10.4% of all opioid marketing encounters (Figure 1).
We also found variations in the changes in opioid marketing practices post release of the CDC guidelines by physician specialty and geographic locations. The decline in total monthly opioid marketing spending and number of encounters per physician post release of the CDC guidelines was greater among specialist physicians than PCPs and in urban PCSAs than rural PCSAs (Figure 2 and Figure 3). Post release of the CDC guidelines, the immediate increase in level of spending per encounter was greater among specialist physicians than PCPs by $0.32 (95% CI, $0.16-$0.48; P < .001); however, the rate of increase in amount of spending per encounter was lower among specialist physicians compared with PCPs by $0.02 per month (95% CI, –$0.03 to –$0.01; P = .005) (Figure 4). Likewise, post release of the CDC guidelines, the immediate increase in level of spending per encounter was greater in urban than rural areas by $0.26 (95% CI, $0.05-$0.46; P = .014); however, the rate of increase was lower in urban PCSAs compared with rural PCSAs by $0.02 per month (95% CI, –$0.04 to –$0.01; P = .039) (Figure 4).
In this study that examined 684,343 non–research-related opioid marketing encounters involving food and beverages between August 2013 and December 2017, we found that post release of the CDC guidelines pharmaceutical companies reduced the total monthly amount spent on opioid marketing per physician and monthly number of opioid marketing encounters per physician. However, the amount spent on food and beverage per encounter increased. We also noted a shift in trend in prescription opioid marketing practices; before the release of the CDC guidelines, the amount spent per encounter on opioid marketing was declining, but post release of the guidelines, it started to increase.
In addition, we found that physicians who received higher marketing spending per encounter accounted for a disproportionately larger share of all encounters. This finding may be consistent with more focused marketing targeting of high-volume prescribers. For example, in February 2021, a charge was brought against a large consulting company, alleging that it advised “opioid manufacturers to target prescribers who write the most prescriptions, for the most patients, and thereby make the most money.”47
We also observed that the rate of change in spending per encounter post release of the CDC guidelines compared with before the release of the guidelines was significantly higher among PCPs than specialist physicians. The CDC guidelines targeted PCPs, and PCPs prescribe about half of all prescription opioids,48,49 which may explain why they were more heavily targeted with a higher rate of opioid marketing spending per encounter post release of the CDC guidelines.
The rate of increase in marketing spending per encounter post release of the CDC guidelines was also significantly higher in rural than in urban PCSAs. Perhaps this is because rural areas have a higher rate of opioid prescriptions,38,39 potentially making them more attractive for marketing spending per encounter.
Several studies’ findings have shown that pharmaceutical opioid marketing targeted to physicians is associated with increases in opioid prescriptions by physicians receiving these payments.30-33 It is important to continue ongoing education for physicians to increase their awareness of changes in pharmaceutical opioid marketing practices. Study findings have shown and suggested that educational interventions for physicians, as well as legislation that limits the value of gifts received by physicians, may be beneficial in addressing the potential influence of pharmaceutical opioid marketing on physician prescribing.16,50,51
Our study focused on food and beverage encounters and did not evaluate other forms of pharmaceutical opioid marketing, such as spending on education, consulting fees, honoraria, and grants. Also, our analysis evaluates response to the CDC opioid guidelines at the national level and may not have accounted for some state-level policy changes on opioid prescribing during the study period. For example, in 2016, Massachusetts limited first-time opioid prescriptions to 7 days, and in 2017, Utah recommended that alternatives to opioid treatment should be tried before initiating opioid treatment.52,53
After the release of the CDC guidelines on opioid prescribing, total monthly amount spent per physician and monthly frequency of marketing encounters per physician decreased and instead the value of food and beverage gift items during each encounter increased. It is important to continue to educate physicians to maintain awareness of pharmaceutical opioid marketing practices.
Author Affiliations: Department of Health Services Research (ATT) and Division of Health Pharmacy Coverage Change and Management (RW, TB), School of Public Health, University of Minnesota Twin Cities, Minneapolis, MN; Department of Finance, University of Minnesota Carlson School of Management (PK-M), Minneapolis, MN; National Bureau of Economic Research (PK-M), Minneapolis, MN; Department of Health Services Research, Mayo Clinic (MMJ), Rochester, MN.
Source of Funding: This research was funded by Agency for Healthcare Research and Quality (AHRQ) (R01 HS025164) (principal investigator: Karaca-Mandic).
Author Disclosures: Dr Karaca-Mandic has provided consulting services to Sempre Health, holds an executive position and equity in XanthosHealth, serves as advisor to Koya Medical, all for unrelated work, and served as the principal investigator on the AHRQ grant that partially funded this work. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.
Authorship Information: Concept and design (ATT, PK-M, RW, MMJ, TB); acquisition of data (PK-M, TB); analysis and interpretation of data (ATT, PK-M, MMJ, TB); drafting of the manuscript (ATT, RW, MMJ, TB); critical revision of the manuscript for important intellectual content (ATT, PK-M, RW, MMJ, TB); statistical analysis (ATT); obtaining funding (PK-M, TB); administrative, technical, or logistic support (PK-M, RW, MMJ, TB); and supervision (PK-M, TB).
Address Correspondence to: Adeniyi T. Togun, MD, PhD, MPH, MS, Department of Health Services Research, School of Public Health, University of Minnesota Twin Cities, 420 Delaware St SE, MMC 729, Minneapolis, MN 55455. Email: firstname.lastname@example.org.
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