Project description:ObjectiveThe US CDC identified prescription drug monitoring programs (PDMPs) as a tool to address the contemporary opioid crisis, but few studies have investigated PDMP usability and effectiveness from the users' perspective. Even fewer have considered how practices differ across medical domains. In this study, we aimed to address these gaps, soliciting perspectives on PDMPs from providers contending with the opioid crisis: physicians working in emergency departments (EDs) and pain management clinics. We aimed to provide practical design recommendations to improve PDMP workflow integration, as well as controlled substance history retrieval, interpretation, and decision support.MethodsWe conducted 16 in-depth semi-structured interviews with practicing emergency and pain physicians regarding their procedures, problems, and proposed solutions surrounding their use of CURES, California's PDMP. We investigated design problems in CURES by combining users' feedback with our usability inspection, drawing upon an extensive body of design literature. Then, we generated alternatives using design methods.ResultsWe found CURES's design did not accommodate the unique information needs of different medical domains. Further, clinicians had trouble accessing CURES and retrieving patients' controlled substance histories, mainly due to usability problems that could be addressed with little technical adjustment. Additionally, CURES rendered patient histories in large, cluttered tables, devoid of overview or context, making interpretation difficult and precarious. Lastly, our interviewees had rarely noticed or used advanced features, such as decision support.Discussion and conclusionUsability barriers inhibited adoption and effective use. We provide practical recommendations for improving opioid control by way of improving PDMP design, based on interviewees' suggestions and research-based design principles. Our findings have implications for other disciplines, including surgery and primary care.
Project description:ImportanceAlthough manufacturer-sponsored coupons are commonly used, little is known about how patients use them within a treatment episode.ObjectivesTo examine when and how frequently patients use manufacturer coupons during a treatment episode for a chronic condition, and to characterize factors associated with more frequent use.Design, setting, and participantsThis is a retrospective cohort study of a 5% nationally representative sample of anonymized longitudinal retail pharmacy claims data from October 1, 2017, to September 30, 2019, obtained from IQVIA's Formulary Impact Analyzer. The data were analyzed from September to December 2022. Patients with new treatment episodes using at least 1 manufacturer coupon over a 12-month period were identified. This study focused on patients with 3 or more fills for a given drug and characterized the association of the outcomes of interest with patient, drug, and drug class characteristics.Main outcomes and measuresThe primary outcomes were (1) the frequency of coupon use, measured as the proportion of prescription fills accompanied by manufacturer coupon within the treatment episode, and (2) the timing of first coupon use relative to the first prescription fill within the treatment episode.ResultsA total of 36 951 treatment episodes accounted for 238 474 drug claims and 35 352 unique patients (mean [SD] age, 48.1 [18.2] years; 17 676 women [50.0%]). Among these episodes, nearly all instances (35 103 episodes [95.0%]) of first coupon use occurred within the first 4 prescription fills. Approximately two-thirds of treatment episodes (24 351 episodes [65.9%]) used a coupon for the incident fill. Coupons were used for a median (IQR) of 3 (2-6) fills. The median (IQR) proportion of fills with a coupon was 70.0% (33.3%-100.0%), and many patients discontinued the drug after the last coupon. After adjustment for covariates, there was no significant association between an individual's out-of-pocket costs or neighborhood-level income and the frequency of coupon use. The estimated proportion of fills with a coupon was greater for products in competitive (19.5% increase; 95% CI, 2.1%-36.9%) or oligopolistic (14.5% increase; 95% CI, 3.5%-25.6%) markets than monopoly markets when there is only 1 drug in the therapeutic class.Conclusions and relevanceIn this retrospective cohort analysis of individuals receiving pharmaceutical treatment for chronic diseases, the frequency of manufacturer-sponsored drug coupon use was associated with the degree of market competition, rather than patients' out-of-pocket costs.
Project description:ImportanceDrug companies offer coupons to lower the out-of-pocket costs for prescription drugs, yet little is known about why they do so for some drugs but not for others.ObjectiveTo examine whether the following factors are associated with manufacturer drug coupon use: (1) patient-cost characteristics (mean per-patient cost per drug, mean patient copay); (2) drug characteristics (generics availability or "later-in-class-entrant" drugs); (3) drug-class characteristics (in-class coupon use among competitors; in-class generic competition; in-class mean cost and copay).Design setting and participantsThis was a retrospective cohort analysis of anonymized transactional pharmacy claims sourced from retail US pharmacies from October 2017 to September 2019, supplemented with information derived from Medi-Span, Red Book, and FDA.gov. Data were analyzed from September 2020 to February 2021.Main outcomes and measuresThe primary outcome was availability of a manufacturer's coupon. The secondary outcome was the mean proportion of transactions in which a coupon was used for each product.ResultsThe sample of 2501 unique brand-name prescription drugs accounted for a total of 8 995 141 claims. Manufacturers offered a coupon for 1267 (50.7%) of these drugs. When the manufacturer offered a coupon, it was used in a mean (SD) 16.3% (20.3%) of the transactions. Within a drug class, higher mean total cost per patient was positively associated with the likelihood of coupon use (odds ratio [OR], 1.03 per 10% increase; 95% CI, 1.01-1.04), but higher mean patient copay was inversely associated (OR, 0.98; 95% CI, 0.97-0.99). For drug characteristics, single-source later-in-class-entrant products were associated with a greater likelihood of coupon use compared with first entrants and multisource brands (OR, 1.44; 95% CI, 1.09-1.89). The intensity of coupon use was associated with later-in-class-entrant products and the class mean per-patient cost (4.16-percentage-point increase; 95% CI, 1.20-7.13; 0.27 per 10% increase; 95% CI, 0.09-0.44). Drugs with a new in-class brand-name competitor had greater mean coupon use compared with drugs without a new competitor (10.2% of claims with a coupon vs 5.9%).Conclusions and relevanceIn this cohort study of transactional pharmacy claims, higher mean per-patient total cost within a class was significantly associated with the likelihood of coupon use, but not patient out-of-pocket cost. Manufacturers' coupons were more likely to be used for expensive later-in-class-entrant products facing within-class competition where coupon use was prevalent.
Project description:ImportanceMedicaid enrolls a disproportionate share of US adults with hepatitis C virus (HCV), and most receive Medicaid benefits through managed care organizations (MCOs). Medicaid MCOs often impose stricter requirements to access HCV medications than traditional fee-for-service Medicaid, which may inhibit use. Though Medicaid MCOs generally cover prescription drugs, several states have carved out direct-acting antiviral HCV medications from MCO coverage and opted to cover them under fee-for-service. Whether these carve outs were associated with changes in medication use is unknown.ObjectiveTo examine the association between Medicaid-covered HCV medication fills and carve outs of these medications from MCO coverage.Design setting and participantsThis cross-sectional study examined changes in fills of Medicaid-covered direct-acting antiviral HCV medications in 4 states (Indiana, Michigan, New Hampshire, and West Virginia) that carved out these drugs from Medicaid MCOs between 2015 and 2017. A synthetic control approach was used to compare changes in HCV prescription fills between states that did and did not carve out these medications from MCO prescription drug coverage. Data of direct-acting antiviral HCV prescription fills were obtained from the Medicaid State Drug Utilization Data files, January 2015 to June 2020. Data analysis was conducted from November 2020 to June 2021.ExposuresCarve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage.Main outcomes and measuresDirect-acting antiviral HCV prescriptions filled per 100 000 Medicaid enrollees.ResultsIn this cross-sectional study, carve outs were associated with a mean quarterly increase of 22.1 (95% CI, 12.7-34.1) HCV prescriptions per 100 000 Medicaid enrollees, a relative increase of 86.3% compared with synthetic control states. Compared with each state's respective synthetic control, HCV prescription fills were associated with an increase of 11.5 (95% CI, 5.1-19.0) HCV prescription fills per 100 000 Medicaid enrollees per quarter in Indiana, 36.6 (95% CI, 23.5-53.9) in Michigan, 20.7 (95% CI, 11.1-32.8) in West Virginia, and 43.6 (95% CI, 25.9-68.4) in New Hampshire.Conclusions and relevanceIn this cross-sectional study of data from 39 states and the District of Columbia, carve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage were associated with significant increases in HCV medication use. Given their clinical benefits, greater uptake of HCV medication may help improve the health of Medicaid enrollees with HCV and reduce the economic burden of untreated HCV on the US health care system.
Project description:BackgroundIn 2016, California updated its prescription drug monitoring program (PDMP), adding two key features: automated proactive reports to prescribers and mandatory registration for prescribers and pharmacists. The effects of these changes on prescribing patterns have not yet been examined. We aimed to evaluate the joint effect of these two PDMP features on county-level prescribing practices in California.MethodsUsing county-level quarterly data from 2012 to 2017, we estimated the absolute change associated with the implementation of these two PDMP features in seven prescribing indicators in California versus a control group comprising counties in Florida and Washington: opioid prescription rate per 1000 residents; patients' mean daily opioid dosage in milligrams of morphine equivalents[MME]; prescribers' mean daily MME prescribed; prescribers' mean number of opioid prescriptions per day; percentage of patients getting >90 MME/day; percentage of days with overlapping prescriptions for opioids and benzodiazepines; multiple opioid provider episodes per 100,000 residents.ResultsProactive reports and mandatory registration were associated with a 7.7 MME decrease in patients' mean daily opioid dose (95 %CI: -11.4, -2.9); a 1.8 decrease in the percentage of patients prescribed high-dose opioids (95 %CI: -2.3, -0.9); and a 6.3 MME decrease in prescribers' mean daily dose prescribed (95 %CI: -10.0, -1.3).ConclusionsCalifornia's implementation of these two PDMP features was associated with decreases in the total quantity of opioid MMEs prescribed, and indicators of patients prescribed high-dose opioids compared to states that had PDMP's without these features. Rates of opioid prescribing and other high-risk prescribing patterns remained unchanged.
Project description:BackgroundIncreasing spending and use of prescription drugs pose an important challenge to governments that seek to expand health insurance coverage to improve population health while controlling public expenditures. Patient cost-sharing such as deductibles and coinsurance is widely used with aim to control healthcare expenditures without adversely affecting health.MethodsWe conducted a systematic umbrella review with a quality assessment of included studies to examine the association of prescription drug insurance and cost-sharing with drug use, health services use, and health. We searched five electronic bibliographic databases, hand-searched eight specialty journals and two working paper repositories, and examined references of relevant reviews. At least two reviewers independently screened the articles, extracted the characteristics, methods, and main results, and assessed the quality of each included study.ResultsWe identified 38 reviews. We found consistent evidence that having drug insurance and lower cost-sharing among the insured were associated with increased drug use while the lack or loss of drug insurance and higher drug cost-sharing were associated with decreased drug use. We also found consistent evidence that the poor, the chronically ill, seniors and children were similarly responsive to changes in insurance and cost-sharing. We found that drug insurance and lower drug cost-sharing were associated with lower healthcare services utilization including emergency room visits, hospitalizations, and outpatient visits. We did not find consistent evidence of an association between drug insurance or cost-sharing and health. Lastly, we did not find any evidence that the association between drug insurance or cost-sharing and drug use, health services use or health differed by socioeconomic status, health status, age or sex.ConclusionsGiven that the poor or near-poor often report substantially lower drug insurance coverage, universal pharmacare would likely increase drug use among lower-income populations relative to higher-income populations. On net, it is probable that health services use could decrease with universal pharmacare among those who gain drug insurance. Such cross-price effects of extending drug coverage should be included in costing simulations.
Project description:BackgroundWhile the mandate to check patients' prescription history in Prescription Drug Monitoring Program (PDMP) database before prescribing/dispensing controlled drugs has been shown to be an important tool to curb opioid abuse, less is known about whether the mandate can reduce the misuse of other commonly abused prescription drugs. We examined whether PDMP use mandates were associated with changes in prescription stimulant and depressant quantities.MethodsUsing data from Automated Reports and Consolidate Ordering System (ARCOS), we employed difference-in-differences design to estimate the association between PDMP use mandates and prescription stimulant and depressant quantities in 50 U.S. states and the District of Columbia from 2006 to 2020. Limited PDMP use mandate was specific only to opioids or benzodiazepines. Expansive PDMP use mandate was non-specific to opioid or benzodiazepine and required prescribers/dispensers to check PDMP when prescribing/dispensing targeted controlled substances in Schedule II-V. The main outcomes were population-adjusted prescription stimulant (amphetamine, methylphenidate, lisdexamfetamine) and depressant (amobarbital, butalbital, pentobarbital, secobarbital) quantities in grams.ResultsThere was no evidence that limited PDMP use mandate was associated with a reduction in the prescription stimulant and depressant quantities. However, expansive PDMP use mandate that was non-specific to opioid or benzodiazepine and required prescribers/dispensers to check PDMP when prescribing/dispensing targeted controlled substances in Schedule II-V was associated with 6.2% (95% CI: -10.06%, -2.08%) decline in prescription amphetamine quantity.ConclusionExpansive PDMP use mandate was associated with a decline in prescription amphetamine quantity. Limited PDMP use mandate did not appear to change prescription stimulant and depressant quantities.
Project description:ObjectiveTo estimate the impact of implementing prescription drug monitoring program (PDMP) best practices on prescription opioid use.Data sources2007-2012 Medicare claims for noncancer pain patients, and PDMP attributes from the Prescription Drug Abuse Policy System.Study designWe derived PDMP composite scores using the number of best practices adopted by states (range: 0-14), classifying states as either no PDMP, low strength (0 < score < median), or high strength (score ≥ median). Using generalized linear models, we quantified the association between the PDMP score category and opioid use measures-overall and stratified by disability/age. Sensitivity analyses assessed the general Medicare sample regardless of pain diagnoses, individual PDMP characteristics, and compared GEE model findings to models with state fixed effects.Principal findingsCompared to non-PDMP states, strong PDMP states had lower opioid cumulative doses (-296 mg; 95% CI: -512, -132), days supplied (-7.84; 95% CI: -10.6, -5.04), prescription fill rates (0.97; 95% CI: 0.95, 0.98), and mean daily doses (-2.31 mg; 95% CI: -3.14, -1.48) but greater prevalence of high opioid doses in disabled adults, whereas there was little or no change in older adults. Findings in states with weak PDMPs were substantively similar to those of strong PDMPs. Results from sensitivity analyses were mostly consistent with main findings except there was a null relationship with mean daily doses and high doses in models with state fixed effects.ConclusionsComprehensive or minimal adoption of PDMP best practices was associated with mostly comparable effects on Medicare beneficiaries' opioid use; however, these effects were concentrated among nonelderly disabled adults.
Project description:ObjectiveOpioid overdose is a public health epidemic adversely impacting individuals and communities. To combat this, California passed a law mandating that prescribers offer a naloxone prescription in certain circumstances. Our objective was to evaluate associations with California's naloxone prescription mandate and emergency department (ED) overdose visits/hospitalizations, opioid and naloxone prescribing, and 30-day mortality.MethodsThis retrospective cohort study included data from January 1, 2018, to December 31, 2019, and included all Kaiser Permanente Southern California (KPSC) members aged >10 years across 15 KPSC EDs. Exposure was defined as presentation to the ED within the study period. The primary outcome was ED visits for opioid overdose pre- and post-implementation of California's naloxone prescription mandate.ResultsA total of 1.1 million ED visits (534K pre/576K post) were included in the study population. ED opioid overdose visits were 344 (6.4/10,000) pre-policy and 351 (6.1/10,000) post-policy implementation, while non-opioid overdose visits were 309 (5.8/10,000) pre-implementation and 411 (7.1/10,000) post-implementation. The unadjusted rate of visits with opioid prescriptions decreased significantly (14.9% pre to 13.5% post) after implementation. ED naloxone prescriptions increased substantially (104 pre vs. 6031 post). Primary adjusted interrupted time series analysis found no statistical difference between monthly opioid overdose visits pre versus post (odds ratio 1.02, 95% confidence interval [CI] 0.98‒1.07). Difference-in-differences analysis revealed no significant changes in hospitalization (coefficient [CE] = ‒0.05, 95% CI = ‒0.11 to 0.02) or 30-day mortality (CE = ‒0.01, 95% CI = ‒0.03 to 0.01).ConclusionThis study revealed that the implementation of California's naloxone prescription mandate was associated with significantly increased naloxone prescribing and decreased opioid prescribing, but no significant change in ED opioid overdose visits, hospitalizations, or 30-day mortality. This indicates that increasing naloxone prescribing alone may not be sufficient to lower opioid overdose rates.