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Background: The Rhode Island State Legislature passed the Uniform Controlled Substances Act in 2016 to limit opioid prescriptions. We aimed to objectively evaluate its effect on opioid prescribing for hand surgery patients and also identify risk factors for prolonged opioid use. Methods: A 6-month period (January-June 2016) prior to passage of the law was compared with a period following its implementation (July-December 2017). Thumb carpometacarpal arthroplasty and distal radius fracture fixation were classified as “major surgery” and carpal tunnel and trigger finger release as “minor surgery.” Prescription Drug Monitoring Database was used to review controlled substances filled during the study periods. Results: A total of 1380 patients met our inclusion criteria, with 644 prelaw and 736 postlaw patients. Patients undergoing “major surgery” saw a significant decrease in the number of pills issued in the first postoperative prescription (41.1 vs 21.0) and a corresponding decrease in morphine milligram equivalents (MMEs) (318.6 vs 159.2 MMEs) after implementation. A 30% decrease in MMEs was also seen in those undergoing “major surgery” in the first 30 days postoperatively (544.7 vs 381.7 MMEs). Risk factors for prolonged opioid use included male sex and preoperative opioid use. Conclusions: In Rhode Island, opioid-limiting legislation resulted in a significant decrease in the number of pills and MMEs of the initial prescription and a 30% decrease in total MMEs in the 30-day postoperative period after “major hand surgery.” Additional research is needed to explore the association between legislation and clinical outcomes.

Background Mandatory disclosure of the price of prescription drugs within direct-to-consumer pharmaceutical advertisements (DTCA) has been proposed as a potential means of curbing rising drug costs in the United States. While price transparency in DTCA has widespread public support, empirical evidence regarding the effects of such drug prices disclosures remains limited. Objectives This study assessed the degree to which a price disclosure was noticed, the individual characteristics associated with price disclosure recognition, and the impact on perceived drug affordability, effectiveness, and safety. Methods A randomized experiment was conducted among 2,138 members of the Amerispeak online panel. Participants were shown a television commercial for a drug treating either type II diabetes, deep vein thrombosis/pulmonary embolism (DVT/PE), or rheumatoid arthritis (RA) that disclosed the list price, disclosed the list price plus the average out-of-pocket cost, or had no price disclosure. Results Roughly forty percent of participants noticed when a price was disclosed while 20–24% noticed information about individual costs varying (the higher of these percentages occurred when the average out-of-pocket cost was provided). Attention did not vary systematically with the cost amount. Recognition of the different elements of the price disclosure were most predicted by sociodemographic variables such as race, education, and income as well as health characteristics. Price disclosure altered perceived affordability of the advertised medication in a manner consistent with the costs provided, but such consistent significant effects were not found for perceived drug effectiveness and safety. Conclusions Repeated exposure to price disclosure in television DTCA or supplementary sources of price information may be necessary to increase attention to drug price information, especially among those who are most vulnerable to the burden of drug costs. Price transparency appears useful for adjusting affordability perceptions, but additional research needs to examine how such perceptions factor into healthcare decision-making and drug pricing.

Background Patients are often exposed to contradictory information about pharmaceutical products from various types of advertising. For example, direct-to-consumer advertising (DTCA) tend to emphasize a drug's benefits, while drug injury advertising emphasizes the worst side effects. Regarding DTCA as a drug information source, many researchers in pharmacy field focus on investigating the misinformation in DTCA and corrective advertising. However, no prior research has examined the effects of such contradictory advertising messages on patients' prescription medicine-related beliefs and medication adherence. This is a significant gap in the research literature on pharmaceutical advertising effects and medication adherence. Objective This is aimed to examine how exposure to DTCA and drug injury advertising would influence patients’ chronic accessibility of drug-related beliefs and their medication adherence behavior. Methods An online survey was conducted with a sample of 213 patients taking prescription blood thinners. Results The findings from this study did not support the predicted relationship between exposure to DTCA and consumers' drug-related belief accessibility or their medication adherence. However, this study found a significant interaction effect of exposure to DTCA and exposure to drug injury ads on patients’ medication adherence. The analysis results demonstrate that, for those who were exposed to drug injury ads, a significant negative relationship emerged between DTCA exposure and medication adherence. Conclusion This study provides important empirical evidence of a negative interaction effect of exposure to DTCA and drug injury ads on patients' medication adherence, which demonstrates that the influence of DTCA and drug injury ad exposures on patients' medication adherence is not independent, separate process but an interactive process. A communication campaign with corrective advertising could alleviate the negative interaction effect of exposure to contradictory information from different types of pharmaceutical ads on patients’ medication adherence.

Background The Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise. Objectives This study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians’ use of and perceptions of the PI. Methods Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians’ interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI. Results The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., “with or without food”) in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list. Conclusion This qualitative research suggests physicians may prefer more clarity in some sections of the PI.

Background Prescription affordability is a key component of healthcare accessibility and a determinant of health outcomes. Prior studies indicate that up to 1 in 4 Americans report difficulty affording prescriptions. Objective(s): This study aims to identify factors associated with cost-based prescription refusal. Methods We identified 17,869 study participants from the 2017 National Health Interview Survey who had been prescribed at least one medication in the past 12 months. The outcome was defined as inability to afford at least one prescription medication. Covariates included demographic data, medical history, and social attitudes. Logistic regression models were constructed to identify predictors of cost-based prescription refusal. Results Among 8223 study participants, 8.1% reported the inability to afford at least one prescription medication in the past 12 months. Twenty-seven covariates were correlated with prescription unaffordability, and 8 were selected by the LASSO: Income (Odds ratio (OR) 0.55), Concerned About Bills (OR 2.0), Emergency Department Visits past 12 months (OR 1.33), Dissatisfaction with Medical Care (OR 1.3), Seeking Insurance Through the Health Insurance Marketplace (OR 1.26), Feeling Sad Most of the Time (OR 1.24), History of Asthma (OR 1.26) and History of Diabetes (OR 1.24). Conclusions Prescription unaffordability remains a significant public health problem and is more common among low-income individuals and patients with, chronic medical conditions.

Background Polypharmacy, the use of multiple medications by one individual, may be associated with adverse health outcomes including poor cognition. However, it remains unclear whether a longitudinal relationship exists. Objectives To investigate the association between polypharmacy and 3-year cognitive ability in older adults. Methods A longitudinal cohort study of older adults 65 years and older, residing in the community, who participated in waves 12 (2012), 13 (2013) and 16 (2016) of the Household Income and Labour Dynamics (HILDA) Survey was conducted. Polypharmacy was defined as the regular use of 5 or more prescription medications. Cognitive ability was assessed using backwards digit span test (BDS), 25-item version of the National Adult Reading Test (NART-25) and symbol-digit modalities test (SDM). Linear regression was used to test the longitudinal association between polypharmacy and cognitive test scores at 3 years. All analyses were adjusted for age, sex, education, comorbidities, socioeconomic and lifestyle factors, and baseline cognitive test scores. Results A total of 2141 participants (mean age 72.9 years, 54.4% female) were included in the study sample. Polypharmacy was present in 27.3%. After adjusting for potential confounders, polypharmacy was negatively associated with cognitive ability at 3 years: BDS: −0.067 (95% CI = −0.353 to −0.051), NART-25: −0.071 (95% CI = −1.428 to −0.294), SDM: −0.073 (95% CI = −2.960 to −0.696). Conclusion Polypharmacy was associated with poorer cognitive ability at 3 years, even after adjusting for comorbidities and other confounders. Future research should consider the long-term impact of polypharmacy on cognitive ability, and identify strategies to optimise medication use and cognition in older adults.

Objectives Most spending for prescription drugs is on branded drugs that do not have direct generic equivalents but many of these drugs do have therapeutic alternatives within class. We estimate the potential savings from providing patients a financial incentive to switch from a higher cost drug to a lower cost, therapeutic alternative drug. Methods We used individual state-transition microsimulations to model medication use and spending with and without financial incentives over a 12-month time horizon with a healthcare sector perspective. Costs and utilization inputs were from individuals on branded insulins or multiple sclerosis drugs enrolled in a regional mixed-model health maintenance organization. Base-case model used a one-time financial incentive of $83 and $250 offered to patients on higher cost insulin and multiple sclerosis treatments, respectively, to switch to lower cost drugs within class. Results Savings per individual offered an incentive in the insulin and multiple sclerosis classes were, respectively, $84 (95% CI $46-$122) and $2,127 (95% CI $267-$3,987). Varying the incentive size and switch probability resulted in maximum savings of $712 at elasticity of 0.2 and incentive size $250 for the insulin drug class. For the multiple sclerosis drug class, maximum savings of $5945 was at elasticity of 0.2 and incentive size of $1000. Short time horizon makes our savings estimates conservative. Conclusions If programs such as financial incentives could encourage even a small proportion of patients to switch among drugs within therapeutic class, then substantial savings could be generated.

With increasing drug prices in the past decade, affordability and medication adherence are a growing concern for near-poor older adults, especially for those who are not receiving Low-Income Subsidy in Medicare Part D. SeniorCare is a pharmaceutical assistance program in Wisconsin for near-poor older adults, providing comprehensive prescription coverage with flat copayments.To evaluate five-year trends in financial hardship and medication adherence and to examine factors associated with these outcomes in SeniorCare members.SeniorCare program enrollment and pharmacy claims data from 2014 to 2018 were used. The study population was near-poor older adults in SeniorCare with annual family income ≤200% of the federal poverty level. Financial burden was assessed using the proportion of total annual out-of-pocket costs to total annual income. Medication adherence was assessed by adapting the measures endorsed by the Pharmacy Quality Alliance and National Quality Forum. Descriptive statistics and independent t-tests were used to evaluate the trends, and multivariate logistic regressions were conducted to examine factors associated with financial burden and medication adherence.From 2014 to 2018, mean annual out-of-pocket costs per member declined by 3.7% (p 0.001) for all drugs, while those for specialty drugs increased by 31.2% (p 0.05). Around 3.3% spent more than 5% of their income for prescription drugs in 2014, which decreased to 2.4% in 2018 (p 0.001). The proportions of adherent patients increased from 78.1% to 81.2% (p 0.001) for diabetes medications (excluding insulins), from 77.3% to 79.5% (p 0.001) for statins, and from 79.8% to 80.8% (p 0.05) for RASA. Members subject to a $500 annual deductible were more likely to experience high financial burden (adjusted odds ratio (AOR) = 1.677, p 0.001) and less likely to be adherent to diabetes medications (AOR = 0.484, p 0.001).The near-poor older adults enrolled in Wisconsin SeniorCare program had low financial burden and good medication adherence within the program.

Background The improper storage of and unsafe disposal methods for leftover and expired prescription medication represent a risk for diversion, misuse, and other public health issues. Health care providers are well positioned to offer education and resources for the safe disposal of medication. Objectives A quality improvement pilot was constructed to provide education and a medication disposal packet to patients who received a prescription for an opioid on discharge from Emory University Orthopaedics and Spine Hospital after surgery. Objectives were to assess the packet’s utility and to determine whether proximity of existing community takeback bins had any effect on packet usage. Methods Five weeks after discharge, patients received an automated phone call to evaluate their use of the disposal packet. Call responses were the primary data point for determining success, with a goal of greater than 50% packet use. Demographic data were collected retrospectively to assess the count of medication disposal bins within the patient’s ZIP Code. Results Of a total of 532 unique patients, 239 responded to the automated survey, indicating how they planned to use the disposal packet provided to them on discharge. Of the 239 responses, 150 (63%) patients either used or planned to use the packet. In addition, a chi-square test of independence and a z test for the difference in proportion of packets used showed that the existence of 2 or more community takeback bins per ZIP Code was associated with packet nonuse (P Conclusion Public health resources can help address medication disposal issues that contribute to environmental contamination, opioid misuse, overdose, and death. Emory University Orthopaedics and Spine Hospital outpatients have a need for safe medication disposal initiatives and education, especially in communities with fewer existing means.

WHAT IS KNOWN AND OBJECTIVE Approximately half of the patients with threatened miscarriage suffer an abortion, and consistent medication therapy to prevent threatened miscarriage is lacking. Our goal was to investigate the real-world pharmacological treatment patterns of patients with threatened miscarriage in China, with a focus on the trend and rationality of progestogen use over the last 7 years. METHODS We performed a cross-sectional analysis of data from the Hospital Prescription Analysis Cooperation Project that is overseen by the Chinese Pharmaceutical Association. Information was extracted from prescriptions of outpatients with threatened miscarriage between January 2014 and December 2020. We quantified the types of medications using the first level anatomical therapeutic chemical (ATC) classification code and the frequency of use of medicines classified as category X by the United States Food and Drug Administration (FDA). We also calculated the prevalence of the most frequently used progestogens by assessing prescription rates, determined the sum of the defined daily doses (DDDs) and defined daily cost (DDC) and evaluated the rationality of progestogens according to drug labels and guidelines. RESULTS AND DISCUSSION Of the 91,464 patients included in this study, 69.4% were from the eastern region, 92.5% were from tertiary hospitals, and 72.9% were between 25 and 34 years old. The average number of medications per patient was 1.4. The following types of medicines were the most prevalent: "genitourinary system and sex hormones" (90.7%), "alimentary tract and metabolism" (10.8%) and "blood and blood-forming organs" (9.9%). Progestogens were prescribed for 81,080 patients (88.6%), among which oral progesterone (39.7%) was the most commonly used, followed by oral dydrogesterone (34.4%), progesterone injection (26.0%), oral allylestrenol (0.7%) and progesterone gel (0.4%). In other words, 10,991 (12.0%) patients used more than one progestogen, and the top three combinations were oral dydrogesterone plus progesterone injection (5.6%), oral progesterone plus progesterone injection (4.7%) and oral dydrogesterone plus oral progesterone (1.1%). The prescription rate of dydrogesterone increased gradually, whereas that of progesterone, especially progesterone injection, obviously decreased. Among 34,760 prescriptions of progestogens with complete usage information, the primary errors of progestogen use were "low frequency" (18.4%), "high single dose" (15.9%) and "low single dose" (11.3%). In addition, 137 prescriptions were identified with drug-progestogen interactions, and 61 were identified with contraindications for progestogens. A total of 4.5% of prescriptions included FDA category X medicines. WHAT IS NEW AND CONCLUSION Our findings are the first to provide information on medication use in patients with threatened miscarriage over the last seven years in China. Medicines targeting the "genitourinary system and sex hormones," especially progestogens, were the most commonly prescribed medications, among which dydrogesterone was the most prevalent. However, it is remarkable that the use of progestogens for the treatment of threatened abortion is still controversial; thus, high-quality large sample studies are still required, especially among Chinese patients. Since usage errors in progestogen records and exposure to category X medicines were common, more efforts are needed to guarantee the safety and rationality of medicines used in pregnant women.

Like many countries in the world, China is also facing growing drug expenditures year by year. In particular, the rising cost of prescription drugs has been one of the critical factors leading to the serious burden on health insurance programs. The high cost of prescription drugs not only threatens the health budget but also limits the nation's investment in other public sectors. China implemented the National Centralized Drug Procurement (NCDP) policy, also known as the "4 + 7" policy, in tertiary hospitals in various provinces and cities across the country on 18 December 2019, aiming to lessen personal and national health insurance burdens by reducing drug procurement prices. The aim of this study is to explore the impact of the implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments and on national health insurance expenditures.This study adopts interrupted time series (ITS) to evaluate the impact of China's implementation of the NCDP policy on the drug expenditures of patients treated in outpatient and emergency departments in a tertiary hospital. The NCDP policy was officially implemented on 18 December 2019. A segmented regression model is utilized to analyse the average monthly drug expenditures of patients treated in outpatient and emergency departments from January 2018 to June 2021, including the average monthly per-visit drug expenditures of all patients and the average monthly per-visit drug expenditures of patients who paid for drugs with health insurance and those who did not use health insurance.After the implementation of the NCDP policy, the overall average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments were immediately reduced by 233.954 CNY (p 0.01). Compared with the continued downward trend for drug expenditures before the implementation of the NCDP policy, the long-term trend after policy implementation was not obvious (p = 0.0519730.05). Similarly, the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who use health insurance to procure drugs also immediately decreased by 505.287 CNY (p 0.01), but the long-term trends before (p = 0.4690.05) and after policy implementation (p = 0.510.05) did not exhibit obvious change. For the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments who did not use health insurance, the implementation of the NCDP policy did not produce an immediate reduction in drug expenditures (p = 0.36030.05). Although the average monthly per-visit drug expenditures decreased by 9.078 CNY (p 0.01) before policy implementation, this trend ended after the policy was implemented (p = 0.07350.05), and no other changes were triggered.This study reviews the data for a period of time before and after the implementation of the NCDP policy. The policy is shown to significantly decrease the average monthly per-visit drug expenditures of patients treated in outpatient and emergency departments.

Objectives: The significant and rising cost of prescription drugs is a pressing concern for patients and payers. However, little is known about spending on and utilization of drugs prescribed by otolaryngologists. Methods: Utilizing publicly available Medicare Part D Prescriber Public Use data, we conducted a retrospective cross-sectional analysis of 34 small-molecule drugs commonly prescribed by otolaryngologists (defined as 2017 Medicare Part D spending ≥$500 000) to Medicare beneficiaries. Prescription data was characterized by drug type (brand name vs generic). Primary outcomes for each prescription drug included the total annual cost and the total annual number of days supplied. Results: From 2013 to 2017, spending on drugs prescribed by otolaryngologists to Medicare beneficiaries decreased by $32.1 million ($131.7–$99.5 million; relative decrease 24.4%; compound annual growth rate [CAGR] −5.4%), while total utilization increased by 24.9 million days supplied (74.6–99.5 million; relative increase 33.3%; CAGR 5.9%). For brand name drugs, there was a decrease in spending ($71.1–$26.7 million; relative decrease −62.4%; CAGR −17.8%) and utilization (11.2–3.1 million days supplied; relative decrease −72.5%; CAGR −22.8%). In contrast, generic drugs demonstrated increased spending ($60.6–$72.8 million; relative increase 20.2%; CAGR 3.7%) and utilization (63.5–96.4 million days supplied; relative increase 51.9%; CAGR 8.7%). Conclusions: Spending on drugs prescribed by otolaryngologists to Medicare Part D beneficiaries declined between 2013 and 2017 in part due to a transition from brand name drugs to lower-cost generic equivalents.

Introduction Nationwide prevalence of potentially harmful drug prescribing during pregnancy is unknown in France, and several risk classification systems (RCS) exist to guide prescribers. Objective The aim of this study was to estimate the nationwide prevalence of potentially harmful drug prescribing during pregnancy in France and to describe maternal characteristics associated with this prescription. Methods This drug utilisation study, conducted on the French health databases (67 million beneficiaries), included all pregnancies beginning in 2016–2017, regardless of pregnancy outcome. Potentially harmful drug prescribing was defined as at least one reimbursement during pregnancy of Swedish RCS category D drugs, Australian RCS category D/X drugs, or contraindicated drugs in France for drugs not listed in these two RCSs. Maternal characteristics associated with potentially harmful drug prescribing were described using a univariate logistic regression analysis. Results Among the 1,844,447 pregnant women identified, the prevalence of potentially harmful drug prescribing was higher according to the Australian RCS (3.9%) than according to the Swedish RCS (2.2%), with good agreement between the two RCSs (Kappa = 0.81 [0.74–0.87]). This prevalence increased to 9.2% and 6.9%, respectively, when considering contraindications in France. Prescribing of teratogenic drugs, including retinoids and valproate, was highest during the first trimester, whereas prescribing of foetotoxic drugs decreased after the first trimester but remained high for nonsteroidal anti-inflammatory drugs (N = 10,021). In women with no chronic diseases, polymedication (five or more drugs) was the strongest maternal characteristic associated with potentially harmful drug prescribing in both RCSs. Conclusions Potentially harmful drug prescribing during pregnancy is not uncommon in France. This study supports the comparative analysis of RCS to assess potentially harmful drug prescribing in claims databases. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01117-4.

Generally considered an epidemic among young people, substance misuse has been a growing issue among older Americans for the past 40 years. Legal substances, such as alcohol, tobacco, and prescription drugs, including opioids and marijuana, are of primary concern when it comes to aging Baby Boomers. By 2050, 22% of Americans will be aged ≥65 years. Currently, eHealth interventions are receiving attention in treating substance misuse among younger Americans. The current study has two aims: to evaluate the effectiveness of eHealth interventions for older adults treated for substance misuse problems, as well as to investigate behavioral outcomes in reducing substance misuse. A comprehensive search of databases yielded 35,041 articles that examined reductions in substance misuse and problem behaviors as a primary outcome with eHealth interventions delivered to older adults. Once duplicate and irrelevant articles were removed, seven were left to be analyzed. Findings suggest use of technology to assess and intervene with older adults using various substances shows promise and, as a whole, older adults are receptive to online learning, screening and assessment, and interventions. [ Journal of Gerontological Nursing, 47 (10), 23–29.]

The market share of 90-day prescriptions has risen dramatically in recent years, primarily because of increasing incentivization by insurers, pharmacies, and pharmacy benefit managers. Although 90-day prescriptions may benefit patients, they are potentially dangerous for those at risk for suicide. Prior authorization requirements by some insurers for coverage of shorter prescriptions and some pharmacists' newfound ability to unilaterally convert 30-day prescriptions with refills into 90-day supplies have complicated physicians' efforts to prevent harm to these patients. Here, the authors discuss the patient safety challenges posed by 90-day prescriptions and suggest potential mitigation strategies that would still preserve the benefits of larger medication supplies.

Objective Medication nonadherence is linked to worsened clinical outcomes and increased costs. Existing system-level adherence interventions rely on insurer claims for patient identification and outcome measurement, yet suffer from incomplete capture and lags in data acquisition. Data from pharmacies regarding prescription filling, captured in retail dispensing, may be more efficient. Data sources Pharmacy fill and insurer claims data. Study design We compared adherence measured using pharmacy fill data to adherence using insurer claims data, expressed as proportion of days covered (PDC) over 12 months. Agreement was evaluated using correlation/validation metrics. We also explored the relationship between adherence in both sources and disease control using prediction modeling. Data extraction methods Large pragmatic trial of cardiometabolic disease in an integrated delivery network. Principal findings Among 1113 patients, adherence was higher in pharmacy fill (mean = 50.0%) versus claims data (mean = 47.4%), although they had moderately high correlation (R = 0.57, 95% CI: 0.53-0.61) with most patients (86.9%) being similarly classified as adherent or nonadherent. Sensitivity and specificity of pharmacy fill versus claims data were high (0.89, 95% CI: 0.86-0.91 and 0.80, 95% CI: 0.75-0.85). Pharmacy fill-based PDC predicted better disease control slightly more than claims-based PDC, although the difference was nonsignificant. Conclusions Pharmacy fill data may be an alternative to insurer claims for adherence measurement.

INTRODUCTION The delivery of health care by primary care general practices rapidly changed in response to the coronavirus disease 2019 (COVID-19) pandemic in early 2020. AIM This study explores the experience of a large group of New Zealand general practice health-care professionals with changes to prescribing medication during the COVID-19 pandemic. METHODS We qualitatively analysed a subtheme on prescribing medication from the General Practice Pandemic Experience New Zealand (GPPENZ) study, where general practice team members nationwide were invited to participate in five surveys over 16 weeks from 8 May 2020. RESULTS Overall, 78 (48%) of 164 participants enrolled in the study completed all surveys. Five themes were identified: changes to prescribing medicines; benefits of electronic prescription; technical challenges; clinical and medication supply challenges; and opportunities for the future. There was a rapid adoption of electronic prescribing as an adjunct to use of telehealth, minimising in-person consultations and paper prescription handling. Many found electronic prescribing an efficient and streamlined processes, whereas others had technical barriers and transmission to pharmacies was unreliable with sometimes incompatible systems. There was initially increased demand for repeat medications, and at the same time, concern that vulnerable patients did not have usual access to medication. The benefits of innovation at a time of crisis were recognised and respondents were optimistic that e-prescribing technical challenges could be resolved. DISCUSSION Improving e-prescribing technology between prescribers and dispensers, initiatives to maintain access to medication, particularly for vulnerable populations, and permanent regulatory changes will help patients continue to access their medications through future pandemic disruption.

Background A study has shown that industry payments to physicians for drugs are associated not only with higher drug prescriptions but also with higher non-drug costs due to additional utilization of healthcare services. However, the association between industry payments to cardiologists for antiplatelet drugs and the costs and number of percutaneous coronary interventions they perform has not been investigated. Objective To examine the association between industry payments to cardiologists for antiplatelet drugs and the costs and number of percutaneous coronary interventions they perform. Design Using the 2016 Open Payments Database linked to the 2017 Medicare Provider Utilization and Payment Data, we examined the association between the value of industry payments related to the antiplatelet drugs prasugrel and ticagrelor and healthcare spending and volume for cardiovascular procedures, adjusted for potential cofounders. Subjects A total of 7456 cardiologists who performed diagnostic cardiac catheterizations on Medicare beneficiaries in 2017. Main Measures Primary outcomes included (1) healthcare spending on cardiac procedures, (2) diagnostic cardiac catheterization volumes, and (3) rates of coronary stenting. Secondary outcomes were total expenditures for all drugs and for antiplatelet drugs. Key Results Industry payments for antiplatelet drugs were associated with higher healthcare spending on cardiac procedures (adjusted difference, +$50.9 for additional $100 industry payments; 95% CI, +$25.5 to +$76.2; P < 0.001), diagnostic cardiac catheterizations (+0.1 procedures per cardiologist; 95% CI, +0.03 to +0.1; P=0.001), and stent use (+0.5 per 1000 diagnostic cardiac catheterizations per cardiologist; 95% CI, +0.2 to +0.9; P=0.002). Industry payments for antiplatelet drugs were associated with higher total costs for all drugs and antiplatelet drugs. Conclusions Industry payments to cardiologists for antiplatelet drugs were associated with both prescribing of antiplatelet drugs and the use of cardiac procedures and stents. Further research is warranted to understand whether the observed associations are causal or reflect a greater propensity for higher volume proceduralists to have relationships with industry.

Policy Points In the absence of federal action on rising prescription drug costs, we reviewed the details of five states that have enacted prescription drug-pricing boards seeking to lower drug prices based on products' value. Within these states, six such boards are currently authorized; they have similarities but vary in terms of structure, authority, scope, and leverage. As of June 2021, only one of the boards in our sample has conducted pricing reviews; legislators in other states can learn from the successes and challenges of existing boards. Prescription drug-pricing boards represent a novel and promising way to curb state spending and pay for value in prescription drugs but face legal and political barriers in implementation. Context Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with a variety of policies to contain spending and achieve value in prescription drugs. As part of this series of reforms, some state legislatures have recently authorized prescription drug-pricing boards to address the high prices of brand-name prescription drugs and assess the value of those drugs. Methods We identified state prescription drug-pricing boards in the United States, defined as any agency authorized by a state legislature to review specific drugs and pursue value-based drug prices. To describe the characteristics of the boards, we obtained public records of authorizing legislation, guidance documents, and board meeting minutes. We compared the boards' powers and responsibilities and analyzed completed pricing reviews. Findings Six state drug-pricing boards in five states met our definition; their design varied substantially. Two of the boards (New York Medicaid and Massachusetts) have authority over drug rebates paid by state Medicaid programs, one (New York Drug Accountability Board) has jurisdiction over state-regulated commercial insurance, and another three (Maine, Maryland, and New Hampshire) oversee non-Medicaid, state-funded insurance. Three boards are authorized to require manufacturers to confidentially submit information related to the pricing and clinical effectiveness of reviewed drugs to inform value determinations. Only one board (New York Medicaid) had completed pricing reviews as of June 3, 2021. Conclusions Boards' structure, scope, and statutory leverages to compel manufacturers to negotiate lower net costs are key factors that influence whether and to what extent boards can achieve cost savings for states. Though legal constraints may limit the effective reach of prescription drug-pricing boards, these agencies can enable states to address rising prescription drug costs, in part by virtue of their very existence. To overcome practical limitations, states seeking to implement similar policies can build on the experiences and designs of current boards.

INTRODUCTION: Psychoactive substance use may be risky for adults with functional impairments. This study investigates cannabis use and prescription opioid and tranquilizer/sedative (mis)use among adults aged ≥50 years reporting functional impairments in the U.S. METHODS: This cross-sectional analysis of adults aged ≥50 years from the 2015–2019 cohorts of the National Survey on Drug Use and Health estimates the prevalence of past-year medical and nonmedical cannabis use, and prescription opioid and tranquilizer/sedative use and misuse, according to the number of functional impairments reported. The adjusted odds of medical and nonmedical use or misuse of each substance in relation to any impairment, number of impairments, and specific impairments were estimated using logistic regression. Analyses were conducted in December 2020. RESULTS: Compared with those reporting no impairments, those reporting any impairment were more likely to report use of cannabis and (mis)use of prescription opioids and tranquilizers/sedatives (all p

Background: Responses to problem substance use have largely focused on illicit drugs, but reports on rising prescription drug misuse worldwide raise questions about their combined use with alcohol ...

Introduction: Medication errors (MEs) are frequent and, in some cases, can lead to hospitalization, disability, increased healthcare costs or, even, death. Most of pediatric medications are administered by parents or caregivers at home. It is necessary to explore the MEs at home to improve pediatric patient safety.Areas covered: This study aimed to review the current literature on the frequency of pediatric MEs by parents or caregivers at home, their associated factors, and pediatric ME reporting systems. Citable original articles of any type of study design or reviews published from 2013 to 2021 were searched in Medline, Scopus, Embase, and ScienceDirect databases.Expert opinion: The available data about the frequency of pediatric MEs at home varied from 30% to 80%. Current research suggests the risk of making a ME in pediatric patients at home may depend on the characteristics of the caregiver and may increase if a prescription contains ≥3 drugs. Findings conclude that providing dosing tools more closely matched to prescribed dose volumes, recommending the use of syringes as a measurement tool, and educational intervention for caregivers could be useful to reduce MEs. Concerning the reporting systems for pediatric MEs in the outpatient setting, no information was found.

PURPOSE: In pharmacoepidemiology, correctly defining the exposure period of pharmacological treatment is a challenging step when information on the time in treatment is missing or incomplete.METHODS: In this review, we describe several methods for defining exposure to pharmacological treatments using secondary data sources that lack such information.RESULTS AND CONCLUSION: Several methods for assessing the duration of redeemed prescriptions and combining them into temporal sequences are available. We present a set of considerations to make researchers aware of the potentials and pitfalls of these methods that may aid in minimizing biases in research using these methods. Additionally, we highlight that, to date, there is no one-size-fits-all solution. Thus, the choice of method should be based on their area of applicability combined with a careful mapping to the research scenario under investigation.

Obstetrical healthcare providers frequently field questions about the safety of medications recommended or prescribed to their pregnant patients. Most women use as least 1 medication during pregnancy; however, there is little information about the safety or appropriate dosing of many medications during this phase of life. In addition, the development of drugs for use in pregnant women trails behind the development of drugs intended for other sectors of the population. Our goal is to inform the obstetrics community about the US Food and Drug Administration authority and their role in approving drugs for marketing. We begin with the statutes that led to the creation of the Food and Drug Administration and its current organization. We then cover drug development and the Food and Drug Administration review process, including the role of the advisory committee. The different types of drug approvals are discussed, with some specific examples. Finally, we enumerate the drugs specifically approved for use in obstetrics and contrast them with drugs commonly used by pregnant women and drugs used "off-label" during pregnancy. The Food and Drug Administration is committed to protecting and advancing the public health of pregnant women by guiding the development and ensuring the availability of effective and safe therapeutics for obstetrical indications and for medical conditions during pregnancy. We hope this review will inspire more research addressing drug use during pregnancy.

Background: Postoperative atrial fibrillation (POAF) commonly occurs after coronary artery bypass graft (CABG) surgery. Patients with POAF are at higher risk of stroke and mortality. The use of oral anticoagulation (OAC) in POAF remains inconsistent, and the care gap is unknown. Objective: We sought to evaluate rate of adherence and factors associated with OAC use in POAF patients after isolated CABG. Methods: In this study, all patients who had an isolated CABG between April 1, 2019 and March 30, 2020, at Health Sciences North, Sudbury retrospectively were evaluated. We identified all patients who developed POAF and captured the use of OAC. Multivariable logistic regression models were used to identify predictors of OAC prescription. Results: In total, 339 CABG patients between April 1, 2019 and March 30, 2020, were identified; 86 patients developed POAF. No patients had major perioperative bleeding. All POAF patients had an indication for OAC therapies based on CHADS 65 score. However, only 17 (19.8%) patients with POAF had OAC prescription at the time of hospital discharge. Baseline characteristics were similar between those with or without OAC. In multivariable analysis, the use of dual antiplatelet therapy was associated with a decreased use of OAC therapy in POAF (OR 0.037 (95% CI 0.005, 0.29), P = .002). Moreover, in comparison to surgeon A, surgeon B was associated with a decreased use of OAC therapy, whereas surgeon C was associated with an increased use of OAC therapy in POAF (OR 0.15 (95% CI 0.03, 0.83), P = .03 and OR 6.49 (95% CI 1.21, 34.82), P = .03, respectively). None of the CHADS 65 elements, including age, hypertension, stroke, diabetes mellitus or congestive heart failure, correlated with the use of OAC. Key findings: Eighty percent of patients who developed POAF after isolated CABG failed to receive stroke prevention therapies. The use of dual antiplatelet therapy and individual surgeons’ preference were associated with the use of OAC therapy among POAF. Conclusions: This data set suggests that approximately only 1 in 5 patients with POAF after isolated CABG got prescribed OAC.

BackgroundPrescription drug use has soared in the USA within the last two decades. Prescription drugs can impair motor skills essential for the safe operation of a motor vehicle, and therefore can affect traffic safety. As one of the epicentres of the opioid epidemic, Florida has been struck by high opioid misuse and overdose rates, and has concurrently suffered major threats to traffic disruptions safety caused by driving under the influence of drugs. To prevent prescription opioid misuse in Florida, Prescription Drug Monitoring Programs (PDMPs) were implemented in September 2011.ObjectiveTo examine the impact of Florida’s implementation of a mandatory PDMP on drug-related MVCs occurring on public roads.MethodsWe employed a difference-in-differences approach to estimate the difference in prescription drug-related fatal crashes in Florida associated with its 2011 PDMP implementation relative to those in Georgia, which did not use PDMPs during the same period (2009–2013). The analyses were conducted in 2020.ResultsIn Florida, there was a significant decline in drug-related vehicle crashes during the 22 months post-PDMP. PDMP implementation was associated with approximately two (−2.21; 95% CI −4.04 to –0.37; pConclusionsThe implementation of PDMPs in Florida provided important benefits for traffic safety, reducing the rates of prescription opioid-related vehicle crashes.

Patients want more information and active participation in medical decisions. Information and active participation correlate with increased adherence. A conversation guide, combining patient-relevant drug information with steps of shared decision-making, was developed to support physicians in effective and efficient prescription talks. Six GP trainees in community-based primary care practices participated in a controlled pilot study in sequential pre-post design. Initially, they conducted 41 prescription talks as usual, i.e., without knowing the guide. Then, they conducted 23 talks considering the guide (post-intervention phase). Immediately after the respective talk, patients filled in a questionnaire on satisfaction with the information on medication and physician–patient interaction, and physicians about their satisfaction with the talk and the application of the guide. Patients felt better informed after guide-based prescription talks (e.g., SIMS-D in median 10 vs. 17, p

Background Dispensed prescription medicine labels (prescription labels) are important information sources supporting safe and appropriate medicines use. Objective To develop and user test patient-centred prescription label formats. Methods Five stages: developing 12 labels for four fictitious medicines of varying dosage forms; diagnostic user testing of labels (Round 1) with 40 consumers (each testing three labels); iterative label revision, and development of Round 2 labels (n = 7); user testing of labels (Round 2) with 20 consumers (each testing four labels); labelling recommendations. Evaluated labels stated the active ingredient and brand name, using various design features (eg upper case and bold). Dosing was expressed differently across labels: frequency of doses/day, approximate times of day (eg morning), explicit times (eg 7 to 9 AM), and/or explicit dosing interval. Participants' ability to find and understand medicines information and plan a dosing schedule were assessed. Results Participants demonstrated satisfactory ability to find and understand the dosage for all label formats. Excluding active ingredient and dosing schedule, 14/19 labels (8/12 in Round 1; 6/7 in Round 2) met industry standard on performance. Participants' ability to correctly identify the active ingredient varied, with clear medicine name sign-posting enabling all participants evaluating these labels to find and understand the active ingredient. When planning a dosing schedule, doses were correctly spaced if the label stated a dosing interval, or frequency of doses/day. Two-thirds planned appropriate dosing schedules using a dosing table. Conclusions Effective prescription label formatting and sign-posting of active ingredient improved communication of information on labels, potentially supporting safe medicines use. Patient and public involvement Consumers actively contributed to the development of dispensed prescription medicine labels. Feedback from consumers following the first round was incorporated in revisions of the labels for the next round. Patient and public involvement in this study was critical to the development of readable and understandable dispensed prescription medicine labels.

Background: US direct-to-consumer advertising spending for medicine has soared in recent decades. Advertising has been shown to impact drug utilization. Most Alzheimer’s disease patients are above age 65 and may take a range of prescription medications for various disease states. Objective: To investigate how direct-to-consumer advertising is associated with the drug utilization of patients ≥65 years old. Methods: Using advertising expenditure data and Medicare Part D drug purchase claims, we performed regression analyses for each of the highest-spending drugs and age group, with cumulative monthly spending as the predictor variable and drug utilization as the response variable. For each drug, we ran a second set of regression analyses to determine if the spending-utilization correlation showed a significant difference between the two patient age groups (older than 65, younger than 65). Results: For all 14 drugs in our study, advertising spending is positively correlated with utilization (p

OBJECTIVES To determine whether elimination of co-pays for prescription drugs affects medication adherence and total health care spending. STUDY DESIGN Retrospective comparative study. METHODS We conducted a difference-in-differences comparison in the year before and after expansion of a Zero Dollar Co-pay (ZDC) prescription drug benefit in commercially insured Louisiana residents. Blue Cross and Blue Shield of Louisiana members with continuous disease management program enrollment were analyzed, of whom 6463 were enrolled in the ZDC program and 1821 were controls who were ineligible because their employers did not opt in. RESULTS After ZDC expansion, medication adherence fell in the control group and rose in the ZDC group, with a relative increase of 2.1 percentage points (P = .002). Medical spending fell by $71 per member per month (PMPM) (P = .027) in the ZDC group relative to controls. Overall, there was no significant increase in the cost of drugs between treatment and controls. However, when drugs were further categorized, there was a significant increase of $8 PMPM for generic drugs and no significant difference for brand name drugs. Comparisons of medication adherence rates by household income showed the largest relative increase post ZDC expansion among low-income members. CONCLUSIONS Elimination of co-pays for drugs indicated to treat chronic illnesses was associated with increases in medication adherence and reductions in overall spending of $63. Benefit designs that eliminate co-pays for patients with chronic illnesses may improve adherence and reduce the total cost of care.

Background It is not clear how the noncommunicable diseases (NCDs) performed in the association of depression with use of prescription drugs. Methods This cross-sectional study involved 20,836 participants with at least one NCDs who aged over 20 years old in the National Health and Nutrition Examination Survey (NHANES) from 2005–2016. Ordinal logistic regression under complex sampling was used to examine the association of depression with use of prescription drugs in patients with different categories of NCDs. Result Among patients with respiratory diseases (OR: 1.41, 95% CI: 1.13–1.76), genitourinary diseases (OR: 1.59, 95% CI: 1.28–1.98), and cardiovascular diseases (OR: 1.43, 95% CI: 1.27–1.60), the risk of depression was higher among those who used prescription drugs than those who did not. The results showed that the association of depression with use of prescription drugs was significantly stronger, especially in patients with genitourinary diseases ≥65 years of age (OR: 1.91, 95% CI: 1.01–3.61). Trend analysis showed that the categories of prescription drugs used and the risk of depression was significantly statistically different (P for trend Limitations Self-reported prevalence of depression may differ from actual prevalence of depression. The categories of NCDs studied in this article are limited and the association between specific drugs and depression is not analyzed. Conclusions In patients with NCDs, use of prescription drugs increased the risk of depression, and this risk increased significantly, especially in patients with genitourinary diseases who aged over 65 years. The risk of depression was increasing with the categories of prescription drugs used.

In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower-cost generics become available. Delayed generic drug uptake may increase spending and worsen medication adherence and patient outcomes. We assessed recent trends and factors associated with generic uptake.Among 227 drugs facing new generic competition from 2012 to 2017, we used a national claims database to measure generic uptake in the first and second year after generic entry, defined as the proportion of claims for a generic version of the drug. Using linear regression, we evaluated associations between generic uptake and key drug characteristics.Mean generic uptake was 66.1% (standard deviation 22.1%) in the first year and 82.7% (standard deviation 21.6%) in the second year after generic entry. From 2012 to 2017 generic uptake decreased 4.3% per year in the first year (95% confidence interval, 2.8%-5.8%, P.001) and 3.2%/year in the second year (95% confidence interval, 1.2%-5.1%). Generic uptake was lower for injected than oral drugs in the first year (38.5% vs 70.0%, P.001) and second year (50.3% vs 86.9%, P.001). In the second year, generic uptake was higher among drugs with an authorized generic (86.1 vs 80.1%, P = .045) and those with ≥3 generic competitors (87.7% vs 78.6%, P = .055).Early generic uptake decreased over the past several years. This trend may adversely affect patients and increase prescription drug spending. Policies are needed to encourage generic competition, particularly among injected drugs administered in a hospital or clinic setting.

PURPOSE Understanding potential bias due to rarity of the outcome is important when monitoring newly approved drugs and drugs with low availability to the general public. Although there is an increasing use of online surveys to investigate health outcomes, the limits of inference due to drug availability have not been studied. The goal of this study was to quantify the relationship between dispensing of prescription drugs and estimates of use in an online general population survey. METHODS An online repeated, cross-sectional survey from 2018 to 2020 was used to estimate the number of adults in the United States who used prescription drugs in the general population and compared to estimated number of prescriptions dispensed over an equivalent time period. Joinpoint regression was used to quantify thresholds. A sample of respondents was retested to estimate reliability statistics. RESULTS A model with a single threshold was the best fit, with the estimated threshold of 565 000 (95% CI: 9500-11 600 000) prescriptions dispensed per year. Above the threshold, there was a significant association between dispensing and estimates (p

Objective We determine how aggregate costs have changed for commonly used emergency department (ED) medications, and assess drivers of cost increases. Methods Using the National Hospital Ambulatory Medical Care Survey (NHAMCS), we identified the top 150 ED medications administered and prescribed at discharge in 2015. We used average wholesale prices (AWP) for each year from 2006 to 15 from the Red Book (Truven Health Analytics Inc.). Average wholesale price per patient (AWPP) was calculated by dividing AWP by drug uses. This was then multiplied by the total drug administrations or prescriptions to estimate the total cost in a given the year. All prices were converted to 2015 dollars. Results Aggregate costs of drugs administered in the ED increased from $688.7 million in 2006 to $882.4 million in 2015. For discharge prescriptions, aggregate costs increased from $2.031 billion in 2006 to $4.572 billion in 2015. AWPP for drugs administered in the ED in 2015 was 14.5% higher than in 2006 and 24.3% higher at discharge. The largest absolute increase in AWPP for drugs administered was for glucagon, which increased from $111 in 2006 to $235 in 2015. The largest AWPP increase at discharge was for epinephrine auto-injector, which increased from $124 in 2006 and to $481 in 2015. Conclusion Over the course of the study period, the aggregate costs of the most common medications administered in the ED increased by 28% while the costs of medications prescribed at discharge increased 125%.

Background: Cost-related medication underuse (CRMU) has been reported within the general population in Canada. In this study, we assessed patterns of CRMU among Canadian adults with cancer. Methods: This is a cross-sectional study using survey data. We accessed data sets from the 2015/16 Canadian Community Health Survey (CCHS) and reviewed the records of adults (≥ 18 yr) with a history of cancer who were prescribed medication in the previous 12 months. We collected information about sociodemographic features, health behaviours and CRMU, and conducted a multivariable logistic regression analysis for factors associated with CRMU. Results: A total of 8581 participants were eligible for the current study. In the weighted multivariable logistic regression analysis, the following factors were associated with CRMU: younger age (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.79–3.63), female sex (male sex v. female sex OR 0.62, 95% CI 0.44–0.88), Indigenous racial background (Indigenous v. White OR 2.37, 95% CI 1.49– 3.77), unmarried status (OR 1.59, 95% CI 1.09–2.30), poor self-perceived health (excellent v. poor self-perceived health OR 0.36, 95% CI 0.17–0.77), lower annual income (< $20 000 v. income ≥ $80 000 OR 3.08, 95% CI 1.75–5.41) and lack of insurance for prescription medications (OR 2.49, 95% CI 1.77–3.50). Interpretation: The toll of CRMU among adults seems to be unequally carried by women, racial minorities, and younger (< 65 yr) and uninsured patients with cancer. Discussion about a national pharmacare program for people without private insurance is needed.

BACKGROUND: Physician and patient-related characteristics can influence prescription of medications to older patients within primary healthcare. Use of Brazilian criteria may indicate the real prevalence of prescription of potentially inappropriate medications to this population. OBJECTIVES: To evaluate prescription of potentially inappropriate medications to older patients within primary care and identify patient-related and prescribing physician-related factors. DESIGN AND SETTING: This cross-sectional study was conducted in 22 public primary care facilities in Brazil, among older people (≥ 60 years) who were waiting for medical consultations. METHODS: Interviews were conducted before and after the medical consultations. If the patient received a medical prescription at the consultation, all the drugs prescribed and the physician's medical council registration number were recorded. Prevalence ratios were estimated to ascertain the magnitude of prescription of potentially inappropriate medications, along with patient and physician-related factors associated with such prescription. RESULTS: In total, 417 older patients were included; 45.3% had received ≥ 1 potentially inappropriate medication, and 86.8% out of 53 physicians involved had prescribed ≥ 1 potentially inappropriate medication. The strongest patient-related factor associated with higher prevalence of prescription of potentially inappropriate medications was polypharmacy. Among physician-related factors, the number of patients attended, number of prescriptions and length of medical practice < 10 years were positively associated with prescription of potentially inappropriate medications. CONCLUSIONS: High prevalence of prescription of potentially inappropriate medications was observed. Physician-related characteristics can influence prescription of medications to older people within primary healthcare. This suggests that there is a need for interventions among all physicians, especially younger physicians.

Patients with chronic obstructive pulmonary disease (COPD) need long-term use of COPD medications to manage their conditions. However, COPD patients enrolling in Medicare Advantage plans (MAPs) may enter the coverage gap, resulting in increasing financial burden. The purpose of this study was to identify characteristics of COPD patients who enter the Medicare coverage gap and the factors associated with time to enter the coverage gap. A retrospective cross-sectional study was conducted using a Texas MAP database between 2011 and 2014. Patients aged ≥65 years with a diagnosis of COPD and taking medication to treat COPD were included. Patients were divided into mainly 2 groups: "no gap" versus "gap," based on their pharmacy outpatient spending. Within "gap," patients were further categorized into "coverage gap" and gap with "catastrophic coverage." Multinomial logistic regression was conducted to identify characteristics associated with reaching "coverage gap" and "catastrophic coverage." Cox proportional hazards were performed to evaluate factors associated with time to reaching "coverage gap." A total of 3142 COPD patients were identified: "no gap" (79%) and "gap" (21%). Among patients in "gap," 51% fell into "catastrophic coverage." Age, low-income subsidy (LIS) level, and Centers for MedicareMedicaid (CMS) risk score were significant factors associated with entering both "coverage gap" and "catastrophic coverage." Younger age, greater CMS risk score, and higher LIS benefit were associated with a higher hazard ratio of reaching the coverage gap. These characteristics may assist health maintenance organizations to identify beneficiaries who can potentially be provided with services with or without counseling on drug utilization.

Background Consumers and primary care physicians (PCPs) sometimes encounter deceptive promotional claims about prescription drugs. Whether consumers and PCPs can detect deceptive claims or whether those claims negatively affect medical decision making, however, remain important, unanswered research questions. Objectives This article explores (1) the ability of consumers and PCPs to identify deceptive prescription drug promotion at various levels of deception, (2) the influence of such tactics on obstructing risk recognition, and (3) whether perceived deception mediates relationships between exposure to deceptive tactics and various outcomes (including false-claim acceptance, attitudes, information-seeking intentions, and interest toward the promoted drug). Methods Two experiments—1 with consumers (N = 366) and 1 with PCPs (N = 378)—were conducted to determine whether participant exposure to deceptive prescription drug website content corresponds to detection and acceptance (or rejection) of claims and tactics. In each experiment, the number of deceptive claims and tactics on a consumer- or PCP-targeted website for a fictitious chronic pain medication were varied, in a 1 × 3 (none, fewer, more) between-subjects design. Results Among consumers, exposure to more deceptive claims or tactics did not increase suspicion about the veracity of the website (relative to fewer claims and tactics) and actually had a limited positive direct effect on false-claim acceptance and attitudes toward the drug. Among PCPs, a mediation effect existed such that exposure to more deceptive claims and tactics resulted in higher perceived website deceptiveness relative to those in the fewer deceptive claims condition, which, in turn, resulted in lower acceptance of deceptive claims and tactics, lower perceived drug effectiveness, more negative attitudes toward the drug, and lower interest and intentions. Conclusion These experiments demonstrate potential differences between consumers and PCPs as well as implications for consumer and PCP vulnerability to website deception.

We have been conducting research with the aim of generating evidence for the safety of perinatal drugs. As a result of reviewing the records of inquiries to the Drug Information Office of our hospital, we found a large discrepancy between the description of perinatal drugs in package inserts in Japan and the description of the Pregnancy Risk Category according to the U.S. Food and Drug Administration. In the Japan Environment and Children's Study (JECS), we determined the proportion of drug and supplement use among 97464 pregnant women. We clarified that prescriptions of antihypertensive drugs for pregnant women increased during the second half of pregnancy, while prescriptions of anti-epileptic and anti-anxiety drugs decreased after pregnancy using a claims database. A survey of pharmacists and pharmacy students revealed a lack of awareness of effective folic acid intake to reduce the risk of neural tube defects in infants. The percentage of pre-pregnancy folic acid supplementation among pregnant women participating in the Babies and their Parents' Longitudinal Observation in Suzuki Memorial Hospital on Intrauterine Period (BOSHI) study, the JECS, and the Tohoku Medical Megabank (TMM) Birth and Three-Generation (BirThree) cohort study was 6.3-18.0%. As a result of close examination of the records of inquiries to the Drug Information Office of our hospital, and of cases in which our lactation plan sheet was applied, it was found that there were discrepancies between the information on the drug package insert and the information on Medications & Mother's Milk, etc. in Japan. The results obtained have been clinically applied in daily practice and we are continuing our research while taking measures.

BACKGROUND AND OBJECTIVES Prescription Drug Monitoring Programs (PDMP) detect high-risk prescribing and patient behaviors. This study describes the characteristics associated with documented PDMP access when prescribing opioids. METHODS Retrospective chart review of 695 opioid prescriptions written from inpatient and outpatient medical and psychiatric settings. Data were abstracted and analyzed to identify characteristics associated with documented PDMP access. RESULTS One-third of the charts had PDMP access documented within the week of opioid prescription; 12% showed PDMP consultation on the same day. Services varied greatly from 10.5% (inpatient medicine) to 57% (inpatient psychiatry) with regard to same-day PDMP access (P

Trauma exposure and comorbid substance use are highly prevalent among female drug court participants. Despite the pervasiveness of the issue, few studies have investigated the impact of posttraumatic stress symptoms (PTSS) and nonmedical prescription drug use among this specific population. The present study examined the impact of posttraumatic stress, social support, and nonmedical prescription drug use on graduation outcomes among female participants in a specialized drug court program (N = 210). Participants either received motivational enhancement therapy/cognitive behavioral therapy (MET-CBT; N = 210) or both MET-CBT and Seeking Safety through intensive outpatient treatment (n = 109). The findings indicated that graduation was negatively correlated with posttraumatic stress, r = -.19, p = .007, d = 0.40; past 90-day nonmedical prescription painkiller, opiate, and analgesic use, r = -.19, p = .001, d = 0.44; tangible social support, r = -.24, p = < .001, d = 0.51; and past-month substance use problems, r = -.25, p < .001, d = .50. In addition, past-month substance use problems, OR = 0.84, 95% CI [0.72, 0.97]; PTSS, OR = 0.90, 95 % CI [0.82, 0.99]; and tangible social support, OR = 0.94, 95% CI [0.89, 0.98], were significant negative predictors of graduation. These results speak to the importance of facilitating the development of specialized evidence-based drug court interventions that target and improve comorbid substance use and trauma outcomes among female drug court participants to reduce recidivism and set a precedent for future research to replicate and expand upon these findings.

POLICY POINTS: Spending on prescription drugs is much higher per capita in the United States than in most other industrialized nations, including France. Lower prescription drug spending in France is due to different approaches to managing drug prices, volume of prescribing, and global health budgets. Linking a drug's price to value both at the launch of the drug and over its lifetime is key to controlling spending. Regulations on prescription volume and global spending complement the interventions on prices. If the United States adopted the French approach to regulating drug pricing, Medicare could potentially save billions of dollars annually on prescription drug spending. CONTEXT: Prescription drug spending per capita in the United States is higher than in most other industrialized countries. Policymakers seeking to lower drug spending often suggest benchmarking prices against other countries, including France, which spends half as much as the United States per capita on prescription drugs. Because differences in drug prices may result from how markets are organized in each nation, we sought to directly compare drug prices and pricing regulations between the United States and France. METHODS: For the six brand‐name drugs with the highest gross expenditures in Medicare Part D in 2017, we compared the price dynamics in France and the United States between 2010 and 2018 and analyzed associations between price changes in each country and key regulatory events. We also comprehensively reviewed US and French laws and regulations related to drug pricing. FINDINGS: Prices for the six drugs studied were higher in the United States than in France. In 2018, if Medicare had paid French prices for the brand‐name drugs in our cohort, the agency would have saved $5.1 billion. We identified 12 factors that explain why the United States spends more than France on drugs, including variations in unit prices and the volume of prescriptions, driven by use of health technology assessment and value‐based pricing in France. CONCLUSIONS: Key drivers of lower drug spending in France compared to the United States are that the French government regulates drug prices when products are launched and prohibits substantial price increases after launch. The regulation of prescription drugs in France is governed by rules that can inform discussions of US prescription drug policy and potential Medicare price negotiations.

Background The use of herbs and supplements (HS) is common among patients with cancer, yet limited information exists about potential medication interactions (PMIs) with HS use around chemotherapy. Methods Patients with breast or prostate cancer who had recently finished chemotherapy at 2 academic medical centers were surveyed by telephone. Interviewers inquired about all medications, including HS, before, during, and after chemotherapy. Micromedex, Lexicomp, and Natural Medicines Comprehensive Database interaction software programs were used to determine PMIs. Results A total of 67 subjects (age range, 39-77 years) were evaluated in this study. Participants were primarily White patients (73%) with breast cancer (87%). The median number of medications was 11 (range, 2-28) during the entire study and was highest during chemotherapy (7; range, 2-22). Approximately four-fifths (84%) used HS. A total of 1747 PMIs were identified, and they represented 635 unique PMIs across all 3 timeframes, with most occurring during chemotherapy. Prescription-related PMIs (70%) were the most common type, and they were followed by HS-related (56%) and anticancer treatment-related PMIs (22%). Approximately half of the PMIs (54%) were categorized as moderate interactions, and more than one-third (38%) were categorized as major interactions. Patient use of HS increased from 51% during chemotherapy to 66% after chemotherapy, and this correlated with an increased prevalence of HS PMIs (46% to 60%). HS users were more likely to be at risk for a major PMI than non-HS users (92% vs 70%; P = .038). Conclusions The use of HS remains prevalent among patients with cancer and may place them at risk for PMIs both during chemotherapy and after the completion of treatment. Lay summary This study evaluates the risk of potential medication interactions for patients with breast or prostate cancer undergoing chemotherapy. The results show that patients often use herbs and supplements during treatment. Prescription medications are most often associated with medication interactions, which are followed by herb and supplement-related interactions. More than one-third of potential medication interactions are considered major. Patients should be educated about the risk of herb and supplement-related medication interactions during treatment.

Background The prevalence and clinical presentation of acne vulgaris in Latin America are comparable to that in Europe and the United States. This review aims at insight into the role of Over the Counter (OTC) products in acne treatment and maintenance in Latin America. Methods A panel of dermatologists from Latin America employed an online procedure to answer questions on this topic: What is used, by whom, when, how, and why? Before the meeting, a survey was completed by dermatologists from Latin America on OTC products for acne recommended by the panel in their clinical practice. The survey information and a literature review on Latin American acne guidelines and clinical studies were used to address this topic. Results The survey responders' choices on OTC products for monotherapy comprised alpha-hydroxy acid and beta-hydroxy acid-containing serum, ceramides-containing foaming cleanser, a soap-free exfoliating cleanser, adapalene, and benzoyl peroxide-containing products. The clinicians recommended OTC cleansing products mainly for younger patients at a starter level and for women with adult acne. The use of these OTC products is similar to practice described in therapeutic acne guidelines and algorithms for Latin American countries, Spain and Portugal, Europe, and the United States. Conclusions Advisors agreed that OTC products and skincare recommendations, in addition to the use of prescription medications, are a crucial part of successful acne therapy. Participants noted that the use of quality OTC products could improve acne symptomatology and severity. J Drugs Dermatol. 2021;20(3):244-250. doi:10.36849/JDD.2021.5779 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

OBJECTIVE: To determine the long‐run impact of a commercial accountable care organization (ACO) on prescription drug spending, utilization, and related quality of care. DATA SOURCES/STUDY SETTING: California Public Employees' Retirement System (CalPERS) health maintenance organization (HMO) member enrollment data and pharmacy benefit claims, including both retail and mail‐order generic and brand‐name prescription drugs. STUDY DESIGN: We applied a longitudinal retrospective cohort study design and propensity‐weighted difference‐in‐differences regression models. We examined the relative changes in outcome measures between two ACO cohorts and one non‐ACO cohort before and after the ACO implementation in 2010. The ACO directed provider prescribing patterns toward generic substitution for brand‐name prescription drugs to maximize shared savings in pharmacy spending. DATA COLLECTION/EXTRACTION METHODS: The study sample included members continuously enrolled in a CalPERS commercial HMO from 2008 through 2014 in the Sacramento area. PRINCIPAL FINDINGS: The cohort differences in baseline characteristics of 40 483 study participants were insignificant after propensity‐weighting adjustment. The ACO enrollees had no significant differential changes in either all or most of the five years of the ACO operation for the following measures: (1) average total spending and (2) average total scripts filled and days supplied on either generic or brand‐name prescription drugs, or the two combined; (3) average generic shares of total prescription drug spending, scripts filled or days supplied; (4) annual rates of 10 outpatient process quality of care metrics for medication prescribing or adherence. CONCLUSIONS: Participation in the commercial ACO was associated with negligible differential changes in prescription drug spending, utilization, and related quality of care measures. Capped financial risk‐sharing and increased generics substitution for brand names are not enough to produce tangible performance improvement in ACOs. Measures to increase provider financial risk‐sharing shares and lower brand‐name drug prices are needed.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic and subsequent restrictions on dental services have had a significant impact on the provision of dental care in Australia and around the world. Objectives: To investigate the impact of COVID-19 on medications prescribed by dentists under the Australian Pharmaceutical Benefits Scheme (PBS). Methods: Data on the number of dental prescriptions dispensed for all medications listed on the PBS Dental Schedule, from January 2019 to June 2020, were extracted from publicly available data sets. Analysis of prescription trends was performed for 1) total medications, 2) each major medication class, and 3) individual medications. The number of prescriptions dispensed in each month from January 2020 to June 2020 was compared to the same month in 2019 to determine the relative (percentage) change, and z statistics were used to determine whether changes were statistically significant. Results: There was a significant decrease in dental prescriptions in April 2020 compared to April 2019 (14,785, 18%; P < 0.05). Decreases in prescriptions for antibiotics (10,512, 16%; P < 0.05) and opioid analgesics (3,129, 18%; P < 0.05) were smaller compared to other major medication classes. There was a significant increase in June 2020, compared with June 2019, for prescriptions of amoxicillin with clavulanic acid (4,903, 20%; P < 0.05), tramadol (89, 46%; P < 0.05), and oxycodone (381, 73%; P < 0.05). Conclusion: Dental service restrictions during COVID-19 likely drove an unmet need for routine dental treatment, which had significant implications for public oral health following easing of restrictions. During the initial surge and subsequent lockdown, antibiotics and opioid analgesics may have been used an as alternative to routine operative treatment. Continued professional guidance is required to ensure dental prescribing remains evidence based during the pandemic period. Knowledge Transfer Statement: The COVID-19 pandemic and subsequent restrictions on dental practice have had a profound impact on the provision of dental care in Australia and elsewhere in the world. In this context, population-level medication surveillance is important to identify and respond to changes in prescribing patterns that have arisen due to COVID-19 and restrictions on the provision of dental care. This research is particularly important for governments, regulators, and professional associations to ensure therapeutic guidelines and recommendations during the pandemic period remain relevant and evidence based.

The current study observes that while several studies have been conducted on the direct-to-consumer advertising (DTCA) of prescription drugs, none has explicitly evaluated the ethical dimension DTCA of prescriptions, as such a knowledge gap still exists with regard to the ethics of DTCAs. To contribute to filling this gap, the current study evaluates the ethical DTCA of prescription drugs using Pfizer's Lipitor ad, which because of public outcry, was terminated shortly after it was launched. The study concludes that what may be legal may not necessarily be ethical. Thus marketing decision marketers must expand their focus group testing of DTCAs to include assessment of their ethics.

There is limited evidence to support pharmacogenetic (PGx) testing in children. We conducted a retrospective review of PGx testing among 452 patients at an academic children's hospital to determine the potential utility of PGx in diseases of childhood and to identify targets for future pediatric pharmacogenetic research. An actionable gene-drug pair associated with the 28 genes tested (Clinical Pharmacogenetics Implementation Consortium (CPIC) level A or B, Pharmacogenomics Knowledge Base (PharmGKB) level 1A or B, or US Food and Drug Administration (FDA) recommendation and a PharmGKB level) was present in 98.7% of patients. We identified 203 actionable gene-drug-diagnosis groups based on the indications for each actionable drug listed in Lexicomp. Among patients with an actionable gene-drug-diagnosis group, 49.3% had a diagnosis where the drug was a therapeutic option and PGx could be used to guide treatment selection. Among patients with an associated diagnosis, 30.9% had a prescription for the actionable drug allowing PGx guided dosing. Three genes (CYP2C19, CYP2D6, and CYP3A5) accounted for all the gene-drug-diagnosis groups with matching diagnoses and prescriptions. The most common gene-drug-diagnosis groups with matching diagnoses and prescriptions were CYP2C19-citalopram-escitalopram-depression 3.3% of patients tested; CYP2C19-dexlansoprazole-gastritis-esophagitis 3.1%; CYP2C19-omeprazole-gastritis-esophagitis 2.4%; CYP2D6-atomoxetine-attention deficit hyperactivity disorder 2.2%; and CYP2C19-citalopram-escitalopram-obsessive-compulsive disorder 1.5%. PGx could be used to guide selection of current treatment options or medication dosing in almost half (48.7%) of pediatric patients tested. Mood disorders and gastritis/esophagitis are promising targets for future study of PGx testing because of the high prevalence of these diagnoses and associated actionable gene-drug pairs in the pediatric population.

This study aimed to quantify the association between pharmaceutical industry payments to physicians for pimavanserin and both pimavanserin prescription volume and Medicare expenditures.This retrospective cross-sectional study used 2016 and 2017 data from Open Payments and the Medicare Part D Prescriber Public Use Files. The authors used Poisson regression models to quantify the association between physician payments for pimavanserin and pimavanserin prescription volume and linear regression models to quantify the association with Medicare expenditures for pimavanserin.Of 1,609 physicians who prescribed pimavanserin, 45% received payments, which totaled to $6,369,922. Each $10,000 in physician payments was associated with a 14% increase in pimavanserin prescription volume (incident rate ratio=1.14, 95% confidence interval [CI]=1.13-1.14). Every $100 in physician payments was associated with a $175.84 increase in Medicare pimavanserin expenditures (95% CI=$161.55-$190.13).Extensive physician payments have been associated with increased pimavanserin prescription volume and Medicare expenditures.

Srinivas R Nalamachu,1 Rebecca L Robinson,2 Lars Viktrup,3 Joseph C Cappelleri,4 Andrew G Bushmakin,4 Leslie Tive,5 Jennifer Mellor,6 Niall Hatchell,6 James Jackson6 1Mid America PolyClinic, Overland Park, KS, USA; 2Patient Outcomes and Real-World Evidence, Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Bio-Medicines Core Team, Eli Lilly and Company, Indianapolis, IN, USA; 4Statistics, Pfizer Inc, Groton, CT, USA; 5Medical Affairs, Pfizer Inc, New York, NY, USA; 6Real World Research, Adelphi Real World, Bollington, Cheshire, UKCorrespondence: Rebecca L RobinsonEli Lilly and Company, Lilly Research Labs, Lilly Corporate Center, Indianapolis, IN 46285, USATel +1 317-224-5833Fax +1 317-277-0490Email rlrobinson@lilly.comPurpose: The purpose of this study was to assess how patient-reported pain is related to osteoarthritis (OA) treatment patterns in routine clinical practice.Patients and Methods: Data were collected between February and May 2017 from 153 United States (US) primary care physicians, rheumatologists, and orthopedic surgeons. Each invited up to nine consecutive patients to rate their OA pain in the last week. Physicians provided demographic, clinical, and treatment information for patients, including nonpharmacologic therapies ever recommended, currently recommended over-the-counter (OTC) medications, and currently and ever prescribed medications for the management of OA. Findings for patients with mild (0─3), moderate (4─6), and severe current pain (7─10) were compared using appropriate statistics.Results: Among the 841 patients (61% female; mean 65 years; 57% knee OA), 45% reported mild, 36% moderate, and 19% severe current OA pain. Current treatment modalities differed by pain severity (P< 0.05). Most patients (70%) had been recommended nonpharmacologic therapy and 40% were currently recommended OTC medications. More patients with moderate (81%) or severe pain (78%) currently received prescription medications, with or without nonpharmacologic therapy, versus those with mild pain (67%). Overall, 47% of patients currently received just one prescription drug, while 49% had received one prescription drug ever. Nonsteroidal anti-inflammatory drugs (NSAIDs) were the most common current (58%) and ever received (88%) prescriptions. Current NSAID prescriptions were not associated with pain severity. Acetaminophen recommendations, opioid prescriptions (current and ever), and multiple prescription medications tried were numerically highest in the severe pain group (all P< 0.05 by pain severity). In all groups, > 80% of treatment switches were due to lack of efficacy.Conclusion: Real-life treatment patterns for OA in the US are significantly associated with current patient-reported pain. Combining nonpharmacologic and pharmacologic treatments is common but higher pain ratings are associated with multiple failed prescription treatments. Current use of acetaminophen and opioids, but not NSAIDs, increases alongside pain severity.Keywords: nonprescription drugs, prescription drugs, therapeutics, pain management, practice patterns, physicians