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\"Groundbreaking research has given us many remarkable new medicines, but America's drug evaluation process, once the envy of the world, is being seriously compromised. Under pressure from drugmakers, the FDA has been lowering its approval standards and has let poorly effective or risky products enter the market--while our prescription prices, the highest in the world, put crucial treatments beyond the reach of many. In Rethinking Medications, Dr. Jerry Avorn explains how we got here and what we can do to ensure that our medicines are dependably effective, safe, and affordable\"-- Provided by publisher.

IMPORTANCE:It is important to understand the magnitude and distribution of the economic burden of prescription opioid overdose, abuse, and dependence to inform clinical practice, research, and other decision makers. Decision makers choosing approaches to address this epidemic need cost information to evaluate the cost effectiveness of their choices. OBJECTIVE:To estimate the economic burden of prescription opioid overdose, abuse, and dependence from a societal perspective. DESIGN, SETTING, AND PARTICIPANTS:Incidence of fatal prescription opioid overdose from the National Vital Statistics System, prevalence of abuse and dependence from the National Survey of Drug Use and Health. Fatal data are for the US population, nonfatal data are a nationally representative sample of the US civilian noninstitutionalized population ages 12 and older. Cost data are from various sources including health care claims data from the Truven Health MarketScan Research Databases, and cost of fatal cases from the WISQARS (Web-based Injury Statistics Query and Reporting System) cost module. Criminal justice costs were derived from the Justice Expenditure and Employment Extracts published by the Department of Justice. Estimates of lost productivity were based on a previously published study. EXPOSURE:Calendar year 2013. MAIN OUTCOMES AND MEASURES:Monetized burden of fatal overdose and abuse and dependence of prescription opioids. RESULTS:The total economic burden is estimated to be $78.5 billion. Over one third of this amount is due to increased health care and substance abuse treatment costs ($28.9 billion). Approximately one quarter of the cost is borne by the public sector in health care, substance abuse treatment, and criminal justice costs. CONCLUSIONS AND RELEVANCE:These estimates can assist decision makers in understanding the magnitude of adverse health outcomes associated with prescription opioid use such as overdose, abuse, and dependence.

The authors analyzed data from five national surveillance programs and report that rates of abuse and diversion of opioid medications increased during 2002–2010 and flattened or decreased during 2011–2013. These findings suggest progress in reducing abuse of opioid analgesics. Whatever the measure, the past two decades have been characterized by increasing abuse and diversion of prescription drugs, including opioid medications, in the United States. An estimated 25 million people initiated nonmedical use of pain relievers between 2002 and 2011. 1 The number of deaths per year attributed to prescription opioid medications reached 16,651 in 2010. 2 In response to the epidemic, hundreds of local, regional, state, and federal interventions have been implemented. For example, 49 states have enacted legislation to create prescription-drug monitoring programs. 3 The U.S. Office of National Drug Control Policy has responded to the epidemic with numerous recommendations, including . . .

Abstract Objective State prescription drug monitoring programs (PDMPs) can help detect individuals with multiple provider episodes (MPEs; also referred to as doctor/pharmacy shopping), an indicator of prescription drug abuse and/or diversion. Although unsolicited reporting by PDMPs to prescribers of opioid analgesics is thought to be an important practice in reducing MPEs and the potential harm associated with them, evidence of its effectiveness is mixed. This exploratory research evaluates the impact of unsolicited reports sent by Massachusetts’ PDMP to the prescribers of persons with MPEs. Methods Individuals with MPEs were identified from PDMP records between January 2010 and July 2011 as individuals having Schedule II prescriptions (at least one prescription being an opioid) from four or more distinct prescribers and four or more distinct pharmacies within six months. Based on available MA-PDMP resources, an unsolicited report containing the patient’s 12-month prescription history was sent to prescribers of a subset of patients who met the MPE threshold; a comparison group closely matched on demographics and baseline prescription history, whose prescribers were not sent a report, was generated using propensity score matching. The prescription history of each group was examined for 12 months before and after the intervention. Results There were eighty-four patients (intervention group) whose prescribers received an unsolicited report and 504 matched patients (comparison group) whose prescribers were not sent a report. Regression analyses indicated significantly greater decreases in the number of Schedule II opioid prescriptions (P < 0.01), number of prescribers visited (P < 0.01), number of pharmacies used (P < 0.01), dosage units (P < 0.01), total days’ supply (P < 0.01), total morphine milligram equivalents (MME; P < 0.01), and average daily MME (P < 0.05) for the intervention group relative to the comparison group. A post hoc analysis suggested that the observed intervention effects were greater for individuals with an average daily dose of less than 100 MMEs. Conclusions This study suggests that PDMP unsolicited reporting to prescribers can help reduce risk measures in patients’ prescription histories, which may improve health outcomes for patients receiving opioid analgesics from multiple providers.

Background The concept of pharmaceutical care is operationalized through pharmaceutical professional services, which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes. Objective The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a medication review with follow-up (MRF) service for older adults with polypharmacy in Spanish community pharmacies against the alternative of having their medication dispensed normally. Methods The study was designed as a cluster randomized controlled trial, and was carried out over a time horizon of 6 months. The target population was older adults with polypharmacy, defined as individuals taking five or more medicines per day. The study was conducted in 178 community pharmacies in Spain. Cost-utility analysis adopted a health service perspective. Costs were in euros at 2014 prices and the effectiveness of the intervention was estimated as quality-adjusted life-years (QALYs). In order to analyze the uncertainty of ICER results, we performed a non-parametric bootstrapping with 5000 replications. Results A total of 1403 older adults, aged between 65 and 94 years, were enrolled in the study: 688 in the intervention group (IG) and 715 in the control group (CG). By the end of the follow-up, both groups had reduced the mean number of prescribed medications they took, although this reduction was greater in the IG (0.28 ± 1.25 drugs; p  < 0.001) than in the CG (0.07 ± 0.95 drugs; p  = 0.063). Older adults in the IG saw their quality of life improved by 0.0528 ± 0.20 ( p  < 0.001). In contrast, the CG experienced a slight reduction in their quality of life: 0.0022 ± 0.24 ( p  = 0.815). The mean total cost was €977.57 ± 1455.88 for the IG and €1173.44 ± 3671.65 for the CG. In order to estimate the ICER, we used the costs adjusted for baseline medications and QALYs adjusted for baseline utility score, resulting in a mean incremental total cost of −€250.51 ± 148.61 (95 % CI −541.79 to 40.76) and a mean incremental QALY of 0.0156 ± 0.004 (95 % CI 0.008–0.023). Regarding the results from the cost-utility analysis, the MRF service emerged as the dominant strategy. Conclusion The MRF service is an effective intervention for optimizing prescribed medication and improving quality of life in older adults with polypharmacy in community pharmacies. The results from the cost-utility analysis suggest that the MRF service is cost effective.

Objective To study the association between benzodiazepine prescribing patterns including dose, type, and dosing schedule and the risk of death from drug overdose among US veterans receiving opioid analgesics.Design Case-cohort study.Setting Veterans Health Administration (VHA), 2004-09.Participants US veterans, primarily male, who received opioid analgesics in 2004-09. All veterans who died from a drug overdose (n=2400) while receiving opioid analgesics and a random sample of veterans (n=420 386) who received VHA medical services and opioid analgesics.Main outcome measure Death from drug overdose, defined as any intentional, unintentional, or indeterminate death from poisoning caused by any drug, determined by information on cause of death from the National Death Index.Results During the study period 27% (n=112 069) of veterans who received opioid analgesics also received benzodiazepines. About half of the deaths from drug overdose (n=1185) occurred when veterans were concurrently prescribed benzodiazepines and opioids. Risk of death from drug overdose increased with history of benzodiazepine prescription: adjusted hazard ratios were 2.33 (95% confidence interval 2.05 to 2.64) for former prescriptions versus no prescription and 3.86 (3.49 to 4.26) for current prescriptions versus no prescription. Risk of death from drug overdose increased as daily benzodiazepine dose increased. Compared with clonazepam, temazepam was associated with a decreased risk of death from drug overdose (0.63, 0.48 to 0.82). Benzodiazepine dosing schedule was not associated with risk of death from drug overdose.Conclusions Among veterans receiving opioid analgesics, receipt of benzodiazepines was associated with an increased risk of death from drug overdose in a dose-response fashion.

Objective. In the United States, per-capita opioid dispensing has increased concurrently with analgesic-related mortality and morbidity since the 1990s. To deter diversion and abuse of controlled substances, most states have implemented electronic prescription drug monitoring programs (PDMPs). We evaluated the impact of state PDMPs on opioid dispensing. Methods. We acquired data on opioids dispensed in a given quarter of the year for each state and the District of Columbia from 1999 to 2008 from the Automation of Reports and Consolidated Orders System and converted them to morphine milligram equivalents (MMEs). We used multivariable linear regression modeling with generalized estimating equations to assess the effect of state PDMPs on per-capita dispensing of MMEs. Results. The annual MMEs dispensed per capita increased progressively until 2007 before stabilizing. Adjusting for temporal trends and demographic characteristics, implementation of state PDMPs was associated with a 3% decrease in MMEs dispensed per capita (p= 0.68). The impact of PDMPs on MMEs dispensed per capita varied markedly by state, from a 66% decrease in Colorado to a 61% increase in Connecticut. Conclusions. Implementation of state PDMPs up to 2008 did not show a significant impact on per-capita opioids dispensed. To control the diversion and abuse of prescription drugs, state PDMPs may need to improve their usability, implement requirements for committee oversight of the PDMP, and increase data sharing with neighboring states.

Despite the significant cost of prescription (Rx) drug abuse and calls from policymakers for effective interventions, there is limited research on the effects of policies intended to limit such abuse. This study estimates the effects of prescription drug monitoring (PDMP) programs, which constitute a key policy targeting access to non-medical use of Rx drugs. Based on objective indicators of abuse as measured by substance abuse treatment admissions and mortality related to Rx drugs, estimates do not suggest any substantial effects of instituting an operational PDMP. We find, however, that mandatory-access provisions, which raised PDMP utilization rates by actually requiring providers to query the PDMP prior to prescribing a controlled drug, are significantly associated with a reduction in Rx drug abuse. The effects are driven primarily by a reduction in opioid abuse, generally strongest among young adults (ages 18 to 24), and underscore important dynamics in the policy response. Robustness checks are consistent with a causal interpretation of these effects. We also assess potential spillovers of mandatory PDMPs on the use of other illicit drugs and find a complementary reduction in admissions related to cocaine and marijuana abuse.

Objective. Emergency department (ED) providers are high volume but low quantity prescribers of opioid analgesics (OA). Few studies have examined differences in opioid prescribing decisions specifically among ED providers. The aim of this study was to describe OA prescribing decisions of ED providers at geographically diverse centers, including utilization of prescribing guidelines and prescription drug monitoring programs (PDMP). Methods. This was a multi-center cross-sectional Web-based survey of ED providers who prescribe OA. Respondents were asked about their OA prescribing decisions, their use of PDMPs, and their use of prescribing guidelines. Data was analyzed using descriptive statistics and chi-square tests of association were used to assess the relationship between providers' opioid prescribing decisions and independent covariates. Results. The total survey population was 957 individuals and 515 responded to the survey for an overall response rate of 54%. The frequency of respondents who prescribed different types of pain medication was variable between centers. Fifty-nine percent (219/369) of respondents were registered to access a PDMP, and 5% (18/369) were not aware whether their state had a PDMP. Forty percent (172/426) of respondents used OA prescribing guidelines, while 24% (103/426) did not, and 35% (151/426) were unaware of prescribing guidelines. Sixteen percent (68/439) of respondents indicated they have prescribed OA to expedite patient discharge, and 12% (54/439) to improve patient satisfaction. No significant differences in OA prescribing decisions were found between groups either by use of PDMP or by guideline adherence. Conclusions. In this multi-center survey study of ED clinicians, OA prescribing decisions varied between centers and found some providers occasionally prescribe OA for non-medical reasons including expediting ED discharge and increasing patient satisfaction. The utilization of prescribing guidelines and PDMPs was not associated with differences in OA prescribing decisions.

AbstractObjectivesTo evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms.DesignPragmatic, factorial randomised controlled trial.SettingPrimary care physicians in Ontario, CanadaParticipantsAll primary care physicians were randomly assigned a group if they were eligible and actively prescribing antibiotics to patients 65 years or older. Physicians were excluded if had already volunteered to receive antibiotic prescribing feedback from another agency, or had opted out of the trial.InterventionA letter was mailed in January 2022 to physicians with peer comparison antibiotic prescribing feedback compared with the control group who did not receive a letter (4:1 allocation). The intervention group was further randomised in a 2x2 factorial trial to evaluate case-mix adjusted versus unadjusted comparators, and emphasis, or not, on harms of antibiotics.Main outcome measuresAntibiotic prescribing rate per 1000 patient visits for patients 65 years or older six months after intervention. Analysis was in the modified intention-to-treat population using Poisson regression.Results5046 physicians were included and analysed: 1005 in control group and 4041 in intervention group (1016 case-mix adjusted data and harms messaging, 1006 with case-mix adjusted data and no harms messaging, 1006 unadjusted data and harms messaging, and 1013 unadjusted data and no harms messaging). At six months, mean antibiotic prescribing rate was 59.4 (standard deviation 42.0) in the control group and 56.0 (39.2) in the intervention group (relative rate 0.95 (95% confidence interval 0.94 to 0.96). Unnecessary antibiotic prescribing (0.89 (0.86 to 0.92)), prolonged duration prescriptions defined as more than seven days (0.85 (0.83 to 0.87)), and broad spectrum prescribing (0.94 (0.92 to 0.95)) were also significantly lower in the intervention group compared with the control group. Results were consistent at 12 months post intervention. No significant effect was seen for including emphasis on harms messaging. A small increase in antibiotic prescribing with case-mix adjusted reports was noted (1.01 (1.00 to 1.03)).ConclusionsPeer comparison audit and feedback letters significantly reduced overall antibiotic prescribing with no benefit of case-mix adjustment or harms messaging. Antibiotic prescribing audit and feedback is a scalable and effective intervention and should be a routine quality improvement initiative in primary care.Trial registrationClinicalTrials.gov NCT04594200