Dataset Information

Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial.

ABSTRACT:

Background

Highly effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related nonadherence.

Objective

We sought to assess an intervention to stimulate appropriate generic cardiovascular drug use without creating administrative or financial barriers that may impede essential medication use.

Trial design

The SAMPLES (Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples) trial is a clustered, randomized controlled trial of the effect of providing physicians with free generic samples of hydrochlorothiazide for hypertensive patients and simvastatin for patients with hyperlipidemia. We will randomize 660 primary care physicians in Pennsylvania, clustered by physician practice, to receive free samples for both conditions or to receive no samples. We will use data on filled prescriptions obtained from a state-sponsored prescription drug assistance program to perform an intention-to-treat evaluation of the impact of the intervention on physician prescribing behavior (proportion of prescriptions that are generic) and patient adherence. Secondary outcomes will include physician adherence to established guidelines and overall prescription drug costs.

Conclusion

This trial will define the potential role of an innovative approach to stimulate clinically appropriate cost-effective prescribing. We will determine whether free generic samples can reduce overall drug costs as well as out-of-pocket costs to the patient without sacrificing efficacy and whether this approach results in improved adherence to essential cardiovascular medications. This intervention may also improve adherence to practice guidelines and improve the quality of care received. If effective, this strategy could be used broadly by private insurers or government payers aiming to stimulate more cost-effective and higher-quality care.

SUBMITTER: Shrank WH

PROVIDER: S-EPMC2683845 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial.

Shrank William H WH Choudhry Niteesh K NK Solomon Daniel H DH Snedden Thomas M TM Lee Thomas H TH Glynn Robert J RJ Brown Theresa V TV Jolda Caitlin C Spetman Michelle M Brookhart Maurice Alan MA Schneeweiss Sebastian S Avorn Jerry J

American heart journal 20090211 4

<h4>Background</h4>Highly effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related nonadherence.<h4>Objective</h4>We sought to assess an intervention to stimulate appropriate generic cardiovascular drug use without creating administrative or financial barriers that may impede essential medication use.<h4>Trial design</h4>The SAMPLES (Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based G ...[more]

PMID: 19332186

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Project description:Generic pharmaceuticals should have very little price dispersion. Economics' Law of One Price suggests that identical goods, in the absence of trade frictions and under conditions of free competition and price flexibility, should sell for the same price, and the FDA ensures that generics are identical. In this study, we examine whether generic pharmaceuticals indeed have the low price dispersion that theory predicts, and if not, whether the dispersion seen for pharmaceuticals used to treat neuropsychiatric conditions is substantially higher than that of other drugs. Such a difference may offer an explanation for the price dispersion seen: namely, a strategy that takes advantage of buyers' cognitive constraints and impaired ability to comparison shop. We thus assembled a list of generic pharmaceuticals and their prices using www.GoodRx.com, based on a convenience sample of the 5 most popular drugs for 10 common medical conditions listed there. Three neuropsychiatric diagnoses were used: Alzheimer's disease, depression and schizophrenia. Seven other diagnoses served as controls: asthma; diabetes mellitus-type II; high cholesterol; hypertension; osteoarthritis; osteoporosis; and urinary tract infection. For each drug, we identified the highest and lowest prices and calculated the mean, median and coefficient of variation (CV). We further calculated the ratios of the highest price to the median price and of the highest to lowest price. We found that the mean price CV was 43%. For neuropsychiatric drugs and controls, it was 61% and 35%, respectively. The mean high-to-median ratio was3.7 for neuropsychiatric drugs and 1.9 for controls. The mean high-to-low ratio was 5.9 for neuropsychiatric drugs and 2.8 for controls. In short, generic medications have high price dispersion, despite public availability of prices. Although our study did not examine why this price dispersion is present, the especially large high-to-low price ratio for neuropsychiatric medications suggests a strategy that exploits vulnerable patients.

Project description:BackgroundDiscarding pharmaceuticals in the garbage or into the sewage system are still the most common methods in many countries. This study aims to investigate the guidance provided by pharmacists to customers on the disposal of unused and expired household medications in São Paulo State, Brazil.MethodThe study population consisted of 630 pharmacists from the State of São Paulo, who work in community pharmacies. They answered an online questionnaire with questions composed in three blocks: demographic, work, and academic information on the pharmacist; guidance about the disposal of household medications; and knowledge regarding the reverse logistics of these medications. An invitation to participate in the questionnaire was made via WhatsApp, individually and collectively. Inferential statistics were performed using the chi-square test and were considered significant when p < 0.05%.ResultsAmong the participating pharmacists, the majority were women under 60 years old,56 (8.89%) stated that they never orient the customer regarding the disposal of unused and expired household medications, while 574 (91,12%) indicated that they almost provide guidance. The frequency with which they provided guidance was influenced by the number of years since graduation (p = 0.0047), the time they had worked in pharmacies and drugstores (p = 0.0007), and whether or not they had a graduate degree (p = 0.0181). Regarding the disposal of medications, among the 643 responses provided by the pharmacists,516 (80.25%) indicated that they oriented customers to return them to a pharmacy.ConclusionA small number of pharmacists always orient customers on the proper disposal that should be followed for unused and expired household medications, prioritizing their return to a pharmacy. In general, these pharmacists have longer periods of work experience and higher academic qualifications. Thus, it is important to increase knowledge through professional training and further education programs.

Project description:It is well-documented that the financial burden of out-of-pocket expenditures for prescription drugs often leads people with medication-sensitive chronic illnesses to restrict their use of these medications. Less is known about the extent to which such cost-related medication underuse is associated with increases in subsequent hospitalizations and deaths.We compared the risk of hospitalizations among 5401 and of death among 6135 middle-aged and elderly adults with one or more cardiovascular diseases (diabetes, coronary artery disease, heart failure, and history of stroke) according to whether participants did or did not report restricting prescription medications because of cost.A retrospective biannual cohort study across 4 cross-sectional waves of the Health and Retirement Study, a nationally representative survey of adults older than age 50. Using multivariate logistic regression to adjust for baseline differences in sociodemographic and health characteristics, we assessed subsequent hospitalizations and deaths between 1998 and 2006 for respondents who reported that they had or had not taken less medicine than prescribed because of cost.Respondents with cardiovascular disease who reported underusing medications due to cost were significantly more likely to be hospitalized in the next 2 years, even after adjusting for other patient characteristics (adjusted predicted probability of 47% compared with 38%, P < 0.001). The more survey waves respondents reported cost-related medication underuse during 1998 to 2004, the higher the probability of being hospitalized in 2006 (adjusted predicted probability of 54% among respondents reporting cost-related medication underuse in all 4 survey waves compared with 42% among respondents reporting no underuse, P < 0.001). There was no independent association of cost-related medication underuse with death.In this nationally representative cohort, middle-aged and elderly adults with cardiovascular disease who reported cutting back on medication use because of cost were more likely to report being hospitalized over a subsequent 2-year period after they had reported medication underuse. The more extensively respondents reported cost-related underuse over time, the higher their adjusted predicted probability of subsequent hospitalization.

Dataset Information

Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial.

Background

Objective

Trial design

Conclusion

Publications

Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial.

Similar Datasets

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