Rationale and Design of the Study Assessing the Effect of Cardiovascular Medications Provided As Low-cost, Evidence-based Generic Samples (SAMPLES) Trial

Overview

Journal Am Heart J

Specialty Cardiology & Vascular Diseases

Date 2009 Apr 1

PMID 19332186

Citations 2

Authors

William H Shrank

Niteesh K Choudhry

Daniel H Solomon

Thomas M Snedden

Thomas H Lee

Robert J Glynn

Theresa V Brown

Caitlin Jolda

Michelle Spetman

Maurice Alan Brookhart

Sebastian Schneeweiss

Jerry Avorn

Affiliations

Soon will be listed here.

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.

Citing Articles

Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial.

Oyler D, Westgate P, Walsh S, Dolly Prothro J, Miller C, Roberts M BMC Oral Health. 2024; 24(1):414.

PMID: 38575929 PMC: 10996080. DOI: 10.1186/s12903-024-04201-0.

The effect of medication samples on self-reported prescribing practices: a statewide, cross-sectional survey.

Pinckney R, Helminski A, Kennedy A, MacLean C, Hurowitz L, Cote E J Gen Intern Med. 2010; 26(1):40-4.

PMID: 20809157 PMC: 3024102. DOI: 10.1007/s11606-010-1483-x.

References

Fischer M, Avorn J . Economic implications of evidence-based prescribing for hypertension: can better care cost less?. JAMA. 2004; 291(15):1850-6. DOI: 10.1001/jama.291.15.1850. View

Shrank W, Joseph G, Choudhry N, Young H, Ettner S, Glassman P . Physicians' perceptions of relevant prescription drug costs: do costs to the individual patient or to the population matter most?. Am J Manag Care. 2006; 12(9):545-51. View

Doherty R . Assessing the new medicare prescription drug law. Ann Intern Med. 2004; 141(5):391-5. DOI: 10.7326/0003-4819-141-5-200409070-00100. View

Choudhry N, Patrick A, Antman E, Avorn J, Shrank W . Cost-effectiveness of providing full drug coverage to increase medication adherence in post-myocardial infarction Medicare beneficiaries. Circulation. 2008; 117(10):1261-8. PMC: 2722033. DOI: 10.1161/CIRCULATIONAHA.107.735605. View

Adair R, Holmgren L . Do drug samples influence resident prescribing behavior? A randomized trial. Am J Med. 2005; 118(8):881-4. DOI: 10.1016/j.amjmed.2005.02.031. View

Jackevicius C, Mamdani M, Tu J . Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002; 288(4):462-7. DOI: 10.1001/jama.288.4.462. View

. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994; 344(8934):1383-9. View

Chobanian A, Bakris G, Black H, Cushman W, Green L, Izzo Jr J . The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003; 289(19):2560-72. DOI: 10.1001/jama.289.19.2560. View

Boltri J, Gordon E, Vogel R . Effect of antihypertensive samples on physician prescribing patterns. Fam Med. 2002; 34(10):729-31. View

10.

Scott A, Culley E, ODonnell J . Effects of a physician office generic drug sampling system on generic dispensing ratios and drug costs in a large managed care organization. J Manag Care Pharm. 2007; 13(5):412-9. PMC: 10437434. DOI: 10.18553/jmcp.2007.13.5.412. View

11.

Brewer D . The effect of drug sampling policies on residents' prescribing. Fam Med. 1998; 30(7):482-6. View

12.

McGlynn E, Asch S, Adams J, Keesey J, Hicks J, DeCristofaro A . The quality of health care delivered to adults in the United States. N Engl J Med. 2003; 348(26):2635-45. DOI: 10.1056/NEJMsa022615. View

13.

Haas J, Phillips K, Gerstenberger E, Seger A . Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997-2000. Ann Intern Med. 2005; 142(11):891-7. DOI: 10.7326/0003-4819-142-11-200506070-00006. View

14.

Jones P, Davidson M, Stein E, Bays H, McKenney J, Miller E . Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am J Cardiol. 2003; 92(2):152-60. DOI: 10.1016/s0002-9149(03)00530-7. View

15.

. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002; 106(25):3143-421. View

16.

Kohl H, Shrank W . Increasing generic drug use in Medicare Part D: the role of government. J Am Geriatr Soc. 2007; 55(7):1106-9. DOI: 10.1111/j.1532-5415.2007.01286.x. View

17.

Schneeweiss S, Patrick A, MacLure M, Dormuth C, Glynn R . Adherence to statin therapy under drug cost sharing in patients with and without acute myocardial infarction: a population-based natural experiment. Circulation. 2007; 115(16):2128-35. DOI: 10.1161/CIRCULATIONAHA.106.665992. View

18.

Goldman D, Joyce G, Zheng Y . Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007; 298(1):61-9. PMC: 6375697. DOI: 10.1001/jama.298.1.61. View

19.

Avorn J, Soumerai S . Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing". N Engl J Med. 1983; 308(24):1457-63. DOI: 10.1056/NEJM198306163082406. View

20.

Fischer M, Schneeweiss S, Avorn J, Solomon D . Medicaid prior-authorization programs and the use of cyclooxygenase-2 inhibitors. N Engl J Med. 2004; 351(21):2187-94. DOI: 10.1056/NEJMsa042770. View