Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: Cohortand nested case-control studies

Annals of Internal Medicine

Volumn 161, Issue 2, 2014, Pages 96-103

  Kesselheim, Aaron S ^a   Bykov, Katsiaryna ^a   Avorn, Jerry ^a   Tong, Angela ^a   Doherty, Michael ^a   Choudhry, Niteesh K ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARDIOVASCULAR AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; GENERIC DRUG; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ADULT; AGE; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CASE CONTROL STUDY; COHORT ANALYSIS; COLOR; CONTROLLED STUDY; DRUG USE; FEMALE; HEALTH INSURANCE; HEART INFARCTION; HOSPITAL DISCHARGE; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PHYSICAL PARAMETERS; PILL; PILL APPEARANCE; PILL COLOR; PILL SHAPE; PRESCRIPTION; PRIORITY JOURNAL; SEX; UNITED STATES;

ADRENERGIC BETA-ANTAGONISTS; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CARDIOVASCULAR AGENTS; CASE-CONTROL STUDIES; COHORT STUDIES; DRUGS, GENERIC; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MEDICATION ADHERENCE; MYOCARDIAL INFARCTION;

EID: 84904402832     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M13-2381     Document Type: Article

References (43)

1. Haas JS, Phillips KA, Gerstenberger EP, Seger AC. Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997-2000. Ann Intern Med. 2005;142:891-7. [PMID: 15941695]
2. Nightingale SL. Therapeutic equivalence of generic drugs: letter to health practitioners. U.S. Food and Drug Administration. 28 January 1998. Accessed at www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm on 16 January 2014.
3. Boh M, Opolski G, Poredos P, Ceska R, Jezovnik M. Therapeutic equivalence of the generic and the reference atorvastatin in patients with increased coronary risk. Int Angiol. 2011;30:366-74. [PMID: 21747355]
4. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300:2514-26. [PMID: 19050195]
5. Shrank WH, Choudhry NK, Liberman JN, Brennan TA. The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money. Health Aff (Millwood). 2011;30:1351-7. [PMID: 21734210]
6. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007;298:61-9. [PMID: 17609491] (Pubitemid 47026771)
7. Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, et al. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006;166:1836-41. [PMID: 17000939] (Pubitemid 44455165)
8. Colivicchi F, Bassi A, Santini M, Caltagirone C. Discontinuation of statin therapy and clinical outcome after ischemic stroke. Stroke. 2007;38:2652-7. [PMID: 17761916] (Pubitemid 47493999)
9. Green JB, Ross JS, Jackevicius CA, Shah ND, Krumholz HM. When choosing statin therapy: the case for generics. JAMA Intern Med. 2013;173:229-32. [PMID: 23303273]
10. Dicken JE. Drug Pricing: Research on Savings from Generic Drug Use (GAO-12-371R). Washington, DC: U.S. Government Accountability Office; 2012. Accessed at www.gao.gov/assets/590/588064.pdf on 16 January 2014.
11. Greene JA, Kesselheim AS. Why do the same drugs look different? Pills, trade dress, and public health. N Engl J Med. 2011;365:83-9. [PMID: 21732842]
12. Cutler C, Kesselheim A, Gabardi S, Andersson BS, Carpenter P, Khoury HJ, et al American Society of Blood and Marrow Transplantation. Generic immunosuppressants in hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2011;17:285-90. [PMID: 21087678]
13. Engelberg AB. The case for standardizing the appearance of bioequivalent medications. J Manag Care Pharm. 2011;17:321-3. [PMID: 21534643]
14. Faasse K, Cundy T, Gamble G, Petrie KJ. The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects. Psychosom Med. 2013;75:90-6. [PMID: 23115341]
15. Roullet B, Droulers O. Pharmaceutical packaging color and drug expectancy. Advances in Consumer Research. 2005;32:164-71.
16. 60 Minutes. Glaxo whistle-blower lawsuit: bad medicine. CBS News. 29 December 2010. Accessed at www.cbsnews.com/stories/2010/12/29/60minutes/ main7195247-page2.shtml on 16 January 2014.
17. Kenagy JW, Stein GC. Naming, labeling, and packaging of pharmaceuticals. Am J Health Syst Pharm. 2001;58:2033-41. [PMID: 11715825] (Pubitemid 33043387)
18. World Health Organization. Adherence to Long-Term Therapies: Evidence for Action. Geneva: World Health Organization; 2003. Accessed at www.who.int/chp/knowledge/publications/adherence-introduction.pdf on 16 January 2014.
19. Cutler DM, Everett W. Thinking outside the pillbox - medication adherence as a priority for health care reform. N Engl J Med. 2010;362:1553-5. [PMID: 20375400]
20. Kesselheim AS, Misono AS, Shrank WH, Greene JA, Doherty M, Avorn J, et al. Variations in pill appearance of antiepileptic drugs and the risk of nonadherence. JAMA Intern Med. 2013;173:202-8. [PMID: 23277164]
21. Kronish IM, Ye S. Adherence to cardiovascular medications: lessons learned and future directions. Prog Cardiovasc Dis. 2013;55:590-600. [PMID: 23621969]
22. Akincigil A, Bowblis JR, Levin C, Jan S, Patel M, Crystal S. Long-term adherence to evidence based secondary prevention therapies after acute myocardial infarction. J Gen Intern Med. 2008;23:115-21. [PMID: 17922172] (Pubitemid 351222564)
23. Fischer MA, Choudhry NK, Brill G, Avorn J, Schneeweiss S, Hutchins D, et al. Trouble getting started: predictors of primary medication nonadherence. Am J Med. 2011;124:1081. [PMID: 22017787]
24. Brookhart MA, Patrick AR, Schneeweiss S, Avorn J, Dormuth C, Shrank W, et al. Physician follow-up and provider continuity are associated with long-term medication adherence: a study of the dynamics of statin use. Arch Intern Med. 2007;167:847-52. [PMID: 17452550] (Pubitemid 46658345)
25. Choudhry NK, Fischer MA, Avorn J, Liberman JN, Schneeweiss S, Pakes J, et al. The implications of therapeutic complexity on adherence to cardiovascular medications. Arch Intern Med. 2011;171:814-22. [PMID: 21555659]
26. Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007;297:177-86. [PMID: 17213401] (Pubitemid 46089734)
27. Ho PM, Magid DJ, Masoudi FA, McClure DL, Rumsfeld JS. Adherence to cardioprotective medications and mortality among patients with diabetes and ischemic heart disease. BMC Cardiovasc Disord. 2006;6:48. [PMID: 17173679]
28. Ho PM, Magid DJ, Shetterly SM, Olson KL, Maddox TM, Peterson PN, et al. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008;155:772-9. [PMID: 18371492] (Pubitemid 351410514)
29. Choudhry NK, Avorn J, Glynn RJ, Antman EM, Schneeweiss S, Toscano M, et al Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial. Full coverage for preventive medications after myocardial infarction. N Engl J Med. 2011;365:2088-97. [PMID: 22080794]
30. Shah ND, Dunlay SM, Ting HH, Montori VM, Thomas RJ, Wagie AE, et al. Long-term medication adherence after myocardial infarction: experience of a community. Am J Med. 2009;122:961. [PMID: 19560749]
31. Smith DH, Kramer JM, Perrin N, Platt R, Roblin DW, Lane K, et al. A randomized trial of direct-to-patient communication to enhance adherence to β-blocker therapy following myocardial infarction. Arch Intern Med. 2008;168:477-83. [PMID: 18332291] (Pubitemid 351547210)
32. Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11:44-7. [PMID: 18237359] (Pubitemid 351160875)
33. Petersen LA, Wright S, Normand SL, Daley J. Positive predictive value of the diagnosis of acute myocardial infarction in an administrative database. J Gen Intern Med. 1999;14:555-8. [PMID: 10491245] (Pubitemid 29441635)
34. Gagne JJ, Glynn RJ, Avorn J, Levin R, Schneeweiss S. A combined comorbidity score predicted mortality in elderly patients better than existing scores. J Clin Epidemiol. 2011;64:749-59. [PMID: 21208778]
35. Biron P, Carignan R. Chromoconfusion: a new type of pill-pill "interaction" in cardiology. Can Med Assoc J. 1974;110:1346-7. [PMID: 4834524]
36. Cohen M. Pill description on pharmacy label adds measure of safety. Philly.com. 8 August 2011. Accessed at www.philly.com/philly/blogs/healthcare/- Pill-Description-on-Pharmacy-Label-Adds-Measure-of-Safety-.html on 16 January 2014.
37. Consumer Reports. A closer look at prescription bottle labels. June 2011. Accessed at www.consumerreports.org/health/best-buy-drugs/prescription-labels/ bottle-pictures/index.htm on 16 January 2014.
38. Sundar RP, Becker MW, Bello NM, Bix L. Quantifying age-related differences in information processing behaviors when viewing prescription drug labels. PLoS One. 2012;7:e38819. [PMID: 22719955]
39. Yu LX, Geba GP. Generic pills from the patient perspective: dressed for success? JAMA Intern Med. 2013;173:208-9. [PMID: 23277345]
40. Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j)(4)(H)(ii) (2013).
41. Center for Drug Evaluation and Research. Draft Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. Silver Springs, MD: U.S. Food and Drug Administration; 2013. Accessed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM377938.pdf on 16 January 2014.
42. Choudhry NK, Fischer MA, Avorn J, Liberman JN, Schneeweiss S, Pakes J, et al. The implications of therapeutic complexity on adherence to cardiovascular medications. Arch Intern Med. 2011;171:814-22. [PMID: 21555659]
43. Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001;104:2746-53. [PMID: 11723030] (Pubitemid 33108145)