The backlash against bioequivalence and the interchangeability of brand-name and generic drugs

CMAJ. Canadian Medical Association Journal

Volumn 183, Issue 12, 2011, Pages 1350-1351

  Kesselheim, Aaron S ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; GENERIC DRUG; IMMUNOSUPPRESSIVE AGENT;

BIOEQUIVALENCE; CANADA; DRUG COST; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG MARKETING; DRUG SAFETY; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW; MEDICAL SOCIETY; NOTE; PATIENT COMPLIANCE; PHARMACIST; PRESCRIPTION; UNITED STATES;

EID: 80052540900     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.110808     Document Type: Note

References (14)

1. Shrank W.H., Asch S.M., Joseph G.J., et al. The implications of choice: prescribing generic or preferred pharmaceuticals im - Proves medication adherence for chronic conditions. Arch Int Med 2006;166:332-337 (Pubitemid 43244321)
2. Reiffel J.A., Kowey P.R. Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias. Am J Cardiol 2000;85:1151-1153 (Pubitemid 30214268)
3. Kesselheim A.S., Misono A.S., Lee J.L., et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: A systematic review and meta-analysis. JAMA 2008;300:2514-2526
4. Liow K., Barkley G.L., Pollard J.D., et al. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology 2007;68:1249-1250 (Pubitemid 46625968)
5. Eban K. Bad bargain? Self 2009 June. Available: www.self .com /health /2009/06/dangers-of-generic-drugs?currentPage=1 (accessed 2011 May 18).
6. Huckman M. Pfizer's Lipitor vs. generics: heart of the matter for me. CNBC. 2007 Oct. 29. Available: www.cnbc.com/id /21528009 (accessed 2011 May 18).
7. Davit B.M., Nwakama P.E., Buehler G.J., et al. Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 2009;43:1583-1597
8. Duh M.S., Paradis P.E., Latrémouille-Viau D., et al. The risks and costs of multiple-generic substitution of topiramate. Neurology 2009; 72:2122-2129
9. Devine S.T., Weisbart E., Barron J., et al. Acute epilepsy exacerbations in patients switched between A-rated anti-epileptic drugs. Curr Med Res Opin 2010;26:455-463
10. Tsadok M.A., Jackevicius C.A., Rahme E. Amiodarone-induced thyroid dysfunction: Brand-name versus generic formulations. CMAJ 2011;183:E817-E823
11. Condition-specific drug substitution legislation: epilepsy. Denver (CO) and Wshington (DC): National Conference of State Leg - islatures; 2011. Available: www.ncsl.org /default. aspx ?tabid =14424 (accessed 2011 May 18).
12. Hamburg MA. Information regarding anti-epileptic drugs: U.S. Food and Drug Administration in response to requests in Senate Report No. 111-39 and House Agricultural Committee Report No. 111-279. Available: www.hpm .com /pdf/FDA %20 Anti %20Epileptic%20Drug%20Report%20to%20Congress%20-% 20 2011.pdf (accessed 2011 May 18).
13. PrescriptionSolutions. Survey: nearly one-third don't know or believe generics have same active ingredients and effectiveness as brand-name drugs. 2009 June 22. Available: www .prescriptionsolutions .com /RxSolWeb /mvc /staticContent .do ?page URL = /rxsol /chp /rxsolutions -com /consumer /about-us /press -release /20090625 -generics .html (accessed 2011 June 22).
14. Shrank W.H., Liberman J.N., Fischer M.A., et al. The consequences of requesting "dispense as written." Am J Med 2011;124:309-317