Formulation substitution: A frequently overlooked variable in cardiovascular drug management

Progress in Cardiovascular Diseases

Volumn 47, Issue 1, 2004, Pages 3-10

  Reiffel, James A ^a,b,c  

^a Columbia Univ Coll Phys Surgs ^*  (United States)

^b NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^c 161 Fort Washington Ave ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ANTIARRHYTHMIC AGENT; ANTICONVULSIVE AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARBAMAZEPINE; CYCLOSPORIN A; DIGITALIS; DIGOXIN; DISOPYRAMIDE; FLECAINIDE; MEXILETINE; PHENYTOIN; PROCAINAMIDE; PROPAFENONE; PSYCHOTROPIC AGENT; QUINIDINE; SOTALOL; WARFARIN;

AWARENESS; BIOEQUIVALENCE; BLEEDING; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; DEFIBRILLATOR; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG SAFETY; EXPERIENCE; FOOD AND DRUG ADMINISTRATION; FREQUENCY ANALYSIS; GOVERNMENT; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART VENTRICLE ARRHYTHMIA; HEART VENTRICLE TACHYCARDIA; HUMAN; PATIENT MONITORING; PHYSICIAN; PRACTICE GUIDELINE; RECURRENT DISEASE; REVIEW; SEIZURE; SUBSTITUTION THERAPY; SUPRAVENTRICULAR TACHYCARDIA; TACHYCARDIA; TREATMENT OUTCOME;

EID: 7044233384     PISSN: 00330620     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pcad.2004.04.002     Document Type: Article

References (45)

1. Anonymous. Generic drugs. Med Lett. 41:1998;47-48
2. Dighe S.V. A review of the safety of generic drugs. Transplant Proc. 31:(Suppl 3A):1999;23S-24S
3. Benditt D.G. Generic antiarrhythmic drugs What constitutes equivalency? J Interv Card Electrophysiol. 3:1999;145-147
4. Benet L.Z., Goyan J.E. Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy. 15:1995;433-440
5. Sabatini S., Ferguson R.M., Helderman J.H., et al. Drug substitution in transplantation A National Kidney Foundation white paper. Am J Kidney Dis. 33:1999;389-397
6. Colaizzi J.L., Lowenthal D.T. Critical therapeutic categories A contraindication to generic substitution? Clin Ther. 8:1986;370-379
7. Reiffel J.A. Formulation substitution and other pharmacokinetic variability Under appreciated variables affecting antiarrhythmic efficacy and safety in clinical practice. Am J Cardiol. 85:2000;46D-52D
8. Vasquez E.M., Min D.I. Transplant pharmacist's opinions on generic product selection of critical-dose drugs. Am J Health Syst Pharm. 56:1999;615-621
9. Meredith P.A. Generic drugs Therapeutic equivalence. Drug Safety. 15:1986;233-242
10. American Academy of Neurology. Assessment Generic substitution for antiepileptic medication. Neurology. 40:1990;1641-1643
11. Wittowsky A.K. Generic warfarin Implications for patient care. Pharmacotherapy. 17:1997;640-643
12. Kahan Bad. Considerations concerning generic formulation of immunosuppressive drugs. Transplant Proc. 31:1999;1635-1641
13. Anonymous. Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug application; clarification - FDA. Clarification. Fed Reg. 62:1997;63268-63269
14. Benet L.Z. Understanding bioequivalence testing. Transplant Proc. 31:(Suppl 3A):1999;75-95
15. Nightingale S.L., Morrison J.C. Generic drugs and the prescribing physician. [published erratum appears in JAMA 259:1650, 1988] JAMA. 258:1987;1200-1204
16. Rheinstein P.H. The generic drug approval process. Am Family Phys. 48:1993;1357-1360
17. Meyer M.C. Generic drug product equivalence Current status. Am J Managed Care. 4:1997;1183-1189
18. Henny J.E. From the Food and Drug Administration Review of generic bioequivalence studies. JAMA. 282:1999;1995
19. Meyer G.F. History and regulatory issues of generic drugs. Transplant Proc. 31:(Suppl 3A):1999;10S-12S
20. Banahan B.F., Kolassa E.M. A physician survey on generic drugs and substitution of critical dose medications. Arch Intern Med. 157:1997;2080-2088
21. Anonymous. Physicians are concerned about generic drug bioequivalence, but often unaware of FDA standards. Am J Health Syst Pharm. 54:1997;2799-2800
22. Anonymous. Revocation of Office of Generic Drug's interim policy statement on inactive ingredients Food and Drug Administration, HHS Notice. Fed Reg. 64:1999;23340-23341
23. Rheinstein P.H. The generic drug approval process. Am Family Physician. 48:1993;1357-1360
24. Approved drug products with therapeutic equivalence evaluations. 10th ed.:1999;DHHS/Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD
25. Pidgen A. Bioequivalence and generic prescribing An industrial view. J Pharm Pharmacol. 48:1996;11-16
26. American Home Products Corporation: Wyeth Ayerst files citizen petition for Cordarone: Cites inadequate bioequivalence studies. July 23, 1998. Available from http://www.ahp.com/release/ahp-072398c.htm
27. Meng X., Mojaverian M.X., Doedee M., et al. Bioavailability of amiodarone tablets administered with and without food in healthy subjects. Am J Cardiol. 87:2001;432-435
28. Nuwer M.R., Browne T.R., Dosdon W.E., et al. Generic substitution for antiepileptic drugs. Neurology. 40:1990;1647-1651
29. Kasmer R.J., Nara A.R., Green J.A., et al. Comparable steady-state bioavailability between two preparations of conventional-release procainamide hydrochloride. Drug Intell Clin Pharm. 21:1987;183-186
30. Hilleman D.E., Patterson A.J., Mohiuddin S.M., et al. Comparative bioequivalence and efficacy of two sustained-release procainamide formulations inpatient with cardiac arrhythmias. Drug Intell Clin Pharm. 22:1988;554-558
31. Grubb B.P. Recurrence of ventricular tachycardia after conversion from proprietary to generic procainamide. Am J Cardiol. 63:1989;1532-1533
32. Ozahowski T.P., Greenberg M.I., Mock R.P. Clinical inequivalence of generic and brand name type IA antiarrhythmic drugs. [abstract] Pace. 21:1998;809
33. Reiffel J.A., Kowey P.R. Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias. Am J Cardiol. 85:2000;1151-1152
34. Hendeles L., Hochhaus G., Kazerouniun S. Generic and alternative brand name pharmaceutical equivalent Select with caution. Am J Hosp Pharm. 50:1993;323-329
35. Parker R.E., Martinez D.R., Covington T.R. Drug product selection - Part 3 The Orange Book. Am Pharm NS. 31:1991;47-57
36. Approved drug products with therapeutic equivalence evaluations. 13th ed.:1993;Food and Drug Administration, Center for Drugs and Biologics, Washington, DC
37. Reiffel J.A. Is it rationale, reasonable or excessive, and consistently applied? One view of the increasing FDA emphasis on safety first for the release and use of antiarrhythmic drugs for supraventricular arrhythmias. J Cardiovasc Pharmacol Ther. 6:2001;333-339
38. Reiffel J.A. Issues in the use of generic antiarrhythmic drugs. Curr Opin Cardiol. 16:2001;23-29
39. Schwab M., Oetzel C., Morike K., et al. Using trade names. A risk factor for accidental drug overdose. Arch Intern Med. 162:2002;1065-1066
40. Richton-Hewett S., Foster E., Apstein C.S. Medical and economic consequences of a blinded oral anticoagulant brand change at a municipal hospital. Arch Intern Med. 148:1988;806-808
41. Vasquez E.M., Min D.I. Transplant pharmacists' opinions on generic product selection of critical-dose drugs. Am J Health Syst Pharm. 56:1999;615-621
42. Kahan B.A.D. Recommendations concerning the introduction of generic formulations of cyclosporine. Transplant Proc. 31:1999;1634. discussion 1675-1684
43. Diamond B.I., Albrecht J.W. Medical and psychiatric implications of generic drugs. Psychopathology. 1:1987;92-98
44. Herxheimer A. Drug selection and information Some recommendations from the World Health Organization. J R Coll Physicians of London. 27:1993;384-385
45. Vercaigne L.M., Zhanel G.C. Clinical significance of bioequivalence and interchangeability of narrow therapeutic range drugs Focus on warfarins. J Pharm Pharm Sci. 1:1998;92-94