Prescription drug product substitution decision support

Journal of the American Pharmacists Association

Volumn 47, Issue 3, 2007, Pages 328-347

  Manolakis, Patti Gasdek ^a  

^a PMM Consulting LLC   (United States)

Author keywords

Bioequivalence; Co payments; Communication; Food and drug administration; Managed care; Narrow therapeutic index drugs; Patients; Physicians; Prescribers; Substitution (generic); Substitution (therapeutic); Technology

Indexed keywords

DRUG; GENERIC DRUG;

ARTICLE; DECISION SUPPORT SYSTEM; HUMAN; PHARMACIST; PHARMACOKINETICS;

DECISION SUPPORT TECHNIQUES; DRUGS, GENERIC; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACISTS; THERAPEUTIC EQUIVALENCY;

EID: 34548245113     PISSN: 15443191     EISSN: 15443450     Source Type: Journal    
DOI: 10.1331/JAPhA.2007.07502     Document Type: Article

References (18)

1. Generic Pharmaceutical Association. Statistics. Available at: www.gphaonline.org/Content/NavigationMenu/AboutGenerics/Statistics/default.htm. Accessed January 16, 2007.
2. American Pharmaceutical Association. Substitution of Critical Dose Drugs: Issues, Analysis, and Decision Making. 2000. Available at: www.pharmacist.com/ pdf/critical-dose.pdf. Accessed October 12, 2006.
3. Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 26th ed. Cumulative Supplement 12. December 2006;viii-ix. Available at: www.fda.gov/cder/orange/obcs.pdf. Accessed January 16, 2007.
4. Food and Drug Administration. Frequently Asked Questions About Therapeutic Biological Products. Available at: www.fda.gov/cder/biologics/qa. htm. Accessed November 2, 2006.
5. Food and Drug Administration. U.S. FDA Considerations: Discussion by National Regulatory Authorities With World Health Organization (WHO) on Possible International Non-proprietary Name (INN) Policies for Biosimilars. September 1, 2006.
6. Food and Drug Administration. FDA Guidance Concerning Demonstration of Comparability of Human Biological Products Including Therapeutic Biotechnology-Derived Products. Available at: www.fda.gov/cder/guidance/compare. htm. Accessed November 2, 2006.
7. Thames WA, Smith SL, Scheifele AC, et al. Evaluation of the U.S. Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 μg every 2 weeks in both naive patients and patients switched from epoetin alfa. Pharmacotherapy. 2004;24:313-23.
8. Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 26th ed. 2006;iii-xxii, 2-1. Available at: www.fda.gov/cder/orange/obannual.pdf. Accessed August 14, 2006, to January 16, 2007.
9. Food and Drug Administration. Guidance for FDA Staff and Industry: Marketing Unapproved Drugs - Compliance Policy Guide. June 2006. Available at: www.fda.gov/cder/guidance/6911fnl.pdf. Accessed October 22, 2006.
10. Food and Drug Administration. Questions and Answers on the Unapproved Drug Compliance Policy Guide. 2003. Available at: www.fda.gov/cder/compliance/ CPG-QandA.htm. Accessed October 23, 2006.
11. Food and Drug Administration. Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products - Submitting NDAs. April 28, 2004. Available at: www.fda.gov/cder/guidance/6275fnl.pdf. Accessed December 2, 2006.
12. Exocrine Pancreatic Insufficiency Drug Products: Draft Guidance for Submitting NDAs, Notices, 69 Federal Register 23410-4 (2004).
13. Food and Drug Administration. Questions and Answers on Pancreatic Insufficiency Drug Products. April 27, 2004. Available at: www.fda.gov/cder/ drug/infopage/pancreatic-drugs/pancreatic-QA.htm. Accessed October 17, 2006.
14. Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. Electronic Orange Book. Available at: www.fda.gov/cder/ob. Accessed November 17, 2006, to January 16, 2007, to conduct active ingredient queries.
15. Food and Drug Administration. FDA Ensures Equivalence of Generic Drugs. 2003. Available at: www.fda.gov/cder/consumerinfo/generic-equivalence.htm. Accessed January 16, 2007.
16. Food and Drug Administration. Facts About Generic Drugs. 2006. Available at: www.fda.gov/cder/consumerinfo/generic-FactsAbout-text.htm. Accessed January 16, 2007.
17. Food and Drug Administration. Generic Drugs: What Everyone Should Know. 2005. Available at: www.fda.gov/cder/consumerinfo/generic-what-everyone-should- know.htm. Accessed January 16, 2007.
18. Wisniewski L, Holquist C. The absence of a trade name does not equal a generic drug. Drug Topics. October 10, 2005;52.Available at: www.fda.gov/cder/drug/MedErrors/no-tradename.pdf. Accessed January 5, 2007.