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generic drug

Pharmaceutical agent without Brand-name. Not protected by trade-mark. Epidemiology: - increase in adverse events seen (hospitalizations & emergency department visits) after switching from brand name ARB (valsartan, candesartan, losartan) to generic (17%) [15] Notes: - for a generic to be considered bioequivalent to a Brand-name drug, it must produce similar peak & overall blood levels - the difference in bioavailability between most bioequivalent products is usually < 4% [4] - other characteristics need NOT be the same: a) time to reach peak drug concentrations b) formulation c) release rate from the tablet or capsule - extended-release generics may cause clinician concerns [7] - generic extended-release metoprolol succinate may have different pharmacokinetics than Toprol-XL [7] - changes in pill color or shape with subsequent refills may cause patient concers & discontinuation of medication [8] - American College of Physician's recommends using generics when feasible [9] - generics may be associated with better medication compliance than brand name drugs [10,11] - prices for generic drug may vary 40-fold in one city [13] - when market competition drops, generic drug prices rise [14] - the cost of generic drugs may be lower when patients purchase medications directly from online suppliers & leave their insurance cards out of the equation [16] - the Mark Cuban Cost Plus Drug Company launched an online pharmacy in 2022 that sells common generic drugs at cost + 15% + $3 pharmacy fee + $5 shipping fee [17]

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pharmacology generic

References

  1. Prescriber's Letter 13(1): 2006 Detail-Document#: 220101 (subscription needed) http://www.prescribersletter.com
  2. Prescriber's Letter 13(9): 2006 Detail-Document#: 220901 (subscription needed) http://www.prescribersletter.com
  3. Prescriber's Letter 15(5): 2008 Timed-Release Generic Products: Are they Equivalent to the Brand Product? Detail-Document#: 240503 (subscription needed) http://www.prescribersletter.com
  4. Prescriber's Letter 15(7): 2008 Generic Drug Variability Detail-Document#: 240704 (subscription needed) http://www.prescribersletter.com
  5. Prescriber's Letter 16(1): 2009 CHART: Generic Substitution for Commonly Prescribed Drugs Detail-Document#: 250108 (subscription needed) http://www.prescribersletter.com
  6. Prescriber's Letter 16(10): 2009 Anticipated Availability of First-Time Generics Detail-Document#: 251011 (subscription needed) http://www.prescribersletter.com
  7. Orciari Herman A FDA Planning Study of Generic Metoprolol Over Safety, Efficacy Concerns. NEJM Journal Watch. May 9, 2014 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
  8. Kesselheim AS et al Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction: Cohort and Nested Case-Control Studies. Ann Intern Med. 2014;161(2):96-103 PMID: 25023248 http://annals.org/article.aspx?articleid=1887026
  9. Choudhry NK et al Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. Published online 24 November 2015 PMID: 26594818 http://annals.org/article.aspx?articleid=2471597
  10. Gagne JJ, Choudhry NK, Kesselheim AS et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-407 PMID: 25222387
  11. Gagne JJ, Kesselheim AS, Choudhry NK et al Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015 Nov;52(Pt A):14-8. PMID: 26386779
  12. Johansen ME, Richardson C Estimation of Potential Savings Through Therapeutic Substitution. JAMA Intern Med. Published online May 09, 2016 PMID: 27159226 http://archinte.jamanetwork.com/article.aspx?articleid=2520679 - Sharfstein JM, Greene J Promise and Peril for Generic Drugs JAMA Intern Med. Published online May 09, 2016 PMID: 27159885 http://archinte.jamanetwork.com/article.aspx?articleid=2520673 - Ross JS Therapeutic Substitution-Should It Be Systematic or Automatic? JAMA Intern Med. Published online May 09, 2016 PMID: 27158769 http://archinte.jamanetwork.com/article.aspx?articleid=2520675 - Kesselheim AS et al Prevalence and Predictors of Generic Drug Skepticism Among Physicians. Results of a National Survey. JAMA Intern Med. Published online May 09, 2016 PMID: 27158897 http://archinte.jamanetwork.com/article.aspx?articleid=2520676 - Patel MS et al Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. Published online May 09, 2016 PMID: 27159011 http://archinte.jamanetwork.com/article.aspx?articleid=2520677
  13. Hauptman PJ, Goff ZD, Vidic A et al Variability in Retail Pricing of Generic Drugs for Heart Failure. JAMA Intern Med. Published online November 15, 2016. PMID: 27846638 http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2582937
  14. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High generic drug prices and market competition: A retrospective cohort study. Ann Intern Med 2017 Jul 4; PMID: 28672324
  15. Leclerc J, Blais C, Rochette L, Hamel D, Guenette L, Poirier P. Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada. A Population-Based Time Series Analysis. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e003891. Published October 3, 2017 PMID: 28974512 http://circoutcomes.ahajournals.org/content/10/10/e003891 - Alter DA When Do We Decide That Generic and Brand-Name Drugs Are Clinically Equivalent? Perfecting Decisions With Imperfect Evidence. Circulation: Cardiovascular Quality and Outcomes. 2017; 10:e004158. Published October 3, 2017 PMID: 28974513 http://circoutcomes.ahajournals.org/content/10/10/e004158
  16. NEJM JWatch Editors Medication Prices Often Lower Without Insurance Physician's First Watch, Dec 11, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Ornstein C, Thomas K Prescription Drugs May Cost More With Insurance Than Without It. New York Times. Dec 9, 2017 https://www.nytimes.com/2017/12/09/health/drug-prices-generics-insurance.html
  17. Lalani HS, Kesselheim AS, Rome BN. Potential Medicare Part D savings on generic drugs from the Mark Cuban Cost Plus Drug Company. Ann Intern Med 2022 Jun 21 PMID: 35724381 https://www.acpjournals.org/doi/10.7326/M22-0756