A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study

BMC Pharmacology and Toxicology

Volumn 14, Issue , 2013, Pages

  Dunne, Suzanne ^a   Shannon, Bill ^a   Dunne, Colum ^a   Cullen, Walter ^a  

^a UNIVERSITY OF LIMERICK   (Ireland)

Author keywords

Biosimilar; Drug; Economics; Generic; Healthcare; Ireland; Medicine; Pharmaceutical; Prescribing

Indexed keywords

GENERIC DRUG;

BIOEQUIVALENCE; CLINICAL TRIAL (TOPIC); COST; DRUG COST; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; EUROPE; GOOD MANUFACTURING PRACTICE; HEALTH CARE POLICY; HEALTH ECONOMICS; HUMAN; IRELAND; PATIENT SAFETY; PRESCRIPTION; PUBLIC HEALTH SERVICE; REVIEW; UNITED STATES; ANIMAL; DRUG CONTROL; ECONOMICS; EUROPEAN UNION;

ANIMALS; COSTS AND COST ANALYSIS; DRUG AND NARCOTIC CONTROL; DRUGS, GENERIC; EUROPE; EUROPEAN UNION; HUMANS; UNITED STATES;

MLCS; MLOWN;

EID: 84879832854     PISSN: 20506511     EISSN: None     Source Type: Journal    
DOI: 10.1186/2050-6511-14-1     Document Type: Review

References (131)

1. Generic Drugs http://www.who.int/trade/glossary/story034/en/index.html.
2. Birkett DJ. Generics - equal or not?. Aust Prescr 2003, 26(4):85-87.
3. FDA basics - Drugs http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192696.htm.
4. Approval of Generic Drugs http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm127615.pdf.
5. Understanding Generic Drugs http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm.
6. Hatch-Waxman Act summary [Drug Price Competition and Patent Term Restoration Act of 1984] http://thomas.loc.gov/cgi-bin/bdquery/z?d098:SN01538:@@@L&summ2=m&.
7. Office of Generic Drugs presentation http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM226568.pdf.
8. Generic Drugs: Overview of ANDA Review Process http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.pdf.
9. Simoens S. International comparison of generic medicine prices. Curr Med Res Opin 2007, 23(11):2647-2654. 10.1185/030079907X233395, 17877848.
10. What Are Generic Drugs? http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm.
11. US-FDA Guidance for Industry - Bioavailability and Bioequivalence. FDA Guidances for Industry US-FDA.
12. Process for Approving Generic Drugs http://www.fda.gov/Training/ForHealthProfessionals/ucm090215.htm.
13. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008, 300(21):2514-2526. 10.1001/jama.2008.758, 2713758, 19050195.
14. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J. 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(10):1583-1597. 10.1345/aph.1M141, 19776300.
15. Patel V, Cordato DJ, Dias M, Beran RG. Changed constitution without change in brand name-the risk of generics in epilepsy. Epilepsy Res 2012, 98(2-3):269-272.
16. EMA Q&A on Generic Medicine http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/11/WC500012382.pdf.
17. EU Authorisation Procedures http://ec.europa.eu/health/authorisation-procedures_en.htm.
18. The Centralised Procedure http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm.
19. The Mutual Recognition Procedure http://ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm.
20. The Decentralised Procedure http://ec.europa.eu/health/authorisation-procedures-decentralised_en.htm.
21. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0083:EN:HTML.
22. Notice to Applicants Volume 2A Procedures for marketing authorisation http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2005-11_en.pdf.
23. Marketing Authorisation Process for Generic Medicines http://198.170.119.137/gen-authorisation.htm.
24. Committee For Medicinal Products For Human Use Guideline on the Investigation of Bioequivalence. European Medicines Agency website 2010, European Medicines Agency, Committee For Medicinal Products For Human Use.
25. McGinn D, Godman B, Lonsdale J, Way R, Wettermark B, Haycox A. Initiatives to enhance the quality and efficiency of statin and PPI prescribing in the UK: impact and implications. Expert Rev Pharmacoecon Outcomes Res 2010, 10(1):73-85. 10.1586/erp.09.73, 20121565.
26. Dylst P, Vulto A, Simoens S. The impact of reference-pricing systems in Europe: a literature review and case studies. Expert Rev Pharmacoecon Outcomes Res 2011, 11(6):729-737. 10.1586/erp.11.70, 22098289.
27. Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, Garuoliene K, Herholz H, Joppi R, Kalaba M, et al. Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications. Expert Rev Pharmacoecon Outcomes Res 2010, 10(6):707-722. 10.1586/erp.10.72, 21155704.
28. Puig-Junoy J. Impact of European pharmaceutical price regulation on generic price competition: a review. PharmacoEconomics 2010, 28(8):649-663. 10.2165/11535360-000000000-00000, 20515079.
29. Godman B, Shrank W, Wettermark B, Andersen M, Bishop I, Burkhardt T, Garuolienè K, Kalaba M, Laius O, Joppi R, et al. Use of Generics-A Critical Cost Containment Measure for All Healthcare Professionals in Europe?. Pharmaceuticals 2010, 3(8):2470-2494.
30. Simoens S. Generic medicine pricing in Europe: current issues and future perspective. J Med Econ 2008, 11(1):171-175. 10.3111/13696990801939716, 19450118.
31. European Generic Medicines Association - Healthcare Economics http://198.170.119.137/gen-economics.htm.
32. Why do medications have brand names and generic names? http://www.nhs.uk/chq/Pages/1003.aspx?CategoryID=73&SubCategoryID=108.
33. Sinclair U. The Jungle 1906, Doubleday, Jabber & Compan.
34. 100 Years of Protecting and Promoting Women's Health http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118458.htm.
35. Milestones in U.S. Food and Drug Law History http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/default.htm.
36. What Are "Biologics" Questions and Answers http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm.
37. Biosimilars http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm.
38. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products 1965, Eur-Lex: The Council Of The European Communities, Official Journal of the European Union.
39. Pharmaceuticals In The European Union http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=1684.
40. Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products 1975, Eur-Lex: The Council Of The European Communities, Official Journal of the European Union.
41. Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products 1975, Eur-Lex: The Council Of The European Communities, Official Journal of the European Union.
42. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products 1993, Eur-Lex: The Council Of The European Communities, Official Journal of the European Union.
43. Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high- technology medicinal products, particularly those derived from biotechnology 1993, Eur-Lex: The Council Of The European Communities, Official Journal of the European Union.
44. New visual identity, web/e-mail addresses and organisation chart of the European Medicines Agency http://www.epha.org/IMG/pdf/EMEA_Communication_NewVisiualIdentity_en.pdf.
45. Directive 2011/62/EU Of The European Parliament And Of The Council Of 8 June 2011 Amending Directive 2001/83/EC On The Community Code Relating To Medicinal Products For Human Use, As Regards The Prevention Of The Entry Into The Legal Supply Chain Of Falsified Medicinal Products http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf.
46. Falsified medicines http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm.
47. FAQ on Biosimilar Medicines http://www.egagenerics.com/index.php/biosimilar-medicines/faq-on-biosimilars.
48. Questions and Answers on biosimilar medicines (similar biological medicinal products) http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf.
49. European Public Assessment Reports http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&murl=menus%2Fmedicines%2Fmedicines.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit&jsenabled=true.
50. DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: is biotech different?. Manag Decis Econ 2007, 28(4-5):469-479.
51. DiMasi J. Risks in new drug develoopment: Approval success rates for investigational drugs. Clin Pharmacol Ther 2001, 69(5):297-307. 10.1067/mcp.2001.115446, 11371997.
52. New Drug Development and Review Process http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053131.htm.
53. Guidance on the establishment of new INN stems http://www.who.int/medicines/services/inn/StemBook_2011_Final.pdf.
54. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, Brookhart MA, Avorn J, Shrank WH. Seizure Outcomes Following the Use of Generic versus Brand-Name Antiepileptic Drugs: A Systematic Review and Meta-Analysis. Drugs 2010, 70(5):605-621. 610.2165/10898530-000000000-000000000, 10.2165/10898530-000000000-00000, 3056509, 20329806.
55. Amit G, Rosen A, Wagshal AB, Bonneh DY, Liss T, Grosbard A, Ilia R, Katz A. Efficacy of substituting innovator propafenone for its generic formulation in patients with atrial fibrillation. Am J Cardiol 2004, 93(12):1558-1560. 10.1016/j.amjcard.2004.02.071, 15194037.
56. Araszkiewicz AA, Szabert K, Godman B, Wladysiuk M, Barbui C, Haycox A. Generic olanzapine: health authority opportunity or nightmare?. Expert Rev Pharmacoecon Outcomes Res 2008, 8(6):549-555. 10.1586/14737167.8.6.549, 20528365.
57. Alessi-Severini S, Honcharik PL, Simpson KD, Eleff MK, Collins DM. Evaluation of an interchangeability switch in patients treated with clozapine: A retrospective review. J Clin Psychiatr 2006, 67(7):1047-1054.
58. Paton C. Generic clozapine: outcomes after switching formulations. Br J Psychiatr J Mental Sci 2006, 189:184-185.
59. Bulsara C, McKenzie A, Sanfilippo F, Holman CDJ, Emery JE. 'Not the full Monty': a qualitative study of seniors' perceptions of generic medicines in Western Australia. Aust J Prim Health 2010, 16(3):240-245. 10.1071/PY10006, 20815994.
60. Hassali MAA, Shafie AA, Jamshed S, Ibrahim MIM, Awaisu A. Consumers' views on generic medicines: A review of the literature. Int J Pharm Pract 2009, 17(2):79-88.
61. Figueiras MJ, Cortes MA, Marcelino D, Weinman J. Lay views about medicines: the influence of the illness label for the use of generic versus brand. Psychol Health 2010, 25(9):1121-1128. 10.1080/08870440903137170, 20309776.
62. Babar ZU, Grover P, Stewart J, Hogg M, Short L, Seo HG, Rew A. Evaluating pharmacists' views, knowledge, and perception regarding generic medicines in New Zealand. Res Soc Admin Pharm RSAP 2011, 7(3):294-305.
63. Quintal C, Mendes P. Underuse of generic medicines in Portugal: an empirical study on the perceptions and attitudes of patients and pharmacists. Health Pol (Amsterdam, Netherlands) 2012, 104(1):61-68.
64. Heikkila R, Mantyselka P, Ahonen R. Do people regard cheaper medicines effective? Population survey on public opinion of generic substitution in Finland. Pharmacoepidemiol Drug Saf 2011, 20(2):185-191. 10.1002/pds.2084, 21254290.
65. Heikkila R, Mantyselka P, Ahonen R. Price, familiarity, and availability determine the choice of drug - a population-based survey five years after generic substitution was introduced in Finland. BMC Clin Pharmacol 2011, 11:20. 10.1186/1472-6904-11-20, 3262749, 22171800.
66. Graedon J, Graedon T. Are Generic Drugs Safe?. Prevention (Emmaus, Pa) 2008, 175:173-174. http://www.prevention.com/health/healthy-living/find-out-how-use-generic-drugs-safely.
67. Ringe JD, Moller G. Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int 2009, 30(2):213-221. 10.1007/s00296-009-0940-5, 19430791.
68. Kanis JA, Reginster JY, Kaufman JM, Ringe JD, Adachi JD, Hiligsmann M, Rizzoli R, Cooper C. A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos Int J Established Result Cooperat Between Eur Found Osteoporos Nat Osteoporos Found USA 2012, 23(1):213-221.
69. Diez-Perez A, Adachi JD, Agnusdei D, Bilezikian JP, Compston JE, Cummings SR, Eastell R, Eriksen EF, Gonzalez-Macias J, Liberman UA, et al. Treatment failure in osteoporosis. Osteoporos Int J Established Result Cooperat Between Eur Found Osteoporos Nat Osteoporos Found USA 2012, 23(12):2769-2774.
70. Privitera MD. Generic Antiepileptic Drugs: Current Controversies and Future Directions. Epilepsy Curr 2008, 8(5):113-117. 10.1111/j.1535-7511.2008.00261.x, 2566607, 18852829.
71. Jain K. Investigation and management of loss of efficacy of an antiepileptic medication using carbamazepine as an example. J R Soc Med 1993, 86(3):133-136. 1293899, 8459373.
72. Mayer T, May TW, Altenmuller DM, Sandmann M, Wolf P. Clinical Problems with Generic Antiepileptic Drugs: Comparison of Sustained-Release Formulations of Carbamazepine. Clin Drug Investig 1999, 18(1):17-26.
73. Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs?: A review of issues. Seizure 2006, 15(3):165-176. 10.1016/j.seizure.2005.12.010, 16504545.
74. Ferner RE, Lenney W, Marriott JF. Controversy over generic substitution. BMJ (Clin Res ed) 2010, 340:c2548.
75. Shrank WH, Liberman JN, Fischer MA, Girdish C, Brennan TA, Choudhry NK. Physician perceptions about generic drugs. Ann Pharmacother 2011, 45(1):31-38. 10.1345/aph.1P389, 21205953.
76. Shrank WH, Cox ER, Fischer MA, Mehta J, Choudhry NK. Patients' perceptions of generic medications. Health Aff (Millwood) 2009, 28(2):546-556.
77. Talati R, Scholle JM, Phung OP, Baker EL, Baker WL, Ashaye A, Kluger J, Coleman CI, White CM. Efficacy and safety of innovator versus generic drugs in patients with epilepsy: a systematic review. Pharmacotherapy 2012, 32(4):314-322. 10.1002/j.1875-9114.2012.01099.x, 22461121.
78. Johnston A. Challenges of therapeutic substitution of drugs for economic reasons: focus on CVD prevention. Curr Med Res Opin 2010, 26(4):871-878. 10.1185/03007990903578462, 20144139.
79. Johnston A, Stafylas P, Stergiou GS. Effectiveness, safety and cost of drug substitution in hypertension. Br J Clin Pharmacol 2010, 70(3):320-334. 10.1111/j.1365-2125.2010.03681.x, 2949902,2949902, 20716230.
80. Duerden MG, Hughes DA. Generic and therapeutic substitutions in the UK: are they a good thing?. Br J Clin Pharmacol 2010, 70(3):335-341. 10.1111/j.1365-2125.2010.03718.x, 2949903, 20716231.
81. Simoens S. Generic and therapeutic substitution: ethics meets health economics. Int J Clin Pharm 2011, 33(3):469-470. 10.1007/s11096-011-9500-7, 21431935.
82. Johnston A, Asmar R, Dahlof B, Hill K, Jones DA, Jordan J, Livingston M, Macgregor G, Sobanja M, Stafylas P, et al. Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe. Br J Clin Pharmacol 2011, 72(5):727-730. 10.1111/j.1365-2125.2011.03987.x, 3243005, 21486316.
83. Fusier I, Tollier C, Husson MC. Medicines containing pharmaceutical excipients with known effects: a French review. Pharm World Sci PWS 2003, 25(4):152-155.
84. Mumoli N, Cei M, Luschi R, Carmignani G, Camaiti A. Allergic reaction to Croscarmellose sodium used as excipient of a generic drug. QJM 2011, 104(8):709-710. 10.1093/qjmed/hcq175, 20855286.
85. Reiffel JA. Formulation Substitution and Other Pharmacokinetic Variability: Underappreciated Variables Affecting Antiarrhythmic Efficacy and Safety in Clinical Practice. Am J Cardiol 2000, 85:46D-52D. 10.1016/S0002-9149(00)00906-1, 10822040.
86. Coloe J, Zirwas MJ. Allergens in corticosteroid vehicles. Dermatitis Contact Atopic Occup Drug Offic J Am Contact Dermatitis Soc North American Contact Dermatitis Group 2008, 19(1):38-42.
87. Laroche ML, Traore H, Merle L, Gaulier JM, Viana M, Preux PM. Quality of phenobarbital solid-dosage forms in the urban community of Nouakchott (Mauritania). Epilepsia 2005, 46(8):1293-1296. 10.1111/j.1528-1167.2005.01805.x, 16060942.
88. Fauci AS, Harrison TR. Harrison's principles of internal medicine 2008, New York; London: McGraw-Hill Medical.
89. Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/news/generic-substitution-terminated-for-oral--tacrolimus.
90. British Medical Association and the Royal Pharmaceutical Society of Great Britain: British National Formulary 2012, BMJ Publishing Group, 63.
91. Items Unsuitable for Generic Prescribing http://www.nhssb.n-i.nhs.uk/prescribing/documents/Regional List Generic Exceptions Jul08.pdf.
92. OECD Health Data 2012 - Frequently Requested Data http://www.oecd.org/health/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm.
93. Delivery of Pharmaceuticals in Ireland - Getting a Bigger Bang for the Buck http://www.esri.ie/UserFiles/publications/RS24.pdf.
94. Generic Market Shares in Europe 2006, http://198.170.119.137/doc/fac-GxMktEur_2006.pdf.
95. Economies in Drug Usage in the Irish Healthcare Setting http://www.dohc.ie/publications/pdf/economies_drug_usage.pdf?direct=1.
96. Generic Drug Utilisation In Ireland In 2008, http://www.ncpe.ie/u_docs/doc_163.pdf.
97. Finance Shared Services Primary Care Reimbursement Service: Statistical Analysis Of Claims And Payments 2007, http://www.hse.ie/eng/Staff/PCRS/PCRS_Publications/2007_Report.pdf.
98. Tilson L, O'Leary A, Usher C, Barry M. Pharmacoeconomic Evaluation in Ireland. PharmacoEconomics 2010, 28(4):307-322. 10.2165/11318790-000000000-00000, 20222754.
99. Tilson L, McGowan B, Ryan M, Barry M. Generic Drug Utilisation on the General Medical Services (GMS) Scheme in 2001. Ir Med J 2003, 96(6):176-179.
100. Generic Prescribing http://www.stjames.ie/GPsHealthcareProfessionals/Newsletters/NMICBulletins/NMICBulletins2009/Generic bulletin NMIC v15No1 web with refs.pdf.
101. Gatyas G. IMS Institute Reports U.S. Spending on Medicines Grew 2.3 Percent in 2010, to $307.4 Billion. In: IMS Institute for Healthcare Informatics. IMS Website 2011,
102. Prescriptions Dispensed in the Community: England, Statistics for 2000 to 2010 http://www.ic.nhs.uk/webfiles/publications/007_Primary_Care/Prescribing/Prescriptions dispensed in the community 2000 - 2010/Prescriptions_Dispensed_2000_2010.pdf.
103. Bennie M, Godman B, Bishop I, Campbell S. Multiple initiatives continue to enhance the prescribing efficiency for the proton pump inhibitors and statins in Scotland. Expert Rev Pharmacoecon Outcomes Res 2012, 12(1):125-130. 10.1586/erp.11.98, 22280202.
104. Godman B, Abuelkhair M, Vitry A, Abdu S, et al. Payers endorse generics to enhance prescribing efficiency; impact and future implications, a case history approach. GABI 2012, 1(2):21-35.
105. Generic Drug Savings In The U.S. (Fourth Annual Edition 2012, http://www.gphaonline.org/sites/default/files/IMS Study Aug 2012 WEB.pdf.
106. Generic Pharmaceutical Association New Study Finds Use of Generic Prescription Drugs Saved Consumers and the U.S. Health Care System $931 Billion Over Past 10 Years 2011, Generic Pharmacetical Association. GhPa online, Generic Pharmaceutical Association.
107. Proposed Model for Reference Pricing and Generic Substitution http://www.dohc.ie/publications/pdf/reference_pricing_generic_substitution.pdf?direct=1.
108. Kanavos P. Do generics offer significant savings to the UK National Health Service?. Curr Med Res Opin 2007, 23(1):105-116. 10.1185/030079907X159506, 17257472.
109. Kanavos P, Taylor D. Pharmacy discounts on generic medicines in France: is there room for further efficiency savings?. Curr Med Res Opin 2007, 23(10):2467-2476. 10.1185/030079907X219571, 17764613.
110. Kanavos P, Costa-Font J, Seeley E. Competition in off-patent drug markets: Issues, regulation and evidence. Econ Pol 2008, 23(55):499-544.
111. Chandra A, Gruber J, McKnight R. Patient Cost-Sharing and Hospitalization Offsets in the Elderly. Am Econ Rev 2010, 100(1):193-213. 10.1257/aer.100.1.193, 2982192, 21103385.
112. IPHA Statement on the report on a Proposed Model for Reference Pricing and Generic Substitution http://www.ipha.ie/news/latest-news.aspx?page=3&article=bfe9dcd0-7ae8-4f11-989a-875322ee8bc7.
113. Garuoliene K, Godman B, Gulbinovic J, Wettermark B, Haycox A. European countries with small populations can obtain low prices for drugs: Lithuania as a case history. Expert Rev Pharmacoecon Outcomes Res 2011, 11(3):343-349. 10.1586/erp.11.24, 21671703.
114. Barron D. Concerns about generic substitution. Irish Medical News 2011, 28:1.
115. Hassali MA, Kong DCM, Stewart K. Utilisation of generic medicines in the Australian healthcare system. J Generic Med 2004, 2(1):42-52.
116. Scuderi M. Generic substitution in a Brisbane community pharmacy. Aust Pharm 2002, 21:116-121.
117. Andersson K, Sonesson C, Petzold M, Carlsten A, Lonnroth K. What are the obstacles to generic substitution? An assessment of the behaviour of prescribers, patients and pharmacies during the first year of generic substitution in Sweden. Pharmacoepidemiol Drug Saf 2005, 14(5):341-348. 10.1002/pds.1055, 15624198.
118. Andersson KA, Petzold MG, Allebeck P, Carlsten A. Influence of mandatory generic substitution on pharmaceutical sales patterns: a national study over five years. BMC Health Serv Res 2008, 8:50. 10.1186/1472-6963-8-50, 2276486, 18312635.
119. Andersson K, Bergstrom G, Petzold MG, Carlsten A. Impact of a generic substitution reform on patients' and society's expenditure for pharmaceuticals. Health Pol (Amsterdam, Netherlands) 2007, 81(2-3):376-384.
120. Wettermark B, Godman B, Andersson K, Gustafsson LL, Haycox A, Bertele V. Recent national and regional drug reforms in Sweden: implications for pharmaceutical companies in Europe. PharmacoEconomics 2008, 26(7):537-550. 10.2165/00019053-200826070-00001, 18563945.
121. Banahan BF, Kolassa EM. A Physician Survey on Generic Drugs and Substitution of Critical Dose Medications. Arch Intern Med 1997, 157(18):2080-2088. 10.1001/archinte.1997.00440390066010, 9382664.
122. Kirking DM, Gaither CA, Ascione FJ, Welage LS. Physicians' individidual and organizational views on generic medications. J Am Pharm Assoc 2001, 41(5):718-722.
123. Shrank WH, Stedman M, Ettner SL, DeLapp D, Dirstine J, Brookhart MA, Fischer MA, Avorn J, Asch SM. Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use. J Gen Intern Med 2007, 22(9):1298-1304. 10.1007/s11606-007-0284-3, 2219782, 17647066.
124. Feely J, McGettigan P, O'Shea B, Chan R, McManus J. Low rate of generic prescribing in the Republic of Ireland compared to England and Northern Ireland: Prescribers' concerns. Ir Med J 1997, 90(4):146-147.
125. Murphy MB. Review of Indicative Drug Target Savings Scheme. In: Review of Indicative Drug Target Savings Scheme 1997, Lenus website: Health Service Executive.
126. Practice Managers Manual http://www.lenus.ie/hse/bitstream/10147/51033/1/PracticeManagersBook08.pdf.
127. Walley T, Murphy M, Codd M, Johnston Z, Quirke T. Effects of a monetary incentive on primary care prescribing in Ireland: changes in prescribing patterns in one health board 1990-1995. Pharmacoepidemiol Drug Saf 2000, 9(7):591-598. 10.1002/pds.544, 11338918.
128. Primary care: a new direction http://www.dohc.ie/publications/pdf/primcare.pdf?direct=1.
129. Harris CM, Scrivener G. Fundholders' Prescribing Costs: The First Five Years. BMJ: Brit Med J 1996, 313(7071):1531-1534. 10.1136/bmj.313.7071.1531, 2353056, 8978232.
130. Pope ND. Generic Substitution of Narrow Therapeutic Index Drugs. US Pharmacist 2009, 34(6):12-19. Generic Drug Review Supplement.
131. Okechukwu I, Bennett K, Feely J. General practitioners' ranking of evidence-based prescribing quality indicators: a comparative study with a prescription database. Br J Clin Pharmacol 2006, 62(2):218-224. 10.1111/j.1365-2125.2006.02621.x, 1885100, 16842397.