Soft regulations in pharmaceutical policy making: An overview of current approaches and their consequences

Applied Health Economics and Health Policy

Volumn 7, Issue 3, 2009, Pages 137-147

  Wettermark, Björn ^a,b,g   Godman, Brian ^c,d   Jacobsson, Bengt ^e   Haaijer Ruskamp, Flora M ^f  

^a KAROLINSKA INSTITUTE   (Sweden)

^b STOCKHOLM COUNTY COUNCIL   (Sweden)

^c MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

^e SÖDERTÖRN UNIVERSITY   (Sweden)

^f UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^g KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG CHOICE; HEALTH CARE QUALITY; HUMAN; INFORMATION DISSEMINATION; JOB PERFORMANCE; MEDICAL AUDIT; MEDICATION THERAPY MANAGEMENT; MONITORING; PRESCRIPTION; QUALITY CONTROL; REVIEW; STANDARDIZATION;

DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; EUROPEAN UNION; HUMANS; POLICY MAKING; PRESCRIPTION DRUGS; PUBLIC HEALTH;

EID: 84890797972     PISSN: 11755652     EISSN: 11791896     Source Type: Journal    
DOI: 10.1007/BF03256147     Document Type: Review

References (106)

1. Thorpe KE. The rise in health care spending and what to do about it. Health Affairs 2005; 24: 1436-1445
2. Lee T, Emanuel E. Tier 4 drugs and the fraying of the social compact. N Eng J Med 2008; 359: 333-335
3. Garattini S, Bertele V, Godman B, et al. Enhancing the rational use of new medicines across European healthcare systems: a position paper. Eur J Clin Pharmacol 2008; 64: 1137-1138
4. Kusnik-Joinville O, Weill A, Salanave B, et al. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab 2008; 34: 266-272
5. Schondelmeyer S, Purvis L, Gross D. Rx watchdog report: trends in manufacturer prices of speciality prescription drugs used byMedicare beneficiaries 2004 to 2007 [online]. Available from URL: http://assets.aarp.org/ rgcenter/health/2008-15-specialty-q407.pdf [Accessed 2008 Oct 6]
6. Zuvekas SH, Cohen JW. Prescription drugs and the changing concentration of health care expenditures. Health Affairs 2007; 26: 249-257
7. Garattini L, Motterlini N, Cornago D. Prices and distribution margins of in-patent drugs in pharmacy: a comparison in seven European countries. Health Policy 2008; 85: 305-313 (Pubitemid 351179534)
8. Wallack S, Weinberg DB, Thomas CP. Health plans' strategies to control prescription drug spending. Health Affairs 2004; 23: 141-148 (Pubitemid 39531461)
9. WHO. World health statistics 2008: global health indicators [online]. Available from URL: http://www.who.int/whosis/whostat/EN-WHS08-Table4-HSR.pdf. [Accessed 2008 Aug 30]
10. Rice RE, Atkin CK, editors. Public communication campaigns. 3rd ed. London: SAGE Publications Inc., 2001
11. Godman B, Wettermark B, Hoffmann M, et al. Multi-faceted national and regional drug reforms and initiatives in ambulatory care in Sweden: global relevance. Expert Rev Pharmacoeconomics Outcomes Res 2009; 9: 65-83
12. Bero LA, Grilli R, Grimshaw JM, et al. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group.BMJ 1998; 317: 465-468
13. Grimshaw JM, Thomas RE, MacLennan G, et al. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess 2004; 8: iii-iv, 1-72 (Pubitemid 38279464)
14. Walley T, Mrazwek M, Mossialos E. Regulating pharmaceutical markets: improving efficiency and controlling costs in the UK. Int J Health Plann Manage 2005; 20: 375-398 (Pubitemid 41762891)
15. Chapman S, Durieux P, Walley T. Good prescribing practice in regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. In: Mossialos E,Mrazek M, Walley T, editors. Berkshire: Open University Press, 2004
16. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patient's care. Lancet 2003; 362: 1225-1230 (Pubitemid 37255352)
17. Freemantle N, Nazareth I, Eccles M, et al. A randomised controlled trial if the effect of educational outreach by community pharmacists on prescribing in UK general practice. Br J Gen Pract 2002; 52: 290-295 (Pubitemid 35021402)
18. O'Brien MA, Oxman AD, Davis DA, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 1997; (4): CD000409
19. VonFerber L,Bausch J,Köster I, et al. Pharmacotherapeutic circles: results of an 18-month peer-review prescribing-improvement programme for general practitioners. Pharmacoeconomics 1999; 16: 273-283
20. Schneider A, Wensing M, Biessecker K, et al. Impact of quality circles for improvement of asthma care: results of a randomised controlled trial. J Eval Clin Pract 2007; 14: 185-190 (Pubitemid 351347689)
21. Wettermark B, Godman B, Andersson K, et al. Recent national and regional drug reforms in Sweden: implications for pharmaceutical companies in Europe. Pharmaco-economics 2008; 26: 537-550 (Pubitemid 351871549)
22. Godman B, Bucsics A, Burkhardt T, et al. Insight into recent reforms and initiatives in Austria: implications for key stakeholders. Expert Rev Pharmacoecon Outcomes Res 2008; 8: 357-371
23. Wutzke SE, Artist MA, Kehoe LA, et al. Evaluation of a national programme to reduce inappropriate use of antibiotics for upper respiratory tract infections: effects on consumer awareness, beliefs, attitudes and behaviour in Australia. Health Promot Int 2007; 22: 53-64
24. Gonzales R, Corbett KK, Wong S, et al. "Get smart Colorado": impact of a mass media campaign to improve community antibiotic use. Med Care 2008; 46: 597-605
25. Pepin S, Ricordeau P. L'assurance maladie la consommation d'antibiotiques: situation en France au regard des autres pays Européens, 2006 [online]. Available from URL: http://www.ameli.fr/fileadmin/user-upload/ documents/pointreperen-6.pdf [Accessed 2008 Feb 1]
26. Paris V. Pharmaceutical regulation in France 1980-2003. Int J Health Plann Manage 2005; 20: 307-328
27. L'Assurance Maladie. La maitrise medicalisee des depenses d'assurance maladie dans les deux-sevres bilan 2005/2006 et perspectives 2006 [online]. Available from URL: http://www.ameli.fr/fileadmin/user-upload/documents/ maitrise-medicalise.pdf [Accessed 2008 Jul 10]
28. Grandfils N, Sermet C. Pharmaceutical policy in France: a mosaic of reforms. Eurohealth 2006; 12: 15-17
29. Villagra V, Ahmed T. Effectiveness of a disease management program for patients with diabetes. Health Affairs 2004; 23: 255-266 (Pubitemid 38952404)
30. Schmacke N, Lauterberg J. Criticismof new German chronic disease management is unfair [letter]. BMJ 2002; 325: 971
31. Busse R. Disease management programs in Germany's Statutory Health Insurance System. Health Affairs 2004; 23 (3): 56-67
32. Nagel H, Baehring T, Scherbaum W. Implementing disease management programmes for type 2 diabetes in Germany. Manag Care 2006 Nov; 15: 50-53
33. Verrue CL, Petrovic M, Mehuys E, et al. Pharmacists' interventions for optimization of medication use in nursing homes : a systematic review. Drugs Aging 2009; 26: 37-49
34. Beishon J,McBride T. Scharaschkin S, et al. National Audit Office. Prescribing costs in primary care. London National Audit Office 2007 [online]. Available from URL: http://www.nao.org.uk/publications/nao-reports/06-07/ 0607454.pdf [Accessed 2007 May 21]
35. Hunter DJ, Fairfield G. Managed care: disease management. BMJ 1997; 315: 50-53
36. Cooper RJ, Anderson C, Avery T, et al. Nurse and pharmacist supplementary prescribing in the UK: a thematic review of the literature. Health Policy 2008; 85: 277-292 (Pubitemid 351179531)
37. VanGanse E, ChambaG, Becquart B, et al. France: pharmaceutical pricing and reimbursement information October 2007 [online]. Available from URL: http://ppri.oebig.at/Downloads/Results/France-PPRI-2007.pdf [Accessed 2008 Jan 20]
38. Moïse P, Docteur E. OECD health working papers no. 28: pharmaceutical pricing and reimbursement in Sweden, 13 Sep 2007 [online]. Available fromURL: http://www.olis. oecd.org/olis/2007doc.nsf/FREDATCORPLOOK/NT 00002E52/$FILE/JT03231887.PDF [Accessed 2008 Feb 2]
39. Ethics agreement between Swedish County Councils (SKL) and National Corporation of Swedish Pharmaceutical Industries (LIF) [online]. Available from URL: http://www. lif.se/cs/default.asp?id=9582. [Accessed 2008 Oct 11]
40. Rothman D, Chimonas S. New developments in managing physician-industry relationships. JAMA 2008; 300: 1067-1069
41. PhRMA. Code on interactions with healthcare professionals 2008 [online]. Available from URL: http://www.phrma.org/code-on-interactions-with-healthcare- professionals/ [Accessed 2008 Oct 17]
42. Jones IM, Greenfield S, Bradely P. Prescribing new drugs: qualitative study of influences on consultants and general practitioners. BMJ 2001; 323: 378-381 (Pubitemid 32762465)
43. Watkins C, Harvey I, Carthy P, et al. Attitudes and behaviour of general practitioners and their prescribing costs: a national cross sectional survey. Qual Saf Health Care 2003; 12: 29-34 (Pubitemid 36241253)
44. Prosser H, Almond S, Walley T. Influences on GPs' decision to prescribe new drugs: the importance of who says what. Fam Pract 2003; 20: 61-68 (Pubitemid 36163787)
45. Rietveld AH, Haaijer-Ruskamp F. Policy options for cost containment of pharmaceuticals. Int J Risk SafMed 2002; 15: 29-54 (Pubitemid 36398725)
46. Walley T, Mossialos E. Financial incentives and prescribing in regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. Mossialos E, Mrazek M, Walley T, editors. Berkshire: Open University Press, 2004
47. Le Pen C. The drug budget silo mentality: the French case. Value Health 2003; 6 Suppl. 1: S10-9
48. Godman B, Haycox A, Schwabe U, et al. Having your cake and eating it: Office of Fair Trading proposal for funding new drugs to benefit patients and innovative companies. Pharmacoeconomics 2008; 26: 91-98
49. Hyde R. Doctors to pay for patients' medicines in Germany [world report]. Lancet 2007; 370: 1118
50. Fattore G, Jommi C. The last decade of Italian pharmaceutical policy: instability or consolidation? Pharmacoeconomics 2008; 26: 5-15
51. Barton S. Using clinical evidence. BMJ 2001; 322: 503-504
52. Jacoby A, Smith M, Eccles M. A qualitative study to explore influences on general practitioners' decisions to prescribe new drugs. Br J Gen Pract 2003; 53: 120-125 (Pubitemid 36187498)
53. Mason J, Freemantle N, Nazareth I, et al. When is it cost-effective to change the behaviour of health professionals. JAMA 2001; 286: 2988-2992 (Pubitemid 33140363)
54. Walshe K, Freeman T. Effectiveness of quality improvement: learning from evaluations. Qual Saf Healthcare 2002; 11: 85-87 (Pubitemid 35265309)
55. Moynihan R. Doctors' education: the invisible influence of drug company sponsorship. BMJ 2008; 336: 416-417
56. Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ 2003; 326: 1202-1205
57. Mason A, Drummond M, Hunter J et al. Prescribing incentive schemes: a useful approach? Appl Health Econ Health Policy. 2005; 4: 111-117
58. Harris C, Scrivener G. Fundholders' prescribing costs: the first five years. BMJ 1996; 313: 1531-3441 (Pubitemid 27016892)
59. Sturm H, Austvoll-Dahlgren A, Aaserud M, et al. Pharmaceutical policies: effects of financial incentives for prescribers. CochraneDatabase Syst Rev 2007; (3): CD006731 (Pubitemid 351805597)
60. Martens J, Werkhiven M, Severens J, et al. Effects of a behaviour independent financial incentive on prescribing behaviour of general practitioners. J Eval Clin Pract 2007; 13: 369-373 (Pubitemid 46789637)
61. Atella V, Schafheutle E, Noyce P, et al. Affordability of medicines and patients' cost-reducing behaviour: empirical evidence based on SUR estimates from Italy and the UK. Appl Health Econ Health Policy 2005; 4: 23-35 (Pubitemid 41352123)
62. Hassell K, Atella V, Schafheutle EI, et al. Cost to the patient or cost to the healthcare system? Which one matters the most for GP prescribing decisions? A UK-Italy comparison. Eur J Public Health 2003; 13: 18-23 (Pubitemid 36356421)
63. Sermet C, Andrieu V, Godman B, et al. Ongoing pharmaceutical reforms in France: implications for key stakeholder groups. Appl Health Econ Health Policy. In press
64. Brown LD. Political challenges for healthcare reforms. Pharmacoeconomics 2006; 24 Suppl. 2: 96-99
65. Stephenson J, Imrie J. Why do we need randomised controlled trials to assess behavioural interventions? BMJ 1998; 316: 611-613
66. Jacobsson B, Sahlin-Andersson K. The dynamics of transnational regulations: constellations among states, international organizations and business corporations. Paper presented at the EGOS 18th Colloquium; 2002 Jul 4-6; Barcelona
67. Levi-Faur D. The global diffusion of regulatory capitalism. Ann Am Acad Political Soc Sci 2005; 598: 12-32
68. Djelic M-L, Sahlin-Andersson K. Transnational governance: institutional dynamics of regulation. New York: Cambridge University Press, 2006
69. Mörth U, editor. Soft law in governance and regulation: an interdisciplinary analysis. Cheltenham: Edward Elgar, 2004
70. Jacobsson B, Sahlin-Andersson K. Dynamics of soft regulations. In: Djelic M-L, Sahlin-Andersson K, editors. Transnational governance: institutional dynamics of regulation. New York: Cambridge University Press, 2006
71. Brunsson N, Jacobsson B.Aworld of standards.New York: Oxford University Press, 2000
72. PowerM. The audit society: rituals of verification. Oxford: Oxford University Press, 1997
73. Rochaix L, Wilsford D. State autonomy, policy paralysis: paradoxes of institutions and culture in the French health care system. J Health Polit Policy Law 2005; 30: 97-119 (Pubitemid 40627008)
74. Mossialos E, Oliver A. An overview of pharmaceutical policy in four countries: France, Germany, the Netherlands and the United Kingdom. Int J Health Plann Manage 2005; 20: 291-306
75. Duerden M, Miller J, Godman B, et al. Centralised guidance: how NICE and SIGN impact on care in the UK. In: Klusen N, Straub C, editors. Bausteine fur ein neues Gesundheitswesen: Technik, Ethik, "Okonomie" No.6 of the series "Beitrage zum Gesundheitsmanagement" by Nobert Klusen and Andreas Meusch. Baden-Baden: Nomos Verlagsgesellschaft, 2003: 51-61
76. McEleny P, Bowie P, Robins JB, et al. Getting a validated guideline into local practice: implementation and audit of the SIGN guideline on the prevention of deep vein thrombosis in a district general hospital. Scott Med J 1998; 43: 23-25 (Pubitemid 28098306)
77. Smith PC, York N. Quality incentives: the case of UK general practitioners. Health Affairs 2004; 23: 112-118
78. RolandM. Linking physicians' pay to the quality of care: a major experiment in the United Kingdom. N Eng J Med 2004; 351: 1448-1454
79. Doran T, FullwoodC,GravelleH, et al. Pay-for-performance programs in family practices in the United Kingdom. N Engl J Med 2006; 355: 375-384 (Pubitemid 44127540)
80. Rehnqvist N. Improving accountability in a decentralised system: a Swedish perspective in measuring up. In: Smith P, editor. Improving health system performance in OECD countries, 2002 [online]. Available fromURL: http://www. ikwilwerken.nl/pdf/eu/8102011ehealthsystem.pdf [Accessed 2008 Feb 1]
81. Schiotz M, Merkur S. Health quality information in Sweden. Eur Observ 2007; 9: 5-7
82. Doran T, Fullwood C, Kontopantelis E, et al. Effect of financial incentives on inequalities in the delivery of primary clinical care in England: analysis of clinical activity indicators for the quality and outcomes framework. Lancet 2008; 372: 728-736
83. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001
84. Epstein AM, Lee TH, Hamel MB. Paying physicians for high-quality care. N Engl J Med 2004; 350: 406-410
85. Epstein AM. Paying for performance in the United States and abroad. N Engl J Med 2006; 355: 406-408 (Pubitemid 44127545)
86. Faber M, Bosch M, Wollersheim H, et al. Public reporting in health care: how do consumers use quality-of-care information? [A systematic review]. Med Care 2009; 47: 1-8
87. Organisation for Economic Co-operation and Development. Paris: OECD, 2007. (Data on file)
88. Simoens S. International comparison of generic medicine prices. Curr Med Res Opin 2007; 23: 2647-2654 (Pubitemid 350146403)
89. Seeley E, Kanavos P. Generic medicines from a societal perspective: savings for healthcare systems? Eurohealth 2008; 14: 18-22
90. Chaix-Couturier C, Durand-Zaleski I, Jolly D, et al. Effects of financial incentives on medical practice: results from a systematic review of the literature and methodological issues. Int J Qual Health Care 2000; 12: 133-142 (Pubitemid 30262229)
91. Mason A. New medicines in primary care: a review of influences on general practitioner prescribing. J Clin Pharm Ther 2008; 33: 1-10
92. Wettermark B, Pehrsson A, Juhasz-Haverinen M, et al. Financial incentives linked to self-assessment of prescribing patterns: a new approach for quality improvement of drug prescribing in primary care. Quality in Primary Care. 2009; 17 (3): 179-189
93. Barrett A, Roques T, Small M, et al. How much will herceptin really cost? BMJ 2006; 333: 1118-1120
94. Ritzer G editor. The MacDonaldization of society: revised new century edition. Portland: Pine Forge Press, 2000
95. Mossialos E, Mrazek M. Methods for monitoring and evaluating processes and outcomes. Int J Risk Safety Med 2002; 15: 55-66
96. Adams AS, Soumerai SB, Lomas J, et al. Evidence of self-report bias in assessing adherence to guidelines. Int J Qual Health Care 1999; 11: 187-192 (Pubitemid 29302446)
97. Meyer JW, Rowan B. Institutionalized organizations: formal structure as myth and ceremony. Am J Sociol 1977; 83: 340-363
98. Kesselheim AS, Brennan TA. Overbilling vs downcoding: the battle between physicians and insurers. N Eng J Med 2005; 352: 855-857
99. Doran T, Fullwood C, Reeves D, et al. Exclusion of patients from pay-for-performance targets by English physicians [published erratum appears in N Engl J Med 2008 Jul 31; 359: 546] N Engl J Med 2008; 359: 274-284
100. Hutchinson L. Evaluating and researching the effectiveness of educational interventions. BMJ 1999; 318: 1267-1269 (Pubitemid 29210059)
101. Garattini S, Bertele' V. How can we regulate medicines better. BMJ 2007; 335: 803-805
102. Grimshaw J, Campbell M, Eccles M, et al. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract 2000; 17: S11-8 (Pubitemid 30105646)
103. Eccles M, Grimshaw J, Campbell M, et al. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care 2003; 12: 47-52 (Pubitemid 36241256)
104. Kanavos P, Ross-Degnan D, Fortress E, et al. Measuring, monitoring and evaluating policy outcomes in the pharmaceutical sector. In: Mossialos E, Mrazek M, Walley T, editors. Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. Berkshire: Open University Press, 2004: 97-113
105. Pope C, Mays N. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ 1995; 311: 42-45
106. Carthy P, Harvey I, Brawn R, et al. A study of factors associated with cost and variation in prescribing among GPs. Fam Pract 2000; 17: 36-41 (Pubitemid 30105632)