dokument o farmakopolitici - srpska verzija 2

7/23/2019 Dokument o Farmakopolitici - Srpska Verzija 2

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1. ............................................................................................................................................... 3

1.1. ...................................................................................................................................... 3

1.2. ................................................................................................................. 5

1.3. ............................................ 6

1.4. ................................................................................................................................ 8

2. .................................................................................................................... 9

2.1 ().............................................................................................................. 9

2.2. .............................................................................................................. 10

2.2.1 ........................................ 10

2.2.2 ................................... 13

2.3. .................................................................................... 15

2.3.1. .................................. 15

2.3.2. .................................................................................................................. 17

3. / ............................................................................................. 23

4. , .................................................. 23

4.1. ............................................................... 234.1.1. ............................................................................................ 26

4.2. ............................... 28

4.2.1. ................................................................................................................... 29

4.2.2. ( 3).............................................................. 30

5. .... 32

5.1. ..................................................................................................................................... 32

5.2. ...................................................................................................................................... 36

6. ............................................................................................................................. 40

7. ...................................................................................................................................... 41

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7.

1. WHO. Health financing: Health expenditure per capita. Data by country.2014(http://apps.who.int/gho/data/view.main.1920ALL?lang=en).2. Kalaba M, Godman B, Vuksanovic A, Bennie M, Malmstrom RE. Possible ways to enhance renin-angiotensin prescribing efficiency: Republic of Serbia as a case history? Journal of comparativeeffectiveness research. 2012;1(6):539-49.3. Government S. Republikizavod za statistiku Srbije 2013.4. Government S. Ministarstvo finansijahttp://www.mfin.gov.rs2013.5. Bank W. The World Bankhttp://worldbank.org2014.

6. (IHME) IfHMaE. The Global Burden of Disease Study - Generating Evidence, Guiding Policy.2010;http://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdf.7. Serbia IoPHo. INSTITUT ZA JAVNO ZDRAVLjE SRBIJE - 'DR MILAN JOVANOVIBATUT' -REPUBLIKA SRBIJA:http://www.batut.org.rs/download/izvestaji/Odabrani%20zdravstveni%20pokazatelji%202012.pdf;2012.8. Kanavos P. Do generics offer significant savings to the UK National Health Service? Currentmedical research and opinion. 2007;23(1):105-16.9. McGinn D, Godman B, Lonsdale J, Way R, Wettermark B, Haycox A. Initiatives to enhance thequality and efficiency of statin and PPI prescribing in the UK: impact and implications. Expert reviewof pharmacoeconomics & outcomes research. 2010;10(1):73-85.10. Kanavos P, Taylor D. Pharmacy discounts on generic medicines in France: is there room for

further efficiency savings? Current medical research and opinion. 2007;23(10):2467-76.11. Malmstrom RE, Godman BB, Diogene E, Baumgartel C, Bennie M, Bishop I, et al. Dabigatran - acase history demonstrating the need for comprehensive approaches to optimize the use of new drugs.Frontiers in pharmacology. 2013;4:39.12. Valerie Paris AB. Value in Pharmaceutical Pricing. OECD Health Working Papers, No. 63: OECDPublishing; 2013 [citedhttp://dx.doi.org/10.1787/5k43jc9v6knx-en].13. Chalkidou K, Marquez P, Dhillon PK, Teerawattananon Y, Anothaisintawee T, Gadelha CA, et al.Evidence-informed frameworks for cost-effective cancer care and prevention in low, middle, and high-income countries. The lancet oncology. 2014;15(3):e119-e31.14. Sermet C, Andrieu V, Godman B, Van Ganse E, Haycox A, Reynier JP. Ongoing pharmaceuticalreforms in France: implications for key stakeholder groups. Applied health economics and healthpolicy. 2010;8(1):7-24.15. Godman B, Bucsics A, Burkhardt T, Haycox A, Seyfried H, Wieninger P. Insight into recent

reforms and initiatives in Austria: implications for key stakeholders. Expert review ofpharmacoeconomics & outcomes research. 2008;8(4):357-71.16. Wettermark B GB, Eriksson C et al. Einfhrung neuer Arzneimittel in europischeGesundheitssysteme (Introduction of new medicines into European healthcare systems). GGW.2010;10(3):243417. Godman B CS, Suh HS, Finlayson A, Bennie M, Gustafsson L. Ongoing measures to enhanceprescribing efficiency across Europe: implications for other countries. J Health Tech Assess2013;1:27-42.18. van de Vooren K, Duranti S, Curto A, Garattini L. A critical systematic review of budget impactanalyses on drugs in the EU countries. Applied health economics and health policy. 2014;12(1):33-40.19. Kolasa K, Schubert S, Manca A, Hermanowski T. A review of Health Technology Assessment(HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact onpolicymaking processes in Poland. Health policy (Amsterdam, Netherlands). 2011;102(2-3):145-51.20. Horn H, Nink K, McGauran N, Wieseler B. Early benefit assessment of new drugs in Germany -Results from 2011 to 2012. Health policy (Amsterdam, Netherlands). 2014.
http://apps.who.int/gho/data/view.main.1920ALL?lang=en)http://apps.who.int/gho/data/view.main.1920ALL?lang=en)http://apps.who.int/gho/data/view.main.1920ALL?lang=en)http://www.mfin.gov.rs2013/http://www.mfin.gov.rs2013/http://www.mfin.gov.rs2013/http://worldbank.org/http://worldbank.org/http://worldbank.org/http://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://www.batut.org.rs/download/izvestaji/Odabrani%20zdravstveni%20pokazatelji%202012.pdf;http://www.batut.org.rs/download/izvestaji/Odabrani%20zdravstveni%20pokazatelji%202012.pdf;http://dx.doi.org/10.1787/5k43jc9v6knx-en%5dhttp://dx.doi.org/10.1787/5k43jc9v6knx-en%5dhttp://dx.doi.org/10.1787/5k43jc9v6knx-en%5dhttp://dx.doi.org/10.1787/5k43jc9v6knx-en%5dhttp://www.batut.org.rs/download/izvestaji/Odabrani%20zdravstveni%20pokazatelji%202012.pdf;http://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://www.healthmetricsandevaluation.org/sites/default/files/policy_report/2011/GBD_Generating%20Evidence_Guiding%20Policy_Report%20overview.pdfhttp://worldbank.org/http://www.mfin.gov.rs2013/http://apps.who.int/gho/data/view.main.1920ALL?lang=en)


42/51

: 42 / 51

21. Henschke C, Sundmacher L, Busse R. Structural changes in the German pharmaceutical market:price setting mechanisms based on the early benefit evaluation. Health policy (Amsterdam,Netherlands). 2013;109(3):263-9.22. Godman B, Paterson K, Malmstrom RE, Selke G, Fagot JP, Mrak J. Improving the managed entryof new medicines: sharing experiences across Europe. Expert review of pharmacoeconomics &outcomes research. 2012;12(4):439-41.23. New drugs and indications in 2011. France is better focused on patients interests afterthe Mediator scandal, but stagnation elsewhere. PRESCRIRE INTERNATIONAL. 2012;21(126):106-7.24. Kelly RJ, Smith TJ. Delivering maximum clinical benefit at an affordable price: engagingstakeholders in cancer care. The lancet oncology. 2014;15(3):e112-e8.25.The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices ofcancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439-42.26. Uyl-de Groot C dVE, Verweij J, Sullivan R. Dispelling the myths around cancer care delivery: Itsnot all about costs. Journal of Cancer Policy 2014;2:229.27. Aggarwal A GO, Fojo T. Cancer economics, policy and politics: What informs the debate?Perspectives from the EU, Canada and US. Journal of Cancer Policy 2014;2:1-11.28. Coleman MP, Forman D, Bryant H, Butler J, Rachet B, Maringe C, et al. Cancer survival in

Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995-2007 (the International CancerBenchmarking Partnership): an analysis of population-based cancer registry data. Lancet.2011;377(9760):127-38.29. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: JustumPretium--the just price. Journal of clinical oncology : official journal of the American Society of ClinicalOncology. 2013;31(28):3600-4.30. Bajcetic M KM, Godman B, Sipetic T et al. Ongoing programmes to reduce the high rate ofantibiotic consumption in Serbia; current situation and future direction. Pharmacoepidemiology anddrug safety. 2012;21 (Suppl 3):98.31. Bjorkhem-Bergman L, Andersen-Karlsson E, Laing R, Diogene E, Melien O, Jirlow M, et al.Interface management of pharmacotherapy. Joint hospital and primary care drug recommendations.European journal of clinical pharmacology. 2013;69 Suppl 1:73-8.32. Joppi R, Dematte L, Menti AM, Pase D, Poggiani C, Mezzalira L. The Italian Horizon ScanningProject. European journal of clinical pharmacology. 2009;65(8):775-81.33. Wettermark B, Persson ME, Wilking N, Kalin M, Korkmaz S, Hjemdahl P, et al. Forecasting drugutilization and expenditure in a metropolitan health region. BMC health services research.2010;10:128.34. Cars T, Wettermark B, Malmstrom RE, Ekeving G, Vikstrom B, Bergman U, et al. Extraction ofelectronic health record data in a hospital setting: comparison of automatic and semi-automaticmethods using anti-TNF therapy as model. Basic & clinical pharmacology & toxicology.2013;112(6):392-400.35. Lecluse LL, Naldi L, Stern RS, Spuls PI. National registries of systemic treatment for psoriasis andthe European 'Psonet' initiative. Dermatology (Basel, Switzerland). 2009;218(4):347-56.36. Iannone F, Gremese E, Atzeni F, Biasi D, Botsios C, Cipriani P, et al. Longterm retention of tumornecrosis factor-alpha inhibitor therapy in a large italian cohort of patients with rheumatoid arthritis fromthe GISEA registry: an appraisal of predictors. The Journal of rheumatology. 2012;39(6):1179-84.

37. Raaschou P, Simard JF, Holmqvist M, Askling J. Rheumatoid arthritis, anti-tumour necrosis factortherapy, and risk of malignant melanoma: nationwide population based prospective cohort study fromSweden. BMJ (Clinical research ed). 2013;346:f1939.38. Norlin JM, Steen Carlsson K, Persson U, Schmitt-Egenolf M. Switch to biological agent inpsoriasis significantly improved clinical and patient-reported outcomes in real-world practice.Dermatology (Basel, Switzerland). 2012;225(4):326-32.39. Forslund T, Raaschou P, Hjemdahl P, Krakau I, Wettermark B. Usage, risk, and benefit of weight-loss drugs in primary care. Journal of obesity. 2011;2011:459263.40. Troncoso A, Diogene E. Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia,Spain: the need to manage the introduction of new drugs. European journal of clinical pharmacology.2014;70(2):249-50.41. Thorne K, Jayathissa S, Dee S, Briggs N, Taylor J, Reid S, et al. Adherence and outcomes ofpatients prescribed dabigatran (Pradaxa) in routine clinical practice. Internal medicine journal.

2014;44(3):261-5.


43/51

: 43 / 51

42. Godman B, Wettermark B, Hoffmann M, Andersson K, Haycox A, Gustafsson LL. Multifacetednational and regional drug reforms and initiatives in ambulatory care in Sweden: global relevance.Expert review of pharmacoeconomics & outcomes research. 2009;9(1):65-83.43. Gustafsson LL, Wettermark B, Godman B, Andersen-Karlsson E, Bergman U, Hasselstrom J, etal. The 'wise list'- a comprehensive concept to select, communicate and achieve adherence torecommendations of essential drugs in ambulatory care in Stockholm. Basic & clinical pharmacology& toxicology. 2011;108(4):224-33.44. Garuoliene K AT, Marcinkevicius M. Pharmaceutical policy and the effects of the economic crisis:Lithuania. EuroHealth. 2011;17:1-4.45. Garuoliene K, Godman B, Gulbinovic J, Wettermark B, Haycox A. European countries with smallpopulations can obtain low prices for drugs: Lithuania as a case history. Expert review ofpharmacoeconomics & outcomes research. 2011;11(3):343-9.46. Voncina L, Strizrep T, Godman B, Bennie M, Bishop I, Campbell S, et al. Influence of demand-side measures to enhance renin-angiotensin prescribing efficiency in Europe: implications for thefuture. Expert review of pharmacoeconomics & outcomes research. 2011;11(4):469-79.47. Bennie M, Godman B, Bishop I, Campbell S. Multiple initiatives continue to enhance theprescribing efficiency for the proton pump inhibitors and statins in Scotland. Expert review ofpharmacoeconomics & outcomes research. 2012;12(1):125-30.48. Godman B, Bishop I, Finlayson AE, Campbell S, Kwon HY, Bennie M. Reforms and initiatives inScotland in recent years to encourage the prescribing of generic drugs, their influence andimplications for other countries. Expert review of pharmacoeconomics & outcomes research.2013;13(4):469-82.49. Woerkom M, Piepenbrink H, Godman B, Metz J, Campbell S, Bennie M, et al. Ongoing measuresto enhance the efficiency of prescribing of proton pump inhibitors and statins in The Netherlands:influence and future implications. Journal of comparative effectiveness research. 2012;1(6):527-38.50. Simoens S. A reviewof genericmedicine pricing in Europe. GaBI. 2012;1(1):8-12.51. Dylst P, Vulto A, Godman B, Simoens S. Generic medicines: solutions for a sustainable drugmarket? Applied health economics and health policy. 2013;11(5):437-43.52. Baumgrtel C GB, Malmstrm R, Andersen M et al. What lessons can be learned from the launchof generic clopidogrel? GaBI Journal. 2012;1(2):58-68.53. Markovic-Pekovic V, Skrbic R, Godman B, Gustafsson LL. Ongoing initiatives in the Republic ofSrpska to enhance prescribing efficiency: influence and future directions. Expert review ofpharmacoeconomics & outcomes research. 2012;12(5):661-71.54. vogler S. The impact of pharmaceutical pricing and reimbursement policies on generics uptake:implementation of policy options on generics in 29 European countriesan overview. BiosimilarsInitiative Journal (GaBI Journal). 2012;1(2):93-100.55. Dylst P, Vulto A, Simoens S. Tendering for outpatient prescription pharmaceuticals: what can belearned from current practices in Europe? Health policy (Amsterdam, Netherlands). 2011;101(2):146-52.56. Fraeyman J, Van Hal G, Godman B, Beutels P. The potential influence of various initiatives toimprove rational prescribing for proton pump inhibitors and statins in Belgium. Expert review ofpharmacoeconomics & outcomes research. 2013;13(1):141-51.57. PHARMAC. PHARMAC tender reveals vibrant market for pharmaceuticals:http://www.pharmac.health.nz/news/media-2014-02-12-tender/;2014.

58. PHARMAC. INVITATION TO TENDERSUPPLY OF PHARMACEUTICALS TO DHBHOSPITALS AND/OR TO COMMUNITY PHARMACIES.2012:http://www.pharmac.health.nz/assets/invitation-to-tender-2012-13.pdf.59. PHARMAC. Purchasing Medicineshttp://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013.60. Zeng W. A price and use comparison of generic versus originator cardiovascular medicines: ahospital study in Chongqing, China. BMC health services research. 2013;13(1):390.61. Yu X, Li C, Shi Y, Yu M. Pharmaceutical supply chain in China: current issues and implications forhealth system reform. Health policy (Amsterdam, Netherlands). 2010;97(1):8-15.62. Sun Q, Santoro MA, Meng Q, Liu C, Eggleston K. Pharmaceutical policy in China. Health affairs(Project Hope). 2008;27(4):1042-50.63. Ludt S, Campbell SM, Petek D, Rochon J, Szecsenyi J, van Lieshout J, et al. Which practicecharacteristics are associated with the quality of cardiovascular disease prevention in European

primary care? Implementation science : IS. 2013;8:27.64. Caires de Souza AL, de Assis Acurcio F, Guerra Junior AA, Rezende Macedo do Nascimento RC,Godman B, Diniz LM. Insulin glargine in a Brazilian state: should the government disinvest? An
http://www.pharmac.health.nz/news/media-2014-02-12-tender/;http://www.pharmac.health.nz/news/media-2014-02-12-tender/;http://www.pharmac.health.nz/assets/invitation-to-tender-2012-13.pdfhttp://www.pharmac.health.nz/assets/invitation-to-tender-2012-13.pdfhttp://www.pharmac.health.nz/assets/invitation-to-tender-2012-13.pdfhttp://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/infosheet-05-purchasing-medicines-2013.pdf2013http://www.pharmac.health.nz/assets/invitation-to-tender-2012-13.pdfhttp://www.pharmac.health.nz/news/media-2014-02-12-tender/;


44/51

: 44 / 51

assessment based on a systematic review. Applied health economics and health policy.2014;12(1):19-32.65. Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, et al. Efficacy and safety oflevetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the AsiaSKATE II Study. Epilepsy & behavior : E&B. 2010;18(1-2):100-5.66. Droz-Perroteau C, Dureau-Pournin C, Vespignani H, Marchal C, Blin P, Blazejewski S, et al. TheEULEV cohort study: rates of and factors associated with continuation of levetiracetam after 1 year.British journal of clinical pharmacology. 2011;71(1):121-7.67. Werhahn KJ, Klimpe S, Balkaya S, Trinka E, Kramer G. The safety and efficacy of add-onlevetiracetam in elderly patients with focal epilepsy: a one-year observational study. Seizure : the

journal of the British Epilepsy Association. 2011;20(4):305-11.68. Lo BW, Kyu HH, Jichici D, Upton AM, Akl EA, Meade MO. Meta-analysis of randomized trials onfirst line and adjunctive levetiracetam. The Canadian journal of neurological sciences Le journalcanadien des sciences neurologiques. 2011;38(3):475-86.69. Sabo A, Tomic Z, Stilinovic N, Milijasevic B, Mikov M, Vukmirovic S, et al. Consumption of serumlipid-reducing drugs in Serbia compared with Scandinavian countries: a population-based study,2004-2008. Pharmacoepidemiology and drug safety. 2011;20(1):45-9.70. Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, et al. Policies to enhanceprescribing efficiency in europe: findings and future implications. Frontiers in pharmacology.2010;1:141.71. Consortium SM. Bevacizumab.2014;http://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Search.72. NICE. Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid orcapecitabine for the treatment of metastatic colorectal cancer - TA212http://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212.73. NICE. Breast cancer - bevacizumab (in combination with a taxane) (TA214)http://guidance.nice.org.uk/TA214.74. NICE. Bevacizumab in combination with capecitabine for the first-line treatment of metastaticbreast cancer (TA263).http://guidance.nice.org.uk/TA263.75. NICE. Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment ofadvanced ovarian cancer (TA284)http://guidance.nice.org.uk/TA284.76. NICE. Colorectal cancer (metastatic) 2nd line - cetuximab, bevacizumab and panitumumab(review) (TA242)http://guidance.nice.org.uk/TA242.77.ConsortiumSM.Cetuximab.http://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximab.78. Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K, DeLapp D, et al. The implications ofchoice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronicconditions. Archives of internal medicine. 2006;166(3):332-7.79. Shrank WH, Fox SA, Kirk A, Ettner SL, Cantrell CH, Glassman P, et al. The effect of pharmacybenefit design on patient-physician communication about costs. Journal of general internal medicine.2006;21(4):334-9.80. Shrank WH, Joseph GJ, Choudhry NK, Young HN, Ettner SL, Glassman P, et al. Physicians'

perceptions of relevant prescription drug costs: do costs to the individual patient or to the populationmatter most? The American journal of managed care. 2006;12(9):545-51.81. Shrank WH, Stedman M, Ettner SL, DeLapp D, Dirstine J, Brookhart MA, et al. Patient, physician,pharmacy, and pharmacy benefit design factors related to generic medication use. Journal of generalinternal medicine. 2007;22(9):1298-304.82. Wladysiuk M, Araszkiewicz A, Godman B, Szabert K, Barbui C, Haycox A. Influence of patient co-payments on atypical antipsychotic choice in Poland: implications once generic atypicals areavailable. Applied health economics and health policy. 2011;9(2):101-10.83. Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologicand synthetic DMARDs across 46 European countries. Annals of the rheumatic diseases.2014;73(1):198-206.84. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, et al. Efficacy and safetyof dabigatran compared with warfarin at different levels of international normalised ratio control for

stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010;376(9745):975-83.
http://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Searchhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Searchhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Searchhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Searchhttp://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212http://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212http://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212http://guidance.nice.org.uk/TA214http://guidance.nice.org.uk/TA214http://guidance.nice.org.uk/TA263http://guidance.nice.org.uk/TA263http://guidance.nice.org.uk/TA263http://guidance.nice.org.uk/TA284http://guidance.nice.org.uk/TA284http://guidance.nice.org.uk/TA284http://guidance.nice.org.uk/TA242http://guidance.nice.org.uk/TA242http://guidance.nice.org.uk/TA242http://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?p=0&r=20&q=cetuximabhttp://guidance.nice.org.uk/TA242http://guidance.nice.org.uk/TA284http://guidance.nice.org.uk/TA263http://guidance.nice.org.uk/TA214http://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212http://publications.nice.org.uk/bevacizumab-in-combination-with-oxaliplatin-and-either-fluorouracil-plus-folinic-acid-or-ta212http://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Searchhttp://www.scottishmedicines.org.uk/General/Homepage_Search_Results?q=bevacizumab&Submit=Search


45/51

: 45 / 51

85. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ (Clinical research ed).1998;317(7160):703-13.86. Kontopantelis E, Reeves D, Valderas JM, Campbell S, Doran T. Recorded quality of primary carefor patients with diabetes in England before and after the introduction of a financial incentive scheme:a longitudinal observational study. BMJ quality & safety. 2013;22(1):53-64.87. Ose D, Rochon J, Campbell SM, Wensing M, van Lieshout J, Uhlmann L, et al. Secondaryprevention in patients with coronary heart diseases: what factors are associated with health status inusual primary care? PloS one. 2012;7(12):e51726.88. Kiviniemi V, Peura P, Helin-Salmivaara A, Martikainen JE, Hartikainen J, Huupponen R, et al.Suboptimal use of statins at treatment initiation. European journal of clinical pharmacology.2011;67(9):971-3.89. Feely J, Bennett K. Epidemiology and economics of statin use. Irish medical journal.2008;101(6):188-91.90. Hovstadius TS, Petterson G, Astrand B. Prevalence and therapeutic intensity of dispensed druggroups for individuals with multiple medications: a register-based study of 2.2 million individuals.JPHSR. 2010;1:14555.91. Mimica Matanovic S, Vlahovic-Palcevski V. Potentially inappropriate medications in the elderly: acomprehensive protocol. European journal of clinical pharmacology. 2012;68(8):1123-38.92. Popovic B, Quadranti NR, Matanovic SM, Lisica ID, Ljubotina A, Duliba DP, et al. Potentiallyinappropriate prescribing in elderly outpatients in Croatia. European journal of clinical pharmacology.2014.93. Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity andimplications for health care, research, and medical education: a cross-sectional study. Lancet.2012;380(9836):37-43.94. Patterson SM, Hughes C, Kerse N, Cardwell CR, Bradley MC. Interventions to improve theappropriate use of polypharmacy for older people. The Cochrane database of systematic reviews.2012;5:Cd008165.95. Lewis T. Using the NO TEARS tool for medication review. BMJ (Clinical research ed).2004;329(7463):434.96. Matanovic SM, Vlahovic-Palcevski V. Potentially inappropriate prescribing to the elderly:comparison of new protocol to Beers criteria with relation to hospitalizations for ADRs. European

journal of clinical pharmacology. 2014;70(4):483-90.97. Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. The American journal ofgeriatric pharmacotherapy. 2007;5(4):345-51.98. Maher RL, Hanlon J, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert opinionon drug safety. 2014;13(1):57-65.99. Koh Y, Kutty FB, Li SC. Drug-related problems in hospitalized patients on polypharmacy: theinfluence of age and gender. Therapeutics and clinical risk management. 2005;1(1):39-48.100. Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medicationsdefined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Archivesof internal medicine. 2011;171(11):1013-9.101. Scotland N. Polypharmacy Quick Reference Guidance for Clinicians:http://www.qihub.scot.nhs.uk/media/458907/polypharmacy_guidance_for_clinicians_october2012.pdf;

October 2012.102. Ghibelli S, Marengoni A, Djade CD, Nobili A, Tettamanti M, Franchi C, et al. Prevention ofinappropriate prescribing in hospitalized older patients using a computerized prescription supportsystem (INTERcheck((R))). Drugs & aging. 2013;30(10):821-8.103. Coma A, Zara C, Godman B, Agusti A, Diogene E, Wettermark B, et al. Policies to enhance theefficiency of prescribing in the Spanish Catalan region: impact and future direction. Expert review ofpharmacoeconomics & outcomes research. 2009;9(6):569-81.104. Norman C, Zarrinkoub R, Hasselstrom J, Godman B, Granath F, Wettermark B. Potentialsavings without compromising the quality of care. International journal of clinical practice.2009;63(9):1320-6.105. Wettermark B, Bergman U, Krakau I. Using aggregate data on dispensed drugs to evaluate thequality of prescribing in urban primary health care in Sweden. Public health. 2006;120(5):451-61.106. Wettermark B, Pehrsson A, Jinnerot D, Bergman U. Drug utilisation 90% profiles--a useful tool

for quality assessment of prescribing in primary health care in Stockholm. Pharmacoepidemiology anddrug safety. 2003;12(6):499-510.
http://www.qihub.scot.nhs.uk/media/458907/polypharmacy_guidance_for_clinicians_october2012.pdf;http://www.qihub.scot.nhs.uk/media/458907/polypharmacy_guidance_for_clinicians_october2012.pdf;http://www.qihub.scot.nhs.uk/media/458907/polypharmacy_guidance_for_clinicians_october2012.pdf;


46/51

: 46 / 51

107. Conrad DA, Perry L. Quality-based financial incentives in health care: can we improve quality bypaying for it? Annual review of public health. 2009;30:357-71.108. Eijkenaar F, Emmert M, Scheppach M, Schoffski O. Effects of pay for performance in healthcare: a systematic review of systematic reviews. Health policy (Amsterdam, Netherlands).2013;110(2-3):115-30.109. Olsson E, Ingman P, Ahmed B, Kalvemark Sporrong S. Pharmacist-patient communication inSwedish community pharmacies. Research in social & administrative pharmacy : RSAP.2014;10(1):149-55.110. Olsson E, Kalvemark Sporrong S. Pharmacists' experiences and attitudes regarding genericdrugs and generic substitution: two sides of the coin. The International journal of pharmacy practice.2012;20(6):377-83.111. Wales NHSEa. Electronic Drug Tariff. 2014:http://www.ppa.org.uk/edt/April_2014/mindex.htm.112. Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ, et al. Protocol for the New MedicineService Study: a randomized controlled trial and economic evaluation with qualitative appraisalcomparing the effectiveness and cost effectiveness of the New Medicine Service in communitypharmacies in England. Trials. 2013;14:411.113. Society RP. Medicines Use Review.http://wwwrpharmscom/health-campaigns/medicines-use-reviewasp.2014.114. NHS. Q&A about the New Medicine Service (NMS).http://wwwnhsuk/NHSEngland/AboutNHSservices/pharmacists/Pages/medicine-service-qaaspx.2014.115. PSNC. NMS and MURstop tips from community pharmacieshttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuary2014.116. Cumbria N. Clinical Medication Review:http://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;2013.117. WHO. WHO Guideline on Country Pharmaceutical Pricing Policies.2013:http://www.who.int/childmedicines/publications/WHO_GPPP.pdf.118. Ferrario A KP. Managed entry agreements for pharmaceuticals: The European experience: LSE;2013 [citedhttp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf] .119. Leopold C, Vogler S, Mantel-Teeuwisse AK, de Joncheere K, Leufkens HG, Laing R. Differencesin external price referencing in Europe: a descriptive overview. Health policy (Amsterdam,Netherlands). 2012;104(1):50-60.120. Vogler S, Zimmermann N, Habl C, Piessnegger J, Bucsics A. Discounts and rebates granted topublic payers for medicines in European countries. Southern med review. 2012;5(1):38-46.121. Mitka M. Ezetimibe prescribing fails to keep up with evidence. JAMA : the journal of the

American Medical Association. 2014;311(13):1279-80.122. Godman B, Schwabe U, Selke G, Wettermark B. Update of recent reforms in Germany toenhance the quality and efficiency of prescribing of proton pump inhibitors and lipid-lowering drugs.PharmacoEconomics. 2009;27(5):435-8.123. Jnsson B RS, Wilking N. Cost effectiveness in practice and its effect on clinical outcomes.Journal of Cancer Policy 2014;2:1221.124. Rawlins M. Paying for modern cancer care--a global perspective. The lancet oncology.2007;8(9):749-51.

125. Kesselheim AS. Rising health care costs and life-cycle management in the pharmaceuticalmarket. PLoS medicine. 2013;10(6):e1001461.126. Vernaz N, Haller G, Girardin F, Huttner B, Combescure C, Dayer P, et al. Patented drugextension strategies on healthcare spending: a cost-evaluation analysis. PLoS medicine.2013;10(6):e1001460.127. Adamski J, Godman B, Ofierska-Sujkowska G, Osinska B, Herholz H, Wendykowska K, et al.Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations forEuropean payers. BMC health services research. 2010;10:153.128. Williamson S. Patient access schemes for high-cost cancer medicines. The lancet oncology.2010;11(2):111-2.129. Cohen P FA. Are payers treating orphan drugs differently? Journal of Market Access & HealthPolicy 2014;2:23513 -http://dx.doi.org/10.3402/jmahp.v2.130. Drummond M, Towse A. Orphan drugs policies: a suitable case for treatment. The European

journal of health economics : HEPAC : health economics in prevention and care. 2014;15(4):335-40.131. Cote A, Keating B. What is wrong with orphan drug policies? Value in health : the journal of theInternational Society for Pharmacoeconomics and Outcomes Research. 2012;15(8):1185-91.
http://www.ppa.org.uk/edt/April_2014/mindex.htmhttp://www.ppa.org.uk/edt/April_2014/mindex.htmhttp://www.ppa.org.uk/edt/April_2014/mindex.htmhttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://wwwnhsuk/NHSEngland/AboutNHSservices/pharmacists/Pages/medicine-service-qaaspxhttp://wwwnhsuk/NHSEngland/AboutNHSservices/pharmacists/Pages/medicine-service-qaaspxhttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;http://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;http://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;http://www.who.int/childmedicines/publications/WHO_GPPP.pdfhttp://www.who.int/childmedicines/publications/WHO_GPPP.pdfhttp://www.who.int/childmedicines/publications/WHO_GPPP.pdfhttp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf%5dhttp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf%5dhttp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf%5dhttp://dx.doi.org/10.3402/jmahp.v2http://dx.doi.org/10.3402/jmahp.v2http://dx.doi.org/10.3402/jmahp.v2http://dx.doi.org/10.3402/jmahp.v2http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf%5dhttp://www.who.int/childmedicines/publications/WHO_GPPP.pdfhttp://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;http://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/Guidelines/MedicationReview-PracticeGuide2011.pdf;http://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://psnc.org.uk/wp-content/uploads/2014/01/NMS-and-MUR-top-tips-Jan-2014.pdfJanuaryhttp://wwwnhsuk/NHSEngland/AboutNHSservices/pharmacists/Pages/medicine-service-qaaspxhttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://wwwrpharmscom/health-campaigns/medicines-use-reviewasphttp://www.ppa.org.uk/edt/April_2014/mindex.htm


47/51

: 47 / 51

132. New 50 million pound cancer fund already intellectually bankrupt. Lancet. 2010;376(9739):389.133. Collins M, Latimer N. NICE's end of life decision making scheme: impact on population health.BMJ (Clinical research ed). 2013;346:f1363.134. Marshall H. UK Cancer Drugs Fund receives 400 million boost. The Lancet. 2013;14:e494.135. Godman B. EditorialHealth authority perspective on biosimilars. GaBI Journal. 2013;2(1):10-1.136. Wild C, Simpson S, Douw K, Geiger-Gritsch S, Mathis S, Langer T. Information service on newand emerging health technologies: identification and prioritization processes for a European union-wide newsletter. International journal of technology assessment in health care. 2009;25 Suppl 2:48-55.137. Packer C, Fung M, Stevens A. Analyzing 10 years of early awareness and alert activity in theUnited kingdom. International journal of technology assessment in health care. 2012;28(3):308-14.138. Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest amongpanel members producing clinical practice guidelines in Canada and United States: cross sectionalstudy. BMJ (Clinical research ed). 2011;343:d5621.139. Allen D, Harkins KJ. Too much guidance? Lancet. 2005;365(9473):1768.140. Lima-Dellamora ED, Caetano R, Gustafsson LL, Godman BB, Patterson K, Osorio-de-CastroCG. An Analytical Framework for Assessing Drug and Therapeutics Committee Structure and WorkProcesses in Tertiary Brazilian Hospitals. Basic & clinical pharmacology & toxicology. 2014.141. Kathleen Holloway TG. Drug and Therapeutics Committees: A practical guide:http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf;2003.142. Jack A. Drug Development. Compound interests: how a partnership between academics and adrug company came unstuck. BMJ (Clinical research ed). 2013;347:f5356.143. Holbrook A, Lexchin J, Pullenayegum E, Campbell C, Marlow B, Troyan S, et al. What doCanadians think about physician-pharmaceutical industry interactions? Health policy (Amsterdam,Netherlands). 2013;112(3):255-63.144. Godman B, Gustafsson LL. A new reimbursement system for innovative pharmaceuticalscombining value-based and free market pricing. Applied health economics and health policy.2013;11(1):79-82.145. Yu SY, Yang BM, Kim JH. New anti-rebate legislation in South Korea. Applied health economicsand health policy. 2013;11(4):311-8.146. Davis C, Abraham J. Is there a cure for corporate crime in the drug industry? BMJ (Clinicalresearch ed). 2013;346:f755.147. J A. Pharmaceuticalization of Society in Context: Theoretical, Empirical and Health Dimensions.Sociology 2010;44:603-22.148. Pharma E. Surveying Tomorrows BioPharma Landscape. The NASDAQ Biotech Index Up Closehttp://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012.149. Belfrits G. The case for biosimilarsa payers persective. GaBI Journal. 2013;2(1):12.150. Laslop A. Biosimilar monoclonal antibodieschallenges and opportunities in Europe. Genericsand Biosimilars Initiative Journal. 2013;2(3):110-1.151. Commission E. What you need to know about Biosimilar Medicinal Products. A consensusinformation document:http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf; 2013.152. C B. Austria increases dialogue in order to involve physicians more with biosimilars. GaBI

Journal. 2013;1:8.153. Declerck P SS. A European perspective on the market accessibility of biosimilars. Biosimilars2012;2:33-40.154. M A. Biosimilars in oncology: current and future perspectives. GaBI Journal. 2013;2(2):91-4.155. Organisation WH. Drug and therapeutics committees - a practical guidehttp://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf2003.156. Medicines WPPo. Promoting rational use of medicines: core components.http://appswhoint/medicinedocs/pdf/h3011e/h3011epdf.2003.157. Godman B, Wettermark B, Miranda J, Bennie M, Martin A, Malmstrom RE. Influence of multipleinitiatives in Sweden to enhance ARB prescribing efficiency following generic losartan; findings andimplications for other countries. International journal of clinical practice. 2013;67(9):853-62.158. Federation Cot. Premier drives Health Innovation:http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;2012.

159. Godman B AM, Vitry A, Abdu S, Bennie M, Bishop I et al. Payers endorse generics to enhanceprescribing efficiency; impact and future implications, a case history approach. GaBI. 2012;1(2):21-35.
http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf;http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf;http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf;http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf;http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf2003http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf2003http://appswhoint/medicinedocs/pdf/h3011e/h3011epdfhttp://appswhoint/medicinedocs/pdf/h3011e/h3011epdfhttp://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://www.conseildelafederation.ca/en/latest-news/15-2012/141-premiers-drive-health-innovation;http://appswhoint/medicinedocs/pdf/h3011e/h3011epdfhttp://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf2003http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf;http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf2012http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf;


48/51

: 48 / 51

160. Godman B BM, Baumgrtel C, Sovi Brkii L et al. Essential to increase the use of generics inEurope to maintain comprehensive healthcare? Farmeconomia: Health Economics and TherapeuticPathways 2012;13 (Suppl 3):5-20.161. Duerden MG, Hughes DA. Generic and therapeutic substitutions in the UK: are they a goodthing? British journal of clinical pharmacology. 2010;70(3):335-41.162. Ferner RE, Lenney W, Marriott JF. Controversy over generic substitution. BMJ (Clinical researched). 2010;340:c2548.163. Lester H, Campbell S. Developing Quality and Outcomes Framework (QOF) indicators and theconcept of 'QOFability'. Quality in primary care. 2010;18(2):103-9.164. Kwon HY, Hong JM, Godman B, Yang BM. Price cuts and drug spending in South Korea: thecase of antihyperlipidemic agents. Health policy (Amsterdam, Netherlands). 2013;112(3):217-26.165. Vogler S, Zimmermann N, Leopold C, de Joncheere K. Pharmaceutical policies in Europeancountries in response to the global financial crisis. Southern med review. 2011;4(2):69-79.166. Development and validation of an international appraisal instrument for assessing the quality ofclinical practice guidelines: the AGREE project. Quality & safety in health care. 2003;12(1):18-23.167. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is "quality ofevidence" and why is it important to clinicians? BMJ (Clinical research ed). 2008;336(7651):995-8.168. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framingthe question and deciding on important outcomes. Journal of clinical epidemiology. 2011;64(4):395-400.169. Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, et al. Going from evidence torecommendations. BMJ (Clinical research ed). 2008;336(7652):1049-51.170. Campbell SM, Kontopantelis E, Hannon K, Burke M, Barber A, Lester HE. Framework andindicator testing protocol for developing and piloting quality indicators for the UK quality and outcomesframework. BMC family practice. 2011;12:85.171. Garattini S, Bertele V, Godman B, Haycox A, Wettermark B, Gustafsson LL. Enhancing therational use of new medicines across European health care systems. European journal of clinicalpharmacology. 2008;64(12):1137-8.172. Health MSf. National Medicine Policy:http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;2012.173. Process on Corporate Social Responsibility in the Field of Pharmaceuticals - Platform on Accessto Medicines in Europe. Working Group on Mechanism of Coordinated Access to Orphan MedicinalProducts (MoCA-OMP)http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/orphans_conlusions_en.pdf; 2012.174. Claudia Habl FB. EMINET - Initial investigation to assess the feasibility of a coordinated systemto access orphan medicineshttp://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011.175. Andersson K, Sonesson C, Petzold M, Carlsten A, Lonnroth K. What are the obstacles to genericsubstitution? An assessment of the behaviour of prescribers, patients and pharmacies during the firstyear of generic substitution in Sweden. Pharmacoepidemiology and drug safety. 2005;14(5):341-8.176. Andersson KA, Petzold MG, Allebeck P, Carlsten A. Influence of mandatory generic substitutionon pharmaceutical sales patterns: a national study over five years. BMC health services research.2008;8:50.
http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/orphans_conlusions_en.pdf;http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/orphans_conlusions_en.pdf;http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/access_orphans_initialinvest_052011_en.pdf2011http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/orphans_conlusions_en.pdf;http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;http://www.msh.org/sites/msh.org/files/mds3-ch04-national-medicine-plan-mar2012.pdf;


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