title: International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry - a systematic review.
abstract: OBJECTIVE
  To review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry.
  
  
  METHODS
  Systematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients' or providers' behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group. The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented.
  
  
  RESULTS
  A total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as non-essential drugs, and without adequate exemptions they affect vulnerable groups disproportionately. The majority of studies relating to doctors evaluated the effects of educational approaches (78 studies), reimbursement restrictions (48 studies) and incentive systems (22 studies). Evidence on these policies is of mixed quality. It appears possible to influence prescribing modestly, through various means, but it is essential that messages to prescribers are based on good evidence of effectiveness and cost-effectiveness. Twenty-nine studies related to industry regulation, and they were of mixed quality. Evidence from studies of reference pricing suggests that this may result in cost savings. These are, however, achieved not by companies reducing or restraining prices, or by reductions in the overall volume of prescriptions, but by some shifts in use and shifting costs to patients, with consequent adverse effects on the equity of access to medicines. Other price and profit controls remain almost completely lacking in evaluative evidence.
  
  
  CONCLUSIONS
  It may be that the undesirable consequences of policies influencing patients, particularly user charges, can outweigh the benefits. To influence demand for pharmaceuticals, it is more appropriate to influence prescribing doctors and although interventions to improve prescribing practice have been developed, they often achieve relatively modest benefits and sometimes at high cost. Good evaluative evidence related to industry regulation is scarce despite its policy importance.
authors.affiliation: Assistant Professor, College of Pharmacy, Yeungnam University, Gyeongsan, South Korea.
authors.forename: Iyn-Hyang
authors.initials: IH
authors.lastname: Lee
authors.affiliation: Professor of Health Economics and Policy, Department of Health Sciences, University of York, York, UK karen.bloor@york.ac.uk.
authors.forename: Karen
authors.initials: K
authors.lastname: Bloor
authors.affiliation: Senior Statistician, Department of Health Sciences, University of York, York, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: Professor of Health Economics, Department of Health Sciences, University of York, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Maynard
mesh_terms: D003132:Commerce; D003363:Cost Control; D017047:Cost Sharing / Q000706:statistics & numerical data; D016527:Drug Costs / Q000706:statistics & numerical data*; D004363:Drug Utilization / Q000191:economics*; D004502:Education, Medical, Continuing / Q000706:statistics & numerical data; D005252:Fees, Pharmaceutical / Q000706:statistics & numerical data*; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000706:statistics & numerical data; D011787:Quality of Health Care / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: Pharmaceutical policy; pharmaceutical industry; prescribing; systematic review; user charges
references.citation: BMJ. 2011 Jun 28;342:d3590
references.pmid: 21712336
references.citation: J Health Serv Res Policy. 2006 Jan;11(1):27-31
references.pmid: 16378529
references.citation: Health Policy. 1994 Jan 15;26(3):191-206
references.pmid: 10133131
references.citation: BMJ. 1993 Nov 6;307(6913):1186-9
references.pmid: 8251847
references.citation: Int J Health Serv. 2004;34(1):101-22
references.pmid: 15088676
references.citation: J Eval Clin Pract. 2007 Jun;13(3):369-73
references.pmid: 17518801
references.citation: Pharmacoeconomics. 1999 Mar;15(3):291-303
references.pmid: 10537436
references.citation: J Eval Clin Pract. 2012 Apr;18(2):262-8
references.pmid: 21040251
references.citation: Health Policy. 2003 Sep;65(3):269-75
references.pmid: 12941494
references.citation: Health Policy. 2006 Dec;79(2-3):337-44
references.pmid: 16549221
references.citation: Am J Manag Care. 2006 Sep;12(9):509-17
references.pmid: 16961440
references.citation: Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005979
references.pmid: 16625648
references.citation: BMJ. 1996 Jun 8;312(7044):1469-71
references.pmid: 8664631
references.citation: Fam Pract. 2008 Feb;25(1):27-32
references.pmid: 18245796
references.citation: N Engl J Med. 2006 Jul 27;355(4):375-84
references.pmid: 16870916
references.citation: N Engl J Med. 2008 Mar 27;358(13):1354-61
references.pmid: 18367738
references.citation: Soc Sci Med. 1991;33(6):681-7
references.pmid: 1957188
references.citation: JAMA. 2001 Dec 19;286(23):2988-92
references.pmid: 11743840
references.citation: N Engl J Med. 1991 Oct 10;325(15):1072-7
references.pmid: 1891009
references.citation: Health Aff (Millwood). 1994 Summer;13(3):98-111
references.pmid: 7927165
references.citation: Br J Gen Pract. 2000 Apr;50(453):271-5
references.pmid: 10897509
references.citation: Health Policy. 2007 May;81(2-3):376-84
references.pmid: 16945449
references.citation: Health Serv Res. 2005 Oct;40(5 Pt 1):1297-317
references.pmid: 16174135
references.citation: Am J Manag Care. 2011 Jan;17(1):79-86
references.pmid: 21348571
references.citation: Clin Ther. 2012 Mar;34(3):632-9
references.pmid: 22381716
references.citation: BMJ. 1996 Jul 6;313(7048):33-5
references.pmid: 8664771
references.citation: Health Serv Res. 1995 Dec;30(5):672-85
references.pmid: 8537226
references.citation: BMJ. 1996 Jun 15;312(7045):1525-7
references.pmid: 8646148
references.citation: Health Serv Res. 2006 Oct;41(5):1876-94
references.pmid: 16987306