Evidence Based Prescribing:

Transcription

1 Evidence Based Prescribing: Myths, Realities, and Strategies for Practice Elissa Ladd, PhD, RN, FNP BC MGH Institute of Health Professions

2 Safety Cost Efficacy Drugs save lives and improve health when used appropriately and rationally All drugs have risks New drugs are inherently more risky Over 25 years, 1 in 5 new drugs was withdrawn or acquired a black box warning Half of black box warning occurred within 7 years of drug introduction Half of withdrawals occurred within two years of approval Lasser et al. JAMA 2002;287(17):2215; Wolfe, 2005

3 Between 1997 and 2002 prescription drug expenses increased from 14% to 23% of total health care expenses In 2002, average expenses for Rx drugs were about $1,100 per person (75% higher than 1997) In 2002, average out of pocket expenses for prescription drugs were about 50% higher than in 1997 ( More than 90% of persons 65 years old used a least one medication per week More than 40% used at least 5 medications per week 12% used at least 10 medications per week Kaufman DW. JAMA 2002;287:337

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5 Kaiser Family Foundation,(2008). Views on Prescription Drugs and the Pharmaceutical Industry. Available at: Introduction of new drugs New patented brand name drugs are more costly than older generic drugs Proliferation of Me Too drugs Mirror isomers of the original drug Negligible difference between old and new version Claritin (loratidine) and Clarinex (desloratidine) Celexa (citalopram) and Lexapro (escitalopram) Prilosec (omeprazole) and Nexium (esomeprazole) Developed in response to patent expirations of profitable drug classes

6 Drug Cost: Other Factors Drug marketing 8 of the 9 major drug companies spent twice as much on marketing and advertising than R & D (Families USA, 2001; Angell, 2004) Pharmaceutical companies spend $12 15 billion annually (Brennan et al., 2006) For comparison, the 2007 NIH budget is $29 billion (Fugh Berman, 2007)

7 Gagnon, M. & Lexchin, J. (2008). The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in the US. Plos Medicine, 5(1): e1. doi: /journal.pmed Other Major Factors: Aging population Demographic trends: medications for chronic illnesses Increasing reliance on pharmacologic solutions Increasing use of lifestyle drugs

8 ALLHAT Study (2002): chlorothiazide was superior to new drugs re: safety and efficacy ENHANCE Study (2008): Zetia (ezetimibe) reduced cholesterol by % but caused no reduction in atherosclerotic plaque

9 Evidence Based Prescribing is the conscientious, explicit, and judicious use of current best evidence in making [prescribing] decisions about the care of individual patients. (Sackett, Rosenberg, & Gray, 1996) Evidence sources: the unwitting use of biased information Patient Expectations: does the patient expect to leave with a prescription? Antibiotics Drugs that they have seen on TV Defensive untargeted prescribing: Antibiotics just in case the patient has strep Source: British Medical Association Board of Science (2007). Evidence Based Prescribing.

10 Pharmaceutical Marketing: Detailing Samples Meals Industry sponsored continuing education programs Leads prescribers to prescribe drugs that differ from their preferred choices (Chren et al., 2000) Decreases the likelihood that they will follow guidelines (Chren et al., 2000) Source: British Medical Association Board of Science (2007). Evidence Based Prescribing. Studies consistently show that promotion increases prescribing * Studies consistently show that physicians and nurse practitioners do not believe that promotion affects their prescribing** *Chren MM et al. JAMA 1994 Mar 2;271(9):684 9; Lurie N et al. J Gen Int Med 1990;5: ; Wazana A. JAMA 2000 Jan 19;283(3): **Sigworth SK et al. JAMA. 2001;286(9): McKinney WP et al. JAMA 1990;264(13):1693 7; Crigger, N., Barnes, K., Junko, A., Rahal, S., & Sheek, C. (2009). Nurse practitioners' perceptions and participation in pharmaceutical marketing. Journal of Advanced Nursing, 65(3),

11 Rapid proliferation of market based sources of information in the 1980s 1990s Increasing concern about the quality of this information by leading medical and policy based individuals and groups Academic Detailing term coined 25 years ago Avorn and Soumerai (1983). Improving therapy decisions through educational outreach: a randomized clinically controlled trial of academically based detailing. New England Journal of Medicine, 308, Academic Detailing Also known as prescriber education and outreach Practice of sending highlytrained clinicians to prescribers practices in order to discuss objective, comparative, evidence based information on benefits, risks and costeffectiveness of commonly used drugs Lisa Stallings, BSN, RN, Academic Detailing Manager and Lock-In Program Manager, provides clinical updates during an educational seminar for HID Pharmacy Services Medicaid Provider in 20 states.

12 Specifically, Academic Detailing programs: Operate independent of drug companies and are located in a medical school or school of pharmacy Provide unbiased, balanced, evidencebased information to prescribers regarding the safety and efficacy of drugs Employs physicians, pharmacists, nurses and other clinical professionals to give prescribers reliable guidance on potential benefits and possible harms of specific drugs Prescription Project, 2007 Use one to one interactions tailored to meet the needs of individual prescribers in their own practice settings Help promote appropriate prescribing habits and costeffectiveness so that access to quality care and health of patients will be enhanced Prescription Project, 2007

13 Current programs: MA VT PA ME DC NH SC Federal legislation passes with Health Care Reform: Sunshine Act provisions Strategies: How do we evaluate what is the current best evidence? What is the quality of the information? Is the information produced by independent unbiased sources? Was the information produced as a way to market a product? Who funded the study? ( follow the money ) Who funded the program? (CE/CME)

14 Evidence Based Prescribing Resources: How do I translate this to my practice? Consumer Reports Health Best Buy Drugs Public education project of Consumers Union (independent non profit group) Goal: to provide access to needed medicines for all Americans Increase awareness of affordable and proven alternatives to high cost medications

15 Comprehensive comparative scientific analysis of commonly used drug classes Funded in part by a grant from the Institute of Medicine Drug Effectiveness Review Project (DERP) program of public and private organizations and multiple states to evaluate drug effectiveness Used by state and federal gov t to inform policy Evaluation teams have no financial interest in any pharmaceutical company or product

16 Quality of the science Drug effectiveness and safety Side effects Convenience of use Cost in comparison to other drugs in the same class Common but not exclusive recommendation of generic drug alternatives

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20 buy drugs/index.htm RxFacts.org independent drug information service Funded by the Pennsylvania Department of Aging Information for health professionals and patients Academic detailing program

21 Medical Letter independent organization that provides treatment guidelines and information on drugs Subscription No ads or other monies from pharmaceutical industry

22 Prescriber Letter Independent source of information without ads or financial from pharmaceutical companies Sponsored by the American Academy of Family Physicians The Cochrane Library Goal is to improve healthcare decision making globally, through systematic reviews of the effects of healthcare interventions Relies on grants and does not take conflicted funding

23 Based on research of head to head comparisons of health care interventions, ie pharmaceutical treatments Clinician Guides: Oral medications for Type II DM Choosing antidepressants for adults Non opioid analgesics for osterarthritis Choosing medications for adults with RA

24 Documented long term safety and efficacy: JAMA No difference between brand and generic cardiovascular drugs, including those in NTI classes. Kesselheim, et al. (2008). Clinical equivalence of generic and brand name drugs used in cardiovascular disease: A systematic review and metaanalysis. Journal of the American Medical Association. 11 articles studied Warfarin/Coumadin 6 prospective studies the generic performed similar with respect to clinical endpoints such as number of required dose adjustments and adverse events 5 retrospective studies evaluated outcomes using pre/post test design and found no clinical outcome differences 1 found small but clinically significant decrease in INR in patients, but no increase in morbidity or mortality 1 retrospective study found increased health care utilization, but the comparator was not rated bioequivalent by FDA

25 The Wal Mart $4 Drug Program Over 350 generic medications $4 per prescription or $10 for a 90 day supply

26 Target Walgreens CVS Kroger Cost: still very much an issue! Uninsured: may be an issue 200% federal poverty level Income Premium Subsidy Difference Single $21,660 $3500 $2135 $1365 Family $44,100 $9434 $6656 $2778 Premium: capped at 6.3% of income Penalty: no more than 2.5% of income Source: NYTimes, April 20, 2010

27 Donut Hole smaller but still a factor Sunshine Provisions: mandates reporting of all payments made to physicians by pharmaceutical and medical device companies consulting fees, food, travel, education, research, etc. Does not include other provider language, ie NPs, PAs

28 If I learned that my doctor was getting his(her) information from industry paid lecturers, in seminars sponsored by drug companies, or from reprints selectively given to him(her) from drug reps, I d get another doctor. Dr. Jerome Kassirer, Former Editor, New England Journal of Medicine Safety Cost Efficacy

29 Questions? Contact info: