The following presentation contains some items that are covered by copyright and are used under Fair Use for education and the federally legislated TEACH Act. Any use for other purposes must follow U.S. copyright rules. Click to edit Master title style The contents of this module are accurate at the timeMaster of publication. Click to edit subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Case Your patient does not get relief from the generic medication you prescribed Click to edit Master title style You trytotoedit substitute medication Click Master asubtitle style from another class that is only available in a name brand UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Organizational Influences on Click to edit Master title style Click to edit Master title Prescribing style Click to edit Master text styles Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Objectives Review the principles of evidence-based formulary development Describe how pharma influences organizations Click to edit Master title style Describe and examine the impact of organizational influences on prescribing Clickpractical to edit Master style Identify ways forsubtitle prescribers to address organizational influences Communicate relevant issues for patient care UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Case You complete the prior authorization (PA) paperwork Click to edit Master title style Patient gets the name brand medication, but at a higher co-pay Click to edit Master subtitle style The patient wonders why this is true, how these decisions are made, if one is really better than the other UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Organizational Influences – Home institution – Insurances Click to edit Master title style – Government – Professional societies Click to edit Master subtitle style – Pharmaceutical companies and chains UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Some Formulary Characteristics Pros • Reduce cost • Improve quality • Simplify Clickdelivery to edit Cons Paperwork Master• title style • Confusion • Frustration Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Principles of Evidence-Based Drug Formularies Click to edit Master title style Click to edit Master subtitle style Garber, AM. Health Affairs. 2001;20(5):62-82; Simon GE, et al. J Gen Intern Med. 2005;20:964-968. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE The Preferred Formulary Statins from 4 Large Pharmacy Benefit Managers (PBMs) Brand Drugs (manufacturer) Crestor Lescol/XL (Astra) (Novartis) PBMs Generic Lipitor (Pfizer) Pravachol (BMS) X X Zocor (Merck) Lovastatin Click to edit X Master title XstyleX Aetna Caremark X X Click to edit Master subtitle style Express Scripts Medco X X X X X X X Federal Trade Commission. Pharmacy benefit managers: ownership of mail-order pharmacies. 2005, Aug. Available at: http://www.ftc.gov/reports/pharmbenefit05/050906pharmbenefitrpt.pdf Accessed March 15, 2007. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Players in the U.S. Commercial Drug Supply Chain Premium CONSUMER Member Cost Share or Payment for Drug if Cash Pay Negotiated Payment EMPLOYER/PLAN SPONSOR OR HEALTH INSURER Payment Flow Rebate Flow Click to edit Master title style PHARMACY BENEFITS MANAGER PHARMACY (Retail, Mail-order) Product Flow Click to edit Master subtitle style DRUG MANUFACTURER Prompt Pay Volume Discounts Negotiated Payment DRUG WHOLESALER/ DISTRIBUTER Kaiser Family Foundation. Follow the pill: understanding the U.S. commercial pharmaceutical supply chain. 2005. Available at: http://www.kff.org/rxdrugs/7296.cfm Accessed October, 2006. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Conflicting Formularies Out-Patient Click to edit Master title style Hospital-Based Formulary X = Formulary Click to edit Master subtitle style This may be frustrating and confusing… UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Preferred Formulary Status Influences Medication Use Patient Response to Change in the Formulary’s Preferred Statins Click to edit Master title style Patients whose Statin Remained Preferred 4.0% Discontinued Use of All Statins 9.1% Patients whose Statin Lost Preferred Status 8.0% Sw itched to a Preferred Drug 48.5% Click to edit Master subtitle style 88.0% Remained on Drug 42.4% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Huskamp HA, et al. N Engl J Med. 2003;349(23):2224-2232. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Formularies Pros • Contain costs • Easy access to Cons proven meds • Subject change Click to edit Master titleto style • Prescribers waste time • Allows for quality control and • Patients waste time and money improvement Click to edit Master subtitle style • Patient safety is compromised UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Government Influences U.S. Department of Health and Human Services Food and Drug Administration Click to edit Master title style Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Veterinary Medicine National Center for Toxicological Research Click to edit Master subtitle style Food and Drug Administration. Available at: www.fda.gov Accessed February 27, 2008. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Government Influences Provides oversight of the Medicaid rebate program and anti-kickback statutes Click editrequires Master title style Rebateto program that Medicaid pricing equals all other formulary programs Clickprogram to edit provides Master asubtitle style Rebate strong financial incentive for pharmaceutical companies to hide pricing concessions UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Non-Government Influences on Prescribing Institute of Medicine (IOM) Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Institute of Medicine Reports Addressing the FDA’s resource challenges Strengthening the scientific base of the agency Integrating pre and post market review Click to edit Enhancing Master title style post market safety monitoring Conducting confirmatory drug safety and efficacy studies Click to edit Master subtitle style Enhancing the value of clinical trial registration IOM Reports Enhancing the FDA’s post market regulation and enforcement Institute of Medicine of the National Academies. Challenges for the FDA: the future of drug safety - workshop summary. Available at: http://www.iom.edu/CMS/3740/24155/45823.aspx Accessed March 11, 2008. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE National Pharmacy Influence Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Patient Programs Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Professional Societies and Expert Panels Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE PhRMA Code on Interactions with Healthcare Professionals Not interfere with the independence of a Focus on informing healthcare professionals Intended to benefit patients and to Click to edit Master title style Support medical research and education healthcare professional’s prescribing practices about products by providing scientific and enhance the practice of medicine educational information Click to edit Master subtitle style Pharmaceutical Research and Manufacturers of America (PhRMA). Code on interactions with healthcare professionals. 2008. Available at: http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ Accessed February 12, 2008. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Click to edit Master title style Click to edit Master subtitle style Choudry NK. J Am Med Assoc. 2002;287(5):612-617. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Do you think this had an impact on their recommendations? (Please enter your answer below) Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE What can we do? (Please enter your answer below) Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Institutional Responses Click to edit Master title style Click to edit Master subtitle style Links active as of: August 21, 2008. http://med.stanford.edu/coi/siip/policy.html http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Policy%20on%20Vendor%20Relationships.pdf http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Device%20Companies.pdf UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Key Points – Formularies are developed with available evidence and influenced by pharmaceutical company pricing and market forces –Click Prescribers shouldMaster use available evidence to edit title styleto guide prescribing – Government agencies, private organizations Click to edit Master subtitle style and academic health centers have started to question prescriber-industry relationships – Discuss prescribing decisions with patients UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Recommendations Get involved with professional societies Give feedback to or serve on Pharmacy and Therapeutics Committee Click Master title style Talk to to youredit patients about prescribing Help patients identify appropriate resources Click tousing editlow Master subtitlemedication style Consider cost generic programs/sample centers Promote communication during transitions of care UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE References Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. J Am Med Assoc. 2002;287(5):612-617. Federal Trade Commission. Pharmacy benefit managers: ownership of mail-order pharmacies. 2005, Aug. Available at: http://www.ftc.gov/reports/pharmbenefit05/050906pharmbenefitrpt.pdf Accessed March 15, 2007. Food and Drug Administration. Available at: www.fda.gov. Accessed February 27, 2008. Garber AM. Evidence-based coverage policy. Health Affairs. 2001;20(5):62-82. Huskamp HA, Deverka PA, Epstein AM, Epstein RS, McGuigan KA, Frank RG. The effect of incentive-based formularies on prescription-drug utilization and spending. N Engl J Med. 2003;349(23):2224-2232. Institute of Medicine of the National Academies. Pray L, Robinson S (Rapporteurs). Challenges for the FDA: the future of drug safety - workshop summary. Forum on Drug Discovery, Development, and Translation. Board on Health Sciences Policy. 2007; The National Academies Press: Washington, D.C. Available at: http://www.iom.edu/CMS/3740/24155/45823.aspx Accessed March 11, 2008. Kaiser Family Foundation. Follow the pill: understanding the U.S. commercial pharmaceutical supply chain. 2005. Available at: http://www.kff.org/rxdrugs/7296.cfm Accessed October, 2006. Pharmaceutical Research and Manufacturers of America (PhRMA). Code on interactions with healthcare professionals. 2008. Available at: http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ Accessed February 12, 2008. Simon GE, Psaty BM, Hrachovec JB, Mora M. Principles for evidence-based drug formulary policy. J Gen Intern Med. 2005;20(10):964-968. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE References - Policies Partners HealthCare. Policy on interactions with pharmaceutical and medical device companies. Available at: http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Device%20Companies.pdf Accessed August 21, 2008. Stanford School of Medicine. Policy and guidelines for interactions between the Stanford University School of Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the pharmaceutical, biotech, medical device, and hospital and research equipment and supplies industries ("Industry"). Available at: http://med.stanford.edu/coi/siip/policy.html Accessed August 20, 2008. UMass Memorial Medical Center. Policy Manual. # 1143 Policy on Vendor Relationships. Effective Date: 7/1/2008. Available at: http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Policy%20on%20Vendor%20Re lationships.pdf Accessed August 18, 2008. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Resources • • Consumer Reports Best Buy Drugs http://www.consumerreports.org/health/best-buy-drugs/index.htm • • Institute of Medicine Reports http://www.iom.edu/cms/2955.aspx • • Journal Watch http://www.jwatch.org/ • • Medical Letter http://www.medicalletter.org/ • • Medline (through the U.S. National Library of Medicine) http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed Click to edit Master title style Attorney General Consumer and Prescriber Education Grant Program Initiated Resources • • http://www.rxfacts.org/ Click to edit Master subtitle style Georgetown University http://www.pharmedout.org/ • MGH Institute of Health Professionals http://www.perxinfo.org/perx.html • University of Kentucky http://www.cecentral.com/ • University of North Carolina, Chapel Hill http://harryguess.unc.edu/ • University of Massachusetts Medical School/ Meyers Primary Care Institute http://www.umassmed.edu/meyers/index.aspx Brigham & Women's Hospital UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Resources Institutions with Available Policies Partners HealthCare http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Devic e%20Companies.pdf Click to edit Master title style Stanford School of Medicine Click to edit Master subtitle style http://med.stanford.edu/coi/siip/policy.html UMass Memorial Health Care http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Po licy%20on%20Vendor%20Relationships.pdf UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Resources Additional Learning Modules in This Series Communicating with Patients Evidence-Based Medicine (EBM) Click to edit Master title style Pharmaceutical Development and Regulation Pharmaceutical Marketing Click to edit MasterRepresentative subtitle style (PR) Provider-Pharmaceutical Communication Links to Web-Access and Downloadable Versions Available at: http://www.umassmed.edu/meyers/index.aspx UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 1. Evidence-based formularies are intended to reduce cost, improve quality and simplify medication delivery. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 1. A: True. The goals of an evidence-based formulary are to support cost-effective, quality care by promoting the use of a limited number of medications that Click to edit Master title style have proven effective for specific diseases. This practice should also simplify delivery as prescribers may become more familiar with a smaller number of medications, and institutional pharmacies may not need to maintain large inventories. Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 2. Efficacy data is the only factor pharmacy benefits managers use in determining preferred formulary status for drugs. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 2. B: False. In an ideal world formularies would be based on clear evidence to support appropriate decision-making for patients. In practice they are influenced by Click to edit Master title style several factors. For one thing, clear evidence is not always adequate to make these decisions. Additionally, the business of medicine involves pricing of medications and contractual agreements between pharmaceutical makers and pharmacy benefitto mangers, in somesubtitle cases providers attempt to Click edit and, Master style maintain autonomy in decision making by influencing formulary decisions. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 3. Differences between hospital-based formularies and outpatient pharmaceutical benefits are likely to contribute to patient confusion about their medications or medication errors. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 3. A: True. For example, your patient may be discharged home on a medication despite the fact that it might not be covered by your patient’s outpatient pharmacy Click to edit Master title style benefit, or could require a larger co-payment. This may be frustrating for your patients and you as you work through the system to determine whether you will change the medication to one covered by your patient’s insurer for outpatient treatment, a prior authorization In some cases Click ortocomplete edit Master subtitleform. style a patient might be discharged on a me-too medication that may be different from what they already have at home. This could cause confusion and increased side effects and risks from unintentional double dosing. UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 4. The Institute of Medicine (IOM) is a branch of the US government. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 4. B: False. The Institute of Medicine is a private, non-governmental organization. It is largely composed of unpaid volunteer experts who author reports based on Click to edit Master title style evidence and is free from many of the constraints of governmental organizations. Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 5. In a NEJM study of patients whose statin lost preferred formulary status, nearly 50% of patients switched to the preferred drug showing the impact of formulary decision-making on prescribing. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 5. A: True. Additionally 9% stopped using statins altogether only 42% remained on the old drug. This study clearly shows that formulary decisions can drive Click to edit Master title style prescribing. Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 6. A number of major US pharmacy chains now offer some generic medications at low prices to the consumer. This may aid patient compliance with medications, and influence prescribing. A. True B. False Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 6. A: True. To our knowledge there have been no detailed studies of this practice, but anecdotal evidence suggests that providers may direct patients to these Click to edit Master title style locations to fill prescriptions. This may support use of cost-effective generics and patient compliance, which may also influence prescribing. Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 7. The US Government’s rebate program requires that Medicaid pricing equals that of other formulary programs. This is designed to maintain pricing equity, but may provide an incentive for pharmaceutical companies to hide pricing concessions to other groups. A. True Click to edit Master title style B. False Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 7. A: True. This is designed to maintain pricing equity, but may provide an incentive for pharmaceutical companies to hide pricing concessions to other groups. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 8. Many pharmaceutical companies provide patient support programs that include coupons for trials of drugs, low cost medication programs for low income patients, and freely accessible information regarding diseases and treatments. These programs may help patients, and may influence prescribing. A. True Click to edit Master title style B. False Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 8. A: True. These programs may help patients, and may influence prescribing. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 9. Prescribing can be influenced by which of the following organizational mechanisms: A. B. C. D. E. Institutional pharmacy and therapeutics committees. Clinical pathways developed by professional societies. Insurance company tiering processes. Pharmaceutical company pricing and marketing practice. All of the above. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 9. E: All of the above. Clinicians should be aware of these influences when making decisions to ensure that they are prescribing appropriately. Click to edit Master title style Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 10. The PhRMA code on interactions with healthcare professionals states that pharmaceutical representatives should focus on informing healthcare professionals about products by providing scientific and educational information. A. True Click to edit Master title style B. False Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Answer 10. A: True. Some pharmaceutical companies are further adjusting their support of CME and physician outreach even as this presentation is under preparation. Click to edit Master title style Clinicians should be aware of potential bias in all sponsored educational programs, and integrate this into their clinical decision-making. Please see our module on communication with pharmaceutical representatives for additional information. Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 11. Did completing this module help you to understand the principles of evidence-based formulary development? A. Yes, definitely B. Yes, probably C. Probably not D. Definitely not E. Not sure Click to edit Master title style 12. Would you recommend this training module to a colleague? A. Yes, definitely B. Yes, probably C. Probably not D. Definitely not E. Not sure Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE Questions 13. Will you do anything differently in your practice as a result of this training module? A. Yes, definitely B. Yes, probably C. Probably not D. Definitely not E. Not sure Click to edit Master title style 14. Please tell us about any changes you are considering or planning: Click to edit Master subtitle style UMASS MEDICAL SCHOOL MEYERS PRIMARY CARE INSTITUTE