Impact of Pharmacy Legislation on Changing Practice Virgil Van Dusen, RPh, JD Bernhardt Professor of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma 5/26/2015 1
Change is the law of life. John F. Kennedy 5/26/2015 2
Legislation Has Been a Driving Force of Change in Pharmacy Practice Pure Food and Drug Act of 1906 Food Drug and Cosmetic Act of 1938 Comprehensive Drug Abuse and Prevention Act of 1970 Poison Prevention Packaging Act of 1970 Prescription Drug Marketing Act of 1987 Omnibus Budget Reconciliation Act of 1990 5/26/2015 3
Legislation Has Been a Driving Force of Change in Pharmacy Practice Health Insurance Portability and Accountability of 1996 FDA Modernization Act of 1997 Drug Addict Treatment Act of 2000 Combat Methamphetamine Epidemic Act of 2005 Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Drug Quality and Security Act of 2013 5/26/2015 4
So Many Laws Affecting Pharmacy… Civil Rights Act of 1964 Advertising Law Employee Polygraph Protection Medication Guides Act of 1988 Patient Package Inserts Age Discrimination in Medical Device Amendment Employment Act of 1967 Fair Labor Standards Act Drug Price Competition and Patent Term Restoration Act Americans with Disabilities Act Equal Pay Act of 1963 REMS Family and Medical Leave Act Federal Anti-Tamper Act of 83 Communications Privacy Act of 1976 5/26/2015 5
Top 20 Legislative Acts and Regulations Impacting Contemporary Pharmacy Practice 5/26/2015 6
1) Comprehensive Drug Abuse and Prevention Act of 1970: Records Required Records: Acquisition Dispensation Inventory 5/26/2015 7
Rite Aid Agrees to Pay $5 Million for CDS Violations http://www.justice.gov/archive/opa/pr/2009/January/09-opa-028.html 5/26/2015 8
2) Comprehensive Drug Abuse and Prevention Act of 1970: Valid Rxs Prescription Legitimacy A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. 21 C.F.R § 1306.04(a) 5/26/2015 9
Walgreens Paid $80 Million for Oxycodone Violations http://www.justice.gov/usao/co/news/2013/jun/6-11-13.html 5/26/2015 10
3) Inspections State Board of Pharmacy Food and Drug Administration Drug Enforcement Administration An Arkansas Pharmacists Association memo (August 8, 2014) indicated that each DEA office has to do a number of pharmacy inspections per year. There is a multitude of other state and federal agencies that could inspect a pharmacy as well. 5/26/2015 11
4) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 While online pharmacies can be valid, this law has requirements for such pharmacies; Notify the DEA of intent to distribute through the Internet Declaration of compliance with laws and regulations In-person medical evaluation of patient Reporting of CDSs dispensed monthly http://www.dea.gov/pubs/pressrel/pr041309.html 5/26/2015 12
California Board of Pharmacy Fines Pharmacists and Pharmacies $600 Million Since 2009 for Invalid Prescriptions http://www.nabp.net/news/state-boards-of-pharmacy-take-action-to-stop-licensees-involved-in-unlawful-internet-drug-outlet- schemes 5/26/2015 13
5) Comprehensive Drug Abuse and Prevention Act of 1970: Pain Treatment The treatment of pain with controlled substances is unquestionably a legitimate medical purpose. Nevertheless, this area is a slippery slope. Decisions to intervene and/or not dispense, however, should be based on patient safety, weighing all factors. http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm 5/26/2015 14
Cardinal Health Pays $34 Million To Settle Pain Killer Case http://www.justice.gov/usao/co/news/2008/October08/10_2_08.html 5/26/2015 15
6) Comprehensive Drug Abuse and Prevention Act of 1970: E-Prescribing Prescriber Requirements Two-factor authentication, no agent access to authentication Pharmacy Requirements System must be approved by certified third-party auditor Must archive the e-script http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html 5/26/2015 16
6) Comprehensive Drug Abuse and Prevention Act of 1970: E-Prescribing The following links have a partial list of approved pharmacies and prescribers: http://surescripts.com/network-connections/mns/connected- pharmacies http://surescripts.com/network-connections/mns/prescriber- software 5/26/2015 17
7) Comprehensive Drug Abuse and Prevention Act of 1970: Employment A registrant must not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause. 21 C.F.R. § 1301.76(a) 5/26/2015 18
Obtaining a Waiver Waiver requests are made by the registrant http://www.nabp.net/news/missouri-news-waivers-required-to-employ-certain-individuals/ http://www.deadiversion.usdoj.gov/faq/waiver_1301_76.htm Performing Background Checks http://www.uspharmacist.com/content/c/10388/?t= men%27s_health,miscellaneous 5/26/2015 19
8) Combat Methamphetamine Epidemic Act of 2005 Under the CMEA limits are placed on the OTC sale of pseudoephedrine. (g/day and g/30days) The products must be stored behind the counter or in a locked cabinet in an area where customers do not have access. http://www.deadiversion.usdoj.gov/meth/ 5/26/2015 20
CVS Pays $77.6 Million To Settle with DEA in Meth Case http://www.justice.gov/usao/cac/Pressroom/pr2010/148.html 5/26/2015 21
9) Prescription Monitoring Programs Federal legislation 2002: Harold Rogers Prescription Drug Monitoring Program At: https://www.bja.gov/Funding/14PDMPsol.pdf 2005: National All Schedules Prescription Electronic Reporting Act www.deadiversion.usdoj.gov/faq/rx_monitor.htm State legislation Almost all states have such programs Helps prevent “doctor shopping” 5/26/2015 22
CVS Pays $11 Million to Settle Drug Records Case http://www.justice.gov/usao/okw/news/2013/2013_04_03.html 5/26/2015 23
10) Omnibus Budget Reconciliation Act of 1990 OBRA-90 Mandate Prospective Drug Review Screening, professional judgment Patient Counseling Offer to discuss, waiver of counseling Documentation of Relevant Information Reasonable effort, patient information, comments 5/26/2015 24
10) Omnibus Budget Reconciliation Act of 1990 Professional Standard Established by law/regulation Negligence-based cases Duty, breach of duty, causation, and damages Plaintiff Attorney’s Friend Primary standard used in prosecuting many actions 5/26/2015 25
11) Health Insurance Portability and Accountability Act of 1996 The Health Insurance Portability and Accountability Act was enacted in 1996. Effective dates: 2003, 2005. It’s purpose is to protect PHI (protected health information). Privacy Rules and Security Rules Impact on: Employees, documents, computers, business agreements HIPAA rules continue to evolve with changes as recent as 2013. http://www.hhs.gov/news/press/2013pres/01/20130117b.html 5/26/2015 26
11) Health Insurance Portability and Accountability Act of 1996 The OCR (Office of Civil Rights) first enforced HIPAA in 2008 with a charge against Providence Health. http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/providenceresolutionagreement.html Since that time other organizations have been found in violation of HIPAA and given hefty fines. CVS: $2,250,000 http://www.ftc.gov/news-events/press-releases/2009/02/cvs-caremark-settles-ftc-chargesfailed-protect-medical-financial Rite-Aid: $1,000,000 http://www.youtube.com/watch?v= U0-FQQetEzY Walgreens: $1,440,000 http://www.beckershospitalreview.com/legal-regulatory-issues/walgreens-pays-1-44m-for-alleged-hipaa-violation.html 2 large NYC hospitals fined $4.8 million for data breach in 2014. http://www.esecurityplanet.com/network-security/two-nyc-hospitals-fined-4.8-million-for-data-breach.html 5/26/2015 27
12) Prescription Drug Marketing Act of 1987 States authorized to license wholesalers Banned the re-importation of prescription drugs Banned counterfeiting of drug coupons Prohibited the sale of prescription drugs by hospitals or health care facilities, certain exception Drug pedigrees established Addressed the issue of sample drugs 5/26/2015 28
12) Prescription Drug Marketing Act of 1987 Primary Area of Concern for Pharmacy: Samples 1 st offense: $250,000 + 10 years 2 nd offense: $250,000 3 rd offense: $1,000,000 Key: Finder’s fee up to ½ of fine ($125,000). 5/26/2015 29
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