Top 20. CPFI Annual Conference 2015 June Change is the law of life. Impact of Pharmacy Legislation on Changing Practice

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1 Impact of Pharmacy Legislation on Changing Practice Change is the law of life. Virgil Van Dusen, RPh, JD Bernhardt Professor of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma John F. Kennedy 1 2 Legislation Has Been a Driving Force of Change in Pharmacy Practice 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 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 So Many Laws Affecting Pharmacy Top 20 Advertising Law Medication Guides Patient Package Inserts Medical Device Amendment Drug Price Competition and Patent Term Restoration Act REMS Federal Anti-Tamper Act of 83 Civil Rights Act of 1964 Employee Polygraph Protection Act of 1988 Age Discrimination in Employment Act of 1967 Fair Labor Standards Act Americans with Disabilities Act Equal Pay Act of 1963 Family and Medical Leave Act Communications Privacy Act of 1976 Legislative Acts and Regulations Impacting Contemporary Pharmacy Practice 5 6 1

2 1) Comprehensive Drug Abuse and Prevention Act of 1970: Records Rite Aid Required Records: Acquisition Dispensation Inventory Agrees to Pay $5 Million for CDS Violations ) Comprehensive Drug Abuse and Prevention Act of 1970: Valid Rxs Walgreens 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 (a) Paid $80 Million for Oxycodone Violations ) Inspections 4) Ryan Haight Online Pharmacy Consumer Protection Act of 2008 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. 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

3 California Board of Pharmacy 5) Comprehensive Drug Abuse and Prevention Act of 1970: Pain Treatment Fines Pharmacists and Pharmacies $600 Million Since 2009 for Invalid Prescriptions 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 Cardinal Health 6) Comprehensive Drug Abuse and Prevention Act of 1970: E-Prescribing Prescriber Requirements Pays $34 Million To Settle Pain Killer Case Two-factor authentication, no agent access to authentication Pharmacy Requirements System must be approved by certified third-party auditor Must archive the e-script ) Comprehensive Drug Abuse and Prevention Act of 1970: E-Prescribing The following links have a partial list of approved pharmacies and prescribers: 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 (a)

4 Obtaining a Waiver Waiver requests are made by the registrant Performing Background Checks 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 CVS Pays $77.6 Million To Settle with DEA in Meth Case 9) Prescription Monitoring Programs Federal legislation 2002: Harold Rogers Prescription Drug Monitoring Program At: : National All Schedules Prescription Electronic Reporting Act State legislation Almost all states have such programs Helps prevent doctor shopping CVS Pays $11 Million to Settle Drug Records Case 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 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 11) Health Insurance Portability and Accountability Act of 1996 The Health Insurance Portability and Accountability Act was enacted in Effective dates: 2003, 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 ) 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. Since that time other organizations have been found in violation of HIPAA and given hefty fines. CVS: $2,250,000 Rite-Aid: $1,000,000 Walgreens: $1,440, large NYC hospitals fined $4.8 million for data breach in ) 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 ) Prescription Drug Marketing Act of ) Drug Quality and Security Act of 2013 Primary Area of Concern for Pharmacy: Samples 1 st offense: $250, years 2 nd offense: $250,000 3 rd offense: $1,000,000 Key: Finder s fee up to ½ of fine ($125,000). 29 Drugs produced by compounders that are not registered as outsourcing facilities must meet the conditions of section 503A to qualify for the exemptions specified in that section. This Act really has a focus on outsourcers! If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight. How do you know if someone is a licensed outsourcer? PharmacyCompounding/ucm htm 30 5

6 13) Drug Quality and Security Act of 2013 Enter the New England Compounding Center In 2012 NECC recalled more than 2,000 products after distributing 17,000 vials of methylprednisolone for injection contaminated with fungi to 23 states that resulted in 44 deaths. U.S. Bankruptcy Judge Henry J. Boroff declared NECC insolvent, clearing the way for meningitis victims from Tennessee to file product liability claims against medical providers, health clinics and other sellers of the tainted product. 14) Poison Prevention Packaging Act of 1970 Intent of Act to protect children from accidental poisonings due to household substances Administered by the CPSC Commission The law establishes the standards for child resistant containers Key: Act requires the use of child-resistant containers for packaging on most OTC drugs and nearly all prescription drugs. Container may not be reused unless glass or threaded plastic and then with new closure ) Veterans Health Care Act of 1992: 340B Drugs In 1992, section 602 of the Veterans Health Care Act (P.L ) enacted section 340B of the Public Health Service Act, requiring that drug manufacturers provide outpatient drugs at special reduced prices to designated covered entities serving underserved and uninsured populations. Under the contract, the covered entity owns the inventory, but the drugs are delivered directly to the pharmacy. The dispensing pharmacy receives a dispensing fee. A separate physical inventory is not required as it can be managed by means of software management. 340B Drugs Who are these covered entities? Certain federally qualified health centers Migrant Health Centers Health Care for the Homeless Office of Tribal Programs Urban Indian organizations Family planning projects State-operated AIDS Drug Assistance Programs & similar types of clinics, facilities & hospitals Children s hospitals ) Non-Profit Institutions Act of 1938 Major exception to the Robinson-Patman Act which then allowed for price-discrimination among buyers. Exempts nonprofit schools, colleges, universities, churches and charitable institutions from the R-P Act when the purchases are for their own use. This Act is an issue when you are trying to survive in your business. There are limits on how the nonprofit can sell but challenging violations is time consuming and expensive. 17) State Criminal Laws and Malpractice Allows for criminal punishment for negligent acts. Negligent acts of pharmacists can result in convictions. You can be held liable for the acts of your subordinates. State Boards of Pharmacy may act based on your conviction. Accidents happen. However, breach of a law/regulation intended to protect may subject a pharmacy to criminal prosecution

7 Pharmacist Negligence Pharmacist Found Guilty of Manslaughter in Medication Error ) Expanded Pharmacy Role in Health Care Advanced Pharmacy Practice Designations Vary across the states Medication Therapy Management Vary across the states Collaborative Practice Agreements 48 states allow in some capacity Provider Recognition ) Apology Legislation Approximately 30 states have enacted "I'm Sorry" laws, also known as "apology" laws. I'm sorry laws protect health care providers that make statements of sympathy following an adverse incident from having those same statements used as proof of their liability in a subsequent malpractice lawsuit. Generally, I'm sorry laws only protect statements of sympathy or benevolent gestures and not actual admissions of fault or negligence. However, a few states have laws that allow a health care provider to actually admit their fault or negligence as part of an apology without that admission being used against the health care provider as proof of liability in a subsequent lawsuit. Prepare for it. Using the Apology Chances are good that you will some day need to apologize. Imagine: 100 Rxs/day, working 25 days per month with an error rate of 0.05% you will have one error per month. Practice it. Worst time to practice: In front of the patient! Perform it. You do it. Don t send a technician out to handle this problem ) Conscientious Objection Laws Laws Can Make Life Complex These laws/regulations address the right of a medical professional to refuse to dispense prescriptions to which the professional has a moral or religious opposition. State specific No consensus among the states Some require pharmacists to dispense Others establish conscience clauses that allows refusal Employers may have their own policies

8 Some Things Don t Change