Impact of Pharmacy Legislation on Changing Practice Virgil Van - - PowerPoint PPT Presentation
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
Virgil Van Dusen, RPh, JD Bernhardt Professor of Pharmacy Southwestern Oklahoma State University Weatherford, Oklahoma
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John F. Kennedy
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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
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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
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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
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Legislative Acts and Regulations
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Required Records:
Acquisition Dispensation Inventory
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http://www.justice.gov/archive/opa/pr/2009/January/09-opa-028.html
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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
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)
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http://www.justice.gov/usao/co/news/2013/jun/6-11-13.html
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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.
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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
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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
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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
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http://www.justice.gov/usao/co/news/2008/October08/10_2_08.html
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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
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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
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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)
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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
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Under the CMEA limits are placed on the OTC sale of
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/
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Pays $77.6 Million To Settle with DEA in
http://www.justice.gov/usao/cac/Pressroom/pr2010/148.html
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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”
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Pays $11 Million to Settle Drug
http://www.justice.gov/usao/okw/news/2013/2013_04_03.html
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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
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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
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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
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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
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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
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Primary Area of Concern for Pharmacy: Samples 1st offense: $250,000 + 10 years 2nd offense: $250,000 3rd offense: $1,000,000 Key: Finder’s fee up to ½ of fine ($125,000).
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Drugs produced by compounders that are not registered as
to qualify for the exemptions specified in that section.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm
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?
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm378645.htm
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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.
http://www.insurancejournal.com/news/national/2013/07/29/299797.htm
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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
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In 1992, section 602 of the Veterans Health Care Act (P.L. 102-585) 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.
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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
Children’s hospitals
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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.
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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.
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Pharmacist Found Guilty of Manslaughter
http://www.uspharmacist.com/content/d/pharmacy%20law/c/16572/
http://www.justice.gov/opa/pr/14-indicted-connection-new-england-compounding-center-and- nationwide-fungal-meningitis
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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
http://www.nga.org/files/live/sites/NGA/files/pdf/2015/1501TheExpandingRoleOfPharmacists.pdf
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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
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.
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Prepare for it.
Chances are good that you will some day need to apologize.
Imagine: 100 Rxs/day, working 25 days per month with an error rate
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.
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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
https://scholarworks.iupui.edu/bitstream/handle/1805/4404/conscientiousobjectionpharmacists.pdf?sequence= 1
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