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Online Prescription Drug Distribution

Online Prescription Drug Distribution. November 2006. State Sovereignty. Pharmacy licensure Pharmacist licensure Web site use Medical Records – creation, retention, storage Applicable state laws… Deceptive practices Adults/minors. Electronic Verifications. Scheduled drugs Patient age

MikeCarlo
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Online Prescription Drug Distribution

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  1. Online Prescription Drug Distribution November 2006

  2. State Sovereignty • Pharmacy licensure • Pharmacist licensure • Web site use • Medical Records – creation, retention, storage • Applicable state laws… • Deceptive practices • Adults/minors

  3. Electronic Verifications • Scheduled drugs • Patient age • Patient identity • Billing/reimbursement info • Medical record maintenance/updating

  4. National “Pharma” Law Lacking • States regulate pharmacists, pharmacies and physicians • States have differing “deceptive” and “trade practices” acts

  5. Federal Laws • HIPAA • FDA • Medicare/Medicaid • Wire fraud, etc. • FTC • ADA

  6. Multi-jurisdictional Concerns • Re: physicians, pharmacists, etc – where does transaction occur? • In what state(s) is practitioner licensed? • What transactional requirements are there? • Viagra example

  7. North Carolina Case - 2003 • NC Bd. of Pharmacy v. Canada Drug Outlet, et al • Alleged various defendants owned businesses in NC known as “Canada Drugs”, “Canadian Meds of Asheville”, “Discount Drugs of Canada” and “PrescriptionCare of North Carolina”

  8. Plaintiff Allegations • Bd rule 21 N.C.A.C. 46.1804 (in part): • In order to assure the practitioner-pharmacist-patient relationship exists and to promote the safe and secure distribution of drugs and devices, prescription orders may be received for filling and refilling only by a pharmacist or bona fide employee of the pharmacy • Allege patients give info to defendants, who then send it to a Canadian pharmacy for filling, with mailing into the U.S.

  9. Allegationspg. 2 • That none of the defendants are licensed to practice pharmacy or operate pharmacy • That they “control pharmacy goods & services” and “take & record patient histories relating to drug therapy” and “record and report drug and device therapy” at locations or via persons not properly licensed.

  10. Some Defenses… • That jurisdiction over out-of-state pharmacies lies with the federal gov’t and not the states • That some defendants are not a pharmacy or pharmacist, but only assisting individuals in NC seeking scripts. • That no violation of Pharmacy Bd rules. Only Sec. of HHS has authority

  11. OnlineDistribution Issues • Licensure • Enforcement • Jurisdiction • Product quality • Patient identity • Medical records • Privacy

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