Licensure Defense from the Board of Pharmacy

Transcription

1 Licensure Defense from the Board of Pharmacy Tony J. Park, Pharm.D., J.D. Ivan Petrzelka, Pharm.D., J.D., M.B.A. California Pharmacy Lawyers Board of Pharmacy Mandate B&P Protection of the Public is Board s Highest Priority Protection of the public shall be the highest priority for the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.... Property Interest vs Privilege INT vs RPH/PHY/LSC/WLS Investigations Catalysts Consumer Complaints Jurisdiction Role of Board of Pharmacy Inspectors To collect data NOT to consult or even advise regarding regulatory compliance To report their findings back to Board of Pharmacy Enforcement Division Notice of Violations 14 days to respond 1

2 Unprofessional Conduct By whom Pharmacist AND by the Pharmacy Within a licensed facility Outside a licensed facility Driving under the influence / Wet & reckless Public intoxication Other crimes Note on Marijuana CA Prop 64 (the campaign for the Adult Use of Marijuana Act) Non-Discipline v. Discipline Only disciplinary actions get posted on the Board of Pharmacy website Mandatory self-disclosure if licensed in another state Employment repercussions self-disclosure if question asks, have you EVER been found in violation of any pharmacy law. Enforcement Action Non-Disciplinary Letter of Admonishment Citation and/or Fine 2

3 Enforcement Action Disciplinary Letter of Reprimand Accusation Revocation Suspension Probation Probation Monitor Common Terms: Obey All Laws, Tolling, Supervised Practice, Posting of Probation Notice, Cannot be PIC, No Supervision of Interns, No New Ownership, Investigation & Prosecution Costs Recovery, Community Services, Ethics, Remedial Education ISO Interim Suspension Order Cease & Desist Order for LSCs only Appeals Informal Office Conference Stipulated Settlement Agreement MSC/PHC Administrative Hearing Threat of Non-adoption Writ of mandamus Arbitrary & Capricious burden of proof Opportunities for Reinstatement, Post-Probation, Post-Revocation Petition to Amend Probation Petition for Early Termination of Probation Petition for Reinstatement 3

4 Current Trends In Regulatory Enforcement LSCs & Non-Sterile compounders Controlled substance corresponding responsibility Patient Consultation CURES upload failure Inventory discrepancies Fraud, Waste & Abuse + DEA/FDA/DPH/DHCS Corresponding Responsibility MBC, DEA, or wholesaler may be source of complaint BOP investigates all complaints Typical fact pattern: Filling Rx s from prescribers engaging in pattern prescribing Limiting inquiry to technical aspects of Rx, i.e., did the prescriber issue the Rx, is it on proper form, etc. Cash payments Corresponding Responsibility Problem prescriber Dr. Crook CURES reports - identify all pharmacies that dispensed Rxs from the prescriber Investigation Accusation Discipline 4

5 Unapproved Drugs Compounding of drugs that are not part of FDAapproved product. Domperidone Not approved in US for any indication Approved in some countries for gastroparesis FDA issued several Warning Letters to compounders and banned import of Domperidone Domperidone IS NOT on the Do Not Compound list Allegations misbranded & unapproved drugs Unapproved Drugs FDCA exempts patient-specific pharmacy compounded drugs from prior approval, misbranding and adulteration provisions if: API is not on list of products withdrawn from the market for safety reasons, AND Product does not present demonstrable compounding difficulties, AND USP/NF Monograph exists, or API is on the list of approved compounds (pending) API is part of FDA-approved drug Conduct Outside of Work Alcohol or drug related incidents Mandatory disclosure of certain criminal convictions upon renewal or when applying for licensure DUIs held to constitute crime substantially related to the qualifications, functions and duties of licensee Public intoxication same as DUI for discipline 5

6 Conduct Outside of Work Almost always includes PRP if probation is granted Supervised practice Impairment at work not necessary for discipline based on substance abuse Discipline by Other State, etc. Grounds for discipline in CA Board does not have to prove the truth of the original allegations Suspension or revocation of license in other state automatic suspension in CA (BPC ) Board MAY set aside the automatic suspension if in interest of justice Licensee is entitled to a hearing (90 days) Unlicensed Activity Interstate shipments without license Most states require out-of-state license or registration Acting as Wholesaler without license Furnishing drugs for resale to another PHY or WLS 6

7 Compounding Unlicensed Activity (No LSC) No Master Formula (Even Magic Mouthwash) Beyond Use Date / Expired Ingredients Hazardous Compounding / Waiver PBM Audits Ask The Lawyers Questions??? (Billable Rate: $0.00/hr.) Thank You! Speaker Contact Information: Tony J. Park, Pharm.D., J.D. Ivan Petrzelka, Pharm.D., J.D., MBA California Pharmacy Lawyers TPark@CAPharmacyLaw.com IPetrzelka@CAPharmacyLaw.com 7