Missouri Board Of Pharmacy Board Update September 13, 2015 Tom Glenski, R.Ph. Andi Miller, PharmD Chief Inspector Inspector
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Program Objectives Identify recent regulatory and statutory changes for licensees Outline how to increase compliance with Missouri's regulatory requirements Identify available compliance resources for licensees
Program Design 2015 and 2016 legislative session 2015 regulations Compliance resources for licensees Board news Questions
Pre-Assessment Questions True or False 1. In 2015 Missouri passed legislation creating a prescription drug monitoring program. 2. Hospitals no longer need a distributor license to distribute drugs to other hospitals. 3. The Board is working on revising the sterile compounding rule. 4. Thiotepa is an example of a drug FDA has approved importation to alleviate a shortage. 5. A physician s office may distribute drugs to a hospital without a distributor license.
2015 Legislative Session
Pharmacy Related Legislative Proposals Prescription Monitoring Program (PMP) aka Prescription Drug Monitoring Program (PDMP) Four proposals Privacy issues Funding issues (Did not pass)
Pharmacy Related Legislative Proposals Medication synchronization MAC pricing Medical marijuana (Did not pass)
Board Legislation Reporting of disciplinary actions Non-resident renewals Statistical reporting (Did not pass)
Successful Legislation HB 709 Extends prescriptive authority for APRNs, PAs & Assistant Physicians to Schedule II hydrocodone products. Five day supply limit. Effective August 28, 2015
? 2016? Expansion of pharmacist clinical/ immunization services Medicaid expansion PMP MAC pricing Medication synchronization Medical marijuana
2016 Board Proposals Non-resident renewals Mandatory disciplinary reporting Charitable pharmacy Immunization Grounds for discipline Drug outsourcers and third party logistics providers
2015 Regulation Activity
2015 Regulation Activity Revised 20 CSR 2220-5.020 Drug Distributor Licensing Requirements Revisions in process 20 CSR 2220-4.010 General Fees 20 CSR 2220-2.700 Pharmacy Technician Registration 20 CSR 2220-6.080 Medication Therapy Services by Protocol
20 CSR 2220-5.020 Drug Distributor Licensing Requirements 5/30/2015 effective date 5% gross sales rule Redefined for pharmacies that have no sales Now includes 5% of pharmacies total drug purchase
20 CSR 2220-5.020 Drug Distributor Licensing Requirements No distributor license required for: Hospital to hospital Hospital to health care entity under common control or ownership Alleviate drug shortage from FDA approved importer or manufacturer SNS or state emergency stockpile Out of state pharmacy licensed in home state
20 CSR 2220-5.020 Drug Distributor Licensing Requirements Caution: BNDD/DEA and other state s requirements still apply
Hospitals Other hospitals (licensed by DHSS or operated by the state) Health care entity under common control or ownership Offsite pharmacy Offsite practitioner Offsite clinic Ambulatory surgery center Ambulance
Hospitals Entities not under common control/ownership X Independent and chain pharmacies X Private physician practices X Entities leasing/renting space at hospital X Other hospital s healthcare entities X Public ambulance districts X Local health departments If questions, contact your legal counsel
Hospitals Distribution is from hospital not X Clinic to hospital X Ambulatory surgery center to hospital Does not include further distribution within health system X Practitioner to other entities X Clinic to other entities
Drug shortage FDA approved importer or manufacturer FDA drug shortages website Example: Thiotepa Maintain documentation of FDA authorization
Out of state (OOS) pharmacies MO pharmacy may receive drug from OOS pharmacy holding no MO license MO pharmacy must maintain records: Proof of OOS pharmacy s home state licensure Distribution record (invoice) Name/address of OOS pharmacy Date of distribution Drug name/strength/quantity Two years Purchase limit: 5% of limit MO pharmacy s annual Rx sales
Out of state (OOS) pharmacies Caution: BNDD/DEA records and licensure requirements still apply Other state s licensure requirements may apply to MO pharmacy shipping into their state
20 CSR 2220-4.010 General Fees Revision in process Fee reductions Permanent
20 CSR 2220-2.700 Pharmacy Technician Licensure Revision in process List of prohibitive acts Requires documented training
20 CSR 2220-6.080 Medication Therapy Services by Protocol Revision in process (staled since 2012)
Other Board Regulation Activity
Other Regulation Activity Board is working on: New Return for destruction Revisions Pharmacist-in-charge responsibilities Class J shared pharmacy services Sterile compounding Pharmacist administration
Presented by Andi Miller, PharmD, Inspector COMPLIANCE TOOLS
Areas of compliance General Immunizations Individual professions Specific questions
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Board News
Board News New Board members Christina Lindsay Kansas City Christian Tadrus Moberly Douglas Lang St. Louis New office employees Compliance coordinator activities Jennifer Luebbert New ninth inspector position Kansas City inspector opening
Board News New licensing system New electronic inspection program Upcoming events Board meeting - October 14 - Columbia Lunch with the Chief Webinar October 13
Post-Assessment Questions 1. In 2015 Missouri passed legislation creating a prescription drug monitoring program. FALSE 2. Hospitals no longer need a distributor license to distribute drugs to other hospitals. TRUE 3. The Board is working on revising the sterile compounding rule. TRUE 4. Thiotepa is an example of a drug FDA has approved importation to alleviate a shortage. TRUE 5. A physician s office may distribute drugs to a hospital without a distributor license. FALSE
QUESTIONS
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