Intro to pharm law

Intro to pharm law

  1. Explain the differences between statutes, rules, guidelines, and standards and how and where laws/rules are made.

  2. Introduce key pharmacy practice and controlled substance federal and state statutes and regulations and key agencies involved in health care regulation.

  3. Review basics of government, civics, and advocacy.

  4. Describe the Board of Pharmacy and its role in regulating pharmacy practice.

    1. Board is not paid position

    2. If a pharmacist gets in trouble:

      1. Pharmacist gets written up

      2. Complaint gets seen by attorney to see if its an actual violation

      3. If violation is found (will be reviewed probable cause panel)

      4. If 2nd violation, pharmacist will go in front of board, license in danger

        1. Need attorney

      5. Decide punishments for pharmacists who messed up

    3. Probable Cause Panel

      1. 2 members of board (at least one pharmacist)

      2. Look at all cases sent in by local inspectors

      3. Decide if case is big enough to send in front of board

      4. Filter out cases that weren’t that bad

    4. Pharmacist mental health/addition/criminal history

      1. Reporting will not prevent applicant from getting license

      2. NOT reporting = lying on application = red flag for board

    5. Who is allowed to attend Board of Pharmacy meetings?

      1. Open to public

      2. People can support pharmacist in front of board for discipline

Professionals Resource Network (PRN)

  • Caught with drugs, DUI

  • PRN evaluates

  • Lots of Pharmacy students go in front of PRN

  • Decide if they can be safe to practice

  • May put conditions on license (if they had opioid product, they can only work doing counseling, no access to drugs)

  • Usually more than 10% of pharmacists have substance abuse problem

  • 8-10 people come before board with PRN

  • Lady became so addicted she became a crack whore

    • 7 years with PRN, got license back

How often does the Florida Board of Pharmacy intereact with Board of pharmacy from the other states

  • Big annual meeting

  • FL is in district 3, semi-annual meetings

Board members must disclose if they have relationship with pharmacist if they are being seen for a disciplinary case

  • Yes

  • Have to recuse yourself if you have prior knowledge of case

Can consequences determined by board be overturn in light of new evidence

  • Yes, ruling can be appealed

  • Goes to division of administrative hearing

  • Looks at all facts of case, if judge disagrees, ruling/punishment overturned 

Board determines what continuing education course content needs to have

  • Continuing education committee (3 members)

  • Must approve whenever provider wants to make program

  • Must turn in 45 days before presentation

  • Mandated 2 hour validating controlled substance course In 2015

  • Provider must be approved as having enough knowledge

Expert Eyewitness

  • Expert in particular field (bob is controlled substances)

PY1 advice

Statute: legislature writes the law/statutes

Rules: board of pharmacy interprets statute into rules for pharmacists to make sure they follow the law