A Day in the Life of a Pharmacy Inspector

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A Day in the Life of a Pharmacy Inspector

• Mike Beck, R.Ph.
• Board of Pharmacy Inspector

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Agenda

• Background on Administrative Law
• Board of Pharmacy Structure
• Duties of a Pharmacy Inspector
• Disciplinary Process
• Resources

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Law vs. Rule

• Oregon Revised Statute (ORS)
• Oregon Administrative Rule (OAR)

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Oregon Revised Statutes (ORS)

• Laws
• Passed by Legislature
• Grants Board authority
• More difficult to change
• blue pages in law book
• Chapters 689 475

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Oregon Administrative Rule (OAR)

• Rules
• Created by Board of Pharmacy
• More detailed than Statute
• Easier to change
• Required to notify Stakeholders (licensees)
• Public Rules Hearing
• Divisions 041 080

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Examples

• ORS 689.405 Grounds for Discipline
• (1)The State BOP may refuse to issue or renew, or
  may suspend, revoke or restrict the license of
  any person or the certificate of registration of
  any drug outlet upon one or more of the following
  grounds
• (a) Unprofessional conduct as that term is
  defined by the rules of the Board

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Examples

• OAR 855-019-0055 Grounds for Discipline
• (2) Unprofessional conduct means
• (a) Repeated or gross negligence
• (b) Fraud or misrepresentation
• (c) Illegal use of drugs
• (d) Theft of drugs
• (e) Dispensing a drugprescription is bogus
• (f) Prohibited acts
• (g) Authorizing a person to practice pharmacy
• (h) Any conductcontrary to accepted Standards
  of Practice.

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Oregon Board of Pharmacy

• Appointed by Governor
• Volunteers
• 7 Members
• 5 Pharmacists
• 2 Public
• Executive Director
• non voting
• Meet every 2 months

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Oregon Board of Pharmacy Staff
Compliance Licensing
Administrative Pharmacist Recovery Network (PRN)
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Oregon Board of PharmacyLicensing Functions

• People
• Pharmacists
• Interns
• Technicians

• Outlets
• Pharmacies
• Retail, Hospital, LTC
• Wholesalers
• Manufacturers
• Drug Rooms
• Non-Prescription

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Oregon Board of PharmacyCompliance Staff

• Compliance Director
• Chief Investigator
• 4 Inspectors
• Compliance Secretary

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Duties of a Pharmacy Inspector

• Inspect Registrants
• Investigate Complaints
• Information Resource for Licensees

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Inspections

• Pharmacies
• Retail
• Hospital
• LTC
• Manufacturers
• Wholesalers
• Drug Rooms
• Non Prescription Drug Outlets
• Correctional Facilities
• County Health
• Family Planning Clinics

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Inspections (contd)

• PIC Self-Inspection Report
• Due Feb 1st each year
• Licenses current
• Minimum Equipment
• Record keeping
• Prescriptions
• Inventories
• Policies Procedures

• Technicians
• Training
• P P
• Counseling

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Inspections (contd)

• Deficiency Notice
• (New name)
• Communication tool
• New name
• Identified deficiency
• 30 days to respond
• No disciplinary action

• Notice of Non-Compliance
• More serious violation
• 15 days to respond
• May result in disciplinary action

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Deficiency Notice/Notice of Non-Compliance

• Compliance reviews responses
• Presented to Board at next Board Meeting
• Board decides what action to take (if any)

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Most Common Violations

• Procedures and Required Documents
• Technicians
• Pharmaceuticals Labeling
• Return of Medications
• Telephone Prescriptions
• Controlled Substances

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1. Procedures Required Documents

• Failure to have/locate Drug Outlet Procedures
• PIC Report not completed
• Failure to have
• Current Laws Rules
• Newsletters for the past 3 years
• Updated References

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2. Technicians

• Unregistered persons performing technician
  functions
• Failure to have/locate
• Current Technician Procedures
• Original training In-Service training documents

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3. Pharmaceuticals Labeling

• Improper labeling of prepackaged drugs
• Customized Patient Medication Packages (I.e.
  Salad packs) 60-day exp
• Outdated medications not quarantined

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4. Return of Medications

• Accepting previously dispensed medications
• Board in the process of changing this rule

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5. Telephone Prescriptions

• Failure to record the identity of R.Ph.
  (name/initials) receiving the oral prescription
  on the hard copy

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6. Controlled Substances

• Soma Midrin not included in the annual
  inventory
• Hard copy lacking prescribers DEA /or address
• CII invoices not filed separately
• Incomplete DEA 222 forms
• Dispensing CIIs before obtaining the
  prescribers manual signature

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Proposed Rule Changes

• Pseudoephedrine
• Return of Medications
• Technicians
• Vaccinations

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Investigations

• Consumer complaints
• Drug diversion
• Violations reported by other licensees or
  agencies
• DEA, FDA, law enforcement, other Boards, DOJ

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Investigations

• Receive initial complaint
• Phone, letter, fax, anonymous
• Interviews
• Retrieve evidence
• Audit of CS
• Compile facts for written report
• Preponderance of Evidence
• Present to Board
• Board decides what action to take

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Most Common Complaints

1. Dispensing Errors
2. Patient Counseling
3. Security Violations
4. Diversion
5. Licensee Impairment
6. Falsification of Documents

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1. Dispensing Errors

• Incorrect Drug/Strength
• Incorrect Sig
• Incorrect Doctor name
• Short count
• Examples
• Zantac/Zyrtec liquid
• Serzone/Seroquel
• Zestril/Lisinopril strength errors

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2. Patient Counseling

• Inadequate or no counseling provided
• Examples
• Preven
• Vivotef (oral Typhoid)

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3. Security Violations

• Non-R.Ph. having keys access to the pharmacy
• Technician, Intern, Spouse/Owner
• Pharmacist leaves pharmacy premises with
  employees still on-site
• Examples
• R.Ph.-McDonalds
• R.Ph.-Golfing

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4. Diversion

• Pharmacist or Technician stealing money or drugs
• Usually for personal use
• Examples
• R.Ph.-CSs to pay for Methamphetamine
• R.Ph.-Vancomycin
• R.Ph. Tech-controlled substances
• Tech-CS for favors
• R.Ph.-AIDS drugs to Nigeria

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5. Licensee Impairment

• Pharmacist or Technician impaired on the job
• Using drugs or alcohol
• Other
• Examples
• R.Ph.- Alcohol
• Age-related
• R.Ph./Tech-IV drugs

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6. Falsification of Documents

• Failure to respond truthfully to questions
• Original application
• Renewal
• Background checks
• Examples
• DUII
• Possession of CS
• Attorney advice

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Disciplinary Action

• Pharmacist
• Letter of Concern
• Appearance
• Reprimand
• Probation w/conditions
• Fine
• Suspension
• Revocation
• PRN referral

• Technician
• all or none
• Refuse to issue
• Refuse to renew
• Not formal DA, not disclosable to public

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Disciplinary Actions
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Disciplinary Action (contd)

• Board votes Disciplinary Action
• Board issues Notice of Proposed Disciplinary
  Action
• Description of case details
• Board issues a Consent Order
• Details of the action to be taken
• Both parties sign, if agree
• Licensee/Registrant has right to a Hearing

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Contested Cases

• Hearing
• Similar to deposition
• Attorneys involved
• Administrative Law Judge hears both sides
• Decision presented to Board
• Board has final decision-making authority
• Court of Appeals

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In the End

• Notice of Proposed Disciplinary Action and
  Consent Order
• Disclosable to Public
• Reported to NABP
• PRN Referrals Letters of Concern
• Not disclosable
• Kept on file for future

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Hints from an Inspector

• If you are ever questioned by the Board, please
  cooperate truthfully fully
• Any correspondence to the Board, please make
  professional
• If you ever are uneasy about a situation, witness
  a violation, please report it

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Helpful Resources

• PIC Inspection Report
• Quarterly Newsletters
• OBOP Website www.pharmacy.state.or.us
• 1 hour Law CE online
• DEA Website www.usdoj.gov/dea/
• DEA Publication Pharmacist Manual