a day in the life of a pharmacy inspector mike beck, r.ph. board of pharmacy inspector
TRANSCRIPT
A Day in the Life of a Pharmacy A Day in the Life of a Pharmacy InspectorInspector
Mike Beck, R.Ph.Mike Beck, R.Ph.
Board of Pharmacy InspectorBoard of Pharmacy Inspector
Agenda Background on Administrative Law
Board of Pharmacy Structure
Duties of a Pharmacy Inspector
Disciplinary Process
Resources
Law vs. Rule
Oregon Revised Statute (ORS)
Oregon Administrative Rule (OAR)
Oregon Revised Statutes (ORS) “Laws”
Passed by Legislature
Grants Board authority
More difficult to change
“blue pages” in law book
Chapters 689 & 475
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
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…
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 drug…prescription is bogus… (f) Prohibited acts (g) Authorizing a person to practice pharmacy (h) Any conduct…contrary to accepted
Standards of Practice.
Oregon Board of Pharmacy Appointed by Governor “Volunteers” 7 Members
– 5 Pharmacists– 2 Public
Executive Director – non voting
Meet every 2 months
Oregon Board of Pharmacy Staff
Compliance Licensing
Administrative Pharmacist Recovery Network (PRN)
Oregon Board of PharmacyLicensing Functions
People– Pharmacists– Interns– Technicians
Outlets– Pharmacies
• Retail, Hospital, LTC
– Wholesalers– Manufacturers– Drug Rooms– Non-Prescription
Oregon Board of PharmacyCompliance Staff
Compliance Director
Chief Investigator
4 Inspectors
Compliance Secretary
Duties of a Pharmacy Inspector
Inspect Registrants
Investigate Complaints
Information Resource for Licensees
Inspections
Pharmacies• Retail• Hospital• LTC
Manufacturers Wholesalers Drug Rooms Non Prescription Drug Outlets Correctional Facilities County Health Family Planning Clinics
Inspections (cont’d)
PIC Self-Inspection Report– Due Feb 1st each year
Licenses current Minimum Equipment Record keeping
– Prescriptions– Inventories– Policies & Procedures
Technicians– Training– P & P
Counseling
Inspections (cont’d)
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
Deficiency Notice/Notice of Non-Compliance
Compliance reviews responses
Presented to Board at next Board Meeting
Board decides what action to take (if any)
Most Common Violations
1. Procedures and Required Documents
2. Technicians
3. Pharmaceuticals & Labeling
4. Return of Medications
5. Telephone Prescriptions
6. Controlled Substances
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
2. Technicians
Unregistered persons performing technician functions
Failure to have/locate:– Current Technician Procedures– Original training & In-Service training
documents
3. Pharmaceuticals & Labeling
Improper labeling of prepackaged drugs Customized Patient Medication
Packages (I.e. Salad packs) 60-day exp Outdated medications not quarantined
4. Return of Medications
Accepting previously dispensed medications Board in the process of changing this rule
5. Telephone Prescriptions
Failure to record the identity of R.Ph. (name/initials) receiving the oral prescription on the hard copy
6. Controlled Substances
Soma® & Midrin® not included in the annual inventory
Hard copy lacking prescriber’s DEA# &/or address
CII invoices not filed separately Incomplete DEA 222 forms Dispensing CII’s before obtaining the
prescriber’s manual signature
Proposed Rule Changes
Pseudoephedrine Return of Medications Technicians Vaccinations
Investigations
Consumer complaints Drug diversion Violations reported by other licensees or
agencies– DEA, FDA, law enforcement, other Boards,
DOJ
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
Most Common Complaints
1. Dispensing Errors
2. Patient Counseling
3. Security Violations
4. Diversion
5. Licensee Impairment
6. Falsification of Documents
1. Dispensing Errors Incorrect Drug/Strength Incorrect Sig Incorrect Doctor name Short count Examples
– Zantac®/Zyrtec® liquid– Serzone®/Seroquel®– Zestril®/Lisinopril strength errors
2. Patient Counseling
Inadequate or no counseling provided
Examples
– Preven®
– Vivotef® (oral Typhoid)
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.-McDonald’s – R.Ph.-Golfing
4. Diversion
Pharmacist or Technician stealing money or drugs
Usually for personal use Examples
– R.Ph.-CS’s to pay for Methamphetamine– R.Ph.-Vancomycin– R.Ph. & Tech-controlled substances– Tech-CS for “favors”– R.Ph.-AIDS drugs to Nigeria
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
6. Falsification of Documents
Failure to respond truthfully to questions– Original application– Renewal
Background checks Examples
– DUII– Possession of CS– Attorney advice
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
Disciplinary Actions
108
73
42 31
1
0
20
32
44
35
13
11
1
1
32
8
6
3
0
20
40
60
80
100
120
140
160
1999 2000 2001 2002
PRN Referrals
Revocation/Suspension
Probation/CivilPenaltyER Suspension
Reprimands
Disciplinary Action (cont’d)
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
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
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
“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
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