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 Documents2. Technicians3. Pharmaceuticals & Labeling4. Return of Medications5. Telephone Prescriptions6. 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 Errors2. Patient Counseling3. Security Violations4. Diversion5. Licensee Impairment6. 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

7342 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