A Day in the Life of a Pharmacy Inspector

1. A Day in the Life of a Pharmacy Inspector Mike Beck, R.Ph. Board of Pharmacy Inspector

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

3. Oregon Revised Statute (ORS) Oregon Administrative Rule (OAR) Law vs. Rule

4. Oregon Revised Statutes (ORS) • “Laws” • Passed by Legislature • Grants Board authority • More difficult to change • “blue pages” in law book • Chapters 689 & 475

5. 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

6. 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…

7. 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.

8. Oregon Board of Pharmacy • Appointed by Governor • “Volunteers” • 7 Members • 5 Pharmacists • 2 Public • Executive Director • non voting • Meet every 2 months

9. Oregon Board of Pharmacy Staff

10. People Pharmacists Interns Technicians Outlets Pharmacies Retail, Hospital, LTC Wholesalers Manufacturers Drug Rooms Non-Prescription Oregon Board of PharmacyLicensing Functions

11. Oregon Board of PharmacyCompliance Staff • Compliance Director • Chief Investigator • 4 Inspectors • Compliance Secretary

12. Duties of a Pharmacy Inspector • Inspect Registrants • Investigate Complaints • Information Resource for Licensees

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

14. 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)

15. 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 Inspections (cont’d)

16. Deficiency Notice/Notice of Non-Compliance • Compliance reviews responses • Presented to Board at next Board Meeting • Board decides what action to take (if any)

17. Most Common Violations • Procedures and Required Documents • Technicians • Pharmaceuticals & Labeling • Return of Medications • Telephone Prescriptions • Controlled Substances

18. 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

19. 2. Technicians • Unregistered persons performing technician functions • Failure to have/locate: • Current Technician Procedures • Original training & In-Service training documents

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• Improper labeling of prepackaged drugs • Customized Patient Medication Packages (I.e. Salad packs) 60-day exp • Outdated medications not quarantined

21. 4. Return of Medications • Accepting previously dispensed medications • Board in the process of changing this rule

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

23. 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

24. Proposed Rule Changes • Pseudoephedrine • Return of Medications • Technicians • Vaccinations

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

26. 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

27. Most Common Complaints • Dispensing Errors • Patient Counseling • Security Violations • Diversion • Licensee Impairment • Falsification of Documents

28. 1. Dispensing Errors • Incorrect Drug/Strength • Incorrect Sig • Incorrect Doctor name • Short count • Examples • Zantac®/Zyrtec® liquid • Serzone®/Seroquel® • Zestril®/Lisinopril strength errors

29. 2. Patient Counseling • Inadequate or no counseling provided • Examples • Preven® • Vivotef® (oral Typhoid)

30. 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

31. 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

32. 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

33. 6. Falsification of Documents • Failure to respond truthfully to questions • Original application • Renewal • Background checks • Examples • DUII • Possession of CS • Attorney advice

34. 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 Action

35. Disciplinary Actions

36. 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

37. 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

38. 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

39. “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

40. 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