Midwinter Meeting February 29, 2020
The Who, Where, When, What, Why and How of Pharmacy Inspections Sharilee McIntyre Pharmacy Inspector Division of Occupational and Professional Licensing
Utah Department of Commerce Division of Occupational and Professional Licensing (DOPL)
Disclosure • Sharilee McIntyre does not have conflicts of interest to disclose. • We will not be discussing off-label uses of drugs.
Learning Objectives At the conclusion of this activity, pharmacists should be able to successfully: 1. Identify areas where facilities are compliant or non-compliant. 2. Distinguish what documentation shall be provided upon request. 3. Review what the Division’s authority is regarding when an inspection can be conducted.
Learning Objectives At the conclusion of this activity, technicians should be able to successfully: 1. Distinguish why inspections are conducted. 2. Identify what operating standards are required for a Class B pharmacy. 3. Demonstrate how to assist the facility with compliance regarding beyond use dating.
The Division of Occupational and Professional Licensing, also known as DOPL, is one of seven agencies within the Utah Department of Commerce. DOPL is legislatively charged to administer and enforce specific laws related to the licensing and regulation of certain occupations and professions. .
58 ‐ 17b ‐ 103 Administrative inspections (1) The division may for the purpose of ascertaining compliance with the provisions of this chapter, require a self ‐ audit or enter and inspect the business premises of a person: (a) licensed under Part 3, Licensing; or (b) who is engaged in activities that require a license under Part 3, licensing.
(2) Before conducting an inspection under Subsection(1), the division shall, after identifying the person in charge; (a) give proper identification; (b) request to see the applicable license or licenses; (c) describe the nature and purpose of the inspection; and (d) provide upon request, the authority of the division to conduct the inspection and the penalty for refusing to permit the inspection as provided in section 58-17b-504 (4) An inspection described in Subsection (1) shall be conducted during regular business hours .
(3) In conducting an inspection under Subsection (1), the division may, after meeting the requirements of Subsection (2): (a) examine any record, prescription, order, drug, device, equipment, machine, electronic device or media, or area related to activities for which a license has been issued or is required by Part 3, Licensing, for the purpose of ascertaining compliance with the applicable provisions of this chapter; (b) reproduce any record or media at the division's own cost; (c) take a drug or device for further analysis if considered necessary; (d) temporarily seize a drug or device that is suspected to be adulterated, misbranded, outdated, or otherwise in violation of this chapter, pending an adjudicative proceeding on the matter; (e) box and seal drugs suspected to be adulterated, outdated, misbranded, or otherwise in violation of this chapter; and (f) dispose of or return a drug or device obtained under this Subsection (3) in accordance with procedures established by division rule.
1.Pharmacy inspection – Class A, Class B, Class C, Class D, Class E 2.Automation inspection 3.Non ‐ sterile compounding inspection 4.Sterile compounding inspection *Hazardous compounding inspection
1. Observation 2. Documentation
Pharmacists What documentation shall be provided upon request from the Division?
1. Controlled Substance annual and perpetual records 2. Standard operating procedures 3. Social media history 4. Your controlled substance history 5. Your work history 6. Invoices 7. Facility phone records 8. Counseling logs 9. Training records 10.Social Security Card 11.Financial records 12.Shipping records
The mission of DOPL is to protect the public and to enhance commerce through licensing and regulation.
Pharmacy Technicians Under what circumstances does the Division conduct inspections? A. Your mom said they had to. B. They received a complaint. C. The facility is new. D. The facility has not been seen since they opened in 2000. E. There has been diversion at the facility. F. It was your birthday. We wanted to celebrate with you. G. We drew you out of a hat.
Class B
Class B observations 1. Electronic or written lists of employees is incomplete or missing 2. Personnel not wearing their name badge with classification 3. Perpetual controlled substance inventory is not reconciled 4. Annual controlled substance inventory is out of date. 5. Suppliers’ invoices of controlled substances are not received by clearly recording their initials of the controlled substances.
Automation Inspection Observations 1. Missing documentation on site in the pharmacy. 2. Standard operating procedures are not complete. 3. Record of medications filled and stocked into an automated pharmacy system is not maintained and does not include the identification of the persons filling, stocking and checking for accuracy. 4. All containers of medications stored in the automated pharmacy system shall be packaged and labeled in accordance with federal laws and regulations. 5. Automated pharmacy system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated pharmacy system.
Non-Sterile Compounding Observations 1. Office use compounding 2. Selling to other pharmacies 3. Compounded items that are essentially a copy of a regularly and commonly available product. 4. SOP is not complete 5. Training is not complete 6. Items are not labeled with the date of receipt, and assigned a conservative expiration date, not to exceed three years after receipt, to the component. 7. Transferred items do not have the name, lot or control number, transfer date and expiration date on the container. 8. Container does not meet USP requirements. 9. Containers and closures are not being stored off of the floor. 10. Beyond use dating is not being assigned correctly 11. Only one preparation is compounded at one time in a specific workspace. 12. Master and preparation sheets do not include all items that are needed. 13. Labeling is not complete
Sterile Compounding Observations 1. Immediate risk compounding is occurring and not following the definition of immediate risk. 2. Documentation is incomplete 3. Standard operating procedures are not complete or being followed 4. Training is not complete 5. Cleaning is not being done correctly 6. Air and surface sampling is not being done correctly. Facilities do not have a map 7. Smoke study done under dynamic conditions is not being conducted 8. Master and compounding preparation sheet has missing items 9. Stability information for beyond use dating is incorrect 10. Facility does not have a formal QA program that addresses in process checks
Tips for Success • Documentation • Accessibility • Know the law and rule • Ask questions • Mock inspections
Pharmaceutical Administration Facility (PAF) (44) "Pharmaceutical administration facility" means a facility, agency, or institution in which: (a) prescription drugs or devices are held, stored, or are otherwise under the control of the facility or agency for administration to patients of that facility or agency; (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist or pharmacy intern with whom the facility has established a prescription drug supervising relationship under which the pharmacist or pharmacy intern provides counseling to the facility or agency staff as required, and oversees drug control, accounting, and destruction; and (c) prescription drugs are professionally administered in accordance with the order of a practitioner by an employee or agent of the facility or agency U.C.A. 58-17b-102 (44)
dopl.utah.gov (801) 243 ‐ 2733 Sharilee McIntyre smcintyre@utah.gov
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