Pharmaceutical Services Requirements: formerly 10D and 10C.7

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1 Pharmaceutical Services Requirements: formerly 10D and 10C.7 Frank S. Emanuel, Pharm.D., FASHP Associate Professor/Division Director Florida A and M University College of Pharmacy Jacksonville

2 Disclosure Statement I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant money for this continuing education program, or any affiliation with an organization whose philosophy could potentially bias my presentation. 2

3 Objectives At the completion of this activity, participants will be able to: Identify the rules and regulations that impact pharmaceutical services in a nursing care facility; Identify the role of the consultant pharmacist; Describe what to expect during a pharmacy survey. 3

4 Authority to Inspect Duly authorized agents and employees of the department shall have the power to inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician s office, or any other place in the state in which drugs and medical supplies are manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for the purpose of determining if any of the provisions of this chapter or any rule promulgated under its authority is being violated. Chapter , Chapter , Chapter , Florida Statutes 4

5 I. Current Pharmacy Permits A. Community Pharmacy B. Institutional Pharmacy C. Nuclear Pharmacy D. Special Pharmacy 5

6 II. Medication Labeling A. Name and address of dispensing pharmacy B. Prescriber s name C. Patient s name D. Date of original filling/ refill E. Prescription number or other identification adequate to readily identify prescription F. Directions for patient use G. Controlled substances bear transfer crime warning labeling H. Expiration Date I. Quantity of drug placed in the container J. Unit Dose medication properly labeled K. Prepackaged medication label bears expiration date 6

7 III. Current Consultant Pharmacist 7

8 IV. Medication Requiring Refrigeration stored in a refrigerator 8

9 V. If MAR system is being used, the MAR labeling is prepared or reviewed and approved by the consultant pharmacist and policy and procedure defines how subsequent reproduction of MAR labeling of the initially dispensed order shall be reviewed. 9

10 VI. Medicinal drugs stored in emergency kits are those medications deemed by Medical Director, Director of Nursing, and Consultant Pharmacist as necessary. 10

11 VII. Emergency Kit is readily available and kept sealed. Medication administered from emergency kits properly accounted for through procedural controls. 11

12 VIII. P & P manual delineates procedure for disposition of unused medications, both controlled substances and noncontrolled substances. 12

13 IX. Records exist for receipt and disposition of all controlled drugs 13

14 X. Account of controlled drugs is reconciled periodically. 14

15 Pharmacy may be cited for the following deficiencies: Failure to remove outdated pharmaceuticals. Misbranded or adulterated products held for sale. Failure to meet regulation of daily operating hours. DEA biennial inventory not current or available. Closed sign missing, prescription department not padlocked. Daily operating hours not posted. Failure to notify the Board of Pharmacy of a change in prescription department manager. Failure to notify the Board of Pharmacy of a change in Consultant Pharmacist. Failure to properly identify pharmacy technicians. Results of Parenteral and Enteral quality assurance program not documented or available for inspection. Policy and Procedure manual not current or available for inspection. Improper storage of legend drugs. 15

16 Pharmacy may be cited for the following deficiencies, continuation: Generic substitution sign not displayed. Failure to have certified by dispensing pharmacists the daily hard-copy computer printout or daily log. Improper documentation of destruction of controlled substances. Controlled substance prescription do not contain required information: Practitioner s name, DEA number, patient s address. Failure to have pharmacy minimally equipped. (i.e. references, compounding equipment and a current copy of the laws and rules governing the practice of pharmacy in the state of Florida). Consultant Pharmacist s monthly reports not current or available for inspection. 16

17 What to Expect During Surveys of Institutional Pharmacies Purpose: To determine how your pharmacy services are structured, delivered and integrated. 17

18 Where and When will the survey take place? The interview may take place in the location of your choice, usually on the second day of the survey. 18

19 Who Will Participate? The individual responsible for providing or directing pharmacy services. Other Staff may also be designated, i.e. Consultant Pharmacists, Clinical Pharmacist or Pharmacy Supervisor. 19

20 What Will Occur? The surveyor will address issues related to: Delivery of medications Storage of Medications Cleanliness of medication carts, rooms, and refrigerators Methods of dealing with discontinued medications What provisions you make for an emergency medication supply, including contents of emergency boxes Narcotics and other controlled substances Suppliers and services TPN Education of Patients and/ or family in selfmedication Your performanceimprovement activities related to pharmaceutical services 20

21 Indicators for Surveyor Assessment of the Performance of Drug Regimen Reviews Reviews must be performed by a pharmacist. Reviews performed vs Average Census. Reviews should be performed in facility. Average Prescription Utilization. Excessive Reviews on the same date. Potential Drug Therapy Problems 21

22 What Documents Need to Be Available? Minutes of pharmacy review meetings Controlled substance logs A sample medication administration record The formulary Acceptable abbreviations for your facility Pharmacy reports to the Director of Nursing/ Administrator Consultant Pharmacists Report 22