Section 132.65. Pharmaceutical services.

 

(1)   Definitions. As used in this section:

(a) "Medication" has the same meaning as the term "drug" defined in s. 450.06 , Stats.

(b) "Prescription medication" has the same meaning as the term"prescription drug" defined in s. 450.07 , Stats.

(c) "Schedule II drug" means any medication listed in s. 961.16 , Stats.

(2)   Services.

(a) Each facility shall provide for obtaining medications for the residents directly from licensed pharmacies.

(b) The facility shall establish, maintain, and implement such policies and procedures as are necessary to comply with this section and assure that resident needs are met.

(4)   Emergency medication kit.

(a) A facility may have one or more emergency medication kits. All emergency medication kits shall be under the control of a pharmacist.

(b) The emergency kit shall be sealed and stored in a locked area.

(5)   Contingency supply of medications.

(a) Maintenance. A facility may have a contingency supply of medications not to exceed 10 units of any medication. Any contingency supply of medications must be under the control of a pharmacist.

(b) Storage. Contingency drugs shall be stored at a nursing unit, except that those medications requiring refrigeration shall be stored in a refrigerator.

(c) Single units. Contingency medications shall be stored in single unit containers, a unit being a single capsule, tablet, ampule, tubex, or suppository.

(d) Committee authorization. The quality assessment and assurance committee shall determine which medications and strengths of medications are to be stocked in the contingency storage unit and the procedures for use and re-stocking of the medications.

(e) Control. Unless controlled by a "proof-of-use" system, as provided by sub. (6) (e) , a copy of the pharmacy communication order shall be placed in the contingency storage unit when any medication is removed.

(6)   Requirements for all medication systems.

(b) Storing and labeling medications. Unless exempted under par. (f) , all medications shall be handled in accordance with the following provisions:

1. `Storage.' Medications shall be stored near nurse's stations, in locked cabinets, closets or rooms, conveniently located, well lighted, and kept at a temperature of no more than 85 ° F. (29 ° C.).

2. `Transfer between containers.' Medications shall be stored in their original containers, and not transferred between containers, except by a physician or pharmacist.

3. `Controlled substances.' Separately locked and securely fastened boxes or drawers, or permanently affixed compartments, within the locked medication area shall be provided for storage of schedule II drugs, subject to 21 USC ch. 13 , and Wisconsin's uniform controlled substance act, ch. 961 , Stats.

4. `Separation of medications.' Medications packaged for individual residents shall be kept physically separated.

5. `Refrigeration.' Medications requiring refrigeration shall be kept in a separate covered container and locked, unless the refrigeration is available in a locked drug room.

6. `External use of medications.' Poisons and medications for external use only shall be kept in a locked cabinet and separate from other medications, except that time-released transdermal drug delivery systems, including nitroglycerin ointments, may be kept with internal medications.

7. `Accessibility to drugs.' Medications shall be accessible only to the registered nurse or designee. In facilities where no registered nurse is required, the medications shall be accessible only to the administrator or designee. The key shall be in the possession of the person who is on duty and assigned to administer the medications.

8. `Labeling medications.' Prescription medications shall be labeled with the expiration date and as required by s. 450.11 (4) , Stats. Non-prescription medications shall be labeled with the name of the medication, directions for use, the expiration date and the name of the resident taking the medication.

(c) Destruction of medications.

1. `Time limit.' Unless otherwise ordered by a physician, a resident's medication not returned to the pharmacy for credit shall be destroyed within 72 hours of a physician's order discontinuing its use, the resident's discharge, the resident's death or passage of its expiration date. No resident's medication may be held in the facility for more than 30 days unless an order is written every 30 days to hold the medication.

2. `Procedure.' Records shall be kept of all medication returned for credit. Any medication not returned for credit shall be destroyed in the facility and a record of the destruction shall be witnessed, signed and dated by 2 or more personnel licensed or registered in the health field.

(d) Control of medications.

1. `Receipt of medications.' The administrator or a physician, nurse, pharmacist, or the designee of any of these may be an agent of the resident for the receipt of medications.

2. `Signatures.' When the medication is received by the facility, the person completing the control record shall sign the record indicating the amount received.

3. `Discontinuance of schedule II drugs.' The use of schedule II drugs shall be discontinued after 72 hours unless the original order specifies a greater period of time not to exceed 60 days.

(e) Proof-of-use record.

1. For schedule II drugs, a proof-of-use record shall be maintained which lists, on separate proof-of-use sheets for each type and strength of schedule II drug, the date and time administered, resident's name, physician's name, dose, signature of the person administering dose, and balance.

2. Proof-of-use records shall be audited daily by the registered nurse or designee, except that in facilities in which a registered nurse is not required, the administrator or designee shall perform the audit of proof-of-use records daily.

(f) Resident control and use of medications. Medications which, if ingested or brought into contact with the nasal or eye mucosa, would produce toxic or irritant effects shall be stored and used only in accordance with the health, safety, and welfare of all residents.

(7)   Additional requirements for unit dose systems.

(a) Scope. When a unit dose drug delivery system is used, the requirements of this subsection shall apply in addition to those of sub. (6) .

(b) General procedures.

1. The individual medication shall be labeled with the drug name, strength, expiration date, and lot or control number.

2. A resident's medication tray or drawer shall be labeled with the resident's name and room number.

3. Each medication shall be dispensed separately in single unit dose packaging exactly as ordered by the physician, and in a manner to ensure the stability of the medication.

4. An individual resident's supply of drugs shall be placed in a separate, individually labeled container and transferred to the nursing station and placed in a locked cabinet or cart. This supply shall not exceed 4 days for any one resident.

5. If not delivered from the pharmacy to the facility by the pharmacist, the pharmacist's agent shall transport unit dose drugs in locked containers.

6. The individual medication shall remain in the identifiable unit dose package until directly administered to the resident. Transferring between containers is prohibited.

7. Unit dose carts or cassettes shall be kept in a locked area when not in use.

History: Cr. Register, July, 1982, No. 319 , eff. 8-1-82; r. and recr. (3) (b), am. (6) (a), (b) 6. and (c), Register, January, 1987, No. 373 , eff. 2-1-87; am. (3) (b) 2., (6) (b) 8. and (c) 1. and 3., Register, February, 1989, No. 398 , eff. 3-1-89; correction in (1) (c) made under s. 13.93 (2m) (b) 7., Stats., Register, August, 2000, No. 536 ; correction made to (6) (d) 1. under s. 13.93 (2m) (b) 7., Stats., Register December 2003 No. 576 ; CR 04-053 : am. (2) and (5) (d), r. (3) (a), renum. and am. (3) (b) 1. and 2., r. (6) (c) 3. Register October 2004 No. 586 , eff. 11-1-04; CR 06-053 : r. (3) and (6) (a) and (f) 1. and 2., renum. (6) (f) 2. to be (6) (f), Register August 2007 No. 620 , eff. 9-1-07.