Section 134.67. Pharmaceutical services.

 

(1)   Definitions. In this section:

(a) "Medication" has the meaning prescribed for "drug" in s. 450.06 , Stats.

(b) "Prescription medication" has the meaning prescribed for "prescription drug" in s. 450.07 , Stats.

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

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

(3)   Supervision.

(a) The facility shall have a written agreement with a pharmacist and a registered nurse who, with the administrator, shall develop the pharmaceutical policies and procedures appropriate to the size and nature of the facility that will ensure the health, safety and welfare of the residents, including policies and procedures concerning:

1. Handling and storage of medications;

2. Administration of medications, including self-administration;

3. Review of medication errors;

4. Maintenance of an emergency medication kit under sub. (4) ; and

5. Automatic termination of medication orders which are not limited as to time and dosages.

(b) The pharmacist or, in a small facility, a registered nurse shall visit the facility at least quarterly to review drug regimens and medication practices and shall submit a written report of findings and recommendations to the facility administrator.

(c) The facility shall maintain a current pharmacy manual which includes policies and procedures and defines functions and responsibilities relating to pharmacy services. The manual shall be revised annually to keep it abreast of developments in services and management techniques.

(d) A pharmacist or, in a small facility, a registered nurse shall review the medication record of each resident at least quarterly for potential adverse reactions, allergies, interactions and contraindications, and shall advise the physician of any changes that should be made in it.

(4)   Emergency medication kit.

(a) If a facility has an emergency medication kit, the emergency medication kit shall be under the control of a pharmacist.

(c) The emergency kit shall be sealed and stored in a locked area accessible only to licensed nurses, physicians, pharmacists and other persons who may be authorized in writing by the physician designated under s. DHS 134.66 (2) (d) to have access to the kit.

(5)   Requirements for all medication systems.

(a) Obtaining new medications.

1. When a medication is needed which is not stocked, a registered nurse or designee shall telephone an order to the pharmacist who shall fill the order and release the medication in return for a copy of the physician's written order.

2. When a new medication is needed which is stocked, a copy of the resident's new medication order shall be sent to the pharmacist filling medication orders for the resident.

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

1. Medications shall be stored in locked cabinets, closets or rooms, be conveniently located in well-lighted areas and be kept at a temperature of no more than 85ºF. (29ºC.);

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

3.

a. Separately locked and securely fastened boxes or drawers, or permanently affixed compartments within the locked medications area, shall be provided for storage of schedule II drugs, subject to 21 USC ch. 13 and ch. 961 , Stats. ;

b. 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 the dose, and balance;

c. 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;

d. When the medication is received by the facility, the person completing the control record shall sign the record and indicate the amount received;

4. Medications packaged for an individual resident shall be kept physically separated from other residents' medications;

5. Medications requiring refrigeration shall be kept in a separate covered container in a locked refrigeration unit, unless the refrigeration unit is available in a locked drug room;

6. Medications that are known to be poisonous if taken internally or that are labeled "for external use only" shall be kept physically separated from other medications within a locked area, except that time-released transdermal drug delivery systems, including nitroglycerin ointments, may be kept with internal medications;

7. Medications shall be accessible only to the registered nurse or designee, except that in facilities where no registered nurse is required, 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. Prescription medications shall be labeled as required by s. 450.07 (4) , Stats., and with the expiration date. Nonprescription medications shall be labeled with the name of the medication, directions for use, expiration date and the name of the resident taking the medication; and

9. The facility may not give a medication to a resident after the expiration date of the medication.

(c) Destruction of medications.

1. Unless otherwise ordered by a physician, a resident's medication not returned to the pharmacy for credit shall be destroyed within 72 hours after receipt 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 by a physician every 30 days to hold the medication.

2. Records shall be kept of all medications returned for credit. Any medication under subd. 1. not returned for credit shall be destroyed in the facility and a record of the destruction shall be prepared which shall be signed and dated by 2 or more personnel who witnessed the destruction and who are licensed or registered in the health care field.

(d) Resident control and use of medications.

1. Residents may have medications in their possession or stored at their bedsides if ordered by a physician or otherwise permitted under s. DHS 134.60 (4) (d) 4.

2. Medications in the possession of a resident which, if ingested or brought into contact with the nasal or eye mucosa would produce toxic or irritant effects, shall be stored and used by a resident only in accordance with the health, safety and welfare of all residents.

(6)   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. (5) .

(b) General procedures.

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

2. A resident's medication tray or drawer in a unit dose system 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 that ensures the stability of the medication.

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

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

6. Individual medications 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.

Cr. Register, June, 1988, No. 390 , eff. 7-1-88; CR 04-053 : r. and recr. (2), r. (4) (b) and (5) (c) 3. Register October 2004 No. 586 , eff. 11-1-04.