Section 350.1410  Medication Policies and Procedures

a)         Every facility shall adopt written policies and procedures for properly and promptly obtaining, dispensing, administering, returning and disposing of drugs and medications.  These policies and procedures shall be consistent with the Act and this Part and shall be followed by the facility.  These policies and procedures shall be in compliance with all applicable federal, State and local laws.  Medication policies and procedures shall be developed with the advice of a pharmaceutical advisory committee that includes at least one licensed pharmacist, one physician, the administrator and the director of nursing. This committee shall meet at least quarterly. 

b)         For the purpose of this Subpart, "licensed prescriber" means a physician; a dentist; a podiatrist; an optometrist certified to use therapeutic ocular pharmaceutical agents; a physician assistant to whom prescriptive authority has been delegated by a supervising physician; or an advanced practice nurse practicing under a valid collaborative agreement.

c)         All legend medications maintained in the facility shall be on individual prescription or from the licensed prescriber's personal office supply, and shall be labeled as set forth in Section 350.1440.  A licensed prescriber who supplies medication from his or her personal office supply shall comply with Sections 33 and 54.5 of the Medical Practice Act of 1987 [225 ILCS 60/33 and 54.5]; or Section 51 of the Illinois Dental Practice Act [225 ILCS 25/51]; or the Podiatric Medical Practice Act of 1987 [225 ILCS 100]; or Section 15.1 of the Illinois Optometric Practice Act of 1987 [225 ILCS 80/15.1]; or Section 15-20 of the Nursing and Advanced Practice Nursing Act [225 ILCS 65/15-20]; or Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95/7.5]. 

d)         All medications administered shall be recorded as set forth in Section 350.1620.  Medications shall not be recorded as having been administered prior to their actual administration to the resident.

e)         The staff pharmacist or consultant pharmacist shall participate in the planned in-service education program of the facility on topics related to pharmaceutical services.

f)         A pharmacist shall obtain a Division III license to operate an on-premises pharmacy in accordance with the Pharmacy Practice Act of 1987 [225 ILCS 85] and the rules of the Illinois Department of Professional Regulation (68 Ill. Adm. Code 1330).

g)         No facility shall maintain a stock supply of controlled drugs or legend drugs, except for those in emergency medication kits or convenience boxes, as described in this Section.

h)         A facility may stock drugs that are regularly available without prescription.  These shall be administered to a resident only upon written order of a licensed prescriber.  Administration shall be from the original containers, and shall be recorded in the resident's clinical record. 

i)          A facility may keep convenience boxes containing medications to be used for initial doses.

1)         The contents and number of convenience boxes shall be determined by the pharmaceutical advisory committee.  The contents shall be listed on the outside of each box.

2)         Each convenience box shall be the property of and under the control of the pharmacy that supplies the contents of the box, and it shall be kept in a locked medicine room or cabinet. 

3)         No Schedule II controlled substances shall be kept in convenience boxes.

j)          Emergency medication kits shall be approved by the facility's pharmaceutical advisory committee, and shall be available for immediate use at all times in locations determined by the pharmaceutical advisory committee. 

1)         Each emergency medication kit shall be sealed after it has been checked and refilled. 

2)         Emergency medication kits shall contain all of the equipment needed to administer the medications.

3)         The contents of emergency medication kits shall be labeled on the outside of each kit.  The kits shall be checked and refilled by the pharmacy after use and as otherwise needed.  The pharmaceutical advisory committee shall review the list of substances kept in emergency medication kits at least quarterly.  Written documentation of this review shall be maintained. 

k)         The following requirements shall be met when controlled substances are kept as part of the emergency medication kits: 

1)         If an emergency medication kit is not stored in a locked room or cabinet, or if the kit contains controlled substances that require refrigeration, then the controlled substances portion of the kit shall be stored separately in a locked cabinet or room (or locked refrigerator or locked cabinet within a refrigerator, as appropriate) and labeled with a list of the substances and a statement they they are part of the emergency medication kit.  The label of the emergency medication kit shall list the substance and the specific location where it is stored. 

2)         Controlled substances for emergency medication kits shall be obtained from a federal Drug Enforcement Administration registered hospital, pharmacy, or licensed prescriber. 

3)         Only the director of nursing, registered nurse on duty, licensed practical nurse on duty, consultant pharmacist or licensed prescriber shall have access to controlled substances stored in emergency medication kits. 

4)         No more than ten different controlled substances shall be kept as part of an emergency medication kit, and there shall be no more than three single doses of any one controlled substance. 

5)         Controlled substances in emergency medication kits may be administered only by persons licensed to administer medications, in compliance with 21 CFR 1306.11 and the Illinois Controlled Substances Act [720 ILCS 570]. 

6)         A proof-of-use sheet shall be stored with each controlled substance.  Entries shall be made on the proof-of-use sheet by the nursing staff or licensed prescriber when any controlled substance from the kit is used. The consultant pharmacist shall receive and file for two years a copy of all completed proof-of-use sheets. 

7)         Whenever the controlled substance portion of an emergency medication kit is opened, the consultant pharmacist shall be notified within 24 hours.  During any period when this kit is opened, a shift count shall be done on all controlled substances until the kit is closed or locked, or the controlled substance is replaced.  Shift counts are not mandatory when the kit is sealed.  Forms for shift counts shall be kept with the controlled substances portion of the emergency medication kit. 

8)         The consultant pharmacist shall check the controlled substances portions of emergency medication kits at least monthly and so document on the outside of each kit. 

9)         Failure to comply with any provision of this Section, or with any applicable provision of State or federal statutes or State regulations pertaining to controlled substances shall result in loss of the privilege of having or placing controlled substances in emergency medication kits until the facility can demonstrate that it is in compliance with such regulations.  This is in addition to the usual methods of corrective action available to the Department, such as fines or other penalties.

l)          Oxygen may be administered in a facility. The oxygen supply shall be stored and handled in accordance with the  National Fire Protection Association (NFPA) Standard No. 99: Standard for Health Care Facilities (2002, no later amendments or editions included) for nonflammable medical gas systems.  The facility shall comply with directions for use of oxygen systems as established by the manufacturer and the applicable provisions of NFPA 99 and the NFPA Life Safety Code (see Section 350.340). 

1)         Facilities shall store medical grade products separately from industrial grade products.  The storage area for medical grade products shall be well defined with one area for receiving full medical gas vessels and another for storing empty vessels.

2)         All personnel who will be handling medical gases shall be trained to recognize the various medical gas labels.  Personnel shall be trained to examine all labels carefully.

3)         If the facility's supplier uses 360-degree wrap-around labels to designate medical oxygen, personnel shall be specifically trained to make sure each vessel they connect to the oxygen system bears such a label.

4)         All facility personnel responsible for changing or installing medical gas vessels shall be trained to connect medical gas vessels properly.  Personnel shall understand how vessels are connected to the oxygen supply system and shall be alerted to the serious consequences of changing connections.

5)         If a medical gas vessel fitting does not seem to connect to the oxygen system fitting, the supplier shall be contacted immediately.  The vessel shall be returned to the supplier to determine the fitting or connection problem.

6)         Once a medical gas vessel has been connected to the oxygen supply system, but prior to introducing the product into the system, a trained facility staff member shall ensure that the correct vessel has been connected properly.

(Source:  Amended at 27 Ill. Reg. 5924, effective April 01, 2003)