Section 380.630  Pharmaceutical Services and Medication Administration

a)         All consumers shall be assessed for drug allergies, and drug histories shall be documented and reported to the pharmacy and physician.  Pharmacies shall immediately notify the physician and the facility of any potential drug interactions prior to dispensing the medication. 

b)         Pharmaceutical Treatment

1)         A consumer shall not be given unnecessary drugs.  An unnecessary drug is any drug used in an excessive dose, including in duplicative therapy; for excessive duration; without adequate monitoring; without adequate indication for its use; or in the presence of adverse consequences that indicate the drug should be reduced or discontinued.

2)         No drug shall be administered except upon the order of a person lawfully authorized to prescribe for and treat mental illness.

3)         All drug orders shall be written, dated, and signed by the person authorized to give the order.  The name, quantity, or specific duration of therapy, dosage, and time or frequency of administration of the drug and the route of administration if other than oral shall be specific.

4)         Verbal orders for drugs and treatment shall be received only by those authorized under Illinois law to do so from their supervising physician.  Orders shall be recorded immediately in the consumer's record by the person receiving the order and shall include the date and time of the order.  (Section 3-106 of the Act)

5)         A facility with a pharmacy on the premises shall comply with the Controlled Substances Act. Facilities without pharmacies shall ensure that pharmacies with which they make arrangements, or contract, comply with the Controlled Substances Act.

c)         Medication Policies

1)         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 comply with all federal and State laws and administrative rules relating to the procurement, storage, dispensing, administration and disposal of medications.

2)         The medication policies and procedures shall be developed with the advice of a licensed pharmacist, the medical director and the director of health services.

3)         The facility shall ensure that pharmaceutical services are arranged and their administration is supervised in accordance with the Medical Practice Act of 1987 and the Nurse Practice Act.  The facility shall ensure that:

A)        A physician is responsible for the medical services provided to individuals and the management of consumers' medications;

B)        A licensed prescriber prescribes and monitors all prescription medications;

C)        A psychiatrist performs an examination of the consumer prior to the initiation of psychotropic medications;

D)        Screening for and documentation of abnormal involuntary movements, including tardive dyskinesia in individuals receiving prescribed psychotropic medications, is completed at least every six months by employees trained in performing this type of assessment;

E)        A psychiatrist reviews all medications prescribed and shall be available for consultation on the prescribed medications. Psychiatrist documentation within the individual's record shall include, but is not limited to, the rationale for continuing current medications and/or initiating new medications, and medication side effects. When clinically indicated, a psychiatrist and facility shall arrange for consultation with the appropriate medical specialist.

i)          A psychiatrist, a psychiatric nurse practitioner, or an advanced practice nurse review medications and perform case management on consumers as needed in triage centers.

ii)         A psychiatrist review medications and see individuals three times weekly in crisis stabilization units. In addition, a psychiatrist shall be immediately available by phone 24 hours per day and respond on site within 24 hours.

iii)        A psychiatrist review medications and see individuals at least monthly in transitional living units and in RRS units;

F)         In recovery and rehabilitation supports and transitional living, a psychiatrist or registered professional nurse evaluates the ability of each consumer to self-administer medications within the first three months after admission, and then at least annually, after a consumer completes a self-medication training program, prior to the consumer moving to community-based services or prior to transition to community living;

G)        A clinical pharmacist reviews each consumer's chart to evaluate for unnecessary medications in accordance with the Drug Burden Index, and for potential adverse drug events based upon the total pharmacotherapy regimen and pre-existing medical conditions;

H)        A psychiatrist provides the written order for a consumer to self-administer medications or participate in a self-administration of medication training program based on the results of the consumer's evaluation.  The order shall become part of the individual's record;

I)         Consumers in transitional living units and recovery and rehabilitation supports units who are able to independently self-administer medications have access to their medications.

i)          The facility has a written policy on determining the level of independence, and documentation of the level of independence will be placed in the consumer's treatment plan. 

ii)         Level I independence means that the consumer shall have a secured medicine storage cabinet in his or her bedroom for which he or she has the key or the combination to the lock. 

iii)        Level II independence means that the consumer shall be responsible for independently requesting his or her medication from a central medication area, which shall be staffed by a licensed medical professional, at the appropriate times;

J)         When facilities supervise the self-administration of medication training programs, or administer the medications, medications are secured from unauthorized access, and only a psychiatrist, pharmacist, or registered or licensed practical nurse shall supervise the self-administration of a medication training program or administer medications and have access to medications.  A psychiatrist, pharmacist or licensed nurse shall be available at all times for consultation and supervision of the self-administration of medications training program;

K)        A physician or pharmacist is available to consult with the QMHP or MHP in reference to staff's behavioral or other observations relating to the individual's level, dosage and types of side effects from any prescribed medications;

L)        A physician or pharmacist makes available to consumers information on expected consequences and the potential benefits and possible side effects of any prescribed medication.  If requested, this information will also be made available to employees and families; and

M)       All Schedule II controlled substances are stored so that two separate locks, using two different keys, shall be unlocked to obtain these substances.

d)         Emergency Medication Kits

1)         A facility shall not maintain a stock supply of controlled drugs, except for those in the emergency medication kits, as described in this subsection (d).

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

3)         A facility may keep emergency medication kits containing medications to be used for initial doses.

4)         Each emergency medication kit 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. Schedule II controlled substances shall not be kept in emergency medication kits.

5)         The contents and number of emergency medication kits shall be approved by the facility's pharmacist, medical director and director of health services, and shall be available for immediate use at all times in locations determined by them.

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

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

C)        The contents of emergency medication kits shall be labeled on the outside of each kit.  The label shall include expiration dates of any medications contained in the 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.  The facility shall maintain written documentation of this review.

D)        The contents and number of emergency medication kits shall be determined by the pharmacist, medical director and the director of health services.  The contents should include, at a minimum, but not be limited to, behavioral medications and medications to specifically address anaphylactic and dystonic reactions. The contents shall be listed on the outside of each box.

6)         The facility shall comply with the following requirements when controlled substances are kept as part of the emergency medication kits:

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

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

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

D)        No more than 10 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.

E)        Controlled substances in emergency medication kits shall be administered only by persons licensed to administer medications, in compliance with 21 CFR 1306.11 and 1306.21, and the Illinois Controlled Substances Act.

F)         A proof-of-use sheet shall be stored with each controlled substance. The nursing staff or licensed prescriber shall enter the date and time that a drug was administered to a consumer, the dose, the name of the consumer, and the name of the prescriber on the proof-of-use sheet when any controlled substance from the kit is used. The completed proof-of-use sheets shall be filed with the consultant pharmacist and shall be retained for two years.

G)        The consultant pharmacist shall be notified within 24 hours after the controlled substance portion of an emergency medication kit is opened. During any period when the kit is opened, a shift count shall be done on all controlled substances until the kit is re-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.

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