Section 2081.10  Authority

 

This Part is promulgated pursuant to the Illinois Controlled Substances Act that empowers the Department of Human Services to codify the efforts of this State to conform with the regulatory systems of the federal government and other states to establish national coordination of efforts to control the abuse of Schedule II, III, IV and V retail dispensed drugs.  It relates to the collection of prescription information listed in Schedule II, III, IV and V within Sections 206, 208, 210 and 212 of the Act, or in the federal Schedule II, III, IV and V and "Amendment of Schedules" list of drugs at 21 USC 812(b)(2), (b)(3), (b)(4), (b)(5) and (c).

 

Section 2081.20  Definitions and Incorporation by Reference

 

No incorporations by reference in this Part include any later amendments or editions.  The definitions that apply to this Part are those found in the Act and those in this Section.

 

"Act" means the Illinois Controlled Substances Act [720 ILCS 570].

 

"Birth Date" means the medication recipient's birth date.

 

"Central Repository" means a place designated by the Department where Schedule II, III, IV and V drug data is stored or housed.

 

"Clinical Director" means a DHS administrative employee licensed to either prescribe or dispense controlled substances who shall run the clinical aspects of the DHS Prescription Monitoring Program and its Prescription Information Library [720 ILCS 570/102(d-5)].

 

"Controlled Substance" means a drug, substance, or immediate precursor in the Schedules of Article II of the Illinois Controlled Substances Act, or a drug or other substance, or immediate precursor, designated as a controlled substance by the DHS [720 ILCS 570/102(f)].

 

"DEA Number" means the United States Drug Enforcement Agency prescriber or dispenser registration number.

 

"Department" or "DHS" means the Illinois Department of Human Services, or its successor agency.

 

"Dispenser" means any practitioner or pharmacy that dispenses a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a prescriber [720 ILCS 570/102(p) and (q)].

 

"DPH" means the Illinois Department of Public Health.

 

"Electronic Device" means using a computer system to transmit prescriptions from a prescriber directly to a dispenser.

 

"Exempt Prescribers in Hospitals and Institutions" means prescribers in hospitals or institutions licensed under the Hospital Licensing Act [210 ILCS 85] who authorize the administration or dispensing of Schedule II drugs within the hospital or institution, for consumption within the hospital or institution (e.g., controlled substance prescriptions when a prescriber does not maintain his or her own DEA and State controlled substance license, but prescribes based upon the institution's (hospital's) controlled substance licenses).

 

"Facsimile Equipment" means any device capable of sending or receiving facsimiles of documents through connection with a telecommunications network.

 

"HFS" means the Illinois Department of Healthcare and Family Services.

 

"Illinois Controlled Substances License Number" means the State license number issued by the Illinois Department of Financial and Professional Regulation (DFPR) permitting prescribers to possess, prescribe or dispense, and permitting dispensers to possess and dispense, controlled substances in Illinois pursuant to the Controlled Substances Act (see 77 Ill. Adm. Code 3100).

 

"Licensed Healthcare Provider" means any individual who meets the professional licensing requirements and follows the standards set forth by DFPR and are authorized to prescribe or dispense controlled substances within Illinois.

 

"Long Term Care" or "LTC" means:

 

any facility defined by Section 1-113 of the Nursing Home Care Act; and

 

any skilled nursing facility or a nursing facility that meets the requirements of section 1819(a), (b), (c) and (d) or section 1919(a), (b), (c) and (d) of the Social Security Act (42 U.S.C. 1395i-3(a), (b), (c) and (d) and 1396r(a), (b), (c) and (d)).

 

"Long Term Care Pharmacy" or "LTC Pharmacy" means those pharmacies that, either as a primary or secondary focus, provide prescription services to those inpatient institutions licensed as LTC facilities by DPH.

 

"Mid-level Practitioner" means:

 

a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95];

 

an advanced practice registered nurse who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatric physician, in accordance with Section 65-40 of the Nurse Practice Act [225 ILCS 65];

 

an advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist who has been granted authority to prescribe by a hospital affiliate in accordance with Section 65-45 of the Nurse Practice Act;

 

an animal euthanasia agency; or

 

a prescribing psychologist. [720 ILCS 570/102(z-10)]

 

"National Drug Code Identification Number" or "NDC Identification Number" means the number used to provide uniform product identification for all substances recognized as drugs in the United States Pharmacopoeia National Formulary, USP31-NF26 (US Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland  20852 (2013)).

 

"Patient ID" means the identification of the individual receiving the medication or the responsible individual obtaining the medication on behalf of the recipient or the owner of the animal.  The standards for establishing patient ID for the purpose of proper filling of a prescription are established by 77 Ill. Adm. Code 2080.70(d).

 

"Patient Location Code" means the portion of a LTC pharmacy's system of electronic files that identifies with which LTC facility, and what classification of care, the individual patient is associated.

 

"Prescribed" means ordered by a prescriber verbally, electronically or in writing.

 

"Prescriber" means the healthcare professional that is authorized to prescribe medications as set forth in the various professional practices of the State of Illinois.

 

"Prescription Information Library" or "PIL" means an electronic library containing 12 months of controlled substance, retail, prescription information that is accessible only by prescribers and dispensers for patient treatment usage [720 ILCS 570/102(nn-5)].

 

"Prescription Monitoring Program" or "PMP" means the entity that collects, tracks, and stores reported data on controlled substances and select drugs [720 ILCS 570/102(nn-10)].

 

"Prescription Monitoring Program Advisory Committee" or "PMPAC" means a committee consisting of licensed healthcare providers representing all professions that are licensed to prescribe or dispense controlled substances.  The committee serves in a consultant context regarding longitudinal evaluations of compliance with evidence based clinical practice and controlled substances.  The committee makes recommendations regarding scheduling of controlled substances and recommendations concerning continuing education designed at improving the health and safety of the citizens of Illinois regarding pharmacotherapies of controlled substances (e.g., the choice of medications, the frequency of refills, concomitant pharmacotherapies of other medications, all of which affect clinical response and possible dependency on those therapies).

 

"Quantities of a Controlled Substance Dispensed" means the total of a National Drug Code product dispensed whether it is in a solid unit such as a tablet or capsule, in a liquid unit such as milliliters, or in another unit as specified within the product identification.

 

"Recipient's Name" means the given or common name of a person who is the intended user of a dispensed medication.  It may also mean the species or common name or common given name of an animal that is the intended user of a dispensed medication.  If an animal's name is entered, the owner's name is required also.

 

"Schedule Drug" means any substances listed in the federal Controlled Substances Act (21 U.S.C. 812) or the Illinois Controlled Substances Act [720 ILCS 570] or by the Department pursuant to its authority under Section 202 of the Illinois Controlled Substances Act.  Schedule, I, II, III, IV and V substances are listed in section 812 of the federal Controlled Substances Act (21 U.S.C. 812(b)(2), (b)(3), (b)(4), (b)(5) and (c)) and Sections 204, 206, 208, 210 and 212 of the Illinois Controlled Substances Act.

 

"Sex" means the medication recipient's biological status of being male or female at birth.

 

(Source:  Amended at 47 Ill. Reg. 10948, effective July 7, 2023)

 

Section 2081.30  General Description

 

The PMP monitors all controlled substances for Schedule II, III, IV and V drugs that are dispensed within the State of Illinois, except for those dispensed to hospital inpatients and by drug abuse treatment programs licensed by the Department.  The LTC pharmacies transmit patient medication profiles to the PMP.  Each time a Schedule II, III, IV or V drug is dispensed, the dispenser must transmit specific information to a central repository designated by the Department.

 

Section 2081.40  Long Term Care Pharmacies Responsibility

 

LTC pharmacies shall transmit the patient medication profiles to the PMP weekly (see 720 ILCS 570/316(c)).  The Department shall impose a civil fine of $100 per day for willful failure to comply with statutory reporting requirements.  Assessment of the fine begins on the day after the report was required to be submitted and ends on the day the failure to report is remedied.  Fines shall be payable to the Prescription Monitoring Program.

 

a)         This information shall include, but not be limited to, all the following data fields to provide the clinical oversight required by Section 5-5.12(f) of the Public Aid Code or as modified by DPH, HFS or DHS:

 

1)         Dispenser DEA number.

 

2)         Name of the medication as listed in Appendix A.

 

3)         Dispenser name and address.

 

4)         Patient information that should be kept up to date at all times:

 

A)        Patient's name.

 

B)        Patient ID.

 

C)        Patient sex (M for male, F for female or U for unknown).

 

D)        Patient birth date (yyyymmdd – year, month, day).

 

E)        Patient ethnicity (if available).

 

F)         Patient location code (LTC facility State provider number and corresponding location at the facility, i.e., unit and room).

 

G)        Pre-existing conditions.

 

H)        Patient weight, when available electronically.

 

I)         Patient height, when available electronically.

 

5)         For each prescription dispensed, the following information must be included:

 

A)        The NDC identification number of the Schedule II, III, IV or V drugs or select drugs.

 

B)        Quantity of the drug dispensed.

 

C)        Dosing of the drug dispensed.

 

D)        Date when the drug was dispensed.

 

E)        Date prescription was written.

 

F)         Prescriber DEA number.

 

G)        Prescriber full name.

 

H)        Diagnosis.

 

I)         Days' supply (based on dispensed quantity).

 

6)         For any patient admissions to acute care facilities, the following information shall be included:

 

A)        Date admitted, if known to the dispenser.

 

B)        Date discharged, if discharged at time of transmission, if known to the dispenser.

 

C)        Reason for admission, if known to the dispenser.

 

D)        Any changes to medication therapy involving medications in Appendix A, if known to the dispenser.

 

b)         As directed by the Clinical Director for PMP, aggregate data and specialized reports may be developed relative to the selected drugs for clinical studies as covered under Art. VIII, Part. 21 of the Code of Civil Procedure [735 ILCS 5] (Medical Studies).

 

(Source:  Amended at 47 Ill. Reg. 10948, effective July 7, 2023)

 

Section 2081.50  Error Reporting

 

a)         If a prescriber notices an error in his or her prescription information, that prescriber shall report it to the Department by using the built-in PMP error reporting system within 7 days after discovery of the error.

 

b)         A dispenser who notices an error in a prescription he or she has dispensed and transmitted shall retract the incorrect prescription and retransmit the prescription correctly within 7 days after discovery of the error.

 

Section 2081.60  Long Term Care Clinical Information (Repealed)

 

(Source:  Repealed at 47 Ill. Reg. 10948, effective July 7, 2023)

 

Section 2081.70  Designated Medications

 

For tracking purposes, the Department, by recommendation of the PMPAC may designate and list drugs, other substances or immediate precursors as:

 

a)         A Schedule I, if the Department finds that:

 

1)         the substance has high potential for abuse; and

 

2)         the substance has no currently accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision [720 ILCS 570/203].

 

b)         A Schedule II, if the Department finds that:

 

1)         the substance has high potential for abuse;

 

2)         the substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and

 

3)         the abuse of the substance may lead to severe psychological or physiological dependence. [720 ILCS 570/205]

 

c)         A Schedule III, if the Department finds that:

 

1)         the substance has a potential for abuse less than the substances listed in Schedule II;

 

2)         the substance has currently accepted medical use in treatment in the United States; and

 

3)         abuse of the substance may lead to moderate or low physiological dependence or high psychological dependence. [720 ILCS 570/207]

 

d)         A Schedule IV, if the Department finds that:

 

1)         the substance has a low potential for abuse relative to substances in Schedule III;

 

2)         the substance has currently accepted medical use in treatment in the United States; and

 

3)         abuse of the substance may lead to limited physiological dependence or psychological dependence relative to the substances in Schedule III. [720 ILCS 570/209]

 

e)         A Schedule V, if the Department finds that:

 

1)         the substance has low potential for abuse relative to the controlled substances listed in Schedule IV;

 

2)         the substance has currently accepted medical use in treatment in the United States; and

 

3)         abuse of the substance may lead to limited physiological dependence or psychological dependence relative to the substances in Schedule IV, or the substance is a targeted methamphetamine precursor as defined in the Methamphetamine Precursor Control Act [720 ILCS 648]. [720 ILCS 570/211]

 

Section 2081.80  Mid-Level Practitioners Prescriptive Authority Reporting

 

In order to prevent erroneous association of prescriptions and remain compliant with the PMP, any supervising or collaborating physician who has delegated prescriptive authority to a mid-level practitioner is required to log in and fill out the electronic form on the PMP website (www.ilpmp.org) detailing what prescriptive authority he or she has delegated (see Section 318(k) of the Act).  It is incumbent upon the collaborating or supervising physician to keep this record up to date.  The form will require, but not be limited to, the following data fields:

 

a)         Mid-level practitioner's information necessary for the electronic PMP form:

 

1)         Name (First, MI, Last);

 

2)         DEA number;

 

3)         Profession; and

 

4)         Mid-Level Practitioner's Professional License Numbers.

 

b)         Delegating physician or podiatrist:

 

1)         Name (First, MI, Last);

 

2)         DEA number;

 

3)         Profession; and

 

4)         Mid-Level Practitioner's Professional License Numbers.

 

c)         List of drugs delegated.

 

Section 2081.APPENDIX A   Name of Medications for Prescription Monitoring Program − Long Term Care Reporting

 

BEHAVIORAL HEALTH MEDICATIONS

 

Antipsychotics as listed but not limited to:

Aripiprazole

Asenapine

Chlorpromazine

Clozapine

Droperidol

Fluphenazine

Haloperidol

Iloperidone

Loxapine

Lurasidone

Mesoridazine

Molindone

Olanzapine

Paliperidone

Perphenazine

Prochlorperazine

Quetiapine

Risperidone

Thioridazine

Thiothixene

Trifluoperazine

Ziprasidone

 

Antidepressants as listed but not limited to:

 

Selective Serotonin Reuptake Inhibitors (SSRIs)

Citalopram

Escitalopram

Paroxetine

Fluoxetine

Fluvoxamine

Sertraline

 

Serotonin-Norepinepherine Reuptake Inhibitors (SNRIs)

Desvenlafaxine

Duloxetine

Venlafaxine

 

Serotonin Antagonist and Reuptake Inhibitors (SARIs)

Nefazodone

Trazodone

 

Tricyclic Antidepressants (TCAs)

Amitriptyline

Clomipramine

Desipramine

Doxepin

Imipramine

Nortriptyline

Protriptyline

Trimipramine

 

Tetracyclic Antidepressants (TeCAs)

Amoxapine

Maprotiline

Mirtazapine

 

Monoamine Oxidase Inhibitors (MAOIs)

Isocarboxazid

Phenelzine

Selegiline

Tranylcypramine

Pirlindole

 

Miscellaneous Agents

Divalproex

 

Norepinepherine – Dopamine Inhibitor

Bupropion

 

5-HT1A Receptor Agonists

Buspirone

Aripiprazole

 

5-HT2A Receptor Agonists

Aripiprazole

 

5-HT2 Receptor Antagonists

Nefazodone

 

Mood Stabilizers

Carbamazepine

Divalproex

Gabapentin

Lamotrigine

Lithium

Oxcarbazepine

Topiramate

Valproic Acid

 

Anti-anxiety Medications as listed but not limited to:

Alprazolam

Buspirone

Chlordiazepoxide

Clonazepam

Clorazepate

Diazepam

Hydroxyzine

Lorazepam

Oxazepam

 

ADHD Medications as listed but not limited to:

Amphetamine

Amphetamine (ER)

Atomoxetine

Dexmethylphenidate

Dexmethylphenidate (ER)

Dextroamphetamine

Guanfacine

Lisdexamfetamine Dimesylate

Methamphetamine

Methylphenidate

Methylphenidate (ER)

Methylphenidate (LA)

Methylphenidate patch

Modafinil

Phentermine

Sibutramine

 

Antihistamine Medications as listed but not limited to:

 

First Generation Antihistamines:

Brompheniramine

Carbinoxamine

Chlorpheniramine

Clemastine

Cyproheptadine

Diphenhydramine

Doxylamine Succinate

Promethazine

Triprolidine

 

Second Generation Antihistamines:

Acrivastine

Cetirizine

Desloratadine

Fexofenadine

Levocetirizine

Loratadine

 

Other Antihistamines:

Azelastine

Cimetidine

Dimenhydrinate

Emedastine

Famotidine

Hydroxyzine

Ketotifen

Meclizine

Nizatidine

Olopatadine

Ranitidine

 

ENZYME INDUCERS/INHIBITORS

 

Amiodarone

Amlodipine

Amobarbital

Armodafinil

Bortezomib

Bosentan

Carbamazepine

Celecoxib

Chloroquine

Chlorpromazine

Cimetidine

Cinacalcet

Ciprofloxacin

Clomipramine

Clotrimazole

Clozapine

Cyclosporine

Darifenacin

Delavirdine

Desipramine

Dexamethasone

Dexlansoprazole

Dexmedetomidine

Diclofenac

Diltiazem Hydrochloride

Diphenhydramine

Disulfiram

Doxorubicin

Doxycycline

Duloxetine

Efavirenz

Erythromycin

Esomeprazole

Felodipine

Fluconazole

Fluoxetine

Flurbiprofen

Fluvastatin

Fluvoxamine

Fosamprenavir (as amprenavir)

Fosaprepitant

Fosphenytoin (as phenytoin)

Fospropofol

Gemifibrozil

Haloperidol

Ibuprofen

Imatinib

Imipramine

Indinavir

Indomethacin

Irbesartan

Isoniazid

Itraconazole

Ketoconazole

Lansoprazole

Letrozole

Lidocaine

Loratadine

Losartan

Mefenamic acid

Methadone

Methimazole

Methoxsalen

Metronidazole

Mexiletine

Miconazole

Modafinil

Nafcillin

Nefazodone

Nelfinavir

Nevirapine

Nicardipine

Nifedipine

Norfloxacin

Ofloxacin

Omeprazole

Oxcarbazepine

Paroxetine

Pentobarbital

Phenobarbital

Phenytoin

Pioglitazone

Piroxican

Posaconazole

Primaquine

Primidone

Propofol

Pyrimethamine

Quinidine

Quinine

Raberprazole

Ranolazine

Rifampin

Rifapentine

Ritonavir

Rosiglitazone

Saquinavir

Secobarbital

Sertraline

Sitaxsentan

Sorafenib

Sulfadiazine

Sulfamethoxazole

Sulfisoxazole

Tamoxifen

Telithromycin

Terbinafine

Tetracycline

Thiabendazole

Thioridazine

Thiotepa

Ticlopidine

Tolbutamide

Tranylcypromine

Trazodone

Trimethoprim

Verapamil

Voriconazole

Warfarin

Zafirlukast

Zileuton

 

MEDICATIONS WITH ANTICHOLINERGIC EFFECTS

 

Level # 1:  Potential ACH activity by receptor binding activity:

 

Drug Class / Generic Name

 

Antipsychotics:

Fluphenazine

Olanzapine

Perphenazine

Prochlorperazine

Trifluoperazine

 

Anxiolytic:

Alprazolam

Chlordiazepoxide

Clonazepam

Clorazepate

Diazepam

Flurazepam

Lorazepam

Oxazepam

Temazepam

Triazolam

 

Antidepressant:

Fluoxetine

Paroxetine

Sertraline

Fluvoxamine

Phenelzine

 

Antibiotics/Antivirals:

Amantadine

Ampicillin

Clindamycin

Gentamicin

Vancomycin

 

Analgesics:

Codeine

Fentanyl

Morphine

Oxycodone

Tramadol

 

Cardiovascular:

Captopril

Chlorthalidone

Digoxin

Diltiazem Hydrochloride

Dipyridamole

Furosemide

Hydralazine

Isosorbide

Nifedipine

Triamterene

Warfarin

 

Corticosteroids:

Dexamethasone

Methylprednisolone

Prednisone

Triamcinolone

 

H2 Antagonist:

Famotidine

Nizatidine

 

Anticonvulsants:

Divalproex

Valproic Acid

 

Level # 2: ACH adverse events, dose related:

 

Antipsychotics:

Chlorpromazine

Loxapine

Molindone

Pimozide

 

Antihistamine:

Cyproheptadine

 

Cardiovascular:

Disopyramide

 

Muscle Relaxants:

Cyclobenzaprine

 

H2 Antagonist:

Cimetidine

Ranitidine

 

Anticonvulsants:

Carbamazepine

Oxcarbazepine

 

Level # 3: Markedly Anticholinergic:

 

Antipsychotics:

Clozapine

Mesoridazine

Thioridazine

 

Antidepressants:

Amitriptyline

Desipramine

Doxepin

Imipramine

Nortriptyline

Protriptyline

Trimipramine

 

Antihistamines:

Bropheniramine

Carbinoxamine

Chlorpheniramine

Clemastine

Diphenhydramine

Hydroxazine

Promethazine

 

Muscle Relaxants:

Orphenidrine

 

Vertigo Agents:

Dimenhydrinate

Meclizine

Scopolamine

 

GI Antispasmodics:

Dicyclomine

Hyoscyamine

Propantheline

 

Parkinson Disease:

Procyclidine

Benztropine

Trihexphenidyl

 

Urinary Antispasmodics:

Oxybutynin

Tolterodine

Flavoxate