HB4413 94TH GENERAL ASSEMBLY

LRB094 16147 RAS 51387 b

94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
HB4413

Introduced 01/06/06, by Rep. David E. Miller

SYNOPSIS AS INTRODUCED:

225 ILCS 85/3	from Ch. 111, par. 4123
225 ILCS 85/15.7 new

Amends the Pharmacy Practice Act of 1987. Provides that a pharmacist may, as part of the care provided by a health care facility, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice. Defines "emergency contraception drug therapy" and "health care facility". Requires a pharmacist to complete a training program before initiating emergency contraception drug therapy and to provide the recipient of the drug therapy with a standardized fact sheet developed by the State Board of Pharmacy. Effective immediately.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 5. The Pharmacy Practice Act of 1987 is amended by changing Section 3 and by adding Section 15.7 as follows:

(225 ILCS 85/3) (from Ch. 111, par. 4123)

(Section scheduled to be repealed on January 1, 2008)

Sec. 3. Definitions. For the purpose of this Act, except where otherwise limited therein:

(a) "Pharmacy" or "drugstore" means and includes every store, shop, pharmacy department, or other place where pharmaceutical care is provided by a pharmacist (1) where drugs, medicines, or poisons are dispensed, sold or offered for sale at retail, or displayed for sale at retail; or (2) where prescriptions of physicians, dentists, veterinarians, podiatrists, or therapeutically certified optometrists, within the limits of their licenses, are compounded, filled, or dispensed; or (3) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore", "Medicine Store", "Prescriptions", "Drugs", "Medicines", or any word or words of similar or like import, either in the English language or any other language; or (4) where the characteristic prescription sign (Rx) or similar design is exhibited; or (5) any store, or shop, or other place with respect to which any of the above words, objects, signs or designs are used in any advertisement.

(b) "Drugs" means and includes (l) articles recognized in the official United States Pharmacopoeia/National Formulary (USP/NF), or any supplement thereto and being intended for and having for their main use the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as approved by the United States Food and Drug Administration, but does not include devices or their components, parts, or accessories; and (2) all other articles intended for and having for their main use the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as approved by the United States Food and Drug Administration, but does not include devices or their components, parts, or accessories; and (3) articles (other than food) having for their main use and intended to affect the structure or any function of the body of man or other animals; and (4) articles having for their main use and intended for use as a component or any articles specified in clause (l), (2) or (3); but does not include devices or their components, parts or accessories.

(c) "Medicines" means and includes all drugs intended for human or veterinary use approved by the United States Food and Drug Administration.

(d) "Practice of pharmacy" means the provision of pharmaceutical care to patients as determined by the pharmacist's professional judgment in the following areas, which may include but are not limited to (1) patient counseling, (2) interpretation and assisting in the monitoring of appropriate drug use and prospective drug utilization review, (3) providing information on the therapeutic values, reactions, drug interactions, side effects, uses, selection of medications and medical devices, and outcome of drug therapy, (4) participation in drug selection, drug monitoring, drug utilization review, evaluation, administration, interpretation, application of pharmacokinetic and laboratory data to design safe and effective drug regimens, (5) drug research (clinical and scientific), and (6) compounding and dispensing of drugs and medical devices.

(e) "Prescription" means and includes any written, oral, facsimile, or electronically transmitted order for drugs or medical devices, issued by a physician licensed to practice medicine in all its branches, dentist, veterinarian, or podiatrist, or therapeutically certified optometrist, within the limits of their licenses, by a physician assistant in accordance with subsection (f) of Section 4, or by an advanced practice nurse in accordance with subsection (g) of Section 4, containing the following: (l) name of the patient; (2) date when prescription was issued; (3) name and strength of drug or description of the medical device prescribed; and (4) quantity, (5) directions for use, (6) prescriber's name, address and signature, and (7) DEA number where required, for controlled substances. DEA numbers shall not be required on inpatient drug orders.

(f) "Person" means and includes a natural person, copartnership, association, corporation, government entity, or any other legal entity.

(g) "Department" means the Department of Professional Regulation.

(h) "Board of Pharmacy" or "Board" means the State Board of Pharmacy of the Department of Professional Regulation.

(i) "Director" means the Director of Professional Regulation.

(j) "Drug product selection" means the interchange for a prescribed pharmaceutical product in accordance with Section 25 of this Act and Section 3.14 of the Illinois Food, Drug and Cosmetic Act.

(k) "Inpatient drug order" means an order issued by an authorized prescriber for a resident or patient of a facility licensed under the Nursing Home Care Act or the Hospital Licensing Act, or "An Act in relation to the founding and operation of the University of Illinois Hospital and the conduct of University of Illinois health care programs", approved July 3, 1931, as amended, or a facility which is operated by the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities) or the Department of Corrections.

(k-5) "Pharmacist" means an individual health care professional and provider currently licensed by this State to engage in the practice of pharmacy.

(l) "Pharmacist in charge" means the licensed pharmacist whose name appears on a pharmacy license and who is responsible for all aspects of the operation related to the practice of pharmacy.

(m) "Dispense" means the delivery of drugs and medical devices, in accordance with applicable State and federal laws and regulations, to the patient or the patient's representative authorized to receive these products, including the preparation, compounding, packaging, and labeling necessary for delivery, computer entry, and verification of medication orders and prescriptions, and any recommending or advising concerning the contents and therapeutic values and uses thereof. "Dispense" does not mean the physical delivery to a patient or a patient's representative in a home or institution by a designee of a pharmacist or by common carrier. "Dispense" also does not mean the physical delivery of a drug or medical device to a patient or patient's representative by a pharmacist's designee within a pharmacy or drugstore while the pharmacist is on duty and the pharmacy is open.

(n) "Mail-order pharmacy" means a pharmacy that is located in a state of the United States, other than Illinois, that delivers, dispenses or distributes, through the United States Postal Service or other common carrier, to Illinois residents, any substance which requires a prescription.

(o) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or medical device: (1) as the result of a practitioner's prescription drug order or initiative that is dispensed pursuant to a prescription in the course of professional practice; or (2) for the purpose of, or incident to, research, teaching, or chemical analysis; or (3) in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(p) "Confidential information" means information, maintained by the pharmacist in the patient's records, released only (i) to the patient or, as the patient directs, to other practitioners and other pharmacists or (ii) to any other person authorized by law to receive the information.

(q) "Prospective drug review" or "drug utilization evaluation" means a screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs), drug-food interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.

(r) "Patient counseling" means the communication between a pharmacist or a student pharmacist under the direct supervision of a pharmacist and a patient or the patient's representative about the patient's medication or device for the purpose of optimizing proper use of prescription medications or devices. The offer to counsel by the pharmacist or the pharmacist's designee, and subsequent patient counseling by the pharmacist or student pharmacist, shall be made in a face-to-face communication with the patient or patient's representative unless, in the professional judgment of the pharmacist, a face-to-face communication is deemed inappropriate or unnecessary. In that instance, the offer to counsel or patient counseling may be made in a written communication, by telephone, or in a manner determined by the pharmacist to be appropriate.

(s) "Patient profiles" or "patient drug therapy record" means the obtaining, recording, and maintenance of patient prescription information, including prescriptions for controlled substances, and personal information.

(t) "Pharmaceutical care" includes, but is not limited to, the act of monitoring drug use and other patient care services intended to achieve outcomes that improve the patient's quality of life but shall not include the sale of over-the-counter drugs by a seller of goods and services who does not dispense prescription drugs.

(u) "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, required under federal law to bear the label "Caution: Federal law requires dispensing by or on the order of a physician". A seller of goods and services who, only for the purpose of retail sales, compounds, sells, rents, or leases medical devices shall not, by reasons thereof, be required to be a licensed pharmacy.

(v) "Unique identifier" means an electronic signature, handwritten signature or initials, thumb print, or other acceptable individual biometric or electronic identification process as approved by the Department.

(w) "Current usual and customary retail price" means the actual price that a pharmacy charges a retail purchaser.

(x) "Emergency contraception drug therapy" means one or more prescription drugs, used separately or in combination in a non-patient specific regimen, that are to be administered to or self-administered by the patient in a dosage and manner for preventing pregnancy when used after intercourse, and that are found safe and effective for that use by the U.S. Food and Drug Administration and dispensed for that purpose.

(y) "Health care facility" means any State licensed or regulated public or private hospital, home health agency, clinic in which there is physician oversight, center, medical school, medical training institution, laboratory or diagnostic facility, physician's office, infirmary, dispensary, ambulatory surgical treatment center, or other institution or location wherein health care services are provided to any person, including physician organizations and associations, networks, joint ventures, and all other combinations of those organization.

(Source: P.A. 93-571, eff. 8-20-03; 93-1075, eff. 1-18-05; 94-459, eff. 1-1-06.)

(225 ILCS 85/15.7 new)

(Section scheduled to be repealed on January 1, 2008)

Sec. 15.7. Initiation of emergency contraception drug therapy. As part of the care provided by a health care facility, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, a pharmacist licensed under this Act may, in accordance with any policies, procedures, or protocols of the facility, plan, or physician, initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice.

Prior to performing any procedure authorized under this Section, a pharmacist must complete a training program on emergency contraception. The training program shall include, but not be limited to, training on the conduct of sensitive communications, quality assurance, referral to additional services, and documentation.

For each emergency contraception drug therapy initiated, a pharmacist must provide the recipient of the emergency contraception drugs with a standardized fact sheet that includes, but is not limited to, (i) the indications for use of the drug, (ii) the appropriate method for using the drug, (iii) the need for medical follow-up, and (iv) any other information deemed appropriate by the Board. The Board shall develop this form in consultation with the Department of Public Health, the American College of Obstetricians and Gynecologists, the Illinois Pharmacists Association, and other health care organizations. Use of the fact sheet shall not preclude the use of existing publications developed by nationally recognized medical organizations.

Section 99. Effective date. This Act takes effect upon becoming law.