093_HB2778eng

 
HB2778 Engrossed                     LRB093 03709 AMC 03739 b

 1        AN ACT concerning pharmacies.

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

 4        Section 5.  The Pharmacy Practice Act of 1987 is  amended
 5    by changing Section 3 and adding Section 15.5 as follows:

 6        (225 ILCS 85/3) (from Ch. 111, par. 4123)
 7        (Section scheduled to be repealed on January 1, 2008)
 8        (Text of Section before amendment by P.A. 92-880)
 9        Sec. 3. Definitions.  For the purpose of this Act, except
10    where otherwise limited therein:
11        (a)  "Pharmacy"  or  "drugstore" means and includes every
12    store,  shop,  pharmacy  department,  or  other  place  where
13    pharmaceutical care is provided by  a  pharmacist  (1)  where
14    drugs,  medicines,  or poisons are dispensed, sold or offered
15    for sale at retail, or displayed for sale at retail;  or  (2)
16    where  prescriptions  of physicians, dentists, veterinarians,
17    podiatrists,  or  therapeutically   certified   optometrists,
18    within  the limits of their licenses, are compounded, filled,
19    or dispensed; or (3) which has upon it  or  displayed  within
20    it,  or  affixed  to  or  used  in connection with it, a sign
21    bearing  the  word   or   words   "Pharmacist",   "Druggist",
22    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
23    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
24    any word or words of similar or like import,  either  in  the
25    English  language  or  any  other  language; or (4) where the
26    characteristic prescription sign (Rx) or  similar  design  is
27    exhibited;  or  (5)  any  store, or shop, or other place with
28    respect to which any of the above words,  objects,  signs  or
29    designs are used in any advertisement.
30        (b)  "Drugs"  means  and includes (l) articles recognized
31    in  the   official   United   States   Pharmacopoeia/National
 
HB2778 Engrossed            -2-      LRB093 03709 AMC 03739 b
 1    Formulary  (USP/NF),  or  any  supplement  thereto  and being
 2    intended for and having for their  main  use  the  diagnosis,
 3    cure,  mitigation,  treatment or prevention of disease in man
 4    or other animals, as approved by the United States  Food  and
 5    Drug  Administration,  but  does not include devices or their
 6    components, parts, or accessories; and (2) all other articles
 7    intended for and having for their  main  use  the  diagnosis,
 8    cure,  mitigation,  treatment or prevention of disease in man
 9    or other animals, as approved by the United States  Food  and
10    Drug  Administration,  but  does not include devices or their
11    components, parts, or accessories; and  (3)  articles  (other
12    than  food)  having for their main use and intended to affect
13    the structure or any function of the body  of  man  or  other
14    animals;  and  (4)  articles  having  for  their main use and
15    intended for use as a component or any articles specified  in
16    clause (l), (2) or (3); but does not include devices or their
17    components, parts or accessories.
18        (c)  "Medicines"  means  and  includes all drugs intended
19    for human or veterinary use approved  by  the  United  States
20    Food and Drug Administration.
21        (d)  "Practice   of  pharmacy"  means  the  provision  of
22    pharmaceutical  care  to  patients  as  determined   by   the
23    pharmacist's  professional  judgment  in the following areas,
24    which  may  include  but  are  not  limited  to  (1)  patient
25    counseling,  (2)  interpretation   and   assisting   in   the
26    monitoring  of  appropriate  drug  use  and  prospective drug
27    utilization  review,  (3)  providing   information   on   the
28    therapeutic   values,   reactions,  drug  interactions,  side
29    effects, uses, selection of medications and medical  devices,
30    and  outcome  of  drug  therapy,  (4)  participation  in drug
31    selection,  drug   monitoring,   drug   utilization   review,
32    evaluation,  administration,  interpretation,  application of
33    pharmacokinetic  and  laboratory  data  to  design  safe  and
34    effective drug regimens,  (5)  drug  research  (clinical  and
 
HB2778 Engrossed            -3-      LRB093 03709 AMC 03739 b
 1    scientific),  and (6) compounding and dispensing of drugs and
 2    medical devices.
 3        (e)  "Prescription" means and includes any written, oral,
 4    facsimile, or electronically transmitted order for  drugs  or
 5    medical  devices,  issued by a physician licensed to practice
 6    medicine in  all  its  branches,  dentist,  veterinarian,  or
 7    podiatrist,  or therapeutically certified optometrist, within
 8    the  limits  of  their  licenses, by a physician assistant in
 9    accordance with  subsection  (f)  of  Section  4,  or  by  an
10    advanced  practice nurse in accordance with subsection (g) of
11    Section 4, containing the following: (l) name of the patient;
12    (2) date when prescription was issued; (3) name and  strength
13    of  drug or description of the medical device prescribed; and
14    (4) quantity, (5) directions for use, (6) prescriber's  name,
15    address and signature, and (7) DEA number where required, for
16    controlled  substances.  DEA numbers shall not be required on
17    inpatient drug orders.
18        (f)  "Person"  means  and  includes  a  natural   person,
19    copartnership,  association,  corporation, government entity,
20    or any other legal entity.
21        (g)  "Department" means the  Department  of  Professional
22    Regulation.
23        (h)  "Board of Pharmacy" or "Board" means the State Board
24    of Pharmacy of the Department of Professional Regulation.
25        (i)  "Director"   means   the  Director  of  Professional
26    Regulation.
27        (j)  "Drug product selection" means the interchange for a
28    prescribed pharmaceutical product in accordance with  Section
29    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
30    and Cosmetic Act.
31        (k)  "Inpatient drug order" means an order issued  by  an
32    authorized prescriber for a resident or patient of a facility
33    licensed  under  the  Nursing  Home  Care Act or the Hospital
34    Licensing Act, or "An Act in relation  to  the  founding  and
 
HB2778 Engrossed            -4-      LRB093 03709 AMC 03739 b
 1    operation  of  the  University  of  Illinois Hospital and the
 2    conduct of University  of  Illinois  health  care  programs",
 3    approved  July  3,  1931,  as amended, or a facility which is
 4    operated by the Department of Human Services (as successor to
 5    the   Department   of   Mental   Health   and   Developmental
 6    Disabilities) or the Department of Corrections.
 7        (k-5)  "Pharmacist"   means   an   individual   currently
 8    licensed by this State to engage in the practice of pharmacy.
 9        (l)  "Pharmacist in charge" means the licensed pharmacist
10    whose name appears on a pharmacy license who  is  responsible
11    for  all  aspects of the operation related to the practice of
12    pharmacy.
13        (m)  "Dispense" means the delivery of drugs  and  medical
14    devices, in accordance with applicable State and federal laws
15    and   regulations,   to   the   patient   or   the  patient's
16    representative  authorized   to   receive   these   products,
17    including  the compounding, packaging, and labeling necessary
18    for delivery, and any recommending or advising concerning the
19    contents and therapeutic values and uses thereof.  "Dispense"
20    does  not  mean  the  physical  delivery  to  a  patient or a
21    patient's representative  in  a  home  or  institution  by  a
22    designee  of  a  pharmacist or by common carrier.  "Dispense"
23    also does not mean the physical delivery of a drug or medical
24    device  to  a  patient  or  patient's  representative  by   a
25    pharmacist's  designee  within  a pharmacy or drugstore while
26    the pharmacist is on duty and the pharmacy is open.
27        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
28    located in a state of the United States, other than Illinois,
29    that delivers, dispenses or distributes, through  the  United
30    States  Postal  Service  or other common carrier, to Illinois
31    residents, any substance which requires a prescription.
32        (o)  "Compounding"   means   the   preparation,   mixing,
33    assembling, packaging, or  labeling  of  a  drug  or  medical
34    device:  (1)  as  the result of a practitioner's prescription
 
HB2778 Engrossed            -5-      LRB093 03709 AMC 03739 b
 1    drug order or initiative that  is  dispensed  pursuant  to  a
 2    prescription  in  the course of professional practice; or (2)
 3    for the purpose of, or incident to,  research,  teaching,  or
 4    chemical  analysis;  or  (3)  in anticipation of prescription
 5    drug orders based on routine, regularly observed  prescribing
 6    patterns.
 7        (p)  "Confidential    information"   means   information,
 8    maintained  by  the  pharmacist  in  the  patient's  records,
 9    released only (i) to the patient or, as the patient  directs,
10    to  other  practitioners and other pharmacists or (ii) to any
11    other person authorized by law to receive the information.
12        (q)  "Prospective  drug  review"  or  "drug   utilization
13    evaluation"  means  a  screening  for  potential drug therapy
14    problems  due  to   therapeutic   duplication,   drug-disease
15    contraindications,  drug-drug interactions (including serious
16    interactions with nonprescription or over-the-counter drugs),
17    drug-food interactions, incorrect drug dosage or duration  of
18    drug treatment, drug-allergy interactions, and clinical abuse
19    or misuse.
20        (r)  "Patient counseling" means the communication between
21    a  pharmacist  or  a  student  pharmacist  under  the  direct
22    supervision  of  a  pharmacist and a patient or the patient's
23    representative about the patient's medication or  device  for
24    the   purpose   of  optimizing  proper  use  of  prescription
25    medications  or  devices.   The  offer  to  counsel  by   the
26    pharmacist  or  the  pharmacist's  designee,  and  subsequent
27    patient  counseling  by the pharmacist or student pharmacist,
28    shall be  made  in  a  face-to-face  communication  with  the
29    patient   or   patient's   representative   unless,   in  the
30    professional  judgment  of  the  pharmacist,  a  face-to-face
31    communication is deemed  inappropriate  or  unnecessary.   In
32    that instance, the offer to counsel or patient counseling may
33    be  made  in  a  written communication, by telephone, or in a
34    manner determined by the pharmacist to be appropriate.
 
HB2778 Engrossed            -6-      LRB093 03709 AMC 03739 b
 1        (s)  "Patient profiles" or "patient drug therapy  record"
 2    means  the  obtaining,  recording, and maintenance of patient
 3    prescription and personal information.
 4        (t)  "Pharmaceutical care" includes, but is  not  limited
 5    to,  the  act  of  monitoring drug use and other patient care
 6    services  intended  to  achieve  outcomes  that  improve  the
 7    patient's quality of life but shall not include the  sale  of
 8    over-the-counter  drugs by a seller of goods and services who
 9    does not dispense prescription drugs.
10        (u)  "Medical device"  means  an  instrument,  apparatus,
11    implement,  machine,  contrivance, implant, in vitro reagent,
12    or other similar or related article, including any  component
13    part  or  accessory,  required  under federal law to bear the
14    label "Caution: Federal law requires dispensing by or on  the
15    order  of  a  physician". A seller of goods and services who,
16    only for the  purpose  of  retail  sales,  compounds,  sells,
17    rents,  or  leases  medical  devices  shall  not,  by reasons
18    thereof, be required to be a licensed pharmacy.
19    (Source: P.A. 89-202,  eff.  7-21-95;  89-507,  eff.  7-1-97;
20    90-116,  eff.  7-14-97;  90-253,  eff.  7-29-97; 90-655, eff.
21    7-30-98; 90-742, eff. 8-13-98.)

22        (Text of Section after amendment by P.A. 92-880)
23        Sec. 3. Definitions.  For the purpose of this Act, except
24    where otherwise limited therein:
25        (a)  "Pharmacy" or "drugstore" means and  includes  every
26    store,  shop,  pharmacy  department,  or  other  place  where
27    pharmaceutical  care  is  provided  by a pharmacist (1) where
28    drugs, medicines, or poisons are dispensed, sold  or  offered
29    for  sale  at retail, or displayed for sale at retail; or (2)
30    where prescriptions of physicians,  dentists,  veterinarians,
31    podiatrists,   or   therapeutically  certified  optometrists,
32    within the limits of their licenses, are compounded,  filled,
33    or  dispensed;  or  (3) which has upon it or displayed within
34    it, or affixed to or used  in  connection  with  it,  a  sign
 
HB2778 Engrossed            -7-      LRB093 03709 AMC 03739 b
 1    bearing   the   word   or   words  "Pharmacist",  "Druggist",
 2    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
 3    "Medicine Store", "Prescriptions", "Drugs",  "Medicines",  or
 4    any  word  or  words of similar or like import, either in the
 5    English language or any other  language;  or  (4)  where  the
 6    characteristic  prescription  sign  (Rx) or similar design is
 7    exhibited; or (5) any store, or shop,  or  other  place  with
 8    respect  to  which  any of the above words, objects, signs or
 9    designs are used in any advertisement.
10        (b)  "Drugs" means and includes (l)  articles  recognized
11    in   the   official   United   States  Pharmacopoeia/National
12    Formulary (USP/NF),  or  any  supplement  thereto  and  being
13    intended  for  and  having  for their main use the diagnosis,
14    cure, mitigation, treatment or prevention of disease  in  man
15    or  other  animals, as approved by the United States Food and
16    Drug Administration, but does not include  devices  or  their
17    components, parts, or accessories; and (2) all other articles
18    intended  for  and  having  for their main use the diagnosis,
19    cure, mitigation, treatment or prevention of disease  in  man
20    or  other  animals, as approved by the United States Food and
21    Drug Administration, but does not include  devices  or  their
22    components,  parts,  or  accessories; and (3) articles (other
23    than food) having for their main use and intended  to  affect
24    the  structure  or  any  function of the body of man or other
25    animals; and (4) articles  having  for  their  main  use  and
26    intended  for use as a component or any articles specified in
27    clause (l), (2) or (3); but does not include devices or their
28    components, parts or accessories.
29        (c)  "Medicines" means and includes  all  drugs  intended
30    for  human  or  veterinary  use approved by the United States
31    Food and Drug Administration.
32        (d)  "Practice  of  pharmacy"  means  the  provision   of
33    pharmaceutical   care   to  patients  as  determined  by  the
34    pharmacist's professional judgment in  the  following  areas,
 
HB2778 Engrossed            -8-      LRB093 03709 AMC 03739 b
 1    which  may  include  but  are  not  limited  to  (1)  patient
 2    counseling,   (2)   interpretation   and   assisting  in  the
 3    monitoring of  appropriate  drug  use  and  prospective  drug
 4    utilization   review,   (3)   providing  information  on  the
 5    therapeutic  values,  reactions,  drug   interactions,   side
 6    effects,  uses, selection of medications and medical devices,
 7    and outcome  of  drug  therapy,  (4)  participation  in  drug
 8    selection,   drug   monitoring,   drug   utilization  review,
 9    evaluation, administration,  interpretation,  application  of
10    pharmacokinetic  and  laboratory  data  to  design  safe  and
11    effective  drug  regimens,  (5)  drug  research (clinical and
12    scientific), and (6) compounding and dispensing of drugs  and
13    medical devices.
14        (e)  "Prescription" means and includes any written, oral,
15    facsimile,  or  electronically transmitted order for drugs or
16    medical devices, issued by a physician licensed  to  practice
17    medicine  in  all  its  branches,  dentist,  veterinarian, or
18    podiatrist,  or therapeutically certified optometrist, within
19    the limits of their licenses, by  a  physician  assistant  in
20    accordance  with  subsection  (f)  of  Section  4,  or  by an
21    advanced practice nurse in accordance with subsection (g)  of
22    Section 4, containing the following: (l) name of the patient;
23    (2)  date when prescription was issued; (3) name and strength
24    of drug or description of the medical device prescribed;  and
25    (4)  quantity, (5) directions for use, (6) prescriber's name,
26    address and signature, and (7) DEA number where required, for
27    controlled substances. DEA numbers shall not be  required  on
28    inpatient drug orders.
29        (f)  "Person"   means  and  includes  a  natural  person,
30    copartnership, association, corporation,  government  entity,
31    or any other legal entity.
32        (g)  "Department"  means  the  Department of Professional
33    Regulation.
34        (h)  "Board of Pharmacy" or "Board" means the State Board
 
HB2778 Engrossed            -9-      LRB093 03709 AMC 03739 b
 1    of Pharmacy of the Department of Professional Regulation.
 2        (i)  "Director"  means  the  Director   of   Professional
 3    Regulation.
 4        (j)  "Drug product selection" means the interchange for a
 5    prescribed  pharmaceutical product in accordance with Section
 6    25 of this Act and Section 3.14 of the  Illinois  Food,  Drug
 7    and Cosmetic Act.
 8        (k)  "Inpatient  drug  order" means an order issued by an
 9    authorized prescriber for a resident or patient of a facility
10    licensed under the Nursing Home  Care  Act  or  the  Hospital
11    Licensing  Act,  or  "An  Act in relation to the founding and
12    operation of the University  of  Illinois  Hospital  and  the
13    conduct  of  University  of  Illinois  health care programs",
14    approved July 3, 1931, as amended, or  a  facility  which  is
15    operated by the Department of Human Services (as successor to
16    the   Department   of   Mental   Health   and   Developmental
17    Disabilities) or the Department of Corrections.
18        (k-5)  "Pharmacist"   means  an  individual  health  care
19    professional and provider currently licensed by this State to
20    engage in the practice of pharmacy.
21        (l)  "Pharmacist in charge" means the licensed pharmacist
22    whose  name  appears  on  a  pharmacy  license  and  who   is
23    responsible  for  all aspects of the operation related to the
24    practice of pharmacy.
25        (m)  "Dispense" means the delivery of drugs  and  medical
26    devices, in accordance with applicable State and federal laws
27    and   regulations,   to   the   patient   or   the  patient's
28    representative  authorized   to   receive   these   products,
29    including  the compounding, packaging, and labeling necessary
30    for delivery, and any recommending or advising concerning the
31    contents and therapeutic values and uses thereof.  "Dispense"
32    does not mean  the  physical  delivery  to  a  patient  or  a
33    patient's  representative  in  a  home  or  institution  by a
34    designee of a pharmacist or by  common  carrier.   "Dispense"
 
HB2778 Engrossed            -10-     LRB093 03709 AMC 03739 b
 1    also does not mean the physical delivery of a drug or medical
 2    device   to  a  patient  or  patient's  representative  by  a
 3    pharmacist's designee within a pharmacy  or  drugstore  while
 4    the pharmacist is on duty and the pharmacy is open.
 5        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
 6    located in a state of the United States, other than Illinois,
 7    that  delivers,  dispenses or distributes, through the United
 8    States Postal Service or other common  carrier,  to  Illinois
 9    residents, any substance which requires a prescription.
10        (o)  "Compounding"   means   the   preparation,   mixing,
11    assembling,  packaging,  or  labeling  of  a  drug or medical
12    device: (1) as the result of  a  practitioner's  prescription
13    drug  order  or  initiative  that  is dispensed pursuant to a
14    prescription in the course of professional practice;  or  (2)
15    for  the  purpose  of, or incident to, research, teaching, or
16    chemical analysis; or (3)  in  anticipation  of  prescription
17    drug  orders based on routine, regularly observed prescribing
18    patterns.
19        (p)  "Confidential   information"   means    information,
20    maintained  by  the  pharmacist  in  the  patient's  records,
21    released  only (i) to the patient or, as the patient directs,
22    to other practitioners and other pharmacists or (ii)  to  any
23    other person authorized by law to receive the information.
24        (q)  "Prospective   drug  review"  or  "drug  utilization
25    evaluation" means a  screening  for  potential  drug  therapy
26    problems   due   to   therapeutic  duplication,  drug-disease
27    contraindications, drug-drug interactions (including  serious
28    interactions with nonprescription or over-the-counter drugs),
29    drug-food  interactions, incorrect drug dosage or duration of
30    drug treatment, drug-allergy interactions, and clinical abuse
31    or misuse.
32        (r)  "Patient counseling" means the communication between
33    a  pharmacist  or  a  student  pharmacist  under  the  direct
34    supervision of a pharmacist and a patient  or  the  patient's
 
HB2778 Engrossed            -11-     LRB093 03709 AMC 03739 b
 1    representative  about  the patient's medication or device for
 2    the  purpose  of  optimizing  proper  use   of   prescription
 3    medications   or  devices.   The  offer  to  counsel  by  the
 4    pharmacist  or  the  pharmacist's  designee,  and  subsequent
 5    patient counseling by the pharmacist or  student  pharmacist,
 6    shall  be  made  in  a  face-to-face  communication  with the
 7    patient  or   patient's   representative   unless,   in   the
 8    professional  judgment  of  the  pharmacist,  a  face-to-face
 9    communication  is  deemed  inappropriate  or unnecessary.  In
10    that instance, the offer to counsel or patient counseling may
11    be made in a written communication, by  telephone,  or  in  a
12    manner determined by the pharmacist to be appropriate.
13        (s)  "Patient  profiles" or "patient drug therapy record"
14    means the obtaining, recording, and  maintenance  of  patient
15    prescription   information,   including   prescriptions   for
16    controlled substances, and personal information.
17        (t)  "Pharmaceutical  care"  includes, but is not limited
18    to, the act of monitoring drug use  and  other  patient  care
19    services  intended  to  achieve  outcomes  that  improve  the
20    patient's  quality  of life but shall not include the sale of
21    over-the-counter drugs by a seller of goods and services  who
22    does not dispense prescription drugs.
23        (u)  "Medical  device"  means  an  instrument, apparatus,
24    implement, machine, contrivance, implant, in  vitro  reagent,
25    or  other similar or related article, including any component
26    part or accessory, required under federal  law  to  bear  the
27    label  "Caution: Federal law requires dispensing by or on the
28    order of a physician". A seller of goods  and  services  who,
29    only  for  the  purpose  of  retail  sales, compounds, sells,
30    rents, or  leases  medical  devices  shall  not,  by  reasons
31    thereof, be required to be a licensed pharmacy.
32        (v)  "Unique  identifier"  means an electronic signature,
33    handwritten signature or  initials,  thumb  print,  or  other
34    acceptable  individual biometric or electronic identification
 
HB2778 Engrossed            -12-     LRB093 03709 AMC 03739 b
 1    process as approved by the Department.
 2    (Source: P.A. 92-880, eff. 1-1-04.)

 3        (225 ILCS 85/15.5 new)
 4        Sec. 15.5.  Prescription information.
 5        (a)  Uncoordinated  multiple  controlled  substances  and
 6    drug seeking tendencies pose  a  significant  threat  to  the
 7    health,  safety,  and  welfare  of patients.  To address this
 8    threat,  the  General  Assembly  believes  a  physician   who
 9    prescribes  controlled  substances  should  be  provided with
10    prescription information from pharmacies.
11        (b)  Upon request, a pharmacist shall provide a physician
12    licensed to practice medicine in  all  its  branches  who  is
13    prepared   to   prescribe  or  has  prescribed  a  controlled
14    substance for a patient with information from  the  patient's
15    most  recent patient profile, including information about any
16    prescriptions for controlled substances.