98TH GENERAL ASSEMBLY
State of Illinois
2013 and 2014
HB5631

 

Introduced , by Rep. Robyn Gabel

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/26.5 new

    Amends the Pharmacy Practice Act. Defines "bleeding disorder", "blood clotting product", and "established patient". Establishes certain requirements, standards of care, and business practices that pharmacies and pharmacists shall comply with when dispensing blood clotting products.


LRB098 18058 ZMM 53187 b

 

 

A BILL FOR

 

HB5631LRB098 18058 ZMM 53187 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Pharmacy Practice Act is amended by adding
5Section 26.5 as follows:
 
6    (225 ILCS 85/26.5 new)
7    Sec. 26.5. Blood clotting products.
8    (a) For the purposes of this Section:
9    "Bleeding disorder" means a medical condition
10characterized by a deficiency or absence of one or more
11essential blood clotting components in the human blood,
12including all forms of hemophilia, acquired hemophilia, von
13Willebrand disease, and other bleeding disorders that result in
14uncontrollable bleeding or abnormal blood clotting.
15    "Bleeding disorder" does not include a bleeding condition
16secondary to another medical condition or diagnosis, except for
17acquired hemophilia.
18    "Blood clotting product" means a medicine approved for
19distribution by the FDA that is used for the treatment and
20prevention of symptoms associated with bleeding disorders,
21including, but not limited to, recombinant and plasma derived
22factor products, von Willebrand factor products,
23antifibrinolytics, bypass products for patients with

 

 

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1inhibitors, prothrombin complex concentrates, and activated
2prothrombin complex concentrates. "Blood clotting product"
3does not include medical products approved solely for the
4treatment or prevention of side effects of a blood clotting
5drug.
6    "Established patient" means a bleeding disorder patient
7that has been dispensed a legend blood clotting product by the
8pharmacy on more than 3 occasions in a single year.
9    (b) All pharmacies and pharmacists shall comply with the
10following requirements when dispensing blood clotting
11products:
12        (1) Prescriptions for blood clotting products shall be
13    dispensed as written or authorized by the prescribing
14    physician and in accordance with State and federal law. No
15    changes or substitutions shall be made unless approved by
16    the prescriber. If the pharmacy has received prescriber
17    authorization to change or substitute the blood clotting
18    product originally prescribed, the patient or the
19    patient's designee shall be notified and counseled through
20    the preferred contact method identified by the patient or
21    designee regarding the change or substitution prior to
22    dispensing.
23        (2) If requested by the patient or the patient's
24    designee, the pharmacy shall ship and deliver blood
25    clotting products to the patient or the patient's designee
26    as prescribed within 2 business days after receiving a

 

 

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1    prescription or refill request from an established patient
2    and within 3 business days after receiving a prescription
3    or refill request from a new patient in nonemergency
4    situations. Nonemergency situations include, but are not
5    limited to, routine prophylaxis requests. Appropriate cold
6    chain management and packaging practices shall be used to
7    ensure that proper drug temperature, stability, integrity,
8    and efficacy are maintained during shipment in accordance
9    with manufacturer requirements.
10        (3) Patients shall be provided with a designated
11    pharmacy contact telephone number for reporting problems
12    with a delivery or product on each dispensing at no cost to
13    the patient.
14        (4) Unless otherwise authorized by the patient or the
15    patient's designee, the pharmacy shall contact the patient
16    for authorization to dispense prior to shipping a refill of
17    any blood clotting product to the patient. The date of
18    patient authorization shall be documented in the
19    pharmacy's prescription records.
20        (5) Barring extenuating circumstances, prescriptions
21    for blood clotting products shall be dispensed within plus
22    or minus 10% of prescribed assays, or as otherwise
23    authorized or directed by the prescriber.
24    (c) Prior to dispensing any blood clotting product, the
25pharmacy shall ask the patient or the patient's designee to
26designate a preferred contact method for receiving

 

 

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1notifications in the event of a recall or withdrawal of the
2product dispensed or any related ancillary medical device or
3supplies dispensed by the pharmacy. The preferred contact
4method shall be documented with the patient information.
5    Notice of blood clotting product or ancillary medical
6device or supplies recalls and withdrawals shall be provided to
7the patient through the patient's preferred contact method
8within 24 hours of receipt of a recall or withdrawal
9notification from the manufacturer or any state or federal
10entity that requires or recommends patient notification. The
11pharmacy shall also notify the prescribing physician within 24
12hours of such recall or withdrawal and shall obtain a
13prescription for an alternative blood clotting product if a new
14or amended prescription is required to dispense or deemed
15necessary and appropriate by the prescriber.
16    If attempts to contact the patient through the preferred
17contact method are unsuccessful, the pharmacy shall mail
18notification to the patient or the patient's authorized
19designee within the required 24 hours or the next business day.
20    The time, date, and method of notification to the patient
21and prescriber shall be documented in the pharmacy's records
22and maintained for 2 years after the date of recall or
23withdrawal.
24    (d) In addition to the provisions of subsections (b) and
25(c), pharmacies that dispense blood clotting products to
26established patients or that offer or advertise to provide

 

 

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1blood clotting products specifically for bleeding disorder
2patients shall comply with the following standards of care:
3        (1) The pharmacy shall annually notify the Board in
4    writing of the pharmacy's intent to provide legend blood
5    clotting products for bleeding disorder patients.
6    Notification shall be made on or before January 31 of each
7    year in a manner and form approved by the Board.
8        (2) The pharmacy shall identify in advance or make
9    arrangements with a supplier or suppliers capable of
10    providing all brands, assays, and vial sizes of blood
11    clotting products approved by the FDA, including products
12    manufactured from human plasma and those manufactured from
13    recombinant technology techniques. A list of all
14    designated or identified suppliers shall be maintained at
15    the pharmacy and made available during inspection. This
16    requirement shall not be construed to require a pharmacy to
17    purchase products prior to receiving a valid prescription
18    order.
19        (3) A pharmacist shall be available 24 hours a day, 7
20    days a week, every day of the year, either on site or on
21    call, to fill prescriptions for blood clotting products
22    within the time frames designated by this Section.
23        (4) Pharmacists engaged in dispensing blood clotting
24    products or who provide patient counseling regarding blood
25    clotting products to bleeding disorder patients shall have
26    sufficient knowledge, experience, and training to perform

 

 

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1    the duties assigned. To ensure continued competency,
2    pharmacists engaged in counseling bleeding disorder
3    patients shall complete 4 continuing education hours
4    related to blood clotting products, infusion treatment or
5    therapy, or blood clotting disorders and diseases that
6    shall count towards the pharmacist's continuing education
7    requirements under this Act. Proof of compliance with this
8    paragraph (4) shall be maintained at the pharmacy for a
9    minimum of 4 years and shall be made available during
10    inspection or at the request of the Board.
11        (5) If requested by the patient or the patient's
12    designee, the pharmacy shall provide for the shipment and
13    delivery of blood clotting products to the patient or the
14    patient's designee as prescribed within 2 business days
15    after receiving a prescription or refill request from an
16    established patient and within 3 business days after
17    receiving a prescription or refill request from a new
18    patient in nonemergency situations.
19        (6) Established patients shall be dispensed blood
20    clotting products within 12 hours after notification from a
21    physician of the patient's emergent need for a blood
22    clotting product. For the purposes of this paragraph,
23    determination of an emergent need shall be within the
24    professional medical judgment of the physician. Emergent
25    need requests shall be documented in the pharmacy's
26    prescription records.

 

 

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1        (7) The pharmacy shall provide or have available for
2    purchase containers for the disposal of hazardous waste,
3    including, but not limited to, sharp or equivalent
4    biohazard waste containers.
5        (8) The pharmacy shall have ancillary medical devices
6    and supplies required to infuse a blood clotting therapy
7    product into a human vein, including syringes, needles,
8    sterile gauze, field pads, gloves, alcohol swabs, numbing
9    creams, tourniquets, medical tape, and cold compression
10    packs available for purchase. If such supplies are
11    depleted, the pharmacy shall restock the required
12    ancillary medical devices and supplies in a reasonable
13    amount of time, not to exceed 7 days.
14        (9) The pharmacy shall have contact information
15    available for a nurse or nursing service or agency with
16    experience in providing infusion-related nursing services
17    or nursing services for bleeding disorder patients if such
18    services are not provided by the pharmacy.
19        (10) If requested by the patient or the patient's
20    authorized designee, the pharmacist shall explain any
21    known insurance copayments, deductibles, coinsurance
22    payments, or lifetime maximum insurance payment limits.
23    For purposes of complying with this paragraph, the pharmacy
24    may rely on information supplied by the patient's insurer.
25        (11) The pharmacy shall register with the National
26    Patient Notification System, or its successor, to receive

 

 

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1    recall notification for all products included in the
2    National Patient Notification System. The pharmacy shall
3    maintain current and accurate contact information with the
4    National Patient Notification System.
5    (e) Pharmacies that provide legend blood clotting products
6to treat or prevent symptoms of established bleeding disorder
7patients, or that offer or advertise to provide blood clotting
8products specifically for bleeding disorder patients, shall
9develop and follow written policies and procedures to ensure
10compliance with this Section. The pharmacy shall review the
11policies and procedures on an annual basis and document such
12review. The pharmacy's written policies and procedures shall
13include procedures for:
14        (1) processing prescriptions for blood clotting
15    products by pharmacy staff to ensure the timely handling
16    and dispensing of blood clotting products;
17        (2) processing partial fill requests by patients to
18    reduce or eliminate excessive dispensing;
19        (3) providing and documenting recall notifications in
20    accordance with this Section;
21        (4) transferring, dispensing, refilling, or delivering
22    blood clotting products to established patients in the
23    event of an emergency or disaster;
24        (5) notifying patients prior to terminating business
25    or terminating the dispensing of any blood clotting product
26    or prior to a known or anticipated termination of pharmacy

 

 

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1    services for a bleeding disorder patient; such
2    notification shall be provided in writing and, when
3    reasonably possible, shall be provided at least 7 days
4    prior to any such termination;
5        (6) shipping or providing blood clotting products to
6    the patient within the time frames required in this
7    Section;
8        (7) receiving, processing, and dispensing prescription
9    or dispensing requests for a blood clotting product to
10    bleeding disorder patients, including procedures for
11    handling and processing physician requests indicating a
12    patient's emergent need for a blood clotting product;
13        (8) ensuring appropriate cold chain management and
14    packaging practices are used to ensure proper drug
15    temperature, stability, integrity, and efficacy are
16    maintained during shipment in accordance with manufacturer
17    requirements; and
18        (9) handling and processing preauthorization
19    notifications and requests and communicating
20    preauthorization requirements to the patient and
21    applicable prescriber.
22    (f) This Section shall not be construed to require
23dispensing without appropriate payment or payment
24arrangements. If the pharmacy is waiting for authorization,
25certification, or other action from a third-party payor prior
26to dispensing, the pharmacy shall notify the patient that the

 

 

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1prescription is available for dispensing and explain any
2alternative payment options. Notification shall be provided as
3soon as reasonably practicable. Notification shall be provided
4to the patient prior to the expiration of the shipping and
5delivery time frames required by subsection (d).