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| 1 | AN ACT concerning health.
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| 2 | Be it enacted by the People of the State of Illinois,
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| 3 | represented in the General Assembly:
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| 4 | Section 1. Short title. This Act may be cited as the | ||||||||||||||||||||||||||
| 5 | Patient-Assisted Hemophilia Medication Administration Act. | ||||||||||||||||||||||||||
| 6 | Section 5. Findings. The General Assembly finds that: | ||||||||||||||||||||||||||
| 7 | (1) Patients that have rare bleeding disorders such as | ||||||||||||||||||||||||||
| 8 | hemophilia and Von Willebrand Disease can create large | ||||||||||||||||||||||||||
| 9 | demands on health care resources, and such patients | ||||||||||||||||||||||||||
| 10 | necessitate the provision of unique care. Patients with | ||||||||||||||||||||||||||
| 11 | these diseases may suffer profuse, life-threatening | ||||||||||||||||||||||||||
| 12 | bleeding even through minor trauma. Patients commonly may | ||||||||||||||||||||||||||
| 13 | receive human or recombinant blood factors | ||||||||||||||||||||||||||
| 14 | prophylactically throughout each week to keep blood factor | ||||||||||||||||||||||||||
| 15 | levels within safe levels. | ||||||||||||||||||||||||||
| 16 | (2) During an emergency situation, which may include | ||||||||||||||||||||||||||
| 17 | either a minor or major trauma event, it is the standard of | ||||||||||||||||||||||||||
| 18 | care and opinion of experts that, "if in doubt, treat", | ||||||||||||||||||||||||||
| 19 | preferably within 2 hours. | ||||||||||||||||||||||||||
| 20 | (3) For severe or life-threatening bleeding, patients | ||||||||||||||||||||||||||
| 21 | need appropriate clotting factors by intravenous push over | ||||||||||||||||||||||||||
| 22 | one to 2 minutes followed by additional follow up | ||||||||||||||||||||||||||
| 23 | prophylactic care. | ||||||||||||||||||||||||||
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| 1 | (4) Because of the need for immediate treatment, it is | ||||||
| 2 | common for patients with rare bleeding disorders to carry | ||||||
| 3 | with them at all times their own clotting factor, | ||||||
| 4 | including, but not limited to, factor VIII, factor IX, and | ||||||
| 5 | Von Willebrand factor; desmopressin; anti-inhibitor | ||||||
| 6 | coagulant complex; or related substances. | ||||||
| 7 | (5) The risk of overdose of rare disease blood | ||||||
| 8 | treatment factors is rare and low relative to the risk of | ||||||
| 9 | harm to such patients from failure to adequately dose rare | ||||||
| 10 | blood disease treatment factors if treatment is not | ||||||
| 11 | administered quickly when an emergency bleed occurs. | ||||||
| 12 | Failure to treat quickly at the time of trauma may also | ||||||
| 13 | necessitate increased administration of rare blood disease | ||||||
| 14 | treatment factors for a period of days or weeks compared to | ||||||
| 15 | normal prophylactic care doses. Treating patients with | ||||||
| 16 | medication that patients have on hand also lessens the | ||||||
| 17 | likelihood that a patient will suffer adverse and | ||||||
| 18 | potentially life-threatening side effects from the | ||||||
| 19 | generation of alloantibodies, inhibitory antibodies, | ||||||
| 20 | triggering antibodies, or undesirable binding of HLA class | ||||||
| 21 | II antigens. | ||||||
| 22 | (6) Patients and their associated caregivers who may be | ||||||
| 23 | nonmedical personnel, such as parents, are frequently | ||||||
| 24 | trained on how to administer rare blood disease treatment | ||||||
| 25 | factors to address acute trauma events. However, there may | ||||||
| 26 | be times when the caregiver is either not present or | ||||||
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| 1 | incapacitated; or otherwise solely in the presence of those | ||||||
| 2 | who have not been trained in how to provide intravenous | ||||||
| 3 | infusions. | ||||||
| 4 | (7) Patients and their associated caregivers have | ||||||
| 5 | experienced failure to immediately treat in response to | ||||||
| 6 | acute trauma, even when the patient has his or her own | ||||||
| 7 | rescue medication on hand, because of confusion in the | ||||||
| 8 | scope of permissible practice. | ||||||
| 9 | (8) It is the goal of the General Assembly to encourage | ||||||
| 10 | emergency management technicians, assistant emergency | ||||||
| 11 | medical technicians, and paramedics certified under | ||||||
| 12 | Illinois statutes to assist a patient with a rare blood | ||||||
| 13 | disease in emergency situations. | ||||||
| 14 | Section 10. Definitions. In this Act: | ||||||
| 15 | "Administer" means to directly apply, via injector, or | ||||||
| 16 | deliver, via infusion, a medication associated with a rare | ||||||
| 17 | blood disease to the body of an individual. | ||||||
| 18 | "Emergency personnel" includes any emergency medical | ||||||
| 19 | technician, assistant emergency medical technician, and | ||||||
| 20 | paramedic licensed under the Emergency Medical Services (EMS) | ||||||
| 21 | Systems Act.
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| 22 | "Emergency situations" includes at least the following: | ||||||
| 23 | situations where a call is initiated to or received by 9-1-1 or | ||||||
| 24 | other emergency response service; events where an emergency | ||||||
| 25 | medical technician, assistant emergency medical technician, or | ||||||
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| 1 | paramedic has been specially retained to be present; an | ||||||
| 2 | accident scene; ambulance transport; airlift transport; | ||||||
| 3 | situations where federal emergency response agencies have been | ||||||
| 4 | called to a scene; or situations which otherwise arise in a | ||||||
| 5 | location in the State of Illinois that is not an urgent care | ||||||
| 6 | center or hospital. | ||||||
| 7 | "Health care practitioner" means a physician licensed to | ||||||
| 8 | practice medicine in all its branches under the Medical | ||||||
| 9 | Practice Act of 1987; a physician assistant under the Physician | ||||||
| 10 | Assistant Practice Act of 1987 with prescriptive authority; or | ||||||
| 11 | an advanced practice registered nurse with prescribing | ||||||
| 12 | authority under Article 65 of the Nurse Practice Act. | ||||||
| 13 | "Patient-carried medication" means: | ||||||
| 14 | (1) for a patient who is a resident in the State of | ||||||
| 15 | Illinois, medication that has been prescribed by a health | ||||||
| 16 | care practitioner in connection with the treatment, | ||||||
| 17 | therapy, or prophylactic care of a rare blood disease and | ||||||
| 18 | is in the possession, custody, or control of the patient or | ||||||
| 19 | the patient's caregiver or legal guardian. | ||||||
| 20 | (2) for a patient who is not a resident in the State of | ||||||
| 21 | Illinois, medication that has been prescribed by a | ||||||
| 22 | physician, physician assistant with prescribing authority, | ||||||
| 23 | advanced practice nurse with prescriptive authority who is | ||||||
| 24 | licensed in the state of the patient's residency; is in | ||||||
| 25 | connection to the treatment, therapy, or prophylactic care | ||||||
| 26 | of a rare blood disease; and is in the possession, custody, | ||||||
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| 1 | or control of a patient, patient caregiver, or patient's | ||||||
| 2 | legal guardian; provided that the prescription medication | ||||||
| 3 | is accompanied by either an original or copy of the | ||||||
| 4 | prescription signed by an authorizing physician or the | ||||||
| 5 | packaging indicates the name of a dispensing pharmacy and | ||||||
| 6 | the prescription was written in the name of the patient. | ||||||
| 7 | "Rare blood diseases" means a group of disorders that share | ||||||
| 8 | the inability to form a proper blood clot, characterized by | ||||||
| 9 | extended bleeding after injury, surgery, trauma, or | ||||||
| 10 | menstruation, or sometimes spontaneously, without a known or | ||||||
| 11 | identifiable cause. "Rare blood diseases" includes hemophilia | ||||||
| 12 | A and B, Von Willebrand Disease, and such additional conditions | ||||||
| 13 | as may be determined by the Illinois Department of Public | ||||||
| 14 | Health pursuant to notice and rulemaking. | ||||||
| 15 | "Rare blood disease treatment factors" includes Factor | ||||||
| 16 | VII; Factor VIII; Factor IX; Von Willebrand factor; | ||||||
| 17 | desmopressin; anti-inhibitor coagulant complex; complexes, | ||||||
| 18 | conjugates, or derivatives thereof (including those complexed | ||||||
| 19 | to polyethylene glycol; genetically modified or synthesized | ||||||
| 20 | variants; or partial fragments of such factors that provide | ||||||
| 21 | clinical activity); and such additional medications as may be | ||||||
| 22 | determined by the Illinois Department of Public Health pursuant | ||||||
| 23 | to notice and rulemaking used in the treatment of rare blood | ||||||
| 24 | disease.
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| 25 | Section 15. Administering patient-carried medication. Any | ||||||
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| 1 | emergency personnel may assist a patient with a rare blood | ||||||
| 2 | disease in emergency situations to administer patient-carried | ||||||
| 3 | medication if the administration is: | ||||||
| 4 | (1) consistent with written instructions from an | ||||||
| 5 | authorizing physician, such as a written care plan; | ||||||
| 6 | (2) consistent with the package labeling; | ||||||
| 7 | (3) via routes of delivery that are within the scope of | ||||||
| 8 | training of the emergency personnel; or | ||||||
| 9 | (4) consistent with a care plan that previously was | ||||||
| 10 | filed by or on behalf of the patient with the chief | ||||||
| 11 | emergency personnel officer, or his or her designee, | ||||||
| 12 | provided that the care plan has been independently approved | ||||||
| 13 | by a health care practitioner. | ||||||
| 14 | The activity authorized under this Section may be taken | ||||||
| 15 | irrespective of the age of the patient and without the need to | ||||||
| 16 | secure separate consent from the patient or the patient's | ||||||
| 17 | caregiver or a legal guardian if the emergency personnel take | ||||||
| 18 | steps to deliver the patient to a receiving hospital and the | ||||||
| 19 | receiving hospital is informed of the pending arrival of the | ||||||
| 20 | rare blood disease patient, along with the treatment instituted | ||||||
| 21 | by the emergency personnel. | ||||||
| 22 | Section 20. Liability. When emergency personnel administer | ||||||
| 23 | patient-carried medication in good faith, the emergency | ||||||
| 24 | personnel, and their employer, employees, and agents, as well | ||||||
| 25 | as the health care practitioner or, for out-of-state residents, | ||||||
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| 1 | prescribing physician, physician assistant with prescribing | ||||||
| 2 | authority, or advanced practice nurse with prescriptive | ||||||
| 3 | authority, shall incur no civil or professional liability, | ||||||
| 4 | except for willful and wanton conduct, as a result of any | ||||||
| 5 | injury or death arising from the assistance of the | ||||||
| 6 | administration of a patient-carried medication for patients | ||||||
| 7 | with a rare blood disease. | ||||||
| 8 | Section 25. Training program. The Department of Public | ||||||
| 9 | Health may conduct or approve a training program for emergency | ||||||
| 10 | personnel to recognize and learn additional treatment | ||||||
| 11 | protocols for rare blood disorders. | ||||||
| 12 | Section 90. The State Mandates Act is amended by adding | ||||||
| 13 | Section 8.44 as follows: | ||||||
| 14 | (30 ILCS 805/8.44 new) | ||||||
| 15 | Sec. 8.44. Exempt mandate. Notwithstanding Sections 6 and 8 | ||||||
| 16 | of this Act, no reimbursement by the State is required for the | ||||||
| 17 | implementation of any mandate created by this amendatory Act of | ||||||
| 18 | the 101st General Assembly.
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