2015 -- S 0169

========

LC000793

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2015

____________

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES

     Introduced By: Senators Ottiano, and Archambault

     Date Introduced: February 05, 2015

     Referred To: Senate Health & Human Services

     (by request)

It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness

Insurance Policies" is hereby amended by adding thereto the following section:

     27-18-82. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management: groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #DEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that The World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization core principles require that all personnel associated with financing and supporting

healthcare activities should provide for the costs of managing healthcare waste. This is the duty of

care. The World Health Organization places the responsibility for genotoxic waste on the chief

pharmacist and further states that the chief pharmacist also has the special responsibility of

ensuring that genotoxic products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the environmental risks of medicinal products" which was released in

June of 2014, drafted by BIO Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christan G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed sustainable

prescribing: feasibility for reducing water contamination by drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) healthcare organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

LC000793 - Page 2 of 16

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer; reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, feces, and vomit, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be adopted by the Rhode Island department of health,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Provide a sufficient collection method so that providers and patients can safely collect

and contain extremely hazardous excretions for a period of time as determined by the United

States Food and Drug Administration ("FDA") and referenced on the relevant FDA prescription

insert(s); and

     (3) Provide for safe and proper disposal of said collected extremely hazardous excretions.

     (d) Consistent with the core principles of the World Health Organization for achieving

safe and sustainable management of healthcare waste, all personnel associated with financing and

supporting healthcare activities should provide for the costs of managing the healthcare waste

identified in this chapter.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

LC000793 - Page 3 of 16

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, "extremely hazardous excretions" means any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c) of this section, including, but not limited to, drugs listed in the NIOSH list of

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

time.

     SECTION 2. Chapter 27-18.5 of the General Laws entitled "Individual Health Insurance

Coverage" is hereby amended by adding thereto the following section:

     27-18.5-11. Cancer patient safety and environmental protection. -- (a) Purpose. It is

the policy of the state of Rhode Island not to permit introduction of pollutants into the ground

waters and water systems of the state or otherwise to be discharged in concentrations which are

known to be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode

Island department of environmental management: groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #DEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that The World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

LC000793 - Page 4 of 16

Organization core principles require that all personnel associated with financing and supporting

healthcare activities should provide for the costs of managing healthcare waste. This is the duty of

care. The World Health Organization places the responsibility for genotoxic waste on the chief

pharmacist and further states that the chief pharmacist also has the special responsibility of

ensuring that genotoxic products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the environmental risks of medicinal products" which was released in

June of 2014, drafted by BIO Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christan G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed sustainable

prescribing: feasibility for reducing water contamination by drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer; reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

      (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

LC000793 - Page 5 of 16

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, feces, and vomit, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be adopted by the Rhode Island department of health,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Provide a sufficient collection method so that providers and patients can safely collect

and contain extremely hazardous excretions for a period of time as determined by the United

States Food and Drug Administration ("FDA") and referenced on the relevant FDA prescription

insert(s); and

     (3) Provide for safe and proper disposal of said collected extremely hazardous excretions.

     (d) Consistent with the core principles of the World Health Organization for achieving

safe and sustainable management of health-care waste, all personnel associated with financing

and supporting healthcare activities should provide for the costs of managing the healthcare waste

identified in this chapter.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, "extremely hazardous excretions" shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c) of this section, including, but not limited to, drugs listed in the NIOSH list of

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

time.

     SECTION 3. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service

LC000793 - Page 6 of 16

Corporations" is hereby amended by adding thereto the following section:

     27-19-73. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management: groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #DEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that The World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization core principles require that all personnel associated with financing and supporting

healthcare activities should provide for the costs of managing healthcare waste. This is the duty of

care. The World Health Organization places the responsibility for genotoxic waste on the chief

pharmacist and further states that the chief pharmacist also has the special responsibility of

ensuring that genotoxic products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the environmental risks of medicinal products" which was released in

June of 2014, drafted by BIO Intelligence Service, a division of Deloitte Consulting LLP,

LC000793 - Page 7 of 16

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christan G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed sustainable

prescribing: feasibility for reducing water contamination by drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer; reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

LC000793 - Page 8 of 16

excretions, including, but not limited to, urine, feces, and vomit, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be adopted by the Rhode Island department of health,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Provide a sufficient collection method so that providers and patients can safely collect

and contain extremely hazardous excretions for a period of time as determined by the United

States Food and Drug Administration ("FDA") and referenced on the relevant FDA prescription

insert(s); and

     (3) Provide for safe and proper disposal of said collected extremely hazardous excretions.

     (d) Consistent with the core principles of the World Health Organization for achieving

safe and sustainable management of healthcare waste, all personnel associated with financing and

supporting healthcare activities should provide for the costs of managing the healthcare waste

identified in this chapter.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, "extremely hazardous excretions" shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c) of this section, including, but not limited to, drugs listed in the NIOSH list of

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

time.

     SECTION 4. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service

Corporations" is hereby amended by adding thereto the following section:

     27-20-69. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management: groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #DEM OWM-HW 01-14, most recent revision dated

LC000793 - Page 9 of 16

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that The World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization core principles require that all personnel associated with financing and supporting

healthcare activities should provide for the costs of managing healthcare waste. This is the duty of

care. The World Health Organization places the responsibility for genotoxic waste on the chief

pharmacist and further states that the chief pharmacist also has the special responsibility of

ensuring that genotoxic products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the environmental risks of medicinal products" which was released in

June of 2014, drafted by BIO Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christan G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed sustainable

prescribing: feasibility for reducing water contamination by drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

LC000793 - Page 10 of 16

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) healthcare organizations· and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer; reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, feces, and vomit, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be adopted by the Rhode Island department of health,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Provide a sufficient collection method so that providers and patients can safely collect

LC000793 - Page 11 of 16

and contain extremely hazardous excretions for a period of time as determined by the United

States Food and Drug Administration ("FDA") and referenced on the relevant FDA prescription

insert(s); and

     (3) Provide for safe and proper disposal of said collected extremely hazardous excretions.

     (d) Consistent with the core principles of the World Health Organization for ·achieving

safe and sustainable management of healthcare waste, all personnel associated with financing and

supporting healthcare activities should provide for the costs of managing the healthcare waste

identified in this chapter.

     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, extremely hazardous excretions shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c) of this section, including, but not limited to, drugs listed in the NIOSH list of

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

time.

     SECTION 5. Chapter 27-41 of the General Laws entitled Health Maintenance

Organizations" is hereby amended by adding thereto the following section:

     27-41-86. Cancer patient safety and environmental protection. -- (a) Purpose. It is the

policy of the state of Rhode Island not to permit introduction of pollutants into the ground waters

and water systems of the state or otherwise to be discharged in concentrations which are known to

be toxic, carcinogenic, mutagenic, or teratogenic as the same are defined in the Rhode Island

department of environmental management: groundwater quality rules and the rules and

regulations for hazardous waste management. More specifically, the Rhode Island department of

environmental management, in regulation #DEM OWM-HW 01-14, most recent revision dated

January 7, 2014, defines certain antineoplastic or cytotoxic chemotherapy agents and drugs as

"extremely hazardous waste."

     (b) Findings. (1) It is acknowledged by medical experts that bodily wastes of patients

undergoing chemotherapy treatment may contain levels of chemicals that are toxic, carcinogenic,

mutagenic or teratogenic for a certain period of time, to such an extent that The World Health

Organization defines genotoxic waste as chemotherapy drug waste including urine, feces and

vomit from patients, which may contain potentially hazardous amounts of the administered

cytostatic drugs or of their metabolites, and which should be considered genotoxic for at least

LC000793 - Page 12 of 16

forty-eight (48) hours and sometimes up to one week after drug administration. According to the

World Health Organization, ten percent (10%) of known carcinogens are chemicals used to cure

cancer.

     (2) While, according to the American Society of Clinical Oncology, the cost of one

additional cancer patient resulting from the exposure to these harmful chemicals is approximately

one hundred seventy thousand dollars ($170,000) per treatment year, the cost of the

implementation of cytotoxic chemical safety protocols is estimated to be less than two percent

(2%) of that cost.

     (3) The World Health Organization further states that any discharge of genotoxic waste

into the environment could have disastrous ecological consequences. The World Health

Organization core principles require that all personnel associated with financing and supporting

health-care activities should provide for the costs of managing healthcare waste. This is the duty

of care. The World Health Organization places the responsibility for genotoxic waste on the chief

pharmacist and further states that the chief pharmacist also has the special responsibility of

ensuring that genotoxic products are used safely, and that genotoxic waste is managed safely.

     (4) The European Commission, Executive Agency for Health and Consumers undertook a

comprehensive "Study on the environmental risks of medicinal products" which was released in

June of 2014, drafted by BIO Intelligence Service, a division of Deloitte Consulting LLP,

reviewing the prevalence of contaminants in drinking water and noting the extreme dangers

arising from improper disposal of cytotoxic chemotherapy drugs.

     (5) Dr. Christan G. Daughton, former chief of environmental chemistry for the United

States Environmental Protection Agency, notes in a paper entitled "Eco-directed sustainable

prescribing: feasibility for reducing water contamination by drugs" published in the journal

"Science of the Total Environment" on June 3, 2014, that generally, the best practice for lowering

the level of drugs in our environment is reduction of dosages, but that "[c]ertain drug classes

(especially cytotoxic chemotherapeutics) may not be amenable to this approach; the best control

measure for such highly toxic drugs may simply be the prevention of urine and feces from

entering sewers."

     (6) The federal Occupational Safety and Health Administration ("OSHA") is the main

federal agency charged with the enforcement of safety and health legislation. OSHA, in concert

with the National Institute for Occupational Safety and Health ("NIOSH") and the Joint

Commission on Healthcare, an independent, not-for-profit organization that accredits and certifies

more than twenty thousand (20,000) health care organizations and programs in the United States,

stated in a 2011 letter to every hospital in the country that "[e]very day in healthcare settings

LC000793 - Page 13 of 16

across America, workers are exposed to hundreds of powerful drugs used for cancer

chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are

used to relieve and heal patients, many of them present serious hazards to the health and safety of

your workers. Some of these drugs have been known to cause cancer; reproductive and

developmental problems, allergic reactions, and other adverse effects that can be irreversible even

after low-level exposures."

     (7) Further, because of the risk of ongoing exposure to these extremely hazardous

excreted drugs, the American Cancer Society has published a comprehensive list of safety

precautions regarding the in-home personal hygiene for individuals undergoing chemotherapy

and their families.

     (8) Therefore, for the protection of both the public health and the environment, the

general assembly shall require that standards are set forth pursuant to this section to address this

serious health and safety issue.

     (c) Chemotherapy precautions following treatment. All physicians, pharmacists, or other

health care professionals licensed in the state of Rhode Island authorized to prescribe and/or

administer chemotherapy treatment shall:

     (1) Provide written notice from the prescribing pharmacist to each patient undergoing

such treatment as to the hazards posed to patients and their families of extremely hazardous

excretions, including, but not limited to, urine, feces, and vomit, for a period following treatment

as generally determined by the food and drug administration label accompanying said

chemotherapy drug or drugs. To the extent such notices are generally consistent with those now

provided for patients undergoing treatment with radioactive drugs, or consistent with the

recommendations of the World Health Organization with regard to cytotoxic drugs, or otherwise

consistent with similar standards that may be adopted by the Rhode Island department of health,

then the prescribing pharmacist will not be held liable for the form of such notice;

     (2) Provide a sufficient collection method so that providers and patients can safely collect

and contain extremely hazardous excretions for a period of time as determined by the United

States Food and Drug Administration ("FDA") and referenced on the relevant FDA prescription

insert(s); and

     (3) Provide for safe and proper disposal of said collected extremely hazardous excretions.

     (d) Consistent with the core principles of the World Health Organization for achieving

safe and sustainable management of healthcare waste, all personnel associated with financing and

supporting healthcare activities should provide for the costs of managing the healthcare waste

identified in this chapter.

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     (e) Receipt of notice from the party administering chemotherapy drugs or their agent

responsible for proper disposal of the hazardous wastes by the prescribing pharmacist or chief

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

     (f) For the purposes of this section, "extremely hazardous excretions" shall mean any

excretion from a patient on a regimen of chemotherapy agents that are antineoplastic or cytotoxic,

and which may be excreted during the period of administration or the time period referenced in

subsection (c) of this section, including, but not limited to, drugs listed in the NIOSH list of

antineoplastic and other hazardous drugs, as the same may be updated or amended from time to

time.

     SECTION 6. This act shall take effect on September 1, 2015.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES

***

     This act would require that protections related to the disposal of extremely hazardous

wastes generated by the use of toxic, carcinogenic, mutagenic, or teratogenic chemotherapy drugs

be implemented by pharmacists, physicians, healthcare providers, and insurers in the state of

Rhode Island.

     This act would take effect on September 1, 2015.

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