2015 -- H 5290

========

LC000903

========

     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: Representative Joseph M. McNamara

     Date Introduced: February 04, 2015

     Referred To: House Corporations

     It is enacted by the General Assembly as follows:

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

"extremely hazardous waste."

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

 

1

cancer.

2

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

3

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

4

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

5

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

6

(2%) of that cost.

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

arising from improper disposal of cytotoxic chemotherapy drugs.

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

entering sewers."

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 2 of 16

1

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

2

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

3

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

4

after low-level exposures."

5

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

6

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

7

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

8

and their families.

9

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

10

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

11

serious health and safety issue.

12

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

13

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

14

administer chemotherapy treatment shall:

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

insert(s); and

28

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

29

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

30

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

31

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

32

identified in this chapter.

33

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

34

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

 

LC000903 - Page 3 of 16

1

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

2

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

3

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

4

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

5

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

6

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

7

time.

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

"extremely hazardous waste."

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

cancer.

28

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

29

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

30

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

31

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

32

(2%) of that cost.

33

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

34

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

 

LC000903 - Page 4 of 16

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

arising from improper disposal of cytotoxic chemotherapy drugs.

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

entering sewers."

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

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

29

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

30

after low-level exposures."

31

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

32

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

33

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

34

and their families.

 

LC000903 - Page 5 of 16

1

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

2

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

3

serious health and safety issue.

4

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

5

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

6

administer chemotherapy treatment shall:

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

insert(s); and

20

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

21

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

22

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

23

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

24

identified in this chapter.

25

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

26

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

27

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

28

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

29

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

30

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

31

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

32

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

33

time.

34

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

 

LC000903 - Page 6 of 16

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

"extremely hazardous waste."

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

cancer.

20

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

21

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

22

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

23

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

24

(2%) of that cost.

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 7 of 16

1

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

2

arising from improper disposal of cytotoxic chemotherapy drugs.

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

entering sewers."

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

after low-level exposures."

23

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

24

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

25

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

26

and their families.

27

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

28

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

29

serious health and safety issue.

30

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

31

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

32

administer chemotherapy treatment shall:

33

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

34

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

 

LC000903 - Page 8 of 16

1

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

insert(s); and

12

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

13

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

14

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

15

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

16

identified in this chapter.

17

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

18

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

19

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

20

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

21

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

22

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

23

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

24

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

25

time.

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 9 of 16

1

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

2

"extremely hazardous waste."

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

cancer.

12

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

13

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

14

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

15

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

16

(2%) of that cost.

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

arising from improper disposal of cytotoxic chemotherapy drugs.

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 10 of 16

1

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

2

entering sewers."

3

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

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

13

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

14

after low-level exposures."

15

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

16

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

17

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

18

and their families.

19

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

20

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

21

serious health and safety issue.

22

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

23

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

24

administer chemotherapy treatment shall:

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 11 of 16

1

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

2

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

3

insert(s); and

4

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

5

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

6

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

7

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

8

identified in this chapter.

9

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

10

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

11

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

12

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

13

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

14

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

15

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

16

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

17

time.

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

"extremely hazardous waste."

29

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

30

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

31

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

32

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

33

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

34

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

 

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1

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

2

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

3

cancer.

4

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

5

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

6

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

7

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

8

(2%) of that cost.

9

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

10

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

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

arising from improper disposal of cytotoxic chemotherapy drugs.

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

entering sewers."

29

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

30

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

31

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

32

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

33

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

34

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

 

LC000903 - Page 13 of 16

1

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

2

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

3

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

4

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

5

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

6

after low-level exposures."

7

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

8

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

9

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

10

and their families.

11

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

12

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

13

serious health and safety issue.

14

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

15

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

16

administer chemotherapy treatment shall:

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

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

29

insert(s); and

30

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

31

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

32

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

33

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

34

identified in this chapter.

 

LC000903 - Page 14 of 16

1

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

2

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

3

pharmacist shall satisfy the responsibility of the prescribing pharmacist hereunder.

4

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

5

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

6

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

7

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

8

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

9

time.

10

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

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LC000903 - Page 15 of 16

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES

***

1

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

2

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

3

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

4

Rhode Island.

5

     This act would take effect on September 1, 2015.

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