2014 -- S 2524

========

LC004631

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2014

____________

A N   A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

     

     Introduced By: Senator Walter S.Felag

     Date Introduced: February 27, 2014

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

1

     SECTION 1. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled "Uniform

2

Controlled Substances Act" is hereby amended to read as follows:

3

     21-28-3.18. Prescriptions. -- (a) An apothecary in good faith may sell and dispense

4

controlled substances in schedule II, III, IV and V to any person upon a valid prescription by a

5

practitioner licensed by law to prescribe or administer those substances, dated and signed by the

6

person prescribing on the day when issued and bearing the full name and address of the patient to

7

whom, or of the owner of the animal for which the substance is dispensed and the full name,

8

address and registration number under the federal law of the person prescribing, if he or she is

9

required by that law to be registered. If the prescription is for an animal, it shall state the species

10

of the animal for which the substance is prescribed.

11

      (b) When filling a hard-copy prescription for a schedule II controlled substance, the

12

apothecary filling the prescription shall sign his or her full name and shall write the date of filling

13

on the face of the prescription.

14

      (c) The prescription shall be retained on file by the proprietor of the pharmacy in which

15

it was filled for a period of two (2) years so as to be readily accessible for inspection by any

16

public officer or employee engaged in the enforcement of this chapter.

17

      (d) (1) Hard copy prescriptions for controlled substances in schedule II shall be filed

18

separately and shall not be refilled.

19

      (2) The director of health may, after appropriate notice and hearing pursuant to section

 

1

42-35-3, promulgate rules and regulations for the purpose of adopting a system for electronic data

2

transmission of prescriptions for controlled substances in schedule II, III and IV.

3

      (3) A practitioner may sign and transmit electronic prescriptions for controlled

4

substances and a pharmacy may dispense an electronically transmitted prescription in accordance

5

with the code of federal regulations, title 21 part 1300, et seq.

6

     (4) If the practitioner requests prescription fill status notification as part of the electronic

7

prescription, the pharmacy shall provide such notification to the practitioner and indicate whether

8

the electronic prescription is dispensed, partially dispensed or not dispensed and returned to the

9

pharmacy's stock.

10

      (e) A prescription for a schedule II narcotic substance to be compounded for the direct

11

administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal

12

infusion may be transmitted by the practitioner or practitioner's agent to the pharmacy by

13

facsimile. The facsimile will serve as the original prescription.

14

      (f) A prescription for a schedule II substance for a resident of a long term care facility

15

may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by

16

facsimile. The facsimile serves as the original prescription.

17

      (g) A prescription for a schedule II narcotic substance for a patient residing in a hospice

18

certified by Medicare under title XVIII of the Social Security Act, 42 U.S.C. section 1395 et seq.,

19

or licensed by the state, may be transmitted by the practitioner or practitioner's agent to the

20

dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the

21

prescription that the patient is a hospice patient. The facsimile serves as the original written

22

prescription.

23

      (h) An apothecary, in lieu of a written prescription, may sell and dispense controlled

24

substances in schedules III, IV, and V to any person upon an oral prescription of a practitioner. In

25

issuing an oral prescription the prescriber shall furnish the apothecary with the same information

26

as is required by subsection (a) of this section and the apothecary who fills the prescription, shall

27

immediately reduce the oral prescription to writing and shall inscribe the information on the

28

written record of the prescription made. This record shall be filed and preserved by the proprietor

29

of the pharmacy in which it is filled in accordance with the provisions of subsection (c) of this

30

section. In no case may a prescription for a controlled substance listed in schedules III, IV, or V

31

be filled or refilled more than six (6) months after the date on which the prescription was issued

32

and no prescription shall be authorized to be refilled more than five (5) times. Each refilling shall

33

be entered on the face or back of the prescription and note the date and amount of controlled

34

substance dispensed, and the initials or identity of the dispensing apothecary.

 

LC004631 - Page 2 of 6

1

      (i) In the case of an emergency situation as defined in federal law, an apothecary may

2

dispense a controlled substance listed in schedule II upon receiving an oral authorization of a

3

prescribing practitioner provided that:

4

      (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the

5

patient during the emergency period and dispensing beyond the emergency period must be

6

pursuant to a written prescription signed by the prescribing practitioner.

7

      (2) The prescription shall be immediately reduced to writing and shall contain all the

8

information required in subsection (a) of this section.

9

      (3) The prescription must be dispensed in good faith in the normal course of professional

10

practice.

11

      (4) Within seven (7) days after authorizing an emergency oral prescription, the

12

prescribing practitioner shall cause a prescription for the emergency quantity prescribed to be

13

delivered to the dispensing apothecary. The prescription shall have written on its face

14

"Authorization for emergency dispensing" and the date of the oral order. The prescription upon

15

receipt by the apothecary shall be attached to the oral emergency prescription which had earlier

16

been reduced to writing.

17

      (j) (1) The partial filling of a prescription for a controlled substance listed in schedule II

18

is permissible, if the apothecary is unable to supply the full quantity called for in a prescription or

19

emergency oral prescription and he or she makes a notation of the quantity supplied on the face of

20

the prescription or oral emergency prescription which has been reduced to writing. The remaining

21

portion of the prescription may be filled within seventy-two (72) hours of the first partial filling,

22

however, if the remaining portion is not, or cannot be filled within seventy-two (72) hours, the

23

apothecary shall notify the prescribing practitioner. No further quantity may be supplied beyond

24

seventy-two (72) hours without a new prescription.

25

      (2) (i) A prescription for a schedule II controlled substance written for a patient in a long

26

term care facility (LTCF), or for a patient with a medical diagnosis documenting a terminal

27

illness, may be filled in partial quantities to include individual dosage units. If there is a question

28

whether a patient may be classified as having a terminal illness, the pharmacist must contact the

29

practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing

30

practitioner have a corresponding responsibility to assure that the controlled substance is for a

31

terminally ill patient.

32

      (ii) The pharmacist must record on the prescription whether the patient is "terminally ill"

33

or an "LTCF patient." A prescription that is partially filled, and does not contain the notation

34

"terminally ill" or "LTCF patient", shall be deemed to have been filled in violation of this chapter.

 

LC004631 - Page 3 of 6

1

      (iii) For each partial filling, the dispensing pharmacist shall record on the back of the

2

prescription (or on another appropriate record, uniformly maintained, and readily retrievable),

3

the:

4

      (A) Date of the partial filling;

5

      (B) Quantity dispensed;

6

      (C) Remaining quantity authorized to be dispensed; and

7

      (D) Identification of the dispensing pharmacist.

8

      (iv) The total quantity of schedule II controlled substances dispensed in all partial fillings

9

must not exceed the total quantity prescribed.

10

      (v) Schedule II prescriptions for patients in a LTCF, or patients with a medical diagnosis

11

documenting a terminal illness, are valid for a period not to exceed sixty (60) days from the issue

12

date, unless sooner terminated by the discontinuance of medication.

13

      (k) Automated data processing systems. - As an alternative to the prescription record

14

keeping provision of subsection (h) of this section, an automated data processing system may be

15

employed for the record keeping system, if the following conditions have been met:

16

      (1) The system shall have the capability of producing sight-readable documents of all

17

original and refilled prescription information. The term "sight-readable" means that an authorized

18

agent shall be able to examine the record and read the information. During the course of an on-

19

site inspection, the record may be read from the CRT, microfiche, microfilm, printout, or other

20

method acceptable to the director. In the case of administrative proceedings, records must be

21

provided in a paper printout form.

22

      (2) The information shall include, but not be limited to, the prescription requirements

23

and records of dispensing as indicated in subsection (h) of this section.

24

      (3) The individual pharmacist responsible for completeness and accuracy of the entries

25

to the system must provide documentation of the fact that prescription information entered into

26

the computer is correct. In documenting this information, the pharmacy shall have the option to

27

either:

28

      (i) Maintain a bound log book, or separate file, in which each individual pharmacist

29

involved in the dispensing shall sign a statement each day, attesting to the fact that the

30

prescription information entered into the computer that day has been reviewed and is correct as

31

shown. The book or file must be maintained at the pharmacy employing that system for a period

32

of at least two (2) years after the date of last dispensing; or

33

      (ii) Provide a printout of each day's prescription information. That printout shall be

34

verified, dated, and signed by the individual pharmacist verifying that the information indicated is

 

LC004631 - Page 4 of 6

1

correct. The printout must be maintained at least two (2) years from the date of last dispensing.

2

      (4) An auxiliary record keeping system shall be established for the documentation of

3

refills, if the automated data processing system is inoperative for any reason. The auxiliary

4

system shall ensure that all refills are authorized by the original prescription, and that the

5

maximum number of refills is not exceeded. When this automated data processing system is

6

restored to operation, the information regarding prescriptions filled and refilled during the

7

inoperative period, shall be entered into the automated data processing system within ninety-six

8

(96) hours.

9

      (5) Any pharmacy using an automated data processing system must comply with all

10

applicable state and federal laws and regulations.

11

      (6) A pharmacy shall make arrangements with the supplier of data processing services or

12

materials to ensure that the pharmacy continues to have adequate and complete prescription and

13

dispensing records if the relationship with the supplier terminates for any reason. A pharmacy

14

shall ensure continuity in the maintenance of records.

15

      (7) The automated data processing system shall contain adequate safeguards for security

16

of the records, to maintain the confidentiality and accuracy of the prescription information.

17

Safeguards against unauthorized changes in data after the information has been entered and

18

verified by the registered pharmacist shall be provided by the system.

19

      (l) Prescriptions for controlled substances as found in schedules II, will become void

20

unless dispensed within ninety (90) days of the original date of the prescription, and in no event

21

shall more than a thirty (30) day supply be dispensed at any one time.

22

      (1) In prescribing controlled substances in schedule II, practitioners may write up to

23

three (3) separate prescriptions, each for up to a one-month supply, each signed and dated on the

24

date written. For those prescriptions for the second and/or third month, the practitioner must write

25

the earliest date each of those subsequent prescription may be filled, with directions to the

26

pharmacist to fill no earlier than the date specified on the face of the prescription.

27

      (m) The prescriptions in schedules III, IV, and V will become void unless dispensed

28

within one hundred eighty (180) days of the original date of the prescription. For purposes of this

29

section, a "dosage unit" shall be defined as a single capsule, tablet or suppository, or not more

30

than one five (5) ml. of an oral liquid.

31

      (1) Prescriptions in Schedule III cannot be written for more than one hundred (100)

32

dosage units and not more than one hundred (100) dosage units may be dispensed at one time.

33

      (2) Prescriptions in Schedule IV and V may be written for up to a ninety (90) day supply

34

based on directions. No more than three hundred and sixty (360) dosage units may be dispensed

 

LC004631 - Page 5 of 6

1

at one time.

2

     SECTION 2. This act shall take effect upon passage.

========

LC004631

========

 

LC004631 - Page 6 of 6

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS - UNIFORM CONTROLLED SUBSTANCES ACT

***

1

     This act would require pharmacies, pursuant to the request of the prescribing practitioner,

2

to provide a fill notification to the practitioner for electronic prescriptions.

3

     This act would take effect upon passage.

========

LC004631

========

 

LC004631 - Page 7 of 6