Section 2085.10  Definitions

 

As used in this Part, unless the context otherwise requires:

 

            "Delta-9-THC" means delta-9-tetrahydrocannabinol capsules issued by the National Cancer Institute for the treatment of cancer chemotherapy patients.

 

            "DEA" means the Drug Enforcement Administration of the United State Department of Justice or its successor agency.

 

            "Guidelines" means the "Group C Guidelines for the Use of Delta-9-tetrahydrocannabinol NSC 134454 for Nausea and Vomiting Induced by Antineoplastic Chemotherapy", Protocol 180-12, September, 1080, issued by the National Cancer Institute".

 

            "Mechanism" means the "Mechanism of Drug Distribution for Delta-9-Tetrahydrocannabinol (NSC-134454)" issued by the National Cancer Institute.

 

            "NCI" means the National Cancer Institute or its successor agency.

 

            "Research Order Forms" means the duplicate order forms supplied by the Department to authorized hospital pharmacies for prescribing delta-9-THC to cancer chemotherapy patients and entitled "Research Order for delta-9-THC Medication".

 

Section 2085.15  Eligibility

 

Hospitals and their pharmacies which have been registered and approved by the NCI and the DEA to use delta-9-THC in the treatment of cancer chemotherapy patients may be authorized by the Department to use delta-9-THC for such purposes in Illinois.  The authorization will be granted upon satisfactory completion of the Department authorization procedure.

 

Section 2085.20  Authorization Procedure

 

a)         Hospital

 

1)         Submit copies of Federal registration forms to the Department with a cover letter that:

 

A)        identifies the institution,

 

B)        indicates agreement to comply with Federal and State regulations and protocol concerning the use of THC, and

 

C)        agreement to promptly notify the Department in writing of any physician enrolled or disenrolled in the research.

 

2)         Notification to the Department of a physician's enrollment will be accomplished by the hospital's endorsement on the individual physician's letter of registration.  A copy of the hospital letter is Exhibit A.  The Department will accomplish coordination with the Department of Law Enforcement and seek their concurrence for the authorization.

 

b)         Physician

            Physician will submit copy of Federal registration form to the Department with a cover letter that:

 

1)         indicates the physician's DEA control number,

 

2)         his(her) Illinois Controlled Substances number,

 

3)         agreement to comply with Federal and State regulations and protocol concerning the use of THC, and

 

4)         agrees to notify the Department of disassociation with the research. A copy of the physician's letter is at Exhibit B.

 

Section 2085.25  Terms and Conditions of Authorization

 

a)         The hospital pharmacy upon receipt of written authorization by the Department may dispense delta-9-THC to cancer chemotherapy patients in conformity with this Part, all requirements imposed by the NCI as set forth in the Mechanisms and the Guidelines and all applicable regulations of the DEA.  Failure to adhere to such applicable requirements may result in the suspension or revocation of Department authorization.

 

b)         In determining whether to approve an application, the Department will consider the following factors:

 

1)         Whether the application contains false or fraudulent information or material;

 

2)         Whether the applicant maintains current Federal and State licenses as required by law;

 

3)         Whether the applicant has established and maintains adequate security of its drug stocks and in the handling of such stocks;

 

4)         Whether the applicant has agreed to comply with the procedures imposed by NCI as set forth under the Mechanism and the Guidelines and other applicable protocols; and

 

5)         Whether the applicant maintains and adheres to acceptable professional standards in the provision of medical and/or hospital services.

 

c)         In determining whether to suspend or revoke an authorization, the Department will consider the following criteria:

 

1)         The intentional nature of the violation;

 

2)         The potential or actual injury or harm to an individual or the public resulting from the violation;

 

3)         The severity of the violation;

 

4)         The potential for diversion resulting from the violation; and

 

5)         Whether the violation is one incident describing a course of conduct of repeated failure to comply with existing rules concerning the use of Marijuana in the treatment of cancer chemotherapy patients.

 

d)         Any action by the Department to deny, revoke or suspend an authorization shall be in accordance with the applicable provisions of Subpart F and such provisions of the Illinois Administrative Procedure Act (Ill. Rev. Stat. 1981, ch. 127, pars. 1001 et seq.) as apply to contested cases.

 

Section 2085.30  Informed Consent

 

Persons authorized to use delta-9-THC in the treatment of cancer chemotherapy patients shall insure that prior to the dispensing of any delta-9-THC medication, informed consent has been obtained from the patient.  Such informed consent shall be in writing and meet all requirements imposed by the NCI and 77 Ill. Adm. Code 2055.480 (b) and (f).  An institutional informed consent form may be used.  The execution of the informed consent form issued by the NCI as part of the Guidelines by the patient shall be deemed compliance with the requirements of this Subsection.  The original executed informed consent form shall remain in the patient's primary record file.  In the case of a minor, the parent or legal guardian must execute the informed consent form.

 

Section 2085.35  Research Order Blanks for Dispensing Delta-9-THC Capsules

 

a)         The hospital pharmacy may dispense delta-9-THC upon presentation of a "Research Order for Delta-9-Tetrahydrocannabinol Medication" signed by a physician who:

 

1)         Has a current DEA registration and Illinois Controlled Substances number;

 

2)         Has registered with the pharmacy by filing a Form FDA-1573 and has been approved by the participating pharmacy, the Department, the Illinois Department of Law Enforcement, and NCI;

 

3)         Affirms that the patient consent form has been signed by the patient;

 

4)         Limits the use of the drug to the indications outlined in the Guidelines;

 

5)         Will report adverse drug reactions on Form FD 1639-a to the Investigational Drug Branch of the NCI and the Department; and

 

6)         Has met all other requirements imposed by the NCI as set forth in the Mechanism.

 

b)         Procedure for Filling a Research Order for Medication:

 

1)         delta-9-THC medication may be dispensed only pursuant to a "Research Order for Delta-9-THC Medication" issued by the Department.  All Research Order Forms for delta-9-THC medication shall be written in duplicate.  The following items of information are on a valid research order:

 

A)        The name, address and zip code of the hospital pharmacy.

 

B)        The pharmacy DEA registration number.

 

C)        The patient's full name, address and zip code.

 

D)        The date of issuance.

 

E)        The period of time covered by the research order:

            AGENCY NOTE:  The Research Order expiration date represents the period of time for which the THC has been dispensed to the participating patient. The Research Order expiration and the lot expiration date need not always be the same.  The lot expiration date represents the period of time for which NCI states the THC to be effective.

 

F)         The name, strength, quantity and lot number of the drug.

 

G)        The directions for use.

 

H)        The name of the person (other than the patient) to whom the drug may have given on behalf of the patient, if anyone.

 

I)         Confirmation of informed patient consent.

 

J)         The signature of the prescribing physician.

 

K)        The DEA registration number and the Illinois Controlled Substances registration number of the prescribing physician.

 

L)        Confirmation that the physician is registered with the hospital to prescribe delta-9-THC.

            AGENCY NOTE:  A samples research order form is attached as Exhibit C.

 

2)         For outpatient treatment, if any of the above items are missing, the Research Order is to be considered invalid and is not to be filled.  For inpatient treatment, the pharmacist shall, upon receipt of a completed physician order (the written order of a physician as required for controlled substances by law and current hospital procedures pursuant to Section 313 of the Illinois Controlled Substances Act (Ill. Rev. Stat. 1981, ch. 56˝, par. 1313)) complete the Research Order and fill it. When filled by the pharmacy for inpatient treatment, the physician and patient signatures are not required on the Research Order Form.  The informed consent form must be completed by both inpatients and outpatients.

 

3)         The hospital pharmacy, at the time of presentment of a Research Order and prior to filling shall include on the Research Order, the date of filling, confirmation of the prescribing physician's affiliation with the hospital, the signature of person to whom the medication is delivered, the method used to verify the identification of the recipient and the signature of the dispensing pharmacist.

 

4)         Partial filling of a quantity ordered pursuant to the Research Order shall constitute a completed order for recordkeeping purposes.

 

Section 2085.40  Labeling Requirements

 

a)         Medication for Outpatient Use

            The hospital pharmacy shall affix to the package or container of delta-9-THC Medication a label showing date of filling, the hospital pharmacy name, address and telephone number, the pharmacy DEA number, the serial number of the research order, the name of the patient, the name of the prescribing physician, the directions for use, the period covered by the research order, the name, strength and quantity of medication, the pharmacist's initials, and the following cautionary statements:  The medication is non-refillable, the patient is to return unused portions of the medication, and Federal and State law prohibits the transfer or use of the medication by any person other than the person for whom it is prescribed.  A sample label is attached as Exhibit D.

 

b)         Medication for Inpatient Use

            Delta-9-THC Medication prescribed and dispensed for a patient who is institutionalized may be exempt from the provisions of subparagraph 1 above in accordance with 21 CFR 1306.14(b).

 

Section 2085.45  Packaging Requirements

 

All delta-9-THC medication dispensed pursuant to the authorization granted under this Part shall be in containers having child-proof caps in conformance with the requirements of 16 CFR 1700, Annex A of this Part.

 

Section 2085.50  Confidentiality of Cancer Chemotherapy Patients Receiving delta-9-THC Medication

 

The provisions of 77 Ill. Adm. Code 2055.480(g), Confidentiality of Research Subjects, are applicable to cancer chemotherapy patients receiving delta-9-THC medication as part of a program approved by the Department under this Part.

 

Section 2085.55  Reports and Recordkeeping

 

a)         Copies of all reports and forms required under the Mechanism and the Guidelines to be submitted to the NCI and DEA shall be submitted to the Department.

 

b)         Research orders filled by the hospital pharmacy shall be kept on pharmacy premises separate and apart from other pharmacy documents and shall be filed by date of filling.  Such Research Orders shall be available to Department personnel for inspection and audit.

 

c)         The original and one copy of the Research Order for delta-9-THC Medication shall be delivered to the hospital pharmacy.  The original Research Order Form for delta-9-THC Medication shall be retained by the hospital pharmacy and by the 15^th of the month following the month in which the Research Order Form was filled, the duplicate shall be returned to the Department.  The duplicate copy shall not contain any patient or recipient identifying information.  The pharmacy shall retain their copies of the orders for the same period as required for controlled substances pursuant to the Illinois Pharmacy Act (Ill. Rev. Stat. 1981, ch. 111, par. 4030).

 

d)         Any unused medication shall be returned to the distributing pharmacy upon completion of the Research Order expiration date.  Any unused amount of THC shall be recorded on the form which issued the THC to the patient. It may be redispensed to the same patient pursuant to a new Research Order. Such redistribution period shall not extend beyond the lot expiration date.

 

Section 2085.60  Audits and Inspections

 

Department staff shall be permitted access during normal working hours to all records and areas for the purpose of conducting audits and inspections to determine compliance with applicable laws, regulations and requirements of the NCI governing the use of delta-9-THC in the treatment of cancer chemotherapy patients.

 

Section 2085.65  Security

 

a)         All delta-9-THC shall be stored within the pharmacy storage area in compliance with the provisions of Title 21 of the Code of Federal Regulations, Part 1301.75(a).  The minimum security required thereunder is a securely locked, substantially constructed cabinet.

 

b)         Research Order forms shall be accounted for, maintained and secured to prevent unauthorized access and use.

 

c)         All medications governed by this Part require the same physical security as demanded by the rules and regulations governing Schedule II controlled substances.

 

d)         Contaminated medication shall be returned for disposal as authorized by the Department.

 

Section 2085.EXHIBIT A  DASA Form 229-1

 

(Hospital Letter Head)

 

 

Chief of Licensing

Department of Alcoholism and Substance Abuse

300 N. State Street–Suite 1500

Chicago, Illinois 60610

 

Sir:

 

We hereby apply for authorization from the Department to conduct research with Delta-9-Tetrahydrocannabinol.  Enclosed is a copy of Form DEA–225 "New Application for Registration under Controlled Substances Act of 1970", and a copy of our application to the National Cancer Institute (NCI) to participate in their research study.  The research will be conducted under the NCI approved Protocol I 80-12 "Group C Guidelines for the Use of Delta-9-Tetrahydrocanncbinol NSC 134454 for Nausea and Vomiting Induced by Antineoplastic Chemotherapy".  Applications for the individual physicians who have been approved by this hospital to issue the research order for medication are also enclosed.

 

We agree to comply with all pertinent Federal and State regulations and protocols concerning the use of THC.  We will notify the Department in writing of any new physician enrolled, or any who no longer wish to participate in the research study.

 

Sincerely,

 

 

Director of Pharmacy Services

Hospital Administrator

 

 

Section 2085.EXHIBIT B  DASA Form 229-2

 

(Physician Letter Head)

 

Chief of Licensing

Illinois Department of Alcoholism and Substance Abuse

300 N. State Street–Suite 1500

Chicago, Illinois 60610

 

Sir:

 

I hereby apply for authorization from the Department to conduct research with Delta-9-Tetrahydrocannabinol under the National Cancer Institute (NCI) approved Protocol I 80-12 "Group C Guidelines for the Use of Delta-9-Tetrahydrocannabinol NSC 134454 for Nausea and Vomiting Induced by Antineoplastic Chemotherapy".  Enclosed is a copy of FDA Form 1573 "Statement of Investigator" which has been submitted to NCI.

 

I agree to limit drug usage to the indications outlined in Group C Guidelines, to ensure that each patient has completed an informed consent form, to report adverse drug reactions immediately to the Department, as well as NCI, and to comply with Federal and State regulations concerning the use of THC.  I will notify the Department if I no longer choose to participate in the research study.

 

Sincerely,

 

			M.D.
Physician's Name
DEA #
Illinois Controlled Substance #
Hospital Name and Address:

 

The above named physician has met the professional qualifications and possesses the requisite professional experience in Cancer Chemotherapy to participate in NCI Protocol I 80-12.  This physician is approved to practice this therapy, under the NCI Protocol I 80-12, at ____________ Hospital.

 

Director of Pharmacy Services

Hospital Administrator

 

 

Section 2085.EXHIBIT C  Special Instructions Covering Research Medication Order Forms for Delta-9-Tetrahydrocannabinol

 

The Department will provide blanks of serially numbered Official Medication Order Forms to authorized registrant hospital pharmacies.  The forms shall be in the following format:

 

A.	HEADING SECTION
	Each order form heading shall contain the following information.
	1.	In the upper left hand corner shall be printed "State of Illinois Department of Alcoholism and Substance Abuse" with the agency telephone number.
	2.	In the upper middle portion, the name, address and zip code of the hospital pharmacy shall be imprinted between the prepunched holes.  Below this, the DEA registration number for the hospital pharmacy should appear. The individual registrant hospital pharmacy is responsible to accomplish that printing, which may be typewritten or stamped.
	3.	In the upper right hand corner, the words "Order Serial Number" shall be imprinted.  This order serial number will serve as a control number and be placed on the hospital pharmacy's dispensing label.
B.	TITLE SECTION
	Order forms shall contain the following information in the Title Section.
	a)	"RESEARCH ORDER FOR DELTA-9-TETRAHYDROCANNABINOL MEDICATION."
	b)	"Valid for ONE bottle of NOT MORE THAN 25 capsules at the above pharmacy ONLY."  This will explain to the patient that this prescription can be filled only at the designated pharmacy indicated at the top of the order form.
	c)	"This order is NOT REFILLABLE."  This will explain to the patient that this medication cannot be refilled and that the patient's physician must issue a new written order each time a patient requires Delta-9-Tetrahydrocannabinol medication.
C.	PHYSICIAN SECTION
	The physician's section shall contain the following information:
	1.	The patient's name.  This will identify the person for which this medication is being prescribed.
	2.	Date.  This date will signify the date on which the order was issued by the physician.
	3.	Patient's address.  This will identify the patient's place of residence and Zip Code.
	4.	Period covered by this order.  This information will provide the time frame in which the Delta-9-Tetrahydrocannabinol medication is to be used by this patient.  Any use of the contents of this medication outside of the specified time periods constitutes unauthorized use.
	5.	Agent.  If the patient is unable to pick up the medication in person, the prescribing physician will designate an alternate, by name, to receive the desired medication for delivery to the patient.
	6.	Delta-9-THC in (Strength) mg. in (Written Quantity) caps.
	.	The strength of Delta-9-THC, whether 2.5 or 5.0 mg., should be designated numerically in the first space.  The quantity of Delta-9-THC capsules should be written out in long hand to ensure that the correct quantity will be dispensed and also to guard against alteration of the designated quantity.
	7.	Sig.  This portion of the medication order form is provided for the physician to instruct the patient as to frequency and quantity of the Delta-9-THC medication to be administered during treatment.
	8.	"PATIENT IS TO RETURN UNUSED MEDICATION."  This is to explain to the patient that unused medication must be returned to the hospital pharmacy for disposal.
	9.	I AFFIRM THAT INFORMED PATIENT CONSENT HAS BEEN OBTAINED.  This statement is included on the form to show patient consent prior to the administration of any medication.  This statement implies that the prescribing physician has informed the patient of all risks and side effects associated with use of this medication, and this statement is attested to by cosignatures of both patient and physician.
	10.	M.D. ILLINOIS CONTROLLED SUBSTANCES NUMBER.  Obtained from the Department of Registration and Education to permit ordering controlled substances.
	11.	M.D. DEA NUMBER.  Obtained from DEA to permit ordering controlled substances.
D.	PHARMACY SECTION
	When an order for Delta-9-Tetrahydrocannabinol has been prepared by a hospital pharmacist for a patient, the dispensing pharmacist must provide the following information on the lower portion of the order form.
	1.	Date filled.  The pharmacist must enter in the appropriate space on the order form the actual date on which the prescription was filled.
	2.	M.D. HOSPITAL AFFILIATION.  The pharmacist must check the list of enrolled physicians and determine that the prescribing physician is eligible to order Delta-9-THC through the hospital.  If so, enter the word "Confirmed" in the space provided.
	3.	RECIPIENT'S SIGNATURE.  The pharmacist must have the person who receives the medication sign for it, whether it is the patient or another designated agent.
	4.	VERIFICATION OF RECIPIENT.  If the person receiving the ordered medication is a person other than the patient, the pharmacist must take steps to ascertain that the individual is the designated agent before releasing the medication.  Identifying information, e.g., address, phone number, drivers license number, may be indicated in this space.
	5.	R.P.H. SIGNATURE.  The dispensing pharmacist must sign the order form.

 

 

Section 2085.EXHIBIT D  Special Instructions Covering Research Medication Labels for Delta-9-Tetrahydrocannabinol Containers

 

SPECIAL INSTRUCTIONS COVERING RESEARCH MEDICATION

LABELS FOR DELTA-9-TETRAHYDROCANNABINOL CONTAINERS

 

HOSPITAL PHARMACY 1234 MAIN STREET ANYWHERE, ILLINOIS
DEA NO. XX 0000000			PHONE NO.  (     ) 000-0000
RO NO:	123-456		PHYSICIAN:
JOHN DOE			DATE: 10-10-80
ONE CAPSULE EVERY SIX HOURS AS NEEDED.
DELTA-9-THC		5MG (#25)
VALID FROM 10-10-80 to 10-20-80			(RPH INITIALS)

 

CAUTION:  FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED.

 

THIS PRESCRIPTION CANNOT BE REFILLED   RETURN UNUSED PORTION TO DISPENSING PHARMACY FOR PROPER DISPOSAL.

 

KEEP OUT OF REACH OF CHILDREN.  IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A PHYSICIAN IMMEDIATELY.

 

Section 2085.EXHIBIT E   Research Order for Delta-9-Tetrahydrocannabinol

 

STATE OF ILLINOIS

ORDER SERIAL

NUMBER

(Name of Hospital)

No.

DANGEROUS DRUGS COMMISSION (312) 822-9860

(Address & ZIP Code)

(Pharmacy DEA Number)

RESEARCH ORDER FOR DELTA -9- TETRAHYDROCANNABINOL Valid for ONE bottle of NOT MORE THAN 25 capsules at above pharmacy ONLY.  ORDER NOT REFILLABLE.

PATIENT'S NAME:

DATE:

PATIENT'S ADDRESS:

ZIP:

PERIOD COVERED BY THIS ORDER:

198

TO

198

AGENT (if applicable):

ORDER:

DELTA-9-THC AT

MGS

AT

CAPSULES,

(Strength)

(Quantity written in longhand)

SIG:

PATIENT IS TO RETURN UNUSED MEDICATION,

I AFFIRM THAT INFORMED PATIENT CONSENT HAS BEEN OBTAINED.

M.D.

(Patient's Signature)

M.D.  ILL CONTROLLED SUBS NO:

M.D. FEDERAL DEA NO:

DATE FILLED:

M.D. HOSPITAL AFFILIATION:

RECIPIENT'S SIGNATURE:

VERIFICATION OF RECIPIENT:

REG PHARMACIST'S SIGNATURE & NUMBER:

DDC FORM 299 (Series October 1980) Retain original in pharmacy; forward duplicate to DDC