Subject: marinol

Marinol is a synthetically made drug containing THC, the
active ingredient in marijuana.  THC is used mainly to suppress
nausea in cancer patients during chemotherapy, or in AIDS 
patients during AZT therapy.  Marinol is distributed as a pill.

When a patient is throwing up, it can be difficult for them to
take a pill and hold it down long enough for it to take effect.  
Dermal patches have been suggested, but they are no good against 
sudden attacks because they take to long to start working.

When a person smokes marijuana, they can control how much and
how fast the drug enters their system.  This is called
`autotitration' and is much more difficult with pills

Marinol is an expensive chemical to manufacture.  An extract
of marijuana can be isomerized resulting in a high-THC tincture
which will do the same job much less expensively.  Of course,
the makers of Marinol would not be able to make that much
money from this, because you cannot patent a plant.

Another factor is the so-called `munchies.'  Many people 
claim that marijuana can actually stimulate the appetite.
Nobody has said the same for Marinol.  Marijuana contains
many other chemicals besides THC.  Perhaps one or many of
these are responsible for this effect.  However the `munchies'
have not been verified by scientific experiment.

----------------------------
The following concerns Marinol and workplace drug testing...
   

MRO ALERT 
Vol IV No.4 

April/May 1993
 
FDA Approves THC for AIDS Patients  

		First MRO Case Report
 
In March of 1993, the Food and 
Drug Administration approved the use of synthetic 
delta-9tetrahydrocannabinol (THC) for use in the management 
of anorexia and nausea associated with Acquired 
Immunodeficiency Syndrome (AIDS)[It was actually December 
1992.]. Soon thereafter, MRO ALERT received the first 
report from an MRO who had a marijuana positive with this 
as the alternative medical explanation (see case report at 
end).
 
The chemical name for the synthetic preparation of 
THC is dronabinol. It is available under the trade name 
Marinol (registered trademark of Roxane Laboratories). 
Marinol is a Schedule II compound, which is formulated in 
2.5 mg, 5 mg or 10 mg gelatin capsules for oral 
administration. The use of Marinol will result in a 
positive confirmed THC urine drug test result. There is 
little pharmacokinetics data and detection time-dose 
information at this time. It is reasonable to assume that 
detection time would be a few days after a single oral 
dose.
 
The MRO should be aware that the package insert for 
Marinol warns that, because of the drug's profound effects 
on the mental status, patients should be warned not to 
drive, operate complex machinery or engage in activity 
requiring sound judgment and unimpaired coordination. 
Therefore, the MRO should determine whether the person who 
is taking Marinol has a safety sensitive position. [It is 
my clinical experience that behavioral tolerance takes 
place fairly rapidly. MRO ALERT makes assumptions that are 
based on the PDR write-up that overemphasizes 
psychological effects.]
 
In the DOT program, the MRO 
should notify the employer that the individual presents a 
safety risk and should be placed on medical leave. In light 
of the psychoactive nature of the drug and lack of 
tolerance to these effects, the use of Marinol should 
disqualify the individual from safety related 
transportation activities while taking the prescribed drug. 
[It would be more appropriate for an individualized or a 
case-by-case review. The same concerns were articulated 
when methadone maintenance began.]
 
Employers should also 
recognize that the employee has a covered disability under 
the ADA. Therefore, there is an obligation to make 
reasonable accommodations, such as in the case where 
driving is only a small part of the individual's job. If, 
on the other hand, the job is solely driving, the 
individual would not be qualified while on Marinol.
 
With 
a valid prescription, the MRO should report the test result 
as a negative. The illicit use of marijuana as an adjunct 
to AZT is not uncommon. The use of the marijuana plant is 
still unauthorized (and illegal), and not a legitimate 
alternative medical explanation under federal programs.
 

The strong antiemetic effects of synthetic marijuana has 
been utilized especially against nausea and vomiting caused 
by cancer chemotherapeutic agents. It is recommended that 
the drug only be used when other antiemetic agents have 
failed. This restriction is required because a substantial 
proportion of patients treated with Marinol experience 
disturbing psychotomimetic reactions. [Not substantiated by 
my clinical experience. What is your documentation?]
 
THC has been available in the United States for oral use an 
antiemetic in teaching hospitals and cancer centers under 
special arrangements with the federal government. [Use is 
restricted within schedule II that is idiosyncratic to 
Marinol.] In addition, many states have authorized the use 
of marijuana and/or oral THC by any physician for treatment 
of nausea related to chemotherapy.
 
There is a very 
limited use of THC for management of glaucoma.[An off-label 
use that is technically not allowed] These few cases have 
been permitted to use marijuana by court order. Other users 
are considered to be in violation of the controlled 
substance act. The unapproved use of the drug does not 
constitute an alternative medical explanation. [The DEA has 
represented to the FDA that it has not been prosecuting 
physicians for legitimate "off label" uses.]
 
CASE REPORT: MARIJUANA VERIFIED NEGATIVE
 
The case report was presented 
by Robert J. Bugarin, M.D., an AAMRO certified MRO at 
Substance Abuse Management, Inc. in Milwaukee, Wisconsin.
 

	TYPE OF TEST:   Pre-Employment Assessment, 
Non-DOT
	POSITION APPLYING FOR:  Clerical
	CHAIN OF 
CUSTODY:        Intact
	NIDA LABORATORY:        Smith Kline
	SCREENING 
CUTOFF: 100 ng/ml
	CONFIRMATION CUTOFF:    15 
ng/ml
	QUANTIFICATION LEVEL:   64 ng/ml
	LABORATORY 
COMMENT:        Creatinine less than 200 mg/l;
		Specific gravity 
less than 1.003.
 
MEDICAL REVIEW OFFICER FINDINGS VIA 
TELEPHONE INTERVIEW:
 
1) Proper identification of donor a) 
Last Name b) Social Security number c) Date of birth 2) 
Position applying for: Clerical 3) Medical History
 
The 
donor is HIV (+) since spring of 1991. Medical care 
consists of AZT and other medications not provided by donor 
during interview. Donor was prescribed Marinol 
(delta-9-tetrahydrocannabinol, THC) for treatment of severe 
nausea and vomiting secondary to AZT and other 
medications.
 
Donor denied use of cocaine, heroin, 
amphetamines or phencyclidine.
 
Donor denied history of 
chemical dependency, alcoholism or rehabilitative 
treatments.
 
Donor denied medical care for cancer and 
chemotherapy.
 
Regulatory and Procedural Update
 
 

Treating physician provided written documentation of 
medical care for donor: Marinol 2.5 mg BID.
 
Pharmacy 
provided written documentation of prescription for Marinol 
issued before test date.
 
MRO verified test as negative 
based upon medical supervision and authorization of Marinol 
use as supported by appropriate documentation.
 
Test was 
reported as negative.  The information regarding the 
donor's positive HIV status has been kept in confidence.
 

This case history represents my first verified negative 
marijuana case as a certified Medical
Review Officer. With 
the growing number of HIV positive individuals, the medical 
use of
Marinol (THC) has interfaced with urine drug 
testing.
 
The Americans with Disabilities Act (ADA) 
mandates that urine drug testing is not considered a 
medical test. The issue of confidentiality for the donor, 
in this case who is HIV-positive and on Marinol, does not 
represent a "safety-sensitive risk" while performing 
clerical duties and therefore, was not disclosed to the 
employer.
 
With the application of Marinol for medical 
treatment, illustrated by this isolated case, the number of 
verified negative marijuana drug tests could well increase. 
Submitted by Robert J. Bugarin, M.D.
 
[The clinical and 
medicolegal inaccuracies in the article needs further 
review to be useful. It would have been more appropriate to 
present the topic in a more cautious and scientific manner. 
It is difficult to believe that more pharmacokinetic data 
was not available in this most exhaustively studied drug.]
 

Tod H. Mikuriya, M.D. Certified Medical Review 
Officer
June 4, 1993
{PAGE|3}
 
 


 
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