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} --