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What Should Recommending Physicians & Dispensaries Advise Women of Child-bearing Age about the Risks of Using Marijuana During Pregnancy

Arizona regulations require that recommending physicians and dispensaries advise qualifying patients about any risks associated with the use of medical marijuana. So, as a clinician and a potential dispensary medical director, the question of what to advise female patients of child bearing age about the risk to the fetus, if any, of using marijuana during pregnancy is of real concern. The answer isn’t simple.

In Canada, qualifying patients may be legally prescribed a drug named Sativex, which contains THC (tetrahydrocannabinol) and CBD (cannabidiol), the two primary active ingredients in marijuana. One of the most respected and authoritative medical textbooks is “Harrison’s Textbook of Medicine.” In discussing THC and CBD in its digital edition, “Harrison’s Practice,” it states:

“Cannabinoids have been associated with reproductive toxicity. Animal studies indicate possible effects on fetal development and spermatogenesis. USE IN PREGNANCY IS CONTRAINDICATED. (Emphasis added.) Women of childbearing potential and males who are capable of causing pregnancy should use a reliable form of contraception for the duration of treatment and for 3 months following discontinuation.”

With respect to lactation, “Harrison’s Practice” states that THC and CBD enter breast milk and is thus contraindicated as well.

However, on the Sativex website, this contraindication of taking THC and CBD during pregnancy is not so blanket. It states that taking the drug during pregnancy is contraindicated “unless the potential risks to the fetus and/or embryo are considered to be outweighed by the benefit of treatment.”

But the foregoing contraindications and cautions are based primarily on animal studies, and many experts believe the risk of marijuana to the fetus is actually quite low based on human studies. In “Marijuana Myths, Marijuana Facts” by Morgan and Zimmer, it states that experts now agree that marijuana does not cause birth defects and, at worst, may be associated with slightly lower birth weights.

Indeed, most human studies have not found an increase in the risk for birth defects among babies exposed to marijuana while in the womb. In one study of 1246 women who reported occasional marijuana use during pregnancy, the frequency of birth defects was not elevated. A few studies have reported a very small increase in the risk for gastroschiasia, a rare defect in which the infant is born with intestines outside of the abdomen. There have been inconclusive studies that heavy use of marijuana during pregnancy may cause developmental brain problems in children exposed in utero.

So, what is a physician to advise female patients who are or may become pregnant? In my opinion, it would be advisable to exercise caution and follow the warning on the Sativex website, i.e. that marijuana should not be used during pregnancy unless any potential effects to the fetus are outweighed by the benefit of treatment. And with respect to women who are breast feeding, marijuana should definitely not be used.

Jason E. Gittman, MD, FCCP
jgittman@medlawconsults.com
http://www.medlawconsults.com

By |2011-05-05T09:51:39-07:00May 5th, 2011|Stories & Articles|Comments Off on What Should Recommending Physicians & Dispensaries Advise Women of Child-bearing Age about the Risks of Using Marijuana During Pregnancy

DHS Prohibits Medical Directors from Issuing Certificates to Any Patients

As regular readers of this blog may recall, I recently posted an article entitled “Can the Medical Director of an Arizona Medical Marijuana Dispensary also Write Certifications for Qualifying Patients?  Good Question.”  Well, I spoke with Don Herrington, Asst. Director of ADHS, today and. according to him, the answer is NO.

At issue was the changed language of R9-17-313.E in the final rules which seemed to indicate that a medical director could write certifications for qualifying patients as long as the patient did not obtain the marijuana from the dispensary with which the director was associated:

“A medical director for a dispensary shall not provide a written certification for medical marijuana for a qualifying patient obtaining medical marijuana from the dispensary.”

While Mr. Herrington acknowledged that the wording in the foregoing rule might well be interpreted to allow medical directors to write certifications, he informed me that it was still DHS’s intention that medical directors not do so for any patients no matter which dispensary they used.  Apparently DHS is concerned about a conflict of interest occurring, the logic of which escapes me.  He said that DHS may publish a clarification of the rule before the end of the year.

Mr. Herrington did add that physicians who eventually become dispensary medical directors may write certifications up until the time when their medical directorship becomes active, which is presumably when the dispensary opens its doors for business.

In my opinion, this rule is unfair to both medical directors and their patients.  Medical directorships are part time positions, and many, if not most, medical directors are also involved in direct patient care.  This rule, as interpreted by DHS, deprives medical directors who are also clinicians from writing certifications for their patients who have conditions which may benefit from medical marijuana.  It would also require the patients of medical directors in private practice who qualify for medical marijuana to go elsewhere for written certifications.

Jason E. Gittman, MD, FCCP
http://www.medlawconsults.com/

jgittman@medlawconsults.com

 

By |2011-04-07T17:00:25-07:00April 7th, 2011|Medical Directors|1 Comment

Can a the Medical Director of an Arizona Medical Marijuana Dispensary also Write Certifications for Qualifying Patients? Good Question

As an experienced MD clinician who is a strong believer in the right of patients to obtain medical marijuana if it may provide relief for their specific medical condition, I was  interested in serving as a medical director for a non-profit that will be successful in obtaining a license to operate a dispensary from DHS later this year.  In addition, I was also looking forward to be able to write certifications for qualifying patients.  However, the language set forth in R9-17-312.E in the second (1/31) draft rules explicitly prohibited a medical director from providing certifications to any qualifying patients:

“A medical director shall not establish a physician-patient relationship or provide a  written certification for medical marijuana for a qualifying patient.”

I suppose DHS felt there might be a conflict of interest if a medical director also provided certifications to patients.  Perhaps the agency was concerned that a director might be tempted to act unprofessionally and provide a certification to an unqualified patient in order to drum up business for the dispensary for which he or she was associated – a very unlikely scenario.

So, you can imagine my delight when I read the final rules that seemed to do away with this unnecessary prohibition.  The corresponding rule, R9-17-313.E, no longer states that a medical director cannot have a physician-patient relationship nor provide certifications for any patients qualifying for marijuana as in the prior draft.  The current rule appears to just prohibit the medical director from writing certifications for qualifying patients who would obtain marijuana from “the dispensary” for which he or she serves as director:

“A medical director for a dispensary shall not provide a written certification for medical marijuana for a qualifying patient obtaining medical marijuana from the dispensary”

But my delight soon turned to confusion when I read this specific answer to one of the FAQ’s on the DHS website:

“What will a dispensary’s medical director do? The duties of a dispensary’s medical director include developing information and training for dispensary agents and customers. A medical director is not permitted by the rules to provide written certifications for medical marijuana.”

Any reasonable interpretation of R-9-17-313.E would conclude that the phrase “the dispensary” means the dispensary for which the medical director works.  For the FAQ to be accurate, the phrase “the dispensary” in the rule would have to mean any dispensary in Arizona.  If, indeed, this were the intention of DHS, then why would it change the language in the second draft rule which was so clear about such a prohibition and left no room for interpretation?

Clearly, this is a matter that needs to be clarified for those physicians, like myself, who would like to serve as a dispensary medical director and also provide written certifications for qualifying patients.

Jason E. Gittman, MD
http://www.medlawconsults.com/

jgittman@medlawconsults.com

By |2011-04-01T18:17:56-07:00April 1st, 2011|Medical Directors|Comments Off on Can a the Medical Director of an Arizona Medical Marijuana Dispensary also Write Certifications for Qualifying Patients? Good Question