Download Testimony on HB 523 Dear Chairperson Coley and committee

Testimony on HB 523
Dear Chairperson Coley and committee members,
My name is Chet Kaczor, and I am a pharmacist here in Columbus. Thank you for the opportunity to
provide testimony regarding HB 523, which aims to legalize medical marijuana in the State of Ohio.
Marijuana (cannabis sativa) may have efficacy in the treatment of some diseases, yet remains a schedule
I controlled substance in the United States. While I am the Director of Pharmacy Services at Nationwide
Children’s Hospital, as well as the current president of the Ohio Pharmacists Association, I give this
testimony on behalf of myself as a medical professional and do not necessarily represent the opinions of
the organization for which I work.
Because of the lack of an FDA-approved product, illicit use of marijuana for medical purposes is likely
occurring in the State of Ohio. I commend you as legislators for identifying a potential need in the
community and considering legislation to resolve this gap. However, I strongly urge caution as to if and
how this is implemented and encourage you to educate yourself as much as possible to make an
informed decision. Essentially, enacting this legislation is acting in a role similar to the Food and Drug
Administration (FDA) when it considers whether or not to approve a new drug. The issue here is that
there is a relative paucity of high quality, placebo-controlled, randomized clinical trials assessing clinical
response, and there is no guarantee that the amount of active drug(s) are the same from one lot to
another or one manufacturer to another. Furthermore, marijuana is a complex combination of
pharmacologically active compounds, which definitely classify it as a drug/drugs. For these and the
below reasons, I have major reservations about this proposal, and I strongly oppose any effort to divorce
the drug’s dispensation from a licensed pharmacist.
Make no mistake, marijuana is a drug. Marijuana contains more than 60 pharmacologically active
compounds, called cannabinoids, and binds at cannabinoid receptors which results in physiologic
response depending on potency of the formulation and amounts of active ingredients. There are two
known cannabinoid receptors, CB1 and CB2. CB1 is found in the central nervous system and inhibits the
release of numerous neurotransmitters (brain chemicals) including norepinephrine and gamma amino
butyric acid (GABA). CB2 is found in immune system tissues and may regulate immune and
inflammatory response/reaction. Delta-9-tetrahydrocannabinol (THC) is the primary active compound
that produces euphoric effects.
Marijuana, primarily THC, pharmacokinetics (how the drug is absorbed, distributed, metabolized or
broken down, and eliminated) and pharmacodynamics (what the drug does to the body) somewhat
depend on the route of administration. Inhaled marijuana onset of action is nearly immediate, with
peak effects around 30 minutes and duration of action around four hours. Ingested marijuana has a
delayed onset of action, between 30 minutes and a few hours, but may last for up to 12 hours.
The liver metabolizes (breaks down) marijuana, primarily through the cytochrome P450 system, through
CYP2C9 and CYP3A4. THC crosses the placenta and accumulates in breast milk. Breast milk
concentrations can be as high as eight times maternal plasma concentrations. As for elimination of
marijuana, it is mostly eliminated through feces and urine, but takes about 24-36 hours to eliminate half
of the drug, so several days to eliminate the drug entirely.
So what does all this mean to healthcare professionals? This drug must be clinically reviewed and
handled just as any other pharmacologically active FDA-approved medication is considered. There may
be drug-drug interactions with other CNS depressants such as gabapentin (Neurontin) and many others
which can cause respiratory depression. There are known drug-drug interactions with any drug that is
significantly metabolized by CYP2C9 or CYP3A4. For example, posaconazole, a drug used to treat fungal
infections, may increase the concentrations of THC, which could lead to toxicities or increased side
effects depending on marijuana dose.
In terms of toxicity, ingested marijuana presents a significant risk because of the duration of action (how
long it stays in the body). Clinical presentation of toxicity in the pediatric population can include
lethargy, inability to speak, random motor activity (limbs flailing), respiratory depression, or coma. In
adults, tachycardia or racing heartbeat, high blood pressure, agitation, and rarely heart attack.
States that decriminalize marijuana have seen an increase in the number of children requiring
hospitalization or emergency room visits. A study conducted in Colorado assessed the proportion of
ingestion visits in patients younger than 12 years and found that they increased from 0 before
legalization to 790 visits afterward. Eight patients required admission to the hospital and two were
admitted to the intensive care unit. Another study found a 30% annual increase in calls regarding
pediatric marijuana exposures to poison control centers in States that decriminalized marijuana. This is
why dispensing medical marijuana should require pharmacist oversight, just as pharmacists are required
to conduct prospective drug utilization review for other medications. Pharmacists can help educate the
public about the benefits, side effects, and dangers of marijuana use and accidental ingestions.
Finally, using OARRS to track medical marijuana is a good idea, if healthcare professionals are the only
ones able to access and review/submit data. There is a massive amount of Protected Health
Information (PHI) which should not be accessed by anyone who does not have a legitimate medical
purpose for doing so. There will likely be large liability risks and HIPAA PHI exposure issues if nonmedical professionals are given access to such a database. It is clear that the drug should be tracked in
OARRS, and the pharmacist is the only viable professional to perform this function in the dispensary.
For these reasons, I stress caution in decriminalizing medical marijuana in the State of Ohio, and want to
state my firm opposition to any proposal that would remove the pharmacist from their needed role in
dispensing the drug. And, once an FDA-approved drug exists for treatment indications, medical
marijuana should no longer be permitted to be used either. This is a drug which requires proper study
and approval by FDA. It also requires that healthcare professionals including physicians and pharmacists
evaluate appropriateness of therapy and dose, drug-drug and drug-disease state interactions, and
adherence to therapy. Pharmacists need to educate patients regarding the risks and benefits of use,
side effects, adverse effects, and much more.
Thank you for the opportunity to share my thoughts on HB 523.
Respectfully Submitted,
Chet Kaczor, PharmD, MBA
Director, Pharmacy Services
Nationwide Children’s Hospital
President, Ohio Pharmacists Association
References:
1. Medical Marijuana. Up-to-date – accessed online. 5/23/2016.
http://www.uptodate.com/contents/search
2. Wang GS, Roosevelt G, Heard K. Pediatric marijuana exposures in a medical marijuana state.
JAMA Pediatr 2013; 167:630.
3. Wang GS, Roosevelt G, Le Lait MC, et al. Association of unintentional pediatric exposures with
decriminalization of marijuana in the United States. Ann Emerg Med 2014; 63:684.