Download May 24, 2016 Testimony on HB 523 before the Ohio Senate

OHIO PHARMACISTS ASSOCIATION
2674 Federated Blvd., Columbus, OH 43235 • Phone: (614) 389-3236 • Fax: (614) 389-4582
May 24, 2016
Testimony on HB 523 before the Ohio Senate Government Oversight and Reform Committee
Ernest Boyd, R.Ph., MBA, Executive Director, Ohio Pharmacists Association
Chairman Coley, Vice Chair Seitz, Ranking Member Yuko, and members of the Senate Government
Oversight and Reform Committee; I’m Ernest Boyd, a pharmacist and the Executive Director of the
Ohio Pharmacists Association. We greatly appreciate the opportunity to speak in regards to this
committee’s consideration of HB 523.
The issue of medical marijuana has required myself and our member pharmacists to do quite a bit of
dialogue, reflection, analysis, and soul-searching – just as you have, I’m sure. We can appreciate the
difficult position and pressure the legislature is under to get something done quickly, and believe me
when I say that we understand that achieving perfection on such a difficult issue is not likely.
While it is my understanding that there are some changes that will be made to HB 523, for the
purposes of today’s testimony, I would like to speak to the sub-bill that was adopted last week on
May 17. While our members have serious discomfort and concern about the dispensing of a FDAdesignated Schedule I substance (meaning the drug has a high potential for abuse, has no currently
accepted medical use in treatment in the United States, and has a lack of accepted safety for use), we
feel that sub-bill reflects a serious step in the right direction if the legislature is going to pursue
legalizing medical marijuana in the state of Ohio.
However, as I have heard much dialogue on some likely changes that will be occurring to the bill this
week, I must strongly advise that removing the pharmacist as the gatekeeper, final check, counselor,
OARRS reviewer, and overseer of the dispensing of this unproven drug would be a grave mistake.
When our members and our board discussed this issue over the last few months, the simple response
was basically, “It’s Schedule I substance. The answer is no.” But more recently, as reality was staring
us and the legislature square in the eyes, we realized that if medical marijuana is truly going to be
dispensed to Ohioans, then it is the duty and responsibility of the pharmacist to ensure that it is done
in a safe, effective manner.
What is a safe, effective manner? In our opinion, that means the drug would be prescribed by a
specially trained physician; limited to a specific, refined list of chronic conditions; regulated like other
controlled substances using already-established mechanisms; tracked in Ohio’s Automated Rx
Reporting System (OARRS); monitored and reviewed for quality and effectiveness; limited quantity
allowances; and dispensed, controlled, and managed by a trained, licensed pharmacist.
So why a pharmacist? Why not a dispensary employee – or “bud-tender,” as I’ve been told they are
referred to as?
www.ohiopharmacists.org • [email protected]
Expertise. With 6-8 years of doctorate-level education in chemistry, human anatomy, the unique
composition of medications, how drugs work in the body, proper dosing of drugs, how drugs interact
with other drugs, side effects, and effective utilization of a patient’s entire drug therapy regimen,
there are no health care professionals who are better equipped to manage a patient’s prescribed
treatment plan. Let’s just pretend that “bud-tenders” know everything there is to know about
medical marijuana (which, would be more than the FDA knows). They do not know about how the
drug works with a patient’s disease state, and they certainly don’t know how it interacts with other
drugs. And physicians, while well-trained in diagnoses and setting treatment plans, their training on
drug therapy, side effects, and interactions is very limited when compared to that of pharmacists.
With a drug that has yet to be fully vetted by the FDA for drug interactions and other concerns, all we
have are limited anecdotes and incomplete studies – which coincidentally is similar to the testing
threshold that medical marijuana advocates have in support of the drug’s effectiveness.
Access. Here we are, we haven’t even approved medical marijuana to be distributed yet, and
advocates are already complaining about access. Contrary to what opponents to pharmacists as
dispensers will tell you, Ohio has an abundance of pharmacists who could be employed in a medical
marijuana dispensary. While there are certainly some who will avoid it, we have had several
pharmacists already self-identify as willing to perform the necessary oversight of the drug’s
distribution. Ohio is graduating more pharmacists than ever before. In fact, Ohio has the second
highest number of pharmacy colleges in the country – second only to California. Just this year,
another pharmacy school graduated their inaugural class of 48 new Doctor of Pharmacy recipients.
The job market in Ohio is strong, and I can tell from meeting with hundreds of students across the
state this year, they are eager to stay in Ohio. Further, I have the utmost concern and understanding
for patients and parents who have been forced to obtain medical marijuana through the black
market. The testimony has been incredibly compelling, and I truly identified with the fear and
concerns they had obtaining the product in back alleys and unsafe neighborhoods. Surely, having
those fears alleviated may be worth the cost of driving a few miles to get the product safely.
Safety. More than half of all rehospitalizations are because of medication misuse. It is both our
health care system’s biggest cost driver and our lowest hanging fruit. Medical marijuana may offer
some individuals benefits, but the fact is that it also can worsen symptoms for patients who may be
taking other drugs in conjunction with it. Pharmacists can work with physicians to ensure the drug is
dosed properly based upon a patient’s height, weight, responsiveness to the drug, and other drugs
the patient might be taking.
Cost. Of course, there are some proponents who will say that pharmacists are too expensive. First
off, I find it absurd that cost would be an adequate reason for compromising patient safety. Second,
the results are in – medical marijuana is extremely profitable; in some ways, even more profitable
than pharmacies. Marijuana Business Daily’s 2015 fact book showed that an average sales per square
foot for a recreational marijuana store is $1,773 and $1,143 for a medical marijuana dispensary,
compared to pharmacy, which is $241 per square foot. Additionally, I would argue that the number
of prevented hospitalizations a pharmacist would provide as a result from inappropriate marijuana
consumption would more than make up for their cost. In a system that pays health care providers
increasingly based upon outcomes, medical marijuana dispensaries left unchecked by a health care
professional have a great risk of increasing costs on the system as a whole, while penalizing providers
(hospitals, doctors, nurses, and pharmacists alike) when their patients suffer adverse reactions due to
medical marijuana that is ingested outside of an actual health care professional’s control and
guidance.
Oversight. Part of the job of the pharmacist is to dispense drugs to patients, and part of their job is to
not dispense drugs to patients. Pharmacists know when drug therapy is appropriate and when it isn’t.
“Bud-tenders” do not. Sometimes, the best answer a pharmacist can give is, “no.” Further, if a
patient presents to dispensary with their prescription or recommendation, who will be reviewing
OARRS to ensure that dispensing the drug is warranted and appropriate? The pharmacist not only
does that with all other controlled substances today, but they can be legally trusted with that data.
OPA has serious concerns that there is no final check on this system, and we are vehemently opposed
to having a “bud-tender” with unfettered access to the sensitive patient information contained in
OARRS and the whereabouts of every controlled substance and opioid in the state. Additionally, part
of the benefit of having pharmacists physically in the dispensary is to ensure patients are not being
fed junk science. There are instances when pharmacists catch pharmacy technicians giving patients
advice on treatments or over-the-counter products that they are totally unqualified to give, and they
intervene accordingly. With all due respect to the patients and parents who have seen sincere
benefits from some utilization of these products, these examples are still highly anecdotal, and we
must acknowledge that many of the assertions of the drug’s benefits are unproven and unfounded.
With all I have heard from a number of medical marijuana proponents speaking to all the wizardly,
magical benefits of these products, I would have even greater concern of “bud-tenders” offering
incorrect, outright false, and frankly dangerous council to patients with serious medical conditions
about the supposed healing powers of “Lucky Charms” and “Dankey Doodle.” Inevitably, patients ask
question at the point of sale, and who will be there to ensure that questions are answered and to
ensure that a qualified individual is giving the right information?
I find the push to have “bud-tenders” serve as honorary pharmacists for a substance that hasn’t met
the high standards of the drugs we already dispense to be not only unsafe and ill-advised, but it is
frankly an insult to our profession and the health care system as a whole. In Ohio, this legislature and
our health care professionals do not take scope of practice lightly. While that has been a source of
consternation for us all over the years, I believe Ohioans are ultimately better off because of it.
Allowing the dispensing of an unproven, unapproved drug flies in the face of all that careful work that
this body is known for.
I will remind committee members that just two years ago, we led a difficult but ultimately successful
fight, to expand the immunizations that pharmacists are permitted to administer to a patient.
Pharmacists were already performing the service, however the legislation merely sought to expand
what we were already doing with great results. With some of the opposition we saw from some
organizations and legislators, you would have thought we were asking to perform heart surgeries.
However, with enough discussion, this General Assembly made the right decision to expand
pharmacist’s immunization scope – but not without requiring a prescription in some instances, a
protocol-driven relationship with a physician for each immunizing pharmacist, mandated
communication back to the doctor or the Department of Health, extensive mandated immunization
training, yearly OSHA training, 15 minutes of patient wait time post-immunization, and signed
consent forms to boot – all for approved, mainstream drugs that pharmacists already have extensive
doctorate-level education to provide.
Just in this General Assembly, Governor Kasich signed HB 4, which expanded access to the life-saving
drug naloxone – a medicine that has been around since the 70s. The drug can immediately bring an
overdose victim back to life. While administration puts the patient into immediate withdrawal, the
actual side effects are of no more concern than a couple aspirin tablets. HB 4 aimed to increase
access to the drug by allowing the pharmacist to dispense it without a prescription. Even then, the
pharmacist must enter into a protocol with a physician and then counsel and train the patient prior
to dispensing.
Right now, the Ohio Senate is considering HB 505, which allows pharmacists to substitute FDAapproved “interchangeable biosimilar” medications to patients. The “interchangeability” standard is
even more stringent than a normal FDA approval, and even in the House-passed version of the bill, if
the pharmacist dispenses an interchangeable biosimilar medication to a patient, the pharmacist must
report back to the prescriber on what was dispensed – regardless of whether a substitution was even
made.
This legislature goes to painstaking lengths in these above instances (and many more) to ensure
professional scope of practices are appropriate for all health care professionals, and are ultimately in
the patient’s best interest. The legislature has made it abundantly clear over the last several decades,
that while 6-8 years in pharmacy training is valuable and deserving of increased, incremental
responsibilities, those steps must occur carefully and with adequate checks and balances. Those
same standards should apply when it comes to getting “Banana Kush” and “Maui Waui” into the
hands of the public.
As I understand there is clamoring by some to remove the pharmacist’s role as it is currently crafted
in the working sub-bill, I believe it makes no logical sense to push to have marijuana – a drug that
despite this massive amount of public pressure and demand, still has yet to meet the quality, safety,
and efficacy standards set by the FDA – to be dispensed by a layperson with no formalized, collegiate
medical or pharmacological training whatsoever. I ask you to think about what is ultimately in the
best interest of the patient when deciding whether or not to allow an unqualified, under-educated
“bud-tender” to not only dispense a Schedule I controlled substance, but to do so without any health
care professional to so much as peek through the window to ensure that patients are being
appropriately and adequately counselled on how to correctly take this unapproved drug.
There is an old adage that is used often in these halls: “Let’s walk before we run.” Connecticut, New
York, and Louisiana (just last week) moved forward with their medical marijuana laws that ensure
proper utilization of the pharmacist in the dispensing of the drug. I think you’d all agree that Ohio
usually keeps a more measured pace when compared to those states. The fact is that there is no
good case to eliminate the pharmacist from the medical marijuana equation, unless of course, you
stand to financially benefit from not having to employ one. I implore this committee and the
legislature to maintain the role of the pharmacist in the dispensing of all drugs, because it is
ultimately what is in the best interest of the patient.
Thank you Chairman Coley, Vice Chair Seitz, Ranking Member Yuko, and members of this committee.
Thank you as well to Steven Alexander and Scott Partika for their hard work on this legislation behind
the scenes. I appreciate the opportunity to speak on HB 523 today, and I’d be happy to answer any
questions you may have.