• Utah Vets for MedC

Differences Between Proposition 2 and the Replacement (“Compromise”) Bill

Our friends at TRUCE have compiled some of the differences between Prop2 and the "Compromise", we've added the full breakdown on our blog because the post is too long for a traditional facebook post.

There are literally hundreds of notable differences between the bills, and at least scores of significant ones. These are a few of the important ones.

Prop 2 - Free Market Based: A private model based on Utah entrepreneurship throughout the processes of private cultivation, production and dispensing. See section 26-60b-301 (1) and many other parts of Prop 2.

Replacement Bill - Mixed Economic Basis: The replacement program is overall far more complex, bureaucratic - and will almost certainly be much more expensive to both the state and patients - than Proposition 2.

The Replacement Bill allows private cultivation and processing, and very limited retail outlets, but also puts the state of Utah directly (and uniquely) into the cannabis dispensing and selling business, creating multiple conflicts with federal law not present in any other state program and raising numerous operational issues [discussed separately below)

Prop 2 - Privately owned and operated cannabis dispensaries: Allows the establishment of up to 20-29 medical cannabis dispensaries very similar in regulation and operation to those operating in nearly all of the states with successful running programs. (The number is based on Utah’s having 29 counties and on allowing dispensaries based on one per 150,000 residents.)

Staff have to meet certain background requirements. Operating costs would be borne by the owners. TRUCE supports establishing higher training requirements and certification for staff. See Prop 2, section 26-60b-304 (b)

Replacement Bill - Medical Cannabis “Pharmacies” -and- a state-run “Central Fill Pharmacy” -and- 13 State Health Department “pickup” points -and- a state run (or state-contracted) secure medical cannabis transport system: Sets up complex frameworks for multiple untried concepts which are expected to work in parallel and seamlessly, while asking the state to operate outside of federal law.

[The Central Fill “Pharmacy,” new State Health Department roles, and the transport system are discussed separately.]

Up to seven privately owned medical cannabis “pharmacies” initially allowed. (These establishments differ significantly from the established definition of pharmacies and may violate Federal Food Drug and Cosmetic Act Section 503A).

Somewhat similar to Prop 2’s dispensaries. Provides (a more limited) range of medical cannabis products, except requiring registered pharmacists who would have to be present during every transaction. This provision necessitates multiple pharmacists on staff to cover lunch breaks, sick leave, vacations, etc., and alone makes operating costs a likely multiple of those in the dispensary model.

Minnesota has used clinical pharmacists (in different roles than in this program, and a specialization not required in the Replacement Bill), and their patient costs (for this and other reasons) are widely considered the highest in the nation in a challenging economic environment for owners.

Adding pharmacists gives the bill some of the “medical trappings” opponents have insisted on - but the actual value for cost and complexity added - and how those roles interface with the roles of recommending doctors - are unclear at best.

Actual pharmacies carry thousands of products and variants, most with serious to lethal possible side effects. Managing this complexity requires the daily application of all of a pharmacist’s training. These “cannabis pharmacies” will have perhaps a few hundred products maximum, none of which have life-threatening side effects and so largely will require only a trivial amount of the main role pharmacies need pharmacists for.

[The legal and clinical aspects of roles specified for doctors and pharmacists re dose recommending, schedules, counseling and patient titration are discussed separately.]

Replacement Bill - Central Fill Pharmacy: Sets up a (highly) complex new state bureaucracy which will put the state in the cannabis dispensing business, and which will also change the operation of the state’s 13 regional Health Departments [discussed separately].

The value of this operation is entirely unclear, since a system for private dispensing is also established, so two parallel (and inevitably overlapping) systems are expected to be set up at once. Why not simply set up additional private retail outlets, especially given all of the novel issues raised and costs incurred?

Utah will be directly dispensing a federally illegal Schedule 1 substance, with questionable protection from the federal amendment allowing other state programs to operate without federal interference - an amendment which currently has to be annually renewed by Congress.

Security, the need for a free-standing operation (because Schedule 1 substances are to be handled and stored there) and other requirements (a pharmacist present during all hours the Central Fill is open, e.g.) ensure that the Central Fill operation and capitalization itself will be costly.

Its ancillary operations (State Health Departments and transport system) will add further significant capital and operating costs, and in our reading we can’t say how medicine will be priced to patients either in terms of the state’s costs, start-up and ongoing - or in comparison to the prices being charged by the private “pharmacies,” nor how the Central Fill will choose which products to purchase from which processors.

Nor do we see clear timelines for how and when all of this will be accomplished.

It’s as if when the state set up the DABC to operate state owned liquor stores - it simultaneously also licensed a number of private liquor stores to open. What possible need is there for both? One possible motivation is the (totally unrealistic) fears raised about a proliferation of “pot shops” supposedly near schools, but neither program promises significantly more than a score of outlets for the entire state. This seems a high price to pay for false security indeed.

Prop 2 - No comparable concept.

Replacement Bill - State Health Department medicine “pickup” points: Medicines ordered by MDs will be “poured” at the Central Fill securely shipped to the state’s 13 regional Health Departments for patient pickup. [Doctors specifying doses and schedules raises issues discussed below]

Dispensing federally illegal substances is an entirely new role for State Health Department offices and raises a host of issues.

TRUCE’s understanding is that Schedule 1 substances (like cannabis) can’t be stored in a facility which handles and stores any other Schedule 2, 3, and 4 substances (most other drugs), so it would seem 13 new secure sites would have to be set up at anunknown (but high) capital and operating costs on an unknown timelines all over Utah. Prop 2’s secure dispensaries are to be set up at operator’s own costs.

Further, all kinds of people (adults, children and infants) are constantly entering and leaving state health department offices, so again, on practical and security groundsalone separate facilities seem called for.

These free-standing facilities would therefore seem to require a host of all new state employees dedicated to running them.

Separate from whether new facilities are (very likely) required are issues of:

-Compliance with civil service work rules and existing job descriptions. -Possible legal jeopardy for these state workers. -Employee and Union rights to object for jeopardy or on conscientious grounds. -Special training required.

-How will cannabis (and cash) be secured on site. -Hiring of new security staff. -Tracking who handles cannabis and cash, who enters and leaves, etc. (unspecified in in the bill from our reading).

Significantly, for a proposal aiming to ensure professional patient counseling, those using pickup points will receive NO counseling - not from pharmacists and not from “budtenders.” This is simply headscratching and absolutely invites adverse events and suboptimal medical outcomes.

Pickup points will involved the state in cash transactions. The bill allows skirting of

federal banking regulations by setting up a provision for debit card (but not credit card) transactions. Patients without debit cards will have to pay in cash and so the health departments will need safes, cash tracking systems and other related security systems just as the private “pharmacies” have.

Delayed patient availability of medicine: Besides the two business day wait in the bill compared to the private “pharmacies,” these pickup points are (to our knowledge) open only five days a week (localities may vary) and closed on state holidays. Two business days plus a weekend plus a holiday create a possible 5 day wait for medicine pickup compared to the private pharmacies. Pain and nausea flareups and unexpected seizure cascades, etc. are no respecters of Pioneer Day, problems the private outlets don’t pose for patients.

They are also not open late (to our knowledge) and many patients may likely still have day jobs and live hours away.

Prop 2 - No comparable concepts or issues.

Replacement Bill - Secure cannabis transport system: Each of the 13 pickup points will have to be supplied from the Central Fill Pharmacy via a secure courier system, either run by the state or contracted by the state.

Current private systems utilize US Department of Transportation licensed commercial drivers and vehicles explicitly prohibited from transporting cannabis. So a system will have to be created publicly or privately at considerable capital cost. It will have to be highly secure as it will be a target for criminals.

Operating costs will also be much to astronomically higher than those incurred by operators of the private pharmacies, as the pharmacies will be purchasing in bulk. The Replacement Bill specifies that orders must be shipped within two business days, so if a pickup point in Blanding needs one or two orders, a vehicle must be dispatched to make a ten hour round trip. The system will be transporting both cash and cannabis.

Again, why not avoid ALL of the Central Fill/Satellite/Transport problems (and lower the cost of medicine) by allowing more privately owned retail outlets instead?

Prop 2 - No comparable concepts or issues.

Prop 2 - Medical Professionals allowed to recommend: Medical professionals who hold DEA Schedule 2 prescribing licenses (other than veterinarians), including Physician Assistants (PAs) and Nurse Practitioners (RPNs) can recommend for diagnosed qualifying conditions.

Limits on numbers of patients for general practitioners and specialists: 20% of patient load for non-specialists, greater for specialists covering particular qualified conditions, e.g., cancer. Doctor/patient relationship required. See (26-60b-107 (1)-(4))

Replacement Bill - Only MDs and DOs (Doctors of Osteopathy) are allowed to recommend. The PAs and RPNs who provide much to most front line medical care especially in dispersed rural areas - who the state officially trusts to prescribe potentially lethal opioids and other powerful, dangerous drugs - are excluded for reasons which make no sense to us other than the drafter’s known fears of both the motives of many prospective patients and the UMA’s possible feelings about the competence and trustworthiness of these dedicated medical professionals.

General practitioners and specialists can recommend for 175 patients. Specialists for covered conditions can recommend for 300 patients. We don’t know typical doctor caseloads, but the percentage model seems preferable to TRUCE. (We would prefer to TRUST physicians and to make the choice of the best medicine a matter between patients and doctors compared to the model in either bill.)

The net effect of who can recommend in the Replacement Bill only creates senseless, arbitrary hardships, further delays and yet more increased costs and hoops to jump through for suffering people compared to the adequate model of Prop 2.

Prop 2 - Forms and Amounts of Medicinal Cannabis Allowed: Along with all the forms allowed in the “replacement bill,” Prop 2 allows for edible forms and (non-blister packed) whole flower (full cannabinoid and terpene spectrum unprocessed cannabis).

All forms will have at a minimum listed amounts of THC and CBD and product weight and seed to sale tracking. Other information about other cannabinoids and terpenes can also be provided. The Replacement Bill specifies other detailed batch and date information, etc. to be included. TRUCE would not object to this being added to Prop 2.

Vaporizable forms and vaporization devices can be offered for sale. Cigarette-likeforms are prohibited, as is smoking.

Unprocessed cannabis: 2 ounces/14 days or an amount (of any cannabis product) containing a maximum of 10 grams of THC.

Just as a doctor can give samples of a prescription medicine to patients, dispensaries can provide product at no cost to patients, either on a compassionate basis or to allow patients to sample different forms and strains. See (26-60b-502)

Unlike the Replacement bill’s focus on exactly replicating the FDA medical model, Prop 2 allows for the established principle of patient participation in establishing the optimal forms and dosing of cannabis medicines.

Disallowing and discouraging this as the Replacement Bill does is clinically contraindicated.

Replacement Bill - Forms and Amounts of Medicinal Cannabis Allowed: Edibles (except plain gelatin cubes) are removed and whole flower is restricted to “individual dose” blister packs (Line 1226, Draft 2).

Forms include: “(A) a tablet; (B) a capsule; (C) a concentrated oil; (D) a liquid suspension; (E) a topical preparation; (F) a transdermal preparation; (G) a sublingual preparation; (H) a cube that is designed for ingestion through chewing or holding in the mouth for slow dissolution” and the blister packs.

There are special provisions “for use only after the individual's qualifying condition has failed to substantially respond to at least two other forms, a resin or wax.” (Lines 1213- 32, Draft 2)

“Pharmacies” are prohibited from providing products that they are allowed to sell at no cost. (Line 2598, Draft 2)

The amounts of medicine allowed to be dispensed by the “pharmacies” follows a complex formula based on the distance between the patient’s residence and the pharmacy, what the recommender specified and other variables. Dosage amounts are roughly comparable to Prop 2, other than exclusion of nearly all edibles. (Lines 2528-52, Draft 2)

From our reading, how this applies to the Central Fill/State Health Department pickup points is less clear.

Edible forms have superior clinical absorption outcomes and increased patient acceptance for some patients and conditions. With the same precautions in homes used for all dangerous and/or addictive medicines including, e.g., Fentanyl Lollipops, there is no reason to deny access to qualified patients. No child-appealing packaging to be allowed under either bill of course.

The blister packs make home preparation of oils and tinctures more labor intensive and may effect the clinical profile by breaking up flowers (cannabinoids and terpenes are volatile and degrade when they’re broken up and exposed to open environments) and detracts from intangible aspects of treatment noted by many patients.

The gelatin cubes as the sole form of edibles don’t serve all patients. Gelatin is made from animal byproducts and so could not be used by vegetarians, Hindus, and members of some other faiths.

Patient acceptance is especially important to child and elderly patients and to those suffering with Alzheimer’s, other dementias, those undergoing chemotherapy and in the advanced stages of cancer, etc.

Vaporization is allowed, but Landlords could evict patients for the presence of vapor where this “would cause the landlord to lose a monetary or licensing-related benefit under federal law.” (Lines 1687-90, Draft 2)

Prop 2 - Patient growing of cannabis: Allows patients holding cards to grow up to six plants -if the state fails to have opened a dispensary within 100 miles of their residence by 2021, andonly as long as they have suitable and suitably located facilities (away from residential areas).

[This provision - while widely misunderstood by both Prop 2 proponents and opponents (in different ways) was always intended as a goad for the state to not “foot drag” on allowing dispensaries to open as projected and it was never anticipated the provision would ever apply to even a handful of patients.]

See (26-60b-201(d)) Replacement Bill - Patient growing of cannabis prohibited.

Prop 2 - Affirmative defense: Beginning when the law is enacted (12/1/18), an individual who would qualify for a medical cannabis card after July 1, 2020 (when cards can be issued) can use qualification as an affirmative defense to criminal charges for use, possession, or manufacture. Burden of proof to a judge that the individual qualifies lies with the individual charged, and officers can make charges if they feel the individual is not in compliance with the provisions defined in Prop 2.

Law enforcement and state agencies are instructed to not expend law enforcement resources on investigating and pressing charges for violations of federal law which appear to be in compliance with the provisions of Prop 2, nor to refer the individuals to federal authorities.

Similar protections are specified for those providing services to dispensaries.

Replacement Bill - Similar provisions, but delayed date of implementation [until when??]

Prop 2 - Dose and Form Selection, Titration, Patient role: Supports patient titration (effective dose testing). Patients will be able to work with dispensary staff on determining the most effective forms, strains and doses of medicine.

This “dose-response determination” is a key principle of cannabis therapeutics which differs from the model for FDA-vetted synthetic drugs. Safe experimentation is made possible by cannabis’ non-toxic nature. Typically cannabis patients are urged to “start low and go slow” in terms of increasing their dose until they achieve the optimal clinical effect.

There are over 100 cannabinoids and also many scores of terpene mixes in natural cannabis, and growers/processors are continually developing strains (or “cultivars”) with different blends of these which have a virtually infinite number of distinct clinical profiles even though a few cannabinoids and terpene blends are more common.

This is not “laxity” and there is nothing “recreational” about it, rather it’s central to the effective practice of cannabis medicine. It’s also a huge benefit as single molecule pharmaceutical drugs

offer no such flexibility and nor the ability to tailor variants and amounts to patient conditions and physiologies.

Note: Patients and physicians (and truth be told patients on their own) do variations of (on and off label) dose titration millions of times a day in America for their prescription drugs.

Replacement Bill - Aspects of recommending, ordering, Doctor vs Pharmacist role and federal law: In addition to the above, there are aspects of the replacement bill we feel either get needlessly “out in the (legal) weeds” or which are ill-considered.

Having either physicians or pharmacists specify, i.e., “order” exact amounts, products, dosing schedules and durations is not only not clinically inferior in the case of cannabis medicine, but edges perilously close to “prescribing,” and bringing these professionals into issues which might effect their certifications and doctor’s prescribing privileges. We would prefer the recommending model specified in Prop 2 and used in a score of states for the professionals and the patients’ sakes.

The situation for patients who would have to use the State Health Department pickup points from the Central Fill pharmacy strikes us as the most senseless part of the entire Replacement Bill with its layers of cost, complexity and delay which end up providing no counseling to patients and which guarantees a greater frequency of adverse events with inferior patient results. We feel it will also end up with patients feeling stigmatized even if legal.

Also, we haven’t exhaustively analyzed every line of text about their roles, and who recommends and how the two professions interact and how much counseling is given to patients. E.g., we feel that at the current state of training for all involved, the much (by opponents) derided “budtenders” may generally be more experienced in helping patients optimize doses at a much higher “bang for bucks” quotient, although we support more training for all professions involved, and if the (cost effective) budtenders are to be retained (Prop 2 model), we would support requiring a fairly extensive certification program, with ongoing continuing education requirements. Such programs do exist and could be customized for Utah. If the name rankles, rename the (certified) budtenders as Medical Cannabis Dispensary Assistants (MCAD’s) or some such.

Finally and frankly, we simply don’t see the value added by hiring a hugely expensive flotilla of pharmacists, given the duties outlined in the Replacement Bill. We could see the state establishing an office with perhaps one to three consulting clinical pharmacists as a resource for dispensaries, which we feel would achieve 90% of the clinical benefit sought at a small fraction of the cost.

Replacement Bill - Negative aspects of higher cost, harder to get medicines compared to Prop 2: One of the “unintended consequences” of the Replacement Bill will almost certainly be how it interacts with the current illegal market.

Under Prop 2, TRUCE estimates that market will either shrink significantly or at least not grow once the system of dispensaries is up and running. If patients can relatively conveniently access equal or even slightly higher cost legal medicine without breaking the law, most will gladly do so to be able to come out in the open and not risk jobs, custody, housing, etc.

Under the Replacement Bill with all of the costs outlined above, the cost of state-legal medicines is likely to up to a multiple of those already available, and they are likely to be both harder to get

and take (much longer) to obtain, plus they won’t include many popular and medically efficacious products readily available elsewhere, e.g., most edibles.

That is, we feel this complex program will take much longer to stand up - and - we’ve documented the delays from order to fill time in the Central model, so two kinds of program delays. Some will still have reasons to buy these, but many (perhaps most) will continue to source them where they’re available now.

Further, the fact that medical cannabis is in fact now legal will greatly increase demand, so the result is very likely to be growth and perhaps explosive growth in the smuggling from legal states and of illicit, criminally produced and untested products.

This in turn will inevitably increase diversion to youth, i.e., the very outcome the Replacement Bill’s drafters say they most want to avoid.

But in fact, the bill’s approach amounts to the state cutting off its nose to spite its face.

Download TRUCE Utah's compleate analysis

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