The state health department released its first draft of medical-marijuana rules late Thursday, providing a glimpse at how the program may work in Arizona.
The rules spell out who may qualify for medical marijuana, establish operating criteria for dispensaries and provide strict guidelines for doctors who may recommend marijuana.
Read the draft rules Send your opinion on rules to the state
The release kicks off a three-week public-comment period, but the Arizona Department of Health Services will have final say on how to implement a medical-marijuana program in the state.
In November, voters passed Proposition 203, which will allow qualifying patients with certain debilitating medical conditions to receive up to 2?1/2 ounces of marijuana every two weeks from dispensaries or cultivate up to 12 marijuana plants if they live 25 miles or farther from a dispensary.
The state health department must finish drafting the rules by April 13. The agency will then review applications from people who want to use medical marijuana or operate a dispensary. The program should be fully functioning by summer 2011, when dispensaries have had time to grow the plants.
ADHS Director Will Humble said the department had two goals: Make the rules strict enough to prohibit people who don’t have serious medical conditions from abusing the system without impeding patients’ access to marijuana, and ensure that medical experts are deeply involved in the process of patients obtaining and using marijuana.
“I’m taking this seriously that this is the medical-marijuana act, not the recreational-marijuana act,” Humble said.
The rules cover everything from the definition of “current photograph” for identification cards to the number of hand-washing sinks a dispensary must have.
ADHS officials spent the past four weeks writing the 47-page draft, which is available on the department’s website.
Staffers researched other states’ medical-marijuana rules and reviewed rules for other state programs.
But because the medical-marijuana program is unlike any other existing program, officials used their creativity and their personal experience of crafting other state protocol, said Tom Salow, acting manager of administrative counsel and rules at ADHS.
Doctor involvement
According to Prop. 203, qualified patients or their designated caregivers could get a doctor’s recommendation to receive medical marijuana.
Doctors must certify in writing that their patient likely will benefit from using marijuana as a medicine to treat his or her debilitating disease. these conditions include cancer, HIV/AIDS, hepatitis C and multiple sclerosis.
Marijuana is not a federally-approved medicine. But department officials drafted rules so that doctors would oversee the program and be held accountable for patients’ access to marijuana, Humble said.
Here are some key proposals related to physician involvement in the program:
-?Requires a medical director.
ADHS wants all dispensaries to hire a medical director who will be on-call or on-site at the facility.
Medical directors would make sure patients or their caregivers document changes in their symptoms and track their marijuana usage. They also would ensure dispensaries provide educational materials, such as how to administer marijuana safely, signs of substance abuse or dependency, and possible side effects.
Medical directors would not be allowed to write medical-marijuana recommendations for patients.
-?Defines physician-patient relationship.
The department wants to require doctors to have an ongoing physician-patient relationship before they recommend marijuana.
That means the patient would need to have seen the doctor for at least one year and had at least four visits for the debilitating condition, or the doctor assumes primary responsibility for managing the patient’s debilitating condition and for providing routine care.
-?Specifies “severe and chronic pain.”
Medical-marijuana opponents have expressed concern that Prop. 203 lists “severe and chronic pain” as a symptom that would qualify a patient to receive medical-marijuana recommendations.
The department’s proposal specifies the patient must have severe and chronic pain as a result of a chronic or debilitating disease or its treatment.
-?Holds physicians accountable.
Physicians will be the “gatekeepers” of Arizona’s medical-marijuana program, Humble said. The department wants physicians to thoroughly assess the risks and benefits of their patient’s marijuana use and make sure only patients who truly need marijuana for medical use have access to it.
The department’s proposal does not require doctors to provide proof, such as MRIs and X-rays to prove chronic pain, in addition to their medical-marijuana recommendations. this means the rules “put the onus on the physician to practice ethical procedures,” said Laura Nelson, ADHS chief medical officer.
Regulating system
Even before Election Day, entrepreneurs looking to cash in on the state’s medical-marijuana industry had been preparing to open non-profit dispensaries.
Prop. 203 caps the number of dispensaries in the state: only one dispensary is allowed for every 10 pharmacies.
The department’s rules do not specify how it will review and approve dispensary applications, but officials expect to decide on a process by the time they begin accepting applications.
The rules are designed to provide oversight on dispensaries. Requirements include:
-?The department will require an electronic security system that consists of panic buttons and video surveillance that ADHS can access and monitor at any time.
-?Dispensary applicants must provide a slew of documents and records, including security policies; floor plans drawn to scale locating each hand-washing sink, panic button and video camera; a business plan that details the dispensary’s ongoing viability; and even whether a dispensary board member has any unpaid court-ordered child support.
-?A dispensary must grow at least 70 percent of the marijuana it provides patients. It may not acquire from or sell to other dispensaries more than 30 percent of its marijuana.
-?Dispensaries also must follow specific guidelines for inventory control. a dispensary agent must document at the beginning and end of each day how much marijuana the dispensary acquires, harvests, sells, disposes of and disburses. Among other requirements, the agent must specify the date and method of disposal, date and amount of harvested pot, and the estimated amount of marijuana infused in edible products.
Looking forward
The public-comment period ends Jan. 7. The department will release a new draft of the rules Jan. 31 and hold public meetings mid-February.
Prop. 203 requires the department to develop an electronic data and verification system to keep track of patient and dispensary information. Law-enforcement and dispensary agents must be able to access this system at any time.
The department will focus on developing this system starting next week.
Salow said he hopes a wide variety of people submit their opinions, especially those who opposed Prop. 203. he said department officials will read and review every comment.
Humble said he is open to changing any part of the initial draft, as long as the suggestion fits under the department’s goals for the program.
“We’re not going to change our goal, period, no matter what anyone comments. Our overall goal is to make this a medical-marijuana law. so whatever comments that we get in have to fit within that framework,” Humble said.