Posts Tagged ‘cannabis’

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Dispensary Zoning Case

December 13th, 2012

Last week a Superior Court judge ordered Maricopa County to process the zoning paperwork that has been submitted by the applicant for the Sun City CHAA.  The Maricopa County Attorney asked for a Stay of the decision while he appealed the case to the Court of Appeals.  This morning, the Superior Court judge denied that request for a Stay.  There’s still an appeal pathway for the Maricopa County Attorney if he asks for a Stay of the decision from the Appellate court while the pre-emption arguments are made at the Appellate level.  For our part- we did not take a position at today’s hearing… and we will simply continue to wait for the applicant in the Sun City CHAA to turn in its zoning paperwork, which would complete the application.  At that point we would process it the same as the other 98.

By the way- AZ now has 3 operating dispensaries, one in Glendale and one in Tucson.  Another dispensary in Cochise County opened today.  Because of the 3 operating dispensaries and provision in the voter approved language that only people that live more than 25 miles away from a dispensary are authorized to cultivate, more than 70% of Arizonans now live in areas where self-cultivation will no longer be permitted.  However, we’re grandfathering the cultivation rights for current card-holders until they renew their card or move into an area that’s within 25 miles of a dispensary.

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Dispensary Court Ruling

December 4th, 2012

  

A Superior Court judge ruled today in the dispensary case concerning the applicant in the Sun City CHAA.  The judge ordered the county to begin processing the required zoning paperwork.  This was the only application for this area,  so the next step for the applicant is to submit to us a completed application including  the zoning paperwork from the county.   The Department will process this application the same as the other 98 applications.

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Glendale Dispensary Opening Postponed

November 19th, 2012

Last Thursday I announced in a blog post that our team had just returned from a field inspection for a dispensary applicant in Glendale, that there were no major deficiencies, and that we had awarded the dispensary an “Approval to Operate”.   Today the Applicant asked for a short delay in the effective date for their Operating License in order to ensure that things run smoothly when they officially begin operations.  Our team approved a delay in their license’s effective date this afternoon.  

Once the new dispensary begins its operations, we will no longer be approving “requests to cultivate” among new (and renewing) cardholders in most of the metro area… because self-grow (12 plants) is only allowed when the patient lives more than 25 miles from the nearest operating dispensary according to the law.  The vast majority of the Valley is within 25 miles of this new (but not yet operating) dispensary. 

As an FYI…  once a dispensary is operating, it is required by our rules to be “…  operating and available to dispense medical marijuana to qualifying patients and designated caregivers at least 30 hours weekly between the hours of 7:00 a.m. and 10:00 p.m.”

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First Dispensary

November 15th, 2012

Our team just returned from a field inspection for a dispensary applicant in Glendale.  There were no major deficiencies, and we awarded the dispensary an “approval to operate” late this afternoon.  This is the first dispensary approval to operate we’ve issued in the State.  By law, we’re not allowed to publicly disclose the address. 

The fact that a dispensary is now licensed in the Valley also means that the “self-grow” part of the law will change on Friday.  Beginning tomorrow we’ll be declining new “requests to cultivate” among new cardholders in most of the metro area…  because self-grow (12 plants) is only allowed when the patient lives more than 25 miles from the nearest dispensary.  The vast majority of the Valley is within 25 miles of this new dispensary.   

We’re also adding a new feature to our website to help people figure out if they live within 25 miles of a dispensary.  Because of the changes to the system, we’ just took the it offline.  We’ll work on it over the weekend and most of the application process should be up and running on Monday.

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Breastfeeding & Cannabis

September 4th, 2012

Some AZ health care providers and parents have asked questions about whether medical marijuana is safe for use while breastfeeding.  The short answer is no, because the active chemical in marijuana is passed to the baby through breast milk. For this reason, most experts, including the American Academy of Pediatrics and the CDC advise moms not to use marijuana (medical or not) while breastfeeding.   

Tetrahydrocannabinol (the psychoactive ingredient in Cannabis) stays in the body for four to six weeks.  It’s found in the urine of breastfeeding babies whose mothers use marijuana. It’s also fat soluble, which means it builds up with chronic use and can be stored in fat tissue for months. We also know that babies are much more vulnerable than adults to illness, infection, chemicals, and so on. That alone is a good reason to avoid marijuana and anything else potentially harmful that can enter your baby’s body through your milk.  

The Academy of Breastfeeding Medicine has a protocol that you can use to make breastfeeding decisions.  For more information about the effects of marijuana and other medications, go to the National Libraries of Medicine’s LactMed database. For answers to this and other breastfeeding questions, call the ADHS 24-hour breastfeeding hotline at 1-800-833-4642. 

Of course- all sorts of prescription and over-the-counter medicines are also transferred to infants in breast milk- but pediatricians are more familiar with which medicines are safe to take while breastfeeding because they’re tested by the FDA- and most medicine labels discuss breastfeeding.

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M2 Petition Decision

July 19th, 2012

The voter approved list of conditions that already qualify patients for an AZ Medical Marijuana Registration Card (with a doctor’s certification) includes any of the following: any chronic or debilitating disease or medical condition (or its treatment) that causes severe and chronic pain, severe nausea, severe and persistent muscle spasms, wasting, or seizures, cancer, glaucoma, HIV, Hepatitis C, ALS, Crohn’s disease, agitation of Alzheimer’s disease.  The AZ Medical Marijuana Act also requires us to periodically accept petitions to permanently add new medical conditions to the list of conditions that qualify folks for a card.  

We accepted petitions from the public to add new medical conditions back in January.  Folks submitted numerous articles as a part their petitions for PTSD 1; PTSD 2; Depression; Migraines; and Generalized Anxiety Disorder.  We also received lots of informal comments regarding adding PTSD; Depression; Migraines; Generalized Anxiety Disorder and General comments.  We also heard in person testimony from dozens of folks at our public hearing in May.

Because my guiding principle for making the decision was to use science and research, we contracted with the U of A College of Public Health to do an evidence review of published scientific studies to help us to make a more informed decision.  You can see the UA’s analyses for Depression; Generalized Anxiety Disorder; Migraine Headaches; and Post Traumatic Stress Disorder (PTSD) on our petition website.   The UA used the GRADE methodology to evaluate the quality of the studies looking at the benefits and harms of using Cannabis to treat or provide relief for the conditions that were petitioned to add to the list of qualifying conditions for a Medical Marijuana Registration card.  Also, our ADHS Medical Advisory Committee reviewed and analyzed the data and provided me with recommendations earlier this week.

We heard and received a host of moving stories from the public both on-line and during our a public hearing in May.  Many of the commenters and folks that testified self-reported that they believe Cannabis provided relief for the petitioned conditions.  However, our literature review found limited scientific evidence to document whether Cannabis is helpful or not for the petitioned conditions or that support permanently adding the petitioned conditions to the statutory list of qualifying debilitating conditions identified in the Act.  In short- I didn’t approve the petitions because of the lack of published data regarding the risks and benefits of using Cannabis to treat or provide relief for the petitioned conditions. 

However, some of the petitioned conditions (such as migraine headaches) already qualify patients for a medical marijuana registration card if they cause severe and chronic pain, severe nausea, severe and persistent muscle spasms, wasting, or seizures.

Whatever you think of the decision, just know that our team and I really took an objective and close look at the scientific evidence before making this decision.  And remember, the Act provides for a judicial review of this decision and a continuing petition process.  In fact, we’ll be accepting petitions again next week.

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GRADEing Studies & Evidence

July 19th, 2012

As I mentioned in my previous post, scientific studies (e.g. experimental v. observational design) have different strengths and weaknesses. Sources of evidence range from case reports at the lower end to well-designed large randomized experimental clinical studies that minimize bias.  Relying on poor quality evidence can lead to policy decisions that aren’t in patients’ best interests- and it’s super important to figure out the actual “weight of evidence” that published studies provide- so public health can make good evidence-based decisions. 

That’s where the Grading of Recommendations Assessment, Development and Evaluation- or GRADE system comes in.  The GRADE system was developed to provide researchers and policy makers a systematic way of grading the strength of studies to help policy makers in medicine and public health to interpret studies and make better decisions.  The GRADE system has all kinds of applications.  For example, the U of A used the GRADE methodology to evaluate the quality of the studies looking at the benefits and harms of using Cannabis to treat the conditions that were petitioned to add to the list of qualifying conditions for a medical marijuana card.

You can read alot more about the GRADE system and how it works in this article in the British Medical Journal (unfortunately you need to pay to read the whole thing).

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The Scientific Literature Gradient

July 18th, 2012

Medicine and public health have relied on peer-reviewed published scientific literature to help guide progress in patient treatment and public health interventions for decades- even centuries. For example, when we did the fact-finding to inform our decision about whether to add the petitioned conditions to the list of disorders that qualify for AZ medical marijuana cards- we (and the UA) turned to the scientific literature. Within the scientific literature- there are different categories of research designs that each have their strengths and weaknesses. 

Studies to assess the effectiveness of an intervention (like whether Cannabis is an effective treatment for depression) can have an Experimental or Observational design. For example, a randomized and controlled experimental study selects participants at random and places them in the intervention or control group and then follows up on the subjects over time to assess any differences in outcomes. Experimental studies generally provide the highest quality and most reliable results. 

An Observational study isn’t really experimental- rather, it’s a study that looks at natural variation regarding an intervention (or exposure) and looks at differences in outcomes among people or populations. Controlled observational studies can look at before and after conditions. For example, a cohort observational study can look at populations prospectively, retrospectively, or as part of a time series. Observational studies can also be of case-control or cross-sectional design. Observational studies can also simply look at a series of cases and look at interventions and outcomes without a control group. 

In general, the highest quality studies use the experimental approach and include a randomized design. Studies in the category can be very high quality if there is little bias and confounders are identified and controlled for… and if the study is large. Observational studies are generally of lower quality- although they can be quite useful if they limit bias, are consistent, direct, and control for confounding factors. The lowest quality study is what’s called a case series with no controls. Often, case series studies are simply observations made by clinicians- but without control groups… and they usually don’t control for confounders or bias.

 Anyway- you get the idea… scientific studies are absolutely critical to helping the public health system design interventions, make policy decisions, and measure results. Published scientific literature allows us to use science to inform our policy decisions and interventions in an objective way- increasing the likelihood that the public health system makes a positive impact in people’s lives.  Understanding what makes a published scientific study strong and compelling is critical to sorting through the published scientific literature for the types of strong studies that make for solid foundations for policy and intervention decisions. 

My post tomorrow will summarize ways to evaluate the quality and reliability of various kinds of studies.

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M2 Contracts On Deck

June 23rd, 2012

We have a couple of new projects in the works to ensure that the dispensary system reflects a medical rather than a recreational system.  We’re working with Arizona’s pharmacy/poison control systems to put together a contract to provide technical assistance and educational materials to the future dispensary medical directors.  We’re also putting together a contract to hire a vendor to help us ensure that the future dispensaries are truly “non-profit”.  The  contractor will be reviewing the required dispensary audited financial statements to make sure they’re on the up-and-up in terms of truly being “non-profit”.  For example- (among other things) the contractor will be looking for evidence that dispensaries are getting “fair value” for goods, services, salaries, and reimbursements- to make sure that they don’t use a shell game to over-pay for things or services as a way of moving assets out of the dispensary.  Stay tuned.

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Selection Tuesday

June 21st, 2012

Overall, we ended up receiving 486 medical marijuana dispensary applications among our 126 Community Health Analysis Areas (CHAAs).  Twenty-seven of the CHAAs had no applicant at all- leaving 99 Community Health Analysis Areas with at least 1 applicant.  Seventy-five of the 99 had more than 1 applicant.  Assuming that each of these end up being complete, we’ll need to randomly select successful applicants in 75 of the CHAAs (we’ll be posting an updated summary of how many complete applications there are by CHAA in a few weeks).  Here’s how it’ll work for the competitive CHAAs on Selection Tuesday (August 7):  

We’ll be using a device that blows balls inside of a clear cage to randomly select the successful applicant in each CHAA.  Applicants will be assigned a random code in advance…  and the person with the code that matches the ball that blows into the chamber will be allocated a Registration Certificate.  We’ll repeat this process for each of the competitive CHAAs.  The process will be webcast live on a URL that we identify a few days before August 7.  The Act doesn’t allow us to identify the successful applicants by name or even business name publicly- so the live announcement will be made using the code that only the applicants will have.  Each applicant will receive their unique identifier electronically so they’ll know whether they won their CHAA drawing via the webcast.  The Certificates will be mailed later that day. 

Everybody that’s allocated a Dispensary Registration Certificate will have a little less than a year to build out and get an “Approval to Operate”.  Keep in mind that an application for Approval to Operate a dispensary is not complete until we get a written notice that the dispensary is ready for an inspection and they meet our criteria.  Our team recently put together some tools to help Registration Certificate holders meet our Approval to Operate criteria, including an Approval to Operate Application Checklist, Approval to Operate Application Instructions, and the Dispensary Inspection Checklist.

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