Posts Tagged ‘medical marijuana’

Dispensary Drawing Procedures Report Published

August 31st, 2012

We carefully planned our processes for randomly selecting medical marijuana registration certificates in competitive districts to make sure the process was fair and transparent.  Part of our planning included contracting with Henry & Horne, LLP to independently observe the entire process.  The contract included a requirement to develop a final report documenting their observations.  The final report, entitled Independent Accountants’ Report on Applying Agreed-upon Procedures was submitted this week and has been posted on our dispensary website

All of the written materials related to the August 7 drawings are now posted and available on our website, including the Random Selection Agenda; Random Selection Eligible Application Report; Random Selection Protocol; Random Selection Protocol Selection Video; Dispensary Certificate Allocation Results; and the new Henry & Horne CPAs Report on Applying Agreed-Upon Drawing Procedures

Have a safe Labor Day weekend.

New “Home-Grown” ITS Programs

August 28th, 2012

Team ITS delivered and deployed 2 more new web modules for the Medical Marijuana application this week: the 1) dispensary agent processing module; and 2) a new version of the Verification System which more efficiently facilitates card verification for law enforcement officers and employers in real time. 

Thanks much to everyone who assisted in the development of these modules. From ITS, special “Thanks” to Dimiter Pekin (Project Manager), Jennifer Tweedy & Team, Contractors - Cleavon Blair and Roger Stepper, Michael Conklin, Loretta Jackson and Lloyd Kalicki. Thanks again to the Program Administration and Management for providing ITS with necessary support, cooperation and great ideas as needed!  The team is currently working on the following modules that are scheduled to go-live soon including the “point of sale” application which will be able to track dispensary sales in real-time, and a dispensary inspection module.

 

Dispensary Selection Results

August 7th, 2012

For about four hours this morning, balls were hopping in the bingo machine as we randomly chose one dispensary for each of the 68 competitive districts.  All the drawings are online for you to watch – there were 404 applications considered in the 68 drawings.  There were also 29 CHAAs where there was only one eligible applicant.  There were two CHAAs that we did not select today because of pending court action.  There were also 27 areas where no applications were made – making up the 126 areas in the state. 

The results are posted- you’ll notice that only the dispensary application number is on the list; that’s because of the confidentiality clause in the Medical Marijuana Act.  

The successful applicants will be notified by mail and need to fill out some more paperwork to get the certificates.  I talked about that last week.  We anticipate sending some certificates out this month depending on how quickly the applicants respond.

One Day at a Time

August 6th, 2012

The AZ Attorney General issued an Opinion and a media release this afternoon about the Arizona Medical Marijuana Act.  The Opinion states, in part, that the voter approved Act is pre-empted by Federal Law – specifically the part that allows the cultivation, selling or distribution of marijuana.  It references 2 recent court cases that states cannot ‘authorize’ actions that are forbidden under federal law.

Today’s Opinion is just that, an Attorney General Opinion…  not a court order, and a court (or courts) may or may not agree.  Attorney General Horne has said in his media release today that he expects that there will be a motion for accelerated resolution of this issue in a pending court case.

The AGs Office also advised us this afternoon that today’s Opinion doesn’t prevent us from proceeding with tomorrow’s planned lottery on Tuesday, August 7, and the issuance of Registration Certificates- so we’ll be proceeding tomorrow as planned at 9 a.m.  I’m not sure how or whether today’s Opinion will impact the issuance of subsequent Operating Licenses for the folks that are allocated a Registration Certificate tomorrow morning. 

 So, at least for now, we’ll take it one day at a time.

Registration Certificate Selection Tuesday

August 3rd, 2012

Next Tuesday (August 7) is “Selection Tuesday” for our medical marijuana dispensary applicants.  By the end of the day, we’ll have whittled the initial pool of 486 medical marijuana dispensary applications down to 99.  We won’t be allocating the full allotment of 126 Registration Certificates on Tuesday because 27 of our Community Health Analysis Areas had no applicant at all- leaving 99 Community Health Analysis Areas with at least 1 applicant.  About 75 of the 99 had 2 or more applicants- so we’ll have about 75 drawings on Tuesday.  We’ll post an updated summary of how many eligible applications there are by district on our website before the drawing.

We’ll be using a device that blows pre-labeled ping pong type balls inside of a clear cage to randomly select the successful applicant in each competitive area.  We’ll go CHAA by CHAA starting at #1 and continuing through #126.  The agenda for the day is posted on our website (the first selection will begin at 9 am and we’ll finish around 1 pm).  Applicants will be e-mailed the number of their ball(s) in advance…  and all applicants will be notified of the selection results electronically by Wednesday.  The successful applicants will receive their Registration Certificate after they complete their required Dispensary Agent paperwork.

The process will be webcast live on this internet URL and the entire event will be recorded and posted on the ADHS dispensary website.  Because of the large number of applicants and the limited capacity of our facility, credentialed media, a few Agency staff and our independent auditors will be the only folks that’ll be invited to the selection location.  The Act doesn’t allow us to identify the applicants by name or even business name- so we’ll use application numbers to identify the successful applicants.  We’ll also post a table of the successful applicants (by application number) on our dispensary website by the close of business on Tuesday.

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 and cultivation facility (if it’s in the business plan) 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

Dispensary Application Update

July 23rd, 2012

Most of the applicants for medical marijuana registration certificates have been able to correct deficiencies in their applications…  and 460 of the 486 applications we received are now complete.  Five applications have been withdrawn, 3 have been denied, 15 are pending, and 3 are on the clock to respond to requests for additional information.  

The complete applications are currently being evaluated to determine which will be eligible and move on to the random selection process on August 7th.  At least 25 applications will be allocated certificates without going through the random selection process because they’re the only application in their district (CHAA).  We’ll be providing more information about the August 7th agenda in the next couple of weeks.  We’ll probably be issuing 95-99 dispensary registration certificates in about 3 weeks.

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 1PTSD 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.

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.

Medical Condition Petition Status

July 6th, 2012

The AZ Medical Marijuana Act requires us to periodically accept petitions to add new medical conditions to the list of conditions that qualify folks for an AZ Medical Marijuana Registration Card.  In January, we accepted petitions from the public and had a public hearing in May.  Folks submitted numerous articles as a part their petitions for PTSD 1PTSD 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 contracted with the U of A to review published scientific studies related to marijuana use and the petitioned conditions.  You can see the UA analyses for Depression; Generalized Anxiety Disorder; Migraine Headaches; and Post Traumatic Stress Disorder (PTSD) on our petition website.  Our ADHS medical team will be meeting within the next week or so and will be providing me with their analysis and recommendations.  The ultimate decision rests with me,  the Director, and I have a decision deadline in late July.

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.