Stakeholders and regulators remain at odds over how medicinal marijuana will be distributed in the Florida starting Jan. 1.
Department of Health officials are reading the measure signed into law in June as authorizing just five dispensary organizations with one retail outlet each. They proposed that a distribution “infrastructure” requirement can be met with a “transportation plan” for deliveries.
“It’s a nightmare,” said Jeff Sharkey of the Medical Marijuana Business Association. “This particular part of the rules is totally inefficient and unworkable.”
Pharmacists say they had no input in development of the rule. The law authorizing doctors to order a cannabis extract for patients created dispensing organizations then exempted them from the Pharmacy Practice Act, which regulates pharmacists.
Now, however, DOH is being encouraged to pull pharmacists into the process before issuing a final draft of proposed regulations.
“These products were approved for medical purposes. They are going to be used by very sickly patients and you can’t look at this in a medical vacuum,” said Sean Schwinghammer of Surf Med, a Hialeah pharmacy and home medical supply company.
“Pharmacies need to be involved; (they) are the best at reviewing drug interactions, working with patients, consulting with doctors. They do it every day,” Schwinghammer testified during the Aug. 1 hearing on proposed rules.
At least two other states have incorporated pharmacies in their medicinal marijuana distribution plans. The Connecticut program is the first in the country based on a pharmaceutical/medical model. Last November, a Michigan law passed which would allow patients to purchase medical marijuana from a licensed pharmacy if the federal government reclassifies the drug as Schedule II.
“We should at least have a seat at the table to help guide the discussion process on this,” said Michael Jackson, the CEO for the Florida Pharmacy Association. “We’re looking at a product that is being allowed to be used in the state to treat certain diseases and we’re specifically trained to be involved with patient care and treatment of diseases that this product is to treat.”
Jackson said the Association’s members discussed the law during a July conference and are trying to figure out how to participate in the discussion.
“If you are talking about a dispensing organization you probably should have an expert at the table to help answer questions about the appropriate way of doing this,” said Jackson.
DOH appears to be standing by its decision to satisfy the law’s distribution infrastructure requirement by having a home delivery plan submitted in the license application. At two public hearings DOH official have said the law restricts handling of the product to only the dispensary organization and the patient.
It is possible for a nursery to have a pharmacy as part of the entity that applies for a license but it is not clear why a pharmacy would participate if it cannot distribute the product.
What is left is a distribution infrastructure with one retail location and a home delivery system; a scenario critics say is neither convenient, simple nor safe.
“Totally unworkable; it doesn’t work for the patients nor the dispenser,” said Sharkey about the option of either having patients drive hours to a rural location or a 20-year in a Toyota delivering medicinal marijuana statewide.
“What is missing is that when the kid shows up at the door,’ he’s a courier. He’s not going to be able to answer any questions,” said Sharkey. “I’m not pushing pharmacies but with pharmacists you can ask about drug interactions. They’ll tell you how it works. That whole piece is missing here.”