As medical marijuana becomes a more popular option for patients seeking treatment for a variety of illnesses, and as some states struggle to effectively track their product, questions regarding cannabis regulation are starting to increase.
Track-and-trace is a hot topic in the pharmaceutical industry, made all the more urgent as the next phase of deadlines for the Drug Supply Chain Security Act (DSCSA) quickly approach.
Dr. Moe Afaneh, pharmacist and COO of BioTrackTHC, a full-vertical seed-to-sale cannabis tracking company, told Pharmaceutical Processing that while in most states, the cannabis industry has stricter regulations than the traditional pharmaceutical industry, technically there are no federal requirements for how a medical marijuana business must operate.
Afaneh said that while the cannabis supply chain itself does not differ much from state to state where it’s legal—the product is grown, processed, broken down into byproducts, transported, and then sold from a dispensary—there is significant variation in how businesses track and report on the supply chain to their respective governing agencies.
For instance, although labeling of products is required, the information on these labels remains highly customizable and any specific mandatory information will differ from state to state.
Afaneh did, however, say that in general, there often must be strain information, business information, license numbers, potency, dosage size, and other identifying markers. He adds that a barcode/tracking ID that can be scanned typically is required, something those in the pharma industry should be familiar with.
When asked if the medical cannabis industry faces similar regulatory pressures as the traditional pharma industry, particularly in light of DSCSA, Afaneh mentioned the Cole Memo, saying that it’s the closest thing the industry has seen to a federally regulated structure.
Credit: BioTrackTHC
The Obama-era Cole Memo, which was rescinded by the Department of Justice in January 2018, stated that as long as states enlist strict tracking and regulatory frameworks to ensure their state-approved cannabis programs are not creating a nuisance, the federal government would not interfere.
Afaneh said many in the industry still consider the Cole Memo to be the standard expectation, adding that, as with other pharmaceuticals, medical cannabis products must be validated.
“All products are required to pass a QA laboratory test by a state-licensed lab,” Afaneh said. “The QA and lab results can only be input by a third party lab. That way, it takes the testing out of the hands of the businesses who could potentially benefit from altering test results and puts it in the hands of a non-beneficiary party.”
When speaking about contamination of cannabis, it typically means something different than when referring to traditional pharma products, according to Afaneh who explained, “[Cannabis] contamination is usually the result of moldy product, disallowed pesticides, packaging complications, or expiration dates.”
However, just like traditional drugs, cannabis is a target for theft and diversion along the supply chain. Furthermore, because there is a lack of consistent track-and-trace guidelines, marijuana businesses have been known to report false information regarding inventory and sales. In Oregon, for example, federal and state officials have serious concerns about marijuana being diverted into the black market.
In a July news release, Oregon health officials stated, “The [diversion] issues have heightened the risk for medical marijuana to be diverted from patients, who rely on cannabis to treat medical conditions.” The release also claims, “Reporting and tracking of growers and cannabis has been inadequate and inaccurate, and monthly compliance has been historically low, ranging between 26 percent and 42 percent during 2017.”
Afaneh said that states like Oregon are struggling to identify the proper number of grows to supply the proper number of dispensaries.
“This is why in states like Oregon we’re seeing a significant oversupply of grown cannabis and retailers are driving down prices due to a surplus of supply,” he said. “In other states, there’s a surplus of retail dispensaries and a shortage of grows, which enables the growers to hold all of the power and drive up prices due to increased demand and a shortage in sellable wholesale product. In either event, the disproportionate supply and demand causes problems for supply chain sustainability.”
Credit: BioTrackTHC
At present, communication between the medicinal marijuana industry and the pharmaceutical industry is present only in some states—New York and Connecticut, for example, require a licensed pharmacist on site to consult on and dispense cannabis products. Additionally, in those states, dispensaries are required to report via ASAP reporting—just like traditional pharmacies—as well as check their state prescription monitoring program (PMP) before dispensing, which Afaneh claimed creates an interconnected network between the industries.
Because cannabis reporting mirrors pharmacy reporting in those two states, Afaneh believes the information being submitted essentially lays the groundwork for insurance reimbursements because it provides the required information an insurance company would need to cover a patient’s access to medical marijuana.
In other states, however, pharmacists can lose their licenses for recommending cannabis as a treatment option. “Overall,” Afaneh said, “[the industries] stay separate, but everyone knows that pharma is just awaiting a federal change of some sort before they’re willing to go all in.”
The medical marijuana industry is new and, as with any new industry, there is a great deal of learning and evolving. Afaneh believes that the U.S. will continue to improve the regulatory framework surrounding cannabis and the expectation of the businesses involved, and increased regulatory requirements moving forward can be expected.
Medical cannabis and traditional pharmaceutical products are not truly the same. Contamination and diversion have different consequences that vary in severity and risk. The two industries face different manufacturing and supply challenges. They are regulated and prescribed differently.
However, the one thing many believe they have in common, at least for now, is that patients depend on them, and because of this, it is crucial that both industries can deliver their products safely, reliably, and efficiently to the end user.
BioTrackTHC, founded in 2010, provides commercial business tracking, government traceability, and oversight services to the regulated cannabis industry. Afaneh, a pharmacist and executive with 15 years of business experience, has helped the company launch customized medical cannabis software for application within the various regulatory frameworks.
