By Peter Pitts
August 10, 2018 at 5:00 am ET
One of the positive side effects of the opioid crisis is a renewed (and long overdue) focus on new ways to advance pain management.
One therapy, cannabis, has long been discussed as a legitimate therapeutic alternative — but has been caught up in the debate over its nonmedical uses, along with its cousin, hemp-derived cannabidiol. Regardless of where you may stand on these issues, we are moving forward. The times they are a-changing. And, as with many advances in health care policy, states are presenting themselves as the laboratories of invention.
In New York, for example, cannabis is now a legal alternative to opioids. The policy, announced July 12, is a result of emergency regulations filed by New York State Health Commissioner Howard Zucker. Per Zucker, medical cannabis “has been shown to be an effective treatment for pain that may also reduce the chance of opioid dependence” and that offering providers treatment options other than opioids “is a critical step in combating the deadly opioid epidemic affecting people across the state.”
The new policy allows patients who have been prescribed opioids to request cannabis as an alternative treatment and adds several new qualifying conditions. The broadened scope of conditions will now cover patients with severe pain that is not classified as “chronic,” and also includes a provision allowing patients with opioid use disorder to use medical cannabis if they are enrolled in a certified treatment program. As part of the new program, patients and caregivers will receive ID cards that can be used along with a government-issued photo ID at registered dispensing facilities.
In addition to the new disease indications, the regulations are designed to increase certifying authority to nurse practitioners and physician assistants and allows for the approval of five additional organizations to manufacture and dispense. Home delivery will also be permitted.
While the emergency regulations are temporary, the New York State Department of Health has filed to adopt them permanently. Currently, cannabis is legally used by more than 62,000 patients via about 1,700 registered practitioners in the existing New York program. Health officials anticipate a reduction in opioid use and dependence, as well as a significant boost to state coffers, with legal cannabis sales expected to reach between $50 million and $70 million in 2018 (up from $20 million last year).
But it’s important to understand that there’s no benefit without some risk — and using cannabis for pain management and other disease mitigation isn’t risk-free. Some key issues include:
No current standard in quality or production
There are few guidelines when it comes to how cannabis plants must be raised for dispensaries that sell the drug to patients. Each plant could be vastly different from another grower’s plants, which in turn means that the buds will likely have very different levels of tetrahydrocannabinol or CBD. A joint rolled from one plant will provide a different intensity of a high than another plant, and there is no monitoring of the patient’s use of the drug to ensure that they are finding the right type of plant for their needs.
No dosing standard
When patients are prescribed any other type of medication, they are given a dosing schedule by the doctor telling them how much to take, how to take it and how often. When people are prescribed cannabis, they get a card that allows them to access dispensaries that sell the drug. They are not given any guidelines about how they should take it or in what amounts — something that would never happen with any other medication.
Potential for help and harm through chronic use
Chronic smoke inhalation and overdose on edibles are just two of the risks of chronic use of cannabis that we know about. Use of the drug legally for medicinal or recreational purposes has not been studied heavily, so we don’t know the extent of the harm that can come to those who take the drug for long periods of time and/or in large amounts. The California, Colorado and Nevada experience hasn’t yet impacted rates of use/abuse. Watch this space.
Easier access = increased cannabis abuse
When it becomes easier for people to get cannabis, it means that they use more and have more in their homes. This in turn means that those who don’t have medical cannabis cards — including teens and young adults — have increased access to the drug and may be more inclined to use and abuse it, developing a drug dependency when they may not have otherwise.
Legalization changes public opinion of harm potential
As more and more states legalize cannabis for medicinal — or recreational — purposes, it gives the impression to those who don’t take the time to do the research that all doses of cannabinoids are harmless. In fact, for all drugs prescribed by a doctor, even prescription pills that are highly addictive such as OxyContin and Percodan, the prevailing attitude is that the doctor’s OK makes them safe to use in any way or combination. Many don’t realize that a doctor’s prescription comes with guidelines for usage that must be followed for maximum safety and that since cannabis rarely even comes with this assistance, it is very important “proper use” is supported by education and technology.
More options are better — but as the saying goes, if you can’t measure it, then it doesn’t count. Broadening cannabis’ legal bona fides for pain treatment isn’t the end of the debate; it is only the beginning. Now we must develop ways to measure its effectiveness and develop ways to capture the real-world evidence that must drive evolving best medical practice and reimbursement policies.
In the immortal words of Gen. George C. Marshall: “When a thing is done, it’s done. Don’t look back. Look forward to your next objective.”
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and chief regulatory officer at Adherent Health LLC.
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