Tuesday, July 12, 2011

Pharmacists’ Role in Medical Marijuana Remains a Bit Hazy

ASHP House of Delegates vote may yield more direction

by Charlotte Huff
As more states legalize marijuana, pharmacists and other clinicians are left somewhat stranded on the front lines, trying to navigate a path between conflicting legal requirements and effectively treating their patients.

Fifteen states and the District of Columbia have approved medical usage of marijuana and at least a dozen more are considering various stages of legislation, according to the Marijuana Policy Project, a Washington, D.C.-based lobbying organization. Meanwhile, pharmacists say they are facing more questions than answers. Among their concerns: what to do if a hospital patient brings in marijuana; what about medication reconciliation and potential clinical interactions; and how to verify the safety of the product itself.

“In some ways this is an instance where the legality has gotten ahead of how we know how to use it,” said Cynthia Reilly, RPh, director of the Practice Development Division at the American Society of Health-System Pharmacists (ASHP). “There are so many unknowns, but clinicians are being faced with patients who are using it.”

This month, ASHP’s House of Delegates is scheduled to vote on a medical marijuana policy during the group’s Summer Meeting. The policy was developed in response to a request last year by a New Jersey delegate. It talks primarily about the need for more research and standardization of the drug itself, and is part of a broader effort by the professional association to educate members about legal and clinical issues related to medical marijuana.
ASHP officials also plan to hold an educational webinar this fall to reach as many members as feasible, Ms. Reilly said. Pharmacists want to look out for their patients’ safety, she said.

“Regardless of whether it’s legal, they do feel an obligation to at least be able to advise their patients.”

Pharmacists find themselves working in a gray area between what state laws have legalized and the inherent limitations of federal law. Marijuana is classified as a Schedule I controlled substance under the federal Controlled Substances Act, which means there is no federally recognized use and all possession and distribution is criminalized. Pharmacists “can’t dispense it or handle it or have anything to do with it,” said Tom Van Hassel, RPh, MPA, director of pharmacy at Yuma Regional Medical Center in Yuma, Ariz.

This spring, Arizona residents began applying for medical marijuana cards, and clinicians began to weigh the “what ifs,” Mr. Van Hassel said. “So if a patient comes in and the doctor has given them an order for [medical marijuana], how do we get it? Do they bring in their own?”
One likely scenario, Mr. Van Hassel said, is the case of a cancer patient who has been prescribed marijuana to cope with chemotherapy-related nausea. “Let’s say he wants to smoke his marijuana cigarette prior to or [while] receiving his chemo. What exactly are we supposed to do in that situation?”

Providing Guidance
In its policy recommendation, ASHP officials laid out the legal issues involved with medical marijuana, stating that it opposed pharmacists or health care facilities being involved in any way with the procurement, storage, preparation or distribution of medical marijuana. But the policy, which could be amended even if it’s approved this month, stated that more assistance is needed to resolve clinical safety questions. Among the organization’s recommendations are the following:
Develop processes that could provide standardized marijuana to facilitate research efforts.
Encourage the Drug Enforcement Administration to eliminate barriers prohibiting marijuana research, including a review of its status as a Schedule I controlled substance.
Foster educational efforts to help pharmacists answer questions about therapeutic and legal issues related to medical marijuana use.

Russ Lazzaro, MS, RPh, the New Jersey delegate who at last year’s meeting requested adding medical marijuana as a new business item, said that he doesn’t disagree with the organization’s stance. Mr. Lazzaro, who has since taken a job as a pharmacy manager at NewYork-Presbyterian Hospital, was at that point practicing in New Jersey, where medical marijuana legislation was passed in January 2010.

Still, the call for more research doesn’t help pharmacists who worry about medical marijuana users who walk in today, Mr. Lazzaro said. “What are we actually going to do when patients bring in their own? It still leaves us in a legal quandary.”

By April, Arizona’s board of pharmacy had already fielded two pharmacist questions, both expressing a related concern. “If a patient comes into our hospital with medical marijuana that is legally prescribed, are we allowed to [keep] it in our vault in the pharmacy with the other home medications that we store?” wrote one. In response, the pharmacy board referred the pharmacist to a state rule, which details when a patient can bring an at-home medication into the hospital. One of the requirements is that the pharmacist or medical practitioner be able to identify the drug. “If I was the hospital, I wouldn’t allow it to be used, because I couldn’t identify it,” said Hal Wand, RPh, MBA, executive director at the Arizona State Board of Pharmacy.
Mr. Wand said the marijuana could be sent home with the patient’s family member or caregiver, but stressed that he was only expressing a personal opinion. “Each medical staff and P&T [pharmacy and therapeutics] committee is going to make their own decision on this.”

Practice Uncertainties
Among the states that have legalized marijuana for medical use, there’s considerable variability regarding specifics, including whether at-home cultivation is permitted, as well as which medical conditions are covered. Nearly all of the states require the user to carry an identification card. For more state-by-state specifics, the Marijuana Policy Project provides an online chart. (Scan 2-D bar code on this page to access.)

In Arizona, which began taking applications in mid-April, hospitals can verify if a patient is legally authorized to use the drug, Mr. Van Hassel said. The names of all cardholders are submitted to the state’s prescription drug monitoring program, he said.
But other problems might crop up, he said. For one thing, Yuma Regional is a nonsmoking facility, so where does prescribed marijuana fit in? Plus, there’s the quality and safety issue, given the variability in marijuana products. How can the safety and potency of the product be verified?

There also are potential security headaches, Mr. Van Hassel said. Medical marijuana will have to be stored in a locked vault somewhere. Otherwise, the patient could potentially argue that it had been stolen, and the hospital was on the hook to replace it, as it would with a stolen pair of eyeglasses.

“It’s a whole can of worms,” he said. “One solution to one problem may cause a problem in another area.”

At this point, there’s not much research to assess effectiveness, safety or related issues, such as interactions with other drugs, ASHP officials wrote in their proposed policy recommendation. But marijuana’s classification as a Schedule I drug makes further clinical insights unlikely anytime soon, as existing federal policies largely restrict any research on that class of substances. For that reason, ASHP officials questioned if medical marijuana would need to be reclassified from Schedule I to Schedule II to facilitate research.

In the meantime, the clinical uncertainties are numerous, said David Craig, PharmD, a pain specialist at H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla. “It’s not an FDA-approved drug,” he said, ticking off concerns that other clinicians have raised. “We don’t have safety studies. And we don’t know how it might interact positively or negatively with other drugs that patients might be taking.” Additionally, there’s always a question about potency, as well as whether the marijuana might be contaminated in some way, he said.

Assessing Clinical Risk
Some of these concerns may be unfounded, based on feedback from two pharmacists who practice in states where marijuana has been legal for at least 10 years.

Elaine Levy, RPh, system director of pharmacy for Sharp HealthCare, a San Diego-based nonprofit hospital system, couldn’t recall any instance in which a patient had been admitted with medical marijuana. Neither do patients ask to use the herb on-site—for example, in the outpatient chemotherapy room, Ms. Levy said.

When compiling a list of patient medications, clinicians don’t ask specifically about medical marijuana, she added. If the patient volunteered it, the drug would be added to their list of admitting medications.

Similarly, Cindy O’Bryant, PharmD, BCOP, oncology pharmacy specialist at the University of Colorado Cancer Center in Aurora, couldn’t cite any instances of cancer patients wanting to use on-site. The hospital’s nonsmoking policy would preclude that anyway, she pointed out.
“For the most part, these patients are using it because it helps them,” she said, trying to assuage the fears of pharmacists in states where marijuana is on the cusp of medical legalization. “They feel like they are getting some benefit from it. They will behave. They won’t come in and have a big smokefest in the middle of the cancer center.”

When asking patients about their medications, Dr. O’Bryant doesn’t specify medical marijuana but does query about alternative therapies. If they ’fess up, she’s not preoccupied with how they obtained the herb but rather with vetting any potential clinical issues. “My concern is what other drugs they are on, are there any potential interactions and are they doing anything that will put them at risk for any synergistic side effects,” she said.

To gain some insight, Dr. O’Bryant looks at drug interactions related to dronabinol (Marinol, Unimed Pharmaceuticals, Inc.), an FDA-approved drug therapy that contains tetrahydrocannabinol (THC), the main psychoactive substance in marijuana. But it’s an inexact approach, she acknowledged. “You are trying to extrapolate from dronabinol to smoking marijuana, which might not be all that correct.”

Dr. Craig also asks palliative medicine patients at Moffitt about marijuana use, even though the drug hasn’t been legalized for medical purposes in Florida. It’s important to be aware of patient use, so clinicians can watch out for signs of abuse or use of other illegal drugs, he said. Some Moffitt oncologists want to know, because studies have shown that marijuana, used either recreationally or medicinally, can cause immune suppression and increase the risk for infections and even some types of cancer (Eur J Immunol 2010;40:3358-3371).

With some diagnoses, it’s particularly important to know if patients are smoking marijuana, Ms. Reilly said. For example, if they have an underlying breathing condition, such as chronic obstructive pulmonary disease or asthma, that needs to be factored into management decisions. “They may be [smoking medical marijuana] for another condition, but it may be exacerbating their asthma,” she said.

For some clinical insights, Ms. Reilly suggested a review article in the American Journal of Health-System Pharmacy (2007;64:1037-1044). Along with highlighting marijuana’s immunosuppressive properties, the article cites studies that show that the drug might aggravate underlying psychiatric symptoms or heart disease. The article also listed a litany of potential interactions with other drugs. Combining marijuana with opioids, for example, can “lead to cross-tolerance and mutual potentiation of effects,” the authors wrote. Taken with alcohol, benzodiazepines or muscle relaxants, marijuana can result in excessive depression of the central nervous system (CNS). (For additional risks, as well as some benefits, see sidebar, page 10).

Medical Marijuana: Pro/Con

Increases appetite and counteracts weight loss, nausea and vomiting in patients with debilitating illnesses, such as AIDS and advanced cancer.
Relieves symptoms associated with certain neurologic disorders, including muscle spasticity in patients with multiple sclerosis.
Eases pain in chronic conditions, including sickle cell anemia, migraine headache, phantom limb pain, and cancer.
May reduce frequency of seizures in patients with epilepsy.
Reduces intraocular pressure in glaucoma.

Contains 50%-70% more carcinogens linked to lung cancer than tobacco.
May lead to psychological dysfunction and addiction.

Cardiac adverse effects include tachycardia, hypertension, syncope, palpitations, stroke, acute myocardial infarction.

Increases symptoms of chronic bronchitis (e.g., coughing, sputum production, wheezing).
Considered a gateway drug, leading to exposure and addiction to more harmful drugs.
Source: Am J Health-Syst Pharm 2007;64:1037-1044

At ABQ Health Partners, an Albuquerque, N.M.-based system of physician-owned clinics, patients initially weren’t prescribed opioids if they were taking medical marijuana because of concerns about CNS effects, said Ernest Dole, PharmD, FASHP, a pharmaceutical care coordinator there who focuses on pain management. But over time—medical marijuana has been legal in New Mexico since 2007—the clinicians realized that the policy wasn’t necessarily consistent. Even when a patient is taking opioids, it’s difficult despite one’s best efforts to identify all of the prescriptions they might be getting from another provider, that might amplify an opioid’s effects, Dr. Dole said.

So the clinic system will occasionally prescribe an opioid to someone already using medical marijuana. But it’s a rare circumstance, he stressed. And the doctors at the clinic have decided not to prescribe marijuana to clinic patients.

“It’s a risk management issue,” he said. “We can’t with any certainty predict the CNS-cumulative clouding effects.”

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