Marijuana use is on the rise as more states legalize it for medicinal and recreational purposes, and physicians are fielding more questions about its safety.
Although smoking tobacco is responsible for approximately one in four deaths from cardiovascular disease, the effects of smoking marijuana on the heart are not fully understood. Some studies suggest that marijuana can trigger heart attacks and strokes in some users.
Ersilia DeFilippis, MD, a second-year cardiology fellow at Columbia University Irving Medical Center and NewYork-Presbyterian, first became interested in marijuana’s effect on the heart a few years ago when studying heart attacks in people under 50. “We noted that 10% of patients in a registry of young heart attack patients had used marijuana and/or cocaine,” she says.
DeFilippis and colleagues recently reviewed the medical literature to find out what’s known about marijuana’s effect on the heart and what’s still unknown. Their full report was published Jan. 20 in the Journal of the American College of Cardiology.
Cannabinoids Can Interact with Drugs Used to Treat Heart Disease
Cannabinoids inhibit certain enzymes in the body, which affects the metabolism of many drugs for heart disease, including antiarrhythmics, statins, calcium-channel blockers, beta-blockers, and warfarin.
Naples doctors lose licenses over-controlled substance prescriptions
A sign sits on the door of doctors Francis and Jane Harrington’s Naples practice after the state revoked their licenses. The pair have been on the Drug Enforcement Administration’s radar for over two years due to their controlled substance prescriptions.
A concerned pharmacist at a nearby CVS Pharmacy tipped off the DEA in 2016. The pharmacist said Francis Harrington was using his wife’s DEA registration information since he was suspended. That led to the two-year investigation that found out his wife allowed him to do it.
Some patients walked to the Naples building not knowing the doctor’s office was closed. On Feb. 7 a medical board voted the Harringtons would lose their license. Their office is located in the same building as the Naples Pharmacy.
Dept. of Health documents show Naples Pharmacy was caught filling prescriptions for amphetamines, oxycodone and other controlled substances from Harrington that were not dated or signed. Residents said they have heard of similar incidents in the area before.
“It happened at another drug store that I used to go to and the people were super duper nice,” said Kate Frankel, who lives in Naples, “but you never know what’s happening behind closed screens.”
“Doctors are held to a higher standard,” said David Laug, a Naples resident, “but I think they need to be scrutinized more strongly.”
The Harringtons did not show up for their hearing, nor did they respond to attempts for comment. Documents show Naples Pharmacy paid a fine. The pharmacy said “no comment.
CDER’s Controlled Substances Program Finds New Leader
The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Wednesday said that its newly established Controlled Substances Program (CSP) will be led by Marta Sokolowska, associate director for controlled substances in the Office of the Center Director.
CSP, which encompasses the Controlled Substances Staff (CSS) and Controlled Substances Initiatives (CSI), will help to coordinate CDER activities and emerging issues around controlled substances, including prescription opioids, benzodiazepines and stimulants. The program will also work within the agency and with outside groups on strategies and policies related to controlled substances, in addition to providing expertise on certain drug applications and drug scheduling, according to an email from Douglas Throckmorton, deputy center director for regulatory programs, to CDER staff.
The CSP in March is expected to launch an opioid data warehouse to better integrate diverse internal and external data sources, better assess vulnerabilities in certain populations, inform CDER of trends and support regulatory changes.
Rx-to-OTC Switches: FDA Signs Off on Three Drugs
The US Food and Drug Administration (FDA) last Friday converted three prescription drugs to over-the-counter (OTC) drugs, increasing access to the medicines, including one for arthritis pain and two for redness of the eyes and itching due to allergies.
The process of such prescription drug to OTC drug switches (known as Rx-to-OTC switches) is usually initiated by the manufacturer, FDA said.
“For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional,” the agency said.
FDA granted one switch to GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain, which was first approved by FDA in 2007 as a prescription drug for the relief of the pain of osteoarthritis of joints. FDA explained some of the potential side effects and also cautioned that it may take up to seven days to work.
The other two switches approved were for Alcon’s Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%), which was first approved by FDA as a prescription drug in 1996, and Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%), which was first approved in 2004. Both drugs are for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander.
Bill to let physician assistants prescribe controlled substances passes House on the fourth try
The state House has passed a bill to let physician assistants to prescribe highly regulated drugs, a step advocates say is needed to improve health-care access in rural Kentucky, the only state where PAs lack such authority.
House Bill 135, sponsored by Rep. Steve Sheldon (R-Bowling Green) would allow “modified prescriptive authority” of controlled substances in federal Schedules II, III, IV, and V after the assistant has been licensed and has practiced for one year.
It passed the House Feb. 6 on a 91-1 vote, with Rep. Lynn Bechler (R-Marion) voting against it. This was the fourth time the legislation had been filed, and the first time it’s gained any traction.
Sheldon said the Kentucky Board of Medical Licensure, the Kentucky Academy of Physician Assistants, the Kentucky Pharmacists Association, and the Kentucky Medical Association were involved in the drafting of this bill.