Medical marijuana clinical research gains momentum in Pennsylvania
The Pennsylvania Department of Health has approved eight universities as Certified Academic Clinical Research Centers in the state’s medical marijuana program, signaling the first step towards clinical research to commence in the commonwealth.
In a statement issued Monday, Gov. Tom Wolf said, “The research component of Pennsylvania’s medical marijuana program sets it apart from the rest of the nation.”
To date, such research has been limited given that cannabis is still illegal under federal law.
“Today, medical research is so limited by the federal government that only a few doctors can even have access to medical marijuana. Pennsylvania’s premiere medical schools will be able to help shape the future of treatment for patients who are in desperate need not just here, but across the country,” Wolf stated.
The eight universities include:
- Drexel University College of Medicine, Philadelphia;
- Lewis Katz School of Medicine at Temple University, Philadelphia;
- Penn State College of Medicine, Hershey;
- Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia;
- Perelman School of Medicine at the University of Pennsylvania, Philadelphia;
- University of Pittsburgh School of Medicine, Pittsburgh;
- Lake Erie College of Osteopathic Medicine (LECOM), Erie; and
- Philadelphia College of Osteopathic Medicine, Philadelphia.
In addition, the Department of Health developed temporary regulations to implement the recommendations of the Medical Marijuana Advisory Board, which includes expanding the list of serious medical conditions. These temporary regulations take effect on Thursday.
“We have expanded the number of serious medical conditions to include neurodegenerative diseases, terminal illness, dyskinetic and spastic movement disorders and opioid-use disorder,” stated Secretary of Health Rachel Levine. “It’s important to note that medical marijuana is not a substitute for proven treatments for opioid-use disorder. In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”
Pennsylvania is the first state to add opioid-use disorder separately as an approved condition for medical marijuana patients.
“By adding opioid-use disorder as an approved medical condition under the program, we not only give physicians another tool for treatment of this devastating disease, but we allow for research to be conducted on medical marijuana’s effectiveness in treatment,” Levine added. “Only approved conditions under the law can be studied through our research program.”
Other recommendations include:
- Revising the serious chronic pain definition to no longer require patients to use opioids before using medical marijuana;
- Permitting medical marijuana to be dispensed in dry leaf or plant form, for administration by vaporization;
- Allowing physicians to opt out of the public-facing practitioner list while remaining in the Patient and Caregiver Registry; and
- Requiring patients to pay the $50 medical marijuana identification card fee once in a 12-month period.
The Medical Marijuana Program was signed into law by Wolf on April 17, 2016. More than 37,000 patients have registered to participate in the program, with more than 16,000 who have received their identification cards and received medical marijuana at a dispensary. One thousand physicians have registered for the program with more than 600 certified as practitioners.
FDA approves first drug to treat MS in pediatric patients
WASHINGTON — The U.S. Food and Drug Administration has approved Gilenya (fingolimod) to treat relapsing multiple sclerosis in children and adolescents age 10 years and older, marking the first FDA approval of a drug to treat MS in pediatric patients.
The FDA first approved Gilenya in 2010 to treat adults with relapsing MS.
“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” stated Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can have a profound impact on a child’s life. This approval represents an important and needed advance in the care of pediatric patients with multiple sclerosis.”
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by periods of remission. Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people with MS experience their first symptoms, like vision problems or muscle weakness, between the ages of 20 to 40. Two to five percent of people with MS have symptom onset before age 18 and estimates suggest that 8,000 to 10,000 children and adolescents in the United States have MS.
The clinical trial evaluating the effectiveness of Gilenya in treating pediatric patients with MS included 214 evaluated patients aged 10 to 17 and compared Gilenya with another MS drug, interferon beta-1a. In the study, 86 percent of patients receiving Gilenya remained relapse-free after 24 months of treatment, compared with 46 percent of those receiving interferon beta-1a.
Fairchild Air Force Base pharmacy taps ‘Innovation’ for automation
Fairchild Air Force Base pharmacy in Washington State has implemented Innovation’s PharmASSIST Light-Way storage and retrieval system with initial use as a will call management system for prescription storage and patient pickup, the maker of pharmacy automation solutions announced on Monday.
“We’re extremely pleased with how quickly and smoothly this initial installation and end-user training of PharmASSIST Light-Way went at Fairchild AFB. Feedback has been very positive with the staff touting Light-Way’s user friendliness as key to their early productivity,” stated Chris Cole, program manager, federal healthcare at Innovation. ”As with any new product we introduce, we’re actively soliciting user feedback from their team with a goal of continually improving the product in the various modalities it supports.”
The PharmASSIST Light-Way pick-to-light technology is designed to offer a simple means of placing and picking prescriptions into the system’s storage locations (i.e., cubbies/slots). All picking and placing is controlled via barcode scanning and guided with pick-to-light queuing. This reduces the opportunity for human error. All storage locations are size configurable and light up when users place prescriptions into the locations or when a patient presents at the pick-up window. To drive greater efficiencies, the system is integrated with the pharmacy’s PharmASSIST Symphony workflow management platform, which is used throughout U.S. Air Force Pharmacy.
According to Innovation, it foresees expanded use of PharmASSIST Light-Way as a productivity tool at other steps in the prescription fulfillment process. For example, the system has the capability to be used to collate prescriptions between filling and verification, and also for inventory management for picking fast moving inventory at manual filling stations to speed up the manual filling process.