PHARMACY

Ark. House passes bill requiring pharmacist consultants at pot dispensaries

BY David Salazar

LITTLE ROCK, Ark. — As it builds a framework for Arkansas' forthcoming medical marijuana program — which voters approved as an amendment to the state constitution in November — the Arkansas House of Representatives on Tuesday evening took a step forward in involving the state’s pharmacists in the medical marijuana program. The House passed a bill requiring pharmacist consultation for dispensaries, sending it to the Arkansas Senate, where it made its way out of committee Wednesday for a Thursday vote with the recommendation that it pass.  

HB2190, which passed the House 81-8, amends the state consitutional medical marijuana guidelines to require medical marijuana dispensaries to appoint a pharmacist consultant who will be available by phone or video conference during the dispensary’s operating hours for patient consultation. The pharmacist consultant also would develop and provide training to the dispensary at least once a year, including risk-benefit and side effect guidelines and spotting signs of substance abuse.

“We helped craft this biill and Sen. Jason Rapert and Rep. Clint Penzo have both been champs in recognizing one fundamental aspect of this new amendment in Arkansas, which is that we want to keep marijuana that's legal in Arkansas medical,” Arkansas Pharmacists Association EVP and CEO Scott Pace told Drug Store News Wednesday. “Our overriding concern was to make sure that patient safety was put first and foremost, and we didn't think that was necessarily the case unless a healthcare professional like a medication expert was involved. … We think it's going to great for pharmacists … because they're going to be able to help make a program successful that the voters want to see be successful.”

Under the amendment, pharmacist consultants would be integral in overseeing a dispensary’s educational materials for patients about possible side effects; notifying prescribers about side effects; effects of different strengths of marijuana strains and products; potential drug-drug interactions, including alcohol, prescription drugs and supplements; techniques for marijuana and paraphernalia use; and information about different ways to administer medical marijuana. Pharmacists also would develop a system for patients and caregivers to document symptoms, as well as policies for refusing medical marijuana to patients who appear to be abusing it.

“I would characterize this first as a big step for patients,” Pace said. “We think it's so important for patients that they're at least going to have access via video conference or phone to a medical professional who's a medication expert, because we don‘t want to see drug-drug or drug-disease state interactions happen.”

The bill includes a provision protecting pharmacist consultants under the law from arrest, prosecution and penalty — including from the Arkansas State Board of Pharmacy and other licensing boards — for performing their duties as a consultant for a dispensary.

Additionally, bill prohibits dispensaries from selling marijuana paraphernelia that requires patients to combust the marijuana to ingest it. Instead, it requires dispensaries to sell vaporizers and provide patients with educational material about methods for ingesting medical marijuana, as well as potential health risks of smoking versus vaporizing.

“We put that in there because we wanted to discourage what is arguably the mot harmful way of ingesting marijuana, which is to light it on fire and inhale it into your lungs — that's not the way we want to see this used to keep it medical,” Pace said. “But if patients decide that they want to go smoke it, there's nothing that's going to prohibit that in this legislation.”  

HB2190 is among a slew of bills on medical marijuana Arkansas legislators have considered this year as it gears up to implement its medical marijuana program, approved by Arkansas voters in November as an amendment to the state constitution. Many of the bills have made it to the desk of Gov. Asa Hutchinson.

Hutchinson has signed HB1026, which delays the state’s medical marijuana program implementation from March 9 to May 8. Currently awaiting Hutchinson’s signature or veto is a bill allowing the state’s health department to reschedule marijuana if the federal government does first, one preventing Arkansas National Guard and military officials from using medical marijuana and one that bans physicians from recommending medical marijuana via telemedicine.

A full list of bills being considered can be found here.

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Trump’s FDA pick to push to approve generics more quickly

BY Brian Berk

WASHINGTON — President Donald Trump’s choice to lead the Food and Drug Administration hopes to lower drug costs by approving cheaper generic drugs more quickly.

According to Bloomberg, former FDA Deputy Commissioner Scott Gottlieb would make streamlining drug approvals his top priority, with a particular focus on complex medications that combine old drugs with newer delivery devices, as well as ones with unusually complicated formulations. The news outlet added such changes in approach could come without Congressional approval.

“It is an opportunity for a new administration to make a mark, and do something on an issue where there’s a substantial amount of public interest,” Jack Hoadley, an analyst and professor at Georgetown University’s Health Policy Institute, told the news source.

On Jan. 31, President Trump called pharmaceutical prices “astronomical” and sought more competition to lower said prices.

In a March 6 speech, Gottlieb stated: “The market isn’t working.” His Senate confirmation hearing has yet to be scheduled.

For more, click here.

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FDA approves MS drug

BY Brian Berk

WASHINGTON — The Food and Drug Administration approved Genentech’s Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (PPMS).

This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional. 

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

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.

PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15% of patients with MS have PPMS.

The efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.

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