PHARMACY

Iowa Gov. Kim Reynolds signs bipartisan opioid bill into law

NACDS applauds enactment of House File 2377

BY Antoinette Alexander

DUBUQUE, Ohio — In an effort to battle the opioid epidemic, Iowa is tackling the issue of doctor shopping and over-prescribing in the state with a bipartisan piece of legislation signed Monday by Gov. Kim Reynolds.

Reynolds said House File 2377 represents a significant step forward in Iowa’s efforts to address the opioid epidemic. The governor signed the bill in front of overdose victims’ families, law enforcement, state and local officials and others at Mercy Medical Center in Dubuque.

“Opioid-related deaths have more than doubled over the past decade,” said Reynolds. “And like I said in my Condition of the State address, this will not end until we take action. With this legislation, we are taking the first step to reverse this heart-wrenching trend.”

House File 2377 helps prevent doctor shopping and over-prescribing by:

  • Requiring all prescribers to register for and use the prescription monitoring program;
  • Allowing for proactive notification to recognize patients at high risk for abuse and addiction;
  • Requiring electronic prescribing in order to eliminate the risk of fraud; and
  • Allowing licensing boards to assess penalties for providers who over prescribe.

House File 2377 also aims to take a “compassionate” approach to ensure those who need immediate help with an overdose receive it by providing for immunity from criminal liability for those who call 911 to seek care for someone who has overdosed on drugs.

The opioid bill passed the Iowa Senate on April 30, 48-0 and the Iowa House on May 2, 95-0.

The state’s move to require e-prescribing, effective Jan. 1, 2020, drew praise from NACDS.

“Governor Reynolds and the leadership of the Iowa Senate and of the Iowa House of Representatives have taken decisive action on the opioid abuse epidemic by looking to electronic prescribing to help curb fraud, abuse and waste. The Iowa General Assembly’s Opioid Epidemic Evaluation Study Committee and the Iowa Board of Pharmacy deserve thanks as well for their engagement and leadership,” said NACDS president and CEO Steve Anderson in a statement issued Monday.

“NACDS also recognizes the Iowa Retail Federation and NACDS member companies for working hard to make the case for solutions to the opioid abuse epidemic, based on pharmacists’ experiences on the front lines of healthcare delivery,” Anderson added.

A poll conducted by Morning Consult and commissioned by NACDS in January 2018 found 75 percent of Iowa voters support a requirement that all prescriptions must be handled electronically, rather than via paper or fax, as a way to help address the opioid abuse epidemic. Reflecting a strong intensity of opinion, 44 percent of Iowa voters “strongly support” such a requirement — with strong support seen on a bipartisan basis and across political ideologies.

NACDS noted that the legislation is consistent with an array of public policy recommendations announced by NACDS, and with NACDS’ comments to the President’s Commission on Combating Drug Addiction and the Opioid Crisis.

At the federal level, NACDS has endorsed the Every Prescription Conveyed Securely Act (H.R. 3528 and S. 2460). The bill would require that Schedule II through V controlled substances for Medicare Part D beneficiaries are prescribed electronically.

“Together, federal and state actions will enhance the use of e-prescribing to help reduce fraud, abuse and waste of controlled substances. NACDS salutes Iowa’s leadership in this regard,” Anderson said.

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Medical marijuana clinical research gains momentum in Pennsylvania

BY Antoinette Alexander

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.

 

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FDA approves first drug to treat MS in pediatric patients

BY Antoinette Alexander

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.

 

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