Small Doses: March 2018 Edition

Small Doses is back, bringing you a roundup of the latest pharmacy news in an easy-to-swallow pill. 

Pharmacists are busy people, and keeping up with the news is tough, so we're here to help. There's a lot that goes on in healthcare that you might have missed. This month, catch up on stories about pill mills, a fentanyl-amnesia link, and much more news from around the world of pharmacy. 

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Up next: Pill mill prosecution

U.S. Agencies Step Up Pill Mill Prosecution

The U.S. Department of Justice and the DEA are continuing their battle against pill mills.

U.S. Attorney General Jeff Sessions stated in late January, that there will be a DEA-led “surge” that will focus on doctors and pharmacists  who dispense unusually large amounts of narcotics. Sessions has also announced the DOJ’s formation of the Joint Criminal Opioid Darknet Enforcement (J-CODE) team, which consists of dozens of FBI agents and intelligence analysts dedicated to stopping the illegal sale of opioids on the internet. 

“DEA agents and analysts will scour the 80 million reports the agency receives every year from drug manufacturers and distributors to identity what the DOJ calls statistical outliers,” says Adam Overstreet, counsel in the Health Care practice group at Burr & Forman in Birmingham, AL.

“The DOJ’s ‘pill mill’ initiative is showing no signs of slowing down in 2018-in fact, it is gaining steam.”

In late 2017, the DEA identified 26 pharmacies in California, Hawaii, and Nevada that may be illegally trafficking opioids. The investigation is part of the agency’s Operation Faux Pharmacy, which has resulted in the seizure of nearly 600,000 dosage units of scheduled drugs nationwide.

Last August, a New Jersey pharmacist was convicted in federal court of distributing and illegally dispensing oxycodone from two pharmacies he owned-just one of several cases the DOJ brought against pharmacists in 2017.

Case Report Links Fentanyl to Amnesia

Fentanyl-taken alone or in combination with stimulants-may cause amnesia, according to a new case report.

Published in the January 30, 2018, issue of the Annals of Internal Medicine, the case report is the first to link between fentanyl use and a form of amnesia that comes on suddenly and produces distinctive MRI results.

“Buying opioids on the street isn’t like buying Tylenol,” says Marc W. Haut, PhD, lead author, neuropsychologist, professor, and chair of West Virginia University’s Department of Behavioral Medicine and Psychiatry. “You don’t know what you’re buying. People may think they’re buying something that’s just an opiate, but it may have fentanyl in it, and it may have cocaine.”

Between 2012 and 2016, 14 people in Massachusetts with a history of substance use developed an unusual amnestic syndrome that included acute, complete, and bilateral hippocampal lesions on MRIs.

Haut and his colleagues studied the case of an additional patient: a 30-year-old man who was transferred from a local hospital in Maryland to a tertiary medical center in West Virginia for persistent memory impairment. The researchers used laboratory testing and neuroimaging to support the theory that fentanyl use may trigger amnesia in some individuals.

“Further study will be required to confirm the fentanyl–amnesia link in a larger population and pinpoint the mechanisms behind it. The amnesia’s typical duration and frequency are also unknown,” WVU says in a statement.

Will New Blood Pressure Guidelines Increase Drug Scripts?

New guidelines on hypertension from the American College of Cardiology (ACC) and the American Heart Association (AHA) include major changes in blood pressure treatment in order to prevent hypertension problems earlier.

Instead of 32%  of U.S. adults having high blood pressure, as seen with the previous definition, the new guidelines will result in 46% of the U.S. adult population having high blood pressure.

The guidelines-the first major change since 2003-propose earlier lifestyle changes and blood pressure medication for some patients who have a reading of 130/80 mm Hg, rather than 140/90 mm Hg.

Related article: Clinical Challenge: Treating Nasal Congestion with Concomitant Hypertension

“The intent of the guidelines is not so more prescriptions will be written, but rather for the purpose of early detection and prevention,” Rob Greenfield, MD, tells Drug Topics’ sister publication Managed Healthcare Executive. He is a cardiologist and director of Non-Invasive and Preventive Cardiology, and of the Lipid Clinics at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in Fountain Valley, CA.  

The majority of Americans who require pharmacologic intervention will be those who are already taking medication for hypertension, says Kurt W. Kaulback, MD, FACC, clinical director of the Cardiovascular Services, Inspira Health Network; and Interventional Cardiologist at Inspira Medical Group Cardiovascular Services, both located in Mullica Hill, N.J.

Particular attention should be paid to individuals with a history of cardiac and cerebrovascular complications of hypertension such as congestive heart failure, stroke, and heart attack, he says.

CVS Program Aims to Cut Rheumatoid Arthritis Costs

CVS Health has launched Transform Rheumatoid Arthritis Care to help pharmacy benefit management clients better manage care and costs.

Drugs to treat RA account for nearly half of overall specialty drug trends, according to CVS, and clients enrolled in the new program could see savings of up to 5% on their annual RA drugs. The program includes value-based management strategies, including outcomes-based contracts and a new indication-based formulary for autoimmune conditions.

Related article: CVS Limits Opioid Use

"Treating rheumatoid arthritis costs the U.S. healthcare system $19 billion a year. Both spend and trend have also been rising for the autoimmune category in recent years and market analysts expect this category to be the fastest-growing drug class over the next five years," says  Alan Lotvin, MD, executive vice president for CVS Specialty, the specialty pharmacy of CVS Health.

"Our program is unique in that we can pull together resources enabled by our integrated pharmacy care model to deliver both a truly member-focused clinical management program, while also helping to manage the rising costs within the autoimmune category through new approaches to contracting and formulary management.”

Members enrolled in the program receive personalized care and disease-specific expertise from the RA CareTeam, which includes specially-trained pharmacists and nurses. “The RA CareTeam provides a range of support specific to the member's needs including symptom, comorbidity, and side effect management; care coordination; and coaching and education,” according to CVS Health. The RA CareTeam also offers initial clinical assessments, benefits verification, and medication dispensing and distribution.

Certain Antithyroid Drugs May Cause Birth Defects

Antithyroid drugs (ATDs) taken during the first trimester of pregnancy are associated with an increased risk of birth defects, according to a new study.

Prenatal exposure to methimazole (MMI, Tapazole) and propylthiouracil (PTU) resulted in relative increases in the risk for congenital malformations of 31% and 16%, respectively, according to a South Korean study published in Annals of Internal Medicine.

The increased risk for malformations associated with MMI remained among those who switched to PTU several months before their pregnancy or during the first trimester.

The study included a cohort of more than 2.8 million pregnancies that resulted in live births between 2008 and 2010.

Of the total pregnancies, 12,891 pregnancies were exposed to ATDs during the first trimester.

“Exposure to ATDs during the first trimester was associated with increased risk for congenital malformations, particularly for pregnancies in which women received prescriptions for MMI or both ATDs,” the researchers wrote.