Examining the News Affecting Pharmacy & Clinics
March 2015, Vol 3, No 3 - The Vitals

In This Article

ACIP Updates 9vHPV Guidelines

The Advisory Committee on Immunization Practices (ACIP) released updated guidelines for the use of the 9-valent human papillomavirus (9vHPV) vaccine (Petrosky E et al. MMWR Morb Mortal Wkly Rep. 2015;64:300-304). These updates come amid their February annual meeting.

The committee recommended 9vHPV (Gardasil 9; Merck and Co, Inc) as 1 of 3 HPV vaccines used for routine vaccination for patients 11 or 12 years of age. In addition, they recommend vaccination of women 13 to 26 years of age, as well as men 13 to 21 years of age who have not been previously vaccinated. The vaccination is also recommended for men through 26 years of age who have sex with men, and for immunocompromised patients—including patients with HIV—who were not previously vaccinated.

The recommendations were based on a review of clinical trial data on the efficacy, immunogenicity, and safety of 9vHPV from October 2013 to February 2015 by the ACIP HPV Vaccine Work Group. Evidence and work group discussions were presented to ACIP before recommendations were made at their annual meeting.

The recommendations also include information on HPV-associated disease; 9vHPV efficacy, immunogenicity, and safety, as well as the health impact and cost-effectiveness of the vaccine; administration/ special populations; precautions and contraindications; cervical cancer screening; and future policy issues.

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FDA Warns About Cardiovascular Effects of Hepatitis C Combination Therapy with Amiodarone

The US Food and Drug Administration (FDA) has issued a warning that serious slowing of the heart can occur when the antiarrhythmic drug amiodarone is taken together with the hepatitis C drug ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir (Sovaldi) in combination with another direct-acting antiviral for the treatment of the hepatitis C virus (HCV) (FDA Drug Safety Communication. March 24, 2015). In addition, the FDA is recommending that healthcare professionals should not prescribe either Harvoni or Sovaldi in combination with another direct-acting antiviral (eg, daclatasvir or simeprevir, with amiodarone).

This safety communication is based on an FDA review of submitted postmarketing adverse-event reports, which indicated that patients could develop serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi was combined with another direct-acting antiviral taken together with amiodarone. In one case, the death of a patient was from cardiac arrest; in other cases, 3 patients required the placement of a pacemaker to regulate their heart rhythms. Other patients recovered after discontinuing either the HCV drugs or amiodarone, or both. The cause of these events could not be determined, the FDA reported.

The FDA further recommends that in cases where alternative treatment options are unavailable, heart monitoring should occur in an inpatient hospital setting for the first 48 hours, followed by monitoring in a doctor’s office or self-monitoring of the heart rate every day through at least the first 2 weeks of treatment.

Patients taking these combination medications should seek medical attention immediately if they experience signs or symptoms of symptomatic bradycardia, including near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, and/or confusion or memory problems.

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Motivational Interviews Effective in Reducing Obesity

Motivational interviewing (MI) and counseling by providers and registered dietitians (RDs) to caregivers of overweight children between 2 and 8 years of age positively impacts obesity, according to a study published online ahead of print in Pediatrics.

To date, limited data existed evaluating the impact of MI on pediatric obesity. “This is among the first large-scale trials to show statistically significant reductions in BMI [body mass index] by using MI delivered by PCPs [primary care providers] and RDs,” according to Kenneth Resnicow, PhD, Department of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, and colleagues.

As part of a randomized controlled trial, the investigators evaluated child BMI percentile at 2-year follow-up among 42 practices from the Pediatric Research in Office Settings network of the American Academy of Pediatrics assigned to 1 of 3 groups. The groups consisted of usual care, including BMI percentile at baseline and 1- and 2-year follow-up (Group 1); 4 provider-delivered MI counseling sessions to parents of the index child over 2 years (Group 2); and 4 provider-delivered MI sessions and 6 RD-provided MI sessions (Group 3).

At the primary outcome of interest, the adjusted BMI percentiles were 90.3 (Group 1), 88.1 (Group 2), and 87.1 (Group 3), with the Group 3 mean significantly lower than in Group 1 (P = .02). “How the intervention can be brought to scale (in particular, how to train physicians to effectively use MI and how best to train RDs and integrate them into primary care settings) merits future research,” they concluded.

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Increase Seen in Hypertension-related Death

Recent data released by the Centers for Disease Control and Prevention indicate a 23.1% increase in hypertension-related death.

“The age-adjusted hypertension-related death rate increased 23.1%, whereas the rate for all other causes combined decreased 21.0% from 2000 through 2013,” the investigators found (Kung H-C and Jiaquan X. NCHS Data Brief. March 2015. No. 193). In addition, they found that the rates for hypertension-related death increased for men and women between 45 and 64 years of age, and >85 years of age, during that time frame.

The data were collected using national multiple cause-of-death data files from the National Vital Statistics Systems from 2000 to 2013. The data included information collected from death certificates filed by the 50 states and the District of Columbia in the United States. Hypertension-related mortality was defined as any mention of hypertension on death certificates. Decedents ≥45 years of age were included in the analysis. Overall, the report indicates that approximately 1 in 6 patients with hypertension-related deaths had hypertension as the underlying cause of death, and the rest of the patients had hypertension as a contributing cause of death for other underlying causes.

“This report provides a comprehensive picture of the burden of hypertension-related mortality in the United States from 2000 through 2013,” the authors concluded.

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Business News

5 Facts About the Unitedhealth Group Merger with PBM

1. UnitedHealth Group’s free-standing pharmacy care services business, OptumRx, will be combining with Catamaran Corporation, a pharmacy benefit management (PBM) company.
2. OptumRx has a clinical synchronization approach that connects pharmacy and care management systems, processes and teams to create higher quality, more consistent and compliant patient outcomes, as well as savings for individuals and plan sponsors
3. UnitedHealth Group will acquire Catamaran’s outstanding common stock for $61.50 per share, cash. The acquisition is expected to be accretive to UnitedHealth Group’s net earnings, approximately $0.30 per share in 2016.
4. The acquisition will diversify the customer and business mix of OptumRx, and accelerate its technology leadership and flexible service offerings. It is also expected to create significant value for their combined customer base beyond the scale, and enhanced service.
5. The transaction is expected to take place in the fourth quarter of 2015 (UnitedHealth Group press release; March 30).

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Last modified: May 20, 2015
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