June 2016, Vol 4, No 6 - The Vitals
E. K. Charles

In This Article




Nasal Spray Flu Vaccine Gets a Thumbs Down from ACIP

According to a recent announcement, the Advisory Community on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention voted that the live attenuated influenza vaccine (LAIV), which is also known as the nasal spray flu vaccine, should not be used in the upcoming flu season.

This vote is based on data indicating poor, or relatively lower, LAIV effectiveness from 2013 through 2016. In particular, preliminary data among children aged 2 through 17 years during the 2015 to 2016 seasons indicated that effectiveness of that vaccine was approximately 3%.

It should be noted that the original data prior to and following licensure of this vaccine suggested it was comparable to, or better than the inactivated influenza vaccine. The cause of the LAIVs recent poor performance is currently unknown.

ACIP emphasized that, despite this vote, annual flu vaccinations with inactivated influenza or recombinant influenza vaccines are still recommended for everyone aged ≥6 months.

Pharmacists and other healthcare providers should be prepared for any implication this recommendation may have on the pediatric population and vaccination rates in the upcoming flu season.

  1. Centers for Disease Control and Prevention. ACIP votes down use of LAIV for 2016-2017 flu season. www.cdc.gov/media/releases/2016/s0622-laiv-flu.html. Published June 22, 2016. Accessed June 24, 2016.

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First Cholera Vaccine Approved by the FDA

Vaxchora, a vaccine for the prevention of cholera associated with serogroup 01, has been approved by the US Food and Drug Administration (FDA) for adults aged 18 to 64 years traveling to cholera-infected areas. It is the only FDA approved vaccine for the prevention of cholera.

“The approval of Vaxchora represents a significant addition to the cholera prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions,” stated Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA, Springfield, MD, in a press release by the organization.

The FDA approval was based on randomized, placebo-controlled data showing the efficacy of the vaccine among 197 US volunteers aged 18 through 45 years. Vaxchora demonstrated rates of 90% efficacy among patients challenged with oral ingestion of the bacterium that causes cholera 10 days postvaccination, and 80% efficacy in patients challenged 3 months postvaccination. Two placebo controlled studies were conducted to assess immune system response to the vaccine, and a randomized, placebo-controlled, multicenter trial was conducted to assess the vaccine’s safety.

Vaxchora is a live, weakened vaccine administered orally as a single, liquid dose that should be given ≥10 days before traveling to a cholera-affect area.

  1. US Food and Drug Administration. FDA approves vaccine to prevent cholera for travelers. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506305.htm. Published June 10, 2016. Accessed June 24, 2016.

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Law Prohibiting Minors from Buying OTC Cough Medicine Gains Traction

Delaware has become the 12th state in the nation to pass a law prohibiting minors from purchasing over-the-counter (OTC) medicines containing dextromethorphan (DXM).1 The law intends to help combat the number of teenagers who abuse DXM.

According to the National Institute on Drug Abuse, DXM is 1 of 2 commonly abused cough and cold medicines, along with promethazine-codeine cough syrup.2 In high quantities, these drugs affect the brain in similar ways as illegal drugs; repeated use can lead to addiction. DXM abuse is linked to impaired motor function, numbness, increased heart rate and blood pressure, and, in rare cases, may cause hypoxic brain damage.

DXM has been available OTC as a component of cough medicine for >50 years.1 Consumers will need to show proof of age (≥18 years) to purchase it in Delaware, and in other states where this law has been passed.

  1. House of Representatives 148th General Assembly. House Bill No. 329. http://legis.delaware.gov/LIS/lis148.nsf/vwLegislation/HB+329/$file/legis.html?open. Accessed June 24, 2016.
  2. National Institute on Drug Abuse. Drug facts: cough and cold medicine abuse. www.drugabuse.gov/publications/drugfacts/cough-cold-medicine-abuse. Updated May 2014. Accessed June 24, 2016.

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AMA to Lobby Congress to Lift Ban on CDC Gun Violence Research

The American Medical Association (AMA) recently adopted a policy calling gun violence in the United States a “public health crisis” that needs a comprehensive response and solution. This statement was released in the wake of the Orlando, FL, mass shooting.

The AMA also announced that it will actively lobby Congress to overturn legislation that has prohibited the Centers for Disease Control and Prevention (CDC) from researching gun violence for the past 20 years. In the past, the AMA has supported numerous long-standing policies to increase the safety of firearms and their use, in addition to reducing and preventing firearm violence.

“An epidemiological analysis of gun violence is vital so physicians and other health providers, law enforcement, and society at large may be able to prevent injury, death and other harms to society resulting from firearms,” stated Steven J. Stack, MD, President, AMA, Chicago, IL, in a press release by the association.

  1. The American Medical Association. AMA calls gun violence “a public health crisis;” will actively lobby Congress to lift ban on CDC gun violence research. www.ama-assn.org/ama/pub/news/news/2016/2016-06-14-gun-violence-lobby-congress.page. Published June 14, 2016. Accessed June 24, 2016.

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AMCP Recommendations Seeks to Improve the Exchange of Healthcare Economic Data

In a recent consensus statement, the Academy of Managed Care Pharmacy (AMCP) provided recommendations to improve the sharing of healthcare economic information used in pharmaceutical coverage decision-making.

The recommendations were published in the July issue of the Journal of Managed Care & Specialty Pharmacy, and based on information developed during a forum the AMCP held in the first quarter of the year.

The purpose of the forum was to address the need for revisions, and/or guidance to Section 114 of the Food and Drug Administration Modernization Act of 1997. The meeting included a wide variety of stakeholders from the managed care and biopharmaceutical industries, as well as healthcare providers, pharmacoeconomic and policy experts, and patient advocacy groups.

Altogether, the forum participants focused on 4 terms in Section 114: the scope of healthcare economic information; the scope of “formulary committee or similar entity”; the definition of “competent and reliable scientific evidence”; and the parameters of how information “directly relates to an approved indication.”

The results of the forum will be submitted to the US Food and Drug Administration as a guidance document for consideration.

  1. AMCP partnership forum: FDAMA Section 114—improving the exchange of health care economic data. J Manag Care Spec Pharm. 2016;22:826-831.

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