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CDC: Opioid prescribing varies widely by state

BY Michael Johnsen

ATLANTA — Health care providers wrote 259 million prescriptions for opioid painkillers in 2012 — many more in some states than in others — according to a Vital Signs report released Tuesday by the Centers for Disease Control and Prevention that highlights the danger of overdose. The report also includes an example of a state that reversed its overdose trend. 

 
Health care providers in the highest prescribing state, Alabama, wrote almost three times as many of these prescriptions per person as those in the lowest prescribing state, Hawaii. Most of the highest prescribing states were in the South. Previous research has shown that regional variation in use of prescriptions cannot be explained by the underlying health status of the population, the CDC stated. 
 
The Vital Signs report also contains a study highlighting the success of Florida in reversing prescription drug overdose trends. Results showed that after statewide legislative and enforcement actions in 2010 and 2011, the death rate from prescription drug overdose decreased 23% between 2010 and 2012. Florida officials had taken these actions in response to a 28% increase in the drug overdose death rate over the preceding years (2006-2010).
 
Declines in death rates in Florida for specific prescription painkillers (oxycodone, methadone, and hydrocodone) and sedatives paralleled declines in prescribing rates for those drugs. This report was based on Florida Medical Examiners Commission data from 2006 to 2012 and IMS Health National Prescription Audit data from 2008 to 2012.
 
“Prescription drug overdose is epidemic in the United States. All too often, and in far too many communities, the treatment is becoming the problem,” stated CDC director Tom Frieden. “Overdose rates are higher where these drugs are prescribed more frequently. States and practices where prescribing rates are highest need to take a particularly hard look at ways to reduce the inappropriate prescription of these dangerous drugs.”
 
For this Vital Signs report, CDC analyzed 2012 prescribing data collected from retail pharmacies in the United States by a commercial vendor. CDC calculated prescribing rates by state for various types of opioid painkillers.
 
Key findings include:
 
  • Southern states — Alabama, Tennessee, and West Virginia in particular — had the most painkiller prescriptions per person;
  • The Northeast, especially Maine and New Hampshire, had the most prescriptions per person for long-acting/extended-release painkillers and for high-dose painkillers; and
  • State variation was the greatest for oxymorphone (a specific type of painkiller), among all prescription painkillers. Nearly 22 times as many prescriptions were written for oxymorphone in Tennessee as were written in Minnesota.
 
According to the CDC, steps that states can take to address the overprescribing of painkillers include:
 
  • Considering ways to increase use of prescription drug monitoring programs, which are state-run databases that track prescriptions for painkillers and can help find problems in overprescribing. Impact of these programs is greater when they make data available in real time, are universal (used by all prescribers for all prescriptions for all controlled substances), and are actively managed (for example, send alerts to prescribers when problems are identified);
  • Considering policy options, including laws and regulation, relating to pain clinics to reduce prescribing practices that are risky to patients;
  • Evaluating their own data and programs and considering ways to assess their Medicaid, workers’ compensation programs, and other state-run health plans to detect and address inappropriate prescribing of painkillers; and
  • Identifying opportunities to increase access to substance abuse treatment and considering expanding first responder access to naloxone, a drug used when people overdose.
 

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Industry calls on FDA to preserve INN drug identity practice for biosimilars

BY Michael Johnsen

WASHINGTON — As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.
 
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe, it has worked in the United States for chemical drugs and currently approved biologics, therefore it should be the standard for U.S. biosimilars," stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” Neas said. “Instead, it will upset the very systems needed to accurately dispense and track medicines, risking increased mistakes and provider confusion.”
 
As the letter states, “While we agree that it is important to gather data that allows providers to better understand how biologics and biosimilars are performing among various patient groups and to assist in the tracking of adverse events, as we mention above, we believe that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are sufficient. In addition, because adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code and lot number, there is no compelling evidence that biosimilars should be handled differently.”
 
“American patients deserve access to safe, cost-effective biosimilars,” added Steve Miller, SVP and chief medical officer, Express Scripts. “By introducing just 11 biosimilars, we can reduce our nation’s medical bill by $250 billion over 10 years, which would put important treatments within the reach of those who need them most. We’re committed to working with all stakeholders to create a viable pathway for biosimilars in the U.S.”
 
This letter follows concerns recently raised by the National Council for Prescription Drug Programs, citing serious operational problems with the implementation of a system other than the currently accepted INN construct. In a letter to the FDA, NCPDP cautioned about the impact such a change would have on the standard operating procedures inherent in the healthcare system. The standards-setting organization warned FDA that, “making changes to the current databases and the SOP’s by which they are developed, maintained and used takes time and resources. This can result in confusion, errors and misunderstanding, resulting in a very real risk to patients, during any transition.”
 
Neas noted that patient safety is of critical importance, stating, “The generic industry fully supports vigorous efforts to ensure these products continue to be fully identifiable as they move through the supply chain to the prescriber and the patient. To protect patient safety, the FDA should maintain the INN system for naming medicines, and apply it to biosimilars.”
 
 
The full list of signatories to the FDA letter includes:
 
Academy of Managed Care Pharmacy 
American Federation of Labor and Congress of Industrial Organizations 
American Federation of State, County and Municipal Employees 
American Foreign Service Protective Association 
America’s Health Insurance Plans 
California Public Employees Retirement System 
Communications Workers of America 
CVS Caremark
Employees Retirement System of Texas
Express Scripts
International Union, United Automobile, Aerospace & Agricultural Implement Workers of America, UAW
J.B. Hunt Transport, Inc.
Kentucky Teachers Retirement System
Know Your Rx Coalition (Kentucky)
MetLife, Inc.
Military Officers Association of America
Missoula County, Montana
National Association of Chain Drug Stores 
National Coalition on Health Care 
Ohio Public Employees Retirement System 
Pharmaceutical Care Management Association 
Portico Benefit Services
Premier, Inc.
Prime Therapeutics
Public Sector HealthCare Roundtable
School Employees Retirement System of Ohio 
State Health Plan of North Carolina
State Teachers Retirement System of Ohio 
UAW Retiree Medical Benefits Trust
U.S. Public Interest Research Group 
Walgreens
West Virginia Public Employees Insurance Agency
 

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Spicy Street Taco claims top spot as Doritos Jacked mystery flavors are revealed

BY Michael Johnsen

PLANO — Doritos brand, from PepsiCo’s Frito-Lay division, has just unveiled three new flavors that will hit store shelves in the spring. As a part of a challenge that began April 29, fans have been asked to taste, debate and vote for their favorite mystery flavors with a chance to win cash prizes.

Spicy Street Taco (red bag), Chocolate Chipotle Bacon (blue bag) and Caribbean Citrus Jerk (orange bag) will be the three new additions to Doritos Jacked line, which are 40% bigger in size and thickness compared to regular Doritos.

Spicy Street Taco was the fan favorite, collecting the most votes on TheBoldFlavorExperiment.com. It will be brought back to store shelves as an official Doritos flavor in the fall and available in a 10 oz. bag for a suggested retail price of $4.29 and a 3.375 oz. bag for a SRP of $1.49.

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