FDA Takes Two Important Actions on Drug Shortages

Strategic plan and proposed rule on early notification by manufacturers will help agency build on recent progress

The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.

Today’s announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.

FDA Drug Shortage Proposed Rule and Strategic Plan

Today, the U.S. Food and Drug Administration (FDA) will announce the release of the Drug Shortage Proposed Rule and Strategic Plan. 

As a very important stakeholder, FDA invites you to participate in an upcoming teleconference later today, where you will have the opportunity to ask questions.

Date: Thursday, October 31, 2013

Time: 1:15 pm ET
Dial-in for U.S. Callers: 888-455-4289, passcode “FDA”

Dial-in for international callers: 1-210-835-2398, passcode “FDA"

The stakeholder teleconference will consist of a short presentation by Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), FDA, and CAPT Valerie Jensen, R.Ph., Associate Director of the Drug Shortages Program, CDER and will be followed by an opportunity for questions and answers.  The moderator for the teleconference will be Beth Fritsch, R.Ph., M.B.A., Deputy Director, Office of Health and Constituent Affairs, Office of the Commissioner, FDA.

A replay of the stakeholder teleconference will be available about one hour after the call ends, for 30 days, by calling 866-405-7299, or for international callers, 203-369-0609.   The passcode for U.S. and International callers is 332.

We appreciate your ongoing support of FDA and its mission and look forward to your participation.

Sincerely,

CAPT Beth F. Fritsch, R.Ph., M.B.A.

Deputy Director

Office of Health and Constituent Affairs

Office of External Affairs

Office of the Commissioner

U.S. Food and Drug Administration

PQS Names Vice President for Professional Relations

Springfield, VA, Oct 28, 2013 - Pharmacy Quality Solutions, Inc. (PQS), announced the hiring of Elliott M. Sogol, PhD, RPh, FAPhA to fill the newly created position of Vice President for Professional Relations. As PQS continues to work collaboratively with health plans, PBMs, and pharmacies, PQS tapped Sogol who has over three decades experience and a proven track record in the community pharmacy practice environment, the pharmaceutical industry, and academia. In this new role, Sogol will support community pharmacy engagement with EQuIPP™, the first national platform for pharmacy quality measurement, benchmarking, and feedback that enables pharmacies and insurance plans to monitor key quality indicators.

What Matters Most

If you are at a business event, dining with a client, with business associates, or if your boss is footing the bill, then eating is the second (or third) purpose of the meal. You are there to do business. The meal is merely the tool you are using to develop the relationship. In these cases, it is poor etiquette (and bad business strategy) to do anything that detracts from the business at hand.

That would include poring over the menu while ignoring your guests, quizzing the wait staff about ingredients of a dish, ordering anything complicated or disruptive, ordering dessert if the timeframe doesn’t allow for it, bringing your own condiments and, unfortunately, requesting a doggie bag.

You need to project power and authority, and there is something vaguely weak and humiliating about doing any of the above, especially taking a little doggy bag home from a restaurant. You’re there for business. You shouldn’t be concentrating on your food.

Good manners must be learned and practiced to succeed in the world. Repeating an action often enough makes the action becomes automatic and helps you feel confident. Continually work on your business etiquette skills and you will be better able to focus on business without worrying about saying the wrong thing or making the wrong gesture.

The objective is to be gracious and make people feel comfortable in our presence.

Two Basis Things to Remember:

Understand your role – Guest or Host - understand what is expected of you.

It is not about the food but about building relationships.

“Good manners sometimes means simply putting up with other people’s bad manners.”

H. Jackson Brown Jr.

Ellen Reddick, is a consultant, writer, and former senior executive with more than 25 years of experience in the technology industry. She is the owner & managing partner of Impact Factory Utah

CDC Update on the Multistate Outbreak of Fungal Meningitis and Other Infections: One Year Later

A year ago this month, the Centers for Disease Control and Prevention activated its Emergency Operations Center as part of the response to the tragic outbreak of fungal meningitis linked to three contaminated lots of preservative-free methylprednisolone acetate (MPA) produced by the New England Compounding Center (NECC). As of October 23, 2013, there have been 751 cases of fungal meningitis and other infections associated with this outbreak; 64 of these patients have died. Since July 2013, one new case has been diagnosed.  

This week, CDC has two papers in the New England Journal of Medicine, one describing the clinical aspects of the infections associated with this outbreak and the other summarizing the epidemiologic investigation. The clinical paper, focusing on the early stages of the outbreak, describes patients who experienced a wide variety of illnesses, including meningitis, stroke, arachnoiditis (inflammation of one of the membranes around the brain and spinal cord), and epidural or paraspinal infections which ranged in severity from very mild to life-threatening. The epidemiology paper finalizes the original preliminary report published by the New England Journal of Medicine and details the efforts undertaken by public health agencies to identify and stop the outbreak.

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Conversation Etiquette

We’re all capable of the occasional social blunder. Of course, some of us seem more prone to it than others, but even the savviest of professionals aren’t impervious to such gaffes. No scenario is richer with these potential faux pas than the everyday conversation, in which you can say the wrong thing, do the wrong thing, and occasionally spit on others when trying to pronounce nouns with German etymology.

We’ve all had our moments with conversation etiquette mistakes.

Practice and self-awareness are excellent ways to ensure we master every first and lasting impression. Please keep in mind that the communication process is only complete once the receiver has understood the message of the sender.

‘The single biggest problem in communication is the illusion that it has taken place.’ George Bernard Shaw

1 - Interrupting

This is the No. 1 conversation etiquette mistake, committed by everybody at one time or another. It’s unbearable for the one getting cut off, and it shows the interrupter truly has no

Influenza Season is Almost Here

As the 2013-2014 influenza season quickly approaches, now is an opportune time to send reminders and schedule appointments for patients’ flu vaccinations. Seniors and people with chronic health conditions—like asthma, diabetes, and heart disease—are at a higher risk for serious complications from the flu. According to the Centers for Disease Control and Prevention, last season overall deaths attributed to flu and pneumonia were the highest in nearly a decade, and people 65 years and older accounted for half of all flu-related hospitalizations. Recommending and offering flu vaccine to Medicare beneficiaries ahead of the flu season is very crucial, as patients are more likely to get vaccinated when flu vaccination is recommended and offered by a health care professional.

Generally, Medicare Part B covers one influenza vaccination and its administration per influenza season for Medicare beneficiaries without co-pay or deductible.  Note: The influenza vaccine and its administration are covered under Medicare Part B. Influenza vaccine is not a Part D-covered drug.

For more information on coverage and billing of the influenza virus vaccine and its administration, please visit:

• CMS Medicare Learning Network® Preventive Services Educational Products and CMS Immunizations web pages. (Check back for CMS 2013-2014 influenza season updates — coming soon to these web pages). 
• MLN Matters® Article #MM8433, “Influenza Vaccine Payment Allowances - Annual Update for 2013-2014 Season.”
• While some providers may offer the flu vaccine, others can help their patients locate a vaccine provider within their local community. HealthMap Vaccine Finder is a free, online service where users can search for locations offering flu and other adult vaccines.

Online Medical Journals Accept Fake Study: Could the Public Be Hurt?

A fake study that was accepted at dozens of medical journals for a fee has experts worried that lax oversight of published studies could affect the health of patients searching for medical answers online.

The fake paper was written by John Bohannon, a science journalist who received his doctorate in molecular biology at the University of Oxford. Bohannon submitted the paper to 302 open-access medical journals as an experiment over 10 months.

The results of Bohannon’s experiment were published in Science, a peer-reviewed general science publication that charges subscription fees.

“I chose, for the start of this, to [target] open-access publishers who charge fees for scientists to publish,” Bohannon told ABCNews.com. “Acceptances kept on coming more frequently than rejections. … I thought it would be more like 10 percent.”

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APhA kicks off American Pharmacists Month

WASHINGTON — The message in October is "Know Your Pharmacist, Know Your Medicine" as the American Pharmacists Association launches its annual American Pharmacists Month.

The APhA said the messaging for the month is based on "one essential fact" seen in pharmacies, clinics and other care sites: The more patients know their pharmacist, the more they will know about their medications, the documented successes and cautionary tales, the risks and benefits and potential side effects and contraindications of medications. Patients, the APhA said, should choose their pharmacists as carefully as they choose their doctors.

The organization said that while Americans spend billions on medications every year, the most expensive medications are the ones that don't work properly or cause harm due to misuse. Failure to take medications as prescribed causes more than 1.5 million medication-related adverse events, and costs the healthcare system about $290 billion each year, the group said. But when patients know their pharmacist and feel comfortable seeking their advice, the likelihood of medication errors decreases.

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