Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone

AUDIENCE: Pain Management, Anesthesiology

ISSUE: FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use. 

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

BACKGROUND: To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

RECOMMENDATION: Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, includng a link to the FDA Drug Safety Communications, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm

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Pharmacists Increasingly Take On Clinical Roles

By Anna Gorman

KHN Staff Writer

Feb 11, 2014

NORTHRIDGE, Calif. -- Jill Freedman felt like her heart was jumping out of her chest. She knew her blood pressure was too high and feared having a heart attack or a stroke.
"I was freaking out," said Freedman, 55. "You get very emotional when you think you could drop dead at any moment."
Her doctor doubled one of her medications, she said, but that only made her feel worse. So Freedman turned to the one person she knew she could count on -- her pharmacist.
Read More

American Heart Month

Heart disease is responsible for 1 of every 4 deaths in the United States, making it the leading cause of death in our nation. As we observe American Heart Month, there are some key steps you and your loved ones can take to protect against heart disease.

By maintaining a healthy diet, getting regular exercise and not smoking, you can dramatically reduce the risk of premature death or disability due to heart disease. Awareness of risk factors is also critical to preventing heart disease. Far too many people who are at high risk for heart disease don’t know it. That is why it is so important to get your blood pressure and cholesterol checked regularly and to speak with your doctor about your health history.

When a Small Reminder Makes a Big Difference

Have you ever had one of those little warning icons light up on your car’s dash and you don’t know what it means?  You know that some signals require attention right away and others can wait.  The thing is, most of the time you have to look up the icon to make that decision.

When it comes to medicines and people’s lives, there is no substitute for being clear about a warning, and for injectable drugs the stakes are particularly high.  Beginning December 1st, manufacturers of injectable drugs will have to comply with new labeling standards that help ensure that important warnings — warnings that can help prevent life-threatening situations — are obvious and clear.  The standards were established by the U.S. Pharmacopeial Convention (USP).  USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP's mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

In short, this USP standard states that warning messages – for example, “Warning – Paralyzing Agent” or “Dilute Before Using” – are the only markings that should appear on ferrules and cap overseals of injectable drugs.  The ferrules and cap overseals must remain clear of any markings, including logos, except for markings intended to prevent an imminent life-threatening situation.  The standard goes on to say that warnings must be printed in contrasting color and clearly visible under ordinary conditions of use.  Finally, products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent.

With the new USP labeling standard, if a healthcare provider sees a warning on a ferrule or cap overseal, he or she will know immediately that it is a vital, possibly life-saving piece of information that must be observed and acted upon before administering the drug to the patient.

Warning messages on ferrules and cap overseals may go a very long way to helping practitioners protect their patients from harm.

The Legislative Session to Begin January 27th

The holidays are over and the New Year is fresh out of the gates.  With it comes change:  large and small, internal and external, desired and endured.  This is also the time of the year that the lawmakers of the state prepare to make changes – often changes that directly affect us in the way we practice pharmacy.  As the legislative session convenes, we need to be prepared to weigh in on those bills that relate to how we do business – for good or for ill.

Many people don’t get involved because they don’t know how.  They are afraid of doing the wrong thing or making things worse.  Others feel that they are just one voice – what good can they do?  That is the point of being part of a professional association.  If one representative gets one e-mail from one constituent, it will have a small effect.  If dozens get e-mails from dozens of constituents, it will have a larger effect.  In that spirit, here are some tips for contacting those who represent you.

2014 to Offer Continued Success for UPhA

What a wonderful year it has been for the Utah Pharmacy Association.  We are excited as we enter the New Year and look forward to the new opportunities that the New Year will bring to the profession of pharmacy. 

On the National pharmacy front we continue to see much discussion about provider status and how we as pharmacists can and should play a larger role in the direct care of our patients…and get paid for that care.  The American Pharmacists Association and other National pharmacy associations are deeply committed to helping pharmacists receive provider status.  There is much discussion as to how that would and could change our roles as pharmacists. 

As professionals, we need to be aware of these ideas and goals on a national basis, but more importantly, we need to be involved locally.  We are only days away from our 2014 Utah Legislative Session.  We are aware of a few items that have already been introduced that will affect our profession.  We cannot continue to sit idle on the side lines and expect that someone else will take care of our needs.  Now is the time to be involved.  Your first step should be to offer your services and knowledge to your State Senator and Representative.  They should know you and know that you can be a resource for them if they have pharmacy or health care related questions.