To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: Small but Powerful! Auxiliary Labels

Let's talk about pharmacy auxiliary labels for a minute; you know, those small labels that you add to a prescription vial or are automatically printed for you on the label if your software system permits. If you still use the "rows" of different colored labels in a holder then you periodically have to tear off the backing as it tends to accumulate.

When auxiliary labels of different colors, etc. are applied to a container, they are easily noticed and read. However, if they are printed on the label with the same color ink, there is a very good chance they are not going to be read. In some cases, the printing may be as small as 4 to 6 point, compared to about 10 point fonts for parts of the rest of the label.

These auxiliary labels, properly used, serve a very important purpose as we all know. The question is, how many (if any) auxiliary labels should be used for each prescription? Oftentimes what you see in regulations is "Auxiliary labels as appropriate." The question is, "appropriate for what"? Too many auxiliary labels on a container render the labels almost useless. Too few auxiliary labels and the pharmacist may be involved in litigation for failure to warn, etc.

Is there any place that tells you exactly which labels to use for which drug? I don't think so. Many say you just look at the package insert and pick out what is sufficiently important to warrant an auxiliary label. Really? With all the information contained in a package insert, where does one draw the line? Too much information may cause the patient to hesitate to take the medication.

This is a subject that is often overlooked during the education of a pharmacist; I have not seen any continuing education on this topic, and still wonder what "as appropriate" means. If a situation gets to the point of litigation due to an adverse event when insufficient labeling was on the prescription container, the pharmacist can be at a great disadvantage.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

U.S. Supreme Court to Review Vermont's Prescription Data Mining Case
The U.S. Supreme Court has agreed to determine the constitutionality of a Vermont law that requires a doctors' consent before their identifying information in prescription records can be sold or used for marketing prescription drugs. Data mining companies and PhARMA has challenged this law on First Amendment grounds. The Vermont federal district court upheld the law after trial; however, a divided panel of the Second Circuit Court of Appeals reversed that decision in November 2010. Vermont physicians pushed for this law because of their concerns about privacy and because they view this data mining practice as an intrusion into the way they practice medicine.
http://pharmalive.com/news/index.cfm?articleID=754007&categoryid=9&newsletter=1

Methamphetamine Abuse Continues to Flourish Despite Tracking Laws
Tracking the sales of cold medicines used to make methamphetamine have failed to slow the drug trade. Instead, they have created a large, highly lucrative market for profiteers to buy over-the-counter products and sell them to meth producers at a huge markup.

Thousands of new people have entered into the methamphetamine underworld over the last few years, according to an AP review, stating that it's almost like a subcriminal culture. DEA agents explain that the lawbreakers use GPS units set up in a van with a list of every single pharmacy or retail outlet. They'll spend the entire week going store to store and buy to the limit. Next, inside their vehicles they punch out blister packs into a bucket and even clip coupons.
http://www.google.com/hostednews/ap/article/ALeqM5iHhoQ0Kc7zuwJDCYkdjkRCwB47Xg?docId=3758fd7c9cb7452eb65547aaa92ea9ef

Morphine Overdoses with Approved Product
Roxane Laboratories and the FDA have notified healthcare professionals that serious adverse events and deaths have resulted from accidental overdoses of morphine sulfate oral solutions (especially with the high potency 100-mg/5-mL product). The morphine sulfate oral solutions were ordered in milligrams (mg) but were mistakenly interchanged for milliliters (mL) of the product in most of these cases.

Morphine sulfate oral solution is a pre-1938 unapproved drug that has been on the market for well over 50 years. The approval of this specific product is part of FDA's unapproved drugs initiative. Up to this recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly FDA approved product labeling and packaging feature revisions were intended to reduce the risk of medication errors.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts
/ucm239559.htm

FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings
A maximum of 325 milligrams of acetaminophen per tablet/capsule has been requested by the FDA to manufacturers to reduce risk of liver toxicity. The FDA is also requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

The higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.
http://pharmalive.com/news/index.cfm?articleID=755057&categoryid=9&newsletter=1

�that auxiliary labels are all around us? Look at your automobile, some home appliances, tags on your mattresses, etc.

Label Review
Review your professional practice activities related to "auxiliary labels" to make sure that they are serving their intended purpose and meet regulatory standards.