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Last Updated
December 12, 2014
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December 11, 2014
New Guidelines Supporting mL for OTC Liquid Medicine Dosing
The Consumer Healthcare Products Association (CHPA) Board of Directors recently approved changes to
CHPA’s voluntary guidelines addressing dosing of liquid pediatric over-the-counter (OTC) medicines.
 Key changes to the voluntary guidelines include: 
• Deleting “spoon” labeling (i.e., teaspoon, tablespoon) on dosing directions and dosing devices,
• Specifying use of “mL” only in dosing directions and on devices, and
• Deleting the provision in dosing directions of a definition of any volumetric unit of measure
(i.e., mL = milliliter).

The updated guidelines replace the previous version of this document approved in November 2009 that
specifies mL as the preferred unit of measure.

The changes are supported by the Centers for Disease Control and Prevention (CDC) PROTECT
(Preventing Overdoses and Treatment Errors in Children Taskforce) Initiative, who partners with the
CHPA Educational Foundation on the UpandAway.org safe medicine storage campaign. 

In addition, the National Council on Prescription Drug Programs has also recommended a move to “mL
only” labeling (for prescription liquid medicines), and a recent FDA draft guidance document
addressing issues aimed at enhancing safe use of OTC pediatric liquid acetaminophen products also
specifies that dosing directions should be provided in mL only

December 10, 2014
Drug Trials Snapshots, with John J. Whyte, M.D., MPH, Director, Professional Affairs and Stakeholder Engagement, CDER, FDA
The FDA relies upon mandated, industry-sponsored clinical trials to make decisions about medical
products. In years past, questions about adequate and equal inclusion of women and people in racial
minority groups have been raised. Many stakeholder groups want FDA to require drug companies to
include certain percentages of demographic subgroups in clinical trials and analyze subgroup data
by sex, race and age before a drug is approved. While the FDA has many regulations and policies in
place regarding clinical trials, these studies are the responsibility of the manufacturer that is
developing the drug. To address stakeholder concerns, FDA released an “Action Plan to Enhance the Collection and
Availability of Demographic Subgroup Data.” One priority stated in the report is to make
demographic data from clinical trials more available and transparent. To reach this goal, FDA’s
Center for Drug Evaluation and Research is releasing drug trials snapshots that outline the
participation of people in clinical trials by sex, race and age. The drug trial snapshots highlight
information in an easy-to-read format. 

December 10, 2014
Report Finds Long-Term Painkiller Use on the Rise
Nearly 7 million insured Americans filled at least one prescription for an opioid between 2009 and
2013, according to a new Express Scripts report. Data also showed that, while fewer patients are
taking opioids these days, those that do so are using the drugs for longer periods. "Not only are
more people using these medications chronically, they are using them at higher doses than we would
necessarily expect," stated Dr. Glen Stettin, Express Scripts senior vice president. "And they are
using them in combinations for which there isn't a lot of clinical justification." (source:   NY
Times). 

December 8, 2014
Automated Reminders Improve Medication Adherence & Cholesterol Control
In a published study, researchers observed that people who received automated reminders were more
likely to refill their blood pressure and cholesterol medications. The study included more than
21,000 Kaiser Permanente members in Oregon, Washington, Georgia, and Hawaii who had diabetes or
heart disease and who were on medications for management of their disease from 2010-2011. The
researchers examined the PROMPT reminder program and used three arms: usual care, an automated
telephone intervention, and a personalized health report and educational mailings. The interactive
phone calls lasted about 2-3 minutes, reminding patients to refill their prescription and then
giving them the option to be transferred to an automated refill line, or in some cases to speak
with the pharmacist.

At the beginning of the study, patients were taking their medications a little more than half the
time. Adherence levels went up among all participants, but increased by more (1.6-3.7%) among
participants who received the reminders. This may not seem significant, but the authors say that,
in a large population, even small changes can make a big difference.  Patients in the enhanced
group also saw significant reductions in their cholesterol levels. The effect was more apparent in
those considered uncontrolled with levels above 100 mg/dl. On average, this group had a 3.6mg/dl
greater reduction in cholesterol compared to people with usual care who started uncontrolled but
received no reminders.

The small jump might not mean a lot to an individual patient, but on a population level, it could
translate into fewer health complications such as heart attacks, resulting in fewer deaths and
fewer hospitalizations to make a positive impact on public health. 

(Ref: Cynthia S. Rand, PhD et al. Improving Adherence to Cardiovascular Disease Medications with
Information Technology. American Journal of Managed Care, November 2014).

December 8, 2014
FDA Final Rule: Changes to Pregnancy & Lactation Labeling Info for Rx Drug and Biological Products
There are over six million pregnancies in the United States every year, and pregnant women take an
average of three to five prescription drugs during pregnancy. Women with pre-existing medical
conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs
to treat those conditions during pregnancy and breastfeeding. Women may also need to take
medications for new or acute conditions that may occur during pregnancy or breastfeeding. The new
labeling format and requirements reorganizes information and is structured to help inform health
care professionals’ prescribing decisions and the counseling of patients using prescription drugs.

The FDA is also issuing a draft guidance for industry to help drug and biological product
manufacturers comply with the new labeling content and format requirements. The draft guidance
provides a detailed description of how the labeling is to be formatted subsection-by-subsection,
noting the type of information that should be included under each heading.  Although comments on a
guidance can be submitted at any time, public comments should be submitted within 60 days of
publication to ensure that they are considered when the FDA begins work on finalizing the draft
guidance.