FDA updates ongoing safety review of Actos
SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.
As part of its ongoing safety review of Actos (pioglitazone), the FDA said that information about this risk will be added to the "warnings and precautions" section of the label for the drug and other pioglitazone-containing medicines. In response, Takeda said that it "is working with [the] FDA to make appropriate updates to the prescribing information."
The drug maker also confirmed that it is supporting a 10-year epidemiological study that investigates the questions raised about the association of Actos and bladder cancer. The study, which commenced in 2002, is being conducted by the University of Pennsylvania and Kaiser Permanente Diabetes Registry of Northern California. Takeda noted it will support the study through its conclusion at the end of 2012 and will report on the study results upon completion.
Report: EMR market to pass $6 billion mark by 2015
DALLAS — The market for electronic medical records in the United States may exceed $6 billion in value in five years, according to a new report by research firm MarketsandMarkets.
In the report, “U.S. Electronic Medical Records (EMR) Market, 2010-2015 (Market Share, Winning Strategies and Adoption Trends),” released this month, the firm said that the market was expected to grow from $2.17 billion in 2009 to $6.05 billion in 2015.
The report noted that the electronic medical record market space in the United States is “highly fragmented,” with Allscripts’ 15.7% share dominating a physician office EMR market that includes more than 1,000 players.
Shellpak blister packaging could boost medication adherence, study finds
RICHMOND, Va. — Patients who used a calendar blister packaging system for their medications showed greater medication adherence than those using traditional vials, according to a new study published in the journal Clinical Therapeutics.
The study, which used pharmacy dispensing data on 3.1 million pharmacy patients taking generic medications for cardiovascular diseases, found that MeadWestvaco’s Shellpak blister packaging increased the likelihood that they would get refills on their prescriptions. For example, new medication users increased the average length of their therapies by nine days over a year, while ongoing users increased it by five days, and those taking fixed-dose combination formulations of two medications in a single tablet increased it by 12 to 17 days.
In addition, patients using Shellpak were more likely to reach “full refill adherence” at least 80% of days covered with medication in a year than those using vials, with the greatest effect seen in new medication users.
“We know there are many factors affecting medication adherence, and we know that the most successful solutions will involve multiple components,” study author and life sciences research consultancy Venebio founder Lenn Murrelle said. “What’s exciting about this study is that medication packaging alone was found to have a positive effect on medication refill behavior.”