FALLS CHURCH - Recalls continue to be an ever-increasing time-expense on healthcare, according to mid-year statistics from RASMAS .
RASMAS collects and posts recalls and product safety notices for the healthcare industry. Between January and June 2010, RASMAS statistics show that the number of product safety notices and alerts increased 10 percent over the same period in 2009, as compared with a 4 percent increase from 2008 to 2009. RASMAS has released 1,752 alerts to its subscribers as of the end of June 2010; an average of 67 per week. This compares to 62 alerts per week in the same 2009 period.
Bill Klein, manager of RASMAS data, attributes the rise in the number of notices to to the large number of over-the-counter drug recalls by McNeil Consumer Healthcare and the numerous recalls of tainted food.
“It could be that the FDA or manufacturers are pushing out alerts at a faster pace,” says Klein. “In the past manufacturers and the FDA would identify a problem, conduct an investigation, and eventually the recall notice would be published in an FDA Enforcement Report.” But with the criticism over Tylenol and other issues, Klein believes that the FDA may be moving faster when there is a problem. “The Heparin recalls of 2008 were a wake-up call to the FDA and Congress,” says Klein.
When food recall statistics are excluded from the results, RASMAS data shows that general healthcare recalls have surged by over 15 percent. Klein reports that the busiest month for recalls this year was March, when healthcare facilities received 420 recall notices, compared to 286 recall notices issued in March 2009, a 47 percent increase.
Last year, peanut recalls were a major issue that negatively affected both consumers and the healthcare industry, Klein says. This year, other food issues have surfaced, including Salmonella-contaminated food ingredients.
Recall Themes in 2010
Some major types of recalls in the first half of this year:
- Toys and Cribs: While cadmium tainted Shrek glasses from McDonald’s made the news this year, some older recall issues have not been resolved. Health Canada issued a reminder notice that Fisher Price “Little People” manufactured prior to 1991 should be discarded, because they can be lodged in a child’s throat. Health Canada has become aware of the death of a 10-month-old child resulting from the use of one of these older products. The death occurred after an older “Little People” figure became lodged in the child’s throat. Drop Side and Fixed Side Cribs were also subject to numerous CPSC and Health Canada recalls this year. These recalls highlight the issue of millions of recalled products that remain in homes and on shelves because recall announcements were missed.
- HVP and Salmonella: Contaminated or possibly contaminated food continued to be a big issue in 2010. The recalls this year include Salmonella-contaminated HVP (Hydrolyzed Vegetable Protein) supplied by Basic Food Flavors of Las Vegas, Nevada. Another contributor to recalls was Salmonella-contaminated pepper from the Mincing Overseas Spice Company.
- Imports: Some drugs made overseas had issues with quality. Claris Lifesciences recalled intravenous Metronidazole, Ondansetron, and Ciprofloxacin due to “floating matter” which could be an indication of lack of sterility or contamination. The Indian manufacturer Aurobindo Pharma Limited, Andhra Pradesh recalled Sertraline HCL Tablets, 100 mg. because a foreign tablet of Zolpidem Tartrate Tablets, 10 mg, was found in a bottle.
- Undeclared Ingredients, Out of Specification: A number of recalls this year have been for ingredients that were not declared. For instance, JTM Foods Inc. of Erie, Pennsylvania recalled marshmallow treats because of undeclared colors FD&C Yellow #5 and Yellow #6. Many recalls were for drugs “out of specification” for various parameters such as stability and expiration date. PL Developments, Inc. of Westbury, NY recalled over 1.4 million bottles of Ketotifin eye drops in March because they were out of specification for pH.
- Market Withdrawals: Pfizer pulled the drug Mylotarg (gemtuzumab ozogamicin for injection) used for the treatment of relapsed acute myeloid leukemia. Pfizer took the action at the request of the FDA after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit.
Below are statistics from RASMAS for the first half of 2010:
All Recalls/Alerts Per Month Released By RASMAS
All Recalls/Alerts per Month by RASMAS, Excluding Food
Breakdown of RASMAS Alerts by Subject Area, January-June 2010
|Children’s Consumer Products||9%||8%|
|Engineering and Facilities||6%||5%|
|Operating Room Products||5%||12%|