News in Brief: Week of July 1-5

July 03, 2013 05:04 pm News Staff
[News in Brief]

Cracked Vials Prompt Hepatitis B Vaccine Recall

According to an FDA announcement(, a Merck & Co. Inc. subsidiary has initiated a voluntary recall of one lot of its its adult hepatitis B (recombinant) vaccine (RECOMBIVAX HB) because of the potential for cracked vials.

The only lot impacted by the recall -- No. J001183 -- was distributed in the United States between March 12 and May 2, 2013. According to Merck, there is adequate inventory to replace recalled product at this time.

The FDA recommends that if product from this lot has been administered, revaccination is not necessary, but physicians and other health care professionals should inventory and quarantine all product from the affected lot and return the product to Merck.

Adverse effects that may be related to use of these products can be via the FDA and CDC's Vaccine Adverse Event Reporting System(

Providers Without Authority Writing Prescriptions, Says OIG Report

The Medicare program paid $5.4 million for prescription drugs in 2009 that were ordered by individuals who did not have the legal authority to prescribe the medications, says a new report( issued by the Office of the Inspector General (OIG).

In 2009, Medicare inappropriately paid for 72,552 prescriptions ordered by 14 prescriber types who "clearly do not have the authority to prescribe in any state," according to the report. These provider types included dietitians, nutritionists, massage therapists, athletic trainers and nursing technicians, among others.

The report noted a long list of abuses, including that 713 dietitians and nutritionists wrote more than 20,000 prescriptions in 2009, which resulted in charges of about $1.6 million for the Medicare program. Massage therapists ordered 12,082 prescriptions at a cost of $798,991, and athletic trainers ordered another 8,795 prescriptions at a cost of nearly $700,000. In addition, contractors who complete home repairs or modifications to accommodate a health condition ordered 2,827 prescriptions at a cost of $178,443.

The report found that most of the prescriptions ordered by individuals without legal prescribing authority were for commonly used medications. But nearly 30,000 of the ordered prescriptions were for controlled substances, and of those prescriptions, 7,679 were for Schedule II medications, which have a high potential for abuse.

The OIG report called on CMS to take a series of steps to curb inappropriate prescribing, including an increase in prescriber monitoring.

EHR Association Develops, Releases First Code of Conduct

The Electronic Health Record (EHR) Association, a collaboration of more than 40 EHR companies, recently announced the release of its first EHR developer code of conduct. The code is designed to show member companies' commitment to safe health care delivery, continued innovation and high integrity. It covers topics such as general business practices, interoperability, data portability, clinical and billing documentation, and patient engagement.

According to a recent press release(, the code is available online(, as is a list of frequently asked questions and an implementation guide. The association expects the code to evolve along with the rapidly growing health information technology industry.

Administration Postpones Coverage Requirement for Larger Businesses

The Obama administration is postponing for one year( a provision in the health care reform law that requires businesses with 50 or more employees to provide health insurance coverage for those employees.

The requirement, which was enacted as part of the Patient Protection and Affordable Care Act, was scheduled to take effect on Jan. 1. The new 2015 implementation deadline is intended to allow federal regulators to work on streamlining the requirement and to give affected businesses more time to comply.

The postponement does not affect other parts of the Affordable Care Act, such as the individual insurance mandate or the establishment of state-based health insurance marketplaces.

Patient Registry Online, Accepting Registrations

The Agency for Healthcare Research and Quality (AHRQ) has announced( its Registry of Patient Registries( (RoPR) now is available online and is accepting registrations for patient registries.

A database of existing patient registries, RoPR was designed with extensive stakeholder participation to promote collaboration, reduce redundancy and improve transparency in registry-based research.

Information on how to list a registry( in the RoPR can be found at the AHRQ website. In addition, registration for a one-hour RoPR informational webinar( is open. The webinar is scheduled for July 23 at 11 a.m. EDT and will provide step-by-step instructions on listing a registry.