News in Brief: Week of June 13-17

June 15, 2011 06:10 pm News Staff

FDA Encourages Docs to Report Drug Shortages

There were 178 drug shortages -- a record high -- in the United States last year, and, according to the FDA, the increase in the number of shortages has continued in 2011. This has prompted the agency to ask health care professionals to report such shortages(

Physicians also can help by alerting the FDA when information on the agency's drug shortages Web page( does not agree with what they are experiencing in their practices.

Health care professionals with concerns about price-gouging during shortages are encouraged to contact the FDA's Office of Criminal Investigations(

In addition to the FDA's drug shortages Web page, physicians and other health care professionals can find information about ongoing drug shortages, resolved shortages and drugs that are no longer available on the American Society of Health-System Pharmacists website(

New Hardship Exemptions Proposed for Medicare e-Prescribing Incentive Program

In response to concerns from physicians regarding the penalties CMS will impose beginning in 2012 for physicians not doing electronic prescribing, CMS recently released a proposed rule for changes to its Medicare Electronic Prescribing Incentive Program(

The proposed changes would expand the list of hardship exemptions for which physicians can apply. Without an exemption, physicians face a penalty that amounts to a 1 percent Medicare pay cut in 2012. The original rule allows exemptions for rural physicians with limited Internet access and for physicians with limited access to pharmacies that accept electronic prescriptions, but CMS now is proposing exceptions for physicians with limited prescribing activity, physicians who delayed implementing e-prescribing because they intend to participate in Medicare's 2011 electronic health record incentive program, and physicians who live in areas that restrict e-prescribing (e.g., states that prohibit electronic orders for narcotics). Physicians would have until Oct. 1, 2011 to apply for an exemption.

The proposed rule appears in the June 1 Federal Register( Public comments from organizations and individuals will be accepted until July 25.

FDA Moves to Clarify Confusion About Risperidone, Ropinirole

The FDA issued a drug safety announcement( on June 13 to alert the public to more than 200 medication error reports in which patients were given the antipsychotic medication risperidone, which is marketed as Risperdal, instead of the dopamine agonist ropinirole, which is marketed as Requip, and vice versa. The agency said five patients who took the wrong medication needed to be hospitalized.

The FDA said the following factors contributed to the confusion between the two products:

  • similarities of both the brand and generic names;
  • similarities in the container labels and carton packaging;
  • illegible handwriting on prescriptions; and
  • overlapping product characteristics, such as drug strengths, dosage forms and dosing intervals.

The agency issued the following advice for health care professionals:

  • clearly print the drug name on written prescriptions;
  • spell out the drug name when prescribing by telephone;
  • counsel patients about their prescribed medication, making sure the patient understands its purpose, which may help ensure the patient gets the correct medication; and
  • report adverse events or medication errors involving ropinirole or risperidone to the FDA's MedWatch program(

The FDA said it is asking the manufacturers of ropinirole and risperidone, GlaxoSmithKline and Johnson & Johnson, respectively, and generic manufacturers to update their container labels and carton packaging to make it easier to identify the products.

Cystic Fibrosis Foundation Offers Resources for Parents, Docs

The Cystic Fibrosis Foundation has launched a new online resource( to help parents and physicians of infants who have tested positive for cystic fibrosis, or CF. According to the foundation, 90 percent of positive CF test results are false-positives.

The new Web resource, which is intended to help families deal with the stress associated with a positive test, explains what CF is, how each state screens for CF, what a sweat test is and why a newborn may need one, and steps to take if a diagnosis of CF is confirmed. The foundation's resources also include a Web page( for health care professionals.

Most New Osteopathic Medical School Class Members Will Train in Primary Care

The vast majority of students in the first graduating class of A.T. Still University School of Osteopathic Medicine Arizona, or ATSU-SOMA, in Mesa, has chosen to go on to primary care residencies.

According to a news release( from ATSU-SOMA, almost 84 percent of the 92 new physicians will train in residencies in family medicine, internal medicine, pediatrics and OB-Gyn, as well as general surgery andemergency medicine.

A partnership between ATSU-SOMA and the National Association of Community Health Centers has played a large role in encouraging students to choose a primary care specialty, said ATSU-SOMA.

The osteopathic medical students are placed at 11 community clinics around the country for three of their four years of medical school, rather than for only two years, which is more common. In addition, students learn a clinical presentation model that distills patients' symptoms into larger schemes and participate in innovations that emphasize interactive presentations, collaboration and teamwork, and communication skills.

CMS Extends Deadline for Pioneer ACO Model

CMS' Center for Medicare & Medicaid Innovation has extended two deadlines for its Pioneer ACO Model, which is designed to spur the adoption of accountable care organizations, or ACOs, within Medicare.

CMS announced that letters of intent for the model will be due on June 30 instead of June 10, and applications now must be postmarked on or before Aug. 19 instead of the previous deadline of July 18.

For more information on the Pioneer ACO Model, including the request for applications, visit the Innovation Center website(