AMA Announces New Policies on DTC Advertising, Price Transparency

At its annual meeting in June, the American Medical Association (AMA) voted for a temporary moratorium on direct-to-consumer (DTC) advertising of newly approved prescription drugs. AMA President-elect Ronald M. Davis, M.D., said a moratorium would allow physicians to become better educated on the advantages and disadvantages of a drug before prescribing it, and better able to determine its suitability for a patient’s medical needs. The time interval of the moratorium would be decided by the U.S. Food and Drug Administration (FDA). The AMA also adopted guidelines for pharmaceutical companies to follow in the preparation of DTC advertising and called for additional research into the effects of DTC advertising on patient-physician relationships, health outcomes, and health care costs.

After discussing price transparency for patients, the AMA urged the health insurance industry to end efforts to conceal medical service pricing systems, noting that there is no legitimate rationale for such concealment, and pledged to take action to promote true price transparency. Other issues on which the association voted include patient adherence to treatment plans, influenza vaccine supply and distribution, health coverage for all, and direct public appeals for organ donations. For more information on these policy decisions, visit the AMA Web site at http://www.ama-assn.org/ama/pub/category/1578.html.

AAP Supports Recommendations of IOM Emergency Care Report

In a series of three reports on emergency care services, the Institute of Medicine (IOM) of the National Academies stated that insufficient funding and uncompensated care have reduced the capacity of the U.S. emergency medical system. Among the key findings of the report are that although children constitute 27 percent of all emergency department visits, only 6 percent of U.S. emergency departments have the necessary supplies for pediatric emergency care, and that many drugs and medical devices have not been adequately tested on or dosed properly for children. The report recommends that pediatric presence be enhanced throughout emergency care, and that Congress increase funding for the federal Emergency Medical Services for Children (EMSC) program to $37.5 million per year for five years. The American Academy of Pediatrics (AAP) commended the report, which it said highlights critical gaps for children in equipment, research, and disaster preparedness, and pledged its help in ensuring the recommendations are carried out. The AAP has been lobbying Congress to increase fiscal year 2007 funding for the EMSC program; President Bush’s budget proposal recommended that funding for the program be eliminated. For more information, visit http://www.aap.org/advocacy/washing/pecr_rel.htm. The full reports are available at http://www.iom.edu/CMS/2955.aspx, and from the National Academies Press (telephone 800–624–6242).

CDC Urges Awareness of Measles in Travelers to World Cup

The Centers for Disease Control and Prevention (CDC) advised physicians and travelers to be aware of potential exposure to the measles virus in Germany, where the 2006 World Cup soccer championship took place. More than 1,000 cases of measles have been reported in the North Rhine-Westphalia region of Germany since January 1, and three of the games’ host cities (Cologne, Dortmund, and Gelsenkirchen) are in this area. The CDC recommends that physicians ask patients with fever about their vaccination history and recent international travel, and that travelers returning from Germany see a health care provider if they develop symptoms of measles. More information about the measles outbreak and travel precautions is available on the CDC Web site at http://www.cdc.gov/travel.

FDA, ISMP Launch Campaign to Reduce Errors Caused by Abbreviations

The FDA and the Institute for Safe Medication Practices (ISMP) have launched a nationwide educational campaign to reduce the number of medication errors caused by unclear medical abbreviations. Medication errors are responsible for more than 7,000 deaths each year, according to the IOM, with mistakes occurring anywhere in the system from prescription to administration. The FDA and ISMP campaign addresses the use of potentially confusing abbreviations in all forms of medical communication, from written prescriptions to commercial advertising, and focuses on stopping the use of these abbreviations by health care professionals, medical students and writers, the pharmaceutical industry, and FDA staff. Common abbreviations that the campaign will target include “U” for “unit” (mistaken for “0,” “4,” and “cc”) and “IU” for “international unit” (mistaken for “IV” and “10”). A list of abbreviations, symbols, and dose designations associated with medication errors is available at http://www.ismp.org/PDF/Error-Prone.pdf; campaign materials can be accessed at http://www.fda.gov/cder/drug/MedErrors.

CMS Proposes Changes to Physician Fee Schedule Methodology

The Centers for Medicare and Medicaid Services (CMS) has issued a notice of proposed changes to the Medicare physician fee schedule that include increases for evaluation and management services (i.e., those involved in evaluating a patient’s condition and determining treatment). The CMS expects that providing financial support to physicians for helping patients manage their illnesses more effectively will result in improved outcomes for patients. The notice also proposes changes to the calculation of practice expenses to make the methodology more transparent, comprehensible, and consistent, and to use data reviewed by the AMA Relative Value Update Committee. For example, a bottom-up methodology involving procedure-level data would be used to calculate direct costs, and the “nonphysician work pool” exception would be eliminated. The proposed notice appears in the June 29, 2006, Federal Register; comments will be accepted until August 21, and a final rule will be announced in November. For more information, visit http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1887.

SAMHSA Reports 2.4 Million Persons Initiated Pain Relievers in One Year

According to a report released by the Substance Abuse and Mental Health Services Administration (SAMHSA) using data extracted from the 2004 National Survey on Drug Use and Health, more persons initiated nonmedical use of narcotic pain relievers in one year than initiated use of marijuana or cocaine. The report, “Nonmedical Users of Pain Relievers,” showed that in the 12 months preceding the survey, 2.4 million persons age 12 or older began nonmedical use of prescription pain relievers, 2.1 million began use of marijuana, and 1 million began use of cocaine. The report also showed that pain medications were the first drug of abuse in only 26 percent of new users: 66 percent had previously used marijuana, 25 percent had used hallucinogens, and 21 percent had used inhalants. The full report is available on the SAMHSA Web site at http://www.oas.samhsa.gov.

HHS Issues Final Rule for Smallpox Vaccine Injury Compensation

The U.S. Department of Health and Human Services (HHS) has announced the final rules for its Smallpox Vaccine Injury Compensation program, which provides eligible members of an HHS-approved smallpox emergency response plan and others injured by a smallpox vaccine with medical benefits and lost employment income. Superseding and updating rules published in the December 16, 2003, Federal Register, and effective immediately, the final rules clarify the definition of a child survivor, extend the period in which a person may receive the vaccination and be considered for benefits, and address who may be considered for benefits. As well as smallpox vaccine recipients, eligibility may extend to persons who were not vaccinated but were injured after contact with a vaccinated individual. For more information, visit http://www.hhs.gov/news/press/2006pres/20060616.html.