Children's Drug Testing Needed

A team of European researchers has called for greater scrutiny of the off-label use of prescription drugs in children.

The researchers studied prescribing practices in the children's wards of five hospitals in England, Sweden, Germany, Italy, and the Netherlands. They examined 2262 drug prescriptions that were written for 624 children during a 4-week period in 1998. The researchers found that almost half, or 1036, of the prescriptions were either for drugs not licensed for use in children or were off-label: administered outside the scope of the license in terms of age, dosage, frequency, or intended use of the drug.

The findings, which appeared January 8 in BMJ, revealed that two thirds of the children received an unlicensed or off-label drug prescription while hospitalized. Drugs used for the treatment of asthma and pain relief were most frequently prescribed off-label.

Study authors said the use of off-label or unlicensed drugs to treat children is probably widespread throughout Europe. They called for action from the European Union, national health departments, and the European Medicines Evaluation Agency to increase clinical trials of medications in children.

While disturbing to family members and health care professionals, spontaneous movement in patients diagnosed with brain death may be more common than previously realized.

In the January 11 issue of Neurology, researchers from Argentina and Spain reported on movement in patients who showed no brain activity on electroencephalogram tests. The Argentinean study included 38 patients diagnosed with brain death during an 18-month period. Fifteen, or 39%, had motor movements such as bending of toes or jerking of fingers. In all cases, movement occurred in the first 24 hours after the diagnosis; no movements were seen after 72 hours.

The study from Spain described movements in a 30-year-old woman and an 11-month-old child. Both extended their arms, flexed their wrists, and curled up their fingers each time a mechanical ventilator inflated their lungs. José Bueri, MD, of J. M. Ramos Mejia Hospital in Buenos Aires, said the movements are spinal reflexes. "Family members and others need to understand that these movements originate in the spinal cord, not in the brain, and their presence does not mean that there is brain activity," Bueri said. Improved understanding of how these movements occur has important implications for organ procurement for transplantation, he noted.

Snoring may serve as a wake-up call for pregnant women who are likely to develop hypertension and deliver infants with low birth weights. Because snoring is common during pregnancy, investigators in Sweden set out to determine if it affects the health of pregnant women. Researchers at Umea University Hospital studied more than 500 pregnant women, and they analyzed birth weight and Apgar scores of their infants.

Last month in Chest, the researchers reported that 24% of the women said snoring started or worsened by their third trimester; 23% said they snored every night or almost nightly in the last week before delivery. Of habitual snorers, 11% had sleep apnea, compared with 2% who snored less often.

Pregnancy-induced hypertension was present in 14% of the habitual snorers, but in only 6% of infrequent snorers. Of habitual snorers, 10% had preeclampsia, compared with 4% of those who snored infrequently. Infants of habitual snorers were more likely to have lower birth weights and lower Apgar scores, the researchers reported.

Study author Karl Franklin, MD, said pregnant women may be particularly vulnerable to snoring because of increased abdominal pressure that affects breathing and upper airway resistance. He said further study is needed to determine if increased upper airway resistance causes preeclampsia.

Setting the stage for worldwide quality improvement efforts, the Joint Commission International (JCI) has published the first comprehensive set of international quality standards for hospitals.

The standards will serve as a basis for JCI accreditation of individual health care facilities, as well as for establishing accreditation programs in nations outside the United States. The standards can guide international health care organizations in preparing for a JCI survey, seeking or maintaining accreditation, and improving overall performance.

"Health care organizations around the world are seeking to create environments that focus on quality and strive for continuous improvement," said Karen Timmons, JCI chief executive officer. The standards are adaptable to local legal, religious, and cultural practices. They have been evaluated in tests in Latin America, Western Europe, and the Middle East. In addition to patient care and safety, they address family rights, infection control, and other areas.

The JCI, established in 1998 by the Joint Commission on Accreditation of Healthcare Organizations, has provided consulting services to more than 40 nations, including Poland, Russia, and South Africa. For more information on the standards, send e-mail to pvanoste@jc-ia.com, see http://www.jcwc.com, or telephone (630) 268-3432.