HEALTH

CDC report finds few pediatric emergency visits due to OTC cough-cold medicines

BY Michael Johnsen

ELK GROVE VILLAGE, Ill. The journal Pediatrics, published by the American Academy of Pediatrics, on Monday afternoon released a Centers for Disease Control and Prevention report finding that a relatively low number of emergency department visits for children under 12 years of age are associated with prescription and over-the-counter cough and cold medicines; and of those, a majority of those visits is due to unsupervised or accidental ingestion by children between the ages of 2 and 5 years.

“This CDC review puts the overall discussion of pediatric cough and cold remedies into perspective by focusing on concrete data that address the real issue. These medicines are safe when used as directed, and this government review underscores the importance of educating consumers—especially those with small children—on the safe use and safekeeping of medicine,” stated Linda Suydam, president of the Consumer Healthcare Products Association. 

According to the report, an estimated 7,091 patients nationwide aged 12 years and younger were treated in emergency departments for adverse drug events from cough and cold medications, accounting for 5.7 percent of emergency department visits for all medications in this age group. Almost two-thirds, 64 percent, were for children aged 2 to 5 years. Unsupervised ingestions accounted for 66 percent of estimated emergency department visits, meaning that the child was not necessarily overdosed by their guardian, but happened upon the medicine and consumed it without supervision. “The other third were adults … in general giving an overdose due to a medication problem of some sort,” commented Richard Dart, director of the Rocky Mountain Poison and Drug Center, during a conference call hosted by CHPA at noon today.

“It’s very clear … these really are situations where parents were confused and [either] gave the wrong dosage,” commented Linda Suydam, CHPA president, or inadvertently left the medicines out where curious children could access them. The report underscores two important messages, Suydam said, the need for child-proof packaging and the need for education of appropriate OTC use among parents. The industry is committed to both initiatives, Suydam said. CHPA recently introduced www.otcsafety.org, designed to deliver “parents and healthcare professionals with one message—OTC medicines need to be respected.”

Even then, most children did not require admission or extended observation (93 percent). 

The ADA suggested that targeted education against caregivers may help reduce unsupervised ingestions.

The CDC, in the report, expressed concern that if cough/cold medicines for children younger than six were pulled off the market in an effort to reduce those adverse events, parents may be inclined to administer cough and cold medicines indicated for older children, or for adults, anyway. “Even after the recall of products for children aged 2 years, 64 percent of parents responding to a national survey still considered these medications very safe or somewhat safe and 20 percent plan to continue to use OTC cough and cold medication for their children 2 years,” the report read.

Indeed, it may have been this reason that the Food and Drug Administration earlier this month officially declared that cough and cold medicines were not appropriate to administer to children under the age of two, Suydam said.

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FDA approves label change for Prilosec OTC

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration last week approved Procter & Gamble’s proposed label change for Prilosec OTC.

The design changes include a new Prilosec OTC logo throughout the labeling, a reformatted 2-count professional sample card, a redesigned inner panel of the 2-count consumer sample card, a reformatted package insert and redesigned principal display panel.

The application did not include any changes to the Drug Facts or blister card backing. As part of the approval, P&G must remove “NEW LOOK! SAME RELIEF!” messaging prior to July 18.

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Marsh offers free vitamin program for expectant mothers

BY Michael Johnsen

INDIANAPOLIS Marsh Supermarkets on Thursday implemented a new program designed to help expectant mothers manage health care costs with its Prenatal Select Program, a program that provides free prenatal vitamins using selected products made by the Ethex Corporation.

“We at Marsh understand that while pregnancy is a time of joy, it can also bring with it many concerns,” stated Chris Duffy, Marsh vice president of pharmacy. “Marsh is happy to help alleviate one financial concern with the introduction of our free prenatal vitamin program.”

The news comes in the same month that the Centers for Disease Control and Prevention reported that younger women between the ages of 18 and 24 are the least aware of the benefits in supplementing with folic acid during pregnancy.

In analyzing the results of five national surveys conducted annually by the Gallup Organization between 2003 and 2007, 61 percent of women in this age group were aware of the benefits of folic acid, but only 6 percent knew when folic acid should be taken. In addition, only 30 percent of women in this age group, which accounts for approximately one-third of all births, supplemented with folic acid.

The program is available to anyone with a valid prescription for prenatal vitamins. Once the prescription is presented, the shopper can receive 30 day despensings of selected prenatal vitamins absolutely free with no strings attached for up to one year. The Prenatal Select Program is available at all 41 Marsh pharmacy locations in Indiana. Marsh Pharmacists are available to explain the program and answer any questions.

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