Leading OTC drug firms will voluntarily expand the use of child-resistant packaging to all cough/cold products while also considering new child-proof package designs to reduce the risk of accidental ingestion, the Consumer Healthcare Products Association says.

"Our companies are all committed to the idea of child-resistant packaging, and most products already have that, and we are working very quickly to make sure all products do," CHPA President Linda Suydam said during a Jan. 28 conference call with news media.

CHPA's announcement that firms will expand child-resistant packaging to products for which it is not required followed the same-day publication of a Centers for Disease Control-funded study that shows unsupervised ingestion accounted for two-thirds of children's emergency department visits related to OTC and prescription cough/cold medicines between 2004 and 2005.

A separate study that analyzed the American Association of Poison Control Centers' database, which is currently under review and has yet to be published, reinforces the CDC's finding that cases involving 2- to 5-year-olds account for the majority of all adverse events related to accidental ingestion, Richard Dart, Rocky Mountain Poison and Drug Center director, said during the conference call.

However, this study adds that 75 percent of all fatal adverse events related to accidental ingestion or overdose of cough/cold products occur in children under 2 years old, Dart said.

While lauding manufacturers' October 2007 decision to remove from the market OTC cough/cold products for children under 2 years old because of potential misuse, Dart said the industry should heed the CDC's suggestions to prevent unsupervised ingestion by older toddlers (¹ Also see "Infant Cold Products Pulled; Waxman Looks For More OTC Risks" - Pink Sheet, 15 October, 2007., p. 6).

More Child-Proof Packaging May Reduce AEs

One of the suggestions made in the CDC study published in the journal Pediatrics is to use childproof packaging on more products to further reduce accidental ingestion related-adverse events.

The researchers, led by Melissa K. Schaefer of the Division of Healthcare Quality Promotion at CDC's National Center for Preparedness, Detection and Control of Infectious Diseases in Atlanta, support their recommendation by noting that current child-resistant packaging reduced the number of children's deaths due to accidental medicine ingestion by 45 percent.

The study also recommends developing innovative changes to child-resistant packaging to further reduce the risk of accidental ingestion. For example, the researchers suggest adding adaptors to liquid medication bottles so medicine can only be accessed with a needle-less syringe.

In addition to being the most common age group to ingest cough/cold medicine without supervision, 2- to 5-year-olds also accounted for 64 percent of overall emergency room visits for cough/cold medications, say Schaefer et al.

Also, a "significantly higher proportion" (8 percent) of cough/cold medication emergency room visits resulted from medication errors like administering an excessive dose than "all other medications combined."

However, pulling cough/cold medication from retail shelves is not the best solution, researchers say. "If these medications are removed from the market, caregivers may be tempted to substitute products that are labeled for use by older children and adults," Schaefer and colleagues write.

The report cites a national survey that found after the recall of cough/cold products for children under 2 years old, 64 percent of parents still considered the medications very safe or somewhat safe and 20 percent planned to continue to use OTC cough/cold medication for their children under 2 (² Also see "Pediatric Cough/Cold Concerns Cool Parents’ Plans On Continued Use – Survey" - Pink Sheet, 7 January, 2008., p. 11).

"Thus, if products marketed to young children are made unavailable, some children will likely continue to find and ingest these products," the authors write.

"Although cough and cold medications represent a small proportion of all emergency department visits for adverse drug events among pediatric patients, focus on these medications highlights how targeted strategies, particularly packaging innovations, could reduce pediatric adverse events from other medications," Schaefer et al. conclude.

Industry Will Review Package Options

Suydam said CHPA and its member companies are interested in exploring suggestions in the study - including alternative child-resistant package designs - if they will improve safety.

Before the industry considers specific potential package changes, it needs to review different potential package options, she said, adding the industry also wants to "work with parents to make sure that we get a dosing mechanism that is in fact as safe as possible."

In addition to expanding and reviewing the use of childproof packaging, the industry needs to emphasize to parents that OTC cough/cold products "are real medicines and ... they can't be left in a way that very curious children can get into them," Suydam said.

CHPA has launched an educational campaign for parents and is providing tips online for storing and administering OTC drugs at OTCsafety.org (³ Also see "CHPA Rolls Out Pediatric Cough/Cold Education Campaign" - Pink Sheet, 5 November, 2007., p. 9).

The trade group says educationwill more effectively reduce the risk of accidental ingestion by small children than removing OTC cough/cold products from the shelves.

Like the CDC study authors, the trade group says if the medicines are not available, caregivers may be tempted to substitute products that are labeled for use by older children and adults.

"Rather than take away the access, we have to . . . renew our efforts to engage parents and educate them about the best possible way to use these medicines and store them safely," Suydam said.

- Elizabeth Crawford (e.crawford@elsevier.com) and Rebekah Moan

Child-Resistant Packaging In The Works For More OTC Cold Products – CHPA

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