Ensuring Safe Use of Over-the-Counter Cough and Cold Products in Children

Over-the-counter (OTC) cough and cold products for children have been a topic of debate for years. With no clear demonstration of efficacy, a recommendation to use these products for the common cold is not an evidence-based one. However, caregivers and healthcare providers want to intervene to make children more comfortable while they are ill. Caregivers believe in OTC product efficacy and are likely to begin treatment without consulting a pediatrician or other healthcare provider.¹ Now that safety concerns have been raised and infant deaths have been reported as a result of these products, we must re-examine the evidence and our need to treat when effective treatments are not available. With the latest Food and Drug Administration (FDA) recommendations and Consumer Healthcare Products Association (CHPA) decisions that discourage the use of these products in young children, where does that leave the patient, their caregivers, and healthcare providers?

While the FDA advises against the use of nonprescription products for the treatment of cough and cold in children younger than 6 years of age, the CHPA has decided to advise against the use of these products in children less than 4 years of age. The reason for this decision is unclear and does not seem to be supported by any objective data, but the FDA is in agreement with the CHPA's decision. Some manufacturers have decided to limit dosing instructions on the label to those at least 6 years of age based on the FDA recommendation.

A survey reported by Eiland and colleagues determined that almost 90% of caregivers stated they always follow the dosing instructions on the label for nonprescription products.² Therefore, removing dosing recommendations for young children from labels will prompt many caregivers to call the physician or ask the pharmacist for dosing recommendations. This provides an opportunity to assist the caregiver in choosing appropriate therapy, minimizing use of unnecessary products, and ensuring safe dosing for the child.

For the 10% of families that reported sometimes or never following the dosing instructions, these products are still available and may be misused. When dosing information is not provided, care-givers often use the instructions available on the label for older children and rationalize what they believe would be an appropriate dose for their child. A recent study discovered that 51% of care-givers would give a product to a 13-month old, after examining the dosing instructions stating that a physician should be consulted before giving the product to anyone < 24 months of age.³ This same study discovered that the directions on the package influence caregivers' decisions only about 47% of the time.

Healthcare providers must be more aware and thorough when recommending OTC products. As an example, when a health care provider recommends diphenhydramine for an allergic reaction in a child under 6, they must remember that there will be no dosing instructions on the label and they will need to inform the caregiver of the appropriate dose to administer. While some products begin providing dosing recommendations at 4 years of age, others have chosen to start at 6 years of age. This inconsistency makes it difficult for the healthcare professional to know whether the information will be provided on the product label.

The use of combination products may contribute to unintentional overdoses and exposure to unnecessary medications. Unfortunately the number of multiple ingredient products exceeds single ingredient entities on pharmacy shelves. This makes it difficult for families to find an appropriate product and may give the impression that multiple ingredient products are preferred. The Slone study revealed that over 50% of products used by caregivers were combination products.⁴ Marketing has been shown to influence caregiver decision in selecting an OTC product.² Therefore, well known brand names may be chosen rather than searching for the best ingredient for the child's symptoms.

When products are purchased in facilities where a pharmacist is not available, such as convenience stores and grocery stores, the opportunity to educate is missed. The need for public education programs to assist families in selecting appropriate products is crucial. Pharmacists working in clinic or hospital environments should inquire about products that parents are giving their children and use those opportunities to provide education on product selection.

Now, more than ever, the pharmacist is in a position to educate caregivers and healthcare professionals on the safe use of OTC medications for cough and cold in children. Pharmacists should show the caregiver how to measure the recommended amount and provide general education on selecting and using OTC cough and cold products for their children. Important points to communicate are included in the Table.

One must keep in mind that these medications have not been proven harmful when dosed and used appropriately. The safety concerns have arisen from improper dosing, using multiple products containing duplicate medications, and using formulations that are not recommended for children. There will be times when these products are recommended for use by healthcare providers and even more instances when families will want to use them as self-treatment. The pharmacist plays a crucial role in ensuring that these medications are chosen appropriately, dosed as recommended, and administered in a way that will minimize error.