Kids, Colds, And OTC Meds

 

 

# 5878

 

With cold and flu season on the way, this is probably a good time to remind my readers that the CDC and the FDA continue to warn parents over the use of many over-the-counter (OTC) cough and cold medications in young children.

 

In January of 2008 the FDA issued a warning to parents that OTC cough and cold remedies were no longer considered to be safe or effective for children  under the age of 2.

 

Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age

FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

(Continue . . . )

 

 

Despite this announcement, the debate over the safety and effectiveness of these same medications for older children continued, with some experts calling to ban their use for children under the age of 6.

 

In a bit of a pre-emptive strike, in the fall of 2008 the CHPA (Consumer Healthcare Products Association ) announced that its members were voluntarily modifying the product labels on many of their OTC meds to state "do not use" in children under 4 years of age. 

 

Despite these recommendations, and the publicity they generated, old habits apparently die hard.

 

Earlier this year the C.S. Mott Children’s Hospital National Poll on Children’s Health indicated that for a majority of parents, those warnings are going unheeded.

 

 

The following excerpts are from the University of Michigan Health System’s press release:

 

February 14, 2011

ANN ARBOR ,Mich.

Parents continue to give cough and cold meds to young kids, despite FDA warnings

Research has linked over-the-counter cough and cold products to poisoning or death in hundreds of children, ages 2 and younger. Studies have also shown that these medicines do little to control symptoms. As a result, in 2008, the United States Food and Drug Administration formally recommended that OTC cough and cold products not be given to children under age 2.

 

A poll released today by the C.S. Mott Children’s Hospital National Poll on Children’s Health shows that 61-percent of parents of children, ages 2 and younger, gave their children OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child’s doctor says OTC cough and cold medications are safe for children under 2; half of their physicians said they are effective.

(Continue . . . )

 

 

For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse  to `do something’ to alleviate their misery is strong.   

 

But all medicines . . . even those available over-the-counter – have risks.  And for very small children, the FDA and the CDC  believe those risks outweigh any benefit they might derive from these types of products.

 

This from the CDC.

 

Cold and Cough Medicines: Information for Parents

It's winter, and parents may be tempted to reach for over-the-counter medicines to ease their child's sniffling and coughs. But recent safety concerns have prompted drug manufacturers to change their labels stating that cough and cold medicines should NOT be given to children younger than age 4. Parents can take some steps now to help keep their children safe.

 

Each year, thousands of children under age 12 go to emergency rooms after taking over-the-counter cough and cold medicines. Most of these children were unsupervised when they took the medicine.

 

In response to safety concerns, the leading manufacturers of children's cough and cold medicines are voluntarily changing the labels on these products to state that they should not be used in children younger than 4 years of age.

(Continue . . .)

 

Adding to the risks, in December of 2010 we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the dangerously ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.

 

And in August of last year (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.

 

The question remains, what can a parent do to help relieve their child’s symptoms without resorting to potentially harmful OTC meds?

 

Again the CDC has some suggestions that may help.

 

Symptom Relief

• How to Feel Better
• Over-the-Counter (OTC) Medicines
• Questions and Answers for Parents about Over-the-Counter (OTC) Medicines
• Related Materials

»» Read More

Poll: Despite FDA Warning Parents Use OTC Cold Remedies For Kids Under 2

 

 

 

# 5319

 

In January of 2008 the FDA issued a warning to parents that OTC (over-the-counter) cough and cold remedies were no longer considered to be safe or effective for children  under the age of 2.

 

 

Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age

FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

(Continue . . . )

 

Despite these recommendations, and the publicity they generated, old habits apparently die hard.

 

 

Three years later the C.S. Mott Children’s Hospital National Poll on Children’s Health indicates that for a majority of parents, those warnings are going unheeded.

 

 

 

The following excerpts are from the University of Michigan Health System’s press release:

 

February 14, 2011

ANN ARBOR ,Mich.

Parents continue to give cough and cold meds to young kids, despite FDA warnings

Research has linked over-the-counter cough and cold products to poisoning or death in hundreds of children, ages 2 and younger. Studies have also shown that these medicines do little to control symptoms. As a result, in 2008, the United States Food and Drug Administration formally recommended that OTC cough and cold products not be given to children under age 2.

 

A poll released today by the C.S. Mott Children’s Hospital National Poll on Children’s Health shows that 61-percent of parents of children, ages 2 and younger, gave their children OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child’s doctor says OTC cough and cold medications are safe for children under 2; half of their physicians said they are effective.

 

(Continue . . . )

 

 

Particularly concerning is the assertion by roughly half of the parents that their healthcare providers continue to recommend these products for their children under the age of 2.

 

The safety and effectiveness of OTC cold remedies for children between the ages of 2 and 6 is still under review by the FDA.  

 

Complicating matters, in December we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.

 

And in August 2010 (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.

 

For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse is to `do something’ to alleviate their misery is strong.   

 

But all medicines . . . even those available over-the-counter – have risks.  And for very small children, the FDA believes those risks outweigh any benefit they might derive from these types of products.

»» Read More

JAMA: Inconsistent Dosing Instructions For OTC Meds

 

 

# 5104

 

 

Imagine you purchase a bottle of liquid medicine and the instructions on the box tell you to take 2 tablespoons (30mL) every 4 hours and give your 6 year-old child 1 tablespoon (15mL) every four hours.  

 

The handy measuring device provided by the manufacturer looks like this:

 

Figure 2 from the JAMA study

Nowhere on this measuring cup are there Tablespoon markings. . .  only teaspoons, and mL. 

 

And the largest measurement – 4tsp - isn’t even a recommended dose.  It is too much for a child, and not enough for an adult.

 

Of course, you may consider yourself lucky. Some medicines don’t even provide a measuring device. 

 

Welcome to the confusing world of inconsistent OTC (Over-the-Counter) drug dosing instructions.

 

And while you might consider yourself capable of doing the mental conversion gymnastics in your head, not everyone is equally medically astute.

 

Besides . . any bleary-eyed, stressed out, and sleep deprived parent ladling out medicine to a sick child in the middle of the night can be subject  to confusion - particularly when the instructions are less than perfectly clear.

 

In the fall of 2009, the FDA and the Consumer Health Products Association (CHPA) each released similar new voluntary guidelines for the packaging and dosing instructions of liquid medications, particularly those intended for use by children.

 

The FDA’s recommendations were pretty simple, with the main ones being:

 

• Measuring devices should be included for all over-the-counter liquid medications.
• Devices should be marked with calibrated units of measure that are the same as those specified in the labeled dosage directions.
• Abbreviations used on devices should be the same as those used in directions.
• Devices should not bear extraneous or unnecessary markings.
• Devices should not be significantly larger than the largest dose described.
• Abbreviations should conform to international or national standards.
• Abbreviations should be defined on devices and/or label directions.
• Decimals and fractions should be used with care and conform to recommendations

 

 

While most of these recommendations may seem fairly obvious, apparently they weren’t to the manufacturers.

 

According to this study, nearly all (well, 98.6%) of oral OTC medications examined prior to these guidelines being released contained dosing directions and measuring devices that were `highly variable or inconsistent’.

 

Ambiguities and inconsistencies that could easily lead to the under-dosing or over-dosing of a child with the medication.

 

JAMA has two free articles available on the subject.

 

A study study that takes an eye-opening look at the poorly conceived OTC dosing instructions on 200 popular pediatric oral liquid medications surveyed in 2009, and an editorial on the study.

 

First, a look at the study.  I’ve only posted a snippet from the abstract.  You’ll want to read the whole thing.

 

Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications

H. Shonna Yin, MD, MS; Michael S. Wolf, PhD, MPH, MA; Benard P. Dreyer, MD; Lee M. Sanders, MD, MPH; Ruth M. Parker, MD

JAMA. Published online November 30, 2010. doi:10.1001/jama.2010.1797

Abstract (Excerpts reformatted)

Results Measuring devices were packaged with 148 of 200 products (74.0%).

 

Within this subset of 148 products, inconsistencies between the medication's dosing directions and markings on the device were found in 146 cases (98.6%).

 

These included missing markings (n = 36, 24.3%) and superfluous markings (n = 120, 81.1%).

 

Across all products, 11 (5.5%) used atypical units of measurement (eg, drams, cc) for doses listed.

 

Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%), 155 (77.5%), and 37 (18.5%) products, respectively.

 

A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbreviation, 163 did not define at least 1 abbreviation.

 

Conclusion At the time the FDA released its new guidance, top-selling pediatric OTC liquid medications contained highly variable and inconsistent dosing directions and measuring devices.

 

 

You’ll also want to read the accompanying editorial.

 

Ensuring Safe and Effective Use of Medication and Health Care

Perfecting the Dismount

Darren A. DeWalt, MD, MPH

 

 

CHPA, which is a trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements, released a statement yesterday in response to the publication of these two articles in JAMA.

 

You can read it at the link below.

CHPA Statement Outlining Measuring and Dosing Improvements Already Made for Liquid OTC Medicines for Children

 

 

For now, the guidelines issued by CHPA and the FDA are strictly voluntary.

 

It will likely require another study some time in the future to determine how much progress has been made in the adoption of these recommendations.

»» Read More

Inappropriate Use Of OTC Medicines In Children

 

 

# 4850

 

 

From the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), an illuminating press release on a paper to be presented today on the widespread parental misuse of over-the-counter (OTC) medicines for children.

 

A research team led by Dr. Rebekah Moles of the University of Sydney, New South Wales, reports that the inappropriate use, and incorrect dosing of OTC meds lead to a large number of accidental drug poisonings each year.

 

Running through a  variety of scenarios, nearly 100 adult caregivers were asked to decide what OTC medicines were appropriate for a child given their symptoms, and asked to measure out an appropriate dose.

 

 

A brief excerpt from the press release outlining the abysmal results follows.  By all means, click the link to read it in its entirety.

 

 

Widespread parental misuse of medicines puts children at risk

(Excerpt)

Common OTC medicines were made available, together with different types of dosing devices, including household spoons. Participants then chose whether or not to give a medicine, at what stage, and at what dose. They were asked to measure the dose for the researchers. Because doses for children are often small, the risk of getting the measurement wrong is greatly increased, the researchers say.

 

"Taking all the scenarios together, 44% of participants would have given an incorrect dose, and only 64% were able to measure accurately the dose they intended to give. We found that 15% of participants would give a medicine without taking their child's temperature, and 55% would give medicine when the temperature was less than 38 degrees", said Dr. Moles. Paracetamol was the preferred treatment, even for coughs and cold, and was used most often – 61% of the time – despite the child having no fever. Only 14% of carers managed the fever scenario correctly.

(Continue . . .)

»» Read More