FL: Fluoride Exposure in the US (2010)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To define the prevalence of over-the-counter and prescription medication use among US children less than 12 years of age and to determine the prevalence and patterns of use of the most commonly used medications.

Inclusion Criteria:
  • Children, zero to 11 years (less than 12 years) of age
  • All prescription and OTC medications, vitamins, herbal products and supplements
  • 48 contiguous US states and the District of Columbia.
Exclusion Criteria:
  • Survey was not designed to capture illicit medication use or intentional misuse
  • Exception of topical emollients and diaper creams.
Description of Study Protocol:

Recruitment

This is a random digit-dial telephone survey of medication use in the previous seven days for a representative sample of the US population. Between February 1998 and April 2007, 2,857 children from zero to 11 years of age from the 48 contiguous US states were enrolled.

Design

  • Data from the Slone Survey was used to define the prevalence of over-the-counter and prescription medication use among US children less than 12 years of age and to determine the prevalence and patterns of use of the most commonly used medications
  • Household telephone numbers were selected randomly and, when a household was contacted successfully, one individual living in the household was selected randomly for interview
  • A parent or guardian gave informed consent and completed the interview. All medication use by the subject (including prescription and OTC products, vitamins, minerals, herbal products and supplements) in the past seven days was ascertained through a structured interview.

Statistical Analysis

Prevalence estimates were weighted according to household size, to adjust for the probability of selection. Comparisons of prevalence over time were performed by using Mantel-Haenszel X2 analysis. Statistical analyses were performed with SAS 9.1 (SAS Institute, Cary, NC).

Data Collection Summary:

Timing of Measurements

Between February 1998 and April 2007.

Dependent Variables

Any medications or prescription medications; use of asthma medications; use of acetaminophen and ibuprofen; use of analgesic or antipyretic, age, prevalence percentage. 

Independent Variables

Age, weekly prevalence of use of medications, duration (study years), product or ingredients.

Control Variables

  • Medications
  • Age. 

 

 

Description of Actual Data Sample:
  • Initial N: Overall survey response rate was 61%
  • Attrition (final N): 2,857 children [female 1,397 (49%); male 1,460 (51%)]
  • Age: Zero to 11 years of age.

Ethnicity

  • Hispanic ethnicity
    • No: 2,381 (83%)
    • Yes: 431 (15%)
  • Refused/unknown: 45 (1.6%).

Other Relevant Demographics

  • Race: White 70%, black 13%, Asian 2.5%, Native American 0.9% , other 12%
  • Refused or unknown: 60 (2.1%)
  • Census region: Midwest 25%, Northeast 19%, South 27%, West 30%
  • Parent’s highest education level
  • Year and month of enrollment
  • Any medication
  • Prescription medication only.

Location

United States.

 

Summary of Results:
Overall, 56% of children had used one or more medication product in the seven days preceding the interview, with 15%, 7.1%, 3.1% and 1.9% taking two, three, four or five or more medications, respectively, during that time period.
  • Twenty percent of children took one or more prescription-only medications, but 6% used two or more prescription-only drugs within a given week
  • No herbal products or supplements other than vitamins, iron and fluoride among products used by 0.5% or more of children in any age group of generally healthy children
  • The most commonly used over-the-counter medication products were acetaminophen alone, multivitamins and ibuprofen alone
  • The most commonly used prescription-only medications across all age groups were amoxicillin, albuterol and multivitamins with fluoride
  • OTC products accounted for the majority of all products used, with single-ingredient acetaminophen (peak prevalence of use of 23% among children less than 24 months of age), multivitamins (peak prevalence of 24% among children two to five years of age) and single-ingredient ibuprofen (prevalence of approximately 7% across age groups) being the most frequently used OTC medication products throughout childhood
  • Among children less than two years of age, use of benzocaine and simethicone, as well as various cough and cold and allergy products (acetaminophenpseudoephedrine, diphenhydramine and pseudoephedrine), also was fairly common
  • The most commonly consumed active ingredients (excluding vitamins) were acetaminophen, iron, ibuprofen and various cough and cold ingredients (pseudoephedrine, dextromethorphan and various first-generation antihistamines)
  • Among children two to five years of age, diphenhydramine, unspecified cough medicines and vitamin C were each used by more than 1% of children, as were two topical products (triple-antibiotic ointment and hydrocortisone). Among children six to 11 years of age, loratadine, diphenhydramine and vitamin C were used relatively frequently. Of note, we found no herbal products that were used by 0.5% or more of subjects in any age group.
  • Other commonly used prescription medication products for children two to five years of age included asthma or allergy medications (cetirizine, montelukast, and fluticasone) and fluoride
  • For children six to 11 years of age, in addition to asthma or allergy medications (montelukast, cetirizine, and fluticasone), medications for attention-deficit disorder (methylphenidate, mixed amphetamine salts, and atomoxetine) were noted.

Fluoride

Prevalence of fluoride (prescribed by physician) use differed by age group:

  • Zero to 23 months: 0.5%
  • Two to five years: 1.3%
  • Six to 11 years: 0.8%

When prevalence was measured as an active ingredient (many substances are found in combination in different products), the prevalence rates of fluoride were: 

  • Zero to 23 months: 2.8%
  • Two to five years: 4.1%
  • Six to 11 years: 2.6%

Changes in Prevalence

  • The overall weekly prevalence of use of any analgesic or antipyretic drug was 19%, and rates did not change significantly over the time of our survey [P=0.5; only complete years of data collection (1999 to 2006) were used in this analysis].
  • There were, however, substantial increases in the use of long-acting beta-adrenergic receptor agonists (from 0.3% in 1999 to 2000 to 3.8% in 2005 to 2006; P<0.0001) and leukotriene receptor antagonists (from 0.3% to 3.5%; P<0.0001) and a decrease in the use of mast cell stabilizers (from 0.8% to 0%; P<0.006)
  • The weekly prevalence of use of short-acting beta-adrenergic receptor agonists and inhaled corticosteroids did not change significantly over the course of the study
  • No statistically significant secular trends in pediatric analgesic or antipyretic use from 1999 through 2006, although there was a suggestion of a small decrease in acetaminophen use and a small increase in ibuprofen use over time.
Author Conclusion:
  • This study provides population-based data on the medication products and active ingredients used most commonly by US children
  • It demonstrates that more than one half of children less than 12 years of age use one or more medication product in a given week and approximately one fourth use multiple medications, with OTC products (especially vitamins, analgesic or antipyretic agents, iron and cough or cold medications) accounting for the majority of medication exposures
  • Given this large amount of medication exposure, it is essential to continue to monitor the use of medications by children as part of ongoing efforts to ensure the safety of these products.
Funding Source:
Government: National Institutes of Health ; Food and Drug administration
Industry:
Various pharmaceutical companies
University/Hospital: Slone Epidemiology Center internal funds
Reviewer Comments:
  • This is a very well designed study in children. This is a representative sample. The study was able  to define the specific active ingredients taken by subjects.
  • The study is based on a survey analysis. There is a possible bias in reporting. Survey is based on only parent reporting. Future studies should consider hospital-based surveys and collect information.
  • Data collectors are not blinded for the outcome
  • Other factors accounted for the outcome was not reported
  • Duration of the illness and the use of ingredients are necessary
  • Information on the illness or health conditions of the children are also necessary
  • Further studies are required to study the adverse events including growth and mental health development associated with available OTC medications, pediatric cough or cold medications and prescription medications in children because of the long-term use and frequent use of these medications. Duration of use of OTC , prescription and multivitamins are also required.
  • More information on demographic details are required with regard to their height, body weight and income
  • A comparison of use of medications in boys and girls are required including race.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? N/A
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? No
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? N/A
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes