Download Document

The Current Status of OTC Labels:
A Systematic Look at Pediatric OTC Liquid Medications
H. Shonna Yin, MD, MS
Michael S. Wolf, PhD, MPH
Lee M. Sanders, MD, MPH
Benard P . Dreyer, MD
Ruth M. Parker, MD
IOM Roundtable on Health Literacy
The Safe Use Initiative and Health Literacy: A Workshop
Tuesday, April 27, 2010
Inconsistency
& Medication Labeling
• Inconsistency and variability in
medication labeling is a source
of confusion for patients
– IOM Workshop “Standardizing
Medication Labels: Confusing
Patients Less” (Oct 2007)
• Confusion increases risk for error
• Health literacy and patient safety issue
Why Pediatric OTC Medications?
• First attempt to systematically look at
variability in OTC products
• Pediatric focus chosen
– Prevalence of OTC
medication use in children
– Unique challenges of
dosing liquid medications
– Findings likely to be
reflective of sample
National Initiatives with Implications
for Pediatric Medication Safety
• FDA Safe Use Initiative / “Guidance for
Industry: Dosage Delivery Devices for
OTC Liquid Drug Products” (11/09)
• CDC PROTECT Initiative
– CHPA Guidance (11/09)
• No prior systematic assessment of
inconsistencies
Product Selection
• Product list obtained from
Health
– T op selling OTC medications over prior year
• 200 top-selling OTC products selected
using these inclusion criteria:
– Oral liquid medication
– Analgesic, cough/cold, allergy, or GI product
– Dosing directions for child <12 years of age
Products By Category (n=200)
1 1%
22%
analgesic
cough / cold
8%
allergy
GI
59%
Products By Age Group (n=200)
1%
infant = <2 years
child = >2 to <12 years
adult = >12 years
12%
41%
22%
infant only
infant + child
infant + child + adult
child only
24%
child + adult
Issues Identified in FDA Guidance
Issues Identified in FDA Guidance
#1 No dosage delivery device for nonprescription liquid formulation
products
Issues Identified in FDA Guidance
#1 No dosage delivery device for nonprescription liquid formulation
products
#2 Inconsistency between label and dosage delivery device (within
product variability)
A.
B.
C.
D.
Superfluous markings on device
Missing necessary markings on device
Markings for unit(s) of measurement do not match
Format of numeric text (decimals / fractions) does not match
Issues Identified in FDA Guidance
#1 No dosage delivery device for nonprescription liquid formulation
products
#2 Inconsistency between label and dosage delivery device (within
product variability)
#3 Inconsistency across products (between product variability)
A.
B.
C.
D.
“Nonstandard” abbreviation for milliliter (not “mL”)
“Nonstandard” abbreviation for teaspoon (not “tsp”)
Units of measurement other than milliliter, teaspoon, and tablespoon
Inconsistent use of numeric text (decimals / fractions)
Issues Identified in FDA Guidance
#1 No dosage delivery device for nonprescription liquid formulation
products
#2 Inconsistency between label and dosage delivery device (within
product variability)
#3 Inconsistency across products (between product variability)
#4 Lack of consumer guidance on appropriate use
A. No definition(s) of abbreviations for unit(s) of measurement
B. No strategy to ensure delivery device used with drug product
C. No statement about appropriate use of device when physician-recommended
doses do not match dose amounts on device
Issues Identified in FDA Guidance
#1 No dosage delivery device for nonprescription liquid formulation
products
#2 Inconsistency between label and dosage delivery device (within
product variability)
#3 Inconsistency across products (between product variability)
#4 Lack of consumer guidance on appropriate use
#1. No dosage delivery device for nonprescription
liquid formulation products
• 25% of products did not include a device
1%
2%
11%
25%
no dosage delivery device
dosing cup
dropper
oral syringe
other
61%
#2. Inconsistency between label and dosage delivery
device (within product variability)
• 99% had one or more inconsistencies
Type of inconsistency
%
Superfluous markings on device
Missing necessary markings on device
Markings for unit(s) of measurement do not
match
81%
22%
89%
Format of numeric text (decimals / fractions)
does not match
53%
#2. Inconsistency between label and dosage delivery
device (within product variability)
Example
missing
necessary
markings
superfluous
markings
#2. Inconsistency between label and dosage delivery
device (within product variability)
missing
necessary
marking
superfluous markings
#2. Inconsistency between label and dosage delivery
device (within product variability)
Example
• 40
77 = 52% inconsistent in text used for milliliter
DEVICE
L
A
B
E
L
mL
ml
ML
mL
27
24
11
ml
4
10
1
ML
0
0
0
#3. Inconsistency across products (between product
variability)
3A. “Nonstandard” abbreviation for milliliter (not “mL”)*
• 67% used a nonstandard abbreviation for milliliter
% Products
100
80
60
60
56
40
20
11
1
0
mL*
ml
mls
ML
* USP standard, FDA recommended standard
#3. Inconsistency across products (between product
variability)
3B. “Nonstandard” abbreviation for teaspoon (not “tsp”)*
• 63% used a nonstandard abbreviation for teaspoon
% Products
100
80
64
52
60
40
20
11
0
tsp*
tsps
TSP
* FDA recommended standard
#3. Inconsistency across products (between product
variability)
3C. Units of measurement other than milliliter, teaspoon,
and tablespoon
• 14% used other units of measurement
– eg. Drams, cc, fluid ounces, DSSP (“dessert-spoonfuls”)
#3. Inconsistency across products (between product
variability)
3D. Inconsistent use of numeric text (decimals / fractions)
• Decimals
– 13% lacked use of leading zero for decimal <1
• 0.X is Joint Commission standard
• Fractions
– 64% did not use small font size for numerals
• Small (eg. ½ , 1 ½)*
• Large (eg. 1/2 , 1 1/2)
* Recommended format
#4. Lack of consumer guidance on appropriate use
4A. No definition(s) of abbreviations for unit(s) of
measurement
• Examples of definitions
– TBSP (tablespoon)
– tsp=teaspoon
• Only 7% had at least 1 definition
• Only 1% had all relevant definitions
#4. Lack of consumer guidance on appropriate use
4B. No strategy to ensure delivery device used with
drug product
• 65% no statement to only use
device with product
• 97% no mechanism which secures
device to bottle
#4. Lack of consumer guidance on appropriate use
4C. No statement about appropriate use of device
when physician-recommended doses do not match
dose amounts on device
• 0% with statement
Summary
• Enormously high rate of inconsistency and
variability in labels and devices for pediatric
OTC liquid medications
• Variability and inconsistency sources of patient
confusion and error
– Patient safety issue
• Efforts to standardize labels and dosing devices
greatly needed
superfluous
marking
missing
necessary
marking
superfluous
markings
missing necessary
markings
only tablespoon markings
We can do better than this!
We can do better than this!
H. Shonna Yin, MD, MSc
[email protected]
Department of Pediatrics
NYU School of Medicine / Bellevue Hospital Center
550 First Avenue NBV 8S411
New York, NY 10016
Combination of
Units of Measurement Used (n=200)
2%
2%
1%
1%
2%
1%
5%
8%
2%
18%
5%
2%
4%
1%
46%
mL only
tsp only
TBSP only
mL + tsp
mL + TBSP
tsp + TBSP
mL + tsp + TBSP
other only
mL + other
tsp + other
TBSP + other
mL + tsp + other
mL + TBSP + other
tsp + TBSP + other
mL + tsp + TBSP + other
#3. Inconsistency across products (between product
variability)
• # of different units of measurement
– Mean (SD) = 1.9 (0.9)
# of different units of
measurement
%
1
28
2
58
3
11
4
2
5
1
6
2
#1. No dosage delivery device for nonprescription
liquid formulation products
• GI products least likely to include a device
96%
76%
analgesic
4%
51%
93%
cough/cold
24%
No Dosage Delivery Device
allergy
7%
Device Included
GI
49%
p<0.001
#1. No dosage delivery device for nonprescription
liquid formulation products
• Small companies least likely to include a device
90%
95%
small
46%
private
label
large
54%
5%
10%
No Dosage Delivery Device
Device Included
p<0.001
#3. Inconsistency across products (between product
variability)
Abbreviation for tablespoon other than one most
commonly used (not “TBSP”)
• 32% used abbreviation for tablespoon other than
“TBSP”
100
% Products
82
80
60
40
14
20
14
5
0
TBSP
Tbsp
tbsp
TBS
#4. Lack of consumer guidance on appropriate use
4A. No definition(s) of abbreviations for unit(s) of
measurement
100%
96%
milliliter
teaspoon
45%
55%
tablespoon
4%
No Definition
Definition Present
#2. Inconsistency between label and dosage delivery
device (within product variability)
Inconsistency in text used for units of measurement
milliliter
teaspoon
tablespoon
Any above inconsistency
% with
inconsistency
48%
88%
86%
89%
#3. Inconsistency across products (between product
variability)
3D. Use of units of measurement other than milliliter,
teaspoon, and tablespoon
• GI products most likely to use other units of
measurement
46%
97%
analgesic
cough/cold
allergy
GI
3%
Other Units of Measurement
No Other Units of Measurement
54%
p<0.001
#3. Inconsistency across products (between product
variability)
3D. Use of units of measurement other than milliliter,
teaspoon, and tablespoon
• Products with dosing for adults more likely to use
other units of measurement
97%
80%
Adult
dosing
No adult
dosing
20%
3%
Other Units of Measurement
No Other Units of Measurement
p=0.001