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U.S. Food and Drug Administration |
This article originally appeared in the October 1994 FDA Consumer. |
by Paula Kurtzweil
"Just a spoonful of sugar helps the medicine go down, the medicine go
down, the medicine go down in the most delightful way.
--from "Mary Poppins."
In the Walt Disney movie, Mary Poppins suggests a "spoonful" as the
correct dose of sugar to ease the not-so-pleasant things in life, like taking
bad-tasting medicine. But when giving or taking medicine, FDA warns consumers
to put away their spoons and use a more exact measure--the proper dosing
device.
Sugar aside, consumers also should take steps to make sure parts of the
dosing device don't go down with the medication. FDA has received reports of
swallowing or choking on the caps of syringes used to administer liquid
medicines, although no deaths have occurred.
While FDA's warnings apply to everyone, they especially target parents
and others who care for infants, young children, and ailing older people who
take liquid medicines.
The advice applies whether the medicine is prescription or over-the-
counter and refers to measuring devices packaged with the medicine or
distributed by pharmacists, physicians, or other health-care professionals.
Extent of Misuse
Since 1988, FDA's Center for Devices and Radiological Health has
received four reports of children swallowing or choking on plastic caps of
hypodermic syringes used to give liquid medication. One other case, reported
in a scientific journal, involved a 6-month-old girl who required
cardiopulmonary resuscitation.
Health professionals believe that in some or all of the cases, the
hypodermic syringe cap was not removed before giving the medicine. As the
medicine was being given, the cap came off and entered the child's mouth. Or,
these children may have picked up the caps and put them in their mouths.
Another problem associated with liquid medication is misuse or
misdosing. FDA has received reports about people misreading the markings on
dose cups, using the wrong size dose cup from a different bottle of medicine,
and misreading the directions. These have sometimes resulted in giving several
times the recommended dosage.
Dosing Made Accurate
Consumers can get various types of dosing instruments for liquid
medicines: hypodermic and oral syringes, oral droppers, cylindrical dosing
spoons, and plastic medicine cups. They measure in one or more units of
ounces, teaspoons, tablespoons, cubic centimeters, or milliliters. These
devices are more accurate than tableware teaspoons, dessertspoons (a spoon
between a teaspoon and tablespoon in size), and tablespoons commonly used to
measure doses.
Common tableware teaspoons come in many sizes. They may be as small as
2.5 milliliters (mL) or larger than 9.5 mL, according to a 1981 article in
U.S. Pharmacist. The measuring teaspoon holds 5 mL, so on oral syringes and
droppers, the teaspoon mark is at the same place as the 5-mL mark.
Syringes offer additional benefits: They're easy to use, especially with
infants, young children, and ailing older adults; relatively inexpensive; and
available in various sizes. There are two types: an oral syringe designed
especially for administering liquid medicines and the standard hypodermic
syringe without the needle.
According to Susan Bounds, a consumer safety officer in FDA's Center for
Devices and Radiological Health, parents and other care-givers often receive
the standard hypodermic syringe when a doctor hands them a written
prescription, or a pharmacist or other health-care professional hands them
medicine. Health professionals frequently give patients hypodermic syringes
rather than oral syringes because they cost less. In some cases, she said, the
health-care professional draws the medicine into the syringe for the customer
to demonstrate how it is done.
Potential Problems
Both types of syringes often come with caps. According to the American
Pharmaceutical Association, manufacturers "cap" their syringes to protect the
syringe's nozzle. The cap also may keep medicine from leaking out of the
syringe. This is useful in health-care facilities, so the syringe can be
capped between the time the nurse or pharmacist measures the medicine and it
is given to a patient. Parents whose children are in day care may also fill
syringes and recap them for later administration by a day-care worker.
The caps are supposed to be removed before the medicine is drawn up into
any syringe and administered. But because the caps sometimes are not distinct
from the rest of the syringe, the care-giver may be unaware that a cap is
there. And, with hypodermic syringes, the medicine can be drawn up and given
with the cap in place. This creates a potentially life-threatening situation
if the cap gets into the child's windpipe or esophagus.
Also, if the caps are not properly thrown away, infants and toddlers may
pick them up and put them in their mouths. If they swallow, they are likely to
choke.
In May 1994, FDA wrote to makers of syringes and other dosing
instruments to ask their cooperation in addressing the potential hazards of
syringe caps. Specifically, FDA sought input on:
* approaches for reducing hazards--for example, through device design,
label changes, or education initiatives
* the feasibility of packaging oral dosing syringes without caps.
According to Tom McGinnis, a registered pharmacist in FDA's Office of
Health Affairs, the latter idea is possible because syringes intended for oral
use do not have to be sterilized, and, therefore, a cap is not necessary. Only
syringes used to inject a substance into the body need to be absolutely free
of contaminants and therefore must have a cap.
Within two weeks of requesting input, FDA heard from six firms
interested in working with FDA to address the problem and suggesting ways to
correct it.
Inappropriately marked plastic dosing cups also have posed some
problems. In 1992, FDA received a report of a child who had been given three
times the safe dose of a liquid acetaminophen product, 2 teaspoons. The dosing
cup packaged with the drug gave measurements in tablespoons rather than
teaspoons. The parents measured to the 2-tablespoon level marked on the cup,
and the child got triple the recommended dose.
FDA Action
Soon after FDA received the report of the acetaminophen dosing cup
error, the agency learned of similar incidents with other acetaminophen drug
products and pediatric cough/cold preparations. As a result, FDA undertook a
survey of over-the-counter liquid medication makers to ensure that the
labeling of these products is compatible with their dose cups and that the
cups are easily readable. FDA's action prompted eight drug firms to recall
nationwide over 980,000 bottles of oral medications and their accompanying
dosage delivery devices because the devices were not consistent with the
products' labeled directions.
Some solutions to dosing device problems may be a few years away. FDA
has begun a public education campaign to increase health professional and
consumer awareness of misdosing hazards and potential syringe cap problems
with liquid medicines.
The agency hopes this campaign will alert consumers to the potential
dangers and avert any further problems while FDA and the manufacturers work on
appropriate changes.
How to Use Dosing Instruments
* Remove caps from hypodermic and oral syringes before drawing medicine
and giving it to yourself or another person. Keep the caps out of reach of
infants and toddlers.
* For oral dosing syringes, unless the syringe is filled with medicine for
later use, do not recap. Throw out caps immediately.
* For hypodermic syringes, do not recap; throw out caps immediately.
* Follow label directions for dosage amounts and time intervals. If you
have any questions, call your pharmacist.
* Use the plastic dosing cup that comes with the medicine; don't
substitute a cup from another drug product.
* Verify that dosing instrument measurements are compatible with product
label.
* Use a standard measuring spoon or proper dosing device to measure
medicines--not tableware spoons.
* Follow package directions for the proper cleaning and handling of dosing
devices.
Safety Tips
* Use child-resistant caps, and do not leave medicine uncapped.
* Store medicine as directed and in a safe place out of reach of children.
* Don't give medicine to children unless it is recommended for them on the
label or by a doctor.
* Don't take drugs prescribed for someone else or give yours to someone
else.
* Don't use medicine for purposes not mentioned on the container or in
package directions, unless so directed by a doctor.
* Don't try to remember the dose used during previous illnesses; read the
label each time.
* Keep liquid medicines in their original bottles; don't transfer them to
other containers.
* Use a prescribed medicine for as long as the doctor recommends to ensure
complete recovery.
* Check with your doctor or pharmacist if you have any problems with or
questions about your medicine.
Standard hypodermic syringe with protective cap on (left) and off (right) the
device
The illustration shows a standard hypodermic syringe with plastic cap in
place to protect the nozzle end of the container (left) and with the plastic
cap off the device (right). While not designed for administration of liquid
medications to infants and children, syringes like these are often available
to consumers.
NOTE: When in place, the protective plastic cap appears to be an
integral, yet inconspicuous, part of the device.
Syringe can be loaded with cap in place
The plastic cap is simply intended to be a protective barrier to the
syringeœs nozzle.
Figure A shows how a liquid medication can be drawn up into a hypodermic
syringe without removal of the protective cap. Liquid can easily enter the
syringe nozzle through clearance around the cap.
Figure B shows the loading of liquid medication into the barrel of the
syringe after removal of the plunger, with the protective nozzle cap still in
place. In either case, the potential exists for administering liquid
medication to a child without first removing the protective plastic cap.
NOTE: The cap on most of the commercially available hypodermic syringes
is not airtight.
Potential hazard of using capped syringe when administering liquid medication
If left on a loaded hypodermic syringe, the protective plastic cap can be
ejected inadvertently into the throat during administration of the contents,
especially since a parent/care-giver has no way of seeing what is happening in
a young patient's closed mouth.
NOTE: There has been at least one report of a near-fatal aspiration of
one of these syringe caps.
(Source: American Pharmaceutical Association)
Paula Kurtzweil is a member of FDA's public affairs staff.
Publication No. (FDA) 94-3209
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