Avoiding Problems: Liquid Medication and Dosing Devices

by Food and Drug Administration (FDA)

"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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.