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When prescribing, dispensing, or administering formoterol fumarate (Foradil Aerolizer) or tiotropium bromide (Spiriva HandiHaler), consider the distinct possibility that these medications may be swallowed mistakenly rather than inhaled through their accompanying devices. Formoterol fumarate is a longacting beta2 agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD), and tiotropium bromide is an anticholinergic bronchodilator used for COPD. Each medication is available as a dry powder within a capsule, and the capsules are packaged in blister cards. When used correctly, the capsule is removed from the blister card and placed into the inhaler device. In the device, the capsule is punctured to allow the medication to be dispersed into the lungs as the patient inhales through the inhaler mouthpiece.
Because capsule dosage forms usually are associated with oral administration, formoterol fumarate and tiotropium bromide have been swallowed by mistake. The Institute for Safe Medication Practices (ISMP) has received numerous reports describing situations where patients have received these medications by the ineffective oral route. Most of the reports have come from hospitals and long-term care (LTC) facilities. A few reports, however, have involved community pharmacy patients.
Reports have cited the following contributing factors:
Order communicationPrescriptions may be communicated ambiguously. For example, a prescription with the instructions "Foradil one capsule orally every 12 hours" was received and dispensed by a pharmacy. These instructions led the patient to believe that the medication was to be swallowed. Also, medication administration records (MARs) may list these medications along with other oral medications. Such instructions often begin with the phrase "1 capsule," leading nurses to think that the product is an oral medication.
EducationPatients and practitioners who are unfamiliar with this dosage form may mistakenly administer the medication orally.
StorageThese products may be stored along with other oral medications in patient homes or in medication drawers and automated dispensing cabinets in LTC facilities. If the inhaler device is separated from the capsules, caregivers are likely to assume (due to the dosage form) that the capsules are to be swallowed.
Packaging and labelingPackaging is similar to that of other oral unit-dose medications, and blister labeling is inadequate to protect against oral use.
Safe Practice Recommendations
To prevent similar errors with these medications, consider the following: Products should be ordered and entered into computer systems as "Foradil Aerolizer" and "Spiriva HandiHaler" to better distinguish the medication when it prints out on a patient's MAR or pharmacy label.
Instructions for both patients and staff members must clearly express the need for the medication to be inhaled: for example, "Inhale the contents of one capsule every 12 hours using Aerolizer." Avoid using instructions that begin with "One capsule?" or that include the word "oral," which may be misinterpreted. If a prescriber's instructions are nonspecific (eg, "1 capsule bid" or "use once daily"), pharmacists should express the instructions in a manner that clearly states how the medication is to be used.
Shortcuts could be programmed into computer systems to ensure that these products are ordered and dispensed with the proper instructions. For example, if the word "Spiriva" is entered in the instructions field, the phrase "Inhale the contents of 1 capsule once daily using HandiHaler" would be printed.
Auxiliary messages stating "FOR USE ONLY WITH INHALER. DO NOT SWALLOW CAPSULE" or "FOR INHALATION ONLY" should print out prominently on MARs. Similar auxiliary labels could be placed on boxes and blister labels to help differentiate these capsules from other oral medications that may be stored in the same place. Otherwise, these products should be stored separately from oral dosage forms.
Patients, caregivers, and staff members must be educated regarding the proper administration of these medications before they are dispensed or administered. Training kits containing an inhaler device, placebo capsules, and patient education materials are available from each manufacturer.
Capsules should be stored in the box provided along with the inhaler device. Do not dispense the capsules separately. In LTC facilities, put the patient's name on the inhaler device to ensure that it is returned to the correct patient's box of medication.
The manufacturers of both products are aware of the errors that have occurred, and we at ISMP have asked them to place a warning on the blister cards. The FDA also is aware of our concerns. These errors should serve as a reminder that health professionals need to be very clear in their verbal and written instructions.
Dr. Kelly is the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition.