December 30, 2009: Incidents Reported with Spiriva Capsules and Inhalation Device
As of December 2009, ISMP Canada has received 24 reports of Spiriva (tiotropium bromide monohydrate) being taken orally instead of by inhalation. In addition, there have been 2 reports of hydromorphone controlled release capsules being inserted into the inhalation device for Spiriva (the HandiHaler) and administered by inhalation.Spiriva is indicated for “long term, once daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema”. The drug is provided as a powder-filled capsule (Figure 1) that is intended for inhalation through the HandiHaler, a specifically designed inhalation device.
Incidents have been reported to ISMP Canada by both acute care and long-term care facilities and by consumers receiving care as outpatients. One consumer commented, “I am wondering why capsules such as those used for Spiriva are designed such that they look like an oral capsule….I am amazed that medications designed for inhalation are not distinctively different from those to be taken by mouth.”
The reports have documented incorrect orders (e.g., “spiriva 1 capsule NG daily”) and incorrect transcription of appropriate orders. However, most of the reports have described inadvertent oral administration of the drug after the capsule was placed in a medication cup within the patient’s reach.
Spiriva has low oral bioavailability. As such, the concern about these incidents is related not to the effects of the drug taken orally, but rather to the potential for poor therapeutic outcomes with repeated omission of inhaled doses. Concerns about this problem have been raised by others, including the Food and Drug Administration in the United States.
The 2 reports describing inadvertent administration by inhalation of Hydromorph Contin (hydromorphone controlled release) 3 mg capsules, instead of Spiriva, noted the similar colour and shape of the capsules (compare Figure 2 with Figure 1).
This information has been provided to raise awareness and to emphasize the need to ensure adequate differentiation between oral and inhalation products, and the need to ensure distinctive processes for labelling, handling, and administering these products. For example, Spiriva capsules should NOT be placed into medication cups, but rather, only provided to the patient together with the HandiHaler. Additional recommendations have been made by ISMP (US) and include:
• Incorporate clear instructions for both patient and staff, when ordering and dispensing Spiriva that the medication is to be inhaled.
• Provide prominent auxiliary messages on Medication Administration Records (MARs)—e.g., “FOR INHALATION ONLY. FOR USE ONLY WITH INHALER.”
More detailed information on recommendations is available from the August 2009 Pennsylvania State Board of Pharmacy Newsletter: www.dos.state.pa.us/bpoa/lib/bpoa/20/phabd/03_august_09_pharmacy.pdf
ISMP Canada has notified both the manufacturer, Boehringer Ingelheim Canada Ltd., and Health Canada about these reports.
