"Misadministration of capsules for inhalation Medication Errors"
Safety Page Misadministration of capsules for inhalation The Food & Drug Administra- an as-needed basis. Spiriva Handi- “FOR INHALATION USE ONLY,” tion would like to alert health- Haler (tiotropium bromide inhala- “FOR USE WITH INHALER care providers to errors invol- tion powder) is a long-acting anti- ONLY,” or “NOT FOR ORAL ving the inadvertent oral adminis- cholinergic agent manufactured USE.” tration of Foradil Aerolizer and by Boehringer Ingelheim. Spiriva While the FDA is working with Spiriva HandiHaler capsules for HandiHaler was approved on Jan. the manufacturer on labeling and inhalation. In total, the FDA 30, 2004, under NDA 21-395, for packaging changes to minimize has received 30 cases concern- the scheduled, maintenance treat- potential user error and maximize ing the inadvertent ment of asthma and patient safety, we offer the follow- oral administration COPD. ing suggestions: of the Foradil Aero- Two risk factors •Counsel healthcare providers lizer product and two for errors need to who administer and dispense this concerning the Spiri- be taken into con- product (pharmacists and physi- va HandiHaler prod- sideration by health- cians who sample it) on its proper uct. Although most care practitioners use, including the correct route of cases did not indicate and consumers alike administration and the potential an adverse event, one when pre- for confusion with oral case report described scribing, products. difficulty breathing following oral dispensing, or receiv- •Counsel patients about ingestion, one reported hospital- ing Foradil Aerolizer or the potential confusion ization due to a chronic obstruc- Spiriva HandiHaler. The and ways to avoid it. tive pulmonary disease (COPD) first involves the current •Advise healthcare pro- exacerbation, and there was one packaging, labels, and viders to avoid dispens- unrelated death. labeling of the products. ing the capsules for in- The unintentional oral adminis- The unit-dose labels do halation separately from tration of the Foradil Aerolizer and not prominently indicate the inhalation device. Spiriva HandiHaler capsules stems that the product is •If the capsules for in- from the fact that these capsules re- for “INHALATION USE halation are dispensed semble those typically taken orally. ONLY.” The principal display pan- separately as unit-dose capsules, Additionally, the capsules are sup- els of the labels appear crowded. advise healthcare providers and plied in unit-of-use packages that This crowding obscures the warn- patients to affix a cautionary label do not prominently display “NOT ing. A more prominently displayed or statement indicating “FOR IN- FOR ORAL USE.” Swallowing the warning statement may help pre- HALATION USE WITH SPECIAL capsules for inhalation, rather than vent misadministration. INHALER ONLY.” using the capsule via the appropri- Additionally, the size and •Advise patients who are using ate inhalation device may lead to shape of the capsules promote the oral medications to store the cap- delayed onset of action, reduced swallowing, rather than inha- sules for inhalation together with efficacy, and inadequate drug de- lation, of the Foradil Aerolizer the inhaler in a location where the livery. and Spiriva HandiHaler capsules. capsules are unlikely to be con- Foradil Aerolizer (formoterol fu- This confusion might be reduced fused with other oral medica- marate inhalation powder) is a if the capsule were adequately tions. long-acting, selective beta-2 adreno- marked with one of the following, •Circle or otherwise highlight the receptor agonist manufactured by “FOR INHALATION USE ONLY” Novartis. Foradil Aerolizer was ap- by statement on the product package proved on Feb. 16, 2001, under NDA Tina Tezky, Pharm.D., and and container if possible. 20-831, for the scheduled, mainte- Carol Holquist, R.Ph. Tina M. Tezky, Pharm.D., is a Safety Evaluator, and Carol nance treatment of asthma and Holquist is Director of the Division of Medication Errors COPD, and for the prevention of and Technical Support (DMETS), Office of Drug Safety, exercise-induced bronchospasm on at the Food & Drug Administration. To report a problem with an FDA-regulated product, please call 1-800-FDA-1088. 48 DRUG TOPICS APRIL 4 2005 www.drugtopics.com