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