Pharmacovigilance in hospice/palliative care: rapid report of net clinical effect of metoclopramide.

Understanding the performance of prescribed medications in day-to-day practice is important to minimize harm, maximize clinical benefits, and, eventually, better target the people who are most likely to benefit, especially in hospice/palliative care where there may be limited time to optimize prescribing. Metoclopramide, a benzamide prokinetic antiemetic, is widely used for a number of indications including nausea, vomiting, hiccups, and reflux. It has recently had a new "black box" warning issued by the Food and Drug Administration in relation to tardive dyskinesia to limit use to 12 weeks. A consecutive cohort of patients from 12 participating centers in two countries who were having metoclopramide initiated had data collected at three time points--baseline, 2 days (clinical benefit), and day 7 (clinical harm). Additionally, harms could be recorded at any time. Of the 53 people included in the cohort, 23 (43%) reported benefit at 48 hours, but only 18 (34%) of these people were still using it one week after commencing it. For the other 5, the medication was ceased due to harms. The most frequent harms were akathisia (n=4), headache (n=4), and abdominal pain (n=4). Nine people (17%) had no clinical benefit and experienced harms. Overall, one in three people gained net clinical benefit at one week. Limiting effects include side-effects that need to be sought actively in clinical care.