CLINICAL NEWS
blood samples were obtained from 56
healthy adult volunteers, which were
then driven to a flight site an hour away
from the hospital. Half of the samples
were loaded onto the drone, and half
remained stationary on the ground.
The samples loaded on the drone then
flew on a mile loop and stayed in the
air from six to 38 minutes. All samples
were then driven back to the laboratory where they underwent 33 common
blood tests.
The researchers did not detect much
of a difference between the samples that
had been flown on the drones and those
that stayed on the ground. The overall
concordance was 97 percent, and the
length of the drone flight had no impact
on the blood sample results. Only one
test, for total carbon dioxide, had results
that varied.
According to Timothy Amukele,
MD, PhD, a pathologist at Johns Hopkins who was involved in the study, said,
“If we now have a cheaper way to move
samples, it is a good thing, especially for
patients who are hard to reach, whether
they live in rural areas or places without
good roads.” Next steps for this study
include applying this concept to a pilot
study with real patients in real clinical
settings.
Source: Amukele TK, Sokoll LJ, Pepper D, et al. Can unmanned aerial
systems (drones) be used for the routine transport of chemistry,
hematology, and coagulation laboratory specimens? PLoS One. 2015
July 29. [Epub ahead of print]
FDA Proposes New
Quality Monitoring
Protocol to Prevent
Drug Shortages
The U.S. FDA, in conjunction with
the Center for Drug Evaluation and
Research and the Center for Biologics
Evaluation and Research, issued a draft
T:7”
Table 6: Grade 3/4 Adverse Reactions Reported in ≥2% Patients
and With a ≥1% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone groups
System Organ Class/ Preferred Term REVLIMID/Dex# Placebo/Dex#
(N=353)
(N=350)
n (%)
n (%)
Eye Disorders
Cataract
6 (1.7)
1 (0.3)
Cataract Unilateral
5 (1.4)
0 (0.0)
Psychiatric Disorder
Depression
10 (2.8)
6 (1.7)
Venous and Arterial Thromboembolism [see Boxed Warning, Warnings
and Precautions (5.4)]
Deep vein thrombosis (DVT) was reported as a serious (7.4%) or severe
(8.2%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone
group compared to 3.1 % and 3.4% in the placebo/dexamethasone group,
respectively in the 2 studies in patients with at least 1 prior therapy with
discontinuations due to DVT adverse reactions reported at comparable rates
between groups. In the NDMM study, DVT was reported as an adverse
reaction (all grades: 10.3%, 7.2%, 4.1%), as a serious adverse reaction
(3.6%, 2.0%, 1.7%), and as a Grade 3/4 adverse reaction (5.6%, 3.7%,
2.8%) in the Rd Continuous, Rd18, and MPT Arms, respectively.
Discontinuations and dose reductions due to DVT adverse reactions were
reported at comparable rates between the Rd Continuous and Rd18 Arms
(both <1%). Interruption of REVLIMID treatment due to DVT adverse
reactions was reported at comparable rates between the Rd Continuous
(2.3%) and Rd18 (1.5%) arms.
Pulmonary embolism (PE) was reported as a serious adverse drug reaction
(3.7%) or Grade 3/4 (4.0%) at a higher rate in the REVLIMID/dexamethasone
group compared to 0.9% (serious or grade 3/4) in the placebo/dexamethasone
group in the 2 studies in patients with, at least 1 prior therapy, with
discontinuations due to PE adverse reactions reported at comparable rates
between groups. In the NDMM study, the frequency of adverse reactions of
PE was similar between the Rd Continuous, Rd18, and MPT Arms for
adverse reactions (all grades: 3.9%, 3.3%, and 4.3%, respectively), serious
Myocardial infarction was reported as a serious (1.7%) or severe (1.7%)
adverse drug reaction at a higher rate in the REVLIMID/dexamethasone
group compared to 0.6 % and 0.6% respectively in the placebo/
dexamethasone group. Discontinuation due to MI (including acute) adverse
reactions was 0.8% in REVLIMID/dexamethasone group and none in the
placebo/dexamethasone group. In the NDMM study, myocardial infarction
(including acute) was reported as an adverse reaction (all grades: 2.4%,
0.6%, and 1.1%), as a serious adverse reaction, (2.3%, 0.6%, and
1.1%), or as a severe adverse reaction (1.9%, 0.6%, and 0.9%) in the
Rd Continuous, Rd18, and MPT Arms, respectively.
Stroke (CVA) was reported as a serious (2.3%) or severe (2.0%) adverse drug
reaction in the REVLIMID/dexamethasone group compared to 0.9% and
0.9% respectively in the placebo/dexamethasone group. Discontinuation
due to stroke (CVA) was 1.4% in REVLIMID/dexamethasone group and
0.3% in