AZ Prescription Compounding Task Force

Prescription Compounding Task Force
The recent tragedy caused by contaminated compounded
prescription drugs distributed across the country by a pharmacy
in Massachusetts has probably been the “biggest story” in
pharmacy in the last decade. Unfortunately, it is not the kind
of news that pharmacy as a profession is proud of. Any time
a patient suffers a negative outcome is a “failure” both for the
professional involved and for the profession as a whole. In
this extreme case, there were at least 656 cases where patients
were infected by various organisms in the products and 39
deaths in 19 states.
On October 6, NECC [the New England Compounding
Center] expanded its recall to include all products
in circulation that were distributed from its facility in
Framingham, Mass. As part of the ongoing investigation,
FDA [Food and Drug Administration] and CDC
[Centers for Disease Control and Prevention] have
been testing various NECC products for evidence of
contamination. Laboratory testing at CDC and FDA has
found bacterial and/or fungal contamination in unopened
vials of betamethasone, cardioplegia, and triamcinolone


solutions distributed and recalled from NECC, as shown
in the table below.
Laboratory-Confirmed Organisms from Product Samples
Associated With NECC Recalled Lots of Betamethasone,
Cardioplegia, and Triamcinolone Solutions
Medication Lot Number
Bacterial
and Fungal
Contamination
Betamethasone
6 mg/mL injectable
– 5 mL per vial
08202012@141 Paenibacillus
pabuli/amolyticus,
Bacillus idriensis,
Bacillus flexus,
Bacillus simplex,
Lysinibacillus sp.,
Bacillus niacin,
Kocuria rosea,
Bacillus lentus
Betamethasone
6 mg/mL injectable
– 5 mL per vial
07032012@22 Bacillus niabensis,
Bacillus circulans
Betamethasone
12 mg/mL
injectable – 5 mL
per vial
0730201@22 Bacillus lentus,
Bacillus circulans,
Bacillus niabensis,
Paenibacillus
barengoltzii/
timonesis
Betamethasone
6 mg/mL injectable
– 5 mL per vial
08202012@44 Bacillus lentus,
Bacillus firmus,
Bacillus pumilus
Betamethasone
6 mg/mL injectable
– 5mL per vial
08152012@84 Penicillium sp.,
Cladosporium sp.
Triamcinolone*
40 mg/mL – 1 mL
vial
06062012@60 Bacillus lentus,
Bacillus circulans

Triamcinolone
40 mg/mL
injectable – 2 mL
per vial
08172012@60 Aspergillus
tubingensis,
Penicillium sp.
Triamcinolone
40 mg/mL
injectable – 10 mL
per vial
08242012@2 Aspergillus fumigatus
Cardioplegia
solution
265.5 mL per bag
09242012@55 Bacillus halmapalus/
horikoshii,
choshinensis
*Identification of other bacteria for this product is pending.
As a result of the size and scope of the situation depicted
above, the Board has determined to form a special compounding
task force as soon as practicable (most likely by the January
2013 meeting). The goal of the task force will be to review all
rules and statutes in Arizona and elsewhere and form a consensus
on what are the best practices for pharmacy compounding.
Then Board staff will codify new rules designed to prevent a
repeat of any of the negative patient outcomes that occurred as
a result of this tragedy. If you feel you can contribute and are
able to make the time commitment, which will be substantial,
please send a cover letter and a brief résumé to the Board office
at PO Box 18520, Phoenix, AZ 85005
Source found here