Eye Opening: Are Compounded Drugs Causing Harm?

Background: The United States Pharmacopoeia developed a guidebook, the USP 797, which contains strict guidelines to assure sterility of compounded drugs, however, State statutes and regulations do not necessarily require adherence to these guidelines.  In early 2010, the Tennessee Department of Health [TDH] was alerted to five cases of alpha hemolytic streptococcus endophthalmitis following vitreous fluid injections at a local ophthalmology practice. The only common link was the compounding pharmacy that drew up syringes from a multidose vial. TDH staff observed practices at the clinic and the pharmacy. The practices used by the pharmacist (i.e., no mask, talking during the procedure, no vertical barrier) during compounding were highly suspicious as being the source of contamination. However, the technician was compliant with State rules and regulations as required by the Tennessee Board of Pharmacy.  

Objective: To assess sterility processes for compounded drugs required by States.  

Methods: We reviewed the rules and regulations, specifically requirements of personal protective equipment, for sterile drug compounding in each State and the District of Columbia.  States were separately classified into three general categories, those which: (1) incorporated specific language requiring compliance with USP 797; (2) identified specific personal protective equipment (PPE) to be used by compounding pharmacy staff, or (3) did not address PPE for compounding procedures. If PPE was only required for compounding cytotoxic agents (but not for non-cytotoxic agents), we classified the State into group (3). For States with compounding guidelines other than the USP 797, the specific PPE required was recorded.

Results: Twenty-one States (41%) require compliance to the USP 797 by December 31, 2010, 11 States (22%) have incorporated some language requiring some PPE when compounding sterile drugs and 19 States (37%) had no requirements or only required PPE when compounding cytotoxic agents. Twenty-three States (45%) did not require the use of laminar flow hood and masks.  

States not requiring USP 797 but specify required protective equipment
Equipment:	Number of States (n=11)
Shoe Covers	5
Head Covers	7
Masks	8
Gown	11
Gloves	11
Laminar Flow Hood	10
Mask and Laminar Flow Hood	7
Mask and Head Cover	5
Mask, Head Cover and Booties	3

Conclusions: There is wide variation in the required adoption of PPE and/or USP 797 by different States potentially resulting in non-sterile compounded products that may cause patient harm.