Atropine Labeling and Formulation Inconsistencies Observed Between Pharmacies

Atropine labeling and formulation practices vary between US compounding pharmacies, according to a study published in Eye & Contact Lens. Since atropine 0.01% may only be obtained from a compounding pharmacy, establishing a uniform set of best practices may benefit patients using this myopia control treatment, the report suggests.

Investigators included a convenience sample of parents of children who were prescribed atropine 0.01% (n=13) and randomly assigned them to obtain 2 doses of the drug ( each a 3-month supply) from 1 of 9 compounding pharmacies. Overall, the team obtained 24 samples, which were evaluated for labeling practices, atropine concentration, pH, osmolarity, and viscosity.

The researchers noted atropine labeling and formulation variations between pharmacies, the report shows. Storage instructions were inconsistent, with some labels recommending refrigeration (33%), others suggesting storage in a dark, cool, dry place (33%), and still others stating to store at room temperature (33%).

Some pharmacies used pre compounded atropine, while others compounded to-order. The median number of days from compounding to receipt was 8 (range, 2- 87) days for the first order and 9 (range, 1-89) days for the second order. Atropine labeling inconsistencies also led to differences in median beyond use dates (BUDs), which ranged between 7 and 175 days for the first order and between 10 and 171 days for the second order. One bottle arrived without a BUD date and another sample had different BUDs on the bottle and packaging materials.

The overall median percentage of atropine compared with the label claim was 93.3% (range, 70.4%-104.1%), and 25% of samples had a concentration under 90% of the target.

In addition to atropine labeling inconsistencies, the samples demonstrated different concentrations of tropic acid (median, 2.5%; range, 0.1%-9.8%), benzalkonium chloride (median, 0.005%; range, 0.000%-0.010%), and total impurities (median, 3.5%; range, 0.3%-20.3%). A total of 5 samples had more than 10% impurities.

“Patients rely on accurate labeling of a medication to understand its proper use and storage,” the study authors explain. “Compounding pharmacies are not required to follow the same labeling requirements of FDA-approved drugs.”

Study limitations include the use of convenience sampling and a small sample size of compound pharmacies used in the atropine labeling assessment.