By Sweta Patel
SIGNIFICANT DRUG LOSS REPORTING CHANGES IN CALIFORNIA
Significant drug loss reporting changes are coming to California via an amendment to 16 CCR § 1715.6. Previously, pharmacies were required to report any loss of controlled substances. However, starting on April 1st, pharmacies must report within 30 days of discovery any of the following:
“(1) Any loss of a controlled substances, in one of the following categories that causes the aggregate amount of unreported losses discovered in that category, on or after the same day of the previous year, to equal or exceed:
(A) For tablets, capsules, or other oral medication, 99 dosage units.
(B) For single-dose injectable medications, lozenges, film, such as oral, buccal and sublingual, suppositories, or patches, 10 dosage units.
(C) For injectable multi-dose medications, medications administered by continuous infusion, or any other multi- dose unit not described in subparagraph (A), two or more multi-dose vials, infusion bags, or other containers.
(2) Any loss of a controlled substance, regardless of the amount, attributed to employee theft, in addition to the reporting requirements and time frames mandated by Business and Professions Code section 4104.
(3) Any other significant loss as determined by the pharmacist-in-charge, including but not limited to losses deemed significant relative to the dispensing volume of the pharmacy.”
Pharmacies are no longer required to report the loss of a single tablet, which eliminates excessive reporting. For the most part the amended regulation provides clear parameters for reporting. However, subpart (3) arguably gives the Board significant enforcement discretion. If a loss is not reported because it is determined not to be “significant relative to the dispensing volume of the pharmacy,” then the pharmacy should retain proper documentation to support such a decision. Only time will tell if there are restrictions to the discretion afforded under subpart (3).
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