N.H. Admin. Code § Ph 2301.05 - Drug Security
The institution drug security protocols shall be detailed in the institution's policies and procedures and shall include, but not be limited to, the following:
(a) Drugs stored in
any area or department of the facility shall be labeled and kept secure and
shall be accessible only to authorized personnel;
(b) When controlled drugs are stored in
authorized areas other than in the pharmacy, special locked storage for all
controlled substances requiring additional security shall be used;
(c) When using an automated medication supply
system, a secure system shall be developed to assign, discontinue, or change
personnel access codes;
(d) The
institution shall have a pharmacy labeling, inspection, and inventory
management system that ensures that outdated, mislabeled, or otherwise unusable
medications shall not be available for patient use. Inspections by the
institutional pharmacy shall be periodically performed but, at a minimum, no
less than every 90 days; and
(e) A
retrievable record of each inspection specified in (d) above shall be
maintained in the pharmacy for at least 2 years and shall be available to the
board upon request;
(f) Significant
controlled drug losses shall be reported to the pharmacy within 24 hours and
resolved within 72 hours. If the drug is determined to be missing or
unaccounted for, it shall be reported to the board and DEA as specified by
21 CFR §
1301.76 -b.
(g) A pharmacy shall consider a controlled
drug loss to be significant when:
(1) The
percentage of dosage units of a specific drug exceeds 2% of monthly dispensing
volume; or
(2) Fifteen or more
dosage units are not accounted for.
(h) The written report referenced in (a)
shall contain at least the following:
(1)
Date of discovery;
(2) Identity of
the person making the discovery;
(3) Name and location of the pharmacy from
which the drug is missing;
(4)
Name, strength, dosage form, NDC, and quantity of the missing drug(s);
and
(5) Cause of the controlled
drug loss as determined by the investigation.
Notes
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