4729-17-03 Security and control of drugs in an institutional facility.

(A) In the absence of a licensed pharmacist, drugs ordered by a prescriber for patient treatment may be obtained in the following manner:

(1) Where a licensed pharmacist is not present twenty-four hours-a-day, drugs for patient treatment may be made available to licensed health care professionals authorized pursuant to the Revised Code to administer drugs in the course of their professional practice by the use of contingency drug supplies pursuant to the provisions of paragraph (A)(2) of this rule. A licensed pharmacist shall be available for emergencies when the institutional pharmacy is closed.

(2) Contingency drugs shall be used only in the absence of a licensed pharmacist, and shall be stored in a locked cabinet(s) or other enclosure(s) constructed and located outside of the institutional pharmacy. The storage area must be sufficiently secure to deny access, without obvious damage, to unauthorized persons. The responsible person shall:

(a) Designate those who may obtain access to the drug supply;

(b) Determine, in conjunction with the appropriate interdisciplinary committees, the drugs that are to be included in the contingency drug supply;

(c) Ensure that such drugs are properly labeled and packaged in sufficient quantities to provide drug therapy during the period when the institutional pharmacy is not open;

(d) Provide controls adequate to prevent diversion of the drugs, and institute record keeping procedures to account adequately for the drugs when used and the positive identification of the person who obtained the drugs from the drug supply;

(e) Provide procedures for the inspection of the contingency drug inventory to assure proper utilization and replacement of the drug supply.

(3) For a pharmacy located on the premises of the institutional facility, when a drug is not available from the contingency drug supply and such drug is required to treat the immediate needs of an inpatient or outpatient whose health would otherwise be jeopardized, such drug may be obtained from the institutional pharmacy pursuant to written policies and procedures implemented by the responsible person.

(a) The policies and procedures shall:

(i) Identify the personnel authorized to access the pharmacy and the conditions under which access may be gained to the pharmacy;

(ii) Ensure a minimum of two employees of the institution, one of whom shall be a health care professional licensed pursuant to Chapter 4723. (Nursing Practice Act) or 4731. (Medical Practice Act) of the Revised Code and authorized by such chapter to administer drugs in the course of their professional practice, to accompany each other when accessing the pharmacy;

(iii) Provide a written record documenting emergency access to the pharmacy. Such record shall include the names, titles, and positive identification of all institutional personnel accessing the pharmacy, date and time of access, the name and quantity of drugs obtained, the name of the patient, and the name of the ordering prescriber.

(b) The written record of each access to the institutional pharmacy when it is closed and a pharmacist is not present shall be filed, within twenty-four hours, with the responsible person and maintained in the pharmacy for three years.

(B) Supplies of dangerous drugs may be maintained in patient care areas according to written policies and procedures developed and implemented by the responsible person. The policies and procedures shall:

(1) Provide for a limited quantity of dangerous drugs to be maintained at any one location;

(2) Provide for the proper storage and labeling of all such drugs;

(3) Provide for storage in a secure area. If dangerous drugs cannot be stored in a secure area, they shall be stored in a container which is sealed with a tamper-evident seal that must be broken to gain access to the drugs;

(4) Provide for notification of the responsible person, or designated pharmacist, when the dangerous drug supply has been accessed and/or drugs used;

(5) Provide for replacement of the drugs used, and the dangerous drug supply to be re-sealed;

(6) Provide for inspection of the dangerous drug supply, on a regular basis, to detect unauthorized use of such drugs and which drugs have exceeded their expiration or beyond use date;

(7) Provide adequate record keeping procedures to document the disposition of drugs from the supply.

(C) Security

(1) All areas occupied by an institutional pharmacy shall be capable of being secured by key, or other effective mechanism, so as to prevent access by unauthorized personnel.

(2) In the absence of a licensed pharmacist, all areas occupied by an institutional pharmacy shall be secured so as to prevent access by unauthorized personnel.

(3) The responsible person shall develop and implement policies and procedures which will detect and deter the diversion and/or adulteration of drugs.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.09 , 4729.28 , 4729.51
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/91, 1/10/96, 3/1/99, 1/1/06, 1/1/09