Board of Pharmacy Updates

VHCA (8/22/2008)

At the July 29th meeting of the Nursing Facility Advisory Committee (NFAC) meeting, Scotti Russell, Executive Director of the Virginia Board of Pharmacy, discussed issues and interpretation of regulations specifically related to long term care facilities.  She forwarded the following items to NFAC members.

OTC Medications
The Board of Pharmacy proposed amendments to its regulations in December 2007 to allow OTC drugs to be stocked in long term care facilities.  These proposals, currently under administrative review prior to being published for public comment, specifically address provider’s concerns regarding permission to stock and use “floor stock” over the counter medications in long term care facilities.  At this time there is not a date available when a change will be effective.

Compliance Packaging Labeling
According to Guidance 110-12 available on its website, the Board requires in 18 VAC 110-20-340 that pharmacies that dispense compliance packaging do so in compliance with USP-NF standards.  Compliance packaging that is comprised of a series of individual containers or pockets labeled with the specific date and time when the contents of that container are to be taken, and which may contain more than one different drug, must comply with USP-NF standards for customized patient medication packages.  USP requires that if the packaging allows for the separation of the individual containers, that the labels for each individual container be labeled with the identity of each of the drug products contained within.  However, the main packaging label must still contain all the requirements for any outpatient labeling in Virginia law including, but not limited to, patient name, drug name and strength, quantity, directions for use, prescriber's name, pharmacy or pharmacist name and address, date of initial dispensing, etc.  In addition the main label must contain a physical description identifying each solid dosage form contained within the individual containers. 

For residents of long term care or other inpatient facilities who are leaving the facility for short periods of time, the facility may want to send only those individual containers needed during the time the resident is away.  If the needed containers are separated from the main package, then the containers sent with the resident will not contain all required labeling for an outpatient label. 

The Board will consider this practice to be in compliance with labeling requirements provided the individual containers are labeled as described above, and provided the containers are sent packaged with other documentation that contains the complete information required for labeling.  Such documentation could be a copy of the main compliance package label, a medication administration record containing all required information, or other document that contains all required information. 

Repackaging Medications
The Board of Pharmacy guidance document (110-23) provides specific guidance under which medications can be repackaged for long term care facilities.  According to the guidance, the primary provider pharmacy for a long term care facility may repackage a resident's prescription drugs, dispensed by another pharmacy, into the unit-dose or compliance packaging system used by the LTCF to assist in maintaining a uniform or more accurate system of administration.  Such repackaging may only be done at the provider pharmacy.  Unit dose repackaging shall comply with requirements of 18 VAC 110-20-420 and compliance packaging shall comply with 18 VAC 110-20-340 (B).  Records shall be maintained of all such repackaging of previously dispensed medications to include date; repackaging pharmacist's initials (or those of the checking pharmacist); and the pharmacy name, address, and prescription number of the original dispensing.  Any portion of a resident's medication not placed into unit dose or compliance packaging shall be kept for subsequent repackaging at the provider pharmacy in the original labeled container, shall be stored within the prescription department but separate from any working stock of drugs used for dispensing by the pharmacy, and shall only be used for the patient to whom the medication was originally dispensed. 

Use of Stat-Drug Boxes in Assisted Living Facilities
Guidance related to the use of stat drug boxes in assisted living facilities (110-11) is available on the Board of Pharmacy website.  According to the regulation governing state boxes in ALFs, (18VAC110-20-550 Stat-drug box) an additional drug box called a stat-drug box may be prepared by a pharmacy to provide for initiating therapy prior to the receipt of ordered drugs from the pharmacy.  A stat-drug box shall be provided to those facilities in which only those persons licensed to administer are administering drugs.

This regulation is interpreted to allow stat-drug boxes to be provided for use in long term care facilities, including assisted living facilities that use medication aides to administer routine medications.  However, stat-drug boxes may only be used under the condition that there is an order by a prescriber for any drug removed from the stat-drug box, and that only a licensed nurse, pharmacist, or prescriber be allowed to access or administer a drug from the stat-drug box.  Medication aides are not “persons licensed to administer” and may not access or administer medications from a stat-drug box.