The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
Division of Health Care Quality
10 West Street, 5th Floor, Boston, MA 02111
(617) 753-8000

JANE SWIFT
GOVERNOR
ROBERT P. GITTENS
SECRETARY
HOWARD K. KOH, M.D., MPH
COMMISSIONER	

CIRCULAR LETTER:  DHCQ 02-04-425

TO: 	    LTCF Administrators

FROM:	   Paul Dreyer, Ph.D
              	   Director, Division of Health Care Quality

              	   Grant Carrow, Ph.D.
               	   Director, Drug Control Program

DATE:          April 16, 2002

SUBJECT:   Guidelines for medications in LTCFs.

The Department of Public Health has developed the enclosed “Guidelines for Use of Unit-Dose Packaging for the Management and Administration of Pharmaceuticals in Long Term Care Facilities” and the “Policy on Return for Redispensing of Medications from Long Term Care Facilities”.
 
The Department’s Long Term Care Advisory Group, composed of representatives from long term care facilities, pharmacies and regulatory agencies, was charged with examining the causes of medication waste in long term care facilities.  These guidelines were developed with the advice of the Advisory Group. 

Neither the use of a unit-dose packaging system nor the return of medications for redispensing is mandated by DPH.  Facilities will decide for themselves whether or not a unit-dose system and/or return for redispensing is appropriate for their needs.  If, and when, these systems are implemented, these guidelines must be followed.  Facilities that are interested in establishing these systems are advised to work closely with their respective payors and pharmacy vendors to address the common concerns associated with the implementation of a new medication system. 

We are also providing clarification of the licensure regulations related to the transfer and disposal of medications – both as these functions relate to unit-dose and return/redispensing, and the Department’s current interpretation of these requirements for all licensed LTCFs.  In addition, we have provided clarification for medical leaves of absence.

The applicable regulations are as follows:

Disposal or transfer of medications:  

150.008(B)(4):  Medication may be released to patients or residents on discharge only on the written authorization of a physician, physician assistant or nurse practitioner. Otherwise they shall be held for disposal.

150.008(D)(12):  Medications having a specific expiration date shall be removed from usage and destroyed at expiration.  All medications no longer in use shall be disposed of or destroyed as directed by the Department.

(13):  Following a patient or resident’s death, transfer or discharge, all drugs prescribed for that individual, if not transferred with him, shall be disposed of as directed by the Department.

150.008(G)(1):  When drugs are transferred with a patient or resident, an accurate record shall be made at the time of discharge including the following: date, name and new address of patient or resident; name of drug, strength, quantity, pharmacy and physician’s name or physician assistant name and his supervising physician’s name or nurse practitioner name and his supervising physician’s name.

CLARIFICATION: The Department’s long-standing policy on this matter remains in effect.  That is, completed drug disposal forms must be maintained at the facility, and must be available for review during an on-site visit.  Such records must be retained for two years.

Medical leaves of absence:

For patients or residents on MLOA, medications should be held in the LTCF until the patient’s or resident’s return.  If, upon return, the physician’s orders continue these medications, administration of the held medications may resume as long as the expiration dates have not passed.

If you have any questions, please feel free to call Donna Allen, Assistant Director, Division of Health Care Quality at (617) 753-8106 or Adele Audet, Assistant Director, Drug Control Program at (617) 983-6700.