Author: Admin
Company: ASCP

American Society of Consultant Pharmacists
1321 Duke Street
Alexandria, VA  22314-3563
Phone:  703-739-1300
FAX:     703-739-1321
E-mail:  info@ascp.com
www.ascp.com

	August 29, 2005

	Division of Dockets Management (HFA-305)
	Food and Drug Administration
	5630 Fishers Lane, Rm. 1061
	Rockville, MD  20852

	Docket No. 2005D–0174

The American Society of Consultant Pharmacists is pleased to provide comments regarding the Food and Drug Administration Guidance on Expiration Dating of Unit-Dose Repackaged Drugs, as released in the Federal Register under Docket No. 2005D-0174.

The American Society of Consultant Pharmacists (ASCP) is the international professional association that provides leadership, education, advocacy, and resources to advance the practice of senior care pharmacy.  Consultant pharmacists specializing in senior care pharmacy practice are essential participants in the health care system, recognized and valued for the practice of pharmaceutical care for the senior population and people with chronic illness. In their role as medication therapy experts, consultant pharmacists take responsibility for their patients’ medication-related needs; ensure that their patients’ medications are the most appropriate, the most effective, the safest possible, and are used correctly; and identify, resolve, and prevent medication-related problems that may interfere with the goals of therapy.  ASCP’s 6,500+ members manage and improve drug therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, subacute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care.

The dispensing and administration processes in the long-term care nursing facilities, assisted living facilities, group homes, and correctional facilities that ASCP members service are very similar to those in hospitals, as mentioned in the proposed Compliance Policy Guide.  Due to the need for convenient medication packaging that allows for efficient, accurate, and reconcilable distribution and administration, unit dose packaging has been the primary type of packaging system used by long-term care pharmacies for over 30 years.

We commend the Food and Drug Administration for providing guidance on this long-standing issue.  While we realize that pharmacies repackaging medications will not be required to have stability studies supporting the expiration dates they use, we find a few of the proposed guidelines, as currently written, potentially problematic.

Bulk containers of tablets and capsules packaged by the manufacturer are often only available in bottles of 100 or more, while most medication orders are dispensed in quantities of 7, 15, or multiples of 30.  None of these dispensed quantities are conducive to repackaging bulk bottle quantities in their entirety because it is inevitable that there will be some tablets or capsules left over.  According to the proposed Compliance Policy Guide, this would be in violation of the requirement to repackage the entire contents of a bulk container in one operation.  Even though many pharmacies “pre-package” some medications in advance of orders being received, not all medications are dispensed frequently enough to justify pre-packaging at all or in the quantities necessary to fulfill the proposed guidelines.

For example, methocarbamol is a muscle relaxant that is used on occasion, but not frequently in the long-term care setting.  For cost-effective reasons, a pharmacy may choose to pre-package the top 100 medications they dispense based on dispensed quantities or number of prescription orders.  Methocarbamol does not likely fall on this list; therefore, it is not pre-packaged on a routine basis.  When an order for methocarbamol is received by the pharmacy, they pull their bulk container of #100 tablets from the shelf, repackage an appropriate quantity for that particular order (e.g., #30), and return the bulk container to the shelf for future use.  To abide by the proposed guidelines, which state the entire contents of the bulk container should be repackaged in one operation, the pharmacy would be left with #70 tablets – a quantity that would likely never be dispensed from a pharmacy.  To remedy this situation, the pharmacy would have to repackage three full bottles of #100 tablets each for dispensing of the original order in addition to pre-packaging potential useable quantities of #30 tablets per card or box for future use. This is not only time-intensive, but could be a monetary loss for the pharmacy if it does not use those additional repackaged cards/boxes or if future orders for that medication are not prescribed in quantities equal to the quantities they repackaged.  There is a lack of evidence describing why a container must be repackaged in its entirety versus other options, such as noting the opened date on a bulk container and maintaining an expiration date within one year from that date for repackaged medications originating from that bulk container.  For these reasons, we recommend editing statement #3 on page 3 of the Compliance Guide to read:

	“The original bulk container of drug product has not been opened 	previously and the entire contents are repackaged in one operation, 	when possible.”

The second issue we would like to discuss is the temperature recommendations in statement #4 on page 3 of the Compliance Guide.  Many repackaging processes appropriately use momentary heat to seal unit dose packages. Therefore, for clarification purposes, we recommend editing statement #4 to read:

	“Where no temperature is specified in the labeling of the original drug 	product, a controlled room temperature (as defined in the General Notices 	and Requirements 	section of the USP) should be maintained during 	repackaging and storage of both 	solid and liquid oral dosage form drug 	products, except for momentary introduction of heat required for the 	sealing process.”

We appreciate the opportunity to provide feedback on the proposed guidance document regarding expiration dating of unit-dose repackaged medications.  If we can answer any questions or provide information about our members’ use of specialized packaging, we would be glad to do so.

	Sincerely,

	
	Carla Saxton, RPh, CGP
	Assistant Director, Policy and Advocacy
	American Society of Consultant Pharmacists
	1321 Duke St.
	Alexandria, VA  22314
	(703) 739-1316 ext. 129
	E-mail: csaxton@ascp.com