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Drug Distribution and Control: Distribution–Technical Assistance Bulletins

ASHP Technical Assistance Bulletin on Repackaging Oral Solids and Liquids in Single Unit and Unit Dose Packages
To maximize the benefits of a unit dose drug distribution system, all drugs must be packaged in single unit or unit dose packages.a However, not all drugs are commercially available in single unit (orunit dose) packages. Therefore, the institutional pharmacist must often repackage drugs obtained in bulk containers (e.g., bottles of 500 tablets) into single unit packages so that they may be used in a unit dose system. Certain precautions must be taken if the quality of drugs repackaged by the pharmacist is to be maintained. The guidelines presented herein will assist the pharmacist indeveloping procedures for repackaging drugs in a safe and acceptable manner: 1. 2. The packaging operation should be isolated, to the extent possible, from other pharmacy activities. Only one drug product at a time should be repackaged in a specific work area. No drug products other than the one being repackaged should be present in the immediate packaging area. Also, no labels other than those for theproduct being repackaged should be present in the area. Upon completion of the packaging run, all unused stocks of drugs and all finished packages should be removed from the packaging area. The packaging machinery and related equipment should then be completely emptied, cleaned, and inspected before commencing the next packaging operation. All unused labels (if separate labels are used) should beremoved from the immediate packaging area. The operator should verify that none remains in the packaging machine(s). If labels are prepared as part of the packaging operation, the label plate (or analogous part of the printing apparatus) should be removed or adjusted to “blank” upon completion of the run. This will help assure that the correct label is printed during any subsequent run. There shouldbe a procedure to reconcile the number of packages produced with the number of labels used (if any) and destroyed (if any) and the number of units or volume of drug set forth to be packaged. Before beginning a packaging run, an organoleptic evaluation (color, odor, appearance, and markings) of the drug product being repackaged should be made. The bulk container should also be examined for evidenceof water damage, contamination, or other deleterious effects. All packaging equipment and systems should be operated and used in accordance with the manufacturer’s or other established instructions. There should be valid justification and authorization by the supervisor for any deviation from those instructions on the part of the operator. The pharmacist should obtain data on the characteristicsof all packaging materials used. This information should include data on the chemical composition, light transmission, moisture permeability, size, thickness (alone or in laminate), recommended sealing temperature, and storage requirements. Unit dose packages and labels should, to the extent possible, comply with the “ASHP Guidelines for Single Unit and Unit Dose Packages of Drugs.”1 Wheneverfeasible, a responsible individual, other than the packaging operator, should verify that (a) the packaging system (drug, materials, and machines) is set up correctly and (b) all procedures have been performed properly. Ultimate responsibility for all packaging operations rests with the pharmacist. Control records of all packaging runs must be kept. These records should include the followinginformation: (1) complete description of the product, i.e., name, strength, dosage form, route of administration, etc.; (2) the product’s manufacturer or supplier; (3) control number; (4) the pharmacy’s control number if different from the manufacturer’s; (5) expiration dates of the original container and the repackaged product; (6) number of units packaged and the date(s) they were packaged; (7)...