|
Editorial: Avastin: Packaging, Repackaging, or Prepackaging?
Note: This is a long Editorial, but it comes at a critical time for pharmacists, ophthalmologists, and patients involved with Avastin.
It has been brought to my attention this week that some state boards of pharmacy have determined that the act of "repackaging" Avastin by pharmacists is illegal. I respectfully disagree.
The topic of packaging, repackaging, or prepackaging seems to be one of the issues involved in the preparation of individual dosage units of Avastin for use by ophthalmologists. The activities of packaging, pharmacist-repackaging, and prepackaging are functions a pharmacist routinely performs. There may be a misunderstanding of what "pharmacist-repackaging," "commercial-repackaging," and "prepackaging" are and who does it. In a general sense, pharmacist-repackaging is a part of the dispensing and compounding functions of a pharmacist; commercial-repackaging is not.
What is somewhat confusing is that the "pharmacist-repackaging" activities of a pharmacist, i.e., taking 50 capsules from a container of 500, labeling and dispensing is actually one use of the term and the formal activities of a registered commercial-repackager are different. Let's look at some definitions.
Packaging involves the process of packing or placing into a package. A package is a container in which something is packed for transporting and/or use. According to the USP, "package" is synonymous with the term "container." A "container" is "that which holds the article (or drug)." Note: This may refer to the original packaging by the manufacturer (commercial product) or pharmacist (compounded preparation).
Repackaging means changing the container, wrapper, quantity, or product labeling of a drug or device to further the distribution of the drug or device (NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy).
From USP General Chapter <1146> Packaging Practice-Repackaging a Single Solid Oral Drug Product into a Unit-Dose Container, we read that repackaging is the act of removing a preparation from its original primary container and placing it into another primary container, usually of smaller size. A repackager is an establishment that repackages drugs and sends them to a second location in anticipation of a need. Repackaging firms repackage preparations for distribution (e.g., for resale to distributors, hospitals, or other pharmacies), a function that is beyond the regular practice of a pharmacy. Distribution is not patient specific in that there are no prescriptions. Unlike dispensers, repackaging firms are required to register with the FDA and to comply with the Current Good Manufacturing Practice regulations.
Prepackaging means the act of transferring a drug, manually or by use of an automated pharmacy system, from a manufacturer's or distributor's original container to another container in advance of receiving a prescription drug order or for a patient's immediate need for dispensing by a pharmacy or practitioner authorized to dispense in the establishment in which the prepackaging occurred. A pharmacy may prepackage drugs under the following circumstances. (Three circumstances are listed related to written policies and procedures, conditions to ensure the integrity of the drug and labeling requirements). (NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy).
USP General Chapter <681> Repackaging into Single-Unit Containers and Unit-Dose Containers for Nonsterile Solid and Liquid Dosage Forms, provides repackaging guidance to those engaged in pharmaceutical dispensing, not commercial repackaging. Again, the term "repackaging" is used for dispensing.
USP General Chapter <1136> Packaging-Unit-of-Use provides guidance in the use and application of unit-of-use packaging and is intended for use by drug manufacturers, repackagers, and pharmacists. A "unit-of-use" container is one that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling.
Most prescriptions that are dispensed are "repackaged" during the dispensing process. Once a prescription is received and evaluated, the medication is taken from a bulk container and "repackaged" into a size appropriate for the patient. Many pharmacies "repackage" or "prepackage" into "unit of issue" sizes, such as 30s, 60s, as prescribed by practitioners, using counting machines prior to receipt of a prescription; or, in the case of sterile products, into individual use syringes.
Hospitals routinely "repackage" or "prepackage" many medications, including sterile products. These may be in the form of antibiotics that are repackaged into the size appropriate for their hospital. It may also involve freezing of the repackaged syringes to enhance stability and later these repackaged, frozen syringes, are removed, thawed, and dispensed for administration to the patient.
Pharmacists routinely "repackage" medication into "bingo cards" or other packaging units for dispensing to various facilities.
When a pharmacist appropriately compounds more of a medication than is needed for a single prescription, the bulk preparation is properly labeled and stored, until it is "repackaged" later for the next prescription.
Repackaging is also done for office use medications. When the prescription medication needs to be administered in a physician's office but requires manipulations prior to administration, this is often done by a pharmacist. Does it need to be done in the physician's office? It is best done in a pharmacy that is properly equipped and follows current standards of practice.
Many facilities, especially hospitals, see the value of outsourcing some of the pharmacy activities to pharmacies equipped to manipulate a drug product and then deliver it to the hospital for administration. Outsourcing of intravenous admixtures, total parenteral nutrition solutions and others can be can be to a large company or to any qualified compounding pharmacy, as per the regulations of the individual states. This is becoming more prevalent as many institutions that are not compliant with USP <797> outsource to a USP <797> compliant compounding pharmacy.
I'm not sure that "ownership" of the specific medication is always a factor but may be considered. In fact, if a pharmacist purchased the drug, manipulated it, and sold it for resale, that would be considered by many to be manufacturing. However, if a pharmacist's services were obtained for manipulating drugs (as in the previous paragraph) by a facility and the facility (hospital or doctor's office) owned the drug, then that would not be "manufacturing" as the pharmacist is not selling the drug for resale but are reimbursed for their services. The question might arise as to whether or not the pharmacist under contract for pharmaceutical services (compounding/repackaging) must work at the facility (hospital or doctor's office) or can they work at their pharmacy, as is usually the case.
Do pharmacists package, repackage, and prepackage medications? Yes, it is an integral and routine part of pharmacy practice. Pharmacy could not be practiced without repackaging of medications. The preparation of individual dosage units of Avastin by USP <797> compliant pharmacies has helped ophthalmologists throughout the US successfully prevent blindness in tens of thousands of patients. Isn't that what we all want? If it is illegal, then the state boards of pharmacy need to shut down a lot of the "repackaging" activities going on in independent, chain, and hospital pharmacies throughout the U.S.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
| 
