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Sterile Preparations for Institutional Use
This section pertains to the responsibilities of the pharmacy for maintaining product quality and control after the CSP leaves the pharmacy for distribution and use within the organized health care system to which the pharmacy belongs. The pharmacy is responsible for the quality of all CSPs prepared by or dispensed from the pharmacy, throughout the life cycle of the CSP, regardless of where the CSP exists physically within the organized health care system. In fulfilling this general responsibility, the pharmacy is responsible for the proper packaging, handling, transport, and storage of CSPs prepared by or dispensed from it, including the appropriate education, training, and supervision of pharmacy personnel assigned to these functions. The pharmacy should assist in the education and training of nonpharmacy personnel responsible for carrying out any aspect of these functions.
Establishing, maintaining, and assuring compliance with comprehensive written policies and procedures encompassing these responsibilities is a further responsibility of the pharmacy. Where nonpharmacy personnel are assigned tasks involving any of these responsibilities, the policies and procedures encompassing those tasks should be developed by the pharmacy in consultation with other institutional departments as appropriate. Activities or concerns that should be addressed as the pharmacy fulfills these responsibilities are as follows.
Inappropriate processes or techniques involved with packaging, handling, and transport can adversely affect product quality and package integrity. While pharmacy personnel routinely perform many of the tasks associated with these functions, some tasks, such as transport, handling, and placement into storage, may be fulfilled by nonpharmacy personnel who are not under the direct administrative control of the pharmacy. Under these circumstances, appropriate written policies and procedures are established by the pharmacy with the involvement of other departments or services whose personnel are responsible for carrying out those CSP-related functions for which the pharmacy has a direct interest. The performance of the nonpharmacy personnel is monitored for compliance to established policies and procedures.
The critical requirements that are unique to CSPs and that are necessary to ensure product quality and packaging integrity must be addressed in written procedures. For example, techniques should be specified to prevent the depression of syringe plungers or dislodging of syringe tips during handling and transport. Additionally, disconnection of system components (for example, where CSPs are dispensed with administration sets attached to them) must be prevented throughout the life cycle of the product. Foam padding or inserts are particularly useful where CSPs are transported by pneumatic tube systems. Regardless of the methods used, the pharmacy has to evaluate their effectiveness and the reliability of the intended protection. Evaluation should be continuous, for example, through a surveillance system, including a system of problem reporting to the pharmacy.
Inappropriate transport and handling can adversely affect the quality of certain CSPs having unique stability concerns. For example, the physical shaking that might occur during pneumatic tube transport, or undue exposure to heat or light, have to be addressed on a product-specific basis. Alternate transport modes or special packaging measures might be needed for the proper assurance of quality of these CSPs. The use of tamper-proof closures and seals on CSP ports can add an additional measure of security to ensure product integrity regardless of transport method used.
Chemotoxic and other hazardous CSPs require safeguards to maintain the integrity of the CSP and to minimize the exposure potential of these products to the environment and to personnel who may come in contact with them. Special requirements associated with the packaging, transport, and handling of these agents include the prevention of accidental exposures or spills and the training of personnel in the event of an exposure or spill. Examples of special requirements of these agents also include exposure-reducing strategies such as the use of Luer lock syringes and connections, syringe caps, the capping of container ports, sealed plastic bags, impact-resistant containers, and cautionary labeling. Appropriate cushioning for pneumatic tube transport should be selected and evaluated to ensure that the products so conveyed can withstand the stresses induced by the system. Pneumatic transport of nonevaluated packaging alternatives should be avoided. Additional references should be consulted as necessary for further information on handling chemotoxic and other hazardous drugs.
The pharmacy is responsible for ensuring that CSPs in the patient-care setting maintain their quality until administered. The immediate labeling of the CSP container will display prominently and understandably the requirements for proper storage and expiration dating. Delivery and patient-care-setting personnel must be properly trained to deliver the CSP to the appropriate storage location. Outdated and unused CSPs must be returned to the pharmacy for disposal or possible reuse.
Written procedures have to exist to ensure that storage conditions in the patient-care setting are suitable for the CSP-specific storage requirements. Procedures include daily monitoring and documentation of drug storage refrigerators to ensure temperatures between 2 and 8 and the monthly inspection of all drug storage locations by pharmacy personnel. Inspections must confirm compliance with appropriate storage conditions, separation of drugs and food, proper use of multiple-dose containers, and the avoidance of using single-dose products as multiple-dose containers. CSPs, as well as all other drug products, must be stored in the patient-care area in such a way as to secure them from unauthorized personnel, visitors, and patients.
Procedures essential for generally ensuring product quality, especially sterility assurance, when readying a CSP for its subsequent administration include proper hand-washing, aseptic technique, site care, and change of administration sets. Additional procedures may also be essential for certain products, devices, or techniques. Examples where such special procedures are needed include in-line filtration, the operation of automated infusion control devices, and the replenishment of drug products into the reservoirs of implantable or portable infusion pumps.
The pharmacy must have the sole authority for determining whether a CSP not administered as originally intended can be used for an alternate patient or under alternate conditions. All CSPs that are not used as originally intended must be returned to the pharmacy for appropriate disposition, which may include redispensing, but only if adequate continuing quality can be fully ensured. The following may provide such assurance: the CSP was maintained under continuous refrigeration and protected from light, if required; no evidence of tampering or any readying for use outside the pharmacy exists; and there is sufficient time remaining until the originally assigned beyond-use time and date will be reached. Thus, initial preparation and thaw times should be documented and reliable measures should have been taken to prevent and detect tampering. Compliance with all procedures associated with maintaining product quality is essential. The CSP must not be redispensed if there is not adequate assurance that product quality and packaging integrity (including the connections of devices, where applicable) were continuously maintained between the time the CSP left and the time that it was returned to the pharmacy. Additionally, CSPs must not be redispensed if redispensing cannot be supported by the originally assigned beyond-use time.
The assurance of CSP quality and packaging integrity is highly dependent upon the proper adherence of all personnel to the pertinent written procedures. The pharmacy must design, implement, and maintain a formal education, training, and competency assessment program that encompasses all the functions and tasks addressed in the foregoing sections and all personnel to whom such functions and tasks are assigned. This program includes the assessment and documentation of procedural breaches, administration mishaps, side effects, allergic reactions, and complications associated with dosage or administration, such as extravasation. This program should be coordinated with the institution's adverse-event and incident reporting programs.
Packing and Transporting CSPs
The following sections on Packing CSPs for Transit and Transit of CSPs describe how to maintain sterility and stability of CSPs until they are delivered to patient care locations for administration.
When CSPs are distributed to locations outside the premises in which they are compounded, compounding personnel select packing containers and materials that are expected to maintain physical integrity, sterility, and stability of CSPs during transit. Packing is selected that simultaneously protects CSPs from damage, leakage, contamination, and degradation; and protects personnel who transport packed CSPs from harm. The standard operating procedures manual of the compounding facility specifically describes appropriate packing containers and insulating and stuffing materials, based on information from product specifications, vendors, and experience of compounding personnel. Written instructions that clearly explain how to safely open containers of packed CSPs are provided to patients and other recipients.
Compounding facilities that ship CSPs to locations outside their own premises must select modes of transport that are expected to deliver properly packed CSPs in undamaged, sterile, and stable condition to recipients.
Compounding personnel should ascertain that temperatures of CSPs during transit by the selected mode will not exceed the warmest temperature specified on the storage temperature range on CSPs labels. It is recommended that compounding personnel communicate directly with the couriers to learn shipping durations and exposure conditions that CSPs may encounter.
Compounding personnel must include specific handling and exposure instructions on the exteriors of containers packed with CSPs to be transported and obtain reasonable assurance of compliance therewith from transporters. Compounding personnel must periodically review the delivery performance of couriers to ascertain that CSPs are being efficiently and properly transported.
Compounding facilities that ship CSPs to patients and other recipients outside their own premises must ascertain or provide, whichever is the appropriate case, the following assurances:
  1. Labels and accessory labeling for CSPs include clearly readable beyond-use dates, storage instructions, and disposal instructions for out-of-date units.
  2. Each patient or other recipient is able to store the CSPs properly, including the use of a properly functioning refrigerator and freezer if CSPs are labeled for such storage.